Page last updated: 2024-11-04

ribavirin

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

Rebetron: Rebetron is tradename [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID37542
CHEMBL ID1643
CHEBI ID63580
SCHEMBL ID3727
MeSH IDM0019062

Synonyms (208)

Synonym
AB00430481-15
AB00430481-16
smr000058315
MLS000028486
KBIO1_000782
DIVK1C_000782
EU-0101063
ribavirin, antiviral
drg-0028
ribavirin capsules
varazid
ribamidil
1,2,4-triazole-3-carboxamide, 1-beta-d-ribofuranosyl-
1h-1,2,4-triazole-3-carboxamide, 1-beta-d-ribofuranosyl-
ribovirin
1-beta-d-ribofuranosyl-1,2,4-triazole-3-carboxamide
ribavirina [inn-spanish]
ribavirinum [inn-latin]
rebetron
ribavirine [inn-french]
SPECTRUM_001826
brn 0892462
ribamidyl
hsdb 6513
1-beta-d-ribofuranosyl-1h-1,2,4-triazole-3-carboxamide
cas-36791-04-5
BSPBIO_003352
IDI1_000782
LOPAC0_001063
SMP1_000261
PRESTWICK3_000993
SPECTRUM5_002075
icn-1229
tribavirin
1h-1,2,4-triazole-3-carboxamide, 1-.beta.-d-ribofuranosyl-
1-[(2r,3r,4s,5r)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1,2,4-triazole-3-carboxamide
ribav
rbv ,
virazid
1-.beta.-d-ribofuranosyl-1,2,4-triazolo-3-carboxamide
rebretron
ribavirine
NCGC00090726-01
AB00430481
rtca
36791-04-5
nsc-163039
rebetol
ribasphere
nsc163039
copegus
virazole
RIBAVIRIN ,
viramid
vilona
DB00811
copegus (tn)
rebetol (tn)
virazole (tn)
ribavirin (jp17/usp/inn)
ribasphere (tn)
D00423
BPBIO1_001195
KBIOSS_002331
KBIO2_004896
KBIOGR_001804
KBIO2_002328
KBIO3_002854
KBIO2_007464
SPECTRUM3_001876
NINDS_000782
SPECTRUM4_001252
SPECTRUM1503938
SR-01000076112-3
BSPBIO_001085
NCGC00090726-06
NCGC00090726-04
NCGC00090726-03
NCGC00090726-05
virazide
HMS2090L15
R 9644 ,
HMS2094O09
R0077
1-(beta-d-ribofuranosyl)-1,2,4-triazole-3-carboxamide
NCGC00090726-07
ro-20-9963
ravanex
rg-964
c-virin
r-964
ribacine
cotronak
1-[(2r,3r,4s,5r)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,2,4-triazole-3-carboxamide
MLS002222317
HMS502H04
ribavirin mylan
ribavirin teva
ribavirin biopartners
chebi:63580 ,
sch 18908
sch-18908
CHEMBL1643
AKOS001715163
NCGC00090726-08
NCGC00090726-09
HMS2098G07
HMS3263E08
EN300-59237
tox21_200967
NCGC00258520-01
1-[(2r,3r,4s,5r)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-1h-1,2,4-triazole-3-carboxamide
A823370
1-[(2r,3s,5r)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1,2,4-triazole-3-carboxamide
nsc-758650
pharmakon1600-01503938
nsc758650
dtxcid603557
dtxsid8023557 ,
tox21_110259
HMS2232P07
CCG-38985
ribavirin [usan:usp:inn:ban]
unii-49717awg6k
49717awg6k ,
ribavirina
ribavirinum
1-((2r,3r,4s,5r)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1h-1,2,4-triazole-3-carboxamide
1-(beta-d-ribofuranosyl)-1h-1,2,4-triazole-3-carboxamide
ribavirine;
BCP0726000138
252269-50-4
LP01063
BRD-K60369935-001-02-7
S2504
ribofluranosyl carboxamide
gtpl6842
bdbm50154375
cid_37542
ribavirin [vandf]
ribavirin component of peginterferon
ribavirin [usp-rs]
ribavirin [orange book]
ribavirin [mart.]
ribavirin teva pharma b.v.
ribavirin [ema epar]
ribavirin [ep monograph]
ribavirin [usp monograph]
ribavirin [usan]
ribavirin [hsdb]
ribavirin [jan]
ribavirin [mi]
ribavirin [who-dd]
ribavirin [inn]
HY-B0434
1-beta-ribofuranosyl-1,2,4-triazole-3-carboamide
1-(beta -d-ribofuranosyl)-1,2,4-triazole-3-carboxamide
IWUCXVSUMQZMFG-AFCXAGJDSA-N
SCHEMBL3727
tox21_110259_1
NCGC00090726-12
NCGC00261748-01
tox21_501063
1-?-d-ribofuranosyl-1h-1,2,4-triazole-3-carboxamide
ribavirin, british pharmacopoeia (bp) reference standard
AB00430481_17
AB00430481_18
mfcd00058564
4PB1
GS-3572
SR-01000721904-2
sr-01000721904
ribavirin, united states pharmacopeia (usp) reference standard
ribavirin, pharmaceutical secondary standard; certified reference material
ribavirin, european pharmacopoeia (ep) reference standard
SR-01000076112-2
sr-01000076112
SR-01000076112-4
SR-01000076112-11
SBI-0051033.P003
HMS3715G07
Q421862
Z594284196
ribavirin (copegus)
AS-34178
ribavirin,(s)
BRD-K60369935-001-18-3
SDCCGSBI-0051033.P004
NCGC00090726-25
1-b-d-ribofuranosyl-1,2,4-triazole-3-carboxamide
NCGC00090726-30
ribavirin 100 microg/ml in acetonitrile:methanol
1-beta-d-ribofuranosyl-1h-1,2,4-triazole-3-carboxamide
HB4522
1-ss-d-ribofuranosyl-1,2,4-triazole-3-carboxamide
ribavirin (usp monograph)
ribavirinum (inn-latin)
riba
1-beta-d-ribofuranosyl-1h-1,2, 4-triazole-3-carboxamide
ribavirin (ep monograph)
virazolee
ribavirin (mart.)
ribavirin (usp-rs)
ribavirina (inn-spanish)
j05ap01
ribavirine (inn-french)
ribavirin (usan:usp:inn:ban)
1-beta-d-ribofuranosyl-1,2,4-triazolo-3-carboxamide

Research Excerpts

Toxicity

Of the 24 consecutive patients treated for HCV using telaprevir/pegylated interferon/ribavirin, 50% (12/24) developed serious adverse events and 29% (7/24), discontinued HCV treatment due to adverse events. Although the most frequent adverse event was anemia, no patients discontinued the use of either ribavirin or sofosbuvir.

ExcerptReferenceRelevance
" The selective index (ratio of the median toxic dose: median efficacious dose) of LY253963 in HEp2 tissue culture cells was greater than 100 against both RSV and PIV3."( Toxicity and antiviral activity of LY253963 against respiratory syncytial and parainfluenza type 3 viruses in tissue culture and in cotton rats.
Ambrose, MW; Gilbert, BE; Meyer, HL; Wyde, PR,
)
0.13
" 3N-3DU exhibited comparable toxicity to ribavirin in KB cells, was 4-fold less toxic in WISH cells and 4-fold more toxic in LLC-MK2 cells."( Antiviral and cytotoxicity evaluation of 3-nitro-3-deazauridine.
Allen, LB; Cook, PD; Holland, CS; Kehoe, MJ; McNamara, DJ; Teepe, AG, 1989
)
0.28
" Their adverse effects mostly involve bone marrow depression (e."( Adverse effects and drug interactions of clinical importance with antiviral drugs.
Morris, DJ, 1994
)
0.29
" The children tolerated the drug well, and treatment was not associated with any clinically significant adverse effects."( Safety, tolerance, and pharmacokinetics of systemic ribavirin in children with human immunodeficiency virus infection.
Connor, E; Connor, J; Lane, J; Morrison, S; Oleske, J; Sonke, RL, 1993
)
0.29
" The combination regimen was safe and well tolerated."( A phase-I study of the safety, pharmacokinetics, and antiviral activity of combination didanosine and ribavirin in patients with HIV-1 disease. AIDS Clinical Trials Group 231 Protocol Team.
Bassiakos, Y; Booth, D; Clax, PA; Connor, JD; Cooney, E; Crumpacker, CS; Erice, A; Griffith, BP; Holden-Wiltse, J; Hussey, S; Japour, AJ; Johanneson, N; Lertora, JJ; McLaren, C; Meehan, PM; Pollard, R; Timpone, J; Walesky, M; Wood, K, 1996
)
0.29
" No serious adverse events were observed and less than 10% withdrew."( Ribavirin enhances the efficacy but not the adverse effects of interferon in chronic hepatitis C. Meta-analysis of individual patient data from European centers.
Alberti, A; Bellobuono, A; Brouwer, JT; Cavalletto, L; Chemello, L; Hansen, BE; Ideo, G; Schalm, SW; Schvarcz, R; Weiland, O, 1997
)
0.3
"To determine adverse events of ribavirin in the treatment of chronic hepatitis C, 41 patients (18 with cirrhosis), treated with ribavirin at an initial dose of 600-1200mg day(-1), were analysed retrospectively (six patients were treated twice because adverse effects during the first treatment necessitated cessation of ribavirin)."( Effects of cirrhosis, interferon and azathioprine on adverse events in patients with chronic hepatitis C treated with ribavirin.
Blot, C; Mathurin, P; Moussalli, J; Opolon, P; Perrin, M; Plassart, F; Poynard, T; Thevenot, T, 1997
)
0.3
" The potential for ribavirin to likewise exacerbate the adverse events associated with the alpha interferons is reviewed."( Safety of combination interferon alfa-2b/ribavirin therapy in chronic hepatitis C-relapsed and treatment-naive patients.
Maddrey, WC, 1999
)
0.3
" This observational study arguably provides the most complete information available on ribavirin-associated adverse effects."( Intravenous ribavirin for hantavirus pulmonary syndrome: safety and tolerance during 1 year of open-label experience. Ribavirin Study Group.
Baum, KF; Behrman, RE; Bell, LJ; Chapman, LE; Christenson, JC; Holman, RC; Jolson, HM; Khan, AS; Koster, FT; Ksiazek, TG; Mertz, GJ; Pavia, AT; Peters, CJ; Rollin, PE; Rubin, PJ; Sadek, RF; Simpson, GL, 1999
)
0.3
" The adverse effects of IFN are well established and familiar to hepatologists all over the world."( Adverse effects and other safety aspects of the hepatitis C antivirals.
Chutaputti, A, 2000
)
0.31
" Clinical and biological adverse effects were recorded."( Safety and efficacy of interferon-ribavirin combination therapy in HCV-HIV coinfected subjects: an early report.
Benhamou, Y; Bochet, M; Bréchot, C; Chaix, ML; Fontaine, H; Katlama, C; Lagneaux, JL; Landau, A; Pialoux, G; Pol, S; Poynard, T; Zylberberg, H, 2000
)
0.31
"3% of treated subjects (who were previous non-responders to interferon therapy), respectively; (3) anaemia is a frequent adverse event."( Safety and efficacy of interferon-ribavirin combination therapy in HCV-HIV coinfected subjects: an early report.
Benhamou, Y; Bochet, M; Bréchot, C; Chaix, ML; Fontaine, H; Katlama, C; Lagneaux, JL; Landau, A; Pialoux, G; Pol, S; Poynard, T; Zylberberg, H, 2000
)
0.31
" During the treatment the patient developed a typical flue-like syndrome, dry cough with exertional dyspnea that was initially interpreted as a typical side effect of interferon-alpha treatment."( [Pulmonal sarcoidosis: A rare side effect of interferon-alpha treatment for chronic hepatitis C infection].
Kallinowski, B; Pohl, J; Stremmel, W, 2000
)
0.31
"The purpose of this descriptive study is to review the adverse effects of combination therapy, interferon alfa-2b and ribavirin, in a sample of patients with chronic hepatitis C who were part of a larger multi-center trial (Bonkovsky, 1999)."( Assessment of side effects in patients with chronic hepatitis C receiving combination therapy.
Miller, BW; Zucker, DM,
)
0.13
" Since BR does exhibit myelosuppression, the most common chemotherapy-related side effect in humans, careful judgment is warranted should BR be included in multidrug regimens, although BR's potent cytotoxicity to tumor cells in preclinical models still makes it a promising drug."( Toxicity and efficacy of benzamide riboside in cancer chemotherapy models.
Arguello, F; Greene, JF; Jayaram, HN; Yalowitz, JA, 2002
)
0.31
" The temporal relation between the administration of the drug and the detection of toxic affects (nephrotic syndrome) and subsequent improvement upon withdrawal also supports a causative role for interferon-ribavirin."( Nephrotoxicity of interferon alfa-ribavirin therapy for chronic hepatitis C.
Willson, RA, 2002
)
0.31
"Interferon-alpha plus ribavirin therapy for chronic hepatitis C is associated with adverse effects that lead to therapy discontinuation in up to 27% of patients in randomized controlled trials."( Premature discontinuation of interferon plus ribavirin for adverse effects: a multicentre survey in 'real world' patients with chronic hepatitis C.
Ascione, T; Bruno, R; Campanone, A; De Sena, R; Felaco, FM; Filice, G; Gaeta, GB; Piccinino, F; Precone, DF; Spadaro, A; Stanzione, M; Stornaiuolo, G, 2002
)
0.31
"8%] patients failed to finish combination therapy because of adverse events."( Premature discontinuation of interferon plus ribavirin for adverse effects: a multicentre survey in 'real world' patients with chronic hepatitis C.
Ascione, T; Bruno, R; Campanone, A; De Sena, R; Felaco, FM; Filice, G; Gaeta, GB; Piccinino, F; Precone, DF; Spadaro, A; Stanzione, M; Stornaiuolo, G, 2002
)
0.31
" Management of these adverse effects has a great impact on the compliance of affected patients during the course of their treatment."( The role of nursing in managing treatment-associated adverse effects in patients with hepatitis C.
Leone, NE,
)
0.13
" Combination therapy with pegylated interferons (peginterferon alfa-2a and alfa-2b) yields an adverse event profile similar to standard interferon, although the frequency of certain adverse events may vary by preparation."( Side effects of therapy of hepatitis C and their management.
Fried, MW, 2002
)
0.31
"The treatment of chronic hepatitis C patients was enhanced when the combination of interferon alfa-2b and ribavirin was shown to be safe and more effective than interferon monotherapy."( The safety and tolerability of daily infergen plus ribavirin in the treatment of naíïve chronic hepatitis C patients.
Boyd, DG; McHutchinson, J; Pockros, PJ; Reddy, R; Reindollar, R; Wilkes, LB; Wright, T, 2003
)
0.32
" The adverse effects are dose dependent and often reversible."( Chronic hepatitis C treatment. Side effects and their management.
Al-Kayyal, BM; Shobokshi, OA; Tantawe, AO, 2003
)
0.32
"Although information on efficacy and adverse drug reactions is lacking, ribavirin has been used empirically for the treatment of severe acute respiratory syndrome (SARS)."( Common adverse events associated with the use of ribavirin for severe acute respiratory syndrome in Canada.
Dresser, L; Knowles, SR; Matukas, L; Phillips, EJ, 2003
)
0.32
" Approximately 8% of patients receiving recombinant IFNalpha-2b plus ribavirin discontinue treatment because of adverse events."( Good safety profile and efficacy of leucocyte interferon-alpha in combination with oral ribavirin in treatment-naive patients with chronic hepatitis C: a multicentre, randomised, controlled study.
Annese, M; Babudieri, S; Bacca, D; Barbarini, G; Barbaro, G; Belloni, G; Francavilla, R; Fruttaldo, L; Grisorio, B; Hazra, C; Lucchini, A; Matarazzo, F; Rizzo, G; Torre, D, 2003
)
0.32
" There were no serious adverse events, and most adverse events were mild."( Pharmacokinetics and safety of viramidine, a prodrug of ribavirin, in healthy volunteers.
Lin, CC; Philips, L; Xu, C; Yeh, LT, 2004
)
0.32
"Among 35 patients who received concomitant didanosine (400 mg/day in 86%) and ribavirin (> or = 10 mg/kg/day in 91%), 20 (57%) developed one or more adverse events after a mean of 87 days."( High rate of didanosine-related mitochondrial toxicity in HIV/HCV-coinfected patients receiving ribavirin.
Antela, A; Bárcena, R; Casado, JL; Dronda, F; Moreno, A; Moreno, L; Moreno, S; Muriel, A; Navas, E; Perez-Elías, MJ; Quereda, C, 2004
)
0.32
"An evaluation of the US Food and Drug Administration's Adverse Event Reporting System identified that patients coinfected with human immunodeficiency virus and chronic hepatitis C virus who were treated with a regimen of ribavirin and didanosine, with or without stavudine, were at increased risk for events associated with mitochondrial toxicity, including fatal hepatic failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis."( Nucleoside analogues and mitochondrial toxicity.
Boxwell, D; Fleischer, R; Sherman, KE, 2004
)
0.32
" Ribavirin is directly toxic to red blood cells and is associated with hemolysis, which is usually dose-related but self-limited."( Hematologic side effects of interferon and ribavirin therapy.
Kowdley, KV, 2005
)
0.33
" Unfortunately though, lighter patients may also suffer, as fixed dosing can provide these patients with an excessive amount of drug, increasing their risk for adverse events."( Weight-based dosing: which impact on efficacy and safety of therapy?
Almasio, PL, 2004
)
0.32
" Therapy was discontinued by 4, 6 and 2 patients because of adverse events in the above three groups."( Treatment of genotype 1b HCV-related chronic hepatitis: efficacy and toxicity of three different interferon alfa-2b/ribavirin combined regimens in naive patients.
Angarano, G; Cibelli, DC; Fazio, V; Palumbo, E; Saracino, A; Scotto, G, 2005
)
0.33
" Adverse events leading to reduction of dose of drugs occurred in 40% and adverse events leading to discontinuation treatment occurred in 12%."( [Efficacy and safety of pegylated-interferon plus ribavirin in HIV-infected patients co-infected with hepatitis C virus in clinical practice: a 32 cases observational follow-up].
Bernard, N; Beylot, J; Bonarek, M; Bonnet, F; Dramé, M; Lacoste, D; Lafon, ME; Morlat, P; Ramanampamonjy, R; Rambeloarisoa, J; Seydi, M; Trimoulet, P, 2005
)
0.33
" Tolerance and safety were evaluated by the rate of treatment's discontinuation for any reason, and occurrence of serious clinical adverse events, respectively."( Safety and efficacy of peginterferon plus ribavirin in patients with chronic hepatitis C and bridging fibrosis or cirrhosis.
Boyer, N; Cazals-Hatem, D; Consigny, Y; Degott, C; Marcellin, P; Marrache, F; Martinot, M; Ripault, MP; Valla, D, 2005
)
0.33
" The adverse events were the typical of those reported in the treatment with interferon and ribavirin."( [An open-label pilot study evaluating the efficacy and safety of peginterferon alfa-2a combined with ribavirin in children with chronic hepatitis C].
Chen, DW; Dong, Y; Jia, WZ; Mao, YL; Tang, HM; Xu, ZQ; Yang, XJ; Zhang, HF; Zhu, SS, 2005
)
0.33
" No severe adverse events occurred and most of the patients well tolerated the treatment."( [An open-label pilot study evaluating the efficacy and safety of peginterferon alfa-2a combined with ribavirin in children with chronic hepatitis C].
Chen, DW; Dong, Y; Jia, WZ; Mao, YL; Tang, HM; Xu, ZQ; Yang, XJ; Zhang, HF; Zhu, SS, 2005
)
0.33
" All subjects in Group 1 completed treatment, while two subjects in Group 2 stopped therapy due to treatment-related adverse events."( Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C.
Alberti, A; Almasio, PL; Berrutti, M; Boccato, S; Cattaneo, C; Craxi, A; Demelia, L; Ideo, G; Pellicano, R; Picciotto, A; Rizzetto, M; Sorbello, O; Torre, F; Valenza, M; Venezia, G, 2005
)
0.33
" There were no serious adverse events and it was not necessary to reduce dosages or even cease therapy prematurely."( Efficacy and safety of chronic hepatitis C treatment in hemophilic patients.
Dite, P; Husa, P; Husova, L; Penka, M; Roznovsky, L; Smejkal, P,
)
0.13
"PSE allowed the safe use of peg-IFN plus ribavirin in HCV cirrhotic patients with severe cytopenias who otherwise would never have been treated."( Safe use of pegylated interferon/ribavirin in hepatitis C virus cirrhotic patients with hypersplenism after partial splenic embolization.
Bárcena, R; Blázquez, J; Foruny, JR; Gil-Grande, L; Moreno, A; Moreno, J; Moreno, S; Muriel, A; Pérez-Elías, MJ; Quereda, C; Rodriguez-Sagrado, MA; Sánchez, J, 2005
)
0.33
" Adverse events led to dose modification in 37 (31%) and discontinuation in 8 (7%)."( Interferon alfa-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: efficacy, safety, and pharmacokinetics.
Baczkowski, A; Geffner, M; González-Peralta, RP; Gupta, S; Haber, B; Jonas, MM; Kelly, DA; Lang, T; Laughlin, M; Lurie, Y; Martin, S; Mieli-Vergani, G; Molleston, J; Murray, KF; Shelton, M, 2005
)
0.33
"The adverse effects of antiviral drugs are dose dependent and often reversible."( [Treatment of the side effects of antiviral therapy].
Vcev, A, 2005
)
0.33
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" As the use of aerosolized ribavirin to treat respiratory syncytial virus infections continues, it is imperative that careful attention be paid to possible adverse effects of therapy in the high-risk population of immunosuppressed patients."( Aerosolized ribavirin-induced reversible hepatotoxicity in a hematopoietic stem cell transplant recipient with Hodgkin lymphoma.
Bueso-Ramos, C; Chaves, J; Huen, A; Safdar, A; Vadhan-Raj, S, 2006
)
0.33
"6%) was discontinuation due to adverse events."( Efficacy and safety of pegylated interferon-alpha2b plus ribavirin for the treatment of chronic hepatitis C in HIV-infected patients.
Altés, J; Baguena, F; Casanova, A; de Castro, ER; Delejido, A; Garcia, MJ; Rota, R; Sala, M; Santin, M; Shaw, E; Valero, S, 2006
)
0.33
"7%) patients stopped IFN therapy due to the adverse events after initiation of IFN alone therapy."( [Side effects of interferon therapy for chronic hepatitis C].
Arase, Y, 2006
)
0.33
" Limited efficacy in patients with hepatitis C virus (HCV) genotype 1 and the side effect profile will necessitate the development of new therapeutic approaches."( Treating viral hepatitis C: efficacy, side effects, and complications.
Cornberg, M; Manns, MP; Wedemeyer, H, 2006
)
0.33
"peg-IFNalpha-2a plus RBV is effective and safe to achieve SVR in HCV/HIV coinfected patients non-responsive to prior IFN treatment."( Efficacy and safety of peg-IFN alfa-2a with ribavirin for the treatment of HCV/HIV coinfected patients who failed previous IFN based therapy.
Fernández-Carbia, A; González-Lassalle, E; Marxuach-Cuétara, AM; Ríos-Bedoya, CF; Rodríguez-Orengo, JF; Rodríguez-Torres, M; Salgado-Mercado, R, 2007
)
0.34
" The introduction of combined therapy with pegylated interferons and ribavirin has increased the sustained virologic response (SVR) in the much higher percentage than with previous treatment options, while the level of adverse effects has not changed significantely."( [Efficacy and safety of peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C virus infection].
Delić, D,
)
0.13
" Physicians were instructed to adjust the dose of both drugs if adverse events occurred."( [Efficacy and safety of peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C virus infection].
Delić, D,
)
0.13
" The safety record was good, the most common adverse effects including cytopenia, rash and local reactions at the site of administration."( [Efficacy and safety of peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C virus infection].
Delić, D,
)
0.13
"Combination therapy with peginterferon alfa-2a and ribavirin is safe and well tolerated, with SVR achieved in 86."( [Efficacy and safety of peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C virus infection].
Delić, D,
)
0.13
"To distinguish adverse events related to ribavirin therapy from those attributable to severe acute respiratory syndrome (SARS), and to determine the rate of potential ribavirin-related adverse events."( Adverse events associated with high-dose ribavirin: evidence from the Toronto outbreak of severe acute respiratory syndrome.
Dresser, L; Loeb, M; Louie, M; Mazzulli, T; McGeer, A; Muller, MP; Raboud, J; Rea, E; Richardson, SE, 2007
)
0.34
" Logistic regression was used to evaluate the association between ribavirin use and each adverse event (progressive anemia, hypomagnesemia, hypocalcemia, bradycardia, transaminitis, and hyperamylasemia) after adjusting for SARS-related prognostic factors and corticosteroid use."( Adverse events associated with high-dose ribavirin: evidence from the Toronto outbreak of severe acute respiratory syndrome.
Dresser, L; Loeb, M; Louie, M; Mazzulli, T; McGeer, A; Muller, MP; Raboud, J; Rea, E; Richardson, SE, 2007
)
0.34
"High-dose ribavirin is associated with a high rate of adverse events."( Adverse events associated with high-dose ribavirin: evidence from the Toronto outbreak of severe acute respiratory syndrome.
Dresser, L; Loeb, M; Louie, M; Mazzulli, T; McGeer, A; Muller, MP; Raboud, J; Rea, E; Richardson, SE, 2007
)
0.34
"This study investigates whether dose modifications for adverse hematologic effects or the use of hematopoietic growth factors influenced the outcome of therapy for hepatitis C virus (HCV) infection in patients who were coinfected with HCV and human immunodeficiency virus (HIV) and who were participants in a randomized, controlled trial."( Hematologic toxicity associated with interferon-based hepatitis C therapy in HIV type 1-coinfected subjects.
Behler, CM; Chung, RT; Lin, F; Peters, MG; Robbins, GK; Vittinghoff, E; Volberding, PA, 2007
)
0.34
" Doses were modified for a number of adverse effects (including hematologic toxicity), and hematopoietic growth factors were administered at the discretion of the physician."( Hematologic toxicity associated with interferon-based hepatitis C therapy in HIV type 1-coinfected subjects.
Behler, CM; Chung, RT; Lin, F; Peters, MG; Robbins, GK; Vittinghoff, E; Volberding, PA, 2007
)
0.34
" Agranulocytosis was detected which was accounted as a side effect of pegylated interferon treatment."( [Side effect of pegylated-interferon treatment in chronic C hepatitis: agranulocytosis].
Farkas, A; Halász, T; Horváth, G; Tolvaj, G, 2006
)
0.33
"Therapies including nucleoside analogs are associated with severe toxic side effects and acquirement of drug resistance."( Formulations of biodegradable Nanogel carriers with 5'-triphosphates of nucleoside analogs that display a reduced cytotoxicity and enhanced drug activity.
Han, HY; Kohli, E; Vinogradov, SV; Zeman, AD, 2007
)
0.34
"Commonly reported adverse effects were noted in 90% of patients, most occurring during the first three months, with a stable prevalence thereafter and resolution after treatment end."( Safety and efficacy of combination therapy with peginterferon alfa-2a (40kD) and ribavirin in the outpatient setting: prospective analysis of 197 patients with chronic hepatitis C viral infection.
Beorchia, S; Chandelier, C; Combis, JM; Delassalle, P; Desmorat, H; Douvin, C; Filoche, B; Fontanges, T; Hanslik, B; Jacques, JP; Ouzan, D,
)
0.13
" The aim of this study was to analyze adverse effects during the treatment with pegylated IFN-alpha and ribavirin in children with CHC."( Adverse effects during the treatment with pegylated interferon and ribavirin in children with chronic hepatitis C.
Figlerowicz, M; Kowala-Piaskowska, A; Mozer-Lisewska, I; Słuzewski, W, 2007
)
0.34
" After 12-16 weeks of the therapy somatic adverse effects decreased significantly."( Adverse effects during the treatment with pegylated interferon and ribavirin in children with chronic hepatitis C.
Figlerowicz, M; Kowala-Piaskowska, A; Mozer-Lisewska, I; Słuzewski, W, 2007
)
0.34
"Administration of pegylated IFN-alpha and ribavirin in children with CHC is related to characteristic adverse effects."( Adverse effects during the treatment with pegylated interferon and ribavirin in children with chronic hepatitis C.
Figlerowicz, M; Kowala-Piaskowska, A; Mozer-Lisewska, I; Słuzewski, W, 2007
)
0.34
" Despite the lack of benefit with this regimen, induction therapy with this schedule was safe and well tolerated in co-infected patients."( Safety and efficacy of an induction dose of pegylated interferon alpha-2a on early hepatitis C virus kinetics in HIV/HCV co-infected patients: the CORAL-1 multicentre pilot study.
Berenguer, J; Clotet, B; Montes-Ramírez, M; Planas, R; Quereda, C; Rubio, R; Santín, M; Solà, R; Tural, C, 2007
)
0.34
"7% of the patients experienced at least one adverse event."( Safety, tolerability and efficacy of peginterferon alpha-2a and ribavirin in chronic hepatitis C in clinical practice: The German Open Safety Trial.
Alshuth, U; Gelbmann, CM; Hüppe, D; Lafrenz, M; Link, R; Lohmeyer, J; Mauss, S; Möller, B; Niederau, C; Wiedmann, KH; Witthöft, T, 2007
)
0.34
"The adverse reactions (ADR) derived from the treatment of hepatitis C with peginterferon alpha and ribavirin causes dose reductions and discontinuations of the treatment that compromise its efectiveness."( [Toxicity of the treatment of chronic hepatitis C with peginterferon alpha (2a or 2b) plus ribavirin in patients not previously treated].
Llopis González, A; Márquez Peiró, JF; Morales Suárez-Varela, M; Pérez Peiró, C; Valero Alcocer, VE, 2007
)
0.34
" Frequencies of adverse events (AEs) and serious AEs were similar among treatment arms and CD4 strata."( Effect of baseline CD4 cell count on the efficacy and safety of peginterferon Alfa-2a (40KD) plus ribavirin in patients with HIV/hepatitis C virus coinfection.
Clotet, B; Clumeck, N; Cooper, DA; Depamphilis, J; Dieterich, DT; Montaner, J; Opravil, M; Rockstroh, JK; Sasadeusz, J; Torriani, FJ, 2008
)
0.35
" Therapy was discontinued in 3 patients as a result of adverse events."( Efficacy and safety of peginterferon-alpha2b and ribavirin combination therapy in children with chronic hepatitis C infection.
Camarena, C; de Guevara, CL; de la Vega, A; Díaz, C; Díez-Dorado, R; Frauca, E; Hierro, L; Jara, P; Larrauri, J; Miños-Bartolo, G; Rueda, M, 2008
)
0.35
" PEG-IFN-alpha2b and ribavirin were reasonably well tolerated, with no unexpected or permanent adverse effects."( Efficacy and safety of peginterferon-alpha2b and ribavirin combination therapy in children with chronic hepatitis C infection.
Camarena, C; de Guevara, CL; de la Vega, A; Díaz, C; Díez-Dorado, R; Frauca, E; Hierro, L; Jara, P; Larrauri, J; Miños-Bartolo, G; Rueda, M, 2008
)
0.35
"Haematological adverse events related to pegylated interferon (PEG-IFN) and ribavirin (RBV) therapy could affect the patients' quality of life; however, the risk factors for severe haematological toxicity associated with this therapy in patients coinfected with hepatitis C virus (HCV) and HIV are unclear."( Predictors of severe haematological toxicity secondary to pegylated interferon plus ribavirin treatment in HIV-HCV-coinfected patients.
Arizcorreta-Yarza, A; Collado, A; Fernández-Fuertes, E; Girón-González, JA; González-Serrano, M; López-Cortés, LF; Lozano, F; Macías, J; Merino, D; Mira, JA; Pineda, JA; Ríos-Villegas, MJ; Rivero, A; Torres-Tortoso, M; Valera-Bestard, B, 2007
)
0.34
"The safety of albinterferon alfa-2b was acceptable, with a similar adverse event profile in both treatment arms."( Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients.
Bailey, RJ; Bain, VG; Cronin, PW; Kaita, KD; Marotta, P; McHutchison, JG; Patel, K; Pulkstenis, E; Subramanian, GM; Swain, MG; Yoshida, EM, 2008
)
0.35
"Albinterferon alfa-2b administered at 4-week intervals was safe and well-tolerated and demonstrated significant antiviral activity in patients with genotype 2/3, chronic hepatitis C virus."( Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients.
Bailey, RJ; Bain, VG; Cronin, PW; Kaita, KD; Marotta, P; McHutchison, JG; Patel, K; Pulkstenis, E; Subramanian, GM; Swain, MG; Yoshida, EM, 2008
)
0.35
"The combination of telaprevir, peginterferon alfa-2a, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations."( Antiviral effects and safety of telaprevir, peginterferon alfa-2a, and ribavirin for 28 days in hepatitis C patients.
Khunvichai, A; Kieffer, TL; Lawitz, E; McHutchison, JG; McNair, L; Muir, AJ; Rodriguez-Torres, M, 2008
)
0.35
"The aim of the study was an assessment of the incidence and types of neuropsychiatric serious adverse events (NSAE) in patients with compensated chronic hepatitis C (CHC) treated with recombinant or pegylated interferon-alpha (IFN-alpha) plus ribavirin (RBV)."( [Neuropsychiatric adverse events in patients with chronic hepatitis C treated with pegylated or recombinant interferon-alpha].
Borkowska, A; Drózdz, W; Dybowska, D; Halota, W; Kozielewicz, D; Ziółkowska-Kochan, M, 2008
)
0.35
" In conclusion, antiviral treatment is safe if transfusion requirement, iron toxicities and neutropenia are monitored."( Safety and efficacy of pegylated interferon alpha-2a and ribavirin for the treatment of hepatitis C in patients with thalassemia.
Fischer, R; Giardina, PJ; Harmatz, P; Jonas, MM; Kwiatkowski, JL; Neufeld, EJ; Olivieri, N; Porter, J; Vichinsky, E; Wright, EC, 2008
)
0.35
" Approximately 90% of patients suffer from at least one adverse effect; 15% will therefore have reduced drug dose and 5% will discontinue treatment."( [Side effects during interferon-alpha therapy of hepatitis C with special consideration of thyroid dysfunction].
Obołończyk, L; Siekierska-Hellmann, M; Sworczak, K, 2007
)
0.34
" Improved treatment regimens, including the standard of care pegylated interferon alfa and ribavirin, have increased sustained virologic response rates; however, treatment has a long duration and is often associated with adverse events that may affect adherence."( Treatment options for patients with hepatitis C: role of pharmacists in optimizing treatment response and managing adverse events.
Smith, JP, 2008
)
0.35
"To determine the incidence and severity of adverse effects of treatment in patients with chronic hepatitis B and C (CHB and CHC)."( [Haematologic adverse effects of treatment of chronic viral hepatitis B and C].
Kristian, P; Pellová, A; Porubcin, S; Schréter, I, 2008
)
0.35
" In two cases, the treatment was discontinued due to its adverse effects."( [Haematologic adverse effects of treatment of chronic viral hepatitis B and C].
Kristian, P; Pellová, A; Porubcin, S; Schréter, I, 2008
)
0.35
"The data confirm a high incidence of haematologic adverse effects, mostly mild."( [Haematologic adverse effects of treatment of chronic viral hepatitis B and C].
Kristian, P; Pellová, A; Porubcin, S; Schréter, I, 2008
)
0.35
"To illustrate the side effect profile of pegIFN-alpha in the treatment of CHC."( Safety of peginterferon in the treatment of chronic hepatitis C.
Hashemi, N; Herrine, SK; Navarro, VJ; Rossi, S, 2008
)
0.35
"Most adverse events occurring with combination therapy can be anticipated and managed appropriately; therefore, premature discontinuation of therapy owing to side effects is not required in most patients."( Safety of peginterferon in the treatment of chronic hepatitis C.
Hashemi, N; Herrine, SK; Navarro, VJ; Rossi, S, 2008
)
0.35
" We also show that T-705 is as effective as, and less toxic than, ribavirin, as infected T-705-treated hamsters on average maintain their weight better and recover more rapidly than animals treated with ribavirin."( Treatment of late stage disease in a model of arenaviral hemorrhagic fever: T-705 efficacy and reduced toxicity suggests an alternative to ribavirin.
Bailey, KW; Furuta, Y; Gowen, BB; Hall, JO; Jung, KH; Morrey, JD; Smee, DF; Stevens, JR; Wong, MH, 2008
)
0.35
" Fifteen patients (22%) did not complete the study, in 5 (8%) cases because of severe adverse events."( Swiss multicenter study evaluating the efficacy, feasibility and safety of peginterferon-alfa-2a and ribavirin in patients with chronic hepatitis C in official opiate substitution programs.
Broers, B; Frei, M; Fried, R; Herold, M; Huber, M; Isler, M; Kölliker, C; Monnat, M; Oppliger, R; Schmid, P; Schönbucher, P; Seidenberg, A, 2008
)
0.35
" Unfortunately, both peg-IFN alpha and RBV are responsible for a wide range of adverse events and potentially severe toxicities, particularly hematological alterations."( Bone marrow toxicity in HCV genotype 5a-infected patient after peg-IFN alpha-2a and ribavirin therapy.
Boumis, E; Capone, A; Drapeau, CM; Noto, P; Petrosillo, N; Remotti, D, 2008
)
0.35
"7%) due to adverse effects."( Efficacy and safety of peginterferon alpha-2a/ribavirin in treatment-naive Cameroonian patients with chronic hepatitis C.
Nerrienet, E; Njouom, R; Pasquier, C; Rousset, D; Sartre, MT; Tchendjou, P; Timba, I, 2008
)
0.35
" This case report illustrates vestibulocochlear and autonomic nervous system adverse effects of pegylated interferon-alpha-2b/ribavirin, emphasizing the importance of early recognition and cessation of therapy to prevent permanent neurootologic injury."( Interferon-alpha-2b/ribavirin-induced vestibulocochlear toxicity with dysautonomia in a chronic hepatitis C patient.
Galizio, C; Johnson, K; Sargent, LA; Ubogu, EE, 2008
)
0.35
" A multi-centre, randomized, controlled, prospective study assessed sustained virological response (SVR), adverse events such as depressive episodes and retention rate of HCV treatment in opioid-dependent patients."( Retention rate and side effects in a prospective trial on hepatitis C treatment with pegylated interferon alpha-2a and ribavirin in opioid-dependent patients.
Ebner, N; Fischer, G; Jachmann, CA; Matzenauer, C; Thau, K; Wanner, C; Winklbaur, B, 2009
)
0.35
" Antiviral treatment with pegylated interferon-alfa (IFN-alpha) plus ribavirin is often complicated by psychiatric adverse events, significantly affecting patients adherence."( Hepatitis C treatment in patients with drug addiction: clinical management of interferon-alpha-associated psychiatric side effects.
Mauss, S; Schaefer, M, 2008
)
0.35
" HCV therapy is generally safe in the population of coinfected patients with advanced immunosuppression."( Efficacy and safety of pegylated interferon plus ribavirin in HIV and hepatitis C virus-coinfected patients with advanced immunosuppression.
Arponen, S; Collado, A; Delgado, M; Gil, Ide L; González-Serrano, M; Gutiérrez-Valencia, A; López-Ruz, MA; Macías, J; Merino, D; Mira, JA; Omar, M; Pineda, JA; Ríos-Villegas, MJ; Rivero, A; Torres-Tortosa, M, 2009
)
0.35
" Adverse event rates were similar between groups except for diarrhea (viramidine 29."( Safety and efficacy of viramidine versus ribavirin in ViSER2: randomized, double-blind study in therapy-naive hepatitis C patients.
Chun, E; Gish, RG; Gitlin, N; Halliman, DG; Heise, J; Marcellin, P; Rodriguez-Torres, M, 2010
)
0.36
"This study aimed to assess the relationship between interferon (IFN)-related adverse effects and Hepatitis C virus (HCV) virologic response in HIV/HCV-coinfected individuals treated with pegylated interferon and ribavirin."( HIV/Hepatitis C virus-coinfected virologic responders to pegylated interferon and ribavirin therapy more frequently incur interferon-related adverse events than nonresponders do.
Bishop, R; Cortez, KJ; Kottilil, S; Masur, H; McLaughlin, M; Murphy, A; Osinusi, A; Polis, MA; Proschan, M; Rasimas, JJ; Rosenstein, D, 2010
)
0.36
" Other adverse effects, such as anemia and ophthalmologic toxicities, were also more frequent in responders compared with nonresponders."( HIV/Hepatitis C virus-coinfected virologic responders to pegylated interferon and ribavirin therapy more frequently incur interferon-related adverse events than nonresponders do.
Bishop, R; Cortez, KJ; Kottilil, S; Masur, H; McLaughlin, M; Murphy, A; Osinusi, A; Polis, MA; Proschan, M; Rasimas, JJ; Rosenstein, D, 2010
)
0.36
"Our study demonstrates coupling of antiviral effect and occurrence of adverse events in HIV/HCV-coinfected patients."( HIV/Hepatitis C virus-coinfected virologic responders to pegylated interferon and ribavirin therapy more frequently incur interferon-related adverse events than nonresponders do.
Bishop, R; Cortez, KJ; Kottilil, S; Masur, H; McLaughlin, M; Murphy, A; Osinusi, A; Polis, MA; Proschan, M; Rasimas, JJ; Rosenstein, D, 2010
)
0.36
"001) and grade 3 or 4 adverse events (34."( Efficacy and safety of pegylated interferon combined with ribavirin for the treatment of older patients with chronic hepatitis C.
Chang, WY; Chen, SC; Chuang, WL; Dai, CY; Hou, NJ; Hsieh, MY; Huang, CF; Huang, JF; Lin, ZY; Wang, LY; Yang, JF; Yu, ML, 2010
)
0.36
"Older patients with HCV infection, especially those in the subgroup infected with HCV-1, had a greater frequency of adverse events and poorer adherence to the standard-of-care regimen, which may be the major reason for treatment inferiority."( Efficacy and safety of pegylated interferon combined with ribavirin for the treatment of older patients with chronic hepatitis C.
Chang, WY; Chen, SC; Chuang, WL; Dai, CY; Hou, NJ; Hsieh, MY; Huang, CF; Huang, JF; Lin, ZY; Wang, LY; Yang, JF; Yu, ML, 2010
)
0.36
"The adverse effects of antiviral drugs are dose dependent and often reversible."( [Management of side effects during antiviral therapy].
Vcev, A, 2009
)
0.35
" I will review the most common adverse events reported during the therapy of chronic hepatitis B and C, with some recommendations for proper management."( Adverse effects of drugs in the treatment of viral hepatitis.
Negro, F, 2010
)
0.36
" Ten patients developed cirrhotic complications during the treatment, and 11 stopped treatment due to treatment-related adverse events."( [Clinical efficacy and safety of the combination therapy of peginterferon alpha and ribavirin in cirrhotic patients with HCV infection].
Cheong, HR; Cho, M; Heo, J; Kang, DH; Kim, DU; Kim, GH; Song, GA; Woo, HY; Yoon, KT, 2010
)
0.36
"Of the 24 study patients, no patient stopped the treatment due to treatment-related adverse events."( Efficacy and safety of combination therapy of natural human interferon beta and ribavirin in chronic hepatitis C patients with genotype 2 and high virus load.
Akuta, N; Arase, Y; Hirakawa, M; Hosaka, T; Ikeda, K; Kawamura, Y; Kobayashi, M; Kumada, H; Matsumoto, N; Saito, S; Sezaki, H; Suzuki, F; Suzuki, Y; Yatsuji, H, 2010
)
0.36
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" The standard of care (SOC) of pegylated IFN and ribavirin combination therapy has limited efficacy with ~50% sustained viral response, and is associated with a considerable adverse event profile in many patients."( Safety of small molecules in combination with interferon-based therapy for hepatitis C virus.
Rustgi, VK, 2010
)
0.36
"Patient sub-classes with poor prognosis with SOC are identified, as are their associated adverse event profiles."( Safety of small molecules in combination with interferon-based therapy for hepatitis C virus.
Rustgi, VK, 2010
)
0.36
"In HIV/ hepatitis C virus (HCV) coinfection, adverse events (AEs) during HCV therapy account for 12%-39% of treatment discontinuations."( Women experience higher rates of adverse events during hepatitis C virus therapy in HIV infection: a meta-analysis.
Andersen, J; Bhattacharya, D; Carrat, F; Chung, RT; Currier, JS; Peters, MG; Torriani, F; Umbleja, T, 2010
)
0.36
" Interferons may induce adverse events that usually, but not always, reverse within a few days after the end of therapy."( A multidisciplinary therapeutic approach for reducing the risk of psychiatric side effects in patients with chronic hepatitis C treated with pegylated interferon α and ribavirin.
Abate, G; Bertino, G; Boemi, P; Calvagno, GS; Di Pino, A; Giancarlo, C; Ignaccolo, L; Judica, A; Maiorca, D; Mastrosimone, G; Mauceri, B; Misseri, M; Neri, S; Palermo, F; Petralia, A; Rizzotto, A; Vadalà, G, 2010
)
0.36
"Treatment of patients with chronic hepatitis C with alpha-interferon and ribavirin usually produces adverse events within the first 3 months."( An open-safety study of dual antiviral therapy in real-world patients with chronic hepatitis C.
Cottone, M; D'Amico, G; Fasola, S; Giannuoli, G; Graviano, D; Madonia, S; Malizia, G; Patti, S; Tinè, F, 2010
)
0.36
" The baseline viral load had no impact on SVR in the present series nor were any serious adverse events reported."( Efficacy and safety of a novel pegylated interferon alpha-2a in Egyptian patients with genotype 4 chronic hepatitis C.
El-Ghannam, M; El-Ray, A; Mounir, B; Taha, AA, 2010
)
0.36
"The novel pegylated interferon alpha-2a assessed in the present study was effective for the treatment of patients with genotype 4 CHC, and was safe and well tolerated."( Efficacy and safety of a novel pegylated interferon alpha-2a in Egyptian patients with genotype 4 chronic hepatitis C.
El-Ghannam, M; El-Ray, A; Mounir, B; Taha, AA, 2010
)
0.36
" The incidence of severe adverse events did not differ between the two groups."( The efficacy and safety of pegylated interferon plus ribavirin combination therapy in chronic hepatitis c patients with hepatocellular carcinoma post curative therapies - a multicenter prospective trial.
Chen, SC; Chiu, CF; Chuang, WL; Dai, CY; Hou, NJ; Hsieh, MY; Huang, CF; Huang, CI; Huang, JF; Lin, ZY; Wang, LY; Yang, JF; Yeh, ML; Yu, ML, 2011
)
0.37
" No serious adverse event was observed."( Safety and efficacy of peginterferon alpha plus ribavirin in patients with chronic hepatitis C and coexisting heart disease.
De Vincentiis, L; Durante-Mangoni, E; Iossa, D; Pinto, D; Ragone, E; Utili, R, 2011
)
0.37
" The use of these drugs has been correlated with a range of adverse effects, including influenza-like symptoms, hematological changes and neuropsychiatric disturbances."( Pegylated-interferon-α(2a) in clinical practice: how to manage patients suffering from side effects.
Almasio, PL; Calvaruso, V; Mazza, M, 2011
)
0.37
"The research literature was reviewed with the aim of answering the question 'is irritability an underappreciated side effect of interferon and ribavirin treatment for hepatitis C'."( Irritability: an underappreciated side effect of interferon treatment for chronic hepatitis C?
Blacklaws, H; Gardner, A; Usher, K, 2011
)
0.37
" Good research is the foundation for evidence-based practice; therefore, the possibility exists that, based on current research evidence, patients may not be receiving a standard care that adequately addresses the entirety of the side effect spectrum."( Irritability: an underappreciated side effect of interferon treatment for chronic hepatitis C?
Blacklaws, H; Gardner, A; Usher, K, 2011
)
0.37
"Irritability is an underappreciated psychological side effect of interferon therapy."( Irritability: an underappreciated side effect of interferon treatment for chronic hepatitis C?
Blacklaws, H; Gardner, A; Usher, K, 2011
)
0.37
" Treatment of HCV infection with Peg-IFN in combination with ribavirin can eradicate HCV infection in 40-90% of patients; however, a major barrier to treatment uptake and delivery is the association of this therapy with frequent and, at times, serious adverse effects."( Management of adverse effects of Peg-IFN and ribavirin therapy for hepatitis C.
Cooper, C; Dalgard, O; Hunyady, B; Jia, J; Ogurtsov, P; Peck-Radosavljevic, M; Shiffman, ML; Sulkowski, MS; Yurdaydin, C, 2011
)
0.37
" Thirty patients were enrolled to receive pegIFN once a week with ribavirin twice daily for 12 weeks; viral load and experienced adverse effects were then assessed."( Efficacy and safety of pegylated interferon in children and adolescents infected with chronic hepatitis C: a preliminary study.
Abdel-Aziz, DH; El-Gazayerly, ON; El-Sayed, MH; Sabry, NA, 2011
)
0.37
" After the intervention, the increase in both hemoglobin and absolute neutrophil counts did not differ between the 2 side effect management strategies."( Randomized trial comparing dose reduction and growth factor supplementation for management of hematological side effects in HIV/hepatitis C virus patients receiving pegylated-interferon and ribavirin.
Aberg, JA; Aboulafia, D; Bonilla, H; Dimova, R; Doonquah, L; Dove, L; Galpin, J; Glesby, MJ; Hassanein, T; Jacobson, IM; Johnston, B; Liu, RC; Pearce, D; Rodriguez, J; Talal, AH; Zeremski, M, 2011
)
0.37
"Dermatological adverse events (AEs) are an existing concern during hepatitis C virus (HCV) infection and peginterferon/ribavirin treatment."( Dermatological side effects of hepatitis C and its treatment: patient management in the era of direct-acting antivirals.
Bourlière, M; Buggisch, P; Cacoub, P; Dupin, N; Dusheiko, G; Hézode, C; Lübbe, J; Picard, O; Pujol, R; Roujeau, JC; Segaert, S; Thio, B, 2012
)
0.38
" All of the patients continued the combination therapy owing to disappearance of severely adverse events contained the exacerbation of depression."( Efficacy and safety of combination therapy of natural human interferon beta and ribavirin in chronic hepatitis C patients.
Akuta, N; Arase, Y; Hosaka, T; Ikeda, K; Imai, N; Kawamura, Y; Kobayashi, M; Kumada, H; Matsumoto, N; Saito, S; Seko, Y; Sezaki, H; Suzuki, F; Suzuki, Y, 2011
)
0.37
"Single oral doses of ribavirin 400 mg were safe and well tolerated in this population."( Pharmacokinetics, safety, and tolerability of ribavirin in hemodialysis-dependent patients.
Glue, P; Gupta, SK; Kantesaria, B, 2012
)
0.38
" The aim of this study is to evaluate the reason for premature discontinuation during PEG-IFN α-2b and RBV treatment due to adverse effects in patients with chronic HCV infection."( Evaluation of the adverse effect of premature discontinuation of pegylated interferon α-2b and ribavirin treatment for chronic hepatitis C virus infection: results from Kyushu University Liver Disease Study.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kotoh, K; Maruyama, T; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K; Tanabe, Y, 2012
)
0.38
"7%) discontinued treatment because of adverse effects."( Evaluation of the adverse effect of premature discontinuation of pegylated interferon α-2b and ribavirin treatment for chronic hepatitis C virus infection: results from Kyushu University Liver Disease Study.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kotoh, K; Maruyama, T; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K; Tanabe, Y, 2012
)
0.38
"Premature discontinuation due to the adverse effects of PEG-IFN α-2b and RBV treatment by patients with chronic HCV infection is mainly due to neuropsychiatric symptoms and is more common for older than for younger patients."( Evaluation of the adverse effect of premature discontinuation of pegylated interferon α-2b and ribavirin treatment for chronic hepatitis C virus infection: results from Kyushu University Liver Disease Study.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kotoh, K; Maruyama, T; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K; Tanabe, Y, 2012
)
0.38
"Effective management of adverse events (AEs) is important to prevent treatment discontinuation and optimize hepatitis C virus infection eradication rates."( Boceprevir and telaprevir for the treatment of chronic hepatitis C: safety management in clinical practice.
Hézode, C, 2012
)
0.38
" The ratios of discontinuation of telaprevir only or of all the study drugs because of adverse events were 21."( Efficacy and safety of telaprevir, a new protease inhibitor, for difficult-to-treat patients with genotype 1 chronic hepatitis C.
Chayama, K; Hayashi, N; Kumada, H; Okanoue, T; Toyota, J; Tsubouchi, H, 2012
)
0.38
" This large multinational open-label study aimed to better define the incidence of serious adverse events (SAEs) and non-serious adverse events of special interest in patients receiving peginterferon alfa-2a/ribavirin."( Safety of peginterferon alfa-2a plus ribavirin in a large multinational cohort of chronic hepatitis C patients.
Berak, H; Dusheiko, GM; Ferenci, P; Gane, EJ; Hadziyannis, SJ; Han, KH; Harley, HA; Horsmans, YJ; Husa, P; Jenny Heathcote, E; Lee, SS; Messinger, D; Roberts, SK; Tatsch, F, 2012
)
0.38
"Pegylated-interferon (peg-IFN) and ribavirin combination therapy for the treatment of hepatitis C virus (HCV) infection is well known to be associated with significant adverse effects."( Distortion-product otoacoustic emissions: a useful test for monitoring ototoxicity induced by pegylated interferon and ribavirin treatment in patients with chronic hepatitis C.
Casale, M; Faiella, F; Galati, G; Mazzarelli, C; Pappacena, M; Picardi, A; Potena, M; Salvinelli, F; Vespasiani Gentilucci, U,
)
0.13
"The efficacy of pegylated interferon-α and ribavirin (pegIFN/RBV) in the treatment of Hepatitis C infection is limited by psychiatric adverse effects (IFN-PE)."( Gene expression profiles predict emergence of psychiatric adverse events in HIV/HCV-coinfected patients on interferon-based HCV therapy.
Katsounas, A; Kottilil, S; Lempicki, RA; Masur, H; Murphy, AA; Osinusi, A; Polis, M; Rasimas, J; Raza, H; Rosenstein, D; Yang, J, 2012
)
0.38
" Determining precisely the risk of serious adverse events (SAEs) and mortality from a single study is rather difficult because of the infrequency of such events."( Meta-analysis: mortality and serious adverse events of peginterferon plus ribavirin therapy for chronic hepatitis C.
Kishikawa, T; Koike, K; Minami, T; Sato, M; Tateishi, R; Yoshida, H, 2013
)
0.39
" The adverse event (AE) impact of PI-PR remains under-reported."( Impact of adverse events on costs and quality of life in protease inhibitor-based combination therapy for hepatitis C.
Carter, JA; Gao, X; Haider, S; Rustgi, VK; Stephens, JM, 2012
)
0.38
" The primary endpoints were composed of the rates of SVR, the rates of relapse, the rates of anemia, and the rates of discontinuation due to severe adverse events, respectively."( [Efficacy and safety of a protease inhibitor with pegylated interferon and ribavirin in patients with untreated chronic hepatitis C: a meta analysis].
Li, MY; Yuan, XL; Zhang, DZ, 2012
)
0.38
"01 and higher discontinuation rate owing to severe adverse events, 12."( [Efficacy and safety of a protease inhibitor with pegylated interferon and ribavirin in patients with untreated chronic hepatitis C: a meta analysis].
Li, MY; Yuan, XL; Zhang, DZ, 2012
)
0.38
" Both the incidence of adverse events and the frequency of discontinuation owing to severe adverse events were higher in patients receiving the triple therapy than those receiving the standard double therapy."( [Efficacy and safety of a protease inhibitor with pegylated interferon and ribavirin in patients with untreated chronic hepatitis C: a meta analysis].
Li, MY; Yuan, XL; Zhang, DZ, 2012
)
0.38
" In the prospect of the imminent introduction of new direct acting antiviral agents, with demonstrated higher rates of adverse effects, our study aimed to assess the severity and incidence of several types of adverse effects in a cohort of genotype 1 infected Romanian patients."( Adverse effects of peg-Interferon and Ribavirin combined antiviral treatment in a Romanian hepatitis C virus infected cohort.
Irimia, E; Mogoantă, L; Predescu, O; Streba, L; Streba, LA, 2012
)
0.38
" We recorded their viral loads, hemoglobin values and thrombocyte counts, as well as any dermatological, psychiatric or constitutional adverse effect after twelve doses, eight and twelve months of treatment, with two follow-up examinations at three and six months after treatment completion."( Adverse effects of peg-Interferon and Ribavirin combined antiviral treatment in a Romanian hepatitis C virus infected cohort.
Irimia, E; Mogoantă, L; Predescu, O; Streba, L; Streba, LA, 2012
)
0.38
" We only encountered grade 1 and 2 dermatological adverse effects."( Adverse effects of peg-Interferon and Ribavirin combined antiviral treatment in a Romanian hepatitis C virus infected cohort.
Irimia, E; Mogoantă, L; Predescu, O; Streba, L; Streba, LA, 2012
)
0.38
"We did not encounter severe hematological adverse effects that would require Ribavirin dosage adjustments."( Adverse effects of peg-Interferon and Ribavirin combined antiviral treatment in a Romanian hepatitis C virus infected cohort.
Irimia, E; Mogoantă, L; Predescu, O; Streba, L; Streba, LA, 2012
)
0.38
"This article focuses on the adverse effects of hepatitis C therapy, which includes pegylated interferon alfa-2a or -2b with ribavirin."( Managing adverse effects of interferon-alfa and ribavirin in combination therapy for HCV.
Afridi, MS; Slim, J, 2012
)
0.38
"9% had adverse affects (G1/4 50."( [Efficacy and safety of peginterferon alfa-2a and ribavirin treatment of chronic hepatitis C in the Republic of Serbia].
Bojović, K; Božić, M; Fabri, M; Milošević, I; Nožić, D; Trkulja, B,
)
0.13
" Longer therapy increases the possibility of the development of adverse affects."( [Efficacy and safety of peginterferon alfa-2a and ribavirin treatment of chronic hepatitis C in the Republic of Serbia].
Bojović, K; Božić, M; Fabri, M; Milošević, I; Nožić, D; Trkulja, B,
)
0.13
" Data were abstracted for complete early virologic response (EVR), sustained virologic response (SVR), relapse, treatment discontinuations, hematologic and dermatologic adverse events, and growth inhibition."( Efficacy and safety of pegylated interferon alfa-2a or alfa-2b plus ribavirin for the treatment of chronic hepatitis C in children and adolescents: a systematic review and meta-analysis.
Cooper, CL; Druyts, E; Kanters, S; Mills, EJ; Thorlund, K; Wu, P; Yaya, S, 2013
)
0.39
" Discontinuation due to adverse events and discontinuation due to viral breakthrough were each 4%, discontinuation due to a lack of response was 15%, and relapse was 7%."( Efficacy and safety of pegylated interferon alfa-2a or alfa-2b plus ribavirin for the treatment of chronic hepatitis C in children and adolescents: a systematic review and meta-analysis.
Cooper, CL; Druyts, E; Kanters, S; Mills, EJ; Thorlund, K; Wu, P; Yaya, S, 2013
)
0.39
"The results of this meta-analysis indicate that peg-IFN/RBV combination treatment is effective and safe in treating children and adolescents with HCV."( Efficacy and safety of pegylated interferon alfa-2a or alfa-2b plus ribavirin for the treatment of chronic hepatitis C in children and adolescents: a systematic review and meta-analysis.
Cooper, CL; Druyts, E; Kanters, S; Mills, EJ; Thorlund, K; Wu, P; Yaya, S, 2013
)
0.39
" Baseline and demographic characteristics, response to treatment at weeks 12, 48 and 72, and the nature and frequency of adverse effects were analyzed."( Safety and efficacy of treatment with pegylated interferon alpha-2a with ribavirin in chronic hepatitis C genotype 4.
Antón, MD; Arocena, C; Barrera, JM; Boadas, J; Crespo, J; Dalmau, B; Del Olmo, JA; Diago, M; Erdozaín, JC; Giné, J; Gracia-Samaniego, J; Montoro, M; Perez, R; Planas, R; Solá, R; Suarez, D; Urquijo, JJ,
)
0.13
"Chemi-enzymatic synthesis of ribavirin acrylate and subsequent RAFT co-polymerization with acrylic acid afforded a formulation of a broad spectrum antiviral drug which avoids accumulation in erythrocytes, the origin of the main side effect of ribavirin."( Macromolecular prodrugs of ribavirin combat side effects and toxicity with no loss of activity of the drug.
Kryger, MB; Smith, AA; Wohl, BM; Zelikin, AN, 2013
)
0.39
" However, there was an increased risk of serious adverse events in the TPR group (RR=1."( The efficacy and safety of telaprevir-based regimens for treating chronic hepatitis C virus genotype 1 infection: a meta-analysis of randomized trials.
Jia, Z; Li, D; Liang, HJ; Ma, L; Wei, X; Yang, D, 2013
)
0.39
" Adverse effects resulted in treatment discontinuation by 12."( Telaprevir can be successfully and safely used to treat older patients with genotype 1b chronic hepatitis C.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kawano, A; Kotoh, K; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K; Tanabe, Y, 2013
)
0.39
"To report the rates of grade IV adverse events and hepatitis C virus (HCV) treatment discontinuation associated with the use of telaprevir, pegylated interferon, and ribavirin."( High incidence of serious adverse events in HIV-infected patients treated with a telaprevir-based hepatitis C virus treatment regimen.
Ballard, C; Cachay, ER; Colwell, B; Hill, L; Lin, JC; Mathews, WC; Torriani, FJ; Wyles, DL, 2013
)
0.39
" The United States of America National Institutes of Health Division of AIDS grading system was used to rate severity of adverse events."( High incidence of serious adverse events in HIV-infected patients treated with a telaprevir-based hepatitis C virus treatment regimen.
Ballard, C; Cachay, ER; Colwell, B; Hill, L; Lin, JC; Mathews, WC; Torriani, FJ; Wyles, DL, 2013
)
0.39
"Of the 24 consecutive patients treated for HCV using telaprevir/pegylated interferon/ribavirin, 50% (12/24) developed serious adverse events and 29% (7/24) discontinued HCV treatment due to adverse events, despite an intensive multidisciplinary monitoring approach."( High incidence of serious adverse events in HIV-infected patients treated with a telaprevir-based hepatitis C virus treatment regimen.
Ballard, C; Cachay, ER; Colwell, B; Hill, L; Lin, JC; Mathews, WC; Torriani, FJ; Wyles, DL, 2013
)
0.39
"In this HIV clinic-based experience, a high rate of grade IV adverse events and treatment discontinuations were observed associated with HCV telaprevir-based treatment."( High incidence of serious adverse events in HIV-infected patients treated with a telaprevir-based hepatitis C virus treatment regimen.
Ballard, C; Cachay, ER; Colwell, B; Hill, L; Lin, JC; Mathews, WC; Torriani, FJ; Wyles, DL, 2013
)
0.39
" IBD can become exacerbated during treatment with interferon (IFN), and serious adverse events, such as pancytopenia or hepatotoxicity, can be compounded by drug interactions."( Efficacy and safety of treatment of hepatitis C in patients with inflammatory bowel disease.
Allen, AM; Kim, WR; Larson, J; Loftus, EV, 2013
)
0.39
" There was one serious adverse event, which was not considered to be treatment related."( Safety and efficacy of faldaprevir with pegylated interferon alfa-2a and ribavirin in Japanese patients with chronic genotype-1 hepatitis C infection.
Kuboki, M; Nishiguchi, S; Omata, M; Sakai, Y; Sakamoto, W; Steinmann, G; Tsuda, Y; Tsunematsu, S; Urano, Y, 2014
)
0.4
" The main adverse effects of telaprevir therapy are anemia and skin rash."( [Clinical use of telaprevir: stopping rules, predicting response, treatment length, and management of adverse effects].
Planas, R; Tural, C, 2013
)
0.39
" Similarly, the adverse effects in this trial did not differ from those found in patients with genotype 1 HCV monoinfection."( [Safety and efficacy of telaprevir in patients with HIV and hepatitis C virus coinfection].
Macías, J; Rivero, A, 2013
)
0.39
" Single-dose ribavirin was safe and well tolerated in all subjects."( Pharmacokinetics and safety of single-dose ribavirin in patients with chronic renal impairment.
Glue, P; Gupta, SK; Kantesaria, B, 2013
)
0.39
" The RBV dose was reduced because of adverse events (AEs) in 71% and 53% of severe and moderate renal impairment groups, respectively."( Safety, tolerability, and pharmacokinetics of ribavirin in hepatitis C virus-infected patients with various degrees of renal impairment.
Blotner, S; Brennan, BJ; Grippo, JF; Magnusson, MO; Martin, P; Nieforth, K; Solsky, J; Wang, K; Wat, C; Wilkins, JJ, 2013
)
0.39
" Such lesions may develop as adverse effects by telaprevir, since the lesions disappeared following discontinuation of telaprevir in a 65-year-old man, in whom both pegylated-interferon (Peg-IFN) and ribavirin were continued, and reappeared when he took telaprevir again by his decision."( Telaprevir-induced, but not pegylated interferon-associated, retinopathy as a noteworthy adverse effect during triple antiviral therapy in patients with chronic hepatitis C.
Inao, M; Mochida, S; Nakayama, N; Sugawara, K, 2014
)
0.4
"Ophthalmologic examinations should be done carefully during triple therapy, since the incidence was higher than that in previous Peg-IFN therapy, and lesions may develop as adverse effects by telaprevir, but not by Peg-IFN, especially in those showing preferable IL28B SNPs allele and/or anemia during the therapy."( Telaprevir-induced, but not pegylated interferon-associated, retinopathy as a noteworthy adverse effect during triple antiviral therapy in patients with chronic hepatitis C.
Inao, M; Mochida, S; Nakayama, N; Sugawara, K, 2014
)
0.4
" Adverse events were consistent with those reported in clinical trials of peginterferon and ribavirin, and no unique adverse events appeared to be associated with GSK2336805."( A double-blind, randomized, placebo-controlled study to assess the safety, antiviral activity and pharmacokinetics of GSK2336805 when given as monotherapy and in combination with peginterferon alfa-2a and ribavirin in hepatitis C virus genotype 1-infected
Adkison, K; Cutrell, A; Elko-Simms, C; Gardner, S; Hamatake, R; Hong, Z; Rodriguez-Torres, M; Walker, J, 2014
)
0.4
"Only two adverse events, anaemia and dysgeusia, occurred 20% more often with the BOC-containing regimens compared with PR."( Overall safety profile of boceprevir plus peginterferon alfa-2b and ribavirin in patients with chronic hepatitis C genotype 1: a combined analysis of 3 phase 2/3 clinical trials.
Albrecht, JK; Bacon, B; Balart, L; Bourliere, M; Brass, CA; Bronowicki, JP; Bruno, S; Burroughs, M; Davis, MN; Felizarta, F; Helmond, FA; Kwo, P; Manns, MP; McCone, J; Pedicone, LD; Poordad, F; Reddy, KR; Rossaro, L; Schiff, E; Shiffman, ML; Sings, HL; Sulkowski, MS; Vierling, JM, 2014
)
0.4
"Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection."( Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C.
Abdurakhmanov, D; Colombo, M; DeMasi, R; Fernández, I; Ferreira, PA; Hill, A; Iraqi, W; Läuffer, JM; Lonjon-Domanec, I; Moreno, C; Strasser, SI; Streinu-Cercel, A; Urbanek, P; Verheyen, A; Wedemeyer, H, 2014
)
0.4
"Data about adverse events are needed to optimise telaprevir-based therapy in a broad spectrum of patients."( Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir.
Bansal, M; Bichoupan, K; Branch, AD; Dieterich, DT; Gaglio, PJ; Giannattasio, ER; Kalia, H; Liu, LU; Marfo, K; Martel-Laferriere, V; Odin, JA; Perumalswami, P; Reinus, JF; Schiano, TD; Schwartz, JM, 2014
)
0.4
"To investigate adverse events of telaprevir-based therapy in patients with and without advanced fibrosis or cirrhosis in a real-world setting."( Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir.
Bansal, M; Bichoupan, K; Branch, AD; Dieterich, DT; Gaglio, PJ; Giannattasio, ER; Kalia, H; Liu, LU; Marfo, K; Martel-Laferriere, V; Odin, JA; Perumalswami, P; Reinus, JF; Schiano, TD; Schwartz, JM, 2014
)
0.4
" Multivariable fully adjusted models were built to assess the effect of advanced fibrosis on specific adverse events and discontinuation of treatment due to an adverse event."( Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir.
Bansal, M; Bichoupan, K; Branch, AD; Dieterich, DT; Gaglio, PJ; Giannattasio, ER; Kalia, H; Liu, LU; Marfo, K; Martel-Laferriere, V; Odin, JA; Perumalswami, P; Reinus, JF; Schiano, TD; Schwartz, JM, 2014
)
0.4
" More critical monitoring in older and female patients with low platelets throughout treatment may reduce adverse event-related discontinuations."( Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir.
Bansal, M; Bichoupan, K; Branch, AD; Dieterich, DT; Gaglio, PJ; Giannattasio, ER; Kalia, H; Liu, LU; Marfo, K; Martel-Laferriere, V; Odin, JA; Perumalswami, P; Reinus, JF; Schiano, TD; Schwartz, JM, 2014
)
0.4
" Two patients withdrew prematurely from study medications due to adverse events."( Efficacy and safety of danoprevir-ritonavir plus peginterferon alfa-2a-ribavirin in hepatitis C virus genotype 1 prior null responders.
Brennan, BJ; Gane, EJ; Kulkarni, R; Larrey, DG; Le Pogam, S; Morcos, PN; Nájera, I; Petric, R; Rouzier, R; Shulman, NS; Smith, P; Tran, JQ; Wiercinska-Drapalo, A; Yetzer, ES; Zhang, Y, 2014
)
0.4
" These results suggested that the side-effect profiles differed among the various IFNs."( [Comparative study of the time period between the initiation of various interferon therapies and the onset of suicide- or diabetes-related side effect].
Kobayashi, T, 2013
)
0.39
"In a dose of 400 mg once daily, the drug has been safe and generally well tolerated with most adverse reactions attributable to the concurrent use of ribavirin or peginterferon plus ribavirin."( Review article: the efficacy and safety of sofosbuvir, a novel, oral nucleotide NS5B polymerase inhibitor, in the treatment of chronic hepatitis C virus infection.
Koff, RS, 2014
)
0.4
" These combinations significantly increase sustained virological response (SVR) rates, but they also increase the rates of adverse events (AEs)."( Safety of direct-acting antivirals in the treatment of chronic hepatitis C.
Ridruejo, E, 2014
)
0.4
"Every patient will experience adverse effects to differing degrees; a systematic approach to their management can be very helpful."( Safety of direct-acting antivirals in the treatment of chronic hepatitis C.
Ridruejo, E, 2014
)
0.4
" During treatment, there were no adverse reactions such as dizziness, vomiting, and notable decreases in hemoglobin, white blood cells, and platelets in the two groups."( [Efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease].
Cai, K; Chen, YH; Qian, JH; Wang, L; Yu, HJ; Zhang, HP; Zhang, QL, 2014
)
0.4
" With low dosage and few adverse reactions, it holds promise for clinical application."( [Efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease].
Cai, K; Chen, YH; Qian, JH; Wang, L; Yu, HJ; Zhang, HP; Zhang, QL, 2014
)
0.4
" As transplant community identified HCV viral clearance as a critical matter, efficacious and safe anti-HCV therapies are awaited."( Antiviral activity and safety profile of silibinin in HCV patients with advanced fibrosis after liver transplantation: a randomized clinical trial.
Brambilla, N; Bringiotti, RS; Castellaneta, A; Castellaneta, NM; D'Amato, M; Di Leo, A; Giacovelli, G; Rendina, M; Rizzi, SF; Rovati, L; Zappimbulso, M, 2014
)
0.4
" Treatment discontinuation due to adverse effects and the development of bacterial infection did not differ between the Spx and non-Spx/TCP groups."( Efficacy and safety of splenectomy in telaprevir-based triple therapy for chronic hepatitis C patients with thrombocytopenia and advanced fibrosis.
Akahoshi, T; Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kawano, A; Kotoh, K; Maehara, Y; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K; Tanabe, Y, 2014
)
0.4
" The occurrence of adverse effects was assessed during treatment and follow up."( Safety and efficacy of Hansenula-derived PEGylated-interferon alpha-2a and ribavirin combination in chronic hepatitis C Egyptian children.
Abdel-Aty, EF; Abdel-Ghaffar, AY; Abdel-Ghaffar, TY; Allam, AA; Behairy, BE; Ehsan, NA; El Naghi, S; El-Araby, HA; El-Guindi, MA; El-Hennawy, AM; El-Karaksy, H; El-Raziky, MS; El-Sebaie, H; Helmy, H; Sira, MM, 2014
)
0.4
" Only mild reversible adverse effects were observed and children tolerated the treatment well."( Safety and efficacy of Hansenula-derived PEGylated-interferon alpha-2a and ribavirin combination in chronic hepatitis C Egyptian children.
Abdel-Aty, EF; Abdel-Ghaffar, AY; Abdel-Ghaffar, TY; Allam, AA; Behairy, BE; Ehsan, NA; El Naghi, S; El-Araby, HA; El-Guindi, MA; El-Hennawy, AM; El-Karaksy, H; El-Raziky, MS; El-Sebaie, H; Helmy, H; Sira, MM, 2014
)
0.4
"Interferon-beta plus ribavirin therapy was safe in elderly patients, with lower proportions of patients with a dose reduction of interferon-beta or ribavirin and treatment discontinuation."( Interferon-beta plus ribavirin therapy can be safely and effectively administered to elderly patients with chronic hepatitis C.
Miyagi, Y; Nomura, H; Tanimoto, H; Yamashita, N, 2014
)
0.4
" A high rate of serious adverse events (N = 30) was observed in 22 patients including 2 fatalities in cirrhotic diabetes patients."( Safety and efficacy of protease inhibitor based combination therapy in a single-center "real-life" cohort of 110 patients with chronic hepatitis C genotype 1 infection.
Degen, O; Eißing, F; Hennigs, A; Hertling, S; Hüfner, A; Jordan, S; Lohse, AW; Lüth, S; Röder, C; Schmiedel, S; Schulze zur Wiesch, J; Sterneck, M; van Lunzen, J; Wehmeyer, MH, 2014
)
0.4
"The results of this meta-analysis suggest that Peg-IFN plus RBV is effective and safe for HCV-6 patients."( Efficacy and safety of pegylated interferon plus ribavirin therapy for chronic hepatitis C genotype 6: a meta-analysis.
Hu, H; Liu, F; Ren, H; Wang, X; Wei, F, 2014
)
0.4
" Anticipating the adverse events of PIs, informing patients about their risk and manage them appropriately and efficiently is important for safe and successful treatment outcome."( [Management of side effects induced by antiviral therapy for chronic hepatitis infection].
Smolić, M; Smolić, R; Vcev, A, 2013
)
0.39
" A high rate of serious adverse events (28%) was documented during treatment."( Limited effectiveness and safety profile of protease inhibitor-based triple therapy against chronic hepatitis C in a real-world cohort with a high proportion of advanced liver disease.
Cornberg, M; Deterding, K; Höner Zu Siederdissen, C; Maasoumy, B; Manns, MP; Markova, AA; Port, K; Rogalska-Taranta, M; Wedemeyer, H, 2014
)
0.4
" Adverse effects such as tuberculosis, anemia, and cardiac failure resulting in discontinuation of therapy were seen in three."( Efficacy and safety of hepatitis C antiviral therapy in moderate and severe chronic kidney disease.
Abraham, P; Alagammai, PL; Basu, G; Goel, A; Mahajan, R; Ramachandran, J; Sivakumar, J; Tamilarasi, V, 2014
)
0.4
"5% of patients (n = 62) reported at least one serious adverse events (SAEs) (total SAEs = 103)."( Safety and efficacy of triple therapy with peginterferon, ribavirin and boceprevir within an early access programme in Spanish patients with hepatitis C genotype 1 with severe fibrosis: SVRw12 analysis.
Arenas, JI; Bárcena, R; Buti, M; Calleja, JL; Crespo, J; de la Revilla, J; Delgado, M; Fernández-Rodríguez, CM; Forns, X; Gea, F; Larrubia, JR; Navarro, JM; Pascasio, JM; Pérez-Álvarez, R; Planas, R; Romero-Gómez, M; Ruiz-Antorán, B; Solá, R; Sousa, JM, 2015
)
0.42
"The aim of the study was to analyze the incidence, management and cost associated to hematological and dermatological adverse effects (AE) in chronic hepatitis C patients on triple therapy (TT) with telaprevir (TVR) or boceprevir (BOC)."( [Incidence, management and costs of adverse effects in chronic hepatitis C patients on triple therapy with telaprevir or boceprevir: first 12 weeks of treatment].
Climente-Martí, M; Gómez-Álvarez, S; Guglieri-López, B; Ventura-Cerdá, JM, 2015
)
0.42
"In conclusion, substantial dose reduction and daily administration of low doses of TAC compose a safe and efficient immunosuppressive regimen during TVR-based triple therapy."( Daily low-dose tacrolimus is a safe and effective immunosuppressive regimen during telaprevir-based triple therapy for hepatitis C virus recurrence after liver transplant.
Achterfeld, A; Canbay, A; Gerken, G; Herzer, K; Jochum, C; Papadopoulos-Köhn, A; Paul, A; Timm, J, 2015
)
0.42
" Adjusting the TVR starting dose may reduce these adverse effects."( Adjusting the starting dose of telaprevir according to renal function decreases adverse effects and affects the sustained virological response rate.
Anan, A; Fukunaga, A; Hirano, G; Irie, M; Iwashita, H; Iwata, K; Kitamura, Y; Kunimoto, H; Kuno, S; Morihara, D; Nishizawa, S; Sakisaka, S; Sakurai, K; Shakado, S; Sohda, T; Takata, K; Takeyama, Y; Tanaka, T; Tsuchiya, N; Watanabe, H; Yokoyama, K; Yoshikane, M; Yotsumoto, K, 2015
)
0.42
"Adjusting the TVR starting dose according to the TVR/unadjusted eGFR ratio decreased adverse effects and affected the SVR rate."( Adjusting the starting dose of telaprevir according to renal function decreases adverse effects and affects the sustained virological response rate.
Anan, A; Fukunaga, A; Hirano, G; Irie, M; Iwashita, H; Iwata, K; Kitamura, Y; Kunimoto, H; Kuno, S; Morihara, D; Nishizawa, S; Sakisaka, S; Sakurai, K; Shakado, S; Sohda, T; Takata, K; Takeyama, Y; Tanaka, T; Tsuchiya, N; Watanabe, H; Yokoyama, K; Yoshikane, M; Yotsumoto, K, 2015
)
0.42
" They were divided into group A (age: <65 years; n = 21) and group B (age: ≥65 years; n = 14) in order to compare the treatment completion rate, sustained virological response at week 24 (SVR24), and adverse events between the groups."( Efficacy and safety of telaprevir-based antiviral treatment for elderly patients with hepatitis C virus.
Arizumi, T; Chishina, H; Hagiwara, S; Inoue, T; Kitai, S; Kouno, M; Kudo, M; Minami, Y; Takita, M; Ueshima, K; Yada, N, 2014
)
0.4
" Sofosbuvir-based combinations are safe and well tolerated without side effects directly related to the drug."( Overall efficacy and safety results of sofosbuvir-based therapies in phase II and III studies.
Mangia, A; Piazzolla, V, 2014
)
0.4
" No patient discontinued due to an adverse event or laboratory abnormality."( Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Barr, E; Bourliere, M; DeJesus, E; Dutko, F; Gerstoft, J; Haber, B; Hezode, C; Howe, AY; Hwang, P; Kugelmas, M; Mallolas, J; Murillo, A; Nahass, R; Pol, S; Robertson, M; Serfaty, L; Shaughnessy, M; Shibolet, O; Sulkowski, M; Vierling, JM; Wahl, J; Weis, N; Zuckerman, E, 2015
)
0.42
" Adverse events reported in more than 10% of patients were fatigue (66 patients, 26% [95% CI 21-32]), headache (58 patients, 23% [95% CI 18-29]), and asthenia (35 patients, 14% [95% CI 10-19])."( Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Alric, L; Balart, L; Barr, E; Bronowicki, JP; Dutko, F; Gane, E; Ghalib, R; Ghesquiere, W; Guyader, D; Haber, B; Howe, AY; Hwang, P; Lagging, M; Lawitz, E; Lester, L; Pearlman, B; Robertson, M; Shaughnessy, M; Sievert, W; Sund, F; Tam, E; Wahl, J, 2015
)
0.42
" The most frequent adverse events in patients with/without cirrhosis were gastrointestinal and skin events, which were mostly mild or moderate in intensity."( Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis.
Angus, P; Asselah, T; Böcher, W; Bourlière, M; Bronowicki, JP; Buti, M; Gallivan, JP; Gane, EJ; Lohse, AW; Manns, M; Mensa, FJ; Müllhaupt, B; Roberts, S; Sabo, JP; Schuchmann, M; Soriano, V; Stern, JO; Stickel, F; Voss, F; Zeuzem, S, 2015
)
0.42
" Adverse events (AEs) were mainly grade 1/2; serious AEs were infrequent (4."( Efficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4.
Beumont, M; Bourgeois, S; Fevery, B; Francque, S; Grange, JD; Hezode, C; Jessner, W; Lenz, O; Marcellin, P; Moreno, C; Ouwerkerk-Mahadevan, S; Peeters, M; Samuel, D; Shukla, U; Zoulim, F, 2015
)
0.42
" Comparison of ivermectin and ribavirin showed that ivermectin was safe at 50μg/ml and lower concentrations."( Evaluation of cytotoxicity and antiviral activity of ivermectin against Newcastle disease virus.
Anjum, AA; Ashraf, M; Azeem, S; Hameed, R; Rasheed, MA, 2015
)
0.42
" No adverse effect due to PSE pretreatment was found in any patients."( Safety and efficacy of partial splenic embolization in telaprevir-based triple therapy for chronic hepatitis C.
Abe, H; Aizawa, Y; Atsukawa, M; Fukuda, T; Itokawa, N; Iwakiri, K; Kawamoto, C; Kondo, C; Matsushita, Y; Nakagawa, A; Nakatsuka, K; Sakamoto, C; Shimada, N; Tsubota, A, 2015
)
0.42
"PSE, in conjunction with triple combination therapy, is a useful and safe method to treat genotype 1b chronic hepatitis C patients with hypersplenism-induced thrombocytopenia."( Safety and efficacy of partial splenic embolization in telaprevir-based triple therapy for chronic hepatitis C.
Abe, H; Aizawa, Y; Atsukawa, M; Fukuda, T; Itokawa, N; Iwakiri, K; Kawamoto, C; Kondo, C; Matsushita, Y; Nakagawa, A; Nakatsuka, K; Sakamoto, C; Shimada, N; Tsubota, A, 2015
)
0.42
" Unfortunately, anemia remains a common adverse effect."( Comparative safety study on severe anemia by simeprevir versus telaprevir-based triple therapy for chronic hepatitis C.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kawano, A; Kotoh, K; Koyanagi, T; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K, 2015
)
0.42
" Moreover, ITPA genotype and age may be useful for individualizing treatment to reduce the risk of anemia-related adverse effects."( Comparative safety study on severe anemia by simeprevir versus telaprevir-based triple therapy for chronic hepatitis C.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kawano, A; Kotoh, K; Koyanagi, T; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K, 2015
)
0.42
"There is little information regarding the incidence of bacterial infections as an adverse effect of telaprevir (TVR)-based triple therapy."( Bacterial infection as an adverse effect of telaprevir-based triple therapy for chronic hepatitis C infection.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kawano, A; Kotoh, K; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K; Tanabe, Y, 2015
)
0.42
" Commonly observed adverse drug reactions included fever, hair fall, fatigue, anemia, and diarrhea."( Safety and efficacy of Qurse-e-istisqua in chronic hepatitis C infection: an exploratory study.
Aslam, M; Chopra, D; Manak, S; Rehan, HS; Siddiqui, KM; Wardhan, N; Yadav, M,
)
0.13
" One patient discontinued LDV-SOF because of an adverse event (AE)."( Ledipasvir and sofosbuvir in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis: An integrated safety and efficacy analysis.
Afdhal, N; Bourlière, M; Ding, X; Dvory-Sobol, H; Feld, JJ; Gane, E; Hyland, R; Knox, S; Lawitz, E; Mangia, A; Marcellin, P; McHutchison, JG; Mizokami, M; Omata, M; Pang, P; Pol, S; Reddy, KR; Subramanian, GM; Sulkowski, M; Symonds, W; Welzel, TM; Yang, J; Zeuzem, S, 2015
)
0.42
"This analysis suggests that 12 weeks of LDV-SOF is safe and effective for treatment-naïve patients with HCV genotype 1 and compensated cirrhosis."( Ledipasvir and sofosbuvir in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis: An integrated safety and efficacy analysis.
Afdhal, N; Bourlière, M; Ding, X; Dvory-Sobol, H; Feld, JJ; Gane, E; Hyland, R; Knox, S; Lawitz, E; Mangia, A; Marcellin, P; McHutchison, JG; Mizokami, M; Omata, M; Pang, P; Pol, S; Reddy, KR; Subramanian, GM; Sulkowski, M; Symonds, W; Welzel, TM; Yang, J; Zeuzem, S, 2015
)
0.42
" The occurrence of anemia and hyperamylasemia was associated with SFTS patients receiving ribavirin therapy, which might be adverse event of this drug administration."( Common adverse events associated with ribavirin therapy for Severe Fever with Thrombocytopenia Syndrome.
Cao, WC; Cui, N; Fan, YD; Guo, CT; Hu, JG; Liu, W; Lu, QB; Qin, SL; Wang, HY; Wang, LY; Yang, ZD; Zhang, SY; Zhang, XA, 2015
)
0.42
" Sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12) and the rate of discontinuations due to adverse events (AE) were evaluated."( Boceprevir or Telaprevir Based Triple Therapy against Chronic Hepatitis C in HIV Coinfection: Real-Life Safety and Efficacy.
Bhagani, S; Collado, A; de Los Santos-Gil, I; Delgado, M; Fehr, J; Haberl, A; López-Cortés, LF; Lutz, T; Mandorfer, M; Márquez, M; Mauss, S; Munteanu, DI; Neukam, K; Pineda, JA; Rivero, A; Rivero-Juárez, A; Rockstroh, JK; Scholten, S; Stoeckle, M, 2015
)
0.42
" We analyzed treatment-emergent adverse events (AEs) and laboratory abnormalities in patients who were randomized to 8, 12, and 24 weeks of LDV/SOF with or without RBV."( Safety and tolerability of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic hepatitis C virus genotype 1 infection: Analysis of phase III ION trials.
Afdhal, N; Alqahtani, SA; Ding, X; Fried, M; Gordon, SC; Kowdley, KV; Kwo, P; Mangia, A; Marcellin, P; McHutchison, JG; Pang, PS; Pound, D; Reddy, KR; Sulkowski, M; Yang, JC; Zeuzem, S, 2015
)
0.42
"8%) discontinued treatment due to adverse events."( Efficacy and safety of low accelerating dose regimen of interferon/ribavirin antiviral therapy in patients with hepatitis C virus recurrence after liver transplantation.
Gao, Y; Li, H; Liu, Z; Su, H; Sun, Y; Tang, R; Zhang, D; Zhang, M; Zhou, S; Zhou, X, 2015
)
0.42
" 1%), adverse events (AEs) requiring hospitalization (22% vs."( Safety and Efficacy of Simeprevir/Sofosbuvir in Hepatitis C-Infected Patients With Compensated and Decompensated Cirrhosis.
Dasgupta, A; Nyberg, A; Nyberg, L; Pauly, M; Piasecki, B; Ready, J; Redd, J; Saxena, V; Terrault, NA; Winston, B, 2015
)
0.42
" Frequency of adverse safety outcomes were similar to matched untreated controls, suggesting that safety events reflect the natural history of cirrhosis and are not related to treatment."( Safety and Efficacy of Simeprevir/Sofosbuvir in Hepatitis C-Infected Patients With Compensated and Decompensated Cirrhosis.
Dasgupta, A; Nyberg, A; Nyberg, L; Pauly, M; Piasecki, B; Ready, J; Redd, J; Saxena, V; Terrault, NA; Winston, B, 2015
)
0.42
" Adverse events included eye stye, insomnia, and pain from an infiltrated intravenous line."( Pharmacokinetics and safety of co-administered paritaprevir plus ritonavir, ombitasvir, and dasabuvir in hepatic impairment.
Awni, WM; Bernstein, BM; Ding, B; Dutta, S; Khatri, A; Lawitz, EJ; Marbury, TC; Menon, RM; Mullally, VM; Podsadecki, TJ, 2015
)
0.42
" The incidence of adverse effects, such as anemia, severe rash, and the elevation of serum creatinine, was markedly higher in the telaprevir group."( Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non-cirrhotic patients with chronic hepatitis C virus genotype 1b infection.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kawano, A; Kotoh, K; Koyanagi, T; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K, 2015
)
0.42
" DCV + ASV had lower adverse events rates than comparators."( Comparative efficacy and safety of daclatasvir/asunaprevir versus IFN-based regimens in genotype 1b hepatitis C virus infection.
Behl, AS; Betts, KA; Kalsekar, A; Li, J; Signorovitch, JE; Song, Y; Sorg, RA, 2015
)
0.42
" Interferon-based treatments are associated with a high incidence of adverse effects."( Prevalence and detection of neuropsychiatric adverse effects during hepatitis C treatment.
Faus, MJ; Gallego, A; Guardiola, JM; Mangues, MA; Masip, M; Pagès, N; Torras, X; Tuneu, L, 2015
)
0.42
"The aim of the study was to evaluate neuropsychiatric adverse effects of interferon-based treatment for chronic hepatitis C in standard multidisciplinary clinical practice."( Prevalence and detection of neuropsychiatric adverse effects during hepatitis C treatment.
Faus, MJ; Gallego, A; Guardiola, JM; Mangues, MA; Masip, M; Pagès, N; Torras, X; Tuneu, L, 2015
)
0.42
"Neuropsychiatric adverse effects were evaluated in relation to severity, management and outcome."( Prevalence and detection of neuropsychiatric adverse effects during hepatitis C treatment.
Faus, MJ; Gallego, A; Guardiola, JM; Mangues, MA; Masip, M; Pagès, N; Torras, X; Tuneu, L, 2015
)
0.42
" During treatment, we detected 1679 neuropsychiatric adverse effects in 618 patients (86."( Prevalence and detection of neuropsychiatric adverse effects during hepatitis C treatment.
Faus, MJ; Gallego, A; Guardiola, JM; Mangues, MA; Masip, M; Pagès, N; Torras, X; Tuneu, L, 2015
)
0.42
"Neuropsychiatric adverse effects during interferon-based treatments in patients with chronic hepatitis C were common but mostly mild or moderate."( Prevalence and detection of neuropsychiatric adverse effects during hepatitis C treatment.
Faus, MJ; Gallego, A; Guardiola, JM; Mangues, MA; Masip, M; Pagès, N; Torras, X; Tuneu, L, 2015
)
0.42
" However, the treatment may be associated with important adverse effects and a high economic impact."( [Cost-effectiveness and safety of telaprevir and boceprevir for chronic hepatitis C in real-world clinical practice].
Clemente-Ricote, G; García-González, X; Giménez-Manzorro, Á; Ochoa-Palominos, A; Rodríguez-González, CG; Sanjurjo-Sáez, M, 2015
)
0.42
" We evaluated sustained virological response, the cost per patient achieving sustained virological response, and the cost of the supportive treatment for adverse events associated with triple therapy."( [Cost-effectiveness and safety of telaprevir and boceprevir for chronic hepatitis C in real-world clinical practice].
Clemente-Ricote, G; García-González, X; Giménez-Manzorro, Á; Ochoa-Palominos, A; Rodríguez-González, CG; Sanjurjo-Sáez, M, 2015
)
0.42
" Due to adverse events, 8 (13."( [Cost-effectiveness and safety of telaprevir and boceprevir for chronic hepatitis C in real-world clinical practice].
Clemente-Ricote, G; García-González, X; Giménez-Manzorro, Á; Ochoa-Palominos, A; Rodríguez-González, CG; Sanjurjo-Sáez, M, 2015
)
0.42
" Due to adverse events, a high number of patients required supportive care, whose costs should be added to those of triple therapy."( [Cost-effectiveness and safety of telaprevir and boceprevir for chronic hepatitis C in real-world clinical practice].
Clemente-Ricote, G; García-González, X; Giménez-Manzorro, Á; Ochoa-Palominos, A; Rodríguez-González, CG; Sanjurjo-Sáez, M, 2015
)
0.42
" Treatment was well tolerated overall with more than one-half (57%) reporting no adverse events."( Safety and efficacy of simeprevir plus sofosbuvir with or without ribavirin in patients with decompensated genotype 1 hepatitis C cirrhosis.
Barnes, M; Gautam, M; Gonzalez, S; Habib, A; Mantry, P; McAfee, J; Modi, AA; Nazario, H; Teachenor, O; Trotter, JF; Tujague, L; Weinstein, J, 2016
)
0.43
" Fever was the most frequently reported side effect occurring in 98."( Safety and Efficacy of Combined Treatment with Pegylated Interferon Alpha-2b and Ribavirin for HCV Genotype 4 in Children.
Besheer, M; El-Karaksy, HM; El-Raziky, MS; Mogahed, EA; Mubarak, S; Saleh, D, 2016
)
0.43
" Correction of adverse events was held lower dosages of interferon and/or ribavirin."( [Effectiveness and safety of antiviral therapy of military personnel suffering from chronic hepatitis C].
Gusev, DA; Kozlov, KV; Shakhmanov, DM; Shishkin, MK; Sukachev, VS; Zhabrov, SS; Zhdanov, KV, 2015
)
0.42
" Sustained virological response at 12 weeks, treatment-emergent adverse events (AEs), and graded laboratory abnormalities were analyzed according to age group."( Safety and efficacy of ledipasvir/sofosbuvir for the treatment of genotype 1 hepatitis C in subjects aged 65 years or older.
Afdhal, NH; Eggleton, E; Knox, SJ; Kowdley, K; Mangia, A; Mizokami, M; Omata, M; Pang, P; Park, SH; Saab, S; Subramanian, M; Zhu, Y, 2016
)
0.43
" This study aimed to compare severe adverse events (SAEs) amongst therapeutic combinations for HCV in a community clinic setting."( Adverse events associated with ribavirin in sofosbuvir-based therapies for patients with chronic hepatitis C: A community practice experience.
Chang, PW; Huynh, TT; Rosinski, AA; Tong, LT; Tong, MJ, 2016
)
0.43
" Adverse events were recorded from baseline to 12 or 24 weeks of treatment."( Adverse events associated with ribavirin in sofosbuvir-based therapies for patients with chronic hepatitis C: A community practice experience.
Chang, PW; Huynh, TT; Rosinski, AA; Tong, LT; Tong, MJ, 2016
)
0.43
" Conversely, sofosbuvir plus simeprevir reached similar SVR rates at week 12 post-treatment compared to all ribavirin-containing regimens, but with significantly fewer adverse events (P = 0."( Adverse events associated with ribavirin in sofosbuvir-based therapies for patients with chronic hepatitis C: A community practice experience.
Chang, PW; Huynh, TT; Rosinski, AA; Tong, LT; Tong, MJ, 2016
)
0.43
"The previous standard treatment for chronic hepatitis C (CHC) patients, comprising a combination of pegylated interferon (IFN) and ribavirin, was associated with suboptimal efficacy and severe adverse reactions."( Sofosbuvir-based therapy for patients with chronic hepatitis C: Early experience of its efficacy and safety in Korea.
Cho, EJ; Cho, Y; Kim, YJ; Lee, JH; Yoon, JH; Yu, SJ, 2015
)
0.42
" Only five patients (20%) experienced minor adverse events, including grade 1 fatigue and headache."( Sofosbuvir-based therapy for patients with chronic hepatitis C: Early experience of its efficacy and safety in Korea.
Cho, EJ; Cho, Y; Kim, YJ; Lee, JH; Yoon, JH; Yu, SJ, 2015
)
0.42
"In a real clinical practice, sofosbuvir-based therapy for CHC patients in Korea achieved optimal antiviral efficacy with insignificant adverse events."( Sofosbuvir-based therapy for patients with chronic hepatitis C: Early experience of its efficacy and safety in Korea.
Cho, EJ; Cho, Y; Kim, YJ; Lee, JH; Yoon, JH; Yu, SJ, 2015
)
0.42
" In this pharmacokinetic study, sofosbuvir full dose (400mg once daily) administered every day with another direct antiviral agent did not accumulate in hemodialysis patients and was safe and effective."( Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C.
Bernard Chabert, B; Descamps, D; Desnoyer, A; Fontaine, H; Gervais, A; Harent, S; Heurgué-Berlot, A; Hillaire, S; Laradi, A; Larrouy, L; Lê, MP; Muret, P; Peytavin, G; Pinto, A; Pospai, D; Salmon, D; Simonpoli, AM; Yazdanpanah, Y; Zucman, D, 2016
)
0.43
" Cases were patients who experienced hepatic decompensation and/or serious adverse events (SAE) during or within one month of completing treatment."( Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus.
Agarwal, R; Ahmad, J; Bach, N; Bansal, M; Bichoupan, K; Branch, A; Chang, C; Dieterich, D; Friedman, S; Gardenier, D; Grewal, P; Harty, A; Im, G; Khaitova, V; Kim-Schluger, L; Ku, L; Leong, J; Liu, L; Motamed, D; Ng, M; Odin, J; Patel, N; Perumalswami, P; Schiano, T; Yalamanchili, R, 2016
)
0.43
" In orthotopic liver transplantation (OLT) recipients, the interferon-free treatment of HCV re-infection with novel direct-acting antivirals has been demonstrated to be safe and effective in clinical trials, but real-world data are missing."( Efficacy and safety of sofosbuvir/ledipasvir for the treatment of patients with hepatitis C virus re-infection after liver transplantation.
Ciesek, S; Costa, R; Klempnauer, J; Lohse, AW; Lüthgehetmann, M; Manns, MP; Mix, H; Nashan, B; Otto, B; Pischke, S; Polywka, S; Proske, V; Sterneck, M; von Hahn, T; Wedemeyer, H, 2016
)
0.43
" Regarding safety, adverse events and serious adverse events were more frequently reported in patients taking concomitant ARAs, though baseline population differences may have played a role."( Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With or Without Ribavirin in HCV-Infected Patients Taking Concomitant Acid-Reducing Agents.
Asselah, T; Bennett, M; Forns, X; Liu, L; Moller, J; Pedrosa, M; Planas Vila, R; Reau, N; Rustgi, V; Shiffman, ML, 2016
)
0.43
" HCV treatment was discontinued for adverse events in 17% of patients."( Addition of boceprevir to PEG-interferon/ribavirin in HIV-HCV-Genotype-1-coinfected, treatment-experienced patients: efficacy, safety, and pharmacokinetics data from the ANRS HC27 study.
Alric, L; Bellissant, E; Bourlière, M; Carrieri, P; Colson, P; Garraffo, R; Ghosn, J; Halfon, P; Molina, JM; Naqvi, A; Piroth, L; Poizot-Martin, I; Renault, A; Solas, C, 2016
)
0.43
" Skin eruptions and isolated cases of severe cutaneous adverse reactions (SCAR) have been reported."( [Cutaneous adverse events of telaprevir/peginterferon/ribavirin therapy for chronic hepatitis C: A multicenter prospective cohort study].
Botta, D; Gaudy-Marqueste, C; Grob, JJ; Lorcy, S; Mancini, J; Oulies, V; Portal, I; Quiles, N; Richard, MA, 2016
)
0.43
"Our aim was to assess the incidence of skin eruption and the clinical characteristics of mucocutaneous adverse events (AE), and to identify potential risk factors for telaprevir-associated skin eruption."( [Cutaneous adverse events of telaprevir/peginterferon/ribavirin therapy for chronic hepatitis C: A multicenter prospective cohort study].
Botta, D; Gaudy-Marqueste, C; Grob, JJ; Lorcy, S; Mancini, J; Oulies, V; Portal, I; Quiles, N; Richard, MA, 2016
)
0.43
" There were no serious adverse events (AEs), discontinuations due to AEs or grade 3/4 elevations in total and/or direct bilirubin."( Efficacy and safety of grazoprevir + ribavirin for 12 or 24 weeks in treatment-naïve patients with hepatitis C virus genotype 1 infection.
Baruch, Y; Ben Ari, Z; Bhanja, S; Bruck, R; Gane, E; Howe, AY; Hwang, P; Mollison, L; Robertson, MN; Wahl, J; Zhao, Y; Zuckerman, E, 2016
)
0.43
" Patients with GT3 HCV were analyzed to assess predictors of treatment response and adverse events using descriptive statistics and multivariable logistic regression."( Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study.
Akushevich, L; Di Bisceglie, AM; Feld, JJ; Frazier, LM; Fried, MW; Kuo, A; Maan, R; Mailliard, M; Manns, MP; Nelson, DR; Schmidt, M; Sherman, K; Sterling, R; Vainorius, M; Zeuzem, S, 2016
)
0.43
" Therefore, rOC43-ns2DelRluc represents a promising safe and sensitive platform for high-throughput antiviral screening and quantitative analysis of viral replication."( Safe and Sensitive Antiviral Screening Platform Based on Recombinant Human Coronavirus OC43 Expressing the Luciferase Reporter Gene.
Desforges, M; Liu, G; Shen, L; Talbot, PJ; Tan, W; Yang, Y; Ye, F, 2016
)
0.43
"Many adverse drug reactions are caused by the cytochrome P450 (CYP)-dependent activation of drugs into reactive metabolites."( Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
Jones, LH; Nadanaciva, S; Rana, P; Will, Y, 2016
)
0.43
" Adverse events were reported in 11 patients (46%) and were managed clinically without discontinuation of therapy."( Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection.
Amundsen, BM; Chandraker, A; Chung, RT; Chute, D; Curry, MP; Elias, N; Gabardi, S; Hanifi, JM; Heher, EC; Lin, MV; Pavlakis, M; Riella, LV; Rutherford, AE; Sise, ME, 2016
)
0.43
" Common adverse events (AEs) included fatigue, anaemia, nausea, headache, insomnia, rash and flu-like symptoms."( Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study.
Akushevich, L; Alqahtani, S; Darling, J; Di Bisceglie, A; Frazier, LM; Fried, MW; Galati, JS; Kuo, A; Lim, JK; Morelli, G; Nelson, DR; Pockros, P; Reddy, RK; Sulkowski, MS; Vainorius, M; Welzel, TM; Zeuzem, S, 2017
)
0.46
"In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection."( Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study.
Akushevich, L; Alqahtani, S; Darling, J; Di Bisceglie, A; Frazier, LM; Fried, MW; Galati, JS; Kuo, A; Lim, JK; Morelli, G; Nelson, DR; Pockros, P; Reddy, RK; Sulkowski, MS; Vainorius, M; Welzel, TM; Zeuzem, S, 2017
)
0.46
" Safety outcomes were presented by the incidence of adverse events."( Effectiveness and Safety of Ombitasvir-Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin for HCV Genotype 1 Infection for 12 Weeks Under Routine Clinical Practice.
Chamorro-de-Vega, E; Collado Borrell, R; Escudero-Vilaplana, V; Fernandez-Llamazares, CM; Gimenez-Manzorro, A; Herranz, A; Ibañez-Garcia, S; Lallana Sainz, E; Lobato Matilla, E; Lorenzo-Pinto, A; Manrique-Rodriguez, S; Marzal-Alfaro, M; Ribed, A; Rodriguez-Gonzalez, CG; Romero Jimenez, RM; Sanjurjo, M; Sarobe Gonzalez, C, 2016
)
0.43
" Adverse events occurred in 91."( Effectiveness and Safety of Ombitasvir-Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin for HCV Genotype 1 Infection for 12 Weeks Under Routine Clinical Practice.
Chamorro-de-Vega, E; Collado Borrell, R; Escudero-Vilaplana, V; Fernandez-Llamazares, CM; Gimenez-Manzorro, A; Herranz, A; Ibañez-Garcia, S; Lallana Sainz, E; Lobato Matilla, E; Lorenzo-Pinto, A; Manrique-Rodriguez, S; Marzal-Alfaro, M; Ribed, A; Rodriguez-Gonzalez, CG; Romero Jimenez, RM; Sanjurjo, M; Sarobe Gonzalez, C, 2016
)
0.43
" Combination of peginterferon/ribavirin with first generation direct acting antivirals is less effective and associated with serious adverse events."( von Willebrand factor antigen (vWF-Ag): A non-invasive predictor of treatment response and serious adverse events in HCV patients with interferon triple therapy.
Etschmaier, A; Ferenci, P; Ferlitsch, A; Ferlitsch, M; Hametner, S; Hofer, H; Horvatits, T; Maieron, A; Paternostro, R; Peck-Radosavljevic, M; Quehenberger, P; Reiberger, T; Rutter, K; Salzl, P; Trauner, M, 2016
)
0.43
" The combination of elbasvir/grazoprevir also demonstrated a superior safety and tolerability profile based on fewer serious adverse events, no serious drug-related adverse events, and no treatment discontinuations."( Efficacy and safety of elbasvir/grazoprevir and sofosbuvir/pegylated interferon/ribavirin: A phase III randomized controlled trial.
Asante-Appiah, E; Barr, E; Flisiak, R; Gerstoft, J; Halota, W; Horvath, G; Jancoriene, L; Kazenaite, E; Kileng, H; Koklu, S; Leiva, R; Nguyen, BY; Patel, S; Platt, HL; Prinzing, R; Qiu, J; Ruiz-Tapiador, JA; Sperl, J; Streinu-Cercel, A; Urbanek, P; Wahl, J; Werling, K, 2016
)
0.43
" Interferon-based hepatitis C virus (HCV) therapy is safe and effective among people receiving opioid substitution therapy (OST), but treatment uptake remains low."( Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials.
Brainard, DM; Bronowicki, JP; Brown, A; Carr, V; Dore, GJ; Grebely, J; Kreter, B; Mauss, S; Natha, M; Puoti, M; Wyles, D; Yang, J; Yun, C; Zhu, Y, 2016
)
0.43
"28), and serious adverse events (4% vs 3%; P = ."( Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials.
Brainard, DM; Bronowicki, JP; Brown, A; Carr, V; Dore, GJ; Grebely, J; Kreter, B; Mauss, S; Natha, M; Puoti, M; Wyles, D; Yang, J; Yun, C; Zhu, Y, 2016
)
0.43
" Therapy was discontinued because of severe adverse events (SAEs) in 39% of cases and virological inefficacy in 24%."( Efficacy and safety of boceprevir-based triple therapy in HCV cirrhotic patients awaiting liver transplantation (ANRS HC29 BOCEPRETRANSPLANT).
Alric, L; Anty, R; Beaulieux, F; Botta-Fridlund, D; Bouix, C; Canva, V; Carrieri, MP; Conti, F; D'Alteroche, L; Duclos-Vallée, JC; Durand, F; Duvoux, C; Fontaine, H; Lebray, P; Leroy, V; Maynard, M; Métivier, S; Pageaux, GP; Paul, C; Petrov-Sanchez, V; Pradat, P; Roche, B; Roque-Afonso, AM; Samuel, D; Vilotitch, A; Wellems, C, 2017
)
0.46
" Adverse events occurred in 151 (72."( Real-world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study.
Berak, H; Bialkowska, J; Bolewska, B; Fleischer-Stępniewska, K; Flisiak, R; Garlicki, A; Halota, W; Horban, A; Jabłkowski, M; Janczewska, E; Jaroszewicz, J; Karpińska, E; Karwowska, K; Knysz, B; Kryczka, W; Lucejko, M; Madej, G; Mozer-Lisewska, I; Nazzal, K; Piekarska, A; Pisula, A; Rostkowska, K; Simon, K; Tomasiewicz, K; Tronina, O; Tudrujek, M; Wawrzynowicz-Syczewska, M; Wiercińska-Drapało, A; Zarębska-Michaluk, D, 2016
)
0.43
" The primary outcome measures were the sustained virological response weeks 12 (SVR12) post-treatment and adverse events (AEs)."( Efficacy and Safety of Ribavirin with Sofosbuvir Plus Ledipasvir in Patients with Genotype 1 Hepatitis C: A Meta-Analysis.
He, QF; Zhang, DZ; Zhang, QF, 2016
)
0.43
"This study compares the safety profiles of pegylated interferon (PEG-IFN) α-2a and α-2b administered in combination with ribavirin, based on the variable of time to withdrawal from treatment due to adverse events."( Comparison of the Safety Profiles of Pegylated Interferon α-2a and α-2b Administered in Combination with Ribavirin for Chronic Hepatitis C Infection: A Real-World Retrospective Cohort Study.
Hawke, P; Ide, K; Imai, T; Kawasaki, Y; Masaki, N; Sato, I; Yamada, H, 2016
)
0.43
"Excellent SVR12 rates and the favorable side-effect profile of DAA-combination therapy can be well translated into "real-world"."( Second-generation direct-acting-antiviral hepatitis C virus treatment: Efficacy, safety, and predictors of SVR12.
Beck, R; Berg, CP; Egetemeyr, DP; Lauer, UM; Malek, NP; Schwarz, JM; Werner, CR, 2016
)
0.43
" Among the side effects of this therapy, alopecia universalis is a rarely reported side effect which causes significant cosmetic concern to the patient."( Alopecia universalis as a side effect of pegylated interferon α-ribavirin combination therapy for hepatitis C: a rare case report.
Amrani, A; Dayal, S; Jain, VK; Verma, P, 2017
)
0.46
" The most common adverse event (AE) in elderly patients was a grade 2 anaemia (35."( Efficacy and safety of sofosbuvir/simeprevir plus flat dose ribavirin in genotype 1 elderly cirrhotic patients: A real-life study.
Ascione, A; Barbarini, G; Ceccherini-Silberstein, F; D'Ambrosio, C; Ettorre, GM; Fondacaro, L; Giannelli, V; Ialongo, P; Izzi, A; Marignani, M; Messina, V; Moretti, A; Pace Palitti, V; Pellicelli, AM; Perno, CF; Sacco, R; Scifo, G; Siciliano, M; Tarquini, P; Vignally, P, 2017
)
0.46
"Sofosbuvir/simeprevir plus a daily flat dose of RBV 800 mg for 12 weeks was highly effective and safe in genotype 1 elderly patients with compensated cirrhosis."( Efficacy and safety of sofosbuvir/simeprevir plus flat dose ribavirin in genotype 1 elderly cirrhotic patients: A real-life study.
Ascione, A; Barbarini, G; Ceccherini-Silberstein, F; D'Ambrosio, C; Ettorre, GM; Fondacaro, L; Giannelli, V; Ialongo, P; Izzi, A; Marignani, M; Messina, V; Moretti, A; Pace Palitti, V; Pellicelli, AM; Perno, CF; Sacco, R; Scifo, G; Siciliano, M; Tarquini, P; Vignally, P, 2017
)
0.46
" The most common adverse effect was anemia (hemoglobin <10 g/dL), especially for patients aged ≥ 65 with the inosine triphosphate pyrophosphatase CC genotype at rs1127354 (26."( Effectiveness and safety of sofosbuvir plus ribavirin for HCV genotype 2 patients 65 and over with or without cirrhosis.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Higashi, N; Kajiwara, E; Kato, M; Kawano, A; Koyanagi, T; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K, 2016
)
0.43
" Secondary end-points of the study include SVR 4, virological relapse and appearance of adverse events."( Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in "real-life" cohort.
Bhayani, V; Kabrawala, M; Mehta, R; Nandaniya, P; Nandwani, S; Shah, M; Tekriwal, R, 2016
)
0.43
"9 %) patients reported adverse events during the course of sofosbuvir-based treatment."( Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in "real-life" cohort.
Bhayani, V; Kabrawala, M; Mehta, R; Nandaniya, P; Nandwani, S; Shah, M; Tekriwal, R, 2016
)
0.43
"Sofosbuvir-based treatment is safe and efficacious in clinical practice in Indian patients with HCV genotype-1 and genotype-3 infection."( Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in "real-life" cohort.
Bhayani, V; Kabrawala, M; Mehta, R; Nandaniya, P; Nandwani, S; Shah, M; Tekriwal, R, 2016
)
0.43
" Nine patients (15%) had ≥ 1 drug-related serious adverse event and 7 (11%) discontinued all study drugs due to an adverse event."( Twice-Daily Telaprevir for Posttransplant Genotype 1 Hepatitis C Virus: A Prospective Safety, Efficacy, and Pharmacokinetics Study.
Brown, KA; Brown, RS; Fontana, RJ; Levitsky, J; Rubin, RA; Russo, MW; Vargas, H; Yoshida, EM, 2018
)
0.48
" Adverse events were similar to, but exceeded, those in immunocompetent patients."( Twice-Daily Telaprevir for Posttransplant Genotype 1 Hepatitis C Virus: A Prospective Safety, Efficacy, and Pharmacokinetics Study.
Brown, KA; Brown, RS; Fontana, RJ; Levitsky, J; Rubin, RA; Russo, MW; Vargas, H; Yoshida, EM, 2018
)
0.48
"Paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without ribavirin is effective and safe in patients with genotype 1 HCV infection in real-life clinical setting in Hong Kong."( Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong.
But, DY; Chan, CK; Chan, HL; Chan, KH; Fung, J; Hui, YT; Lai, CL; Lai, MS; Lam, YS; Lao, WC; Li, C; Lui, GC; Seto, WK; Tsang, OT; Wong, GL; Wong, VW; Yuen, MF, 2017
)
0.46
" We included in the analysis demographic, clinical, and virologic data and details of serious adverse events (SAEs), including mortality rate 6 months after treatment."( Efficacy and Safety of Therapy With Simeprevir and Sofosbuvir in Liver Transplant Recipients Infected by Hepatitis C Virus Genotype 4: Cohort Spanish Society of Liver Transplantation Cohort.
Castells, L; Fernandez Vazquez, I; Herrero, JI; Londoño, M; Narvaez Rodriguez, I; Otero, A; Pascasio, JM; Prieto, M; Sanchez Antolin, G; Testillano, M, 2016
)
0.43
"3%) had serious adverse events, including three deaths (1."( Effectiveness and safety of sofosbuvir-based regimens plus an NS5A inhibitor for patients with HCV genotype 3 infection and cirrhosis. Results of a multicenter real-life cohort.
Alonso, S; Ampuero, J; Badia, E; Baliellas, C; Buti, M; Carrión, JA; Castro, Á; Devesa, MJ; Esteban, R; Fernandez, I; Fernandez-Carrillo, C; Fernández-Rodríguez, CM; Gea, F; Gómez, A; Granados, R; Lens, S; Llerena, S; Montero, JL; Olveira, A; Pascasio, JM; Planas, JM; Polo, B; Real, Y; Rincón, D; Riveiro-Barciela, M; Rubín, A; Salmeron, J; Turnes, J, 2017
)
0.46
" LDV- SOF plus RBV therapy had significantly higher rate of the overall adverse events (RR=0."( Efficacy and Safety of Ledipasvir/Sofosbuvir with and without Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: a meta-analysis.
Chen, Y; Jiang, X; Song, Y; Tao, T, 2017
)
0.46
"This meta-analysis suggests that LDV-SOF based therapy is a safe and effective treatment for patients with GT 1 HCV."( Efficacy and Safety of Ledipasvir/Sofosbuvir with and without Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: a meta-analysis.
Chen, Y; Jiang, X; Song, Y; Tao, T, 2017
)
0.46
" The safety data available for LDV/SOF±RBV and OBV/PTV/r±DSV±RBV show that discontinuation due to adverse events was necessary in no more than 3% of patients and the frequency of serious adverse events was between 0 and 11%, in particular in real-world studies."( Hepatitis C: efficacy and safety in real life.
Flisiak, R; Flisiak-Jackiewicz, M; Pogorzelska, J, 2017
)
0.46
" The safety analysis showed more adverse events and a stronger decline of haemoglobin for RBV containing regimens."( Real-world use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection.
Berg, T; Böker, KH; Cornberg, M; Günther, R; Hüppe, D; Link, R; Manns, MP; Mauss, S; Niederau, C; Petersen, J; Pfeiffer-Vornkahl, H; Sarrazin, C; Schober, A; Serfert, Y, 2017
)
0.46
" The most common adverse events (AEs) were rash and/or pruritus (23."( Safety and effectiveness of a 12-week course of sofosbuvir and simeprevir ± ribavirin in HCV-infected patients with or without HIV infection: a multicentre observational study.
Angarano, G; Bruno, G; Buccoliero, G; Dell'Acqua, R; Fabrizio, C; Fasano, M; Giammario, A; Ladisa, N; Milano, E; Milella, M; Minniti, S; Saracino, A; Scudeller, L; Tartaglia, A, 2017
)
0.46
" The primary endpoint was dropout from treatment due to adverse events during the relevant standard treatment duration based on guidelines from the Japan Society of Hepatology."( The Safety Profile of Telaprevir-Based Triple Therapy in Clinical Practice: A Retrospective Cohort Study.
Ide, K; Iketani, R; Kawasaki, Y; Masaki, N; Yamada, H, 2017
)
0.46
" No deaths, serious adverse events (AEs), Grade 4 AEs or AEs leading to treatment discontinuation occurred."( Efficacy, safety and pharmacokinetics of simeprevir and TMC647055/ritonavir with or without ribavirin and JNJ-56914845 in HCV genotype 1 infection.
Arastéh, K; Bourgeois, S; Buggisch, P; Francque, S; Hoeben, E; Horsmans, Y; Jacquemyn, B; Kakuda, TN; Luo, D; Moreno, C; Nevens, F; Orlent, H; Schattenberg, JM; Van Remoortere, P; Van Vlierberghe, H; Vandebosch, A; Verloes, R; Vijgen, L, 2017
)
0.46
" Details of serious adverse events (SAEs) were recorded."( Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort.
Albillos, A; Ampuero, J; Arenas, J; Bañares, R; Calleja, JL; Crespo, J; Diago, M; Fernandez, I; García-Eliz, M; García-Samaniego, J; Gea, F; Jorquera, F; Lens, S; Llaneras, J; Llerena, S; Mariño, Z; Morillas, RM; Muñoz, R; Navascues, CA; Pascasio, JM; Perelló, C; Rincón, D; Rodriguez, CF; Ruiz-Antorán, B; Sacristán, B; Serra, MA; Simon, MA; Torras, X; Turnes, J, 2017
)
0.46
" Serious adverse events were reported in 3% (8 of 264) patients and no patient had a decompensation-related event."( Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Barr, E; Haber, BA; Hézode, C; Howe, AYM; Hwang, P; Jacobson, IM; Kwo, PY; Lawitz, E; Peng, CY; Robertson, M; Wahl, J, 2017
)
0.46
" Most common adverse events (AEs) were fatigue, neutropenia, anemia, asthenia and headache."( Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study.
Ackerman, P; Berenguer, J; Cheinquer, H; Côté, P; Dieterich, D; Eley, T; Fessel, WJ; Gadano, A; Hernandez, D; Hughes, E; Lazzarin, A; Liu, Z; Matthews, G; McPhee, F; Mendez, P; Molina, JM; Moreno, C; Noviello, S; Pineda, JA; Pulido, F; Rivero, A; Rockstroh, J; Sulkowski, MS; Zakharova, N, 2017
)
0.46
"In this study, a nationwide database was used to identify the risk factors for treatment discontinuation due to adverse events during telaprevir, peginterferon, and ribavirin (T/PR) treatment, and estimate the increase in the occurrence of adverse events when patients have multiple risk factors at the same time."( Risk Factors for Treatment Discontinuation Caused by Adverse Events When Using Telaprevir, Peginterferon, and Ribavirin to Treat Chronic Hepatitis C: A Real-World Retrospective Cohort Study.
Ide, K; Iketani, R; Kawasaki, Y; Masaki, N, 2017
)
0.46
" Rates of discontinuation due to adverse events (AEs) (3."( Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients.
Conway, B; Lazzarin, A; Luetkemeyer, A; Molina, JM; Nelson, M; Portsmouth, S; Romanova, S; Rubio, R; Srinivasan, S; Xu, D, 2017
)
0.46
"8%) reporting adverse events."( Efficacy and Safety of Direct Acting Antivirals for the Treatment of Mixed Cryoglobulinemia.
Almarzooqi, S; Emery, JS; Feld, JJ; Janssen, HLA; Kowgier, M; Kuczynski, M; La, D; Shah, H; Wong, D, 2017
)
0.46
" The combination was generally well tolerated, with an adverse event profile consistent with that observed in previous clinical trials of SMV or DCV separately."( Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation: The Phase II SATURN study.
Andreone, P; Berenguer, M; Calleja, JL; Cieciura, T; Donato, MF; Durlik, M; Fagiuoli, S; Forns, X; Herzer, K; Janssen, K; Jessner, W; Kalmeijer, R; Lenz, O; Mariño, Z; Ouwerkerk-Mahadevan, S; Peeters, M; Shukla, U; Sterneck, M; Verbinnen, T, 2017
)
0.46
" The therapy was found to be reasonably safe with no major adverse effects noted with the use of sofosbuvir, ledipasvir or daclatasvir."( Sofosbuvir-based treatment is safe and effective in Indian hepatitis C patients on maintenance haemodialysis: A retrospective study.
Akhil, MS; Arumugam, K; Ganesh Prasad, NK; Kirushnan, B; Martin, M; Ravichandran, R, 2018
)
0.48
" Other correlates with adverse events of clinical importance included concomitant ribavirin treatment, sex, race, and presence of cirrhosis, consistent with previous observations."( Exposure-Safety Response Relationship for Ombitasvir, Paritaprevir/Ritonavir, Dasabuvir, and Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: Analysis of Data from Five Phase II and Six Phase III Studies.
Awni, W; DaSilva-Tillmann, B; Dutta, S; Lin, CW; Liu, W; Menon, R; Podsadecki, T; Shulman, N, 2017
)
0.46
" Clinical and laboratory adverse events (AEs) were recorded from baseline to FU12."( Real-World Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir/+Dasabuvir±Ribavirin (OBV/PTV/r/+DSV±RBV) Therapy in Recurrent Hepatitis C Virus (HCV) Genotype 1 Infection Post-Liver Transplant: AMBER-CEE Study.
Bolewska, B; Buivydiene, A; Durlik, M; Flisiak, R; Jabłkowski, M; Jakutiene, J; Karpińska, E; Karwowska, KM; Katzarov, K; Kupcinskas, L; Pisula, A; Rostkowska, K; Simonova, M; Tolmane, I; Tronina, O; Wawrzynowicz-Syczewska, M, 2017
)
0.46
" The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pre-treatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment."( Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 - final results of the REV1TAL study.
Bollipo, S; Cheng, W; Chivers, S; Dore, G; Fragomeli, V; Galhenage, S; Gazzola, A; George, J; Gow, P; Iser, D; Jones, T; Levy, M; Lubel, J; MacQuillan, G; Mitchell, JL; Nazareth, S; Pianko, S; Roberts, SK; Sasadeusz, J; Strasser, S; Stuart, KA; Thompson, A; Tse, E; Wade, A; Weltman, M; Wigg, A; Zekry, A, 2017
)
0.46
" Baseline demographic, clinical and laboratory information, on-treatment biochemical, virological and haematological indices and details on serious adverse events were collected locally."( Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 - final results of the REV1TAL study.
Bollipo, S; Cheng, W; Chivers, S; Dore, G; Fragomeli, V; Galhenage, S; Gazzola, A; George, J; Gow, P; Iser, D; Jones, T; Levy, M; Lubel, J; MacQuillan, G; Mitchell, JL; Nazareth, S; Pianko, S; Roberts, SK; Sasadeusz, J; Strasser, S; Stuart, KA; Thompson, A; Tse, E; Wade, A; Weltman, M; Wigg, A; Zekry, A, 2017
)
0.46
" Although the most frequent adverse event was anemia, no patients discontinued the use of either ribavirin or sofosbuvir."( Effectiveness and safety of community-based treatment with sofosbuvir plus ribavirin for elderly patients with genotype 2 chronic hepatitis C.
Abe, H; Arai, T; Atsukawa, M; Iio, E; Itokawa, N; Iwakiri, K; Kato, K; Kondo, C; Okubo, T; Shimada, N; Tanaka, Y; Tsubota, A, 2017
)
0.46
"Treatment with sofosbuvir/ribavirin for genotype 2-infected CHC was effective and safe even for elderly patients, although the incidence of adverse events including ribavirin-related anemia was relatively high."( Effectiveness and safety of community-based treatment with sofosbuvir plus ribavirin for elderly patients with genotype 2 chronic hepatitis C.
Abe, H; Arai, T; Atsukawa, M; Iio, E; Itokawa, N; Iwakiri, K; Kato, K; Kondo, C; Okubo, T; Shimada, N; Tanaka, Y; Tsubota, A, 2017
)
0.46
" Adverse events were generally mild and transient."( Effectiveness and safety of ledipasvir/sofosbuvir±ribavirin in the treatment of HCV infection: The real-world HARVEST study.
Augustyniak, K; Badurek, A; Baka-Ćwierz, B; Berak, H; Białkowska, J; Flisiak, R; Garlicki, A; Gietka, A; Janczewska, E; Kozielewicz, D; Mazur, W; Mozer-Lisewska, I; Musialik, J; Nowak, K; Olszok, I; Piekarska, A; Pleśniak, R; Sikorska, K; Simon, K; Stolarz, W; Tomasiewicz, K; Wawrzynowicz-Syczewska, M; Zarębska-Michaluk, D; Łucejko, M, 2017
)
0.46
"Treatment with LDV/SOF±RBV is an effective and safe option for patients with HCV, including those with advanced liver disease or a history of non-response to PEG-IFN-based therapy."( Effectiveness and safety of ledipasvir/sofosbuvir±ribavirin in the treatment of HCV infection: The real-world HARVEST study.
Augustyniak, K; Badurek, A; Baka-Ćwierz, B; Berak, H; Białkowska, J; Flisiak, R; Garlicki, A; Gietka, A; Janczewska, E; Kozielewicz, D; Mazur, W; Mozer-Lisewska, I; Musialik, J; Nowak, K; Olszok, I; Piekarska, A; Pleśniak, R; Sikorska, K; Simon, K; Stolarz, W; Tomasiewicz, K; Wawrzynowicz-Syczewska, M; Zarębska-Michaluk, D; Łucejko, M, 2017
)
0.46
" Combination of Interferon and Ribavirin is the current anti-HCV therapy in practice and is associated with certain hematologic adverse effects."( Hematologic adverse effects and efficacy monitoring in chronic Hepatitis C patients treated with interferon and ribavirin combination therapy.
Ashraf, M; Bukhsh, A; Gul, A; Khiljee, S; Omer, MO; Rafique, G, 2017
)
0.46
"To compare the rate of treatment discontinuation due to adverse events for telaprevir-based triple (T/PR) and pegylated interferon-alfa-2b and ribavirin (PR) therapy for the treatment of hepatitis C virus (HCV) infection in patients over the age of 65 years, in Japan."( Safety Profile of Telaprevir-Based Triple Therapy in Elderly Patients: A Real-World Retrospective Cohort Study.
Akutagawa, M; Ide, K; Iketani, R; Kawasaki, Y; Masaki, N; Yamada, H; Yamanaka, M, 2017
)
0.46
" The number and percentage of patients with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs consistent with hepatic decompensation were reported."( Safety of the 2D/3D direct-acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis - A pooled analysis.
Cohen, DE; Cohen, E; Feld, JJ; Foster, GR; Fried, MW; Larsen, L; Mobashery, N; Nelson, DR; Poordad, F; Tatsch, F; Wedemeyer, H, 2017
)
0.46
" Data were analyzed to assess the on-treatment and off-therapy HCV viral load and on-treatment adverse events."( Real-world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without ribavirin for patients with chronic hepatitis C virus genotype 1b infection in Taiwan.
Chen, DS; Chen, PJ; Hong, CM; Kao, JH; Liu, CH; Liu, CJ; Su, TH; Tseng, TC; Yang, HC, 2018
)
0.48
" The primary efficacy endpoint was sustained virologic response 12, whereas the primary safety endpoint was drug discontinuation or occurrence of grade 3/4 adverse events."( Efficacy and Safety of Simeprevir or Daclatasvir in Combination With Sofosbuvir for the Treatment of Hepatitis C Genotype 4 Infection.
Alaseeri, A; Albenmousa, A; Albiladi, H; Alghamdi, AS; Aljarodi, M; Almugharbal, M; Alothmani, HS; Alsahafi, A; Babatin, MA; Bzeizi, KI; Sanai, FM,
)
0.13
" Adverse events occurred in 32% of patients (grade 1 and 2), but none discontinued treatment."( Efficacy and Safety of Simeprevir or Daclatasvir in Combination With Sofosbuvir for the Treatment of Hepatitis C Genotype 4 Infection.
Alaseeri, A; Albenmousa, A; Albiladi, H; Alghamdi, AS; Aljarodi, M; Almugharbal, M; Alothmani, HS; Alsahafi, A; Babatin, MA; Bzeizi, KI; Sanai, FM,
)
0.13
"SMV/SOF or DCV/SOF combinations are safe and highly effective in HCV-GT4 treatment."( Efficacy and Safety of Simeprevir or Daclatasvir in Combination With Sofosbuvir for the Treatment of Hepatitis C Genotype 4 Infection.
Alaseeri, A; Albenmousa, A; Albiladi, H; Alghamdi, AS; Aljarodi, M; Almugharbal, M; Alothmani, HS; Alsahafi, A; Babatin, MA; Bzeizi, KI; Sanai, FM,
)
0.13
" In our study, we will report the real-life experience of serious adverse events (SAEs) that were reported by the National Committee for Control of Viral Hepatitis (NCCVH, Cairo, Egypt) program while treating chronic HCV using the triple therapy, sofosbuvir combined with pegylated interferon and ribavirin (PEG/RIBA/SOF), which led to premature discontinuation of treatment."( Serious Adverse Events with Sofosbuvir Combined with Interferon and Ribavirin: Real-Life Egyptian Experience.
Abdo, M; Abouelkhair, M; Doss, W; Elakel, W; Elbaz, T; Elgarem, N; Elsayed, MH; Elserafy, M; Elshazly, Y; Esmat, G; Gaballa, A; Hassany, M; Mahran, Z; Mehrez, M; Mohey, MA; Omar, A; Waked, I; Yosry, A, 2017
)
0.46
" The most common adverse events were headache (143 [22%] of 664), fatigue (129 [19%] of 664), and nausea (83 [13%] of 664)."( Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2,
Almasio, PL; Barr, E; Bruno, S; Buti, M; Butterton, JR; Dutko, FJ; Fernsler, D; Gao, W; Grandhi, A; Hassanein, TI; Huang, HC; Jancoriene, L; Lawitz, E; Li, JJ; Liu, H; Muellhaupt, B; Nguyen, BT; Pearlman, B; Plank, RM; Robertson, MN; Ruane, PJ; Shepherd, A; Su, FH; Tannenbaum, B; Vierling, JM; Wahl, J; Wan, S; Yeh, WW; Yoshida, EM, 2017
)
0.46
"02), while it increased the risk of serious adverse events (p = 0."( Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysis.
Abdel-Daim, MM; Abushouk, AI; Ahmed, H; Loutfy, SA; Menshawy, A; Mohamed, A; Negida, A, 2017
)
0.46
" No serious adverse events (AEs) were observed."( Efficacy and safety of sofosbuvir and daclatasvir in treatment of kidney transplantation recipients with hepatitis C virus infection.
Li, T; Liu, F; Qu, YD; Wang, L; Xue, Y; Zhang, LX, 2017
)
0.46
"In our cohort of cirrhotic HCV/HIV-coinfected patients, DAAs were highly safe and efficacious."( Efficacy and safety of direct antiviral agents in a cohort of cirrhotic HCV/HIV-coinfected patients.
Cairó, M; Carrion, JA; Cifuentes, C; Crespo, M; Cucurull, J; Erice, E; Force, L; Guardiola, JM; Laguno, M; Marco, A; Navarro, J; Roget, M; Vilaró, J; Vilchez, HH, 2017
)
0.46
" The safety profile was similar across treatment arms, with adverse events tending to occur more frequently among participants receiving RBV."( Efficacy and safety of 12 weeks of elbasvir ± grazoprevir ± ribavirin in participants with hepatitis C virus genotype 2, 4, 5 or 6 infection: The C-SCAPE study.
Badshah, C; Barr, E; Brown, A; Durkan, C; Foster, GR; Haber, B; Hézode, C; Lahser, F; Roberts, SK; Robertson, M; Wahl, J; Zekry, A; Zhang, B; Zuckerman, E, 2018
)
0.48
" All patients reported at least one (serious) adverse event, of which 28% of patients developed anaemia."( Peg-interferon and ribavirin treatment in HIV/HCV co-infected patients in Thailand: efficacy, safety and pharmacokinetics.
Apornpong, T; Avihingsanon, A; Burger, DM; Chaiyahong, P; Chittmittraprap, S; Colbers, A; Cuprasitrut, T; de Kanter, CTMM; Khemnark, S; Smolders, EJ; Tangkijvanich, P; Thammajaruk, N, 2018
)
0.48
" Demographic, clinical, adverse event, and virologic data were collected every 12 weeks during treatment and during the follow-up period."( Safety and Effectiveness of Ledipasvir and Sofosbuvir, With or Without Ribavirin, in Treatment-Experienced Patients With Genotype 1 Hepatitis C Virus Infection and Cirrhosis.
Akushevich, L; Ben-Ari, Z; Fried, MW; Gallant, J; Hassan, M; Kuo, A; Landis, CS; Liapakis, AM; Lim, JK; Lok, AS; Michael, L; Nelson, DR; Park, JS; Pockros, PJ; Shiffman, ML; Terrault, NA; Vainorius, M; Zeuzem, S, 2018
)
0.48
" The main endpoints were assessment of sustained virological response and serious adverse events rates."( Effectiveness and safety of original and generic sofosbuvir for the treatment of chronic hepatitis C: A real world study.
Bessone, F; Borzi, SM; Cartier, M; D'Amico, C; Descalzi, VI; Fainboim, HA; Figueroa Escuti, S; Frías, S; Gadano, AC; Gaite, LA; Galdame, OA; Haddad, L; Longo, C; Marciano, S; Marino, M; Peralta, M; Perez Ravier, R; Reggiardo, MV; Vistarini, C, 2018
)
0.48
" Direct-acting antiviral (DAA) drug regimens are safe and highly effective, allowing administration of treatment also in elderly."( Efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for the treatment of HCV genotype 1b compensated cirrhosis in patients aged 70 years or older.
Bataga, S; Brisc, C; Caruntu, FA; Chiriac, S; Cijevschi Prelipcean, C; Curescu, M; Gheorghe, L; Girleanu, I; Goldis, A; Iacob, S; Miftode, E; Mihai, C; Preda, C; Rogoveanu, I; Singeap, AM; Sporea, I; Stanciu, C; Stefanescu, G; Trifan, A, 2017
)
0.46
"To determine frequency and pattern of adverse events reporting in a subset of Pakistani population being treated for chronic hepatitis C with sofosbuvir combination therapy."( Sofosbuvir Adverse Events Profile in a Subset of Pakistani Population.
Iqbal, S; Raza, A; Yousaf, MI; Yousuf, MH, 2018
)
0.48
" Patients were screened for subjective as well as objective evidence of adverse events at regular intervals."( Sofosbuvir Adverse Events Profile in a Subset of Pakistani Population.
Iqbal, S; Raza, A; Yousaf, MI; Yousuf, MH, 2018
)
0.48
"Sofosbuvir showed less severe adverse effects in terms of symptomatology and less frequent neutropenia and thrombocytopenia as compared to previous regimens."( Sofosbuvir Adverse Events Profile in a Subset of Pakistani Population.
Iqbal, S; Raza, A; Yousaf, MI; Yousuf, MH, 2018
)
0.48
" Patients were closely monitored for treatment-related adverse effects and the potential need for adjustment in their immunosuppression."( The safety and efficacy of ledipasvir/sofosbuvir with or without ribavirin in the treatment of orthotopic liver transplant recipients with recurrent hepatitis C: real-world data.
Fung, P; Lingiah, VA; Punnoose, M; Pyrsopoulos, N; Trilianos, P, 2018
)
0.48
"The combination of LED/SOF with RBV for 12 weeks or LED/SOF for 24 weeks is very effective and safe in treating OLT recipients with RHC."( The safety and efficacy of ledipasvir/sofosbuvir with or without ribavirin in the treatment of orthotopic liver transplant recipients with recurrent hepatitis C: real-world data.
Fung, P; Lingiah, VA; Punnoose, M; Pyrsopoulos, N; Trilianos, P, 2018
)
0.48
" Our aim was to analyze the characteristics associated with the presence of adverse events in patients receiving this antiviral regimen, with ribavirin in cirrhotic patients."( Safety assessment in Child A cirrhotic patients treated with Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin.
Calina, OC; Hristea, A; Jipa, RE; Manea, ED; Olariu, C; Stefan, I,
)
0.13
" We recorded 201 adverse events in 98 (71."( Safety assessment in Child A cirrhotic patients treated with Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin.
Calina, OC; Hristea, A; Jipa, RE; Manea, ED; Olariu, C; Stefan, I,
)
0.13
"We found a high number of adverse events, but most of them were mild or moderate and only one quarter of them required medical intervention."( Safety assessment in Child A cirrhotic patients treated with Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin.
Calina, OC; Hristea, A; Jipa, RE; Manea, ED; Olariu, C; Stefan, I,
)
0.13
" Treatment was well tolerated with 37% reporting no adverse events."( Safety and efficacy of ledipasvir/sofosbuvir with or without ribavirin in hepatitis C genotype 1 patients including those with decompensated cirrhosis who failed prior treatment with simeprevir/sofosbuvir.
Gonzales, GR; Gonzalez, SA; Modi, AA; Nazario, HE, 2018
)
0.48
" The most common adverse events recorded were fatigue, headache, nausea, asthenia, and gastrointestinal troubles."( Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4.
Abdel-Gabaar, M; Abdel-Moneim, A; Aboud, A; Ramadan, M; Zanaty, MI, 2018
)
0.48
"Patients who suffered any adverse event (AE) were 74/240 (30."( Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis.
Aghemo, A; Ascione, A; Bruno, S; Craxì, A; De Luca, M; Fontanella, L; Gasbarrini, A; Giannini, EG; Izzi, A; Marzioni, M; Melazzini, M; Messina, V; Montilla, S; Orlandini, A; Petta, S; Puoti, M; Sangiovanni, V; Trotta, MP; Villa, E; Zignego, AL, 2018
)
0.48
"Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65."( Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis.
Aghemo, A; Ascione, A; Bruno, S; Craxì, A; De Luca, M; Fontanella, L; Gasbarrini, A; Giannini, EG; Izzi, A; Marzioni, M; Melazzini, M; Messina, V; Montilla, S; Orlandini, A; Petta, S; Puoti, M; Sangiovanni, V; Trotta, MP; Villa, E; Zignego, AL, 2018
)
0.48
" Other adverse events, including dizziness, indigestion, and headache, were found in 26 (16."( Efficacy and safety of sofosbuvir plus ribavirin for Korean patients with hepatitis C virus genotype 2 infection: A retrospective multi-institutional study.
Chae, HB; Jang, JW; Kang, YW; Kim, HS; Kim, SB; Kim, SH; Kim, YM; Ko, SY; Lee, BS; Lee, JD; Lee, SH; Lee, TH; Song, IH; Song, MJ, 2018
)
0.48
" Adverse events leading to treatment discontinuations were not observed."( Effectiveness and safety of simeprevir-based regimens for hepatitis C in Italy: The STIly observational study.
Aghemo, A; Brancaccio, G; D'Offizi, G; Gaeta, GB; Giorgini, A; Hasson, H; Menzaghi, B; Palma, M; Termini, R, 2018
)
0.48
" However, information about the rate of adverse events (AEs) across different DAA regimens is limited."( Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals: a clinical randomized study.
Andersen, ES; Bukh, J; Christensen, PB; Fahnøe, U; Gerstoft, J; Kjær, MS; Laursen, AL; Mössner, B; Pedersen, MS; Røge, BT; Schønning, K; Sølund, C; Weis, N, 2018
)
0.48
" One patient had three serious adverse events, which were considered to be not related to study treatment: tooth abscess, abdominal pain, and gastroenteritis."( Safety and Efficacy of Ledipasvir-Sofosbuvir With or Without Ribavirin for Chronic Hepatitis C in Children Ages 6-11.
Arnon, R; Balistreri, WF; Bansal, S; Brainard, DM; Evans, HM; Garrison, KL; Gillis, LA; Gonzalez-Peralta, RP; Jonas, MM; Kersey, K; Lin, CH; Massetto, B; Murray, KF; Narkewicz, MR; Parhy, B; Rosenthal, P; Schwarz, K; Shao, J; Wen, J; Whitworth, S, 2018
)
0.48
" As advanced age is associated with increasing risk of development of cirrhosis and hepatocellular carcinoma, elderly patients are in special need of safe and effective antiviral therapies."( Efficacy and safety of sofosbuvir and daclatasvir with or without ribavirin in elderly patients with chronic hepatitis C virus infection.
Abdel-Samiee, M; Abdo, M; Elbaz, T; Esmat, G; Gamil, M; Hassan, EA; Moustafa, A; Omar, H; Qawzae, A; Zaghloul, AM, 2019
)
0.51
" Most adverse events (AEs) were consistent with clinical sequelae of advanced liver disease or known toxicities of ribavirin."( Efficacy and safety of sofosbuvir-velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial.
Brainard, DM; Chayama, K; De-Oertel, S; Dvory-Sobol, H; Ikeda, F; Kanda, T; Kurosaki, M; Matsuda, T; Mita, E; Nishiguchi, S; Sakamoto, M; Sakamoto, N; Stamm, LM; Takehara, T; Takikawa, Y; Tamori, A; Tanaka, Y; Tatsumi, T; Ueno, Y; Yatsuhashi, H; Zhang, G, 2019
)
0.51
" No serious adverse effects like anemia and decompensation were reported."( Direct-acting antiviral Therapy Is Safe and Effective in Pediatric Chronic Hepatitis C: The Public Health Perspective.
Dhiman, RK; Duseja, A; Grover, GS; Premkumar, M; Rathi, S; Satsangi, S; Taneja, S, 2019
)
0.51
" Demographic, clinical and virologic data were analysed, and adverse events (AEs) recorded."( Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA-C real-world cohort.
Anton, MD; Badia, E; Bonacci, M; Calleja, JL; Carmona, I; Carrión, JA; Castellote, J; Castro Urda, JL; de la Vega, J; Diago, M; Fernández, I; Fernández-Bermejo, M; Fernández-Rodríguez, C; Figueruela, B; Gallego, A; García Buey, L; García, ND; García-Samaniego, J; Gea, F; Hernández-Conde, M; Llerena, S; Menéndez, F; Molina, E; Montoliu, S; Moreno-Palomares, JJ; Moreno-Planas, JM; Morillas, RM; Pascasio, JM; Perelló, C; Piqueras Alcol, B; Romero-Gómez, M; Rosales-Zabal, JM; Salmeron, FJ; Sánchez Ruano, JJ; Souto-Rodríguez, R, 2019
)
0.51
" Adverse events were recorded for safety analysis."( Real-world effectiveness and safety of sofosbuvir plus daclatasvir with or without ribavirin for genotype 2 chronic hepatitis C in Taiwan.
Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC, 2019
)
0.51
" SOF/DCV/ribavirin regimen resulted in more adverse events, significantly higher bilirubin levels, and decline of hemoglobin during treatment than SOF/DCV regimen."( Real-world effectiveness and safety of sofosbuvir plus daclatasvir with or without ribavirin for genotype 2 chronic hepatitis C in Taiwan.
Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC, 2019
)
0.51
"SOF/DCV with or without ribavirin is highly effective and safe for patients with genotype 2 HCV infection in real-world experience in Taiwan."( Real-world effectiveness and safety of sofosbuvir plus daclatasvir with or without ribavirin for genotype 2 chronic hepatitis C in Taiwan.
Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC, 2019
)
0.51
" SOF-based therapy was well-tolerated, and no serious adverse events were reported."( Safety and efficacy of sofosbuvir-based direct-acting antiviral regimens for hepatitis C virus genotype 6 in Southwest China: Real-world experience of a retrospective study.
Chen, B; Chen, EQ; Jiang, W; Tang, H; Tao, YC; Wang, ML; Wang, YH; Wu, DB, 2019
)
0.51
" Adverse events were monitored during the treatment period."( The Efficacy and Safety of Direct-acting Antiviral Treatment for Chronic Hepatitis C Patients: A Single Center Study.
Choe, WH; Kim, AR; Kim, JH; Kwon, SY; Park, SJ; Yoo, BC, 2018
)
0.48
" The most common adverse events were anemia, dyspepsia, and insomnia."( The Efficacy and Safety of Direct-acting Antiviral Treatment for Chronic Hepatitis C Patients: A Single Center Study.
Choe, WH; Kim, AR; Kim, JH; Kwon, SY; Park, SJ; Yoo, BC, 2018
)
0.48
" A total of 4 serious adverse events were reported and considered treatment-unrelated."( Efficacy and safety of 12 weeks of daclatasvir, asunaprevir plus ribavirin for HCV genotype-1b infection without NS5A resistance-associated substitutions.
Chen, DS; Chen, PJ; Cheng, PN; Chien, RN; Chuang, WL; Hsu, SJ; Huang, CF; Huang, JF; Huang, YH; Hung, CH; Kao, JH; Lin, CY; Liu, CH; Liu, CJ; Peng, CY; Su, CW; Yu, ML, 2019
)
0.51
"Truncated regimen of DCV + ASV plus ribavirin for 12 weeks was highly effective and safe in HCV-1b patients without NS5A L31/Y93 RAS."( Efficacy and safety of 12 weeks of daclatasvir, asunaprevir plus ribavirin for HCV genotype-1b infection without NS5A resistance-associated substitutions.
Chen, DS; Chen, PJ; Cheng, PN; Chien, RN; Chuang, WL; Hsu, SJ; Huang, CF; Huang, JF; Huang, YH; Hung, CH; Kao, JH; Lin, CY; Liu, CH; Liu, CJ; Peng, CY; Su, CW; Yu, ML, 2019
)
0.51
" The treatment discontinuation rate due to adverse events (AEs) and serious AE rate were assessed for safety."( Real-world effectiveness and safety of sofosbuvir and ledipasvir with or without ribavirin for patients with hepatitis C virus genotype 1 infection in Taiwan.
Chen, DS; Chen, PJ; Hong, CM; Kao, JH; Liu, CH; Liu, CJ; Su, TH; Tseng, TC; Yang, HC, 2018
)
0.48
"Interferon-alpha (IFN-α)-based therapy is associated with several hematological adverse events in hepatitis C virus (HCV)-infected patients with advanced fibrosis."( Fib-4 Predicts Early Hematological Adverse Events Induced by Interferon-Based Triple Therapy in Chronic Hepatitis C Virus Patients.
Abushouk, AI; Al-Husseini, M; El-Raey, F; Johar, D; Mohammed, EG; Montasser, MF; Salaheldin, M; Zaky, S, 2019
)
0.51
" Sustained virologic response at post-treatment Week 12 (SVR12), adverse events (AEs) and comedication management were assessed for patients initiating treatment before 1 June 2017."( Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Back, D; Bondin, M; Bourgeois, S; Buggisch, P; Charafeddine, M; Crown, E; Curescu, M; Dorr, P; Ferenci, P; Flisiak, R; Kleine, H; Larrey, D; Marra, F; Norris, S, 2019
)
0.51
" The primary safety endpoint was treatment withdrawal rates secondary to severe adverse events."( Effectiveness and safety of daclatasvir/sofosbuvir with or without ribavirin in genotype 3 hepatitis C virus infected patients. Results in real clinical practice.
Castro-Iglesias, A; Cid-Silva, P; Delgado-Blanco, M; Margusino-Framiñán, L; Martín-Herranz, I; Mena-de-Cea, A; Pernas-Souto, B; Pertega-Díaz, S; Rodríguez-Osorio, I, 2019
)
0.51
" No patient treatment withdrawal secondary to severe adverse events was observed."( Effectiveness and safety of daclatasvir/sofosbuvir with or without ribavirin in genotype 3 hepatitis C virus infected patients. Results in real clinical practice.
Castro-Iglesias, A; Cid-Silva, P; Delgado-Blanco, M; Margusino-Framiñán, L; Martín-Herranz, I; Mena-de-Cea, A; Pernas-Souto, B; Pertega-Díaz, S; Rodríguez-Osorio, I, 2019
)
0.51
" The regimen was safe and well tolerated."( Effectiveness and safety of daclatasvir/sofosbuvir with or without ribavirin in genotype 3 hepatitis C virus infected patients. Results in real clinical practice.
Castro-Iglesias, A; Cid-Silva, P; Delgado-Blanco, M; Margusino-Framiñán, L; Martín-Herranz, I; Mena-de-Cea, A; Pernas-Souto, B; Pertega-Díaz, S; Rodríguez-Osorio, I, 2019
)
0.51
" Sustained virological response (SVR12/24) rate and serious adverse event (SAE) rate with 95% confidence intervals were aggregated."( Sofosbuvir-based regimen is safe and effective for hepatitis C infected patients with stage 4-5 chronic kidney disease: a systematic review and meta-analysis.
Chen, J; Fang, Z; Li, M; Li, Y; Lin, Q, 2019
)
0.51
" Data on treatment outcomes and adverse events (AE) were analysed in patients with available sustained virologic response 12 weeks after cessation of treatment (SVR12) information overall and by subgroups."( Real-world effectiveness and safety of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir hepatitis C treatment in a single centre in Germany.
Atanasov, PK; Buggisch, P; Lee, J; Petersen, J; Stoehr, A; Supiot, R; Ting, J; Wursthorn, K, 2019
)
0.51
" However, ribavirin is associated with adverse events that can limit its use."( Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis.
Bank, L; Bernstein, D; Epstein, M; Krishnan, P; Lucey, MR; Martinez, M; Nelson, DR; Pockros, PJ; Polepally, AR; Poordad, F; Ravendhran, N; Reindollar, R; Sedghi, S; Trinh, R; Unnebrink, K, 2019
)
0.51
"Our results show that DAAs are highly effective and safe in elderly patients."( Efficacy and safety of direct-acting antivirals for hepatitis C in the elderly: A systematic review and meta-analysis.
Graf, C; Herrmann, E; Mücke, MM; Mücke, VT; Vermehren, J; Zeuzem, S, 2019
)
0.51
" The patients were evaluated in respect of demographic, clinical and virological data, sustained virologic response (SVR) and adverse events."( [EFFICACY AND SAFETY OF OMBITASVIR/PARITAPREVIR/RITONAVIR AND DASABUVIR IN PATIENTS WITH HCV 1B GENOTYPE INFECTION: REAL WORLD DATA].
Skorokhodova, N; Tsarova, O; Zhyvytsia, D, 2019
)
0.51
" Adverse events (AEs) were reported by 61."( Efficacy and safety of a two-drug direct-acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6.
Barr, E; Burnevich, E; Buti, M; Feld, JJ; Foster, GR; Gane, E; Hanna, GJ; Jackson, B; Katchman, H; Klopfer, S; Lahser, F; Lawitz, E; Platt, HL; Rabinovitz, M; Robertson, MN; Shaughnessy, M; Tomasiewicz, K; Yeh, WW, 2019
)
0.51
"7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision."( Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice - Vie-KinD study.
Ahumada, A; Aldamiz-Echevarría, T; Baliellas, C; Barril, G; Benlloch, S; Bonet, L; Carmona, I; Castaño, MA; Castro, Á; de Álvaro, C; de Los Santos, I; Delgado, M; Devesa-Medina, MJ; García-Buey, L; García-Samaniego, J; Gea-Rodríguez, F; González-Parra, E; Gutiérrez, ML; Jiménez-Pérez, M; Laguno, M; Londoño, MC; Losa, JE; Mallolas, J; Manzanares, A; Martín-Granizo, I; Montero-Alonso, M; Montes, ML; Morán-Sánchez, S; Morano, L; Muñoz-Gómez, R; Navascués, CA; Polo-Lorduy, B; Riveiro-Barciela, M; Rivero, A; Roget, M; Serra, MÁ, 2019
)
0.51
" Direct-acting antiviral therapy is efficacious and safe even in patients with advanced liver disease and/ or previous virological failure; Model-for-End-Liver-Disease <10 and alanine aminotransferase reduction during therapy were found to be reliable predicting markers of sustained-virological-response."( Efficacy, Safety, and Predictors of Direct-acting antivirals in Hepatitis C Virus Patients with Heterogeneous Liver Diseases.
Cescon, M; De Pace, V; Galli, S; Maggi, F; Morelli, MC; Pistello, M; Ravaioli, M; Re, MC; Vero, V, 2019
)
0.51
"Sofosbuvir-based regimens are effective and safe for treating patients with chronic HCV and moderate to severe CKD, and in those with associated hepatic decompensation."( Sofosbuvir-containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment.
Abdel Haleem, H; Abdel-Razek, W; Anees, M; El-Sayed, MH; El-Serafy, M; El-Shazly, Y; Eletreby, R; Elkhouly, R; Elshenawy, M; Esmat, G; Hamdy, M; Hassany, M; Kamal, E; Kasem, G; Salama, M; Salama, R; Shafeek, A, 2020
)
0.56
" Incidence rates of liver adverse events (LAE) were calculated; Poisson regression model was used to identify factors associated with LAE."( Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts.
Bonora, S; Cingolani, A; d'Arminio Monforte, A; Lo Caputo, S; Marinaro, L; Mussini, C; Puoti, M; Rossotti, R; Saracino, A; Soria, A; Tavelli, A; Uberti-Foppa, C, 2020
)
0.56
" Adverse events were observed in 191 patients (41."( Real-Life Effectiveness and Safety of Sofosbuvir-Based Therapy in Genotype 2 Chronic Hepatitis C Patients in South Korea, with Emphasis on the Ribavirin Dose.
Chung, WJ; Jang, ES; Jeong, SH; Kim, IH; Kim, KA; Kim, YS; Lee, BS; Lee, YJ, 2020
)
0.56
"This work aims to evaluate the therapeutic survey of adverse events during antiviral treatment of hepatitis in the three major University Hospitals in Abidjan."( Pharmacological management of adverse events during treatment of chronic viral hepatitis in three Ivorian university hospitals
.
Allah-Kouadio, E; Allouka, KCE; Gnépéhi, OB; Kohi, DS; N'guessan-Irié, AG; Siransy-Kouakou, NG, 2020
)
0.56
"A retrospective cross-sectional descriptive study of 203 patients from August 1, 2015, to July 31, 2018, enumerated adverse events during antiviral treatments, drugs used for their management, and their clinical or biological impact."( Pharmacological management of adverse events during treatment of chronic viral hepatitis in three Ivorian university hospitals
.
Allah-Kouadio, E; Allouka, KCE; Gnépéhi, OB; Kohi, DS; N'guessan-Irié, AG; Siransy-Kouakou, NG, 2020
)
0.56
"Correction of the adverse events was made either using causal treatment or using symptomatic drugs."( Pharmacological management of adverse events during treatment of chronic viral hepatitis in three Ivorian university hospitals
.
Allah-Kouadio, E; Allouka, KCE; Gnépéhi, OB; Kohi, DS; N'guessan-Irié, AG; Siransy-Kouakou, NG, 2020
)
0.56
" Only four patients discontinued treatment before week 4 due to non-hepatic adverse events."( Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study.
Bunchorntavakul, C; Charatcharoenwitthaya, P; Chonprasertsuk, S; Komolmit, P; Piratvisuth, T; Sanpajit, T; Sethasine, S; Siripipattanamongkol, C; Sobhonslidsuk, A; Sukeepaisarnjaroen, W; Sutthivana, C; Tangkijvanich, P; Tanwandee, T; Wongpaitoon, V, 2020
)
0.56
" All the studies that reported the sustained virologic response (SVR) and adverse events of DAAs in HIV/HCV co-infected patients were included."( Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis.
Fan, XG; Ma, SJ; Xiong, YH; Zheng, YX, 2020
)
0.56
"6%) were the most effective combinations for HIV/HCV co-infected patients, with SVR rates of approximately 94% and above while severe adverse events were rare."( Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis.
Fan, XG; Ma, SJ; Xiong, YH; Zheng, YX, 2020
)
0.56
" GZR/EBR ± RBV was the optimal combination recommended for HIV/HCV co-infected patients based on the excellent treatment effects and insignificant adverse events."( Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis.
Fan, XG; Ma, SJ; Xiong, YH; Zheng, YX, 2020
)
0.56
" Safety was determined by adverse events and ribavirin, when combined, was administered in escalating doses to all patients with GFR <60 mL/min."( HEPATITIS C TREATMENT OF RENAL TRANSPLANT AND CHRONIC KIDNEY DISEASE PATIENTS: EFFICACY AND SAFETY OF DIRECT-ACTING ANTIVIRAL REGIMENS CONTAINING SOFOSBUVIR.
Amaral, ACC; Carvalho-Filho, RJ; Ferraz, MLG; Michels, FBL; Souza, ALDS; Vieira, GA,
)
0.13
" The treatment was well tolerated and there were no major clinically relevant adverse events, with the most prevalent being asthenia (57."( HEPATITIS C TREATMENT OF RENAL TRANSPLANT AND CHRONIC KIDNEY DISEASE PATIENTS: EFFICACY AND SAFETY OF DIRECT-ACTING ANTIVIRAL REGIMENS CONTAINING SOFOSBUVIR.
Amaral, ACC; Carvalho-Filho, RJ; Ferraz, MLG; Michels, FBL; Souza, ALDS; Vieira, GA,
)
0.13
"The direct-acting antivirals were safe and efficacious in CKD patients treated with SOF-containing regimens, with the observation of high SVR rates, good tolerability and few severe adverse events."( HEPATITIS C TREATMENT OF RENAL TRANSPLANT AND CHRONIC KIDNEY DISEASE PATIENTS: EFFICACY AND SAFETY OF DIRECT-ACTING ANTIVIRAL REGIMENS CONTAINING SOFOSBUVIR.
Amaral, ACC; Carvalho-Filho, RJ; Ferraz, MLG; Michels, FBL; Souza, ALDS; Vieira, GA,
)
0.13
" The safety variable was withdrawal secondary to severe adverse events (SAEs)."( Effectiveness and safety of sofosbuvir/velpatasvir ± ribavirin vs glecaprevir/pibrentasvir in genotype 3 hepatitis C virus infected patients.
Castro-Iglesias, Á; Cid-Silva, P; Delgado-Blanco, M; Margusino-Framiñán, L; Martín-Herranz, I; Mena-de-Cea, Á; Rotea-Salvo, S; Sanclaudio-Luhia, AI; Suárez-López, F; Vázquez-Rodríguez, P, 2020
)
0.56
"SOF/VEL±RBV or GLE/PIB are safe and effective for treating G3-HCV-infections, with a lower effectiveness in patients with advanced fibrosis F3-4."( Effectiveness and safety of sofosbuvir/velpatasvir ± ribavirin vs glecaprevir/pibrentasvir in genotype 3 hepatitis C virus infected patients.
Castro-Iglesias, Á; Cid-Silva, P; Delgado-Blanco, M; Margusino-Framiñán, L; Martín-Herranz, I; Mena-de-Cea, Á; Rotea-Salvo, S; Sanclaudio-Luhia, AI; Suárez-López, F; Vázquez-Rodríguez, P, 2020
)
0.56
" Rates of adverse events (AEs) in the patients was 59."( Real-world efficacy, safety, and clinical outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin combination therapy in patients with hepatitis C virus genotype 1 or 4 infection: The Turkey experience experience.
Asan, A; Aygen, B; Barut, Ş; Batırel, A; Bilgin, H; Çelen, MK; Çelik, İ; Demirtürk, N; Ersöz, G; Karakeçili, F; Kınıklı, S; Mıstık, R; Şimşek, F; Türker, N; Turkish Society Of Clinical Microbiology And Infectious Diseases, TSGFVHOT; Ural, O; Yıldız, O; Zararsız, G, 2020
)
0.56
" Demographic data, adverse events, renal function and metabolic profiles were recorded."( Effectiveness and safety of ledipasvir/sofosbuvir for genotype 2 chronic hepatitis C infection: Real-world experience from Taiwan.
Chang, TT; Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC; Wu, CH; Wu, IC; Yang, EH, 2021
)
0.62
" Neither drug-related severe adverse events nor discontinuation due to drug-related adverse event were reported."( Effectiveness and safety of ledipasvir/sofosbuvir for genotype 2 chronic hepatitis C infection: Real-world experience from Taiwan.
Chang, TT; Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC; Wu, CH; Wu, IC; Yang, EH, 2021
)
0.62
"Twelve weeks of LDV/SOF treatment provided an excellent and safe regimen for GT2 CHC infection, particularly in non-cirrhotic patients."( Effectiveness and safety of ledipasvir/sofosbuvir for genotype 2 chronic hepatitis C infection: Real-world experience from Taiwan.
Chang, TT; Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC; Wu, CH; Wu, IC; Yang, EH, 2021
)
0.62
" Serious adverse events were reported in 16/349 (4."( Efficacy and Safety of Ledispavir/Sofosbuvir with or without Ribavirin in patients with Decompensated Liver Cirrhosis and Hepatitis C Infection: a Cohort Study.
Baicus, C; Chifulescu, AE; Diculescu, M; Gheorghe, LS; Iacob, S; Iliescu, L; Istratescu, D; Manuc, M; Meianu, C; Pop, CS; Preda, C; Stanciu, C; Tieranu, C; Trifan, A; Tugui, L; Voiosu, T, 2020
)
0.56
" The secondary outcome includes the hospital length of stay, ventilator-free days in 28 days, median time from start of study treatment to negative nasopharyngeal swab, and adverse events."( Assessment of the efficacy and safety of Ribavirin in treatment of coronavirus-related pneumonia (SARS, MERS and COVID-19): A protocol for systematic review and meta-analysis.
Jiang, Z; Li, W; Wang, Y; Xi, X; Zhu, Y, 2020
)
0.56
"We aimed to analyze and evaluate the safety signals of ribavirin-interferon combination through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS), so as to provide reference for the rationale use of these agents in the management of relevant toxicities emerging in patients with novel coronavirus pneumonia (COVID-19)."( Assessment of the Potential Adverse Events Related to Ribavirin-Interferon Combination for Novel Coronavirus Therapy.
Hong, D; Shan, W; Zhao, Q; Zhu, J, 2020
)
0.56
"A total of 55 safety signals were detected from the top 250 adverse event reactions in 2200 reports, but 19 signals were not included in the drug labels."( Assessment of the Potential Adverse Events Related to Ribavirin-Interferon Combination for Novel Coronavirus Therapy.
Hong, D; Shan, W; Zhao, Q; Zhu, J, 2020
)
0.56
"The ADE (adverse drug event) signal detection based on FAERS is helpful to clarify the potential adverse events related to ribavirin-interferon combination for novel coronavirus therapy; clinicians should pay attention to the adverse reactions of gastrointestinal and blood systems, closely monitor the fluctuations of the platelet count, and carry out necessary mental health interventions to avoid serious adverse events."( Assessment of the Potential Adverse Events Related to Ribavirin-Interferon Combination for Novel Coronavirus Therapy.
Hong, D; Shan, W; Zhao, Q; Zhu, J, 2020
)
0.56
" Increased bilirubin was the most common grade 3 or 4 laboratory adverse event (n = 15."( Effectiveness and Safety of Interferon-Free Direct-Acting Antiviral Hepatitis C Virus Therapy in HIV/Hepatitis C Virus Coinfected Individuals: Results From a Pan-European Study.
Aho, I; Amele, S; Bhagani, S; Chkhartisvili, N; Clarke, A; Domingo, P; Falconer, K; Fonquernie, L; Jabłonowska, E; Leen, C; Lundgren, J; Maltez, F; Matulionyte, R; Mocroft, A; Peters, L; Rockstroh, J; Rodger, A; Sarcletti, M; Stephan, C; Szlavik, J; Wandeler, G; Zaccarelli, M; Østergaard, L, 2021
)
0.62
" It was associated with high risk IFN-related adverse reactions due to reduced renal clearance of IFN."( Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease: A real-life experience.
Abd-Elsalam, S; Abo-Amer, YE; Ahmed, R; Badawi, R; El-Abgeegy, M; Elguindy, AMA; Elkadeem, M; Elsergany, HF; Elshweikh, SA; Hawash, N; Mansour, L; Mohmed, AA; Soliman, MY; Soliman, S, 2020
)
0.56
" Secondary Endpoints: All causes mortality, Frequency of respiratory progression (defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support), time to defervescence (in those with fever at enrolment), frequency of requirement for supplemental oxygen or non-invasive ventilation, frequency of requirement for mechanical ventilation, frequency of serious adverse events as per DAIDS table grade of severity."( Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised controlled trial (SEV-COVID Trial): A structured summary of a study protocol for a randomized controlled trial.
Bahurupi, YA; Bandyopadhyay, A; Chikara, G; Moirangthem, B; Panda, PK; Saha, S; Singh, BC, 2020
)
0.56
" The secondary outcome measures were SVR12 stratified by the presence of decompensated cirrhosis, prior treatment, HCC, and HIV/hepatitis C virus coinfection and the occurrence rate of serious adverse events requiring treatment cessation or hospitalization."( Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort.
Ang, TL; Fock, KM; Koh, J; Kumar, LS; Kumar, R; Kwek, A; Law, NM; Lee, ZC; Li, W; Tan, J; Tan, YB; Teo, EK; Thurairajah, PH; Wong, YJ, 2021
)
0.62
" Apart from one patient who developed myositis, no other serious adverse events were observed."( Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort.
Ang, TL; Fock, KM; Koh, J; Kumar, LS; Kumar, R; Kwek, A; Law, NM; Lee, ZC; Li, W; Tan, J; Tan, YB; Teo, EK; Thurairajah, PH; Wong, YJ, 2021
)
0.62
"The SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real-world setting."( Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort.
Ang, TL; Fock, KM; Koh, J; Kumar, LS; Kumar, R; Kwek, A; Law, NM; Lee, ZC; Li, W; Tan, J; Tan, YB; Teo, EK; Thurairajah, PH; Wong, YJ, 2021
)
0.62
" Adverse effects were not observed."( Sofosbuvir-based Treatment for HCV: A Safe Option in Patients Undergoing Hemodialysis.
Farooq, MO; Malik, K; Mengal, FUA; Salim, A, 2020
)
0.56
" In conclusion Pegylated interferon based therapy showed better clinical response with less adverse events as compared to conventional interferon based therapy."( Comparative safety and efficacy of conventional interferon versus pegylated-interferon based therapy for HCV: A retrospective cohort study from Gujranwala, Pakistan.
Ahmed, M; Bashir, A; Farooq, MS; Iftikhar, U; Kamran, SH; Saeed, H; Saleem, N; Saleem, Z, 2020
)
0.56
" Body temperature returning to normal within 72 h and remaining so for 24 h was the primary outcome; release of oral herpes and adverse events were the secondary outcomes."( Efficacy and safety of interferon α-2b spray for herpangina in children: A randomized, controlled trial.
Chen, BQ; Chen, Y; Deng, JK; Dou, YL; Gan, L; Hao, JH; Lei, M; Liao, YN; Lin, AW; Long, YY; Luo, RP; Nong, GM; Wang, SN; Yan, WL; Yang, Z; Ye, YZ; Yu, H; Zhou, L, 2021
)
0.62
" No adverse reaction occurred."( Efficacy and safety of interferon α-2b spray for herpangina in children: A randomized, controlled trial.
Chen, BQ; Chen, Y; Deng, JK; Dou, YL; Gan, L; Hao, JH; Lei, M; Liao, YN; Lin, AW; Long, YY; Luo, RP; Nong, GM; Wang, SN; Yan, WL; Yang, Z; Ye, YZ; Yu, H; Zhou, L, 2021
)
0.62
" It was safe for use."( Efficacy and safety of interferon α-2b spray for herpangina in children: A randomized, controlled trial.
Chen, BQ; Chen, Y; Deng, JK; Dou, YL; Gan, L; Hao, JH; Lei, M; Liao, YN; Lin, AW; Long, YY; Luo, RP; Nong, GM; Wang, SN; Yan, WL; Yang, Z; Ye, YZ; Yu, H; Zhou, L, 2021
)
0.62
" Virological response (VR) was measured, as well as the biochemical parameters related to treatment efficacy and adverse events at baseline and after treatment, at 4 (VR4) and 12 (VR12) weeks post-treatment."( Efficacy and Safety of Ombitasvir plus Paritaprevir, Ritonavir and Ribavirin in Non-cirrhotic Treatment-naïve and Treatment-experienced Egyptians with Chronic HCV Genotype-4 Infection.
Ahmed, M; Gomaa, AA; Mansey, AE; Rabea, HM; Wahsh, EA, 2021
)
0.62
" Adverse events (A/Es) were reported in 59."( Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study.
Baek, YH; Cho, HC; Heo, NY; Hong, Y; Kang, YW; Lee, SS; Lee, SW; Park, SJ; Seo, KI; Shin, JW; Yoon, JS; Yoon, KT, 2021
)
0.62
" The secondary endpoint was virologic response rate at end-of-treatment and adverse event outcome."( Efficacy and safety of danoprevir plus sofosbuvir in GT 1, 2, 3, or 6 chronic hepatitis C patients with or without cirrhosis in China.
Feng, K; Huang, P; Ke, L; Lin, C; Liu, J; Pan, S; Yang, X; Zeng, Y, 2021
)
0.62
" The most common adverse events were hepatic steatosis, upper respiratory tract infection, hypercholesterolaemia, hypertriglyceridaemia, blood bilirubin increased, and total bile acids increased."( Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open-label, phase 2 study.
Chen, J; Gao, H; Guan, Y; Hua, R; Huang, Y; Jiang, Y; Kong, F; Li, C; Li, G; Ma, H; Mao, X; Meng, C; Niu, J; Tan, Y; Wang, J; Wang, Z; Wen, X; Wu, Q; Xin, Y; Xiong, Q; Xu, B; Zhang, X; Zhang, Y; Zhao, L, 2022
)
0.72
" It has been found that this combination may change the severity of XYP-associated adverse events (AEs)."( Clinical features of adverse events associated with Xiyanping-Ribavirin combination: A systematic review.
Chen, S; Chen, Z; Liang, A; Qiu, R; Shang, H; Sun, Y; Wang, P; Zhang, X; Zhao, C; Zheng, R, 2022
)
0.72
"To provide a comprehensive review about the clinal features of AEs of XYP-RB combination from randomized controlled trials, cohort studies, case-control studies, case reports, case series, and data from the National Adverse Drug Reaction Monitoring Information System (NADRMIS)."( Clinical features of adverse events associated with Xiyanping-Ribavirin combination: A systematic review.
Chen, S; Chen, Z; Liang, A; Qiu, R; Shang, H; Sun, Y; Wang, P; Zhang, X; Zhao, C; Zheng, R, 2022
)
0.72
" The sustained virologic response (SVR) and adverse event (AE) rates were calculated with a random-effects model."( Efficacy and safety of direct-acting antiviral therapy for hepatitis C virus in elderly patients (≥65 years old): A systematic review and meta-analysis.
Ahn, SB; An, J; Jun, DW; Ko, MJ; Lee, J; Park, DA; Yim, SY; Yoo, JJ, 2022
)
0.72
" Studies suggest ribavirin aerosol could be a safe and efficacious treatment option in the fight against coronaviruses."( A randomized, placebo-controlled study to evaluate safety and pharmacokinetics of inhaled ribavirin.
Barakat, M; Brkovic, A; Couroux, P; Israel, RJ; Pamidi, C; Patel, J; Vittitow, JL, 2022
)
0.72
"Included studies were randomized trials comparing the same SOF-based medication regimens with and without RBV in HCV patients and measuring serious adverse events (SAEs) and/or sustained virologic response at 12 weeks post-treatment (SVR-12)."( Safety and efficacy of sofosbuvir-based medication regimens with and without ribavirin in hepatitis C patients: A systematic review and meta-analysis.
Ebell, M; Elshafie, S; Trivedi-Kapoor, R, 2022
)
0.72
" In terms of safety, we monitored the development of adverse reactions, liver cytolysis, cholestasis, and hematologic disorders."( A Real-World Study to Compare the Safety and Efficacy of Paritaprevir/Ombitasvir/Ritonavir and Dasabuvir, with or without Ribavirin, in 587 Patients with Chronic Hepatitis C at the Fundeni Clinical Institute, Bucharest, Romania.
Bacinschi, X; Gales, L; Haineala, B; Iliescu, L; Mercan, A; Popescu, GC; Rodica, A; Serban, D; Toma, L; Zgura, A, 2022
)
0.72
" Methods Adults receiving 24-week SOF+RBV treatment for HCV GT3-6 infection were prospectively enrolled and observed through 24 weeks post-treatment for treatment-emergent adverse events (AEs) considered related to SOF and/or RBV by treating physicians and for a sustained virologic response at 12 and 24 weeks post-treatment (SVR12, SVR24)."( Real-world Safety and Effectiveness of 24-week Sofosbuvir and Ribavirin Treatment in Patients Infected with Rare Chronic Hepatitis C Virus Genotypes 3, 4, 5, or 6 in Japan.
Aoki, K; Force, L; Ishizaki, A; Konishi, H; Liu, LJ; Mita, E; Mizutani, H; Nakamoto, D; Ng, LJ; Shing, D, 2023
)
0.91
" This study aims to measure the urinary concentration of RBV and its main metabolites in order to evaluate the drug metabolism ability of HCV patients and to evaluate the adverse effects, such as anemia, with respect to RBV metabolite levels."( Precision Medicine: Determination of Ribavirin Urinary Metabolites in Relation to Drug Adverse Effects in HCV Patients.
Biliotti, E; Calvani, R; Capuani, G; Giampaoli, O; Miccheli, A; Sciubba, F; Spagnoli, M; Taliani, G; Tomassini, A, 2022
)
0.72
" Safety was determined by adverse effects reported in records and efficacy was documented by clearance of HCV-RNA to see ETR and SVR."( Effectiveness And Safety Of Direct Acting Antiviral Agents In Thalassaemic Patients With Chronic Hepatitis C.
Ahmed, SH; Hayat, M; Hussain, W; Memon, NA; Merchant, AA; Parkash, A,
)
0.13
"Combined Sofosbuvir and Daclatasvir were found to be effective and safe for treating HCV in Thalassaemia Major Children."( Effectiveness And Safety Of Direct Acting Antiviral Agents In Thalassaemic Patients With Chronic Hepatitis C.
Ahmed, SH; Hayat, M; Hussain, W; Memon, NA; Merchant, AA; Parkash, A,
)
0.13
" However, a comprehensive review of the adverse event (AE) profile of the DAAs is lacking."( Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study.
El-Marakby, MG; Sabri, NA; Solayman, MH, 2023
)
0.91

Pharmacokinetics

There are no pharmacokinetic reasons for initial dose adjustment of ribavirin in patients with hepatic dysfunction. Although mean Cmax increased with the severity of hepatic Dysfunction, there was no change in extent of absorption or renal clearance.

ExcerptReferenceRelevance
" We present pharmacokinetic parameters of our clinical study and examine some of the reasons for the lower toxicity found in our trials."( Clinical pharmacokinetic study of tiazofurin administered as a 1-hour infusion.
Engeler, GP; Hoffman, R; Jayaram, HN; Kneebone, P; Lapis, E; Paulik, E; Tricot, G; Weber, G; Zhen, W, 1992
)
0.28
" After a single 400 mg intravenous infusion, mean terminal plasma half-life (t1/2) was 27."( Pharmacokinetics and long-term tolerance to ribavirin in asymptomatic patients infected with human immunodeficiency virus.
Agrawal, KC; Ferencz, N; George, WJ; Hyslop, NE; Lacour, JT; Lertora, JJ; Rege, AB; VanDyke, RB, 1991
)
0.28
" To determine if this beneficial effect was due to increased delivery of drug, the pharmacokinetic properties of ribavirin and RTA when administered as an aerosol or by intraperitoneal injection were examined."( Aerosol and intraperitoneal administration of ribavirin and ribavirin triacetate: pharmacokinetics and protection of mice against intracerebral infection with influenza A/WSN virus.
Gilbert, BE; Robins, RK; Wilson, SZ; Wyde, PR, 1991
)
0.28
"A phase I and pharmacokinetic study of tiazofurin (NSC 286193), a C-nucleoside that inhibits IMP dehydrogenase, has been completed."( Phase I and pharmacokinetic study of tiazofurin (NSC 286193) administered by 5-day continuous infusion.
Bishop, J; Coates, A; Fox, R; Grygiel, J; Raghavan, D; Sampson, D; Woods, R, 1986
)
0.27
"The pharmacokinetic disposition of tiazofurin in plasma and cerebrospinal fluid was examined in rhesus monkeys."( Pharmacokinetics of tiazofurin in the plasma and cerebrospinal fluid of rhesus monkeys.
Balis, FM; Collins, JM; Grygiel, JJ; Lester, CM; Poplack, DG, 1985
)
0.27
" Tiazofurin levels were measured using a high-pressure liquid chromatography assay, and pharmacokinetic studies were performed in patients treated at each dose level."( Phase I evaluation and pharmacokinetics of tiazofurin (2-beta-D-ribofuranosylthiazole-4-carboxamide, NSC 286193).
Boldt, DH; Clark, GM; Hersh, MR; Kuhn, JG; Melink, TJ; Patton, TF; Siegler, R; Sternson, LA; Von Hoff, DD, 1985
)
0.27
" Safety and pharmacokinetic parameters were monitored; five children had comprehensive pharmacokinetic evaluations."( Safety, tolerance, and pharmacokinetics of systemic ribavirin in children with human immunodeficiency virus infection.
Connor, E; Connor, J; Lane, J; Morrison, S; Oleske, J; Sonke, RL, 1993
)
0.29
" The pharmacokinetic studies performed at weeks 4, 6, and 12 on specimens collected from the 15 individuals who completed 12 weeks of therapy revealed no pharmacokinetic interaction between ddI and ribavirin."( A phase-I study of the safety, pharmacokinetics, and antiviral activity of combination didanosine and ribavirin in patients with HIV-1 disease. AIDS Clinical Trials Group 231 Protocol Team.
Bassiakos, Y; Booth, D; Clax, PA; Connor, JD; Cooney, E; Crumpacker, CS; Erice, A; Griffith, BP; Holden-Wiltse, J; Hussey, S; Japour, AJ; Johanneson, N; Lertora, JJ; McLaren, C; Meehan, PM; Pollard, R; Timpone, J; Walesky, M; Wood, K, 1996
)
0.29
"The primary objective of this study was to determine whether pharmacokinetic interactions occurred between interferon alpha-2b (IFN) and ribavirin in patients with chronic hepatitis C infections."( Ribavirin and interferon alfa-2b in chronic hepatitis C: assessment of possible pharmacokinetic and pharmacodynamic interactions.
Bell, A; Dash, C; Dusheiko, GM; Flannery, B; Glue, P; Grellier, L; Khakoo, S; Lypnyj, D; Murray-Lyon, I; Walters, K; Wells, B, 1998
)
0.3
" Ribavirin and IFN pharmacokinetic parameters for combined ribavirin and IFN were similar to those during monotherapy with either compound, although the power of this study to detect differences was low."( Ribavirin and interferon alfa-2b in chronic hepatitis C: assessment of possible pharmacokinetic and pharmacodynamic interactions.
Bell, A; Dash, C; Dusheiko, GM; Flannery, B; Glue, P; Grellier, L; Khakoo, S; Lypnyj, D; Murray-Lyon, I; Walters, K; Wells, B, 1998
)
0.3
"There was no evidence of pharmacokinetic interactions between IFN and ribavirin in this study."( Ribavirin and interferon alfa-2b in chronic hepatitis C: assessment of possible pharmacokinetic and pharmacodynamic interactions.
Bell, A; Dash, C; Dusheiko, GM; Flannery, B; Glue, P; Grellier, L; Khakoo, S; Lypnyj, D; Murray-Lyon, I; Walters, K; Wells, B, 1998
)
0.3
" A three-compartment model was chosen for the pharmacokinetic analysis with the Akaike Information Criterion."( Pharmacokinetics and absolute bioavailability of ribavirin in healthy volunteers as determined by stable-isotope methodology.
Drusano, GL; Glue, P; Gupta, SK; McNamara, P; Nash, J; Preston, SL, 1999
)
0.3
" Pharmacokinetic sampling and tolerability assessments were performed up to 168 h post dose."( The single dose pharmacokinetics of ribavirin in subjects with chronic liver disease.
Clement, RP; Glue, P; Gupta, S; Salfi, M; Schenker, S; Zambas, D, 2000
)
0.31
" Although mean Cmax increased with the severity of hepatic dysfunction, there was no change in extent of absorption or renal clearance of ribavirin."( The single dose pharmacokinetics of ribavirin in subjects with chronic liver disease.
Clement, RP; Glue, P; Gupta, S; Salfi, M; Schenker, S; Zambas, D, 2000
)
0.31
"There are no pharmacokinetic reasons for initial dose adjustment of ribavirin in patients with hepatic dysfunction."( The single dose pharmacokinetics of ribavirin in subjects with chronic liver disease.
Clement, RP; Glue, P; Gupta, S; Salfi, M; Schenker, S; Zambas, D, 2000
)
0.31
" Loss of HCV-RNA at 24 weeks after completion of treatment was considered a response to interferon and ribavirin treatment in a logistic regression analysis of clinical and pharmacokinetic variables and treatment response in the interferon-naive patients."( Population pharmacokinetic and pharmacodynamic analysis of ribavirin in patients with chronic hepatitis C.
Glue, P; Gupta, S; Hajian, G; Jen, JF; Zambas, D, 2000
)
0.31
" Single- and multiple-dose pharmacokinetic studies and viral dynamics were assessed by serial measurements of serum concentrations of both compounds and HCV RNA, respectively, at weeks 1 and 24."( Viral dynamics and pharmacokinetics in combined interferon alfa-2b and ribavirin therapy for patients infected with hepatitis C virus of genotype 1b and high pretreatment viral load.
Akuta, N; Arase, Y; Ikeda, K; Kobayashi, M; Kumada, H; Saitoh, S; Someya, T; Suzuki, F; Suzuki, Y; Tsubota, A, 2002
)
0.31
" Pharmacokinetic analysis of ribavirin provides information on its mechanism of action and for developing more rational treatment for IFN-resistant HCV."( Viral dynamics and pharmacokinetics in combined interferon alfa-2b and ribavirin therapy for patients infected with hepatitis C virus of genotype 1b and high pretreatment viral load.
Akuta, N; Arase, Y; Ikeda, K; Kobayashi, M; Kumada, H; Saitoh, S; Someya, T; Suzuki, F; Suzuki, Y; Tsubota, A, 2002
)
0.31
" A population pharmacokinetic model was used to describe the ribavirin dose-concentration relationship and the influence of covariates."( Ribavirin dosing in chronic hepatitis C: application of population pharmacokinetic-pharmacodynamic models.
Affrime, MB; Chung, C; Glue, P; Gupta, SK; Hajian, G; Heft, S; Jen, J; Laughlin, M, 2002
)
0.31
" The aim of this study was to critically evaluate current dosage recommendations on the basis of a population pharmacokinetic analysis."( Dosage of ribavirin in patients with hepatitis C should be based on renal function: a population pharmacokinetic analysis.
Bruchfeld, A; Lindahl, K; Schvarcz, R; Ståhle, L, 2002
)
0.31
" Single- and multiple-dose pharmacokinetic studies were assessed by serial measurements of serum concentrations of both compounds at weeks 1 and 24."( Pharmacokinetics of ribavirin in combined interferon-alpha 2b and ribavirin therapy for chronic hepatitis C virus infection.
Hirose, Y; Izumi, N; Kumada, H; Tsubota, A, 2003
)
0.32
"To compare the two-stage method, a widely used analytical method in pharmacokinetic studies, with nonparametric population modeling by using the same data set for determining the oral bioavailability of ribavirin."( Comparative pharmacokinetic analysis by standard two-stage method versus nonparametric population modeling.
Drusano, GL; Preston, SL; Tam, VH, 2003
)
0.32
" Having accurate and precise estimation of population pharmacokinetic parameters and their true variances is crucial, as, at any dose, there'will be a lower probability of encountering a concentration-driven toxicity because of fewer outliers as the variance associated with the parameters decreases."( Comparative pharmacokinetic analysis by standard two-stage method versus nonparametric population modeling.
Drusano, GL; Preston, SL; Tam, VH, 2003
)
0.32
"The authors performed a pharmacokinetic study in 21 HCV-positive renal or liver transplant patients."( Ribavirin pharmacokinetics in renal and liver transplant patients: evidence that it depends on renal function.
Chatelut, E; Izopet, J; Kamar, N; Lafont, T; Manolis, E; Rostaing, L, 2004
)
0.32
"A total of 428 plasma concentrations were analyzed by a population pharmacokinetic method using the NONlinear Mixed Effect Model program."( Ribavirin pharmacokinetics in renal and liver transplant patients: evidence that it depends on renal function.
Chatelut, E; Izopet, J; Kamar, N; Lafont, T; Manolis, E; Rostaing, L, 2004
)
0.32
" We aimed to adjust the individual dose and frequency of intraventricular administration based on the peak level and half-life of ribavirin in the CSF in order to maintain the CSF ribavirin concentration at the target level."( Pharmacokinetics and effects of ribavirin following intraventricular administration for treatment of subacute sclerosing panencephalitis.
Hosoya, M; Kimura, H; Mori, K; Mori, S; Sawaishi, Y; Shigeta, S; Suzuki, H; Tomoda, A, 2004
)
0.32
" The pharmacokinetic profiles of ribavirin were assessed by the measurement of plasma concentrations."( Assessment of adverse reactions and pharmacokinetics of ribavirin in combination with interferon alpha-2b in patients with chronic hepatitis C.
Fujiyama, S; Hamada, A; Saito, H; Sasaki, Y; Uchida, M; Yamasaki, M, 2004
)
0.32
"The current study was carried out to evaluate pharmacokinetic profiles of viramidine and ribavirin in patients (n = 8 per dose group) with compensated hepatitis C infection following oral dosing of viramidine (400, 600, or 800 mg bid for 4 weeks)."( Ascending multiple-dose pharmacokinetics of viramidine, a prodrug of ribavirin, in adult subjects with compensated hepatitis C infection.
Aora, S; Gish, R; Lau, D; Lin, CC; Peterson, J; Rossi, S; Teng, A; Xu, C; Yeh, LT, 2005
)
0.33
"The intracellular triphosphorylation and plasma pharmacokinetics of lamivudine (3TC), stavudine (d4T), and zidovudine (ZDV) were assessed in a pharmacokinetic substudy, in 56 human immunodeficiency virus-hepatitis C virus (HIV-HCV) coinfected patients receiving peginterferon alfa-2a (40KD) 180 microg/week plus either placebo or ribavirin (RBV) 800 mg/day in the AIDS PEGASYS Ribavirin International Coinfection Trial."( Effect of ribavirin on intracellular and plasma pharmacokinetics of nucleoside reverse transcriptase inhibitors in patients with human immunodeficiency virus-hepatitis C virus coinfection: results of a randomized clinical study.
Back, D; Borucki, MJ; Dieterich, D; Gries, JM; Hoggard, PG; Lissen, E; Rodriguez-Torres, M; Soriano, V; Sulkowski, M; Torriani, FJ; Wang, K, 2005
)
0.33
" Pharmacokinetic sampling was performed on days 1 through 4 and 22 through 25."( Absence of clinically relevant pharmacokinetic interaction between ribavirin and tenofovir in healthy subjects.
Cheng, A; Ebrahimi, R; Kearney, BP; Mittan, A; Ramanathan, S, 2006
)
0.33
" We modeled HCV kinetics incorporating pharmacokinetic and pharmacodynamic parameters."( Pharmacodynamics of PEG-IFN alpha differentiate HIV/HCV coinfected sustained virological responders from nonresponders.
Cullen, C; Grace, M; Hussain, M; Markatou, M; Perelson, AS; Powers, KA; Ribeiro, RM; Talal, AH, 2006
)
0.33
" The pharmacokinetic profile of both peginterferons, mRNA expression of a selected group of interferon-induced gene transcripts, and serum HCV-RNA levels were assessed."( A randomised trial to compare the pharmacokinetic, pharmacodynamic, and antiviral effects of peginterferon alfa-2b and peginterferon alfa-2a in patients with chronic hepatitis C (COMPARE).
Bordens, R; Cullen, C; Cutler, D; Grace, M; Harvey, J; Jackson, M; Laughlin, M; Poo, J; Silva, M; Wagner, F, 2006
)
0.33
"A population pharmacokinetic analysis was performed using plasma concentration data (n = 7025) from 380 patients to examine the relationship between ribavirin dose and its pharmacokinetics."( Pharmacokinetics of ribavirin in patients with hepatitis C virus.
Duff, F; Jorga, K; Lamb, M; Snoeck, E; Wade, JR, 2006
)
0.33
"This study investigated the molecular and pharmacokinetic mechanisms of the enhanced antiviral efficacy associated with pegylated interferon (PEG-IFN) alpha-2b and ribavirin."( Pharmacokinetics and enhanced PKR response in patients with chronic hepatitis C treated with pegylated interferon alpha-2b and ribavirin.
Asahina, Y; Doi, F; Higaki, M; Hosokawa, T; Izumi, N; Kitamura, T; Kurosaki, M; Matsunaga, K; Miyake, S; Nakanishi, H; Tsuchiya, K; Uchihara, M; Ueda, K; Umeda, N, 2007
)
0.34
"Peginterferon alpha-2a pharmacokinetic and pharmacodynamic variability is associated with EVR in both AA and CA with HCV infection, but do not explain the racial disparity in combination treatment efficacy."( Peginterferon pharmacokinetics in African American and Caucasian American patients with hepatitis C virus genotype 1 infection.
Dowling, TC; Hoofnagle, JH; Howell, CD; Jeffers, L; Paul, M; Taylor, M; Terrault, NA; Wahed, AS, 2008
)
0.35
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"A rapid and sensitive quantitative assay method was developed for determining ribavirin pharmacokinetic in human plasma."( Rapid and sensitive HPLC-MS/MS method for pharmacokinetic assessment of ribavirin in healthy Chinese.
Chen, TF; Deng, CY; Huang, XZ; Lin, QX; Lin, SG; Liu, XY; Peng, HY; Shan, ZX; Yang, M; Yu, XY; Zhou, ZL; Zhu, P, 2008
)
0.35
"Bioequivalence of the new Russian oral ribavirin-containing agents was estimated by the pharmacokinetic and bioavailability parameters vs."( [Comparative estimation of pharmacokinetics of generic ribavirin-containing drugs].
Nisrin, A; Pisarev, VV; Savchenko, AIu; Smirnova, LB, 2008
)
0.35
" Blood samples were collected predose and up to 168 h after the first dose and at week 12 for pharmacokinetic analysis."( Pharmacokinetics and response of obese patients with chronic hepatitis C treated with different doses of PEG-IFN alpha-2a (40KD) (PEGASYS).
Bressler, B; Grippo, JF; Heathcote, EJ; Wang, K, 2009
)
0.35
"In this study we sought to characterize the relationship between several pharmacokinetic and pharmacodynamic parameters and virologic responses among HIV/hepatitis C virus genotype-1 co-infected patients receiving pegylated interferon-alpha-2b (peg-IFN2b) and ribavirin."( Therapeutic response to peg-IFN-alpha-2b and ribavirin in HIV/HCV co-infected African-American and Caucasian patients as a function of HCV viral kinetics and interferon pharmacodynamics.
Chen, G; Dewar, RL; Ferenci, P; Haagmans, BL; Kottilil, S; Levy-Drummer, RS; Masur, H; McLaughlin, M; Neumann, AU; Polis, MA; Rozenberg, L; Silva, M; Viola, MS, 2009
)
0.35
" However, peg-IFN2b concentrations and pharmacokinetic parameters, peg-IFN2b(max) and peg-IFN2b half-life, were similar in both groups and did not predict sustained virologic responders."( Therapeutic response to peg-IFN-alpha-2b and ribavirin in HIV/HCV co-infected African-American and Caucasian patients as a function of HCV viral kinetics and interferon pharmacodynamics.
Chen, G; Dewar, RL; Ferenci, P; Haagmans, BL; Kottilil, S; Levy-Drummer, RS; Masur, H; McLaughlin, M; Neumann, AU; Polis, MA; Rozenberg, L; Silva, M; Viola, MS, 2009
)
0.35
"Further studies are needed to evaluate whether these pharmacodynamic predictions are a result of differential host response to peg-IFN2b or other viral factors conferring relative resistance to peg-IFN2b."( Therapeutic response to peg-IFN-alpha-2b and ribavirin in HIV/HCV co-infected African-American and Caucasian patients as a function of HCV viral kinetics and interferon pharmacodynamics.
Chen, G; Dewar, RL; Ferenci, P; Haagmans, BL; Kottilil, S; Levy-Drummer, RS; Masur, H; McLaughlin, M; Neumann, AU; Polis, MA; Rozenberg, L; Silva, M; Viola, MS, 2009
)
0.35
" A modeling framework that includes pharmacokinetic and pharmacodynamic parameters was developed."( Pharmacodynamics of PEG-IFN-alpha-2a in HIV/HCV co-infected patients: implications for treatment outcomes.
Affonso de Araujo, ES; Barone, AA; Cotler, SJ; Dahari, H; Haagmans, BL; Layden, TJ; Neumann, AU, 2010
)
0.36
"15) and overall pharmacokinetic parameters were similar in SVRs and non-SVRs."( Pharmacodynamics of PEG-IFN-alpha-2a in HIV/HCV co-infected patients: implications for treatment outcomes.
Affonso de Araujo, ES; Barone, AA; Cotler, SJ; Dahari, H; Haagmans, BL; Layden, TJ; Neumann, AU, 2010
)
0.36
" We retrospectively assessed the pharmacodynamic effects of pegylated interferon (PEG-IFN) alfa-2a and ribavirin by evaluating the relationship between changes in hematologic parameters, body weight, and virologic response."( Association of host pharmacodynamic effects with virologic response to pegylated interferon alfa-2a/ribavirin in chronic hepatitis C.
Chung, RT; Di Bisceglie, AM; Hassanein, T; Lentz, E; Poordad, FF; Prabhakar, A; Zhou, X, 2010
)
0.36
"We examined the association between IL28B single-nucleotide polymorphism rs12979860, hepatitis C virus (HCV) kinetic, and pegylated interferon alpha-2a pharmacodynamic parameters in HIV/HCV-coinfected patients from South America."( Pharmacodynamics of PEG-IFN-[alpha]-2a and HCV response as a function of IL28B polymorphism in HIV/HCV-coinfected patients.
Barone, AA; Cotler, SJ; Dahari, H; de Araujo, ES; Layden, TJ; Melo, CE; Neumann, AU, 2011
)
0.37
" The aim of this study was to assess the safety and pharmacokinetic (PK) profile of raltegravir and ribavirin when dosed separately and together."( Pharmacokinetic and safety profile of raltegravir and ribavirin, when dosed separately and together, in healthy volunteers.
Ashby, J; Back, D; D'Avolio, A; Dickinson, L; Erlwein, OW; Garvey, L; Lamba, H; Latch, N; Legg, K; McClure, MO; Weston, R; Winston, A, 2011
)
0.37
" Nevertheless, valuable pharmacokinetic (PK) and safety data were obtained at moderate dose, with potential treatment implications for other indications."( Safety and pharmacokinetics of ribavirin for the treatment of la crosse encephalitis.
Caceres, M; Carr, R; Chebib, MG; De Los Reyes, EC; Hunt, WG; Khan, RR; McJunkin, JE; Minnich, LL; Nahata, MC; Taravath, S; Welch, CA; Whitley, RJ, 2011
)
0.37
"Although the results do not support the use of RBV for LACVE, this nevertheless is the largest study of antiviral treatment for LACVE to date and the largest pharmacokinetic analysis of IV RBV in children for any indication."( Safety and pharmacokinetics of ribavirin for the treatment of la crosse encephalitis.
Caceres, M; Carr, R; Chebib, MG; De Los Reyes, EC; Hunt, WG; Khan, RR; McJunkin, JE; Minnich, LL; Nahata, MC; Taravath, S; Welch, CA; Whitley, RJ, 2011
)
0.37
" The difference in pegylation between the two peginterferons has a significant impact on their pharmacokinetic properties."( Comparison of peginterferon pharmacokinetic and pharmacodynamic profiles.
Bruno, R; Cima, S; Fagiuoli, S; Filice, G; Maiocchi, L; Novati, S; Sacchi, P, 2012
)
0.38
" Pharmacokinetic parameters (C(max), T(max), AUC, CL/F) were estimated using noncompartmental methods."( The pharmacokinetics of peginterferon alfa-2a and ribavirin in African American, Hispanic and Caucasian patients with chronic hepatitis C.
Blotner, SD; Brennan, BJ; Grippo, JF; Hagedorn, CH; Marbury, TC; Morcos, PN; Morrison, R; Sulkowski, M; Wang, K, 2012
)
0.38
"There was no difference in the pharmacokinetic parameters for PEG-IFN alfa-2a following single-dose or steady-state administration between African American or Hispanic patients compared with Caucasian patients."( The pharmacokinetics of peginterferon alfa-2a and ribavirin in African American, Hispanic and Caucasian patients with chronic hepatitis C.
Blotner, SD; Brennan, BJ; Grippo, JF; Hagedorn, CH; Marbury, TC; Morcos, PN; Morrison, R; Sulkowski, M; Wang, K, 2012
)
0.38
"No differences were observed in PEG-IFN alfa-2a pharmacokinetic parameters between African American or Hispanic patients compared with Caucasian patients."( The pharmacokinetics of peginterferon alfa-2a and ribavirin in African American, Hispanic and Caucasian patients with chronic hepatitis C.
Blotner, SD; Brennan, BJ; Grippo, JF; Hagedorn, CH; Marbury, TC; Morcos, PN; Morrison, R; Sulkowski, M; Wang, K, 2012
)
0.38
"We report a population pharmacokinetic (PK) and pharmacodynamic (PD) model of orally administered ribavirin in patients with chronic hepatitis C virus (HCV) infection enrolled in a multicenter clinical trial, including the estimation of covariate effects on ribavirin PK parameters and sustained viral response (SVR)."( Population pharmacokinetics and pharmacodynamics of ribavirin in patients with chronic hepatitis C genotype 1 infection.
Dowling, TC; Fossler, MJ; Howell, CD; Jin, R; McHutchison, JG, 2012
)
0.38
" This article reviews the pharmacokinetic and drug interaction profile of telaprevir."( Telaprevir: pharmacokinetics and drug interactions.
Beaumont, M; Garg, V; Kauffman, RS; van Heeswijk, RP, 2012
)
0.38
" Week one PEGIFN serum concentrations in 42 HCV genotype 1-infected patients treated with conventional PEGIFN/RBV were analyzed using multicompartmental pharmacokinetic models."( Pegylated interferon fractal pharmacokinetics: individualized dosing for hepatitis C virus infection.
Alder, L; Gumbo, T; Jain, MK; Lee, WM; Pasipanodya, JG, 2013
)
0.39
" The elimination half-life of both plasma and erythrocyte RBV did not differ between the 2 phases."( Effects of dipyridamole coadministration on the pharmacokinetics of ribavirin in healthy volunteers.
Abei, M; Homma, M; Hyodo, I; Kohda, Y; Suzuki, Y, 2013
)
0.39
" Blood and urine samples were collected pre-dose and up to 168 hours post-dose for pharmacokinetic analyses."( Pharmacokinetics and safety of single-dose ribavirin in patients with chronic renal impairment.
Glue, P; Gupta, SK; Kantesaria, B, 2013
)
0.39
"In this article, the authors summarize boceprevir's pharmacokinetic and pharmacodynamic properties."( The pharmacokinetic evaluation of boceprevir for treatment of hepatitis C virus.
Bichoupan, K; Dieterich, DT; Shankar, H, 2013
)
0.39
" In a prior Phase I study, GSK2336805 was well tolerated and had an antiviral and pharmacokinetic profile suitable for once-daily administration."( A double-blind, randomized, placebo-controlled study to assess the safety, antiviral activity and pharmacokinetics of GSK2336805 when given as monotherapy and in combination with peginterferon alfa-2a and ribavirin in hepatitis C virus genotype 1-infected
Adkison, K; Cutrell, A; Elko-Simms, C; Gardner, S; Hamatake, R; Hong, Z; Rodriguez-Torres, M; Walker, J, 2014
)
0.4
" In this review we provide an overview of the clinical pharmacokinetic characteristics of these agents by describing their absorption, distribution, metabolism and excretion."( Viral hepatitis C therapy: pharmacokinetic and pharmacodynamic considerations.
Arends, JE; Burger, DM; de Kanter, CT; de Knegt, RJ; Drenth, JP; Reesink, HW; van der Valk, M, 2014
)
0.4
" Blood and urine samples were collected pre-dose and up to 168 h post-dose for pharmacokinetic analyses."( Exploring the influence of renal dysfunction on the pharmacokinetics of ribavirin after oral and intravenous dosing.
Glue, P; K Gupta, S; Kantesaria, B, 2014
)
0.4
"Blood samples for pharmacokinetic and VK analyses were collected from 51 patients enrolled in the PROGRESS study."( Induction dosing of peginterferon alfa-2a (40 KD) and/or high-dose ribavirin in genotype 1 CHC patients with difficult-to-treat characteristics: pharmacokinetic and viral kinetic (PK/VK) assessment from PROGRESS.
Brennan, BJ; DePamphilis, J; Grippo, JF; Leong, R; Morcos, PN; Thommes, JA,
)
0.13
" Plasma samples were collected through 144 hours after administration for pharmacokinetic assessments."( Pharmacokinetics and safety of co-administered paritaprevir plus ritonavir, ombitasvir, and dasabuvir in hepatic impairment.
Awni, WM; Bernstein, BM; Ding, B; Dutta, S; Khatri, A; Lawitz, EJ; Marbury, TC; Menon, RM; Mullally, VM; Podsadecki, TJ, 2015
)
0.42
" Raltegravir pharmacokinetic parameters remained unchanged whether administered on or off anti-HCV therapy."( Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir.
Barrail-Tran, A; Cheret, A; Furlan, V; Molina, JM; Piroth, L; Rosa, I; Rosenthal, E; Taburet, AM; Vincent, C, 2015
)
0.42
" Pharmacokinetic parameters were determined in rats following oral (p."( Effects of Silymarin, Glycyrrhizin, and Oxymatrine on the Pharmacokinetics of Ribavirin and Its Major Metabolite in Rats.
Fan, S; Jin, X; Li, J; Liao, S; Shi, W; Wang, J; Wang, X; Zhang, T; Zhang, W; Zhang, Z; Zhong, B, 2016
)
0.43
" In one patient receiving the once daily regimen, sofosbuvir-007 half-life was slightly higher (38h) than for patients with normal renal function receiving a full dose."( Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C.
Bernard Chabert, B; Descamps, D; Desnoyer, A; Fontaine, H; Gervais, A; Harent, S; Heurgué-Berlot, A; Hillaire, S; Laradi, A; Larrouy, L; Lê, MP; Muret, P; Peytavin, G; Pinto, A; Pospai, D; Salmon, D; Simonpoli, AM; Yazdanpanah, Y; Zucman, D, 2016
)
0.43
" In this pharmacokinetic study, sofosbuvir full dose (400mg once daily) administered every day with another direct antiviral agent did not accumulate in hemodialysis patients and was safe and effective."( Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C.
Bernard Chabert, B; Descamps, D; Desnoyer, A; Fontaine, H; Gervais, A; Harent, S; Heurgué-Berlot, A; Hillaire, S; Laradi, A; Larrouy, L; Lê, MP; Muret, P; Peytavin, G; Pinto, A; Pospai, D; Salmon, D; Simonpoli, AM; Yazdanpanah, Y; Zucman, D, 2016
)
0.43
" In this study, we present a pharmacokinetic profile of ribavirin in Atlantic salmon (Salmo salar), efficacy prediction indexes, and the measure of its withdrawal time."( Pharmacokinetics, efficacy prediction indexes, and residue depletion of ribavirin in Atlantic salmon's (Salmo salar) muscle after oral administration in feed.
Anadón, A; Araya-Jordán, C; Cornejo, J; Maddaleno, A; Martínez, MA; Muñoz, R; San Martín, B, 2016
)
0.43
" A population pharmacokinetic model for paritaprevir was developed using data from formulation, bioavailability, and drug-drug interaction studies that evaluated the pharmacokinetics of paritaprevir (coadministered with ritonavir to enhance exposure) with or without ombitasvir and/or dasabuvir at different paritaprevir dose levels."( Dose- and Formulation-Dependent Non-Linear Pharmacokinetic Model of Paritaprevir, a Protease Inhibitor for the Treatment of Hepatitis C Virus Infection: Combined Analysis from 12 Phase I Studies.
Awni, WM; Beck, D; Dutta, S; Khatri, A; Liu, W; Menon, RM; Mensing, S; Polepally, AR, 2016
)
0.43
" Coadministration of dasabuvir increased paritaprevir bioavailability by 59 %; however, ombitasvir coadministration did not affect the pharmacokinetic profile of paritaprevir."( Dose- and Formulation-Dependent Non-Linear Pharmacokinetic Model of Paritaprevir, a Protease Inhibitor for the Treatment of Hepatitis C Virus Infection: Combined Analysis from 12 Phase I Studies.
Awni, WM; Beck, D; Dutta, S; Khatri, A; Liu, W; Menon, RM; Mensing, S; Polepally, AR, 2016
)
0.43
"To evaluate the efficacy and safety of this drug regimen and the impact of the addition of boceprevir(BOC) on atazanavir (ATV) or raltegravir (RAL) pharmacokinetic parameters in a subgroup of patients."( Addition of boceprevir to PEG-interferon/ribavirin in HIV-HCV-Genotype-1-coinfected, treatment-experienced patients: efficacy, safety, and pharmacokinetics data from the ANRS HC27 study.
Alric, L; Bellissant, E; Bourlière, M; Carrieri, P; Colson, P; Garraffo, R; Ghosn, J; Halfon, P; Molina, JM; Naqvi, A; Piroth, L; Poizot-Martin, I; Renault, A; Solas, C, 2016
)
0.43
"Total exposure, measured by area under the plasma concentration-time curve (AUC), was generated for the DAAs, ritonavir, and ribavirin using population pharmacokinetic modeling of data (N = 2093 patients) from 6 Phase 3 studies and 1 Phase 2 study."( Effects of Mild and Moderate Renal Impairment on Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, and Ribavirin Pharmacokinetics in Patients with Chronic HCV Infection.
Badri, PS; Eckert, D; Menon, RM; Mensing, S; Polepally, AR, 2017
)
0.46
"The population pharmacokinetic models for each component of the 3D ± ribavirin regimen (DAAs and ritonavir, n = 2348) and ribavirin (n = 1841) adequately described their respective plasma concentration-time data."( Population pharmacokinetics of paritaprevir, ombitasvir, dasabuvir, ritonavir and ribavirin in hepatitis C virus genotype 1 infection: analysis of six phase III trials.
Awni, WM; Dutta, S; Eckert, D; Khatri, A; Menon, RM; Mensing, S; Podsadecki, TJ; Polepally, AR; Sharma, S, 2017
)
0.46
" Serial pharmacokinetic sampling was performed for calcineurin inhibitors, telaprevir, and ribavirin."( Twice-Daily Telaprevir for Posttransplant Genotype 1 Hepatitis C Virus: A Prospective Safety, Efficacy, and Pharmacokinetics Study.
Brown, KA; Brown, RS; Fontana, RJ; Levitsky, J; Rubin, RA; Russo, MW; Vargas, H; Yoshida, EM, 2018
)
0.48
" Pharmacokinetics and safety assessments were performed, and pharmacokinetic parameters were calculated using non-compartmental methods and summarized using descriptive statistics and compared statistically by geometric least-squares mean ratios and 90% confidence intervals."( Pharmacokinetics and Safety of Velpatasvir and Sofosbuvir/Velpatasvir in Subjects with Hepatic Impairment.
Brainard, DM; Curtis, C; Lasseter, K; Lawitz, E; Ling, KHJ; Marbury, T; Mathias, A; Mogalian, E; Moorehead, L; Murray, B; Osinusi, A; Perry, R, 2018
)
0.48
" A population pharmacodynamic model will be developed."( A population pharmacodynamic model characterizing neutropenia associated with pegylated interferon alpha 2-a therapy in patients with chronic hepatitis C viral infection.
Hindi, NN; Saleh, MI, 2018
)
0.48
" Expert opinion: This combination, taken orally with or without food, has an excellent pharmacokinetic and pharmacodynamic profile."( Pharmacodynamic and pharmacokinetic evaluation of the combination of daclatasvir/sofosbuvir/ribavirin in the treatment of chronic hepatitis C.
Brieva, T; Frias, M; Rivero, A; Rivero-Juarez, A, 2018
)
0.48
"Ribavirin is used in the treatment of respiratory paramyxovirus infection in lung transplant recipients; however, its pharmacokinetic profile in the transplant population is unknown despite the potential for alterations due to underlying pathology."( Population pharmacokinetics of ribavirin in lung transplant recipients and examination of current and alternative dosing regimens.
Alffenaar, JC; de Zwart, AES; Evans, AM; Glanville, AR; Marriott, DJE; Milliken, E; Reuter, SE; Riezebos-Brilman, A; Schteinman, A; Verschuuren, EAM, 2019
)
0.51
"Population pharmacokinetic modelling was conducted in NONMEM using concentration-time data from 24 lung transplant recipients and 6 healthy volunteers."( Population pharmacokinetics of ribavirin in lung transplant recipients and examination of current and alternative dosing regimens.
Alffenaar, JC; de Zwart, AES; Evans, AM; Glanville, AR; Marriott, DJE; Milliken, E; Reuter, SE; Riezebos-Brilman, A; Schteinman, A; Verschuuren, EAM, 2019
)
0.51
" Pharmacokinetic data on both calcineurin inhibitors and direct-acting antiviral exposure in liver transplant recipients remain sparse."( Comparison of the effect of direct-acting antiviral with and without ribavirin on cyclosporine and tacrolimus clearance values: results from the ANRS CO23 CUPILT cohort.
Barrail-Tran, A; Botta-Fridlund, D; Cagnot, C; Canva, V; Coilly, A; Conti, F; D'Alteroche, L; Danjou, H; De Ledinghen, V; Duclos-Vallée, JC; Durand, F; Duvoux, C; Fougerou-Leurent, C; Gelé, T; Goldwirt, L; Houssel-Debry, P; Kamar, N; Laforest, C; Lavenu, A; Leroy, V; Moreno, C; Pageaux, GP; Radenne, S; Samuel, D; Taburet, AM, 2019
)
0.51
" However, evidence for ribavirin efficacy in patients with LF is poor and pharmacokinetic (PK) data are not available."( Prospective observational study on the pharmacokinetic properties of the Irrua ribavirin regimen used in routine clinical practice in patients with Lassa fever in Nigeria.
Akhideno, P; Duraffour, S; Edeawe, O; Eifediyi, G; Erameh, C; Groger, M; Günther, S; Koch, T; Kurth, F; Oestereich, L; Ogbaini-Emovon, E; Okogbenin, S; Omansen, TF; Pahlmann, M; Ramharter, M; Sarpong, F; Wagner, C; Wicha, S, 2020
)
0.56
" The primary objective is to describe classical PK parameters for ribavirin (maximum plasma drug concentration, time to maximum plasma drug concentration, area under the plasma drug concentration vs time curve, half-life time T1/2, volume of distribution)."( Prospective observational study on the pharmacokinetic properties of the Irrua ribavirin regimen used in routine clinical practice in patients with Lassa fever in Nigeria.
Akhideno, P; Duraffour, S; Edeawe, O; Eifediyi, G; Erameh, C; Groger, M; Günther, S; Koch, T; Kurth, F; Oestereich, L; Ogbaini-Emovon, E; Okogbenin, S; Omansen, TF; Pahlmann, M; Ramharter, M; Sarpong, F; Wagner, C; Wicha, S, 2020
)
0.56
" In this two-part study, we assessed the pharmacodynamic effects and therapeutic potential of ribavirin in human papillomavirus (HPV)-related malignancies."( Pharmacodynamic and therapeutic pilot studies of single-agent ribavirin in patients with human papillomavirus-related malignancies.
Burman, B; Drutman, SB; Fury, MG; Ho, AL; Katabi, N; Pfister, DG; Wong, RJ, 2022
)
0.72
"In the pharmacodynamic study, ribavirin (400 mg BID for 14 days) was evaluated in 8 patients with HPV-positive localized oropharyngeal carcinoma with phosphorylated-eIF4E (p-eIF4E) ≥ 30%."( Pharmacodynamic and therapeutic pilot studies of single-agent ribavirin in patients with human papillomavirus-related malignancies.
Burman, B; Drutman, SB; Fury, MG; Ho, AL; Katabi, N; Pfister, DG; Wong, RJ, 2022
)
0.72
"Six patients were evaluable in the pharmacodynamic study: 4 had decreased p-eIF4E after 14 days of ribavirin."( Pharmacodynamic and therapeutic pilot studies of single-agent ribavirin in patients with human papillomavirus-related malignancies.
Burman, B; Drutman, SB; Fury, MG; Ho, AL; Katabi, N; Pfister, DG; Wong, RJ, 2022
)
0.72
" Evidence for the safety and efficacy of ribavirin in Lassa fever patients is poor and pharmacokinetic data for both regimens are lacking."( Pharmacokinetics of Ribavirin in the Treatment of Lassa Fever: An Observational Clinical Study at the Irrua Specialist Teaching Hospital, Edo State, Nigeria.
Aihonwalan, L; Akhideno, P; Akhigbe, T; Babatunde, FO; Duraffour, S; Edeawe, O; Eifediyi, G; Erameh, C; Groger, M; Günther, S; Hinrichs, M; Hinzmann, J; Kleist, CJ; Koch, T; Müller, J; Nwatuzor, J; Oestereich, L; Ogbaini-Emovon, E; Okogbenin, S; Pahlmann, M; Ramharter, M; Riedner, M; Sarpong, FN; Thielebein, A; Wagner, C; Wicha, SG, 2023
)
0.91
"Polymerase chain reaction-confirmed Lassa fever patients with mild to moderate disease severity were invited to participate in this prospective, observational pharmacokinetic study."( Pharmacokinetics of Ribavirin in the Treatment of Lassa Fever: An Observational Clinical Study at the Irrua Specialist Teaching Hospital, Edo State, Nigeria.
Aihonwalan, L; Akhideno, P; Akhigbe, T; Babatunde, FO; Duraffour, S; Edeawe, O; Eifediyi, G; Erameh, C; Groger, M; Günther, S; Hinrichs, M; Hinzmann, J; Kleist, CJ; Koch, T; Müller, J; Nwatuzor, J; Oestereich, L; Ogbaini-Emovon, E; Okogbenin, S; Pahlmann, M; Ramharter, M; Riedner, M; Sarpong, FN; Thielebein, A; Wagner, C; Wicha, SG, 2023
)
0.91
"Using a population pharmacokinetic approach, plasma concentrations of ribavirin were best described by a 3-compartment model."( Pharmacokinetics of Ribavirin in the Treatment of Lassa Fever: An Observational Clinical Study at the Irrua Specialist Teaching Hospital, Edo State, Nigeria.
Aihonwalan, L; Akhideno, P; Akhigbe, T; Babatunde, FO; Duraffour, S; Edeawe, O; Eifediyi, G; Erameh, C; Groger, M; Günther, S; Hinrichs, M; Hinzmann, J; Kleist, CJ; Koch, T; Müller, J; Nwatuzor, J; Oestereich, L; Ogbaini-Emovon, E; Okogbenin, S; Pahlmann, M; Ramharter, M; Riedner, M; Sarpong, FN; Thielebein, A; Wagner, C; Wicha, SG, 2023
)
0.91

Compound-Compound Interactions

Ribavirin has recently been demonstrated to be efficacious in combination with interferon (IFN) alpha-2b for the treatment of relapsed hepatitis C infections. This analysis evaluated the cost-effectiveness of TVR combined with pegylated Interferon alfa-2a plus ribavirin.

ExcerptReferenceRelevance
"The antiviral activities of ribavirin (1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide; virazole), either alone or in combination with recombinant human leukocyte (alpha) interferon (rHuIFN-alpha), were evaluated against feline infectious peritonitis virus (FIPV) in feline kidney-cell cultures."( Inhibitory effects of ribavirin alone or combined with human alpha interferon on feline infectious peritonitis virus replication in vitro.
Oostrom-Ram, T; Weiss, RC, 1989
)
0.28
" Inoculation of remantadine in combination with nontoxic concentrations of sodium selenite was found to be a promising combination for inhibition of experimental influenza infection."( [Antiviral action of sodium selenite and its combination with remantadine].
Abdullaev, FI; Abdullaev, II; Lazymova, ZA; Sycheva, IV; Veselovskaia, TV,
)
0.13
" Treatment with ribavirin combined with immune serum was more successful; all infected monkeys given combination treatment survived, including six treated initially on day 10."( Enhanced treatment of Lassa fever by immune plasma combined with ribavirin in cynomolgus monkeys.
Jahrling, PB; Peters, CJ; Stephen, EL, 1984
)
0.27
" They must be administered with caution during pregnancy, because some are known teratogens (e."( Adverse effects and drug interactions of clinical importance with antiviral drugs.
Morris, DJ, 1994
)
0.29
" MDL 74,428 does not also affect the inhibitory effect of ddI combined with ribavirin on the transformation in vitro of C3H/3T3 cells by Moloney murine sarcoma virus (MSV)."( Potentiating effect of (2-[2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methyl]-phenyl]ethenyl) -phosphonic acid (MDL 74,428), a potent inhibitor of purine nucleoside phosphorylase, on the antiretroviral activities of 2',3'-dideoxyinosine combined with rib
Balzarini, J; Bernhardt, A; Mamont, P; Weibel, M, 1994
)
0.29
"The effect of interferon in combination with ribavirin on the plus and minus strands of hepatitis C virus (HCV) RNA in patients with chronic hepatitis C (CHC) was studied by means of nested RT-PCR."( [The effect of interferon in combination with ribavirin on the plus and minus strands of hepatitis C virus RNA in patients with hepatitis].
He, Y; Liu, W; Zeng, L, 1996
)
0.29
"It was shown advisable to use ribavirin (a weak inhibitor of Sindbis virus reproduction) in combination with ACAA."( [Effect of the amide of 1-adamantanecarboxylic acid (AACA) and its combination with ribavirin on the course of experimental infection, caused by the sindbis virus in tissue culture and in mouse brain. Possible isolation of the virus mutant resistant to ri
Andronova, VL, 1997
)
0.3
"In mice administered with the same dose of free or conjugated [3H]ribavirin we determined the levels of radioactivity in liver and erythrocytes and measured the hepatic concentrations of ribavirin triphosphate."( Enhanced accumulation of ribavirin and its metabolites in liver versus erythrocytes in mice administered with the liver targeted drug.
Bignamini, A; Busi, C; Colonna, FP; Di Stefano, G; Fiume, L, 1997
)
0.3
"7-fold higher than in animals administered with the free drug given intramuscularly or orally, respectively."( Enhanced accumulation of ribavirin and its metabolites in liver versus erythrocytes in mice administered with the liver targeted drug.
Bignamini, A; Busi, C; Colonna, FP; Di Stefano, G; Fiume, L, 1997
)
0.3
"We randomly assigned 912 patients with chronic hepatitis C to receive standard-dose interferon alfa-2b alone or in combination with ribavirin (1000 or 1200 mg orally per day, depending on body weight) for 24 or 48 weeks."( Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group.
Albrecht, JK; Cort, S; Goodman, ZD; Gordon, SC; Lee, WM; Ling, MH; McHutchison, JG; Rustgi, VK; Schiff, ER; Shiffman, ML, 1998
)
0.3
" However, the impact of the drug combination upon lymphocyte activity is unknown."( Alpha interferon combined with ribavirin potentiates proliferative suppression but not cytokine production in mitogenically stimulated human lymphocytes.
Kimball, PM; Shiffman, ML; Verbeke, SB, 2000
)
0.31
"Interferon combined with ribavirin has efficacy in the treatment of patients with chronic hepatitis C virus (HCV) infection."( Efficacy of high-dose interferon in combination with ribavirin in patients with chronic hepatitis C resistant to interferon alone.
Bodenheimer, HC; Bodian, C; Esposito, S; Geders, JM; Goldman, IS; Jacobson, IM; Jones, JL; Klion, FM; Lebovics, E; Min, AD; Tobias, H, 2001
)
0.31
"In this study, 5 MU of IFN combined with a standard dose of ribavirin has yielded the highest rate of sustained response reported to date."( Efficacy of 5 MU of interferon in combination with ribavirin for naïve patients with chronic hepatitis C virus: a randomized controlled trial.
Andriulli, A; Attino, V; Bacca, D; Carretta, V; Cela, M; Giangaspero, A; Leandro, G; Mangi, A; Minerva, N; Ventrella, F; Villani, MR, 2001
)
0.31
"To find the criteria for optimisation of the interferon dose, to be used in combination with ribavirin in patients with hepatitis C non responders to interferon alpha monotherapy."( Pilot dose-finding trial on interferon alpha in combination with ribavirin for the treatment of chronic hepatitis C in patients not responding to interferon alone.
Barni, MC; Cadeo, GP; Carosi, G; Cristini, G; Forleo, MA; Gargiulo, F; Paraninfo, G; Puoti, M; Putzolu, V; Quiros-Roldan, E; Rossi, S; Spinetti, A; Zaltron, S; Zanini, B, 2001
)
0.31
"These results suggest that higher interferon doses administered daily in combination with ribavirin could be more effective in those patients with hepatitis C who had not responded to interferon alone."( Pilot dose-finding trial on interferon alpha in combination with ribavirin for the treatment of chronic hepatitis C in patients not responding to interferon alone.
Barni, MC; Cadeo, GP; Carosi, G; Cristini, G; Forleo, MA; Gargiulo, F; Paraninfo, G; Puoti, M; Putzolu, V; Quiros-Roldan, E; Rossi, S; Spinetti, A; Zaltron, S; Zanini, B, 2001
)
0.31
" As treatment strategies to fight cHC have been essentially ameliorated within the recent two years in using pegylated interferon-alfa2b (Peg-IFN-alfa2b) combined with ribavirin, t here is hope that the successful therapeutic outcomes in HCV-mono-infected individuals may be partly translated into benefits for the difficult-to-treat patients with HCV-HIV co-infection."( Interferon-alpha in treatment of chronic hepatitis C in co-infected HIV-patients in combination with ribavirin and as a pre-load therapy in treatment-naive HIV-positive patients. 8th European Conference on Clinical Aspects and Treatment of HIV Infection (
Tossing, G, 2002
)
0.31
" We compared the efficacy and safety of daily interferon alfa-2b in combination with ribavirin with those of interferon alfa-2b three times a week alone or in combination with ribavirin."( Daily or three times a week interferon alfa-2b in combination with ribavirin or interferon alone for the treatment of patients with chronic hepatitis C.
Bernard, PH; Bourlière, M; Canva, V; Capron, D; Chêne, G; Couzigou, P; de Lédinghen, V; Desmorat, H; Fleury, H; Foucher, J; Lévy, S; Mannant, PR; Mion, F; Trimoulet, P; Winnock, M, 2002
)
0.31
"We randomly assigned 321 patients with chronic hepatitis C to receive standard-dose interferon alfa-2b alone or in combination with ribavirin for 48 weeks or daily interferon alfa-2b (3 million units per day for 12 weeks then 3 million units three times per week for 24 weeks) and ribavirin (36 week treatment)."( Daily or three times a week interferon alfa-2b in combination with ribavirin or interferon alone for the treatment of patients with chronic hepatitis C.
Bernard, PH; Bourlière, M; Canva, V; Capron, D; Chêne, G; Couzigou, P; de Lédinghen, V; Desmorat, H; Fleury, H; Foucher, J; Lévy, S; Mannant, PR; Mion, F; Trimoulet, P; Winnock, M, 2002
)
0.31
"5 million units of interferon-alpha(2a) thrice weekly in combination with ribavirin 1,000 or 1,200 mg daily."( Interferon-alpha in combination with ribavirin for the treatment of chronic hepatitis C in patients with persistently normal aminotransferase levels.
Al-Khalid, J; Al-Mekhaizeem, K; Al-Nakib, B; Al-Shamali, M; Asker, H; Hasan, F; Siddique, I, 2002
)
0.31
"We compared the efficacy and safety of the combined therapy of daily interferon alpha-2b and ribavirin with those of interferon alpha-2b three times per week alone or in combination with ribavirin in non-responder patients with hepatitis C virus (HCV) infection."( Daily or three times per week interferon alpha-2b in combination with ribavirin or interferon alone for the treatment of patients with chronic hepatitis C not responding to previous interferon alone.
Abergel, A; Bernard, PH; Bourlière, M; Chêne, G; Couzigou, P; de Lédinghen, V; Fleury, H; Lévy, S; Portal, I; Rémy, AJ; Szostak, N; Tran, A; Trimoulet, P; Winnock, M, 2002
)
0.31
"A total of 376 patients were randomly assigned to receive interferon alpha-2b (6 MU three times per week for 24 weeks followed by 3 MU three times per week for 24 weeks) alone (group A) or in combination with ribavirin for 48 weeks (group B), or daily interferon alpha-2b (3 MU per day for 24 weeks followed by 3 MU three times per week for 24 weeks) and ribavirin (group C)."( Daily or three times per week interferon alpha-2b in combination with ribavirin or interferon alone for the treatment of patients with chronic hepatitis C not responding to previous interferon alone.
Abergel, A; Bernard, PH; Bourlière, M; Chêne, G; Couzigou, P; de Lédinghen, V; Fleury, H; Lévy, S; Portal, I; Rémy, AJ; Szostak, N; Tran, A; Trimoulet, P; Winnock, M, 2002
)
0.31
"The aim of the present, open-labelled, controlled study was to determine whether 5 MU of interferon (IFN) alpha 2b combined with a standard dose of ribavirin might increase the rate of viral clearance in all patients with chronic HCV hepatitis or at least in those with an unfavourable genotype."( High doses of interferon in combination with ribavirin are more effective than the standard regimen in patients with HCV genotype 1 chronic hepatitis.
Andriulli, A; Annese, M; Bacca, D; Carretta, V; Cela, M; Leandro, G; Mangia, A; Minerva, N; Piattelli, M; Santoro, R; Spirito, F; Ventrella, F, 2002
)
0.31
"1%) the standard 3 MU dose of IFN in combination with ribavirin (P=0."( High doses of interferon in combination with ribavirin are more effective than the standard regimen in patients with HCV genotype 1 chronic hepatitis.
Andriulli, A; Annese, M; Bacca, D; Carretta, V; Cela, M; Leandro, G; Mangia, A; Minerva, N; Piattelli, M; Santoro, R; Spirito, F; Ventrella, F, 2002
)
0.31
"Our study suggests that when treating naive patients with genotype 1, there is a significant increase in the rate of sustained virologic clearance by increasing the dose of IFN given in combination with ribavirin."( High doses of interferon in combination with ribavirin are more effective than the standard regimen in patients with HCV genotype 1 chronic hepatitis.
Andriulli, A; Annese, M; Bacca, D; Carretta, V; Cela, M; Leandro, G; Mangia, A; Minerva, N; Piattelli, M; Santoro, R; Spirito, F; Ventrella, F, 2002
)
0.31
" Higher rates of sustained response (33%) without increase of side effects have been observed in preliminary experiences with the new long-acting pegylated interferons in combination with ribavirin."( Clinical experiences with interferon as monotherapy or in combination with ribavirin in patients co-infected with HIV and HCV.
Airoldi, M; Bruno, R; Carosi, G; Castelli, F; El Hamad, I; Filice, G; Moretti, F; Puoti, M; Quiros Roldan, E; Rossi, S; Sacchi, P; Zanini, B,
)
0.13
"Patients received IFN 3 MU daily for 14 days followed by 3 MU three times a week (induction group; n = 10), or IFN 3 MU three times a week from start (standard group; n = 21), in combination with ribavirin 1000-1200 mg/day."( Viral kinetics and treatment response in patients with hepatitis C during induction and standard interferon therapy in combination with ribavirin.
Carlsson, T; Reichard, O; Weiland, O, 2002
)
0.31
" Patients were randomized for either IFN/Riba and amantadine (Ama) including a 2-week initial high IFN induction course (18 MU IFN daily) (group A) or the same 2-week IFN induction course combined with Riba/Ama, followed by Riba/Ama without IFN (group B)."( Chronic hepatitis C patients with a post-treatment virological relapse re-treated with an induction dose of 18 MU interferon-alpha in combination with ribavirin and amantadine: a two-arm randomized pilot study.
Beld, MG; Dijkgraaf, MG; Reesink, HW; Sentjens, RE; Weegink, CJ, 2003
)
0.32
"A randomized trial was conducted to assess the efficacy of daily (QD) or thrice weekly (TIW) administration of interferon-alpha (IFN) in high doses in combination with ribavirin (1."( A randomized trial to assess the efficacy of interferon alpha in combination with ribavirin in the treatment of interferon alpha nonresponders with chronic hepatitis C: superior efficacy of high daily dosage of interferon alpha in genotype 1.
Aggelis, P; Akriviadis, E; Avgerinos, A; Giannoulis, G; Goritsas, K; Hatzakis, A; Hatzis G, G; Kanatakis, S; Ketikoglou, I; Manolakopoulos, S; Paraskevas, E; Raptopoulou, M; Sypsa, V; Tassopoulos, NC; Thomopoulos, K; Tsantoulas, D; Tzathas, C; Vafiadis, I; Vassiliadis, T, 2003
)
0.32
"A randomized trial was conducted to assess the efficacy of interferon-alpha (IFN) daily in combination with ribavirin in 301 naïve patients with chronic hepatitis C (CHC)."( A randomized trial to assess the efficacy of interferon-alpha daily in combination with ribavirin in the treatment of naïve patients with chronic hepatitis C.
Anagnostopoulos, G; Hatzakis, A; Hatzis, G; Kanatakis, S; Ketikoglou, I; Raptopoulou, M; Sidiropoulos, L; Sypsa, V; Tassopoulos, NC; Tsantoulas, D; Vafiadis, I, 2003
)
0.32
"Two hundred twenty five consecutive non-responders to previous antiviral treatment(s) with IFN-alpha alone or in combination with ribavirin or amantadine were treated with IFN-alpha 2b 5 MU daily for 4 weeks, 5 MU tiw for 20 weeks, followed by 3 MU tiw for additional 24 weeks combined with ribavirin 1000-1200 mg/d."( Randomized, controlled trial with IFN-alpha combined with ribavirin with and without amantadine sulphate in non-responders with chronic hepatitis C.
Arnold, R; Berg, T; Herrmann, E; Junge, U; Kullmann, F; Lafrenz, M; Musch, E; Pascu, M; Pausch, J; Ramadori, G; Teuber, G; Weidenbach, H; Wiedmann, KH; Zankel, M; Zeuzem, S, 2003
)
0.32
"The differential tolerability profile of various interferon (IFN)-alpha preparations used in combination with ribavirin for the treatment of chronic hepatitis C needs to be elucidated."( Good safety profile and efficacy of leucocyte interferon-alpha in combination with oral ribavirin in treatment-naive patients with chronic hepatitis C: a multicentre, randomised, controlled study.
Annese, M; Babudieri, S; Bacca, D; Barbarini, G; Barbaro, G; Belloni, G; Francavilla, R; Fruttaldo, L; Grisorio, B; Hazra, C; Lucchini, A; Matarazzo, F; Rizzo, G; Torre, D, 2003
)
0.32
" Recently, we undertook an in vitro drug-drug combination analysis using surrogate model systems of HCV replication and found a reproducible synergy of antiviral effects between the two drugs at physiologically relevant drug concentrations."( Implications of finding synergic in vitro drug-drug interactions between interferon-alpha and ribavirin for the treatment of hepatitis C virus.
Buckwold, VE, 2004
)
0.32
"6%) to interferon alpha-2b in combination with ribavirin therapy."( Interferon alpha-2b in combination with ribavirin for the treatment of chronic hepatitis C: assessment of virological, biochemical and histological treatment response.
Gudinaviciene, I; Jonaitis, L; Kupcinskas, L; Petrenkiene, V, 2004
)
0.32
"0 x 10(5) copies/mL) when given with interferon (IFN)."( Effects of ribavirin combined with interferon-alpha 2b on viral kinetics during first 12 weeks of treatment in patients with hepatitis C virus genotype 1 and high baseline viral loads.
Enomoto, M; Habu, D; Kohmoto, M; Nishiguchi, S; Seki, S; Shiomi, S; Takeda, T; Tamori, A, 2004
)
0.32
" These results indicate that mizoribine in combination with IFN-alpha may have potential for the treatment of HCV infection."( Inhibition of bovine viral diarrhea virus (BVDV) by mizoribine: synergistic effect of combination with interferon-alpha.
Baba, C; Baba, M; Yanagida, K, 2004
)
0.32
" The aim of this study was to investigate the safety and tolerance to treatment with a high and individualized dose of ribavirin in combination with peginterferon."( High-dose ribavirin in combination with standard dose peginterferon for treatment of patients with chronic hepatitis C.
Bruchfeld, A; Lindahl, K; Schvarcz, R; Stahle, L, 2005
)
0.33
"Ribavirin has recently been demonstrated to be efficacious in combination with interferon (IFN) alpha-2b for the treatment of relapsed hepatitis C infections."( Assessment of adverse reactions and pharmacokinetics of ribavirin in combination with interferon alpha-2b in patients with chronic hepatitis C.
Fujiyama, S; Hamada, A; Saito, H; Sasaki, Y; Uchida, M; Yamasaki, M, 2004
)
0.32
" Since mizoribine is currently used in several clinical applications and has not been associated with severe side effects, mizoribine is considered to be of potential use as a new anti-HCV reagent in combination with IFN-alpha."( Mizoribine inhibits hepatitis C virus RNA replication: effect of combination with interferon-alpha.
Abe, K; Dansako, H; Ikeda, M; Kato, N; Naka, K, 2005
)
0.33
"Open, randomized trial was performed in 6 Italian tertiary centers: 102 of the 108 patients screened were randomized to receive 6 MIU of recombinant human IFN beta-1a subcutaneously daily for 24 wk, alone (Group 1, n = 51) or in combination with ribavirin 1,000 to 1,200 mg/d (Group 2, n = 51)."( Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C.
Alberti, A; Almasio, PL; Berrutti, M; Boccato, S; Cattaneo, C; Craxi, A; Demelia, L; Ideo, G; Pellicano, R; Picciotto, A; Rizzetto, M; Sorbello, O; Torre, F; Valenza, M; Venezia, G, 2005
)
0.33
"Recombinant human IFN beta-1a, alone or in combination with ribavirin, has an excellent safety profile and, may represent an alternative for chronic hepatitis C patients who are unable to tolerate pegylated alpha-interferon."( Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C.
Alberti, A; Almasio, PL; Berrutti, M; Boccato, S; Cattaneo, C; Craxi, A; Demelia, L; Ideo, G; Pellicano, R; Picciotto, A; Rizzetto, M; Sorbello, O; Torre, F; Valenza, M; Venezia, G, 2005
)
0.33
"To evaluate the daily high-dose induction therapy with interferon-alpha2b (IFN-alpha2b) in combination with ribavirin for the treatment of patients who failed with interferon monotherapy and had a relapse, based on the assumption that the viral burden would decline faster, thus increasing the likelihood of higher response rates in this difficult-to-treat patient group."( High-dose interferon-alpha2b induction therapy in combination with ribavirin for treatment of chronic hepatitis C in patients with non-response or relapse after interferon-alpha monotherapy.
Fischinger, J; Hass, HG; Kaiser, S; Kreysel, C; Menzel, J, 2005
)
0.33
" Treatment was started with 10 MU IFN-alpha2b daily for 3 wk, followed by IFN-alpha2b 5 MU/TIW in combination with ribavirin (1 000-1 200 mg/d) for 21 wk."( High-dose interferon-alpha2b induction therapy in combination with ribavirin for treatment of chronic hepatitis C in patients with non-response or relapse after interferon-alpha monotherapy.
Fischinger, J; Hass, HG; Kaiser, S; Kreysel, C; Menzel, J, 2005
)
0.33
"To study antiviral activity of arbidol in relation to various antigenic subtypes of influenza virus isolated from humans; efficacy of arbidol action in combination with adamantanic antiviral drugs, ribavirin and ribamidil on reproduction of influenza virus A (IVA) in cell culture."( [Sensitivity of various influenza virus strains to arbidol. Influence of arbidol combination with different antiviral drugs on reproduction of influenza virus A].
Fediakina, IT; Glushkov, RG; Gus'kova, TA; Leneva, IA, 2005
)
0.33
" The inhibiting activity of arbidolin on cell culture viral reproduction enhanced if arbidol was used in combination with amantadine, remantadin, ribavirin and ribamidil."( [Sensitivity of various influenza virus strains to arbidol. Influence of arbidol combination with different antiviral drugs on reproduction of influenza virus A].
Fediakina, IT; Glushkov, RG; Gus'kova, TA; Leneva, IA, 2005
)
0.33
" We determined the optimal ribavirin dose in an initial cohort of a phase 1 study and then subsequently used it, in combination with interferon alfa-2b, in a second cohort of this study and a phase 3 trial."( Interferon alfa-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: efficacy, safety, and pharmacokinetics.
Baczkowski, A; Geffner, M; González-Peralta, RP; Gupta, S; Haber, B; Jonas, MM; Kelly, DA; Lang, T; Laughlin, M; Lurie, Y; Martin, S; Mieli-Vergani, G; Molleston, J; Murray, KF; Shelton, M, 2005
)
0.33
" We describe a case of a HCV genotype 1b patient who had failed previous combination therapies of interferon plus ribavirin and pegylated interferon plus ribavirin and was subsequently successfully treated with a novel triple drug combination consisting of interferon-gamma plus interferon alfacon plus ribavirin with the outcome of a sustained virologic response."( Successful treatment with novel triple drug combination consisting of interferon-gamma, interferon alfacon-1, and ribavirin in a nonresponder HCV patient to pegylated interferon therapy.
Anderson, MH; Balan, V; Rakela, J; Rosati, MJ, 2006
)
0.33
" To clarify the usefulness of combination therapy with IFN and ribavirin in Japanese hepatitis C patients, we treated patients with a relatively high dose of IFN in combination with ribavirin for 24 weeks and examined the effects in relation to the viral parameters."( Twenty-four weeks of interferon alpha-2b in combination with ribavirin for Japanese hepatitis C patients: sufficient treatment period for patients with genotype 2 but not for patients with genotype 1.
Arakawa, Y; Fujiwara, K; Imazeki, F; Kato, N; Komine, F; Moriyama, M; Omata, M; Shiratori, Y; Tanaka, N; Yokosuka, O; Yoshida, H, 2006
)
0.33
"The aim of the study was to assess the cost-effectiveness of peginterferon alfa-2b (pegIFN) compared to interferon alfa-2b (IFN), both in combination with ribavirin, as initial therapy for chronic hepatitis C in Sweden."( Cost-effectiveness of peginterferon alfa-2b in combination with ribavirin as initial treatment for chronic hepatitis C in Sweden.
Bernfort, L; Reichard, O; Sennfält, K, 2006
)
0.33
"5 microg/kg) alone as monotherapy (n=16) or in combination with ribavirin (n=22), for 48 weeks."( Pegylated interferon alpha-2b as monotherapy or in combination with ribavirin in chronic hepatitis delta.
Andriulli, A; Brancaccio, G; Ciancio, A; David, E; Fontana, R; Gaeta, GB; Marrone, A; Niro, GA; Olivero, A; Perri, F; Rizzetto, M; Smedile, A; Stanzione, M, 2006
)
0.33
" We evaluated the safety, efficacy and tolerability of standard interferon-alpha in an accelerating dose regimen in combination with ribavirin in patients with HCV-induced liver cirrhosis and thrombocytopenia."( Standard interferon-alpha in combination with ribavirin for hepatitis C patients with advanced liver disease and thrombocytopenia.
Bergholz, U; Ferenci, P; Gurguta, C; Hofer, H; Steindl-Munda, P, 2006
)
0.33
" We evaluated the efficacy and safety of Viusid in combination with interferon alpha-2b (IFN alpha-2b) and ribavirin in patients with CHC."( Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C.
Gra Oramas, B; Llanio Navarro, R; Ruenes Domech, C; Soler, E; Vilar Gomez, E, 2007
)
0.34
"Interferon (IFN) has been well documented to cause thyroid dysfunction, especially in high risk patients and when combined with ribavirin (RBV)."( Pegylated interferon-alpha2beta in combination with ribavirin does not aggravate thyroid dysfunction in comparison to regular interferon-alpha2beta in a hepatitis C population: meta-analysis.
Attia, JR; Batey, RG; Jones, TL; Tran, HA, 2007
)
0.34
"The pegylation of IFN, in combination with RBV, did not aggravate thyroid diseases in the hepatitis C population."( Pegylated interferon-alpha2beta in combination with ribavirin does not aggravate thyroid dysfunction in comparison to regular interferon-alpha2beta in a hepatitis C population: meta-analysis.
Attia, JR; Batey, RG; Jones, TL; Tran, HA, 2007
)
0.34
"To evaluate the safety and efficacy of interferon alpha daily induction regimen in combination with ribavirin."( Daily interferon induction regimen using different manufactured interferons (alpha-2A or alpha-2B) in combination with ribavirin for treatment of chronic hepatitis C: a prospective randomized study.
Braga, EL; Kalabrik, L; Lyra, AC; Lyra, LG; Nascimento, L; Netto, E,
)
0.13
" ribavirin combined with pegylated interferon in patients with chronic hepatitis C (CHC)."( Virological response and safety outcomes in therapy-nai ve patients treated for chronic hepatitis C with taribavirin or ribavirin in combination with pegylated interferon alfa-2a: a randomized, phase 2 study.
Arora, S; Gish, RG; Murphy, B; Nelson, DR; O'Brien, C; Rajender Reddy, K; Xu, Y, 2007
)
0.34
"Efficacy and safety of interferon induction therapy alone or in combination with ribavirin or ribavirin plus amantadine were evaluated in chronic hepatitis C patients who were nonresponders to primary antiviral treatment."( A randomized trial of induction doses of interferon alone or in combination with ribavirin or ribavirin plus amantadine for treatment of nonresponder patients with chronic hepatitis C.
Andreone, P; Attard, L; Bernardi, M; Biselli, M; Boccia, S; Bonvicini, F; Cursaro, C; Furlini, G; Galli, S; Giacomoni, PL; Gramenzi, A; Lorenzini, S; Verucchi, G, 2007
)
0.34
" This study aimed to assess the safety and efficacy of two different regimens of peg-IFN alfa-2b, in combination with ribavirin, in genotype 3 patients."( Comparison of low-dose pegylated interferon versus standard high-dose pegylated interferon in combination with ribavirin in patients with chronic hepatitis C with genotype 3: an Indian experience.
Bansal, M; Hissar, S; Kumar, M; Midha, V; Sakhuja, P; Sarin, SK; Sood, A; Sood, N; Suneetha, PV, 2008
)
0.35
" We chose a low initial RBV dose, later increased due to tolerance to a mean dose of 600 mg daily (range 200-1000 mg daily) in combination with a peg-IFN alpha-2a 180 mcg weekly in an effort to improve tolerance and minimize withdrawals."( High adherence with a low initial ribavirin dose in combination with pegylated-IFN alpha-2a for treatment of recurrent hepatitis C after liver transplantation.
Gjertsen, H; Hörnfeldt, E; Weiland, O, 2008
)
0.35
"The clinical laboratory investigations of patients with chronic viral hepatitises combined with chronic opisthorchosis are presented."( Clinical-epidemiological features, diagnostics, treatment of chronic viral hepatitises, combined with opisthorchosis in inhabitants of Siberia and the Northern regions of Russia.
Paltsev, AI, 2007
)
0.34
"To report the results of a pilot study using rituximab combined with Peg-interferon (IFN) alpha2b-ribavirin in severe refractory hepatitis C virus (HCV) related mixed cryoglobulinaemia (MC) vasculitis."( Rituximab combined with Peg-interferon-ribavirin in refractory hepatitis C virus-associated cryoglobulinaemia vasculitis.
Cacoub, P; Karras, A; Perard, L; Resche-Rigon, M; Saadoun, D; Sene, D, 2008
)
0.35
" They were treated with rituximab (375 mg/m2 intravenously weekly for 4 weeks) combined with Peg-IFNalpha2b (1."( Rituximab combined with Peg-interferon-ribavirin in refractory hepatitis C virus-associated cryoglobulinaemia vasculitis.
Cacoub, P; Karras, A; Perard, L; Resche-Rigon, M; Saadoun, D; Sene, D, 2008
)
0.35
"Rituximab combined with Peg-IFNalpha2b-ribavirin represents a safe and effective treatment option in severe refractory HCV-MC vasculitis."( Rituximab combined with Peg-interferon-ribavirin in refractory hepatitis C virus-associated cryoglobulinaemia vasculitis.
Cacoub, P; Karras, A; Perard, L; Resche-Rigon, M; Saadoun, D; Sene, D, 2008
)
0.35
" In contrast, we demonstrate that a triple drug combination of IFN, RBV, and an iminosugar eradicated the BVDV infection in a time- and a dose-dependent manner, leading to sustained viral clearance."( Iminosugars in combination with interferon and ribavirin permanently eradicate noncytopathic bovine viral diarrhea virus from persistently infected cells.
Branza-Nichita, N; Dwek, RA; Hussey, M; Michelet, M; Smith, C; Woodhouse, SD; Zitzmann, N, 2008
)
0.35
" The present study evaluated the efficacy and safety of R1626 administered for 4 weeks in combination with peginterferon alfa-2a +/- ribavirin in HCV genotype 1-infected treatment-naive patients."( R1626 plus peginterferon Alfa-2a provides potent suppression of hepatitis C virus RNA and significant antiviral synergy in combination with ribavirin.
Chan, A; Everson, GT; Fried, MW; Ghalib, R; Godofsky, E; Harrison, S; Hill, G; Najera, I; Nelson, D; Nyberg, L; Pockros, PJ; Rodriguez-Torres, M; Shiffman, ML, 2008
)
0.35
"The aim of our study was to conduct a systematic review of studies evaluating antiviral therapy with pegylated interferon (PEG-IFN) alfa in combination with ribavirin for the management of recurrent hepatitis C after liver transplantation."( Systematic review of the treatment of established recurrent hepatitis C with pegylated interferon in combination with ribavirin.
Berenguer, M, 2008
)
0.35
" Hence, combinations of nucleoside analogues beta-D-2'-C-methylcytidine (2'-C-MeC; NM-107) or beta-D-2'-deoxy-2'-fluoro-2'-C-methyleytidine (2'-F-C-MeC; PSI-6130) with interferon-alpha2b (IFN-alpha2b) or triple combination with ribavirin (RBV) were evaluated."( Combinations of 2'-C-methylcytidine analogues with interferon-alpha2b and triple combination with ribavirin in the hepatitis C virus replicon system.
Bassit, L; Bennett, M; Grier, J; Schinazi, RF, 2008
)
0.35
"Huh-7 cells containing the self-replicating subgenomic HCV replicon (Clone B) were used for drug combination studies."( Combinations of 2'-C-methylcytidine analogues with interferon-alpha2b and triple combination with ribavirin in the hepatitis C virus replicon system.
Bassit, L; Bennett, M; Grier, J; Schinazi, RF, 2008
)
0.35
" The aim of this study was to compare virological response rates in patients with chronic hepatitis C virus (HCV)-1 infection treated with 400 mg amantadine or placebo in combination with peginterferon alfa-2a (40 kD) and ribavirin for 48 weeks."( Placebo-controlled trial of 400 mg amantadine combined with peginterferon alfa-2a and ribavirin for 48 weeks in chronic hepatitis C virus-1 infection.
Berg, T; Buggisch, P; Gerken, G; Goeser, T; Herrmann, E; Hinrichsen, H; Hofmann, WP; Manns, M; Spengler, U; Teuber, G; von Wagner, M; Weidenbach, H; Zeuzem, S, 2008
)
0.35
"6 log(10) units was obtained in phase II studies when Debio 025 was combined with interferon (R."( Debio 025, a cyclophilin binding molecule, is highly efficient in clearing hepatitis C virus (HCV) replicon-containing cells when used alone or in combination with specifically targeted antiviral therapy for HCV (STAT-C) inhibitors.
Coelmont, L; Dumont, JM; Kaptein, S; Neyts, J; Paeshuyse, J; Vliegen, I; Vuagniaux, G, 2009
)
0.35
" These mt-QSARs offer also a good opportunity to construct drug-drug Complex Networks (CNs) that can be used to explore large and complex drug-viral species databases."( Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
Chou, KC; González-Díaz, H; Martinez de la Vega, O; Prado-Prado, FJ; Ubeira, FM; Uriarte, E, 2009
)
0.35
" For inclusion, patients should have been treated with interferon alone or combined with ribavirin, with no virological response (non responders and relapsers) and had a liver biopsy before and after treatment."( Histological response study of chronic viral hepatitis C patients treated with interferon alone or combined with ribavirin.
Bergamaschi, D; Focaccia, R; Patzina, R; Prado, K, 2008
)
0.35
"The aim of this study was to compare the efficacy of high-dose interferon (IFN)-alpha-2b with standard dose of IFN-alpha-2b in combination with ribavirin (RBV) for patients with chronic hepatitis C virus (HCV) infection, and to investigate the predictive factors associated with virological response."( Randomized trial of high-dose interferon-alpha-2b combined with ribavirin in patients with chronic hepatitis C: Correlation between amino acid substitutions in the core/NS5A region and virological response to interferon therapy.
Aikata, H; Chayama, K; Imamura, M; Kawakami, Y; Kawaoka, T; Mori, N; Saneto, H; Takahashi, S; Takaki, S, 2009
)
0.35
" The effect of Virazole in combination with Stimforte in reducing the replication of infectious HCV and the accumulation of antigens in HCV-infected mice was additive or synergic, suggesting that it is expedient to use them concurrently."( [Effect of Stimforte in combination with Virazole on infection induced by hepatitis C virus in mice].
Bel'kov, AP; Deriabin, PG; Il'ichev, AV; Isaeva, EI; Mal'dov, DG,
)
0.13
"A large multicenter trial to compare the efficacy of peginterferon alfa-2a with interferon alfa-2a, in combination with ribavirin, in chronic hepatitis C patients."( A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients.
Adler, M; Bastens, B; Brenard, R; D'Heygere, E; Delwaide, J; Hendlisz, A; Henrion, J; Laureys, A; Lenaerts, A; Michielsen, P; Nevens, F; Van Vlierberghe, H,
)
0.13
"7 and 5 log(10) IU/mL, respectively, associated with 1500-mg doses twice daily after monotherapy for 2 weeks and with 1000-mg and 1500-mg doses twice daily after treatment in combination with the standard of care (SOC) for 4 weeks."( RG7128 alone or in combination with pegylated interferon-α2a and ribavirin prevents hepatitis C virus (HCV) Replication and selection of resistant variants in HCV-infected patients.
Berrey, M; Cammack, N; De La Rosa, A; Ewing, A; Kang, H; Kosaka, A; Le Pogam, S; Nájera, I; Seshaadri, A; Symonds, B; Yan, JM, 2010
)
0.36
" From 85 patients receiving RG7128 in combination with SOC, 1 HCV genotype 1-infected patient experienced a viral rebound, and 2 genotype 3-infected patients experienced a transient rebound."( RG7128 alone or in combination with pegylated interferon-α2a and ribavirin prevents hepatitis C virus (HCV) Replication and selection of resistant variants in HCV-infected patients.
Berrey, M; Cammack, N; De La Rosa, A; Ewing, A; Kang, H; Kosaka, A; Le Pogam, S; Nájera, I; Seshaadri, A; Symonds, B; Yan, JM, 2010
)
0.36
" Twelve weeks thereafter, he received IFN-α 3 MU daily for 2 weeks and then 3 times a week for 14 weeks combined with oral ribavirin 600 mg daily during 16 weeks."( Interferon alone or combined with ribavirin for acute prolonged infection with hepatitis C virus in chimpanzees.
Katayama, K; Miyakawa, Y; Mizui, M; Tanaka, J; Tomoguri, T; Yoshizawa, H; Yugi, H, 2011
)
0.37
"To study the clinical efficacy of PEG-Interferon alpha-2a combined with ribavirin in eldly chronic hepatitis."( [Efficacy of peginterferon alpha-2a in combination with ribavirin in treatment of eldly patients with chronic hepatitis C].
Jia, CH; Lan, L; Liu, BW; Yu, J; Yuan, Y; Zhang, H, 2010
)
0.36
" The twenty eldly patients of treatment group receive peg-interferon alpha-2a 135-180 microg subcutaneous injection every week combined with ribavirin 600-1000 mg/d for 48 weeks, and twenty adult patients of control group receive peg-interferon 135-180 microg subcutaneous injection every week combined with ribavirin 800-1200 mg/d for 48 weeks."( [Efficacy of peginterferon alpha-2a in combination with ribavirin in treatment of eldly patients with chronic hepatitis C].
Jia, CH; Lan, L; Liu, BW; Yu, J; Yuan, Y; Zhang, H, 2010
)
0.36
"The eldly patients with Chronic Hepatitis C using general dose peg-IFNalpha-2a combined with lower dose ribavirin can still obtain the similar efficiency and excellent tolerance when the basic diseases such as hypertension, diabetes and side effects were treated successfully."( [Efficacy of peginterferon alpha-2a in combination with ribavirin in treatment of eldly patients with chronic hepatitis C].
Jia, CH; Lan, L; Liu, BW; Yu, J; Yuan, Y; Zhang, H, 2010
)
0.36
" Finally, we demonstrated the additive or synergistic antiviral effect of siRNAs used in combination with ribavirin."( Inhibition of Hazara nairovirus replication by small interfering RNAs and their combination with ribavirin.
Bouloy, M; Crance, JM; Flusin, O; Iseni, F; Peyrefitte, CN; Vigne, S, 2011
)
0.37
"Our study highlights the interest of using RNAi (alone or in combination with ribavirin) to treat nairovirus infection."( Inhibition of Hazara nairovirus replication by small interfering RNAs and their combination with ribavirin.
Bouloy, M; Crance, JM; Flusin, O; Iseni, F; Peyrefitte, CN; Vigne, S, 2011
)
0.37
"The safety and antiviral efficacy of danoprevir was examined over 14 days in combination with pegylated interferon α-2a (180 μg once weekly) and ribavirin (1000-1200 mg/day) in a double-blind, placebo-controlled, phase 1b, multiple ascending dose study consisting of 6 dose cohorts (400 mg, 600 mg, and 900 mg twice daily and 100 mg, 200 mg, and 300 mg 3 times daily)."( Antiviral activity of danoprevir (ITMN-191/RG7227) in combination with pegylated interferon α-2a and ribavirin in patients with hepatitis C.
Bradford, W; Forestier, N; Guyader, D; Larrey, D; Lim, S; Marcellin, P; Patat, A; Porter, S; Qin, X; Rouzier, R; Seiwert, SD; Smith, PF; Zeuzem, S, 2011
)
0.37
"Danoprevir in combination with pegylated interferon α-2a and ribavirin was safe and generally well tolerated."( Antiviral activity of danoprevir (ITMN-191/RG7227) in combination with pegylated interferon α-2a and ribavirin in patients with hepatitis C.
Bradford, W; Forestier, N; Guyader, D; Larrey, D; Lim, S; Marcellin, P; Patat, A; Porter, S; Qin, X; Rouzier, R; Seiwert, SD; Smith, PF; Zeuzem, S, 2011
)
0.37
"Our study showed substantial antiviral efficacy of danoprevir in combination with pegylated interferon α-2a and ribavirin."( Antiviral activity of danoprevir (ITMN-191/RG7227) in combination with pegylated interferon α-2a and ribavirin in patients with hepatitis C.
Bradford, W; Forestier, N; Guyader, D; Larrey, D; Lim, S; Marcellin, P; Patat, A; Porter, S; Qin, X; Rouzier, R; Seiwert, SD; Smith, PF; Zeuzem, S, 2011
)
0.37
" Our aims were to prospectively assess the antiviral efficacy and safety of this drug combination in chronic hepatitis C (CHC) patients."( Open-label phase 1b pilot study to assess the antiviral efficacy of simvastatin combined with sertraline in chronic hepatitis C patients.
Altmeyer, R; Cheng, CW; Chopra, N; Lawitz, E; Lim, SG; McHutchison, JG; Patel, K; Randle, JC; Tillmann, HL, 2011
)
0.37
" Although data sets were not complete, patients with IL28B CT and TT genotype appear to significantly improve when these agents are combined with PEG-INF and RBV."( Phase III results in Genotype 1 naïve patients: predictors of response with boceprevir and telaprevir combined with pegylated interferon and ribavirin.
Kwo, PY, 2012
)
0.38
" The adverse events related to ribavirin and drug-drug interactions during therapy for hepatitis C are discussed."( Severe anaemia related to oseltamivir during treatment of chronic hepatitis C: a new drug interaction?
Buti, M; Esteban, R; Simón-Talero, M, 2012
)
0.38
" We evaluated ITX 5061 in combination with interferon-α, ribavirin, and HCV protease and polymerase inhibitors in a genotype 2a infectious virus system."( Evaluation of ITX 5061, a scavenger receptor B1 antagonist: resistance selection and activity in combination with other hepatitis C virus antivirals.
Lee, H; McKelvy, J; Schooley, RT; Syder, A; Wong-Staal, F; Wyles, DL; Zhu, H, 2012
)
0.38
", Minneapolis, MN, USA) in combination with ribavirin (1,000-1,600 mg) for 48 weeks."( Continuous interferon-α2b infusion in combination with ribavirin for chronic hepatitis C in treatment-experienced patients.
Bergmann, JF; Boonstra, A; de Knegt, RJ; Haagmans, BL; Hansen, BE; Janssen, HL; Kwadijk-de Gijsel, S; Roomer, R; van Vuuren, AJ, 2012
)
0.38
"In this double-blind, placebo-controlled study, 57 HCV genotype (GT)-1 patients (n=27 treatment-naïve [TN]; n=30 treatment-experienced [TE]) with compensated liver disease were randomised for 28-day treatment with 400, 600, or 800 mg BI 207127 three times daily (TID) or placebo (only TN) in combination with peginterferon alfa 2a and ribavirin (PegIFN/RBV)."( Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin.
Abdallah, N; Arastéh, K; Berger, F; Böcher, W; Cerny, A; de Ledinghen, V; Dikopoulos, N; Gerken, G; Gerlach, T; Girlich, B; Heim, MH; Kukolj, G; Larrey, D; Lohse, AW; Marquis, M; Mathurin, P; Scherer, J; Schuchmann, M; Steffgen, J; Stern, JO; Thimme, R; Tran, A; Trautwein, C; Trepo, C; Wu, K; Zarski, JP, 2012
)
0.38
"BI 207127 in combination with PegIFN/RBV demonstrated strong antiviral activity with a favourable safety and tolerability profile."( Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin.
Abdallah, N; Arastéh, K; Berger, F; Böcher, W; Cerny, A; de Ledinghen, V; Dikopoulos, N; Gerken, G; Gerlach, T; Girlich, B; Heim, MH; Kukolj, G; Larrey, D; Lohse, AW; Marquis, M; Mathurin, P; Scherer, J; Schuchmann, M; Steffgen, J; Stern, JO; Thimme, R; Tran, A; Trautwein, C; Trepo, C; Wu, K; Zarski, JP, 2012
)
0.38
"To study the clinical efficacy of PEG Interferon alpha-2a combined with ribavirin in treatment of with hepatitis C cirrhosis patients."( [Efficacy of peg interferon alpha-2a in combination with ribavirin in treatment of with hepatitis C cirrhosis patients].
Liu, GW; Ma, SP; Wang, CF; Zhao, WX, 2011
)
0.37
" Its combination with pegylated interferon and ribavirin needs further evaluation."( Randomized controlled trial of interferon gamma versus amantadine in combination with interferon alpha and ribavirin for hepatitis C genotype 3 non-responders and relapsers.
Abbas, Z; Hamid, S; Jafri, W; Raza, S, 2012
)
0.38
" 23 patients received pegylated interferon in monotherapy or in combination with ribavirin."( The use of peginterferon in monotherapy or in combination with ribavirin for the treatment of acute hepatitis C.
Cacopardo, B; Fatuzzo, F; Montineri, A; Nunnari, G; Portelli, V; Savalli, F, 2012
)
0.38
" The combination with ribavirin did not appear to impact our sustained response rate, although ribavirin appeared to induce a faster normalization of ALT levels."( The use of peginterferon in monotherapy or in combination with ribavirin for the treatment of acute hepatitis C.
Cacopardo, B; Fatuzzo, F; Montineri, A; Nunnari, G; Portelli, V; Savalli, F, 2012
)
0.38
" When used in combination with pegylated interferon and ribavirin, telaprevir has demonstrated a substantial increase in sustained virological response compared with pegylated interferon and ribavirin used alone."( Telaprevir: pharmacokinetics and drug interactions.
Beaumont, M; Garg, V; Kauffman, RS; van Heeswijk, RP, 2012
)
0.38
" Four hundred and twenty-nine HCV genotype (GT)-1 treatment-naïve patients without cirrhosis were randomized 1:1:2:2 to receive 24 weeks of pegylated interferon alfa-2a and ribavirin (PegIFN/RBV) in combination with placebo, faldaprevir 120 mg QD with 3 days of PegIFN/RBV lead-in (LI), 240 mg QD with LI, or 240 mg QD without LI, followed by an additional 24 weeks of PegIFN/RBV."( Faldaprevir combined with pegylated interferon alfa-2a and ribavirin in treatment-naïve patients with chronic genotype 1 HCV: SILEN-C1 trial.
Asselah, T; Bessone, F; Böcher, WO; Datsenko, Y; Fainboim, H; Ferenci, P; Heo, J; Kukolj, G; Lalezari, J; Leggett, B; Mauss, S; Nehmiz, G; Scherer, J; Steinmann, GG; Stern, JO; Sulkowski, MS, 2013
)
0.39
" Sequential cohorts of 20 patients, randomized 16:4 (active:placebo), received IDX184 for 14 days at rising daily doses of 50, 100, 150 or 200 mg in combination with P/R for 14 days."( IDX184 in combination with pegylated interferon-α2a and ribavirin for 2 weeks in treatment-naive patients with chronic hepatitis C.
Box, T; Chen, J; Dejesus, E; Dubuc-Patrick, G; Godofsky, E; Kwo, P; Lalezari, J; Lawrence, S; Mayers, D; McCarville, J; Mehra, P; Nguyen, T; O'Riordan, W; Pietropaolo, K; Poordad, F; Sullivan-Bólyai, J; Zhou, XJ, 2013
)
0.39
"IDX184 in combination with P/R for 14 days was well tolerated and demonstrated greater antiviral activity with more patients achieving undetectable viral load than P/R."( IDX184 in combination with pegylated interferon-α2a and ribavirin for 2 weeks in treatment-naive patients with chronic hepatitis C.
Box, T; Chen, J; Dejesus, E; Dubuc-Patrick, G; Godofsky, E; Kwo, P; Lalezari, J; Lawrence, S; Mayers, D; McCarville, J; Mehra, P; Nguyen, T; O'Riordan, W; Pietropaolo, K; Poordad, F; Sullivan-Bólyai, J; Zhou, XJ, 2013
)
0.39
" We randomly allocated all eligible patients with HCV genotype 1 (cohort A) to receive sofosbuvir 200 mg, sofosbuvir 400 mg, or placebo (2:2:1) for 12 weeks in combination with peginterferon (180 μg per week) and ribavirin (1000-1200 mg daily), after which they continued peginterferon and ribavirin for an additional 12 weeks or 36 weeks (depending on viral response)."( Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial.
Abrams, GA; Afdhal, NH; Albanis, E; Bernstein, DE; Berrey, MM; Bzowej, NH; Darling, JM; Dejesus, E; Dieterich, DT; Freilich, B; Hassanein, T; Hindes, R; Hyland, RH; Jacobson, IM; Jensen, D; Kowdley, KV; Lalezari, JP; Lawitz, E; Lin, M; Mader, M; Mo, H; Muir, A; Nelson, DR; Poordad, FF; Reddy, KR; Rodriguez-Torres, M; Sheikh, AM; Sulkowski, MS; Symonds, WT, 2013
)
0.39
" In all, 290 noncirrhotic HCV genotype (GT)-1 patients with prior null (<1 log10 viral load [VL] drop at any time on treatment) or partial response (≥1 log10 VL drop but never undetectable on treatment) were randomized 2:1:1 to receive 48 weeks of peginterferon alfa-2a and ribavirin (PegIFN/RBV) in combination with faldaprevir 240 mg once daily (QD) with 3 days PegIFN/RBV lead-in (LI), 240 mg QD without LI, or 240 mg twice daily (BID) with LI."( Faldaprevir combined with peginterferon alfa-2a and ribavirin in chronic hepatitis C virus genotype-1 patients with prior nonresponse: SILEN-C2 trial.
Asselah, T; Böcher, WO; Bourlière, M; Bronowicki, JP; Datsenko, Y; Kukolj, G; Larrey, D; Mauss, S; Nehmiz, G; Pawlotsky, JM; Pol, S; Scherer, J; Shafran, SD; Steinmann, GG; Stern, JO; Sulkowski, MS, 2013
)
0.39
"Patients who participated in randomised, controlled trials or an extended access programme of treatment with peginterferon-α2a/ribavirin in combination with a direct-acting anti-viral (telaprevir, danoprevir, faldaprevir, simeprevir, mericitabine, balapiravir) were followed after achieving SVR."( Durability of SVR in chronic hepatitis C patients treated with peginterferon-α2a/ribavirin in combination with a direct-acting anti-viral.
Beinhardt, S; Dulic, M; Ferenci, P; Gschwantler, M; Hofer, H; Holzmann, H; Laferl, H; Maieron, A; Rutter, K; Scherzer, TM; Stättermayer, AF; Steindl-Munda, P; Strassl, R, 2013
)
0.39
" This analysis evaluated the cost-effectiveness of TVR combined with pegylated interferon (Peg-IFN) alfa-2a plus ribavirin (RBV) compared with Peg-IFN alfa-2a and RBV (PR) alone or BOC plus Peg-IFN alfa-2b and RBV in treatment-experienced patients."( Cost-effectiveness of telaprevir in combination with pegylated interferon alpha and ribavirin in treatment-experienced chronic hepatitis C genotype 1 patients.
Bianic, F; Cure, S; Curtis, S; Dusheiko, G; Gavart, S; Lee, S, 2014
)
0.4
"To evaluate the efficacy and safety of telaprevir combined with peginterferon alfa (Peg-IFNa) plus ribavirin (RBV) (collectively, TPR therapy) in patients with chronic hepatitis C (CHC) using a meta-analysis approach."( [Meta-analysis of the efficacy and safety of telaprevir combined with peginterferon alfa plus ribavirin in patients with chronic hepatitis C].
Wang, P; Wang, X; Xu, DH; Yan, SS; Yin, J; Zhang, PJ, 2013
)
0.39
"The therapeutic effect of research group is better than that of control group, suggesting that ornithine aspartate combined with naloxone treatment in hepatic encephalopathy is worthy of promoting."( [Meta-analysis of the efficacy and safety of telaprevir combined with peginterferon alfa plus ribavirin in patients with chronic hepatitis C].
Wang, P; Wang, X; Xu, DH; Yan, SS; Yin, J; Zhang, PJ, 2013
)
0.39
" This 28-day, double-blind, randomized, placebo-controlled study evaluated once daily GSK2336805 60 mg alone or in combination with peginterferon alfa-2a (180 μg per week) and ribavirin (1000-1200 mg daily) (PEG/RIBA) in treatment-naive genotype 1 CHC subjects."( A double-blind, randomized, placebo-controlled study to assess the safety, antiviral activity and pharmacokinetics of GSK2336805 when given as monotherapy and in combination with peginterferon alfa-2a and ribavirin in hepatitis C virus genotype 1-infected
Adkison, K; Cutrell, A; Elko-Simms, C; Gardner, S; Hamatake, R; Hong, Z; Rodriguez-Torres, M; Walker, J, 2014
)
0.4
"GSK2336805 is a potent NS5A inhibitor that showed a substantial antiviral effect as a monotherapy and in combination with peginterferon and ribavirin."( A double-blind, randomized, placebo-controlled study to assess the safety, antiviral activity and pharmacokinetics of GSK2336805 when given as monotherapy and in combination with peginterferon alfa-2a and ribavirin in hepatitis C virus genotype 1-infected
Adkison, K; Cutrell, A; Elko-Simms, C; Gardner, S; Hamatake, R; Hong, Z; Rodriguez-Torres, M; Walker, J, 2014
)
0.4
" This analysis evaluated the cost-effectiveness of TVR combined with pegylated interferon (Peg-IFN) alfa-2a plus ribavirin (RBV), with Peg-IFN and RBV (PR) alone or with boceprevir (B, BOC) plus Peg-IFN alfa-2b and RBV, in naïve patients."( Cost-effectiveness of telaprevir in combination with pegylated interferon alpha and ribavirin in previously untreated chronic hepatitis C genotype 1 patients.
Bianic, F; Cure, S; Curtis, S; Dusheiko, G; Gavart, S; Lee, S, 2014
)
0.4
"CIGB-230, combined with IFN-α-based therapy, modifies the immune response in chronic patients."( HCV-specific immune responses induced by CIGB-230 in combination with IFN-α plus ribavirin.
Aguilar-Noriega, D; Alvarez-Lajonchere, L; Amador-Cañizares, Y; Armas, A; Castellanos, M; Cinza-Estévez, Z; Dausá, M; Dubuisson, J; Dueñas-Carrera, S; González, Y; Guerra, I; Martínez-Donato, G; Núñez, M; Pérez Aguiar, A; Raíces, I; Revé, I; Valenzuela, C; Vasallo, C; Wychowski, C, 2014
)
0.4
" The efficacy and safety of daclatasvir combined with peginterferon alfa-2a (alfa-2a) and ribavirin were assessed in a randomized, double-blind Phase IIa study of Japanese patients with chronic HCV genotype-1 infection."( Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese patients infected with hepatitis C genotype 1.
Hu, W; Hughes, EA; Ishikawa, H; Izumi, N; Kawada, N; Kumada, H; McPhee, F; Osaki, Y; Sata, M; Ueki, T; Yamamoto, K; Yokosuka, O, 2014
)
0.4
"Japanese patients who were treatment-naive (n=25) or prior null (n=12) or partial (n=5) responders received once-daily daclatasvir 10 mg or 60 mg or placebo in combination with alfa-2a and ribavirin."( Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese patients infected with hepatitis C genotype 1.
Hu, W; Hughes, EA; Ishikawa, H; Izumi, N; Kawada, N; Kumada, H; McPhee, F; Osaki, Y; Sata, M; Ueki, T; Yamamoto, K; Yokosuka, O, 2014
)
0.4
"Daclatasvir combined with alfa-2a/ribavirin in treatment-naive patients showed greater efficacy than alfa-2a/ribavirin alone and was generally well tolerated."( Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese patients infected with hepatitis C genotype 1.
Hu, W; Hughes, EA; Ishikawa, H; Izumi, N; Kawada, N; Kumada, H; McPhee, F; Osaki, Y; Sata, M; Ueki, T; Yamamoto, K; Yokosuka, O, 2014
)
0.4
" Further evaluation of filibuvir in combination with other direct-acting antiviral agents may be considered."( A phase 2 study of filibuvir in combination with pegylated IFN alfa and ribavirin for chronic HCV.
Hammond, JL; Marcellin, P; Purohit, VS; Rodriguez-Torres, M; Srinivasan, S; Wang, C; Yoshida, EM,
)
0.13
"To conduct a network meta-analysis (NMA) to determine the comparative efficacy, as measured by sustained virological response (SVR), between boceprevir (BOC), telaprevir (TEL), faldaprevir (FAL), simeprevir (SIM) and sofosbuvir (SOF) in combination with peginterferon-ribavirin (PR) against a control of PR."( Network meta-analysis of direct-acting antivirals in combination with peginterferon-ribavirin for previously untreated patients with hepatitis C genotype 1 infection.
Druyts, E; Lorenzi, M; Mills, EJ; Thorlund, K; Toor, K, 2015
)
0.42
" RCTs assessing standard duration therapy (SDT) or response-guided therapy (RGT) BOC, TEL, FAL, SIM or SOF in combination with PR against a control of PR were eligible for inclusion."( Network meta-analysis of direct-acting antivirals in combination with peginterferon-ribavirin for previously untreated patients with hepatitis C genotype 1 infection.
Druyts, E; Lorenzi, M; Mills, EJ; Thorlund, K; Toor, K, 2015
)
0.42
"The first generation protease inhibitors, boceprevir (BOC) and telaprevir (TVR), are both CYP3A4 inhibitors, which predispose drug-drug interactions (DDIs)."( Drug-drug interactions of telaprevir and boceprevir in HCV-monoinfected and HIV/HCV-coinfected patients can modify the adherence.
Bory, F; Broquetas, T; Cabrero, B; Cañete, N; Carrión, JA; Coll, S; García-Retortillo, M; Giménez, MD; González-Colominas, E; Knobel, H; Pellicer, R; Retamero, A; Salas, E; Solà, R, 2015
)
0.42
" The introduction of triple therapy using SMV in combination with peginterferon and ribavirin (PR) significantly improves the cure rate."( Cost-effectiveness analysis of simeprevir in combination with peginterferon and ribavirin for treatment-naïve chronic hepatitis C genotype 1 patients in Japan.
Cerri, K; Kuwabara, H; Mahlich, J; Treur, M; Westerhout, K; Yatsuhashi, H, 2015
)
0.42
"5 μg/day) for 4 weeks, and then they were given pegylated interferon (Peg-IFN)-α2a plus ribavirin therapy in combination with either vitamin D3 for 48 or 72 weeks according to the response-guided manner."( Randomized study comparing vitamin D3 and 1α-Hydroxyvitamin D3 in combination with pegylated interferon/ribavirin therapy for chronic hepatitis C.
Asabe, S; Funyu, J; Hashimoto, Y; Hosoda, Y; Inao, M; Koshima, Y; Mochida, S; Nakayama, N; Nishikawa, K; Omori-Mizuno, Y; Tanaka, M; Tomita, K; Yakabi, K, 2015
)
0.42
" Because boceprevir is metabolized by metabolic routes common to many other drugs, and is an inhibitor of cytochrome P450 (CYP) 3A4/5, there is a high potential for drug-drug interactions when boceprevir is administered with other therapies, particularly when treating patients with chronic HCV infection who are often receiving other medications concomitantly."( Clinical pharmacology profile of boceprevir, a hepatitis C virus NS3 protease inhibitor: focus on drug-drug interactions.
Butterton, JR; Feng, HP; Hulskotte, EG; Khalilieh, S; Wenning, LA, 2015
)
0.42
" The efficacy, tolerability, and absence of drug-drug interactions of ledipasvir-sofosbuvir suggest that it could be an important option for treatment of genotype 1 hepatitis C virus in Japanese patients."( Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial.
Betular, J; Enomoto, H; Gao, B; Garrison, K; Genda, T; Ide, T; Ikeda, F; Ishizaki, A; Izumi, N; Knox, SJ; Korenaga, M; McHutchison, JG; Mizokami, M; Mo, H; Mochizuki, H; Nakane, K; Nirei, K; Nishigaki, Y; Omata, M; Omote, M; Pang, PS; Sakamoto, N; Symonds, WT; Takehara, T; Toda, N; Toyoda, H; Ueno, Y; Umemura, T; Yanase, M; Yatsuhashi, H; Yokosuka, O, 2015
)
0.42
" We examined the utility of plasma MERS-CoV PCR as a prognostic indicator and compared the efficacies of IFN-α2a and IFN-β1a when combined with ribavirin in reducing MERS-CoV-related mortality rates."( IFN-α2a or IFN-β1a in combination with ribavirin to treat Middle East respiratory syndrome coronavirus pneumonia: a retrospective study.
Al-Jiffri, A; Farahat, F; Mushtaq, A; Shalhoub, S; Shamma, O; Siddiqi, N; Simhairi, R, 2015
)
0.42
"Although several vitamin D-related gene polymorphisms were reported to affect the outcome of pegylated interferon/ribavirin (PR) therapy in chronic hepatitis C patients, there are no reports on the impact of the vitamin D-related gene polymorphisms in PR therapy combined with protease inhibitor (PI)."( Vitamin D-related gene polymorphisms do not influence the outcome and serum vitamin D level in pegylated interferon/ribavirin therapy combined with protease inhibitor for patients with genotype 1b chronic hepatitis C.
Abe, H; Aizawa, Y; Arai, T; Atsukawa, M; Itokawa, N; Iwakiri, K; Kondo, C; Nakagawa, A; Okubo, T; Shimada, N; Tsubota, A, 2015
)
0.42
" Here, we investigated the antiviral efficacy of the peptidomimetic furin inhibitor MI-701 in combination with oseltamivir carboxylate and ribavirin against the infection of highly pathogenic avian influenza viruses (HPAIV) that are activated by the host protease furin."( Peptidomimetic furin inhibitor MI-701 in combination with oseltamivir and ribavirin efficiently blocks propagation of highly pathogenic avian influenza viruses and delays high level oseltamivir resistance in MDCK cells.
Böttcher-Friebertshäuser, E; Dahms, SO; Garten, W; Hardes, K; Klenk, HD; Lu, Y; Steinmetzer, T; Than, ME, 2015
)
0.42
"The percent of serum NS5A-Y93H strains relative to the total strains was quantified using cycling-probe real-time PCR combined with direct sequencing in 444 patients with genotype 1b HCV, and the factors associated with mutation were analyzed."( Significance of variants associated with resistance to NS5A inhibitors in Japanese patients with genotype 1b hepatitis C virus infection as evaluated using cycling-probe real-time PCR combined with direct sequencing.
Ando, S; Imai, Y; Inao, M; Kouyama, J; Mochida, S; Motoya, D; Naiki, K; Nakao, M; Nakayama, N; Sugawara, K; Uchida, Y, 2016
)
0.43
"We studied the therapeutic potential of favipiravir (T-705) for Lassa fever, both alone and in combination with ribavirin."( Efficacy of Favipiravir Alone and in Combination With Ribavirin in a Lethal, Immunocompetent Mouse Model of Lassa Fever.
Bockholt, S; Günther, S; Krasemann, S; Lüdtke, A; Muñoz-Fontela, C; Oestereich, L; Pallasch, E; Rieger, T; Ruibal, P; Wurr, S, 2016
)
0.43
"Most patients with chronic hepatitis C virus (HCV) genotype 1 infection who have had a previous null response (<2-log10 reduction in HCV RNA by treatment week 12) to peginterferon/ribavirin (PegIFN/RBV) do not achieve a sustained virological response (SVR) when re-treated with a first-generation HCV protease inhibitor (PI) administered in combination with PegIFN/RBV."( Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies.
Forns, X; Hézode, C; Le Pogam, S; Lee, SS; Nájera, I; Scalori, A; Thommes, JA; Voulgari, A; Wedemeyer, H, 2016
)
0.43
" Amongst the various NSAID compounds, Mefenamic acid (MEFE) and Meclofenamic acid (MECLO) showed considerable antiviral activity against viral replication individually or in combination with the common antiviral drug, Ribavirin (RIBA)."( Mefenamic acid in combination with ribavirin shows significant effects in reducing chikungunya virus infection in vitro and in vivo.
Abdulrahman, AY; Bahrani, H; Mohamed, Z; Othman, S; Rahman, NA; Rashid, NN; Rothan, HA; Teoh, TC; Yusof, R, 2016
)
0.43
"Daclatasvir (DCV) is a potent, pangenotypic nonstructural protein 5A inhibitor with demonstrated antiviral efficacy when combined with sofosbuvir (SOF) or simeprevir (SMV) with or without ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection."( Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection.
Bahirwani, R; Berg, C; Brown, RS; Castells, L; Chacko, KR; Durand, CM; ElSharkawy, AM; Emond, B; Ferenci, P; Fontana, RJ; Herzer, K; Ionescu-Ittu, R; Jafri, SM; Joshi, S; Knop, V; Lionetti, R; Loiacono, L; Londoño, MC; Montalbano, M; Moreno-Zamora, A; Mubarak, A; Pellicelli, AM; Prieto, M; Reddy, KR; Stadler, B; Stauber, RE; Stenmark, S; Torti, C; Vekeman, F; Weiland, O, 2016
)
0.43
"To evaluate the possible hepatoprotective effects of Jerusalem artichoke tubers (JAT) in combination with interferon and ribavirin."( Synergistic Effects of Jerusalem Artichoke in Combination with Pegylated Interferon Alfa-2a and Ribavirin Against Hepatic Fibrosis in Rats.
Abdel-Hamid, NM; Eisa, MA; Nazmy, MH; Wahid, A, 2016
)
0.43
"This study compares the safety profiles of pegylated interferon (PEG-IFN) α-2a and α-2b administered in combination with ribavirin, based on the variable of time to withdrawal from treatment due to adverse events."( Comparison of the Safety Profiles of Pegylated Interferon α-2a and α-2b Administered in Combination with Ribavirin for Chronic Hepatitis C Infection: A Real-World Retrospective Cohort Study.
Hawke, P; Ide, K; Imai, T; Kawasaki, Y; Masaki, N; Sato, I; Yamada, H, 2016
)
0.43
"Sofosbuvir in combination with simeprevir +/- ribavirin in GT 4 HCV patients with advanced fibrosis achieved high SVR12 rates and was well tolerated."( Sofosbuvir in Combination with Simeprevir +/- Ribavirin in Genotype 4 Hepatitis C Patients with Advanced Fibrosis or Cirrhosis: A Real-World Experience from Belgium.
Bourgeois, S; de Galocsy, C; Degré, D; Delwaide, J; Geerts, A; Gustot, T; Laleman, W; Langlet, P; Lasser, L; Lepida, A; Moreno, C; Negrin Dastis, S; Orlent, H; Reynaert, H; Sersté, T; Starkel, P; Van Steenkiste, C; Vanwolleghem, T, 2017
)
0.46
" We aimed to determine the efficacy and safety of SOF in combination with either SMV or DCV in GT4-infected patients."( Efficacy and Safety of Simeprevir or Daclatasvir in Combination With Sofosbuvir for the Treatment of Hepatitis C Genotype 4 Infection.
Alaseeri, A; Albenmousa, A; Albiladi, H; Alghamdi, AS; Aljarodi, M; Almugharbal, M; Alothmani, HS; Alsahafi, A; Babatin, MA; Bzeizi, KI; Sanai, FM,
)
0.13
" In our study, we will report the real-life experience of serious adverse events (SAEs) that were reported by the National Committee for Control of Viral Hepatitis (NCCVH, Cairo, Egypt) program while treating chronic HCV using the triple therapy, sofosbuvir combined with pegylated interferon and ribavirin (PEG/RIBA/SOF), which led to premature discontinuation of treatment."( Serious Adverse Events with Sofosbuvir Combined with Interferon and Ribavirin: Real-Life Egyptian Experience.
Abdo, M; Abouelkhair, M; Doss, W; Elakel, W; Elbaz, T; Elgarem, N; Elsayed, MH; Elserafy, M; Elshazly, Y; Esmat, G; Gaballa, A; Hassany, M; Mahran, Z; Mehrez, M; Mohey, MA; Omar, A; Waked, I; Yosry, A, 2017
)
0.46
"Although a contributory role of vitamin D levels for the development of chronic hepatitis C has been suggested, the efficacy of vitamin D supplementation in combination with conventional antiviral therapy consisting of pegylated interferon-α (Peg-IFN-α) injection and oral ribavirin (RBV) remains unclear."( Efficacy of vitamin D supplementation in combination with conventional antiviral therapy in patients with chronic hepatitis C infection: a meta-analysis of randomised controlled trials.
Kim, HB; Lee, YJ; Myung, SK; Park, BJ, 2018
)
0.48
" When a combination therapy with interferon-free, direct-acting antivirals is used in patients post-transplantation, consideration of drug-drug interactions with and monitoring CyA are of vital importance."( Ombitasvir-Paritaprevir-Ritonavir Therapy in a Kidney Transplant Recipient With Chronic Hepatitis C Virus Genotype 1 Infection: A Case Report on the Importance of Considering Drug-Drug Interactions and Monitoring Cyclosporine Levels.
Hashimoto, S; Hayashi, K; Nakagawa, Y; Saito, K; Takahashi, K; Takamura, M; Takeuchi, S; Tanabe, Y; Tasaki, M; Terai, S; Tomita, Y; Yamagiwa, S; Yoshida, T, 2018
)
0.48
"This study aimed to compare the efficacy and safety of ulinastatin combined with creatine phosphate sodium and ribavirin combined with creatine phosphate sodium in the treatment of pediatric viral myocarditis."( The efficacy observation of ulinastatin combined with creatine phosphate sodium in pediatric viral myocarditis.
An, XJ; Gao, J; Jia, LB; Li, CL; Wang, ZZ, 2019
)
0.51
" 80 of them received ulinastatin combined with creatine phosphate sodium, and were regarded as observation group; other 75 patients received ribavirin combined with creatine phosphate sodium and were regarded as the control group."( The efficacy observation of ulinastatin combined with creatine phosphate sodium in pediatric viral myocarditis.
An, XJ; Gao, J; Jia, LB; Li, CL; Wang, ZZ, 2019
)
0.51
"The results indicated that, compared with ribavirin combined with creatine phosphate sodium, ulinastatin combined with creatine phosphate sodium had better clinical efficacy in the treatment of pediatric viral myocarditis."( The efficacy observation of ulinastatin combined with creatine phosphate sodium in pediatric viral myocarditis.
An, XJ; Gao, J; Jia, LB; Li, CL; Wang, ZZ, 2019
)
0.51
" Lastly, we investigated the use of baloxavir acid in combination with ribavirin in vitro by implementing the Zero Interaction Potency response surface model."( Enhanced efficacy of endonuclease inhibitor baloxavir acid against orthobunyaviruses when used in combination with ribavirin.
Bassetto, M; Brancale, A; Fernandez-Garcia, Y; Günther, S; Neyts, J; Rocha-Pereira, J; Ter Horst, S, 2020
)
0.56
"Although the combination with PrOD significantly affects the pharmacokinetics of CsA, it is effective and safe with regular monitoring of the CsA blood concentrations and appropriate CsA dose adjustment."( Drug-Drug Interactions With Cyclosporine in the Anti-Hepatitis C Viral PrOD Combination Regimen of Paritaprevir/Ritonavir-Ombitasvir and Dasabuvir in Organ Transplant Recipients With Severe Hepatic Fibrosis or Cirrhosis.
Chang, YL; Chou, YC; Hsu, CC; Huang, YH; Huang, YY; Loong, CC; Wu, TH, 2022
)
0.72
" KM mice were randomly divided into 8 groups namely control group, PCV2 infected, Matrine combined with Osthole high dose treatment (40 mg/kg + 12 mg/kg), medium dose treatment (20 mg/kg + 6 mg/kg), low dose treatment (10 mg/kg + 3 mg/kg), Matrine treatment (40 mg/kg), Osthole treatment (12 mg/kg) and Ribavirin positive control (40 mg/kg) groups."( Matrine combined with Osthole inhibited the PERK apoptosis of splenic lymphocytes in PCV2-infected mice model.
Fan, K; Guo, J; Khan, A; Li, H; Sun, N; Sun, P; Sun, Y; Wan, S; Xu, Y; Yin, W; Zheng, X, 2023
)
0.91
" The expression of GRP78, p-PERK, p-eIF2α, ATF4, CHOP, cleaved caspase-3 and Bax proteins were significantly reduced, while that of Bcl-2 was significantly increased in Matrine combined with Osthole groups, which alleviated the pathological changes caused by PCV2, such as interstitial pneumonia, loss of spleen lymphocytes, infiltration of macrophages and eosinophils."( Matrine combined with Osthole inhibited the PERK apoptosis of splenic lymphocytes in PCV2-infected mice model.
Fan, K; Guo, J; Khan, A; Li, H; Sun, N; Sun, P; Sun, Y; Wan, S; Xu, Y; Yin, W; Zheng, X, 2023
)
0.91

Bioavailability

Oral bioavailability data of ribavirin determined previously in six healthy adults. In vivo, prodrug 2 is orally bioavailable and well-tolerated in rats. Ribavirin appears to be extensively absorbed; however, absolute bioavailability is approximately 50%.

ExcerptReferenceRelevance
" Oral bioavailability was 44."( Pharmacokinetics and long-term tolerance to ribavirin in asymptomatic patients infected with human immunodeficiency virus.
Agrawal, KC; Ferencz, N; George, WJ; Hyslop, NE; Lacour, JT; Lertora, JJ; Rege, AB; VanDyke, RB, 1991
)
0.28
" While readily bioavailable by systemic routes, it was poorly bioavailable by the oral route."( Inhibition of influenza virus replication in mice by GG167 (4-guanidino-2,4-dideoxy-2,3-dehydro-N-acetylneuraminic acid) is consistent with extracellular activity of viral neuraminidase (sialidase).
Dempsey, MH; Penn, CR; Ryan, DM; Ticehurst, J, 1994
)
0.29
" Ribavirin is well absorbed orally and is typically given in doses of 1,000 to 1,200 mg/d."( Therapy of hepatitis C: alpha interferon and ribavirin.
Reichard, O; Schvarcz, R; Weiland, O, 1997
)
0.3
" IFN demonstrated an increase in bioavailability (approximately 2-fold) upon multiple dose administration."( Ribavirin and interferon alfa-2b in chronic hepatitis C: assessment of possible pharmacokinetic and pharmacodynamic interactions.
Bell, A; Dash, C; Dusheiko, GM; Flannery, B; Glue, P; Grellier, L; Khakoo, S; Lypnyj, D; Murray-Lyon, I; Walters, K; Wells, B, 1998
)
0.3
" Ribavirin appears to be extensively absorbed; however, absolute bioavailability is approximately 50%, probably due to first-pass metabolism."( The clinical pharmacology of ribavirin.
Glue, P, 1999
)
0.3
" The marked improvement in the response rate after treatment with the combination regimen (10-fold higher versus that from monotherapy with alpha interferon) highlights the importance of determining the absolute bioavailability of ribavirin as a first step in beginning to investigate the pharmacodynamics of the combination."( Pharmacokinetics and absolute bioavailability of ribavirin in healthy volunteers as determined by stable-isotope methodology.
Drusano, GL; Glue, P; Gupta, SK; McNamara, P; Nash, J; Preston, SL, 1999
)
0.3
"5% in monkeys, and the bioavailability was 29."( Absorption, pharmacokinetics and excretion of levovirin in rats, dogs and cynomolgus monkeys.
Lau, JY; Lin, CC; Lourenco, D; Luu, T; Yeh, LT, 2003
)
0.32
" However, recent preliminary pharmacological studies have suggested that the bioavailability of ribavirin displays great interindividual variability."( Ribavirin quantification in combination treatment of chronic hepatitis C.
Bessard, G; Larrat, S; Plages, A; Souvignet, C; Stanke-Labesque, F; Zarski, JP, 2003
)
0.32
" The oral absorption and bioavailability were 83 and 59%, respectively, in rats and 87 and 55%, respectively, in monkeys."( Pharmacokinetics and metabolism of [(14)C]ribavirin in rats and cynomolgus monkeys.
Lau, JY; Lin, CC; Lourenco, D; Luu, T; Yeh, LT, 2003
)
0.32
"To compare the two-stage method, a widely used analytical method in pharmacokinetic studies, with nonparametric population modeling by using the same data set for determining the oral bioavailability of ribavirin."( Comparative pharmacokinetic analysis by standard two-stage method versus nonparametric population modeling.
Drusano, GL; Preston, SL; Tam, VH, 2003
)
0.32
"Oral bioavailability data of ribavirin determined previously in six healthy adults."( Comparative pharmacokinetic analysis by standard two-stage method versus nonparametric population modeling.
Drusano, GL; Preston, SL; Tam, VH, 2003
)
0.32
" Both methods were similar in determining the mean +/- SD bioavailability (51."( Comparative pharmacokinetic analysis by standard two-stage method versus nonparametric population modeling.
Drusano, GL; Preston, SL; Tam, VH, 2003
)
0.32
" Cyclodextrins (CDs) can form complexes with numerous molecules, improving their bioavailability and their biological properties."( Improved antiviral activity in vitro of ribavirin against measles virus after complexation with cyclodextrins.
Ammerlaan, W; Finance, C; Grancher, N; Kedzierewicz, F; Le Faou, A; Muller, CP; Venard, V, 2004
)
0.32
"A functional food with a high content of natural antioxidants and with high carotenoid bioavailability was developed."( Tomato-based functional food as interferon adjuvant in HCV eradication therapy.
Ascione, A; Caporaso, N; Carbone, A; Fogliano, V; Marmo, R; Morisco, F; Scarpati, S; Stingo, S; Vitaglione, P, 2004
)
0.32
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
" Furthermore, interindividual RBV bioavailability shows high variation, and dose-limiting haemolytic anaemia is a common adverse event."( Early monitoring of ribavirin serum concentration is not useful to optimize hepatitis C virus treatment in HIV-coinfected patients.
Crespo, M; Curran, A; Esteban, JI; Falcó, V; Feijoo, M; Lopez, R; Ocaña, I; Pahissa, A; Pou, L; Ribera, E; Sauleda, S; Villar del Saz, S, 2007
)
0.34
" When mizoribine was administered orally in conscious rats, the bioavailability of mizoribine estimated by urinary excretion percentage of unchanged mizoribine was a dose dependent: 53."( Characterization of intestinal absorption of mizoribine mediated by concentrative nucleoside transporters in rats.
Kamio, Y; Mori, N; Murakami, T; Yokooji, T, 2008
)
0.35
"Bioequivalence of the new Russian oral ribavirin-containing agents was estimated by the pharmacokinetic and bioavailability parameters vs."( [Comparative estimation of pharmacokinetics of generic ribavirin-containing drugs].
Nisrin, A; Pisarev, VV; Savchenko, AIu; Smirnova, LB, 2008
)
0.35
" Celgosivir is well absorbed in vitro and in vivo, and is rapidly converted to castanospermine."( Celgosivir, an alpha-glucosidase I inhibitor for the potential treatment of HCV infection.
Durantel, D, 2009
)
0.35
" Pharmacokinetic studies reveal that both compounds are well tolerated at doses up to 100mg/kg in rats and have favorable pharmacokinetic properties and bioavailability in mice."( Combination of α-glucosidase inhibitor and ribavirin for the treatment of dengue virus infection in vitro and in vivo.
Alonzi, D; Block, TM; Borune, N; Butters, TD; Chang, J; Goh, A; Guo, JT; Kinch, MA; Lakshminarayana, SB; Liu, B; Moriarty, R; Pan, X; Qu, X; Rayahin, JE; Reinkensmeier, G; Schul, W; Shi, PY; Wang, L; Weidner, JM; Xu, X; Yip, A; Yu, W, 2011
)
0.37
" First-order absorption rate constant (0."( Population pharmacokinetics and exposure-response of albinterferon alfa-2b.
Bergsma, TT; Chen, C; Corey, AE; Devalaraja, M; Gastonguay, MR; Riggs, MM; Rogers, JA; Stein, DS; Subramanian, GM; Sun, H; Yu, J, 2012
)
0.38
"5-fold higher than that in control rats, whereas the bioavailability of cephalexin remained unchanged."( Modulation in concentrative nucleoside transporters-mediated intestinal absorption of mizoribine, an immunosuppressive agent, in lipopolysaccharide-treated rats.
Ishiguro, M; Kamio, Y; Mori, N; Murakami, T; Shimomukai, Y; Yokooji, T, 2011
)
0.37
" In vivo, prodrug 2 is orally bioavailable and well-tolerated in rats in which it is processed to ribavirin and accumulates in the liver."( Synthesis and evaluation of a new phosphorylated ribavirin prodrug.
Dong, SD; Lin, CC; Schroeder, M, 2013
)
0.39
" GS-9451 showed good oral bioavailability in all three species tested."( Preclinical characterization of the novel hepatitis C virus NS3 protease inhibitor GS-9451.
Cheng, G; Corsa, AC; Delaney, WE; Kim, CU; Krawczyk, S; Mo, H; Pakdaman, R; Peng, B; Qi, X; Robinson, M; Shen, M; Sheng, XC; Tay, C; Tian, Y; Wang, Y; Yang, C; Yang, H, 2014
)
0.4
"These results suggest that lower early bioavailability of RBV could be one of the reasons for lower SVR in HIV-HCV coinfected patients treated with pegylated interferon/RBV combination therapy."( Lower ribavirin biodisponibility in patients with HIV-HCV coinfection in comparison with HCV monoinfected patients.
Bailly, F; Chiarello, P; Gagnieu, MC; Hatu, G; Livrozet, JM; Maynard, M; Miailhes, P; Parant, F; Pourcelot, E; Pradat, P; Zoulim, F, 2014
)
0.4
" Mean oral bioavailability of ribavirin was 35%, 60%, 57%, and 71% in control subjects and patients with mild, moderate, and severe renal dysfunction, respectively."( Exploring the influence of renal dysfunction on the pharmacokinetics of ribavirin after oral and intravenous dosing.
Glue, P; K Gupta, S; Kantesaria, B, 2014
)
0.4
" ombitasvir and dasabuvir) on paritaprevir bioavailability were included in the model."( Dose- and Formulation-Dependent Non-Linear Pharmacokinetic Model of Paritaprevir, a Protease Inhibitor for the Treatment of Hepatitis C Virus Infection: Combined Analysis from 12 Phase I Studies.
Awni, WM; Beck, D; Dutta, S; Khatri, A; Liu, W; Menon, RM; Mensing, S; Polepally, AR, 2016
)
0.43
" Paritaprevir bioavailability was formulation- and dose-dependent, and increased supraproportionally."( Dose- and Formulation-Dependent Non-Linear Pharmacokinetic Model of Paritaprevir, a Protease Inhibitor for the Treatment of Hepatitis C Virus Infection: Combined Analysis from 12 Phase I Studies.
Awni, WM; Beck, D; Dutta, S; Khatri, A; Liu, W; Menon, RM; Mensing, S; Polepally, AR, 2016
)
0.43
"Acid-reducing agents (ARAs) and proton-pump inhibitors (PPIs) that increase gastric pH can alter the bioavailability of antiviral drugs, particularly relevant in patients with advanced liver disease caused by chronic hepatitis C virus (HCV) infection seeking therapy."( Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With or Without Ribavirin in HCV-Infected Patients Taking Concomitant Acid-Reducing Agents.
Asselah, T; Bennett, M; Forns, X; Liu, L; Moller, J; Pedrosa, M; Planas Vila, R; Reau, N; Rustgi, V; Shiffman, ML, 2016
)
0.43
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

Ribavirin was well tolerated, but we transiently reduced the dosage in two cases because of mild hemolytic anemia, although all patients completed the treatment schedule. Further trials and clinical studies are necessary for the optimal treatment of patients with recurrent hepatitis C.

ExcerptRelevanceReference
" The mortality rate from viral infection was significantly reduced (greater than or equal to 30%) by the following treatment regimens: cytosine arabinoside, adenine arabinoside, iododeoxyuridine, and ribavirin, administered daily for seven consecutive days starting immediately after inoculation of virus, at dosage levels of 4-20 mg/kg, 20-100mg/kg, 100mg/kg, and 20-100 mg/kg, respectively; and chlorite-oxidized oxyamylose, polyriboinosinic-polyribocytidylic acid, and mouse interferon, administered 24 hr before viral challenge, as single doses of 100-500 mg/kg, 20mg/kg, and 10(7)-10(8) international reference units/kg respectively."( Intranasal challenge of mice with herpes simplex virus: an experimental model for evaluation of the efficacy of antiviral drugs.
De Clercq, E; Luczak, M, 1976
)
0.26
" Antiviral activity was manifested by partial to complete suppression of viral cytopathic effect and of viral replication, depending on concentration of ribavirin in the culture medium and dosage of viral inoculum."( In vitro antiviral efficacy of ribavirin against feline calicivirus, feline viral rhinotracheitis virus, and canine parainfluenza virus.
Povey, RC, 1978
)
0.26
" Moderate rhinovirus activity was observed for several compounds at nontoxic dosage levels."( Imidazo[1,2-a]-s-triazine nucleosides. Synthesis and antiviral activity of the N-bridgehead guanine, guanosine, and guanosine monophosphate analogues of imidazo[1,2-a]-s-triazine.
Allen, LB; Bartholomew, DG; Kim, SH; Revankar, GR; Robins, RK, 1978
)
0.26
"1-beta-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide (ribavirin) at a dosage of 300 mg/day, or disguised placebo was administered to patients in a closed population during an epidemic outbreak of influenza in Mexico City."( Clinical evaluation of 1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide (ribavirin) in a double-blind study during an outbreak of influenza.
Briseno-Garcia, B; Nasser-Quinones, H; Salido-Rengell, F, 1977
)
0.26
" Dosage and course of treatment of this drug are discussed."( Interruption study of viremia of patients with hemorrhagic fever with renal syndrome in the febrile phase.
Cosgriff, TM; Hu, ZJ; Huggins, JW; Qu, CF; Smith, JI; Xiang, JM; Yang, ZQ; Zhang, MV; Zhang, TM; Zheng, ZM, 1991
)
0.28
" With long-term dosing (400 mg orally twice a day) ribavirin accumulated, reaching steady state in 2 to 4 weeks in plasma and red blood cells."( Pharmacokinetics and long-term tolerance to ribavirin in asymptomatic patients infected with human immunodeficiency virus.
Agrawal, KC; Ferencz, N; George, WJ; Hyslop, NE; Lacour, JT; Lertora, JJ; Rege, AB; VanDyke, RB, 1991
)
0.28
" Five men in each ribavirin dosage group completed at least 2 months of treatment."( Clinical, virologic, and immunologic effects of combination therapy with ribavirin and isoprinosine in HIV-infected homosexual men.
Courtless, J; LeLacheur, S; Meyer, WA; Parenti, DM; Paxton, H; Schlesselman, SB; Schulof, RS; Simon, GL; Sztein, MB, 1990
)
0.28
" Long treatment schedules and potential for environmental contamination have stimulated the search for alternative dosing schedules."( Further studies with short duration ribavirin aerosol for the treatment of influenza virus infection in mice and respiratory syncytial virus infection in cotton rats.
Ambrose, MW; Gilbert, BE; Knight, V; Wilson, SZ; Wyde, PR, 1992
)
0.28
"A high-dose, short-duration treatment with ribavirin aerosol consisting of a three-fold increase in concentration of drug (60 mg versus 20 mg of ribavirin per mL in the liquid reservoir of the generator administered for about one-third the time of the standard treatment) was as effective as the standard dosage in the treatment of experimental influenza A and B infections in mice and in the treatment of experimental respiratory syncytial virus infection in cotton rats."( High dose-short duration ribavirin aerosol treatment--a review.
Englund, JA; Gilbert, BE; Knight, V; Wyde, PR,
)
0.13
"We have described a reasonably accurate method of predicting ribavirin small-particle aerosol dosage administered by nasal inhalation or endotracheal tube adjusted for age, sex, weight, and fever."( Aerosol treatment of respiratory viral disease.
Gilbert, BE; Knight, V, 1990
)
0.28
" This allowed a total dosage not much less than might have been given by other routes, but with the advantage that it was evenly deposited over the surface of the infected respiratory tract beginning within seconds of the start of treatment and reached higher concentration in nasal secretions than in serum."( Chemotherapy of respiratory viruses.
Gilbert, BE; Knight, V, 1986
)
0.27
" Dosage of the drug and the course of treatment are discussed."( [Interruption of early viremia in patients with epidemic hemorrhagic fever].
Yang, ZQ, 1989
)
0.28
" The imidates 4 and 6 differed greatly in solubility and dosing requirements."( Synthesis and antitumor activity of ribavirin imidates. A new facile synthesis of ribavirin amidine (1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamidine hydrochloride).
Avery, TL; Kini, GD; Robins, RK, 1989
)
0.28
" The optimal dosage varied according to the treatment route and dosage schedule."( Inhibition of murine hepatitis virus infections by the immunomodulator 2,3,5,6,7,8-hexahydro-2-phenyl-8,8-dimethoxy-imidazo[1,2a]pyridine (PR-879-317A).
Call, EW; Huffman, JH; Murray, RJ; Radov, LA; Sidwell, RW; Warren, RP, 1987
)
0.27
" No objective remission was observed at the dosage of 800 mg/m2 for 5 consecutive days."( Phase II study of tiazofurin (NSC 286193) in the treatment of advanced small cell bronchogenic carcinoma.
Carr, DT; Dhingra, HM; Glisson, BS; Holoye, PY; Jeffries, D; Lee, JS; Murphy, WK; Umsawasdi, T, 1988
)
0.27
" These questions concern appropriate routes of administration for antiviral compounds, optimal dosage regimens, risks of long-term prophylaxis, and the emergence of resistant organisms."( Antiviral chemotherapy and chemoprophylaxis.
Dolin, R, 1985
)
0.27
"We describe a method for estimating the dosage of aerosolized ribavirin according to age."( Estimating the dosage of ribavirin aerosol according to age and other variables.
Divine, GW; Gilbert, BE; Knight, V; Yu, CP, 1988
)
0.27
" Although currently available drugs have improved our ability to manage a variety of viral illnesses, much needs to be learned about specific dosage guidelines based on the studies of pharmacokinetics, pharmacodynamics, potential adverse effects and viral resistance, and the role of combination therapy to optimize therapy."( Clinical use of antiviral drugs.
Nahata, MC, 1987
)
0.27
" In conclusion, ribavirin is incompletely absorbed from the gastrointestinal tract, its renal excretion accounts for approximately one third of the drug's elimination, and drug accumulation (greater than threefold) will result with repetitive dosing at the 6- to 8-hour dosing interval currently used."( Ribavirin disposition in high-risk patients for acquired immunodeficiency syndrome.
Connor, JD; Hart, CC; Kalman, CM; Laskin, OL; Longstreth, JA; Roberts, RB; Scavuzzo, D, 1987
)
0.27
" We test new structures in 20 well-selected human tumor xenografts and in the P388 mouse leukemia in dose-response relationships."( Colony assay with human tumor xenografts, murine tumors and human bone marrow. Potential for anticancer drug development.
Bieser, W; Fiebig, HH; Henss, H; Lohr, GW; Schmid, JR, 1987
)
0.27
" A definite relationship exists between dosage and steady-state levels."( Phase I and pharmacokinetic study of tiazofurin (NSC 286193) administered by 5-day continuous infusion.
Bishop, J; Coates, A; Fox, R; Grygiel, J; Raghavan, D; Sampson, D; Woods, R, 1986
)
0.27
" Dose-response experiments indicated that the GTP pool was significantly reduced (65% of control) at 25 microM ribavirin, and increasing concentrations of the drug caused only a small further reduction in the GTP pool (5-10% at 100 microM)."( Mode of action of ribavirin: effect of nucleotide pool alterations on influenza virus ribonucleoprotein synthesis.
Gilbert, BE; Knight, V; Noall, MW; Wray, SK, 1985
)
0.27
" Although the lowest effective in vitro dose of ribavirin is 30-50 mcg/ml, the in vivo dosage requirement may be different."( Ribavirin suppresses replication of lymphadenopathy-associated virus in cultures of human adult T lymphocytes.
Getchell, JP; Hicks, DR; McCormick, JB; Mitchell, SW, 1984
)
0.27
" In a dose-response study, injection of varying amounts of the drug decreased NAD pools in the hepatoma in a dose-dependent fashion."( Tiazofurin-induced selective depression of NAD content in hepatoma 3924A.
Faderan, MA; Liepnieks, JJ; Lui, MS; Weber, G, 1984
)
0.27
" With this dosage regimen, there were no side effects or changes in laboratory values that could be associated with drug-related toxicity."( Evaluation of ribavirin in the treatment of acute hepatitis.
Gupta, P; Patki, SA, 1982
)
0.26
" At the high dosage level, maximum ribavirin serum levels of 24 microgram/ml were observed 2 h postribavirin administration."( Development of antiviral levels of ribavirin in serum and urine of orally treated rats.
Barnett, BB; Sharma, RP; Sidwell, RW; Smee, DF; Spendlove, RS, 1981
)
0.26
" 9-beta-D-Ribofuranosylpurine-6-carboxamide (6a), the corresponding 6-thiocarboxamide (7b), and 4-amino-8-(beta-D-ribofuranosylamino)pyrimido[5,4-d]pyrimidine (8) showed significant in vitro antiviral activity at nontoxic dosage levels."( Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
Madsen, RD; Mancuso, RW; North, JA; Ogden, JR; Revankar, GR; Robins, RK; Rousseau, RJ; Stephen, EL; Westover, JD, 1981
)
0.26
"01), and a negative correlation between NK activities and RTC dosage was obtained."( [Effect of ribavirin on NK activities of murine spleen cells in vitro].
Chen, QY; Mi, CM; Yang, JQ, 1995
)
0.29
" Six patients who continued to have elevated serum ALT and positive HCV RNA after the initial 4 weeks treatment received oral ribavirin at the same dosage for an additional 24 weeks."( Correlation of serum HCV RNA and alanine aminotransferase levels in chronic hepatitis C patients during treatment with ribavirin.
Co, RL; Conrad, A; Hwang, SJ; Lee, SD; Lefkowitz, M; Lo, KJ; Schmid, P; Tong, MJ,
)
0.13
" This emphasizes the need for well-designed research to develop optimal dosage regimens in paediatric patients with bronchiolitis."( Pattern of drug usage in bronchiolitis.
Nahata, MC; Schad, PA, 1994
)
0.29
"To assess whether therapy with Ribavirin may affect the course of chronic delta hepatitis, nine Italian patients with this disease received the drug orally at a dosage of 15 mg/kg daily for 16 weeks."( Ribavirin treatment for chronic hepatitis D: a pilot study.
Bonino, F; Costa, C; Cozzolongo, R; Craxi, A; Di Marco, V; Fabiano, A; Garripoli, A; Rizzetto, M; Smedile, A; Verme, G, 1994
)
0.29
" The most profound and consistent haematologic change, particularly among the moderate and high dosage groups regardless of route of administration, was a significant and severe thrombocytopenia (range, 33-78% reduction in mean platelet counts vs."( Toxicologic effects of ribavirin in cats.
Boudreaux, MK; Cox, NR; Weiss, RC, 1993
)
0.29
" The clinical efficacy of free ribavirin given intravenously at a reduced dosage (5."( Evaluation of free or liposome-encapsulated ribavirin for antiviral therapy of experimentally induced feline infectious peritonitis.
Cox, NR; Martinez, ML; Weiss, RC, 1993
)
0.29
" Ribavirin was well tolerated, but we transiently reduced the dosage in two cases because of mild hemolytic anemia, although all patients completed the treatment schedule."( Pilot study of ribavirin and interferon-beta for chronic hepatitis B.
Higashi, Y; Ishikawa, T; Kakumu, S; Takayanagi, M; Wakita, T; Yoshioka, K, 1993
)
0.29
" Further studies are needed to determine the optimal dosage and duration of therapy."( A pilot study of ribavirin therapy for recurrent hepatitis C virus infection after liver transplantation.
Cameron, R; Cattral, MS; Chung, SW; Greig, PD; Krajden, M; Levy, GA; Rezig, M; Wanless, IR, 1996
)
0.29
" When ribavirin was administered intracranially at a dosage of 10 mg/kg of body weight per day for 10 days, a dosage which results in 100% survival of hamsters infected with subacute sclerosing panencephalitis (SSPE) virus and which inhibits the replication of SSPE virus in hamster brains, the ribavirin concentration in the brains estimated by HPLC and bioassay was kept higher than 50 micrograms/g for 10 days."( Effective ribavirin concentration in hamster brains for antiviral chemotherapy for subacute sclerosing panencephalitis.
Hosoya, M; Ishii, T; Mori, S; Shigeta, S; Suzuki, H, 1996
)
0.29
"5%) were withdrawn prematurely from combination therapy because of side-effects; ribavirin therapy was ceased or dosage reduced in six other patients (25%), again because of side-effects."( Ribavirin and interferon-alpha combination therapy vs interferon-alpha alone in the retreatment of chronic hepatitis C: a randomized clinical trial.
Bellobuono, A; Idéo, G; Mondazzi, L; Silini, E; Tempini, S; Vicari, F, 1997
)
0.3
"Ribavirin (RIBV) is a useful drug in the treatment of chronic type C hepatitis but displays a toxicity for red blood cells (RBC), which limits its dosage and necessitates withdrawal in some patients."( Ribavirin conjugated with lactosaminated poly-L-lysine: selective delivery to the liver and increased antiviral activity in mice with viral hepatitis.
Bongini, A; Busi, C; Colonna, FP; Di Stefano, G; Fiume, L; Mattioli, A, 1997
)
0.3
" Drug doses of 125 and 250 mg/kg on a day-1, -3 and -5 dosing schedule increased the life span (ILS) relative to untreated control mice of 36."( In vitro and in vivo antiproliferative activity of IPCAR, a new pyrazole nucleoside analog.
La Colla, P; Manfredini, S; Marongiu, ME; Montis, AD; Pani, A; Perra, G; Pinna, E; Scintu, F,
)
0.13
" Upon multiple dosing there is extensive accumulation in plasma, and steady state is achieved by approximately 4 weeks."( The clinical pharmacology of ribavirin.
Glue, P, 1999
)
0.3
" Such treatment could be achieved with either a fixed dose of interferon administered daily (QD) or TIW, an induction regimen in which doses greater than 3 MU QD are administered for several weeks to months followed by a reduction in the dose or dosing frequency, or by escalation in the interferon dose."( Use of high-dose interferon in the treatment of chronic hepatitis C.
Shiffman, ML, 1999
)
0.3
" Using the hypothesis to fit the changes in serum HCV RNA measured in a set of patients, it was found that 5 mIU daily dosing on average blocks 81% of HCV production/release, whereas 10 or 15 mIU blocks about 95% of HCV production/release."( Enhancing the response to interferon-alpha.
Begemann, F; Jablonowski, H, 1999
)
0.3
" Two placebo-controlled randomised studies including 150 patients have shown that ribavirin as single therapy at standard dosage (15 mg/kg bodyweight in two divided doses daily) only reduces ALT levels transiently during therapy, whereas HCV RNA levels are not substantially reduced."( Treatment of naive patients with chronic hepatitis C.
Weiland, O, 1999
)
0.3
" In 4 (17%) patients who suffered nausea and diarrhea the ribavirin dosage was reduced by 50% after 1 month of therapy and finally discontinued in all of them."( Pilot study of combination therapy with ribavirin and interferon alfa for the retreatment of chronic hepatitis B e antibody-positive patients.
Carreño, V; Clouet, R; Cotonat, T; López-Alcorocho, JM; Manzarbeitia, F; Pardo, M; Quiroga, JA, 2000
)
0.31
" For the future better optimised treatment schedules and dosing regimens for IFN in combination with ribavirin need to be worked out and individualised according to genotype to further improve treatment results."( Interferon and ribavirin combination therapy: indications and schedules.
Weiland, O,
)
0.13
" The therapeutic response rate can be enhanced by combining interferon-alpha with ribavirin as well as by increasing interferon dosage or prolonging treatment."( [New therapeutic possibilities in chronic hepatitis C].
Criblez, DH, 2000
)
0.31
" The aim of the study was to determine the effect of a higher and daily dosage of IFN-alpha2b plus ribavirin on the viral load and on the response rate in patients infected by genotype 1 and previous nonresponders to interferon."( Quantification of serum hepatitis C virus RNA with daily or standard interferon doses plus ribavirin in nonresponder patients with chronic hepatitis C.
Buti, M; Esteban, R; Guardi, J; Olive, G; Stalgis, C, 2000
)
0.31
" <100 copies/mL) at the end of treatment (week 24) and after 24 weeks of follow-up (week 48) showed dose-response trends for PEG-Intron."( A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C. The Hepatitis C Intervention Therapy Group.
Clement, RP; Glue, P; Gupta, SK; Jacobs, S; Raffanel, C; Rouzier-Panis, R; Sabo, R; Salfi, M, 2000
)
0.31
" Therefore, we compared the efficacy of ribavirin addition to alpha-interferon with a doubling of the dosage of alpha-interferon in case of lack of early virological response to alpha-interferon therapy."( Early addition of ribavirin to interferon in chronic hepatitis C not responsive to interferon monotherapy.
Bellobuono, A; Chiodo, F; Furione, L; Idéo, G; Magliano, E; Mondazzi, L; Tempini, S, 2000
)
0.31
"Sixty patients were administered interferon alpha2b at the dosage of 3 million units 3 times a week."( Early addition of ribavirin to interferon in chronic hepatitis C not responsive to interferon monotherapy.
Bellobuono, A; Chiodo, F; Furione, L; Idéo, G; Magliano, E; Mondazzi, L; Tempini, S, 2000
)
0.31
" Sustained response was observed in 5/12 (42%) patients with early virological response, in 10/24 (42%) patients without early virological response who were administered ribavirin and alpha-interferon, and in only 1/24 (4%) patients who were administered the double dosage of alpha-interferon (p=0."( Early addition of ribavirin to interferon in chronic hepatitis C not responsive to interferon monotherapy.
Bellobuono, A; Chiodo, F; Furione, L; Idéo, G; Magliano, E; Mondazzi, L; Tempini, S, 2000
)
0.31
"This study shows the efficacy of the addition of ribavirin to alpha-interferon and the lack of efficacy of doubling the dosage of alpha-interferon in patients without clearance of hepatitis C virus early on in treatment."( Early addition of ribavirin to interferon in chronic hepatitis C not responsive to interferon monotherapy.
Bellobuono, A; Chiodo, F; Furione, L; Idéo, G; Magliano, E; Mondazzi, L; Tempini, S, 2000
)
0.31
" The assistance of nurses in patient education, in side effect management, in hematologic parameter monitoring, and in medication dosing and administration is crucial to maximizing patient compliance and therapy outcome."( Combination Interferon alfa-2b/ribavirin therapy for the treatment of hepatitis C: nursing implications.
Benson, L; Birkel, A; Caldwell, L; Casarico, B; Stafford-Fox, V,
)
0.13
"A series of 100 patients with chronic hepatitis C not responding to recombinant alpha-interferon 3 MU tiw, were randomly assigned to two groups of 50 patients each: Group A, treated with recombinant alpha-interferon therapy for an additional six months but at a double dosage (6 MU tiw) in association with ribavirin."( High-dose interferon plus ribavirin in chronic hepatitis C not responding to recombinant alpha-interferon.
Bertoni, M; Bresci, G; Capria, A; Parisi, G, 2000
)
0.31
" When interferon alfa-n/n3 and a lower dosage of ribavirin (600-800 mg/d) were used, the risk difference was 0% (95% CI, -7% to 7%)."( Interferon and ribavirin vs interferon alone in the re-treatment of chronic hepatitis C previously nonresponsive to interferon: A meta-analysis of randomized trials.
Aoki, Y; Cid-Ruzafa, J; Cummings, KJ; Fein, SG; Goodman, SN; Lee, SM; Sulkowski, MS; West, ES, 2001
)
0.31
" Strategies to further improve response rates include modification of the interferon dosing schedule with induction dosing and daily interferon, new interferons such as consensus interferon, or interferon with longer half-life and more favorable pharmacokinetics such as pegylated interferons."( Current and future treatment of hepatitis C.
Cornberg, M; Manns, MP; Wedemeyer, H, 2001
)
0.31
" Multivariate analysis showed that infection by hepatitis C virus genotypes 2 or 3 and interferon alpha dosage of 5 million units daily were independent predictors of sustained response."( Pilot dose-finding trial on interferon alpha in combination with ribavirin for the treatment of chronic hepatitis C in patients not responding to interferon alone.
Barni, MC; Cadeo, GP; Carosi, G; Cristini, G; Forleo, MA; Gargiulo, F; Paraninfo, G; Puoti, M; Putzolu, V; Quiros-Roldan, E; Rossi, S; Spinetti, A; Zaltron, S; Zanini, B, 2001
)
0.31
" Oral dosing of interferon is in clinical trials for hepatitis B, and the results may be applicable to HCV."( Can science meet the challenges of the HCV pandemic: new treatment options for chronic hepatitis C.
Roehr, B, 1998
)
0.3
" He believes the Food and Drug Administration's (FDA) approved interferon dosing regimen is not appropriate."( Treating hepatitis C: a clinician's perspective. Interview by Bob Roehr.
Powell, J, 1998
)
0.3
" Results of clinical trials are summarized, and dosing options and side effects are detailed."( Product information.
Bartlett, JG, 1999
)
0.3
"To determine whether a higher dosage of interferon (IFN) associated with ribavirin and/or prolonged time of administration may improve therapeutic efficacy, we conducted a 4-arm randomized trial on patients with chronic hepatitis C not responding to one or more previous treatment courses with IFN monotherapy."( A randomized 4-arm multicenter study of interferon alfa-2b plus ribavirin in the treatment of patients with chronic hepatitis C not responding to interferon alone.
Andreoni, M; Biglino, A; Calleri, G; Cariti, G; Ciancio, A; Ciccone, G; Colletta, C; Croce, G; Di Napoli, A; Macor, A; Maggi, G; Olivero, A; Orsi, PG; Rinaldi, E; Rizzetto, M; Roffi, L; Saracco, G; Smedile, A; Tappero, GF; Terreni, N, 2001
)
0.31
" In dialysis patients only interferon therapy is currently used due to the lack of knowledge concerning ribavirin dosage and side-effects."( Ribavirin treatment in dialysis patients with chronic hepatitis C virus infection--a pilot study.
Andersson, J; Bruchfeld, A; Schvarcz, R; Ståhle, L, 2001
)
0.31
" The exponential decay slopes of the second phase were significantly higher in the combination or twice-daily dosing regimen groups compared with groups 2 or 4 (0."( A potent antiviral effect on hepatitis C viral dynamics in serum and peripheral blood mononuclear cells during combination therapy with high-dose daily interferon alfa plus ribavirin and intravenous twice-daily treatment with interferon beta.
Asahina, Y; Hamano, K; Itakura, J; Izumi, N; Kanazawa, N; Miyake, S; Noguchi, O; Sakai, T; Tsuchiya, K; Uchihara, M, 2001
)
0.31
" Interstitial pneumonitis is a rare but known complication of IFN-alpha when given at a high dosage of 6 to 10 million units per day."( Interstitial pneumonitis in a patient treated with alpha-interferon and ribavirin for hepatitis C infection.
Ahmed, S; Karim, A; Khan, A; Mattana, J; Steinberg, H, 2001
)
0.31
" Dosage reduction was required in 10 patients (26%) because of ribavirin-related anemia or IFN-related side effects."( Sustained suppression of hepatitis C virus by interferon and ribavirin in hemophilic patients not responding to interferon monotherapy.
Colombo, M; Mannucci, PM; Rivi, M; Rumi, MG; Santagostino, E, 2002
)
0.31
" Interferon therapy at a dosage of 3 MU and subcutaneous injection 3 times per week for 6 months normalized serum transaminase in 50% of patients with chronic hepatitis C at the end of treatment."( Hepatitis C virus infection: an overview.
Hwang, SJ, 2001
)
0.31
" Twenty-six percent of patients required dosage modifications of one or both drugs during combination therapy."( Interferon-alpha-2b plus ribavirin: a review of its use in the management of chronic hepatitis C.
Perry, CM; Scott, LJ, 2002
)
0.31
" Serum ribavirin concentrations in steady state, and maximum concentration and accumulation rate of ribavirin after multiple dosing were significantly higher in the presence of sustained virologic response."( Viral dynamics and pharmacokinetics in combined interferon alfa-2b and ribavirin therapy for patients infected with hepatitis C virus of genotype 1b and high pretreatment viral load.
Akuta, N; Arase, Y; Ikeda, K; Kobayashi, M; Kumada, H; Saitoh, S; Someya, T; Suzuki, F; Suzuki, Y; Tsubota, A, 2002
)
0.31
" Options to further enhance response rates include modification of the IFN-dosing schedule with daily dosing of IFN, new IFN such as consensus interferon or modified IFN with longer half-life and more favourable pharmacokinetics such as pegylated IFN (PEG-IFN)."( Hepatitis C: therapeutic perspectives.
Cornberg, M; Manns, MP; Wedemeyer, H,
)
0.13
" In a randomized open study, 61 patients with haemophilia or von Willebrand disease received treatment with a combination of interferon alpha-2b and ribavirin at standard dosage for 6 or 12 months."( A randomized study of alpha-interferon plus ribavirin for 6 months or 12 months for the treatment of chronic hepatitis C in patients with bleeding disorders.
Kinnman, N; Lindmarker, P; Schulman, S; von Sydow, M, 2002
)
0.31
" The dose of 800 mg/day may be the most appropriate lower dose for those patients who require dosage modification for anemia or other side-effects."( Hepatitis C advances in antiviral therapy: what is accepted treatment now?
McHutchison, JG, 2002
)
0.31
"Patients living in Kuwait were assigned to take either interferon alone at a dosage of 5 million units thrice weekly (26 patients) or interferon 5 million units thrice weekly combined with ribavirin 1,000 mg/d (21 patients) for 24 weeks."( Treatment of hepatitis C virus genotype 4-related cirrhosis: ribavirin and interferon combination compared with interferon alone.
Koshy, A; Madda, JP; Marcellin, P; Martinot, M, 2002
)
0.31
" To reduce the likelihood of viral replication, mutation and subsequent development of resistance, daily dosing with IFN may be appropriate."( High sustained response to daily dosing of interferon with ribavirin in chronic hepatitis C patients naïve to therapy.
Abbas, Z; Hamid, S; Tabassum, S, 2002
)
0.31
" Dosage modifications were according to a standard protocol incorporating laboratory values and clinical side effects."( Treatment of posttransplantation recurrence of hepatitis C with interferon and ribavirin: lessons on tolerability and efficacy.
Burgart, LJ; Charlton, M; El-Amin, OM; Kremers, WK; Narayanan Menon, KV; Poterucha, JJ; Rosen, CB; Wiesner, RH, 2002
)
0.31
"Fifty eligible MM patients with active HCV and concomitant liver fibrosis were treated with interferon/ribavirin combination therapy using standard dosing regimens."( Treating hepatitis C in methadone maintenance patients: an interim analysis.
Sylvestre, DL, 2002
)
0.31
" The outcomes evaluated were withdrawal from the study due to anaemia, ribavirin dosage reduction due to a decrease in haemoglobin and haemoglobin levels below 10 g/dL."( Meta-analysis: ribavirin-induced haemolytic anaemia in patients with chronic hepatitis C.
Chan, KA; Chang, CH; Chen, KY; Lai, MY, 2002
)
0.31
" Reported risks were higher among Asian studies, which may be due to differences in study entrance criteria, dosage titration strategy or ethnic vulnerability."( Meta-analysis: ribavirin-induced haemolytic anaemia in patients with chronic hepatitis C.
Chan, KA; Chang, CH; Chen, KY; Lai, MY, 2002
)
0.31
"To determine whether a higher dosage of interferon (IFN) and/or a prolonged time of administration may improve the efficacy of combination therapy, we conducted a 4-arm randomized trial on patients with chronic hepatitis C relapsing after 1 or more previous treatment courses with IFN monotherapy."( A randomized 4-arm multicenter study of interferon alfa-2b plus ribavirin in the treatment of patients with chronic hepatitis C relapsing after interferon monotherapy.
Andreoni, M; Biglino, A; Carenzi, S; Cariti, G; Ciancio, A; Ciccone, G; Croce, G; Manca, A; Olivero, A; Orsi, PG; Rizzetto, M; Roffi, L; Saracco, G; Smedile, A; Tabone, M; Tappero, G, 2002
)
0.31
" An open label prospective trial of 5 MU of interferon daily plus ribavirin dosed according to weight was performed utilizing 40 patients, who were identified as being IFN nonresponders to 1 year or more of continuous IFN administered at a dose of 5 MU/day."( Retreatment of high-dose interferon (5 MU daily) nonresponders with high-dose IFN + ribavirin.
Friedlander, L; Kondaveeti, K; Van Thiel, DH, 2002
)
0.31
"HCV-1-infected patients who can be maintained on >80% of their interferon or peginterferon alpha-2b and ribavirin dosage for the duration of treatment in the setting of a clinical trial exhibit enhanced sustained response rates."( Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C.
Albrecht, JK; Dienstag, J; Garaud, JJ; Lee, WM; Lindsay, KL; Mak, C; Manns, M; McHutchison, JG; Patel, K; Poynard, T; Trepo, C, 2002
)
0.31
" Approved ribavirin dosages vary from a fixed dosage of 800 mg/d to as much as 1200 mg/d on the basis of body weight."( Ribavirin dosing in chronic hepatitis C: application of population pharmacokinetic-pharmacodynamic models.
Affrime, MB; Chung, C; Glue, P; Gupta, SK; Hajian, G; Heft, S; Jen, J; Laughlin, M, 2002
)
0.31
"Our objective was to evaluate ribavirin dosing strategies by comparison of their relative efficacy and toxicity profiles."( Ribavirin dosing in chronic hepatitis C: application of population pharmacokinetic-pharmacodynamic models.
Affrime, MB; Chung, C; Glue, P; Gupta, SK; Hajian, G; Heft, S; Jen, J; Laughlin, M, 2002
)
0.31
" Simulations of these models were developed for different ribavirin doses to obtain efficacy and toxicity profiles across the various dosing strategies."( Ribavirin dosing in chronic hepatitis C: application of population pharmacokinetic-pharmacodynamic models.
Affrime, MB; Chung, C; Glue, P; Gupta, SK; Hajian, G; Heft, S; Jen, J; Laughlin, M, 2002
)
0.31
"This simulation suggests that ribavirin dosage (in combination with pegylated interferon alfa-2b) for patients with chronic hepatitis C should be based on body weight."( Ribavirin dosing in chronic hepatitis C: application of population pharmacokinetic-pharmacodynamic models.
Affrime, MB; Chung, C; Glue, P; Gupta, SK; Hajian, G; Heft, S; Jen, J; Laughlin, M, 2002
)
0.31
" In using peginterferon in combination therapy, the benefits of once weekly dosing need to be weighed against the higher risks of cytopenias and greater costs with the pegylated formulations."( Treatment of patients with hepatitis C and cirrhosis.
Wright, TL, 2002
)
0.31
" Ongoing research on the use of pegylated IFN, weight-adjusted dosing of ribavirin, and the treatment of relapsers and nonresponders will provide valuable data that could be incorporated into future CEAs."( Motion - the available treatments for hepatitis C are cost effective: arguments for the motion.
Terrault, N, 2002
)
0.31
" Ribavirin dosage is currently based on body weight."( Dosage of ribavirin in patients with hepatitis C should be based on renal function: a population pharmacokinetic analysis.
Bruchfeld, A; Lindahl, K; Schvarcz, R; Ståhle, L, 2002
)
0.31
" It allows once-weekly dosing and increases sustained response rates without changing the safety profile."( Polyethylene glycol-interferon: current status in hepatitis C virus therapy.
Cornberg, M; Manns, MP; Wedemeyer, H; Wiegand, J, 2002
)
0.31
"Patients received IFNalpha for a mean +/- SD of 20 +/- 14 months and ribavirin (at a mean +/- SD dosage of 895 +/- 250 mg/day) for 14 +/- 12 months."( Interferon-alpha and ribavirin treatment in patients with hepatitis C virus-related systemic vasculitis.
Cacoub, P; Duhaut, P; Ghillani, P; Leger, JM; Lidove, O; Maisonobe, T; Myers, RP; Piette, JC; Servan, J; Thibault, V, 2002
)
0.31
" Excretion of total radioactivity in urine after oral dosing accounted for 15."( Absorption, pharmacokinetics and excretion of levovirin in rats, dogs and cynomolgus monkeys.
Lau, JY; Lin, CC; Lourenco, D; Luu, T; Yeh, LT, 2003
)
0.32
" It is concluded that the safety and tolerability profiles of the two treatments were similar suggesting that daily dosing of CIFN may be difficult to tolerate resulting in discontinuation of therapy in a significant proportion of patients."( The safety and tolerability of daily infergen plus ribavirin in the treatment of naíïve chronic hepatitis C patients.
Boyd, DG; McHutchinson, J; Pockros, PJ; Reddy, R; Reindollar, R; Wilkes, LB; Wright, T, 2003
)
0.32
" Stepwise multiple logistic regression analysis of the factors (age, gender, viral load, cirrhosis rate, IFN dosage and amino acid substitutions) revealed that the mutation in NS5A-ISDR (>/= 4 vs < 4) was the only independent variable of treatment outcome."( Mutations in the NS5A and E2-PePHD region of hepatitis C virus type 1b and correlation with the response to combination therapy with interferon and ribavirin.
Changchien, CS; Chen, TM; Chen, WJ; Hu, TH; Hung, CH; Lee, CM; Lee, JF; Lu, SN; Tung, HD; Wang, JH, 2003
)
0.32
" Subcutaneous peginterferon-alpha-2a (40kD) was administered at a dosage of 180 micro g once weekly and oral ribavirin was usually administered at a dosage of 1000 or 1200 mg/day."( Peginterferon-alpha-2a (40kD) plus ribavirin: a review of its use in the management of chronic hepatitis C.
Curran, MP; Keating, GM, 2003
)
0.32
" at a daily dosage of 30 mg/kg in two treatment protocols: from the start of immunization (preventive treatment) or from the onset of the first EAE signs after the induction (therapeutic treatment)."( Ribavirin reduces clinical signs and pathological changes of experimental autoimmune encephalomyelitis in Dark Agouti rats.
Medic-Mijacevic, L; Milicevic, I; Mostarica-Stojkovic, M; Pejanovic, V; Pekovic, S; Rakic, L; Stojiljkovic, M; Stosic-Grujicic, S; Subasic, S, 2003
)
0.32
" The steady-state concentration correlated significantly with serum ribavirin clearance after multiple dosing (r = -0."( Pharmacokinetics of ribavirin in combined interferon-alpha 2b and ribavirin therapy for chronic hepatitis C virus infection.
Hirose, Y; Izumi, N; Kumada, H; Tsubota, A, 2003
)
0.32
" While the rationale for erythropoietin treatment of ribavirin-induced anaemia is not straightforward, the currently recommended dosing regimen should be reassessed."( Normal erythropoietin response in chronic hepatitis C patients with ribavirin-induced anaemia.
Del Vecchio, C; Durante Mangoni, E; Marrone, A; Ruggiero, G; Saviano, D; Utili, R, 2003
)
0.32
" IFN-alpha dose-response studies on viral kinetics suggest that inadequate dosing might be a key factor but drug levels have hardly been tested, which is in part due to difficulties in measuring this cytokine in patient samples."( A replicon-based bioassay for the measurement of interferons in patients with chronic hepatitis C.
Bartenschlager, R; Haagmans, BL; Hansen, BE; Kaul, A; Lohmann, V; Schalm, SW; Vrolijk, JM, 2003
)
0.32
" Sixty-eight patients were randomized to receive IFN-alpha-2a at a dosage of either (1) 6 MU given 3 times per week for 24 weeks, followed by 3 MU 3 times per week for an additional 24 weeks (group A; 31 patients); or (2) 9 MU per day for 2 weeks, followed by 3 MU per day for 22 weeks, followed by 3 MU 3 times per week for 24 weeks (group B; 37 patients)."( Comparison of 2 regimens that include interferon-alpha-2a plus ribavirin for treatment of chronic hepatitis C in human immunodeficiency virus-coinfected patients.
Bioulac-Sage, P; Chêne, G; Dupon, M; Lacoste, D; Lafon, ME; Le Bail, B; Neau, D; Ragnaud, JM; Rullier, A; Trimoulet, P; Winnock, M, 2003
)
0.32
" Sustained response with induction dosing was 57%."( Chronic hepatitis C--treatment results in northern India.
Awasthi, G; Midha, V; Sood, A; Sood, N,
)
0.13
" Induction dosing improves the sustained virological response further."( Chronic hepatitis C--treatment results in northern India.
Awasthi, G; Midha, V; Sood, A; Sood, N,
)
0.13
"2 g/day) (group A=127 patients) or IFN alpha-2b (group B=60 patients) of same dosage and duration for 1 year."( High rate of long-term virological response after a 1-year course of interferon +/- ribavirin in chronic hepatitis C relapsers. Results of a 191 patients randomized trial.
Boucher, EJ; Brissot, P; Canva, V; Colimon, R; Deugnier, Y; Guyader, D; Jacquelinet, C; Jacquelinet, S; Turlin, B, 2003
)
0.32
" Initial use of pulse methylprednisolone therapy appears to be a more efficacious and an equally safe steroid regimen when compared with regimens with lower dosage and should be considered as the preferred steroid regimen in the treatment of SARS, pending data from future randomized controlled trials."( High-dose pulse versus nonpulse corticosteroid regimens in severe acute respiratory syndrome.
Chan, JW; Chan-Yeung, M; Ho, JC; Ho, PL; Hung, I; Ip, MS; Lai, KN; Lam, B; Lam, WK; Li, PC; Mok, TY; Ng, CK; Ooi, GC; Tsang, KW; Wong, PC, 2003
)
0.32
" In a whole body autoradiography study in rats following oral dosing (30 mg/kg) of [14C]ribavirin or [14C]viramidine to monkeys, viramidine produced 32% higher radioactivity in the liver than ribavirin, indicating a better liver-targeting properties."( Viramidine, a prodrug of ribavirin, shows better liver-targeting properties and safety profiles than ribavirin in animals.
Hong, Z; Lin, CC; Vitarella, D; Yeh, LT, 2003
)
0.32
"In treating SARS, ICWM was superior to the treatment with western medicine alone in aspects of improving clinical symptom, promoting recovery of immune function and absorption of lung inflammation, decreasing the dosage of hormone used and shortening the therapeutic course."( [Controlled clinical study on 49 patients of SARS treated by integrative Chinese and Western medicine].
Jiao, Q; Wang, BG; Zhang, RL, 2003
)
0.32
" Other ongoing studies using alternative antibody preparations and more intensive dosing schedules are underway."( Prophylactic and preemptive therapies for hepatitis C virus-infected patients undergoing liver transplantation.
Terrault, NA, 2003
)
0.32
" In fact, daily dosing is still proposed for non-pegylated interferon."( First-line therapy with daily versus thrice-weekly interferon alfa-2b plus ribavirin for chronic hepatitis C.
Buggisch, P; Grossmann, J; Koop, K; Reiser, M; Schmiegel, W; Wursthorn, K, 2003
)
0.32
" Rats were dosed orally with 120 mg kg(-1) day(-1) of ribavirin and viramidine and 2000 mg kg(-1) day(-1) of levovirin for 8 days."( Effect of ribavirin, levovirin and viramidine on liver toxicological gene expression in rats.
Fang, C; Lin, CC; Srivastava, P,
)
0.13
"We applied viral response and drug dosage from an international randomized clinical trial of ribavirin plus peginterferon alfa-2b or ribavirin plus interferon alfa-2b to a previously published computer cohort simulation to project lifelong clinical and economic outcomes."( Economic and clinical effects of evaluating rapid viral response to peginterferon alfa-2b plus ribavirin for the initial treatment of chronic hepatitis C.
Albrecht, JK; Davis, GL; Manns, MP; McHutchison, JG; Wong, JB, 2003
)
0.32
"0001), and the mean changes in RBV dosage were -34 mg/day for epoetin alfa versus -146 mg/day (p=0."( Once-weekly epoetin alfa improves anemia and facilitates maintenance of ribavirin dosing in hepatitis C virus-infected patients receiving ribavirin plus interferon alfa.
Bini, EJ; Bowers, PJ; Bräu, N; Dieterich, DT; Hassanein, TI; Sulkowski, MS; Wasserman, R, 2003
)
0.32
"5 microg/kg) and pegylated IFN alpha-2a (40 kDa) (fixed dosage of 180 microg)."( Combined antiviral options for the treatment of chronic hepatitis C.
García-Buey, L; Medina, J; Moreno-Monteagudo, JA; Moreno-Otero, R; Trapero-Marugán, M, 2003
)
0.32
" However, no recommendation exists for dosing patients with impaired renal function."( Ribavirin pharmacokinetics in renal and liver transplant patients: evidence that it depends on renal function.
Chatelut, E; Izopet, J; Kamar, N; Lafont, T; Manolis, E; Rostaing, L, 2004
)
0.32
" The current dosage recommendations for ribavirin are based on body weight (bw)."( Evidence that plasma concentration rather than dose per kilogram body weight predicts ribavirin-induced anaemia.
Bruchfeld, A; Lindahl, K; Schvarcz, R; Ståhle, L, 2004
)
0.32
" In the present study, the authors examined factors influencing total plasma clearance (CL(total)) and the toxic level on red blood cells of ribavirin in such body weight-based dosage adjustment in Japanese chronic hepatitis C patients (13 male and 6 female)."( Dosage adjustment of ribavirin based on renal function in Japanese patients with chronic hepatitis C.
Funakoshi, S; Kiribayashi, Y; Maeda, Y; Maruhashi, A; Moriya, T; Murakami, T; Omoda, K; Takano, M, 2004
)
0.32
" Early reduction of viral load by daily dosage of IFN could enhance viral clearance."( A randomized trial of a 4- vs 12-week daily interferon dose regimen combined with ribavirin in treatment of patients with chronic hepatitis C.
Goyal, A; Guptan, RC; Hashmi, AZ; Kumar, S; Malhotra, V; Sakhuja, P; Sarin, SK, 2004
)
0.32
"Daily IFN dosage with ribavirin is safe and can achieve response in up to 65% patients."( A randomized trial of a 4- vs 12-week daily interferon dose regimen combined with ribavirin in treatment of patients with chronic hepatitis C.
Goyal, A; Guptan, RC; Hashmi, AZ; Kumar, S; Malhotra, V; Sakhuja, P; Sarin, SK, 2004
)
0.32
" Viramidine dosing yielded 50% higher ribavirin levels in the monkey liver but only half in plasma and red blood cells compared to ribavirin dosing."( Pharmacokinetics and safety of viramidine, a prodrug of ribavirin, in healthy volunteers.
Lin, CC; Philips, L; Xu, C; Yeh, LT, 2004
)
0.32
" In conclusion, genotype 1b naive end-therapy responders to usual combined therapy, after a period of daily consolidation therapy with a low dosage of IFN without ribavirin, achieved a better rate of sustained response than the control group."( Low daily dosage of interferon for 1 year after HCV-related end-therapy response. A randomized-controlled study.
Conca, P; Perrella, A; Perrella, O; Ragucci, P; Sorrentino, P; Tarantino, G, 2003
)
0.32
" A retrospective study carried out of 72 probable SARS patients has shown that cases who received pulse methylprendisolone did not differ in cumulative steroid dosage or adverse reactions, although the former patients had less oxygen requirement, better radiographic outcome, and less likelihood of requiring rescue pulse steroid therapy than their counterparts."( SARS: pharmacotherapy.
Tsang, K; Zhong, NS, 2003
)
0.32
" However, recent studies suggest that epoetin alfa can increase hemoglobin levels and facilitate maintenance of RBV dosage in patients with chronic hepatitis C who became anemic during standard combination therapy."( Role of epoetin alfa in maintaining ribavirin dose.
Afdhal, NH, 2004
)
0.32
" Treatment dosage had to be reduced in 20 patients (59%)."( Sustained suppression of hepatitis C virus by high doses of interferon and ribavirin in adult hemophilic patients.
Colombo, M; De Filippi, F; Mannucci, PM; Rivi, M; Rumi, MG; Santagostino, E, 2004
)
0.32
" Anaemia in patients treated with interferon plus RBV combination therapy can be managed effectively and safely with once weekly epoetin alfa without sacrificing optimal dosing of RBV."( Epoetin alfa treatment for acute anaemia during interferon plus ribavirin combination therapy for chronic hepatitis C.
Bräu, N, 2004
)
0.32
" Study 2 included 485 interferon alpha-experienced patients randomized to receive RBV 1000-1200 mg daily plus interferon alpha-2b 3 million IU daily or three times weekly for 4 weeks, followed by three times weekly dosing for 44 weeks."( Changes in haemoglobin during interferon alpha-2b plus ribavirin combination therapy for chronic hepatitis C virus infection.
Ball, L; Brooks, L; Gish, R; Sulkowski, MS; Wasserman, R, 2004
)
0.32
"Early applying of CH-HZ treatment showed good effects in improving CK, LDH, oxygenation index and absolute value of neutrophils, and could reduce the daily maximal dosage of glucocorticoid needed for SARS patients."( [Clinical observation on treatment of SARS with combination of chaihu droplet pill and huoxiang zhengqi droplet pill].
Li, H; Lu, CZ; Tang, KC, 2004
)
0.32
"Early application of CH-HZ treatment in treating SARS could alleviate the injury in lung of SARS patients and the neutrophil dependent inflammatory reaction, and reduce the dosage of glucocorticoid used."( [Clinical observation on treatment of SARS with combination of chaihu droplet pill and huoxiang zhengqi droplet pill].
Li, H; Lu, CZ; Tang, KC, 2004
)
0.32
" All patients were treated with IFNAlpha2b daily for 2 weeks, followed by three times weekly dosing for 22 weeks, with oral ribavirin twice daily, at a total daily dose of 600 or 800 mg."( Factors contributing to ribavirin dose reduction due to anemia during interferon alfa2b and ribavirin combination therapy for chronic hepatitis C.
Akuta, N; Arase, Y; Hosaka, T; Ikeda, K; Kobayashi, M; Kumada, H; Saitoh, S; Someya, T; Suzuki, F; Suzuki, Y; Takaki, S; Tsubota, A, 2004
)
0.32
" Although side effects continue to be a hindrance to the success of therapy, agents such as growth factors and antidepressants may help patients to maintain medication dosing and complete treatment."( Hepatitis C treatment update.
Pearlman, BL, 2004
)
0.32
" We investigated triple combination treatment with induction dosing of interferon-alpha plus ribavirin plus amantadine in these difficult-to-treat patients."( Retreatment of patients with chronic hepatitis C not responding to interferon/ribavirin combination therapy with daily interferon plus ribavirin plus amantadine.
Datz, C; Hackl, F; Hegenbarth, K; Hofer, H; Jessner, W; Peter, F; Schütze, K; Stauber, RE; Steindl-Munda, P, 2004
)
0.32
" In the 1-month study in rats, viramidine or ribavirin dosing at 120 mg/kg/day reduced Hgb concentrations (12-16% and 13-20% compared to controls, respectively) and caused slight erythroid hyperplasia in the bone marrow."( Viramidine demonstrates better safety than ribavirin in monkeys but not rats.
Dadgostari, S; Lin, CC; Vitarella, D; Xu, C; Yeh, LT, 2004
)
0.32
" Dosage reductions of ribavirin and/or peginterferon alfa-2b were required in 10 patients (20%) and seemed less frequent than that needed in clinical trials."( Follow-up of adverse drug reactions from peginterferon alfa-2b-ribavirin therapy.
Bagheri, H; Barange, K; Fouladi, A; Lapeyre-Mestre, M; Montastruc, JL; Payen, JL; Vinel, JP, 2004
)
0.32
" In particular, results of APRICOT - the largest study conducted to date with a pegylated interferon plus ribavirin in patients with HIV-HCV co-infection - indicate that a substantial proportion of patients will achieve sustained virological response (SVR) at week 72 when these drugs are administered for 48 weeks in an appropriate dosage regimen."( Peginterferon-alpha-2a (40kD) plus ribavirin: a review of its use in hepatitis C Virus And HIV co-infection.
Keating, GM; Plosker, GL, 2004
)
0.32
" The treatment schedule was based on subcutaneous administration of recombinant IFNalpha-2b (Intron A) at a dosage of 3 million IU every day, or IL-2 (aldesleukin) at a dose of 1 million IU every day, with oral ribavirin administered 400 mg twice daily (morning and night) [for patients weighing <75 kg] or 500 mg twice daily (for those weighing > or = 75 kg)."( Interleukin-2 plus ribavirin versus interferon-alpha-2b plus ribavirin in patients with chronic hepatitis C who did not respond to previous interferon-alpha-2b treatment.
Brogna, A; Malaguarnera, M; Musumeci, S; Neri, S; Pistone, G; Romano, M, 2004
)
0.32
" Baseline cytopenias, in particular, may limit dosing of interferon and/or ribavirin or preclude therapy entirely when standard guidelines are followed."( Role of growth factors in the treatment of patients with HIV/HCV coinfection and patients with recurrent hepatitis C following liver transplantation.
Fredrick, RT; Hassanein, TI, 2005
)
0.33
" Dose adjustments effectively treat these hematologic side effects, but the resulting suboptimal dosing and potential impact on virologic response are major concerns."( The use of growth factors to manage the hematologic side effects of PEG-interferon alfa and ribavirin.
Collantes, RS; Younossi, ZM, 2005
)
0.33
" Future studies should focus on alternative dosing schedules with more aggressive use of adjuvant therapies, including GFs."( Applicability, tolerability and efficacy of preemptive antiviral therapy in hepatitis C-infected patients undergoing liver transplantation.
Ascher, NA; Bollinger, K; Khalili, M; Roberts, JP; Shergill, AK; Straley, S; Terrault, NA, 2005
)
0.33
" Therefore, under this dosing scheme, heavier patients do not have an equal chance at achieving SVR as do lighter patients."( Weight-based dosing: which impact on efficacy and safety of therapy?
Almasio, PL, 2004
)
0.32
" In this study, we evaluated the effect of drug dosage reduction or the duration of the expected therapy in patients treated with interferon (IFN)-alpha2b plus ribavirin."( The effect of adherence to therapy on sustained response in daily or three times a week interferon alpha-2b plus ribavirin treatment of naive and nonresponder chronic hepatitis C patients.
Akriviadis, E; Hatzis, G; Kanatakis, S; Ketikoglou, I; Paraskevas, E; Raptopoulou, M; Sidiropoulos, L; Tsantoulas, D; Vafiadi, I; Vassiliadis, T, 2005
)
0.33
" These results suggest that the monitoring of plasma ribavirin concentrations may be valid for predicting the early phase of adverse drug reactions, thereby providing useful information for the adjustment of the ribavirin dosing for each patient."( Assessment of adverse reactions and pharmacokinetics of ribavirin in combination with interferon alpha-2b in patients with chronic hepatitis C.
Fujiyama, S; Hamada, A; Saito, H; Sasaki, Y; Uchida, M; Yamasaki, M, 2004
)
0.32
"The current study was carried out to evaluate pharmacokinetic profiles of viramidine and ribavirin in patients (n = 8 per dose group) with compensated hepatitis C infection following oral dosing of viramidine (400, 600, or 800 mg bid for 4 weeks)."( Ascending multiple-dose pharmacokinetics of viramidine, a prodrug of ribavirin, in adult subjects with compensated hepatitis C infection.
Aora, S; Gish, R; Lau, D; Lin, CC; Peterson, J; Rossi, S; Teng, A; Xu, C; Yeh, LT, 2005
)
0.33
" Overall, a sustained virological response occurred in over 50% of patients who received combination therapy for 48 weeks, albeit with a low daily dosage of ribavirin."( Peginterferon alpha-2a (40KD) plus ribavirin: a review of its use in the management of patients with chronic hepatitis C and persistently 'normal' ALT levels.
Keating, GM; Plosker, GL, 2005
)
0.33
" Weekly dosing of peginterferon alfa-2b is a considerable advance for this age group."( Peginterferon alfa-2b plus ribavirin treatment in children and adolescents with chronic hepatitis C.
Ballauff, A; Gerner, P; Jenke, A; Kullmer, U; Lang, T; Pieper-Boustani, H; Wintermeyer, P; Wirth, S, 2005
)
0.33
"Entry criteria were serum HCV-RNA level >/=100 KIU/ml, HCV-genotype 1b, chronic hepatitis, and initial combination treatment of IFN-alpha-2b (6 million units daily for 2 weeks and then 3 times weekly for 6 weeks) and ribavirin (600-800 mg/day) for 8 weeks without stopping or decreasing the dosage of IFN and/or ribavirin."( Significance of serum ribavirin concentration in combination therapy of interferon and ribavirin for chronic hepatitis C.
Akuta, N; Arase, Y; Hosaka, T; Ikeda, K; Kobayashi, M; Kumada, H; Saitoh, S; Sezaki, H; Someya, T; Suzuki, F; Suzuki, Y; Tsubota, A, 2005
)
0.33
" In addition, we also intended to establish a simple rule defining the need for dosage adjustment, using data obtained during the first month of treatment."( Pharmacokinetic/pharmacodynamic and time-to-event models of ribavirin-induced anaemia in chronic hepatitis C.
Bouton, V; Boyer, N; Farcy-Afif, M; Marcellin, P; Sinègre, M; Stocco, J; Tod, M, 2005
)
0.33
"A retrospective analysis of 99 patients treated with IFNalpha plus ribavirin, with known dosage administration history, liver biopsy, demographic data, red blood cell counts, haemoglobin level (1037 measurements, median 10 per patient, range 2-31) and serum creatinine during the entire treatment period (178 days, range 53-382 days) was conducted."( Pharmacokinetic/pharmacodynamic and time-to-event models of ribavirin-induced anaemia in chronic hepatitis C.
Bouton, V; Boyer, N; Farcy-Afif, M; Marcellin, P; Sinègre, M; Stocco, J; Tod, M, 2005
)
0.33
" The proposed rule for the need of dosage adjustment was able to predict the actual evolution of the dosage regimen in 76% of non-adapted patients and 69% of adapted patients."( Pharmacokinetic/pharmacodynamic and time-to-event models of ribavirin-induced anaemia in chronic hepatitis C.
Bouton, V; Boyer, N; Farcy-Afif, M; Marcellin, P; Sinègre, M; Stocco, J; Tod, M, 2005
)
0.33
"The current guidelines for ribavirin dosage administration, based on bodyweight, are adequate, at least in the 45-105 kg range."( Pharmacokinetic/pharmacodynamic and time-to-event models of ribavirin-induced anaemia in chronic hepatitis C.
Bouton, V; Boyer, N; Farcy-Afif, M; Marcellin, P; Sinègre, M; Stocco, J; Tod, M, 2005
)
0.33
"Only 12/24 patients (50%) completed a full year of therapy; 17 (71%) experienced side-effects requiring a 50% dosage reduction or discontinuation of the IFN, PEG-IFN and/or ribavirin."( Pegylated versus standard interferon-alpha in antiviral regimens for post-transplant recurrent hepatitis C: Comparison of tolerability and efficacy.
Apollonio, L; Avellini, C; Caldato, M; Fabris, C; Fumo, E; Minisini, R; Pirisi, M; Toniutto, P, 2005
)
0.33
" Ribavirin could cause dose-dependent reversible haemolytic anaemia, which can be managed with dose reductions or with administration of epoetin alpha at 40,000 IU once weekly without sacrificing the optimal dosing of ribavarin."( Ribavirin in the treatment of hepatitis C.
Abonyi, ME; Lakatos, PL,
)
0.13
"One reason for dosing a drug by body weight is to reduce interpatient variability in clinical response."( Area-under-the-curve for peginterferon alpha-2a and peginterferon alpha-2b is not related to body weight in treatment-naive patients with chronic hepatitis C.
Bruno, R; Ciappina, V; Filice, G; Maiocchi, L; Patruno, S; Sacchi, P; Zocchetti, C, 2005
)
0.33
" Extractability of total ribavirin from liver has been confirmed with liver obtained from monkey dosed with [14C]ribavirin."( A sensitive and specific method for the determination of total ribavirin in monkey liver by high-performance liquid chromatography with tandem mass spectrometry.
Lin, CC; Lourenco, D; Nguyen, M; Yeh, LT, 2005
)
0.33
" No interference could be observed from the excipients commonly present in dosage forms."( Simple fluorimetric method for determination of certain antiviral drugs via their oxidation with cerium (IV).
Askal, HF; Darwish, IA; Khedr, AS; Mahmoud, RM,
)
0.13
" Frequent monitoring of patients and, often, adjustments in the dosage of one or both components of the therapy are necessary during the treatment course."( Patient education and treatment strategies implemented at a pharmacist-managed hepatitis C virus clinic.
Kolor, B, 2005
)
0.33
"4% less (37,638 US dollars) for Peg-2b plus flat dosing of RBV as compared with Peg-2a plus RBV (46,717 US dollars)."( Cost-efficacy analysis of peginterferon alfa-2b plus ribavirin compared with peginterferon alfa-2a plus ribavirin for the treatment of chronic hepatitis C.
Malone, DC; Poordad, FF; Tran, TT, 2005
)
0.33
" Eleven patients required erythropoietin; their mean ribavirin dosage was higher but mean ribavirin concentration was lower compared to the 11 patients who did not require erythropoietin factor."( Ribavirin levels in post liver transplant patients treated for recurrent hepatitis C viral infection.
Fung, J; Jain, A; Kashyap, R; Marcos, A; Vekatramanan, R; Yelochan, B, 2005
)
0.33
" However, there is no consensus on the best dosage or duration of IFN therapy."( Two-year interferon therapy with or without ribavirin in chronic delta hepatitis.
Akarca, US; Batur, Y; Ersoz, G; Gunsar, F; Ilter, T; Karasu, Z; Kobak, AC; Yuce, G, 2005
)
0.33
"Patients (n = 31) with CDH were randomized with a 1:2 ratio as 10 patients (3 females/7 males, age 39 +/- 9) receiving IFN monotherapy (9 MU IFN-alpha2a three times weekly) and 21 patients (8 females/13 males, age 38 +/- 11) receiving IFN plus RBV for 2 years (IFN at the same dosage and RBV at 1000-1200 mg/day)."( Two-year interferon therapy with or without ribavirin in chronic delta hepatitis.
Akarca, US; Batur, Y; Ersoz, G; Gunsar, F; Ilter, T; Karasu, Z; Kobak, AC; Yuce, G, 2005
)
0.33
" There was no significant effect of dosing regimen."( A randomized trial of pegylated interferon alpha-2b plus ribavirin in the retreatment of chronic hepatitis C.
Ahmed, F; Aytaman, A; Berman, DH; Bini, EJ; Bodenheimer, HC; Bräu, N; Brodsky, N; Brown, RS; Cerulli, MA; Chait, M; Edlin, BR; Ehrlich, J; Esposito, SP; Gardner, PW; Geders, JM; Gonzalez, SA; Jacobson, IM; Klion, FM; Lebovics, E; Min, AD; Rahmin, MG; Rovner, D; Russo, MW; Spivack, JE; Tobias, H, 2005
)
0.33
" Comparative trials have been initiated that will provide insight into relative importance of pharmacokinetics, bioactivity and dosing regimen."( Pegylated IFNs for chronic hepatitis C: an update.
Bordens, RW; Cutler, DL; Grace, MJ, 2005
)
0.33
"To assess the baseline factors associated with haematological toxicity that lead to ribavirin or pegylated interferon (peginterferon) dosage reductions in hepatitis C and human immunodeficiency virus (HCV/HIV)-coinfected patients."( Short communication. Baseline factors associated with haematological toxicity that leads to a dosage reduction of pegylated interferon-alpha2a and ribavirin in HIV- and HCV-coinfected patients on HCV antiviral therapy.
Clotet, B; Force, L; Fuster, D; Gómez, G; González García, J; Huertas, JA; Pedrol, E; Planas, R; Sirera, G; Solà, R; Tor, J; Tural, C; Videla, S; Vilaró, J, 2005
)
0.33
"Daily dosing of CIFN plus ribavirin may be a promising concept for selected non-responder patients before considering therapies which are anti-viral but not curative."( Treatment with daily consensus interferon (CIFN) plus ribavirin in non-responder patients with chronic hepatitis C: a randomized open-label pilot study.
Cornberg, M; Hadem, J; Herrmann, E; Manns, MP; Marschal, O; Reiser, M; Schmidt, HH; Schuppert, F; Steffen, M; Wedemeyer, H, 2006
)
0.33
"028), treatment dosage and duration (P=0."( Effects of fatty liver and related factors on the efficacy of combination antiviral therapy in patients with chronic hepatitis C.
Gui Qiang, W; Jian Wu, Y; Shu Chen, L, 2006
)
0.33
" The BMI, WHR, the levels of plasma insulin, genotype, presence of fatty liver, treatment dosage and duration and HOMA-IR were associated with the sustained virologic response."( Effects of fatty liver and related factors on the efficacy of combination antiviral therapy in patients with chronic hepatitis C.
Gui Qiang, W; Jian Wu, Y; Shu Chen, L, 2006
)
0.33
" We investigated the efficacy and safety of a 24-wk course of thalidomide at a dosage of 200 mg/day in eight patients with HCV chronic hepatitis nonresponders to interferon alpha plus ribavirin."( Thalidomide in the treatment of chronic hepatitis C unresponsive to alfa-interferon and ribavirin.
Biasin, M; Clerici, M; Galli, M; Gatti, N; Milazzo, L; Moroni, M; Niero, F; Piacentini, L; Riva, A; Zanone Poma, B, 2006
)
0.33
" The proportion of patients who discontinued the treatment or reduced drug dosage because of adverse events was significantly higher in group B than in group A (27."( Effect of combination therapy with ribavirin and high-dose interferon-alpha2b for 24 weeks in chronic hepatitis C.
Abe, S; Narita, R; Oto, T; Otsuki, M; Tabaru, A, 2006
)
0.33
" Two pegylated interferons are commercially available, both of which have distinct pharmacokinetic properties that necessitate different dosing strategies."( Pegylated interferon plus ribavirin for chronic hepatitis C: the role of combination therapy today, tomorrow and in the future.
Ferenci, P, 2006
)
0.33
" Sixty patients received the same dosage of IFN plus placebo."( Interferon alpha-2b with and without ribavirin in the treatment of hepatitis B e antigen-positive chronic hepatitis B: a randomized study.
Chao, YC; Chen, CL; Chen, DS; Chen, PJ; Hsiao, TJ; Hsieh, TY; Hu, JT; Kao, JH; Lai, MY; Liao, LY; Lin, CL; Liu, CJ; Yang, SS, 2006
)
0.33
" Other IMP dehydrogenase inhibitors administered near maximum tolerated doses using the same dosing regimen as for ribavirin were found to slightly enhance virus replication in the lungs."( Enhancement of the infectivity of SARS-CoV in BALB/c mice by IMP dehydrogenase inhibitors, including ribavirin.
Bailey, K; Barnard, DL; Carson, DA; Cottam, HB; Day, CW; Heiner, M; Hoopes, J; Lauridsen, L; Lee, J; Li, JK; Montgomery, R; Sidwell, RW; Winslow, S, 2006
)
0.33
"The aim of this study was to assess the efficacy, safety and tolerability of pegylated interferon and ribavirin in HIV/hepatitis C virus (HCV)-coinfected patients, prescribed for the same duration and at the same dosage as that used in HCV monoinfection studies."( Role of individualization of hepatitis C virus (HCV) therapy duration in HIV/HCV-coinfected individuals.
Bergin, C; Clarke, S; Farrell, G; Hennessy, M; Hopkins, S; Lambourne, J; McCullagh, L; Mulcahy, F, 2006
)
0.33
" However the pharmacokinetics and tolerability of both peg-alfa-2a and 2b need to be studied more closely in prospective studies before definite dosing recommendations can be made."( Pegylated interferon and ribavirin treatment for hepatitis C in haemodialysis patients.
Bruchfeld, A; Carlsson, T; Lindahl, K; Reichard, O; Schvarcz, R, 2006
)
0.33
" With a presumptive diagnosis of PCT a cutaneous/skin biopsy was performed as well as a porphyrin dosage with urine porphyirins of 4185 microg/24 hs (nv<250)."( [Development of porphyria cutanea tarda in a chronic hepatitis C patient with indetectable viremia under treatment with peg-interferon plus ribavirin].
Alessio, A; Buonsante, ME; Frider, B; Pellerano, G; Tiscornia, J, 2006
)
0.33
"7%) needed a dosage reduction."( Antiviral therapy for hepatitis C virus recurrence following liver transplantation: long-term results from a single center experience.
Boninsegna, S; Brolese, A; Burra, P; Canova, D; D'Aloiso, C; Fagiuoli, S; Germani, G; Guido, M; Masier, A; Pevere, S; Targhetta, S; Tomat, S, 2006
)
0.33
"The combination of alpha-IFN plus ribavirin induced a sustained virologic response in 20% of liver transplant recipients with recurrent HCV, but intolerance of the therapy prompted its discontinuation or a dosage reduction in a large proportion of patients."( Antiviral therapy for hepatitis C virus recurrence following liver transplantation: long-term results from a single center experience.
Boninsegna, S; Brolese, A; Burra, P; Canova, D; D'Aloiso, C; Fagiuoli, S; Germani, G; Guido, M; Masier, A; Pevere, S; Targhetta, S; Tomat, S, 2006
)
0.33
"The results of this study underscore the importance of adequate dosing of ribavirin as well as pegylated interferons in achieving an SVR when treating genotype 1 chronic hepatitis C patients with combination therapy."( A study of low dose peginterferon alpha-2b with ribavirin for the initial treatment of chronic hepatitis C.
Ashikaga, T; Gordon, SR; Grace, ND; Krawitt, EL; Moskowitz, S; Palmer, M; Ray, MA; Yarze, JC, 2006
)
0.33
" Although the recommended dosage was the same as that used at the end of the initial trial, adjustments were permitted."( Re-treatment of chronic hepatitis C patients after relapse: efficacy of peginterferon-alpha-2a (40 kDa) and ribavirin.
Berg, C; Bernstein, DE; Cooksley, G; Diago, M; Goncales, FL; Graham, P; Jensen, DM; Rasenack, J; Sette, H, 2006
)
0.33
"5 microg/kg body weight (BW), in spite of the previously shown flat dose-response curve at doses of > or =1."( Comparison of two PEG-interferon alpha-2b doses (1.0 or 1.5 microg/kg) combined with ribavirin in interferon-naïve patients with chronic hepatitis C and up to moderate fibrosis.
Arn, M; Borovicka, J; Criblez, D; Egger, H; Gonvers, JJ; Helbling, B; Meyenberger, C; Meyer-Wyss, B; Müllhaupt, B; Oneta, C; Rammert, C; Renner, EL; Rich, P; Rossi, L, 2006
)
0.33
"The purpose of the present paper was to investigate the factors possibly involved in the failure of pegylated interferon (Peg IFN) plus ribavirin treatment at standard dosage in hepatitis C virus (HCV) 1b patients, with chronic hepatitis."( Metabolic factors involved in the therapeutic response of patients with hepatitis C virus-related chronic hepatitis.
Ariello, M; Conca, P; Sorrentino, P; Tarantino, G, 2006
)
0.33
" Once-weekly dosing with peg-INF-alpha2a, which has a longer half-life than other forms of INF, plus daily dosing with ribavirin, has been shown to be effective in reducing viral load."( Viral kinetics in the treatment of chronic hepatitis C.
Cotler, SJ; Layden, TJ; Layden-Almer, JE, 2006
)
0.33
" We present herein the results of plasma measurement of ribavirin levels in transplanted patients when using increasing dosage of ribavirin, in comparison with a control cohort of nontransplanted patients."( Plasma ribavirin concentrations during treatment of recurrent hepatitis C with peginterferon alpha-2b and ribavirin combination after liver transplantation.
Boillot, O; Chevallier, P; Ducos, E; Dumortier, J; Gagnieu, MC; Scoazec, JY, 2006
)
0.33
" Treatment was discontinued in 25% of the patients, and dosing was modified in 58%."( Pegylated interferon alpha-2b as monotherapy or in combination with ribavirin in chronic hepatitis delta.
Andriulli, A; Brancaccio, G; Ciancio, A; David, E; Fontana, R; Gaeta, GB; Marrone, A; Niro, GA; Olivero, A; Perri, F; Rizzetto, M; Smedile, A; Stanzione, M, 2006
)
0.33
" The use of ZDV but not weight-based RBV dosing was associated with an increased risk of anaemia, RBV dose reduction or EPO use in coinfected patients treated with PEG-IFN/RBV."( Zidovudine use but not weight-based ribavirin dosing impacts anaemia during HCV treatment in HIV-infected persons.
Alvarez, D; Ball, L; Brau, N; Dieterich, DT; Moorehead, L; Sulkowski, MS, 2006
)
0.33
" This randomized trial showed that the saturation of ribavirin uptake after taking ribavirin capsules does not occur within a dose range of 600 to 800 mg/day, which is a standard dosage used clinically in Japan."( Role of erythrocytes as a reservoir for ribavirin and relationship with adverse reactions in the early phase of interferon combination therapy for chronic hepatitis C virus infections.
Ebinuma, H; Hibi, T; Ishii, H; Kashiwazaki, K; Nishida, J; Saito, H; Shiozaki, H; Tada, S; Takahashi, M; Tanaka, S; Tsukada, N, 2006
)
0.33
" The method has been used to simultaneously determine the total concentrations of ribavirin and viramidine in monkey RBC following 5, 15, and 36 weeks dosing of viramidine or ribavirin (60 mg/kg)."( LC-MS/MS method for simultaneous determination of viramidine and ribavirin levels in monkey red blood cells.
Bu, W; Dadgostari, S; Lin, CC; Nguyen, M; Yeh, LT, 2007
)
0.34
" Further, combination therapy reduces the effective dosage of ribavirin, which would serve to limit its toxicity."( Combinatorial ribavirin and interferon alfacon-1 therapy of acute arenaviral disease in hamsters.
Bailey, KW; Blatt, LM; Gowen, BB; Jung, KH; Pace, AM; Sidwell, RW; Smee, DF; Wong, MH, 2006
)
0.33
"5 and 5 mg/kg/day; ribavirin at 5, 10 and 20 mg/kg/day) certain dosage combinations were superior to either compound used alone as assessed by decreased mortality, lung virus titre, lung score and lung weight parameters."( Activities of oseltamivir and ribavirin used alone and in combination against infections in mice with recent isolates of influenza A (H1N1) and B viruses.
Bailey, KW; Sidwell, RW; Smee, DF; Wong, MH, 2006
)
0.33
"Compared with different combination therapy strategies, peg-interferon alpha-2b plus weight-based dosing of ribavirin in all patients for 24 weeks is the most cost-effective treatment strategy."( Cost-utility analysis of different peg-interferon alpha-2b plus ribavirin treatment strategies as initial therapy for naïve Chinese patients with chronic hepatitis C.
Lin, WA; Tang, SL; Tarn, YH, 2006
)
0.33
"CIFN in combination with ribavirin when given to HCV genotype 1 relapsers after rIFN monotherapy obtains an unsatisfactory rate of sustained viral clearance independently of dosage of the drug."( Different doses of consensus interferon plus ribavirin in patients with hepatitis C virus genotype 1 relapsed after interferon monotherapy: a randomized controlled trial.
Alaimo, G; Almasio, PL; Calvaruso, V; Craxì, A; D'Angelo, F; Di Marco, V; Di Stefano, R; Ferraro, D; Porrovecchio, S, 2006
)
0.33
" Weight-based dosing of ribavirin has emerged as another important consideration."( Customizing treatment to patient populations.
Brown, RS, 2007
)
0.34
" Reducing the dose of ribavirin from full dose (> or =98%) to < or =60% did not affect either W20 VR or SVR as long as ribavirin dosing was not interrupted for more than 7 consecutive days."( Impact of reducing peginterferon alfa-2a and ribavirin dose during retreatment in patients with chronic hepatitis C.
Bonkovsky, HL; Di Bisceglie, AM; Dienstag, JL; Everson, GT; Ghany, MG; Gretch, DR; Lee, WM; Lindsay, KL; Lok, AS; Morgan, TR; Shiffman, ML; Wright, EC, 2007
)
0.34
" Depression occurs in approximately one-third of patients during antiviral therapy and can lead to reduction in treatment dosage or discontinuation of treatment, thus reducing the likelihood of clearing HCV infection."( A randomized trial of paroxetine to prevent interferon-alpha-induced depression in patients with hepatitis C.
Hauser, P; Indest, DW; Loftis, JM; Moles, JK; Morasco, BJ; Rifai, MA, 2007
)
0.34
"Ready dosage form (eye drops) prepared on the basis of recombinant alpha2-IFN exhibits high activity towards herpes simplex type 1 virus in vitro."( Combined antiherpetic effect of complex preparation "Viferon-eye drops" and modified nucleosides.
Andronova, VL; Galegov, GA; Malinovskaya, VV; Vyzhlova, EN, 2006
)
0.33
" The aims of this study were to assess the rate of early (EVR) and sustained virological response (SVR), tolerability and baseline predictive factors associated with EVR and SVR in patients with chronic hepatitis C treated with individualized weight-based dosing regimen for both PegIFN alpha-2b and ribavirin."( Efficacy, tolerability and predictive factors for early and sustained virologic response in patients treated with weight-based dosing regimen of PegIFN alpha-2b ribavirin in real-life healthcare setting.
Damian, D; Gheorghe, C; Gheorghe, L; Grigorescu, M; Iacob, R; Iacob, S; Sirli, R; Sporea, I, 2007
)
0.34
"PegIFN alpha-2b and ribavirin can be safe and successful when using a weight-based dosing regimen, leading to high response rates even in overweight patients."( Efficacy, tolerability and predictive factors for early and sustained virologic response in patients treated with weight-based dosing regimen of PegIFN alpha-2b ribavirin in real-life healthcare setting.
Damian, D; Gheorghe, C; Gheorghe, L; Grigorescu, M; Iacob, R; Iacob, S; Sirli, R; Sporea, I, 2007
)
0.34
" To manage the growing populations of hard-to-treat patients with chronic viral hepatitis, there is a need for more effective treatment modalities, including optimized, individualized dosing and novel antivirals."( [Experiences in antiviral treatment of chronic viral hepatitis B and C in Hungary (1998-2004)].
Pár, A; Szalay, F; Tornai, I, 2007
)
0.34
" To improve the efficacy of retreatment, either interferon and/or ribavirin dosage have been increased, either other antiviral drugs have been added to combination therapy."( [Retreatment of chronic hepatitis C patients non responder to a previous antiviral treatment].
Biliotti, E; Taliani, G, 2007
)
0.34
" It has demonstrated strong antiviral activity in patients chronically infected with genotype 1 HCV when dosed alone or in combination with peginterferon alfa-2a."( Phenotypic and structural analyses of hepatitis C virus NS3 protease Arg155 variants: sensitivity to telaprevir (VX-950) and interferon alpha.
Bartels, DJ; Brennan, DL; Hanzelka, BL; Kwong, AD; Lin, C; Müh, U; Rao, BG; Swenson, L; Tigges, AM; Wei, Y; Zhou, Y, 2007
)
0.34
" The third step consisted in the use of pegylated interferon in order to adapt its pharmacokinetics and to allow a better efficacy with a more tolerable dosing schedule: once weekly subcutaneous injection instead of thrice weekly."( Interferon-based treatment of chronic hepatitis C.
Lejeune, O; Souvignet, C; Trepo, C,
)
0.13
" Thus, this method provides a simple, sensitive, precise and reproducible assay for dosing ribavirin that can be readily adaptable to routine use by clinical laboratories with standard equipment."( Measurement of ribavirin and evaluation of its stability in human plasma by high-performance liquid chromatography with UV detection.
Loregian, A; Pagni, S; Palù, G; Parisi, SG; Scarpa, MC, 2007
)
0.34
" The timing and dosage regimens of steroid in the treatment of SARS are controversial."( Pharmacologic treatment of SARS: current knowledge and recommendations.
Tai, DY, 2007
)
0.34
" The optimal dosing regimen for ZnAL42 was achieved at 17."( Effect of oral gavage treatment with ZnAL42 and other metallo-ion formulations on influenza A H5N1 and H1N1 virus infections in mice.
Bailey, K; Barnard, DL; Day, CW; Hall, TJ; Hickok, SS; Sidwell, RW; Wong, MH, 2007
)
0.34
"The response to pegylated interferon (pegIFN) plus ribavirin (RBV) as treatment of chronic hepatitis C virus (HCV) infection is lower in HIV-coinfected than in HCV-monoinfected patients and could be due to suboptimal RBV dosing and/or insufficient duration of therapy in prior trials."( Role of weight-based ribavirin dosing and extended duration of therapy in chronic hepatitis C in HIV-infected patients: the PRESCO trial.
Aguirrebengoa, K; Arazo, P; Asensi, V; Barreiro, P; Berdún, MA; Cervantes, M; de Los Santos, I; Echeverría, S; Galindo, MJ; García-Samaniego, J; Guardiola, JM; Hernandez-Burruezo, JJ; Losada, E; Miralles, C; Núñez, M; Ocampo, A; Romero, M; San Joaquín, I; Sola, J; Soriano, V, 2007
)
0.34
" No significant differences were observed in the dosage of medicines or other clinical data during the treatment."( Zinc supplementation prevents the increase of transaminase in chronic hepatitis C patients during combination therapy with pegylated interferon alpha-2b and ribavirin.
Kakibuchi, N; Kawakami, T; Kawashima, A; Kita, K; Koyabu, T; Murakami, Y; Okita, M; Takaguchi, K, 2007
)
0.34
" Good virological outcomes can be achieved in HIV co-infected haemophiliacs particularly when growth factors are used to facilitate full dosing of peg-IFN and RBV."( Haematological support during peg-interferon therapy for HCV-infected haemophiliacs improves virological outcomes.
Bergin, C; Farrell, G; Hopkins, S; Kevans, D; Mahmud, N; Norris, S; White, B, 2007
)
0.34
" Moreover, best treatment duration and dosage of recurrent HCV infection with pegylated interferon in combination with ribavirin remains to be defined."( Prophylaxis and treatment of recurrent viral hepatitis after liver transplantation.
Berberat, PO; Encke, J; Gotthardt, D; Mehrabi, A; Merle, U; Riediger, C; Sauer, P; Stremmel, W; Weiss, KH, 2007
)
0.34
" Besides greater hemoglobin reductions with weight-based RBV, safety profiles were similar across RBV dosing groups, including the 1400-mg/day group."( Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial.
Afdhal, N; Becker, S; Bernstein, D; Brass, CA; Brown, RS; Flamm, S; Freilich, B; Godofsky, E; Griffel, LH; Jacobson, IM; Kwo, PY; Mukhopadhyay, P; Pauly, MP; Pound, D; Santoro, J; Strauss, R; Wakil, AE, 2007
)
0.34
"WIN-R (Weight-based dosing of pegINterferon alfa-2b and Ribavirin) was a multicenter, randomized, open-label, investigator-initiated trial involving 236 community and academic sites in the United States, comparing response to pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in treatment-naive patients with chronic hepatitis C and compensated liver disease."( Impact of weight-based ribavirin with peginterferon alfa-2b in African Americans with hepatitis C virus genotype 1.
Albert, C; Araya, V; Black, M; Brass, CA; Brown, RS; Dragutsky, MS; Freilich, B; Galler, GW; Griffel, LH; Hargrave, T; Harvey, J; Jacobson, IM; Kwo, PY; Lambiase, L; McCone, J; Siddiqui, FA, 2007
)
0.34
" Further trials and clinical studies are necessary for the optimal treatment of patients with recurrent hepatitis C, and to determine the dosage of pegylated interferon and ribavirin, to decrease the duration of therapy and the side effects, finally to achieve a healing phase of higher degree."( [Treatment of recurrent hepatitis C virus infection after liver transplantation].
Lengyel, G; Tulassay, Z, 2007
)
0.34
"High-dose peginterferon-alpha (PegIFN-alpha) induction and prolongation of therapy may be an option to improve sustained virological response (SVR) rates among hepatitis C virus (HCV) non-responders, although a higher and a longer dosing of PegIFN-alpha may intensify side effects."( Gamma-glutamyltransferase and rapid virological response as predictors of successful treatment with experimental or standard peginterferon-alpha-2b in chronic hepatitis C non-responders.
Bergmann, JF; Brouwer, JT; de Knegt, RJ; de Vries, RA; Hansen, BE; Janssen, HL; Schalm, SW; van der Schaar, P; van der Sluys Veer, A; van Hoek, B; Verhey, E; Vrolijk, JM; Vroom, B, 2007
)
0.34
" Therapy if given with weight-based dosing may be shortened from 24 to 12, 14 or 16 weeks (genotypes 2 and 3), and from 48 to 24 weeks (genotype 1) in case of hepatitis C virus (HCV) clearance at week 4, without reducing sustained virologic response (SVR)."( Antiviral therapy: chronic hepatitis C.
Heathcote, EJ, 2007
)
0.34
"Currently, the approved dosage of ribavirin has not been studied in patients with 'normal' alanine aminotransferase (ALT) levels."( Predicting efficacy and safety outcomes in patients with hepatitis C virus genotype 1 and persistently 'normal' alanine aminotransferase levels treated with peginterferon alpha-2a (40KD) plus ribavirin.
Berg, T; Hadziyannis, SJ; Jorga, K; Marcellin, P; Puoti, C; Snoeck, E; Swain, MG; Zarski, JP; Zeuzem, S, 2008
)
0.35
" Ribavirin was given daily at a dosage of 30 mg/kg and tiazofurin was given at a dosage of 10 mg/kg every other day for 15 days."( Therapeutic effects of combined treatment with ribavirin and tiazofurin on experimental autoimmune encephalomyelitis development: clinical and histopathological evaluation.
Bjelobaba, I; Dacic, S; Jovanovic, S; Lavrnja, I; Mostarica-Stojkovic, M; Nedeljkovic, N; Pekovic, S; Rakic, L; Stojiljkovic, M; Stojkov, D; Stosic-Grujicic, S, 2008
)
0.35
" In the combination therapy group, patients maintaining a full dosage schedule of PEG IFN-alpha-2a and ribavirin and those requiring dose reductions of either study drug had similar SVR rates (64."( Virological response in patients with hepatitis C virus genotype 1b and a high viral load: impact of peginterferon-alpha-2a plus ribavirin dose reductions and host-related factors.
Hayashi, N; Iino, S; Kiyosawa, K; Kumada, H; Okuno, T; Omata, M; Sakai, T; Yamada, G, 2008
)
0.35
"In peg-IFN alpha-2b plus RBV treatment for chronic hepatitis C, it is important to complete the target length of treatment and to continue the target dosage to achieve SVR, especially for genotype 1 patients."( Association between the treatment length and cumulative dose of pegylated interferon alpha-2b plus ribavirin and their effectiveness as a combination treatment for Japanese chronic hepatitis C patients: project of the Kyushu University Liver Disease Study
Azuma, K; Enjoji, M; Furusyo, N; Hayashi, J; Kajiwara, E; Maruyama, T; Masumoto, A; Nakamuta, M; Nomura, H; Sakai, H; Shimoda, S; Shimono, J; Takahashi, K; Tanabe, Y, 2008
)
0.35
" Dosage and duration depend on some factors as weight, genotype, viral load and a rapid virological response presented by the patient."( Treatment regimens for patients with chronic hepatitis C.
Borque, MJ; Chaparro-Sánchez, M; González-Moreno, L; Moreno-Monteagudo, JA; Moreno-Otero, R; Trapero-Marugan, M, 2008
)
0.35
" Drug dosage was modified or temporarily discontinued if anaemia or bone marrow suppression developed."( Efficacy and tolerability of pegylated interferon alpha 2b and ribavirin in chronic hepatitis C--a report from eastern India.
Dey, S; Nayyar, I; Pal, S; Ray, G,
)
0.13
" Through a better understanding of treatment response and viral kinetics, clinicians are employing altered dosing schedules to minimize the burden of viral illness."( Hepatitis C: current options for nonresponders to peginterferon and ribavirin.
Fried, MW; Thomas, E, 2008
)
0.35
"A prospective non-randomized, open-label comparison was made of naive HCV-infected patients undergoing standard 24- or 48-week treatment with two PEG-IFN combined with weight-based dosing regimen of ribavirin (PEG-IFN-alpha2a/ribavirin, n = 91; PEG-IFN-alpha2b/ribavirin, n = 92)."( Pegylated alpha-interferon-2a plus ribavirin compared with pegylated alpha-interferon-2b plus ribavirin for initial treatment of chronic hepatitis C virus: prospective, non-randomized study.
Del Olmo, JA; Escudero, A; Montes, F; Rodrigo, JM; Rodríguez, F; Serra, MA, 2008
)
0.35
" Furthermore, intensified ribavirin dosing might also improve SVR rates in 'difficult-to-cure' patients."( Ribavirin considerations in treatment optimization.
Dusheiko, G; Nelson, D; Reddy, KR, 2008
)
0.35
"4% cirrhotics) who had been treated with weight-adjusted dosing (1."( Patient's age modifies the impact of the proposed predictors of sustained virological response in chronic hepatitis C patients treated with PEG-interferon plus ribavirin.
Elefsiniotis, IS; Ketikoglou, I; Koutsounas, S; Moulakakis, A; Pantazis, KD; Pavlidis, C; Scarmeas, N; Tsianos, EV, 2008
)
0.35
" Serum HCV-RNA levels before initial dosing (baseline level) and at 24 h, week 1, week 4, week 12, week 24, week 48 and week 72 were assessed in 84 HCV genotype-4 patients treated weekly by PEG-IFN alpha 2a and daily ribavirin."( Viral kinetic of HCV genotype-4 during pegylated interferon alpha 2a: ribavirin therapy.
Al Kaabi, SR; Al Khinji, MA; Al Mohanadi, M; Al-Marri, AD; Amer, AM; Bener, AB; Butt, MT; Derbala, MF; El Dweik, NZ; John, A; Pasic, F; Shebl, FM; Yakoob, R, 2008
)
0.35
" We found that 135 microg peg-IFN alfa-2a weekly was sufficient for treatment of genotype 2 and 3 chronic hepatitis C when combined with RBV dosed daily according to body weight."( Lower-than-standard dose peg-IFN alfa-2a for chronic hepatitis C caused by genotype 2 and 3 is sufficient when given in combination with weight-based ribavirin.
Enquist, R; Glaumann, H; Hollander, A; Lindahl, K; Lindh, G; Mattsson, L; Quist, A; Schvarcz, R; Weiland, O, 2008
)
0.35
" Dosing of R1626 was limited by neutropenia; a study of different dosages of R1626 in combination with peginterferon alfa-2a and ribavirin is underway."( R1626 plus peginterferon Alfa-2a provides potent suppression of hepatitis C virus RNA and significant antiviral synergy in combination with ribavirin.
Chan, A; Everson, GT; Fried, MW; Ghalib, R; Godofsky, E; Harrison, S; Hill, G; Najera, I; Nelson, D; Nyberg, L; Pockros, PJ; Rodriguez-Torres, M; Shiffman, ML, 2008
)
0.35
" This review discusses strategies to optimize peginterferon and ribavirin dosing and the impact that growth factors may have on the ability to achieve a sustained virologic response."( Optimizing the current therapy for chronic hepatitis C virus: peginterferon and ribavirin dosing and the utility of growth factors.
Shiffman, ML, 2008
)
0.35
" Results of several recent trials evaluating optimal dosing of RBV and higher than standard dosing of PEG-IFN in treatment-naïve genotype 1 patients, as well as data from retreatment trials with "induction" doses of PEG-IFN or high-dose RBV in prior non-responders to IFN-based therapy will be reviewed here."( Optimal dose of peginterferon and ribavirin for treatment of chronic hepatitis C.
Gambarin-Gelwan, M; Jacobson, IM, 2008
)
0.35
"Alb-IFN administered q2wk or q4wk may offer comparable efficacy, with an improved dosing schedule, compared with PEG-IFNalpha-2a."( Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C.
Bain, VG; Benhamou, Y; Cronin, PW; Flisiak, R; Grigorescu, M; Kaita, K; McHutchison, JG; Pianko, S; Pulkstenis, E; Rehak, V; Shouval, D; Subramanian, GM; Yoshida, EM; Zeuzem, S, 2008
)
0.35
" Interferon-induced adverse events include flu-like symptoms, bone marrow suppression, and emotional or cognitive effects, whereas hemolytic anemia accounts for most ribavirin dosage reductions."( Treatment options for patients with hepatitis C: role of pharmacists in optimizing treatment response and managing adverse events.
Smith, JP, 2008
)
0.35
"5 g/dL by week 2 was an excellent early predictor for subsequent considerable hemoglobin decreases and might be used to identify candidates for early intervention against anemia in order to help maintain ribavirin dosing and avoid suboptimal exposure."( Early predictors of anemia in patients with hepatitis C genotype 1 treated with peginterferon alfa-2a (40KD) plus ribavirin.
Fried, MW; Hadziyannis, SJ; Jensen, DM; Messinger, D; Reau, N, 2008
)
0.35
" The hits were evaluated for their antiviral activity, cell toxicity, and selectivity in dose-response experiments."( High-throughput screening of a 100,000-compound library for inhibitors of influenza A virus (H3N2).
Ananthan, S; Chung, DH; Jonsson, CB; McDowell, M; Noah, J; Rasmussen, L; Severson, WE; Sosa, MI; White, EL, 2008
)
0.35
" Our data suggest that more than once a week dosing might be desirable early during treatment to maintain high levels of response as measured by gene expression."( Cyclic changes in gene expression induced by Peg-interferon alfa-2b plus ribavirin in peripheral blood monocytes (PBMC) of hepatitis C patients during the first 10 weeks of treatment.
Edenberg, HJ; Kwo, P; McClintick, JN; Taylor, MW; Tsukahara, T, 2008
)
0.35
" Several strategies have been evaluated in order to optimize outcome of current peginterferon-based therapy, including higher dosing of peginterferon and/or ribavirin, and adjusting therapy duration."( What is on the horizon for treatment of chronic hepatitis C?
Bergmann, JF; De Knegt, RJ; Janssen, HL, 2008
)
0.35
" A recent Phase II trial investigating early and sustained virological response showed no statistically significant differences between ribavirin 1000/1200 mg and taribavirin at 800-, 1200-, or 1600-mg dosing, while illustrating a lesser degree of anemia in 800- and 1200-mg dosing of taribavirin."( Taribavirin for the treatment of chronic hepatitis C.
Kearney, KR; Navarro, VJ; Thornton, JJ, 2008
)
0.35
" However, for treatment with pegylated (PEG)-IFN-alpha2b dosed weekly, drug levels fall substantially and viral load rebounds have been observed toward the end of the weekly dosing interval, implying non-constant drug efficacy."( A hepatitis C viral kinetic model that allows for time-varying drug effectiveness.
Perelson, AS; Ribeiro, RM; Shudo, E; Talal, AH, 2008
)
0.35
" RBV dosing was 213."( Abacavir does not influence the rate of virological response in HIV-HCV-coinfected patients treated with pegylated interferon and weight-adjusted ribavirin.
Bonet, L; Cifuentes, C; Gatell, JM; Laguno, M; Laufer, N; Mallolas, J; Murillas, J; Perez, I; Veloso, S; Vidal, F, 2008
)
0.35
"Suboptimal drug exposure attributable to physician-directed dosage reductions of pegylated interferon and/or ribavirin are associated with decreased sustained virologic response rates."( Adherence to hepatitis C virus therapy and early virologic outcomes.
Amorosa, VK; Dorey-Stein, Z; Gross, R; Kostman, JR; Lo Re, V; Localio, AR; O'Flynn, R; Teal, V, 2009
)
0.35
" Ribavirin dosage varies by bodyweight for genotype 1 disease (1000mg/day in patients 75kg), whereas 800mg/day is sufficient to ensure optimal response in all genotype 2/3 patients."( Ribavirin: current role in the optimal clinical management of chronic hepatitis C.
Nelson, DR; Reddy, KR; Zeuzem, S, 2009
)
0.35
" We conducted a pilot study with a sequential regimen using a reduced dosage of peginterferon-alfa 2b in patients with chronic hepatitis C and normal transaminases."( Ribavirin priming in patients with chronic hepatitis C and normal ALT: a pilot study.
Drebber, U; Goeser, T; Heindl, B; Schulte, S; Steffen, HM; Stelzer, A; Töx, U,
)
0.13
"The cumulative dosage of ribavirin per kilogram of body-weight prevents relapse and thus is a significant predictor of sustained virological response (SVR)."( Peginterferon alfa-2a relapse rates depend on weight-based ribavirin dosage in HCV-infected patients with genotype 1: results of a retrospective evaluation.
Ganslmayer, M; Hahn, EG; Herold, C; Zopf, S, 2009
)
0.35
"2 mg/kg ribavirin dosed group (59."( Peginterferon alfa-2a relapse rates depend on weight-based ribavirin dosage in HCV-infected patients with genotype 1: results of a retrospective evaluation.
Ganslmayer, M; Hahn, EG; Herold, C; Zopf, S, 2009
)
0.35
"Weight-adapted ribavirin dosing in combination with peg-IFN alfa-2a to avoid giving low doses of ribavirin should be evaluated."( Peginterferon alfa-2a relapse rates depend on weight-based ribavirin dosage in HCV-infected patients with genotype 1: results of a retrospective evaluation.
Ganslmayer, M; Hahn, EG; Herold, C; Zopf, S, 2009
)
0.35
" The multivariate logistic regression analysis revealed that retreatment, centre with more patients treated, patient age (<55 years), male, genotype 2 and dosage of IFN per weight (<0."( Factors associated with adherence to combination therapy of interferon and ribavirin for patients with chronic hepatitis C: importance of patient's motivation and physician's treatment experience.
Ando, M; Araki, Y; Ikeda, H; Iwasaki, Y; Kobashi, H; Osawa, T; Sakaguchi, K; Shiratori, Y; Tanioka, D; Yamamoto, K, 2009
)
0.35
"For the dosage schedule used in our study, oral ribavirin has no effect in reducing early mortality associated with Japanese encephalitis."( Randomized, controlled trial of oral ribavirin for Japanese encephalitis in children in Uttar Pradesh, India.
Banerjee, G; Baranwal, M; Kumar, R; Singh, S; Tripathi, P; Tripathi, S, 2009
)
0.35
" A small-molecule thrombopoietin mimetic, eltrombo-pag, has demonstrated a dose-response associated increase in platelet count in a phase 2 study, allowing initiation and completion of a 12-week course of peginterferon plus ribavirin in 36%, 53%, and 65% of patients receiving 30 mg, 50 mg, or 75 mg of eltrombopag daily, respectively, compared with 6% in the placebo arm."( Role of growth factors and thrombopoietic agents in the treatment of chronic hepatitis C.
McHutchison, JG; Patel, K; Tillmann, HL, 2009
)
0.35
"Daily weight based interferon alpha-2b dosing and PEG interferon alpha-2b weighed based dosing once weekly both in combination with Ribavirin offer the same efficacy and safety rates."( Weekly pegylated interferon alpha-2b vs daily interferon a-2b versus standard regimen of interferon a-2b in the treatment of patients with chronic hepatitis C virus infection.
Adler, M; Bourgeois, N; Brenard, R; Bruckers, L; Colle, I; Goossens, A; Horsmans, Y; Langlet, P; Michielsen, P; Van Vlierberghe, H,
)
0.13
" Treatment followed standard guidelines with weight-based dosing of pegylated interferon-alpha2b and ribavirin."( Treatment outcomes with pegylated interferon and ribavirin for male prisoners with chronic hepatitis C.
Allen, SA; Chew, KW; Feller, E; Rich, JD; Taylor, LE, 2009
)
0.35
" Also, the median darbepoetin-alfa-weighted dose in group no rHuEPO increased while it remained stable in group rHuEPO, as did the median daily dosage of ribavirin; however, these differences were not statistically significant."( A monocentric observational study of darbepoetin alfa in anemic hepatitis-C-virus transplant patients treated with ribavirin.
Esposito, L; Guitard, J; Kamar, N; Ribes, D; Rostaing, L, 2008
)
0.35
" Patients with absolute neutrophil counts less than 900 cells/mmc and early viral response received lenograstim at the dosage of 263 mcg 24 hours prior to administration of Peg-IFN alpha 2b."( Lenograstim in the treatment of severe neutropenia in patients treated with Peg-IFN and ribavirin: the experience of a single hepatology unit.
Celiento, M; De Rosa, A; Ripa, C; Schiano, A; Tambaro, O; Tarantino, L, 2009
)
0.35
" Dosage regimens of ribavirin might need to be adjusted according to the purine content of the meal."( Effect of dietary purines on the pharmacokinetics of orally administered ribavirin.
Han, L; Hashim, KB; Koo, SH; Lee, EJ; Li, L; Limenta, LM; Quek, HH, 2009
)
0.35
" At the multivariate analysis, only EVR, genotypes 2 and 3, and adherence to full course and dosage of therapy retained their independent predictive power, with corresponding ORs of 25."( Sustained virological responses following standard anti-viral therapy in decompensated HCV-infected cirrhotic patients.
Accadia, L; Andriulli, A; Annicchiarico, BE; Bombardieri, G; Caruso, N; Iacobellis, A; Niro, GA; Siciliano, M; Valvano, MR, 2009
)
0.35
" Treatment ought to be pursued among patients who attain an EVR, and maintain a full course and dosage of therapy."( Sustained virological responses following standard anti-viral therapy in decompensated HCV-infected cirrhotic patients.
Accadia, L; Andriulli, A; Annicchiarico, BE; Bombardieri, G; Caruso, N; Iacobellis, A; Niro, GA; Siciliano, M; Valvano, MR, 2009
)
0.35
"As HCV treatment becomes more complex with new classes of agents, adherence will be increasingly important to treatment success as resistance mutations may develop with suboptimal dosing of HCV enzyme inhibitors."( Review article: adherence to medication for chronic hepatitis C - building on the model of human immunodeficiency virus antiretroviral adherence research.
Bräu, N; Fishbein, D; Stivala, A; Swan, T; Weiss, JJ, 2009
)
0.35
" The United States-based WIN-R trial confirmed the value of combining weight-based ribavirin dosing with weight-based PEG-IFN alfa-2b dosing across a spectrum of patient body weights."( Efficacy of chronic hepatitis C therapy in community-based trials.
Hueppe, D; Jacobson, I; Kwo, P; Marotta, P; Zehnter, E, 2009
)
0.35
"A validated lifetime Markov model was used to project life expectancy, QALYs and lifetime costs for the following strategies: (i) no antiviral therapy (NoAVT); (ii) interferon-alpha-2b plus ribavirin for 48 weeks (IFN + R); (iii) peginterferon-alpha-2b plus weight-based ribavirin for 48 weeks (PEG + R); (iv) peginterferon-alpha-2b plus ribavirin according to German guidelines with genotype-dependent treatment duration, dosage and 12-week viral response evaluation (GUIDE)."( Clinical effectiveness and cost effectiveness of tailoring chronic hepatitis C treatment with peginterferon alpha-2b plus ribavirin to HCV genotype and early viral response: a decision analysis based on German guidelines.
Aidelsburger, P; Manns, MP; McHutchison, JG; Rossol, S; Siebert, U; Sroczynski, G; Wasem, J; Wong, JB, 2009
)
0.35
"Patients treated with PEG-IFN and ribavirin had plasmatic ribavirin dosage at weeks 4 and 12."( Impact of ribavirin plasma level on sustained virological response in patients treated with pegylated interferon and ribavirin for chronic hepatitis C.
Breilh, D; Castéra, L; Couzigou, P; de Lédinghen, V; Djabarouti, S; Foucher, J; Merrouche, W; Saux, MC; Trimoulet, P, 2009
)
0.35
" Because of the high frequency of hemotoxicity and renal insufficiency, ribavirin should be dosed according to renal function."( A practical guide to the management of HCV infection following liver transplantation.
Charlton, M; Veldt, B; Watt, K, 2009
)
0.35
" By means of observing the cytopathic effects (CPE), measuring the absorbance [D(lambda)] and counting the PFU, according to Reed-Muench assay, the TCM-ES's effective dosage of 50 percentage (EC50) and treatment index (TI) to FM1 were calculated."( [Antiviral effects of an effective section of a prescription of traditional Chinese medicine on influenza virus A in vitro].
Feng, XL; Huang, SH; Wei, W; Wu, CY; Xu, SP; Zhang, LL, 2009
)
0.35
" The questionnaire contained items about facility, duration and dosing of treatment, and side effect management using clinical vignettes followed by short questions."( Current clinical care compared with new Dutch guidelines for hepatitis C treatment.
de Knegt, RJ; Drenth, JP; Lamers, MH; Roomer, R; Slavenburg, S; van Oijen, MG, 2009
)
0.35
" The majority of physicians follow the stipulated dosage regimens of pegylated interferon (88%) and ribavirin (83%)."( Current clinical care compared with new Dutch guidelines for hepatitis C treatment.
de Knegt, RJ; Drenth, JP; Lamers, MH; Roomer, R; Slavenburg, S; van Oijen, MG, 2009
)
0.35
" These results suggest fixed-dose VRD given 600 mg BID is insufficient to treat patients with chronic hepatitis C; a weight-based dosing trial of viramidine is currently under way."( A phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naïve patients with chronic hepatitis C: ViSER1 results.
Afdhal, NH; Benhamou, Y; Chun, E; Halliman, DG; Heise, J; Nelson, DR; Pockros, PJ; Shiffman, ML, 2009
)
0.35
" Dose-response curves were generated for all drug combinations, and the degree of drug interaction was quantified using a model that calculates the synergy (or antagonism) between the drugs in double and triple combinations."( Triple combination of oseltamivir, amantadine, and ribavirin displays synergistic activity against multiple influenza virus strains in vitro.
Driebe, EM; Engelthaler, DM; Hoopes, JD; Keim, PS; Le, MH; Nguyen, JT; Prichard, MN; Smee, DF; Spence, RP; Went, GT, 2009
)
0.35
" Pharmacokinetic data demonstrated high exposure and good oral bioavailability, supporting once-daily dosing of TMC-435 in humans."( TMC-435, an NS3/4A protease inhibitor for the treatment of HCV infection.
Tsantrizos, YS, 2009
)
0.35
"Induction dosing with 360 microg/week PEG-IFNalpha-2a for 12 weeks was well tolerated and enhanced early virological response but not SVR rates."( Impact of high-dose peginterferon alfa-2A on virological response rates in patients with hepatitis C genotype 1: a randomized controlled trial.
Cheng, WS; Crawford, DH; Depamphilis, JK; Desmond, PV; Dore, GJ; Marks, PS; McCaughan, GW; Rawlinson, W; Rizkalla, B; Roberts, SK; Sievert, W; Weltman, MD; Yoshihara, M, 2009
)
0.35
" In the CD4 cell count 250 cells/mm(3) group, severe hematological toxicity and pegylated IFN or RBV dosage reductions occurred in 16 (41%) and 12 (31%) patients, respectively."( Efficacy and safety of pegylated interferon plus ribavirin in HIV and hepatitis C virus-coinfected patients with advanced immunosuppression.
Arponen, S; Collado, A; Delgado, M; Gil, Ide L; González-Serrano, M; Gutiérrez-Valencia, A; López-Ruz, MA; Macías, J; Merino, D; Mira, JA; Omar, M; Pineda, JA; Ríos-Villegas, MJ; Rivero, A; Torres-Tortosa, M, 2009
)
0.35
" New formulations of intravenous iron (iron carboxymaltose) and the new generation of erythropoietic agents (darbepoetin and continuous erythropoietin receptor activator) will allow better dosing with the same efficacy and safety."( Use of agents stimulating erythropoiesis in digestive diseases.
Gomollón García, F; Moreno López, R; Sicilia Aladrén, B, 2009
)
0.35
"The antiviral efficacy, as well as the adverse effects, of PEG-IFN alfa-2a and PEG-IFN alfa-2b are similar in US patients with HCV genotype 1 when used in a standard dosing regimen in combination with ribavirin."( Pharmacotherapy of chronic hepatitis C virus infection - the IDEAL trial: '2b or not 2b (= 2a), that is the question'.
Kumada, T; Toyoda, H, 2009
)
0.35
" To date, there is no general consensus on modality, timing and dosing of antiviral treatment of HCV in patients with advanced liver disease and after liver transplantation."( Antiviral therapy of chronic hepatitis C in patients with advanced liver disease and after liver transplantation.
Hofmann, WP; Peveling-Oberhag, J; Zeuzem, S, 2010
)
0.36
" Determination of a viramidine dosage that would yield superior efficacy over ribavirin is needed."( Safety and efficacy of viramidine versus ribavirin in ViSER2: randomized, double-blind study in therapy-naive hepatitis C patients.
Chun, E; Gish, RG; Gitlin, N; Halliman, DG; Heise, J; Marcellin, P; Rodriguez-Torres, M, 2010
)
0.36
" Monitoring of RBV C(trough) may permit early adjustment of RBV dosage to avoid HCV relapse."( Plasma ribavirin trough concentrations at week 4 predict hepatitis C virus (HCV) relapse in HIV-HCV-coinfected patients treated for chronic hepatitis C.
Barreiro, P; González-Lahoz, J; González-Pardo, G; Jiménez-Nácher, I; Madejón, A; Medrano, J; Morello, J; Rodríguez-Novoa, S; Soriano, V, 2010
)
0.36
" Two pegylated interferon (peginterferon)-alpha molecules are commercially available for the treatment of chronic hepatitis C, and these differ in the size and nature of the covalently attached polyethylene glycol (PEG) moiety, with resulting differences in pharmacokinetics and in dosing regimens."( Pegylated interferons for the treatment of chronic hepatitis C: pharmacological and clinical differences between peginterferon-alpha-2a and peginterferon-alpha-2b.
Foster, GR, 2010
)
0.36
" BIT225 has successfully completed a phase Ia dose escalating, single dose safety trial in healthy volunteers and a phase Ib/IIa trial to evaluate the safety and pharmacokinetics of repeated dosing for selected doses of BIT225 in HCV-infected persons."( A novel Hepatitis C virus p7 ion channel inhibitor, BIT225, inhibits bovine viral diarrhea virus in vitro and shows synergism with recombinant interferon-alpha-2b and nucleoside analogues.
Ewart, GD; Huang, Z; Luscombe, CA; Miller, M; Murray, MG; Wilkinson, J, 2010
)
0.36
" The latter include a reduction in the dosage of IFN or RBV and discontinuation of the treatment."( [Adverse reactions of different treatments in chronic hepatitis C].
Dorobăţ, C; Grigore, L; Luca, C; Vâţă, A,
)
0.13
" The main reasons for relapse include treatment initiation with insufficient ribavirin dosage or failure to continue treatment long enough, especially in patients with a slow virologic response."( [Retreatment options for patients with chronic hepatitis C].
Hrstić, I; Ostojić, R; Vucelić, B, 2009
)
0.35
" The presence of this side effect leads to a trade-off between continuing the treatment and exacerbating the side effects versus decreasing dosage to relieve severe side effects while allowing the disease to progress."( Evaluating treatment of hepatitis C for hemolytic anemia management.
Cardona-Meléndez, GM; DebRoy, S; Diaz, E; Kang, M; Kribs-Zaleta, C; Medina-Rios, L; Mubayi, A, 2010
)
0.36
" The dosage of tacrolimus was decreased gradually to minimize immunocompromise."( Flexible and individualized treatment to achieve sustained viral response for recurrent hepatitis C in liver transplant recipients.
Chan, KM; Cheng, SS; Chou, HS; Lee, CF; Lee, WC; Wu, TJ, 2010
)
0.36
" Such an association has not been demonstrated for HCV genotype 2/3 infection, where a fixed 800 mg daily dosing of ribavirin is generally recommended."( Ribavirin plasma concentration is a predictor of sustained virological response in patients treated for chronic hepatitis C virus genotype 2/3 infection.
Alsiö, Å; Buhl, MR; Christensen, PB; Färkkilä, M; Lagging, M; Langeland, N; Mørch, K; Norkrans, G; Pedersen, C; Sangfelt, P; Westin, J, 2011
)
0.37
"We retrospectively analyzed a total of 80 HCV genotype 1 patients (39 SVR and 41 non-SVR patients), who received an enough dosage and a complete 48-week treatment of PEG-IFN alpha-2b plus RBV."( Excellent superiority and specificity of COBAS TaqMan HCV assay in an early viral kinetic change during pegylated interferon alpha-2b plus ribavirin treatment.
Furusyo, N; Hayashi, J; Kainuma, M; Murata, M; Ogawa, E; Otaguro, S; Sawayama, Y; Taniai, H; Toyoda, K, 2010
)
0.36
"5 microg/kg PegIFN-alpha2b once weekly plus ribavirin at a dosage of 1000 mg/d for those under 75 kg or 1200 mg/d for those over 75 kg."( Alkaline phosphatase predicts relapse in chronic hepatitis C patients with end-of-treatment response.
Berg, J; Biesenbach, G; Bodlaj, G; Hubmann, R; Saleh, K; Stojakovic, T, 2010
)
0.36
" Patients treated with peginterferon alfa-2a and ribavirin in standard dosing were included: 49 with genotype 1 treated for 48weeks and 139 with genotype 2 or 3 treated for 24weeks."( Hepatitis C treatment response kinetics and impact of baseline predictors.
Arnholm, B; Buhl, MR; Eilard, A; Färkkilä, M; Hellstrand, K; Lagging, M; Langeland, N; Lindh, M; Mørch, K; Nilsson, S; Norkrans, G; Pedersen, C; Wahlberg, T; Wejstål, R; Westin, J, 2011
)
0.37
" RibaPak (RBP), available as 400 mg and 600 mg ribavirin tablets, offers simplified dosing at two pills daily."( Enhanced adherence to HCV therapy with higher dose ribavirin formulation: final analyses from the ADHERE registry.
Alam, I; Cecil, B; Kistler, KD; Stainbrook, T, 2010
)
0.36
" Studies are focusing on daily or high-dose induction therapy with interferon, the titration of interferon dosing to initial viral load, higher doses of interferon throughout treatment, and adjustment of interferon dosing to the viral responses."( Interferon-ribavirin treatment in chronic hepatitis C--the less talked about aspects.
Ahmed, I; Alam, A; Alvi, A; Butt, AK; Khalid, SR; Khan, AA; Lak, NH; Niazi, A; Sarwar, S; Shafqat, F,
)
0.13
" Strategies including induction dosing with interferon and ribavirin, use of combination high-potency STAT-C molecules and an intensive emphasis on adherence to HCV antiviral therapy will be critical to the success of this promising advance in HCV therapy."( Viral response to specifically targeted antiviral therapy for hepatitis C and the implications for treatment success.
Cooper, C, 2010
)
0.36
" Ribavirin dosage was reduced in 12 patients, and peginterferon dosage was reduced in 2 patients."( Aggressive use of ribavirin and prolonged course of peginterferon to improve the rate of viral response in liver transplant patients with recurrent hepatitis C viral infection.
Black, M; Burke, M; Jain, AB; Singhal, A, 2010
)
0.36
" The study aimed to determine if weight-based dosing of taribavirin (TBV), an oral prodrug of ribavirin (RBV), demonstrated efficacy comparable to RBV while maintaining its previously demonstrated anemia advantage with fixed dose administration."( Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C.
Bacon, BR; Chun, E; Halliman, D; Hammond, J; Hassanein, T; Heise, J; Lawitz, E; Muir, AJ; Poordad, F; Shiffman, ML, 2010
)
0.36
" When patients received a dosage at least 80% or more of the target dosage of PEG-IFN α-2b and 60% or more of the target dosage of RBV, the SVR rate significantly increased to 66."( Pegylated interferon α-2b plus ribavirin for older patients with chronic hepatitis C.
Azuma, K; Furusyo, N; Hayashi, J; Kainuma, M; Kajiwara, E; Kotoh, K; Maruyama, T; Nakamuta, M; Nomura, H; Satoh, T; Shimoda, S; Shimono, J; Takahashi, K; Tanabe, Y, 2010
)
0.36
"Patients were identified using data from the WIN-R trial database, a US multicenter study comparing fixed (800 mg) versus weight-based (800 to 1400 mg) daily dosing of ribavirin in combination with PEG-IFNα-2b (1."( Seizures during pegylated interferon and ribavirin therapy for chronic Hepatitis C: observations from the WIN-R trial.
Ahmed, F; Albert, C; Brand, M; Brass, C; Brown, R; Fixelle, AM; Herrera, JL; Jacobson, IM; Rustgi, VK; Wasserman, RB, 2011
)
0.37
"A high proportion (>80%) of patients achieved an SVR regardless of the telaprevir dosing frequency (q8 h or q12 h) or type of peginterferon alfa used (alfa-2a or alfa-2b)."( Telaprevir is effective given every 8 or 12 hours with ribavirin and peginterferon alfa-2a or -2b to patients with chronic hepatitis C.
Beumont, M; Carosi, G; De Backer, K; Drenth, JP; Ferenci, P; Forns, X; Goeser, T; Luo, D; Marcellin, P; Nevens, F; Picchio, G; Serfaty, L; Van Heeswijk, R, 2011
)
0.37
" We will also focus on how drug dosing may have influenced the outcome of treatment."( Individualizing treatment duration in hepatitis C virus genotype 2/3-infected patients.
Mangia, A, 2011
)
0.37
" The individualized dosing efficacy vs flat dosing to assess optimaL pegylated interferon therapy (IDEAL) trial enrolled 3070 patients from 118 United States centres to compare treatment with peginterferon (PEG-IFN) alfa-2a and ribavirin (RBV) and two doses of PEG-IFN alfa-2b and RBV."( Hepatitis C treatment among racial and ethnic groups in the IDEAL trial.
Albrecht, JK; Boparai, N; Gordon, SC; Hu, KQ; Koury, K; McCone, J; Muir, AJ; Noviello, S; Sulkowski, MS, 2011
)
0.37
" Therefore monitoring plasma concentration of ribavirin is a useful tool for individualizing ribavirin dosing regimens."( Influence of pre-analytical conditions on plasma ribavirin concentrations.
Alric, L; Barange, K; Gandia, P; Houin, G; Izopet, J; Lavit, M; Nicot, F; Séraissol, P; Trancart, S, 2010
)
0.36
"To investigate the association between early plasma ribavirin concentrations and ribavirin dosing with steady-state (Css) concentration and the between- and within-patient variability in plasma ribavirin concentration in clinical practice."( Ribavirin plasma concentration measurements in patients with hepatitis C: early ribavirin concentrations predict steady-state concentrations.
Burger, DM; Dofferhoff, TS; Drenth, JP; Huntjens-Fleuren, HW; Koopmans, PP; Richter, C; Slavenburg, S; Verwey-Van Wissen, CP, 2011
)
0.37
" It is important to complete the target length of treatment and to continue the target dosage to achieve SVR."( [Association between the influential factors and the effectiveness of pegylated interferon alpha-2a plus ribavirin as a combination treatment for chronic hepatitis C patients].
Chen, Y; Chen, Z; He, LL; Lei, BJ; Lei, XZ; Tang, H; Xu, H, 2011
)
0.37
" A key limitation, however, is the toxic side-effect of ribavirin, hemolytic anemia, which often necessitates a reduction of ribavirin dosage and compromises treatment response."( Ribavirin-induced anemia in hepatitis C virus patients undergoing combination therapy.
Dixit, NM; Krishnan, SM, 2011
)
0.37
" IFN therapy requires dosage reduction and close monitoring in patients with a GFR <50 ml/min/1."( Does the antiviral therapy of patients with chronic hepatitis exert nephrotoxic effects?
Bob, F; Bozdog, G; Cioca, D; Curescu, M; Gadalean, F; Gluhovschi, C; Gluhovschi, G; Kaycsa, A; Petrica, L; Sporea, I; Velciov, S; Vernic, C, 2011
)
0.37
" The aim of this study was to assess the safety and pharmacokinetic (PK) profile of raltegravir and ribavirin when dosed separately and together."( Pharmacokinetic and safety profile of raltegravir and ribavirin, when dosed separately and together, in healthy volunteers.
Ashby, J; Back, D; D'Avolio, A; Dickinson, L; Erlwein, OW; Garvey, L; Lamba, H; Latch, N; Legg, K; McClure, MO; Weston, R; Winston, A, 2011
)
0.37
" Encouraging data from small trials have shown a significant increase in SVR rates with the use of different dosing regimens of ribavirin in addition to interferon-based therapy and aggressive erythroid-stimulating agent support in dialysis patients."( Should ribavirin be used to treat hepatitis C in dialysis patients?
Carrion, AF; Fabrizi, F; Martin, P,
)
0.13
"5) months and was treated by CsA and prednisone dosage adjustments."( Successful treatment of fibrosing cholestatic hepatitis after liver transplantation.
Arvelakis, A; Assis, D; Caldwell, C; Cimsit, B; Emre, S; Kulkarni, S; Schilsky, M; Taddei, T, 2011
)
0.37
" The filibuvir doses evaluated ranged from 200-1400 mg daily, and the duration of dosing ranged from 3-10 days."( Antiviral activity of the hepatitis C virus polymerase inhibitor filibuvir in genotype 1-infected patients.
Hammond, JL; Jagannatha, S; Kantaridis, C; Neelakantan, S; Purohit, VS; Simpson, P; Thompson, R; Troke, PJ; Wagner, F, 2011
)
0.37
"Anemia was manageable by carefully adjusting the ribavirin dosage in the standard therapy that followed telaprevir monotherapy."( Antiviral effects of peginterferon alpha-2b and ribavirin following 24-week monotherapy of telaprevir in Japanese hepatitis C patients.
Akaike, J; Arakawa, T; Chayama, K; Kamiya, N; Karino, Y; Kumada, H; Kuwata, Y; Ohmura, T; Ozeki, I; Sato, T; Toyota, J; Yamada, I, 2011
)
0.37
"Patients receiving the investigational dosing had lower levels of HCV RNA at all time points after initiation of therapy."( Twice-weekly pegylated interferon-α-2a and ribavirin results in superior viral kinetics in HIV/hepatitis C virus co-infected patients compared to standard therapy.
Chung, TL; Haagmans, BL; Herrmann, E; Kottilil, S; Lempicki, RA; Murphy, AA; Osinusi, AO; Polis, MA; Sachau, W; Wood, BJ; Wu, L; Yang, J, 2011
)
0.37
" Group 1 comprised patients who received ≥80% of the recommended dosage of both peginterferon and ribavirin."( [Importance of medication adherence to peginterferon-ribavirin combination therapy in patients with chronic hepatitis C].
Eun, HS; Goh, PG; Kim, ES; Kim, HJ; Kim, MJ; Kim, SH; Kim, YJ; Lee, BS; Lee, ES; Lee, HY; Lee, SY; Moon, HS, 2011
)
0.37
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" CIFN was primarily dosed as 15 mcg subcutaneously daily combined with standard doses of RBV."( Retreatment of hepatitis C with consensus interferon and ribavirin after nonresponse or relapse to pegylated interferon and ribavirin: a national VA clinical practice study.
Chapman, S; Cozen, M; Cunningham, F; Currie, SL; Monto, A; Shen, H; Tortorice, K; Yee, HS, 2011
)
0.37
" Our present results may provide a valuable pharmacogenetic diagnostic tool for tailoring PEG-IFN/RBV dosing to minimize drug-induced adverse events."( Genome-wide association study identified ITPA/DDRGK1 variants reflecting thrombocytopenia in pegylated interferon and ribavirin therapy for chronic hepatitis C.
Enomoto, N; Hiasa, Y; Hige, S; Hino, K; Honda, M; Itoh, Y; Izumi, N; Kaneko, S; Koike, A; Kurosaki, M; Matsuura, K; Mizokami, M; Mochida, S; Nishida, N; Nishiguchi, S; Sakamoto, N; Sugauchi, F; Sugiyama, M; Tanaka, E; Tanaka, Y; Tokunaga, K; Yatsuhashi, H, 2011
)
0.37
" The optimal dosage of ribavirin remains unresolved, in light of frequent side effects."( Anti-viral therapy in haemodialysed HCV patients: efficacy, tolerance and treatment strategy.
Canva, V; Castel, H; Colin, M; Deltenre, P; Dharancy, S; Glowacki, F; Hazzan, M; Henrion, J; Lazrek, M; Louvet, A; Mathurin, P; Moreno, C; Noel, C; Ollivier, I; Provôt, F; Stanke, F; Tran, A, 2011
)
0.37
" The aim of this subanalysis of the Weight-based Dosing of PegINterferon α-2b and Ribavirin (WIN-R) study was to assess the impact of Asian (n=118), Hispanic (n=289), and white (n=3919) ethnicity on CHC treatment outcomes."( Impact of Hispanic or Asian ethnicity on the treatment outcomes of chronic hepatitis C: results from the WIN-R trial.
Brass, C; Brown, RS; Freilich, B; Hu, KQ; Jacobson, IM, 2011
)
0.37
" The literature suggests that weight-based dosing of taribavirin at 25 mg/kg demonstrates lower rates of hemolytic anemia with comparable rates of sustained virologic response (SVR) and is the optimum dose for further studies comparing the efficacy of taribavirin with weight-based dosing of ribavirin."( Taribavirin in the treatment of hepatitis C.
Arora, S; Deming, P, 2011
)
0.37
" The dosing strategy of taribavirin favors concentration within the liver to reduce treatment-limiting rates of anemia but may be insufficient to prevent virologic relapse."( Taribavirin in the treatment of hepatitis C.
Arora, S; Deming, P, 2011
)
0.37
"HIV and HCV genotype 1- and 4-coinfected subjects were randomized to receive pegylated interferon-α2a 270 μg/week plus ribavirin 1,600 mg daily and epoetin-β for 4 weeks, followed by pegylated interferon-α2a at standard dosages plus weight-based ribavirin (WBR) dosage for 8 weeks (induction arm [IA]), or pegylated interferon-α2a plus WBR for 12 weeks (standard therapy arm [SA])."( Effect of an induction period of pegylated interferon-α2a and ribavirin on early virological response in HIV-HCV-coinfected patients: results from the CORAL-2 study.
Alvarez, NP; Clotet, B; González, J; Laguno, M; Moltó, J; Ornelas, A; Paredes, R; Sánchez, M; Solà, R; Téllez, MJ; Tural, C; von Wichmann, MÁ; Zamora, AM, 2011
)
0.37
"01]), although rates of dosage reduction and treatment discontinuation were similar across settings."( Outcomes of chronic hepatitis C therapy in patients treated in community versus academic centres in Canada: final results of APPROACH (a prospective study of peginterferon alfa-2a and ribavirin at academic and community centres in Canada).
Balshaw, R; Cooper, C; Elkashab, M; Harris, P; Lalonde, R; Marrotta, PJ; Myers, RP; Sherman, M; Usaty, C; Witt-Sullivan, H, 2011
)
0.37
" Therefore, the ribavirin dosing regimen might need to be reassessed."( Ribavirin dose and treatment outcome of Korean patients with genotype 1 chronic hepatitis C.
Choi, MS; Gwak, GY; Kim, J; Koh, KC; Lee, JH; Paik, SW; Shin, SR; Sinn, DH; Yoo, BC,
)
0.13
" Based on clinical, histological, immunological parameters, and cumulative dosage of PEG-IFNα2b and ribavirin, multivariate analyses revealed that higher platelet counts and higher regulatory T cell frequency at week 12 are indicative of SVR."( Dynamics of regulatory T cells and plasmacytoid dendritic cells as immune markers for virological response in pegylated interferon-α and ribavirin therapy for chronic hepatitis C patients.
Hagiwara, H; Hayashi, N; Higashitani, K; Hiramatsu, N; Iio, S; Inoue, M; Kakita, N; Kanto, T; Kasahara, A; Katayama, K; Matsubara, T; Mita, E; Miyazaki, M; Oze, T; Sakakibara, M; Takehara, T, 2012
)
0.38
" Induction dosing strategies have not yielded positive results, though twice weekly peg-IFN-alpha-2a induction therapy merits further investigation."( Current treatment for chronic hepatitis C virus/HIV-infected individuals: the role of pegylated interferon-alpha and ribavirin.
Bhagani, S, 2011
)
0.37
" Their main advantages consist in maintenance of viral suppression across a longer dosing interval, avoidance of interdose trough and reduced dosing frequencies (twice or even once per month compared to once per week for the actual PEG-IFNs)."( New interferons in the treatment of chronic hepatitis C.
Cernescu, C; Ruţă, S,
)
0.13
" Furthermore, 100 patients were extracted from each Peg-IFN dosage category to adjust for characteristic factors, using the propensity score method."( Reducing Peg-IFN doses causes later virologic response or no response in HCV genotype 1 patients treated with Peg-IFN alfa-2b plus ribavirin.
Doi, Y; Hagiwara, H; Hayashi, E; Hayashi, N; Hijioka, T; Hiramatsu, N; Hosui, A; Iio, S; Imai, Y; Inoue, A; Inui, Y; Ito, T; Kanto, T; Kasahara, A; Kato, M; Kiso, S; Mita, E; Miyagi, T; Miyazaki, M; Oshita, M; Oze, T; Song, C; Takehara, T; Tamura, S; Tatsumi, T; Yakushijin, T; Yoshida, Y; Yoshihara, H, 2012
)
0.38
" No subject discontinued dosing due to adverse events."( Open-label phase 1b pilot study to assess the antiviral efficacy of simvastatin combined with sertraline in chronic hepatitis C patients.
Altmeyer, R; Cheng, CW; Chopra, N; Lawitz, E; Lim, SG; McHutchison, JG; Patel, K; Randle, JC; Tillmann, HL, 2011
)
0.37
"The pharmacokinetics and in dosing regimens of the currently available pegylated interferon (peginterferon) alfa molecules differ greatly, depending on the size and nature of their polyethylene glycol (PEG) moiety."( Comparison of peginterferon pharmacokinetic and pharmacodynamic profiles.
Bruno, R; Cima, S; Fagiuoli, S; Filice, G; Maiocchi, L; Novati, S; Sacchi, P, 2012
)
0.38
" Clinical studies have demonstrated the importance of adherence to therapy, that is, the ability of patients to tolerate and sustain a fully dosed therapy regimen."( Critical review of the use of erythropoietin in the treatment of anaemia during therapy for chronic hepatitis C.
De Gottardi, A; Geier, A; Gerlach, T; Heim, M; Helbling, B; Hirschi, C; Negro, F; Stickel, F; Terziroli, B; Wehr, K, 2012
)
0.38
" Their dosage and the duration of therapy are tailored to the HCV genotype and the time to viral response."( [Chronic hepatitis C virus infection: clinical picture and treatment possibilities].
Annicchiarico, BE; Gasbarrini, A; Siciliano, M,
)
0.13
" However, the side effect profile remains challenging and the dosing schedule complicated."( Hepatitis C treatment highlights from the 2011 American Association for the Study of Liver Disease meeting.
Cooper, C, 2012
)
0.38
"The safety and efficacy of weight-based ribavirin (RBV) dosing regimens in patients with HIV-HCV coinfection has not been demonstrated in randomized clinical trials."( Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial.
Bertasso, A; Bhatti, L; Hassanein, T; Passe And, S; Rodriguez-Torres, M; Serrão, R; Slim, J; Sola, R; Stancic, S; Sterling, R; Sulkowski, M,
)
0.13
"Compared with the standard RBV dose (800 mg/day), weight-based RBV dosing (1000/1200 mg/day) did not significantly increase SVR rates, but did increase the incidence of anemia in HIV-HCV (genotype 1) coinfected patients."( Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial.
Bertasso, A; Bhatti, L; Hassanein, T; Passe And, S; Rodriguez-Torres, M; Serrão, R; Slim, J; Sola, R; Stancic, S; Sterling, R; Sulkowski, M,
)
0.13
" These findings suggest that optimization of ribavirin plasma concentrations during the first week of ribavirin dosing is most critical in AA patients in order to increase the rate of SVR, especially those with the IL-28B TT genotype."( Population pharmacokinetics and pharmacodynamics of ribavirin in patients with chronic hepatitis C genotype 1 infection.
Dowling, TC; Fossler, MJ; Howell, CD; Jin, R; McHutchison, JG, 2012
)
0.38
"This study evaluated impact of obesity on outcome as well as interferon and ribavirin concentrations following standard-of-care fixed dosing with peginterferon-α2a 180 µg once weekly and ribavirin 800 mg daily among 303 HCV genotype 2/3-infected patients enrolled in the per-protocol analysis of a recently completed phase III trial (NORDynamIC)."( Impact of obesity on the bioavailability of peginterferon-α2a and ribavirin and treatment outcome for chronic hepatitis C genotype 2 or 3.
Alsiö, Å; Askarieh, G; Buhl, MR; Christensen, PB; Färkkilä, M; Haagmans, BL; Hellstrand, K; Lagging, M; Langeland, N; Mørch, K; Nasic, S; Norkrans, G; Pedersen, C; Rembeck, K; Westin, J, 2012
)
0.38
" The initial phase of combination pegylated interferon, ribavirin and a protease inhibitor will be associated with increased toxicity and complexity of therapeutic management but, over the course of the decade, strategies including interferon-free combination direct-acting antiviral regimens with enhanced tolerability and simplified dosing schedules and monitoring protocols will emerge."( The changing therapeutic landscape for hepatitis C.
Dore, GJ, 2012
)
0.38
"Therapy-naïve patients with chronic hepatitis C virus (HCV) genotype 1 (G1) were randomised to receive (i) TBV 600 mg BID monotherapy for 4 weeks followed by combination therapy with PIFN [pre-dosing arm (n = 23)] or (ii) TBV administered concurrently with PIFN [standard dosing arm (n = 19)]."( Randomised clinical trial: pre-dosing with taribavirin before starting pegylated interferon vs. standard combination regimen in treatment-naïve patients with chronic hepatitis C genotype 1.
Palmer, M; Rubin, R; Rustgi, V, 2012
)
0.38
" the standard dosing arm [33% vs."( Randomised clinical trial: pre-dosing with taribavirin before starting pegylated interferon vs. standard combination regimen in treatment-naïve patients with chronic hepatitis C genotype 1.
Palmer, M; Rubin, R; Rustgi, V, 2012
)
0.38
"Several direct-acting antivirals for chronic hepatitis C virus (HCV) infection are available, but they are limited by tolerability and dosing schedules."( Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial.
Abrams, GA; Bräu, N; Bronowicki, JP; Diva, U; Everson, GT; Ghalib, RH; Hernandez, D; Hézode, C; Hindes, R; Hughes, EA; Lim, JK; Martorell, C; McPhee, F; Morris, DW; Pol, S; Reindollar, RW; Rustgi, VK; Schnittman, S; Tatum, HA; Thuluvath, PJ; Wind-Rotolo, M; Yin, PD, 2012
)
0.38
"HIV/HCV-coinfected individuals naive to interferon were prospectively randomized to receive peginterferon-α-2a (180 μg/d) plus either RBV standard dosing (1000 or 1200 mg/d if <75 or ≥ 75 kg, respectively) or RBV induction (2000 mg/d) along with subcutaneous erythropoietin β (450 IU/kg/wk), both during the first 4 weeks, followed by standard RBV dosing until completion of therapy."( Comparison of high ribavirin induction versus standard ribavirin dosing, plus peginterferon-α for the treatment of chronic hepatitis C in HIV-infected patients: the PERICO trial.
Aguirrebengoa, K; Asensi, V; Barreiro, P; Castro, A; da Silva, A; Echeverría, S; Guardiola, JM; Hernández-Quero, J; Labarga, P; Mariño, A; Miralles, P; Morano, L; Pineda, JA; Portu, J; Ríos, MJ; Rubio, R; Soriano, V; Téllez, MJ; Terrón, A; Vispo, E, 2012
)
0.38
"14 μg/mL) were comparable in both arms, whereas mean hemoglobin decay was less pronounced in the RBV induction plus erythropoietin arm than in the RBV standard dosing arm (-1."( Comparison of high ribavirin induction versus standard ribavirin dosing, plus peginterferon-α for the treatment of chronic hepatitis C in HIV-infected patients: the PERICO trial.
Aguirrebengoa, K; Asensi, V; Barreiro, P; Castro, A; da Silva, A; Echeverría, S; Guardiola, JM; Hernández-Quero, J; Labarga, P; Mariño, A; Miralles, P; Morano, L; Pineda, JA; Portu, J; Ríos, MJ; Rubio, R; Soriano, V; Téllez, MJ; Terrón, A; Vispo, E, 2012
)
0.38
"A 4-week course of induction therapy with high RBV dosing along with erythropoietin does not improve SVR rates in HIV/HCV-coinfected patients."( Comparison of high ribavirin induction versus standard ribavirin dosing, plus peginterferon-α for the treatment of chronic hepatitis C in HIV-infected patients: the PERICO trial.
Aguirrebengoa, K; Asensi, V; Barreiro, P; Castro, A; da Silva, A; Echeverría, S; Guardiola, JM; Hernández-Quero, J; Labarga, P; Mariño, A; Miralles, P; Morano, L; Pineda, JA; Portu, J; Ríos, MJ; Rubio, R; Soriano, V; Téllez, MJ; Terrón, A; Vispo, E, 2012
)
0.38
" The maximum dosage of ribavirin that can be tolerated by patients with different ITPA polymorphisms remains unknown."( A formula to estimate the optimal dosage of ribavirin for the treatment of chronic hepatitis C: influence of ITPA polymorphisms.
Dixit, NM; Krishnan, SM, 2012
)
0.38
" Patients with moderate ITPA deficiency are predicted to tolerate twice the ribavirin dosage as patients with wild-type ITPA."( A formula to estimate the optimal dosage of ribavirin for the treatment of chronic hepatitis C: influence of ITPA polymorphisms.
Dixit, NM; Krishnan, SM, 2012
)
0.38
" By keeping anaemia tolerable, the predicted optimal dosage may improve adherence, reduce the need for drug monitoring, and increase response rates."( A formula to estimate the optimal dosage of ribavirin for the treatment of chronic hepatitis C: influence of ITPA polymorphisms.
Dixit, NM; Krishnan, SM, 2012
)
0.38
" To improve tolerance for SOC, and ribavirin (RBV) in particular, concentration-guided RBV dosing calculated by a formula taking renal function and weight into consideration was utilized."( Concentration-guided ribavirin dosing with darbepoetin support and peg-IFN alfa-2a for treatment of hepatitis C recurrence after liver transplantation.
Ackefors, M; Gjertsen, H; Weiland, O; Wernerson, A, 2012
)
0.38
" Estimated oral clearances of IT decreased on average by 50%, requiring reduced dosing regimens."( Practical management of boceprevir and immunosuppressive therapy in liver transplant recipients with hepatitis C virus recurrence.
Antonini, TM; Barau, C; Bonhomme-Faivre, L; Coilly, A; Duclos-Vallée, JC; Furlan, V; Noël, C; Roche, B; Roque-Afonso, AM; Samuel, D; Taburet, AM, 2012
)
0.38
"A continuous dosing schedule of aerosolized ribavirin has been used for respiratory syncytial virus (RSV) upper respiratory tract infection and lower respiratory tract infection (LRTI) but is associated with high cost and inconvenient administration."( An adaptive randomized trial of an intermittent dosing schedule of aerosolized ribavirin in patients with cancer and respiratory syncytial virus infection.
Bodey, GP; Champlin, RE; Chemaly, RF; Hosing, C; Munsell, MF; Raad, II; Rathod, DB; Saifan, C; Shah, DP; Torres, HA, 2012
)
0.38
" In conclusion, this pilot study provides evidence showing that TVR-based triple therapy is effective within the first 4 to 12 weeks in LT patients suffering from HCV genotype 1 recurrence, and it also provides evidence showing that drug-drug interactions between TVR and immunosuppressants can be handled appropriately through the close monitoring of trough levels and adequate dosage adjustments."( Telaprevir-based triple therapy in liver transplant patients with hepatitis C virus: a 12-week pilot study providing safety and efficacy data.
Berg, CP; Egetemeyr, DP; Königsrainer, A; Lauer, UM; Malek, NP; Nadalin, S; Werner, CR, 2012
)
0.38
"Intensified dosing of PegIFN α-2a increases SVR rates in patients with elevated LDL even with the difficult-to-cure characteristics of genotype 1, high baseline viral load, and high body weight."( Intensified peginterferon α-2a dosing increases sustained virologic response rates in heavy, high viral load hepatitis C genotype 1 patients with high low-density lipoprotein.
Abdurakhmanov, D; Bakulin, I; Cheinquer, H; Connell, EV; Harrison, SA; Mazur, W; McKenna, M; Messinger, D; Reddy, KR; Rodriguez-Torres, M; Shiffman, ML; Silva, GF; Tatsch, F, 2013
)
0.39
"We did not encounter severe hematological adverse effects that would require Ribavirin dosage adjustments."( Adverse effects of peg-Interferon and Ribavirin combined antiviral treatment in a Romanian hepatitis C virus infected cohort.
Irimia, E; Mogoantă, L; Predescu, O; Streba, L; Streba, LA, 2012
)
0.38
" All eligible patients were provided peg-interferon at the dosage of 180 μg weekly with ribavirin thrice a day for 6 months."( Efficacy of PEG-interferon based treatment in patients with hepatitis C refractory to previous conventional interferon-based treatment.
Devrajani, BR; Kalhoro, M; Shaikh, S, 2012
)
0.38
" Optimization and individualization of PEGIFN dosing could improve outcomes."( Pegylated interferon fractal pharmacokinetics: individualized dosing for hepatitis C virus infection.
Alder, L; Gumbo, T; Jain, MK; Lee, WM; Pasipanodya, JG, 2013
)
0.39
" In a phase three III clinical trial, 2250 mg of telaprevir, which is the same dosage used in clinical trials in Western countries, was given to Japanese patients."( Treatment of chronic hepatitis C virus infection in Japan: update on therapy and guidelines.
Chayama, K; Hayes, CN; Kawakami, Y; Ohishi, W, 2013
)
0.39
"Among the strictly selected nonresponders, IFN-γ-1b (at a dosage of 100 μg thrice a week) in combination with PEG-IFN-α-2a and ribavirin failed to show virological efficacy."( Interferon-gamma with peginterferon alpha-2a and ribavirin in nonresponder patients with chronic hepatitis C (ANRS HC16 GAMMATRI).
Bourlière, M; Bronowicki, JP; Chêne, G; Couzigou, P; Foucher, J; Leroy, V; Marcellin, P; Pérusat, S; Poynard, T; Trimoulet, P, 2013
)
0.39
" According to HCV RNA levels at weeks 4 and 12, patients were reallocated to receive different interferon dosage forms or different courses of treatment."( A preliminary study on the efficacy and influencing factors of interferon for the treatment of genotype 1 chronic hepatitis C with different dosage forms.
Hou, W; Lu, W; Ma, P; Song, SD; Wang, L; Yang, JM, 2013
)
0.39
" These may lead to dosage reduction and sometimes discontinuation of therapy."( How to optimize HCV therapy in genotype 1 patients: management of side-effects.
Chopra, A; Drinnan, T; Klein, PL; Lee, SS, 2013
)
0.39
" Unfortunately, any attempt to modify the duration or dosing of the SOC according to baseline factors has been disappointing and should not be continued at present."( How to optimize HCV therapy in genotype 2 patients.
Aghemo, A; Grassi, E, 2013
)
0.39
" A second wave of protease inhibitors are in phase II and III trials and promise to provide a drug regimen with a better dosing schedule and improved tolerance."( New therapeutic strategies in HCV: second-generation protease inhibitors.
Clark, VC; Nelson, DR; Peter, JA, 2013
)
0.39
" Timely adjustment to dosage and time periods was made according to the virological response to treatment, and the predictive value of rapid virological response (RVR) and complete early virological response (cEVR) for sustained virological response (SVR) were analyzed."( [The effects of individualized therapeutic programs on chronic hepatitis C and the influential factors of virological response].
Cheng, ML; Liu, XF; Wang, J; Zeng, AP, 2012
)
0.38
" Treatment-naïve HCV genotype 1 or 4 patients were randomized to double-blind treatment with oral mericitabine at a dosage of 500 mg twice-daily (BID) for 12 weeks (A), 1,000 mg BID for 8 (B) or 12 weeks (C and D), or placebo BID for 12 weeks (E)."( PROPEL: a randomized trial of mericitabine plus peginterferon alpha-2a/ribavirin therapy in treatment-naïve HCV genotype 1/4 patients.
Bzowej, N; Chen, YC; Ferenci, P; Herring, R; Ipe, D; Jensen, D; Ma, MM; Munson, ML; Najera, I; Pockros, P; Rodriguez-Torres, M; Thommes, J; Vierling, J; Wedemeyer, H; Zeuzem, S, 2013
)
0.39
" Patients received ABT-450/r 150/100 mg once daily and ABT-072 400 mg once daily with weight-based ribavirin 1000-1200 mg/day dosed twice daily for 12 weeks."( A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1.
Bernstein, B; Cohen, DE; Koev, G; Kowdley, KV; Larsen, L; Lawitz, E; Menon, R; Pilot-Matias, T; Podsadecki, T; Poordad, F; Siggelkow, S; Tripathi, R, 2013
)
0.39
" They were treated with pegylated interferon (PEG-IFN) alpha 2a and ribavirin, with the standard dosing schedule."( Replication of hepatitis C virus in peripheral blood mononuclear cells in patients with chronic hepatitis C treated with pegylated interferon alpha and ribavirin.
Inglot, M; Malyszczak, K; Pawlowski, T; Radkowski, M; Szymczak, A; Zalewska, M, 2013
)
0.39
" However, its utilization can be limited by its potential to cause hemolytic anemia as well as its variability in dosing levels and efficacy outcomes."( Synthesis and evaluation of a new phosphorylated ribavirin prodrug.
Dong, SD; Lin, CC; Schroeder, M, 2013
)
0.39
" Among the STAT6 SNPs examined, the dosage effect of the A allele and allele frequency in rs1059513 were inversely correlated with SVR in patients infected with HCV-1 (P = 0."( The impact of polymorphisms in STAT6 on treatment outcome in HCV infected Taiwanese Chinese.
Hsu, YA; Hung, DZ; Liao, WL; Lim, YP; Lin, CY; Peng, CY; Tien, N; Tsai, FJ; Tsai, KH; Wan, L, 2013
)
0.39
" Adherence to the assigned duration of the dosing regimen and adherence to the three times a day (t."( Adherence to assigned dosing regimen and sustained virological response among chronic hepatitis C genotype 1 patients treated with boceprevir plus peginterferon alfa-2b/ribavirin.
Albrecht, JK; Bacon, BR; Brass, CA; Bronowicki, JP; Burroughs, MH; Davis, M; Deng, W; Dutko, FJ; Esteban, R; Gordon, SC; Lawitz, EJ; Poordad, F; Rajender Reddy, K; Sniukiene, V; Sulkowski, MS; Yoshida, EM, 2013
)
0.39
" dosing interval with boceprevir."( Adherence to assigned dosing regimen and sustained virological response among chronic hepatitis C genotype 1 patients treated with boceprevir plus peginterferon alfa-2b/ribavirin.
Albrecht, JK; Bacon, BR; Brass, CA; Bronowicki, JP; Burroughs, MH; Davis, M; Deng, W; Dutko, FJ; Esteban, R; Gordon, SC; Lawitz, EJ; Poordad, F; Rajender Reddy, K; Sniukiene, V; Sulkowski, MS; Yoshida, EM, 2013
)
0.39
"In the Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy study, the participation of 76 academic-based and 42 community-based US centers provided an opportunity to evaluate various metrics of quality and site performance."( Analysis of site performance in academic-based and community-based centers in the IDEAL Study.
Jou, JH; Long, J; McHutchison, JG; Muir, AJ; Noviello, S; Pedicone, LD; Sulkowski, MS,
)
0.13
"A secondary data analysis of the Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy study was performed."( Analysis of site performance in academic-based and community-based centers in the IDEAL Study.
Jou, JH; Long, J; McHutchison, JG; Muir, AJ; Noviello, S; Pedicone, LD; Sulkowski, MS,
)
0.13
" Adherence to ≥80% of peginterferon-α and ribavirin dosing for ≥80% assigned duration was also similar (46% in academic and 47% in community centers)."( Analysis of site performance in academic-based and community-based centers in the IDEAL Study.
Jou, JH; Long, J; McHutchison, JG; Muir, AJ; Noviello, S; Pedicone, LD; Sulkowski, MS,
)
0.13
" The factors determining the complexity of treatment were the number of medications, dosing schedules, administration methods, special instructions, and required preparations associated with antiviral regimens."( Antiviral regimen complexity index as an independent predictor of sustained virologic response in patients with chronic hepatitis C.
Almeida, CV; Cidoncha, EC; Galán, RJ; Martin, MF; Rodriguez, CC; Verdugo, RM,
)
0.13
" These processes will be important to investigate as the dosing schedules of antiviral regimens become increasingly complex."( Adherence to PEG/ribavirin treatment for chronic hepatitis C: prevalence, patterns, and predictors of missed doses and nonpersistence.
Bonner, JE; Esserman, DA; Evon, DM; Fried, MW; Golin, CE; Rao, T, 2013
)
0.39
" Eligible patients were assigned to receive thrice weekly subcutaneous injection of 3MIU standard interferon > or = -2b and weight-base dosage of ribavirin."( Validity of aspartate aminotransferase to platelet ratio index as predictor of early viral response in patients with hepatitis C treated by interferon-based therapy.
Bikharam, D; Musarat, K; Samiullah, S, 2012
)
0.38
" Patients who became anemic (levels of hemoglobin approximately ≤10 g/dL) during the study treatment period (n = 500) were assigned to groups that were managed by ribavirin dosage reduction (n = 249) or erythropoietin therapy (n = 251)."( Effects of ribavirin dose reduction vs erythropoietin for boceprevir-related anemia in patients with chronic hepatitis C virus genotype 1 infection--a randomized trial.
Afdhal, NH; Albrecht, JK; Alves, K; Bacon, BR; Balart, L; Brass, CA; Brown, RS; Burroughs, MH; Calleja, JL; Craxi, A; Deng, W; Dutko, FJ; Flamm, SL; Hézode, C; Koury, KJ; Kowdley, KV; Lawitz, E; Lee, SS; Morgan, TR; Nelson, DR; Nyberg, L; Pedicone, LD; Poordad, F; Reddy, KR; Rossaro, L; Sulkowski, MS; Wahl, J; Wedemeyer, H; Zeuzem, S, 2013
)
0.39
"Rates of SVR were comparable between patients whose anemia was managed by ribavirin dosage reduction (71."( Effects of ribavirin dose reduction vs erythropoietin for boceprevir-related anemia in patients with chronic hepatitis C virus genotype 1 infection--a randomized trial.
Afdhal, NH; Albrecht, JK; Alves, K; Bacon, BR; Balart, L; Brass, CA; Brown, RS; Burroughs, MH; Calleja, JL; Craxi, A; Deng, W; Dutko, FJ; Flamm, SL; Hézode, C; Koury, KJ; Kowdley, KV; Lawitz, E; Lee, SS; Morgan, TR; Nelson, DR; Nyberg, L; Pedicone, LD; Poordad, F; Reddy, KR; Rossaro, L; Sulkowski, MS; Wahl, J; Wedemeyer, H; Zeuzem, S, 2013
)
0.39
"Reduction of ribavirin dosage can be the primary approach for management of anemia in patients receiving peginterferon, ribavirin, and boceprevir for HCV infection."( Effects of ribavirin dose reduction vs erythropoietin for boceprevir-related anemia in patients with chronic hepatitis C virus genotype 1 infection--a randomized trial.
Afdhal, NH; Albrecht, JK; Alves, K; Bacon, BR; Balart, L; Brass, CA; Brown, RS; Burroughs, MH; Calleja, JL; Craxi, A; Deng, W; Dutko, FJ; Flamm, SL; Hézode, C; Koury, KJ; Kowdley, KV; Lawitz, E; Lee, SS; Morgan, TR; Nelson, DR; Nyberg, L; Pedicone, LD; Poordad, F; Reddy, KR; Rossaro, L; Sulkowski, MS; Wahl, J; Wedemeyer, H; Zeuzem, S, 2013
)
0.39
"The dosage of immunosuppressants had to be reduced significantly (TAC: 30-fold; CSA 3,5-fold)."( [HCV reinfection after liver transplantation - management and first experiences with telaprevir-based triple therapy].
Gerken, G; Herzer, K; Jochum, C; Papadopoulos-Köhn, A; Paul, A; Timm, J, 2013
)
0.39
" In the phase 3 IDEAL (Individualized Dosing to Assess Optimal Pegylated Interferon Therapy) clinical trial, a subset of patients receiving peginterferon and ribavirin for treatment of chronic hepatitis C agreed to provide blood samples for genetic testing."( Predictors of consent to pharmacogenomics testing in the IDEAL study.
Albrecht, JK; Brass, CA; Clark, PJ; Gordon, SC; Jazwinski, AB; Lawitz, EJ; Muir, AJ; Noviello, S; Pedicone, LD; Sulkowski, MS; Thompson, AJ, 2013
)
0.39
" Because of its pharmacokinetics, telaprevir has been designed for administration every 8 hours but efficacy is maintained in a twice-daily dosing regimen."( [Biochemical and pharmacological features of telaprevir].
Andrade, RJ; García-Samaniego, J, 2013
)
0.39
" In addition, they review Phase II and III trials of boceprevir as well as its clinical efficacy, dosing and safety."( The pharmacokinetic evaluation of boceprevir for treatment of hepatitis C virus.
Bichoupan, K; Dieterich, DT; Shankar, H, 2013
)
0.39
" These may lead to dosage reduction and early discontinuation of therapy."( Management of anaemia and other treatment complications.
Hézode, C, 2013
)
0.39
" To achieve SVR, an adequate dosage of PEG-IFNα2b (≥1."( Telaprevir-based triple therapy for chronic hepatitis C patients with advanced fibrosis: a prospective clinical study.
Azuma, K; Dohmen, K; Furusyo, N; Hayashi, J; Kajiwara, E; Kawano, A; Kotoh, K; Nakamuta, M; Nomura, H; Ogawa, E; Satoh, T; Shimoda, S; Takahashi, K; Tanabe, Y, 2013
)
0.39
"1 years after narlaprevir dosing in two patients in 5% and 45% of the viral population."( Evolutionary dynamics of hepatitis C virus NS3 protease domain during and following treatment with narlaprevir, a potent NS3 protease inhibitor.
Bergmann, JF; de Bruijne, J; de Knegt, RJ; Hughes, E; Janssen, HL; Molenkamp, R; Rebers, SP; Reesink, HW; Schinkel, J; Thomas, XV; Treitel, MA; Weegink, CJ, 2013
)
0.39
" Patients receiving combination therapy required a higher dosage (mean, 13 946 IU per week [SD, 6449] vs."( Pegylated interferon-α2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 1 receiving hemodialysis: a randomized trial.
Chen, DS; Chen, PJ; Chen, SI; Chuang, WL; Dai, CY; Huang, CF; Huang, JF; Hung, PH; Kao, JH; Liang, CC; Lin, JW; Liu, CH; Liu, CJ; Su, TH; Tsai, HB; Tsai, MK; Yang, HC; Yang, SS; Yu, ML, 2013
)
0.39
" Thus, shortening treatment together with a weight-based RBV dosing approach has been considered satisfactory in patients with positive predictors of response."( How to optimize current treatment of genotype 2 hepatitis C virus infection.
Gadano, AC; Marciano, S, 2014
)
0.4
" The ultimate goal of therapy in chronic HCV infection should include an easily dosed all-oral regimen that is highly effective, inexpensive, pan-genotypic, safe and tolerable, with minimal to no resistance."( What is the future of ribavirin therapy for hepatitis C?
Koh, C; Liang, TJ, 2014
)
0.4
" Previous studies using higher, weight-based ribavirin dosing report that patients carrying polymorphisms encoding reduced predicted ITPase activity show decreased risk of ribavirin-induced anemia but increased risk of thrombocytopenia, with no impact on elimination of virus."( Variants of the inosine triphosphate pyrophosphatase gene are associated with reduced relapse risk following treatment for HCV genotype 2/3.
Buhl, MR; Christensen, PB; Färkkilä, M; Hellstrand, K; Lagging, M; Langeland, N; Lindh, M; Martner, A; Mørch, K; Nilsson, S; Norkrans, G; Nyström, K; Pedersen, C; Rembeck, K; Waldenström, J; Westin, J, 2014
)
0.4
" Therefore it permitted the start of anti-HCV therapy despite severe thrombocytopenia and also avoided any peg-interferon dosage modification or discontinuation."( Romiplostim for severe thrombocytopenia in the treatment of chronic hepatitis C virus infection: a new option for clinicians?
Buccoliero, G; Massa, P; Pisconti, S; Resta, F; Urbano, T, 2014
)
0.4
" With low dosage and few adverse reactions, it holds promise for clinical application."( [Efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease].
Cai, K; Chen, YH; Qian, JH; Wang, L; Yu, HJ; Zhang, HP; Zhang, QL, 2014
)
0.4
" Neither changes in immunosuppressant through levels nor dosage adjustments were necessary."( Antiviral activity and safety profile of silibinin in HCV patients with advanced fibrosis after liver transplantation: a randomized clinical trial.
Brambilla, N; Bringiotti, RS; Castellaneta, A; Castellaneta, NM; D'Amato, M; Di Leo, A; Giacovelli, G; Rendina, M; Rizzi, SF; Rovati, L; Zappimbulso, M, 2014
)
0.4
" Anemia and ribavirin dosage reduction were common."( Telaprevir in treatment of recurrent hepatitis C infection in liver transplant recipients.
Nair, S; Waters, B, 2014
)
0.4
" Patients in the control group (n = 66) received a combination of boceprevir and PR, dosed in accordance with boceprevir's US product circular."( The combination of MK-5172, peginterferon, and ribavirin is effective in treatment-naive patients with hepatitis C virus genotype 1 infection without cirrhosis.
Bacon, BR; Baruch, Y; Bruno, S; Caro, L; Cooreman, MP; Dutko, FJ; Fandozzi, C; Gilbert, CL; Gress, J; Howe, AY; Hwang, P; Manns, MP; Marcellin, P; Mobashery, N; Robertson, MN; Shaw, PM; Shibolet, O; Vierling, JM; Wahl, J, 2014
)
0.4
"001) and required a higher dosage [mean: 13,417 vs."( Peginterferon alfa-2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 2 receiving haemodialysis: a randomised trial.
Chen, DS; Chen, PJ; Chen, SI; Chuang, WL; Dai, CY; Huang, CF; Huang, JF; Hung, PH; Kao, JH; Lee, CY; Liang, CC; Lin, JW; Liu, CH; Liu, CJ; Su, TH; Tsai, HB; Tsai, MK; Yang, HC; Yang, SS; Yu, ML, 2015
)
0.42
" Moreover, the impact of ribavirin dosage on the response to treatment was studied."( Characteristics, treatment, and virologic responses of chronic hepatitis C patients treated with peginterferon alfa-2a and ribavirin in belgium: a sub-analysis of the PROPHESYS study.
Bourgeois, S; De Galocsy, C; Horsmans, Y; Lasser, L; Mulkay, JP; Tomasovic, S; Van Vlierberghe, H, 2014
)
0.4
" Barriers to adherence involved changes in daily routine, being preoccupied with family or work responsibilities, and sleeping through dosing times."( Adherence during antiviral treatment regimens for chronic hepatitis C: a qualitative study of patient-reported facilitators and barriers.
Bonner, JE; Evon, DM; Golin, CE; Grodensky, C; Velloza, J,
)
0.13
" Fixed dosage of Peg-IFN-α2a (135 μg/week) plus RBV (10 mg/kg per day) were given for 4 weeks to treatment group who passed the 4-week waiting time according to clinical safety assessment."( Section 13. Short-course pretransplant antiviral therapy is a feasible and effective strategy to prevent hepatitis C recurrence after liver transplantation in genotype 2 patients.
Chen, CL; Chiu, KW; Hu, TH; Kabiling, C; Lin, CC; Lin, YH; Liu, YW; Wang, CC, 2014
)
0.4
" Five asunaprevir-treated patients had grade 4 alanine aminotransferase elevations that resolved following discontinuation (n=4) or with continued dosing (n=1)."( Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C.
Bessone, F; Bronowicki, JP; Cohen, D; Eley, T; Gadano, A; He, B; Hernandez, D; Hughes, E; Martorell, CT; McPhee, F; Mendez, P; Pol, S; Ratziu, V; Terg, R; Thuluvath, PJ; Younes, Z; Yu, F, 2014
)
0.4
"This is the second of two manuscripts detailing the pharmacodynamic derivation of peginterferon lambda-1a (Lambda) dosing and treatment durations for Phase 3 studies in hepatitis C virus (HCV) infection, based on Phase 2 data."( Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 2: Exposure-response analyses for efficacy and safety variables.
Ahmad, A; Chan, P; Freeman, J; Hillson, J; Horga, MA; Hruska, M; Kansra, V; Lopez-Talavera, JC; Wang, X, 2015
)
0.42
" This is the first of two manuscripts detailing the pharmacodynamic derivation of Lambda dosing and treatment durations for Phase 3 studies in HCV, based on Phase 2 data."( Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 1: Modeling optimal treatment duration and sustained virologic response rates.
Ahmad, A; Chan, P; Freeman, J; Hillson, J; Horga, MA; Hruska, M; Kansra, V; Lopez-Talavera, JC; Wang, X, 2015
)
0.42
" However, impact of dosage changes on antiviral and adverse effects remains unclear."( The real impact of telaprevir dosage on the antiviral and side effects of telaprevir, pegylated interferon and ribavirin therapy for chronic hepatitis C patients with HCV genotype 1.
Harada, N; Hayashi, N; Hiramatsu, N; Imai, Y; Inada, M; Inui, Y; Ito, T; Kasahara, A; Kato, M; Mita, E; Miyagi, T; Morishita, N; Oshita, M; Oze, T; Takehara, T; Tamura, S; Tatsumi, T; Yakushijin, T; Yamada, R; Yoshida, Y; Yoshihara, H, 2015
)
0.42
" Daclatasvir 60 mg once daily and asunaprevir 600 mg twice daily were dosed for 7 days alone followed by combination dosing for 14 days at 30 mg once daily and 200 mg twice daily, respectively."( The pharmacokinetics of daclatasvir and asunaprevir administered in combination in studies in healthy subjects and patients infected with hepatitis C virus.
Bertz, R; Bifano, M; Eley, T; Gardiner, D; Grasela, DM; He, B; Huang, SP; Kandoussi, H; Sevinsky, H; Zhu, K, 2014
)
0.4
"Treatment with GS-9669, a novel nonnucleoside inhibitor (site II) of hepatitis C virus (HCV) nonstructural 5B (NS5B) polymerase, resulted in significant antiviral activity in HCV genotype (GT) 1 patients dosed at 50 and 500 mg once daily (QD) and at 50, 100, and 500 mg twice daily (BID) for 3 days."( Clinical and in vitro resistance to GS-9669, a thumb site II nonnucleoside inhibitor of the hepatitis C virus NS5B polymerase.
Delaney, W; Dvory-Sobol, H; Lawitz, EJ; Mabery, E; McHutchison, J; Miller, MD; Mo, H; Skurnac, T; Svarovskaia, ES; Voitenleitner, C, 2014
)
0.4
"83×10(-4)), a dosage effect of the T allele was observed, with the dominance term not significant for this SNP."( Homozygosity for HLA group 2 alleles predicts treatment failure with interferon-α and ribavirin in chronic hepatitis C virus genotype 1 infection.
Abu Shanab, A; Carr, MJ; Chin, JL; Collison, M; Connell, J; Coughlan, S; Hall, WW; Mac Nicholas, R; McCormick, PA; Merriman, RB; Segurado, R, 2015
)
0.42
"Population and selective clonal sequencing were performed at baseline and at virologic failure in the 4 MK-5172 dosing arms."( Virologic resistance analysis from a phase 2 study of MK-5172 combined with pegylated interferon/ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection.
Barnard, RJ; Black, S; Caro, L; Curry, S; DiNubile, MJ; Gilbert, C; Howe, AY; Hwang, PM; Liu, R; Ludmerer, SW; Mobashery, N; Newhard, W; Nickle, D, 2014
)
0.4
" Although more effective than the earlier standard of care, these regimens have complex dosing schedules, prolonged duration, and deleterious side effects."( Impact of specialty pharmacy on telaprevir-containing 3-drug hepatitis C regimen persistence.
Bridges, GG; Dorholt, M; Frazee, SG; Henderson, RR; Levin, RJ; Visaria, J, 2014
)
0.4
" Randomisation was by presence or absence of ribavirin, 8 or 12 weeks of treatment, and dosage of elbasvir."( Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Barr, E; Bourliere, M; DeJesus, E; Dutko, F; Gerstoft, J; Haber, B; Hezode, C; Howe, AY; Hwang, P; Kugelmas, M; Mallolas, J; Murillo, A; Nahass, R; Pol, S; Robertson, M; Serfaty, L; Shaughnessy, M; Shibolet, O; Sulkowski, M; Vierling, JM; Wahl, J; Weis, N; Zuckerman, E, 2015
)
0.42
"A total of 69 patients with chronic hepatitis C whose hemogloblin (HGB) level had decreased to 100 g/L were divided into two groups for receiving a reduced dosage of ribavirin when their HGB level fell to less than or equal to 100 g/L or for withdrawal of the ribavirin treatment when their HGB level fell to less than or equal to 80 g/L (restricted group), or for receiving a reduced dosage when the HGB level fell to less than or equal to 80 g/L or for withdrawal of the ribavirin treatment when the HGB level fell below less than or equal to 60 g/L (adjusted group)."( [Research of relationship between antiviral efficacy on chronic hepatitis C and the application time and dose of ribavirin].
Guo, L; Han, Y; Zhu, J, 2014
)
0.4
"When patients with chronic hepatitis C develop anemia during the course of anti-HCV ribavirin therapy with Peg-IFNat2a, adjustment of the ribavirin treatment duration and dosage can increase the likelihood of achieving and sustaining SVR and decrease the rate of relapse; these treatment adjustments are not associated with changes in severe adverse effects."( [Research of relationship between antiviral efficacy on chronic hepatitis C and the application time and dose of ribavirin].
Guo, L; Han, Y; Zhu, J, 2014
)
0.4
" Sixty-two patients were randomized into combination therapy with standard ribavirin dosing (group 1) or low and escalating ribavirin dosing (group 2)."( Randomized trial of peginterferon alpha-2b plus low and escalating dose of ribavirin in patients with chronic hepatitis C with high viral load genotype 1.
Araki, Y; Ikeda, F; Iwasaki, Y; Kobashi, H; Miyake, Y; Okamoto, R; Takaki, A; Taniguchi, H; Yamamoto, K, 2015
)
0.42
" This phase 2, randomized, open-label study evaluated an IFN- and RBV-free regimen of once-daily ombitasvir (ABT-267), an NS5A inhibitor, plus paritaprevir (ABT-450), an NS3/4A protease inhibitor dosed with ritonavir (paritaprevir/ritonavir), in pegylated IFN/RBV treatment-experienced Japanese patients with hepatitis C virus subtype 1b or genotype 2 infection."( Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients.
Badri, P; Chayama, K; Kumada, H; Kurosaki, M; Notsumata, K; Pilot-Matias, T; Rodrigues, L; Sato, K; Setze, C; Vilchez, RA, 2015
)
0.42
"We used concentration-guided RBV dosing to achieve an intended 10 μmol/L concentration with darbepoetin support in combination with peg-IFN alfa-2a, 180 μg for genotype 1 and 135 μg for genotype 2/3 to improve tolerance."( Peg-IFN and ribavirin treatment for recurrence of genotype 2 and 3 hepatitis C after liver transplantation.
Ackefors, M; Castedal, M; Dahlgard, O; Gjertsen, H; Verbaan, H; Weiland, O; Wernerson, A, 2015
)
0.42
"Concentration-guided RBV dosing with darbepoetin support substantially improves tolerance and offers high adherence to a full peg-IFN and RBV treatment course in patients with post-transplant HCV relapse."( Peg-IFN and ribavirin treatment for recurrence of genotype 2 and 3 hepatitis C after liver transplantation.
Ackefors, M; Castedal, M; Dahlgard, O; Gjertsen, H; Verbaan, H; Weiland, O; Wernerson, A, 2015
)
0.42
" Allelic discrimination was performed by real-time PCR; plasma concentrations were determined at the end of dosing interval (Ctrough) using an HPLC-UV method."( Role of pharmacogenetic in ribavirin outcome prediction and pharmacokinetics in an Italian cohort of HCV-1 and 4 patients.
Allegra, S; Boglione, L; Cariti, G; Cusato, J; D'Avolio, A; De Nicolò, A; Di Perri, G; Gatto, A, 2015
)
0.42
" The results show that increasing antiviral drug (ribavirin) intake was observed by SWCNTs carrier and therapeutic dosage to kill grass carp reovirus is significantly reduced."( Carbon nanotube-based nanocarrier loaded with ribavirin against grass carp reovirus.
Ling, F; Liu, GL; Wang, GX; Zhu, B, 2015
)
0.42
" Her ribavirin dosage was adjusted based on her changing renal function."( Severe Interferon/Ribavirin-Induced Hyperuricemia and Urate Nephropathy Requiring Rasburicase and Hemodialysis in a Liver Transplant Recipient.
Chewaproug, D; Knorr, JP; Neeli, S; Torres, E; Zaki, R, 2015
)
0.42
"The aim of the study was to investigate whether patients with a previous nonresponse to standard of care treatment with ribavirin dosed according to body weight would respond to a high individualized dose of concentration-monitored ribavirin."( High-Dose Ribavirin Enhances Early Virological Response in Hepatitis C Genotype 1-Infected Patients.
Carlsson, T; Hörnfeld, E; Lindahl, K; Parke, Å; Schvarcz, R; Ståhle, L; Weiland, O, 2015
)
0.42
" Ribavirin was dosed aiming at a plasma concentration of >15 μmol/L."( High-Dose Ribavirin Enhances Early Virological Response in Hepatitis C Genotype 1-Infected Patients.
Carlsson, T; Hörnfeld, E; Lindahl, K; Parke, Å; Schvarcz, R; Ståhle, L; Weiland, O, 2015
)
0.42
" We examined the efficacy and safety of an all-oral interferon-free regimen of ombitasvir, an NS5A inhibitor, and paritaprevir (ABT-450), an NS3/4A protease inhibitor dosed with ritonavir (ombitasvir plus paritaprevir plus ritonavir), given with or without ribavirin."( Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial.
Asselah, T; Berenguer, M; Fleischer-Stepniewska, K; Hall, C; Hassanein, T; Hézode, C; Marcellin, P; Mobashery, N; Pilot-Matias, T; Pol, S; Reddy, KR; Redman, R; Schnell, G; Vilchez, RA, 2015
)
0.42
" After the lead-in pe- riod boceprevir was added in the dosage of 800 mg three times a day orally."( Boceprevir in genotype 1 chronic hepatitis C: first experiences in Serbia.
Babić, JS; Bojović, K; Fabri, M; Janković, G; Jovanović, M; Kostić, V; Mijailović, Z; Svorcan, P,
)
0.13
" Dosage regimens were based on the EMA approved label for each treatment."( A cost utility analysis of simeprevir used with peginterferon + ribavirin in the management of genotype 1 hepatitis C virus infection, from the perspective of the UK National Health Service.
Belsey, J; Ladha, I; Mehnert, A; Pascoe, K; Treur, M; Westerhout, K, 2015
)
0.42
" A therapeutic range was identified for RBV-MP in persons with HCV GT1 disease receiving 24 weeks of sofosbuvir plus ribavirin, suggesting a potential pharmacological basis for individualized ribavirin dosing in IFN-free regimens."( Serum and cellular ribavirin pharmacokinetic and concentration-effect analysis in HCV patients receiving sofosbuvir plus ribavirin.
Bushman, LR; Jimmerson, LC; Kiser, JJ; Kottilil, S; McHutchison, JG; Meissner, EG; Osinusi, A; Petersen, T; Rower, JE; Sims, Z; Wolfe, P, 2015
)
0.42
" Importantly, adjustments to the immunosuppressant dosage were not required."( Daclatasvir, Simeprevir and Ribavirin as a Promising Interferon-Free Triple Regimen for HCV Recurrence after Liver Transplant.
Achterfeld, A; Canbay, A; Gerken, G; Herzer, K; Papadopoulos-Köhn, A; Paul, A; Timm, J; Walker, A, 2015
)
0.42
" Moreover, the utility of prodrug 8t was demonstrated through similar exposure of the parent compound when the prodrugs were dosed in vivo."( Design and synthesis of imidazole N-H substituted amide prodrugs as inhibitors of hepatitis C virus replication.
Cai, J; Chen, B; Chen, J; Ji, M; Li, W; Wang, P; Zhou, G; Zong, X, 2015
)
0.42
" Patients were carefully followed-up for anemia development which was classified as mild, moderate or severe in relation to levels of haemoglobin decreasing; ribavirin dosage reduction and/or epoietin administration were carried out, where needed."( Role of ITPA and IL28B variants in the management of chronic hepatitis C treatment.
Adinolfi, LE; Alessio, L; Boemio, A; Coppola, N; Grandone, A; Marrone, A; Minichini, C; Pisaturo, M; Sagnelli, E; Stanzione, M; Starace, M; Zampino, R, 2015
)
0.42
" According to percentage of expected dose, our patients were divided into two groups: the first group included 7 patients that performed an overall dosage of PEG-IFNα2b ≥ 75% of the scheduled full dose; the second group included 9 patients that performedm PEG-IFNα2b dose < 75% of scheduled full dose."( Treatment of chronic hepatitis C in children with pegylated interferon and ribavirin: the impact of dose.
Immacolata Spagnuolo, M; Iorio, R; Pia Cicalese, M; Terlizzi, V; Tufano, M,
)
0.13
"Plasma and intracellular telaprevir concentrations were determined at the end of dosing interval (Ctrough) using ULPC-MS/MS validated methods; allelic discrimination was performed through real-time PCR."( Intracellular and Plasma Trough Concentration and Pharmacogenetics of Telaprevir.
Allegra, S; Boglione, L; Cariti, G; Cusato, J; D'Avolio, A; De Nicolò, A; Di Perri, G; Fatiguso, G; Mohamed Abdi, A, 2015
)
0.42
" Variation in treatment duration and dosing of ribavirin were analyzed as indicators for individualization."( Benefit of Treatment Individualization in Patients with Chronic Hepatitis C Receiving Peginterferon Alfa-2a and Ribavirin in a Large Noninterventional Cohort Study.
Alshuth, U; Baumgarten, A; Böker, K; Hofmann, WP; Hüppe, D; Lutz, T; Manns, MP; Mauss, S; Moog, G; Pfeiffer-Vornkahl, H; Schober, A; Schott, E; Wedemeyer, H, 2015
)
0.42
" The identification of ITPA protective and SLC29A1 risk genotypes still appears to be a current methodology in RBV dosing during hepatitis C virus therapy with DAAs."( ITPA and SLC29A1 Genotyping for the Prediction of Ribavirin Dose Reduction in Anti-HCV Triple Therapy with Protease Inhibitors.
Cheli, S; Clementi, E; Falvella, FS; Landonio, S; Lombardi, A; Magni, C; Mazzali, C; Mondelli, MU; Rizzardini, G, 2015
)
0.42
" The following data in the treatment-naïve population were reserved to verify the model: (1) a T/PR regimen where T was dosed every 8 h for 8 weeks (T8(q8h)/PR) and (2) a T/PR regimen where T was dosed twice daily for 12 weeks (T12(b."( Modeling population heterogeneity in viral dynamics for chronic hepatitis C infection: Insights from Phase 3 telaprevir clinical studies.
Bartels, DJ; Garg, V; Haseltine, EL; Kieffer, TL; Kimko, H; Luo, H; Tolsma, J, 2015
)
0.42
" Our findings suggest that in interferon-free ribavirin-containing regimens, concerns over ribavirin dosing to achieve previously determined target plasma concentrations are unnecessary."( The impact of ribavirin plasma concentration on the efficacy of the interferon-sparing regimen, sofosbuvir and ribavirin.
Alavi, M; Day, R; Dore, GJ; Martinello, M; Matthews, GV; Schteinman, A; Williams, K, 2016
)
0.43
" Hits were evaluated in direct and orthogonal dose-response counterscreens using a standard recRSV reporter strain expressing Renilla luciferase."( Replication-Competent Influenza Virus and Respiratory Syncytial Virus Luciferase Reporter Strains Engineered for Co-Infections Identify Antiviral Compounds in Combination Screens.
Chung, HK; Lamb, K; Lin, MZ; Plemper, RK; Weisshaar, M; Yan, D, 2015
)
0.42
" Previously, we have shown that ribavirin when applied in clinically relevant dosage (10 μM) modulates activated microglia in complex fashion inducing both anti- and proinflammatory effects, simultaneously causing cytotoxicity."( Low-dose ribavirin treatments attenuate neuroinflammatory activation of BV-2 Cells by interfering with inducible nitric oxide synthase.
Bjelobaba, I; Bozic, I; Jovanovic, M; Laketa, D; Lavrnja, I; Nedeljkovic, N; Pekovic, S; Savic, D; Stojiljkovic, M, 2015
)
0.42
"The impact of ribavirin (RBV) dosage on sustained virologic response (SVR) rates remains elusive in hepatitis C virus genotype 2 (HCV-2) rapid responders receiving 16 weeks of peginterferon (Peg-IFN) plus RBV."( Peginterferon alfa-2a plus Weight-Based or Flat-Dose Ribavirin for Treatment-Naïve Hepatitis C Virus Genotype 2 Rapid Responders: A Randomized Trial.
Chen, DS; Chen, PJ; Chuang, WL; Dai, CY; Huang, CF; Huang, JF; Kao, JH; Liang, CC; Lin, CL; Lin, JW; Liu, CH; Liu, CJ; Su, TH; Yang, HC; Yang, SS; Yu, ML, 2015
)
0.42
"Antiviral treatment for patients with HCV infection and decompensated cirrhosis using interferon in a low accelerating dosage regimen in combination with ribavirin is feasible."( [Antiviral treatment and long-term clinical outcome of decompensated cirrhotic patients with hepatitis C virus infection].
Cai, Z; Dang, S; Deng, H; Guo, Y; Huang, N; Ji, F; Jia, X; Li, Z; Liu, L; Wang, Y; Xue, H; Zhang, S, 2015
)
0.42
" The open-label ALLY-1 study assessed the safety and efficacy of a 60-mg once-daily dosage of daclatasvir (pan-genotypic NS5A inhibitor) in combination with sofosbuvir at 400 mg once daily (NS5B inhibitor) and ribavirin at 600 mg/day for 12 weeks with a 24-week follow-up in two cohorts of patients with chronic HCV infection of any genotype and either compensated/decompensated cirrhosis or posttransplantation recurrence."( Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence.
Fontana, RJ; Hughes, EA; Landis, C; McPhee, F; Noviello, S; Poordad, F; Schiff, ER; Swenson, ES; Vierling, JM; Yang, R, 2016
)
0.43
" Orally administered SA-2 effectively protected mice infected with lethal doses of H1N1 or oseltamivir-resistant strain H1N1-H275Y, conferring 70% or 50% survival at a dosage of 100 mg/kg/d, reducing body weight loss, alleviating the influenza-induced acute lung injury, and reducing lung virus titer."( Antiviral activity of SA-2 against influenza A virus in vitro/vivo and its inhibition of RNA polymerase.
Dou, J; Jin, J; Li, M; Wang, D; Wang, H; Xu, J; Yu, J; Zhou, C, 2016
)
0.43
" The resulting model framework will aid the development of dosing strategies that minimize the incidence of anemia in treatment regimens that include ribavirin."( Modeling Ribavirin-Induced Anemia in Patients with Chronic Hepatitis C Virus.
D'Argenio, DZ; Jimmerson, LC; Kiser, JJ; MacBrayne, CE; Wu, LS, 2016
)
0.43
" We aimed to describe the pharmacokinetics, safety and efficacy of sofosbuvir in 2 dosing regimens and associated antiviral agents in HCV-infected patients requiring hemodialysis."( Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C.
Bernard Chabert, B; Descamps, D; Desnoyer, A; Fontaine, H; Gervais, A; Harent, S; Heurgué-Berlot, A; Hillaire, S; Laradi, A; Larrouy, L; Lê, MP; Muret, P; Peytavin, G; Pinto, A; Pospai, D; Salmon, D; Simonpoli, AM; Yazdanpanah, Y; Zucman, D, 2016
)
0.43
"Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed."( Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin.
Abrahamsson, B; Barazesh Morgani, A; Cristofoletti, R; Dressman, JB; Goodarzi, N; Groot, DW; Langguth, P; Mehta, MU; Polli, JE; Shah, VP, 2016
)
0.43
" RBV dosage affected SVR dose-dependently in patients with the IL28B non-TT genotype treated with SMV triple therapy."( Impact of ribavirin dosage in chronic hepatitis C patients treated with simeprevir, pegylated interferon plus ribavirin combination therapy.
Hagiwara, H; Hayashi, N; Hikita, H; Hiramatsu, N; Hosui, A; Imai, Y; Inada, M; Ito, T; Kaneko, A; Katayama, K; Mita, E; Morishita, N; Oshita, M; Oze, T; Sakamori, R; Tahata, Y; Takehara, T; Tamura, S; Tatsumi, T; Urabe, A; Yakushijin, T; Yamada, R; Yamada, Y; Yoshida, Y, 2016
)
0.43
"57-fold on repeated dosing compared with the first dose."( Dose- and Formulation-Dependent Non-Linear Pharmacokinetic Model of Paritaprevir, a Protease Inhibitor for the Treatment of Hepatitis C Virus Infection: Combined Analysis from 12 Phase I Studies.
Awni, WM; Beck, D; Dutta, S; Khatri, A; Liu, W; Menon, RM; Mensing, S; Polepally, AR, 2016
)
0.43
"The complex pharmacokinetics of paritaprevir were well described by the model, which can be used as a basis for clinical trial dosing and further evaluations in patients with HCV."( Dose- and Formulation-Dependent Non-Linear Pharmacokinetic Model of Paritaprevir, a Protease Inhibitor for the Treatment of Hepatitis C Virus Infection: Combined Analysis from 12 Phase I Studies.
Awni, WM; Beck, D; Dutta, S; Khatri, A; Liu, W; Menon, RM; Mensing, S; Polepally, AR, 2016
)
0.43
"Among 2,053 patients enrolled and dosed with study drug, 410 (20%) were receiving concomitant ARAs; of these, 308 (15%) were taking concomitant PPIs."( Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With or Without Ribavirin in HCV-Infected Patients Taking Concomitant Acid-Reducing Agents.
Asselah, T; Bennett, M; Forns, X; Liu, L; Moller, J; Pedrosa, M; Planas Vila, R; Reau, N; Rustgi, V; Shiffman, ML, 2016
)
0.43
"In this pilot study (RibaC), 58 hepatitis C virus (HCV) genotype 1 infected treatment-naïve patients were randomized to (i) 2 weeks ribavirin double dosing concomitant with pegylated interferon-α (pegIFN-α), (ii) 4 weeks ribavirin mono-therapy prior to adding pegIFN-α, or (iii) standard-of-care (SOC) ribavirin dosing concurrent with pegIFN-α."( Randomized Trial Evaluating the Impact of Ribavirin Mono-Therapy and Double Dosing on Viral Kinetics, Ribavirin Pharmacokinetics and Anemia in Hepatitis C Virus Genotype 1 Infection.
Christensen, P; Dalgard, O; Färkkilä, M; Krarup, H; Lagging, M; Lindahl, K; Nilsson, S; Norkrans, G; Norrgren, H; Nyström, K; Rauning Buhl, M; Stenmark, S; Waldenström, J; Westin, J, 2016
)
0.43
" Anticipated increases in plasma concentrations of tacrolimus and cyclosporin A occurred during telaprevir treatment and were successfully managed through immunosuppressant dose reduction and, for tacrolimus, reduced dosing frequency."( Efficacy of telaprevir-based therapy in stable liver transplant patients with chronic genotype 1 hepatitis C.
Agarwal, K; Berenguer, M; Colombo, M; Daems, B; Didier, S; Fagiuoli, S; Forns, X; Herzer, K; Janssen, K; Kimko, H; Lathouwers, E; Mutimer, D; Navasa, M; Nevens, F; Ouwerkerk-Mahadevan, S; Van Solingen-Ristea, R; Witek, J,
)
0.13
" No clinically relevant drug-drug interactions were noted, but 52% of patients required a change to the dosage of immunosuppressive drugs."( Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence - The ANRS CUPILT study.
Abergel, A; Anty, R; Besch, C; Botta-Fridlund, D; Canva, V; Coilly, A; Conti, F; D'Alteroche, L; Danjou, H; de Ledinghen, V; Debette-Gratien, M; Di Martino, V; Duclos-Vallée, JC; Dumortier, J; Duvoux, C; Fougerou-Leurent, C; Francoz, C; Habersetzer, F; Houssel-Debry, P; Kamar, N; Lebray, P; Leroy, V; Moreno, C; Pageaux, GP; Perre, P; Radenne, S; Rohel, A; Roque-Afonso, AM; Rossignol, E; Samuel, D; Silvain, C, 2016
)
0.43
"67) and ribavirin dosage (OR=0."( Predictors of early treatment discontinuation and severe anemia in a Brazilian cohort of hepatitis C patients treated with first-generation protease inhibitors.
Goncales, ES; Goncales, FL; Lazarini, MS; Mendes, LC; Miotto, N; Pedro, MN; Stucchi, RS; Vigani, AG; Zanaga, LP, 2016
)
0.43
"While data are scarce to draw conclusions applicable for modern DAA therapies, these results support ribavirin treatment based on serum levels instead of purely weight-based dosing in combination with pegylated interferon."( Influence of Ribavirin Serum Levels on Outcome of Antiviral Treatment and Anemia in Hepatitis C Virus Infection.
Geier, A; Kuhn, S; Kuntzen, D; Kuntzen, T; Müllhaupt, B; Seifert, B, 2016
)
0.43
" The patients (N=32) received 180 mcg pegylated interferon alfa-2a once a week plus oral ribavirin in dosage of 800 mg or 1000/1200 mg/day for 24 or 48-week treatment."( ANTIVIRAL TREATMENT OF HEPATITIS C IN SERBIAN PRISON SETTING: MEDICAL TREATMENT OUTCOMES AND PATIENTS' ADHERENCE.
Bojović, K; Delić, D; Katanić, N; Malinić, J; Mitrović, N; Simonović Babić, J,
)
0.13
"To describe international normalized ratio (INR) trends and warfarin dosage adjustments required for four veterans who were receiving warfarin therapy and started treatment for hepatitis C virus (HCV) with ledipasvir/sofosbuvir with or without ribavirin."( Influence of Successful Chronic Hepatitis C Virus Treatment with Ledipasvir/Sofosbuvir on Warfarin Dosing Requirements in Four Veterans.
Britnell, SR; Britt, RB; Vanderman, AJ; Willets, AE; Woodard, CL, 2016
)
0.43
"5 mg/kg per week of Peg-IFN plus RBV and placebo, while Group B received the same dosage of Peg-IFN plus RBV plus association of Silybin 94 mg + vitamin E 30 mg + phospholipids 194 mg in pills for 12 months."( Silybin supplementation during HCV therapy with pegylated interferon-α plus ribavirin reduces depression and anxiety and increases work ability.
Bertino, G; Caraci, F; Chisari, G; Drago, F; Greco, C; Malaguarnera, G; Malaguarnera, M; Motta, M; Nunnari, G; Vacante, M; Vecchio, M, 2016
)
0.43
" Target exposures were achieved for telaprevir with twice daily dosing and for ribavirin with reduced initial dosing."( Twice-Daily Telaprevir for Posttransplant Genotype 1 Hepatitis C Virus: A Prospective Safety, Efficacy, and Pharmacokinetics Study.
Brown, KA; Brown, RS; Fontana, RJ; Levitsky, J; Rubin, RA; Russo, MW; Vargas, H; Yoshida, EM, 2018
)
0.48
" Calcineurin inhibitor dosing levels were substantially reduced with telaprevir."( Twice-Daily Telaprevir for Posttransplant Genotype 1 Hepatitis C Virus: A Prospective Safety, Efficacy, and Pharmacokinetics Study.
Brown, KA; Brown, RS; Fontana, RJ; Levitsky, J; Rubin, RA; Russo, MW; Vargas, H; Yoshida, EM, 2018
)
0.48
" SOF 400 mg/day and R (median dosage 800 mg/day) were given for a median of 35 days before LT."( Prevention of hepatitis C recurrence by bridging sofosbuvir/ribavirin from pre- to post-liver transplant: a real-life strategy.
Berardi, S; Bhoori, S; Caraceni, P; Donato, MF; Iemmolo, RM; Invernizzi, F; Lenci, I; Martini, S; Mazzarelli, C; Montalbano, M; Morelli, C; Pieri, G; Romagnoli, R, 2017
)
0.46
" In the phase II/III clinical studies, ALT and bilirubin increases were reversible with continued dosing or after treatment cessation."( Exposure-Safety Response Relationship for Ombitasvir, Paritaprevir/Ritonavir, Dasabuvir, and Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: Analysis of Data from Five Phase II and Six Phase III Studies.
Awni, W; DaSilva-Tillmann, B; Dutta, S; Lin, CW; Liu, W; Menon, R; Podsadecki, T; Shulman, N, 2017
)
0.46
" Patients were randomly assigned (1:1) to receive 25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir once daily, with weight-based ribavirin dosed twice daily for either 12 weeks or 16 weeks."( Ombitasvir, paritaprevir, and ritonavir plus ribavirin in adults with hepatitis C virus genotype 4 infection and cirrhosis (AGATE-I): a multicentre, phase 3, randomised open-label trial.
Asselah, T; ElKhashab, M; Feld, JJ; Ferenci, P; Hassanein, T; Hézode, C; Mobashery, N; Moreno, C; Papatheodoridis, G; Pilot-Matias, T; Qaqish, RB; Redman, R; Yu, Y; Zeuzem, S, 2016
)
0.43
" We assessed the efficacy and safety of the two direct-acting antiviral drugs ombitasvir, an NS5A inhibitor, and paritaprevir, an NS3/4A protease inhibitor dosed with ritonavir, plus ribavirin in treatment of chronic HCV infection in Egypt."( Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial.
Allam, N; Asselah, T; Doss, W; Esmat, G; Hall, C; Hassany, M; Mobashery, N; Mohey, MA; Qaqish, RB; Redman, R; Shiha, G; Soliman, R; Waked, I; Yosry, A; Zayed, N, 2016
)
0.43
" The patient continued with this warfarin dosage until 18 weeks after completion of his HCV regimen."( Increased warfarin requirements in a patient with chronic hepatitis C infection receiving sofosbuvir and ribavirin.
Peterson, D; Van Ermen, A, 2017
)
0.46
"Our data shows that successful treatment of CHC patients with and without prior RG-101 dosing results in reduction of broad immune activation, and normalisation of miR-122 levels (EudraCT: 2014-002808-25)."( Immune responses in DAA treated chronic hepatitis C patients with and without prior RG-101 dosing.
Barnes, E; Brown, A; de Vree, JML; Klenerman, P; Kootstra, NA; Reesink, HW; Sinnige, MJ; Stelma, F; Swadling, L; van der Ree, MH; van der Valk, M; van Nuenen, AC; Willemse, SB, 2017
)
0.46
" Ribavirin dosing was weight based."( Phase I study of induction chemotherapy with afatinib, ribavirin, and weekly carboplatin and paclitaxel for stage IVA/IVB human papillomavirus-associated oropharyngeal squamous cell cancer.
Dunn, LA; Fury, MG; Haque, SS; Ho, AA; Katabi, N; Pfister, DG; Sherman, EJ, 2018
)
0.48
" RBV was dosed by physician discretion between 200 mg weekly and 200 mg daily."( High Efficacy of ombitasvir/paritaprevir/ritonavir plus dasabuvir in hepatitis C genotypes 4 and 1-infected patients with severe chronic kidney disease.
Afghani, AA; Alghamdi, AS; Alghamdi, MN; AlMousa, A; Alswat, K; AlZanbagi, A; Aseeri, M; Assiri, AM; Babatin, MA; Sanai, FM, 2018
)
0.48
" We describe the clinical management of ribavirin dosing in hepatitis C virus-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin."( Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin.
Bernstein, DE; Feld, JJ; Ferenci, P; Larsen, L; Tatsch, F; Vlierberghe, HV; Younes, Z, 2018
)
0.48
" These include the optimal dosing and duration of treatment, and the potential beneficial effects of therapeutic drug monitoring on the virological response and the incidence of side effects."( Dosing ribavirin in hepatitis E-infected solid organ transplant recipients.
De Winter, BCM; Hesselink, DA; Kamar, N, 2018
)
0.48
" On 23 August, Tac level was found undetectable; hence, dosage was increased."( Ribavirin-induced anaemia reduced tacrolimus level in a hepatitis C patient receiving haemodialysis.
Cheung, CYS; Cooper, SE; Liu, HY, 2018
)
0.48
" The hemopoietic toxicity, sometimes forced patients to reduce the dosage or to discontinue treatment in rare occasions."( Effect of black seed oil supplementation on selected immunological, hematological and Iron status parameters in ribavirin treated female albino rats.
Abd-Elmonem, HA, 2018
)
0.48
" With the development of moderate "early" (less than 12 weeks of antiviral therapy) and for the prevention of "late" (more than 12 weeks of treatment) neutropenia, appointment of immune medicine likopid (glucosaminylmuramyldipeptide) at a dosage of 1 mg, 2 times a day for 20 days, in patients with chronic hepatitis C (genotype 1b ) with ( [Cytopenias and their correction during antiviral therapy of chronic hepatitis C in patients with genotype 1].
Fazylov, VC; Guryanova, SV; Manapova, ER, 2017
)
0.46
" RBV was dosed by physician discretion between 600-1200 mg daily."( Real life efficacy of ledipasvir/sofosbuvir in hepatitis C genotype 4-infected patients with advanced liver fibrosis and decompensated cirrhosis.
Abdo, AA; Al-Hamoudi, WK; Alalwan, AM; Albenmousa, A; Albiladi, H; Alghamdi, AS; AlGhamdi, H; Aljawad, MS; Aljumah, AA; AlMousa, A; Almutairi, NH; Alothmani, HS; Alsahafi, A; AlSaleemi, MS; Alswat, K; Altraif, IH; AlZanbagi, A; Assiri, AM; Awny, A; Babatin, MA; Dahlan, Y; Mousa, WA; Sanai, FM, 2018
)
0.48
" The standardization of dosage method is necessary to carry out treatment with RBV more safely and effectively."( Maintaining Concentration of Ribavirin in Cerebrospinal Fluid by a New Dosage Method; 3 Cases of Subacute Sclerosing Panencephalitis Treated Using a Subcutaneous Continuous Infusion Pump.
Abe, Y; Hashimoto, K; Hosoya, M; Kanno, S; Kawasaki, Y; Maeda, H; Miyazaki, K; Sato, M; Suyama, K; Watanabe, M, 2019
)
0.51
"This study examined the pharmacokinetics of ribavirin in a lung transplant population for which current and alternative dosing regimens were assessed."( Population pharmacokinetics of ribavirin in lung transplant recipients and examination of current and alternative dosing regimens.
Alffenaar, JC; de Zwart, AES; Evans, AM; Glanville, AR; Marriott, DJE; Milliken, E; Reuter, SE; Riezebos-Brilman, A; Schteinman, A; Verschuuren, EAM, 2019
)
0.51
" Monte Carlo simulation was used to assess the ability of dosing regimens to achieve pre-specified target concentrations."( Population pharmacokinetics of ribavirin in lung transplant recipients and examination of current and alternative dosing regimens.
Alffenaar, JC; de Zwart, AES; Evans, AM; Glanville, AR; Marriott, DJE; Milliken, E; Reuter, SE; Riezebos-Brilman, A; Schteinman, A; Verschuuren, EAM, 2019
)
0.51
"5%, both at 12 and 24 weeks) whose average ribavirin dosage was 937."( Sofosbuvir plus ribavirin for the treatment of hepatitis C virus genotype 2 in Korea: What's the optimal dosage of ribavirin in real-world setting?
Cho, HA; Cho, JY; Cho, SB; Choi, SK; Jun, CH; Kim, MW; Lim, SW; Seo, JH; Yoon, JH, 2019
)
0.51
" Age ≥70 years, with liver cirrhosis, and female gender were associated with ribavirin dosage reduction."( Sofosbuvir plus ribavirin for the treatment of hepatitis C virus genotype 2 in Korea: What's the optimal dosage of ribavirin in real-world setting?
Cho, HA; Cho, JY; Cho, SB; Choi, SK; Jun, CH; Kim, MW; Lim, SW; Seo, JH; Yoon, JH, 2019
)
0.51
" Treatment was a combination of sofosbuvir 400 mg/day + daclatasvir 60 mg/day, with or without a weight-adjusted dosing of ribavirin for 12 or 24 weeks."( Effectiveness and safety of daclatasvir/sofosbuvir with or without ribavirin in genotype 3 hepatitis C virus infected patients. Results in real clinical practice.
Castro-Iglesias, A; Cid-Silva, P; Delgado-Blanco, M; Margusino-Framiñán, L; Martín-Herranz, I; Mena-de-Cea, A; Pernas-Souto, B; Pertega-Díaz, S; Rodríguez-Osorio, I, 2019
)
0.51
" For all patients, ribavirin dosing was determined by baseline weight (up to 1,400 mg/day, two divided doses)."( Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection.
Balistreri, WF; Bansal, S; Brainard, DM; Davison, S; Feiterna-Sperling, C; Gillis, LA; Gonzalez-Peralta, RP; Hsueh, CH; Indolfi, G; Jonas, MM; Kelly, DA; Lin, CH; Massetto, B; Murray, KF; Nightingale, S; Parhy, B; Rosenthal, P; Schwarz, KB; Shao, J; Sokal, EM; Wirth, S, 2020
)
0.56
" Patients from 46 centers were dosed for 12 or 24 weeks with or without ribavirin, in line with existing guidelines."( SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial.
Merat, S, 2020
)
0.56
" We evaluated overall adherence (proportion of prescribed doses taken) and nonadherence (<90% adherent) between dosing patterns."( Adherence to Once-daily and Twice-daily Direct-acting Antiviral Therapy for Hepatitis C Infection Among People With Recent Injection Drug Use or Current Opioid Agonist Therapy.
Amin, J; Bruggmann, P; Bruneau, J; Conway, B; Cooper, C; Cunningham, EB; Dalgard, O; Dillon, JF; Dore, GJ; Feld, JJ; Fraser, C; Gane, E; Grebely, J; Hajarizadeh, B; Hellard, M; Lacombe, K; Litwin, AH; Marks, P; Matthews, GV; Powis, J; Read, P; Shaw, D, 2020
)
0.56
" Median effective dose was interpolated from the triplicated experiments and the dose-response curves were generated for each drug-virus combination."( A preclinical assessment to repurpose drugs to target type 1 diabetes-associated type B coxsackieviruses.
Honkimaa, A; Hyöty, H; Sioofy-Khojine, AB, 2020
)
0.56
" Data were analyzed with respect to age, gender, ethnicity, previous ADRs, family history of ADRs, dosage specification, medication frequency specification, body weight, route of administration, herb-drug interactions (ribavirin, cefatriaxone, penicillin sodium, ambroxol hydrochloride, clindamycin, cefoxitin sodium, azithromycin, ceftazidime, amoxicillin sodium and clavulanate potassium, levofloxacin, cefazolin sodium pentahydrate, acyclovir) by univariate analysis and multivariate analysis."( Risk factors associated with the severity of adverse drug reactions by Xiyanping injection: A propensity score-matched analysis.
Chen, S; Kwong, JSW; Li, C; Shang, H; Sun, Y; Tao, L; Zhang, X; Zheng, R; Zhong, C, 2020
)
0.56
"4%) received DCV at a dosage of 60 mg, 52 (16."( Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts.
Bonora, S; Cingolani, A; d'Arminio Monforte, A; Lo Caputo, S; Marinaro, L; Mussini, C; Puoti, M; Rossotti, R; Saracino, A; Soria, A; Tavelli, A; Uberti-Foppa, C, 2020
)
0.56
"DCV use resulted in high SVR rate regardless of dosage and correctness of prescription."( Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts.
Bonora, S; Cingolani, A; d'Arminio Monforte, A; Lo Caputo, S; Marinaro, L; Mussini, C; Puoti, M; Rossotti, R; Saracino, A; Soria, A; Tavelli, A; Uberti-Foppa, C, 2020
)
0.56
" Ribavirin-PRINT-CFI was well tolerated in healthy participants after single dosing and ribavirin-PRINT-IP was well tolerated in healthy and COPD participants after single and repeat dosing."( A Novel Inhaled Dry-Powder Formulation of Ribavirin Allows for Efficient Lung Delivery in Healthy Participants and Those with Chronic Obstructive Pulmonary Disease in a Phase 1 Study.
Baker, SJ; Billiard, J; Chandrasekaran, V; Dennison, J; Dumont, EF; Georgiou, A; Gillies, A; Harrell, AW; Hopchet, N; Ioannou, C; Lahiry, A; Oliver, AJ; Starbuck, DC; van den Berg, F; Yang, S; Young, GC, 2020
)
0.56
" The apparent COVID-19 pandemic provides an opportunity to follow dosage guidelines for treatment with ribavirin, test new therapeutic concepts, and conduct controlled testing to apply the scientific rigor required to address the controversy around this mainstay of antiviral therapy."( Novel coronavirus treatment with ribavirin: Groundwork for an evaluation concerning COVID-19.
Khalili, JS; Mak, NSA; Yan, Y; Zhu, H; Zhu, Y, 2020
)
0.56
" We developed a long-acting DAA system (LA-DAAS) capable of prolonged dosing and explored its cost-effectiveness."( Development of a long-acting direct-acting antiviral system for hepatitis C virus treatment in swine.
Chu, JN; Collins, J; Eweje, F; Faiz, MT; Gwynne, D; Hayward, A; Hess, K; Hua, T; Ishida, K; Katz, S; Koeppen, R; Langer, R; Lopes, A; McManus, R; Miller, JB; Salama, JAF; Slocum, AH; Soares, V; Steiger, C; Sulkowski, MS; Tamang, SM; Thomas, DL; Traverso, G; Verma, M, 2020
)
0.56
" However, practical approaches to the use of this antiviral treatment in a post-transplant patient, including drug interactions, dosing adjustments, and monitoring parameters, are lacking."( Practical considerations when treating chronic hepatitis E in solid organ transplant recipients.
Chacra, W; Chan, C; Choi, DK; Koppe, S; Landers, L; Martin, MT; Mikolajczyk, AE; Naveed, A, 2021
)
0.62
" This review summarizes the current data for the most commonly used drugs for coronavirus disease 2019 and will cover the unique factors that may affect the dosing of these medications in patients with CKD."( Treatment Options for Coronavirus Disease 2019 in Patients With Reduced or Absent Kidney Function.
Govil, A; Luckett, K; Miller-Handley, H, 2020
)
0.56
" This retrospective study compared two dosage forms of interferon; conventional interferon (IR) and Pegylated interferon (PIR) in 370 Hepatitis C patients selected through non probability convenient sampling technique."( Comparative safety and efficacy of conventional interferon versus pegylated-interferon based therapy for HCV: A retrospective cohort study from Gujranwala, Pakistan.
Ahmed, M; Bashir, A; Farooq, MS; Iftikhar, U; Kamran, SH; Saeed, H; Saleem, N; Saleem, Z, 2020
)
0.56
" In the 194 subjects treated with sofosbuvir/ribavirin, median initial ribavirin dosage was 13."( Sofosbuvir-based therapies in genotype 2 hepatitis C virus cirrhosis: A real-life experience with focus on ribavirin dose.
Bellan, M; Crobu, MG; D'Avolio, A; Gualerzi, A; Pirisi, M; Smirne, C, 2021
)
0.62
"The current use of ribavirin in difficult-to-cure chronic hepatitis C patients (HCV) and patients with severe respiratory infections is constrained by the issue of ribavirin-induced hemolytic anemia that affects 30% of treated patients, requiring dosage modification or discontinuation."( Novel variant in glycophorin c gene protects against ribavirin-induced anemia during chronic hepatitis C treatment.
Al-Judaibi, B; Carleton, BC; Drögemöller, BI; Ford, JA; Kim, RB; Lee, SS; Lin, JJ; Loucks, CM; Ramji, A; Ross, CJ; Schwarz, UI; Tam, E; Trueman, JN; Wright, GEB; Yoshida, EM, 2021
)
0.62
"The clinical guidelines suggest that the dosing of cyclosporine (CsA), during combination therapy with paritaprevir/ritonavir-ombitasvir and dasabuvir (PrOD), would be only one-fifth of the pre-PrOD total daily dose to be administered once daily."( Drug-Drug Interactions With Cyclosporine in the Anti-Hepatitis C Viral PrOD Combination Regimen of Paritaprevir/Ritonavir-Ombitasvir and Dasabuvir in Organ Transplant Recipients With Severe Hepatic Fibrosis or Cirrhosis.
Chang, YL; Chou, YC; Hsu, CC; Huang, YH; Huang, YY; Loong, CC; Wu, TH, 2022
)
0.72
" The authors proposed reducing the CsA dosage during PrOD treatment to one-seventh of that of the pre-PrOD treatment of the total daily dose to maintain target CsA levels."( Drug-Drug Interactions With Cyclosporine in the Anti-Hepatitis C Viral PrOD Combination Regimen of Paritaprevir/Ritonavir-Ombitasvir and Dasabuvir in Organ Transplant Recipients With Severe Hepatic Fibrosis or Cirrhosis.
Chang, YL; Chou, YC; Hsu, CC; Huang, YH; Huang, YY; Loong, CC; Wu, TH, 2022
)
0.72
" Recent studies showed sofosbuvir (SOF) can inhibit HEV replication in vitro and has add-on effect when combined with RBV, but the clinical effect of SOF against HEV infection remains controversial and the dosage of SOF warrants further exploration."( High dose sofosbuvir and sofosbuvir-plus-ribavirin therapy inhibit Hepatitis E Virus (HEV) replication in a rabbit model for acute HEV infection.
Dai, L; He, Q; Liang, Z; Lu, F; Shu, J; Wang, L; Zhang, F, 2022
)
0.72
" We report a case of a 48-year-old female patient diagnosed with CVID enteropathy possibly related to norovirus infection who failed a ribavirin-based therapy despite dosage optimization through drug plasma level monitoring."( Ribavirin-resistant chronic norovirus infection-associated enteropathy in common variable immunodeficiency. Case report and review of the literature.
Calderón-Hernanz, B; de Hita-Santabaya, AI; González-Morcillo, G; Riera-Oliver, J; Serrano-López de Las Hazas, J, 2022
)
0.72
"  Methods: In this randomized, open label, controlled pilot trial, we evaluated RBV (n=4) dosed for the initial 24 weeks of treatment versus no RBV (n=4) in tenofovir recipients dosed over 48 weeks."( Ribavirin Does Not Enhance Hepatitis B Virus Nucleotide Antiviral Activity: A Pilot Study.
Coffin, C; Cooper, C; Crawley, A; Fung, S; Keeshan, A; Ma, M; Mortimer, L; Osiowy, C; Patel, N; Vachon, A, 2022
)
0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (5)

RoleDescription
antimetaboliteA substance which is structurally similar to a metabolite but which competes with it or replaces it, and so prevents or reduces its normal utilization.
antiviral agentA substance that destroys or inhibits replication of viruses.
antiinfective agentA substance used in the prophylaxis or therapy of infectious diseases.
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitorA DNA polymerase inhibitor that interferes with the activity of reverse transcriptase, EC 2.7.7.49, a viral DNA polymerase enzyme that retroviruses need in order to reproduce.
anticoronaviral agentAny antiviral agent which inhibits the activity of coronaviruses.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (4)

ClassDescription
1-ribosyltriazoleA 1-glycosyltriazole in which the glycosyl residue is specified as ribosyl.
aromatic amideAn amide in which the amide linkage is bonded directly to an aromatic system.
monocarboxylic acid amideA carboxamide derived from a monocarboxylic acid.
primary carboxamideA carboxamide resulting from the formal condensation of a carboxylic acid with ammonia; formula RC(=O)NH2.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (2)

PathwayProteinsCompounds
The impact of Nsp14 on metabolism (COVID-19 Disease Map)084
Nsp9 interactions (COVID-19 Disease Map)8330

Protein Targets (83)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
interleukin 8Homo sapiens (human)Potency66.82420.047349.480674.9780AID651758
RAR-related orphan receptor gammaMus musculus (house mouse)Potency4.88310.006038.004119,952.5996AID1159521; AID1159523
TDP1 proteinHomo sapiens (human)Potency1.20170.000811.382244.6684AID686978; AID686979
ThrombopoietinHomo sapiens (human)Potency12.58930.02517.304831.6228AID917; AID918
AR proteinHomo sapiens (human)Potency10.08470.000221.22318,912.5098AID1259243; AID1259381
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency25.11890.011212.4002100.0000AID1030
thyroid stimulating hormone receptorHomo sapiens (human)Potency15.84890.001318.074339.8107AID926; AID938
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency7.58460.001022.650876.6163AID1224838; AID1224893
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency7.76190.01237.983543.2770AID1645841
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency51.14780.003041.611522,387.1992AID1159552; AID1159555
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency1.97400.001530.607315,848.9004AID1224819; AID1224820; AID1224821; AID1224823; AID1224841; AID1224842; AID1224848; AID1224849; AID1259401; AID1259403
farnesoid X nuclear receptorHomo sapiens (human)Potency28.74860.375827.485161.6524AID588526; AID743217
pregnane X nuclear receptorHomo sapiens (human)Potency9.10240.005428.02631,258.9301AID1346982
estrogen nuclear receptor alphaHomo sapiens (human)Potency24.07010.000229.305416,493.5996AID1259244; AID743069; AID743075; AID743078
peroxisome proliferator activated receptor gammaHomo sapiens (human)Potency50.11870.001019.414170.9645AID588537
arylsulfatase AHomo sapiens (human)Potency16.94411.069113.955137.9330AID720538
alpha-galactosidaseHomo sapiens (human)Potency50.11874.466818.391635.4813AID2107
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency3.88740.001723.839378.1014AID743083
Histone H2A.xCricetulus griseus (Chinese hamster)Potency34.16060.039147.5451146.8240AID1224845; AID1224896
peripheral myelin protein 22 isoform 1Homo sapiens (human)Potency23.934123.934123.934123.9341AID1967
chromobox protein homolog 1Homo sapiens (human)Potency89.12510.006026.168889.1251AID540317
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency10.32250.00419.984825.9290AID504444
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency20.27350.000323.4451159.6830AID743065; AID743067
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency30.48990.000627.21521,122.0200AID743219
urokinase-type plasminogen activator precursorMus musculus (house mouse)Potency7.07950.15855.287912.5893AID540303
plasminogen precursorMus musculus (house mouse)Potency7.07950.15855.287912.5893AID540303
urokinase plasminogen activator surface receptor precursorMus musculus (house mouse)Potency7.07950.15855.287912.5893AID540303
gemininHomo sapiens (human)Potency0.18360.004611.374133.4983AID624297
survival motor neuron protein isoform dHomo sapiens (human)Potency21.16990.125912.234435.4813AID1458
cytochrome P450 3A4 isoform 1Homo sapiens (human)Potency0.79430.031610.279239.8107AID884; AID885
muscarinic acetylcholine receptor M1Rattus norvegicus (Norway rat)Potency0.05010.00106.000935.4813AID943
lamin isoform A-delta10Homo sapiens (human)Potency0.00400.891312.067628.1838AID1487
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Voltage-dependent calcium channel gamma-2 subunitMus musculus (house mouse)Potency26.60320.001557.789015,848.9004AID1259244
Rap guanine nucleotide exchange factor 3Homo sapiens (human)Potency89.12516.309660.2008112.2020AID720707
Cellular tumor antigen p53Homo sapiens (human)Potency37.43380.002319.595674.0614AID651631; AID651743; AID720552
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Glutamate receptor 2Rattus norvegicus (Norway rat)Potency26.60320.001551.739315,848.9004AID1259244
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Nuclear receptor ROR-gammaHomo sapiens (human)Potency18.83360.026622.448266.8242AID651802
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
GABA theta subunitRattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
Ataxin-2Homo sapiens (human)Potency31.62280.011912.222168.7989AID588378
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)Potency0.79431.000012.224831.6228AID885
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Voltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)IC50 (µMol)622.50000.00032.63119.0000AID1207766
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
Adenosine receptor A3Homo sapiens (human)Ki7.41000.00000.930610.0000AID1802102
Adenosine receptor A2aHomo sapiens (human)Ki7.41000.00001.06099.7920AID1802102
Adenosine receptor A1Homo sapiens (human)Ki7.41000.00020.931610.0000AID1571891; AID1802102
Voltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)IC50 (µMol)622.50000.00032.59559.0000AID1207766
Voltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)IC50 (µMol)622.50000.00032.63119.0000AID1207766
Voltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)IC50 (µMol)622.50000.00032.25459.6000AID1207766
Adenosine receptor A1Mus musculus (house mouse)Ki4.43000.00010.42424.4300AID1571893
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
NS5 Zika virusEC50 (µMol)20.80000.00870.54751.3000AID1558305
Spike glycoproteinBetacoronavirus England 1EC50 (µMol)109.50000.00304.57559.8200AID1804127
Replicase polyprotein 1abBetacoronavirus England 1EC50 (µMol)109.50000.00304.57559.8200AID1804127
glycogen synthase kinase-3 beta isoform 1Homo sapiens (human)EC50 (µMol)300.00000.212522.156283.9400AID434954
Transmembrane protease serine 2Homo sapiens (human)EC50 (µMol)109.50000.00304.51689.8200AID1804127
Polymerase basic protein 2Influenza A virus (A/Puerto Rico/8/1934(H1N1))EC50 (µMol)20.00000.00060.00060.0006AID1729931; AID1778629
Polymerase acidic proteinInfluenza A virus (A/Puerto Rico/8/1934(H1N1))EC50 (µMol)21.26673.22003.22003.2200AID1408128; AID1729931; AID1778629
Procathepsin LHomo sapiens (human)EC50 (µMol)109.50000.00304.48749.8200AID1804127
Replicase polyprotein 1aSevere acute respiratory syndrome-related coronavirusEC50 (µMol)109.50000.00304.61369.8200AID1804127
Replicase polyprotein 1abHuman coronavirus 229EEC50 (µMol)109.50000.00304.61369.8200AID1804127
Replicase polyprotein 1abSevere acute respiratory syndrome-related coronavirusEC50 (µMol)109.50000.00304.45549.8200AID1804127
Replicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2EC50 (µMol)109.50000.00304.11059.8200AID1804127
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusEC50 (µMol)109.50000.00304.57559.8200AID1804127
Angiotensin-converting enzyme 2 Homo sapiens (human)EC50 (µMol)109.50000.00304.57559.8200AID1804127
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (377)

Processvia Protein(s)Taxonomy
viral translationTransmembrane protease serine 2Homo sapiens (human)
proteolysisTransmembrane protease serine 2Homo sapiens (human)
protein autoprocessingTransmembrane protease serine 2Homo sapiens (human)
positive regulation of viral entry into host cellTransmembrane protease serine 2Homo sapiens (human)
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
visual perceptionVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
detection of light stimulus involved in visual perceptionVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
calcium ion import across plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
angiogenesisRap guanine nucleotide exchange factor 3Homo sapiens (human)
adaptive immune responseRap guanine nucleotide exchange factor 3Homo sapiens (human)
signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayRap guanine nucleotide exchange factor 3Homo sapiens (human)
associative learningRap guanine nucleotide exchange factor 3Homo sapiens (human)
Rap protein signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of actin cytoskeleton organizationRap guanine nucleotide exchange factor 3Homo sapiens (human)
negative regulation of syncytium formation by plasma membrane fusionRap guanine nucleotide exchange factor 3Homo sapiens (human)
intracellular signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of GTPase activityRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of angiogenesisRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of angiogenesisRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of protein export from nucleusRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of stress fiber assemblyRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of syncytium formation by plasma membrane fusionRap guanine nucleotide exchange factor 3Homo sapiens (human)
establishment of endothelial barrierRap guanine nucleotide exchange factor 3Homo sapiens (human)
cellular response to cAMPRap guanine nucleotide exchange factor 3Homo sapiens (human)
Ras protein signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of insulin secretionRap guanine nucleotide exchange factor 3Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
adaptive immune responseProcathepsin LHomo sapiens (human)
proteolysisProcathepsin LHomo sapiens (human)
protein autoprocessingProcathepsin LHomo sapiens (human)
fusion of virus membrane with host plasma membraneProcathepsin LHomo sapiens (human)
receptor-mediated endocytosis of virus by host cellProcathepsin LHomo sapiens (human)
antigen processing and presentationProcathepsin LHomo sapiens (human)
antigen processing and presentation of exogenous peptide antigen via MHC class IIProcathepsin LHomo sapiens (human)
collagen catabolic processProcathepsin LHomo sapiens (human)
zymogen activationProcathepsin LHomo sapiens (human)
enkephalin processingProcathepsin LHomo sapiens (human)
fusion of virus membrane with host endosome membraneProcathepsin LHomo sapiens (human)
CD4-positive, alpha-beta T cell lineage commitmentProcathepsin LHomo sapiens (human)
symbiont entry into host cellProcathepsin LHomo sapiens (human)
antigen processing and presentation of peptide antigenProcathepsin LHomo sapiens (human)
proteolysis involved in protein catabolic processProcathepsin LHomo sapiens (human)
elastin catabolic processProcathepsin LHomo sapiens (human)
macrophage apoptotic processProcathepsin LHomo sapiens (human)
cellular response to thyroid hormone stimulusProcathepsin LHomo sapiens (human)
positive regulation of apoptotic signaling pathwayProcathepsin LHomo sapiens (human)
positive regulation of peptidase activityProcathepsin LHomo sapiens (human)
immune responseProcathepsin LHomo sapiens (human)
symbiont-mediated perturbation of host ubiquitin-like protein modificationReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
symbiont-mediated perturbation of host ubiquitin-like protein modificationReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
inflammatory responseAdenosine receptor A3Homo sapiens (human)
signal transductionAdenosine receptor A3Homo sapiens (human)
activation of adenylate cyclase activityAdenosine receptor A3Homo sapiens (human)
regulation of heart contractionAdenosine receptor A3Homo sapiens (human)
negative regulation of cell population proliferationAdenosine receptor A3Homo sapiens (human)
response to woundingAdenosine receptor A3Homo sapiens (human)
regulation of norepinephrine secretionAdenosine receptor A3Homo sapiens (human)
negative regulation of cell migrationAdenosine receptor A3Homo sapiens (human)
negative regulation of NF-kappaB transcription factor activityAdenosine receptor A3Homo sapiens (human)
presynaptic modulation of chemical synaptic transmissionAdenosine receptor A3Homo sapiens (human)
G protein-coupled adenosine receptor signaling pathwayAdenosine receptor A3Homo sapiens (human)
one-carbon metabolic processAdenosylhomocysteinaseHomo sapiens (human)
S-adenosylmethionine cycleAdenosylhomocysteinaseHomo sapiens (human)
synaptic transmission, dopaminergicAdenosine receptor A2aHomo sapiens (human)
response to amphetamineAdenosine receptor A2aHomo sapiens (human)
regulation of DNA-templated transcriptionAdenosine receptor A2aHomo sapiens (human)
phagocytosisAdenosine receptor A2aHomo sapiens (human)
apoptotic processAdenosine receptor A2aHomo sapiens (human)
inflammatory responseAdenosine receptor A2aHomo sapiens (human)
cellular defense responseAdenosine receptor A2aHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayAdenosine receptor A2aHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayAdenosine receptor A2aHomo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathwayAdenosine receptor A2aHomo sapiens (human)
cell-cell signalingAdenosine receptor A2aHomo sapiens (human)
synaptic transmission, cholinergicAdenosine receptor A2aHomo sapiens (human)
central nervous system developmentAdenosine receptor A2aHomo sapiens (human)
blood coagulationAdenosine receptor A2aHomo sapiens (human)
sensory perceptionAdenosine receptor A2aHomo sapiens (human)
locomotory behaviorAdenosine receptor A2aHomo sapiens (human)
blood circulationAdenosine receptor A2aHomo sapiens (human)
negative regulation of cell population proliferationAdenosine receptor A2aHomo sapiens (human)
response to xenobiotic stimulusAdenosine receptor A2aHomo sapiens (human)
response to inorganic substanceAdenosine receptor A2aHomo sapiens (human)
positive regulation of glutamate secretionAdenosine receptor A2aHomo sapiens (human)
positive regulation of acetylcholine secretion, neurotransmissionAdenosine receptor A2aHomo sapiens (human)
regulation of norepinephrine secretionAdenosine receptor A2aHomo sapiens (human)
response to purine-containing compoundAdenosine receptor A2aHomo sapiens (human)
response to caffeineAdenosine receptor A2aHomo sapiens (human)
positive regulation of synaptic transmission, GABAergicAdenosine receptor A2aHomo sapiens (human)
synaptic transmission, glutamatergicAdenosine receptor A2aHomo sapiens (human)
positive regulation of urine volumeAdenosine receptor A2aHomo sapiens (human)
vasodilationAdenosine receptor A2aHomo sapiens (human)
eating behaviorAdenosine receptor A2aHomo sapiens (human)
negative regulation of vascular permeabilityAdenosine receptor A2aHomo sapiens (human)
negative regulation of neuron apoptotic processAdenosine receptor A2aHomo sapiens (human)
positive regulation of circadian sleep/wake cycle, sleepAdenosine receptor A2aHomo sapiens (human)
negative regulation of alpha-beta T cell activationAdenosine receptor A2aHomo sapiens (human)
astrocyte activationAdenosine receptor A2aHomo sapiens (human)
neuron projection morphogenesisAdenosine receptor A2aHomo sapiens (human)
positive regulation of protein secretionAdenosine receptor A2aHomo sapiens (human)
negative regulation of inflammatory responseAdenosine receptor A2aHomo sapiens (human)
regulation of mitochondrial membrane potentialAdenosine receptor A2aHomo sapiens (human)
membrane depolarizationAdenosine receptor A2aHomo sapiens (human)
regulation of calcium ion transportAdenosine receptor A2aHomo sapiens (human)
positive regulation of synaptic transmission, glutamatergicAdenosine receptor A2aHomo sapiens (human)
excitatory postsynaptic potentialAdenosine receptor A2aHomo sapiens (human)
inhibitory postsynaptic potentialAdenosine receptor A2aHomo sapiens (human)
prepulse inhibitionAdenosine receptor A2aHomo sapiens (human)
apoptotic signaling pathwayAdenosine receptor A2aHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionAdenosine receptor A2aHomo sapiens (human)
positive regulation of long-term synaptic potentiationAdenosine receptor A2aHomo sapiens (human)
positive regulation of apoptotic signaling pathwayAdenosine receptor A2aHomo sapiens (human)
G protein-coupled adenosine receptor signaling pathwayAdenosine receptor A2aHomo sapiens (human)
temperature homeostasisAdenosine receptor A1Homo sapiens (human)
response to hypoxiaAdenosine receptor A1Homo sapiens (human)
G protein-coupled adenosine receptor signaling pathwayAdenosine receptor A1Homo sapiens (human)
regulation of respiratory gaseous exchange by nervous system processAdenosine receptor A1Homo sapiens (human)
negative regulation of acute inflammatory responseAdenosine receptor A1Homo sapiens (human)
negative regulation of leukocyte migrationAdenosine receptor A1Homo sapiens (human)
positive regulation of peptide secretionAdenosine receptor A1Homo sapiens (human)
positive regulation of systemic arterial blood pressureAdenosine receptor A1Homo sapiens (human)
negative regulation of systemic arterial blood pressureAdenosine receptor A1Homo sapiens (human)
regulation of glomerular filtrationAdenosine receptor A1Homo sapiens (human)
protein targeting to membraneAdenosine receptor A1Homo sapiens (human)
phagocytosisAdenosine receptor A1Homo sapiens (human)
inflammatory responseAdenosine receptor A1Homo sapiens (human)
signal transductionAdenosine receptor A1Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayAdenosine receptor A1Homo sapiens (human)
cell-cell signalingAdenosine receptor A1Homo sapiens (human)
nervous system developmentAdenosine receptor A1Homo sapiens (human)
negative regulation of cell population proliferationAdenosine receptor A1Homo sapiens (human)
response to inorganic substanceAdenosine receptor A1Homo sapiens (human)
negative regulation of glutamate secretionAdenosine receptor A1Homo sapiens (human)
response to purine-containing compoundAdenosine receptor A1Homo sapiens (human)
lipid catabolic processAdenosine receptor A1Homo sapiens (human)
negative regulation of synaptic transmission, GABAergicAdenosine receptor A1Homo sapiens (human)
positive regulation of nucleoside transportAdenosine receptor A1Homo sapiens (human)
negative regulation of neurotrophin productionAdenosine receptor A1Homo sapiens (human)
positive regulation of protein dephosphorylationAdenosine receptor A1Homo sapiens (human)
vasodilationAdenosine receptor A1Homo sapiens (human)
negative regulation of circadian sleep/wake cycle, non-REM sleepAdenosine receptor A1Homo sapiens (human)
negative regulation of apoptotic processAdenosine receptor A1Homo sapiens (human)
positive regulation of potassium ion transportAdenosine receptor A1Homo sapiens (human)
positive regulation of MAPK cascadeAdenosine receptor A1Homo sapiens (human)
negative regulation of hormone secretionAdenosine receptor A1Homo sapiens (human)
cognitionAdenosine receptor A1Homo sapiens (human)
leukocyte migrationAdenosine receptor A1Homo sapiens (human)
detection of temperature stimulus involved in sensory perception of painAdenosine receptor A1Homo sapiens (human)
negative regulation of lipid catabolic processAdenosine receptor A1Homo sapiens (human)
positive regulation of lipid catabolic processAdenosine receptor A1Homo sapiens (human)
regulation of sensory perception of painAdenosine receptor A1Homo sapiens (human)
negative regulation of synaptic transmission, glutamatergicAdenosine receptor A1Homo sapiens (human)
fatty acid homeostasisAdenosine receptor A1Homo sapiens (human)
excitatory postsynaptic potentialAdenosine receptor A1Homo sapiens (human)
long-term synaptic depressionAdenosine receptor A1Homo sapiens (human)
mucus secretionAdenosine receptor A1Homo sapiens (human)
negative regulation of mucus secretionAdenosine receptor A1Homo sapiens (human)
triglyceride homeostasisAdenosine receptor A1Homo sapiens (human)
regulation of cardiac muscle cell contractionAdenosine receptor A1Homo sapiens (human)
apoptotic signaling pathwayAdenosine receptor A1Homo sapiens (human)
regulation of presynaptic cytosolic calcium ion concentrationAdenosine receptor A1Homo sapiens (human)
negative regulation of long-term synaptic potentiationAdenosine receptor A1Homo sapiens (human)
negative regulation of long-term synaptic depressionAdenosine receptor A1Homo sapiens (human)
G protein-coupled receptor signaling pathwayAdenosine receptor A1Homo sapiens (human)
negative regulation of transcription by RNA polymerase IINuclear receptor ROR-gammaHomo sapiens (human)
xenobiotic metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
regulation of glucose metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
regulation of steroid metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
intracellular receptor signaling pathwayNuclear receptor ROR-gammaHomo sapiens (human)
circadian regulation of gene expressionNuclear receptor ROR-gammaHomo sapiens (human)
cellular response to sterolNuclear receptor ROR-gammaHomo sapiens (human)
positive regulation of circadian rhythmNuclear receptor ROR-gammaHomo sapiens (human)
regulation of fat cell differentiationNuclear receptor ROR-gammaHomo sapiens (human)
positive regulation of DNA-templated transcriptionNuclear receptor ROR-gammaHomo sapiens (human)
adipose tissue developmentNuclear receptor ROR-gammaHomo sapiens (human)
T-helper 17 cell differentiationNuclear receptor ROR-gammaHomo sapiens (human)
regulation of transcription by RNA polymerase IINuclear receptor ROR-gammaHomo sapiens (human)
calcium ion transportVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
sensory perception of soundVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
positive regulation of adenylate cyclase activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
positive regulation of calcium ion transportVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
regulation of atrial cardiac muscle cell membrane repolarizationVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
calcium ion importVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
calcium ion transmembrane transportVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
cardiac muscle cell action potential involved in contractionVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
membrane depolarization during cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
membrane depolarization during SA node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
regulation of heart rate by cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
regulation of potassium ion transmembrane transporter activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
regulation of potassium ion transmembrane transportVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
calcium ion import across plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
skeletal system developmentVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
extraocular skeletal muscle developmentVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
calcium ion transportVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
muscle contractionVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
striated muscle contractionVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
endoplasmic reticulum organizationVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
myoblast fusionVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
neuromuscular junction developmentVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
skeletal muscle adaptationVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
positive regulation of muscle contractionVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
skeletal muscle fiber developmentVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
release of sequestered calcium ion into cytosolVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
calcium ion transmembrane transportVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
cellular response to caffeineVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
calcium ion import across plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
immune system developmentVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
heart developmentVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
regulation of cardiac muscle contraction by regulation of the release of sequestered calcium ionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
embryonic forelimb morphogenesisVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
camera-type eye developmentVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
positive regulation of adenylate cyclase activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
positive regulation of muscle contractionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion transport into cytosolVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion transmembrane transport via high voltage-gated calcium channelVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion transmembrane transportVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
cardiac muscle cell action potential involved in contractionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membrane depolarization during cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membrane depolarization during AV node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
cell communication by electrical coupling involved in cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
regulation of heart rate by cardiac conductionVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
regulation of ventricular cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membrane depolarization during atrial cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calcium ion import across plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of receptor internalizationAtaxin-2Homo sapiens (human)
regulation of translationAtaxin-2Homo sapiens (human)
RNA metabolic processAtaxin-2Homo sapiens (human)
P-body assemblyAtaxin-2Homo sapiens (human)
stress granule assemblyAtaxin-2Homo sapiens (human)
RNA transportAtaxin-2Homo sapiens (human)
negative regulation of signaling receptor activityAngiotensin-converting enzyme 2 Homo sapiens (human)
symbiont entry into host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of cytokine productionAngiotensin-converting enzyme 2 Homo sapiens (human)
angiotensin maturationAngiotensin-converting enzyme 2 Homo sapiens (human)
angiotensin-mediated drinking behaviorAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of systemic arterial blood pressure by renin-angiotensinAngiotensin-converting enzyme 2 Homo sapiens (human)
tryptophan transportAngiotensin-converting enzyme 2 Homo sapiens (human)
viral life cycleAngiotensin-converting enzyme 2 Homo sapiens (human)
receptor-mediated endocytosis of virus by host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of vasoconstrictionAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of transmembrane transporter activityAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of cell population proliferationAngiotensin-converting enzyme 2 Homo sapiens (human)
symbiont entry into host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
receptor-mediated virion attachment to host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
negative regulation of smooth muscle cell proliferationAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of inflammatory responseAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of amino acid transportAngiotensin-converting enzyme 2 Homo sapiens (human)
maternal process involved in female pregnancyAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of cardiac muscle contractionAngiotensin-converting enzyme 2 Homo sapiens (human)
membrane fusionAngiotensin-converting enzyme 2 Homo sapiens (human)
negative regulation of ERK1 and ERK2 cascadeAngiotensin-converting enzyme 2 Homo sapiens (human)
blood vessel diameter maintenanceAngiotensin-converting enzyme 2 Homo sapiens (human)
entry receptor-mediated virion attachment to host cellAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of gap junction assemblyAngiotensin-converting enzyme 2 Homo sapiens (human)
regulation of cardiac conductionAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of L-proline import across plasma membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processAngiotensin-converting enzyme 2 Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (115)

Processvia Protein(s)Taxonomy
serine-type endopeptidase activityTransmembrane protease serine 2Homo sapiens (human)
protein bindingTransmembrane protease serine 2Homo sapiens (human)
serine-type peptidase activityTransmembrane protease serine 2Homo sapiens (human)
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
metal ion bindingVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
guanyl-nucleotide exchange factor activityRap guanine nucleotide exchange factor 3Homo sapiens (human)
protein bindingRap guanine nucleotide exchange factor 3Homo sapiens (human)
protein domain specific bindingRap guanine nucleotide exchange factor 3Homo sapiens (human)
cAMP bindingRap guanine nucleotide exchange factor 3Homo sapiens (human)
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
fibronectin bindingProcathepsin LHomo sapiens (human)
cysteine-type endopeptidase activityProcathepsin LHomo sapiens (human)
protein bindingProcathepsin LHomo sapiens (human)
collagen bindingProcathepsin LHomo sapiens (human)
cysteine-type peptidase activityProcathepsin LHomo sapiens (human)
histone bindingProcathepsin LHomo sapiens (human)
proteoglycan bindingProcathepsin LHomo sapiens (human)
serpin family protein bindingProcathepsin LHomo sapiens (human)
cysteine-type endopeptidase activator activity involved in apoptotic processProcathepsin LHomo sapiens (human)
RNA-dependent RNA polymerase activityReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
cysteine-type endopeptidase activityReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
K63-linked deubiquitinase activityReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
K48-linked deubiquitinase activityReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
3'-5'-RNA exonuclease activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
RNA-dependent RNA polymerase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
cysteine-type endopeptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
mRNA 5'-cap (guanine-N7-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
mRNA (nucleoside-2'-O-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
5'-3' RNA helicase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
K63-linked deubiquitinase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
K48-linked deubiquitinase activityReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
G protein-coupled adenosine receptor activityAdenosine receptor A3Homo sapiens (human)
3'-5'-RNA exonuclease activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA-dependent RNA polymerase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
cysteine-type endopeptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA 5'-cap (guanine-N7-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA (nucleoside-2'-O-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA endonuclease activity, producing 3'-phosphomonoestersReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
ISG15-specific peptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
5'-3' RNA helicase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
protein guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
adenosylhomocysteinase activityAdenosylhomocysteinaseHomo sapiens (human)
protein bindingAdenosylhomocysteinaseHomo sapiens (human)
G protein-coupled adenosine receptor activityAdenosine receptor A2aHomo sapiens (human)
protein bindingAdenosine receptor A2aHomo sapiens (human)
calmodulin bindingAdenosine receptor A2aHomo sapiens (human)
lipid bindingAdenosine receptor A2aHomo sapiens (human)
enzyme bindingAdenosine receptor A2aHomo sapiens (human)
type 5 metabotropic glutamate receptor bindingAdenosine receptor A2aHomo sapiens (human)
identical protein bindingAdenosine receptor A2aHomo sapiens (human)
protein-containing complex bindingAdenosine receptor A2aHomo sapiens (human)
alpha-actinin bindingAdenosine receptor A2aHomo sapiens (human)
G protein-coupled receptor bindingAdenosine receptor A1Homo sapiens (human)
purine nucleoside bindingAdenosine receptor A1Homo sapiens (human)
protein bindingAdenosine receptor A1Homo sapiens (human)
heat shock protein bindingAdenosine receptor A1Homo sapiens (human)
G-protein beta/gamma-subunit complex bindingAdenosine receptor A1Homo sapiens (human)
heterotrimeric G-protein bindingAdenosine receptor A1Homo sapiens (human)
protein heterodimerization activityAdenosine receptor A1Homo sapiens (human)
G protein-coupled adenosine receptor activityAdenosine receptor A1Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription factor activityNuclear receptor ROR-gammaHomo sapiens (human)
protein bindingNuclear receptor ROR-gammaHomo sapiens (human)
oxysterol bindingNuclear receptor ROR-gammaHomo sapiens (human)
zinc ion bindingNuclear receptor ROR-gammaHomo sapiens (human)
ligand-activated transcription factor activityNuclear receptor ROR-gammaHomo sapiens (human)
sequence-specific double-stranded DNA bindingNuclear receptor ROR-gammaHomo sapiens (human)
nuclear receptor activityNuclear receptor ROR-gammaHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
protein bindingVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
ankyrin bindingVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
metal ion bindingVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
alpha-actinin bindingVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel activity involved in cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel activity involved SA node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
protein bindingVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
calmodulin bindingVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
small molecule bindingVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
metal ion bindingVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
molecular function activator activityVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activity involved in cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
protein bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
calmodulin bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
high voltage-gated calcium channel activityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
metal ion bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
alpha-actinin bindingVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activity involved in cardiac muscle cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel activity involved in AV node cell action potentialVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
RNA bindingAtaxin-2Homo sapiens (human)
epidermal growth factor receptor bindingAtaxin-2Homo sapiens (human)
protein bindingAtaxin-2Homo sapiens (human)
mRNA bindingAtaxin-2Homo sapiens (human)
virus receptor activityAngiotensin-converting enzyme 2 Homo sapiens (human)
endopeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
carboxypeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
metallocarboxypeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
protein bindingAngiotensin-converting enzyme 2 Homo sapiens (human)
metallopeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
peptidyl-dipeptidase activityAngiotensin-converting enzyme 2 Homo sapiens (human)
zinc ion bindingAngiotensin-converting enzyme 2 Homo sapiens (human)
identical protein bindingAngiotensin-converting enzyme 2 Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (86)

Processvia Protein(s)Taxonomy
extracellular regionTransmembrane protease serine 2Homo sapiens (human)
nucleoplasmTransmembrane protease serine 2Homo sapiens (human)
plasma membraneTransmembrane protease serine 2Homo sapiens (human)
extracellular exosomeTransmembrane protease serine 2Homo sapiens (human)
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
photoreceptor outer segmentVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
membraneVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
perikaryonVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1FHomo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
plasma membraneRap guanine nucleotide exchange factor 3Homo sapiens (human)
cortical actin cytoskeletonRap guanine nucleotide exchange factor 3Homo sapiens (human)
plasma membraneRap guanine nucleotide exchange factor 3Homo sapiens (human)
microvillusRap guanine nucleotide exchange factor 3Homo sapiens (human)
endomembrane systemRap guanine nucleotide exchange factor 3Homo sapiens (human)
membraneRap guanine nucleotide exchange factor 3Homo sapiens (human)
lamellipodiumRap guanine nucleotide exchange factor 3Homo sapiens (human)
filopodiumRap guanine nucleotide exchange factor 3Homo sapiens (human)
extracellular exosomeRap guanine nucleotide exchange factor 3Homo sapiens (human)
extracellular regionPolymerase basic protein 2Influenza A virus (A/Puerto Rico/8/1934(H1N1))
extracellular regionRNA-directed RNA polymerase catalytic subunitInfluenza A virus (A/Puerto Rico/8/1934(H1N1))
extracellular regionPolymerase acidic proteinInfluenza A virus (A/Puerto Rico/8/1934(H1N1))
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
extracellular regionProcathepsin LHomo sapiens (human)
extracellular spaceProcathepsin LHomo sapiens (human)
nucleusProcathepsin LHomo sapiens (human)
lysosomeProcathepsin LHomo sapiens (human)
multivesicular bodyProcathepsin LHomo sapiens (human)
Golgi apparatusProcathepsin LHomo sapiens (human)
plasma membraneProcathepsin LHomo sapiens (human)
apical plasma membraneProcathepsin LHomo sapiens (human)
endolysosome lumenProcathepsin LHomo sapiens (human)
chromaffin granuleProcathepsin LHomo sapiens (human)
lysosomal lumenProcathepsin LHomo sapiens (human)
intracellular membrane-bounded organelleProcathepsin LHomo sapiens (human)
collagen-containing extracellular matrixProcathepsin LHomo sapiens (human)
extracellular exosomeProcathepsin LHomo sapiens (human)
endocytic vesicle lumenProcathepsin LHomo sapiens (human)
extracellular spaceProcathepsin LHomo sapiens (human)
lysosomeProcathepsin LHomo sapiens (human)
double membrane vesicle viral factory outer membraneReplicase polyprotein 1aSevere acute respiratory syndrome-related coronavirus
double membrane vesicle viral factory outer membraneReplicase polyprotein 1abSevere acute respiratory syndrome-related coronavirus
plasma membraneAdenosine receptor A3Homo sapiens (human)
presynaptic membraneAdenosine receptor A3Homo sapiens (human)
Schaffer collateral - CA1 synapseAdenosine receptor A3Homo sapiens (human)
dendriteAdenosine receptor A3Homo sapiens (human)
plasma membraneAdenosine receptor A3Homo sapiens (human)
synapseAdenosine receptor A3Homo sapiens (human)
double membrane vesicle viral factory outer membraneReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
plasma membraneGamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)
plasma membraneGlutamate receptor 2Rattus norvegicus (Norway rat)
nucleusAdenosylhomocysteinaseHomo sapiens (human)
endoplasmic reticulumAdenosylhomocysteinaseHomo sapiens (human)
cytosolAdenosylhomocysteinaseHomo sapiens (human)
melanosomeAdenosylhomocysteinaseHomo sapiens (human)
extracellular exosomeAdenosylhomocysteinaseHomo sapiens (human)
cytosolAdenosylhomocysteinaseHomo sapiens (human)
plasma membraneAdenosine receptor A2aHomo sapiens (human)
intermediate filamentAdenosine receptor A2aHomo sapiens (human)
plasma membraneAdenosine receptor A2aHomo sapiens (human)
membraneAdenosine receptor A2aHomo sapiens (human)
dendriteAdenosine receptor A2aHomo sapiens (human)
axolemmaAdenosine receptor A2aHomo sapiens (human)
asymmetric synapseAdenosine receptor A2aHomo sapiens (human)
presynaptic membraneAdenosine receptor A2aHomo sapiens (human)
neuronal cell bodyAdenosine receptor A2aHomo sapiens (human)
postsynaptic membraneAdenosine receptor A2aHomo sapiens (human)
presynaptic active zoneAdenosine receptor A2aHomo sapiens (human)
glutamatergic synapseAdenosine receptor A2aHomo sapiens (human)
plasma membraneAdenosine receptor A1Homo sapiens (human)
plasma membraneAdenosine receptor A1Homo sapiens (human)
basolateral plasma membraneAdenosine receptor A1Homo sapiens (human)
axolemmaAdenosine receptor A1Homo sapiens (human)
asymmetric synapseAdenosine receptor A1Homo sapiens (human)
presynaptic membraneAdenosine receptor A1Homo sapiens (human)
neuronal cell bodyAdenosine receptor A1Homo sapiens (human)
terminal boutonAdenosine receptor A1Homo sapiens (human)
dendritic spineAdenosine receptor A1Homo sapiens (human)
calyx of HeldAdenosine receptor A1Homo sapiens (human)
postsynaptic membraneAdenosine receptor A1Homo sapiens (human)
presynaptic active zoneAdenosine receptor A1Homo sapiens (human)
synapseAdenosine receptor A1Homo sapiens (human)
dendriteAdenosine receptor A1Homo sapiens (human)
nucleusNuclear receptor ROR-gammaHomo sapiens (human)
nucleoplasmNuclear receptor ROR-gammaHomo sapiens (human)
nuclear bodyNuclear receptor ROR-gammaHomo sapiens (human)
chromatinNuclear receptor ROR-gammaHomo sapiens (human)
nucleusNuclear receptor ROR-gammaHomo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
plasma membraneGamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)
plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
Z discVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
L-type voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1D Homo sapiens (human)
cytoplasmVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
sarcoplasmic reticulumVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
T-tubuleVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
I bandVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
L-type voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1SHomo sapiens (human)
cytoplasmVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
plasma membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
postsynaptic densityVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
Z discVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
dendriteVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
perikaryonVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
postsynaptic density membraneVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
L-type voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
voltage-gated calcium channel complexVoltage-dependent L-type calcium channel subunit alpha-1CHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cytoplasmAtaxin-2Homo sapiens (human)
Golgi apparatusAtaxin-2Homo sapiens (human)
trans-Golgi networkAtaxin-2Homo sapiens (human)
cytosolAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
membraneAtaxin-2Homo sapiens (human)
perinuclear region of cytoplasmAtaxin-2Homo sapiens (human)
ribonucleoprotein complexAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
plasma membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
extracellular regionAngiotensin-converting enzyme 2 Homo sapiens (human)
extracellular spaceAngiotensin-converting enzyme 2 Homo sapiens (human)
endoplasmic reticulum lumenAngiotensin-converting enzyme 2 Homo sapiens (human)
plasma membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
ciliumAngiotensin-converting enzyme 2 Homo sapiens (human)
cell surfaceAngiotensin-converting enzyme 2 Homo sapiens (human)
membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
apical plasma membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
endocytic vesicle membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
brush border membraneAngiotensin-converting enzyme 2 Homo sapiens (human)
membrane raftAngiotensin-converting enzyme 2 Homo sapiens (human)
extracellular exosomeAngiotensin-converting enzyme 2 Homo sapiens (human)
extracellular spaceAngiotensin-converting enzyme 2 Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (2691)

Assay IDTitleYearJournalArticle
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588349qHTS for Inhibitors of ATXN expression: Validation of Cytotoxic Assay
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID588378qHTS for Inhibitors of ATXN expression: Validation
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID504836Inducers of the Endoplasmic Reticulum Stress Response (ERSR) in human glioma: Validation2002The Journal of biological chemistry, Apr-19, Volume: 277, Issue:16
Sustained ER Ca2+ depletion suppresses protein synthesis and induces activation-enhanced cell death in mast cells.
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347050Natriuretic polypeptide receptor (hNpr2) antagonism - Pilot subtype selectivity assay2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID1347045Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot counterscreen GloSensor control cell line2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1186339Antiviral activity against Vaccinia Virus infected in african green monkey Vero 76 cells assessed as reduction in plaque number after 3 days by plaque reduction assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID539956Antiviral activity against influenza A virus H1N1 infected in MDCK cells assessed as cell viability after 2 days by MTS assay2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID1082875In vivo antiviral activity against Tobacco mosaic virus (TMV) pre-inoculated Nicotiana. tabacum L. leaves assessed as curative effect at 500 ug/mL measured after 3 to 4 days2012Journal of agricultural and food chemistry, Jun-13, Volume: 60, Issue:23
Design, synthesis, antiviral activity, and SARs of 14-aminophenanthroindolizidines.
AID87161Minimum inhibitory concentration required to reduce Coxsackie virus B4 induced cytopathogenicity by 50% in HeLa cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID376983Cytotoxicity against african green monkey Vero cells after 3 days by MTT reduction assay2006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID395951Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in liver at 20 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1638589Antiviral activity against West Nile virus infected in human A549 cells incubated for 4 days by crystal violet staining based plaque reduction assay2019Journal of medicinal chemistry, 03-14, Volume: 62, Issue:5
DDX3X Helicase Inhibitors as a New Strategy To Fight the West Nile Virus Infection.
AID665835In vivo antiviral activity against TMV assessed as curative effect at 500 ug/mL2012European journal of medicinal chemistry, Jul, Volume: 53Design, synthesis and antiviral activity of novel quinazolinones.
AID1265176Antiviral activity against wild type Chikungunya virus IMT infected in HEK293T cells assessed as inhibition of E2 protein expression at 5 uM measured at 24 hrs postinfection by Western blot method2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
AID712811Antiviral activity against amantidine and rimantadine-resistant Influenza B virus (B/HK/5/72) infected in MDCK cells assessed as virus-induced cytopathic effect by MTS assay2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID548441Antiviral activity against Influenza A H3N2 virus subtype infected in MDCK cells assessed as inhibition of virus induced cytopathicity by visual scoring of CPE2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID1687966Antiproliferative activity against human SK-OV-3 cells assessed as reduction in cell growth incubated for 7 days by trypan blue exclusion assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID673221Antiviral activity at Hepatitis C virus genotype 1b infected in human HuH7 cells assessed as inhibition of viral replication at 10 uM after 3 days by renilla luciferase reporter gene assay2012Bioorganic & medicinal chemistry, Aug-01, Volume: 20, Issue:15
C-6 aryl substituted 4-quinolone-3-carboxylic acids as inhibitors of hepatitis C virus.
AID1408333Cytotoxicity against MDCK cells assessed as alteration in cell morphology after 3 days by microscopic method2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID1443675Cytotoxicity against human 293T cells expressing Gluc assessed as inhibition of cell proliferation after 24 hrs by CCK8 assay2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Anti-influenza triterpenoid saponins (saikosaponins) from the roots of Bupleurum marginatum var. stenophyllum.
AID1252407Antiviral activity against Punta Toro virus expressed in African green monkey Vero cells assessed as reduction in cytopathogenicity2015European journal of medicinal chemistry, Sep-18, Volume: 102Novel halogenated 3-deazapurine, 7-deazapurine and alkylated 9-deazapurine derivatives of L-ascorbic or imino-L-ascorbic acid: Synthesis, antitumour and antiviral activity evaluations.
AID1349207Cytotoxicity against human Ava5 cells assessed as cell viability at 200 uM after 72 hrs by XTT assay relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery of naphtho[1,2-d]oxazole derivatives as potential anti-HCV agents through inducing heme oxygenase-1 expression.
AID419594Antiviral activity against Vaccinia virus infected in human HEL cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID535531Transport through ENT1 in rat hepatocytes by oil filtration assay in presence 100 nM of transporter inhibitor NBMRP2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID768188Antiviral activity against influenza A virus H3N3 subtype infected in dog MDCK cells assessed as reduction of virus-induced cytopathogenicity by MTS assay2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID105960Minimum cytotoxic concentration required to cause a microscopically detectable alteration of normal cell morphology in madin-Darby canine kidney cells (MDCK)2001Bioorganic & medicinal chemistry letters, Aug-20, Volume: 11, Issue:16
Novel 3-(2-adamantyl)pyrrolidines with potent activity against influenza A virus-identification of aminoadamantane derivatives bearing two pharmacophoric amine groups.
AID1186330Antiviral activity against Bovine viral diarrhea virus infected in MDBK cells assessed as inhibition of virus-induced cytopathogenicity after 3 to 4 days by MTT assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID94737Evaluated for cell growth inhibition and induction of cellular differentiation of Murine leukemia cell line (L-1210)1990Journal of medicinal chemistry, Jan, Volume: 33, Issue:1
Growth inhibition and induction of cellular differentiation of human myeloid leukemia cells in culture by carbamoyl congeners of ribavirin.
AID1113455Cytotoxicity against MDCK cells assessed as change in cellular morphology2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID658750Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as inhibition of virus-induced cytopathogenicity after 4 days by colorimetric formazan-based MTS assay2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID1611060Selectivity index, ratio of CTD50 for dog MDCK cells to IC50 for Influenza A virus (A/Puerto Rico/8/34 (H1N1)) pdm09 infected in MDCK cells2019Bioorganic & medicinal chemistry letters, 12-01, Volume: 29, Issue:23
Synthesis and structure-activity relationships of novel camphecene analogues as anti-influenza agents.
AID442290Antiviral activity HCV in replicon cells assessed as inhibition of NS3-4A protease activity by RT-PCR2010European journal of medicinal chemistry, Feb, Volume: 45, Issue:2
Synthesis, anti-HCV, antioxidant, and peroxynitrite inhibitory activity of fused benzosuberone derivatives.
AID1717749Cytotoxicity against African green monkey Vero E6 cells by the CCK8 assay2020Journal of medicinal chemistry, 11-25, Volume: 63, Issue:22
Chinese Therapeutic Strategy for Fighting COVID-19 and Potential Small-Molecule Inhibitors against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
AID1631433Antiviral activity against Dengue virus 2 16681 infected in human HuH7 cells after 72 hrs by indirect immunofluorescent flow cytometry2016Journal of medicinal chemistry, 06-23, Volume: 59, Issue:12
The Medicinal Chemistry of Dengue Virus.
AID1783353Selectivity index, ratio of CC50 for human Huh-7 cells to IC50 for Zika virus H/PF/2013 infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based secondary yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID1853005Cytotoxicity against human HCT-116 cells assessed as reduction on cell viability at 100 uM incubated for 48 hrs by MTT assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID395691Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean day of death at 40 mg/kg, po twice daily for 7 days administered 4 hrs before viral-challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1205007Selectivity index, ratio of TC50 for african green monkey Vero cells to IC50 for Coxsackievirus B5 infected in african green monkey Vero cells2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID453100Antiviral activity against HCV by cell based replicon assay2009Bioorganic & medicinal chemistry, Dec-01, Volume: 17, Issue:23
Synthesis, tautomerism, and antimicrobial, anti-HCV, anti-SSPE, antioxidant, and antitumor activities of arylazobenzosuberones.
AID1873828Selectivity index, ratio of CC50 for cytotoxicity against African green monkey Vero cells assessed as reduction in cell viability to IC50 for antiviral activity against Zika virus H/PAN/2016/BEI-259634 infected in African green monkey Vero cells assessed 2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID216364Effects on cell morphology of Vero cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID1498138Cytotoxicity against human HeLa cells assessed as alteration of cell morphology by microscopic analysis2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID1783359Selectivity index, ratio of CC50 for human Huh-7 cells to IC50 for West Nile virus lineage 1 (Italy/2009) infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 48 hrs by immunodetection based direct yield reduction a2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID1113465Cytotoxicity against Homo sapiens (human) HeLa cells assessed as change in cellular morphology2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID1450217Selectivity index, ratio of MCC for African green monkey Vero E6 cells to IC50 for acyclovir-resistant HSV-1 L2 infected in African green monkey Vero E6 cells2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID1594022Antiviral activity against Influenza A virus (A/PR/8/34 (H1N1)) infected in MDCK cells assessed as reduction in viral replication preincubated for 1 hr followed by compound washout and measured after 48 hrs2019Bioorganic & medicinal chemistry letters, 07-01, Volume: 29, Issue:13
Discovery of 5-(5-fluoro-1H-pyrrolo[2,3-b]pyridin-3-yl)pyrazin-2(1H)-one derivatives as new potent PB2 inhibitors.
AID474327Antiviral activity against Influenza A virus Duck/MN/1525/81/H5N1 infected MDCK cells after 3 days by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID87139Concentration required for microscopically detectable alteration of the normal cell morphology in HeLa cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID1503324Cytotoxicity against African green monkey Vero 76 cells assessed as decrease in cell viability after 48 to 96 hrs by MTT assay2017European journal of medicinal chemistry, Dec-01, Volume: 141Inhibitors of Yellow Fever Virus replication based on 1,3,5-triphenyl-4,5-dihydropyrazole scaffold: Design, synthesis and antiviral evaluation.
AID1688552Antiviral activity against recombinant HCV genotype 2a JFH-1 infected in human Huh7.5 cells after 3 days by renilla luciferase reporter gene assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Molecular design, synthesis, and biological evaluation of bisamide derivatives as cyclophilin A inhibitors for HCV treatment.
AID392726Antiviral activity against VSV assessed as inhibition of virus-induced cytopathicity2009Bioorganic & medicinal chemistry letters, Feb-15, Volume: 19, Issue:4
Synthesis of 5-isoxazol-5-yl-2'-deoxyuridines exhibiting antiviral activity against HSV and several RNA viruses.
AID474337Cytotoxicity against MDCK cells after 3 days by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1571901Displacement of [125I]N6-(4-amino-3-iodobenzyl)adenosine-5-N-methyluronamide from mouse A3A adenosine receptor expressed in CHO cell membranes at 10 uM after 60 mins by scintillation proximity assay relative to adenosine 5-N-ethyluronamide2019Journal of medicinal chemistry, 02-14, Volume: 62, Issue:3
Design and in Vivo Characterization of A
AID376980Cytotoxicity against human Hep2 cells after 3 days by MTT reduction assay2006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID1783386Cytotoxicity against human Huh-7 cells infected with SARS-COV-2 assessed as reduction in cell viability by celltiter-glo luminescent cell viability assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID105801Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on MDCK cell line infected with influenza B virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID528352Antiviral activity against Poliovirus infected in human HeLaS3 cells assessed as frequency of viral mutagenesis plaque at 300 uM by guanidine resistance assay2010Journal of medicinal chemistry, Nov-25, Volume: 53, Issue:22
Synthesis of a 6-methyl-7-deaza analogue of adenosine that potently inhibits replication of polio and dengue viruses.
AID1075688Cytotoxicity against human HuH7 cells after 2 days by XTT assay2014Bioorganic & medicinal chemistry letters, Mar-01, Volume: 24, Issue:5
4'-Substituted pyrimidine nucleosides lacking 5'-hydroxyl function as potential anti-HCV agents.
AID383515Antiviral activity against HSV2 G in human HEL cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID68121Concentration required to reduce HSV-1(KOS) induced cytopathogenicity by 50% in ESM(embryonic skin muscle) cell cultures.1992Journal of medicinal chemistry, Jun-12, Volume: 35, Issue:12
(+-)-carbocyclic 5'-nor-2'-deoxyguanosine and related purine derivatives: synthesis and antiviral properties.
AID1207766Inhibition of Cav1.2 current measured using QPatch automatic path clamp system in CHO cells expressing Cav1.2, beta-2 and alpha-2/delta-1 subunits2013Scientific reports, , Volume: 3MICE models: superior to the HERG model in predicting Torsade de Pointes.
AID216972Minimum inhibitory conc. for 50% inhibition of Sindbis virus induced cytopathicity in Vero cells1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Carbocyclic oxetanocins lacking the C-3' methylene.
AID300584Antiviral activity against influenza A/Jingfang/Fm1 (H1N1) infected in mouse assessed as mean survival time of mouse at 100 mg/kg, ip bid after 2 hrs of viral infection for 5 days2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID535511Transport through CNT1 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID766686Antiviral activity against Influenza A virus H3N3 infected in MDCK cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID1372326Antiviral activity against Influenza A virus H5N1 (A/duck/Novosibirsk/56/2005) infected in pig SPEV cells assessed as protection against virus-induced cytopathic effect2018Bioorganic & medicinal chemistry letters, 01-01, Volume: 28, Issue:1
Isosteric ribavirin analogues: Synthesis and antiviral activities.
AID533315Antiviral activity against HCV genotype 1b in TIZ-9 replicon cell after 4 days by blot hybridization analysis2008Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11
Potential for hepatitis C virus resistance to nitazoxanide or tizoxanide.
AID303229Antiviral activity against VSV in HeLa cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID198433Therapeutic index against Rift valley fever virus.1985Journal of medicinal chemistry, Sep, Volume: 28, Issue:9
Synthesis and biological activity of 5-thiobredinin and certain related 5-substituted imidazole-4-carboxamide ribonucleosides.
AID419600Antiviral activity against RSV infected in human HeLa cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID1433140Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID34143Antiviral activity at 100 uM determined in a culture of Adenovirus type 2; IA = inactive1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and biological properties of purine and pyrimidine 5'-deoxy-5'-(dihydroxyphosphinyl)-beta-D-ribofuranosyl analogues of AMP, GMP, IMP, and CMP.
AID1274006Antiviral activity against HHV-2 VR-734-G infected in African green monkey Vero cells assessed as reduction in plaque formation administered simultaneously with virus for 1 hr measured after 72 hrs by crystal violet staining technique2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID611764Antiviral activity against Punta Toro virus infected in Vero cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID474354Antiviral activity against Influenza A virus Solomon Islands/03/2006/H1N1 infected MDCK cells after 42 to 46 hrs by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID221964Compounds was tested for the effect of L-nucleosides of ribavirin on SEB (staphylococcal enterotoxin B)-stimulated T-cell expression of the type 1 cytokine IL-2.2000Journal of medicinal chemistry, Mar-09, Volume: 43, Issue:5
Monocyclic L-nucleosides with type 1 cytokine-inducing activity.
AID535508Transport through CNT3 in mouse hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1485251Antiviral activity against Influenza A virus A/Virginia/ATCC3/2009(H1N1) infected in MDCK cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by formazan-based colorimetric assay2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID87166Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Polio virus-1 in HeLa cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID278362RBV metabolism in Vero E6 cells assessed as RBV-MP concentration at 40 ug/ml after 24 h2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID291034Antiviral activity against reovirus1 virus in Vero cells assessed as reduction of virus plaque formation after 7 days2007Journal of medicinal chemistry, Jun-28, Volume: 50, Issue:13
Novel C-6 fluorinated acyclic side chain pyrimidine derivatives: synthesis, (1)H and (13)C NMR conformational studies, and antiviral and cytostatic evaluations.
AID611762Antiviral activity against Mammalian orthoreovirus 1 infected in Vero cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID634750Antiviral activity against Vesicular stomatitis virus infected in human HEL cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1113453Antiviral activity against Influenza A virus H3N2 infected MDCK cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1767880Antiviral activity against Oseltamivir resistant Influenza A virus (A/Tianjin-Jinnan/15/2009(H1N1) infected in dog MDCK cells assessed as inhibition of surface glycoprotein hemagglutinin2021European journal of medicinal chemistry, Oct-15, Volume: 222Optimization and SAR research at the piperazine and phenyl rings of JNJ4796 as new anti-influenza A virus agents, part 1.
AID216507Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on vero cell line infected with semliki forest virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID217588In vitro antiviral activity against measles virus in Vero cells1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Synthesis and biological activity of certain nucleoside and nucleotide derivatives of pyrazofurin.
AID1778628Cytotoxicity against MDCK cells assessed as reduction in cell viability incubated for 48 hrs by MTT assay2021European journal of medicinal chemistry, Oct-05, Volume: 2211,2,4-Triazolo[1,5-a]pyrimidines: Efficient one-step synthesis and functionalization as influenza polymerase PA-PB1 interaction disruptors.
AID393165Selectivity index, ratio of MCC for MDCK cells to EC50 for influenza A virus H3N22009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design and synthesis of 1,2-annulated adamantane piperidines with anti-influenza virus activity.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID105777Tested for inhibitory effect on RNA virus cell morphology in MDCK cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID71777Concentration that reduces Friend murine leukemia virus titer by 50%1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Unsaturated and carbocyclic nucleoside analogues: synthesis, antitumor, and antiviral activity.
AID1277820Antiviral activity against Dengue virus 2 infected in human HepG2 cells assessed as NS1 level at < maximum non-toxic concentration after 72 hrs by sandwich ELISA (Rvb = 44.5 +/- 3.2 PbU)2016European journal of medicinal chemistry, Mar-03, Volume: 110Discovery of antiviral molecules for dengue: In silico search and biological evaluation.
AID1118650Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1873816Antiviral activity against Huh 7.5 cell culture derived HCV genotype 2a (JFH-AM71) infected in human Huh7-J20 cells assessed as inhibition of viral replication treated for 72 hrs by SEAP reporter gene assay2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID217586In vitro antiviral activity against herpes simplex virus type 2 (HSV-2) in Vero cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Synthesis and biological activity of certain nucleoside and nucleotide derivatives of pyrazofurin.
AID634754Antiviral activity against thymidine kinase-deficient Varicella Zoster virus 07/1 infected in human HEL cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID548428Antiviral activity against thymidine kinase deficient acyclovir-resistant Herpes simplex virus 1 KOS infected in HEL cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID395695Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 g of liver at 40 mg/kg, po twice daily for 7 days administered 4 hrs before viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID88196Cytotoxicity against HeLa cells2003Bioorganic & medicinal chemistry letters, Oct-20, Volume: 13, Issue:20
Synthesis and biological evaluation of thymine nucleosides fused with 3',4'-tetrahydrofuran ring.
AID1436795Cytotoxicity against African green monkey Vero cells assessed as growth inhibition after 48 hrs2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID1753361Antiviral activity against Hantaan 76-118 pseudovirus infected in MDCK cells assessed as reduction in virus replication incubated for 48 hrs by luminescence assay2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40New class of hantaan virus inhibitors based on conjugation of the isoindole fragment to (+)-camphor or (-)-fenchone hydrazonesv.
AID369861Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in serum at 75 mg/kg, po twice daily administered 4 hrs before viral challenge measured on day 4 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1773053Antiviral activity against RSV infected in BALB/c mouse assessed as downregulation of IL-8 expression in lung tissue infected with RSV at 50 mg/kg/day measured after 2 to 6 days post infection by RT-PCR analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID383531Antiviral activity against Reo virus 1 in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1415635Cytotoxicity against MDCK cells after 48 hrs by MTT assay2017MedChemComm, May-01, Volume: 8, Issue:5
Synthesis and
AID86687Minimum inhibitory concentration required to elicit microscopically visible cell morphology in HeLa cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID1691957Antiviral activity against human Norovirus2020European journal of medicinal chemistry, Jun-01, Volume: 195Anti-norovirus activity of C7-modified 4-amino-pyrrolo[2,1-f][1,2,4]triazine C-nucleosides.
AID357949Antiviral activity against Parainfluenza virus type 3 infected in human Hep2 cells assessed as inhibition of virus-induced cytopathogenic effect2001Journal of natural products, Oct, Volume: 64, Issue:10
New antiviral cassane furanoditerpenes from Caesalpinia minax.
AID69823Tested for the antimicrobial activity minimum inhibitory concentration) against Escherichia coli2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID1274007Antiviral activity against DENV-2 New guinea infected in African green monkey Vero cells assessed as reduction in plaque formation administered simultaneously with virus for 1 hr measured after 8 days by crystal violet staining technique2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID218448Percent purine accumulated in human B lymphoblast WI-L2 cells cultured medium was determined1988Journal of medicinal chemistry, Feb, Volume: 31, Issue:2
Synthesis and evaluation of 5-amino-1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamidine and certain related nucleosides as inhibitors of purine nucleoside phosphorylase.
AID634834Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID218029Antiviral activity was measured against Coxsackie virus B4 in african green monkey kidney (Vero B) cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID659146Antiviral activity against Herpes simplex virus 1 KOS infected in HEL cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID1360699Cytotoxicity against MDCK cells assessed as reduction in cell viability measured after 3 to 6 days by MTS assay2018European journal of medicinal chemistry, Jul-15, Volume: 155Synthesis, biological evaluation and molecular modeling of novel azaspiro dihydrotriazines as influenza virus inhibitors targeting the host factor dihydrofolate reductase (DHFR).
AID283990Antiviral activity against vesicular stomatitis virus by CPE assay2007Bioorganic & medicinal chemistry, Jan-01, Volume: 15, Issue:1
Design, synthesis, and biological evaluation of novel iso-D-2',3'-dideoxy-3'-fluorothianucleoside derivatives.
AID474326Antiviral activity against Influenza A virus Duck/MN/1525/81/H5N1 infected MDCK cells after 42 to 46 hrs by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID593221Antiviral activity against Coxsackievirus B6 infected in african green monkey Vero cells assessed as inhibition of viral growth after 24 hrs by Reed-Muench method2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
Inhibitory properties of 2-substituent-1H-benzimidazole-4-carboxamide derivatives against enteroviruses.
AID217890Evaluated for minimum inhibitory concentration against Vero cells (African green monkey) infected with PV-3, RV-1, SV, Coxs B4, SFV virus1990Journal of medicinal chemistry, May, Volume: 33, Issue:5
Stereospecific synthesis and antiviral properties of different enantiomerically pure carbocyclic 2'-deoxyribonucleoside analogues derived from common chiral pools: (+)-(1R,5S)- and (-)-(1S,5R)-2-oxabicyclo[3.3.0]oct-6-en-3-one.
AID278037Antiviral activity against RSV A2 in MA104 cells by CPE assay2007Journal of natural products, Feb, Volume: 70, Issue:2
Dysoxylins A-D, tetranortriterpenoids with potent anti-RSV activity from Dysoxylum gaudichaudianum.
AID216372Antiviral activity against Semliki forest virus infected Vero cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID232803Toxic level was evaluated; None1984Journal of medicinal chemistry, Nov, Volume: 27, Issue:11
Synthesis and antiviral/antitumor activities of certain 3-deazaguanine nucleosides and nucleotides.
AID489677Antiviral activity against RSV infected in human HeLa cells assessed as inhibition of virus-induced cytopathic effect after 3 days by MTS assay2010European journal of medicinal chemistry, Jul, Volume: 45, Issue:7
Benzylidene/2-chlorobenzylidene hydrazides: synthesis, antimicrobial activity, QSAR studies and antiviral evaluation.
AID617985Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as compound concentration required for inhibiting influenza virus yield at 48 h post-infection by crystal violet staining based CPE inhibition assay2011Journal of natural products, Sep-23, Volume: 74, Issue:9
Anti-influenza virus polyketides from the acid-tolerant fungus Penicillium purpurogenum JS03-21.
AID1436799Antiviral activity against Coxsackievirus B5 Faulkner infected in African green monkey Vero cells assessed as reduction in viral-induced cytopathic effect by Reed and Muench analysis2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID1146288Antiviral activity against Rhinovirus 2 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs by microscopic analysis relative to control1978Journal of medicinal chemistry, Sep, Volume: 21, Issue:9
Imidazo[1,2-a]-s-triazine nucleosides. Synthesis and antiviral activity of the N-bridgehead guanine, guanosine, and guanosine monophosphate analogues of imidazo[1,2-a]-s-triazine.
AID567526Selectivity index, ratio of CC50 for african green monkey Vero cells to EC50 for Junin virus IV4454 infected in african green monkey Vero cells2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Imidazo[2,1-b]thiazole carbohydrate derivatives: Synthesis and antiviral activity against Junin virus, agent of Argentine hemorrhagic fever.
AID1873820Antiviral activity against Zika virus H/PAN/2016/BEI-259634 infected in human Huh7.5 cells assessed as inhibition of viral replication by measuring ZIKV E glycoprotein level at 100 uM incubated for 3 days by ELISA analysis relative to control2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID223404Antiviral activity against the influenza Ao/PR/8/34 virus strain1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Synthesis and antiviral evaluation of carbocyclic analogues of 2-amino-6-substituted-purine 3'-deoxyribofuranosides.
AID712814Antiviral activity against Influenza A virus (A/HK/7/87 (H3N2)) infected in MDCK cells assessed as virus-induced cytopathic effect measured 3 days post infection by microscopic analysis2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID383507Antiviral activity against vesicular stomatitis virus in human HeLa cells assessed as inhibition of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1536099Antiviral activity against Junin virus IV4454 infected in African green monkey Vero cells assessed as reduction in vrius yield after 48 hrs by plaque assay2019Bioorganic & medicinal chemistry letters, 02-15, Volume: 29, Issue:4
Modified ribavirin analogues as antiviral agents against Junín virus.
AID1066681Antiviral activity against influenza A virus H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect after 48 hrs by crystal violet staining assay2014Journal of natural products, Feb-28, Volume: 77, Issue:2
Cladosins A-E, hybrid polyketides from a deep-sea-derived fungus, Cladosporium sphaerospermum.
AID1443676Selectivity index, ratio of CC50 for human 293T cells expressing Gluc to EC50 for Influenza A virus WSN/33(H1N1)2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Anti-influenza triterpenoid saponins (saikosaponins) from the roots of Bupleurum marginatum var. stenophyllum.
AID1773424Antiviral activity against Human herpesvirus-1 MacIntyre infected in A549 cells assessed as inhibition of viral adsorption at early stage of replication treated for 1 hr during viral infection followed by replacement with fresh medium and measured after 42021European journal of medicinal chemistry, Dec-05, Volume: 225Novel betulin dicarboxylic acid ester derivatives as potent antiviral agents: Design, synthesis, biological evaluation, structure-activity relationship and in-silico study.
AID1696832Selectivity index, ratio of CC50 for cytotoxicity against human A549 cells to IC50 for antiviral activity against for influenza A virus (A/Duck/Guangdong/212/2004(H5N1)) infected in A549 cells2020Bioorganic & medicinal chemistry letters, 11-15, Volume: 30, Issue:22
Structure-aided optimization of 3-O-β-chacotriosyl epiursolic acid derivatives as novel H5N1 virus entry inhibitors.
AID1773012Inhibition of RSV induced apoptosis in human HEp-2 cells assessed as reduction in PARP cleavage measured after 48 hrs by Western blot analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID548435Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as inhibition of virus induced cytopathicity by visual scoring of CPE2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID290453Selectivity index, ratio of CC50 for Vero E6 cells to IC50 for SARS-CoV Frankfurt12007Bioorganic & medicinal chemistry letters, May-01, Volume: 17, Issue:9
Synthesis and biological evaluation of nucleoside analogues having 6-chloropurine as anti-SARS-CoV agents.
AID301694Inactivation of Trypanosoma cruzi recombinant S-adenosyl-L-homocysteine hydrolase NAD+ form expressed in Escherichia coli JM109 assessed as increase in fluorescence at 200 uM2007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID1485231Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID257890Antiviral activity against Herpes simplex virus 2 G strain in HEL cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID535521Transport through CNT1 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer containing 100 uM NBMPR and thymidine2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID217587In vitro antiviral activity against herpes simplex virus type 2 virus was evaluated.1985Journal of medicinal chemistry, Aug, Volume: 28, Issue:8
Synthesis and biological activity of 6-azacadeguomycin and certain 3,4,6-trisubstituted pyrazolo[3,4-d]pyrimidine ribonucleosides.
AID84217Inhibitory activity against HSV-1 (KOS) replication in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID1336611Antiviral activity against Coxsackie virus B4 infected in African green monkey Vero cells assessed as protection against virus-induced cytopathic effect measured after 3 to 5 days by microscopic analysis2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Synthesis and in vitro antiviral evaluation of 4-substituted 3,4-dihydropyrimidinones.
AID280200Antiviral activity against punta toro virus in Vero cells assessed as inhibition of virus-induced cytopathicity2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID1081159In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as curative effect at 100 ug/ml treated after viral inoculation measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
AID575251Antiviral activity against oseltamivir-susceptible zanamivir-, adamantane-resistant Influenza B virus B/Memphis/20/1996 harboring neuraminidase R152K mutant infected in MDCK cells assessed as inhibition of viral replication after 3 days by microscopic ana2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
In vitro antiviral activity of favipiravir (T-705) against drug-resistant influenza and 2009 A(H1N1) viruses.
AID1408327Antiviral activity against Influenza A virus A/HK/7/87(H3N2) infected in MDCK cells after 3 days by MTS assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID1687965Antiproliferative activity against human SK-OV-3 cells assessed as reduction in cell growth incubated for 4 days by trypan blue exclusion assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID1610162Cytotoxicity against dog MDCK cells assessed as reduction in cell viability incubated for 3 days by coulter counter method2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
AID751301Antiviral activity against Influenza A virus A/Hong Kong/8/68(H3N2) infected in dog MDCK cells after 3 days by CPE assay2013Journal of natural products, Jun-28, Volume: 76, Issue:6
Asperterrestide A, a cytotoxic cyclic tetrapeptide from the marine-derived fungus Aspergillus terreus SCSGAF0162.
AID63918Effective concentration required to inhibit vesicular stomatitis virus(VSV) -induced cytopathicity by 50% in E6SM cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID463990Antiviral activity against Herpes simplex virus 2 G infected in HEL cells assessed as protection from virus-induced cytopathogenicity after 2 to 3 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID634837Antiviral activity against Human immunodeficiency virus 2 infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 days by microscopic analysis2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID535538Transport through CNT2 in mouse hepatocytes by oil filtration assay pre-incubated with 20 ng/mL rotenone for 15 mins and 2 mM 2-deoxyglucose for 10 mins at 37 degC in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID463994Antiviral activity against PIV 3 infected in african green monkey Vero cells assessed as protection from virus-induced cytopathogenicity after 6 to 7 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1724448Selectivity index, ratio of CC50 for human Huh7.5 cells to EC50 for genotype 2a HCV JFH-1 infected in human Huh7.5 cells2020Bioorganic & medicinal chemistry, 10-01, Volume: 28, Issue:19
SAR study of bisamides as cyclophilin a inhibitors for the development of host-targeting therapy for hepatitis C virus infection.
AID1773427Antiviral activity against Enterovirus E LCR-4 infected in A549 cells assessed as reduction in virus titer treated 1 hr post viral infection followed by replacement with fresh medium with compounds and measured after 72 hrs by MTT assay2021European journal of medicinal chemistry, Dec-05, Volume: 225Novel betulin dicarboxylic acid ester derivatives as potent antiviral agents: Design, synthesis, biological evaluation, structure-activity relationship and in-silico study.
AID376982Selectivity index, CC50 for human Hep2 cells to IC50 for RSV Long2006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID751085Antiviral activity against Coxsackievirus B3 infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect2013Journal of natural products, Jun-28, Volume: 76, Issue:6
Sesquiterpenes and alkaloids from the roots of Alangium chinense.
AID1753726Antiviral activity against CHIKV infected in African green monkey Vero cells assessed as inhibition of viral replication at 20 uM measured after 4 days relative to control2021Journal of natural products, 04-23, Volume: 84, Issue:4
Semisynthesis of Dolabellane Diterpenes: Oxygenated Analogues with Increased Activity against Zika and Chikungunya Viruses.
AID216346Tested for antiviral activity against Punta toro virus in African green monkey kidney cell (Vero)2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID369466Selectivity index, ratio of CC50 for african green monkey Vero 76 cells to EC50 for Punta Toro virus Adames2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID64118Tested for minimum inhibitory concentration against HSV-1 (KOS strain) in E6SM cells1993Journal of medicinal chemistry, Oct-01, Volume: 36, Issue:20
Antiviral activity of C-alkylated purine nucleosides obtained by cross-coupling with tetraalkyltin reagents.
AID1436796Antiviral activity against Coxsackievirus B3 (strain Nancy) infected in African green monkey Vero cells assessed as reduction in viral-induced cytopathic effect by Reed and Muench analysis2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID474353Antiviral activity against Influenza A virus Solomon Islands/03/2006/H1N1 infected MDCK cells assessed as inhibition of virus-induced cytopathic effect after 3 days2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID474350Antiviral activity against Influenza A virus California/07/2009 /H1N1 infected MDCK cells assessed as inhibition of virus-induced cytopathic effect after 3 days2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID253419Ratio of cytotoxicity to anti BVDV activity of the compound2004Journal of medicinal chemistry, Oct-07, Volume: 47, Issue:21
Synthesis of benzodithiol-2-yl-substituted nucleoside derivatives as lead compounds having anti-bovine viral diarrhea virus activity.
AID419603Antiviral activity against Reovirus 1 infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID224344Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against G strain of Herpes simplex virus-2 in primary rabbit kidney cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID383523Antiviral activity against Coxsackie virus B4 in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID257892Antiviral activity against Vesicular stomatitis virus in HEL cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID301326Cytotoxicity against Huh7 cells by XTT assay2007Bioorganic & medicinal chemistry, Nov-15, Volume: 15, Issue:22
5'-O-masked 2'-deoxyadenosine analogues as lead compounds for hepatitis C virus (HCV) therapeutic agents.
AID1241029Cytotoxicity against African green monkey Vero 76 cells relative to control2015Bioorganic & medicinal chemistry, Sep-01, Volume: 23, Issue:17
2- and 3-Fluoro-3-deazaneplanocins, 2-fluoro-3-deazaaristeromycins, and 3-methyl-3-deazaneplanocin: Synthesis and antiviral properties.
AID766694Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID1204075Antiviral activity against RSV infected in African green monkey Vero 76 cells after 5 days by plaque reduction assay2015Bioorganic & medicinal chemistry letters, Jun-01, Volume: 25, Issue:11
N-((1,3-Diphenyl-1H-pyrazol-4-yl)methyl)anilines: A novel class of anti-RSV agents.
AID54477Selectivity index as the ratio of CC50/EC50 against Coxsackie B virus type-32002Bioorganic & medicinal chemistry letters, May-20, Volume: 12, Issue:10
Heterocyclic nucleoside analogues: design and synthesis of antiviral, modified nucleosides containing isoxazole heterocycles.
AID369463Antiviral activity against Rift Valley fever virus MP-12 assessed as inhibition of virus-induced visual cytopathic effect after 3 to 5 days2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1186434Inhibition of HCV RNA replication in human Li23 cells (ORL8 system) in presence of 1 IU/mL IFN-alpha by renilla luciferase reporter gene based replication assay2014Bioorganic & medicinal chemistry letters, Sep-01, Volume: 24, Issue:17
Synthesis and inhibitory activity on hepatitis C virus RNA replication of 4-(1,1,1,3,3,3-hexafluoro-2-hydroxy-2-propyl)aniline analogs.
AID395966Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean day of death at 10 mg/kg, po twice daily for 5 days administered 24 hrs post viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1075690Antiviral activity against HCV subtype 1a infected in Huh-7 cells assessed as reduction in viral RNA level at 81.9 uM after 8 to 10 days by quantitative PCR analysis2014Bioorganic & medicinal chemistry letters, Mar-01, Volume: 24, Issue:5
4'-Substituted pyrimidine nucleosides lacking 5'-hydroxyl function as potential anti-HCV agents.
AID1092193In vivo antiviral activity against Tobacco mosaic virus (TMV) inoculated right side of Nicotiana tabacum L. leaves assessed as protection effect at 100 ug/mL preincubated 12 hr before viral challenge measured after 3 to 4 days2012Journal of agricultural and food chemistry, Oct-17, Volume: 60, Issue:41
Design, synthesis, and anti-tobacco mosaic virus (TMV) activity of phenanthroindolizidines and their analogues.
AID1783389Cytotoxicity against African green monkey Vero E6 cells infected with SARS-COV-2 by celltiter-glo luminescent cell viability assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID99700In vitro antiviral activity against Para 3 virus in human laryngeal epithelioma cell line1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
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Discovery and optimization of potent broad-spectrum arenavirus inhibitors derived from benzimidazole.
AID478322Antiviral activity against Influenza A virus H3N2 assessed as inhibition of viral induced cytopathic effect2010Bioorganic & medicinal chemistry letters, May-01, Volume: 20, Issue:9
Click reaction synthesis of carbohydrate derivatives from ristocetin aglycon with antibacterial and antiviral activity.
AID463982Antiviral activity against Reovirus 1 infected in african green monkey Vero cells assessed as protection from virus-induced cytopathogenicity after 6 to 7 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1186327Cytotoxicity against mock-infected human MT4 cells after 96 hrs by MTT assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
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AID1772991Antiviral activity against Respiratory syncytial virus infected in human HEp-2 cells incubated for 60 hrs by MTT assay2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID763858Selectivity index, ratio of CC50 for MDCK cells to EC50 for Influenza B virus (B/Florida/4/2006)2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis and biological activity evaluation of 5-pyrazoline substituted 4-thiazolidinones.
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In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID392504Antiviral activity against Cowpox virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
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Chemoreactive-Inspired Discovery of Influenza A Virus Dual Inhibitor to Block Hemagglutinin-Mediated Adsorption and Membrane Fusion.
AID1524780Antiviral activity against influenza A virus A/Vietnam/1203/2004 x A/PR/8/34 (H5N1) harboring recombinant NS1 infected in MDCK cells assessed as reduction in virus-induced cytopathic effect measured on day 5 by Celltiter-Glo luminescence assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Identification, design and synthesis of novel pyrazolopyridine influenza virus nonstructural protein 1 antagonists.
AID83889Concentration required to reduce HSV-1 (KOS) induced cytopathogenicity by 50% in primary rabbit kidney cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
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Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
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Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
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Antiviral activity of C-5 substituted tubercidin analogues.
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Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID489679Cytotoxicity against human HeLa cells after 3 days by MTS assay2010European journal of medicinal chemistry, Jul, Volume: 45, Issue:7
Benzylidene/2-chlorobenzylidene hydrazides: synthesis, antimicrobial activity, QSAR studies and antiviral evaluation.
AID87156Minimum inhibitory concentration against polio virus 1 in HeLa cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
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AID476929Human intestinal absorption in po dosed human2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Neural computational prediction of oral drug absorption based on CODES 2D descriptors.
AID427554Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36M/R155T double mutation in human HuH7 cells after 48 hrs by RNA replicon assay2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
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Structure-activity relationship studies of 1-(1'-hydroxyalkyl)rupestonic acid methyl esters against influenza viruses.
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Antiviral activity of C-5 substituted tubercidin analogues.
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Activity of T-1106 in a hamster model of yellow Fever virus infection.
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Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
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Synthesis and antiviral activity of 5'-deoxypyrazofurin.
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Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
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Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
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Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID1542953Antiviral activity against Zika virus MR766 infected in African green monkey Vero E6 cells assessed as reduction in virus yield2019ACS medicinal chemistry letters, Apr-11, Volume: 10, Issue:4
Scaffold Morphing Approach To Expand the Toolbox of Broad-Spectrum Antivirals Blocking Dengue/Zika Replication.
AID217270Minimum inhibitory concentration required to elicit microscopically visible cell morphology in Vero cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
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Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID593224Cytotoxicity against african green monkey Vero cells2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
Inhibitory properties of 2-substituent-1H-benzimidazole-4-carboxamide derivatives against enteroviruses.
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Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID478323Antiviral activity against Influenza A virus H3N2 assessed as cell viability by cell based MTS assay2010Bioorganic & medicinal chemistry letters, May-01, Volume: 20, Issue:9
Click reaction synthesis of carbohydrate derivatives from ristocetin aglycon with antibacterial and antiviral activity.
AID768193Antiviral activity against Coxsackievirus B4 infected in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID63768The minimum inhibitory concentration was measured on E6SM cells for morphological alteration1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
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In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID575244Antiviral activity against adamantane-resistant zanamivir-,oseltamivir-susceptible Influenza A virus (A/Washington/01/2007(H3N2)) harboring M2 S31N mutant infected in MDCK cells assessed as inhibition of viral replication after 3 days by microscopic analy2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
In vitro antiviral activity of favipiravir (T-705) against drug-resistant influenza and 2009 A(H1N1) viruses.
AID1171741Cytotoxicity against human Hep2 cells after 48 hrs2014Journal of natural products, Dec-26, Volume: 77, Issue:12
Anti-respiratory syncytial virus prenylated dihydroquinolone derivatives from the gorgonian-derived fungus Aspergillus sp. XS-20090B15.
AID1687962Antiproliferative activity against rat C6 cells assessed as reduction in cell growth at 100 uM incubated for 72 hrs by MTT assay relative to control2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID634835Antiviral activity against Felid herpesvirus 1 infected in CrFK cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1485255Cytotoxicity against African green monkey Vero cells assessed as alterations in cell morphology measured after 5 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID434308Antiviral activity against Herpes simplex virus 2 infected in HEL cells assessed as protection against in virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
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Structure-activity relationship of novel oligopeptide antiviral and antitumor agents related to netropsin and distamycin.
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Synthesis and anti-BVDV activity of novel δ-sultones in vitro: implications for HCV therapies.
AID674872Selectivity index, ratio of TC50 for MDCK cells to IC50 for Influenza A virus (A/Guangdong-Luohu/219/2006(H1N1))2012European journal of medicinal chemistry, Sep, Volume: 55Synthesis and antiviral activity of substituted bisaryl amide compounds as novel influenza virus inhibitors.
AID1261316Antiviral activity against human RSV infected in african green monkey Vero76 cells assessed as inhibition of virus-induced cytopathogenicity after 5 days by plaque reduction assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID6600150% Minimum inhibitory concentration which is required to reduce cytopathogenicity induced by (196) strain of HSV-2 virus on human E6SM cells.1997Journal of medicinal chemistry, Feb-14, Volume: 40, Issue:4
Novel 3'-C/N-substituted 2',3'-beta-D-dideoxynucleosides as potential chemotherapeutic agents. 1. Thymidine derivatives: synthesis, structure, and broad spectrum antiviral properties.
AID1261310Cytotoxicity against BHK cells assessed as cell viability after 48 to 96 hrs by MTT assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID535505Transport through ENT2 in mouse hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID551034Antiviral activity against Tobacco mosaic virus after 72 hrs by half-leaf juice rubbing method2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Bitriazolyl acyclonucleosides synthesized via Huisgen reaction using internal alkynes show antiviral activity against tobacco mosaic virus.
AID1113456Antiviral activity against Punta Toro virus infected in African green monkey Vero cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
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AID569237Antiviral activity against HCMV Davis infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Synthesis of new C5-(1-substituted-1,2,3-triazol-4 or 5-yl)-2'-deoxyuridines and their antiviral evaluation.
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Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID1408326Antiviral activity against Influenza A virus A/HK/7/87(H3N2) infected in MDCK cells assessed as reduction in virus-induced cytopathic effect after 3 days by microscopic method2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID1498121Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID768195Cytotoxicity against human HeLa cells2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID301701Inhibition of Trypanosoma cruzi recombinant S-adenosyl-L-homocysteine hydrolase NAD form expressed in Escherichia coli JM1092007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID383517Antiviral activity against Vaccinia virus in human HEL cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1082879Antiviral activity against Tobacco mosaic virus (TMV) inoculated in 5-6 growth stage leaf assessed as inhibition effect at 500 ug/mL at 25 degC after 72 hr by half-leaf method2012Journal of agricultural and food chemistry, Jun-13, Volume: 60, Issue:23
Design, synthesis, antiviral activity, and SARs of 14-aminophenanthroindolizidines.
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Chrodrimanins I and J from the Antarctic Moss-Derived Fungus Penicillium funiculosum GWT2-24.
AID1638588Antiviral activity against West Nile virus infected in African green monkey Vero cells incubated for 4 days by crystal violet staining based plaque reduction assay2019Journal of medicinal chemistry, 03-14, Volume: 62, Issue:5
DDX3X Helicase Inhibitors as a New Strategy To Fight the West Nile Virus Infection.
AID284539Antiviral activity against Punta Toro virus-induced cytopathogenicity in Vero cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID1055980Antiviral activity against Influenza A virus (A/Hong Kong/7/1987(H3N2)) harboring wild type M2 channel infected in MDCK cells assessed as concentration required to 2 log10 reduction of virus yield after 24 hrs by RT-PCR analysis2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
3-Azatetracyclo[5.2.1.1(5,8).0(1,5)]undecane derivatives: from wild-type inhibitors of the M2 ion channel of influenza A virus to derivatives with potent activity against the V27A mutant.
AID1398130Antiviral activity against Influenza A virus (A/Aichi/2/1968(H3N2)) infected in MDCK cells assessed as inhibition of virus-induced cytopathicity after 48 hrs by crystal violet staining based method2018Bioorganic & medicinal chemistry letters, 09-15, Volume: 28, Issue:17
Generation of methylated violapyrones with improved anti-influenza A virus activity by heterologous expression of a type III PKS gene in a marine Streptomyces strain.
AID1450225Selectivity index, ratio of MCC for African green monkey Vero E6 cells to IC50 for acyclovir and cidofovir-resistant HSV-1 L2 infected in African green monkey Vero E6 cells2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID392527Antiviral activity against influenza H1N1 virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID658615Antiviral activity against Coxsackie virus B4 infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID301692Inactivation of Trypanosoma cruzi recombinant S-adenosyl-L-homocysteine hydrolase NAD+ form expressed in Escherichia coli JM109 at 100 uM2007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID1408332Cytotoxicity against MDCK cells assessed as reduction in cell viability after 3 days by MTS assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID345881Antiviral activity against HCV in human HuH5.2 cells assessed as inhibition of replicon replication2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Discovery of novel arylethynyltriazole ribonucleosides with selective and effective antiviral and antiproliferative activity.
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Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID567525Cytotoxicity against african green monkey Vero cells after 48 hrs by MTT assay2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Imidazo[2,1-b]thiazole carbohydrate derivatives: Synthesis and antiviral activity against Junin virus, agent of Argentine hemorrhagic fever.
AID320046Antiviral activity against influenza B virus expressed in dog MDCK cells assessed as reduction of virus-induced cytopathic effect2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Three-component, one-pot synthesis of novel 2,4-substituted 5-azolylthiopyrimidine library for screening against anti-influenza virus A.
AID416782Antiviral activity against influenza H3N2 virus in MDCK cells assessed as reduction of virus-induced cytopathicity by visual cytopathic effect scoring method2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
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"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
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Design, synthesis, and antiviral activity evaluation of phenanthrene-based antofine derivatives.
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Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
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Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID216381In vitro antiviral activity (virus ratings (VR)) determined by comparing CPE development in drug-treated cells (T) and Vesicular stomatitis virus control cells1984Journal of medicinal chemistry, Nov, Volume: 27, Issue:11
Synthesis and antiviral/antitumor activities of certain 3-deazaguanine nucleosides and nucleotides.
AID1360701Cytotoxicity against human HeLa cells assessed as alterations in normal cell morphology measured after 3 to 6 days by microscopic analysis2018European journal of medicinal chemistry, Jul-15, Volume: 155Synthesis, biological evaluation and molecular modeling of novel azaspiro dihydrotriazines as influenza virus inhibitors targeting the host factor dihydrofolate reductase (DHFR).
AID1594642Selectivity index, ratio of CC50 for cytotoxicity in BHK cells to IC50 for antiviral activity against Dengue virus 1 DGL2 replicon infected in BHK cells2019Bioorganic & medicinal chemistry, 06-01, Volume: 27, Issue:11
Synthesis and biological evaluation of novel imidazole nucleosides as potential anti-dengue virus agents.
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New antiviral cassane furanoditerpenes from Caesalpinia minax.
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In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
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In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID634755Antiviral activity against Parainfluenza-3 virus infected in african green monkey Vero cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID6600650% Minimum inhibitory concentration which is required to reduce cytopathogenicity induced by (Mc Intyre) strain of HSV-1 virus on human E6SM cells.1997Journal of medicinal chemistry, Feb-14, Volume: 40, Issue:4
Novel 3'-C/N-substituted 2',3'-beta-D-dideoxynucleosides as potential chemotherapeutic agents. 1. Thymidine derivatives: synthesis, structure, and broad spectrum antiviral properties.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID216366Antiviral activity against parainfluenza 3 virus infected Vero cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID68124Concentration required to reduce vesicular stomatitis virus(VSV) induced cytopathogenicity by 50% in ESM(embryonic skin muscle) cell cultures.1992Journal of medicinal chemistry, Jun-12, Volume: 35, Issue:12
(+-)-carbocyclic 5'-nor-2'-deoxyguanosine and related purine derivatives: synthesis and antiviral properties.
AID474551Selectivity ratio of IC50 for MDCK cells to EC90 for Influenza B virus Malaysia/2506/2004 by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID361408Antiviral activity against Encephalomyocarditis virus EMC infected in human HeLa assessed as inhibition of virus-induced cytopathic effect after 2 days by MTT assay2002Journal of natural products, Nov, Volume: 65, Issue:11
New saponins from the starfish Certonardoa semiregularis.
AID634761Antiviral activity against Coxsackievirus B4 infected in human HeLa cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID221963Compounds was tested for the effect of L-nucleosides of ribavirin on SEB (staphylococcal enterotoxin B)-stimulated T-cell expression of the type 1 cytokine IFN-gamma2000Journal of medicinal chemistry, Mar-09, Volume: 43, Issue:5
Monocyclic L-nucleosides with type 1 cytokine-inducing activity.
AID776643Cytotoxicity against mouse X5563 cells assessed as growth inhibition2013European journal of medicinal chemistry, Nov, Volume: 69Pyrazole containing natural products: synthetic preview and biological significance.
AID1450218Antiviral activity against HSV-1 L2/Rp-ACV/2 infected in African green monkey Vero E6 cells assessed as reduction in virus-induced cytopathic effect2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID199168Minimum inhibitory concentration required to reduce reo virus type 1 induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID419593Antiviral activity against HSV2 G infected in human HEL cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID472794Antiviral activity against RSV A2 infected in african green monkey Vero cells after 5 days by plaque reduction assay2010Bioorganic & medicinal chemistry, Apr-15, Volume: 18, Issue:8
Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID1505492Cytotoxicity against MDCK cells assessed as change in cell morphology after 3 days by microscopic analysis2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID475851Cytotoxicity against human HEL cells2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID86513Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on HeLa cell line infected with polio 1 virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID1660634Selectivity index, ratio of CC50 for cytotoxicity in dog MDCK cells assessed as reduction in cell viability incubated for 48 hrs by crystal violet staining based assay to IC50 for cytotoxicity in dog MDCK cells assessed as reduction in cell viability incu2020Journal of medicinal chemistry, 07-09, Volume: 63, Issue:13
Chemoreactive-Inspired Discovery of Influenza A Virus Dual Inhibitor to Block Hemagglutinin-Mediated Adsorption and Membrane Fusion.
AID257894Antiviral activity against Parainfluenza-3 virus in vero cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID87339Compound was tested for antiviral activity in HeLa Cell cultures, against herpes simplex virus type 1 (HSV-1), cytopathic effect induced by the virus (CPE)1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Synthesis and antiviral evaluation of nucleosides of 5-methylimidazole-4-carboxamide.
AID659154Antiviral activity against Human immunodeficiency virus 1 3B infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 days by microscopic analysis2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID434310Antiviral activity against sVesicular stomatitis virus infected in HEL cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID1336609Antiviral activity against Reovirus-1 infected in African green monkey Vero cells assessed as protection against virus-induced cytopathic effect measured after 3 to 5 days by microscopic analysis2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Synthesis and in vitro antiviral evaluation of 4-substituted 3,4-dihydropyrimidinones.
AID86834concentration required to inhibit Coxsackie virus B4-induced cytopathicity by 50% in HeLa cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID68119Concentration required to reduce HSV-1 thymidine kinase deficient (TK-)(B2006) induced cytopathogenicity by 50% in ESM(embryonic skin muscle) cell cultures.1992Journal of medicinal chemistry, Jun-12, Volume: 35, Issue:12
(+-)-carbocyclic 5'-nor-2'-deoxyguanosine and related purine derivatives: synthesis and antiviral properties.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1205001Antiviral activity against Coxsackievirus B1 infected in african green monkey Vero cells assessed as reduction in viral-induced cytopathic effect2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID1724447Cytotoxicity against human Huh7.5 cells assessed as decrease in cell viability after 3 days by MTT assay2020Bioorganic & medicinal chemistry, 10-01, Volume: 28, Issue:19
SAR study of bisamides as cyclophilin a inhibitors for the development of host-targeting therapy for hepatitis C virus infection.
AID1852999Cytotoxicity against paclitaxel-resistant human HCT116tax cells incubated for 48 hrs by MTT assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID370204Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in liver at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID436478Antiviral activity against Bovine viral diarrhea virus infected in MDBK cells assessed as inhibition of virus-induced cytopathicity after 3 to 4 days by MTT assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID472785Cytotoxicity against BHK cells after 48 to 96 hrs by MTT assay2010Bioorganic & medicinal chemistry, Apr-15, Volume: 18, Issue:8
Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID1716977Safety index, ratio of CC50 for human HEp-2 cells to EC50 for GFP-fused wild-type RSV subgroup A long infected in human HEp-2 cells2020European journal of medicinal chemistry, Jan-15, Volume: 186Design and synthesis of 2-((1H-indol-3-yl)thio)-N-phenyl-acetamides as novel dual inhibitors of respiratory syncytial virus and influenza virus A.
AID569239Cytotoxicity against HEL cells after 3 days by coulter counter analysis2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Synthesis of new C5-(1-substituted-1,2,3-triazol-4 or 5-yl)-2'-deoxyuridines and their antiviral evaluation.
AID1436805Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for Coxsackievirus B6 (strain Schmitt) infected in African green monkey Vero cells2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID611772Cytotoxicity against human CEM cells assessed as growth inhibition after 3 days by coulter counting analysis2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID1729931Inhibition of RdRP activity in Influenza A virus A/PR/8/34 (H1N1) infected in HEK293T cells co-transfected with NP/PA/PB1/PB2/pPolI-Flu-ffLuc/pRL-SV40 incubated for 24 hrs by minireplicon based dual luciferase assay2021European journal of medicinal chemistry, Jan-01, Volume: 209Synthesis and characterization of 1,2,4-triazolo[1,5-a]pyrimidine-2-carboxamide-based compounds targeting the PA-PB1 interface of influenza A virus polymerase.
AID257471Antiviral activity against influenza A H3N2 virus in MDCK cells2005Bioorganic & medicinal chemistry letters, Dec-01, Volume: 15, Issue:23
Synthesis and biological evaluation of novel bisheterocycle-containing compounds as potential anti-influenza virus agents.
AID1081200Antiviral activity against Tobacco mosaic virus (TMV) infected leaves assessed as viral inhibition at 100 ug/mL at 25 degC for 72 hr2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis, crystal structure, and biological activity of 4-methyl-1,2,3-thiadiazole-containing 1,2,4-triazolo[3,4-b][1,3,4]thiadiazoles.
AID443827Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) assessed as inhibition of virus-induced cytopathic effect by cell-based assay2009Journal of medicinal chemistry, Oct-08, Volume: 52, Issue:19
Diazo transfer-click reaction route to new, lipophilic teicoplanin and ristocetin aglycon derivatives with high antibacterial and anti-influenza virus activity: an aggregation and receptor binding study.
AID474340Selectivity ratio of IC50 for MDCK cells to EC90 for Influenza A virus Duck/MN/1525/81/H5N1 by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1501508Antiviral activity against EV71 Xiangyang-Hubei-09 infected in human RD cells assessed as inhibition of virus-induced cytopathic effect at 16 ug/ml treated 1 hr post viral infection measured after 48 hrs by MTT dye based assay relative to control
AID1081545In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as inactivation effect at 100 ug/ml co-treated with virus for 30 min before inoculation onto leaves measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID105792Antiviral activity against influenza B virus infected MDCK cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID1650128Antiviral activity against Influenza A virus H3N2 A/HK/7/87 infected in MDCK cells assessed as reduction in virus induced cytopathic effect after 4 days by microscopy based method2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Superior inhibition of influenza virus hemagglutinin-mediated fusion by indole-substituted spirothiazolidinones.
AID383532Antiviral activity against Sindbis virus in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID218401Minimum inhibitory concentration required to reduce Coxsackie virus B4 induced cytopathogenicity by 50% in african green monkey (VeroB) cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID1699937Selectivity index, ratio of CC50 for dog MDCK cells to IC50 for Influenza A virus (A/California/07/09(H1N1)) pdm09 infected in MDCK cells2020Bioorganic & medicinal chemistry letters, 12-15, Volume: 30, Issue:24
New type of anti-influenza agents based on benzo[d][1,3]dithiol core.
AID297316Antiviral activity against Vaccinia virus in HEL cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID464002Antiviral activity against Influenza B virus infected in MDCK cells assessed as protection from virus-induced cytopathogenicity after 6 to 7 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID370206Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 mL of serum at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1610160Antiviral activity against Influenza B virus (B/Ned/537/05) infected in dog MDCK cells assessed as reduction in virus-induced cytopathogenicity incubated for 7 days by MTS assay2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
AID1181494Antiviral activity against Influenza B virus (B/HK/05/1972) infected in MDCK cells assessed as reduction in host cell viability after 72 hrs by MTS assay2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID224347Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Vesicular stomatitis virus in primary rabbit kidney cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID82043Antiviral activity against vesicular stomatitis virus infected HEF cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID216410Evaluated for minimum inhibitory concentration against Vesicular stomatitis virus (VSV) in primary rabbit kidney cells1990Journal of medicinal chemistry, May, Volume: 33, Issue:5
Stereospecific synthesis and antiviral properties of different enantiomerically pure carbocyclic 2'-deoxyribonucleoside analogues derived from common chiral pools: (+)-(1R,5S)- and (-)-(1S,5R)-2-oxabicyclo[3.3.0]oct-6-en-3-one.
AID216407Compound was tested for antiviral activity (minimum inhibition concentration) in HeLa cells vesicular stomatitis virus (VSV)1984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID463993Antiviral activity against acyclovir-sensitive Herpes simplex virus 1 KOS infected in HEL cells assessed as protection from virus-induced cytopathogenicity after 2 to 3 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID217870Therapeutic index against Venezuelan equine encephalomyelitis virus.1985Journal of medicinal chemistry, Sep, Volume: 28, Issue:9
Synthesis and biological activity of 5-thiobredinin and certain related 5-substituted imidazole-4-carboxamide ribonucleosides.
AID1716986Antiviral activity against Influenza A virus A/WSN/33(H1N1) infected in MDCK cells measured after 24 hrs by Gaussia luciferase reporter gene method2020European journal of medicinal chemistry, Jan-15, Volume: 186Design and synthesis of 2-((1H-indol-3-yl)thio)-N-phenyl-acetamides as novel dual inhibitors of respiratory syncytial virus and influenza virus A.
AID1687964Antiproliferative activity against human SK-OV-3 cells assessed as reduction in cell growth incubated for 3 days by trypan blue exclusion assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID345882Cytotoxicity against human HuH5.2 cells2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Discovery of novel arylethynyltriazole ribonucleosides with selective and effective antiviral and antiproliferative activity.
AID774117Antiviral activity against Coxsackievirus B3 infected in African green monkey Vero cells assessed as protection against virus-induced cytopathic effect after 48 hrs by Reed-Muench analysis2013Journal of natural products, Oct-25, Volume: 76, Issue:10
Diterpenoids and sesquiterpenoids from the roots of Illicium majus.
AID1578002Cytotoxicity against MDCK cells assessed as reduction in cell viability incubated for 48 hrs2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Novel amides modified rupestonic acid derivatives as anti-influenza virus reagents.
AID535524Transport through CNT3 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer containing 100 uM NBMPR and thymidine2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID442291Antiviral activity against HCV infected in hamster brain assessed as subacute sclerosing panencephalitis2010European journal of medicinal chemistry, Feb, Volume: 45, Issue:2
Synthesis, anti-HCV, antioxidant, and peroxynitrite inhibitory activity of fused benzosuberone derivatives.
AID105978In vitro antiviral activity against influenza virus (type A0/PR/8/34) in Madin-Darby canine kidney (MDCK) host cell cultures (MTC/ID50)1990Journal of medicinal chemistry, Apr, Volume: 33, Issue:4
Synthesis and biological evaluation of carbocyclic analogues of lyxofuranosides of 2-amino-6-substituted-purines and 2-amino-6-substituted-8-azapurines.
AID1135743Antiviral activity against Adenovirus type 3 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect at 1 to 1000 ug/ml after 72 hrs1978Journal of medicinal chemistry, Aug, Volume: 21, Issue:8
Synthesis and antiviral acticity of some phosphates of the broad-spectrum antiviral nucleoside, 1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide (ribavirin).
AID1409406Antiviral activity against Influenza A virus A/duck/Guangdong/674/2014(H5N6) infected in chicken embryo fibroblasts assessed as reduction in cytopathic effect after 48 hrs by CCK-8 assay2018Journal of medicinal chemistry, 11-21, Volume: 61, Issue:22
Structure-Based Optimization of N-Substituted Oseltamivir Derivatives as Potent Anti-Influenza A Virus Agents with Significantly Improved Potency against Oseltamivir-Resistant N1-H274Y Variant.
AID369867Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean serum ALT levels at 75 mg/kg, po twice daily administered 4 hrs before viral challenge measured on day 4 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID533321Selectivity Index, ratio of CC50 for TIZ-9 cell harboring HCV genotype 1b to EC50 for HCV genotype 1b in TIZ-9 replicon cell2008Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11
Potential for hepatitis C virus resistance to nitazoxanide or tizoxanide.
AID634756Antiviral activity against Reovirus-1 infected in african green monkey Vero cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1873813Cytotoxicity against human Huh7-J20 cells assessed as reduction in cell viability by MTS assay2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID611770Cytotoxicity against dog MDCK cells assessed as alteration of cell morphology after 3 days by microscopy2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1853006Cytotoxicity against human wild type HCT-116 cells assessed as reduction on cell viability at 100 to 200 uM incubated for 48 hrs in presence of paclitaxel by MTT assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID575250Antiviral activity against adamantane-resistant zanamivir-,oseltamivir-susceptible Influenza B virus B/Memphis/20/1996 infected in MDCK cells assessed as inhibition of viral replication after 3 days by microscopic analysis using crystal violet stain2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
In vitro antiviral activity of favipiravir (T-705) against drug-resistant influenza and 2009 A(H1N1) viruses.
AID419599Antiviral activity against Coxsackievirus B4 infected in human HeLa cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID436477Cytotoxicity against MDBK cells after 48 to 96 hrs by MTT assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID392536Antiviral activity against Vaccinia virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID432184Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID673223Cytotoxicity against human HuH7 cells assessed as cell viability at 10 uM after 3 days by CellTiter Glo assay2012Bioorganic & medicinal chemistry, Aug-01, Volume: 20, Issue:15
C-6 aryl substituted 4-quinolone-3-carboxylic acids as inhibitors of hepatitis C virus.
AID1873818Cytotoxicity against African green monkey Vero cells assessed as reduction in cell viability by MTS assay2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID395680Selectivity index, ratio of CC50 for african green monkey Vero cells to EC50 for Junin virus Candid-12007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1485247Antiviral activity against Influenza B virus B/Ned/537/05 infected in MDCK cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by formazan-based colorimetric assay2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID86484Minimum inhibitory conc. for 50% inhibition of vesicular stomatitis virus induced cytopathicity in HeLa cells1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Carbocyclic oxetanocins lacking the C-3' methylene.
AID1408322Antiviral activity against Influenza A virus A/PR/8/34(H1N1) infected in MDCK cells assessed as reduction in virus-induced cytopathic effect after 3 days by microscopic method2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID427555Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36A/R155T double mutation in human HuH7 cells after 48 hrs by RNA replicon assay2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID278038Antiviral activity against RSV A2 in MA104 cells by plaque reduction assay2007Journal of natural products, Feb, Volume: 70, Issue:2
Dysoxylins A-D, tetranortriterpenoids with potent anti-RSV activity from Dysoxylum gaudichaudianum.
AID555930Antiviral activity against HCV genotype 1b infected in human Huh-9-13 cells assessed as reduction in viral replication selected after 2 passages at 30 ug/ml by quantitative RT-PCR2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Debio 025, a cyclophilin binding molecule, is highly efficient in clearing hepatitis C virus (HCV) replicon-containing cells when used alone or in combination with specifically targeted antiviral therapy for HCV (STAT-C) inhibitors.
AID1716984Safety index, ratio of CC50 for HEK293T cells to EC50 for antiviral activity against Influenza A virus A/WSN/33(H1N1) infected in human HEK293T cells2020European journal of medicinal chemistry, Jan-15, Volume: 186Design and synthesis of 2-((1H-indol-3-yl)thio)-N-phenyl-acetamides as novel dual inhibitors of respiratory syncytial virus and influenza virus A.
AID1853001Cytotoxicity against human HCT-116 cells overexpressing human BCRP incubated for 48 hrs by MTT assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID1853003Cytotoxicity against human HCT-116 cells assessed as reduction on cell viability at 100 uM incubated for 48 hrs in presence of paclitaxel by MTT assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID370218Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 mL of serum at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1253097Selectivity index, ratio of CC50 for human HuH7-J20 cells expressing secreted alkaline phosphatase reporter gene incubated for 1 hr to EC50 for HCV JFH1 infected in human HuH7-J20 cells preincubated with cells for 1 hr followed by viral inoculation for 3 2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Rethinking the old antiviral drug moroxydine: Discovery of novel analogues as anti-hepatitis C virus (HCV) agents.
AID217479Minimum inhibitory concentration required to reduce vesicular stomatitis virus (VSV) induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID1687958Antiproliferative activity against human CaCo-2 cells assessed as reduction in cell growth at 100 uM incubated for 72 hrs by MTT assay relative to control2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID369462Antiviral activity against Punta Toro virus Adames assessed as inhibition of virus-induced visual cytopathic effect after 3 to 5 days2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID216538The minimum inhibitory concentration required to reduce VSV induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID370199Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean day of death at 30 mg/kg, po twice daily for 5 days administered 24 hrs post viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID257898Antiviral activity against Punta Toro virus in vero cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID1647357Antiviral activity against Chikungunya virus infected in African green monkey Vero cells assessed as reduction in viral replication treated with compound at 1 hr post-viral infection2020Bioorganic & medicinal chemistry letters, 01-15, Volume: 30, Issue:2
Quinolone-N-acylhydrazone hybrids as potent Zika and Chikungunya virus inhibitors.
AID218128Minimum inhibitory concentration against Vaccinia virus1989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID249265Minimum inhibitory concentration against vesicular stomatitis virus was determined2005Bioorganic & medicinal chemistry letters, Mar-15, Volume: 15, Issue:6
QSAR for anti-RNA-virus activity, synthesis, and assay of anti-RSV carbonucleosides given a unified representation of spectral moments, quadratic, and topologic indices.
AID611627Antiviral activity against HIV 1 3B infected in CEM cells assessed as inhibition of virus-induced giant cell formation after 4 days by microscopy2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID1542955Selectivity index, ratio of CC50 for African green monkey Vero B cells to EC50 for Dengue virus type 2 NGC infected in African green monkey Vero B cells2019ACS medicinal chemistry letters, Apr-11, Volume: 10, Issue:4
Scaffold Morphing Approach To Expand the Toolbox of Broad-Spectrum Antivirals Blocking Dengue/Zika Replication.
AID717173Antiviral activity against Influenza A virus (A/X-31(H3N2)) infected in MDCK cells assessed as virus-induced cytopathic effect after 3 days by MTS assay2012Bioorganic & medicinal chemistry, Dec-15, Volume: 20, Issue:24
Microwave assisted synthesis and anti-influenza virus activity of 1-adamantyl substituted N-(1-thia-4-azaspiro[4.5]decan-4-yl)carboxamide derivatives.
AID1472402Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) clone 1 infected in MDCK cells assessed as inhibition of virus-induced cytopathicity measured after 3 passages with 12.5 to 50 uM 2-Isopropyl-N-[2-(piperidin-1-yl)ethyl]aniline hydroc2018Journal of medicinal chemistry, 01-11, Volume: 61, Issue:1
Aniline-Based Inhibitors of Influenza H1N1 Virus Acting on Hemagglutinin-Mediated Fusion.
AID539958Antiviral activity against influenza B virus infected in MDCK cells assessed as cell viability after 2 days by MTS assay2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID106224Tested for inhibitory effect on RNA virus HIV-2 in MT-4 cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID434315Antiviral activity against Parainfluenza-3 virus infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID1131474Antiviral activity against Vesicular stomatitis virus infected in primary rabbit kidney cells assessed as inhibition of virus-induced cytopathogenicity treated immediately after virus adsorption measured 2 days after virus infection1977Journal of medicinal chemistry, Oct, Volume: 20, Issue:10
Synthesis and determination of antiviral activity of the 2'(3')-O-methyl derivatives of ribavirin (1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide).
AID1688554Selectivity index, ratio of CC50 for human Huh7.5 cells to EC50 for HCV genotype 2a JFH-1 infected in human Huh7.5 cells2020European journal of medicinal chemistry, Feb-15, Volume: 188Molecular design, synthesis, and biological evaluation of bisamide derivatives as cyclophilin A inhibitors for HCV treatment.
AID1133181Antiviral activity against Parainfluenza virus 3 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs relative to control1978Journal of medicinal chemistry, Dec, Volume: 21, Issue:12
Synthesis and antiviral and enzymatic studies of certain 3-deazaguanines and their imidazolecarboxamide precursors.
AID464179Cytotoxicity against Herpes simplex virus 2 G infected HEL cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1433143Antiviral activity against Parainfluenza virus 3 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID539921Antiviral activity against Para influenza-3 virus infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID396874Antiviral activity against Venezuelan equine encephalomyelitis virus infected in african green monkey Vero cells assessed as plaque reduction at 250 ug/mL
AID223406Antiviral activity is expressed as virus rating (VR) against the influenza Ao/PR/8/34 virus strain1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Synthesis and antiviral evaluation of carbocyclic analogues of 2-amino-6-substituted-purine 3'-deoxyribofuranosides.
AID395945Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as survival at 20 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID611763Antiviral activity against Sindbis virus infected in Vero cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID1503655Cytotoxicity against human HuH7 cells assessed as growth inhibition after 3 days by XTT method2017European journal of medicinal chemistry, Dec-01, Volume: 141Discovery of novel diarylpyrazolylquinoline derivatives as potent anti-dengue virus agents.
AID235606Ratio of minimum drug concentration to ID50 of the compound (Najayama strain)1988Journal of medicinal chemistry, Sep, Volume: 31, Issue:9
Cyclopentenylcytosine. A carbocyclic nucleoside with antitumor and antiviral properties.
AID54500The minimum inhibitory concentration required to reduce Coxsackie virus type B4 induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID288916Antiviral activity against HSV1 KOS in E6SM cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID1076998Selectivity index, ratio of TC50 for MDCK cells to IC50 for Influenza B virus jifang/13/972014European journal of medicinal chemistry, Apr-09, Volume: 761,2,3-Triazole-containing derivatives of rupestonic acid: click-chemical synthesis and antiviral activities against influenza viruses.
AID396876Antiviral activity against Sandfly fever virus assessed as plaque reduction at 250 ug/mL
AID535518Transport through CNT3 in rat hepatocytes by oil filtration assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID246174Anti BVDV activity in MDBK (Madin-darby bovine kidney) cells2004Journal of medicinal chemistry, Oct-07, Volume: 47, Issue:21
Synthesis of benzodithiol-2-yl-substituted nucleoside derivatives as lead compounds having anti-bovine viral diarrhea virus activity.
AID395699Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in liver at 40 mg/kg, po twice daily for 7 days administered 4 hrs before viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID436486Antiviral activity against Human poliovirus 1 strain Sabin after 2 days by plaque reduction assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID278352Decrease in GTP level in Vero E6 cells at 10 ug/ml2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID1081547In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as curative effect at 100 ug/ml treated after viral inoculation measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID217990Minimum cytotoxic concentration against vaccinia virus in HeLa cell cultures1989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1436797Antiviral activity against Coxsackievirus B2 (strain Ohio-1) infected in African green monkey Vero cells assessed as reduction in viral-induced cytopathic effect by Reed and Muench analysis2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID546576Inhibition of recombinant GSK3-beta at 10 uM by Z'-LYTE kinase assay kit method2010Journal of medicinal chemistry, Dec-23, Volume: 53, Issue:24
Discovery of novel GSK-3β inhibitors with potent in vitro and in vivo activities and excellent brain permeability using combined ligand- and structure-based virtual screening.
AID301697Binding to human recombinant S-adenosyl-L-homocysteine hydrolase NADH form expressed in Escherichia coli JM1092007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID1131477Antiviral activity against Poliovirus type 1 infected in human HeLa cells assessed as inhibition of virus-induced cytopathogenicity treated immediately after virus adsorption measured 2 days after virus infection1977Journal of medicinal chemistry, Oct, Volume: 20, Issue:10
Synthesis and determination of antiviral activity of the 2'(3')-O-methyl derivatives of ribavirin (1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide).
AID1436807Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for Coxsackievirus A16 shzh05-1 infected in African green monkey Vero cells2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID88685Tested for inhibitory effect on RNA virus Polio-1 in HeLa cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1773047Antiviral activity against RSV infected in BALB/c mouse assessed as downregulation of IRF3 expression in lung tissue infected with RSV at 50 mg/kg/day measured after 2 to 4 days post infection by RT-PCR analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID235603Ratio of minimum drug concentration to ID50 of the compound(Adems strain)1988Journal of medicinal chemistry, Sep, Volume: 31, Issue:9
Cyclopentenylcytosine. A carbocyclic nucleoside with antitumor and antiviral properties.
AID1204074Cytotoxicity against African green monkey Vero 76 cells assessed as cell viability after 48 to 96 hrs by MTT method2015Bioorganic & medicinal chemistry letters, Jun-01, Volume: 25, Issue:11
N-((1,3-Diphenyl-1H-pyrazol-4-yl)methyl)anilines: A novel class of anti-RSV agents.
AID395713Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as survival at 50 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID751302Antiviral activity against Influenza A virus (A/WSN/1933(H1N1)) infected in dog MDCK cells after 3 days by CPE assay2013Journal of natural products, Jun-28, Volume: 76, Issue:6
Asperterrestide A, a cytotoxic cyclic tetrapeptide from the marine-derived fungus Aspergillus terreus SCSGAF0162.
AID216180Tested for inhibitory effect on RNA virus Reo-1 in Vero cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1168656Antiviral activity against Dengue virus2014European journal of medicinal chemistry, Nov-24, Volume: 87A perspective on targeting non-structural proteins to combat neglected tropical diseases: Dengue, West Nile and Chikungunya viruses.
AID1696830Antiviral activity against Influenza A virus (A/Duck/Guangdong/212/2004(H5N1)) infected in A549 cells assessed as reduction in virus-induced cytopathic effect by CPE reduction assay2020Bioorganic & medicinal chemistry letters, 11-15, Volume: 30, Issue:22
Structure-aided optimization of 3-O-β-chacotriosyl epiursolic acid derivatives as novel H5N1 virus entry inhibitors.
AID217967In vitro antiviral activity (virus ratings (VR)) determined by comparing CPE development in drug-treated cells (T) and Vaccinia virus control cells1984Journal of medicinal chemistry, Nov, Volume: 27, Issue:11
Synthesis and antiviral/antitumor activities of certain 3-deazaguanine nucleosides and nucleotides.
AID283441Inhibition of influenza A virus (A/duck/Minnesota/1525/1981 (H5N1)) replication in MDCK cells by virus yield reduction assay2007Antimicrobial agents and chemotherapy, Mar, Volume: 51, Issue:3
Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.
AID1415634Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as reduction in viral titer preincubated with cells for 1 hr followed by viral inoculation and measured after 48 hrs by hemagglutination test2017MedChemComm, May-01, Volume: 8, Issue:5
Synthesis and
AID543663Selectivity index, ratio of CC50 for African green monkey vero cells to EC90 for Yellow fever virus 17D2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID1710802Cytotoxicity against human MT4 cells assessed as reduction in cell viability incubated for 3 to 6 days by MTS assay2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID543676Toxicity in syrian golden hamster infected with 10'2 CCID50 Yellow fever virus Jimenez assessed as weight change at 10 mg/kg/day, po administered twice daily for 8 days started 4 hrs prior to viral infection relative to control2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID66939Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against HSV-1 virus in E6SM cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID1135867Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in MDCK cells at 1 mg/ml by agar diffusion method1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID1436804Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for Coxsackievirus B5 Faulkner infected in African green monkey Vero cells2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID65711Antiviral activity against herpes simplex virus-2 G (HSV-2) in E6SM cell cultures2001Journal of medicinal chemistry, Aug-02, Volume: 44, Issue:16
Design, synthesis, DNA binding, and biological evaluation of water-soluble hybrid molecules containing two pyrazole analogues of the alkylating cyclopropylpyrroloindole (CPI) subunit of the antitumor agent CC-1065 and polypyrrole minor groove binders.
AID87144Tested for cytotoxic activity in human epithelial cell line (HeLa)2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID1736919Antiviral activity against Influenza A virus (A/Duck/Guangdong/674/2014 (H5N6)) group-2 infected in chicken embryo fibroblast assessed as reduction in viral infection preincubated for 1 hrs followed by fibroblast infection and measured after 72 hrs by hem2020European journal of medicinal chemistry, Apr-01, Volume: 191Discovery of novel "Dual-site" binding oseltamivir derivatives as potent influenza virus neuraminidase inhibitors.
AID288933Antiviral activity against Punta Toro virus in vero cells2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID370222Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean serum ALT levels at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID665016Inhibition of IMPDH in mouse L1210 cells assessed as formation of [2,8-3H]hypoxanthine from [2,8-3H]IMP after 20 to 60 mins2012Bioorganic & medicinal chemistry, Jun-01, Volume: 20, Issue:11
Novel 1,2,4-triazole and imidazole derivatives of L-ascorbic and imino-ascorbic acid: synthesis, anti-HCV and antitumor activity evaluations.
AID94049Tested for the antimicrobial activity minimum inhibitory concentration) against Klebsiella pneumoniae2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID432180Antiviral activity against Parainfluenza virus type 3 infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID1503656Selectivity index, ratio of CC50 for human HuH7 cells to IC50 for Fluc-tagged DENV2 strain 16681 infected in human HuH7 cells2017European journal of medicinal chemistry, Dec-01, Volume: 141Discovery of novel diarylpyrazolylquinoline derivatives as potent anti-dengue virus agents.
AID1498123Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathicity by MTS assay2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID345883Antiviral activity against HCV in human Huh9.13 cells assessed as inhibition of replicon replication2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Discovery of novel arylethynyltriazole ribonucleosides with selective and effective antiviral and antiproliferative activity.
AID474355Antiviral activity against Influenza A virus Solomon Islands/03/2006/H1N1 infected MDCK cells after 3 days by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1234159Antiviral activity against influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect incubated for 48 hrs by crystal violet staining based assay2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Antiviral Limonoids Including Khayanolides from the Trang Mangrove Plant Xylocarpus moluccensis.
AID436482Antiviral activity against Coxsackie virus type B2 virus infected in african green monkey Vero-76 cells after 3 days by plaque reduction assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID548447Antiviral activity against Reovirus 1 virus infected in african green monkey Vero cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID1066045Antiviral activity against influenza A virus A/Padova/72/2011(H1N1) clinical isolate infected in MDCK cells assessed as inhibition of plaque formation after 2 days by toluidine blue staining assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID1150892Antiviral activity against Parainfluenza virus type 3 infected in human KB cells1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Synthesis of 1-(4-thio-beta-D-ribofuranosyl)-1,2,4-triazole-3-carboxamide.
AID659147Antiviral activity against thymidine kinase-deficient Herpes simplex virus 1 infected in HEL cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID434319Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID156707Evaluation for antiviral activity against herpes simplex virus-2(G) in primary rabbit kidney cell cultures(PRK) (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID68256Minimum inhibitory concentration required for antiviral activity to reduce Vesicular stomatitis virus (VSV) induced cytopathicity in human embryonic skin-muscle cells (ESM)1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis and antiviral activities of 8-alkynyl-, 8-alkenyl-, and 8-alkyl-2'-deoxyadenosine analogues.
AID464184Cytotoxicity against Reovirus 1 infected african green monkey Vero cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID156702Evaluation for antiviral activity against herpes simplex virus-1(F) in primary rabbit kidney cell cultures(PRK) (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID87672In vitro antiviral activity was tested against herpes simplex type 2 (HSV-2)1985Journal of medicinal chemistry, Sep, Volume: 28, Issue:9
Synthesis and biological activity of 5-thiobredinin and certain related 5-substituted imidazole-4-carboxamide ribonucleosides.
AID395953Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 mL of serum at 20 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID218131The minimum inhibitory concentration required to reduce vaccinia virus induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID1890795Cytotoxicity against human HEK293T cells assessed as cell viability after 48 hrs by CCK-8 assay2022Bioorganic & medicinal chemistry letters, 05-15, Volume: 64Design, synthesis, and anti-influenza A virus activity evaluation of novel indole containing derivatives of triazole.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID659290Cytotoxicity against african green monkey Vero cells assessed as morphological changes by microscopic analysis2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID1433144Antiviral activity against Reovirus-1 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID1498124Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as inhibition of virus-induced cytopathicity by MTS assay2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID1731879Selectivity index, ratio of CC50 for cytotoxicity against human HEK-293T cells to IC50 for antiviral activity against Influenza A virus A/WSN/33(H1N1) expressing mGFP infected in HEp-2 cells2021European journal of medicinal chemistry, Mar-15, Volume: 214Synthesis and antiviral activity of a series of novel quinoline derivatives as anti-RSV or anti-IAV agents.
AID395958Toxicity in Pichinde virus An 4763 infected po dosed Syrian golden hamster administered twice daily 72 hrs post viral-challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1081156Induction of systemic acquired resistance activity in TMV infected-Nicotiana tabacum (tobacco) leaves at 100 ug/ml2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
AID659148Antiviral activity against Herpes simplex virus 2 G infected in HEL cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID1542952Cytotoxicity in African green monkey Vero B cells assessed as reduction in cell viability by MTS assay2019ACS medicinal chemistry letters, Apr-11, Volume: 10, Issue:4
Scaffold Morphing Approach To Expand the Toolbox of Broad-Spectrum Antivirals Blocking Dengue/Zika Replication.
AID1186333Antiviral activity against Reovirus type-1 infected in BHK21 cells assessed as inhibition of virus-induced cytopathogenicity after 3 to 4 days by MTT assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID395949Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 g of liver at 20 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID217563concentration required to inhibit parainfluenza-3 virus-induced cytopathicity by 50% in Vero cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID155590Inhibitory dose against Parainfluenza type 3 viral strain Huebner C243 in H.Ep-2 cell line1989Journal of medicinal chemistry, Jul, Volume: 32, Issue:7
Synthesis of 3-deazaneplanocin A, a powerful inhibitor of S-adenosylhomocysteine hydrolase with potent and selective in vitro and in vivo antiviral activities.
AID539918Antiviral activity against Vesicular stomatitis virus infected in human HEL cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID395968Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 g of liver at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1092198In vivo antiviral activity against Tobacco mosaic virus (TMV) inoculated left side of Nicotiana tabacum L. leaves assessed as inactivation effect at 500 ug/mL co-incubated with virus measured after 3 to 4 days2012Journal of agricultural and food chemistry, Oct-17, Volume: 60, Issue:41
Design, synthesis, and anti-tobacco mosaic virus (TMV) activity of phenanthroindolizidines and their analogues.
AID474344Selectivity ratio of IC50 for MDCK cells to EC50 for inhibition of virus-induced cytopathic effect of Influenza A virus Hong Kong/213/2003/H5N12010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID108459In vitro antiviral activity was tested against, measles virus1985Journal of medicinal chemistry, Oct, Volume: 28, Issue:10
Synthesis and biological activity of certain 6-substituted and 2,6-disubstituted 2'-deoxytubercidins prepared via the stereospecific sodium salt glycosylation procedure.
AID1886802Cytotoxicity against golden hamster BHK-21 cells measured after 6 days by MTT assay2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID345885Antiviral activity against HCV in human HuH6 cells assessed as inhibition of replicon replication2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Discovery of novel arylethynyltriazole ribonucleosides with selective and effective antiviral and antiproliferative activity.
AID283440Inhibition of influenza A virus (A/duck/Minnesota/1525/1981 (H5N1)) replication in MDCK cells by neutral red uptake assay2007Antimicrobial agents and chemotherapy, Mar, Volume: 51, Issue:3
Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.
AID1179390Antiviral activity against Vesicular stomatitis virus infected in HeLa cells assessed as inhibition of virus-induced cytopathogenicity2014Bioorganic & medicinal chemistry, Jul-15, Volume: 22, Issue:14
Design, synthesis, antiviral and cytostatic activity of ω-(1H-1,2,3-triazol-1-yl)(polyhydroxy)alkylphosphonates as acyclic nucleotide analogues.
AID82041Antiviral activity against vaccinia virus infected HEF cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID1773015Inhibition of RSV induced apoptosis in human HEp-2 cells assessed as reduction in cleaved caspase-3 expression measured after 60 hrs by Western blot analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID474547Selectivity ratio of IC50 for MDCK cells to EC50 for Influenza A virus Wisconsin/67/2005/H3N2 by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID658746Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as reduction visual scoring of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID402750Antiviral activity against respiratory syncytial virus A2 in human Hep2 cells assessed as inhibition of virus-induced cytopathic effect1998Journal of natural products, Oct, Volume: 61, Issue:10
New iridoids from the medicinal plant Barleria prionitis with potent activity against respiratory syncytial virus.
AID395942Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean serum ALT levels at 50 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection measured on day 7 of vi2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1495715Selectivity index, ratio of CC50 for MDCK cells to IC50 for amantadine/rimantadine-resistant Influenza A virus (A/Puerto Rico/8/34(H1N1))2018Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11
Highly potent activity of isopulegol-derived substituted octahydro-2H-chromen-4-ols against influenza A and B viruses.
AID611761Antiviral activity against Parainfluenza virus 3 infected in Vero cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID659152Antiviral activity against Coxsackie virus B4 infected in HeLa cells2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID767052Antiviral activity against Adenovirus type 7 infected in human HeLa cells assessed as inhibition of virus-induced cytopathogenicity after 48 hrs by crystal violet staining method2013Bioorganic & medicinal chemistry letters, Sep-15, Volume: 23, Issue:18
Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID474544Selectivity ratio of IC50 for MDCK cells to EC50 for Influenza A virus Solomon Islands/03/2006/H1N1 by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1127184Cytotoxicity against human HuH7 cells assessed as cell viability after 3 days by XTT assay2014European journal of medicinal chemistry, May-22, Volume: 79Synthesis, antiproliferative and anti-dengue virus evaluations of 2-aroyl-3-arylquinoline derivatives.
AID99706In vitro antiviral activity against V V virus in human laryngeal epithelioma cell line1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
AID1379365Toxicity in ICR mouse infected with EV71 695F assessed as death at 50 mg/kg, ip qd administered for 7 days measured on day 62017ACS medicinal chemistry letters, Aug-10, Volume: 8, Issue:8
Discovery of Potent EV71 Capsid Inhibitors for Treatment of HFMD.
AID1113458Antiviral activity against Sendai virus infected African green monkey Vero cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID1379348Inhibition of Enterovirus 71 Shenzhen/120F1/09 capsid infected in human RD cells assessed as reduction in virus-induced cell death after 72 hrs by CCK-8 assay2017ACS medicinal chemistry letters, Aug-10, Volume: 8, Issue:8
Discovery of Potent EV71 Capsid Inhibitors for Treatment of HFMD.
AID1126468Antiviral activity against Enterovirus 71 BrCr infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect after 4 days by MTT assay2014Journal of natural products, Apr-25, Volume: 77, Issue:4
Prenylated benzoylphloroglucinols and xanthones from the leaves of Garcinia oblongifolia with antienteroviral activity.
AID717169Cytotoxicity against dog MDCK cells assessed as cell viability by MTS assay2012Bioorganic & medicinal chemistry, Dec-15, Volume: 20, Issue:24
Microwave assisted synthesis and anti-influenza virus activity of 1-adamantyl substituted N-(1-thia-4-azaspiro[4.5]decan-4-yl)carboxamide derivatives.
AID718741Antiviral activity against Influenza A virus (A/Hong Kong/7/1987(H3N2)) H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect2012Bioorganic & medicinal chemistry letters, Dec-01, Volume: 22, Issue:23
Synthesis of isoindole and benzoisoindole derivatives of teicoplanin pseudoaglycon with remarkable antibacterial and antiviral activities.
AID283988Antiviral activity against encephalomyocarditis virus by CPE assay2007Bioorganic & medicinal chemistry, Jan-01, Volume: 15, Issue:1
Design, synthesis, and biological evaluation of novel iso-D-2',3'-dideoxy-3'-fluorothianucleoside derivatives.
AID427558Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36M mutation in human HuH7 cells after 48 hrs by RNA replicon assay relative to wild type2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID659150Antiviral activity against Vesicular stomatitis virus infected in HEL cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID297315Antiviral activity against HSV2 G in HEL cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID105806Minimum toxic concentration required to cause a microscopically detectable alteration of normal MDCK cell morphology1995Journal of medicinal chemistry, Sep-01, Volume: 38, Issue:18
Synthesis and antiviral activity of benzyl-substituted imidazo [1,5-a]-1,3,5-triazine (5,8-diaza-7,9-dideazapurine) derivatives.
AID407615Cytotoxicity against human Huh-5-2 cells2008Bioorganic & medicinal chemistry letters, Jun-01, Volume: 18, Issue:11
Arylethynyltriazole acyclonucleosides inhibit hepatitis C virus replication.
AID1118651Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID105976In vitro minimum drug concentration that inhibited the influenza virus-induced cytopathogenic effects by 50% in Madin-Darby canine kidney (MDCK) host cell cultures1990Journal of medicinal chemistry, Apr, Volume: 33, Issue:4
Synthesis and biological evaluation of carbocyclic analogues of lyxofuranosides of 2-amino-6-substituted-purines and 2-amino-6-substituted-8-azapurines.
AID84599In vitro antiviral activity was tested against, herpes simplex type 2 virus (HSV-2)1985Journal of medicinal chemistry, Oct, Volume: 28, Issue:10
Synthesis and biological activity of certain 6-substituted and 2,6-disubstituted 2'-deoxytubercidins prepared via the stereospecific sodium salt glycosylation procedure.
AID1501505Selectivity index, ratio of CC50 for human RD cells to EC50 for EV71 Xiangyang-Hubei-09 infected in human RD cells
AID1503651Antiviral activity against Fluc-tagged DENV2 strain 16681 infected in human HuH7 cells assessed as inhibition of viral replication at 10 uM after 3 days by luciferase reporter gene assay relative to control2017European journal of medicinal chemistry, Dec-01, Volume: 141Discovery of novel diarylpyrazolylquinoline derivatives as potent anti-dengue virus agents.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID648649Selectivity index, ratio of TC50 for MDCK cells to IC50 for influenza A virus H3N22012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Synthesis and anti-influenza activity of aminoalkyl rupestonates.
AID1081162In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as protective effect at 500 ug/ml treated 12 hr before viral inoculation measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
AID1873814Antiviral activity against Huh 7.5 cell culture derived HCV genotype 2a (JFH-AM71) infected in human Huh7-J20 cells assessed as inhibition of viral replication at 100 uM treated for 72 hrs by SEAP reporter gene assay relative to control2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID401227Antiviral activity against PIV3 in MDCK cells assessed as inhibition of virus-induced cytopathic effect2004Journal of natural products, Apr, Volume: 67, Issue:4
Antiviral flavonoids from the seeds of Aesculus chinensis.
AID1571470Selectivity index, ratio of CC50 for MDCK cells to IC50 for Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells2018MedChemComm, Dec-01, Volume: 9, Issue:12
Synthesis of d-(+)-camphor-based
AID216392Minimum inhibitory concentration against Vesicular stomatitis virus1989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID634833Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID284533Antiviral activity against HSV1 TK- KOS ACV-induced cytopathogenicity in E6SM cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID86500The compound was tested for antiviral activity against VSV-virus in human epithelial cells2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID1252404Antiviral activity against Reovirus 1 expressed in African green monkey Vero cells assessed as reduction in cytopathogenicity2015European journal of medicinal chemistry, Sep-18, Volume: 102Novel halogenated 3-deazapurine, 7-deazapurine and alkylated 9-deazapurine derivatives of L-ascorbic or imino-L-ascorbic acid: Synthesis, antitumour and antiviral activity evaluations.
AID280199Antiviral activity against sindbis virus in Vero cells assessed as inhibition of virus-induced cytopathicity2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID569233Antiviral activity against HSV2 G infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Synthesis of new C5-(1-substituted-1,2,3-triazol-4 or 5-yl)-2'-deoxyuridines and their antiviral evaluation.
AID1736917Antiviral activity against Influenza A virus (A/goose/Guangdong/SH7/2013(H5N1)) group-1 infected in chicken embryo fibroblast assessed as reduction in viral infection preincubated for 1 hrs followed by fibroblast infection and measured after 72 hrs by hem2020European journal of medicinal chemistry, Apr-01, Volume: 191Discovery of novel "Dual-site" binding oseltamivir derivatives as potent influenza virus neuraminidase inhibitors.
AID249870Anti-bovine viral diarrhoea virus activity relative to ribavirin2004Journal of medicinal chemistry, Oct-07, Volume: 47, Issue:21
Synthesis of benzodithiol-2-yl-substituted nucleoside derivatives as lead compounds having anti-bovine viral diarrhea virus activity.
AID1377336Cytotoxicity against MDCK cells assessed as reduction in cell viability after 48 hrs by MTT assay2017European journal of medicinal chemistry, Sep-29, Volume: 138Exploring the cycloheptathiophene-3-carboxamide scaffold to disrupt the interactions of the influenza polymerase subunits and obtain potent anti-influenza activity.
AID634749Antiviral activity against Vaccinia virus infected in human HEL cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID288918Antiviral activity against Vaccinia virus in E6SM cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID396941Antiviral activity against VSV assessed as reduction in plaque formation at 100 ug
AID105769Inhibitory concentration against influenza virus A in MDCK cells1995Journal of medicinal chemistry, Sep-01, Volume: 38, Issue:18
Synthesis and antiviral activity of benzyl-substituted imidazo [1,5-a]-1,3,5-triazine (5,8-diaza-7,9-dideazapurine) derivatives.
AID257895Antiviral activity against Reovirus 1 in vero cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID718740Antiviral activity against Influenza B virus (B/Hong Kong/05/1972) H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect2012Bioorganic & medicinal chemistry letters, Dec-01, Volume: 22, Issue:23
Synthesis of isoindole and benzoisoindole derivatives of teicoplanin pseudoaglycon with remarkable antibacterial and antiviral activities.
AID634090Antiviral activity against HCV genotype 1b infected in human HuH7 cells after 3 days by renilla luciferase reporter assay2012Bioorganic & medicinal chemistry, Jan-01, Volume: 20, Issue:1
The design, synthesis and biological evaluations of C-6 or C-7 substituted 2-hydroxyisoquinoline-1,3-diones as inhibitors of hepatitis C virus.
AID474341Selectivity ratio of IC50 for MDCK cells to EC50 for inhibition of virus-induced cytopathic effect of Influenza A virus Gull/PA/4175/83/H5N12010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID283445Inhibition of viral replication of influenza A virus (A/Hong Kong/213/03(H5N1)) and influenza A virus (A/Ann Arbor/6/60(H2N2)) hybrid virus in MDCK cells by virus yield reduction assay2007Antimicrobial agents and chemotherapy, Mar, Volume: 51, Issue:3
Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.
AID1778629Inhibition of RdRP activity in Influenza A virus A/PR/8/34(H1N1) infected in HEK293T cells incubated for 24 hrs by minireplicon based dual luciferase assay2021European journal of medicinal chemistry, Oct-05, Volume: 2211,2,4-Triazolo[1,5-a]pyrimidines: Efficient one-step synthesis and functionalization as influenza polymerase PA-PB1 interaction disruptors.
AID1082872In vivo antiviral activity against Tobacco mosaic virus (TMV) inoculated right side of Nicotiana. tabacum L. leaves assessed as protection effect at 100 ug/mL preincubated 12 hr before viral challenge measured after 3 to 4 days2012Journal of agricultural and food chemistry, Jun-13, Volume: 60, Issue:23
Design, synthesis, antiviral activity, and SARs of 14-aminophenanthroindolizidines.
AID464175Cytotoxicity against VSV infected human HeLa cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1132045Antibacterial activity against Staphylococcus aureus Oxford1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID432171Antiviral activity against Vaccinia virus infected in in human HEL cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID1651273Antiviral activity against Zika virus infected in African green monkey Vero E6 cells assessed as reduction in viral induced cytopathic effect2020Bioorganic & medicinal chemistry letters, 02-15, Volume: 30, Issue:4
Design, synthesis, and evaluation of novel 4-amino-2-(4-benzylpiperazin-1-yl)methylbenzonitrile compounds as Zika inhibitors.
AID1092195In vivo antiviral activity against Tobacco mosaic virus (TMV) pre-inoculated Nicotiana tabacum L. leaves assessed as curative effect at 100 ug/mL measured after 3 to 4 days2012Journal of agricultural and food chemistry, Oct-17, Volume: 60, Issue:41
Design, synthesis, and anti-tobacco mosaic virus (TMV) activity of phenanthroindolizidines and their analogues.
AID300569Survival of mouse at 100 mg/kg, ip bid after 5 days2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID376986Cytotoxicity against MDCK cells after 3 days by MTT reduction assay2006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID1261341Antiviral activity against VSV2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID436484Antiviral activity against HSV1 infected in Vero-76 cells after 3 days by plaque reduction assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID88351Compound was evaluated for its inhibitory effect on the replication of vesicular stomatitis virus (VSV) in HeLa cells2003Bioorganic & medicinal chemistry letters, Oct-20, Volume: 13, Issue:20
Synthesis and biological evaluation of thymine nucleosides fused with 3',4'-tetrahydrofuran ring.
AID105776Tested for inhibitory effect on RNA virus Influenza B in MDCK cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID229059Concentration required to cause a microscopically detectable alteration in cell morphology in vero cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID533314Antiviral activity against HCV genotype 1b in NTZ-11 replicon cell after 4 days by blot hybridization analysis2008Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11
Potential for hepatitis C virus resistance to nitazoxanide or tizoxanide.
AID87351Compound was tested for antiviral activity in HeLa Cell cultures, against herpes simplex virus type 1 (HSV-1)1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Synthesis and antiviral evaluation of nucleosides of 5-methylimidazole-4-carboxamide.
AID475855Antiviral activity against Vaccinia virus lederle infected in human HEL cells assessed as inhibition of virus-induced cytopathicity2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID275068Antiviral activity against HSV2 in HEL cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID1077004Selectivity index, ratio of TC50 for MDCK cells to IC50 for Influenza A virus (A/FM/1/1947(H1N1))2014European journal of medicinal chemistry, Apr-09, Volume: 761,2,3-Triazole-containing derivatives of rupestonic acid: click-chemical synthesis and antiviral activities against influenza viruses.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID199875Virus rating against rhinovirus type 1A1989Journal of medicinal chemistry, Apr, Volume: 32, Issue:4
Analysis of the in vitro antiviral activity of certain ribonucleosides against parainfluenza virus using a novel computer aided receptor modeling procedure.
AID156709Evaluation for antiviral activity against vaccinia virus in primary rabbit kidney cell cultures(PRK) (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID432176Antiviral activity against HSV1 KOS infected in human HEL cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID1118656Cytotoxicity against MDCK cells assessed as concentration required to cause microscopically visible alternation of cell morphology2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID611757Antiviral activity against VSV infected in HeLa cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID32219Minimum inhibitory concentration of the compound, achieving a complete protection of ATH8 cells against the cytopathic effect of HTLV-III / LAV reverse transcriptase1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Chemotherapeutic approaches to the treatment of the acquired immune deficiency syndrome (AIDS).
AID1265173Antiviral activity against wild type Chikungunya virus IMT infected in HEK293T cells assessed as inhibition of nsP1 protein expression at 5 uM measured at 24 hrs postinfection by Western blot method2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
AID766695Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID1873817Selectivity index, ratio of CC50 for cytotoxicity against human Huh-7 J20 cells assessed as reduction in cell viability to IC50 for antiviral activity against Huh 7.5 cell culture derived HCV genotype 2a (JFH-AM71) infected in human Huh7-J20 cells assesse2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID402534Cytotoxicity against MDCK cells by neutral red assay1997Journal of natural products, Jun, Volume: 60, Issue:6
Two new lignans with activity against influenza virus from the medicinal plant Rhinacanthus nasutus.
AID275067Antiviral activity against HSV1 KOS in HEL cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID658607Cytotoxicity against MDCK cells assessed as minimum compound concentration required to causes microscopically detectable alteration of normal cell morphology2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID217561concentration required to inhibit Punta Toro virus-induced cytopathicity by 50% in Vero cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID1498134Antiviral activity against Yellow fever virus infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID1427857Antiviral activity against Influenza A virus A/95-359 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect
AID1081202Antiviral activity against Tobacco mosaic virus (TMV) infected leaves assessed as viral inhibition at 500 ug/mL at 25 degC for 72 hr2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis, crystal structure, and biological activity of 4-methyl-1,2,3-thiadiazole-containing 1,2,4-triazolo[3,4-b][1,3,4]thiadiazoles.
AID383516Antiviral activity against Vaccinia virus in human E6SM cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID432183Antiviral activity against Coxsackievirus B4 infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID419591Cytotoxicity against human HEL cells assessed as alteration in cell morphology2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID634831Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID21263Permeability coefficient reported (Expressed as Permeability coefficient x 10 e 4 cm/s)1996Journal of medicinal chemistry, Nov-22, Volume: 39, Issue:24
Computation of brain-blood partitioning of organic solutes via free energy calculations.
AID472783Cytotoxicity against human MT4 cells after 96 hrs by MTT assay2010Bioorganic & medicinal chemistry, Apr-15, Volume: 18, Issue:8
Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID611769Cytotoxicity against african green monkey Vero cells assessed as alteration of cell morphology after 3 days by microscopy2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID421728Antiviral activity against Parainfluenza virus type 3 infected in human Hep2 cells assessed as inhibition of virus-induced cytopathogenic effect by plaque reduction assay2009Journal of natural products, May-22, Volume: 72, Issue:5
Antiviral constituents against respiratory viruses from Mikania micrantha.
AID539916Antiviral activity against Herpes simplex virus-2 G infected in human HEL cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID1538477Antiviral activity against Coxsackievirus A16 TA271 infected in human RD cells assessed as inhibition of virus-induced cytopathic effect preincubated with viral suspension for 2 hrs followed by cell addition and measured after 24 hrs by CCK-8 assay2019Journal of natural products, 05-24, Volume: 82, Issue:5
Effects of Acetylshikonin on the Infection and Replication of Coxsackievirus A16 in Vitro and in Vivo.
AID548423Cytotoxicity against human HEL cells assessed as altered cell morphology2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID539949Cytotoxicity against MDCK cells assessed as minimum concentration required to cause microscopically detectable alteration after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID718739Toxicity in MDCK cells assessed as induction of cell morphology changes2012Bioorganic & medicinal chemistry letters, Dec-01, Volume: 22, Issue:23
Synthesis of isoindole and benzoisoindole derivatives of teicoplanin pseudoaglycon with remarkable antibacterial and antiviral activities.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID468093Antiviral activity against SFV infected in BHK cells after 14 hrs by luciferase reporter gene assay2009Journal of natural products, Nov, Volume: 72, Issue:11
Betulin-derived compounds as inhibitors of alphavirus replication.
AID535523Transport through CNT3 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer containing 100 uM NBMPR and 1 mM inosine2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1186430Inhibition of HCV RNA replication in human Li23 cells (ORL8 system) by renilla luciferase reporter gene based replication assay2014Bioorganic & medicinal chemistry letters, Sep-01, Volume: 24, Issue:17
Synthesis and inhibitory activity on hepatitis C virus RNA replication of 4-(1,1,1,3,3,3-hexafluoro-2-hydroxy-2-propyl)aniline analogs.
AID1503319Cytotoxicity against bovine MDBK cells assessed as decrease in cell viability after 72 hrs by MTT assay2017European journal of medicinal chemistry, Dec-01, Volume: 141Inhibitors of Yellow Fever Virus replication based on 1,3,5-triphenyl-4,5-dihydropyrazole scaffold: Design, synthesis and antiviral evaluation.
AID275089Cytotoxicity against Vero cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID217564concentration required to inhibit reovirus-1-induced cytopathicity by 50% in Vero cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID691394Antiviral activity against Hepatitis C virus subtype 1a infected in human HuH7 cells after 2 days by q-PCR analysis2012Bioorganic & medicinal chemistry letters, Oct-15, Volume: 22, Issue:20
A new class of pyrimidine nucleosides: inhibitors of hepatitis B and C viruses.
AID416784Antiviral activity against influenza B virus in MDCK cells assessed as reduction of virus-induced cytopathicity by visual cytopathic effect scoring method2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1773423Antiviral activity against Vesicular stomatitis virus Indiana infected in A549 cells assessed as inhibition of viral adsorption at early stage of replication treated for 1 hr during viral infection followed by replacement with fresh medium and measured af2021European journal of medicinal chemistry, Dec-05, Volume: 225Novel betulin dicarboxylic acid ester derivatives as potent antiviral agents: Design, synthesis, biological evaluation, structure-activity relationship and in-silico study.
AID275073Antiviral activity against para influenza 3 virus in Vero cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID1135881Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in viral excretion by measuring hemagglutination units per ml at 13 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to da1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID216347Tested for antiviral activity against Reo-1 virus in African green monkey kidney cell (Vero)2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID1230107Antiviral activity against Punta Toro virus infected in African green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Design, antiviral and cytostatic properties of isoxazolidine-containing amonafide analogues.
AID593227Selectivity index, ratio of TC50 for african green monkey Vero cells to IC50 for Coxsackievirus A162011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
Inhibitory properties of 2-substituent-1H-benzimidazole-4-carboxamide derivatives against enteroviruses.
AID514140Selectivity index, ratio of CC50 for human HuH7 cells to EC50 for2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Studies on the anti-hepatitis C virus activity of newly synthesized tropolone derivatives: identification of NS3 helicase inhibitors that specifically inhibit subgenomic HCV replication.
AID1753727Antiviral activity against Zika virus infected in African green monkey Vero cells assessed as inhibition of viral replication at 20 uM measured after 4 days relative to control2021Journal of natural products, 04-23, Volume: 84, Issue:4
Semisynthesis of Dolabellane Diterpenes: Oxygenated Analogues with Increased Activity against Zika and Chikungunya Viruses.
AID395932Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 g of liver at 20 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1773049Antiviral activity against RSV infected in BALB/c mouse assessed as downregulation of TLR3 expression in lung tissue infected with RSV at 50 mg/kg/day measured after 2 to 6 days post infection by RT-PCR analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID395972Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 mL of serum at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID105967Minimum inhibitory concentration required to reduce influenza A H2N2 virus induced cytopathogenicity by 50% in madin-Darby canine kidney cells (MDCK)2001Bioorganic & medicinal chemistry letters, Aug-20, Volume: 11, Issue:16
Novel 3-(2-adamantyl)pyrrolidines with potent activity against influenza A virus-identification of aminoadamantane derivatives bearing two pharmacophoric amine groups.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID324792Antiviral activity against YFV Jimenez infected in Syrian golden hamster assessed as mean day to death after 21 days post-infection at 50 mg/kg, ip bid for 7 days2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Activity of T-1106 in a hamster model of yellow Fever virus infection.
AID1261342Antiviral activity against Vaccinia virus2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID1398129Antiviral activity against Influenza A virus (A/Virginia/ATCC1/2009(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathicity after 48 hrs by crystal violet staining based method2018Bioorganic & medicinal chemistry letters, 09-15, Volume: 28, Issue:17
Generation of methylated violapyrones with improved anti-influenza A virus activity by heterologous expression of a type III PKS gene in a marine Streptomyces strain.
AID387602Cytotoxicity against human HeLa cells assessed as alteration in cell morphology by MTS assay2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis and antiviral evaluation of acyclic azanucleosides developed from sulfanilamide as a lead structure.
AID659285Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID1433156Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID217268Effective concentration required to inhibit reovirus-induced cytopathicity by 50% in Vero cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID527723Cytotoxicity against human HuH7 cells after 2 days by XTT assay2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
Synthesis and in vitro antiviral activities of 3'-fluoro (or chloro) and 2',3'-difluoro 2',3'-dideoxynucleoside analogs against hepatitis B and C viruses.
AID324823Antiviral activity against YFV Jimenez infected in Syrian golden hamster liver treated 4 hrs before viral challenge assessed as alanine aminotransferase at 50 mg/kg/day, ip bid for 8 days2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Activity of T-1106 in a hamster model of yellow Fever virus infection.
AID1205006Selectivity index, ratio of TC50 for african green monkey Vero cells to IC50 for Coxsackievirus B2 infected in african green monkey Vero cells2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID376984Antiviral activity against HSV1 15577 in african green monkey Vero cells assessed as reduction of virus induced cytopathic effect2006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID216177Tested for inhibitory effect on RNA virus Coxsackie B4 in Vero cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID257341Selectivity index (toxicity/antiviral activity)2005Bioorganic & medicinal chemistry letters, Dec-15, Volume: 15, Issue:24
Synthesis and in vitro anti-hepatitis B and C virus activities of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID162252Compound was tested for antiviral activity (minimum inhibition concentration) in HeLa cells polio virus type 11984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID1773430Selectivity index, ratio of CC50 for cytotoxicity against human A549 cells to EC50 for antiviral activity against Enterovirus E LCR-4 infected in A549 cells assessed as reduction in virus titer treated 1 hr post viral infection followed by replacement wit2021European journal of medicinal chemistry, Dec-05, Volume: 225Novel betulin dicarboxylic acid ester derivatives as potent antiviral agents: Design, synthesis, biological evaluation, structure-activity relationship and in-silico study.
AID569236Antiviral activity against HCMV AD169 infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Synthesis of new C5-(1-substituted-1,2,3-triazol-4 or 5-yl)-2'-deoxyuridines and their antiviral evaluation.
AID370200Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean day of death at 10 mg/kg, po twice daily for 5 days administered 24 hrs post viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1154645Cytotoxicity against mock-infected human Hep2 cells by XTT assay2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Antiviral C-25 epimers of 26-acetoxy steroids from the South China Sea gorgonian Echinogorgia rebekka.
AID1886810Antiviral activity against DENV2 infected in hamster BHK-21 cells assessed as inhibition of plaque formation by measuring reduction in PFU per well incubated for 6 days by crystal violet staining based assay2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID368962Antiviral activity against RSV B infected human Hep2 cells after 5 days by plaque reduction assay2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID535513Transport through CNT3 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID369461Antiviral activity against La Crosse virus assessed as inhibition of virus-induced visual cytopathic effect after 3 to 5 days2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID434318Antiviral activity against Coxsackievirus B4 infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID71890Tested for inhibitory effect on RNA virus cell growth in FM3A cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1435481Antiviral activity against Coxsackievirus B3 Nancy infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect2017European journal of medicinal chemistry, Jan-27, Volume: 126Synthesis and evaluation of halogenated 12N-sulfonyl matrinic butanes as potential anti-coxsackievirus agents.
AID419596Antiviral activity against thymidine kinase-deficient acyclovir-resistant HSV1 KOS infected in human HEL cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID482710Cytotoxicity against human HeLa cells by MTT assay2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID1505498Cytotoxicity against HGPRT deficient 6-thioguanine-resistant MDCK cells assessed as change in cell morphology after 3 days by microscopic analysis2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID86684Effective concentration required to inhibit vesicular stomatitis virus (VSV)-induced cytopathicity by 50% in HeLa cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID1782693Cytotoxicity in human Hep2 cells assessed as reduction in cell viability measured after 3 days by beckman coulter counting method2021European journal of medicinal chemistry, Aug-05, Volume: 220Phenoxazine nucleoside derivatives with a multiple activity against RNA and DNA viruses.
AID593225Selectivity index, ratio of TC50 for african green monkey Vero cells to IC50 for Coxsackievirus B32011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
Inhibitory properties of 2-substituent-1H-benzimidazole-4-carboxamide derivatives against enteroviruses.
AID763861Selectivity index, ratio of CC50 for MDCK cells to EC50 for Influenza A virus (A/California/07/2009(H1N1))2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis and biological activity evaluation of 5-pyrazoline substituted 4-thiazolidinones.
AID370212Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean day of death at 10 mg/kg, po twice daily for 5 days administered 24 hrs post viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID294253Antiviral activity against HCV in Huh7 ET cells assessed as HCV RNA derived luciferase activity at 10 uM by replicon assay relative to control2007Bioorganic & medicinal chemistry letters, Apr-15, Volume: 17, Issue:8
Structure-activity relationship studies on anti-HCV activity of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID312072Ratio of kcat/Km of Poliovirus RNA dependent RNA polymerase incorporation into sym/sub-C primer relative to control2008Journal of medicinal chemistry, Jan-10, Volume: 51, Issue:1
Effects of introduction of hydrophobic group on ribavirin base on mutation induction and anti-RNA viral activity.
AID66941Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against TK- HSV-1 virus in E6SM cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID1485238Antiviral activity against Sindbis virus infected in African green monkey Vero cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID1118652Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID368957Antiviral activity against RSV RSS infected human Hep2 cells assessed as inhibition of virus-induced cell death after 6 days by XTT assay2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID1783341Cytotoxicity against human A549 cells assessed as reduction in cell viability measured after 24 hrs by MTT assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID674873Antiviral activity against Influenza B virus (strain B/Jifang/13/97) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect2012European journal of medicinal chemistry, Sep, Volume: 55Synthesis and antiviral activity of substituted bisaryl amide compounds as novel influenza virus inhibitors.
AID82052Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on HEF cell line infected with vesicular stomatitis virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID87137Evaluation in HeLa cell cultures for cytotoxicity that is to cause microscopically detectable alteration of normal cell morphology1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID87154Minimum inhibitory concentration against Coxsackie virus B4 in HeLa cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID1135894Cytotoxicity against MDCK cells infected with Influenza A virus Port Chalmers/1/73 (H3N2) after 3 days by carbol fuchsin staining-based assay1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID427551Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease T54A double mutation in human HuH7 cells after 48 hrs by RNA replicon assay2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID96660Dose required to inhibit proliferation of L-1210 Cells by 50%1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID94995Evaluated for cell growth inhibition and induction of cellular differentiation of human myeloid leukemia cell line (K562)1990Journal of medicinal chemistry, Jan, Volume: 33, Issue:1
Growth inhibition and induction of cellular differentiation of human myeloid leukemia cells in culture by carbamoyl congeners of ribavirin.
AID1783340Antiviral activity against Influenza A Puerto Rico/8/34/H1N1 infected in human A549 cells assessed as inhibition of viral replication after 24 hrs by hemagglutination assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID247999Antiviral activity against Coxsackie virus B3 growth by 50% in Vero cells2005Bioorganic & medicinal chemistry letters, Jan-17, Volume: 15, Issue:2
Synthesis and antiviral activity against Coxsackie virus B3 of some novel benzimidazole derivatives.
AID765052Cytotoxicity against african green monkey OR6 cells after 72 hrs by WST1 assay2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Peroxisome proliferator-activated receptor delta antagonists inhibit hepatitis C virus RNA replication.
AID86682Effective concentration required to inhibit Coxsackie virus B4-induced cytopathicity by 50% in HeLa cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID1204069Antiviral activity against BVDV infected in bovine MDBK cells assessed as protection against viral-induced cytopathogenecity after 3 to 4 days by MTT method2015Bioorganic & medicinal chemistry letters, Jun-01, Volume: 25, Issue:11
N-((1,3-Diphenyl-1H-pyrazol-4-yl)methyl)anilines: A novel class of anti-RSV agents.
AID87158Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against polio 1 virus in HeLa cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID1391708Antiviral activity against Influenza A virus (A/WSN/1933(H1N1)) infected in MDCK cells cocultured with human 293T-Gluc cells at 20 uM preincubated with compound for 2 hrs followed by virus infection measured after 24 hrs by luciferase reporter gene assay 2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Secoiridoid analogues from the fruits of Ligustrum lucidum and their inhibitory activities against influenza A virus.
AID1503654Antiviral activity against Fluc-tagged DENV2 strain 16681 infected in human HuH7 cells after 3 days by luciferase reporter gene assay2017European journal of medicinal chemistry, Dec-01, Volume: 141Discovery of novel diarylpyrazolylquinoline derivatives as potent anti-dengue virus agents.
AID1767881Selectivity index, ratio of CC50 for cytotoxicity against dog MDCK cells to IC50 for antiviral activity against Oseltamivir resistant Influenza A virus (A/Tianjin-Jinnan/15/2009(H1N1)) infected in dog MDCK cells2021European journal of medicinal chemistry, Oct-15, Volume: 222Optimization and SAR research at the piperazine and phenyl rings of JNJ4796 as new anti-influenza A virus agents, part 1.
AID1127185Selectivity index, ratio of CC50 for human HuH7 cells to IC50 for DENV2 166812014European journal of medicinal chemistry, May-22, Volume: 79Synthesis, antiproliferative and anti-dengue virus evaluations of 2-aroyl-3-arylquinoline derivatives.
AID395931Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 g of liver at 50 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID416767Antiviral activity against Coxsackievirus B4 in african green monkey Vero cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID273213Antiviral activity against coxsackievirus B3 in HeLa S3 cells assessed as reduction in viral titer2006Journal of medicinal chemistry, Oct-19, Volume: 49, Issue:21
Synthesis and antiviral activity of 5-substituted cytidine analogues: identification of a potent inhibitor of viral RNA-dependent RNA polymerases.
AID105973Concentration required to reduce the viability of MDCK cells1999Bioorganic & medicinal chemistry letters, Dec-20, Volume: 9, Issue:24
Synthesis of 2-(2-adamantyl)piperidines and structure anti-influenza virus A activity relationship study using a combination of NMR spectroscopy and molecular modeling.
AID87165Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Coxsackie virus B4 in HeLa cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID693526Antiviral activity against Influenza B/HK/5/72 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect measured on day 3 post infection by MTS assay2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis of fluorescent ristocetin aglycon derivatives with remarkable antibacterial and antiviral activities.
AID1655773Cytotoxicity against human HuH7 cells assessed as reduction in cell viability by measuring ATP level measured after 72 hrs by CellTiter-Glo luminescent assay2020ACS medicinal chemistry letters, May-14, Volume: 11, Issue:5
Exploring the Implication of DDX3X in DENV Infection: Discovery of the First-in-Class DDX3X Fluorescent Inhibitor.
AID548438Cytotoxicity against MDCK cells assessed as altered cell morphology2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID291037Antiviral activity against coxsackie B4 virus in HeLa cells assessed as reduction of virus plaque formation after 7 days2007Journal of medicinal chemistry, Jun-28, Volume: 50, Issue:13
Novel C-6 fluorinated acyclic side chain pyrimidine derivatives: synthesis, (1)H and (13)C NMR conformational studies, and antiviral and cytostatic evaluations.
AID1432501Cytotoxicity against MDCK cells after 48 hrs by by Reed and Muench analysis2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Structure-activity relationship studies of 1-(1'-hydroxyalkyl)rupestonic acid methyl esters against influenza viruses.
AID84218Inhibitory activity against TK-deficient HSV-1 (KOS) replication in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID464186Cytotoxicity against Human coxsackievirus B4 infected african green monkey Vero cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1081549In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as protective effect at 100 ug/ml treated 12 hr before viral inoculation measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID294255Selectivity index, ratio of toxicity against Huh7 ET cells to viral activity against HCV2007Bioorganic & medicinal chemistry letters, Apr-15, Volume: 17, Issue:8
Structure-activity relationship studies on anti-HCV activity of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID198431In vitro antiviral activity was tested against rift valley fever virus(RVF)1985Journal of medicinal chemistry, Sep, Volume: 28, Issue:9
Synthesis and biological activity of 5-thiobredinin and certain related 5-substituted imidazole-4-carboxamide ribonucleosides.
AID1427860Antiviral activity against Coxsackievirus B3 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect
AID622533Selectivity index, ratio of TC50 for african green monkey vero cells to IC50 for Enterovirus 712011Bioorganic & medicinal chemistry letters, Oct-01, Volume: 21, Issue:19
Synthesis, structure-activity relationship and in vitro biological evaluation of N-arylethyl isoquinoline derivatives as Coxsackievirus B3 inhibitors.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1873829Selectivity index, ratio of CC50 for cytotoxicity against human Huh7.5 cells assessed as reduction in cell viability to IC50 for antiviral activity against Zika virus H/PAN/2016/BEI-259634 infected in human Huh7.5 cells assessed as reduction in viral tite2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID1783395Cytotoxicity against human Calu-3 cells infected with SARS-COV-2 by celltiter-glo luminescent cell viability assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1443672Antiviral activity against Influenza virus A/WSN/33(H1N1) infected in human 293T cells assessed as inhibition of viral replication at 20 uM preincubated for 2 hrs followed by viral infection measured after 24 hrs by luciferase reporter gene assay relative2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Anti-influenza triterpenoid saponins (saikosaponins) from the roots of Bupleurum marginatum var. stenophyllum.
AID712807Antiviral activity against Influenza A virus (A/X-31(H3N2)) infected in MDCK cells assessed as virus-induced cytopathic effect measured 3 days post infection by microscopic analysis2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID1135880Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in viral excretion by measuring hemagglutination units per ml at 7 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to day1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID283442Inhibition of Influenza A virus (A/gull/Pennsylvania/4175/83 (H5N1)) replication in MDCK cells by neutral red uptake assay2007Antimicrobial agents and chemotherapy, Mar, Volume: 51, Issue:3
Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.
AID308657Antiviral activity against influenza A/Hong Kong/7/87 (H3N2) in MDCK cells assessed as inhibition of virus-induced cytopathic effect by MTS assay2007Bioorganic & medicinal chemistry letters, Aug-01, Volume: 17, Issue:15
Design and synthesis of bioactive adamantane spiro heterocycles.
AID657387Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as inhibition of virus induced cytopathicity after 48 hrs2012Bioorganic & medicinal chemistry letters, May-01, Volume: 22, Issue:9
Pyronepolyene C-glucosides with NF-κB inhibitory and anti-influenza A viral (H1N1) activities from the sponge-associated fungus Epicoccum sp. JJY40.
AID1505490Antiviral activity against Influenza virus B/Ned/537/05 infected in MDCK cells assessed as reduction in viral replication at 3 days post infection by microscopic analysis2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID1659828Antiviral activity against Influenza A virus A/WSN/33(H1N1) infected in human 293T cells pretreated for 2 hrs followed by viral infection and measured after 24 hrs by Gaussia luciferase reporter gene assay2020Bioorganic & medicinal chemistry letters, 06-01, Volume: 30, Issue:11
Design, synthesis and anti-influenza A virus activity of novel 2,4-disubstituted quinazoline derivatives.
AID1235016Cytotoxicity against African green monkey Vero cells assessed as growth inhibition by CPE assay2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Bioactive Sesquiterpenes and Lignans from the Fruits of Xanthium sibiricum.
AID383511Cytotoxicity against human HEL cells assessed as alteration of cell morphology2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1505496Antiviral activity against Influenza virus B/Ned/537/05 infected in HGPRT deficient 6-thioguanine-resistant MDCK cells assessed as reduction in viral replication at 3 days post infection by microscopic analysis2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID1783354Selectivity index, ratio of CC50 for human Huh-7 cells to IC50 for Zika virus H/PF/2013 infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based direct yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID1498139Cytotoxicity against MDCK cells assessed as alteration of cell morphology by microscopic analysis2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID622444Cytotoxicity against african green monkey Vero cells infected with Coxsackievirus B3 assessed as growth inhibition after 48 hrs by Reed-Muench analysis2011Bioorganic & medicinal chemistry letters, Oct-01, Volume: 21, Issue:19
Synthesis, structure-activity relationship and in vitro biological evaluation of N-arylethyl isoquinoline derivatives as Coxsackievirus B3 inhibitors.
AID68122Concentration required to reduce HSV-2(G) induced cytopathogenicity by 50% in ESM(embryonic skin muscle) cell cultures.1992Journal of medicinal chemistry, Jun-12, Volume: 35, Issue:12
(+-)-carbocyclic 5'-nor-2'-deoxyguanosine and related purine derivatives: synthesis and antiviral properties.
AID395967Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 g of liver at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1578006Selectivity index, ratio of TC50 for cytotoxicity against dog MDCK cells to IC50 for antiviral activity against Influenza A virus H3N2 infected in dog MDCK cells2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Novel amides modified rupestonic acid derivatives as anti-influenza virus reagents.
AID1055007Cytotoxicity against human BE(2)-C cells assessed as cell viability at 25 uM after 24 hrs by MTT assay relative to control2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Optimization of novel indole-2-carboxamide inhibitors of neurotropic alphavirus replication.
AID324804Antiviral activity against YFV Jimenez infected in Syrian golden hamster assessed as weight change at 50 mg/kg, po bid for 7 days2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Activity of T-1106 in a hamster model of yellow Fever virus infection.
AID87155Minimum inhibitory concentration against Vesicular stomatitis virus in HeLa cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID105799Tested for minimum inhibitory concentration required to cause a microscopically detectable alteration of normal cell morphology by 50% on MDCK cell line1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID156706Evaluation for antiviral activity against herpes simplex virus-2(196) in primary rabbit kidney cell cultures(PRK) (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID548433Antiviral activity against coxsackievirus B4 infected in human HeLa cells assessed as inhibition of virus induced cytopathicity by visual scoring of CPE2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID634746Antiviral activity against Herpes simplex virus 1 KOS infected in human HEL cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1234202Cytotoxic activity against African green monkey Vero cells assessed as cytopathogenic effect incubated for 48 hrs2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Antiviral Matrine-Type Alkaloids from the Rhizomes of Sophora tonkinensis.
AID1071699Selectivity index, ratio of CC50 for cytotoxicity to EC50 for Influenza A virus H5N12014European journal of medicinal chemistry, Mar-03, Volume: 74Synthesis and biological evaluation of 2-oxonicotinonitriles and 2-oxonicotinonitrile based nucleoside analogues.
AID288917Antiviral activity against HSV2 G in E6SM cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID161449Minimum cytotoxic concentration required to cause a microscopically detectable alteration of normal cell morphology and show antiviral activity in primary rabbit kidney (PRK) cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID514138Antiviral activity against HCV Con 1 by subgenomic replicon assay2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Studies on the anti-hepatitis C virus activity of newly synthesized tropolone derivatives: identification of NS3 helicase inhibitors that specifically inhibit subgenomic HCV replication.
AID105959Minimum cytotoxic concentration required to cause a microscopically detectable alteration of MDCK, Madin-Darby canine kidney cell morphology.2003Bioorganic & medicinal chemistry letters, May-19, Volume: 13, Issue:10
Spiro[pyrrolidine-2,2'-adamantanes]: synthesis, anti-influenza virus activity and conformational properties.
AID1610153Cytotoxicity against human HELF cells assessed as minimum cytotoxic concentration by observing alteration in cell morphology incubated for 3 days by microscopic analysis2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
AID1274010Antiviral activity against DENV-2 New guinea infected in African green monkey Vero cells assessed as reduction in plaque formation administered post viral infection after 8 days by crystal violet staining technique2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID1501503Cytotoxicity against human Hep2 cells assessed as reduction in cell viability after 3 days by MTT assay
AID658751Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of virus-induced cytopathogenicity after 4 days by colorimetric formazan-based MTS assay2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID229230Concentration required to reduce vesicular stomatitis virus induced cytopathogenicity by 50% in HeLa cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID1432504Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect after 40 hrs2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Structure-activity relationship studies of 1-(1'-hydroxyalkyl)rupestonic acid methyl esters against influenza viruses.
AID63915Effective concentration required to inhibit Herpes simplex virus-1(HSV-1) / thymine kinase deficient (TK-)B2006 / VMW1837 induced cytopathicity by 50% in E6SM cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID1571468Cytotoxicity against MDCK cells assessed as reduction in cell viability after 48 hrs by MTT assay2018MedChemComm, Dec-01, Volume: 9, Issue:12
Synthesis of d-(+)-camphor-based
AID1261315Antiviral activity against human CVB5 infected in african green monkey Vero76 cells assessed as inhibition of virus-induced cytopathogenicity after 3 days by plaque reduction assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID436485Cytotoxicity against hamster BHK21 cells assessed as reduction in cell viability after 48 to 96 hrs by MTT assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID1077006Cytotoxicity against MDCK cells after 48 hrs2014European journal of medicinal chemistry, Apr-09, Volume: 761,2,3-Triazole-containing derivatives of rupestonic acid: click-chemical synthesis and antiviral activities against influenza viruses.
AID395948Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 g of liver at 50 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1450213Antiviral activity against HSV1 L2 infected in African green monkey Vero E6 cells assessed as reduction in virus-induced cytopathic effect2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID464190Cytotoxicity against Influenza A virus subtype H1N1 infected MDCK cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID474338Selectivity ratio of IC50 for MDCK cells to EC50 for inhibition of virus-induced cytopathic effect of Influenza A virus Duck/MN/1525/81/H5N12010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID763860Selectivity index, ratio of CC50 for MDCK cells to EC50 for Influenza A virus (A/duck/Minnesota/1525/1981(H5N1))2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis and biological activity evaluation of 5-pyrazoline substituted 4-thiazolidinones.
AID1201120Antiviral activity against Influenza A virus (A/Hong Kong/7/1987(H3N2)) infected in MDCK cells assessed as cell viability after 72 hrs by MTS assay2015European journal of medicinal chemistry, Apr-13, Volume: 94A few atoms make the difference: synthetic, CD, NMR and computational studies on antiviral and antibacterial activities of glycopeptide antibiotic aglycon derivatives.
AID1433155Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID1280361Antiviral activity against oseltamivir-resistant influenza A virus LN/1109 (H1N1) infected in dog MDCK cells assessed as inhibition of virus induced cytopathic effect after 40 hrs by Cell-Titer-Glo assay2016European journal of medicinal chemistry, Jan-27, Volume: 108Spiromastilactones: A new class of influenza virus inhibitors from deep-sea fungus.
AID217562concentration required to inhibit Sindbis virus -induced cytopathicity by 50% in Vero cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID226343Concentration required to reduce sindbis virus induced cytopathogenicity by 50% in vero cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID68129Tested for inhibitory effect on DNA virus VV in ESM cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID436483Antiviral activity against Respiratory syncytial virus A2 infected in Vero-76 cells after 5 days by plaque reduction assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID659284Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID370215Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in liver at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID283446Inhibition of viral replication of influenza A virus (A/Vietnam/1203/2004 (H5N1)) and influenza A virus (A/Ann Arbor/6/60(H2N2)) hybrid virus in MDCK cells by neutral red uptake assay2007Antimicrobial agents and chemotherapy, Mar, Volume: 51, Issue:3
Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.
AID1687963Antiproliferative activity against human A-431 cells assessed as reduction in cell growth at 100 uM incubated for 72 hrs by MTT assay relative to control2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID94763Tested for inhibition of virus-induced cytopathogenic effect and cytotoxicity of compound against Japanese encephalitis virus with najayama strain in vero cell1988Journal of medicinal chemistry, Sep, Volume: 31, Issue:9
Cyclopentenylcytosine. A carbocyclic nucleoside with antitumor and antiviral properties.
AID1696839Antiviral activity against Influenza A virus (A/Duck/Guangdong/212/2004(H5N1)) infected in Balb/c mouse assessed as increase in animal survival rate at 80 mg/kg administered intranasally once daily for 5 days starting from 1 day prior to infection and mon2020Bioorganic & medicinal chemistry letters, 11-15, Volume: 30, Issue:22
Structure-aided optimization of 3-O-β-chacotriosyl epiursolic acid derivatives as novel H5N1 virus entry inhibitors.
AID1542954Cytotoxicity in African green monkey Vero E6 cells assessed as reduction in cell viability by MTS assay2019ACS medicinal chemistry letters, Apr-11, Volume: 10, Issue:4
Scaffold Morphing Approach To Expand the Toolbox of Broad-Spectrum Antivirals Blocking Dengue/Zika Replication.
AID432181Antiviral activity against Reovirus 1 infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1783345Antiviral activity against Dengue virus serotype 2 New Guinea C infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based direct yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID370221Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean serum ALT levels at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID264705Antiviral activity against TMV2006Bioorganic & medicinal chemistry letters, May-15, Volume: 16, Issue:10
Discovery of bitriazolyl compounds as novel antiviral candidates for combating the tobacco mosaic virus.
AID392525Antiviral activity against influenza B virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID1886805Antiviral activity against ZIKV infected in African green monkey Vero E6 cells assessed as inhibition of plaque formation by measuring reduction in PFU per well at 12.4 to 100 ug/ml incubated for 72 hrs by crystal violet staining based assay relative to c2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID225769Concentration required to reduce polio virus type 1 induced cytopathogenicity by 50% in HeLa cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID1229725Selectivity index, ratio of CC50 for African green monkey Vero B cells to EC50 for DENV serotype 2 strain New Guinea V2015Journal of medicinal chemistry, Jun-25, Volume: 58, Issue:12
Discovery of Multitarget Antivirals Acting on Both the Dengue Virus NS5-NS3 Interaction and the Host Src/Fyn Kinases.
AID1873819Cytotoxicity against human Huh7.5 cells assessed as reduction in cell viability by MTS assay2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID1886801Cytotoxicity against African green monkey Vero E6 cells measured after 72 hrs by MTT assay2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID301698Binding to Trypanosoma cruzi recombinant S-adenosyl-L-homocysteine hydrolase NADH form expressed in Escherichia coli JM1092007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID1167618Antiviral activity against Hepatitis C virus infected in African green monkey OR6 cells after 72 hrs by luciferase reporter gene assay2014Bioorganic & medicinal chemistry, Nov-01, Volume: 22, Issue:21
Synthesis of 3',4'-difluoro-3'-deoxyribonucleosides and its evaluation of the biological activities: discovery of a novel type of anti-HCV agent 3',4'-difluorocordycepin.
AID1433133Cytotoxicity against african green monkey Vero cells assessed as alteration of normal cell morphology by microscopic analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID393164Cytotoxicity against MDCK cells assessed as changes in cell morphology after 72 hrs by MTS assay2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design and synthesis of 1,2-annulated adamantane piperidines with anti-influenza virus activity.
AID217836Minimum inhibitory concentration required to reduce vaccinia virus(VV) induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID674871Antiviral activity against Influenza A virus (A/Guangdong-Luohu/219/2006(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect2012European journal of medicinal chemistry, Sep, Volume: 55Synthesis and antiviral activity of substituted bisaryl amide compounds as novel influenza virus inhibitors.
AID1071701Selectivity index, ratio of CC50 for cytotoxicity to EC50 for Influenza A virus H3N22014European journal of medicinal chemistry, Mar-03, Volume: 74Synthesis and biological evaluation of 2-oxonicotinonitriles and 2-oxonicotinonitrile based nucleoside analogues.
AID1783356Antiviral activity against West Nile virus lineage 1 (Italy/2009) infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 48 hrs by immunodetection based secondary yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID376981Antiviral activity against RSV Long in human Hep2 cells assessed as reduction of virus induced cytopathic effect2006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID1133178Antiviral activity against HSV1 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs relative to control1978Journal of medicinal chemistry, Dec, Volume: 21, Issue:12
Synthesis and antiviral and enzymatic studies of certain 3-deazaguanines and their imidazolecarboxamide precursors.
AID278358RBV metabolism in Vero E6 cells assessed as RBV-MP concentration at 10 ug/ml after 24 h2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID1773043Antiviral activity against RSV infected in BALB/c mouse assessed as inhibition of viral replication by measuring RSV-M gene expression in lung after 2 to 6 days post infection by RT-PCR analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID478321Antiviral activity against influenza A virus H1N1 assessed as cell viability by cell based MTS assay2010Bioorganic & medicinal chemistry letters, May-01, Volume: 20, Issue:9
Click reaction synthesis of carbohydrate derivatives from ristocetin aglycon with antibacterial and antiviral activity.
AID539929Cytotoxicity against human HeLa cells assessed as minimum concentration required to cause microscopically detectable alteration after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID634751Antiviral activity against Human cytomegalovirus AD169 infected in human HEL cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1501507Selectivity index, ratio of CC50 for human HEP2 cells to EC50 for Coxsackievirus B3 (strain Nancy) infected in human HEP cells
AID416774Antiviral activity against HSV2 G in human HEL cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1869549Cytotoxicity against human HEp-2 cells assessed as reduction in cell viability
AID368959Antiviral activity against RSV RSS infected human Hep2 cells after 5 days by plaque reduction assay2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID1150891Antiviral activity against Rhinovirus type 13 infected in human KB cells1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Synthesis of 1-(4-thio-beta-D-ribofuranosyl)-1,2,4-triazole-3-carboxamide.
AID92456Inhibitory dose of compound required to inhibit cytopathogenic effects of influenza virus with A2/Aichi/2/68 strain in MDCK cells1988Journal of medicinal chemistry, Sep, Volume: 31, Issue:9
Cyclopentenylcytosine. A carbocyclic nucleoside with antitumor and antiviral properties.
AID218063Maximum tolerated concentration (MTC) was evaluated in vero cells.1985Journal of medicinal chemistry, Sep, Volume: 28, Issue:9
Synthesis and biological activity of 5-thiobredinin and certain related 5-substituted imidazole-4-carboxamide ribonucleosides.
AID768187Antiviral activity against influenza B virus infected in dog MDCK cells assessed as reduction of virus-induced cytopathogenicity by MTS assay2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID1081164In vitro antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves at 500 ug/ml2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
AID297320Antiviral activity against Coxsackie virus B4 in Vero cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID1716990Antiviral activity against Influenza A virus A/WSN/33(H1N1) infected in HEK293T cells assessed as relative fluorescence intensity at 20 uM pretreated for 2 hrs followed by viral infection and measured after 24 hrs by Gaussia luciferase reporter gene metho2020European journal of medicinal chemistry, Jan-15, Volume: 186Design and synthesis of 2-((1H-indol-3-yl)thio)-N-phenyl-acetamides as novel dual inhibitors of respiratory syncytial virus and influenza virus A.
AID1773032Antiviral activity against RSV infected in human HEp-2 cells assessed as downregulation of RIG-1 expression at 25 uM treated 48 hpi and measured after 48 hrs by Western blot analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID1372324Cytotoxicity against pig SPEV cells by microscopic analysis2018Bioorganic & medicinal chemistry letters, 01-01, Volume: 28, Issue:1
Isosteric ribavirin analogues: Synthesis and antiviral activities.
AID1118648Antiviral activity against Coxsackievirus B4 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1066046Antiviral activity against influenza A virus A/Padova/30/2011(H1N1) clinical isolate infected in MDCK cells assessed as inhibition of plaque formation after 2 days by toluidine blue staining assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID1610161Cytotoxicity against dog MDCK cells assessed as minimum cytotoxic concentration by observing alteration in cell morphology incubated for 3 days by microscopic analysis2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
AID763863Antiviral activity against Influenza B virus (B/Florida/4/2006) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect by cell-based neutral red uptake assay2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis and biological activity evaluation of 5-pyrazoline substituted 4-thiazolidinones.
AID216386Compound was tested for antiviral activity in HeLa Cell cultures, against vesicular stomatitis virus (VSV), cytopathic effect induced by the virus (CPE)1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Synthesis and antiviral evaluation of nucleosides of 5-methylimidazole-4-carboxamide.
AID701513Cytotoxicity against uninfected human Hep2 cells assessed as cell viability at 25 uM measured after 144 hrs by Cell Titer-Glo assay2012Journal of medicinal chemistry, Oct-25, Volume: 55, Issue:20
(S)-N-(2,5-Dimethylphenyl)-1-(quinoline-8-ylsulfonyl)pyrrolidine-2-carboxamide as a small molecule inhibitor probe for the study of respiratory syncytial virus infection.
AID280196Antiviral activity against RSV Long in HeLa cells assessed as inhibition of virus-induced cytopathicity2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID216362Antiviral activity against Coxsackie B4 virus infected vero cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID217824In vitro antiviral activity was tested against, vaccinia virus (VV)1985Journal of medicinal chemistry, Oct, Volume: 28, Issue:10
Synthesis and biological activity of certain 6-substituted and 2,6-disubstituted 2'-deoxytubercidins prepared via the stereospecific sodium salt glycosylation procedure.
AID1271121Antiviral activity against recombinant HCV genotype 2a JFH1 infected in human Huh7 cells incubated for 5 hrs measured on day 3 post infection by luciferase reporter gene assay2015Journal of medicinal chemistry, Dec-24, Volume: 58, Issue:24
Structure-Based Discovery of Novel Cyclophilin A Inhibitors for the Treatment of Hepatitis C Virus Infections.
AID1082874In vivo antiviral activity against Tobacco mosaic virus (TMV) pre-inoculated Nicotiana. tabacum L. leaves assessed as curative effect at 100 ug/mL measured after 3 to 4 days2012Journal of agricultural and food chemistry, Jun-13, Volume: 60, Issue:23
Design, synthesis, antiviral activity, and SARs of 14-aminophenanthroindolizidines.
AID464191Cytotoxicity against Influenza A virus subtype H3N2 infected MDCK cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID217867In vitro antiviral activity was tested against venezuelan equine encephalomyelitis (VEE)1985Journal of medicinal chemistry, Sep, Volume: 28, Issue:9
Synthesis and biological activity of 5-thiobredinin and certain related 5-substituted imidazole-4-carboxamide ribonucleosides.
AID395973Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in serum at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1226135Cytotoxicity against human HEK293T cells assessed as decrease in cell viability by MTT assay2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
A Broad Anti-influenza Hybrid Small Molecule That Potently Disrupts the Interaction of Polymerase Acidic Protein-Basic Protein 1 (PA-PB1) Subunits.
AID280195Antiviral activity against coxsackie B4 virus in Vero cells assessed as inhibition of virus-induced cytopathicity2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID535504Transport through ENT1 in mouse hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID216229Tested for its anti-polio activity against Vesicular stomatitis virus2002Bioorganic & medicinal chemistry letters, May-20, Volume: 12, Issue:10
Heterocyclic nucleoside analogues: design and synthesis of antiviral, modified nucleosides containing isoxazole heterocycles.
AID1699936Cytotoxicity against dog MDCK cells assessed as reduction in cell viability by MTT assay2020Bioorganic & medicinal chemistry letters, 12-15, Volume: 30, Issue:24
New type of anti-influenza agents based on benzo[d][1,3]dithiol core.
AID1081553In vitro antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves at 500 ug/ml2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID668362In vitro antiviral activity against TMV at 500 ug/ml2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis and antiviral activity of novel pyridazines.
AID1234206Antiviral activity against influenza A virus (A/Hanfang/359/95(H3N2)) infected in MDCK cells assessed as inhibition of virus-induced cytopathogenic effect dosed 1 hr after viral adsorption2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Antiviral Matrine-Type Alkaloids from the Rhizomes of Sophora tonkinensis.
AID1135412Antiviral activity against type 1 parainfluenza virus infected in mouse assessed as mouse mean death day at 99 mg/kg, po thrice a day for 8 days after 1 hr viral infection (Rvb = 8.9 days)1977Journal of medicinal chemistry, Feb, Volume: 20, Issue:2
Synthesis and antiviral activity of certain thiazole C-nucleosides.
AID1200496Antiviral activity against amantadine and ribavirin-resistant influenza A virus A/HuNan-huHui/1222/2010 (H3N2) strain2015European journal of medicinal chemistry, Mar-26, Volume: 93Neoechinulin B and its analogues as potential entry inhibitors of influenza viruses, targeting viral hemagglutinin.
AID1731877Antiviral activity against Influenza A virus A/WSN/33(H1N1) infected in human HEK-293T cells assessed as inhibition of viral replication after 48 hrs by CCK-8 assay2021European journal of medicinal chemistry, Mar-15, Volume: 214Synthesis and antiviral activity of a series of novel quinoline derivatives as anti-RSV or anti-IAV agents.
AID539924Antiviral activity against Coxsackie virus B4 infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID1433146Antiviral activity against Coxsackievirus B4 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID392503Antiviral activity against Camelpox virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID1498133Antiviral activity against Punta Toro virus infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID393166Antiviral activity against influenza B virus2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design and synthesis of 1,2-annulated adamantane piperidines with anti-influenza virus activity.
AID216100Evaluated for cell growth inhibition and induction of cellular differentiation of human B-lymphoblast cell line (WI-L2)1990Journal of medicinal chemistry, Jan, Volume: 33, Issue:1
Growth inhibition and induction of cellular differentiation of human myeloid leukemia cells in culture by carbamoyl congeners of ribavirin.
AID464176Cytotoxicity against Human coxsackievirus B4 infected human HeLa cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID229232Concentration required to reduce vesicular stomatitis virus induced cytopathogenicity by 50% in primary rabbit kidney cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID217896Minimum inhibitory concentration against reovirus in Vero cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID1135885Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in viral excretion by measuring hemagglutination units per ml at 14 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to da1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID421725Antiviral activity against Respiratory syncytial virus infected in human Hep2 cells assessed as inhibition of virus-induced cytopathogenic effect by plaque reduction assay2009Journal of natural products, May-22, Volume: 72, Issue:5
Antiviral constituents against respiratory viruses from Mikania micrantha.
AID400425Selectivity index, ratio of EC50 for RSV A-2 by plaque neutralization over IC50 for human Hep2 cells1998Journal of natural products, May, Volume: 61, Issue:5
Antiviral phenylpropanoid glycosides from the medicinal plant Markhamia lutea.
AID569231Antiviral activity against HSV1 KOS infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Synthesis of new C5-(1-substituted-1,2,3-triazol-4 or 5-yl)-2'-deoxyuridines and their antiviral evaluation.
AID105800Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on MDCK cell line infected with influenza A virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID535527Transport through CNT1 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer containing 100 uM NBMPR and 1 mM uridine2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID387582Cytotoxicity against african green monkey Vero cells assessed as alteration in cell morphology by MTS assay2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis and antiviral evaluation of acyclic azanucleosides developed from sulfanilamide as a lead structure.
AID288929Antiviral activity against VSV in HeLa cells2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID436480Antiviral activity against Reovirus-1 infected in BHK-21 cells assessed as inhibition of virus-induced cytopathicity after 3 to 4 days by MTT assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID763923Cytotoxicity against MDCK cells2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis and biological activity evaluation of 5-pyrazoline substituted 4-thiazolidinones.
AID395976Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean serum ALT levels at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID217894Minimum inhibitory concentration against Sindbis virus in Vero cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID1253098Selectivity index, ratio of CC50 for human HuH7-J20 cells expressing secreted alkaline phosphatase reporter gene preincubated for 1 hr followed by fresh drug administration every 24 hrs for 48 hrs to EC50 for HCV JFH1 infected in human HuH7-J20 cells prei2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Rethinking the old antiviral drug moroxydine: Discovery of novel analogues as anti-hepatitis C virus (HCV) agents.
AID539915Antiviral activity against Herpes simplex virus-1 KOS infected in human HEL cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID156689Antiviral activity was measured against Vaccinia virus in rabbit kidney cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID548448Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID216522Minimum toxic concentration required to cause a microscopically detectable alteration of normal vero cell morphology1995Journal of medicinal chemistry, Sep-01, Volume: 38, Issue:18
Synthesis and antiviral activity of benzyl-substituted imidazo [1,5-a]-1,3,5-triazine (5,8-diaza-7,9-dideazapurine) derivatives.
AID1303368Selectivity index, ratio of CC50 for MDBK cells to EC50 for mock-infected BVDV NADL infected in MDBK cells2016European journal of medicinal chemistry, Jul-19, Volume: 117A combined in silico/in vitro approach unveils common molecular requirements for efficient BVDV RdRp binding of linear aromatic N-polycyclic systems.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1524777Antiviral activity against Influenza A virus (A/California/7/2009(H1N1)) infected in MDCK cells assessed as reduction in virus-induced cytopathic effect measured on day 5 by Celltiter-Glo luminescence assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Identification, design and synthesis of novel pyrazolopyridine influenza virus nonstructural protein 1 antagonists.
AID539948Cytotoxicity against MDCK cells by MTS assay2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID765049Antagonist activity at human PPARalpha assessed as effect on TIPP-703-induced activity at 10 uM2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Peroxisome proliferator-activated receptor delta antagonists inhibit hepatitis C virus RNA replication.
AID717281Antiviral activity against Influenza A virus (A/PR/8/34(H1N1)) infected in MDCK cells assessed as virus-induced cytopathic effect after 3 days by microscopic analysis2012Bioorganic & medicinal chemistry, Dec-15, Volume: 20, Issue:24
Microwave assisted synthesis and anti-influenza virus activity of 1-adamantyl substituted N-(1-thia-4-azaspiro[4.5]decan-4-yl)carboxamide derivatives.
AID1113460Antiviral activity against Human parainfluenza virus 3 infected African green monkey Vero cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID395946Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean day of death at 50 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID472784Cytotoxicity against MDBK cells after 48 to 96 hrs by MTT assay2010Bioorganic & medicinal chemistry, Apr-15, Volume: 18, Issue:8
Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID1194165Antiviral activity against DENV serotype 2 strain New Guinea C infected in african green monkey Vero cells assessed as reduction in production and release of infectious progeny virions after 2 hrs by virus yield-reduction assay2015Bioorganic & medicinal chemistry letters, Apr-15, Volume: 25, Issue:8
Design, synthesis, optimization and antiviral activity of a class of hybrid dengue virus E protein inhibitors.
AID659287Antiviral activity against influenza B virus infected in MDCK cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID68128Tested for inhibitory effect on DNA virus TK-HSV-1(VMW 1837) in ESM cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1152080Cytotoxicity against human HEK293T cells after 24 hrs by MTT assay2014Journal of medicinal chemistry, May-22, Volume: 57, Issue:10
Optimization of small-molecule inhibitors of influenza virus polymerase: from thiophene-3-carboxamide to polyamido scaffolds.
AID395679Cytotoxicity against african green monkey Vero cells after 7 to 8 days by neutral-red dye uptake assay2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID472795Antiviral activity against Vaccinia virus Elstree-Lister infected in african green monkey Vero cells after 3 days by plaque reduction assay2010Bioorganic & medicinal chemistry, Apr-15, Volume: 18, Issue:8
Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID434314Antiviral activity against RSV infected in human HeLa cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID1443884Antiviral activity against full length gluc-tagged Chikungunya virus IMT infected in human BJ cells assessed as reduction in virus infection after 24 hrs by gaussia luciferase reporter gene assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Structural Optimizations of Thieno[3,2-b]pyrrole Derivatives for the Development of Metabolically Stable Inhibitors of Chikungunya Virus.
AID668363In vivo antiviral activity against TMV assessed as inactivation effect at 500 ug/ml2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis and antiviral activity of novel pyridazines.
AID1171740Antiviral activity against Respiratory syncytial virus infected in human Hep2 cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs by XTT assay2014Journal of natural products, Dec-26, Volume: 77, Issue:12
Anti-respiratory syncytial virus prenylated dihydroquinolone derivatives from the gorgonian-derived fungus Aspergillus sp. XS-20090B15.
AID162251Minimum inhibitory concentration required to reduce Polio virus type 1 induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID474542Selectivity ratio of IC50 for MDCK cells to EC90 for Influenza A virus California/07/2009 /H1N1 by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID65707Antiviral activity against Vaccinia virus in E6SM cell cultures2001Journal of medicinal chemistry, Aug-02, Volume: 44, Issue:16
Design, synthesis, DNA binding, and biological evaluation of water-soluble hybrid molecules containing two pyrazole analogues of the alkylating cyclopropylpyrroloindole (CPI) subunit of the antitumor agent CC-1065 and polypyrrole minor groove binders.
AID218033Antiviral activity was measured against Sindbis virus in african green monkey kidney (Vero B) cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID300558Antiviral activity against influenza A/Yuefang/243/72 (H3N2) virus in MDCK cells by CPE assay2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID383512Antiviral activity against HSV1 KOS in human E6SM cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1135879Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in viral excretion by measuring hemagglutination units per ml at 7 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to day1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID1736920Antiviral activity against Influenza A virus (A/goose/Jiangsu/1306/2014 (H5N8)) group-1 infected in chicken embryo fibroblast assessed as reduction in viral infection preincubated for 1 hrs followed by fibroblast infection and measured after 72 hrs by hem2020European journal of medicinal chemistry, Apr-01, Volume: 191Discovery of novel "Dual-site" binding oseltamivir derivatives as potent influenza virus neuraminidase inhibitors.
AID419592Antiviral activity against HSV1 KOS infected in human HEL cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID369465Selectivity index, ratio of CC50 for african green monkey Vero 76 cells to EC50 for La Crosse virus2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID261589Inhibition of West Nile virus VLP replicon in BHK21 cell line2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Identification of compounds with anti-West Nile Virus activity.
AID1571893Displacement of [3H]N6-R-phenylisopropyladenosine from mouse A1A adenosine receptor expressed in CHO cell membranes after 60 mins by scintillation proximity assay2019Journal of medicinal chemistry, 02-14, Volume: 62, Issue:3
Design and in Vivo Characterization of A
AID659283Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID288930Antiviral activity against Coxsackie virus B4 in HeLa cells2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID463981Antiviral activity against Human coxsackievirus B4 infected in human HeLa cells assessed as protection from virus-induced cytopathogenicity after 2 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID290451Antiviral activity against SARS-CoV Frankfurt1 in Vero E6 cells by plaque reduction assay2007Bioorganic & medicinal chemistry letters, May-01, Volume: 17, Issue:9
Synthesis and biological evaluation of nucleoside analogues having 6-chloropurine as anti-SARS-CoV agents.
AID105793Antiviral activity of compound was tested against morphology virus infec+ted MDCK cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID88349Compound was evaluated for its inhibitory effect on the replication of Coxsackie virus B3 (Cox. B3) in HeLa cells2003Bioorganic & medicinal chemistry letters, Oct-20, Volume: 13, Issue:20
Synthesis and biological evaluation of thymine nucleosides fused with 3',4'-tetrahydrofuran ring.
AID1503653Cytotoxicity against human HuH7 cells assessed as cell viability at 200 uM after 3 days by XTT method relative to control2017European journal of medicinal chemistry, Dec-01, Volume: 141Discovery of novel diarylpyrazolylquinoline derivatives as potent anti-dengue virus agents.
AID1409614Overall antiviral activity against SARS-CoV-2 (isolate France/IDF0372/2020) in the Vero E6 cell line at 48 h based on three assays 1) detection of viral RNA by qRT-PCR (targeting the N-gene), 2) plaque assay using lysate 3 days after addition of compound 2020Nature, 07, Volume: 583, Issue:7816
A SARS-CoV-2 protein interaction map reveals targets for drug repurposing.
AID261590Inhibition of West Nile viral Rluc-Neo-Rep in Vero cells2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Identification of compounds with anti-West Nile Virus activity.
AID464181Cytotoxicity against VSV infected HEL cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID257897Antiviral activity against Coxsackie virus B4 in vero cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID369871Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as survival at 30 mg/kg, po twice daily for 5 days 24 hrs post viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID427553Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36A/R155K double mutation in human HuH7 cells after 48 hrs by RNA replicon assay2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID86801Antiviral activity against polio 1 virus infected HeLa cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID762954Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) PR/8 infected in MDCK cells assessed as protection against virus-induced cytopathogenicity after 48 hrs by crystal-violet staining-based assay2013Journal of natural products, Jul-26, Volume: 76, Issue:7
Indole-diterpenoids with anti-H1N1 activity from the aciduric fungus Penicillium camemberti OUCMDZ-1492.
AID535516Transport through CNT1 in rat hepatocytes by oil filtration assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID370213Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 g of liver at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1558283Cytotoxicity against African green monkey Vero cells2020Journal of medicinal chemistry, 01-23, Volume: 63, Issue:2
Drugs for the Treatment of Zika Virus Infection.
AID1246933Selectivity index, ratio of CC50 for MDCK cells by visual method to EC50 for Influenza A virus (A/California/07/2009(H1N1) virus by visual method2015European journal of medicinal chemistry, Sep-18, Volume: 102Synthesis and antiviral activity of some new bis-1,3-thiazole derivatives.
AID463996Antiviral activity against Human coxsackievirus B4 infected in african green monkey Vero cells assessed as protection from virus-induced cytopathogenicity after 2 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1069923Selectivity index, ratio of beta-actin level in human HuH7 cells to viral RNA level in HCV infected in human Huh7 cells2014Bioorganic & medicinal chemistry letters, Feb-15, Volume: 24, Issue:4
Dual inhibition of HCV and HIV by ring-expanded nucleosides containing the 5:7-fused imidazo[4,5-e][1,3]diazepine ring system. In vitro results and implications.
AID611759Antiviral activity against Coxsackievirus B4 infected in HeLa cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID1450221Selectivity index, ratio of MCC for African green monkey Vero E6 cells to IC50 for HSV-1 F+ infected in African green monkey Vero E6 cells2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID257886Antiviral activity against HEL cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID634757Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID88686Tested for inhibitory effect on RNA virus RSV in HeLa cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1505494Antiviral activity against Influenza virus A/X-31 infected in HGPRT deficient 6-thioguanine-resistant MDCK cells assessed as reduction in viral replication at 3 days post infection by microscopic analysis2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID1450224Antiviral activity against acyclovir and cidofovir-resistant HSV-1 L2 infected in African green monkey Vero E6 cells assessed as reduction in virus-induced cytopathic effect2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID548440Antiviral activity against Influenza A H1N1 virus subtype infected in MDCK cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID216502Tested for minimum inhibitory concentration required to cause a microscopically detectable alteration of normal cell morphology by 50% on vero cell line1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID288919Antiviral activity against thymidine kinase-deficient HSV1 B2006 in E6SM cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID535526Transport through ENT2 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer containing 100 uM NBMPR and 1 mM uridine2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID63609Tested for antiviral activity against vaccinia virus in human embryonic skin muscle fibroblast2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID1691562Antiviral activity against Influenza A virus (A/PR 8/34 (H1N1)) clone 2 infected in MDCK cells assessed as reduction in virus-induced cytopathic effect measured after 72 hrs by MTS assay2020European journal of medicinal chemistry, May-15, Volume: 194N-benzyl 4,4-disubstituted piperidines as a potent class of influenza H1N1 virus inhibitors showing a novel mechanism of hemagglutinin fusion peptide interaction.
AID63760The minimum inhibitory concentration was measured on E6SM cells against Herpes simplex virus type 1 (McIntyre strain)1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID432169Cytotoxicity against HEL cells assessed as minimum cytotoxic concentration required to cause microscopically detectable alteration in normal cell morphology2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID65844Cytotoxic concentration required to cause microscopically detectable alteration of normal cell morphology of E6SM cells1996Journal of medicinal chemistry, Jul-05, Volume: 39, Issue:14
Synthesis of acyclo-C-nucleosides in the imidazo[1,2-a]pyridine and pyrimidine series as antiviral agents.
AID1571469Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as reduction in virus titer pretreated with cells for 1 hr followed by viral infection for 1 hr and subsequent unbound virion washout measured after 242018MedChemComm, Dec-01, Volume: 9, Issue:12
Synthesis of d-(+)-camphor-based
AID1486232Selectivity index, ratio of CC50 for bovine MDBK cells to EC50 for Bovine viral diarrhea virus 1-NADL
AID1132058Antiviral activity against Coxsackievirus B1 infected in human HeLa cells by agar diffusion assay1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID218405Minimum inhibitory concentration required to reduce reovirus-1 induced cytopathogenicity by 50% in african green monkey (VeroB)cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID257891Antiviral activity against Vaccinia virus in HEL cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID401230Selectivity index, ratio of CC50 for MDCK cells to IC50 for influenza virus type A H1N12004Journal of natural products, Apr, Volume: 67, Issue:4
Antiviral flavonoids from the seeds of Aesculus chinensis.
AID283447Inhibition of viral replication of influenza A virus (A/Vietnam/1203/2004 (H5N1)) and influenza A virus (A/Ann Arbor/6/60(H2N2)) hybrid virus in MDCK cells by virus yield reduction assay2007Antimicrobial agents and chemotherapy, Mar, Volume: 51, Issue:3
Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.
AID474358Antiviral activity against Influenza A virus Wisconsin/67/2005/H3N2 infected MDCK cells after 3 days by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID395947Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean day of death at 20 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID766691Antiviral activity against Parainfluenza virus 3 infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID218007Minimum inhibitory concentration against vaccinia virus in primary rabbit kidney cell cultures of experiment 21989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID81761In vitro antiviral activity against parainfluenza type 3 (para 3) type 1 (HSV-1) virus was determined in human laryngeal epithelioma (HEp-2,H)expressed as virus rating. Toxic level(>1000 ug/mL)1982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID1205005Selectivity index, ratio of TC50 for african green monkey Vero cells to IC50 for Coxsackievirus B1 infected in african green monkey Vero cells2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID395703Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 mL of serum at 40 mg/kg, po twice daily for 7 days administered 4 hrs before viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1687968Antiproliferative activity against human IGROV-1 cells assessed as reduction in cell growth incubated for 4 days by trypan blue exclusion assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID218005Minimum inhibitory concentration against vaccinia virus in Vero cell cultures of experiment 21989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID453101Antiviral activity against Measles virus infected in intracranially dosed hamster assessed as inhibition of subacute sclerosing panencephalitis2009Bioorganic & medicinal chemistry, Dec-01, Volume: 17, Issue:23
Synthesis, tautomerism, and antimicrobial, anti-HCV, anti-SSPE, antioxidant, and antitumor activities of arylazobenzosuberones.
AID105979In vitro antiviral activity against influenza virus (type A0/PR/8/34) in Madin-Darby canine kidney (MDCK) host cell cultures1990Journal of medicinal chemistry, Apr, Volume: 33, Issue:4
Synthesis and biological evaluation of carbocyclic analogues of lyxofuranosides of 2-amino-6-substituted-purines and 2-amino-6-substituted-8-azapurines.
AID228985Antiviral activity against semliki forest virus (SFV) in Vero cell culture lines1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID217903Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against reo type 1 virus in Vero cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID539931Antiviral activity against Coxsackie virus B4 infected in human HeLa cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID1472390Cytotoxicity against MDCK cells assessed as effect on cell morphology after 72 hrs by microscopic method2018Journal of medicinal chemistry, 01-11, Volume: 61, Issue:1
Aniline-Based Inhibitors of Influenza H1N1 Virus Acting on Hemagglutinin-Mediated Fusion.
AID1204999Antiviral activity against Coxsackievirus B3 infected in african green monkey Vero cells assessed as reduction in viral-induced cytopathic effect2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID249261Minimum inhibitory concentration against coxsackie virus B4 was determined2005Bioorganic & medicinal chemistry letters, Mar-15, Volume: 15, Issue:6
QSAR for anti-RNA-virus activity, synthesis, and assay of anti-RSV carbonucleosides given a unified representation of spectral moments, quadratic, and topologic indices.
AID87147Evaluation for antiviral activity against polio virus-1 in HeLa cell cultures (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID360159Antiviral activity against HCV 1b with NS3-4A R155T mutation in human Huh7 cells after 48 hrs by replicon cell assay2007The Journal of biological chemistry, Aug-03, Volume: 282, Issue:31
Phenotypic and structural analyses of hepatitis C virus NS3 protease Arg155 variants: sensitivity to telaprevir (VX-950) and interferon alpha.
AID1638585Cytotoxicity against African green monkey Vero cells after 3 days by MTT assay2019Journal of medicinal chemistry, 03-14, Volume: 62, Issue:5
DDX3X Helicase Inhibitors as a New Strategy To Fight the West Nile Virus Infection.
AID216979Percentage plaque reduction was determined against Sandfly fever (SF) virus in african green monkey kidney (vero,V) at a conc of 25-100 ug/mL. Toxic level(>1000 ug/mL); 61-901982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID370217Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 mL of serum at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1495714Antiviral activity against amantadine/rimantadine-resistant Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as inhibition of viral replication after 48 hrs by hemagglutination test2018Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11
Highly potent activity of isopulegol-derived substituted octahydro-2H-chromen-4-ols against influenza A and B viruses.
AID1682704Antiviral activity against Influenza A virus (A/Puerto Rico/8/34 (H1N1) infected in MDCK cells assessed as decrease in viral titer preincubated for 1 hr followed by viral infection and cultivated for 48 hrs followed by supernatant transferred to chicken e
AID1181484Cytotoxicity against MDCK cells assessed as reduction in cell viability after 72 hrs by MTS assay2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID434312Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID278348Inhibition of viral RNA levels in HTNV 76-118-infected Vero E6 cells at 2 ug/ml after 3 days2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1092194In vivo antiviral activity against Tobacco mosaic virus (TMV) inoculated right side of Nicotiana tabacum L. leaves assessed as protection effect at 500 ug/mL preincubated 12 hr before viral challenge measured after 3 to 4 days2012Journal of agricultural and food chemistry, Oct-17, Volume: 60, Issue:41
Design, synthesis, and anti-tobacco mosaic virus (TMV) activity of phenanthroindolizidines and their analogues.
AID1610157Antiviral activity against Influenza B virus (B/Ned/537/05) infected in dog MDCK cells assessed as reduction in virus-induced cytopathogenicity incubated for 7 days by microscopic analysis2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
AID693527Cytotoxicity against MDCK cells assessed as minimum concentration required to cause microscopically detectable alteration measured on day 3 post infection by MTS assay2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis of fluorescent ristocetin aglycon derivatives with remarkable antibacterial and antiviral activities.
AID63759The minimum inhibitory concentration was measured on E6SM cells against Herpes simplex virus type 1 (F strain)1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID261586Inhibition of Rluc-FL-WNV replicon in Vero cells2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Identification of compounds with anti-West Nile Virus activity.
AID1610155Antiviral activity against Influenza A virus (A/Ned/378/05(H1N1)) infected in dog MDCK cells assessed as reduction in virus-induced cytopathogenicity incubated for 7 days by microscopic analysis2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
AID1246930Antiviral activity against Influenza A virus (A/California/07/2009(H1N1)) infected in MDCK cell line assessed as reduction of virus induced cytopathic effect by neutral red assay2015European journal of medicinal chemistry, Sep-18, Volume: 102Synthesis and antiviral activity of some new bis-1,3-thiazole derivatives.
AID1831637Antiviral activity against Zika virus infected in human Huh-7 cells assessed as inhibition of viral replication at 12.5 uM measured after 48 hrs by Renilla reporter based luciferase assay relative to control2021ACS medicinal chemistry letters, Dec-09, Volume: 12, Issue:12
Nanoparticular Inhibitors of Flavivirus Proteases from Zika, West Nile and Dengue Virus Are Cell-Permeable Antivirals.
AID220035Concentration required to reduce coxsackie virus 4 induced cytopathogenicity by 50% in HeLa cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID1336613Antiviral activity against Yellow fever virus infected in African green monkey Vero cells assessed as protection against virus-induced cytopathic effect measured after 3 to 5 days by microscopic analysis2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Synthesis and in vitro antiviral evaluation of 4-substituted 3,4-dihydropyrimidinones.
AID283444Inhibition of viral replication of influenza A virus (A/Hong Kong/213/03(H5N1)) and influenza A virus (A/Ann Arbor/6/60(H2N2)) hybrid virus in MDCK cells by neutral red uptake assay2007Antimicrobial agents and chemotherapy, Mar, Volume: 51, Issue:3
Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID536243Selectivity index, ratio of MCC for MDCK cells to EC50 for Influenza A virus (A/Hong Kong/7/1987(H3N2))2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Design and synthesis of bioactive adamantanaminoalcohols and adamantanamines.
AID1783350Antiviral activity against Zika virus H/PF/2013 infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based secondary yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID1408325Antiviral activity against Influenza A virus A/Virginia/ATCC3/2009(H1N1pdm) infected in MDCK cells after 3 days by MTS assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID217269Effective concentration required to inhibit respiratory synaptial (RSV) virus-induced cytopathicity by 50% in Vero cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID63758The minimum inhibitory concentration was measured against Herpes simplex virus type 1 (KOS strain) on E6SM cells1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID400417Antiviral activity against RSV long infected in human Hep2 cells assessed as virus-induced cytopathic effect after 3 days1998Journal of natural products, May, Volume: 61, Issue:5
Antiviral phenylpropanoid glycosides from the medicinal plant Markhamia lutea.
AID370211Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean day of death at 30 mg/kg, po twice daily for 5 days administered 24 hrs post viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1524779Antiviral activity against Influenza A virus (A/Brisbane/10/2007(H3N2)) infected in MDCK cells assessed as reduction in virus-induced cytopathic effect measured on day 5 by Celltiter-Glo luminescence assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Identification, design and synthesis of novel pyrazolopyridine influenza virus nonstructural protein 1 antagonists.
AID421730Therapeutic index, ratio of TC50 for human Hep2 cells to IC50 for Parainfluenza virus type 3 infected in human Hep2 cells2009Journal of natural products, May-22, Volume: 72, Issue:5
Antiviral constituents against respiratory viruses from Mikania micrantha.
AID548430Cytotoxicity against human HeLa cells assessed as altered cell morphology2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID226098Minimum inhibitory concentration against Herpes simplex virus 1(KOS) in primary rabbit kidney cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID611766Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID1691561Antiviral activity against Influenza A virus (A/PR 8/34 (H1N1)) clone 2 infected in MDCK cells assessed as reduction in virus-induced cytopathic effect measured after 72 hrs by microscopic analysis2020European journal of medicinal chemistry, May-15, Volume: 194N-benzyl 4,4-disubstituted piperidines as a potent class of influenza H1N1 virus inhibitors showing a novel mechanism of hemagglutinin fusion peptide interaction.
AID229024Inhibitory activity against vaccinia virus (VV) replication in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID1055015Antiviral activity against Western equine encephalomyelitis virus infected in human BE(2)-C cells assessed as inhibition of viral RNA replication after 18 to 20 hrs by luciferase reporter gene assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Optimization of novel indole-2-carboxamide inhibitors of neurotropic alphavirus replication.
AID1273992Antiviral activity against HHV-2 VR-734-G infected in African green monkey Vero cells assessed as reduction of viral titer at maximal non-toxic concentration after 72 hrs by crystal violet staining assay relative to control2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID434311Antiviral activity against acyclovir-resistant thymidine kinase-deficient HSV1 KOS infected in human HEL cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID1578003Antiviral activity against Influenza A virus H1N1 infected in dog MDCK cells assessed as inhibition in virus-induced cytopathic effect incubated for 40 hrs2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Novel amides modified rupestonic acid derivatives as anti-influenza virus reagents.
AID1710782Antiviral activity against Mammalian orthoreovirus 1 infected in African green monkey Vero cells assessed as reduction in virus-induced cytopathic effect incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID1655774Selectivity index, ratio of CC50 for human HuH7 cells assessed as reduction in cell viability by measuring ATP level measured after 72 hrs by CellTiter-Glo luminescent assay to EC50 for Dengue virus serotype 2 New Guinea C infected at 50 TCID50 in human H2020ACS medicinal chemistry letters, May-14, Volume: 11, Issue:5
Exploring the Implication of DDX3X in DENV Infection: Discovery of the First-in-Class DDX3X Fluorescent Inhibitor.
AID66942Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against vaccinia virus in E6SM cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID291036Antiviral activity against Punta Toro virus in Vero cells assessed as reduction of virus plaque formation after 7 days2007Journal of medicinal chemistry, Jun-28, Volume: 50, Issue:13
Novel C-6 fluorinated acyclic side chain pyrimidine derivatives: synthesis, (1)H and (13)C NMR conformational studies, and antiviral and cytostatic evaluations.
AID68257Minimum inhibitory concentration to reduce cytopathicity by 50% in morphology of human embryonic skin-muscle cells (ESM)1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis and antiviral activities of 8-alkynyl-, 8-alkenyl-, and 8-alkyl-2'-deoxyadenosine analogues.
AID395938Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in serum at 20 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1226134Antiviral activity against Influenza A virus (A/PR/8/34) (H1N1) infected in MDCK cells assessed as reduction in plaque formation after 48 hrs by plaque reduction assay2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
A Broad Anti-influenza Hybrid Small Molecule That Potently Disrupts the Interaction of Polymerase Acidic Protein-Basic Protein 1 (PA-PB1) Subunits.
AID86688Antiviral activity against Coxsackie B4 virus infected HeLa cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID82045Tested for minimum inhibitory concentration required to cause a microscopically detectable alteration of normal cell morphology by 50% on HEF cell line1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID428948Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36A mutation in human HuH7 cells after 48 hrs by RNA replicon assay2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID1472389Cytotoxicity against MDCK cells assessed as decrease in cell viability after 72 hrs by MTS assay2018Journal of medicinal chemistry, 01-11, Volume: 61, Issue:1
Aniline-Based Inhibitors of Influenza H1N1 Virus Acting on Hemagglutinin-Mediated Fusion.
AID424779Therapeutic index, CC50 for human HeLa cells to IC50 for Coxsackie virus B3 Nacy2009Journal of natural products, May-22, Volume: 72, Issue:5
Anti-coxsackie virus B3 norsesquiterpenoids from the roots of Phyllanthus emblica.
AID548431Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as inhibition of virus induced cytopathicity by visual scoring of CPE2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID766689Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID1773013Inhibition of RSV induced apoptosis in human HEp-2 cells assessed as reduction in cleaved caspase-7 expression measured after 48 hrs by Western blot analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID472786Cytotoxicity against african green monkey Vero cells2010Bioorganic & medicinal chemistry, Apr-15, Volume: 18, Issue:8
Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID361406Cytotoxicity against human HeLa cells after 2 days by MTT assay2002Journal of natural products, Nov, Volume: 65, Issue:11
New saponins from the starfish Certonardoa semiregularis.
AID217118Percentage plaque reduction was determined against yellow fever(YF) virus in african green monkey kidney (vero,V).Toxic level(>1000 ug/mL); 61-901982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID474335Antiviral activity against Influenza A virus Vietnam/1203/ 2004H/H5N1 infected MDCK cells after 42 to 46 hrs by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1409404Antiviral activity against Influenza A virus A/goose/Guangdong/SH7/2013(H5N1) infected in chicken embryo fibroblasts assessed as reduction in cytopathic effect after 48 hrs by CCK-8 assay2018Journal of medicinal chemistry, 11-21, Volume: 61, Issue:22
Structure-Based Optimization of N-Substituted Oseltamivir Derivatives as Potent Anti-Influenza A Virus Agents with Significantly Improved Potency against Oseltamivir-Resistant N1-H274Y Variant.
AID297318Antiviral activity against Reovirus 1 in Vero cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID371503Selectivity index, ratio of CC50 for MDBK cells to EC50 for bovine viral diarrhoea virus type-1 NADL2008European journal of medicinal chemistry, Aug, Volume: 43, Issue:8
New 1-indanone thiosemicarbazone derivatives active against BVDV.
AID167327Concentration required to cause a microscopically detectable alteration in cell morphology in primary rabbit kidney cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID1485237Antiviral activity against Coxsackie B4 virus infected in African green monkey Vero cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID70209Antiviral activity against influenza B (Hong kong/5/72) in human epithelial cells2003Bioorganic & medicinal chemistry letters, May-19, Volume: 13, Issue:10
Spiro[pyrrolidine-2,2'-adamantanes]: synthesis, anti-influenza virus activity and conformational properties.
AID701507Antiviral activity against Respiratory syncytial virus Long infected in human Hep2 cells assessed as reduction in virus-induced cytopathogenicity by Cell Titer-Glo assay2012Journal of medicinal chemistry, Oct-25, Volume: 55, Issue:20
(S)-N-(2,5-Dimethylphenyl)-1-(quinoline-8-ylsulfonyl)pyrrolidine-2-carboxamide as a small molecule inhibitor probe for the study of respiratory syncytial virus infection.
AID1578005Antiviral activity against Influenza A virus H3N2 infected in dog MDCK cells assessed as inhibition in virus-induced cytopathic effect incubated for 40 hrs2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Novel amides modified rupestonic acid derivatives as anti-influenza virus reagents.
AID395674Antiviral activity against Punta Toro virus Adames infected Syrian golden hamster assessed as inhibition of liver damage at 30 mg/kg, po twice daily administered 4 hrs before viral challenge measured on day 4 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID475235Therapeutic index, ratio of CC50 for human HuH7 cells to EC50 for HCV 1b2010Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8
Synthesis of new acridone derivatives, inhibitors of NS3 helicase, which efficiently and specifically inhibit subgenomic HCV replication.
AID82034Antiviral activity against HSV-1 virus infected HEF cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID658612Antiviral activity against Parainfluenza-3 virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID1783363Cytotoxicity against MDCK cells assessed as reduction in cell viability measured after 24 hrs by MTT assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID536241Cytotoxicity against MDCK cells by MTS assay2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Design and synthesis of bioactive adamantanaminoalcohols and adamantanamines.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID474349Selectivity ratio of IC50 for MDCK cells to EC90 for Influenza A virus Vietnam/1203/ 2004H/H5N1 by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1610156Antiviral activity against Influenza A virus (A/HK/7/87(H3N2)) infected in dog MDCK cells assessed as reduction in virus-induced cytopathogenicity incubated for 7 days by microscopic analysis2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
AID421731Cytotoxicity against MDCK cells2009Journal of natural products, May-22, Volume: 72, Issue:5
Antiviral constituents against respiratory viruses from Mikania micrantha.
AID1738756Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in dog MDCK cells assessed as reduction in virus-induced cytopathogenicity incubated for 48 hrs by microscopic analysis2020European journal of medicinal chemistry, Aug-01, Volume: 199Discovery of dihydropyrrolidones as novel inhibitors against influenza A virus.
AID1717750Selectivity index, ratio of CC50 for African green monkey Vero E6 cells to EC50 for 2019-nCoV Beta CoV/Wuhan/WIV04/2019 infected in African green monkey Vero E6 cells2020Journal of medicinal chemistry, 11-25, Volume: 63, Issue:22
Chinese Therapeutic Strategy for Fighting COVID-19 and Potential Small-Molecule Inhibitors against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
AID199174The minimum inhibitory concentration required to reduce reovirus type I induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID291033Antiviral activity against parainfluenza 3 virus in Vero cells assessed as reduction of virus plaque formation after 7 days2007Journal of medicinal chemistry, Jun-28, Volume: 50, Issue:13
Novel C-6 fluorinated acyclic side chain pyrimidine derivatives: synthesis, (1)H and (13)C NMR conformational studies, and antiviral and cytostatic evaluations.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID464000Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as protection from virus-induced cytopathogenicity after 6 to 7 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID88296The minimum inhibitory concentration required to reduce HSV-2 (G) induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID416773Antiviral activity against HSV1 KOS in human HEL cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID54506Minimum inhibitory concentration required to reduce Coxsackie virus type B-4-induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID569238Antiviral activity against Vaccinia virus infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Synthesis of new C5-(1-substituted-1,2,3-triazol-4 or 5-yl)-2'-deoxyuridines and their antiviral evaluation.
AID156690Antiviral activity was measured against Vesicular stomatitis virus in rabbit kidney cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID1058584Antiviral activity against Influenza A/PR8/H1N1 virus infected in MDCK cells assessed as inhibition of virus yield after 24 hrs2013Bioorganic & medicinal chemistry, Dec-15, Volume: 21, Issue:24
Tyrosinase and Layer-by-Layer supported tyrosinases in the synthesis of lipophilic catechols with antiinfluenza activity.
AID1274003Cytotoxicity against African green monkey Vero cells assessed as inhibition of cell proliferation after 72 hrs2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID1716982Antiviral activity against Influenza A virus A/WSN/33(H1N1) infected in human HEK293T cells measured after 24 hrs by Gaussia luciferase reporter gene method2020European journal of medicinal chemistry, Jan-15, Volume: 186Design and synthesis of 2-((1H-indol-3-yl)thio)-N-phenyl-acetamides as novel dual inhibitors of respiratory syncytial virus and influenza virus A.
AID392533Antiviral activity against Monkeypox virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID65705Minimum cytotoxic concentration required to cause a microscopically detectable alteration of normal cell morphology2001Journal of medicinal chemistry, Aug-02, Volume: 44, Issue:16
Design, synthesis, DNA binding, and biological evaluation of water-soluble hybrid molecules containing two pyrazole analogues of the alkylating cyclopropylpyrroloindole (CPI) subunit of the antitumor agent CC-1065 and polypyrrole minor groove binders.
AID63943concentration required to inhibit vaccinia virus-induced cytopathicity by 50% in E6SM cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID257901Antiviral activity against Vesicular stomatitis virus in HeLa cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID369467Selectivity index, ratio of CC50 for african green monkey Vero 76 cells to EC50 for Rift Valley fever virus MP-122007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID383508Antiviral activity against Coxsackie virus B4 in human HeLa cells assessed as inhibition of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1503320Antiviral activity against Bovine viral diarrhea virus NADL ATCC VR 534 infected in bovine MDBK cells assessed as protection against virus-induced cytopathic effect after 3 to 4 days by MTT assay2017European journal of medicinal chemistry, Dec-01, Volume: 141Inhibitors of Yellow Fever Virus replication based on 1,3,5-triphenyl-4,5-dihydropyrazole scaffold: Design, synthesis and antiviral evaluation.
AID1409407Antiviral activity against Influenza A virus A/goose/Jiangsu/1306/2014(H5N8) infected in chicken embryo fibroblasts assessed as reduction in cytopathic effect after 48 hrs by CCK-8 assay2018Journal of medicinal chemistry, 11-21, Volume: 61, Issue:22
Structure-Based Optimization of N-Substituted Oseltamivir Derivatives as Potent Anti-Influenza A Virus Agents with Significantly Improved Potency against Oseltamivir-Resistant N1-H274Y Variant.
AID86511Tested for minimum inhibitory concentration required to cause a microscopically detectable alteration of normal cell morphology by 50% on HeLa cell line1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID767059Cytotoxicity against human rhabdomyosarcoma cells after 72 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, Sep-15, Volume: 23, Issue:18
Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID1186340Antiviral activity against HSV1 infected in african green monkey Vero 76 cells assessed as reduction in plaque number after 3 days by plaque reduction assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID224346Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Vaccinia virus in primary rabbit kidney cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID1610159Antiviral activity against Influenza A virus (A/HK/7/87(H3N2)) infected in dog MDCK cells assessed as reduction in virus-induced cytopathogenicity incubated for 7 days by MTS assay2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
AID1501504Antiviral activity against EV71 Xiangyang-Hubei-09 infected in human RD cells assessed as inhibition of virus-induced cytopathic effect by MTT dye based assay
AID68120Concentration required to reduce HSV-1 thymidine kinase deficient (TK-)(VMW 1837) induced cytopathogenicity in by 50% ESM(embryonic skin muscle) cell cultures.1992Journal of medicinal chemistry, Jun-12, Volume: 35, Issue:12
(+-)-carbocyclic 5'-nor-2'-deoxyguanosine and related purine derivatives: synthesis and antiviral properties.
AID216436Concentration required for microscopically detectable alteration of the normal cell morphology in Wi-38 cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID324824Antiviral activity against YFV Jimenez infected in Syrian golden hamster liver treated 4 hrs before viral challenge assessed as weight change at 50 mg/kg/day, ip bid for 8 days2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Activity of T-1106 in a hamster model of yellow Fever virus infection.
AID535530Transport through ENT1 in mouse hepatocytes by oil filtration assay in presence 100 nM of transporter inhibitor NBMRP2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID85120Inhibitory activity against HSV-2 (G) replication in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID1647358Selectivity index, ratio of CC50 for African monkey Vero cells to EC50 for Chikungunya virus infected in African green monkey Vero cells2020Bioorganic & medicinal chemistry letters, 01-15, Volume: 30, Issue:2
Quinolone-N-acylhydrazone hybrids as potent Zika and Chikungunya virus inhibitors.
AID1152077Inhibition of Influenza A virus GST-tagged PB1 (1 to 25) expressed in Escherichia coli binding to Influenza A virus 6His-tagged PA (239 to 716) expressed in Escherichia coli BL21(DE3) by ELISA2014Journal of medicinal chemistry, May-22, Volume: 57, Issue:10
Optimization of small-molecule inhibitors of influenza virus polymerase: from thiophene-3-carboxamide to polyamido scaffolds.
AID427564Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36A/R155K double mutation in human HuH7 cells after 48 hrs by RNA replicon assay relative to wild type2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID46601Tested for inhibitory effect on RNA virus cell growth in CEM cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID774865Selectivity index, ratio of CC50 for human Huh7.5 cells to IC50 for HCV expressing pFL-J6/JFH/JC12013European journal of medicinal chemistry, Nov, Volume: 69Synthesis and antiviral activity of a novel class of (5-oxazolyl)phenyl amines.
AID1261328Antiviral activity against WNV infected in BHK-21 cells assessed as inhibition of virus-induced cytopathogenicity after 3 to 4 days by MTT assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID257899Antiviral activity against Respiratory syncytial virus in HeLa cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID275069Antiviral activity against vaccinia virus in HEL cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID156688Antiviral activity was measured against Herpes simplex virus (HSV-2 G) in rabbit kidney cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID1485243Antiviral activity against para influenza 3 virus infected in African green monkey Vero cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID427559Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36A mutation in human HuH7 cells after 48 hrs by RNA replicon assay relative to wild type2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID1273993Antiviral activity against HHV-2 VR-734-G infected in African green monkey Vero cells assessed as maximal non toxic concentration causing reduction of viral titer after 72 hrs by crystal violet staining assay2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID1501506Antiviral activity against Coxsackievirus B3 (strain Nancy) infected in human HEP2 cells assessed as inhibition of virus-induced cytopathic effect by MTT dye based assay
AID1408128Inhibition of Influenza A virus A/PR/8/34 (H1N1) PA-PB1 interaction expressed in HEK293T cells assessed as decrease in RNA polymerase activity incubated for 24 hrs by minireplicon based luciferase reporter gene assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Synthesis and biological evaluation of a library of hybrid derivatives as inhibitors of influenza virus PA-PB1 interaction.
AID1261309Cytotoxicity against MDBK cells assessed as cell viability after 48 to 96 hrs by MTT assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID301700Ratio of kinact for human recombinant S-adenosyl-L-homocysteine hydrolase NAD+ form to KI for human recombinant S-adenosyl-L-homocysteine hydrolase NAD+2007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID416748Antiviral activity against RSV Long in human HeLa cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID105964Anti-influenza virus activity was evaluated in Madin-Darby canine kidney (MDCK) cells against influenza A H3N2 (X31)1999Bioorganic & medicinal chemistry letters, Dec-20, Volume: 9, Issue:24
Synthesis of 2-(2-adamantyl)piperidines and structure anti-influenza virus A activity relationship study using a combination of NMR spectroscopy and molecular modeling.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1647354Cytotoxicity against African green monkey Vero cells assessed as reduction in cell viability by MTT assay2020Bioorganic & medicinal chemistry letters, 01-15, Volume: 30, Issue:2
Quinolone-N-acylhydrazone hybrids as potent Zika and Chikungunya virus inhibitors.
AID489680Antiviral activity against VSV infected in human HeLa cells assessed as inhibition of virus-induced cytopathic effect after 3 days by MTS assay2010European journal of medicinal chemistry, Jul, Volume: 45, Issue:7
Benzylidene/2-chlorobenzylidene hydrazides: synthesis, antimicrobial activity, QSAR studies and antiviral evaluation.
AID1204998Cytotoxicity against african green monkey Vero cells assessed as inhibition of cell growth after 24 hrs by CPE assay2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID1742427Selectivity index, ratio of CC50 for human HEK293T cells to IC50 for Influenza A virus A/WSN/33(H1N1) infected in HEK293T-Gluc cells2020European journal of medicinal chemistry, Nov-15, Volume: 206Design, synthesis and in vitro anti-influenza A virus evaluation of novel quinazoline derivatives containing S-acetamide and NH-acetamide moieties at C-4.
AID303221Cytotoxicity against HEL cells assessed as alteration in morphology after 3 days2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID99707In vitro antiviral activity against VSV virus in human laryngeal epithelioma cell line1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
AID92451Virus rating is measurement of degree of inhibition of virus-induced cytopathogenic effects and the degree of cytotoxicity produced by the test compound for influenza type A21987Journal of medicinal chemistry, May, Volume: 30, Issue:5
Synthesis and biological activity of unsaturated carboacyclic purine nucleoside analogues.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1306320Antiviral activity against Hepatitis C virus infected in African green monkey Vero cells assessed as reduction of virus-induced cytopathic effect2016Bioorganic & medicinal chemistry letters, 07-15, Volume: 26, Issue:14
An alternative route to the arylvinyltriazole nucleosides.
AID539917Antiviral activity against Vaccinia virus infected in human HEL cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID156703Evaluated for antiviral activity against herpes simplex virus-1(KOS) in primary rabbit kidney cell cultures(PRK) (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID277835Antiviral activity against CV B42007Journal of natural products, Feb, Volume: 70, Issue:2
Cinnamacrins A-C, cinnafragrin D, and cytostatic metabolites with alpha-glucosidase inhibitory activity from Cinnamosma macrocarpa.
AID717172Antiviral activity against Influenza B virus (B/HK/5/72) infected in MDCK cells assessed as virus-induced cytopathic effect after 3 days by microscopic analysis2012Bioorganic & medicinal chemistry, Dec-15, Volume: 20, Issue:24
Microwave assisted synthesis and anti-influenza virus activity of 1-adamantyl substituted N-(1-thia-4-azaspiro[4.5]decan-4-yl)carboxamide derivatives.
AID307142Specific activity of human adenosine kinase2007Bioorganic & medicinal chemistry letters, Jun-01, Volume: 17, Issue:11
Structural effects on the phosphorylation of 3-substituted 1-beta-D-ribofuranosyl-1,2,4-triazoles by human adenosine kinase.
AID218004Minimum inhibitory concentration against vaccinia virus in Vero cell cultures of experiment 11989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID1450222Antiviral activity against acyclovir and foscarnet-resistant HSV-1 L2 infected in African green monkey Vero E6 cells assessed as reduction in virus-induced cytopathic effect2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID1181480Antiviral activity against Influenza A virus A/Virginia/ATCC3/2009 infected in MDCK cells assessed as virus-induced cytopathic effect after 72 hrs by microscopy2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID1501502Cytotoxicity against human RD cells assessed as reduction in cell viability after 3 days by MTT assay
AID533319Selectivity Index, ratio of CC50 for RP7 cell harboring HCV genotype 1b to EC50 for HCV genotype 1b in RP7 replicon cell2008Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11
Potential for hepatitis C virus resistance to nitazoxanide or tizoxanide.
AID1408329Antiviral activity against Influenza B virus B/Ned/537/05 infected in MDCK cells after 3 days by MTS assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID1133182Antiviral activity against Rhinovirus type 13 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs relative to control1978Journal of medicinal chemistry, Dec, Volume: 21, Issue:12
Synthesis and antiviral and enzymatic studies of certain 3-deazaguanines and their imidazolecarboxamide precursors.
AID1538478Selectivity index, ratio of CC50 for cytotoxicity against human RD cells to EC50 for antiviral activity against Coxsackievirus A16 TA271 infected in human RD cells2019Journal of natural products, 05-24, Volume: 82, Issue:5
Effects of Acetylshikonin on the Infection and Replication of Coxsackievirus A16 in Vitro and in Vivo.
AID776646Cytotoxicity against rat Walker 256 cells assessed as growth inhibition2013European journal of medicinal chemistry, Nov, Volume: 69Pyrazole containing natural products: synthetic preview and biological significance.
AID472790Antiviral activity against Yellow fever virus 17D infected in BHK cells assessed as protection from virus-induced cytopathogenicity after 3 to 4 days by MTT method2010Bioorganic & medicinal chemistry, Apr-15, Volume: 18, Issue:8
Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID1710789Selectivity index, ratio of MCC for African green monkey Vero cells to EC50 for Punta Toro virus infected in African green monkey Vero cells2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID475856Antiviral activity against HCV infected in human HuH5.2 cells carrying subgenomic HCV replicon assessed as inhibition of replicon replication by luciferase reporter gene assay2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID1436801Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for Coxsackievirus B1 Conn-5 infected in African green monkey Vero cells2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID395954Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in serum at 50 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID478320Antiviral activity against influenza A virus H1N1 assessed as inhibition of viral induced cytopathic effect2010Bioorganic & medicinal chemistry letters, May-01, Volume: 20, Issue:9
Click reaction synthesis of carbohydrate derivatives from ristocetin aglycon with antibacterial and antiviral activity.
AID155592In vitro antiviral activity (virus ratings (VR)) determined by comparing CPE development in drug-treated cells (T) and Parainfluenza type 3 virus control cells.1984Journal of medicinal chemistry, Nov, Volume: 27, Issue:11
Synthesis and antiviral/antitumor activities of certain 3-deazaguanine nucleosides and nucleotides.
AID593220Antiviral activity against Coxsackievirus B3 infected in african green monkey Vero cells assessed as inhibition of viral growth after 24 hrs by Reed-Muench method2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
Inhibitory properties of 2-substituent-1H-benzimidazole-4-carboxamide derivatives against enteroviruses.
AID674874Selectivity index, ratio of TC50 for MDCK cells to IC50 for Influenza B virus (strain B/Jifang/13/97)2012European journal of medicinal chemistry, Sep, Volume: 55Synthesis and antiviral activity of substituted bisaryl amide compounds as novel influenza virus inhibitors.
AID216942In vitro antiviral activity against Para 3 virus in (vero) V cells of african green monkey kidney1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
AID1783355Selectivity index, ratio of CC50 for human Huh-7 cells to IC50 for Zika virus H/PF/2013 infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based plaque reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID712815Antiviral activity against amantadine-resistant Influenza A virus (A/PR/8/34 (H1N1)) infected in MDCK cells assessed as virus-induced cytopathic effect by MTS assay2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID1092200Antiviral activity against Tobacco mosaic virus (TMV) inoculated in 5-6 growth stage leaf assessed as inhibition effect at 500 ug/mL at 25 degC after 72 hr by half-leaf method2012Journal of agricultural and food chemistry, Oct-17, Volume: 60, Issue:41
Design, synthesis, and anti-tobacco mosaic virus (TMV) activity of phenanthroindolizidines and their analogues.
AID1505488Antiviral activity against Influenza virus A/X-31 infected in MDCK cells assessed as reduction in viral replication at 3 days post infection by microscopic analysis2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID593226Selectivity index, ratio of TC50 for african green monkey Vero cells to IC50 for Coxsackievirus B62011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
Inhibitory properties of 2-substituent-1H-benzimidazole-4-carboxamide derivatives against enteroviruses.
AID87304Concentration required to cause a microscopically detectable alteration in cell morphology in HeLa cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID1132057Cytotoxicity against BHK cells1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1409405Antiviral activity against Influenza A virus A/Chicken/Hebei/LZF/2014(H5N2) infected in chicken embryo fibroblasts assessed as reduction in cytopathic effect after 48 hrs by CCK-8 assay2018Journal of medicinal chemistry, 11-21, Volume: 61, Issue:22
Structure-Based Optimization of N-Substituted Oseltamivir Derivatives as Potent Anti-Influenza A Virus Agents with Significantly Improved Potency against Oseltamivir-Resistant N1-H274Y Variant.
AID395665Antiviral activity against Punta Toro virus Adames infected Syrian golden hamster assessed as mean viral titer per 0.1 mL of serum at 30 mg/kg, po twice daily administered 4 hrs before viral challenge measured on day 4 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID221965Compounds was tested for the effect of L-nucleosides of ribavirin on SEB (staphylococcal enterotoxin B)-stimulated T-cell expression of the type 1 cytokine TNF-alpha2000Journal of medicinal chemistry, Mar-09, Volume: 43, Issue:5
Monocyclic L-nucleosides with type 1 cytokine-inducing activity.
AID539932Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID464185Cytotoxicity against Sindbis virus infected african green monkey Vero cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1234205Cytotoxic activity against MDCK cells assessed as cytopathogenic effect incubated for 48 hrs2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Antiviral Matrine-Type Alkaloids from the Rhizomes of Sophora tonkinensis.
AID482708Antiviral activity against RSV infected in human HeLa cell assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID416781Antiviral activity against influenza H1N1 virus in MDCK cells assessed as reduction of virus-induced cytopathicity by MTS method2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID204956Minimum inhibitory concentration required to reduce sindbis virus induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID1118642Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID712810Antiviral activity against amantadine-sensitive Influenza A virus (A/Ned/378/05 (H1N1)) infected in MDCK cells assessed as virus-induced cytopathic effect measured 3 days post infection by microscopic analysis2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID1890794Antiviral activity against Influenza A virus A/WSN/33 (H1N1) infected in HEK293T cells by Gaussia luciferase reporter assay2022Bioorganic & medicinal chemistry letters, 05-15, Volume: 64Design, synthesis, and anti-influenza A virus activity evaluation of novel indole containing derivatives of triazole.
AID1205002Antiviral activity against Coxsackievirus B2 infected in african green monkey Vero cells assessed as reduction in viral-induced cytopathic effect2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID535534Transport through ENT2 in mouse hepatocytes by oil filtration assay in presence 100 uM of transporter inhibitor NBMRP2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1252406Antiviral activity against Coxsackievirus B4 expressed in African green monkey Vero cells assessed as reduction in cytopathogenicity2015European journal of medicinal chemistry, Sep-18, Volume: 102Novel halogenated 3-deazapurine, 7-deazapurine and alkylated 9-deazapurine derivatives of L-ascorbic or imino-L-ascorbic acid: Synthesis, antitumour and antiviral activity evaluations.
AID105965Anti-influenza virus activity was evaluated in Madin-Darby canine kidney (MDCK) cells against influenza B (Hong Kong/5/72)1999Bioorganic & medicinal chemistry letters, Dec-20, Volume: 9, Issue:24
Synthesis of 2-(2-adamantyl)piperidines and structure anti-influenza virus A activity relationship study using a combination of NMR spectroscopy and molecular modeling.
AID1274008Antiviral activity against HHV-1 CDC Atlanta infected in African green monkey Vero cells assessed as reduction in plaque formation administered post viral infection after 72 hrs by crystal violet staining technique2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID278378Decrease in GTP level in Vero E6 cells at 40 ug/ml after 4 h2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID63604Tested for antiviral activity against VSV-virus in human embryonic skin muscle fibroblasts2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID1600737Antiviral activity against Tacaribe virus infected in African green monkey Vero cells assessed as reduction in virus induced cytopathic effect2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
l-like 3-deazaneplanocin analogues: Synthesis and antiviral properties.
AID253329Cytotoxicity in MDBK (Madin-darby bovine kidney) cells2004Journal of medicinal chemistry, Oct-07, Volume: 47, Issue:21
Synthesis of benzodithiol-2-yl-substituted nucleoside derivatives as lead compounds having anti-bovine viral diarrhea virus activity.
AID1194166Cytotoxicity against DENV serotype 2 strain New Guinea C infected african green monkey Vero B cells by virus yield-reduction assay2015Bioorganic & medicinal chemistry letters, Apr-15, Volume: 25, Issue:8
Design, synthesis, optimization and antiviral activity of a class of hybrid dengue virus E protein inhibitors.
AID217478Minimum inhibitory concentration required to reduce Vesicular stomatitis virus (VSV) induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID1186331Cytotoxicity against mock-infected BHK21 cells after 48 to 96 hrs by MTT assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID521220Inhibition of neurosphere proliferation of mouse neural precursor cells by MTT assay2007Nature chemical biology, May, Volume: 3, Issue:5
Chemical genetics reveals a complex functional ground state of neural stem cells.
AID1538476Cytotoxicity against human RD cells assessed as reduction in cell viability after 12 hrs by CCK8 assay2019Journal of natural products, 05-24, Volume: 82, Issue:5
Effects of Acetylshikonin on the Infection and Replication of Coxsackievirus A16 in Vitro and in Vivo.
AID1873825Antiviral activity against Zika virus H/PAN/2016/BEI-259634 infected in African green monkey Vero cells assessed as reduction in viral titer incubated for 3 days by plaque assay2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID85112Inhibitory activity against HSV-2 (196) replication in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID1731876Selectivity index, ratio of CC50 for cytotoxicity against human HEp-2 cells to IC50 for antiviral activity against RSV Long expressing mGFP infected in HEp-2 cells2021European journal of medicinal chemistry, Mar-15, Volume: 214Synthesis and antiviral activity of a series of novel quinoline derivatives as anti-RSV or anti-IAV agents.
AID474339Selectivity ratio of IC50 for MDCK cells to EC50 for Influenza A virus Duck/MN/1525/81/H5N1 by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1075687Selectivity index, ratio of CC50 for human HuH7 cells to EC50 for HCV subtype 1a2014Bioorganic & medicinal chemistry letters, Mar-01, Volume: 24, Issue:5
4'-Substituted pyrimidine nucleosides lacking 5'-hydroxyl function as potential anti-HCV agents.
AID539919Antiviral activity against acyclovir-resistant TK deficient Herpes simplex virus-1 KOS infected in human HEL cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID88275The minimum inhibitory concentration required to reduce HSV-1(KOS) induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID1118645Antiviral activity against Parainfluenza virus 3 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID280194Antiviral activity against coxsackie B4 virus in HeLa cells assessed as inhibition of virus-induced cytopathicity2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID395711Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean serum ALT levels at 40 mg/kg, po twice daily for 7 days administered 4 hrs before viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1886808Antiviral activity against DENV2 infected in African green monkey Vero E6 cells assessed as inhibition of virus induced cytopathic effect measured after 72 hrs by crystal violet staining based inverted microscopic analysis2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID1409608AUC (viral infection %) for SARS-CoV-2 in the Vero E6 cell line at 48 h by immunofluorescence-based assay (detecting the viral NP protein in the nucleus of the Vero E6 cells).2020Nature, 07, Volume: 583, Issue:7816
A SARS-CoV-2 protein interaction map reveals targets for drug repurposing.
AID436481Cytotoxicity against african green monkey Vero 76 cells by crystal violet staining2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID1265166Antiviral activity against Chikungunya virus infected in HEK293T cells assessed as reduction of infectivity measured at 24 hrs postinfection by gaussia luciferase reporter gene assay2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
AID156845Minimum inhibitory concentration required to reduce herpes simplex virus-2 (G)induced cytopathogenicity by 50% in primary rabbit kidney cells (PRK)1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID257339Antiviral activity against HCV in Huh7 ETcell line at 10 uM assessed by measuring HCV-RNA-derived LUC activity relative to control2005Bioorganic & medicinal chemistry letters, Dec-15, Volume: 15, Issue:24
Synthesis and in vitro anti-hepatitis B and C virus activities of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID1154646Therapeutic ratio of TC50 for mock-infected human Hep2 cells to IC50 for Respiratory syncytial virus infected in human Hep2 cells2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Antiviral C-25 epimers of 26-acetoxy steroids from the South China Sea gorgonian Echinogorgia rebekka.
AID1853002Cytotoxicity against human HEK293 cells incubated for 48 hrs by MTT assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID275087Cytotoxicity against HEL cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID717280Antiviral activity against Influenza A virus (A/PR/8/34(H1N1)) infected in MDCK cells assessed as virus-induced cytopathic effect after 3 days by MTS assay2012Bioorganic & medicinal chemistry, Dec-15, Volume: 20, Issue:24
Microwave assisted synthesis and anti-influenza virus activity of 1-adamantyl substituted N-(1-thia-4-azaspiro[4.5]decan-4-yl)carboxamide derivatives.
AID1113464Antiviral activity against Human coxsackievirus B4 infected human HeLa cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID284531Antiviral activity against in Vesicular stomatitis virus-induced cytopathogenicity in E6SM cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID434306Cytotoxicity against human HeLa cells assessed as change in cell morphology2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID543692Antiviral activity against 10'2 CCID50 Yellow fever virus Jimenez infected in syrian golden hamster assessed as serum survival of animal at 50 mg/kg/day, po administered twice daily for 8 days started 4 hrs prior to viral infection2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID611760Antiviral activity against Coxsackievirus B4 infected in Vero cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID156079Inhibitory activity against purine nucleoside phosphorylase (PNPase); E means not determined1988Journal of medicinal chemistry, Feb, Volume: 31, Issue:2
Synthesis and evaluation of 5-amino-1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamidine and certain related nucleosides as inhibitors of purine nucleoside phosphorylase.
AID730331Antiviral activity against Influenza A virus (A/Puerto Rico/8/1934(H1N1)) infected in MDCK cells assessed as protection against virus-induced cytopathic effect after 48 hrs by crystal violet staining method2013Bioorganic & medicinal chemistry letters, Mar-15, Volume: 23, Issue:6
Aspulvinones from a mangrove rhizosphere soil-derived fungus Aspergillus terreus Gwq-48 with anti-influenza A viral (H1N1) activity.
AID1205000Selectivity index, ratio of TC50 for african green monkey Vero cells to IC50 for Coxsackievirus B3 infected in african green monkey Vero cells2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID1853000Cytotoxicity against human HCT-116 cells overexpressing human MDR1 incubated for 48 hrs by MTT assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID6600450% Minimum inhibitory concentration which is required to reduce cytopathogenicity induced by (KOS) strain of HSV-1 virus on human E6SM cells.1997Journal of medicinal chemistry, Feb-14, Volume: 40, Issue:4
Novel 3'-C/N-substituted 2',3'-beta-D-dideoxynucleosides as potential chemotherapeutic agents. 1. Thymidine derivatives: synthesis, structure, and broad spectrum antiviral properties.
AID658614Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID718710Antiviral activity against Influenza virus A/California/07/09 (H1N1) pdm09 infected in MDCK cells after 48 hrs followed by incubated in chicken erythrocytes for 1 hr by hemagglutinination based end-point dilution method2012Bioorganic & medicinal chemistry letters, Dec-01, Volume: 22, Issue:23
Anti-viral activity of (-)- and (+)-usnic acids and their derivatives against influenza virus A(H1N1)2009.
AID1371009Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as protection against virus-induced cytopathogenicity after 48 hrs by crystal-violet staining-based assay2017Journal of natural products, 04-28, Volume: 80, Issue:4
Chrodrimanins K-N and Related Meroterpenoids from the Fungus Penicillium sp. SCS-KFD09 Isolated from a Marine Worm, Sipunculus nudus.
AID1092196In vivo antiviral activity against Tobacco mosaic virus (TMV) pre-inoculated Nicotiana tabacum L. leaves assessed as curative effect at 500 ug/mL measured after 3 to 4 days2012Journal of agricultural and food chemistry, Oct-17, Volume: 60, Issue:41
Design, synthesis, and anti-tobacco mosaic virus (TMV) activity of phenanthroindolizidines and their analogues.
AID1427858Cytotoxicity against MDCK cells assessed as growth inhibition after 48 hrs
AID1081160In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as curative effect at 500 ug/ml treated after viral inoculation measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
AID421729Antiviral activity against Influenza A virus infected in MDCK cells assessed as inhibition of virus-induced cytopathogenic effect by plaque reduction assay2009Journal of natural products, May-22, Volume: 72, Issue:5
Antiviral constituents against respiratory viruses from Mikania micrantha.
AID82051Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on HEF cell line infected with vaccinia virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID1450220Antiviral activity against foscarnet-resistant HSV-1 F+ infected in African green monkey Vero E6 cells assessed as reduction in virus-induced cytopathic effect2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID1082877In vivo antiviral activity against Tobacco mosaic virus (TMV) inoculated left side of Nicotiana. tabacum L. leaves assessed as inactivation effect at 500 ug/mL co-incubated with virus measured after 3 to 4 days2012Journal of agricultural and food chemistry, Jun-13, Volume: 60, Issue:23
Design, synthesis, antiviral activity, and SARs of 14-aminophenanthroindolizidines.
AID567524Antiviral activity against Junin virus IV4454 infected in african green monkey Vero cells assessed as reduction in virus yield after 48 hrs by plaque assay2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Imidazo[2,1-b]thiazole carbohydrate derivatives: Synthesis and antiviral activity against Junin virus, agent of Argentine hemorrhagic fever.
AID1201116Cytotoxicity against MDCK cells after 72 hrs by MTS assay2015European journal of medicinal chemistry, Apr-13, Volume: 94A few atoms make the difference: synthetic, CD, NMR and computational studies on antiviral and antibacterial activities of glycopeptide antibiotic aglycon derivatives.
AID400704Cytotoxicity against RSV A-2 infected human Hep2 cells after 3 days1998Journal of natural products, May, Volume: 61, Issue:5
Antiviral phenylpropanoid glycosides from the medicinal plant Markhamia lutea.
AID1146287Antiviral activity against Rhinovirus 1A infected in human KB cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs by microscopic analysis relative to control1978Journal of medicinal chemistry, Sep, Volume: 21, Issue:9
Imidazo[1,2-a]-s-triazine nucleosides. Synthesis and antiviral activity of the N-bridgehead guanine, guanosine, and guanosine monophosphate analogues of imidazo[1,2-a]-s-triazine.
AID1274005Antiviral activity against HHV-1 CDC Atlanta infected in African green monkey Vero cells assessed as reduction in plaque formation administered simultaneously with virus for 1 hr measured after 72 hrs by crystal violet staining technique2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID658747Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as reduction visual scoring of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID1181481Antiviral activity against Influenza A virus A/Virginia/ATCC3/2009 infected in MDCK cells assessed as reduction in host cell viability after 72 hrs by MTS assay2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID275070Antiviral activity against vesicular somatitis virus in HEL cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID774863Cytotoxicity against human Huh7.5 cells after 96 hrs by MTT assay2013European journal of medicinal chemistry, Nov, Volume: 69Synthesis and antiviral activity of a novel class of (5-oxazolyl)phenyl amines.
AID474330Antiviral activity against Influenza A virus Gull/PA/4175/83/H5N1 infected MDCK cells after 3 days by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1273990Antiviral activity against HHV1 CDC Atlanta infected in African green monkey Vero cells assessed as reduction of viral titer at maximal non-toxic concentration after 48 hrs by crystal violet staining assay relative to control2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID474357Antiviral activity against Influenza A virus Wisconsin/67/2005/H3N2 infected MDCK cells after 42 to 46 hrs by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID387854Cytotoxicity against HEL cells assessed as alteration in cell morphology by MTS assay2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis and antiviral evaluation of acyclic azanucleosides developed from sulfanilamide as a lead structure.
AID257472Cytotoxicity in MDCK cells infected with influenza A H3N2 virus2005Bioorganic & medicinal chemistry letters, Dec-01, Volume: 15, Issue:23
Synthesis and biological evaluation of novel bisheterocycle-containing compounds as potential anti-influenza virus agents.
AID1710780Selectivity index, ratio of MCC for human HeLa cells to EC50 for Respiratory syncytial virus infected in human HeLa cells2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID1853007Cytotoxicity against paclitaxel-resistant human HCT116tax cells assessed as reduction on cell viability at 100 to 200 uM incubated for 48 hrs in presence of paclitaxel by MTT assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID474540Selectivity ratio of IC50 for MDCK cells to EC50 for inhibition of virus-induced cytopathic effect of Influenza A virus California/07/2009 /H1N12010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1742425Antiviral activity against Influenza A virus A/WSN/33(H1N1) infected in HEK293T-Gluc cells pretreated for 2 hrs followed by viral infection and measured after 24 hrs by Gaussia luciferase reporter gene assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Design, synthesis and in vitro anti-influenza A virus evaluation of novel quinazoline derivatives containing S-acetamide and NH-acetamide moieties at C-4.
AID1234204Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for coxsackievirus B3 infected in African green monkey Vero cells2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Antiviral Matrine-Type Alkaloids from the Rhizomes of Sophora tonkinensis.
AID82315Evaluated for cell growth inhibition and induction of cellular differentiation of human myeloid leukemia cell line (HL-60)1990Journal of medicinal chemistry, Jan, Volume: 33, Issue:1
Growth inhibition and induction of cellular differentiation of human myeloid leukemia cells in culture by carbamoyl congeners of ribavirin.
AID87132Antiviral activity was measured against Polio virus-1 in HeLa cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID6600750% Minimum inhibitory concentration which is required to reduce cytopathogenicity induced by TK-(B2006) strain of HSV-1 virus on human E6SM cells.1997Journal of medicinal chemistry, Feb-14, Volume: 40, Issue:4
Novel 3'-C/N-substituted 2',3'-beta-D-dideoxynucleosides as potential chemotherapeutic agents. 1. Thymidine derivatives: synthesis, structure, and broad spectrum antiviral properties.
AID218252Evaluation for antiviral activity against forest virus in Vero cell cultures (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID1201121Antiviral activity against Influenza B virus (B/Hong Kong/05/1972) infected in MDCK cells assessed as reduction of virus-induced cytopathic effect after 72 hrs by microscopic analysis2015European journal of medicinal chemistry, Apr-13, Volume: 94A few atoms make the difference: synthetic, CD, NMR and computational studies on antiviral and antibacterial activities of glycopeptide antibiotic aglycon derivatives.
AID1146290Antiviral activity against Rhinovirus 13 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs by microscopic analysis relative to control1978Journal of medicinal chemistry, Sep, Volume: 21, Issue:9
Imidazo[1,2-a]-s-triazine nucleosides. Synthesis and antiviral activity of the N-bridgehead guanine, guanosine, and guanosine monophosphate analogues of imidazo[1,2-a]-s-triazine.
AID1687956Antiproliferative activity against human MDA-MB-435 cells assessed as reduction in cell growth at 100 uM incubated for 72 hrs by MTT assay relative to control2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID1505489Antiviral activity against Influenza virus A/X-31 infected in MDCK cells assessed as reduction in viral replication at 3 days post infection by formazan-based MTS assay2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID535514Transport through ENT1 in rat hepatocytes by oil filtration assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1773017Inhibition of RSV induced ROS production in human HEp-2 cells assessed as reduction in accumulation of ROS-positive cells at 25 uM measured after 36 hrs by DCHF-DA staining based flow cytometry analysis (Rvb = 82.2%)2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID463983Antiviral activity against VSV infected in human HeLa cells assessed as protection from virus-induced cytopathogenicity after 1 to 2 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1831638Antiviral activity against West Nile virus infected in human Huh-7 cells assessed as inhibition of viral replication at 12.5 uM measured after 48 hrs by plaque assay relative to control2021ACS medicinal chemistry letters, Dec-09, Volume: 12, Issue:12
Nanoparticular Inhibitors of Flavivirus Proteases from Zika, West Nile and Dengue Virus Are Cell-Permeable Antivirals.
AID1076999Antiviral activity against Influenza B virus jifang/13/97 infected in MDCK cells assessed as inhibition of virus-induced cytopathicity after 40 hrs2014European journal of medicinal chemistry, Apr-09, Volume: 761,2,3-Triazole-containing derivatives of rupestonic acid: click-chemical synthesis and antiviral activities against influenza viruses.
AID166671Evaluation for antiviral activity in primary rabbit kidney cell culture1986Journal of medicinal chemistry, Jul, Volume: 29, Issue:7
Structure-activity relationship of novel oligopeptide antiviral and antitumor agents related to netropsin and distamycin.
AID1336612Antiviral activity against Punta Toro virus infected in African green monkey Vero cells assessed as protection against virus-induced cytopathic effect measured after 3 to 5 days by microscopic analysis2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Synthesis and in vitro antiviral evaluation of 4-substituted 3,4-dihydropyrimidinones.
AID1710778Selectivity index, ratio of MCC for human HeLa cells to EC50 for Vesicular stomatitis virus infected in human HeLa cells2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID1692501Cytotoxicity against African green monkey Vero E6 cells by CCK8 assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
COVID-19: Drug Targets and Potential Treatments.
AID383530Antiviral activity against Parainfluenza 3 virus in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1201117Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as reduction of virus-induced cytopathic effect after 72 hrs by microscopic analysis2015European journal of medicinal chemistry, Apr-13, Volume: 94A few atoms make the difference: synthetic, CD, NMR and computational studies on antiviral and antibacterial activities of glycopeptide antibiotic aglycon derivatives.
AID383522Cytotoxicity against african green monkey Vero cells2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID464192Cytotoxicity against Influenza B virus infected MDCK cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID369870Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean serum ALT levels at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID436479Antiviral activity against Yellow fever virus infected in BHK-21 cells assessed as inhibition of virus-induced cytopathicity after 3 to 4 days by MTT assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID1443674Antiviral activity against Influenza virus A/WSN/33(H1N1) infected in human 293T cells assessed as inhibition of viral replication preincubated for 2 hrs followed by viral infection measured after 24 hrs by luciferase reporter gene assay2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Anti-influenza triterpenoid saponins (saikosaponins) from the roots of Bupleurum marginatum var. stenophyllum.
AID424777Cytotoxicity against human HeLa cells after 48 hrs by MTT assay2009Journal of natural products, May-22, Volume: 72, Issue:5
Anti-coxsackie virus B3 norsesquiterpenoids from the roots of Phyllanthus emblica.
AID482715Cytotoxicity against african green monkey Vero cells by MTT assay2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID432178Antiviral activity against RSV infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID1783344Antiviral activity against Dengue virus serotype 2 New Guinea C infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based secondary yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID1594641Cytotoxicity in BHK cells assessed as reduction in cell viability incubated for 72 hrs by cell count reagent SF based microplate spectrophotometry2019Bioorganic & medicinal chemistry, 06-01, Volume: 27, Issue:11
Synthesis and biological evaluation of novel imidazole nucleosides as potential anti-dengue virus agents.
AID419602Antiviral activity against Parainfluenza-3 virus infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID548450Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID658744Antiviral activity against Coxsackie virus B4 infected in human HeLa cells assessed as inhibition of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID105958Compound was evaluated in MDCK cell cultures for cytotoxicity that is to cause microscopically detectable alteration of normal cell morphology1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID1169736Selectivity index, ratio of CC50 against human HuH7 cells to EC50 against dengue virus 22014Journal of natural products, Nov-26, Volume: 77, Issue:11
Limonoids from the seeds of Swietenia macrophylla with inhibitory activity against dengue virus 2.
AID218065Minimum cytotoxic concentration required to cause a microscopically detectable alteration of normal cell morphology in Vero cells1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID464182Cytotoxicity against acyclovir-sensitive Herpes simplex virus 1 KOS infected HEL cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID463997Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as protection from virus-induced cytopathogenicity by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1150890Antiviral activity against Herpes simplex virus type 1 infected in human KB cells1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Synthesis of 1-(4-thio-beta-D-ribofuranosyl)-1,2,4-triazole-3-carboxamide.
AID283448Cytotoxicity against MDCK cells2007Antimicrobial agents and chemotherapy, Mar, Volume: 51, Issue:3
Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.
AID229026Antiviral activity against vaccinia virus (VV) in primary rabbit kidney (PRK) / embryonic skin-muscle (E6SM) fibroblast culture lines1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID1536100Selectivity index, ratio of CC50 for African green monkey Vero cells to EC50 for Junin virus IV4454 infected in African green monkey Vero cells2019Bioorganic & medicinal chemistry letters, 02-15, Volume: 29, Issue:4
Modified ribavirin analogues as antiviral agents against Junín virus.
AID1118654Cytotoxicity against human HeLa cells assessed as concentration required to cause microscopically visible alternation of cell morphology2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID383510Cytotoxicity against human E6SM cells2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1472385Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathicity after 72 hrs by microscopic method2018Journal of medicinal chemistry, 01-11, Volume: 61, Issue:1
Aniline-Based Inhibitors of Influenza H1N1 Virus Acting on Hemagglutinin-Mediated Fusion.
AID217589In vitro antiviral activity against measles virus was evaluated.1985Journal of medicinal chemistry, Aug, Volume: 28, Issue:8
Synthesis and biological activity of 6-azacadeguomycin and certain 3,4,6-trisubstituted pyrazolo[3,4-d]pyrimidine ribonucleosides.
AID1783360Selectivity index, ratio of CC50 for human Huh-7 cells to IC50 for West Nile virus lineage 1 (Italy/2009) infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 48 hrs by immunodetection based plaque reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID395956Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean serum ALT levels at 20 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1450219Selectivity index, ratio of MCC for African green monkey Vero E6 cells to IC50 for HSV-1 L2/Rp-ACV/2 infected in African green monkey Vero E6 cells2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID218430Antiviral activity was measured against Rhino virus-1A in human diploid (WI-38) cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID464187Cytotoxicity against Punta Toro virus infected african green monkey Vero cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID155596Virus rating against parainfluenza virus type 31989Journal of medicinal chemistry, Apr, Volume: 32, Issue:4
Analysis of the in vitro antiviral activity of certain ribonucleosides against parainfluenza virus using a novel computer aided receptor modeling procedure.
AID1364928Cytotoxicity against African green monkey Vero cells assessed as reduction in cell viability after 4 days by MTT assay2017Bioorganic & medicinal chemistry, 08-15, Volume: 25, Issue:16
The medicinal chemistry of Chikungunya virus.
AID1391707Antiviral activity against Influenza A virus (A/WSN/1933(H1N1)) infected in MDCK cells cocultured with human 293T-Gluc cells at 100 uM preincubated with compound for 2 hrs followed by virus infection measured after 24 hrs by luciferase reporter gene assay2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Secoiridoid analogues from the fruits of Ligustrum lucidum and their inhibitory activities against influenza A virus.
AID1376907Antiviral activity against VSV-G pseudotyped Influenza A virus infected in human SupT1 cells after 48 hrs by firefly luciferase reporter gene assay2017Journal of natural products, 06-23, Volume: 80, Issue:6
Stachybotrysins A-G, Phenylspirodrimane Derivatives from the Fungus Stachybotrys chartarum.
AID1647366Antiviral activity against Zika virus infected in African green monkey Vero cells assessed as reduction in viral replication at 10 uM treated with compound at 6 hrs post infection by plaque formation assay2020Bioorganic & medicinal chemistry letters, 01-15, Volume: 30, Issue:2
Quinolone-N-acylhydrazone hybrids as potent Zika and Chikungunya virus inhibitors.
AID275071Antiviral activity against Coxsackie B4 virus in HeLa cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID432172Antiviral activity against Vesicular stomatitis virus infected in human HEL cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID659282Antiviral activity against Reovirus-1 infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID474356Antiviral activity against Influenza A virus Wisconsin/67/2005/H3N2 infected MDCK cells assessed as inhibition of virus-induced cytopathic effect after 3 days2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1181478Antiviral activity against Influenza A virus (A/PR/8/34(H1N1)) infected in MDCK cells assessed as reduction in host cell viability after 72 hrs by MTS assay2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID99572In vitro antiviral activity against COXB1 virus in human laryngeal epithelioma cell line1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
AID395935Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 mL of serum at 50 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1691559Antiviral activity against Influenza A virus (A/PR 8/34 (H1N1)) clone 1 infected in MDCK cells assessed as reduction in virus-induced cytopathic effect measured after 72 hrs by microscopic analysis2020European journal of medicinal chemistry, May-15, Volume: 194N-benzyl 4,4-disubstituted piperidines as a potent class of influenza H1N1 virus inhibitors showing a novel mechanism of hemagglutinin fusion peptide interaction.
AID527722Antiviral activity against HCV 1a infected in human HuH7 cells assessed as reduction of viral RNA level at 20 ug/ml after 2 days by QRT-PCR analysis2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
Synthesis and in vitro antiviral activities of 3'-fluoro (or chloro) and 2',3'-difluoro 2',3'-dideoxynucleoside analogs against hepatitis B and C viruses.
AID1280363Antiviral activity against amantadine-resistant influenza A virus HN/1222 (H3N2) infected in dog MDCK cells assessed as inhibition of virus induced cytopathic effect after 40 hrs by Cell-Titer-Glo assay2016European journal of medicinal chemistry, Jan-27, Volume: 108Spiromastilactones: A new class of influenza virus inhibitors from deep-sea fungus.
AID1241020Antiviral activity against Tacaribe virus infected in African green monkey Vero 76 cells after 3 days by neutral red dye-based plaque reduction assay2015Bioorganic & medicinal chemistry, Sep-01, Volume: 23, Issue:17
2- and 3-Fluoro-3-deazaneplanocins, 2-fluoro-3-deazaaristeromycins, and 3-methyl-3-deazaneplanocin: Synthesis and antiviral properties.
AID232130Ratio measured as the VR of C-3''-deoxyribofuranoside to the VR at a MIC of 54 ug/mL1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Synthesis and antiviral evaluation of carbocyclic analogues of 2-amino-6-substituted-purine 3'-deoxyribofuranosides.
AID674870Cytotoxicity against MDCK cells incubated for 48 hrs by CPE method2012European journal of medicinal chemistry, Sep, Volume: 55Synthesis and antiviral activity of substituted bisaryl amide compounds as novel influenza virus inhibitors.
AID1081157In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as inactivation effect at 100 ug/ml co-treated with virus for 30 min before inoculation onto leaves measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
AID1132048Antibacterial activity against Streptococcus faecalis I1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID548439Antiviral activity against Influenza A H1N1 virus subtype infected in MDCK cells assessed as inhibition of virus induced cytopathicity by visual scoring of CPE2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID1524783Selectivity index, ratio of CC50 for cytotoxicity against MDCK cells to EC50 for influenza A virus A/Vietnam/1203/2004 x A/PR/8/34 (H5N1) harboring recombinant NS1 infected in MDCK cells2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Identification, design and synthesis of novel pyrazolopyridine influenza virus nonstructural protein 1 antagonists.
AID395936Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 mL of serum at 20 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID280204Cytotoxicity against HeLa cells assessed as alteration in cell morphology2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID54507Compound was tested for antiviral activity (minimum inhibition concentration) in Vero cells coxsackie virus type B41984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID533320Selectivity Index, ratio of CC50 for NTZ-11 cell harboring HCV genotype 1b to EC50 for HCV genotype 1b in NTZ-11 replicon cell2008Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11
Potential for hepatitis C virus resistance to nitazoxanide or tizoxanide.
AID1433152Cytotoxicity against MDCK cells assessed as alteration of normal cell morphology by microscopic analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID1783347Selectivity index, ratio of CC50 for human Huh-7 cells to IC50 for Dengue virus serotype 2 New Guinea C infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based secondary yield reduction 2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID674875Antiviral activity against Influenza A virus (A/Tianjin-Jinnan/15/2009(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect2012European journal of medicinal chemistry, Sep, Volume: 55Synthesis and antiviral activity of substituted bisaryl amide compounds as novel influenza virus inhibitors.
AID622448Antiviral activity against Enterovirus 71 infected in african green monkey vero cells assessed as inhibition of viral replication by Reed-Muench analysis2011Bioorganic & medicinal chemistry letters, Oct-01, Volume: 21, Issue:19
Synthesis, structure-activity relationship and in vitro biological evaluation of N-arylethyl isoquinoline derivatives as Coxsackievirus B3 inhibitors.
AID712816Antiviral activity against amantadine-resistant Influenza A virus (A/PR/8/34 (H1N1)) infected in MDCK cells assessed as virus-induced cytopathic effect measured 3 days post infection by microscopic analysis2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID82037Antiviral activity against TK-HSV-1 virus infected HEF cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID1571891Displacement of [3H]N6-R-phenylisopropyladenosine from human A1A adenosine receptor expressed in CHO cell membranes after 60 mins by scintillation proximity assay2019Journal of medicinal chemistry, 02-14, Volume: 62, Issue:3
Design and in Vivo Characterization of A
AID1783391Antiviral activity against SARS-COV 2 infected in human Caco-2 cells assessed as inhibition of viral replication at MOI of 0.01 and incubated after 2 hrs post infection for 48 hrs by immunodetection assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID1201119Antiviral activity against Influenza A virus (A/Hong Kong/7/1987(H3N2)) infected in MDCK cells assessed as reduction of virus-induced cytopathic effect after 72 hrs by microscopic analysis2015European journal of medicinal chemistry, Apr-13, Volume: 94A few atoms make the difference: synthetic, CD, NMR and computational studies on antiviral and antibacterial activities of glycopeptide antibiotic aglycon derivatives.
AID156699Minimum cytotoxic concentration (MCC) required to cause a microscopically detectable alteration of host cell morphology, when incubated with PRK cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID1886813Antiviral activity against CHIKV infected in African green monkey Vero E6 cells assessed as reduction factor at 3.1 to 25 ug/ml measured after 72 hrs by crystal violet staining based inverted microscopic analysis2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID428949Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36M mutation in human HuH7 cells after 48 hrs by RNA replicon assay2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID1717748Antiviral activity against 2019-nCoV BetaCoV/Wuhan/WIV04/2019 infected in African green monkey VeroE6 cells assessed as reduction in viral yield preincubated with virus for 1 hr followed by cell infection and measured after 2 hrs by qRT-PCR method2020Journal of medicinal chemistry, 11-25, Volume: 63, Issue:22
Chinese Therapeutic Strategy for Fighting COVID-19 and Potential Small-Molecule Inhibitors against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
AID87163Minimum inhibitory concentration required to reduce vesicular stomatitis virus induced cytopathogenicity by 50% in HeLa cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID659291Cytotoxicity against MDCK cells assessed as morphological changes by microscopic analysis2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID406925Selectivity index, ratio of CC50 for Vero cells to EC50 for Measles virus Leningrad 162008Journal of medicinal chemistry, Jul-10, Volume: 51, Issue:13
Potent non-nucleoside inhibitors of the measles virus RNA-dependent RNA polymerase complex.
AID1503313Selectivity index, ratio of CC50 for bovine MDBK cells to EC50 for Bovine viral diarrhea virus NADL ATCC VR 5342017European journal of medicinal chemistry, Dec-01, Volume: 141Inhibitors of Yellow Fever Virus replication based on 1,3,5-triphenyl-4,5-dihydropyrazole scaffold: Design, synthesis and antiviral evaluation.
AID419604Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID88688Tested for inhibitory effect on RNA virus cell morphology in HeLa cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1647362Antiviral activity against Chikungunya virus infected in African green monkey Vero cells assessed as reduction in viral replication at 10 uM treated with compound up to 12 hrs post infection by plaque formation assay2020Bioorganic & medicinal chemistry letters, 01-15, Volume: 30, Issue:2
Quinolone-N-acylhydrazone hybrids as potent Zika and Chikungunya virus inhibitors.
AID217906Minimum inhibitory concentration (MIC) required to elicit a microscopically visible alteration of cell morphology in Vero cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID1372325Antiviral activity against Hepatitis C virus infected in pig SPEV cells assessed as protection against virus-induced cytopathic effect2018Bioorganic & medicinal chemistry letters, 01-01, Volume: 28, Issue:1
Isosteric ribavirin analogues: Synthesis and antiviral activities.
AID701509Selectivity index, ratio of CC50 for human Hep2 cells to EC50 for Respiratory syncytial virus Long infected in human Hep2 cells2012Journal of medicinal chemistry, Oct-25, Volume: 55, Issue:20
(S)-N-(2,5-Dimethylphenyl)-1-(quinoline-8-ylsulfonyl)pyrrolidine-2-carboxamide as a small molecule inhibitor probe for the study of respiratory syncytial virus infection.
AID283989Antiviral activity against coxsackie B virus type 3 by CPE assay2007Bioorganic & medicinal chemistry, Jan-01, Volume: 15, Issue:1
Design, synthesis, and biological evaluation of novel iso-D-2',3'-dideoxy-3'-fluorothianucleoside derivatives.
AID86482Minimum inhibitory conc. for 50% inhibition of coxsackie B4 virus induced cytopathicity in HeLa cells1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Carbocyclic oxetanocins lacking the C-3' methylene.
AID68123Concentration required to reduce vaccinia virus(VV) induced cytopathogenicity by 50% in ESM(embryonic skin muscle) cell cultures.1992Journal of medicinal chemistry, Jun-12, Volume: 35, Issue:12
(+-)-carbocyclic 5'-nor-2'-deoxyguanosine and related purine derivatives: synthesis and antiviral properties.
AID204964The minimum inhibitory concentration required to reduce Sindbis virus induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID218035Concentration required for microscopically detectable alteration of the normal cell morphology in Vero B cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID611758Antiviral activity against RSV infected in HeLa cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID376990Selectivity index, CC50 for human Hep2 cells to IC50 for Cox B3 virus2006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID474328Antiviral activity against Influenza A virus Gull/PA/4175/83/H5N1 infected MDCK cells assessed as inhibition of virus-induced cytopathic effect after 3 days2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID474360Antiviral activity against Influenza B virus Malaysia/2506/2004 infected MDCK cells after 42 to 46 hrs by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID575124Antiviral activity against adamantane-, oseltamivir-, zanamivir-susceptible Influenza A virus (A/Georgia/17/2006(H1N1)) infected in MDCK cells assessed as inhibition of viral replication after 3 days by microscopic analysis using crystal violet stain2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
In vitro antiviral activity of favipiravir (T-705) against drug-resistant influenza and 2009 A(H1N1) viruses.
AID475858Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as inhibition of virus-induced cytopathicity2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID1505491Antiviral activity against Influenza virus B/Ned/537/05 infected in MDCK cells assessed as reduction in viral replication at 3 days post infection by formazan-based MTS assay2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID766688Antiviral activity against Coxsackievirus B4 infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID63761The minimum inhibitory concentration was measured on E6SM cells against Herpes simplex virus type 2 (196 strain)1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID668364In vivo antiviral activity against TMV assessed as curative effect at 500 ug/ml2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis and antiviral activity of novel pyridazines.
AID548443Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of virus induced cytopathicity by visual scoring of CPE2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID1135882Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in viral excretion by measuring hemagglutination units per ml at 13 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to da1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID244630Selectivity index (TC50/IC50) against Coxsackie virus B3 in Vero cells2005Bioorganic & medicinal chemistry letters, Jan-17, Volume: 15, Issue:2
Synthesis and antiviral activity against Coxsackie virus B3 of some novel benzimidazole derivatives.
AID283987Cytotoxicity against human HeLa cells2007Bioorganic & medicinal chemistry, Jan-01, Volume: 15, Issue:1
Design, synthesis, and biological evaluation of novel iso-D-2',3'-dideoxy-3'-fluorothianucleoside derivatives.
AID1082878Antiviral activity against Tobacco mosaic virus (TMV) inoculated in 5-6 growth stage leaf assessed as inhibition effect at 100 ug/mL at 25 degC after 72 hr by half-leaf method2012Journal of agricultural and food chemistry, Jun-13, Volume: 60, Issue:23
Design, synthesis, antiviral activity, and SARs of 14-aminophenanthroindolizidines.
AID354679Antiviral activity against respiratory syncytial virus assessed as effect on virus-induced cytopathic effect1996Journal of natural products, Aug, Volume: 59, Issue:8
Two new naphthoquinones with antiviral activity from Rhinacanthus nasutus.
AID1082876In vivo antiviral activity against Tobacco mosaic virus (TMV) inoculated left side of Nicotiana. tabacum L. leaves assessed as inactivation effect at 100 ug/mL co-incubated with virus measured after 3 to 4 days2012Journal of agricultural and food chemistry, Jun-13, Volume: 60, Issue:23
Design, synthesis, antiviral activity, and SARs of 14-aminophenanthroindolizidines.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1687952Antiproliferative activity against human SNB-75 cells assessed as reduction in cell growth incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID216406Evaluation for antiviral activity against vesion stomatitis virus in primary rabbit kidney cell culture1986Journal of medicinal chemistry, Jul, Volume: 29, Issue:7
Structure-activity relationship of novel oligopeptide antiviral and antitumor agents related to netropsin and distamycin.
AID1543375Antiviral activity against Herpes simplex virus 1 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathogenic effect by microscopic analysis2019Bioorganic & medicinal chemistry, 06-15, Volume: 27, Issue:12
Antiviral activities of Janus-type nucleosides and their related oxime-intermediates.
AID768197Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as reduction of virus-induced cytopathogenicity2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID63919Minimum inhibitory concentration required to elicit microscopically visible cell morphology in E6SM cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID1485236Antiviral activity against Punta Toro virus infected in African green monkey Vero cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID6600550% Minimum inhibitory concentration which is required to reduce cytopathogenicity induced by (Lyons) strain of HSV-2 virus on human E6SM cells.1997Journal of medicinal chemistry, Feb-14, Volume: 40, Issue:4
Novel 3'-C/N-substituted 2',3'-beta-D-dideoxynucleosides as potential chemotherapeutic agents. 1. Thymidine derivatives: synthesis, structure, and broad spectrum antiviral properties.
AID1186342Selectivity index, ratio of CC50 for african green monkey Vero 76 cells to EC50 for Respiratory syncytial virus2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID226101Minimum inhibitory concentration against Vesicular stomatitis virus in primary rabbit kidney cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID273212Antiviral activity against poliovirus in HeLa S3 cells assessed as reduction in viral titer2006Journal of medicinal chemistry, Oct-19, Volume: 49, Issue:21
Synthesis and antiviral activity of 5-substituted cytidine analogues: identification of a potent inhibitor of viral RNA-dependent RNA polymerases.
AID68255Minimum inhibitory concentration required for antiviral activity to reduce Vaccinia virus (VV) induced cytopathicity in human embryonic skin-muscle cells (ESM)1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis and antiviral activities of 8-alkynyl-, 8-alkenyl-, and 8-alkyl-2'-deoxyadenosine analogues.
AID1692496Antiviral activity against nCoV-2019 BetaCoV/Wuhan/WIV04/2019 infected in African green monkey VeroE6 cells assessed as reduction in viral yield preincubated for 1 hr followed by viral infection and further replacement of fresh medium containing compound 2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
COVID-19: Drug Targets and Potential Treatments.
AID1450214Selectivity index, ratio of MCC for African green monkey Vero E6 cells to IC50 for HSV-1 L2 infected in African green monkey Vero E6 cells2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID533318Cytotoxicity against human TIZ-9 cell harboring HCV genotype 1b after 4 days by neutral red dye uptake assay2008Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11
Potential for hepatitis C virus resistance to nitazoxanide or tizoxanide.
AID1742426Cytotoxicity against human HEK293T cells assessed as reduction in cell viability after 48 hrs by CCK8 assay2020European journal of medicinal chemistry, Nov-15, Volume: 206Design, synthesis and in vitro anti-influenza A virus evaluation of novel quinazoline derivatives containing S-acetamide and NH-acetamide moieties at C-4.
AID384286Binding affinity to Plasmodium falciparum spermidine synthase by saturation transfer difference-NMR experiment2008Journal of medicinal chemistry, May-08, Volume: 51, Issue:9
Identification of Plasmodium falciparum spermidine synthase active site binders through structure-based virtual screening.
AID611628Antiviral activity against HIV 2 ROD infected in CEM cells assessed as inhibition of virus-induced giant cell formation after 4 days by microscopy2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID217994Evaluation for antiviral activity against vaccinia virus in primary rabbit kidney cell culture1986Journal of medicinal chemistry, Jul, Volume: 29, Issue:7
Structure-activity relationship of novel oligopeptide antiviral and antitumor agents related to netropsin and distamycin.
AID369468Selectivity index, ratio of CC50 for african green monkey Vero 76 cells to EC50 for Sandfly fever Naples virus2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID774869Antiviral activity against Coxsackie B6 virus Schmitt in african green monkey Vero cells assessed as inhibition virus-induced cytopathic effect after 48 hrs2013European journal of medicinal chemistry, Nov, Volume: 69Synthesis and antiviral activity of a novel class of (5-oxazolyl)phenyl amines.
AID659156Antiviral activity against Parainfluenza-3 virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID218170Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Sindbis virus in African green monkey kidney (Vero B)cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID548437Cytotoxicity against MDCK cells assessed as cell viability by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID216199Tested for antiviral activity against parainfluenza virus in african green monkey kidney cell (Vero)2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID278372RBV metabolism in Vero E6 cells assessed as RBV-TP concentration at 40 ug/ml after 24 h2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID474543Selectivity ratio of IC50 for MDCK cells to EC50 for inhibition of virus-induced cytopathic effect of Influenza A virus Solomon Islands/03/2006/H1N12010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID216969Minimum inhibitory conc. for 50% inhibition of Parainfluenza-3 virus induced cytopathicity in Vero cells1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Carbocyclic oxetanocins lacking the C-3' methylene.
AID539957Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as cell viability after 2 days by MTS assay2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID249868Anti BVDV activity relative to ribavirin2004Journal of medicinal chemistry, Oct-07, Volume: 47, Issue:21
Synthesis of benzodithiol-2-yl-substituted nucleoside derivatives as lead compounds having anti-bovine viral diarrhea virus activity.
AID303235Antiviral activity against Sindbis virus in Vero cells reduction of virus-induced cytopathogenicity after 4 days2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID1436792Antiviral activity against Coxsackievirus B1 Conn-5 infected in African green monkey Vero cells assessed as reduction in viral-induced cytopathic effect by Reed and Muench analysis2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID535510Transport through ENT2 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1169734Antiviral activity against dengue virus 2 infected in human HuH7 cells after 72 hrs by Western blot and ECL detection based assay2014Journal of natural products, Nov-26, Volume: 77, Issue:11
Limonoids from the seeds of Swietenia macrophylla with inhibitory activity against dengue virus 2.
AID1432505Selectivity index, ratio of TC50 for MDCK cells to IC50 for Influenza A virus H3N2 infected in MDCK cells2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Structure-activity relationship studies of 1-(1'-hydroxyalkyl)rupestonic acid methyl esters against influenza viruses.
AID535522Transport through CNT2 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer containing 100 uM NBMPR and 1 mM inosine2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID539922Antiviral activity against Reovirus-1 infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID1241024Antiviral activity against Influenza B virus infected in MDCK cells after 3 days by neutral red dye-based plaque reduction assay2015Bioorganic & medicinal chemistry, Sep-01, Volume: 23, Issue:17
2- and 3-Fluoro-3-deazaneplanocins, 2-fluoro-3-deazaaristeromycins, and 3-methyl-3-deazaneplanocin: Synthesis and antiviral properties.
AID361409Antiviral activity against Vesicular stomatitis Indiana virus infected in human HeLa assessed as inhibition of virus-induced cytopathic effect after 2 days by MTT assay2002Journal of natural products, Nov, Volume: 65, Issue:11
New saponins from the starfish Certonardoa semiregularis.
AID106225Tested for inhibitory effect on RNA virus cell growth in MT-4 cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1081546In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as inactivation effect at 500 ug/ml co-treated with virus for 30 min before inoculation onto leaves measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID767057Selectivity index, ratio of CC50 for human rhabdomyosarcoma cells to EC50 for Enterovirus 71 infected in human rhabdomyosarcoma cells2013Bioorganic & medicinal chemistry letters, Sep-15, Volume: 23, Issue:18
Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID1773007Inhibition of RSV induced apoptosis in human HEp-2 cells assessed as late apoptotic cells at 25 uM measured after 60 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 20.2%)2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID774118Cytotoxicity against African green monkey Vero cells after 48 hrs by Reed-Muench analysis2013Journal of natural products, Oct-25, Volume: 76, Issue:10
Diterpenoids and sesquiterpenoids from the roots of Illicium majus.
AID1265167Cytotoxicity against HEK293T cells assessed as cell viability at antiviral EC50 after 24 hrs by cell titer-glo luminescent cell viability assay2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
AID482704Antiviral activity against Vaccina virus infected in human E6SM cell assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID489678Antiviral activity against Coxsackie virus B4 infected in human HeLa cells assessed as inhibition of virus-induced cytopathic effect after 3 days by MTS assay2010European journal of medicinal chemistry, Jul, Volume: 45, Issue:7
Benzylidene/2-chlorobenzylidene hydrazides: synthesis, antimicrobial activity, QSAR studies and antiviral evaluation.
AID1293608Inhibition of Influenza A virus PR/8/34 6His-tagged PA (239 to 716 residues) interaction with GST-tagged PB1 (1 to 25 residues) expressed in Escherichia coli compound treated in PBS buffer measured after overnight incubation by ELISA2016Journal of medicinal chemistry, Mar-24, Volume: 59, Issue:6
4,6-Diphenylpyridines as Promising Novel Anti-Influenza Agents Targeting the PA-PB1 Protein-Protein Interaction: Structure-Activity Relationships Exploration with the Aid of Molecular Modeling.
AID284535Cytotoxicity against E6SM cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID1152079Inhibition of Influenza A virus A/PR/8/34 infected in MDCK cells after 48 hrs by plaque reduction assay2014Journal of medicinal chemistry, May-22, Volume: 57, Issue:10
Optimization of small-molecule inhibitors of influenza virus polymerase: from thiophene-3-carboxamide to polyamido scaffolds.
AID1265162Antiviral activity against wild type Chikungunya virus IMT infected in HEK293T cells assessed as inhibition of infectivity measured at 24 hrs postinfection by FITC/DAPI staining based array scan VTI HCS reader analysis2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
AID156696Concentration required for microscopically detectable alteration of the normal cell morphology in PRK cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID539925Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID218254Evaluation for antiviral activity against parainfluenza-3 virus in Vero cell cultures (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID1132044Antibacterial activity against Bacillus subtilis1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID575247Antiviral activity against adamantane-resistant zanamivir-,oseltamivir-susceptible Influenza A virus (A/Florida/01/2009(H3N2)) harboring M2 S31N mutant infected in MDCK cells assessed as inhibition of viral replication after 3 days by microscopic analysis2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
In vitro antiviral activity of favipiravir (T-705) against drug-resistant influenza and 2009 A(H1N1) viruses.
AID395963Toxicity in BALB/c mouse2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID108463Compound was tested for antiviral activity against measles virus in vero cells1984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID275072Antiviral activity against RSV in HeLa cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID416776Antiviral activity against VSV in human HEL cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID297312Antiviral activity against VSV in HeLa cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID392725Antiviral activity against Coxsackievirus B3 assessed as inhibition of virus-induced cytopathicity2009Bioorganic & medicinal chemistry letters, Feb-15, Volume: 19, Issue:4
Synthesis of 5-isoxazol-5-yl-2'-deoxyuridines exhibiting antiviral activity against HSV and several RNA viruses.
AID1783357Antiviral activity against West Nile virus lineage 1 (Italy/2009) infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 48 hrs by immunodetection based direct yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID535529Transport through CNT3 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer containing 100 uM NBMPR and 1 mM uridine2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1687950Antiproliferative activity against human HuH-7 cells assessed as reduction in cell growth incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID395952Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean viral titer per 0.1 mL of serum at 50 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID216349Tested for antiviral activity against coxsackie B-4 virus in African green monkey kidney cell (Vero)2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID1132049Antibacterial activity against Streptococcus pyogenes CN101978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID1265168Antiviral activity against wild type Chikungunya virus IMT infected in HEK293T cells assessed as inhibition of infectivity at 5 uM measured at 24 hrs postinfection by FITC/DAPI staining based array scan VTI HCS reader analysis2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
AID1485244Cytotoxicity against dog MDCK cells assessed as alterations in normal cell morphology measured after 5 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID1886819Cytotoxicity against African green monkey Vero E6 cells infected with ZIKV COL345Si measured after 6 days by MTT assay2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID1055008Antiviral activity against Western equine encephalomyelitis virus infected in human BE(2)-C cells assessed as reduction of viral titer at 25 uM after 24 hrs by plaque reduction assay (Rvb = 25.7 +/- 5.2 x 10'6 pfu/ml)2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Optimization of novel indole-2-carboxamide inhibitors of neurotropic alphavirus replication.
AID1485249Antiviral activity against Influenza A virus A/Ned/378/05(H1N1) infected in MDCK cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by formazan-based colorimetric assay2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID1450216Antiviral activity against acyclovir-resistant HSV-1 L2 infected in African green monkey Vero E6 cells assessed as reduction in virus-induced cytopathic effect2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID370227Antiviral activity against Punta Toro virus Adames infected Syrian golden hamster assessed as mean day of death at 30 mg/kg, po twice daily for 6 days administered 4 hrs before viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID482707Antiviral activity against VSV infected in human HeLa cell assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID216945In vitro antiviral activity against V V virus in (vero) V cells of african green monkey kidney1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
AID218433Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Rhinovirus 9 in human diploid (WI-38)cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID400418Antiviral activity against RSV A-2 infected in human Hep2 cells after 3 days by plaque neutralization assay1998Journal of natural products, May, Volume: 61, Issue:5
Antiviral phenylpropanoid glycosides from the medicinal plant Markhamia lutea.
AID1081543Phytotoxicity against Nicotiana tabacum (tobacco) plant2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID105788Antiviral activity against influenza A,H2N2 virus infected MDCK cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID1724446Antiviral activity against HCV genotype 2a JFH-1 infected in human Huh7.5 cells after 3 days by renilla luciferase reporter gene assay2020Bioorganic & medicinal chemistry, 10-01, Volume: 28, Issue:19
SAR study of bisamides as cyclophilin a inhibitors for the development of host-targeting therapy for hepatitis C virus infection.
AID416766Antiviral activity against Coxsackievirus B4 in human HeLa cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID312074Antiviral activity against poliovirus infected HeLa S3 cells assessed as plaque formation at 2 mM2008Journal of medicinal chemistry, Jan-10, Volume: 51, Issue:1
Effects of introduction of hydrophobic group on ribavirin base on mutation induction and anti-RNA viral activity.
AID368958Antiviral activity against RSV RSS infected human Hep2 cells assessed as reduction of viral antigen synthesis after 3 days by ELISA2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID658748Antiviral activity against Influenza B virus infected in MDCK cells assessed as reduction visual scoring of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID416749Antiviral activity against VSV in human HeLa cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1578004Selectivity index, ratio of TC50 for cytotoxicity against dog MDCK cells to IC50 for antiviral activity against Influenza A virus H1N1 infected in dog MDCK cells2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Novel amides modified rupestonic acid derivatives as anti-influenza virus reagents.
AID217264Effective concentration required to inhibit PuntaToro virus-induced cytopathicity by 50% in Vero cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID217590In vitro antiviral activity against parainfluenza type 3 virus in Vero cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Synthesis and biological activity of certain nucleoside and nucleotide derivatives of pyrazofurin.
AID400430Antiviral activity against RSV infected in human Hep2 cells assessed as virus-induced cytopathic effect administered 3 hrs postinfection1998Journal of natural products, May, Volume: 61, Issue:5
Antiviral phenylpropanoid glycosides from the medicinal plant Markhamia lutea.
AID1230119Cytotoxicity against African green monkey Vero cells assessed as alternation of cell morphology by microscopic analysis2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Design, antiviral and cytostatic properties of isoxazolidine-containing amonafide analogues.
AID1066042Antiviral activity against Influenza A virus (A/Wisconsin/67/2005(H3N2)) clinical isolate infected in MDCK cells assessed as inhibition of plaque formation after 2 days by toluidine blue staining assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID659157Antiviral activity against Coxsackie virus B4 infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID1235017Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for Coxsackievirus B3-induced cytopathic effect in African green monkey Vero cells2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Bioactive Sesquiterpenes and Lignans from the Fruits of Xanthium sibiricum.
AID1360697Antiviral activity against Influenza B virus B/Ned/537/05 infected in MDCK cells assessed as protection against virus-induced reduction in cell viability after 3 to 6 days by MTS assay2018European journal of medicinal chemistry, Jul-15, Volume: 155Synthesis, biological evaluation and molecular modeling of novel azaspiro dihydrotriazines as influenza virus inhibitors targeting the host factor dihydrofolate reductase (DHFR).
AID1253095Antiviral activity against HCV JFH1 infected in human HuH7-J20 cells assessed as inhibition of viral life cycle by measuring secreted alkaline phosphatase level preincubated with cells for 1 hr followed by viral inoculation for 3 hrs and fresh drug admini2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Rethinking the old antiviral drug moroxydine: Discovery of novel analogues as anti-hepatitis C virus (HCV) agents.
AID63945Inhibition of virus-induced cytopathicity in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID474348Selectivity ratio of IC50 for MDCK cells to EC50 for Influenza A virus Vietnam/1203/ 2004H/H5N1 by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1238137Antiviral activity against HCV genotype 1 in patient assessed as virological response rate2015Bioorganic & medicinal chemistry letters, Aug-15, Volume: 25, Issue:16
Design and synthesis of imidazole N-H substituted amide prodrugs as inhibitors of hepatitis C virus replication.
AID217989Minimum cytotoxic concentration against vaccinia virus embryonic skin muscle cell cultures1989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID1691542Cytotoxicity against MDCK cells assessed as reduction in cell viability measured after 72 hrs by MTS assay2020European journal of medicinal chemistry, May-15, Volume: 194N-benzyl 4,4-disubstituted piperidines as a potent class of influenza H1N1 virus inhibitors showing a novel mechanism of hemagglutinin fusion peptide interaction.
AID658606Cytotoxicity against MDCK cells assessed as cell viability by colorimetric formazan-based MTS assay2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID535519Transport through ENT1 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer containing 100 uM NBMPR2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID634832Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1237440Antiviral activity against SARS-CoV assessed as inhibition of viral replication2015Bioorganic & medicinal chemistry letters, Aug-01, Volume: 25, Issue:15
Design, synthesis and evaluation of a series of acyclic fleximer nucleoside analogues with anti-coronavirus activity.
AID156710Evaluation for antiviral activity against vesicular stomatitis virus in primary rabbit kidney cell cultures(PRK) (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID199175Compound was tested for antiviral activity (minimum inhibition concentration) in Vero cells reovirus type 11984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID1443885Cytotoxicity against human BJ cells assessed as reduction in cell viability after 24 hrs by CellTiter-Glo luminescent assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Structural Optimizations of Thieno[3,2-b]pyrrole Derivatives for the Development of Metabolically Stable Inhibitors of Chikungunya Virus.
AID396873Antiviral activity against Rift Valley fever virus infected in african green monkey Vero cells assessed as plaque reduction at 250 ug/mL
AID548424Antiviral activity against Herpes simplex virus 1 KOS infected in HEL cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID634088Antiviral activity against HCV genotype 1b infected in human HuH7 cells assessed as reduction in luciferase activity at 10 uM after 3 days2012Bioorganic & medicinal chemistry, Jan-01, Volume: 20, Issue:1
The design, synthesis and biological evaluations of C-6 or C-7 substituted 2-hydroxyisoquinoline-1,3-diones as inhibitors of hepatitis C virus.
AID774870Selectivity index, ratio of CC50 for african green monkey Vero cells to IC50 for Coxsackie B3 virus Schmitt2013European journal of medicinal chemistry, Nov, Volume: 69Synthesis and antiviral activity of a novel class of (5-oxazolyl)phenyl amines.
AID1498135Cytotoxicity against African green monkey Vero cells assessed as alteration of cell morphology by microscopic analysis2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID392501Antiviral activity against Human adenovirus 22009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID1181192Antiviral activity against influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect after 48 hrs by crystal violet staining assay2014Journal of natural products, Jul-25, Volume: 77, Issue:7
Eleganketal A, a highly oxygenated dibenzospiroketal from the marine-derived fungus Spicaria elegans KLA03.
AID218369Cytotoxic concentration required to cause microscopically detectable alteration of normal cell morphology of Vero cells1996Journal of medicinal chemistry, Jul-05, Volume: 39, Issue:14
Synthesis of acyclo-C-nucleosides in the imidazo[1,2-a]pyridine and pyrimidine series as antiviral agents.
AID548445Cytotoxicity against african green monkey Vero cells assessed as altered cell morphology2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID68118Concentration required to cause a microscopically detectable alteration of normal ESM cell morphology.1992Journal of medicinal chemistry, Jun-12, Volume: 35, Issue:12
(+-)-carbocyclic 5'-nor-2'-deoxyguanosine and related purine derivatives: synthesis and antiviral properties.
AID395971Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 mL of serum at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID665017Inhibition of IMPDH in human CEM cells assessed as formation of [2,8-3H]hypoxanthine from [2,8-3H]IMP after 20 to 60 mins2012Bioorganic & medicinal chemistry, Jun-01, Volume: 20, Issue:11
Novel 1,2,4-triazole and imidazole derivatives of L-ascorbic and imino-ascorbic acid: synthesis, anti-HCV and antitumor activity evaluations.
AID693525Antiviral activity against Influenza A/HK/7/87 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect measured on day 3 post infection by MTS assay2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis of fluorescent ristocetin aglycon derivatives with remarkable antibacterial and antiviral activities.
AID1205003Antiviral activity against Coxsackievirus B5 infected in african green monkey Vero cells assessed as reduction in viral-induced cytopathic effect2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID767056Cytotoxicity against human HepG2 cells after 72 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, Sep-15, Volume: 23, Issue:18
Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID1204068Cytotoxicity against bovine MDBK cells assessed as cell viability after 72 hrs by MTT method2015Bioorganic & medicinal chemistry letters, Jun-01, Volume: 25, Issue:11
N-((1,3-Diphenyl-1H-pyrazol-4-yl)methyl)anilines: A novel class of anti-RSV agents.
AID539920Cytotoxicity against african green monkey Vero cells assessed as minimum concentration required to cause microscopically detectable alteration after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID1736921Cytotoxicity against chicken embryo fibroblast assessed as reduction in cell viability after 48 hrs by CCK8 assay2020European journal of medicinal chemistry, Apr-01, Volume: 191Discovery of novel "Dual-site" binding oseltamivir derivatives as potent influenza virus neuraminidase inhibitors.
AID63939concentration required to inhibit HSV-1(KOS)-induced cytopathicity by 50% in E6SM cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID87153Evaluated for minimum inhibitory concentration against HeLa cells (human carcinoma) infected with VSV, Coxs, B4, polio-1 virus1990Journal of medicinal chemistry, May, Volume: 33, Issue:5
Stereospecific synthesis and antiviral properties of different enantiomerically pure carbocyclic 2'-deoxyribonucleoside analogues derived from common chiral pools: (+)-(1R,5S)- and (-)-(1S,5R)-2-oxabicyclo[3.3.0]oct-6-en-3-one.
AID218002Minimum inhibitory concentration against vaccinia virus embryonic skin muscle cell cultures1989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID774868Selectivity index, ratio of CC50 for african green monkey Vero cells to IC50 for Coxsackie B3 virus Nancy2013European journal of medicinal chemistry, Nov, Volume: 69Synthesis and antiviral activity of a novel class of (5-oxazolyl)phenyl amines.
AID1135884Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in viral excretion by measuring hemagglutination units per ml at 14 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to da1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID1773418Cytotoxicity against human A549 cells assessed as reduction in cell viability incubated for 48 hrs by MTT assay2021European journal of medicinal chemistry, Dec-05, Volume: 225Novel betulin dicarboxylic acid ester derivatives as potent antiviral agents: Design, synthesis, biological evaluation, structure-activity relationship and in-silico study.
AID231386Adenylate to guanylate ratio for the cell fraction was determined1988Journal of medicinal chemistry, Feb, Volume: 31, Issue:2
Synthesis and evaluation of 5-amino-1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamidine and certain related nucleosides as inhibitors of purine nucleoside phosphorylase.
AID1436798Antiviral activity against Coxsackievirus B4 J.V.B infected in African green monkey Vero cells assessed as reduction in viral-induced cytopathic effect by Reed and Muench analysis2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID1407825Antiviral activity against Influenza virus H5N12018European journal of medicinal chemistry, Sep-05, Volume: 157Pyrrolopyrimidines: An update on recent advancements in their medicinal attributes.
AID1654870Antiviral activity against Zika virus infected in Vero E6 cells assessed as reduction in virus-induced cytopathic effect incubated for 96 hrs by CCK8 assay2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
2-((4-Arylpiperazin-1-yl)methyl)benzonitrile Derivatives as Orally Available Inhibitors of Hepatitis C Virus with a Novel Mechanism of Action.
AID1443862Cytotoxicity against HEK293T cells assessed as reduction in cell viability after 24 hrs by CellTiter-Glo luminescent assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Structural Optimizations of Thieno[3,2-b]pyrrole Derivatives for the Development of Metabolically Stable Inhibitors of Chikungunya Virus.
AID611765Antiviral activity against Feline coronavirus infected in CRFK cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID1066050Cytotoxicity against HEK293 cells assessed as cell viability after 24 hrs by MTT assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID1127182Cytotoxicity against human HuH7 cells assessed as cell viability at 100 uM after 3 days by XTT assay2014European journal of medicinal chemistry, May-22, Volume: 79Synthesis, antiproliferative and anti-dengue virus evaluations of 2-aroyl-3-arylquinoline derivatives.
AID658742Cytotoxicity against human HeLa cells assessed as minimum compound concentration required to causes microscopically detectable alteration of normal cell morphology2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID1485242Antiviral activity against vesicular stomatitis virus infected in human HeLa cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID1736918Antiviral activity against Influenza A virus (A/chicken/Hebei/LZF/ 2014(H5N2)) group-2 infected in chicken embryo fibroblast assessed as reduction in viral infection preincubated for 1 hrs followed by fibroblast infection and measured after 72 hrs by hema2020European journal of medicinal chemistry, Apr-01, Volume: 191Discovery of novel "Dual-site" binding oseltamivir derivatives as potent influenza virus neuraminidase inhibitors.
AID1546421Cytotoxicity in African green monkey Vero cells assessed as reduction in cell viability by MTT assay2020Bioorganic & medicinal chemistry letters, 01-01, Volume: 30, Issue:1
Synthesis and anti-CVB3 activity of 4-amino acid derivative substituted pyrimidine nucleoside analogues.
AID1133177Antiviral activity against Adenovirus type 3 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs relative to control1978Journal of medicinal chemistry, Dec, Volume: 21, Issue:12
Synthesis and antiviral and enzymatic studies of certain 3-deazaguanines and their imidazolecarboxamide precursors.
AID370207Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in serum at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1873824Antiviral activity against Zika virus H/PAN/2016/BEI-259634 infected in human Huh7.5 cells assessed as reduction in viral titer incubated for 3 days by plaque assay2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID665836In vivo antiviral activity against TMV assessed as protection effect at 500 ug/mL2012European journal of medicinal chemistry, Jul, Volume: 53Design, synthesis and antiviral activity of novel quinazolinones.
AID1055979Cytotoxicity against MDCK cells assessed as minimum cytotoxic concentration after 24 hrs by MTS assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
3-Azatetracyclo[5.2.1.1(5,8).0(1,5)]undecane derivatives: from wild-type inhibitors of the M2 ion channel of influenza A virus to derivatives with potent activity against the V27A mutant.
AID1127180Antiviral activity against DENV2 16681 infected in human Huh-7 cells at 20 uM after 3 days by luciferase reporter gene assay2014European journal of medicinal chemistry, May-22, Volume: 79Synthesis, antiproliferative and anti-dengue virus evaluations of 2-aroyl-3-arylquinoline derivatives.
AID1293611Cytotoxicity against MDCK cells assessed as decrease in cell viability after 48 hrs by MTT assay2016Journal of medicinal chemistry, Mar-24, Volume: 59, Issue:6
4,6-Diphenylpyridines as Promising Novel Anti-Influenza Agents Targeting the PA-PB1 Protein-Protein Interaction: Structure-Activity Relationships Exploration with the Aid of Molecular Modeling.
AID1858559Antiviral activity against SARS-CoV 2 nCoV-2019BetaCoV/Wuhan/WIV04/2019 infected in african green monkey Vero E6 cells measured after 48 hrs2021European journal of medicinal chemistry, Jan-01, Volume: 209Primed for global coronavirus pandemic: Emerging research and clinical outcome.
AID648648Cytotoxicity against MDCK cells2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Synthesis and anti-influenza activity of aminoalkyl rupestonates.
AID87164Minimum inhibitory concentration (MIC) required to elicit a microscopically visible alteration of cell morphology in HeLa cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID1234207Selectivity index, ratio of TC50 for African green monkey MDCK cells to IC50 for influenza A virus (A/Hanfang/359/95(H3N2))2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Antiviral Matrine-Type Alkaloids from the Rhizomes of Sophora tonkinensis.
AID1594023Cytotoxicity against MDCK cells assessed as reduction in cell viability measured after 72 hrs by alamar blue assay2019Bioorganic & medicinal chemistry letters, 07-01, Volume: 29, Issue:13
Discovery of 5-(5-fluoro-1H-pyrrolo[2,3-b]pyridin-3-yl)pyrazin-2(1H)-one derivatives as new potent PB2 inhibitors.
AID659149Antiviral activity against Vaccinia virus infected in HEL cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID280197Antiviral activity against parainfluenza3 virus in Vero cells assessed as inhibition of virus-induced cytopathicity2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID216370Antiviral activity against sindbis virus infected Vero cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID1204070Selectivity index, ratio of CC50 for bovine MDBK cells to EC50 for BVDV infected in bovine MDBK cells2015Bioorganic & medicinal chemistry letters, Jun-01, Volume: 25, Issue:11
N-((1,3-Diphenyl-1H-pyrazol-4-yl)methyl)anilines: A novel class of anti-RSV agents.
AID280203Cytotoxicity against E6SM cells assessed as alteration in cell morphology2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID1271122Selectivity index, ratio of CC50 for mock-infected human Huh7.5 cells to EC50 for recombinant HCV genotype 2a JFH12015Journal of medicinal chemistry, Dec-24, Volume: 58, Issue:24
Structure-Based Discovery of Novel Cyclophilin A Inhibitors for the Treatment of Hepatitis C Virus Infections.
AID392528Antiviral activity against influenza H2N2 virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID357951Therapeutic index, ratio of TC50 for human Hep2 cells to IC50 for Parainfluenza virus type 32001Journal of natural products, Oct, Volume: 64, Issue:10
New antiviral cassane furanoditerpenes from Caesalpinia minax.
AID235487Selectivity index is the ratio of IC50 to EC50 of F-MuLV.1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Unsaturated and carbocyclic nucleoside analogues: synthesis, antitumor, and antiviral activity.
AID301702Ratio of kinact for Trypanosoma cruzi recombinant S-adenosyl-L-homocysteine hydrolase NAD form to KI for Trypanosoma cruzi recombinant S-adenosyl-L-homocysteine hydrolase NAD form2007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID401228Selectivity index, ratio of CC50 for MDCK cells to IC50 for PIV32004Journal of natural products, Apr, Volume: 67, Issue:4
Antiviral flavonoids from the seeds of Aesculus chinensis.
AID224916Antiviral activity against parainfluenza virus type 3 in Vero cell culture lines1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID475861Cytotoxicity against human HuH5.2 cells2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID1511214Antiviral activity against RABV infected in BSR cells preincubated for 4 hrs followed by viral infection and further incubated with compounds for 24 hrs by immunostaining-based assay2019ACS medicinal chemistry letters, Aug-08, Volume: 10, Issue:8
DABMA: A Derivative of ABMA with Improved Broad-Spectrum Inhibitory Activity of Toxins and Viruses.
AID1071706Antiviral activity against Influenza A virus H5N1 by cytopathy assay2014European journal of medicinal chemistry, Mar-03, Volume: 74Synthesis and biological evaluation of 2-oxonicotinonitriles and 2-oxonicotinonitrile based nucleoside analogues.
AID1636440Drug activation in human Hep3B cells assessed as human CYP2D6-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID218166Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Parainfluenza virus-3 in African green monkey kidney (Vero B)cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID1890796Selectivity index, ratio of CC50 for human HEK293T cells to IC50 for antiviral activity against Influenza A virus A/WSN/33 (H1N1) infected in HEK293T cells2022Bioorganic & medicinal chemistry letters, 05-15, Volume: 64Design, synthesis, and anti-influenza A virus activity evaluation of novel indole containing derivatives of triazole.
AID474359Antiviral activity against Influenza B virus Malaysia/2506/2004 infected MDCK cells assessed as inhibition of virus-induced cytopathic effect after 3 days2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID768191Antiviral activity against Punts virus B4 infected in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID291035Antiviral activity against sindbis virus in Vero cells assessed as reduction of virus plaque formation after 7 days2007Journal of medicinal chemistry, Jun-28, Volume: 50, Issue:13
Novel C-6 fluorinated acyclic side chain pyrimidine derivatives: synthesis, (1)H and (13)C NMR conformational studies, and antiviral and cytostatic evaluations.
AID395957Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as inhibition of liver damage at 50 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID370216Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in liver at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID217998Evaluated for minimum inhibitory concentration against Vaccinia virus (VV) in primary rabbit kidney cells1990Journal of medicinal chemistry, May, Volume: 33, Issue:5
Stereospecific synthesis and antiviral properties of different enantiomerically pure carbocyclic 2'-deoxyribonucleoside analogues derived from common chiral pools: (+)-(1R,5S)- and (-)-(1S,5R)-2-oxabicyclo[3.3.0]oct-6-en-3-one.
AID463995Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as protection from virus-induced cytopathogenicity after 2 to 3 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID625277FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of less concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID1546420Antiviral activity against CVB3 infected in African green monkey Vero cells by MTT assay2020Bioorganic & medicinal chemistry letters, 01-01, Volume: 30, Issue:1
Synthesis and anti-CVB3 activity of 4-amino acid derivative substituted pyrimidine nucleoside analogues.
AID474331Antiviral activity against Influenza A virus Hong Kong/213/2003/H5N1 infected MDCK cells assessed as inhibition of virus-induced cytopathic effect after 3 days2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID297313Antiviral activity against Parainfluenza 3 virus in Vero cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID87143Minimum cytotoxic concentration (MCC) required to cause a microscopically detectable alteration of host cell morphology, when incubated with HeLa cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID249185Cytotoxic concentration required to inhibit Vero cell growth by 50%2005Bioorganic & medicinal chemistry letters, Jan-17, Volume: 15, Issue:2
Synthesis and antiviral activity against Coxsackie virus B3 of some novel benzimidazole derivatives.
AID301696Inactivation of Trypanosoma cruzi recombinant S-adenosyl-L-homocysteine hydrolase NADH form expressed in Escherichia coli JM109 assessed by measuring fluorescence2007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID217884Minimum cytotoxic concentration in Vero cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID1132046Antibacterial activity against Staphylococcus aureus Russel1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID1638600Antiviral activity against West Nile virus2019Journal of medicinal chemistry, 03-14, Volume: 62, Issue:5
DDX3X Helicase Inhibitors as a New Strategy To Fight the West Nile Virus Infection.
AID1409609Cytotoxicity of compound against Vero E6 cells by MTT assay.2020Nature, 07, Volume: 583, Issue:7816
A SARS-CoV-2 protein interaction map reveals targets for drug repurposing.
AID1650129Antiviral activity against IInfluenza A virus H3N2 A/HK/7/87 infected in MDCK cells after 4 days by MTS assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Superior inhibition of influenza virus hemagglutinin-mediated fusion by indole-substituted spirothiazolidinones.
AID1131475Antiviral activity against Herpes simplex virus 1 infected in primary rabbit kidney cells assessed as inhibition of virus-induced cytopathogenicity treated immediately after virus adsorption measured 3 days after virus infection1977Journal of medicinal chemistry, Oct, Volume: 20, Issue:10
Synthesis and determination of antiviral activity of the 2'(3')-O-methyl derivatives of ribavirin (1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide).
AID301325Inhibition of HCV replication in Huh7 cells after 48 hrs by luciferase assay2007Bioorganic & medicinal chemistry, Nov-15, Volume: 15, Issue:22
5'-O-masked 2'-deoxyadenosine analogues as lead compounds for hepatitis C virus (HCV) therapeutic agents.
AID87142Minimum cytotoxic concentration required to cause a microscopically detectable alteration of normal cell morphology and show antiviral activity in HeLa cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID1710786Cytotoxicity against African green monkey Vero cells assessed as changes in cell morphology incubated for 3 to 6 days by light microscopy2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID766685Antiviral activity against Influenza B virus infected in MDCK cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID443830Antiviral activity against Influenza A virus (A/Hong Kong/7/87(H3N2)) assessed as cell viability by cell-based MTS assay2009Journal of medicinal chemistry, Oct-08, Volume: 52, Issue:19
Diazo transfer-click reaction route to new, lipophilic teicoplanin and ristocetin aglycon derivatives with high antibacterial and anti-influenza virus activity: an aggregation and receptor binding study.
AID1135739Antiviral activity against Vaccinia virus infected in human KB cells assessed as inhibition of virus-induced cytopathic effect at 1 to 1000 ug/ml after 72 hrs1978Journal of medicinal chemistry, Aug, Volume: 21, Issue:8
Synthesis and antiviral acticity of some phosphates of the broad-spectrum antiviral nucleoside, 1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide (ribavirin).
AID300560Antiviral activity against influenza A/Jingfang/262/95(H1N1) virus in MDCK cells by CPE assay2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID1436794Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for Coxsackievirus B3 (strain Nancy) infected in African green monkey Vero cells2017Bioorganic & medicinal chemistry letters, 02-15, Volume: 27, Issue:4
Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID416771Antiviral activity against Punta Toro virus in african green monkey Vero cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID634753Antiviral activity against thymidine kinase-positive Varicella Zoster virus Oka infected in human HEL cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1280345Cytotoxicity against MDCK cells after 40 hrs by Celltiter-Glo assay2016European journal of medicinal chemistry, Jan-27, Volume: 108Spiromastilactones: A new class of influenza virus inhibitors from deep-sea fungus.
AID396875Antiviral activity against Yellow fever virus infected in rhesus monkey MK2 cells assessed as plaque reduction at 250 ug/mL
AID218434Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Rhinovirus-1A in human diploid (WI-38)cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID1132047Antibacterial activity against Staphylococcus aureus 15171978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID63765The minimum inhibitory concentration was measured on E6SM cells against TK-Herpes simplex virus type 1 (B2006 strain)1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID197658Concentration that reduces Rauscher murine leukemia virus titer by 50%1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Unsaturated and carbocyclic nucleoside analogues: synthesis, antitumor, and antiviral activity.
AID1498132Antiviral activity against Coxsackie virus B4 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID360162Antiviral activity against HCV 1b with NS3-4A R155M mutation in human Huh7 cells after 48 hrs by replicon cell assay2007The Journal of biological chemistry, Aug-03, Volume: 282, Issue:31
Phenotypic and structural analyses of hepatitis C virus NS3 protease Arg155 variants: sensitivity to telaprevir (VX-950) and interferon alpha.
AID611629Antiviral activity against VSV infected in HEL cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID68254Minimum inhibitory concentration required for antiviral activity to reduce TK-HSV-1 (B2006) induced cytopathicity in human embryonic skin-muscle cells (ESM)1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis and antiviral activities of 8-alkynyl-, 8-alkenyl-, and 8-alkyl-2'-deoxyadenosine analogues.
AID1071707Antiviral activity against Influenza A virus H1N1 by cytopathy assay2014European journal of medicinal chemistry, Mar-03, Volume: 74Synthesis and biological evaluation of 2-oxonicotinonitriles and 2-oxonicotinonitrile based nucleoside analogues.
AID548446Antiviral activity against parainfluenza-3 virus infected in african green monkey Vero cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID1315540Antiviral activity against Bovine viral diarrhea virus 1 infected in MDBK cells2016European journal of medicinal chemistry, Sep-14, Volume: 120The therapeutic voyage of pyrazole and its analogs: A review.
AID1869551Antiviral activity against Respiratory syncytial virus infected in human HEp-2 cells assessed as inhibition of virus-induced cytopathic effect by CPE inhibition assay
AID88278Evaluated for minimum inhibitory concentration against TK-B2006 strain of Herpes simplex virus (HSV-1) in primary rabbit kidney cells1990Journal of medicinal chemistry, May, Volume: 33, Issue:5
Stereospecific synthesis and antiviral properties of different enantiomerically pure carbocyclic 2'-deoxyribonucleoside analogues derived from common chiral pools: (+)-(1R,5S)- and (-)-(1S,5R)-2-oxabicyclo[3.3.0]oct-6-en-3-one.
AID1118655Cytotoxicity against African green monkey Vero cells assessed as concentration required to cause microscopically visible alternation of cell morphology2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1409607IC50 for antiviral activity against SARS-CoV-2 in the Vero E6 cell line at 48 h by immunofluorescence-based assay (detecting the viral NP protein in the nucleus of the Vero E6 cells).2020Nature, 07, Volume: 583, Issue:7816
A SARS-CoV-2 protein interaction map reveals targets for drug repurposing.
AID345884Cytotoxicity against human Huh-9-13 cells2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Discovery of novel arylethynyltriazole ribonucleosides with selective and effective antiviral and antiproliferative activity.
AID395975Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean serum ALT levels at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID68126Tested for inhibitory effect on DNA virus HSV-2 (G) in ESM cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID105946Antiviral activity against influenza A H2N2(A2 japan/305/57) in MDCK cells2003Bioorganic & medicinal chemistry letters, May-19, Volume: 13, Issue:10
Spiro[pyrrolidine-2,2'-adamantanes]: synthesis, anti-influenza virus activity and conformational properties.
AID300579Antiviral activity against influenza A/Jingfang/Fm1 (H1N1) infected in mouse assessed as survival of mouse at 100 mg/kg, ip bid after 2 hrs of viral infection for 5 days2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1167619Cytotoxicity against human ORL8 cells after 72 hrs by WST-1 assay2014Bioorganic & medicinal chemistry, Nov-01, Volume: 22, Issue:21
Synthesis of 3',4'-difluoro-3'-deoxyribonucleosides and its evaluation of the biological activities: discovery of a novel type of anti-HCV agent 3',4'-difluorocordycepin.
AID226341Antiviral activity against sindbis virus in Vero cell culture lines1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID368960Antiviral activity against RSV Long infected human Hep2 cells after 5 days by plaque reduction assay2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID1201115Cytotoxicity against MDCK cells after 72 hrs by microscopic analysis2015European journal of medicinal chemistry, Apr-13, Volume: 94A few atoms make the difference: synthetic, CD, NMR and computational studies on antiviral and antibacterial activities of glycopeptide antibiotic aglycon derivatives.
AID84959Concentration required to reduce HSV-2 (G) induced cytopathogenicity by 50% in primary rabbit kidney cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID1505493Cytotoxicity against MDCK cells assessed as reduction in cell viability after 3 days by formazan-based MTS assay2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID218044Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Coxsackie virus B4 in African green monkey kidney (Vero B)cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID648646Antiinfluenza activity against influenza A virus H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect after 36 hrs2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Synthesis and anti-influenza activity of aminoalkyl rupestonates.
AID535506Transport through CNT1 in mouse hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1144797Antiviral activity against Influenza A virus (A2/Asian/J305) infected in Swiss albino mouse assessed as increase in host survival at 20 mg/kg, ip administered 4 hrs before infection, 1 hr after infection followed by twice daily for next 6 days for total o1976Journal of medicinal chemistry, Feb, Volume: 19, Issue:2
Synthesis of tetrazole ribonucleosides and their evaluation as antiviral agents.
AID369464Antiviral activity against Sandfly fever Naples virus assessed as inhibition of virus-induced visual cytopathic effect after 3 to 5 days2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID86523Minimum toxic concentration required to cause a microscopically detectable alteration of normal HeLa cell morphology1995Journal of medicinal chemistry, Sep-01, Volume: 38, Issue:18
Synthesis and antiviral activity of benzyl-substituted imidazo [1,5-a]-1,3,5-triazine (5,8-diaza-7,9-dideazapurine) derivatives.
AID1349210Selectivity index, ratio of CC50 for human Ava5 cells to IC50 for HCV2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery of naphtho[1,2-d]oxazole derivatives as potential anti-HCV agents through inducing heme oxygenase-1 expression.
AID763865Antiviral activity against Influenza A virus (A/California/07/2009(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect by cell-based neutral red uptake assay2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis and biological activity evaluation of 5-pyrazoline substituted 4-thiazolidinones.
AID593228Selectivity index, ratio of TC50 for african green monkey Vero cells to IC50 for Human enterovirus 712011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
Inhibitory properties of 2-substituent-1H-benzimidazole-4-carboxamide derivatives against enteroviruses.
AID634836Antiviral activity against Feline coronavirus infected in CrFK cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID216182Tested for inhibitory effect on RNA virus SV in Vero cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID156693Minimum cytotoxic concentration in primary rabbit kidney (PRK) cell cultures1989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID1073349Antiviral activity against Chikungunya virus2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Chikungunya virus: emerging targets and new opportunities for medicinal chemistry.
AID6600250% Minimum inhibitory concentration which is required to reduce cytopathogenicity induced by (F) strain of HSV-1 virus on human E6SM cells.1997Journal of medicinal chemistry, Feb-14, Volume: 40, Issue:4
Novel 3'-C/N-substituted 2',3'-beta-D-dideoxynucleosides as potential chemotherapeutic agents. 1. Thymidine derivatives: synthesis, structure, and broad spectrum antiviral properties.
AID395939Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean serum ALT levels at 50 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID87141Minimum cytotoxic concentration in HeLa cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID1069924Antiviral activity against HCV infected in human Huh7 cells assessed as reduction in RNA level by luciferase reporter gene assay relative to control2014Bioorganic & medicinal chemistry letters, Feb-15, Volume: 24, Issue:4
Dual inhibition of HCV and HIV by ring-expanded nucleosides containing the 5:7-fused imidazo[4,5-e][1,3]diazepine ring system. In vitro results and implications.
AID1501509Antiviral activity against Coxsackievirus B3 (strain Nancy) infected in human HEP2 cells assessed as inhibition of virus-induced cytopathic effect at 16 ug/ml after 48 hrs by MTT dye based assay
AID1691539Antiviral activity against Influenza A virus (A/PR 8/34 (H1N1)) infected in MDCK cells assessed as reduction in virus-induced cytopathic effect measured after 72 hrs by microscopic analysis2020European journal of medicinal chemistry, May-15, Volume: 194N-benzyl 4,4-disubstituted piperidines as a potent class of influenza H1N1 virus inhibitors showing a novel mechanism of hemagglutinin fusion peptide interaction.
AID464178Cytotoxicity against Herpes simplex virus 1 KOS infected HEL cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID548434Antiviral activity against coxsackievirus B4 infected in human HeLa cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1077005Antiviral activity against Influenza A virus (A/FM/1/1947(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathicity after 40 hrs2014European journal of medicinal chemistry, Apr-09, Volume: 761,2,3-Triazole-containing derivatives of rupestonic acid: click-chemical synthesis and antiviral activities against influenza viruses.
AID434309Antiviral activity against Vaccinia virus infected in human HEL cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID297314Antiviral activity against HSV1 KOS in HEL cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID611767Antiviral activity against Influenza A H3N2 infected in MDCK cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID1710779Selectivity index, ratio of MCC for human HeLa cells to EC50 for Human coxsackievirus B4 infected in human HeLa cells2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID228856In vitro antiviral activity was tested against vaccinia virus(VV)1985Journal of medicinal chemistry, Sep, Volume: 28, Issue:9
Synthesis and biological activity of 5-thiobredinin and certain related 5-substituted imidazole-4-carboxamide ribonucleosides.
AID1066678Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect after 48 hrs by crystal violet staining technique2014Journal of natural products, Feb-28, Volume: 77, Issue:2
Sorbicatechols A and B, antiviral sorbicillinoids from the marine-derived fungus Penicillium chrysogenum PJX-17.
AID766690Antiviral activity against Reovirus-1 infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID766692Antiviral activity against Respiratory syncytial virus Long infected in human HeLa cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID419606Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID1066048Antiviral activity against Influenza A virus (A/Puerto Rico/8/1934(H1N1)) infected in MDCK cells assessed as inhibition of plaque formation after 12 hrs by toluidine blue staining assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID1427837Cytotoxicity against virus infected HEL cells assessed as alteration in cell morphology by microscopic method
AID482714Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID288931Antiviral activity against Respiratory syncytial virus in HeLa cells2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID376987Antiviral activity against influenza A virus H1N1 A/NWS/33 in human MDCK cells assessed as reduction of virus induced cytopathic effect2006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID401225Cytotoxicity against MDCK cells2004Journal of natural products, Apr, Volume: 67, Issue:4
Antiviral flavonoids from the seeds of Aesculus chinensis.
AID575125Antiviral activity against adamantane-, zanamivir-susceptible oseltamivir-resistant Influenza A virus (A/Georgia/20/2006(H1N1)) harboring neuraminidase H274Y mutant infected in MDCK cells assessed as inhibition of viral replication after 3 days by microsc2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
In vitro antiviral activity of favipiravir (T-705) against drug-resistant influenza and 2009 A(H1N1) viruses.
AID1699935Antiviral activity against Influenza A virus (A/California/07/09(H1N1))pdm09 infected in MDCK cells assessed as reduction in viral replication preincubated with compound for 1 hr followed by viral infection and measured after viral cultivation for 48 hrs 2020Bioorganic & medicinal chemistry letters, 12-15, Volume: 30, Issue:24
New type of anti-influenza agents based on benzo[d][1,3]dithiol core.
AID1242265Antiviral activity against human enterovirus 71 infected in ICR mouse assessed as increase in survival rate at 50 mg/kg, ip qd for 8 days dosed 2 hrs post infection and measured at 14 days post infection2015Bioorganic & medicinal chemistry letters, Sep-01, Volume: 25, Issue:17
Quinolizidine alkaloids reduced mortality in EV71-infected mice by compensating for the levels of T cells.
AID206521Tested for the antimicrobial activity minimum inhibitory concentration) against Staphylococcus hominis2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID32220Selectivity index expressed as ratio of compound concentration required to reduce the growth of normal uninfected ATH8 cells by 50% to the compound concentration (MIC)1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Chemotherapeutic approaches to the treatment of the acquired immune deficiency syndrome (AIDS).
AID475233Antiviral activity against HCV 1b infected in human HuH7 cells assessed as inhibition of viral RNA replication after 4 days by replicon assay2010Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8
Synthesis of new acridone derivatives, inhibitors of NS3 helicase, which efficiently and specifically inhibit subgenomic HCV replication.
AID218032Antiviral activity was measured against forest virus in african green monkey kidney (Vero B) cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID1272969Cytotoxicity against MDCK cells after 72 hrs by MTT assay2016Bioorganic & medicinal chemistry letters, Feb-01, Volume: 26, Issue:3
The semi-synthesis of novel andrographolide analogues and anti-influenza virus activity evaluation of their derivatives.
AID1077003Antiviral activity against oseltamivir-resistant Influenza A virus (A/Tianjinjinnan/15/2009/H1N1) infected in MDCK cells assessed as inhibition of virus-induced cytopathicity after 40 hrs2014European journal of medicinal chemistry, Apr-09, Volume: 761,2,3-Triazole-containing derivatives of rupestonic acid: click-chemical synthesis and antiviral activities against influenza viruses.
AID474546Selectivity ratio of IC50 for MDCK cells to EC50 for inhibition of virus-induced cytopathic effect of Influenza A virus Wisconsin/67/2005/H3N22010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1886816Cytotoxicity against African green monkey Vero E6 cells infected with Zika 459148 measured after 72 hrs by MTT assay2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID1578008Selectivity index, ratio of TC50 for cytotoxicity against dog MDCK cells to IC50 for antiviral activity against Influenza B virus infected in dog MDCK cells2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Novel amides modified rupestonic acid derivatives as anti-influenza virus reagents.
AID1696831Cytotoxicity against human A549 cells assessed as reduction in cell viability by MTT assay2020Bioorganic & medicinal chemistry letters, 11-15, Volume: 30, Issue:22
Structure-aided optimization of 3-O-β-chacotriosyl epiursolic acid derivatives as novel H5N1 virus entry inhibitors.
AID474329Antiviral activity against Influenza A virus Gull/PA/4175/83/H5N1 infected MDCK cells after 42 to 46 hrs by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1118644Antiviral activity against HIV-2 ROD infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 days by microscopic analysis2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1485239Antiviral activity against Reovirus 1 infected in African green monkey Vero cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID665833In vitro antiviral activity against TMV assessed as inhibition rate at 500 ug/mL2012European journal of medicinal chemistry, Jul, Volume: 53Design, synthesis and antiviral activity of novel quinazolinones.
AID1687948Antiproliferative activity against mouse B16-F10 cells assessed as reduction in cell growth incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID1503331Antiviral activity against Human respiratory syncytial virus A2 ATCC VR 1540 infected in African green monkey Vero 76 cells assessed as protection against virus-induced cytopathic effect after 5 days by crystal violet staining-based plaque reduction assay2017European journal of medicinal chemistry, Dec-01, Volume: 141Inhibitors of Yellow Fever Virus replication based on 1,3,5-triphenyl-4,5-dihydropyrazole scaffold: Design, synthesis and antiviral evaluation.
AID308659Selectivity index, ratio of EC50 for influenza A/Hong Kong/7/87 (H3N2) to MCC for MDCK cells2007Bioorganic & medicinal chemistry letters, Aug-01, Volume: 17, Issue:15
Design and synthesis of bioactive adamantane spiro heterocycles.
AID257888Antiviral activity against HeLa cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID360157Antiviral activity against wild type HCV 1b Con1 in human Huh7 cells after 48 hrs by replicon cell assay2007The Journal of biological chemistry, Aug-03, Volume: 282, Issue:31
Phenotypic and structural analyses of hepatitis C virus NS3 protease Arg155 variants: sensitivity to telaprevir (VX-950) and interferon alpha.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID463989Antiviral activity against Herpes simplex virus 1 KOS infected in HEL cells assessed as protection from virus-induced cytopathogenicity after 2 to 3 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID155597The minimum inhibitory concentration required to reduce parainfluenza virus type 3 induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID303234Antiviral activity against Reovirus 1 in Vero cells reduction of virus-induced cytopathogenicity after 4 days2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID717171Antiviral activity against Influenza B virus (B/HK/5/72) infected in MDCK cells assessed as virus-induced cytopathic effect after 3 days by MTS assay2012Bioorganic & medicinal chemistry, Dec-15, Volume: 20, Issue:24
Microwave assisted synthesis and anti-influenza virus activity of 1-adamantyl substituted N-(1-thia-4-azaspiro[4.5]decan-4-yl)carboxamide derivatives.
AID1298244Antiviral activity against Influenza A virus A/PR/8/34 infected in MDCK cells assessed as reduction of virus induced cytopathic effect measured by visual scoring of cytopathic effect2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
1,6-Bis[(benzyloxy)methyl]uracil derivatives-Novel antivirals with activity against HIV-1 and influenza H1N1 virus.
AID223415Concentration required to reduce influenza virus A (ishikawa) induced cytopathogenicity by 50%1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID1710777Cytotoxicity against human HeLa cells assessed as changes in cell morphology incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID634760Antiviral activity against Vesicular stomatitis virus infected in human Hela cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID105977Minimum concentration (ug/mL) for in vitro antiviral activity against influenza virus (type A0/PR/8/34) in Madin-Darby canine kidney (MDCK) host cell cultures1990Journal of medicinal chemistry, Apr, Volume: 33, Issue:4
Synthesis and biological evaluation of carbocyclic analogues of lyxofuranosides of 2-amino-6-substituted-purines and 2-amino-6-substituted-8-azapurines.
AID162241The minimum inhibitory concentration required to reduce polio virus type I induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID294254Cytotoxicity against Huh7 ET cells assessed as beta actin level relative to control2007Bioorganic & medicinal chemistry letters, Apr-15, Volume: 17, Issue:8
Structure-activity relationship studies on anti-HCV activity of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID371497Cytotoxicity against MDBK cells after 3 days by MTS/PMS assay2008European journal of medicinal chemistry, Aug, Volume: 43, Issue:8
New 1-indanone thiosemicarbazone derivatives active against BVDV.
AID320045Cytotoxicity against dog MDCK cells2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Three-component, one-pot synthesis of novel 2,4-substituted 5-azolylthiopyrimidine library for screening against anti-influenza virus A.
AID419597Cytotoxicity against human HeLa cells assessed as alteration in cell morphology2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID533313Antiviral activity against HCV genotype 1b in RP7 replicon cell after 4 days by blot hybridization analysis2008Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11
Potential for hepatitis C virus resistance to nitazoxanide or tizoxanide.
AID400432Selectivity index, ratio of EC50 for RSV administered 3 hrs postinfection over IC50 for human Hep2 cells administered 3 hrs after infection1998Journal of natural products, May, Volume: 61, Issue:5
Antiviral phenylpropanoid glycosides from the medicinal plant Markhamia lutea.
AID86512Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on HeLa cell line infected with RSV virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID767050Antiviral activity against influenza A virus H1N1 infected in dog MDCK cells assessed as inhibition of virus-induced cytopathogenicity after 48 hrs by crystal violet staining method2013Bioorganic & medicinal chemistry letters, Sep-15, Volume: 23, Issue:18
Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID395671Antiviral activity against Punta Toro virus Adames infected Syrian golden hamster assessed as mean serum ALT levels at 30 mg/kg, po twice daily administered 4 hrs before viral challenge measured on day 4 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID218169Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against forest virus in African green monkey kidney (Vero B)cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID1472403Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) clone 2 infected in MDCK cells assessed as inhibition of virus-induced cytopathicity measured after 3 passages with 12.5 to 50 uM 2-Isopropyl-N-[2-(piperidin-1-yl)ethyl]aniline hydroc2018Journal of medicinal chemistry, 01-11, Volume: 61, Issue:1
Aniline-Based Inhibitors of Influenza H1N1 Virus Acting on Hemagglutinin-Mediated Fusion.
AID261583Inhibition of West Nile viral Rluc-Neo-Rep in BHK21 cell line2006Journal of medicinal chemistry, Mar-23, Volume: 49, Issue:6
Identification of compounds with anti-West Nile Virus activity.
AID1485246Antiviral activity against Influenza B virus B/Ned/537/05 infected in MDCK cells assessed as host cell viability measured after 3 to 6 days post infection by MTS assay2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID1710800Cytotoxicity against dog MDCK cells assessed as changes in cell morphology incubated for 3 to 6 days by light microscopy2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID475859Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of virus-induced cytopathicity2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID474346Selectivity ratio of IC50 for MDCK cells to EC90 for Influenza A virus Hong Kong/213/2003/H5N1 by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID311338Antiviral activity against Tobacco mosaic virus U1 after 72 hrs by half leaf method2007Journal of natural products, Sep, Volume: 70, Issue:9
Benzylphenethylamine alkaloids from Hosta plantaginea with inhibitory activity against tobacco mosaic virus and acetylcholinesterase.
AID1753360Cytotoxicity against MDCK cells by MTT assay2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40New class of hantaan virus inhibitors based on conjugation of the isoindole fragment to (+)-camphor or (-)-fenchone hydrazonesv.
AID1691541Cytotoxicity against MDCK cells assessed as change in cell morphology measured after 72 hrs by microscopic analysis2020European journal of medicinal chemistry, May-15, Volume: 194N-benzyl 4,4-disubstituted piperidines as a potent class of influenza H1N1 virus inhibitors showing a novel mechanism of hemagglutinin fusion peptide interaction.
AID218167Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Reo virus-1 in African green monkey kidney (Vero B)cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID539954Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID1772992Cytotoxicity against human HEp-2 cells assessed as reduction in cell viability measured after 60 hrs by MTT assay2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID1171742Therapeutic index, ratio of TC50 for human Hep2 cells to IC50 for Respiratory syncytial virus2014Journal of natural products, Dec-26, Volume: 77, Issue:12
Anti-respiratory syncytial virus prenylated dihydroquinolone derivatives from the gorgonian-derived fungus Aspergillus sp. XS-20090B15.
AID1123336Activity at rat liver nucleoside kinase assessed as phosphorylation using [gamma-32P]-ATP after 10 to 20 mins1979Journal of medicinal chemistry, Jun, Volume: 22, Issue:6
Studies on the mechanism of antiviral action of 1-(beta-D-ribofuranosyl)-1,2,4-triazole-3-carboxamide (ribavirin).
AID1710785Antiviral activity against Punta Toro virus infected in African green monkey Vero cells assessed as reduction in virus-induced cytopathic effect incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID1066047Inhibition of influenza A virus RNA-dependent RNA polymerase expressed in HEK293 cells after 24 hrs by dual luciferase reporter gene assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID218376Evaluation for antiviral activity against reo virus-1 in Vero cell cultures (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID482702Antiviral activity against HSV1 KOS infected in human E6SM cell assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID634752Antiviral activity against Human cytomegalovirus Davis infected in human HEL cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID533316Cytotoxicity against human RP7 cell harboring HCV genotype 1b after 4 days by neutral red dye uptake assay2008Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11
Potential for hepatitis C virus resistance to nitazoxanide or tizoxanide.
AID1716976Cytotoxicity against human HEp-2 cells assessed as reduction in cell viability measured after 48 hrs by MTS assay2020European journal of medicinal chemistry, Jan-15, Volume: 186Design and synthesis of 2-((1H-indol-3-yl)thio)-N-phenyl-acetamides as novel dual inhibitors of respiratory syncytial virus and influenza virus A.
AID216714Antiviral activity at 1-3 uM determined in a culture of Visna virus; IA = inactive1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and biological properties of purine and pyrimidine 5'-deoxy-5'-(dihydroxyphosphinyl)-beta-D-ribofuranosyl analogues of AMP, GMP, IMP, and CMP.
AID288932Antiviral activity against Reovirus1 in vero cells2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID763859Selectivity index, ratio of CC50 for MDCK cells to EC50 for Influenza A virus (A/Perth/16/2009(H3N2))2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis and biological activity evaluation of 5-pyrazoline substituted 4-thiazolidinones.
AID369869Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in serum at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID718711Cytotoxicity against MDCK cells after 48 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Dec-01, Volume: 22, Issue:23
Anti-viral activity of (-)- and (+)-usnic acids and their derivatives against influenza virus A(H1N1)2009.
AID1118646Antiviral activity against Reovirus 1 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1852995Cytotoxicity against human HCT-116 cells overexpressing human MDR1 assessed as DNA damage by measuring fluorescence intensity at 100 uM incubated for 30 mins by Hoechst 33342 staining accumulation assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID280205Cytotoxicity against Vero cells assessed as alteration in cell morphology2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID155587Antiviral activity at 10-30 uM determined in a culture of Parainfluenza virus type 3; IA = inactive1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and biological properties of purine and pyrimidine 5'-deoxy-5'-(dihydroxyphosphinyl)-beta-D-ribofuranosyl analogues of AMP, GMP, IMP, and CMP.
AID434307Antiviral activity against HSV1 KOS infected in HEL cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID1077002Selectivity index, ratio of TC50 for MDCK cells to IC50 for Influenza A virus (A/Tianjinjinnan/15/2009/H1N1)2014European journal of medicinal chemistry, Apr-09, Volume: 761,2,3-Triazole-containing derivatives of rupestonic acid: click-chemical synthesis and antiviral activities against influenza viruses.
AID278368RBV metabolism in Vero E6 cells assessed as RBV-TP concentration at 10 ug/ml after 24 h2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID767058Antiviral activity against Enterovirus 71 infected in human rhabdomyosarcoma cells assessed as inhibition of virus-induced cytopathogenicity after 48 hrs by crystal violet staining method2013Bioorganic & medicinal chemistry letters, Sep-15, Volume: 23, Issue:18
Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID1274004Cytotoxicity against African green monkey Vero cells assessed as inhibition of cell proliferation after 8 days2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID301327Antiviral index, ratio of CC50 for Huh7 cells to EC50 for HCV replication2007Bioorganic & medicinal chemistry, Nov-15, Volume: 15, Issue:22
5'-O-masked 2'-deoxyadenosine analogues as lead compounds for hepatitis C virus (HCV) therapeutic agents.
AID63917Effective concentration required to inhibit Vaccinia virus-induced cytopathicity by 50% in E6SM cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID768189Antiviral activity against influenza A virus H1N1 subtype infected in dog MDCK cells assessed as reduction of virus-induced cytopathogenicity by MTS assay2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID1364929Selectivity index, ratio of CC50 for African green monkey Vero cells to IC50 for Chikungunya virus KC9692072017Bioorganic & medicinal chemistry, 08-15, Volume: 25, Issue:16
The medicinal chemistry of Chikungunya virus.
AID400419Cytotoxicity against RSV long infected human Hep2 cells after 3 days1998Journal of natural products, May, Volume: 61, Issue:5
Antiviral phenylpropanoid glycosides from the medicinal plant Markhamia lutea.
AID395707Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in serum at 40 mg/kg, po twice daily for 7 days administered 4 hrs before viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1710799Cytotoxicity against human HEL cells assessed as changes in cell morphology incubated for 3 to 6 days by light microscopy2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID1186332Antiviral activity against Yellow fever virus infected in BHK21 cells assessed as inhibition of virus-induced cytopathogenicity after 3 to 4 days by MTT assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID767053Cytotoxicity against human HeLa cells after 72 hrs by MTT assay2013Bioorganic & medicinal chemistry letters, Sep-15, Volume: 23, Issue:18
Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID1773059Antiviral activity against RSV infected in BALB/c mouse assessed as downregulation of TNF-alpha expression in lung tissue infected with RSV at 50 mg/kg/day measured after 2 to 6 days post infection by RT-PCR analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID68253Minimum inhibitory concentration required for antiviral activity to reduce HSV-2 (G) induced cytopathicity in human embryonic skin-muscle cells (ESM)1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis and antiviral activities of 8-alkynyl-, 8-alkenyl-, and 8-alkyl-2'-deoxyadenosine analogues.
AID87162Minimum inhibitory concentration required to reduce polio virus -1 induced cytopathogenicity by 50% in HeLa cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID303230Antiviral activity against Coxsackie virus B4 in HeLa cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID1131478Antiviral activity against Coxsackievirus B4 infected in human HeLa cells assessed as inhibition of virus-induced cytopathogenicity treated immediately after virus adsorption measured 2 days after virus infection1977Journal of medicinal chemistry, Oct, Volume: 20, Issue:10
Synthesis and determination of antiviral activity of the 2'(3')-O-methyl derivatives of ribavirin (1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide).
AID401229Antiviral activity against influenza virus type A H1N1 in MDCK cells assessed as inhibition of virus-induced cytopathic effect2004Journal of natural products, Apr, Volume: 67, Issue:4
Antiviral flavonoids from the seeds of Aesculus chinensis.
AID1505495Antiviral activity against Influenza virus A/X-31 infected in HGPRT deficient 6-thioguanine-resistant MDCK cells assessed as reduction in viral replication at 3 days post infection by formazan-based MTS assay2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID1133194Inhibition of guanine nucleotide biosynthesis in human EAC assessed as [14C]hypoxanthine incorporation at 1 mM after 60 mins by TLC analysis1978Journal of medicinal chemistry, Dec, Volume: 21, Issue:12
Synthesis and antiviral and enzymatic studies of certain 3-deazaguanines and their imidazolecarboxamide precursors.
AID416780Antiviral activity against influenza H1N1 virus in MDCK cells assessed as reduction of virus-induced cytopathicity by visual cytopathic effect scoring method2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID548436Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID1498122Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID218532Inhibitory concentration against parainfluenza-3 virus in vero cells1995Journal of medicinal chemistry, Sep-01, Volume: 38, Issue:18
Synthesis and antiviral activity of benzyl-substituted imidazo [1,5-a]-1,3,5-triazine (5,8-diaza-7,9-dideazapurine) derivatives.
AID434320Cytotoxicity against HEL cells assessed as change in cell morphology2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID395944Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as survival at 50 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID284537Antiviral activity against Sindbis virus-induced cytopathogenicity in Vero cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID701510Antiviral activity against Respiratory syncytial virus Long infected in human Hep2 cells assessed as log reduction in virus titer at 25 uM by virus plaque reduction assay2012Journal of medicinal chemistry, Oct-25, Volume: 55, Issue:20
(S)-N-(2,5-Dimethylphenyl)-1-(quinoline-8-ylsulfonyl)pyrrolidine-2-carboxamide as a small molecule inhibitor probe for the study of respiratory syncytial virus infection.
AID1181479Antiviral activity against Influenza A virus (A/PR/8/34(H1N1)) infected in MDCK cells assessed as virus-induced cytopathic effect after 72 hrs by microscopy2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID82047Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on HEF cell line infected with HSV-1 virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID1265164Antiviral activity against O'nyong-nyong virus infected in HEK293T cells assessed as inhibition of infectivity measured at 24 hrs postinfection by FITC/DAPI staining based array scan VTI HCS reader analysis2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
AID300559Antiviral activity against influenza A/Jifang/15/90 (H3N2) virus in MDCK cells by CPE assay2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID395677Antiviral activity against Pichinde virus An 4763 in Vero cells assessed as inhibition of virus-induced visual cytopathic effect after 7 to 8 days2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID658613Antiviral activity against Reovirus-1 infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID84957Compound was tested for antiviral activity against herpes simplex virus-2(G) in primary rabbit kidney cells1984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID474334Antiviral activity against Influenza A virus Vietnam/1203/ 2004H/H5N1 infected MDCK cells assessed as inhibition of virus-induced cytopathic effect after 3 days2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID548442Antiviral activity against Influenza A H3N2 virus subtype infected in MDCK cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID320044Antiviral activity against influenza A virus H3N2 (A3 China/15/90) expressed in dog MDCK cells assessed as reduction of virus-induced cytopathic effect2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Three-component, one-pot synthesis of novel 2,4-substituted 5-azolylthiopyrimidine library for screening against anti-influenza virus A.
AID1505499Cytotoxicity against HGPRT deficient 6-thioguanine-resistant MDCK cells assessed as reduction in cell viability after 3 days by formazan-based MTS assay2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID1611059Cytotoxicity against dog MDCK cells assessed as cell death incubated for 48 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 12-01, Volume: 29, Issue:23
Synthesis and structure-activity relationships of novel camphecene analogues as anti-influenza agents.
AID1306319Antiviral activity against Herpes simplex virus type 1 L2 infected in African green monkey Vero E6 cells assessed as reduction of virus-induced cytopathic effect2016Bioorganic & medicinal chemistry letters, 07-15, Volume: 26, Issue:14
An alternative route to the arylvinyltriazole nucleosides.
AID1066043Antiviral activity against oseltamivir-resistant Influenza A virus (A/Parma/24/2009(H1N1)) clinical isolate infected in MDCK cells assessed as inhibition of plaque formation after 2 days by toluidine blue staining assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID1118647Antiviral activity against Sindbis virus infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1081155Induction of systemic acquired resistance activity in TMV infected-Nicotiana tabacum (tobacco) leaves at 50 ug/ml2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
AID1536097Selectivity index, ratio of CC50 for human A549 cells to EC50 for Junin virus IV4454 infected in human A549 cells2019Bioorganic & medicinal chemistry letters, 02-15, Volume: 29, Issue:4
Modified ribavirin analogues as antiviral agents against Junín virus.
AID1235015Antiviral activity against Coxsackievirus B3 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Bioactive Sesquiterpenes and Lignans from the Fruits of Xanthium sibiricum.
AID427565Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36M/R155T double mutation in human HuH7 cells after 48 hrs by RNA replicon assay relative to wild type2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID1135868Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in MDCK cells assessed as plaque reduction after 3 days by agar diffusion method1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID217254In vitro antiviral activity against parainfluenza type 3(para 3) virus was determined in african green monkey kidney (vero,V) expressed as virus rating. Toxic level(>1000 ug/mL)1982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID474332Antiviral activity against Influenza A virus Hong Kong/213/2003/H5N1 infected MDCK cells after 42 to 46 hrs by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID658743Antiviral activity against Vesicular stomatitis virus infected in HeLa cells assessed as inhibition of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID393162Antiviral activity against influenza A virus H3N2 assessed as inhibition of virus-induced cytopathic effect after 72 hrs by MTS assay2009Bioorganic & medicinal chemistry, Feb-15, Volume: 17, Issue:4
Design and synthesis of 1,2-annulated adamantane piperidines with anti-influenza virus activity.
AID768196Antiviral activity against Parainfluenza-3 virus infected in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID246794Effective concentrations at which 10-fold depression of HCV RNA was observed in AVA5 cells (Huh 7 cells with subgenomic HCV replicon BB7I2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID275076Antiviral activity against Punta Toro virus in Vero cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID87146Evaluation for antiviral activity against Coxsackie virus B4 in HeLa cell cultures (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID1542956Selectivity index, ratio of CC50 for African green monkey Vero E6 cells to EC50 for Zika virus MR766 infected in African green monkey Vero E6 cells2019ACS medicinal chemistry letters, Apr-11, Volume: 10, Issue:4
Scaffold Morphing Approach To Expand the Toolbox of Broad-Spectrum Antivirals Blocking Dengue/Zika Replication.
AID665008Cytostatic activity against mouse L1210/0 after 48 hrs by cell counting2012Bioorganic & medicinal chemistry, Jun-01, Volume: 20, Issue:11
Novel 1,2,4-triazole and imidazole derivatives of L-ascorbic and imino-ascorbic acid: synthesis, anti-HCV and antitumor activity evaluations.
AID1118649Antiviral activity against Punta Toro virus infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1303366Cytotoxicity against mock-infected MDBK cells assessed as reduction in cell viability after 72 hrs by MTT assay2016European journal of medicinal chemistry, Jul-19, Volume: 117A combined in silico/in vitro approach unveils common molecular requirements for efficient BVDV RdRp binding of linear aromatic N-polycyclic systems.
AID1126470Selectivity index, ratio of CC50 for African green monkey Vero cells to IC50 for Enterovirus 71 BrCr2014Journal of natural products, Apr-25, Volume: 77, Issue:4
Prenylated benzoylphloroglucinols and xanthones from the leaves of Garcinia oblongifolia with antienteroviral activity.
AID1408324Antiviral activity against Influenza A virus A/Virginia/ATCC3/2009(H1N1pdm) infected in MDCK cells assessed as reduction in virus-induced cytopathic effect after 3 days by microscopic method2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID366287Cytotoxicity against MDCK cells by MTT assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Structure-activity relationship of flavonoids as influenza virus neuraminidase inhibitors and their in vitro anti-viral activities.
AID217114Percentage plaque reduction was determined against venezuelan equine encephalitis (VEE) virus in african green monkey kidney (vero,V) at a conc of 250-500 ug/mL. Toxic level(>1000 ug/mL); 10-301982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID216200Tested for cytotoxic activity in African green monkey kidney cells (Vero)2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID1092199Antiviral activity against Tobacco mosaic virus (TMV) inoculated in 5-6 growth stage leaf assessed as inhibition effect at 100 ug/mL at 25 degC after 72 hr by half-leaf method2012Journal of agricultural and food chemistry, Oct-17, Volume: 60, Issue:41
Design, synthesis, and anti-tobacco mosaic virus (TMV) activity of phenanthroindolizidines and their analogues.
AID301691Inactivation of human recombinant S-adenosyl-L-homocysteine hydrolase NAD+ form expressed in Escherichia coli JM109 at 100 uM2007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID1253093Cytotoxicity against human HuH7-J20 cells expressing secreted alkaline phosphatase reporter gene assessed as cell viability incubated for 1 hr by WST-1 assay2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Rethinking the old antiviral drug moroxydine: Discovery of novel analogues as anti-hepatitis C virus (HCV) agents.
AID539930Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID383524Antiviral activity against Punta Toro virus in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID65708Antiviral activity against herpes simplex virus-1 KOS (HSV-1) in E6SM cell cultures2001Journal of medicinal chemistry, Aug-02, Volume: 44, Issue:16
Design, synthesis, DNA binding, and biological evaluation of water-soluble hybrid molecules containing two pyrazole analogues of the alkylating cyclopropylpyrroloindole (CPI) subunit of the antitumor agent CC-1065 and polypyrrole minor groove binders.
AID474333Antiviral activity against Influenza A virus Hong Kong/213/2003/H5N1 infected MDCK cells after 3 days by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID395668Antiviral activity against Punta Toro virus Adames infected Syrian golden hamster assessed as animals with detectable virus level in serum at 30 mg/kg, po twice daily administered 4 hrs before viral challenge measured on day 4 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID105963Anti-influenza virus activity was evaluated in Madin-Darby canine kidney (MDCK) cells against influenza A H2N2 strain (A2 Japan/305/57)1999Bioorganic & medicinal chemistry letters, Dec-20, Volume: 9, Issue:24
Synthesis of 2-(2-adamantyl)piperidines and structure anti-influenza virus A activity relationship study using a combination of NMR spectroscopy and molecular modeling.
AID395955Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in serum at 20 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1071709Antiviral activity against Influenza A virus H3N2 by cytopathy assay2014European journal of medicinal chemistry, Mar-03, Volume: 74Synthesis and biological evaluation of 2-oxonicotinonitriles and 2-oxonicotinonitrile based nucleoside analogues.
AID416778Cytotoxicity against MDCK cells assessed as drug level causing microscopically detectable alteration of normal cell morphology2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1543374Cytotoxicity against African green monkey Vero cells infected with Herpes simplex virus 1 after 72 hrs by MTT assay2019Bioorganic & medicinal chemistry, 06-15, Volume: 27, Issue:12
Antiviral activities of Janus-type nucleosides and their related oxime-intermediates.
AID1135873Toxicity in ferret infected with Influenza A virus Port Chalmers/1/73 (H3N2) assessed as change in body weight at 13 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to day 3 measured after 7 days relative to untreated control1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID1169735Cytotoxicity against human HuH7 cells after 72 hrs by MTS assay2014Journal of natural products, Nov-26, Volume: 77, Issue:11
Limonoids from the seeds of Swietenia macrophylla with inhibitory activity against dengue virus 2.
AID1716983Cytotoxicity against HEK293T cells assessed as reduction in cell viability measured after 48 hrs by CCK8 assay2020European journal of medicinal chemistry, Jan-15, Volume: 186Design and synthesis of 2-((1H-indol-3-yl)thio)-N-phenyl-acetamides as novel dual inhibitors of respiratory syncytial virus and influenza virus A.
AID1773045Antiviral activity against RSV infected in BALB/c mouse assessed as downregulation of RIG-1 expression in lung tissue infected with RSV at 50 mg/kg/day measured after 2 days post infection by RT-PCR analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID1135871Toxicity in ferret infected with Influenza A virus Port Chalmers/1/73 (H3N2) assessed as change in body weight at 7 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to day 3 measured after 7 days relative to untreated control1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID1071708Antiviral activity against Influenza B virus by cytopathy assay2014European journal of medicinal chemistry, Mar-03, Volume: 74Synthesis and biological evaluation of 2-oxonicotinonitriles and 2-oxonicotinonitrile based nucleoside analogues.
AID216368Antiviral activity against Reo 1 virus infected vero cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID1152081Cytotoxicity against MDCK cells after 48 hrs by MTT assay2014Journal of medicinal chemistry, May-22, Volume: 57, Issue:10
Optimization of small-molecule inhibitors of influenza virus polymerase: from thiophene-3-carboxamide to polyamido scaffolds.
AID1782691Antiviral activity against Respiratory syncytial virus assessed as reduction in virus-induced cytopathic effect by MTS assay2021European journal of medicinal chemistry, Aug-05, Volume: 220Phenoxazine nucleoside derivatives with a multiple activity against RNA and DNA viruses.
AID88297Evaluated for minimum inhibitory concentration against G,196, Lyons strains of Herpes simplex virus (HSV-2) in primary rabbit kidney cells1990Journal of medicinal chemistry, May, Volume: 33, Issue:5
Stereospecific synthesis and antiviral properties of different enantiomerically pure carbocyclic 2'-deoxyribonucleoside analogues derived from common chiral pools: (+)-(1R,5S)- and (-)-(1S,5R)-2-oxabicyclo[3.3.0]oct-6-en-3-one.
AID395937Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in serum at 50 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID528351Antiviral activity against Poliovirus infected in human HeLaS3 cells assessed as frequency of viral mutagenesis plaque at 150 uM by guanidine resistance assay2010Journal of medicinal chemistry, Nov-25, Volume: 53, Issue:22
Synthesis of a 6-methyl-7-deaza analogue of adenosine that potently inhibits replication of polio and dengue viruses.
AID701514Antiviral activity against Respiratory syncytial virus Long infected in human Hep2 cells assessed as post infection time duration of protection against virus-induced cytopathogenicity by Cell Titer-Glo assay2012Journal of medicinal chemistry, Oct-25, Volume: 55, Issue:20
(S)-N-(2,5-Dimethylphenyl)-1-(quinoline-8-ylsulfonyl)pyrrolidine-2-carboxamide as a small molecule inhibitor probe for the study of respiratory syncytial virus infection.
AID1127183Antiviral activity against DENV2 16681 infected in human Huh-7 cells after 3 days by luciferase reporter gene assay2014European journal of medicinal chemistry, May-22, Volume: 79Synthesis, antiproliferative and anti-dengue virus evaluations of 2-aroyl-3-arylquinoline derivatives.
AID776645Cytotoxicity against mouse mammary carcinoma 755 cells assessed as growth inhibition2013European journal of medicinal chemistry, Nov, Volume: 69Pyrazole containing natural products: synthetic preview and biological significance.
AID407614Antiviral activity against Hepatitis C virus infected human Huh-5-2 cells assessed as inhibition of luciferase activity after 4 days by RNA replicon assay2008Bioorganic & medicinal chemistry letters, Jun-01, Volume: 18, Issue:11
Arylethynyltriazole acyclonucleosides inhibit hepatitis C virus replication.
AID1687947Antiproliferative activity against human MDA-MB-435 cells assessed as reduction in cell growth incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID1773426Antiviral activity against Human adenovirus 5 Adenoid 75 infected in A549 cells assessed as inhibition of viral adsorption at early stage of replication treated for 1 hr during viral infection followed by replacement with fresh medium and measured after 72021European journal of medicinal chemistry, Dec-05, Volume: 225Novel betulin dicarboxylic acid ester derivatives as potent antiviral agents: Design, synthesis, biological evaluation, structure-activity relationship and in-silico study.
AID514139Cytotoxicity against human HuH7 cells2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Studies on the anti-hepatitis C virus activity of newly synthesized tropolone derivatives: identification of NS3 helicase inhibitors that specifically inhibit subgenomic HCV replication.
AID218030Antiviral activity was measured against Parainfluenza virus-3 in african green monkey kidney (Vero B) cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID539923Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID308658Cytotoxicity against MDCK cells assessed as changes in cell morphology2007Bioorganic & medicinal chemistry letters, Aug-01, Volume: 17, Issue:15
Design and synthesis of bioactive adamantane spiro heterocycles.
AID634091Cytotoxicity against human HuH7 cells infected with HCV1b after 3 days by MTS assay2012Bioorganic & medicinal chemistry, Jan-01, Volume: 20, Issue:1
The design, synthesis and biological evaluations of C-6 or C-7 substituted 2-hydroxyisoquinoline-1,3-diones as inhibitors of hepatitis C virus.
AID1688553Cytotoxicity against human Huh7.5 cells assessed as reduction in cell viability after 3 days by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Molecular design, synthesis, and biological evaluation of bisamide derivatives as cyclophilin A inhibitors for HCV treatment.
AID370214Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 g of liver at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID108456Minimum inhibitory concentration required to reduce measles virus induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID216504Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on vero cell line infected with coxsackie B4 virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID228733Minimum cytotoxic concentration which causes microscopically detectable alteration of normal cell morphology after 2 days of incubation.1997Journal of medicinal chemistry, Feb-14, Volume: 40, Issue:4
Novel 3'-C/N-substituted 2',3'-beta-D-dideoxynucleosides as potential chemotherapeutic agents. 1. Thymidine derivatives: synthesis, structure, and broad spectrum antiviral properties.
AID443831Antiviral activity against Influenza B virus (B/Hong Kong/5/72) assessed as inhibition of virus-induced cytopathic effect by cell-based assay2009Journal of medicinal chemistry, Oct-08, Volume: 52, Issue:19
Diazo transfer-click reaction route to new, lipophilic teicoplanin and ristocetin aglycon derivatives with high antibacterial and anti-influenza virus activity: an aggregation and receptor binding study.
AID216409Compound was tested for antiviral activity against vesicular stomatitis virus in primary rabbit kidney cells1984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID1118641Antiviral activity against Coxsackievirus B4 infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1498125Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of virus-induced cytopathicity by MTS assay2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID303233Antiviral activity against Parainfluenza 3 in Vero cells reduction of virus-induced cytopathogenicity after 4 days2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID218402Minimum inhibitory concentration required to reduce Sindbis virus induced cytopathogenicity by 50% in african green monkey (VeroB) cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID1710784Antiviral activity against Human coxsackievirus B4 infected in African green monkey Vero cells assessed as reduction in virus-induced cytopathic effect incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID300562Antiviral activity against influenza B/Jifang/13/97 virus in MDCK cells by CPE assay2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID228408Antiviral activity against reovirus type 1 in Vero cell culture lines1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID434317Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID1271120Cytotoxicity against mock-infected human Huh7.5 cells assessed as reduction in cell viability incubated for 5 hrs by MTT assay2015Journal of medicinal chemistry, Dec-24, Volume: 58, Issue:24
Structure-Based Discovery of Novel Cyclophilin A Inhibitors for the Treatment of Hepatitis C Virus Infections.
AID1687969Antiproliferative activity against human IGROV-1 cells assessed as reduction in cell growth incubated for 7 days by trypan blue exclusion assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID1135877Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in rectal temperature at 7 to 14 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to day 3 relative to untreated control1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID229235Inhibitory activity against vesicular stomatitis virus (VSV) replication in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID1687953Antiproliferative activity against rat C6 cells assessed as reduction in cell growth incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID659153Antiviral activity against Respiratory syncytial virus infected in HeLa cells2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID474343Selectivity ratio of IC50 for MDCK cells to EC90 for Influenza A virus Gull/PA/4175/83/H5N1 by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1886806Antiviral activity against ZIKV infected in African green monkey Vero E6 cells assessed as inhibition of plaque formation by measuring reduction in PFU per well incubated for 72 hrs by crystal violet staining based assay2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID1524782Selectivity index, ratio of CC50 for cytotoxicity against MDCK cells to EC50 for Influenza A virus (A/Brisbane/10/2007(H3N2)) infected in MDCK cells2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Identification, design and synthesis of novel pyrazolopyridine influenza virus nonstructural protein 1 antagonists.
AID1372321Antiviral activity against Human herpesvirus 1 L2 infected in African green monkey Vero E6 cells assessed as protection against virus-induced cytopathic effect2018Bioorganic & medicinal chemistry letters, 01-01, Volume: 28, Issue:1
Isosteric ribavirin analogues: Synthesis and antiviral activities.
AID68252Minimum inhibitory concentration required for antiviral activity to reduce HSV-1 (KOS) induced cytopathicity in human embryonic skin-muscle cells (ESM)1994Journal of medicinal chemistry, Apr-29, Volume: 37, Issue:9
Synthesis and antiviral activities of 8-alkynyl-, 8-alkenyl-, and 8-alkyl-2'-deoxyadenosine analogues.
AID297321Antiviral activity against Punta Toro virus in Vero cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID1261313Antiviral activity against YFV infected in BHK-21 cells assessed as inhibition of virus-induced cytopathogenicity after 3 to 4 days by MTT assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID86803Antiviral activity against vesicular stomatitis virus infected HeLa cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID217895Minimum inhibitory concentration against parainfluenza 3 virus in Vero cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID475852Cytotoxicity against MDCK cells2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID1783396Antiviral activity against SARS-COV 2 infected in human Calu-3 cells assessed as inhibition of viral replication at MOI of 0.01 and incubated after 2 hrs post infection for 48 hrs by direct yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID443829Antiviral activity against Influenza A virus (A/Hong Kong/7/87(H3N2)) assessed as inhibition of virus-induced cytopathic effect by cell-based assay2009Journal of medicinal chemistry, Oct-08, Volume: 52, Issue:19
Diazo transfer-click reaction route to new, lipophilic teicoplanin and ristocetin aglycon derivatives with high antibacterial and anti-influenza virus activity: an aggregation and receptor binding study.
AID395970Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in liver at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1273991Antiviral activity against HHV-1 CDC Atlanta infected in African green monkey Vero cells assessed as maximal non toxic concentration causing reduction of viral titer after 48 hrs by crystal violet staining assay2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID1113454Antiviral activity against Unidentified Influenza A virus (H1N1) infected MDCK cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID395950Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in liver at 50 mg/kg, po twice daily for 7 days administered 72 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID63916Effective concentration required to inhibit Herpes simplex virus-2 (HSV-2) induced cytopathicity by 50% in E6SM cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID474325Antiviral activity against Influenza A virus Duck/MN/1525/81/H5N1 infected MDCK cells assessed as inhibition of virus-induced cytopathic effect after 3 days2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1126469Cytotoxicity against African green monkey Vero cells after 4 days by MTT assay2014Journal of natural products, Apr-25, Volume: 77, Issue:4
Prenylated benzoylphloroglucinols and xanthones from the leaves of Garcinia oblongifolia with antienteroviral activity.
AID1204076Selectivity index, ratio of CC50 for African green monkey Vero 76 cells to EC50 for RSV infected in African green monkey Vero 76 cells2015Bioorganic & medicinal chemistry letters, Jun-01, Volume: 25, Issue:11
N-((1,3-Diphenyl-1H-pyrazol-4-yl)methyl)anilines: A novel class of anti-RSV agents.
AID1360698Cytotoxicity against MDCK cells assessed as alterations in normal cell morphology measured after 3 to 6 days by microscopic analysis2018European journal of medicinal chemistry, Jul-15, Volume: 155Synthesis, biological evaluation and molecular modeling of novel azaspiro dihydrotriazines as influenza virus inhibitors targeting the host factor dihydrofolate reductase (DHFR).
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID284529Antiviral activity against Vaccinia virus-induced cytopathogenicity in E6SM cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID535536Transport through CNT2 in mouse hepatocytes by oil filtration assay pre-incubated with 20 ng/mL rotenone for 15 mins and 2 mM 2-deoxyglucose for 10 mins at 37 degC in presence of sodium ions in Kreb-henseleit buffer containing 100 nM NBMPR2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID432175Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID257893Antiviral activity against herpes simplex virus 1 TK- KOS ACVr strain in HEL cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID1498142Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of virus-induced visual cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID284527Antiviral activity against HSV2 G-induced cytopathogenicity in E6SM cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID1146289Antiviral activity against Rhinovirus 8 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs by microscopic analysis relative to control1978Journal of medicinal chemistry, Sep, Volume: 21, Issue:9
Imidazo[1,2-a]-s-triazine nucleosides. Synthesis and antiviral activity of the N-bridgehead guanine, guanosine, and guanosine monophosphate analogues of imidazo[1,2-a]-s-triazine.
AID383514Antiviral activity against HSV2 G in human E6SM cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1710783Antiviral activity against Sindbis virus infected in African green monkey Vero cells assessed as reduction in virus-induced cytopathic effect incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID1186336Antiviral activity against Poliovirus type 1 Sabin strain infected in african green monkey Vero 76 cells assessed as reduction in plaque number after 2 days by plaque reduction assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID1435482Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for Coxsackievirus B3 Nancy infected in African green monkey Vero cells2017European journal of medicinal chemistry, Jan-27, Volume: 126Synthesis and evaluation of halogenated 12N-sulfonyl matrinic butanes as potential anti-coxsackievirus agents.
AID432174Cytotoxicity against human HeLa cells assessed as minimum cytotoxic concentration required to cause microscopically detectable alteration in normal cell morphology2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID1873821Antiviral activity against Zika virus H/PAN/2016/BEI-259634 infected in African green monkey Vero cells assessed as inhibition of viral replication by measuring ZIKV E glycoprotein level at 100 uM incubated for 3 days by ELISA analysis relative to control2022Bioorganic & medicinal chemistry, 08-15, Volume: 68Anti-HCV and Zika activities of ribavirin C-nucleosides analogues.
AID1498141Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as inhibition of virus-induced visual cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID1186334Cytotoxicity against mock-infected african green monkey Vero 76 cells after 48 to 96 hrs by MTT assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID1783365Selectivity index, ratio of CC50 for MDCK cells to IC50 for Influenza A Puerto Rico/8/34/H1N1 infected in MDCK cells2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID1230106Antiviral activity against Coxsackievirus B4 infected in African green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Design, antiviral and cytostatic properties of isoxazolidine-containing amonafide analogues.
AID1498131Antiviral activity against Sindbis Virus infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID659286Antiviral activity against influenza A virus H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathogenicity2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID85127Inhibitory activity against HSV-2 (Lyons) replication in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID368961Antiviral activity against RSV A2 infected human Hep2 cells after 5 days by plaque reduction assay2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID370230Antiviral activity against Punta Toro virus Adames infected Syrian golden hamster assessed as mean viral titer per 0.1 g of liver at 30 mg/kg, po twice daily administered 4 hrs before viral challenge measured on day 4 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID474361Antiviral activity against Influenza B virus Malaysia/2506/2004 infected MDCK cells after 3 days by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1731875Cytotoxicity against human HEp-2 cells assessed as reduction in cell viability after 48 hrs by MTS assay2021European journal of medicinal chemistry, Mar-15, Volume: 214Synthesis and antiviral activity of a series of novel quinoline derivatives as anti-RSV or anti-IAV agents.
AID303237Cytotoxicity against HeLa cells assessed as alteration in morphology after 3 days2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID1131479Inhibition of DNA synthesis in primary rabbit kidney cells assessed as inhibition of [3H]thymidine incorporation into DNA1977Journal of medicinal chemistry, Oct, Volume: 20, Issue:10
Synthesis and determination of antiviral activity of the 2'(3')-O-methyl derivatives of ribavirin (1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide).
AID216970Minimum inhibitory conc. for 50% inhibition of Reo-1 virus induced cytopathicity in Vero cells1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Carbocyclic oxetanocins lacking the C-3' methylene.
AID718709Selectivity index, ratio of CTD50 for MDCK cells to ED50 for influenza virus A/California/07/09 (H1N1) pdm092012Bioorganic & medicinal chemistry letters, Dec-01, Volume: 22, Issue:23
Anti-viral activity of (-)- and (+)-usnic acids and their derivatives against influenza virus A(H1N1)2009.
AID1725102Cytotoxicity against human HepG2 cells assessed as cell viability at 100 uM measured after 4 days by CellTiter-Glo luminescent cell viability assay relative to control2020ACS medicinal chemistry letters, Oct-08, Volume: 11, Issue:10
Discovery of Zika Virus NS2B/NS3 Inhibitors That Prevent Mice from Life-Threatening Infection and Brain Damage.
AID395714Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean day of death at 50 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID383506Cytotoxicity against human HeLa cells2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID303231Antiviral activity against Coxsackie virus B4 in Vero cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID324798Antiviral activity against YFV Jimenez infected in Syrian golden hamster assessed as serum alanine aminotransferase at 50 mg/kg, ip bid for 7 days2007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Activity of T-1106 in a hamster model of yellow Fever virus infection.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1485241Antiviral activity against coxsackie B4 virus infected in human HeLa cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID482709Cytotoxicity against human E6SM cells by MTT assay2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID400431Cytotoxicity against human Hep2 cells administered 3 hrs postinfection1998Journal of natural products, May, Volume: 61, Issue:5
Antiviral phenylpropanoid glycosides from the medicinal plant Markhamia lutea.
AID701508Cytotoxicity against human Hep2 cells by Cell Titer-Glo assay2012Journal of medicinal chemistry, Oct-25, Volume: 55, Issue:20
(S)-N-(2,5-Dimethylphenyl)-1-(quinoline-8-ylsulfonyl)pyrrolidine-2-carboxamide as a small molecule inhibitor probe for the study of respiratory syncytial virus infection.
AID535507Transport through CNT2 in mouse hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1246931Cytotoxicity against MDCK cells assessed as cell viability by visual assay2015European journal of medicinal chemistry, Sep-18, Volume: 102Synthesis and antiviral activity of some new bis-1,3-thiazole derivatives.
AID217250In vitro antiviral activity against herpes simplex type 1 (HSV-1) virus was determined in african green monkey kidney (vero,V) expressed as virus rating. Toxic level(>1000 ug/mL)1982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID475234Cytotoxicity against human HuH7 cells after3 days by MTT assay2010Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8
Synthesis of new acridone derivatives, inhibitors of NS3 helicase, which efficiently and specifically inhibit subgenomic HCV replication.
AID66940Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against HSV-2 virus in E6SM cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID1241033Cytotoxicity against MDCK cells relative to control2015Bioorganic & medicinal chemistry, Sep-01, Volume: 23, Issue:17
2- and 3-Fluoro-3-deazaneplanocins, 2-fluoro-3-deazaaristeromycins, and 3-methyl-3-deazaneplanocin: Synthesis and antiviral properties.
AID395682Selectivity index, ratio of CC50 for african green monkey Vero cells to EC50 for Tacaribe virus TRVL115732007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1081544Induction of systemic acquired resistance activity in TMV infected-Nicotiana tabacum (tobacco) leaves at 100 ug/ml2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID767051Selectivity index, ratio of CC50 for human HeLa cells to EC50 for Adenovirus type 7 infected in human HeLa cells2013Bioorganic & medicinal chemistry letters, Sep-15, Volume: 23, Issue:18
Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID478324Antiviral activity against influenza B virus assessed as inhibition of viral induced cytopathic effect2010Bioorganic & medicinal chemistry letters, May-01, Volume: 20, Issue:9
Click reaction synthesis of carbohydrate derivatives from ristocetin aglycon with antibacterial and antiviral activity.
AID85704In vitro antiviral activity (virus ratings (VR)) determined by comparing CPE development in drug-treated cells (T) and HSV-1 virus control cells1984Journal of medicinal chemistry, Nov, Volume: 27, Issue:11
Synthesis and antiviral/antitumor activities of certain 3-deazaguanine nucleosides and nucleotides.
AID217560concentration required to inhibit Coxsackie virus B4-induced cytopathicity by 50% in Vero cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID1075686Antiviral activity against HCV subtype 1a infected in Huh-7 cells assessed as reduction in viral RNA level at 41 uM after 8 to 10 days by quantitative PCR analysis2014Bioorganic & medicinal chemistry letters, Mar-01, Volume: 24, Issue:5
4'-Substituted pyrimidine nucleosides lacking 5'-hydroxyl function as potential anti-HCV agents.
AID87798Minimum cytotoxic concentration required to cause a microscopically detectable alteration of normal cell morphology in Hela cells1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID155582In vitro antiviral activity was tested against parainfluenza type 3 (para3)1985Journal of medicinal chemistry, Sep, Volume: 28, Issue:9
Synthesis and biological activity of 5-thiobredinin and certain related 5-substituted imidazole-4-carboxamide ribonucleosides.
AID395969Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in liver at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1710787Selectivity index, ratio of MCC for African green monkey Vero cells to EC50 for Sindbis virus infected in African green monkey Vero cells2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID463988Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as protection from virus-induced cytopathogenicity after 4 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1687955Antiproliferative activity against human MDA-MB-231 cells assessed as reduction in cell growth at 100 uM incubated for 72 hrs by MTT assay relative to control2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID387576Cytotoxicity against MDCK cells assessed as decrease in cell viability by MTS assay2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis and antiviral evaluation of acyclic azanucleosides developed from sulfanilamide as a lead structure.
AID1542949Antiviral activity against Dengue virus2019ACS medicinal chemistry letters, Apr-11, Volume: 10, Issue:4
Scaffold Morphing Approach To Expand the Toolbox of Broad-Spectrum Antivirals Blocking Dengue/Zika Replication.
AID712813Antiviral activity against Influenza A virus (A/HK/7/87 (H3N2)) infected in MDCK cells assessed as virus-induced cytopathic effect by MTS assay2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID235813Selectivity ratio of MCC50 to that of EC50 of influenza A H2N2(A2 japan/305/57)2003Bioorganic & medicinal chemistry letters, May-19, Volume: 13, Issue:10
Spiro[pyrrolidine-2,2'-adamantanes]: synthesis, anti-influenza virus activity and conformational properties.
AID1638586Cytotoxicity against human A549 cells after 3 days by MTT assay2019Journal of medicinal chemistry, 03-14, Volume: 62, Issue:5
DDX3X Helicase Inhibitors as a New Strategy To Fight the West Nile Virus Infection.
AID575245Antiviral activity against oseltamivir-susceptible zanamivir-, adamantane-resistant Influenza A virus (A/Texas/12/2007 (clone)(H3N2)) harboring neuraminidase E119I mutant and harboring M2 S31N mutant infected in MDCK cells assessed as inhibition of viral 2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
In vitro antiviral activity of favipiravir (T-705) against drug-resistant influenza and 2009 A(H1N1) viruses.
AID204960Compound was tested for antiviral activity (minimum inhibition concentration) in Vero cells sindbis virus1984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID1636357Drug activation in human Hep3B cells assessed as human CYP3A4-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID1081542Induction of systemic acquired resistance activity in TMV infected-Nicotiana tabacum (tobacco) leaves at 50 ug/ml2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID1687946Antiproliferative activity against human MDA-MB-231 cells assessed as reduction in cell growth incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID1234203Antiviral activity against coxsackievirus B3 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathogenic effect dosed 1 hr after viral adsorption2015Journal of natural products, Jul-24, Volume: 78, Issue:7
Antiviral Matrine-Type Alkaloids from the Rhizomes of Sophora tonkinensis.
AID1852998Cytotoxicity against human HCT-116 cells incubated for 48 hrs by MTT assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID1261314Antiviral activity against Reo-1 virus infected in BHK-21 cells assessed as inhibition of virus-induced cytopathogenicity after 3 to 4 days by MTT assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID1536095Cytotoxicity against human A549 cells assessed as reduction in cell viability after 48 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 02-15, Volume: 29, Issue:4
Modified ribavirin analogues as antiviral agents against Junín virus.
AID1886812Antiviral activity against HHV-1 29R strain infected in African green monkey Vero E6 cells assessed as concentration required for higher viral reduction factor measured after 72 hrs by crystal violet staining based inverted microscopic analysis2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID1435486Antiviral activity against Coxsackievirus B4 JVB infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect2017European journal of medicinal chemistry, Jan-27, Volume: 126Synthesis and evaluation of halogenated 12N-sulfonyl matrinic butanes as potential anti-coxsackievirus agents.
AID1055986Antiviral activity against Influenza A virus (A/Hong Kong/7/1987(H3N2)) harboring wild type M2 channel infected in MDCK cells assessed as concentration required to 1 log10 reduction of virus yield after 24 hrs by RT-PCR analysis2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
3-Azatetracyclo[5.2.1.1(5,8).0(1,5)]undecane derivatives: from wild-type inhibitors of the M2 ion channel of influenza A virus to derivatives with potent activity against the V27A mutant.
AID217585In vitro antiviral activity against Parainfluenza type 3 was evaluated.1985Journal of medicinal chemistry, Aug, Volume: 28, Issue:8
Synthesis and biological activity of 6-azacadeguomycin and certain 3,4,6-trisubstituted pyrazolo[3,4-d]pyrimidine ribonucleosides.
AID1485248Antiviral activity against Influenza A virus A/Ned/378/05(H1N1) infected in MDCK cells assessed as host cell viability measured after 3 to 6 days post infection by MTS assay2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID1592373Antiviral activity against Tobacco mosaic virus inoculated in Nicotiana tabacum leaves assessed as passivation by measuring local lesion numbers at 100 mg/l pre-incubated with virus for 30 mins followed by inoculation and measured up to 4 days2019European journal of medicinal chemistry, Apr-01, Volume: 167Chemical synthesis, crystal structure, versatile evaluation of their biological activities and molecular simulations of novel pyrithiobac derivatives.
AID1716978Antiviral activity against GFP-fused wild-type RSV subgroup A Long infected in human HEp-2 cells assessed as relative fluorescence intensity at 20 uM pretreated for 1 hr followed by viral infection measured 24 to 72 hrs post infection by fluorescence assa2020European journal of medicinal chemistry, Jan-15, Volume: 186Design and synthesis of 2-((1H-indol-3-yl)thio)-N-phenyl-acetamides as novel dual inhibitors of respiratory syncytial virus and influenza virus A.
AID84402Antiviral activity against HSV-1(KOS) strain in primary rabbit kidney (PRK) / embryonic skin-muscle (E6SM) fibroblast culture lines1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID1075689Antiviral activity against HCV subtype 1a infected in Huh-7 cells assessed as reduction in viral RNA level after 8 to 10 days by quantitative PCR analysis2014Bioorganic & medicinal chemistry letters, Mar-01, Volume: 24, Issue:5
4'-Substituted pyrimidine nucleosides lacking 5'-hydroxyl function as potential anti-HCV agents.
AID1485240Cytotoxicity against human HeLa cells assessed as alterations in cell morphology measured after 5 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID474336Antiviral activity against Influenza A virus Vietnam/1203/ 2004H/H5N1 infected MDCK cells after 3 days by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1773034Toxicity in BALB/c mouse infected with RSV-Long assessed as body weight loss at 50 mg/kg/day administered via gastric gavage once daily for 6 days2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID114980The maximum tolerated dose was evaluated in mice (mg/kg of body weight). 1985Journal of medicinal chemistry, Sep, Volume: 28, Issue:9
Synthesis and biological activity of 5-thiobredinin and certain related 5-substituted imidazole-4-carboxamide ribonucleosides.
AID1503650Antiviral activity against Fluc-tagged DENV2 strain 16681 infected in human HuH7 cells assessed as inhibition of viral replication at 1 uM after 3 days by luciferase reporter gene assay relative to control2017European journal of medicinal chemistry, Dec-01, Volume: 141Discovery of novel diarylpyrazolylquinoline derivatives as potent anti-dengue virus agents.
AID648684Antiviral activity against C4 type Human enterovirus 71 FY0805 infected in human RD cells assessed as inhibition of viral replication by plaque reduction assay2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Antiviral effect of geraniin on human enterovirus 71 in vitro and in vivo.
AID1246929Antiviral activity against Influenza A virus (A/California/07/2009(H1N1) infected in MDCK cell line assessed as reduction of virus induced cytopathic effect by visual assay2015European journal of medicinal chemistry, Sep-18, Volume: 102Synthesis and antiviral activity of some new bis-1,3-thiazole derivatives.
AID155586Minimum inhibitory concentration required to reduce parainfluenza type 3 induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID427563Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36M/R155K double mutation in human HuH7 cells after 48 hrs by RNA replicon assay relative to wild type2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID1783343Cytotoxicity against human Huh-7 cells assessed as reduction in cell viability by Celltiter-Glo luminescent cell viability assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID1181483Antiviral activity against Influenza A virus (A/HK/7/1987(H3N2)) infected in MDCK cells assessed as reduction in host cell viability after 72 hrs by MTS assay2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID1055006Antiviral activity against Fort Morgan virus infected in human BE(2)-C cells assessed as reduction of viral titer at 25 uM after 24 hrs by plaque reduction assay (Rvb = 47.1 +/- 10.5 x 10'6 pfu/ml)2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Optimization of novel indole-2-carboxamide inhibitors of neurotropic alphavirus replication.
AID369127Drug resistance, ratio of EC50 for plaque picked A-33903-resistant RSV RSS from passage 2 to EC50 for DMSO-passaged wild type RSV RSS2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID1249918Antiviral activity against Influenza A virus (A/PR/8/1934(H1N1)) infected in MDCK cells assessed as 1-log10 reduction in viral RNA copy number after 24 hrs by quantitative RT-PCR analysis2015ACS medicinal chemistry letters, Aug-13, Volume: 6, Issue:8
Virtual Screening and Biological Validation of Novel Influenza Virus PA Endonuclease Inhibitors.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID156705Evaluation for antiviral activity against herpes simplex virus-1(TK-) (B2006) in primary rabbit kidney cell cultures(PRK) (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID366289Selectivity index, ratio of CC50 to MDCK cells to IC50 to Influenza A Jinan/15/90 H3N2 virus2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Structure-activity relationship of flavonoids as influenza virus neuraminidase inhibitors and their in vitro anti-viral activities.
AID1682702Selectivity index, ratio of CC50 for MDCK cells to IC50 for Influenza A virus (A/Puerto Rico/8/34 (H1N1)) infected in MDCK cells
AID1650130Cytotoxicity against MDCK cells assessed as minimum cytotoxic concentration after 4 days by MTS assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Superior inhibition of influenza virus hemagglutinin-mediated fusion by indole-substituted spirothiazolidinones.
AID1610168Antiviral activity against Human coronavirus 229E infected in human HELF cells assessed as reduction in virus-induced cytopathogenicity incubated for 7 days by microscopic analysis2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
AID474342Selectivity ratio of IC50 for MDCK cells to EC50 for Influenza A virus Gull/PA/4175/83/H5N1 by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1391710Cytotoxicity against MDCK cells assessed as reduction in cell viability by CCK8 assay2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Secoiridoid analogues from the fruits of Ligustrum lucidum and their inhibitory activities against influenza A virus.
AID1853008Inhibition of recombinant human P-gp ATPase activity in presence of MgATP preincubated for 40 min measured after 20 min by Pgp-Glo assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID216179Tested for inhibitory effect on RNA virus PV-3 in Vero cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID288915Cytotoxicity against E6SM cells assessed as alteration in cell morphology2007Journal of medicinal chemistry, Jun-14, Volume: 50, Issue:12
5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID1783352Antiviral activity against Zika virus H/PF/2013 infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based plaque reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID475854Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID1710801Cytotoxicity against cat CRFK cells assessed as reduction in cell viability incubated for 3 to 6 days by MTS assay2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID416772Cytotoxicity against human HEL cells assessed as drug level causing microscopically detectable alteration of normal cell morphology after 3 days2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1253096Cytotoxicity against human HuH7-J20 cells expressing secreted alkaline phosphatase reporter gene assessed as cell viability preincubated for 1 hr followed by fresh drug administration every 24 hrs at 1/10th of initial concentration for 48 hrs by WST-1 ass2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Rethinking the old antiviral drug moroxydine: Discovery of novel analogues as anti-hepatitis C virus (HCV) agents.
AID482711Antiviral activity against Parainfluenza virus 3 infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID54505Compound was tested for antiviral activity (minimum inhibition concentration) in HeLa cells coxsackie virus type 41984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID1081199Induction of systemic acquired resistance in Nicotiana tabacum (tobacco) mosaic virus infected Nicotiana tabacum (tobacco) plant at 100 ug/mL at 25 degC for 72 hr2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis, crystal structure, and biological activity of 4-methyl-1,2,3-thiadiazole-containing 1,2,4-triazolo[3,4-b][1,3,4]thiadiazoles.
AID88350Compound was evaluated for its inhibitory effect on the replication of encephalomyocarditis virus (EMCV) in HeLa cells2003Bioorganic & medicinal chemistry letters, Oct-20, Volume: 13, Issue:20
Synthesis and biological evaluation of thymine nucleosides fused with 3',4'-tetrahydrofuran ring.
AID1435485Antiviral activity against Coxsackievirus B2 Ohio-1 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect2017European journal of medicinal chemistry, Jan-27, Volume: 126Synthesis and evaluation of halogenated 12N-sulfonyl matrinic butanes as potential anti-coxsackievirus agents.
AID1408125Antiviral activity against Influenza A virus A/PR/8/34 (H1N1) infected in MDCK cells measured after 2 days by plaque reduction assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Synthesis and biological evaluation of a library of hybrid derivatives as inhibitors of influenza virus PA-PB1 interaction.
AID217099Percentage plaque reduction was determined against pichinde(PICH) virus in african green monkey kidney (vero,V). Toxic level(>1000 ug/mL); 61-901982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID87192Minimum inhibitory concentration against Herpes simplex virus 1(KOS)1989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID1092197In vivo antiviral activity against Tobacco mosaic virus (TMV) inoculated left side of Nicotiana tabacum L. leaves assessed as inactivation effect at 100 ug/mL co-incubated with virus measured after 3 to 4 days2012Journal of agricultural and food chemistry, Oct-17, Volume: 60, Issue:41
Design, synthesis, and anti-tobacco mosaic virus (TMV) activity of phenanthroindolizidines and their analogues.
AID1226136Cytotoxicity against MDCK cells assessed as decrease in cell viability by MTT assay2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
A Broad Anti-influenza Hybrid Small Molecule That Potently Disrupts the Interaction of Polymerase Acidic Protein-Basic Protein 1 (PA-PB1) Subunits.
AID303236Antiviral activity against Punta Toro virus in Vero cells reduction of virus-induced cytopathogenicity after 4 days2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID392529Antiviral activity against influenza H3N2 virus2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Unified QSAR approach to antimicrobials. 4. Multi-target QSAR modeling and comparative multi-distance study of the giant components of antiviral drug-drug complex networks.
AID463992Antiviral activity against VSV infected in HEL cells assessed as protection from virus-induced cytopathogenicity after 1 to 2 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1113452Antiviral activity against Influenza B virus infected in MDCK cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID1638584Cytotoxicity against human HuH7 cells after 3 days by MTT assay2019Journal of medicinal chemistry, 03-14, Volume: 62, Issue:5
DDX3X Helicase Inhibitors as a New Strategy To Fight the West Nile Virus Infection.
AID290452Cytotoxicity against Vero E6 cells2007Bioorganic & medicinal chemistry letters, May-01, Volume: 17, Issue:9
Synthesis and biological evaluation of nucleoside analogues having 6-chloropurine as anti-SARS-CoV agents.
AID1505497Antiviral activity against Influenza virus B/Ned/537/05 infected in HGPRT deficient 6-thioguanine-resistant MDCK cells assessed as reduction in viral replication at 3 days post infection by formazan-based MTS assay2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Prodrugs of the Phosphoribosylated Forms of Hydroxypyrazinecarboxamide Pseudobase T-705 and Its De-Fluoro Analogue T-1105 as Potent Influenza Virus Inhibitors.
AID218249Evaluation in Vero cell cultures for cytotoxicity that is to cause microscopically detectable alteration of normal cell morphology1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID1261326Antiviral activity against DENV-2 infected in BHK-21 cells assessed as inhibition of virus-induced cytopathogenicity after 3 to 4 days by MTT assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID658616Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID29735Toxic level was evaluated; None1985Journal of medicinal chemistry, Oct, Volume: 28, Issue:10
Synthesis and biological activity of certain 6-substituted and 2,6-disubstituted 2'-deoxytubercidins prepared via the stereospecific sodium salt glycosylation procedure.
AID63766The minimum inhibitory concentration was measured on E6SM cells against Vaccinia virus1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID767055Antiviral activity against Coxsackievirus B5 infected in human HepG2 cells assessed as inhibition of virus-induced cytopathogenicity after 48 hrs by crystal violet staining method2013Bioorganic & medicinal chemistry letters, Sep-15, Volume: 23, Issue:18
Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID395940Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean serum ALT levels at 20 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID726614Antiviral activity against wild type Measles virus mWTFb infected in simian B95a cells assessed as virus-induced cytopathogenicity incubated for 30 mins prior to inoculation measured after 3 days by phase contrast microscopy2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Novel antiviral activity of l-dideoxy bicyclic nucleoside analogues versus vaccinia and measles viruses in vitro.
AID224345Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against KOS strain of Herpes simplex virus-1 in primary rabbit kidney cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID1293615Selectivity index, ratio of CC50 for MDCK cells to EC50 for Influenza A virus PR/8/34 infected in MDCK cells2016Journal of medicinal chemistry, Mar-24, Volume: 59, Issue:6
4,6-Diphenylpyridines as Promising Novel Anti-Influenza Agents Targeting the PA-PB1 Protein-Protein Interaction: Structure-Activity Relationships Exploration with the Aid of Molecular Modeling.
AID303238Cytotoxicity against Vero cells assessed as alteration in morphology after 3 days2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID712809Antiviral activity against amantadine-sensitive Influenza A virus (A/FM/1/47 (H1N1)) infected in MDCK cells assessed as virus-induced cytopathic effect measured 3 days post infection by microscopic analysis2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID482706Antiviral activity against TK-deficient acyclovir-resistant HSV1 KOS infected in human E6SM cell assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID1571900Displacement of [125I]N6-(4-amino-3-iodobenzyl)adenosine-5-N-methyluronamide from human A3A adenosine receptor expressed in CHO cell membranes at 10 uM after 60 mins by scintillation proximity assay relative to adenosine 5-N-ethyluronamide2019Journal of medicinal chemistry, 02-14, Volume: 62, Issue:3
Design and in Vivo Characterization of A
AID416765Cytotoxicity against african green monkey Vero cells assessed as drug level causing microscopically detectable alteration of normal cell morphology after 3 days2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1081163In vitro antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves at 100 ug/ml2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1435487Antiviral activity against Coxsackievirus B5 Faulkner infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect2017European journal of medicinal chemistry, Jan-27, Volume: 126Synthesis and evaluation of halogenated 12N-sulfonyl matrinic butanes as potential anti-coxsackievirus agents.
AID421726Cytotoxicity against human Hep2 cells2009Journal of natural products, May-22, Volume: 72, Issue:5
Antiviral constituents against respiratory viruses from Mikania micrantha.
AID1536096Antiviral activity against Junin virus IV4454 infected in human A549 cells assessed as reduction in vrius yield after 48 hrs by plaque assay2019Bioorganic & medicinal chemistry letters, 02-15, Volume: 29, Issue:4
Modified ribavirin analogues as antiviral agents against Junín virus.
AID1433147Antiviral activity against Punta Toro virus infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID216971Minimum inhibitory conc. for 50% inhibition of forest virus induced cytopathicity in Vero cells1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Carbocyclic oxetanocins lacking the C-3' methylene.
AID1186329Cytotoxicity against mock-infected MDBK cells after 48 to 96 hrs by MTT assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID88523Inhibitory concentration against respiratory syncytial virus in HeLa cells1995Journal of medicinal chemistry, Sep-01, Volume: 38, Issue:18
Synthesis and antiviral activity of benzyl-substituted imidazo [1,5-a]-1,3,5-triazine (5,8-diaza-7,9-dideazapurine) derivatives.
AID1293609Antiviral activity against Influenza A virus PR/8/34 infected in MDCK cells assessed as inhibition of plaque formation treated for 1 hr measured after 2 days by toluidine blue staining-based assay2016Journal of medicinal chemistry, Mar-24, Volume: 59, Issue:6
4,6-Diphenylpyridines as Promising Novel Anti-Influenza Agents Targeting the PA-PB1 Protein-Protein Interaction: Structure-Activity Relationships Exploration with the Aid of Molecular Modeling.
AID432179Cytotoxicity against african green monkey Vero cells assessed as minimum cytotoxic concentration required to cause microscopically detectable alteration in normal cell morphology2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID383513Antiviral activity against HSV1 KOS in human HEL cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID383518Antiviral activity against in Vesicular stomatitis virus in human E6SM cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1118653Cytotoxicity against human HEL cells assessed as concentration required to cause microscopically visible alternation of cell morphology2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1486231Cytotoxicity against bovine MDBK cells assessed as reduction in cell viability after 3 days by MTS/PES assay
AID1379364Toxicity in ICR mouse infected with EV71 695F assessed as death at 100 mg/kg, ip qd administered for 7 days measured on day 52017ACS medicinal chemistry letters, Aug-10, Volume: 8, Issue:8
Discovery of Potent EV71 Capsid Inhibitors for Treatment of HFMD.
AID360168Ratio of IC50 for HCV 1b with NS3-4A R155G mutation to IC50 for wild type HCV 1b2007The Journal of biological chemistry, Aug-03, Volume: 282, Issue:31
Phenotypic and structural analyses of hepatitis C virus NS3 protease Arg155 variants: sensitivity to telaprevir (VX-950) and interferon alpha.
AID1687967Antiproliferative activity against human IGROV-1 cells assessed as reduction in cell growth incubated for 3 days by trypan blue exclusion assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID1729929Cytotoxicity against dog MDCK cells assessed as reduction in cell viability incubated for 48 hrs by MTT assay2021European journal of medicinal chemistry, Jan-01, Volume: 209Synthesis and characterization of 1,2,4-triazolo[1,5-a]pyrimidine-2-carboxamide-based compounds targeting the PA-PB1 interface of influenza A virus polymerase.
AID751219Antiviral activity against Influenza A virus H1N1 infected in dog MDCK cells after 48 hrs by CPE inhibition assay2013Journal of natural products, Jun-28, Volume: 76, Issue:6
Antiviral alkaloids produced by the mangrove-derived fungus Cladosporium sp. PJX-41.
AID220033Antiviral activity against coxsackie B4 in Vero cell culture lines1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID768199Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as reduction of virus-induced cytopathogenicity2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID648650Selectivity index, ratio of TC50 for MDCK cells to IC50 for influenza A virus H1N12012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Synthesis and anti-influenza activity of aminoalkyl rupestonates.
AID432177Antiviral activity against Coxsackievirus B4 infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID468105Antiviral activity against SFV infected in BHK cells assessed as surviving virus fraction at 200 uM after 14 hrs by luciferase reporter gene assay in presence of 50 ug/ml guanosine2009Journal of natural products, Nov, Volume: 72, Issue:11
Betulin-derived compounds as inhibitors of alphavirus replication.
AID1432507Selectivity index, ratio of TC50 for MDCK cells to IC50 for Influenza B virus infected in MDCK cells2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Structure-activity relationship studies of 1-(1'-hydroxyalkyl)rupestonic acid methyl esters against influenza viruses.
AID634759Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1253091Antiviral activity against HCV JFH1 infected in human HuH7-J20 cells assessed as inhibition of viral life cycle by measuring secreted alkaline phosphatase level preincubated with cells for 1 hr followed by viral inoculation for 3 hrs measured at 72 hrs2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Rethinking the old antiviral drug moroxydine: Discovery of novel analogues as anti-hepatitis C virus (HCV) agents.
AID555931Antiviral activity against HCV genotype 1b infected in human Huh-9-13 cells assessed as reduction in viral replication selected after 3 passages at 30 ug/ml by quantitative RT-PCR2009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Debio 025, a cyclophilin binding molecule, is highly efficient in clearing hepatitis C virus (HCV) replicon-containing cells when used alone or in combination with specifically targeted antiviral therapy for HCV (STAT-C) inhibitors.
AID1651271Cytotoxicity against African green monkey Vero E6 cells assessed as cell viability at 40 uM relative to control2020Bioorganic & medicinal chemistry letters, 02-15, Volume: 30, Issue:4
Design, synthesis, and evaluation of novel 4-amino-2-(4-benzylpiperazin-1-yl)methylbenzonitrile compounds as Zika inhibitors.
AID217267Effective concentration required to inhibit parainfluenza-3 virus-induced cytopathicity by 50% in Vero cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID1336610Antiviral activity against Sindbis virus infected in African green monkey Vero cells assessed as protection against virus-induced cytopathic effect measured after 3 to 5 days by microscopic analysis2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Synthesis and in vitro antiviral evaluation of 4-substituted 3,4-dihydropyrimidinones.
AID688918Antiviral activity against Bovine viral diarrhea virus 1-NADL ATCC VR534 infected in MDBK cells assessed as reduction of viral cytopathic effect after 2 days bt MTS assay2012Bioorganic & medicinal chemistry, Oct-01, Volume: 20, Issue:19
Synthesis and biological evaluation of novel homochiral carbocyclic nucleosides from 1-amino-2-indanols.
AID86799Effects on cell morphology of HeLa cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID1082993Antiviral activity against Tobacco mosaic virus (TMV) inoculation on Nicotiana tabacum L. whole leaves assessed as virus inactivation effect at 500 ug/mL measured 3 to 4 days post inoculation2012Journal of agricultural and food chemistry, Sep-05, Volume: 60, Issue:35
Design, synthesis, and antiviral activity evaluation of phenanthrene-based antofine derivatives.
AID395681Selectivity index, ratio of CC50 for african green monkey Vero cells to EC50 for Pichinde virus An 47632007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID361407Antiviral activity against Coxsackievirus B3 Nancy infected in human HeLa assessed as inhibition of virus-induced cytopathic effect after 2 days by MTT assay2002Journal of natural products, Nov, Volume: 65, Issue:11
New saponins from the starfish Certonardoa semiregularis.
AID88277Evaluated for minimum inhibitory concentration against KOS, F, McIntyre strains of Herpes simplex virus (HSV-1) in primary rabbit kidney cells1990Journal of medicinal chemistry, May, Volume: 33, Issue:5
Stereospecific synthesis and antiviral properties of different enantiomerically pure carbocyclic 2'-deoxyribonucleoside analogues derived from common chiral pools: (+)-(1R,5S)- and (-)-(1S,5R)-2-oxabicyclo[3.3.0]oct-6-en-3-one.
AID86357Minimum inhibitory conc. for 50% inhibition of Polio-1 virus induced cytopathicity in HeLa cells1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Carbocyclic oxetanocins lacking the C-3' methylene.
AID1241028Cytotoxicity against African green monkey Vero 76 cells2015Bioorganic & medicinal chemistry, Sep-01, Volume: 23, Issue:17
2- and 3-Fluoro-3-deazaneplanocins, 2-fluoro-3-deazaaristeromycins, and 3-methyl-3-deazaneplanocin: Synthesis and antiviral properties.
AID1398131Cytotoxicity against MDCK cells assessed as reduction in cell viability after 48 hrs by crystal violet staining based method2018Bioorganic & medicinal chemistry letters, 09-15, Volume: 28, Issue:17
Generation of methylated violapyrones with improved anti-influenza A virus activity by heterologous expression of a type III PKS gene in a marine Streptomyces strain.
AID216348Tested for antiviral activity against Sindbis virus in African green monkey kidney cell (Vero)2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID402537Selectivity index, ratio of IC50 for MDCK cells to EC50 for influenza A virus NWS331997Journal of natural products, Jun, Volume: 60, Issue:6
Two new lignans with activity against influenza virus from the medicinal plant Rhinacanthus nasutus.
AID1113463Antiviral activity against Vesicular stomatitis virus infected human HeLa cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID83887Compound was tested for antiviral activity against herpes simplex virus-1(KOS) in primary rabbit kidney cells1984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID383521Antiviral activity against thymidine kinase deficient and acyclovir resistant HSV1 KOS in human HEL cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID535515Transport through ENT2 in rat hepatocytes by oil filtration assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID88279In vitro antiviral activity against herpes simplex virus/1(HSV/1) expressed as viral rating (VR)1981Journal of medicinal chemistry, Oct, Volume: 24, Issue:10
Synthesis and biological activity of certain derivatives of oxazinomycin and related oxadiazole nucleosides.
AID543660Antiviral activity against Yellow fever virus 17D infected in African green monkey Vero cells assessed as inhibition of virus induced cytopathic effect by luciferase reporter gene assay2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID774864Antiviral activity against HCV expressing pFL-J6/JFH/JC1 infected in human Huh7.5 cells assessed as inhibition of viral RNA synthesis after 96 hrs by one-step RT-PCR analysis2013European journal of medicinal chemistry, Nov, Volume: 69Synthesis and antiviral activity of a novel class of (5-oxazolyl)phenyl amines.
AID87281Minimum inhibitory concentration (MIC) required to reduce virus-induced cytopathogenicity by 50% against Vesicular stomatitis virus in HeLa cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID1205004Antiviral activity against Coxsackievirus B6 infected in african green monkey Vero cells assessed as reduction in viral-induced cytopathic effect2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID225768Antiviral activity against polio virus type 1 in HeLa cell culture lines1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID1687957Antiproliferative activity against mouse B16-F10 cells assessed as reduction in cell growth at 100 uM incubated for 72 hrs by MTT assay relative to control2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID63940concentration required to inhibit HSV-1/TK (B2006) or VMW1837-induced cytopathicity by 50% in E6SM cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID81802Antiviral activity against (HIV-1) in MT-4 cells Value in parentheses is inhibitory concentration for cell growth (MT-4)1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID1886811Antiviral activity against HHV-1 29R strain infected in African green monkey Vero E6 cells assessed as reduction factor at 3.1 to 25 ug/ml measured after 72 hrs by crystal violet staining based inverted microscopic analysis2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID395974Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in serum at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1261318Selectivity index, ratio of CC50 for MDBK cells to EC50 for BVDV2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID1181485Cytotoxicity against MDCK cells assessed as change in cell morphology after 72 hrs by microscopy2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID1261324Antiviral activity against HIV-1 infected in MT4 cells assessed as inhibition of virus-induced cytopathogenicity after 4 days by MTT assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID1135742Antiviral activity against Rhinovirus type 13 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect at 1 to 1000 ug/ml after 72 hrs1978Journal of medicinal chemistry, Aug, Volume: 21, Issue:8
Synthesis and antiviral acticity of some phosphates of the broad-spectrum antiviral nucleoside, 1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide (ribavirin).
AID1731874Antiviral activity against RSV Long expressing mGFP infected in HEp-2 cells assessed as reduction in viral replication after 48 hrs by MTS assay2021European journal of medicinal chemistry, Mar-15, Volume: 214Synthesis and antiviral activity of a series of novel quinoline derivatives as anti-RSV or anti-IAV agents.
AID164602Tested for inhibition of virus-induced cytopathogenic effect and cytotoxicity of compound against Punta toro virus with adames strain in vero cell1988Journal of medicinal chemistry, Sep, Volume: 31, Issue:9
Cyclopentenylcytosine. A carbocyclic nucleoside with antitumor and antiviral properties.
AID1783387Antiviral activity against SARS-COV 2 infected in human Huh-7 cells assessed as inhibition of viral replication at MOI of 0.01 and incubated after 2 hrs post infection for 48 hrs by direct yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID1858560Cytotoxicity against African green monkey Vero cells by CCK8 assay method2021European journal of medicinal chemistry, Jan-01, Volume: 209Primed for global coronavirus pandemic: Emerging research and clinical outcome.
AID765050Antagonist activity at human PPARdelta assessed as effect on TIPP-703-induced activity2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Peroxisome proliferator-activated receptor delta antagonists inhibit hepatitis C virus RNA replication.
AID63763The minimum inhibitory concentration was measured on E6SM cells against Herpes simplex virus type 2 (Lyons strain)1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID1364944Antiviral activity against Chikungunya virus C347 infected in African green monkey Vero cells assessed as inhibition of viral-induced cytopathic effect after 2 days by microscopic analysis2017Bioorganic & medicinal chemistry, 08-15, Volume: 25, Issue:16
The medicinal chemistry of Chikungunya virus.
AID611768Antiviral activity against Influenza B virus infected in MDCK cells assessed as protection against virus-induced cytopathicity2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID419598Antiviral activity against VSV infected in human HeLa cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID1611058Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) pdm09 infected in MDCK cells assessed as inhibition of virus replication compound incubated with uninfected host cell for 1 hr followed by viral infection for 24 hrs measured after vi2019Bioorganic & medicinal chemistry letters, 12-01, Volume: 29, Issue:23
Synthesis and structure-activity relationships of novel camphecene analogues as anti-influenza agents.
AID763924Antiviral activity against Influenza A virus (A/duck/Minnesota/1525/1981(H5N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect by cell-based neutral red uptake assay2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis and biological activity evaluation of 5-pyrazoline substituted 4-thiazolidinones.
AID278379Decrease in GTP level in Vero E6 cells at 40 ug/ml after 24 h2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID368964Therapeutic index, CC50 for human Hep2 cells to EC50 for RSV RSS2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID668365In vivo antiviral activity against TMV assessed as protection effect at 500 ug/ml2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis and antiviral activity of novel pyridazines.
AID1433141Antiviral activity against Coxsackievirus B4 infected in human HeLa cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID416769Antiviral activity against Reovirus 1 in african green monkey Vero cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1710774Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as reduction in virus-induced cytopathic effect incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID543661Cytotoxicity against African green monkey Vero cells by luciferase-based cell viability assay2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID1113457Antiviral activity against Human coxsackievirus B4 infected African green monkey Vero cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID634838Antiviral activity against Human immunodeficiency virus 1 infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 days by microscopic analysis2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1536098Cytotoxicity against African green monkey Vero cells assessed as reduction in cell viability after 48 hrs by MTT assay2019Bioorganic & medicinal chemistry letters, 02-15, Volume: 29, Issue:4
Modified ribavirin analogues as antiviral agents against Junín virus.
AID84611Minimum inhibitory concentration required to reduce Herpes simplex virus type 2 (HSV-2 strain G) induced cytopathogenicity by 50%1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID1349209Cytotoxicity against human Ava5 cells assessed as decrease in cell viability after 72 hrs by XTT assay2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery of naphtho[1,2-d]oxazole derivatives as potential anti-HCV agents through inducing heme oxygenase-1 expression.
AID68130Tested for inhibitory effect on RNA virus cell morphology in ESM cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID763864Antiviral activity against Influenza A virus (A/Perth/16/2009(H3N2)) infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect by cell-based neutral red uptake assay2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis and biological activity evaluation of 5-pyrazoline substituted 4-thiazolidinones.
AID54474Tested for its anti-polio activity against Coxsackie B virus type-32002Bioorganic & medicinal chemistry letters, May-20, Volume: 12, Issue:10
Heterocyclic nucleoside analogues: design and synthesis of antiviral, modified nucleosides containing isoxazole heterocycles.
AID68127Tested for inhibitory effect on DNA virus TK-HSV-1 (B2006) in ESM cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID548432Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID395676Antiviral activity against Junin virus Candid-1 in Vero cells assessed as inhibition of virus-induced visual cytopathic effect after 7 to 8 days2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID464183Cytotoxicity against PIV 3 infected african green monkey Vero cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1443863Antiviral activity against full length Gaussia princeps Gluc-tagged Chikungunya virus IMT infected in HEK293T cells assessed as reduction in virus infection after 24 hrs by Gaussia luciferase reporter gene assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Structural Optimizations of Thieno[3,2-b]pyrrole Derivatives for the Development of Metabolically Stable Inhibitors of Chikungunya Virus.
AID766706Cytotoxicity against MDCK cells assessed as morphological changes2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID81897In vitro antiviral activity against vaccinia(VV) virus was determined in human laryngeal epithelioma (HEp-2,H)expressed as virus rating. Toxic level(>1000 ug/mL)1982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID1293613Inhibition of Influenza A virus RdRp transfected in HEK293T cells at 24 hrs by dual luciferase reporter gene-based minireplicon assay2016Journal of medicinal chemistry, Mar-24, Volume: 59, Issue:6
4,6-Diphenylpyridines as Promising Novel Anti-Influenza Agents Targeting the PA-PB1 Protein-Protein Interaction: Structure-Activity Relationships Exploration with the Aid of Molecular Modeling.
AID546577Inhibition of recombinant GSK3-beta Z'-LYTE kinase assay kit method2010Journal of medicinal chemistry, Dec-23, Volume: 53, Issue:24
Discovery of novel GSK-3β inhibitors with potent in vitro and in vivo activities and excellent brain permeability using combined ligand- and structure-based virtual screening.
AID1135720Immunosuppressive activity against PHA-stimulated proliferation in rat T-lymphocytes assessed as cell viability at 1 uM after 6 days by [3H]thymidine incorporation method relative to control1978Journal of medicinal chemistry, Jul, Volume: 21, Issue:7
Synthesis of branched-chain apiosylpyrimidines and their inhibition of lymphocyte proliferation.
AID427566Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36A/R155T double mutation in human HuH7 cells after 48 hrs by RNA replicon assay relative to wild type2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID1135408Toxicity in mouse assessed as survival at 99 mg/kg, po1977Journal of medicinal chemistry, Feb, Volume: 20, Issue:2
Synthesis and antiviral activity of certain thiazole C-nucleosides.
AID1472387Antiviral activity against Influenza A virus (A/Virginia/ATCC3/2009(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathicity after 72 hrs by microscopic method2018Journal of medicinal chemistry, 01-11, Volume: 61, Issue:1
Aniline-Based Inhibitors of Influenza H1N1 Virus Acting on Hemagglutinin-Mediated Fusion.
AID1773425Antiviral activity against Enterovirus E LCR-4 infected in A549 cells assessed as inhibition of viral adsorption at early stage of replication treated for 1 hr during viral infection followed by replacement with fresh medium and measured after 72 hrs by M2021European journal of medicinal chemistry, Dec-05, Volume: 225Novel betulin dicarboxylic acid ester derivatives as potent antiviral agents: Design, synthesis, biological evaluation, structure-activity relationship and in-silico study.
AID1558305Inhibition of RNA-dependent RNA polymerase in Zika virus MR766 infected in African green monkey Vero cells assessed as antiviral activity after 72 hrs by DAPI staining based assay2020Journal of medicinal chemistry, 01-23, Volume: 63, Issue:2
Drugs for the Treatment of Zika Virus Infection.
AID63948Tested for minimum cytotoxic concentration on virus-induced cytopathicity in E6SM cells1993Journal of medicinal chemistry, Oct-01, Volume: 36, Issue:20
Antiviral activity of C-alkylated purine nucleosides obtained by cross-coupling with tetraalkyltin reagents.
AID63942concentration required to inhibit VSV-induced cytopathicity by 50% in E6SM cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID1118631Antiviral activity against Herpes simplex virus type 1 KOS infected in human HEL cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID84084Inhibitory activity against HSV-1 (F) replication in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID94762Inhibitory dose of compound required to inhibit cytopathogenic effects of Japanese encephalitis virus with najayama strain in vero cells1988Journal of medicinal chemistry, Sep, Volume: 31, Issue:9
Cyclopentenylcytosine. A carbocyclic nucleoside with antitumor and antiviral properties.
AID1783393Antiviral activity against SARS-COV 2 infected in monkey Vero E6 cells assessed as inhibition of viral replication at MOI of 0.01 and incubated after 2 hrs post infection for 48 hrs by direct yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID216973Minimum inhibitory conc. for 50% inhibition of alteration of morphology in Vero cells1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Carbocyclic oxetanocins lacking the C-3' methylene.
AID229022Concentration required to reduce vaccinia virus induced cytopathogenicity by 50% in primary rabbit kidney cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID156708Evaluation for antiviral activity against herpes simplex virus-2(Lyons) in primary rabbit kidney cell cultures(PRK) (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID1229714Cytotoxicity against african green monkey Vero B cells2015Journal of medicinal chemistry, Jun-25, Volume: 58, Issue:12
Discovery of Multitarget Antivirals Acting on Both the Dengue Virus NS5-NS3 Interaction and the Host Src/Fyn Kinases.
AID220038Concentration required to reduce coxsackie virus B4 induced cytopathogenicity by 50% in vero cell cultures.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Antiviral activity of C-5 substituted tubercidin analogues.
AID65709Antiviral activity against herpes simplex virus-1 TK-KOS ACV (HSV-1) in E6SM cell cultures2001Journal of medicinal chemistry, Aug-02, Volume: 44, Issue:16
Design, synthesis, DNA binding, and biological evaluation of water-soluble hybrid molecules containing two pyrazole analogues of the alkylating cyclopropylpyrroloindole (CPI) subunit of the antitumor agent CC-1065 and polypyrrole minor groove binders.
AID1131476Antiviral activity against Vaccinia virus infected in primary rabbit kidney cells assessed as inhibition of virus-induced cytopathogenicity treated immediately after virus adsorption measured 2 days after virus infection1977Journal of medicinal chemistry, Oct, Volume: 20, Issue:10
Synthesis and determination of antiviral activity of the 2'(3')-O-methyl derivatives of ribavirin (1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide).
AID1427861Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for Coxsackievirus B3 infected in African green monkey Vero cells
AID1261308Cytotoxicity against human MT4 cells assessed as cell viability after 96 hrs by MTT assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID82048Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on HEF cell line infected with HSV-2 virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID1249921Antiviral activity against Influenza A virus (A/PR/8/1934(H1N1)) infected in HEK293T cells assessed as reduction in viral RNP reconstitution measured at 24 hrs by luciferase reporter gene assay2015ACS medicinal chemistry letters, Aug-13, Volume: 6, Issue:8
Virtual Screening and Biological Validation of Novel Influenza Virus PA Endonuclease Inhibitors.
AID64120Tested for minimum inhibitory concentration against Vaccinia virus in E6SM cells1993Journal of medicinal chemistry, Oct-01, Volume: 36, Issue:20
Antiviral activity of C-alkylated purine nucleosides obtained by cross-coupling with tetraalkyltin reagents.
AID275088Cytotoxicity against HeLa cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID370203Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in liver at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID65710Antiviral activity against herpes simplex virus-1 TK-VMW 1837 (HSV-1) in E6SM cell cultures2001Journal of medicinal chemistry, Aug-02, Volume: 44, Issue:16
Design, synthesis, DNA binding, and biological evaluation of water-soluble hybrid molecules containing two pyrazole analogues of the alkylating cyclopropylpyrroloindole (CPI) subunit of the antitumor agent CC-1065 and polypyrrole minor groove binders.
AID216184Tested for inhibitory effect on RNA virus cell morphology in Vero cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1773038Antiviral activity against RSV Long infected in BALB/c mouse assessed as improvement in lung congestion at 25 to 100 mg/kg/day observed on day 6 after infection by H and E staining based microscopic analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID535517Transport through CNT2 in rat hepatocytes by oil filtration assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID658745Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as inhibition of virus-induced cytopathogenicity after 4 days2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID1118634Antiviral activity against Vaccinia virus infected in human HEL cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1546422Therapeutic Index, ratio of TC50 for African green monkey Vero cells to IC50 for CVB3 infected in African green monkey Vero cells2020Bioorganic & medicinal chemistry letters, 01-01, Volume: 30, Issue:1
Synthesis and anti-CVB3 activity of 4-amino acid derivative substituted pyrimidine nucleoside analogues.
AID416775Antiviral activity against Vaccinia virus Lederle in human HEL cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID712795Cytotoxicity against dog MDCK cells assessed as cell viability after 72 hrs by MTS assay2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID1687960Antiproliferative activity against human DU-145 cells assessed as reduction in cell growth at 100 uM incubated for 72 hrs by MTT assay relative to control2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID216508Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on vero cell line infected with sindbis virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID273211Viability of human HeLa S3 cells2006Journal of medicinal chemistry, Oct-19, Volume: 49, Issue:21
Synthesis and antiviral activity of 5-substituted cytidine analogues: identification of a potent inhibitor of viral RNA-dependent RNA polymerases.
AID200185Antiviral activity at 100 uM determined in a culture of Rhinovirus type 1-A; IA = inactive1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and biological properties of purine and pyrimidine 5'-deoxy-5'-(dihydroxyphosphinyl)-beta-D-ribofuranosyl analogues of AMP, GMP, IMP, and CMP.
AID765048Antagonist activity at human PPARdelta assessed as effect on TIPP-703-induced activity at 10 uM2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Peroxisome proliferator-activated receptor delta antagonists inhibit hepatitis C virus RNA replication.
AID1132065Antiviral activity against influenza A virus NWS/H0N1 infected in BHK cells at 1 mg/ml by agar diffusion assay1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID432173Antiviral activity against thymidine kinase-deficient ACV-resistant HSV1 KOS infected in human HEL cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID216183Tested for inhibitory effect on RNA virus TV in Vero cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1241019Antiviral activity against Rift Valley fever virus infected in African green monkey Vero 76 cells after 3 days by neutral red dye-based plaque reduction assay2015Bioorganic & medicinal chemistry, Sep-01, Volume: 23, Issue:17
2- and 3-Fluoro-3-deazaneplanocins, 2-fluoro-3-deazaaristeromycins, and 3-methyl-3-deazaneplanocin: Synthesis and antiviral properties.
AID416779Cytotoxicity against MDCK cells by MTS assay2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1249919Antiviral activity against Influenza A virus (A/PR/8/1934(H1N1)) infected in MDCK cells assessed as 2-log10 reduction in viral RNA copy number after 24 hrs by quantitative RT-PCR analysis2015ACS medicinal chemistry letters, Aug-13, Volume: 6, Issue:8
Virtual Screening and Biological Validation of Novel Influenza Virus PA Endonuclease Inhibitors.
AID156687Antiviral activity was measured against Herpes simplex virus (HSV-1 KOS) in rabbit kidney cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID1081551In vitro antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves at 100 ug/ml2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID376989Antiviral activity against Cox B3 virus in human Hep2 cells assessed as reduction of virus induced cytopathic effect2006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID216939In vitro antiviral activity against HSV-1 virus in (vero) V cells of african green monkey kidney1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
AID235890Ratio of minimum toxic compound concentration to inhibitory dose against Parainfluenza type 3 viral strain Huebner C243 in H.Ep-2 cell line1989Journal of medicinal chemistry, Jul, Volume: 32, Issue:7
Synthesis of 3-deazaneplanocin A, a powerful inhibitor of S-adenosylhomocysteine hydrolase with potent and selective in vitro and in vivo antiviral activities.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1485235Antiviral activity against Yellow fever virus infected in African green monkey Vero cells assessed as inhibition of viral-induced cytopathic effect measured after 3 to 6 days post infection by microscopic analysis2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID1261317Antiviral activity against Human poliovirus 1 Sabin infected in african green monkey Vero76 cells assessed as inhibition of virus-induced cytopathogenicity by plaque reduction assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID156843Minimum inhibitory concentration required to reduce herpes simplex virus-1 (KOS)induced cytopathogenicity by 50% in primary rabbit kidney cells (PRK)1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID1252402Cytotoxicity against African green monkey Vero cells assessed as alteration in cell morphology by microscopy2015European journal of medicinal chemistry, Sep-18, Volume: 102Novel halogenated 3-deazapurine, 7-deazapurine and alkylated 9-deazapurine derivatives of L-ascorbic or imino-L-ascorbic acid: Synthesis, antitumour and antiviral activity evaluations.
AID87149Evaluation for antiviral activity against vesicular stomatitis virus in HeLa cell cultures (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID475860Cytotoxicity against human HeLa cells2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID1261312Antiviral activity against BVDV infected in MDBK cells assessed as inhibition of virus-induced cytopathogenicity after 3 to 4 days by MTT assay2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID539914Cytotoxicity against human HEL cells assessed as minimum concentration required to cause microscopically detectable alteration after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID105787Antiviral activity tested against influenza A,H1N1 virus infected MDCK cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID475857Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID370202Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 g of liver at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID634748Antiviral activity against thymidine kinase-deficient acv-resistant Herpes simplex virus 1 KOS infected in human HEL cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1154644Antiviral activity against Respiratory syncytial virus infected in human Hep2 cells assessed as virus-induced cytopathicity by XTT assay2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Antiviral C-25 epimers of 26-acetoxy steroids from the South China Sea gorgonian Echinogorgia rebekka.
AID300574Weight change in mouse at 100 mg/kg, ip bid after 14 days2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID535520Transport through ENT2 in rat hepatocytes by oil filtration assay in presence of sodium ions in Kreb-henseleit buffer containing 100 uM NBMPR2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID765053Antiviral activity against HCV infected in african green monkey OR6 cells assessed as inhibition of viral RNA replication after 72 hrs by luciferase reporter gene assay2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Peroxisome proliferator-activated receptor delta antagonists inhibit hepatitis C virus RNA replication.
AID622447Cytotoxicity against african green monkey Vero cells infected with Enterovirus 71 assessed as growth inhibition after 48 hrs by Reed-Muench analysis2011Bioorganic & medicinal chemistry letters, Oct-01, Volume: 21, Issue:19
Synthesis, structure-activity relationship and in vitro biological evaluation of N-arylethyl isoquinoline derivatives as Coxsackievirus B3 inhibitors.
AID217993Minimum cytotoxic concentration against vaccinia virus in primary rabbit kidney cell cultures1989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID1152078Inhibition of Influenza A virus RdRP infected in human HEK293T cells after 24 hrs by dual luciferase reporter gene assay2014Journal of medicinal chemistry, May-22, Volume: 57, Issue:10
Optimization of small-molecule inhibitors of influenza virus polymerase: from thiophene-3-carboxamide to polyamido scaffolds.
AID360164Ratio of IC50 for HCV 1b with NS3-4 R155K mutation to IC50 for wild type HCV 1b2007The Journal of biological chemistry, Aug-03, Volume: 282, Issue:31
Phenotypic and structural analyses of hepatitis C virus NS3 protease Arg155 variants: sensitivity to telaprevir (VX-950) and interferon alpha.
AID244765Minimum cytotoxicity concentration to HeLa cell line was determined2005Bioorganic & medicinal chemistry letters, Mar-15, Volume: 15, Issue:6
QSAR for anti-RNA-virus activity, synthesis, and assay of anti-RSV carbonucleosides given a unified representation of spectral moments, quadratic, and topologic indices.
AID658611Cytotoxicity against african green monkey Vero cells assessed as minimum compound concentration required to causes microscopically detectable alteration of normal cell morphology2012European journal of medicinal chemistry, Jun, Volume: 522-Aminopyrimidine based 4-aminoquinoline anti-plasmodial agents. Synthesis, biological activity, structure-activity relationship and mode of action studies.
AID370220Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as animals with detectable virus level in serum at 10 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1543376Selectivity index, ratio of TC50 against African green monkey Vero cells infected with Herpes simplex virus 1 after 72 hrs by MTT assay to IC50 against Herpes simplex virus 1 infected in African green monkey Vero cells assessed as inhibition of virus-indu2019Bioorganic & medicinal chemistry, 06-15, Volume: 27, Issue:12
Antiviral activities of Janus-type nucleosides and their related oxime-intermediates.
AID1186338Antiviral activity against Vesicular stomatitis virus infected in african green monkey Vero 76 cells assessed as reduction in plaque number after 2 days by plaque reduction assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID482703Antiviral activity against HSV2 G infected in human E6SM cell assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID155599Compound was tested for antiviral activity (minimum inhibition concentration) in Vero cells parainfluenza virus type 31984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID1753364Antiviral activity against pseudotyped recombinant vesicular stomatitis virus delta G Gn-Gc infected HEK293T cells assessed as reduction in virus replication incubated for 48 hrs by luminescence assay2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40New class of hantaan virus inhibitors based on conjugation of the isoindole fragment to (+)-camphor or (-)-fenchone hydrazonesv.
AID1066051Antiviral activity against Influenza A virus (A/Puerto Rico/8/1934(H1N1)) infected in MDCK cells assessed as inhibition of plaque formation after 2 days by toluidine blue staining assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID218253Evaluation for antiviral activity against Sindbis virus in Vero cell cultures (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID768190Cytotoxicity against african green monkey Vero cells2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID434321Cytotoxicity against african green monkey Vero cells assessed as change in cell morphology2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID1433154Antiviral activity against influenza A virus H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID1127181Cytotoxicity against human HuH7 cells assessed as cell viability at 20 uM after 3 days by XTT assay2014European journal of medicinal chemistry, May-22, Volume: 79Synthesis, antiproliferative and anti-dengue virus evaluations of 2-aroyl-3-arylquinoline derivatives.
AID1151007Antiviral activity against Influenza A virus A2/Asian/J305 infected in Swiss albino mouse assessed as increase in host survival at 50 mg/kg, ip administered as 7 doses immediately before virus inoculation and at 1, 5, 24, 30, 48 and 72 hrs after virus inf1976Journal of medicinal chemistry, Aug, Volume: 19, Issue:8
Synthesis of tetrazole ribonucleosides and their evaluation as antiviral agents. 2. 5-Amino-1-(beta-D-ribofuranosyl)-1H-tetrazole and 5-amino-2-(beta-D-ribofuranosyl)-2H-tetrazole.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
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Novel cycloalkylthiophene-imine derivatives bearing benzothiazole scaffold: synthesis, characterization and antiviral activity evaluation.
AID659155Antiviral activity against Human immunodeficiency virus 2 ROD infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 days by microscopic analysis2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
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Novel 12N-substituted matrinanes as potential anti-coxsackievirus agents.
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Synthesis, structure-activity relationship and in vitro biological evaluation of N-arylethyl isoquinoline derivatives as Coxsackievirus B3 inhibitors.
AID659289Cytotoxicity against human HeLa cells assessed as morphological changes by microscopic analysis2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
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Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
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Scaffold Morphing Approach To Expand the Toolbox of Broad-Spectrum Antivirals Blocking Dengue/Zika Replication.
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Synthesis and in vitro antiviral evaluation of 4-substituted 3,4-dihydropyrimidinones.
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RSV604, a novel inhibitor of respiratory syncytial virus replication.
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Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
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Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID1408323Antiviral activity against Influenza A virus A/PR/8/34(H1N1) infected in MDCK cells after 3 days by MTS assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID593223Antiviral activity against Human enterovirus 71 infected in african green monkey Vero cells assessed as inhibition of viral growth after 24 hrs by Reed-Muench method2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
Inhibitory properties of 2-substituent-1H-benzimidazole-4-carboxamide derivatives against enteroviruses.
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Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID64115Minimum inhibitory concentration (MIC) required to elicit a microscopically visible alteration of cell morphology in E6SM cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID463991Antiviral activity against Vaccinia virus infected in HEL cells assessed as protection from virus-induced cytopathogenicity after 2 to 3 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1610158Antiviral activity against Influenza A virus (A/Ned/378/05(H1N1)) infected in dog MDCK cells assessed as reduction in virus-induced cytopathogenicity incubated for 7 days by MTS assay2019European journal of medicinal chemistry, Dec-15, Volume: 184Antitumor and antiviral activities of 4-substituted 1,2,3-triazolyl-2,3-dibenzyl-L-ascorbic acid derivatives.
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5-alkynyl analogs of arabinouridine and 2'-deoxyuridine: cytostatic activity against herpes simplex virus and varicella-zoster thymidine kinase gene-transfected cells.
AID1349206Cytotoxicity against human Ava5 cells assessed as cell viability at 20 uM after 72 hrs by XTT assay relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery of naphtho[1,2-d]oxazole derivatives as potential anti-HCV agents through inducing heme oxygenase-1 expression.
AID1265174Antiviral activity against wild type Chikungunya virus IMT infected in HEK293T cells assessed as inhibition of nsP3 protein expression at 5 uM measured at 24 hrs postinfection by Western blot method2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
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Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1852996Cytotoxicity against in human HCT-116 cells overexpressing human BCRP assessed as DNA damage by measuring fluorescence intensity at 100 uM incubated for 30 mins by Hoechst 33342 staining accumulation assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID1495713Cytotoxicity against MDCK cells after 48 hrs by MTT assay2018Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11
Highly potent activity of isopulegol-derived substituted octahydro-2H-chromen-4-ols against influenza A and B viruses.
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Antiviral flavans from the leaves of Pithecellobium clypearia.
AID1886814Antiviral activity against CHIKV infected in African green monkey Vero E6 cells assessed as concentration required for higher viral reduction factor measured after 72 hrs by crystal violet staining based inverted microscopic analysis2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
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Respiratory syncytial virus fusion inhibitors. Part 3: Water-soluble benzimidazol-2-one derivatives with antiviral activity in vivo.
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Imidazo[1,2-a]-s-triazine nucleosides. Synthesis and antiviral activity of the N-bridgehead guanine, guanosine, and guanosine monophosphate analogues of imidazo[1,2-a]-s-triazine.
AID1071700Selectivity index, ratio of CC50 for cytotoxicity to EC50 for Influenza A virus H1N12014European journal of medicinal chemistry, Mar-03, Volume: 74Synthesis and biological evaluation of 2-oxonicotinonitriles and 2-oxonicotinonitrile based nucleoside analogues.
AID1118635Antiviral activity against Vesicular stomatitis virus infected in human HEL cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
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Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
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Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID546578Inhibition of recombinant CDK2 at 10 uM by Z'-LYTE kinase assay kit method2010Journal of medicinal chemistry, Dec-23, Volume: 53, Issue:24
Discovery of novel GSK-3β inhibitors with potent in vitro and in vivo activities and excellent brain permeability using combined ligand- and structure-based virtual screening.
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Synthesis, structure-activity relationship and in vitro biological evaluation of N-arylethyl isoquinoline derivatives as Coxsackievirus B3 inhibitors.
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4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
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Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID395678Antiviral activity against Tacaribe virus TRVL11573 in Vero cells assessed as inhibition of virus-induced visual cytopathic effect after 7 to 8 days2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1427835Antiviral activity against Human coronavirus 229E infected in HEL cells assessed as reduction in virus-induced cytopathogenicity
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Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
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Novel 3'-C/N-substituted 2',3'-beta-D-dideoxynucleosides as potential chemotherapeutic agents. 1. Thymidine derivatives: synthesis, structure, and broad spectrum antiviral properties.
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Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1773006Inhibition of RSV induced apoptosis in human HEp-2 cells assessed as early apoptotic cells at 25 uM measured after 60 hrs by Annexin V-FITC/PI staining based flow cytometry analysis (Rvb = 10.3%)2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID218406Minimum inhibitory concentration required to reduce semliki forest virus induced cytopathogenicity by 50% in african green monkey (VeroB) cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
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1,6-Bis[(benzyloxy)methyl]uracil derivatives-Novel antivirals with activity against HIV-1 and influenza H1N1 virus.
AID1265180Antiviral activity against wild type Sindbis virus infected in HEK293T cells assessed as inhibition of infectivity measured at 24 hrs postinfection by FITC/DAPI staining based array scan VTI HCS reader analysis2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
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Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID1409611AUC (cytotoxicity %) of compound against Vero E6 cells by MTT assay.2020Nature, 07, Volume: 583, Issue:7816
A SARS-CoV-2 protein interaction map reveals targets for drug repurposing.
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Cinnamacrins A-C, cinnafragrin D, and cytostatic metabolites with alpha-glucosidase inhibitory activity from Cinnamosma macrocarpa.
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Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID1783390Cytotoxicity against human Caco2 cells infected with SARS-COV-2 assessed as reduction in cell viability by celltiter-glo luminescent cell viability assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
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Synthesis and biological properties of purine and pyrimidine 5'-deoxy-5'-(dihydroxyphosphinyl)-beta-D-ribofuranosyl analogues of AMP, GMP, IMP, and CMP.
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Synthesis and antiviral activity of certain thiazole C-nucleosides.
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Dual inhibition of HCV and HIV by ring-expanded nucleosides containing the 5:7-fused imidazo[4,5-e][1,3]diazepine ring system. In vitro results and implications.
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Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
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Synthesis and biological evaluation of novel imidazole nucleosides as potential anti-dengue virus agents.
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Synthesis and antiviral activity of 5'-deoxypyrazofurin.
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Aniline-Based Inhibitors of Influenza H1N1 Virus Acting on Hemagglutinin-Mediated Fusion.
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Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
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Synthesis and biological properties of purine and pyrimidine 5'-deoxy-5'-(dihydroxyphosphinyl)-beta-D-ribofuranosyl analogues of AMP, GMP, IMP, and CMP.
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Structure-Based Optimization of N-Substituted Oseltamivir Derivatives as Potent Anti-Influenza A Virus Agents with Significantly Improved Potency against Oseltamivir-Resistant N1-H274Y Variant.
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AID1472386Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as inhibition of virus-induced cytopathicity after 72 hrs by MTS assay2018Journal of medicinal chemistry, 01-11, Volume: 61, Issue:1
Aniline-Based Inhibitors of Influenza H1N1 Virus Acting on Hemagglutinin-Mediated Fusion.
AID1201122Antiviral activity against Influenza B virus (B/Hong Kong/05/1972) infected in MDCK cells assessed as cell viability after 72 hrs by MTS assay2015European journal of medicinal chemistry, Apr-13, Volume: 94A few atoms make the difference: synthetic, CD, NMR and computational studies on antiviral and antibacterial activities of glycopeptide antibiotic aglycon derivatives.
AID1691560Antiviral activity against Influenza A virus (A/PR 8/34 (H1N1)) clone 1 infected in MDCK cells assessed as reduction in virus-induced cytopathic effect measured after 72 hrs by MTS assay2020European journal of medicinal chemistry, May-15, Volume: 194N-benzyl 4,4-disubstituted piperidines as a potent class of influenza H1N1 virus inhibitors showing a novel mechanism of hemagglutinin fusion peptide interaction.
AID1407824Antiviral activity against Newcastle disease virus2018European journal of medicinal chemistry, Sep-05, Volume: 157Pyrrolopyrimidines: An update on recent advancements in their medicinal attributes.
AID284540Antiviral activity against in Vesicular stomatitis virus- induced cytopathogenicity in HeLa cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID659288Cytotoxicity against HEL cells assessed as morphological changes by microscopic analysis2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID1783364Antiviral activity against Influenza A Puerto Rico/8/34/H1N1 infected in MDCK cells assessed as inhibition of viral replication measured in supernatants of infected cells after 24 hrs by hemagglutination assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID535539Transport through CNT2 in rat hepatocytes by oil filtration assay pre-incubated with 20 ng/mL rotenone for 15 mins and 2 mM 2-deoxyglucose for 10 mins at 37 degC in Kreb-henseleit buffer2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID648645Antiinfluenza activity against influenza A virus H3N2 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect after 36 hrs2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Synthesis and anti-influenza activity of aminoalkyl rupestonates.
AID1433132Cytotoxicity against human HeLa cells assessed as alteration of normal cell morphology by microscopic analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID535533Transport through ENT1 in rat hepatocytes by oil filtration assay in presence 100 uM of transporter inhibitor NBMRP2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID766707Cytotoxicity against african green monkey Vero cells assessed as morphological changes2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
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Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID443832Antiviral activity against Influenza B virus (B/Hong Kong/5/72) assessed as cell viability by cell-based MTS assay2009Journal of medicinal chemistry, Oct-08, Volume: 52, Issue:19
Diazo transfer-click reaction route to new, lipophilic teicoplanin and ristocetin aglycon derivatives with high antibacterial and anti-influenza virus activity: an aggregation and receptor binding study.
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Virtual Screening and Biological Validation of Novel Influenza Virus PA Endonuclease Inhibitors.
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Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
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Discovery of Multitarget Antivirals Acting on Both the Dengue Virus NS5-NS3 Interaction and the Host Src/Fyn Kinases.
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Synthesis and antiviral and enzymatic studies of certain 3-deazaguanines and their imidazolecarboxamide precursors.
AID1167620Selectivity index, ratio of CC50 for human ORL8 cells to EC50 for Hepatitis C virus infected in African green monkey OR6 cells2014Bioorganic & medicinal chemistry, Nov-01, Volume: 22, Issue:21
Synthesis of 3',4'-difluoro-3'-deoxyribonucleosides and its evaluation of the biological activities: discovery of a novel type of anti-HCV agent 3',4'-difluorocordycepin.
AID370225Antiviral activity against Punta Toro virus Adames infected Syrian golden hamster assessed as survival at 30 mg/kg, po twice daily for 6 days administered 4 hrs before viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
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Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
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Synthesis and antiviral and enzymatic studies of certain 3-deazaguanines and their imidazolecarboxamide precursors.
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The semi-synthesis of novel andrographolide analogues and anti-influenza virus activity evaluation of their derivatives.
AID1647355Antiviral activity against Zika virus infected in African green monkey Vero cells assessed as reduction in viral replication treated with compound at 1 hr post-viral infection2020Bioorganic & medicinal chemistry letters, 01-15, Volume: 30, Issue:2
Quinolone-N-acylhydrazone hybrids as potent Zika and Chikungunya virus inhibitors.
AID1349205Antiviral activity against HCV infected in human Ava5 cells assessed as inhibition of viral RNA replication at 20 uM after 3 days by RT-qPCR method relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery of naphtho[1,2-d]oxazole derivatives as potential anti-HCV agents through inducing heme oxygenase-1 expression.
AID1349208Antiviral activity against HCV infected in human Ava5 cells assessed as inhibition of viral RNA replication after 3 days by RT-qPCR method2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery of naphtho[1,2-d]oxazole derivatives as potential anti-HCV agents through inducing heme oxygenase-1 expression.
AID1113462Antiviral activity against Respiratory syncytial virus infected human HeLa cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID345886Cytotoxicity against human HuH6 cells2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Discovery of novel arylethynyltriazole ribonucleosides with selective and effective antiviral and antiproliferative activity.
AID1443880Antiviral activity against full length gluc-tagged Chikungunya virus 2008 Singapore SGP11 infected in HEK293T cells assessed as reduction in virus infection after 24 hrs by gaussia luciferase reporter gene assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Structural Optimizations of Thieno[3,2-b]pyrrole Derivatives for the Development of Metabolically Stable Inhibitors of Chikungunya Virus.
AID1503652Cytotoxicity against human HuH7 cells assessed as cell viability at 20 uM after 3 days by XTT method relative to control2017European journal of medicinal chemistry, Dec-01, Volume: 141Discovery of novel diarylpyrazolylquinoline derivatives as potent anti-dengue virus agents.
AID217905Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against sindbis virus in Vero cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID766708Cytotoxicity against human HeLa cells assessed as morphological changes2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID1265175Antiviral activity against wild type Chikungunya virus IMT infected in HEK293T cells assessed as inhibition of viral capsid protein at 5 uM measured at 24 hrs postinfection by Western blot method2015Journal of medicinal chemistry, Dec-10, Volume: 58, Issue:23
Trisubstituted Thieno[3,2-b]pyrrole 5-Carboxamides as Potent Inhibitors of Alphaviruses.
AID1753728Cytotoxicity against African green monkey Vero cells by MTT assay2021Journal of natural products, 04-23, Volume: 84, Issue:4
Semisynthesis of Dolabellane Diterpenes: Oxygenated Analogues with Increased Activity against Zika and Chikungunya Viruses.
AID1725100Antiviral activity against Zika virus 976 Uganda infected in human HepG2 cells assessed as protection against viral infection by measuring cell survival at 100 uM measured after 4 days by CellTiter-Glo luminescent cell viability assay relative to control2020ACS medicinal chemistry letters, Oct-08, Volume: 11, Issue:10
Discovery of Zika Virus NS2B/NS3 Inhibitors That Prevent Mice from Life-Threatening Infection and Brain Damage.
AID1181493Antiviral activity against Influenza B virus (B/HK/05/1972) infected in MDCK cells assessed as virus-induced cytopathic effect after 72 hrs by microscopy2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID92457Tested for inhibition of virus-induced cytopathogenic effect and cytotoxicity of compound against influenza virus with A2/Aichi/2/68 strain in MDCK cell1988Journal of medicinal chemistry, Sep, Volume: 31, Issue:9
Cyclopentenylcytosine. A carbocyclic nucleoside with antitumor and antiviral properties.
AID275075Antiviral activity against Sindbis virus in Vero cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID395712Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as inhibition of liver damage at 40 mg/kg, po twice daily for 7 days administered 4 hrs before viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID257887Antiviral activity against vero cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID275074Antiviral activity against reovirus 1 in Vero cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID249268Minimum inhibitory concentration against respiratory syncytial virus was determined2005Bioorganic & medicinal chemistry letters, Mar-15, Volume: 15, Issue:6
QSAR for anti-RNA-virus activity, synthesis, and assay of anti-RSV carbonucleosides given a unified representation of spectral moments, quadratic, and topologic indices.
AID482712Antiviral activity against Reovirus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID634758Antiviral activity against Coxsackievirus B4 infected in african green monkey Vero cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID533317Cytotoxicity against human NTZ-11 cell harboring HCV genotype 1b after 4 days by neutral red dye uptake assay2008Antimicrobial agents and chemotherapy, Nov, Volume: 52, Issue:11
Potential for hepatitis C virus resistance to nitazoxanide or tizoxanide.
AID105775Tested for inhibitory effect on RNA virus Influenza A in MDCK cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1486230Antiviral activity against Bovine viral diarrhea virus 1-NADL infected in bovine MDBK cells assessed as reduction in plaque forming units after 72 hrs by crystal violet staining-based assay
AID1081548In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as curative effect at 500 ug/ml treated after viral inoculation measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID1273994Antiviral activity against DENV-2 New guinea infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect after 3 days by crystal violet staining based inverted microscopic analysis relative to control2016European journal of medicinal chemistry, Jan-27, Volume: 108Anti-herpetic and anti-dengue activity of abietane ferruginol analogues synthesized from (+)-dehydroabietylamine.
AID370198Toxicity in po dosed C57BL/6 mouse administered twice daily for 5 days administered 4 hrs before viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID156694Evaluation in PRK cell cultures for cytotoxicity that is to cause microscopically detectable alteration of normal cell morphology1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID1783358Antiviral activity against West Nile virus lineage 1 (Italy/2009) infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 48 hrs by immunodetection based plaque reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID87045Virus rating of against herpes simplex virus type 21989Journal of medicinal chemistry, Apr, Volume: 32, Issue:4
Analysis of the in vitro antiviral activity of certain ribonucleosides against parainfluenza virus using a novel computer aided receptor modeling procedure.
AID438029Inhibition of Dengue virus IMPDH2009Journal of medicinal chemistry, Dec-24, Volume: 52, Issue:24
The medicinal chemistry of dengue fever.
AID665009Cytostatic activity against human CEM/0 after 72 hrs by cell counting2012Bioorganic & medicinal chemistry, Jun-01, Volume: 20, Issue:11
Novel 1,2,4-triazole and imidazole derivatives of L-ascorbic and imino-ascorbic acid: synthesis, anti-HCV and antitumor activity evaluations.
AID1194167Selectivity index, CC50 for african green monkey Vero B cells to EC50 for DENV serotype 2 strain New Guinea C by virus yield-reduction assay2015Bioorganic & medicinal chemistry letters, Apr-15, Volume: 25, Issue:8
Design, synthesis, optimization and antiviral activity of a class of hybrid dengue virus E protein inhibitors.
AID768212Cytotoxicity against MDCK cells assessed as cell viability after 4 days by MTS assay2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID105968Minimum inhibitory concentration required to reduce influenza A H3N2 (X31) virus induced cytopathogenicity by 50% in madin-Darby canine kidney cells (MDCK)2001Bioorganic & medicinal chemistry letters, Aug-20, Volume: 11, Issue:16
Novel 3-(2-adamantyl)pyrrolidines with potent activity against influenza A virus-identification of aminoadamantane derivatives bearing two pharmacophoric amine groups.
AID368963Cytotoxicity against RSV RSS infected human Hep2 cells after 6 days by XTT assay2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID371498Antiviral activity against bovine viral diarrhoea virus type-1 NADL in MDBK cells assessed as inhibition of virus-induced cytopathic effect2008European journal of medicinal chemistry, Aug, Volume: 43, Issue:8
New 1-indanone thiosemicarbazone derivatives active against BVDV.
AID634092Therapeutic index, ratio of CC50 for human HuH7 cells infected with HCV1b to EC50 for HCV genotype 1b2012Bioorganic & medicinal chemistry, Jan-01, Volume: 20, Issue:1
The design, synthesis and biological evaluations of C-6 or C-7 substituted 2-hydroxyisoquinoline-1,3-diones as inhibitors of hepatitis C virus.
AID416770Antiviral activity against Sindbis virus in african green monkey Vero cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID776644Cytotoxicity against mouse Gardner lymphosarcoma cells assessed as growth inhibition2013European journal of medicinal chemistry, Nov, Volume: 69Pyrazole containing natural products: synthetic preview and biological significance.
AID1408126Cytotoxicity against MDCK cells assessed as decrease in cell viability after 48 hrs by MTT assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Synthesis and biological evaluation of a library of hybrid derivatives as inhibitors of influenza virus PA-PB1 interaction.
AID774116Selectivity index, ratio of TC50 for African green monkey Vero cells to IC50 for Coxsackievirus B32013Journal of natural products, Oct-25, Volume: 76, Issue:10
Diterpenoids and sesquiterpenoids from the roots of Illicium majus.
AID1773055Antiviral activity against RSV infected in BALB/c mouse assessed as downregulation of IL-10 expression in lung tissue infected with RSV at 50 mg/kg/day measured after 2 to 6 days post infection by RT-PCR analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID432182Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity after 3 days postinfection2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID155591Viral rating activity against Parainfluenza type 3 viral strain Huebner C243 in H.Ep-2 cell line1989Journal of medicinal chemistry, Jul, Volume: 32, Issue:7
Synthesis of 3-deazaneplanocin A, a powerful inhibitor of S-adenosylhomocysteine hydrolase with potent and selective in vitro and in vivo antiviral activities.
AID717170Cytotoxicity against dog MDCK cells assessed as cell morphology alterations by microscopic analysis2012Bioorganic & medicinal chemistry, Dec-15, Volume: 20, Issue:24
Microwave assisted synthesis and anti-influenza virus activity of 1-adamantyl substituted N-(1-thia-4-azaspiro[4.5]decan-4-yl)carboxamide derivatives.
AID432170Antiviral activity against HSV2 G infected in human HEL cells assessed as inhibition of virus-induced cytopathicity after 3 days2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and antiviral activity of new pyrazole and thiazole derivatives.
AID536238Antiviral activity against Influenza A virus (A/Hong Kong/7/1987(H3N2)) infected in MDCK cells assessed as inhibition of virus-induced cytopathogenicity by MTS assay2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Design and synthesis of bioactive adamantanaminoalcohols and adamantanamines.
AID1654876Selectivity index, ratio of CC50 for cytotoxicity in African green monkey Vero E6 cells to EC50 for Antiviral activity against Zika virus infected in Vero E6 cells2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
2-((4-Arylpiperazin-1-yl)methyl)benzonitrile Derivatives as Orally Available Inhibitors of Hepatitis C Virus with a Novel Mechanism of Action.
AID87134Antiviral activity was measured against Vesicular stomatitis virus in HeLa cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID416768Antiviral activity against Parainfluenza virus type 3 in african green monkey Vero cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1571894Displacement of [3H]2-[p-(2-carboxyethyl)phenylethylamino]-5-N-ethylcarboxamidoadenosine from human A2A adenosine receptor expressed in HEK293 cell membranes at 10 uM after 60 mins by scintillation proximity assay relative to adenosine 5-N-ethyluronamide2019Journal of medicinal chemistry, 02-14, Volume: 62, Issue:3
Design and in Vivo Characterization of A
AID1647356Selectivity index, ratio of CC50 for African monkey Vero cells to EC50 for Zika virus infected in African green monkey Vero cells2020Bioorganic & medicinal chemistry letters, 01-15, Volume: 30, Issue:2
Quinolone-N-acylhydrazone hybrids as potent Zika and Chikungunya virus inhibitors.
AID474550Selectivity ratio of IC50 for MDCK cells to EC50 for Influenza B virus Malaysia/2506/2004 by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1687959Antiproliferative activity against human HuH-7 cells assessed as reduction in cell growth at 100 uM incubated for 72 hrs by MTT assay relative to control2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID297319Antiviral activity against Sindbis virus in Vero cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID548427Antiviral activity against Vesicular stomatitis virus infected in HEL cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID257889Antiviral activity against Herpes simplex virus 1 KOS strain in HEL cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID387575Cytotoxicity against MDCK cells assessed as alteration in cell morphology by MTS assay2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis and antiviral evaluation of acyclic azanucleosides developed from sulfanilamide as a lead structure.
AID1781227Inhibition of Infectious hematopoietic necrosis virus glycoprotein G assessed as antiviral activity at 25 uM measured by RT-qPCR method relative to control2021European journal of medicinal chemistry, Nov-05, Volume: 223Synthesis and biological evaluation of novel coumarin derivatives in rhabdoviral clearance.
AID1252405Antiviral activity against Sindbis virus expressed in African green monkey Vero cells assessed as reduction in cytopathogenicity2015European journal of medicinal chemistry, Sep-18, Volume: 102Novel halogenated 3-deazapurine, 7-deazapurine and alkylated 9-deazapurine derivatives of L-ascorbic or imino-L-ascorbic acid: Synthesis, antitumour and antiviral activity evaluations.
AID1650127Cytotoxicity against MDCK cells assessed as reduction in cell viability after 4 days by MTS assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Superior inhibition of influenza virus hemagglutinin-mediated fusion by indole-substituted spirothiazolidinones.
AID33367Minimum cytotoxic concentration required to cause a microscopically detectable alteration of normal cell morphology and show antiviral activity in african green monkey (Vero B) cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID1651274Selectivity index, ratio of CC50 for African green monkey Vero E6 cells to EC50 for Zika virus infected in African green monkey Vero E6 cells assessed as inhibition of viral induced cytopathic effect2020Bioorganic & medicinal chemistry letters, 02-15, Volume: 30, Issue:4
Design, synthesis, and evaluation of novel 4-amino-2-(4-benzylpiperazin-1-yl)methylbenzonitrile compounds as Zika inhibitors.
AID229236Antiviral activity against vesicular stomatitis virus (VSV) in primary rabbit kidney (PRK) / embryonic skin-muscle (E6SM) fibroblast culture lines1992Journal of medicinal chemistry, Nov-27, Volume: 35, Issue:24
Synthesis and antiviral activity of some new S-adenosyl-L-homocysteine derivatives.
AID1655772Antiviral activity against Dengue virus serotype 2 New Guinea C infected at 50 TCID50 in human HuH7 cells assessed as inhibition of viral replication and 72 hrs later re-infected pre-seeded HuH7 cells with viral supernatant collected from previous infecte2020ACS medicinal chemistry letters, May-14, Volume: 11, Issue:5
Exploring the Implication of DDX3X in DENV Infection: Discovery of the First-in-Class DDX3X Fluorescent Inhibitor.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1226137Inhibition of Influenza A virus (A/PR/8/34) RNA-dependent-RNA polymerase transfected in HEK293T cells after 24 hrs by renilla luciferase activity/minireplicon assay2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
A Broad Anti-influenza Hybrid Small Molecule That Potently Disrupts the Interaction of Polymerase Acidic Protein-Basic Protein 1 (PA-PB1) Subunits.
AID1886815Antiviral activity against Zika 459148 infected in African Green monkey Vero E6 cells assessed as reduction in plaque formation measured after 72 hrs by crystal violet staining based analysis2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID539955Antiviral activity against influenza B virus infected in MDCK cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID1858561Selectivity index, ratio of IC50 for African green monkey Vero cells to IC50 for antiviral activity against SARS-CoV 2 nCoV-2019BetaCoV/Wuhan/WIV04/20192021European journal of medicinal chemistry, Jan-01, Volume: 209Primed for global coronavirus pandemic: Emerging research and clinical outcome.
AID66943Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against vesicular stomatitis virus in E6SM cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID283443Inhibition of Influenza A virus (A/gull/Pennsylvania/4175/83 (H5N1)) replication in MDCK cells by virus yield reduction assay2007Antimicrobial agents and chemotherapy, Mar, Volume: 51, Issue:3
Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.
AID1066049Cytotoxicity against MDCK cells assessed as cell viability after 48 hrs by MTT assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID218006Minimum inhibitory concentration against vaccinia virus in primary rabbit kidney cell cultures of experiment 11989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID360165Ratio of IC50 for HCV 1b with NS3-4A R155T mutation to IC50 for wild type HCV 1b2007The Journal of biological chemistry, Aug-03, Volume: 282, Issue:31
Phenotypic and structural analyses of hepatitis C virus NS3 protease Arg155 variants: sensitivity to telaprevir (VX-950) and interferon alpha.
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Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID1249920Cytotoxicity against MDCK cells assessed as cell viability measured at 24 hrs by MTS assay2015ACS medicinal chemistry letters, Aug-13, Volume: 6, Issue:8
Virtual Screening and Biological Validation of Novel Influenza Virus PA Endonuclease Inhibitors.
AID1135872Toxicity in ferret infected with Influenza A virus Port Chalmers/1/73 (H3N2) assessed as change in body weight at 14 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to day 3 measured after 7 days relative to untreated control1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID1638587Antiviral activity against West Nile virus infected in human HuH7 cells incubated for 4 days by crystal violet staining based plaque reduction assay2019Journal of medicinal chemistry, 03-14, Volume: 62, Issue:5
DDX3X Helicase Inhibitors as a New Strategy To Fight the West Nile Virus Infection.
AID691392Cytotoxicity against human HuH7 cells after 2 days by XTT assay2012Bioorganic & medicinal chemistry letters, Oct-15, Volume: 22, Issue:20
A new class of pyrimidine nucleosides: inhibitors of hepatitis B and C viruses.
AID216947In vitro antiviral activity against VSV virus in (vero) V cells1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
AID34142Virus rating against adenovirus type 21989Journal of medicinal chemistry, Apr, Volume: 32, Issue:4
Analysis of the in vitro antiviral activity of certain ribonucleosides against parainfluenza virus using a novel computer aided receptor modeling procedure.
AID543658Antiviral activity against Yellow fever virus 17D infected in African green monkey Vero cells assessed as inhibition of virus induced cytopathic effect by microscopic analysis2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID392724Antiviral activity against EMCV assessed as inhibition of virus-induced cytopathicity2009Bioorganic & medicinal chemistry letters, Feb-15, Volume: 19, Issue:4
Synthesis of 5-isoxazol-5-yl-2'-deoxyuridines exhibiting antiviral activity against HSV and several RNA viruses.
AID370233Antiviral activity against Punta Toro virus Adames infected Syrian golden hamster assessed as animals with detectable virus level in liver at 30 mg/kg, po twice daily administered 4 hrs before viral challenge measured on day 4 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID593222Antiviral activity against Coxsackievirus A16 infected in african green monkey Vero cells assessed as inhibition of viral growth after 24 hrs by Reed-Muench method2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
Inhibitory properties of 2-substituent-1H-benzimidazole-4-carboxamide derivatives against enteroviruses.
AID416777Antiviral activity against thymidine kinase deficient and acyclovir resistant HSV1 KOS in human HEL cells assessed as protection against virus-induced cytopathicity2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1485245Cytotoxicity against dog MDCK cells assessed as reduction in cell viability measured after 5 to 6 days by MTS assay2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID401226Selectivity index, ratio of CC50 for MDCK cells to IC50 for RSV Long2004Journal of natural products, Apr, Volume: 67, Issue:4
Antiviral flavonoids from the seeds of Aesculus chinensis.
AID217904Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against semliki forest virus in Vero cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID81760In vitro antiviral activity against herpes simplex type 1 (HSV-1) virus was determined in human laryngeal epithelioma (HEp-2,H)expressed as virus rating. Toxic level(>1000 ug/mL)1982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID86683Effective concentration required to inhibit respiratory synaptial(RSV) virus-induced cytopathicity by 50% in HeLa cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID105770Inhibitory concentration against influenza virus B in MDCK cells1995Journal of medicinal chemistry, Sep-01, Volume: 38, Issue:18
Synthesis and antiviral activity of benzyl-substituted imidazo [1,5-a]-1,3,5-triazine (5,8-diaza-7,9-dideazapurine) derivatives.
AID543662Antiviral activity against Yellow fever virus 17D infected in African green monkey Vero cells assessed as reduction in virus yield2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID766693Antiviral activity against Coxsackievirus B4 infected in human HeLa cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID1118632Antiviral activity against thymidine kinase-deficient Herpes simplex virus type 1 infected in human HEL cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
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Antiviral phenylpropanoid glycosides from the medicinal plant Markhamia lutea.
AID1687970Cytotoxicity against human MET5A cells assessed as effect on cell morphology at 20 ug/ml measured upto 7 days by laser scanning confocal microscopy2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID257896Antiviral activity against Sindbis virus in vero cells2006Journal of medicinal chemistry, Jan-26, Volume: 49, Issue:2
Synthesis and biological activity of isoxazolidinyl polycyclic aromatic hydrocarbons: potential DNA intercalators.
AID63764The minimum inhibitory concentration was measured on E6SM cells against TK+/TK-Herpes simplex virus type 1 (VMW1837 strain)1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID82035Antiviral activity against HSV-2 virus infected HEF cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID368977Drug resistance, ratio of EC50 for plaque picked RSV604-resistant RSV RSS from passage 2 to EC50 for DMSO-passaged wild type RSV RSS2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID474351Antiviral activity against Influenza A virus California/07/2009 /H1N1 infected MDCK cells after 42 to 46 hrs by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID539953Antiviral activity against influenza A virus H1N1 infected in MDCK cells assessed as protection against virus-induced cytopathogenicity after 2 days2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Synthesis, antiviral activity and cytotoxicity evaluation of Schiff bases of some 2-phenyl quinazoline-4(3)H-ones.
AID1831639Antiviral activity against Dengue virus infected in human Huh-7 cells assessed as inhibition of viral replication at 12.5 uM measured after 48 hrs by plaque assay relative to control2021ACS medicinal chemistry letters, Dec-09, Volume: 12, Issue:12
Nanoparticular Inhibitors of Flavivirus Proteases from Zika, West Nile and Dengue Virus Are Cell-Permeable Antivirals.
AID1132056Antiviral activity against influenza A virus NWS/H0N1 infected in BHK cells by agar diffusion assay1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID1181482Antiviral activity against Influenza A virus (A/HK/7/1987(H3N2)) infected in MDCK cells assessed as virus-induced cytopathic effect after 72 hrs by microscopy2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Semisynthetic teicoplanin derivatives as new influenza virus binding inhibitors: synthesis and antiviral studies.
AID235800Selectivity index which is the ratio of IC50 to EC50 of R-MuLV.1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Unsaturated and carbocyclic nucleoside analogues: synthesis, antitumor, and antiviral activity.
AID691388Antiviral activity against Hepatitis C virus subtype 1a infected in human HuH7 cells at 20 to 50 ug/mL after 2 days by q-PCR analysis2012Bioorganic & medicinal chemistry letters, Oct-15, Volume: 22, Issue:20
A new class of pyrimidine nucleosides: inhibitors of hepatitis B and C viruses.
AID1767878Cytotoxicity against dog MDCK cells assessed as reduction in cell viability2021European journal of medicinal chemistry, Oct-15, Volume: 222Optimization and SAR research at the piperazine and phenyl rings of JNJ4796 as new anti-influenza A virus agents, part 1.
AID427560Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36L mutation in human HuH7 cells after 48 hrs by RNA replicon assay relative to wild type2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID1767879Selectivity index, ratio of CC50 for cytotoxicity against dog MDCK cells to IC50 for antiviral activity against Influenza A virus HINI infected in dog MDCK cells2021European journal of medicinal chemistry, Oct-15, Volume: 222Optimization and SAR research at the piperazine and phenyl rings of JNJ4796 as new anti-influenza A virus agents, part 1.
AID1773014Inhibition of RSV induced apoptosis in human HEp-2 cells assessed as reduction in cleaved caspase-9 expression measured after 48 hrs by Western blot analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID1066044Antiviral activity against influenza A virus A/Padova/253/2011(H1N1) clinical isolate infected in MDCK cells assessed as inhibition of plaque formation after 2 days by toluidine blue staining assay2013Journal of medicinal chemistry, Dec-27, Volume: 56, Issue:24
Structural investigation of cycloheptathiophene-3-carboxamide derivatives targeting influenza virus polymerase assembly.
AID1364926Antiviral activity against Chikungunya virus KC969207 infected in African green monkey Vero cells after 48 hrs by MTT dye-based assay2017Bioorganic & medicinal chemistry, 08-15, Volume: 25, Issue:16
The medicinal chemistry of Chikungunya virus.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID218072Toxicity level was reported; none1985Journal of medicinal chemistry, Aug, Volume: 28, Issue:8
Synthesis and biological activity of 6-azacadeguomycin and certain 3,4,6-trisubstituted pyrazolo[3,4-d]pyrimidine ribonucleosides.
AID1651272Cytotoxicity against African green monkey Vero E6 cells assessed as reduction in cell viability2020Bioorganic & medicinal chemistry letters, 02-15, Volume: 30, Issue:4
Design, synthesis, and evaluation of novel 4-amino-2-(4-benzylpiperazin-1-yl)methylbenzonitrile compounds as Zika inhibitors.
AID1886809Antiviral activity against DENV2 infected in golden hamster BHK-21 cells assessed as inhibition of plaque formation by measuring reduction in PFU per well at 12.4 to 100 ug/ml incubated for 6 days by crystal violet staining based assay relative to control2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID366288Antiviral activity against Influenza A virus Jinan/15/90 H3N2 assessed as reduction of virus-induced cytopathic effect2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Structure-activity relationship of flavonoids as influenza virus neuraminidase inhibitors and their in vitro anti-viral activities.
AID1435480Cytotoxicity against African green monkey Vero cells assessed as cytopathic effect after 48 hrs2017European journal of medicinal chemistry, Jan-27, Volume: 126Synthesis and evaluation of halogenated 12N-sulfonyl matrinic butanes as potential anti-coxsackievirus agents.
AID297317Antiviral activity against RSV in HeLa cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
Synthesis and antiviral and cytostatic evaluations of the new C-5 substituted pyrimidine and furo[2,3-d]pyrimidine 4',5'-didehydro-L-ascorbic acid derivatives.
AID434313Antiviral activity against Coxsackievirus B4 infected in human HeLa cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID218404Minimum inhibitory concentration required to reduce parainfluenza virus-3 induced cytopathogenicity by 50% in african green monkey (VeroB) cells1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID284525Antiviral activity against HSV1 KOS-induced cytopathogenicity in E6SM cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID142441Cytotoxicity was evaluated1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Unsaturated and carbocyclic nucleoside analogues: synthesis, antitumor, and antiviral activity.
AID1524778Cytotoxicity against MDCK cells assessed as reduction in cell viability measured on day 5 by Celltiter-Glo luminescence assay2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Identification, design and synthesis of novel pyrazolopyridine influenza virus nonstructural protein 1 antagonists.
AID1687954Antiproliferative activity against human A-431 cells assessed as reduction in cell growth incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID648685Cytotoxicity against human RD cells2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Antiviral effect of geraniin on human enterovirus 71 in vitro and in vivo.
AID368975Antiviral activity against DMSO-passaged wild type RSV RSS infected human Hep2 cells by plaque reduction assay2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID611771Cytotoxicity against human HeLa cells assessed as growth inhibition after 3 days by coulter counting analysis2011Bioorganic & medicinal chemistry, Jun-01, Volume: 19, Issue:11
New prodrugs of Adefovir and Cidofovir.
AID1682703Cytotoxicity against MDCK cells assessed as cell death incubated for 48 hrs by MTT assay
AID226099Minimum inhibitory concentration against Herpes simplex virus 2 (G) in primary rabbit kidney cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID1443673Cytotoxicity against human 293T cells expressing Gluc assessed as inhibition of cell proliferation at 20 uM after 24 hrs by CCK8 assay relative to control2017Bioorganic & medicinal chemistry letters, 04-15, Volume: 27, Issue:8
Anti-influenza triterpenoid saponins (saikosaponins) from the roots of Bupleurum marginatum var. stenophyllum.
AID64116Tested for minimum inhibitor concentration against vesicular stomatitis virus (VSV) in E6SM cells1993Journal of medicinal chemistry, Oct-01, Volume: 36, Issue:20
Antiviral activity of C-alkylated purine nucleosides obtained by cross-coupling with tetraalkyltin reagents.
AID1391709Antiviral activity against Influenza A virus (A/WSN/1933(H1N1)) infected in MDCK cells cocultured with human 293T-Gluc cells preincubated with compound for 2 hrs followed by virus infection measured after 24 hrs by luciferase reporter gene assay2018Bioorganic & medicinal chemistry letters, 05-15, Volume: 28, Issue:9
Secoiridoid analogues from the fruits of Ligustrum lucidum and their inhibitory activities against influenza A virus.
AID1077001Antiviral activity against Influenza A virus A/hanfang/359/95(H3N2) infected in MDCK cells assessed as inhibition of virus-induced cytopathicity after 40 hrs2014European journal of medicinal chemistry, Apr-09, Volume: 761,2,3-Triazole-containing derivatives of rupestonic acid: click-chemical synthesis and antiviral activities against influenza viruses.
AID261060Efficacy in BALB/c mouse measured as reduction in log TCID50 of RSV per gram of lung at 90 mg/kg, sc2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Respiratory syncytial virus fusion inhibitors. Part 3: Water-soluble benzimidazol-2-one derivatives with antiviral activity in vivo.
AID370205Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 mL of serum at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID198426Percent increase in survival rate of Rift Valley fever virus infected mice on day 21, by administering 100 (mg/kg)/day of compound1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
AID300561Antiviral activity against influenza A/Hanfang/359/95 (H3N2) virus in MDCK cells by CPE assay2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID665834In vivo antiviral activity against TMV assessed as viral inactivation effect at 500 ug/mL2012European journal of medicinal chemistry, Jul, Volume: 53Design, synthesis and antiviral activity of novel quinazolinones.
AID548449Antiviral activity against Coxsackie virus B4 infected in african green monkey Vero cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID691389Antiviral activity against Hepatitis C virus subtype 1a infected in human HuH7 cells at 10 ug/mL after 2 days by q-PCR analysis2012Bioorganic & medicinal chemistry letters, Oct-15, Volume: 22, Issue:20
A new class of pyrimidine nucleosides: inhibitors of hepatitis B and C viruses.
AID548429Cytotoxicity against human HeLa cells assessed as cell viability by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID475853Antiviral activity against Respiratory syncytial virus Long infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity2010Bioorganic & medicinal chemistry, Apr-01, Volume: 18, Issue:7
Application of the phosphoramidate ProTide approach to the antiviral drug ribavirin.
AID88195Cytotoxic concentration required to cause microscopically detectable alteration of normal cell morphology of HeLa cells1996Journal of medicinal chemistry, Jul-05, Volume: 39, Issue:14
Synthesis of acyclo-C-nucleosides in the imidazo[1,2-a]pyridine and pyrimidine series as antiviral agents.
AID717174Antiviral activity against Influenza A virus (A/X-31(H3N2)) infected in MDCK cells assessed as virus-induced cytopathic effect after 3 days by microscopic analysis2012Bioorganic & medicinal chemistry, Dec-15, Volume: 20, Issue:24
Microwave assisted synthesis and anti-influenza virus activity of 1-adamantyl substituted N-(1-thia-4-azaspiro[4.5]decan-4-yl)carboxamide derivatives.
AID1133179Antiviral activity against HSV2 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect after 72 hrs relative to control1978Journal of medicinal chemistry, Dec, Volume: 21, Issue:12
Synthesis and antiviral and enzymatic studies of certain 3-deazaguanines and their imidazolecarboxamide precursors.
AID1731878Cytotoxicity against human HEK-293T cells assessed as reduction in cell viability after 48 hrs by CCK-8 assay2021European journal of medicinal chemistry, Mar-15, Volume: 214Synthesis and antiviral activity of a series of novel quinoline derivatives as anti-RSV or anti-IAV agents.
AID1778627Antiviral activity against Influenza A virus A/PR/8/34(H1N1) infected in MDCK cells assessed as inhibition of plaque formation for 48 hrs by plaque reduction assay2021European journal of medicinal chemistry, Oct-05, Volume: 2211,2,4-Triazolo[1,5-a]pyrimidines: Efficient one-step synthesis and functionalization as influenza polymerase PA-PB1 interaction disruptors.
AID401224Antiviral activity against RSV Long in MDCK cells assessed as inhibition of virus-induced cytopathic effect2004Journal of natural products, Apr, Volume: 67, Issue:4
Antiviral flavonoids from the seeds of Aesculus chinensis.
AID424778Antiviral activity against Coxsackie virus B3 Nacy infected in human HeLa cells assessed as reduction of virus-induced cytopathic effect by MTT assay2009Journal of natural products, May-22, Volume: 72, Issue:5
Anti-coxsackie virus B3 norsesquiterpenoids from the roots of Phyllanthus emblica.
AID1135883Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in viral excretion by measuring hemagglutination units per ml at 13 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to da1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID1336607Cytotoxicity against African green monkey Vero cells assessed as alterations in cell morphology by microscopic analysis2017Bioorganic & medicinal chemistry letters, 01-15, Volume: 27, Issue:2
Synthesis and in vitro antiviral evaluation of 4-substituted 3,4-dihydropyrimidinones.
AID217996Compound was tested for antiviral activity against vaccinia virus in primary rabbit kidney cells1984Journal of medicinal chemistry, Jul, Volume: 27, Issue:7
Biological activity and a modified synthesis of 8-amino-3-beta-D-ribofuranosyl-1,2,4-triazolo[4,3-a]pyrazine, an isomer of formycin.
AID1135741Antiviral activity against Parainfluenza virus type 3 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect at 1 to 1000 ug/ml after 72 hrs1978Journal of medicinal chemistry, Aug, Volume: 21, Issue:8
Synthesis and antiviral acticity of some phosphates of the broad-spectrum antiviral nucleoside, 1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide (ribavirin).
AID1710795Antiviral activity against influenza A virus infected in dog MDCK cells assessed as reduction in virus-induced cytopathic effect incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID1773040Antiviral activity against RSV Long infected in BALB/c mouse assessed as inhibition of alveolar infiltrates accumulation at 50 mg/kg/day observed on day 6 after infection by H and E staining based microscopic analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID366290Cytotoxicity against MDCK cells assessed as maximal non-cytotoxic concentration by MTT assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Structure-activity relationship of flavonoids as influenza virus neuraminidase inhibitors and their in vitro anti-viral activities.
AID1498140Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as inhibition of virus-induced visual cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID1753363Cytotoxicity against human HEK293T cells measured after 72 hrs by MTT assay2021Bioorganic & medicinal chemistry letters, 05-15, Volume: 40New class of hantaan virus inhibitors based on conjugation of the isoindole fragment to (+)-camphor or (-)-fenchone hydrazonesv.
AID63941concentration required to inhibit HSV-2(G)-induced cytopathicity by 50% in E6SM cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID275086Antiviral activity against HSV1 KOS in HEL cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Synthesis, in vitro antiviral evaluation, and stability studies of novel alpha-borano-nucleotide analogues of 9-[2-(phosphonomethoxy)ethyl]adenine and (R)-9-[2-(phosphonomethoxy)propyl]adenine.
AID472792Antiviral activity against Polio virus type1 Sabin strain Chat infected in african green monkey Vero cells after 2 days by plaque reduction assay2010Bioorganic & medicinal chemistry, Apr-15, Volume: 18, Issue:8
Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID216230Selectivity index as the ratio of CC50/EC50 against Vesicular stomatitis virus2002Bioorganic & medicinal chemistry letters, May-20, Volume: 12, Issue:10
Heterocyclic nucleoside analogues: design and synthesis of antiviral, modified nucleosides containing isoxazole heterocycles.
AID1081161In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as protective effect at 100 ug/ml treated 12 hr before viral inoculation measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis of 4-methyl-1,2,3-thiadiazole derivatives via Ugi reaction and their biological activities.
AID63914Effective concentration required to inhibit Herpes simplex virus-1 (HSV-1) induced cytopathicity by 50% in E6SM cell lines2001Journal of medicinal chemistry, Aug-16, Volume: 44, Issue:17
Synthesis, mechanism of action, and antiviral activity of a new series of covalent mechanism-based inhibitors of S-adenosyl-L-homocysteine hydrolase.
AID1651269Antiviral activity against Zika virus infected in African green monkey Vero E6 cells assessed as inhibition of viral induced cytopathic effect at 40 uM relative to control2020Bioorganic & medicinal chemistry letters, 02-15, Volume: 30, Issue:4
Design, synthesis, and evaluation of novel 4-amino-2-(4-benzylpiperazin-1-yl)methylbenzonitrile compounds as Zika inhibitors.
AID1710796Antiviral activity against influenza B virus infected in dog MDCK cells assessed as reduction in virus-induced cytopathic effect incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID63762The minimum inhibitory concentration was measured on E6SM cells against Herpes simplex virus type 2 (G strain)1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID1691540Antiviral activity against Influenza A virus (A/PR 8/34 (H1N1)) infected in MDCK cells assessed as reduction in virus-induced cytopathic effect measured after 72 hrs by MTS assay2020European journal of medicinal chemistry, May-15, Volume: 194N-benzyl 4,4-disubstituted piperidines as a potent class of influenza H1N1 virus inhibitors showing a novel mechanism of hemagglutinin fusion peptide interaction.
AID474541Selectivity ratio of IC50 for MDCK cells to EC50 for Influenza A virus California/07/2009 /H1N1 by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID774866Cytotoxicity against african green monkey Vero cells after 96 hrs by MTT assay2013European journal of medicinal chemistry, Nov, Volume: 69Synthesis and antiviral activity of a novel class of (5-oxazolyl)phenyl amines.
AID395965Antiviral activity against 500 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean day of death at 30 mg/kg, po twice daily for 5 days administered 24 hrs post viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID524794Antiplasmodial activity against Plasmodium falciparum GB4 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID1252403Antiviral activity against Parainfluenza virus 3 expressed in African green monkey Vero cells assessed as reduction in cytopathogenicity2015European journal of medicinal chemistry, Sep-18, Volume: 102Novel halogenated 3-deazapurine, 7-deazapurine and alkylated 9-deazapurine derivatives of L-ascorbic or imino-L-ascorbic acid: Synthesis, antitumour and antiviral activity evaluations.
AID1200495Antiviral activity against OSV-resistant influenza A virus A/LiaoNing-ZhenXing/1109/2010 (H1N1) strain2015European journal of medicinal chemistry, Mar-26, Volume: 93Neoechinulin B and its analogues as potential entry inhibitors of influenza viruses, targeting viral hemagglutinin.
AID1127179Antiviral activity against DENV2 16681 infected in human Huh-7 cells at 5 uM after 3 days by luciferase reporter gene assay2014European journal of medicinal chemistry, May-22, Volume: 79Synthesis, antiproliferative and anti-dengue virus evaluations of 2-aroyl-3-arylquinoline derivatives.
AID1450223Selectivity index, ratio of MCC for African green monkey Vero E6 cells to IC50 for acyclovir and foscarnet-resistant HSV-1 L2 infected in African green monkey Vero E6 cells2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID360158Antiviral activity against HCV 1b Con1 with NS3-4A R155K mutation in human Huh7 cells after 48 hrs by replicon cell assay2007The Journal of biological chemistry, Aug-03, Volume: 282, Issue:31
Phenotypic and structural analyses of hepatitis C virus NS3 protease Arg155 variants: sensitivity to telaprevir (VX-950) and interferon alpha.
AID106223Tested for inhibitory effect on RNA virus HIV-1 in MT-4 cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID383520Antiviral activity against thymidine kinase deficient and acyclovir resistant HSV1 KOS in human E6SM cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1435488Antiviral activity against Coxsackievirus B6 Schmitt infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect2017European journal of medicinal chemistry, Jan-27, Volume: 126Synthesis and evaluation of halogenated 12N-sulfonyl matrinic butanes as potential anti-coxsackievirus agents.
AID535535Transport through ENT2 in rat hepatocytes by oil filtration assay in presence 100 uM of transporter inhibitor NBMRP2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID217893Minimum inhibitory concentration against forest virus in Vero cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID223416Concentration required to reduce influenza virus B (singapore) induced cytopathogenicity by 50%1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID1071702Selectivity index, ratio of CC50 for cytotoxicity to EC50 for Influenza B virus2014European journal of medicinal chemistry, Mar-03, Volume: 74Synthesis and biological evaluation of 2-oxonicotinonitriles and 2-oxonicotinonitrile based nucleoside analogues.
AID443828Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) assessed as cell viability by cell-based MTS assay2009Journal of medicinal chemistry, Oct-08, Volume: 52, Issue:19
Diazo transfer-click reaction route to new, lipophilic teicoplanin and ristocetin aglycon derivatives with high antibacterial and anti-influenza virus activity: an aggregation and receptor binding study.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1303367Antiviral activity against BVDV NADL infected in MDBK cells assessed as inhibition of virus induced cytopathogenicity after 3 to 4 days by MTT assay2016European journal of medicinal chemistry, Jul-19, Volume: 117A combined in silico/in vitro approach unveils common molecular requirements for efficient BVDV RdRp binding of linear aromatic N-polycyclic systems.
AID1433153Cytotoxicity against MDCK cells assessed as inhibition of cell viability by colorimetric formazan-based MTS assay2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID438025Antiviral activity against Dengue virus2009Journal of medicinal chemistry, Dec-24, Volume: 52, Issue:24
The medicinal chemistry of dengue fever.
AID280198Antiviral activity against reovirus1 in Vero cells assessed as inhibition of virus-induced cytopathicity2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID216503Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on vero cell line infected with Reo 1 virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID712796Cytotoxicity against dog MDCK cells assessed as cell morphology alterations2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID217591In vitro antiviral activity against vaccinia virus in Vero cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Synthesis and biological activity of certain nucleoside and nucleotide derivatives of pyrazofurin.
AID217892Minimum inhibitory concentration against Coxsackie virus B4 in Vero cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID395933Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in liver at 50 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID312073Antiviral activity against poliovirus infected HeLa S3 cells assessed as plaque formation at 0.5 mM relative to control2008Journal of medicinal chemistry, Jan-10, Volume: 51, Issue:1
Effects of introduction of hydrophobic group on ribavirin base on mutation induction and anti-RNA viral activity.
AID89114Minimum cytotoxic concentration in primary rabbit kidney cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID1687951Antiproliferative activity against human DU-145 cells assessed as reduction in cell growth incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID1710781Antiviral activity against Human parainfluenza virus 3 infected in African green monkey Vero cells assessed as reduction in virus-induced cytopathic effect incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID1542950Antiviral activity against Zika virus2019ACS medicinal chemistry letters, Apr-11, Volume: 10, Issue:4
Scaffold Morphing Approach To Expand the Toolbox of Broad-Spectrum Antivirals Blocking Dengue/Zika Replication.
AID1186335Antiviral activity against Coxsackievirus B5 infected in african green monkey Vero 76 cells assessed as reduction in plaque number after 3 days by plaque reduction assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID1710775Antiviral activity against Human coxsackievirus B4 infected in human HeLa cells assessed as reduction in virus-induced cytopathic effect incubated for 3 to 6 days by light microscopic analysis2016Bioorganic & medicinal chemistry, Jan-15, Volume: 24, Issue:2
Synthesis and antiviral properties of novel indole-based thiosemicarbazides and 4-thiazolidinones.
AID217262In vitro antiviral activity against vaccinia(VV) virus was determined in african green monkey kidney (vero,V) expressed as virus rating. Toxic level(>1000 ug/mL)1982Journal of medicinal chemistry, Nov, Volume: 25, Issue:11
Synthesis and antiviral activity of certain carbamoylpyrrolopyrimidine and pyrazolopyrimidine nucleosides.
AID65712Antiviral activity against vesicular simplex virus-1 in E6SM cell cultures2001Journal of medicinal chemistry, Aug-02, Volume: 44, Issue:16
Design, synthesis, DNA binding, and biological evaluation of water-soluble hybrid molecules containing two pyrazole analogues of the alkylating cyclopropylpyrroloindole (CPI) subunit of the antitumor agent CC-1065 and polypyrrole minor groove binders.
AID277832Cytotoxicity against HeLa cells2007Journal of natural products, Feb, Volume: 70, Issue:2
Cinnamacrins A-C, cinnafragrin D, and cytostatic metabolites with alpha-glucosidase inhibitory activity from Cinnamosma macrocarpa.
AID648680Antiviral activity against C4 type Human enterovirus 71 MP10 infected in ICR mouse assessed as increase in survival rate at 50 mg/kg, ip administered 2 hrs post infection qd for 7 days measured up to 14 days2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Antiviral effect of geraniin on human enterovirus 71 in vitro and in vivo.
AID427552Antiviral activity against HCV Con1-mADE replicon with NS3 serine protease V36M/R155K double mutation in human HuH7 cells after 48 hrs by RNA replicon assay2008Antimicrobial agents and chemotherapy, Jan, Volume: 52, Issue:1
Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3-4A serine protease.
AID1205008Selectivity index, ratio of TC50 for african green monkey Vero cells to IC50 for Coxsackievirus B6 infected in african green monkey Vero cells2015ACS medicinal chemistry letters, Feb-12, Volume: 6, Issue:2
Novel N-benzenesulfonyl sophocarpinol derivatives as coxsackie B virus inhibitors.
AID216823In vitro antiviral activity against COXB1 virus in (vero) V cells1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
Synthesis and antiviral activity of certain 9-beta-D-ribofuranosylpurine-6-carboxamides.
AID257340Cytotoxicity against Huh7ET cell line containg HCV replicon at 10 uM assessed by measuring the beta-actin RNA level relative to control2005Bioorganic & medicinal chemistry letters, Dec-15, Volume: 15, Issue:24
Synthesis and in vitro anti-hepatitis B and C virus activities of ring-expanded ('fat') nucleobase analogues containing the imidazo[4,5-e][1,3]diazepine-4,8-dione ring system.
AID464001Antiviral activity against Influenza A virus H3N2 infected in MDCK cells assessed as protection from virus-induced cytopathogenicity after 6 to 7 days by MTT assay2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID218036Minimum cytotoxic concentration (MCC) required to cause a microscopically detectable alteration of host cell morphology, when incubated with Vero B cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID1498120Antiviral activity against Reovirus-1 infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity2018Bioorganic & medicinal chemistry, 07-23, Volume: 26, Issue:12
Expedient synthesis and biological evaluation of alkenyl acyclic nucleoside phosphonate prodrugs.
AID474549Selectivity ratio of IC50 for MDCK cells to EC50 for inhibition of virus-induced cytopathic effect of Influenza B virus Malaysia/2506/20042010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID86492Tested for antiviral activity against coxsackie-B4 virus in human epithelial cell line2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID301699Inhibition of human recombinant S-adenosyl-L-homocysteine hydrolase NAD+ form expressed in Escherichia coli JM1092007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID376988Selectivity index, CC50 for MDCK cells to IC50 for influenza A virus H1N1 A/NWS/332006Journal of natural products, May, Volume: 69, Issue:5
Antiviral flavans from the leaves of Pithecellobium clypearia.
AID1132066Antiviral activity against Coxsackievirus B1 infected in human HeLa cells at 1 mg/ml by agar diffusion assay1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID280193Antiviral activity against VSV in HeLa cells assessed as inhibition of virus-induced cytopathicity2007Journal of medicinal chemistry, Mar-08, Volume: 50, Issue:5
Antiviral activity of triazine analogues of 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine (cidofovir) and related compounds.
AID278349Inhibition of viral RNA levels in HTNV 76-118-infected Vero E6 cells at 40 ug/ml after 3 days2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID402532Antiviral activity against influenza A virus NWS33 in MDCK cells assessed as inhibition of viral cytopathic effect by neutral red assay1997Journal of natural products, Jun, Volume: 60, Issue:6
Two new lignans with activity against influenza virus from the medicinal plant Rhinacanthus nasutus.
AID1783346Antiviral activity against Dengue virus serotype 2 New Guinea C infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based plaque reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID419605Antiviral activity against Coxsackievirus B4 infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity after 3 days2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID1261340Antiviral activity against HSV12015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID1687949Antiproliferative activity against human CaCo-2 cells assessed as reduction in cell growth incubated for 72 hrs by MTT assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and antitumor activities investigation of a C-nucleoside analogue of ribavirin.
AID1306317Cytotoxicity against African green monkey Vero E6 cells2016Bioorganic & medicinal chemistry letters, 07-15, Volume: 26, Issue:14
An alternative route to the arylvinyltriazole nucleosides.
AID1135886Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in viral excretion by measuring hemagglutination units per ml at 14 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to da1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID1135740Antiviral activity against HSV1 infected in human KB cells assessed as inhibition of virus-induced cytopathic effect at 1 to 1000 ug/ml after 72 hrs1978Journal of medicinal chemistry, Aug, Volume: 21, Issue:8
Synthesis and antiviral acticity of some phosphates of the broad-spectrum antiviral nucleoside, 1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide (ribavirin).
AID1783349Selectivity index, ratio of CC50 for human Huh-7 cells to IC50 for Dengue virus serotype 2 New Guinea C infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based plaque reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID548426Antiviral activity against Vaccinia virus infected in HEL cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID478325Antiviral activity against influenza B virus assessed as cell viability by cell based MTS assay2010Bioorganic & medicinal chemistry letters, May-01, Volume: 20, Issue:9
Click reaction synthesis of carbohydrate derivatives from ristocetin aglycon with antibacterial and antiviral activity.
AID768194Antiviral activity against Reovirus-1 infected in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID1298255Cytotoxicity against MDCK cells assessed as cell viability measured after 4 days by formazan-based MTS assay2016Bioorganic & medicinal chemistry, 06-01, Volume: 24, Issue:11
1,6-Bis[(benzyloxy)methyl]uracil derivatives-Novel antivirals with activity against HIV-1 and influenza H1N1 virus.
AID1443881Antiviral activity against full length gluc-tagged Chikungunya virus 2013 Caribbean CNR20235 infected in HEK293T cells assessed as reduction in virus infection after 24 hrs by gaussia luciferase reporter gene assay2017Journal of medicinal chemistry, 04-13, Volume: 60, Issue:7
Structural Optimizations of Thieno[3,2-b]pyrrole Derivatives for the Development of Metabolically Stable Inhibitors of Chikungunya Virus.
AID82039Effects on cell morphology of HEF cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID766687Antiviral activity against Punta Toro virus infected in african green monkey Vero cells assessed as reduction in virus-induced cytopathogenicity2013European journal of medicinal chemistry, Sep, Volume: 67Regioselective synthesis of 6-substituted-2-amino-5-bromo-4(3H)-pyrimidinones and evaluation of their antiviral activity.
AID87157Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against coxsackie B4 virus in HeLa cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID416783Antiviral activity against influenza H3N2 virus in MDCK cells assessed as reduction of virus-induced cytopathicity by MTS method2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1450212Cytotoxicity against African green monkey Vero E6 cells measured after 3 days by trypan blue assay2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
New modified 2-aminobenzimidazole nucleosides: Synthesis and evaluation of their activity against herpes simplex virus type 1.
AID1852994Cytotoxicity against paclitaxel-resistant human HCT116tax cells assessed as DNA damage by measuring fluorescence intensity incubated for 30 mins by Hoechst 33342 staining accumulation assay2022ACS medicinal chemistry letters, Dec-08, Volume: 13, Issue:12
ATP Mimetic Attack on the Nucleotide-Binding Domain to Overcome ABC Transporter Mediated Chemoresistance.
AID765051Selectivity index, ratio of CC50 for african green monkey OR6 cells to ED50 for HCV2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Peroxisome proliferator-activated receptor delta antagonists inhibit hepatitis C virus RNA replication.
AID1716987Antiviral activity against H3N2 infected in MDCK cells measured after 24 hrs by Gaussia luciferase reporter gene method2020European journal of medicinal chemistry, Jan-15, Volume: 186Design and synthesis of 2-((1H-indol-3-yl)thio)-N-phenyl-acetamides as novel dual inhibitors of respiratory syncytial virus and influenza virus A.
AID421727Therapeutic index, ratio of TC50 for human Hep2 cells to IC50 for Respiratory syncytial virus infected in human Hep2 cells2009Journal of natural products, May-22, Volume: 72, Issue:5
Antiviral constituents against respiratory viruses from Mikania micrantha.
AID86483Minimum inhibitory conc. for 50% inhibition of morphology virus induced cytopathicity in HeLa cells1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Carbocyclic oxetanocins lacking the C-3' methylene.
AID648647Antiinfluenza activity against influenza B virus infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect after 36 hrs2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Synthesis and anti-influenza activity of aminoalkyl rupestonates.
AID1132059Cytotoxicity against human HeLa cells by neutral red assay1978Journal of medicinal chemistry, Jan, Volume: 21, Issue:1
Thiazolinone analogues of indolmycin with antiviral and antibacterial activity.
AID1293610Cytotoxicity against HEK293T cells assessed as decrease in cell viability after 24 hrs by MTT assay2016Journal of medicinal chemistry, Mar-24, Volume: 59, Issue:6
4,6-Diphenylpyridines as Promising Novel Anti-Influenza Agents Targeting the PA-PB1 Protein-Protein Interaction: Structure-Activity Relationships Exploration with the Aid of Molecular Modeling.
AID105790Antiviral activity against influenza A,H3N2 virus infected MDCK cell lines.1996Journal of medicinal chemistry, Aug-16, Volume: 39, Issue:17
Synthesis and antiviral activity evaluation of some new aminoadamantane derivatives. 2.
AID474345Selectivity ratio of IC50 for MDCK cells to EC50 for Influenza A virus Hong Kong/213/2003/H5N1 by neutral red dye uptake assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID1433145Antiviral activity against Sindbis virus infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID1082991Antiviral activity against Tobacco mosaic virus (TMV) inoculation on Nicotiana tabacum L. whole leaves assessed as virus infection protective effect at 500 ug/mL measured 3 to 4 days post inoculation2012Journal of agricultural and food chemistry, Sep-05, Volume: 60, Issue:35
Design, synthesis, and antiviral activity evaluation of phenanthrene-based antofine derivatives.
AID419601Cytotoxicity against african green monkey Vero cells assessed as alteration in cell morphology2009European journal of medicinal chemistry, Jun, Volume: 44, Issue:6
Synthesis, antimicrobial and antiviral evaluation of substituted imidazole derivatives.
AID218031Antiviral activity was measured against Reo virus-1 in african green monkey kidney (Vero B) cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID474347Selectivity ratio of IC50 for MDCK cells to EC50 for inhibition of virus-induced cytopathic effect of Influenza A virus Vietnam/1203/ 2004H/H5N12010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID383509Antiviral activity against respiratory syncytial virus in human HeLa cells assessed as inhibition of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID472789Antiviral activity against Bovine viral diarrhea virus NADL infected in MDBK cells assessed as protection from virus-induced cytopathogenicity after 3 to 4 days by MTT method2010Bioorganic & medicinal chemistry, Apr-15, Volume: 18, Issue:8
Antiviral activity of benzimidazole derivatives. II. Antiviral activity of 2-phenylbenzimidazole derivatives.
AID634089Cytotoxicity against human HuH7 cells infected with HCV1b assessed as cell viability at 10 uM after 3 days by MTS assay2012Bioorganic & medicinal chemistry, Jan-01, Volume: 20, Issue:1
The design, synthesis and biological evaluations of C-6 or C-7 substituted 2-hydroxyisoquinoline-1,3-diones as inhibitors of hepatitis C virus.
AID218449Percent purine synthesized in human B lymphoblast WI-L2 cells was determined1988Journal of medicinal chemistry, Feb, Volume: 31, Issue:2
Synthesis and evaluation of 5-amino-1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamidine and certain related nucleosides as inhibitors of purine nucleoside phosphorylase.
AID1280362Antiviral activity against amantadine-resistant influenza A virus JX/312 (H3N2) infected in dog MDCK cells assessed as inhibition of virus induced cytopathic effect after 40 hrs by Cell-Titer-Glo assay2016European journal of medicinal chemistry, Jan-27, Volume: 108Spiromastilactones: A new class of influenza virus inhibitors from deep-sea fungus.
AID535537Transport through CNT2 in rat hepatocytes by oil filtration assay pre-incubated with 20 ng/mL rotenone for 15 mins and 2 mM 2-deoxyglucose for 10 mins at 37 degC in presence of sodium ions in Kreb-henseleit buffer containing 100 nM NBMPR2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Striking species difference in the contribution of concentrative nucleoside transporter 2 to nucleoside uptake between mouse and rat hepatocytes.
AID336178Antiviral activity against Potato virus X in half leaf of Chenopodium quinoa at 9.3 mg/mL after 10 days2002Journal of natural products, Oct, Volume: 65, Issue:10
Bioactive constituents from Iryanthera megistophylla.
AID1578007Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition in virus-induced cytopathic effect incubated for 40 hrs2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Novel amides modified rupestonic acid derivatives as anti-influenza virus reagents.
AID63767The minimum inhibitory concentration was measured on E6SM cells against Vesicular stomatitis virus1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Tricyclic analogues of acyclovir and ganciclovir. Influence of substituents in the heterocyclic moiety on the antiviral activity.
AID368976Antiviral activity against plaque picked RSV604-resistant RSV RSS from passage 2 in human Hep2 cells by plaque reduction assay2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
RSV604, a novel inhibitor of respiratory syncytial virus replication.
AID1773057Antiviral activity against RSV infected in BALB/c mouse assessed as downregulation of iNOS expression in lung tissue infected with RSV at 50 mg/kg/day measured after 2 to 6 days post infection by RT-PCR analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID1830602Antiviral activity against HSV-1 infected in human Huh-7 cells assessed as reduction in plaque forming units at 1 uM measured after 48 hrs by virus titre method2021Bioorganic & medicinal chemistry letters, 11-15, Volume: 52Synthesis and antiviral effect of phosphamide modified vidarabine for treating HSV 1 infections.
AID1427859Selectivity index, ratio of TC50 for MDCK cells to IC50 for Influenza A virus (A/95-359) infected in MDCK cells
AID1272970Therapeutic index, ratio of TC50 for MDCK cells to IC50 for Influenza A virus H3N2 A3/JINGKE/30/952016Bioorganic & medicinal chemistry letters, Feb-01, Volume: 26, Issue:3
The semi-synthesis of novel andrographolide analogues and anti-influenza virus activity evaluation of their derivatives.
AID1783351Antiviral activity against Zika virus H/PF/2013 infected in pre-seeded Huh-7 cells assessed as inhibition of viral replication incubated for 72 hrs by immunodetection based direct yield reduction assay2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID218127Minimum inhibitory concentration against vaccinia virus in primary rabbit kidney cell cultures of experiment 21989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID1135878Antiviral activity against Influenza A virus Port Chalmers/1/73 (H3N2) infected in ferret assessed as reduction in viral excretion by measuring hemagglutination units per ml at 7 mg/kg administered intranasally 7 times on day 0 and 9 times on day 1 to day1979Journal of medicinal chemistry, Feb, Volume: 22, Issue:2
Easily hydrolyzable, water-soluble derivatives of (+/-)-alpha-5-[1-(indol-3-yl)ethyl]-2-methylamino-delta2-thiazoline-4-one, a novel antiviral compound.
AID246507Effective concentrations at which 2-fold depression of HCV RNA was observed in AVA5 cells (Huh 7 cells with subgenomic HCV replicon BB7)2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID1113459Antiviral activity against Mammalian orthoreovirus 1 infected African green monkey Vero cells assessed as reduction of virus-induced cytopathic effect after 3 days by colorimetric formazan-based MTS assay2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID167151Minimum cytotoxic concentration required to cause a microscopically detectable alteration of normal cell morphology in primary rabbit kidney cells1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Nucleic acid related compounds. 51. Synthesis and biological properties of sugar-modified analogues of the nucleoside antibiotics tubercidin, toyocamycin, sangivamycin, and formycin.
AID395930Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as mean day of death at 20 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID395934Antiviral activity against Pichinde virus An 4763 infected Syrian golden hamster assessed as animals with detectable virus level in liver at 20 mg/kg, po twice daily for 7 days administered 24 hrs post viral-challenge measured on day 7 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID1415636Selectivity index, ratio of CC50 for MDCK cells to EC50 for Influenza A virus (A/Puerto Rico/8/34(H1N1))2017MedChemComm, May-01, Volume: 8, Issue:5
Synthesis and
AID1082995Antiviral activity against Tobacco mosaic virus (TMV) assessed as inhibition of viral growth at 500 ug/mL2012Journal of agricultural and food chemistry, Sep-05, Volume: 60, Issue:35
Design, synthesis, and antiviral activity evaluation of phenanthrene-based antofine derivatives.
AID1261322Selectivity index, ratio of CC50 for african green monkey Vero76 cells to EC50 for human RSV2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID370201Antiviral activity against 5000 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as mean viral titer per 0.1 g of liver at 30 mg/kg, po twice daily administered 24 hrs post viral challenge measured on day 3 of viral infection2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID87320Minimum inhibitory concentration against Herpes simplex virus 2(G)1989Journal of medicinal chemistry, Oct, Volume: 32, Issue:10
Novel linked antiviral and antitumor agents related to netropsin and distamycin: synthesis and biological evaluation.
AID474548Selectivity ratio of IC50 for MDCK cells to EC90 for Influenza A virus Wisconsin/67/2005/H3N2 by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID300563Antiviral activity against influenza B/Jingfang/76/98 in MDCK cells by CPE assay2007Bioorganic & medicinal chemistry letters, Sep-01, Volume: 17, Issue:17
Synthesis and anti-influenza activities of carboxyl alkoxyalkyl esters of 4-guanidino-Neu5Ac2en (zanamivir).
AID88687Tested for inhibitory effect on RNA virus VSV in HeLa cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID1186337Antiviral activity against Respiratory syncytial virus infected in african green monkey Vero 76 cells assessed as reduction in plaque number after 5 days by plaque reduction assay2014Bioorganic & medicinal chemistry, Sep-01, Volume: 22, Issue:17
Antiviral activity of benzimidazole derivatives. III. Novel anti-CVB-5, anti-RSV and anti-Sb-1 agents.
AID1408127Cytotoxicity against HEK293T cells assessed as decrease in cell viability after 24 hrs by MTT assay2018European journal of medicinal chemistry, Sep-05, Volume: 157Synthesis and biological evaluation of a library of hybrid derivatives as inhibitors of influenza virus PA-PB1 interaction.
AID156849Minimum inhibitory concentration required to reduce vaccinia virus induced cytopathogenicity by 50% in primary rabbit kidney cells (PRK)1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID1773037Antiviral activity against RSV Long infected in BALB/c mouse assessed as reduction in lung tissue damage by measuring lung index at 50 mg/kg/day measured after 4 to 6 days of virus infection2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID216396Compound was tested for antiviral activity in HeLa Cell cultures, against vesicular stomatitis virus (VSV)1985Journal of medicinal chemistry, Jun, Volume: 28, Issue:6
Synthesis and antiviral evaluation of nucleosides of 5-methylimidazole-4-carboxamide.
AID155439In vitro antiviral activity was tested against, parainfluenza type 3 (Para 3) virus1985Journal of medicinal chemistry, Oct, Volume: 28, Issue:10
Synthesis and biological activity of certain 6-substituted and 2,6-disubstituted 2'-deoxytubercidins prepared via the stereospecific sodium salt glycosylation procedure.
AID1360700Antiviral activity against Respiratory syncytial virus Long infected in human HeLa cells assessed as inhibition of virus-induced cytopathic effect after 3 to 6 days by MTS based microscopy2018European journal of medicinal chemistry, Jul-15, Volume: 155Synthesis, biological evaluation and molecular modeling of novel azaspiro dihydrotriazines as influenza virus inhibitors targeting the host factor dihydrofolate reductase (DHFR).
AID1118640Antiviral activity against Vesicular stomatitis virus infected in human HeLa cells assessed as inhibition of virus-induced cytopathicity2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1432506Selectivity index, ratio of TC50 for MDCK cells to IC50 for Influenza A virus H1N1 infected in MDCK cells2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Structure-activity relationship studies of 1-(1'-hydroxyalkyl)rupestonic acid methyl esters against influenza viruses.
AID383519Antiviral activity against in Vesicular stomatitis virus in human HEL cells assessed as reduction of virus-induced cytopathogenicity2008European journal of medicinal chemistry, Feb, Volume: 43, Issue:2
Synthesis of some novel thiourea derivatives obtained from 5-[(4-aminophenoxy)methyl]-4-alkyl/aryl-2,4-dihydro-3H-1,2,4-triazole-3-thiones and evaluation as antiviral/anti-HIV and anti-tuberculosis agents.
AID1226133Inhibition of Influenza A virus (A/PR/8/34) (H1N1) RNA-dependent-RNA polymerase 6His-tagged-PA/GST-tagged-BP 1 interaction by ELISA2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
A Broad Anti-influenza Hybrid Small Molecule That Potently Disrupts the Interaction of Polymerase Acidic Protein-Basic Protein 1 (PA-PB1) Subunits.
AID1886807Antiviral activity against DENV2 infected in African green monkey Vero E6 cells assessed as inhibition of virus induced cytopathic effect at 3.1 to 25 ug/ml measured after 72 hrs by crystal violet staining based inverted microscopic analysis relative to c2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID1886804Antiviral activity against ZIKV infected in African green monkey Vero E6 cells assessed as inhibition of virus induced cytopathic effect measured after 72 hrs by crystal violet staining based inverted microscopic analysis2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID87160Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against vesicular stomatitis virus in HeLa cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID277830Antiviral activity against VSV2007Journal of natural products, Feb, Volume: 70, Issue:2
Cinnamacrins A-C, cinnafragrin D, and cytostatic metabolites with alpha-glucosidase inhibitory activity from Cinnamosma macrocarpa.
AID63947Tested for cytotoxic activity in human embryonic skin muscle fibroblast (E6SM)2002Bioorganic & medicinal chemistry letters, Mar-11, Volume: 12, Issue:5
New 2-(1-adamantylcarbonyl)pyridine and 1-acetyladamantane thiosemicarbazones-thiocarbonohydrazones: cell growth inhibitory, antiviral and antimicrobial activity evaluation.
AID68125Tested for inhibitory effect on DNA virus HSV-1(KOS) in ESM cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID301695Inactivation of human recombinant S-adenosyl-L-homocysteine hydrolase NADH form expressed in Escherichia coli JM109 assessed by measuring fluorescence2007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID218062Maximum tolerated concentration against Vero cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Synthesis and biological activity of certain nucleoside and nucleotide derivatives of pyrazofurin.
AID84228Inhibitory activity against HSV-1 (McIntyre) replication in E6SM cell cultures of human embryonic skin-muscle2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
A thymidine phosphorylase-stable analogue of BVDU with significant antiviral activity.
AID217592In vitro antiviral activity against vaccinia virus was evaluated.1985Journal of medicinal chemistry, Aug, Volume: 28, Issue:8
Synthesis and biological activity of 6-azacadeguomycin and certain 3,4,6-trisubstituted pyrazolo[3,4-d]pyrimidine ribonucleosides.
AID108464The minimum inhibitory concentration required to reduce measles virus induced cytopathogenicity in primary rabbit kidney cells by 50%1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Synthesis and biological evaluation of 6-amino-1H-pyrrolo[3,2-c]pyridin-4(5H)-one (3,7-dideazaguanine).
AID164600Inhibitory dose of compound required to inhibit cytopathogenic effects of Punta toro virus with adames strain in vero cells1988Journal of medicinal chemistry, Sep, Volume: 31, Issue:9
Cyclopentenylcytosine. A carbocyclic nucleoside with antitumor and antiviral properties.
AID232125Ratio measured as the VR of C-3''-deoxyribofuranoside to the VR at a MIC of 14 ug/mL1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Synthesis and antiviral evaluation of carbocyclic analogues of 2-amino-6-substituted-purine 3'-deoxyribofuranosides.
AID774867Antiviral activity against Coxsackie B3 virus Nancy in african green monkey Vero cells assessed as inhibition virus-induced cytopathic effect after 48 hrs2013European journal of medicinal chemistry, Nov, Volume: 69Synthesis and antiviral activity of a novel class of (5-oxazolyl)phenyl amines.
AID1472404Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) clone 1 infected in MDCK cells assessed as inhibition of virus-induced cytopathicity measured after passage in absence of 2-Isopropyl-N-[2-(piperidin-1-yl)ethyl]aniline hydrochloride 2018Journal of medicinal chemistry, 01-11, Volume: 61, Issue:1
Aniline-Based Inhibitors of Influenza H1N1 Virus Acting on Hemagglutinin-Mediated Fusion.
AID1349204Antiviral activity against HCV infected in human Ava5 cells assessed as inhibition of viral RNA replication at 5 uM after 3 days by RT-qPCR method relative to control2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery of naphtho[1,2-d]oxazole derivatives as potential anti-HCV agents through inducing heme oxygenase-1 expression.
AID1261311Cytotoxicity against african green monkey Vero 76 cells assessed as cell viability after 48 to 96 hrs by crystal violet staining method2015Bioorganic & medicinal chemistry, Nov-01, Volume: 23, Issue:21
Antiviral activity of benzotriazole derivatives. 5-[4-(Benzotriazol-2-yl)phenoxy]-2,2-dimethylpentanoic acids potently and selectively inhibit Coxsackie Virus B5.
AID1524781Selectivity index, ratio of CC50 for cytotoxicity against MDCK cells to EC50 for Influenza A virus (A/California/7/2009(H1N1)) infected in MDCK cells2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
Identification, design and synthesis of novel pyrazolopyridine influenza virus nonstructural protein 1 antagonists.
AID1118643Antiviral activity against HIV-1 3B infected in human CEM cells assessed as inhibition of virus-induced giant cell formation after 4 days by microscopic analysis2011MedChemComm, Jul-01, Volume: 2, Issue:7
Carbocyclic 5'-nor "reverse" fleximers. Design, synthesis, and preliminary biological activity.
AID1360696Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as protection against virus-induced reduction in cell viability after 3 to 6 days by MTS assay2018European journal of medicinal chemistry, Jul-15, Volume: 155Synthesis, biological evaluation and molecular modeling of novel azaspiro dihydrotriazines as influenza virus inhibitors targeting the host factor dihydrofolate reductase (DHFR).
AID253328Cytotoxic concentration against HCV replication in AVA5 cell culture2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
5'-Homoneplanocin A inhibits hepatitis B and hepatitis C.
AID1886818Antiviral activity against ZIKV COL345Si infected in African Green monkey Vero E6 cells assessed as reduction in plaque formation measured after 6 days by crystal violet staining based analysis2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID436476Cytotoxicity against human MT4 cells after 96 hrs by MTT assay2009Bioorganic & medicinal chemistry, Jul-01, Volume: 17, Issue:13
Antiviral and cytotoxic activities of aminoarylazo compounds and aryltriazene derivatives.
AID1081550In vivo antiviral activity against Tobacco mosaic virus (TMV) infected tobacco leaves assessed as protective effect at 500 ug/ml treated 12 hr before viral inoculation measured at 2-3 days after viral challenge2010Journal of agricultural and food chemistry, Jul-14, Volume: 58, Issue:13
5-Methyl-1,2,3-thiadiazoles synthesized via ugi reaction and their fungicidal and antiviral activities.
AID712808Antiviral activity against Influenza A virus (A/Ishikawa/7/82 (H3N2)) infected in MDCK cells assessed as virus-induced cytopathic effect measured 3 days post infection by microscopic analysis2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID226100Minimum inhibitory concentration against Vaccinia virus in primary rabbit kidney cell cultures1989Journal of medicinal chemistry, Aug, Volume: 32, Issue:8
Synthesis and antiviral activity of 3'-C-cyano-3'-deoxynucleosides.
AID659151Antiviral activity against Vesicular stomatitis virus infected in HeLa cells2012Bioorganic & medicinal chemistry, May-01, Volume: 20, Issue:9
Synthesis and biological evaluation of a series of thieno-expanded tricyclic purine 2'-deoxy nucleoside analogues.
AID301693Inactivation of human recombinant S-adenosyl-L-homocysteine hydrolase NAD+ form expressed in Escherichia coli JM109 assessed as increase in fluorescence at 200 uM2007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
The antiviral drug ribavirin is a selective inhibitor of S-adenosyl-L-homocysteine hydrolase from Trypanosoma cruzi.
AID434316Antiviral activity against Reovirus 1 infected in african green monkey Vero cells assessed as protection against virus-induced cytopathogenicity2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis, antiviral and anticancer activity of some novel thioureas derived from N-(4-nitro-2-phenoxyphenyl)-methanesulfonamide.
AID216178Tested for inhibitory effect on RNA virus JV in Vero cell line1993Journal of medicinal chemistry, Nov-12, Volume: 36, Issue:23
Synthesis and antiviral activity of 5'-deoxypyrazofurin.
AID768192Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as reduction of virus-induced cytopathogenicity2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID1773030Antiviral activity against RSV infected in human HEp-2 cells assessed as downregulation of NF-kappaB expression at 25 uM treated 48 hpi and measured after 48 hrs by Western blot analysis2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID216505Tested for minimum inhibitory concentration required to reduce virus-induced cytopathicity by 50% on vero cell line infected with parainfluenza 3 virus1994Journal of medicinal chemistry, Sep-02, Volume: 37, Issue:18
Synthesis and antiviral activity evaluation of some aminoadamantane derivatives.
AID218251Evaluation for antiviral activity against Coxsackie virus B4 in Vero cell cultures (Concentration required to reduce virus-induced cytopathogenicity by 50%)1992Journal of medicinal chemistry, Aug-21, Volume: 35, Issue:17
Antiviral and antitumor structure-activity relationship studies on tetracyclic eudistomines.
AID218431Antiviral activity was measured against Rhino virus-9 in human diploid (WI-38) cells.1986Journal of medicinal chemistry, Feb, Volume: 29, Issue:2
Systematic synthesis and biological evaluation of alpha- and beta-D-xylofuranosyl nucleosides of the five naturally occurring bases in nucleic acids and related analogues.
AID543675Antiviral activity against 10'2 CCID50 Yellow fever virus Jimenez infected in syrian golden hamster assessed as serum ALT level at 10 mg/kg/day, po administered twice daily for 8 days started 4 hrs prior to viral infection2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID718742Antiviral activity against Influenza A virus (A/Puerto Rico/8/1934(H1N1)) H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect2012Bioorganic & medicinal chemistry letters, Dec-01, Volume: 22, Issue:23
Synthesis of isoindole and benzoisoindole derivatives of teicoplanin pseudoaglycon with remarkable antibacterial and antiviral activities.
AID482713Antiviral activity against Sindbis virus infected in african green monkey Vero cells assessed as inhibition of virus-induced cytopathicity2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
"Viologen" dendrimers as antiviral agents: the effect of charge number and distance.
AID1772993Selectivity index, ratio of CC50 for human HEp-2 cells to EC50 for Respiratory syncytial virus infected in human HEp-2 cells2021European journal of medicinal chemistry, Nov-15, Volume: 224Design, synthesis, in vitro and in vivo anti-respiratory syncytial virus (RSV) activity of novel oxizine fused benzimidazole derivatives.
AID1654874Cytotoxicity in African green monkey Vero E6 cells assessed as reduction in cell viability2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
2-((4-Arylpiperazin-1-yl)methyl)benzonitrile Derivatives as Orally Available Inhibitors of Hepatitis C Virus with a Novel Mechanism of Action.
AID1081201Antiviral activity against Tobacco mosaic virus (TMV) infected leaves assessed as viral inhibition at 50 ug/mL at 25 degC for 72 hr2010Journal of agricultural and food chemistry, Mar-10, Volume: 58, Issue:5
Synthesis, crystal structure, and biological activity of 4-methyl-1,2,3-thiadiazole-containing 1,2,4-triazolo[3,4-b][1,3,4]thiadiazoles.
AID217899Minimum inhibitory concentration required to reduce virus induced cytopathicity by 50% was determined against coxsackie B4 virus in Vero cells1992Journal of medicinal chemistry, Sep-04, Volume: 35, Issue:18
Synthesis and antiviral properties of (+/-)-5'-noraristeromycin and related purine carbocyclic nucleosides. A new lead for anti-human cytomegalovirus agent design.
AID1409613Selectivity ratio: ratio of AUC (viral infection %) of SARS-CoV-2 in the Vero E6 cell line compared to AUC (cytotoxicity %) of compound against Vero E6 cells by MTT assay.2020Nature, 07, Volume: 583, Issue:7816
A SARS-CoV-2 protein interaction map reveals targets for drug repurposing.
AID156851Minimum inhibitory concentration required to reduce vesicular stomatitis virus induced cytopathogenicity by 50% in primary rabbit kidney cells (PRK)1989Journal of medicinal chemistry, May, Volume: 32, Issue:5
Synthesis, DNA binding, and biological evaluation of synthetic precursors and novel analogues of netropsin.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID218432Minimum cytotoxic concentration (MCC) required to cause a microscopically detectable alteration of host cell morphology, when incubated with WI-38 cells1987Journal of medicinal chemistry, Jun, Volume: 30, Issue:6
Systematic synthesis and biological evaluation of alpha- and beta-D-lyxofuranosyl nucleosides of the five naturally occurring nucleic acid bases.
AID543686Antiviral activity against 10'2 CCID50 Yellow fever virus Jimenez infected in syrian golden hamster assessed as mean day of death of mice at 50 mg/kg/day, po administered twice daily for 8 days started 4 hrs prior to viral infection relative to control2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID768198Antiviral activity against Coxsackievirus B4 infected in human HeLa cells assessed as reduction of virus-induced cytopathogenicity2013European journal of medicinal chemistry, Aug, Volume: 66Synthesis of 4-aminoquinoline-pyrimidine hybrids as potent antimalarials and their mode of action studies.
AID569232Antiviral activity against thymidine kinase deficient acyclovir-resistant HSV1 KOS infected in HEL cells assessed as inhibition of virus-induced cytopathic effect2011European journal of medicinal chemistry, Feb, Volume: 46, Issue:2
Synthesis of new C5-(1-substituted-1,2,3-triazol-4 or 5-yl)-2'-deoxyuridines and their antiviral evaluation.
AID303232Antiviral activity against RSV in HeLa cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID1592372Antiviral activity against Tobacco mosaic virus inoculated in Nicotiana tabacum leaves assessed as passivation by measuring local lesion numbers at 500 mg/l pre-incubated with virus for 30 mins followed by inoculation and measured up to 4 days2019European journal of medicinal chemistry, Apr-01, Volume: 167Chemical synthesis, crystal structure, versatile evaluation of their biological activities and molecular simulations of novel pyrithiobac derivatives.
AID1600736Antiviral activity against Pichinde virus infected in African green monkey Vero cells assessed as reduction in virus induced cytopathic effect2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
l-like 3-deazaneplanocin analogues: Synthesis and antiviral properties.
AID1729928Antiviral activity against Influenza A virus A/PR/8/34 (H1N1) infected in MDCK cells assessed as reduction in plaque formation treated 1 hr post viral infection and measured after 48 hrs post-infection by toluidine blue staining based plaque reduction ass2021European journal of medicinal chemistry, Jan-01, Volume: 209Synthesis and characterization of 1,2,4-triazolo[1,5-a]pyrimidine-2-carboxamide-based compounds targeting the PA-PB1 interface of influenza A virus polymerase.
AID1433142Antiviral activity against Respiratory syncytial virus infected in human HeLa cells assessed as inhibition of virus-induced cytopathic effect by visual scoring analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis, antiplasmodial activity and mechanistic studies of pyrimidine-5-carbonitrile and quinoline hybrids.
AID1435484Antiviral activity against Coxsackievirus B1 Conn 5 infected in African green monkey Vero cells assessed as inhibition of virus-induced cytopathic effect2017European journal of medicinal chemistry, Jan-27, Volume: 126Synthesis and evaluation of halogenated 12N-sulfonyl matrinic butanes as potential anti-coxsackievirus agents.
AID1886803Antiviral activity against ZIKV infected in African green monkey Vero E6 cells assessed as inhibition of virus induced cytopathic effect at 3.1 to 25 ug/ml measured after 72 hrs by crystal violet staining based inverted microscopic analysis relative to co2022Journal of natural products, 08-26, Volume: 85, Issue:8
Antiviral Profiling of C-18- or C-19-Functionalized Semisynthetic Abietane Diterpenoids.
AID1113461Cytotoxicity against Chlorocebus aethiops (African green monkey) Vero cells assessed as change in cellular morphology2013Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents, , Volume: 22, Issue:4
Synthesis and biological evaluation of 2-(5-substituted-1-((diethylamino)methyl)-2-oxoindolin-3-ylidene)-
AID464177Cytotoxicity against Respiratory syncytial virus infected human HeLa cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID548444Antiviral activity against Influenza B virus infected in MDCK cells assessed as inhibition of virus induced cytopathicity after 2 to 4 days by MTS assay2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
4-[1-(Substituted aryl/alkyl carbonyl)-benzoimidazol-2-yl]-benzenesulfonic acids: synthesis, antimicrobial activity, QSAR studies, and antiviral evaluation.
AID693524Antiviral activity against Influenza A/PR/8/34 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect measured on day 3 post infection by MTS assay2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis of fluorescent ristocetin aglycon derivatives with remarkable antibacterial and antiviral activities.
AID1869554Therapeutic index, ratio of CC50 for Cytotoxicity against human HEp-2 cells to IC50 for Antiviral activity against Respiratory syncytial virus infected in human HEp-2 cells
AID416764Cytotoxicity against human HeLa cells assessed as drug level causing microscopically detectable alteration of normal cell morphology after 3 days2009Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7
Indolylarylsulfones bearing natural and unnatural amino acids. Discovery of potent inhibitors of HIV-1 non-nucleoside wild type and resistant mutant strains reverse transcriptase and coxsackie B4 virus.
AID1201118Antiviral activity against Influenza A virus (A/Puerto Rico/8/34(H1N1)) infected in MDCK cells assessed as cell viability after 72 hrs by MTS assay2015European journal of medicinal chemistry, Apr-13, Volume: 94A few atoms make the difference: synthetic, CD, NMR and computational studies on antiviral and antibacterial activities of glycopeptide antibiotic aglycon derivatives.
AID648651Selectivity index, ratio of TC50 for MDCK cells to IC50 for influenza B virus2012Bioorganic & medicinal chemistry letters, Mar-15, Volume: 22, Issue:6
Synthesis and anti-influenza activity of aminoalkyl rupestonates.
AID1783339Selectivity index, ratio of CC50 for human A549 cells to IC50 for Influenza A Puerto Rico/8/34/H1N1 infected in human A549 cells2021European journal of medicinal chemistry, Nov-15, Volume: 224System-oriented optimization of multi-target 2,6-diaminopurine derivatives: Easily accessible broad-spectrum antivirals active against flaviviruses, influenza virus and SARS-CoV-2.
AID634747Antiviral activity against Herpes simplex virus 2 G infected in human HEL cells assessed as inhibition of viral plaque formation at 250 uM2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Design, synthesis, antiviral and cytostatic evaluation of novel isoxazolidine nucleotide analogues with a 1,2,3-triazole linker.
AID1636356Drug activation in human Hep3B cells assessed as human CYP2C9-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID474352Antiviral activity against Influenza A virus California/07/2009 /H1N1 infected MDCK cells after 3 days by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID303228Antiviral activity against VSV in HEL cells assessed as reduction of virus-induced cytopathogenicity2007Journal of medicinal chemistry, Nov-15, Volume: 50, Issue:23
Ester prodrugs of cyclic 1-(S)-[3-hydroxy-2-(phosphonomethoxy)propyl]-5-azacytosine: synthesis and antiviral activity.
AID1485250Antiviral activity against Influenza A virus A/Virginia/ATCC3/2009(H1N1) infected in MDCK cells assessed as host cell viability measured after 3 to 6 days post infection by MTS assay2017European journal of medicinal chemistry, Jul-28, Volume: 135Host dihydrofolate reductase (DHFR)-directed cycloguanil analogues endowed with activity against influenza virus and respiratory syncytial virus.
AID712812Antiviral activity against amantidine and rimantadine-resistant Influenza B virus (B/HK/5/72) infected in MDCK cells assessed as virus-induced cytopathic effect measured 3 days post infection by microscopic analysis2012ACS medicinal chemistry letters, Dec-13, Volume: 3, Issue:12
Synthesis and Anti-influenza A Virus Activity of 2,2-Dialkylamantadines and Related Compounds.
AID421732Therapeutic index, ratio of TC50 for MDCK cells to IC50 for Influenza A virus infected in MDCK cells2009Journal of natural products, May-22, Volume: 72, Issue:5
Antiviral constituents against respiratory viruses from Mikania micrantha.
AID1432503Antiviral activity against Influenza A virus H1N1 infected in MDCK cells assessed as inhibition of virus-induced cytopathic effect after 40 hrs2017Bioorganic & medicinal chemistry letters, 03-15, Volume: 27, Issue:6
Structure-activity relationship studies of 1-(1'-hydroxyalkyl)rupestonic acid methyl esters against influenza viruses.
AID284538Antiviral activity against Coxsackie virus B4-induced cytopathogenicity in Vero cells2007Bioorganic & medicinal chemistry, Jan-15, Volume: 15, Issue:2
The novel C-5 aryl, alkenyl, and alkynyl substituted uracil derivatives of L-ascorbic acid: synthesis, cytostatic, and antiviral activity evaluations.
AID86836concentration required to inhibit VSV-induced cytopathicity by 50% in HeLa cells1998Journal of medicinal chemistry, Sep-24, Volume: 41, Issue:20
Inactivation of S-adenosyl-L-homocysteine hydrolase and antiviral activity with 5',5',6',6'-tetradehydro-6'-deoxy-6'-halohomoadenosine analogues (4'-haloacetylene analogues derived from adenosine).
AID278350Inhibition of viral RNA levels in HTNV76-118-infected Vero E6 cells at 0.5 ug/ml2007Antimicrobial agents and chemotherapy, Jan, Volume: 51, Issue:1
Activity of ribavirin against Hantaan virus correlates with production of ribavirin-5'-triphosphate, not with inhibition of IMP dehydrogenase.
AID1408328Antiviral activity against Influenza B virus B/Ned/537/05 infected in MDCK cells assessed as reduction in virus-induced cytopathic effect after 3 days by microscopic method2018European journal of medicinal chemistry, Sep-05, Volume: 157Structure-activity relationship studies of lipophilic teicoplanin pseudoaglycon derivatives as new anti-influenza virus agents.
AID1140809Cytotoxicity against MDBK cells after 48 hrs by MTT assay2014Bioorganic & medicinal chemistry letters, May-15, Volume: 24, Issue:10
Synthesis and anti-BVDV activity of novel δ-sultones in vitro: implications for HCV therapies.
AID370209Antiviral activity against 50 PFU Punta Toro virus Adames infected C57BL/6 mouse assessed as survival at 30 mg/kg, po twice daily for 5 days administered 24 hrs post viral challenge2007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections.
AID474545Selectivity ratio of IC50 for MDCK cells to EC90 for Influenza A virus Solomon Islands/03/2006/H1N1 by virus yield reduction assay2010Bioorganic & medicinal chemistry letters, Apr-15, Volume: 20, Issue:8
(-)-Carbodine: enantiomeric synthesis and in vitro antiviral activity against various strains of influenza virus including H5N1 (avian influenza) and novel 2009 H1N1 (swine flu).
AID464180Cytotoxicity against Vaccinia virus infected HEL cells by trypan blue exclusion method2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Synthesis, antibacterial and antiviral properties of curcumin bioconjugates bearing dipeptide, fatty acids and folic acid.
AID1280364Antiviral activity against influenza B virus B/SZ/155 infected in dog MDCK cells assessed as inhibition of virus induced cytopathic effect after 40 hrs by Cell-Titer-Glo assay2016European journal of medicinal chemistry, Jan-27, Volume: 108Spiromastilactones: A new class of influenza virus inhibitors from deep-sea fungus.
AID1082873In vivo antiviral activity against Tobacco mosaic virus (TMV) inoculated right side of Nicotiana. tabacum L. leaves assessed as protection effect at 500 ug/mL preincubated 12 hr before viral challenge measured after 3 to 4 days2012Journal of agricultural and food chemistry, Jun-13, Volume: 60, Issue:23
Design, synthesis, antiviral activity, and SARs of 14-aminophenanthroindolizidines.
AID543659Antiviral activity against Yellow fever virus 17D infected in African green monkey Vero cells assessed as inhibition of virus induced cytopathic effect after 2 hrs by NR dye uptake assay2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Activity of T-705 in a hamster model of yellow fever virus infection in comparison with that of a chemically related compound, T-1106.
AID1246934Selectivity index, ratio of CC50 for MDCK cells by neutral red method to EC50 for Influenza A virus (A/California/07/2009(H1N1) virus by neutral red method2015European journal of medicinal chemistry, Sep-18, Volume: 102Synthesis and antiviral activity of some new bis-1,3-thiazole derivatives.
AID87822Evaluation for antiviral activity against herpes simplex virus type 2 (strain G) in primary rabbit kidney cell culture1986Journal of medicinal chemistry, Jul, Volume: 29, Issue:7
Structure-activity relationship of novel oligopeptide antiviral and antitumor agents related to netropsin and distamycin.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).2014Journal of biomolecular screening, Jul, Volume: 19, Issue:6
A High-Throughput Assay to Identify Inhibitors of the Apicoplast DNA Polymerase from Plasmodium falciparum.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).
AID1804127No assay is provided from Article 10.1002/med.21724: \\The recent outbreaks of human coronaviruses: A medicinal chemistry perspective.\\2021Medicinal research reviews, 01, Volume: 41, Issue:1
The recent outbreaks of human coronaviruses: A medicinal chemistry perspective.
AID1802102Radioligand Binding Assay from Article 10.1021/acschembio.6b00357: \\Structure-Based Screening of Uncharted Chemical Space for Atypical Adenosine Receptor Agonists\\2016ACS chemical biology, 10-21, Volume: 11, Issue:10
Structure-Based Screening of Uncharted Chemical Space for Atypical Adenosine Receptor Agonists.
AID1346059Human inosine monophosphate dehydrogenase 2 (Nucleoside synthesis and metabolism)2012Bioorganic & medicinal chemistry, Jun-01, Volume: 20, Issue:11
Novel 1,2,4-triazole and imidazole derivatives of L-ascorbic and imino-ascorbic acid: synthesis, anti-HCV and antitumor activity evaluations.
AID1346128Human inosine monophosphate dehydrogenase 1 (Nucleoside synthesis and metabolism)2012Bioorganic & medicinal chemistry, Jun-01, Volume: 20, Issue:11
Novel 1,2,4-triazole and imidazole derivatives of L-ascorbic and imino-ascorbic acid: synthesis, anti-HCV and antitumor activity evaluations.
AID977611Experimentally measured binding affinity data (Kd) for protein-ligand complexes derived from PDB2014eLife, Jul-31, Volume: 3Structural basis of nucleoside and nucleoside drug selectivity by concentrative nucleoside transporters.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (11,480)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990592 (5.16)18.7374
1990's781 (6.80)18.2507
2000's4114 (35.84)29.6817
2010's5382 (46.88)24.3611
2020's611 (5.32)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,880 (15.26%)5.53%
Reviews2,023 (16.43%)6.00%
Case Studies1,245 (10.11%)4.05%
Observational196 (1.59%)0.25%
Other6,972 (56.61%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (762)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Does Vitamin D Supplement Improve SVR in Chronic Hepatitis C (Genotype 2,3) in naïve Patients Treated With Peginterferon Alpha and Ribavirin [NCT01146626]60 participants (Anticipated)Interventional2011-08-31Not yet recruiting
A Multi-center, Sequential-cohort, Placebo-controlled, 7-day Treatment Period Study of the Safety and Pharmacokinetics of Multiple Ascending Oral Doses of INX-08189 in Chronically-infected Genotype 1 HCV, Treatment-naïve Subjects [NCT01250366]Phase 170 participants (Actual)Interventional2010-10-31Completed
A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Received Prior Treatment [NCT00336479]Phase 2263 participants (Actual)Interventional2006-06-30Completed
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus [NCT01263860]Phase 3242 participants (Actual)Interventional2010-12-31Completed
A Phase III, Multicentre, Double Blinded Study In Patients With Chronic Hepatitis C Who Are Non-Responders To Prior Peginterferon Alpha + Ribavirin Therapy Comparing Treatment With Thymosin Alpha 1 + Peginterferon Alpha-2a Plus Ribavirin With Peginterfero [NCT01178996]Phase 3552 participants (Actual)Interventional2004-12-31Completed
Low Dose Peginterferon and Ribavirin Therapy for Patients With Chronic Hepatitis C Infected With Genotype 2 or 3 [NCT00056862]Phase 458 participants (Actual)Interventional2003-03-31Completed
A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1 [NCT01185860]Phase 159 participants (Actual)Interventional2009-08-31Completed
Comparison of Three Regimens of PEG-Intron and Ribavirin in the Treatment of Chronic Hepatitis C, Genotype 2 or 3, in Previously Untreated Patients [NCT00302081]Phase 3696 participants (Actual)Interventional2003-08-31Completed
An Open-label, Dose Escalation Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients Expressing Elevated eIF4E [NCT01309490]Phase 1/Phase 237 participants (Anticipated)Interventional2011-03-31Recruiting
Use of Immune Modulatory Properties of Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity: Proposal for Pilot Clinical Trial [NCT03759782]Phase 324 participants (Anticipated)Interventional2019-01-10Recruiting
A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection [NCT01371604]Phase 268 participants (Actual)Interventional2011-07-31Completed
A Randomized, Placebo-controlled, Phase 2a Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I [NCT01142700]Phase 20 participants (Actual)Interventional2010-07-31Withdrawn
Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study [NCT01289496]Phase 213 participants (Actual)Interventional2011-02-28Completed
A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a C [NCT01581138]Phase 264 participants (Actual)Interventional2012-07-31Completed
A Triple Combination Antiviral Coronavirus Therapy (TriACT) RCT Comparing Nitazoxanide, Ribavirin and Hydroxychloroquine vs. Placebo [NCT04605588]Phase 27 participants (Actual)Interventional2020-12-02Terminated(stopped due to Lack of participants willing to enroll)
A Study to Investigate HCV Response Rates in Real World Patients Traditionally Excluded From Clinical Trials: The HEARTLAND Study [NCT03710252]Phase 4100 participants (Actual)Interventional2016-03-31Completed
Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve SVR in Genotype 2,3 Chronic Hepatitis C Patients? [NCT01151397]60 participants (Anticipated)Interventional2011-08-31Not yet recruiting
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed [NCT02822794]Phase 3117 participants (Actual)Interventional2016-07-25Completed
A Phase IIb/IIIa, Randomized Study to Evaluate the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4 [NCT02371408]Phase 2/Phase 3300 participants (Anticipated)Interventional2015-01-31Active, not recruiting
An Open-label, Randomized, Active Control Study to Demonstrate Non-Inferiority in Efficacy, and to Compare Safety and Tolerability of P1101 + Ribavirin to PEG-Intron + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic HCV Genotype 2 Infection [NCT04382937]Phase 3222 participants (Actual)Interventional2016-01-12Completed
A Prospective, Randomized, Open-label Study Evaluating the Viral Kinetics and Pharmacokinetics of Pegasys® Plus Copegus® and PEG-Intron® Plus Rebetol® in Interferon-naïve Patients With Chronic Hepatitis C. [NCT00087607]Phase 4385 participants (Actual)Interventional2004-01-31Completed
A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis [NCT02996682]Phase 3102 participants (Actual)Interventional2016-12-26Completed
Pilot Study of PegInterferon-Ribavirin-Telaprevir Efficacy and Tolerability in HIV-HCV Coinfected Patients Who Had Previously Failed a PegInterferon-Ribavirin Regimen. (ANRS HC26 TelapreVIH) [NCT01332955]Phase 270 participants (Actual)Interventional2011-04-30Completed
Pilot Study to Assess the Efficacy and Safety of Boceprevir, in Combination With Peg-Interferon Alfa and Ribavirin, in Patients With HCV/HIV Co-infection Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin [NCT01335529]Phase 269 participants (Actual)Interventional2011-05-31Completed
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C - An Observational Study in Israel (CITRINE STUDY) [NCT02803138]256 participants (Actual)Observational2016-07-07Completed
Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial) [NCT03549832]40 participants (Actual)Interventional2018-01-01Completed
A Phase III Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Treatment-Naïve Patients With Chronic Hepatitis C Infection [NCT01370642]Phase 3294 participants (Actual)Interventional2011-06-27Completed
Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar [NCT03579576]803 participants (Actual)Observational2017-12-20Completed
An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection [NCT02156570]Phase 420 participants (Anticipated)Interventional2014-10-31Completed
A Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects With Chronic Hepatitis C Previously Treated With an NS5A Inhibitor + Sofosbuvir Therapy [NCT03092375]Phase 3177 participants (Actual)Interventional2017-04-20Completed
Boceprevir Treatment in Liver Pre-transplant HCV Patients [NCT02160080]Phase 320 participants (Anticipated)Interventional2014-01-31Recruiting
A Phase 1b/2a Open-label, Multi-center Study to Assess the Safety, Efficacy and Pharmacokinetics of Intrapatient Dose-adjusted Brequinar and Inhibition of Dihydroorotate Dehydrogenase (DHODH) in Adult Subjects With AML [NCT03760666]Phase 1/Phase 217 participants (Actual)Interventional2018-12-20Terminated(stopped due to No efficacy observed, COVID-19 caused sites to shut down)
SEASON South East Asian Study Of Novel Genotypes in Hepatitis C Infection: Pegylated-Interferon and Ribavirin Therapy (PEGATRON REDIPEN Combination Therapy (PEG-Intron® REDIPEN Plus REBETOL®)) in Treatment Naive Patients With Genotypes 1, 6, 7, 8, 9: A Co [NCT00255008]Phase 4121 participants (Actual)Interventional2005-03-31Terminated(stopped due to Slow enrollment)
A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection [NCT00077636]Phase 41,469 participants (Actual)Interventional2003-12-31Completed
Randomized, Multicenter, Double-blind, Phase IV Pilot Study Evaluating the Effect of PEGASYS Doses of 180 ug or 270 ug in Combination With Copegus Doses of 1200 mg or 1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interfe [NCT00077649]Phase 4188 participants (Actual)Interventional2004-01-31Completed
Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C) [NCT00006164]Phase 31,050 participants (Actual)Interventional2000-06-30Completed
PROTECT - Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation: Efficacy and Safety in Hepatitis C Recurrence Therapy [NCT00378599]Phase 3125 participants (Actual)Interventional2006-05-31Completed
A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin [NCT00708500]Phase 3404 participants (Actual)Interventional2008-08-31Completed
Randomized, Multi-Center, Phase IV, Comparative Study to Assess the Efficacy and Safety of Combined Peg-Interferon Alpha-2a (40 kD) With Ribavirin Combined Therapy for 48 or 72 Weeks of Treatment and 24 Weeks of Follow-Up in Patients With Chronic Hepatiti [NCT02761629]Phase 4180 participants (Actual)Interventional2005-04-30Completed
Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic G [NCT02483156]Phase 2/Phase 380 participants (Actual)Interventional2015-07-31Completed
A Randomized, Open-Label, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection (CERTAIN-2) [NCT02723084]Phase 3136 participants (Actual)Interventional2016-04-08Completed
Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program. [NCT00704522]601 participants (Actual)Observational2005-03-31Completed
Observational Multicenter Study to Evaluate Influence of Insulin Resistance on the Safety and Efficacy (as Measured by Sustained Virological Response) of Treatment With Any Pegylated Interferon and Ribavirin (Standard of Care) in Different Populations of [NCT00705224]250 participants (Actual)Observational2008-05-31Completed
A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection [NCT01193361]Phase 239 participants (Actual)Interventional2010-10-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Inf [NCT00703118]Phase 3663 participants (Actual)Interventional2008-10-31Completed
A Randomized, Double-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patie [NCT00869661]Phase 2413 participants (Actual)Interventional2001-02-28Completed
Effect Of Interferon-Free Direct Acting Antiviral Agents For Treatment Of Hepatitis C Virus Patients On The Normal Kidney [NCT03296930]Phase 4100 participants (Anticipated)Interventional2017-10-01Not yet recruiting
Generic Velpatasvir Plus Sofosbuvir With or Without Ribavirin for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus [NCT03250910]Phase 4228 participants (Actual)Interventional2016-08-01Completed
A Phase 2, Randomized, Open-Label Study Of The Safety, Antiviral Activity, And Pharmacokinetics Of HCV-796 Administered In Combination With Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol In Subjects With Hepatit [NCT00367887]Phase 2246 participants (Actual)Interventional2006-10-31Completed
Peginterferon Plus Ribavirin Combination Therapy for Hepatitis C Six Months After Onset of Acute Infection [NCT02377856]Phase 420 participants (Actual)Interventional2007-06-30Completed
A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic Hepatitis D [NCT02731131]Phase 212 participants (Actual)Interventional2004-09-30Completed
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared With GS-5885, GS-9451 With Tegobuvir or RBV in Treatment-Experienced Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) I [NCT01435226]Phase 2170 participants (Actual)Interventional2011-09-30Completed
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy Using Combinations of Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Ch [NCT01371578]Phase 2163 participants (Actual)Interventional2011-07-31Completed
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis [NCT01483742]Phase 243 participants (Actual)Interventional2012-04-30Completed
A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection [NCT01353248]Phase 2141 participants (Actual)Interventional2011-05-31Completed
Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1 [NCT00402428]Phase 31,331 participants (Actual)Interventional2006-12-31Completed
Efficacy and Safety of the Combination Vitamin D (Vit D), With Pegylated Interferon Alpha-2b (PEG-IFN)/Ribavirin (RBV) in Egyptian Patients With Untreated Chronic Hepatitis C: A Phase III Randomized Open-label Clinical Trial [NCT02099604]Phase 30 participants (Actual)Interventional2014-04-30Withdrawn(stopped due to Study objectives were considered as obsolete regarding the new AAD arrival)
A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C [NCT02097966]0 participants Expanded AccessNo longer available
Prospective, Single-Center, Open Label, Pilot Study of Safety and Efficacy of Triple Anti-Viral Therapy With Pegylated Interferon, Ribavirin, and Boceprevir in Patients With Genotype 1 Chronic HCV With End Stage Renal Disease [NCT02112630]0 participants (Actual)Interventional2013-05-31Withdrawn(stopped due to Poor enrollment)
480 STUDY: Phase 2b Open-label, Randomized Study in Treatment Naïve Subjects With HCV G1 to Compare the Efficacy, Safety, and Tolerability of the 480 µg Dose of Locteron™ Plus Ribavirin Given Bi-Weekly to PEG-Intron™ Plus Ribavirin Given Weekly [NCT00953589]Phase 274 participants (Actual)Interventional2009-07-31Completed
A Phase 2, Open-Label Clinical Trial to Study the Efficacy and Safety of 12 Weeks of the Combination Regimen of MK-3682 + Ruzasvir in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 3, 4, 5 or 6 Infection [NCT02956629]Phase 2282 participants (Actual)Interventional2016-11-16Terminated(stopped due to The study was terminated based on review of Phase 2 efficacy data)
A Phase III, Open-Label Study in Japan to Assess the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2b and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects [NCT01366638]Phase 379 participants (Actual)Interventional2011-05-31Completed
Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C [NCT00104052]Phase 3107 participants (Actual)Interventional2005-02-28Completed
Open Label, Study to Determine the Pharmacokinetic Interactions of Steady State Tipranavir/Ritonavir (500/200 mg) and Steady State Ribavirin and Pegylated Interferon Alfa 2a in HIV Negative, HCV Infected Subjects With Mild Hepatic Impairment and the Pharm [NCT02259855]Phase 136 participants (Actual)Interventional2006-01-31Completed
A Phase II, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study, With an Open-Label Extension, to Evaluate the Efficacy, Safety, and Pharmacokinetics of E5501 in Subjects With Chronic Hepatitis C Virus Related Thrombocytopenia [NCT01355289]Phase 265 participants (Actual)Interventional2011-11-30Completed
A Phase 2a Trial to Evaluate the Safety, Tolerability, and Efficacy of 12 Weeks of Sovaprevir, ACH-0143102 and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotype-1 Viral Infection [NCT01849562]Phase 230 participants (Actual)Interventional2013-04-30Completed
A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment-naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b [NCT01700179]Phase 18 participants (Actual)Interventional2012-09-30Completed
QUANTUM: An International, Multi-center, Blinded, Randomized Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Administration of Regimens Containing PSI-352938, PSI-7977, and Ribavirin in Patients With Chronic Hepa [NCT01435044]Phase 2239 participants (Actual)Interventional2011-09-30Completed
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV In [NCT01434498]Phase 2163 participants (Actual)Interventional2011-09-30Completed
A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Telaprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis [NCT01482390]Phase 280 participants (Actual)Interventional2011-11-30Completed
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepat [NCT01225380]Phase 2324 participants (Actual)Interventional2010-10-31Completed
Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With He [NCT01455090]Phase 2320 participants (Actual)Interventional2011-11-30Completed
A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy [NCT01331850]Phase 2381 participants (Actual)Interventional2011-05-31Completed
A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) an [NCT01309932]Phase 2165 participants (Actual)Interventional2011-03-31Completed
A Relative Bioavailability Study of Ribavirin 200 mg Tablets Under Non-Fasting Conditions [NCT00835536]Phase 127 participants (Actual)Interventional2003-09-30Completed
A Relative Bioavailability Study of Ribavirin 200 mg Tablets Under Fasting Conditions [NCT00835146]Phase 128 participants (Actual)Interventional2003-09-30Completed
An Open-Label, Multicenter, Parallel-Group, Randomized, Phase II/III Study to Evaluate the Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19 [NCT04828564]Phase 2/Phase 3100 participants (Anticipated)Interventional2021-04-30Not yet recruiting
Pilot Study to Assess Efficacy and Safety of a Quadruple Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Non-responders to Pegylated Interferon-Ribavirin Regimen [NCT02107365]Phase 260 participants (Actual)Interventional2013-11-30Completed
Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 & 3 [NCT02216045]Phase 240 participants (Actual)Interventional2014-06-30Completed
Phase 2a, Randomized, Double-Blind Study to Investigate the Safety and Efficacy of Faldaprevir in Combination With Ribavirin and TD-6450 for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 4 Hepatitis C Virus [NCT02593162]Phase 216 participants (Actual)Interventional2015-10-31Completed
Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study [NCT02220868]Phase 410 participants (Actual)Interventional2014-07-31Completed
A Phase II, Randomized, Multi-center, Two Part Study of the Safety and Efficacy of Double-blind, Placebo-controlled INX-08189 in Adjunctive Treatment With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Study Part A, and Open-label INX-08189 [NCT01425970]Phase 2210 participants (Actual)Interventional2012-05-31Terminated(stopped due to Termination of study was due to safety reasons)
A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 [NCT01616524]Phase 3880 participants (Actual)Interventional2012-07-31Completed
A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis [NCT01516918]Phase 2103 participants (Actual)Interventional2012-02-29Completed
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Vi [NCT01356160]Phase 2351 participants (Actual)Interventional2011-07-31Completed
A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection [NCT01030432]Phase 2285 participants (Actual)Interventional2010-02-28Completed
Randomized Controlled Study of Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection [NCT02261662]30 participants (Anticipated)Interventional2014-06-30Recruiting
PEG-Intron Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With Ribavirin) [NCT00039871]Phase 32,333 participants (Actual)Interventional2002-05-31Completed
Treatment of Recently Acquired Hepatitis C Virus Infection [NCT01336010]Phase 482 participants (Actual)Interventional2011-08-31Completed
Pegylated Interferon Alfa-2a Plus Ribavirin for Patients With Chronic Hepatitis c Virus on Opioid Pharmacotherapy: Virological and Psychological Outcomes [NCT01120795]Phase 455 participants (Actual)Interventional2004-02-29Completed
A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials [NCT00943761]Phase 245 participants (Actual)Interventional2009-10-23Completed
Multicenter Study on Efficacy of New Therapeutic Schedules With Peg-Interferon alpha2b and Ribavirin in Patients With Genotype 3 Chronic HCV( Hepatitis C Virus) Infection [NCT01121705]Phase 3360 participants (Actual)Interventional2007-01-31Completed
Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs. [NCT04457050]Phase 4160 participants (Actual)Interventional2017-10-30Completed
[NCT01226771]Phase 3105 participants (Actual)Interventional2010-09-30Completed
Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program. [NCT00723879]115 participants (Actual)Observational2004-10-31Terminated(stopped due to Because of slow recruitment; Despite the study was started long time ago (Oct 2004), we have not reached the projected number of patients (150 patients))
Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients [NCT01137383]Phase 3108 participants (Actual)Interventional2007-12-31Completed
A Double-Blind, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Romiplostim, Administered Once Weekly to Thrombocytopenic Hepatitis C (HCV) Infected Subjects Who Are Not Candidates for Antiviral Treatment With Pegylated Interferon a [NCT01153919]Phase 227 participants (Actual)Interventional2010-06-30Terminated(stopped due to Approval of several new agents for the treatment of HCV infection would mitigate the future need for interferon HCV treatment)
A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection [NCT01581203]Phase 3748 participants (Actual)Interventional2012-05-31Completed
Open-label, Multicenter, Non-Comparative Prospective Study to Assess the Safety of Individualized Combination Therapy With Ribavirin And Peginterferon Alfa-2a (40 kD) in Patients With Chronic Hepatitis C (CHC) (MASTER Study) [NCT01296971]Phase 30 participants (Actual)Interventional2009-12-31Withdrawn(stopped due to study was not started due to an administrative reason on the part of the local Health Authority)
Improvement of the Surveillance and Control of Liver Disease and Complication Due to Chronic Hepatitis C: Project A) Antiviral Drugs Use, Efficacy, Safety and Costs; Project B) Kinetics of Virological Response. [NCT01195181]Phase 4506 participants (Actual)Interventional2005-09-30Completed
PREDICT - Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A [NCT00709228]496 participants (Actual)Observational2006-05-31Completed
Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients. [NCT02890719]Phase 30 participants (Actual)Interventional2017-05-02Withdrawn(stopped due to impossibility of supplying the medication in research of the study by the pharmaceutical company that gave it to the trial)
An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-333 and Ribavirin (RBV) in Treatment-Naive and Non-responder Subjects With Genotype 1 Chronic Hep [NCT01306617]Phase 250 participants (Actual)Interventional2011-02-28Completed
High-dose Versus Standard-dose Weight-based Ribavirin in Combination With Peginterferon Alfa-2a for Patients Infected With Hepatitis C Virus Genotype 1 or 4 [NCT00662220]Phase 3110 participants (Actual)Interventional2008-04-30Terminated(stopped due to Due to the arrival of DAAs replacing standard of care for genotype 1 patients the VIRID study had to be terminated.)
A Phase III, Randomized, Open-label, Two-arm Trial in Japan to Investigate the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Hepatitis C, Genotype 1-Infected Subjects Who Failed to Respond to [NCT01288209]Phase 3106 participants (Actual)Interventional2011-02-28Completed
Randomized, Multicenter Study to Compare the Efficacy of Pegylated Interferon Alfa (PEG-IFN) in Combination With Two Different Doses of Ribavirin in Patients With Chronic Hepatitis C and Subtype 2/3 [NCT01258101]Phase 4395 participants (Actual)Interventional2003-05-31Completed
A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection [NCT01257204]Phase 2196 participants (Actual)Interventional2010-12-31Completed
A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection [NCT00580801]Phase 224 participants (Actual)Interventional2008-01-31Completed
Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naive Subjects: A Comparison of Erythropoietin Use Versus Ribavirin Dose Reduction for the Management of Anemia [NCT01023035]Phase 3687 participants (Actual)Interventional2009-12-07Completed
A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection [NCT01017575]Phase 255 participants (Actual)Interventional2009-12-31Completed
Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II) [NCT00984620]Phase 2160 participants (Actual)Interventional2009-09-30Completed
A Prospective Observational Post-Marketing Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection [NCT02537379]552 participants (Actual)Observational2015-09-15Completed
An Open-label, Multi-center Study to Evaluate Sustained Virologic Response With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Genotype 1 Chronic Hepatitis C Virus Infected Patients With Past PI Failure [NCT02646111]Phase 3120 participants (Anticipated)Interventional2016-01-31Not yet recruiting
Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study. [NCT00728494]99 participants (Actual)Observational2005-10-31Completed
Observational,Post-authorization Prospective Study to Develop and Validate a Prognostic Tool for Optimizing Therapy in Patients With Hepatitis C Virus (HCV) Genotype 1 and 4. [NCT01884402]770 participants (Actual)Observational2010-10-31Completed
Relapse Rate and Predictive Factors in the Treatment of Hepatitis C in Common Clinical Practice [NCT00725842]97 participants (Actual)Observational2009-01-31Terminated(stopped due to Low enrollment)
Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program [NCT00723892]614 participants (Actual)Observational2005-07-31Completed
A Pilot Study of Therapy With Pioglitazone Prior to HCV Treatment in HIV-1 and HCV Genotype 1-Infected Subjects With Insulin Resistance Who Are Prior Nonresponders to Peginterferon and Ribavirin Therapy [NCT00665353]Phase 219 participants (Actual)Interventional2009-03-31Completed
The Activity of Nitazoxanide in Addition to Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Treatment-Naive Genotype 1 Subjects With HIV Coinfection [NCT00991289]Phase 268 participants (Actual)Interventional2010-01-31Completed
Non-insulin-dependent Diabetes Mellitus and Insulin Resistance in Chronic Hepatitis C Patients Treated With Combination Therapy With Pegylated Interferon and Ribavirin in Taiwan [NCT00687999]400 participants (Actual)Interventional2005-12-31Completed
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3 [NCT02551861]Phase 20 participants (Actual)Interventional2015-12-31Withdrawn
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (Protocol No. P05411) [NCT00959699]Phase 299 participants (Actual)Interventional2009-11-30Completed
Phase 2B, Partially Blinded, Randomized Study in Treatment Naive HCV G1 to Compare the Efficacy, Safety, and Tolerability of Three Doses of Locteron Plus Ribavirin Given Bi-weekly in Comparison With PEG-Intron Plus Ribavirin Given Weekly [NCT00863239]Phase 2116 participants (Actual)Interventional2009-03-31Completed
A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Fa [NCT01358864]Phase 3678 participants (Actual)Interventional2011-06-30Completed
[NCT02557646]697 participants (Actual)Observational2009-05-31Completed
A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C G [NCT01573351]Phase 3398 participants (Actual)Interventional2012-05-31Completed
A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis [NCT01482403]Phase 258 participants (Actual)Interventional2011-11-30Completed
A Phase 2 Open-Label Study in Patients With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant to Explore the Safety And Efficacy of Simeprevir and Sofosbuvir With and Without Ribavirin [NCT02165189]Phase 246 participants (Actual)Interventional2014-08-31Completed
TAC (Treatment Africa Hepatitis C) : Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus- [NCT02405013]Phase 2120 participants (Actual)Interventional2015-10-31Completed
Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3. [NCT00411385]Phase 3933 participants (Actual)Interventional2007-02-28Completed
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT3, GT4, GT5, and GT6 Infection [NCT02332720]Phase 2413 participants (Actual)Interventional2015-01-28Completed
A Non-interventional Phase IV Survey to Assess the Antiviral Effectiveness of PegIntron® and Rebetol® Treatment According to the Stage of Liver Fibrosis in Previously Untreated Patients With Genotype 1/4/5/6 Chronic Hepatitis C (CHC) (PRACTICE) [NCT00709059]538 participants (Actual)Observational2004-12-31Completed
An Open-label Randomised Controlled Trial on IFN Beta-1b and Ribavirin Combination, as Treatment for Covid-19 Infection [NCT04494399]Phase 296 participants (Anticipated)Interventional2020-07-29Recruiting
Safety and Efficacy of Hansenula-Derived Pegylated-Interferon Alpha-2a and Ribavirin Customized Combination Therapy in Egyptian Children With Chronic Hepatitis C Infection [NCT02027493]46 participants (Actual)Interventional2009-02-28Completed
Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by PRC National Clinical Research Base of Traditional Chinese Medicine for Major Diseases [NCT02069665]451 participants (Actual)Interventional2011-12-31Completed
Randomized, Multicentric, Partially Double-Blinded Placebo-Controlled Phase II Study for Examining the Influence of Ribavirin on the Initial Virological Response With Treatment of Peginterferon Alfa-2a (40KD) and Ribavirin With a Six Week Pretreatment-Pha [NCT02716779]Phase 268 participants (Actual)Interventional2007-04-30Completed
Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients [NCT03266601]Phase 4668 participants (Actual)Interventional2016-06-01Completed
A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Ch [NCT01353911]Phase 2368 participants (Actual)Interventional2011-06-27Completed
A Prospective, Observational Study to Assess the Virological Response at Week 4 to the Therapy With PEGASYS® (Peginterferon Alfa 2a) Plus COPEGUS® (Ribavirin) in a Population of Treatment Naïve Patients With Chronic Hepatitis C, Genotype 2 or 3. [NCT00700401]262 participants (Actual)Observational2008-11-30Completed
Comparison of Maintenance Treatment by Ribavirin to a Placebo, After an Initial One-year Treatment With Pegylated Interferon-α2a - Ribavirin Association in Hepatitis C Viral Recurrence After Liver Transplantation [NCT00151580]Phase 3200 participants (Actual)Interventional2002-02-28Completed
Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir and Re-assessment of Treatment Duration in Patients With Chronic Hepatitis C [NCT02113631]50 participants (Actual)Interventional2011-09-30Completed
Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, [NCT01359644]Phase 2350 participants (Actual)Interventional2011-06-30Completed
Real Life Experience in the Management of HCV Related Decompensated Cirrhosis With Direct Antiviral Agents [NCT03547895]80 participants (Actual)Interventional2015-06-01Completed
Observational Cohort Study of Clinical Outcomes After Antiviral Therapy in Chronic Hepatitis C Patients [NCT04071353]1,000 participants (Anticipated)Observational2019-08-01Recruiting
Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C [NCT00956982]1,251 participants (Anticipated)Interventional2004-12-31Recruiting
A Phase 2 Randomized, Open Label, Multi-center, Therapeutic Trial of the Efficacy, Immunogenicity, and Safety of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, Combined With Pegylated I [NCT00606086]Phase 2140 participants (Actual)Interventional2007-12-31Completed
PEG Intron/REBETOL Combination Therapy Special Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C- [NCT00724295]1,077 participants (Actual)Observational2005-04-30Completed
Phase 2 Comparison of Weight-based Doses of Taribavirin Combined With Peginterferon Alfa-2b Versus Ribavirin Combined With Peginterferon Alfa-2b in Therapy-naïve Patients With Chronic Hepatitis C Virus Genotype 1 Infection [NCT00446134]Phase 2278 participants (Actual)Interventional2007-03-31Completed
Prospective, Open-label, Randomised Controlled Trial on Efficacy and Tolerability of PegIFN-alpha 2a + Serum Level-adapted RBV vs. PegIFN-alpha 2a + Weight-based RBV in Treatment-naive Patients With Chronic Hepatitis C Genotype 1 [NCT00944684]Phase 232 participants (Actual)Interventional2007-11-30Completed
Prospective Anti-HCV Trial of Peg-Interferon and Ribavirin in Subjects of First Nations, Metis and Caucasian Ethnicity: PRAIRIE Study [NCT00957866]Phase 4160 participants (Anticipated)Interventional2009-05-31Completed
A Prospective, Multicenter, Open-label, Comparative, Efficacy Study of Pegasys® Plus Copegus® in Treatment-naïve Latino Patients With Chronic Hepatitis C-genotype 1, as Compared to Treatment-naïve Non- Latino Caucasian Patients With Chronic Hepatitis C-ge [NCT00107653]Phase 4569 participants (Actual)Interventional2004-10-31Completed
Low Dose Treatment of Ribavirin in Combination With PEG-IFN Alfa-2b in CHC Patients With genotype1 High Viral Load and Low Body Weight [NCT00686777]Phase 475 participants (Actual)Interventional2008-01-31Completed
Neurobehavioral Deficits in HIV/HCV Infection Pre/Post Anti-HCV Therapy [NCT00747539]330 participants (Actual)Observational2008-07-31Completed
A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 [NCT00423670]Phase 2765 participants (Actual)Interventional2007-01-31Completed
A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy [NCT00420784]Phase 2465 participants (Actual)Interventional2007-02-28Completed
Double Filtration Plasmapheresis (DFPP) in Combination With Pegylated Interferon Alfa-2a and Ribavirin for Patients With Chronic Hepatitis C With Genotype 1 and High Viral Load: a Randomized Controlled Trial [NCT00977054]Phase 459 participants (Actual)Interventional2009-09-30Terminated(stopped due to Novel HCV DAA approved by FDA)
Phase 2 Randomized Multicenter Controlled Study of Ribavirin Pre-treatment (8 Weeks) Followed by Standard Therapy With Ribavirin and Pegylated Interferon (48 Weeks) in Transplanted Patients With Recurrence of Chronic Hepatitis C [NCT00993122]Phase 4100 participants (Actual)Interventional2009-10-31Completed
A Phase 2 Treatment Protocol of Intravenous Ribavirin in Adult Subjects With Hemorrhagic Fever With Renal Syndrome (HFRS) in the 121st Combat Support Hospital (Seoul, Korea) [NCT00623168]Phase 250 participants (Anticipated)Interventional2008-02-29Enrolling by invitation
EXtended Therapy in Genotype 3 Infected Patients Who do Not AChieve a Treatment Response at Week 4 (RVR) But do Achieve a Complete Early Virologic Response (cEVR) [NCT01095445]Phase 32 participants (Actual)Interventional2010-02-28Terminated(stopped due to Unlikely to recruit the adequate number of patients within a reasonable timeline)
Optimization of Treatment for Patients With Chronic Hepatitis C Infected With HCV-genotype 2 or 3: 12 vs. 24 Weeks of Treatment Extension for Patients Without Rapid Virological Response [NCT00803309]Phase 499 participants (Actual)Interventional2008-11-30Terminated(stopped due to At the end of the planned recruitment period the expected number of subjects could not be included in the trial.)
Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis [NCT00811967]Phase 350 participants (Actual)Interventional2003-02-28Terminated
Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG-rIL-29 Administered in Combination With Ribavirin to Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection [NCT01001754]Phase 2600 participants (Anticipated)Interventional2010-05-31Active, not recruiting
Effect of High Dose vs. Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3, High Viral Load Without Rapid Virological Response [NCT00830609]Phase 4101 participants (Actual)Interventional2008-11-30Completed
Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4 [NCT02772744]250 participants (Anticipated)Observational2017-11-01Not yet recruiting
A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Faldaprevir and TD 6450 Alone and in Combination With Other Antivirals for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 1 Hepatitis C Virus [NCT02716428]Phase 225 participants (Actual)Interventional2016-05-31Completed
An Open-label Pilot Study of Dose Escalation of PEGASYS on Virological Response in Patients With Chronic Hepatitis C Viral Infection Showing an Early Non-response to a Standard Course of PEGASYS Plus Ribavirin [NCT02791256]Phase 323 participants (Actual)Interventional2005-06-30Terminated
Ribavirin, Its Dosing Regime [NCT00484328]Phase 415 participants (Actual)Interventional2007-07-31Completed
Sustained Viral Response Rate in 50 Subjects With Cirrhosis Due to Hepatitis C, Genotype 1, Treated With 12 Weeks of Sofosbuvir, Ledipasvir and Ribavirin [NCT02705534]Phase 350 participants (Actual)Interventional2016-09-30Completed
Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir [NCT02647632]Phase 226 participants (Actual)Interventional2016-01-31Completed
An Open-label Multicenter Study Evaluating the Efficacy and Safety of 24 or 48 Weeks Pegylated Interferon Alfa-2a 40 kD (PEGASYS) Combination Therapy With Ribavirin (Copegus) in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Ha [NCT00641654]Phase 475 participants (Actual)Interventional2007-01-31Terminated(stopped due to Recruitment problems in Denmark and Norway)
A Randomized, Open-label Study of the Effect of PEGASYS ® Plus COPEGUS® With or Without Concomitant Pioglitazone (Actos®) on Early Viral Kinetics in Treatment-naive Patients With Chronic Hepatitis C, Genotype-1, and Insulin Resistance [NCT00545233]Phase 4155 participants (Actual)Interventional2008-01-31Completed
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC [NCT02771405]Phase 3150 participants (Anticipated)Interventional2016-03-31Recruiting
New Drugs And New Concerns: Gaining Insight Through Pharmacovigilance Of Direct Acting Anti-Viral's In Chronic HCV Patients [NCT04664894]511 participants (Actual)Observational2018-05-15Completed
A Prospective Randomized, Open Labeled, Phase IV, Multicenter Study for Peginterferon Alfa-2a and Weight-based Ribavirin for 16 or 24 Weeks in genotype2 Chronic Hepatitis C Patients Who Achieved Rapid Virologic Response [NCT01056172]Phase 4164 participants (Anticipated)Interventional2010-01-31Recruiting
A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Sub [NCT00528528]Phase 2166 participants (Actual)Interventional2007-10-31Completed
Phase IV Study of Effectiveness of Interferon and Ribavirin Treatment in Thalassemia Major Patients With Chronic Viral Hepatitis C [NCT00887081]Phase 4150 participants (Anticipated)Interventional2009-01-31Recruiting
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs [NCT04278404]5,000 participants (Anticipated)Observational2020-03-05Recruiting
Multicentre, Randomised, Open-label Study Comparing the Tolerability and Viral Reduction of the Combination of IFN Alpha-2b XL + Ribavirin Versus Peg IFN Alpha-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4. [NCT01010646]Phase 284 participants (Anticipated)Interventional2010-03-31Active, not recruiting
Effects of S-Adenosyl Methionine (SAMe) on Viral and Cell Signaling Response to Combination Therapy for Chronic Hepatitis C [NCT00475176]Phase 224 participants (Actual)Interventional2007-05-31Completed
A Blinded, Randomized, Placebo-controlled Trial in Genotype 1 Hepatitis C-Infected Subjects to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeated Doses of TMC435350, With or Without Peginterferon Alpha-2a and Ribavirin [NCT00561353]Phase 2121 participants (Actual)Interventional2008-01-31Completed
A Relative Bioavailability Study of Ribavirin (Geneva Pharmaceutical Technology Corporation, N.J., U.S.A.) 200 Capsules and Rebetol (Schering Corporation, N.J., U.S.A.) 200 mg Capsules in Females Under Non-Fasting Conditions. [NCT00959933]Phase 124 participants (Actual)Interventional2001-04-30Completed
A Relative Bioavailability Study of Ribavirin (Geneva Pharmaceutical Technology Corporation, N.J., U.S.A.) 200 Capsules and Rebetol (Schering Corporation, N.J., U.S.A.) 200 mg Capsules in Females Under Fasting Conditions. [NCT00960479]Phase 138 participants (Actual)Interventional2001-01-31Completed
The Individualized Management With Pegasys and Ribavirin Offering Viral Eradication (IMPROVE) Trial [NCT00483938]Phase 3236 participants (Actual)Interventional2007-06-30Completed
A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve [NCT00535847]Phase 2117 participants (Actual)Interventional2007-10-31Completed
A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Ac [NCT00623428]Phase 3235 participants (Actual)Interventional2008-06-30Completed
Influence of Ribavirin and Interferon on Semen Quality, IRIS Study [NCT00455832]23 participants (Actual)Observational2006-11-30Completed
Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Patients With Hepatitis C Who Have Failed to Respond to a Prior Course of Peginterferon and Ribavirin [NCT00495391]Phase 264 participants (Actual)Interventional2007-07-31Completed
A Phase II Study of Ribavirin in Refractory of Relapsed Acute Myelocytic Leukemia M4 and M5 Subtypes [NCT00559091]Phase 218 participants (Actual)Interventional2007-04-30Completed
A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection [NCT02562742]554 participants (Actual)Observational2015-11-12Completed
A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys [NCT00758043]Phase 3540 participants (Actual)Interventional2008-10-31Completed
Treatment of Acute Hepatitis C Virus in HIV Co-Infection [NCT00845676]Phase 421 participants (Actual)Interventional2008-03-31Completed
A Phase II Randomized Placebo-controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Japanese Treatment-Experienced Patients With Chronic Hepatitis C Infection [NCT00880763]Phase 290 participants (Actual)Interventional2009-04-20Completed
Effect of Boceprevir Therapy on HCV-specific T Cell Responses: Perspectives of Immune Monitoring and Immune Therapy [NCT01403181]30 participants (Actual)Observational2012-04-30Completed
A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Hemophilic Patients With Chronic Hepatitis C Infection [NCT00707772]Phase 4400 participants (Anticipated)Interventional2007-03-31Completed
A Phase III, Multicenter, Open-labeded Study To Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and Ribavirin for 12 Weeks of Treatment in HCV Genotype I Infected Patients [NCT04155515]Phase 3370 participants (Actual)Interventional2019-06-13Completed
Multicentric, Controlled and Randomised Open Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin Using Pharmacologic Measures of Ribavirin Exposition During Combination Peginterferon Alfa-2 and Ribavirin Treatment in Naive [NCT00485342]Phase 3236 participants (Anticipated)Interventional2006-04-30Recruiting
Treatment of Chronic Hepatitis C With PegIntron Injector and Rebetol (Post Marketing Surveillance Study) [NCT00727311]2,302 participants (Actual)Observational2005-08-31Completed
Patient Compliance During PegIntron (Injection Pen) and Rebetol Combination Therapy in Chronic Hepatitis C [NCT00725205]294 participants (Actual)Observational2006-03-31Completed
Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program [NCT00724893]2,430 participants (Actual)Observational2005-08-31Completed
An Open-label, Multicenter Protocol Providing Pegylated-interferon Alfa-2a (PEGASYS®) as Monotherapy or in Combination With Ribavirin (COPEGUS®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols [NCT00800735]Phase 330 participants (Actual)Interventional2009-04-30Completed
A Phase III, Randomized, Double-blind, Placebo-controlled Trial in Japan to Investigate the Efficacy and Safety of TMC435 vs. Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment-Naive, Genotype 1, Hepatitis C- [NCT01292239]Phase 3183 participants (Actual)Interventional2011-02-28Completed
Evaluation of Rapid Virological Response in HCV Patients Treated With PegIntron and Ribavirin - APEGIN Trial [NCT00724854]1,146 participants (Actual)Observational2006-08-31Completed
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin (RBV) in Subjects With (Genotype 1) Hepatitis C Who Did Not Respond to Previous Treatment [NCT00781274]Phase 332 participants (Actual)Interventional2008-12-31Completed
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C [NCT00780416]Phase 3189 participants (Actual)Interventional2008-11-30Completed
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGE [NCT02939989]Phase 333 participants (Actual)Interventional2016-11-21Completed
An Observational Multi-Center Study Exploring the Association of Safety, Patient Characteristics, Virological, and Histological Parameters With Patient Outcome (Relapse Rate, Achievement of Sustained Viral Response in Daily Clinical Practice in Belgium- P [NCT00704756]0 participants (Actual)Observational2009-01-31Withdrawn
A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC [NCT00304551]Phase 3180 participants (Anticipated)Interventional2006-06-30Completed
An Open-label, Randomized Pilot Study to Compare the Effectiveness of Peginterferon-alfa-2b Plus Ribavirin to Peginterferon-alfa-2b Plus Epoetin-alfa and Two Doses of Ribavirin in the Treatment of Chronic Hepatitis C Virus Infection [NCT00248339]Phase 3150 participants (Actual)Interventional2002-05-31Completed
Treatment of Chronic Hepatitis C in Children With Intron Vial or Pen and Rebetol According to German Law (§ 67 Abs 6 AMG) [NCT00727077]3 participants (Actual)Observational2006-06-30Terminated(stopped due to Study halted due to low recruitment. The 3 participants at time of termination transferred into study P04538 (NCT00727077). See NCT00727077 for details/results.)
A Pilot Trial to Determine the Safety and Efficacy of Fluvastatin in Previous Partial Responders to Pegylated Interferon and Ribivirin in Patients With Genotype 1 Hepatitis C [NCT00814606]Phase 20 participants (Actual)Interventional2010-02-28Withdrawn(stopped due to no one ever enrolled)
Treatment of Patients With Compensated Liver Cirrhosis With SCH 54031 + Ribavirin [NCT00687219]Phase 3102 participants (Actual)Interventional2007-06-30Completed
An Open, Randomized, Multicentre Trial to Evaluate Efficacy and Safety of a 24-week Course of PEG-Interferon Alpha-2b Versus a 12-week Course of PEG-Interferon Alpha-2b Alone or Plus Ribavirin in Patients With Acute Hepatitis C [NCT00686517]Phase 3130 participants (Actual)Interventional2003-12-31Completed
Non-Randomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alfa-2a and Copegus Combination Therapy After Single and Multiple Doses in Patients With Chronic Hepatitis C and Moderate Renal Impairment, Severe Renal Impairm [NCT02864199]Phase 463 participants (Actual)Interventional2004-02-29Completed
A Randomized Double-Blind Placebo-Controlled Phase III Study To Evaluate The Safety And Efficacy Of Palivizumab Combined With Aerosolized Ribavirin Compared To Ribavirin Alone To Treat RSV Pneumonia In Patients With Bone Marrow Transplants (BMT) [NCT00014391]Phase 30 participants Interventional1999-02-28Completed
A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients [NCT00925990]Phase 270 participants (Actual)Interventional2009-06-30Completed
A Randomized, Open Labeled, Active-Controlled Trial of 24-Week Versus 48-Week Courses of Peg-Interferon Alpha Plus Ribavirin for Genotype-1 Infected Chronic Hepatitis C Patients [NCT00629967]Phase 4200 participants (Actual)Interventional2005-04-30Completed
Tailored Treatment of Hepatitis C Genotype 1 [NCT00910975]Phase 4100 participants (Actual)Interventional2007-11-30Completed
A Study of SCH 900518 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C (Protocol No. P05104) [NCT00797745]Phase 2111 participants (Actual)Interventional2008-11-30Completed
Viral Kinetics and Liver Gene Expression in Response to Ribavirin and Peginterferon Therapy of Chronic Hepatitis C [NCT00718172]Phase 181 participants (Actual)Interventional2008-07-11Completed
Safety, Pharmacokinetics and Antiviral Effect of BI 201335 NA in HCV-1 Infected Patients Treated for 28 Days for Treatment naïve and Experienced Patients Treated in Combination With Peg Interferon Alfa-2a and Ribavirin [NCT00947349]Phase 222 participants (Actual)Interventional2009-07-31Completed
A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection [NCT00704184]Phase 295 participants (Actual)Interventional2008-07-25Completed
[NCT00216775]50 participants (Actual)Observational2004-12-31Completed
Analysis of Gene Expression of PBMC in the Hepatitis C Virus Genotype 1b-infected Patients During Peg-interferon-α Plus Ribavirin Combination Therapy [NCT00680173]Phase 430 participants (Actual)Interventional2006-08-31Completed
A Multicenter, Randomized, Open-label, Dose-ranging, Phase II Study to Evaluate the Efficacy and Safety in TG-2349 Combination With DAG181 (± Ribavirin) in Treatment naïve Subjects With Chronic Hepatic C Virus Genotype I Infection [NCT03593447]Phase 2133 participants (Actual)Interventional2018-03-15Completed
A Phase III, Multi-center, Open-label Trial to Investigate the Impact of a Treat, Counsel and Cure Strategy in Men Who Have Sex With Men With Hepatitis C Infection in the Swiss HIV Cohort Study [NCT02785666]Phase 3150 participants (Actual)Interventional2016-06-30Completed
Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II) [NCT01132313]Phase 2488 participants (Actual)Interventional2010-05-31Completed
Phase II Trial of Long-term Monotherapy With Ribavirin Against Colchicine on Progression of Chronic Hepatitis C With Advanced Fibrosis in Patients With Non-response to Standard Antiviral Therapy [NCT00840489]Phase 250 participants (Actual)Interventional2009-01-31Terminated(stopped due to Preliminary analysis)
Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C [NCT00940420]Phase 42,695 participants (Actual)Interventional2002-10-31Completed
A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects With Hepatitis C [NCT00372385]Phase 2334 participants (Actual)Interventional2006-08-31Completed
Non-randomized Prospective Study on the Effect of Antiviral Therapy With Peginterferon Alfa-2a and Ribavirin on Bone Mineral Density and Metabolism in Patients With Chronic Viral Hepatitis C Genotype 1 [NCT00948220]Phase 426 participants (Actual)Interventional2003-07-31Completed
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α- [NCT01290679]Phase 3393 participants (Actual)Interventional2011-03-31Completed
Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C - An Epidemiological Study [NCT01402583]1,000 participants (Actual)Observational2011-07-31Completed
A Phase 2 Treatment Protocol of Intravenous Ribavirin in Adult Subjects With Hemorrhagic Fever With Renal Syndrome (HFRS) in Landstuhl Regional Medical Center (Landstuhl, Germany) IND 16,666 [NCT00868946]Phase 20 participants (Actual)Interventional2009-10-31Withdrawn(stopped due to Lack of enrollment)
A Phase II Randomized, Multicenter, Open-label Study of TG4040 (MVA-HCV) in Combination With Pegylated Interferon Alfa-2a and Ribavirin Versus Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naïve Patients With Chronic Genotype 1 Hepatitis C. [NCT01055821]Phase 2140 participants (Actual)Interventional2010-05-31Completed
Hepatitis C Virus Dynamic and Immune Activation in HIV-1 Coinfected Patients Treated With Pegylated Interferon Alfa-2a and Ribavirin [NCT00909129]25 participants (Actual)InterventionalCompleted
A Phase I/II Exploratory Study of Ribavirin in Metastatic Breast Cancer Expressing Elevated eIF4E [NCT01056757]Phase 1/Phase 24 participants (Actual)Interventional2009-12-31Terminated(stopped due to Study closed because of new overlapping study with ribavirin.)
Long-Term Follow-Up of Subjects in a Phase 1, 2, or 3 Clinical Trial in Which Boceprevir or Narlaprevir Was Administered for the Treatment of Chronic Hepatitis C [NCT00689390]Phase 2/Phase 31,954 participants (Actual)Interventional2007-02-20Terminated(stopped due to The study was terminated due to satisfaction of post-marketing commitments)
A Blinded, Randomized, Placebo-controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-450 With Ritonavir (ABT-450/r), ABT-333 or ABT-072 Each Administered Alone and in Combina [NCT01074008]Phase 274 participants (Actual)Interventional2010-03-31Completed
A Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Ge [NCT00851890]Phase 230 participants (Actual)Interventional2009-03-31Completed
An Open, Phase IV, Multicentric Study, Evaluating Safety and Efficacy of Ribavirin (Copegus®) and Peginterferon Alfa-2a (Pegasys®) Combination in Specific Groups [NCT00800748]Phase 4372 participants (Actual)Interventional2006-02-01Completed
Clinical Study of a Biological Response Modifier (Arabinoxylan Rice Bran/MGN-3/Biobran) With Interferon-Alpha for the Treatment of Hepatitis C Infection [NCT02690103]Phase 237 participants (Actual)Interventional2012-07-31Completed
A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection [NCT00561015]Phase 252 participants (Actual)Interventional2007-12-31Completed
Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms [NCT02558114]Phase 45 participants (Actual)Interventional2015-12-31Terminated(stopped due to Lack of recruitment)
Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C [NCT00761735]Phase 394 participants (Actual)Interventional2007-07-31Completed
A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection [NCT01016912]Phase 251 participants (Actual)Interventional2009-12-31Completed
Efficacy and Safety of Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly Cirrhotic Patients: a Real Life Study [NCT02702739]Phase 4270 participants (Actual)Interventional2015-01-31Completed
A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection [NCT01852604]Phase 2143 participants (Actual)Interventional2013-03-31Completed
"Prospective Observational Study to Assess Personality Disorders in Prison Populations for Hepatitis C Treatment. " [NCT01900886]263 participants (Anticipated)Observational2010-12-31Active, not recruiting
Study of Parameters of Early Hepatitis C Virus Dynamics for Predicting the Outcome of Standard Interferon Therapy With Chinese Cohort (Second Phase) [NCT01760148]300 participants (Anticipated)Observational2012-07-31Recruiting
Open Label, Randomised, Pilot Trial of Pegylated Interferon, Ribavirin & Telaprevir vs Pegylated Interferon & Ribavirin Alone in Response Guided Treatment of Acute Hepatitis C Genotype 1 Virus Infection in Patients With HIV-1 Co-infection [NCT02006745]Phase 320 participants (Actual)Interventional2014-01-31Completed
A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Phase II Study on the Efficacy and Safety of Debio 025 Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients [NCT00854802]290 participants (Actual)Interventional2009-01-31Completed
Combination of Alpha Interferon With Long Term Ribavirin Therapy for Patients With Chronic Hepatitis C [NCT00001729]Phase 3120 participants Interventional1997-10-31Completed
An Open-label, Randomized, 5-arm, Parallel-group Study of the Effects on Viral Kinetics, Safety and Pharmacokinetics of Different Dosing Regimens of Debio 025 in Combination With Peginterferon Alpha-2a and Ribavirin in Chronic HCV Genotype 1 Patients Who [NCT00537407]Phase 250 participants (Actual)Interventional2007-09-30Completed
A Pilot Study of Low Dose Interleukin-2 (IL-2) With the Addition of Pegylated Interferon (PEG-IFN Alfa-2b) and Ribavirin (RBV) for the Treatment of Hepatitis C Infection in Subjects With HIV Coinfection [NCT00015652]24 participants InterventionalCompleted
Study of Cerebral Function in Patients With Chronic Hepatitis C Infection Before and After Pegylated Interferon Alfa-2a and Ribavirin Therapy [NCT00788918]100 participants (Actual)Interventional2008-11-30Completed
Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C [NCT00727259]1,995 participants (Actual)Observational2004-10-31Completed
Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study [NCT00726557]246 participants (Actual)Observational2005-10-31Completed
Improving Hepatitis C Treatment in Injection Drug Users [NCT00148031]Phase 4111 participants (Actual)Interventional2003-09-30Completed
Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice [NCT00724451]1,128 participants (Actual)Observational2008-07-31Completed
Retrospective Data Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol [NCT00724373]442 participants (Actual)Observational2007-11-30Completed
Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection [NCT03061032]Phase 3200 participants (Anticipated)Interventional2017-03-31Not yet recruiting
ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, [NCT00901524]Phase 258 participants (Actual)Interventional2009-06-30Completed
A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C [NCT00627926]Phase 31,095 participants (Actual)Interventional2008-03-31Completed
Treatment of Viral Hemorrhagic Fever (Crimean-Congo Hemorrhagic Fever or Lassa Fever) With Intravenous Ribavirin in Department of Defense (DOD) Associated Medical Treatment Facilities: A Phase 2 Study [NCT00992693]Phase 20 participants (Actual)Interventional2009-09-30Withdrawn
Efficacy of High Doses of Both Pegylated Interferon Alfa-2a and Ribavirin for Retreatment of HIV-coinfected Patients With Liver Cirrhosis Due to HCV Genotype 1 or 4 Nonresponders to Previous Standard Therapy. [NCT01006031]Phase 2/Phase 325 participants (Actual)Interventional2009-10-31Completed
Efficacy and Safety of PEG-Intron Plus Rebetol in Subjects With Chronic Hepatitis C Genotype 1 Non Responder to Pegasys [NCT00441584]Phase 3117 participants (Actual)Interventional2005-07-31Terminated(stopped due to Subject accrual was prematurely terminated due slow enrollment.)
Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy [NCT01045278]Phase 4277 participants (Actual)Interventional2008-04-30Completed
Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) Therapy (1.5 mcg/kg/Week + 800-1200 mg/Day) in Naïve Genotype 1 Hepatitis C Patients With High Baseline Viral Load Who Are HCV-RNA Negative at Week 4 and Week 12 [NCT00423800]Phase 356 participants (Actual)Interventional2006-12-31Terminated(stopped due to The study was terminated due to difficulty in recruiting participants.)
A Study to Assess Treatment With PEG-Intron® and Rebetol® in Naïve Patients With Genotype 1 Chronic Hepatitis C and Slow Virological Response [NCT00265395]Phase 31,428 participants (Actual)Interventional2004-12-31Completed
Phase IV Study of Tailored Therapy With Peg Interferon Alfa 2b and Ribavirin for Patients With Genotype 3 and High Viral Load. Genotype 3 Extended Treatment for HCV (GET-C Study) [NCT00255034]Phase 4146 participants (Actual)Interventional2005-02-28Terminated(stopped due to Recruitment targets were unachievable in the currently available population.)
A Phase 2, Randomized, Open-Label Trial of GS-9256 Plus GS-9190 Alone and in Combination With Ribavirin for 28 Days in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0112) [NCT01072695]Phase 246 participants (Actual)Interventional2010-02-28Completed
Comparison of the Sustained Response of Peg-Intron/Ribavirin Combination Therapy in Genotype 1-Infected Hepatitis C Patients for Non-extended Versus 24-week Extended Treatment After 24 Weeks Pilot Treatment in Taiwan [NCT00202839]Phase 4160 participants (Actual)Interventional2005-03-31Completed
Efficacy and Tolerability of Escitalopram for the Prevention of Pegylated Interferon Alfa Associated Depression in Patients With Chronic Hepatitis C Infection: a Randomized Controlled Trial. [NCT00136318]Phase 3208 participants (Actual)Interventional2004-01-31Completed
PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study [NCT00160251]Phase 2357 participants (Actual)Interventional2005-09-30Completed
Efficacy of Low Dose Pegylated Interferon-α 2a Plus Ribavirin for the Treatment of Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients. [NCT00553930]Phase 471 participants (Anticipated)Interventional2007-11-30Completed
Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With Chronic Hepatitis C [NCT00207363]Phase 4610 participants (Actual)Interventional2002-02-28Completed
A Pilot Trial of Combination Therapy With Interferon Alfacon1, Ribavirin, & Rosiglitazone in a Group of Insulin Resistant, Chronic Hepatitis C, GT 1 Patients Who Are Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin [NCT00207402]Phase 434 participants (Actual)Interventional2005-10-31Completed
A Randomized, Multicenter, Open Label Study Evaluating the Efficacy and Safety of Tailored Regimens With Peginterferon Alfa-2a Plus Ribavirin According Viral Kinetics for Genotype 1 Chronic Hepatitis C Patients [NCT01937728]Phase 4542 participants (Actual)Interventional2010-03-31Completed
Effectiveness of Pegylated Interferon Plus Ribavirin in the Treatment of Active and Past Intravenous Drug Users Infected With Hepatitis C [NCT00203606]Phase 466 participants (Actual)Interventional2004-01-31Completed
Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C [NCT00230958]Phase 3900 participants Interventional2003-12-31Completed
Phase 2a Study of Boceprevir for the Treatment of Genotype 6 Hepatitis C [NCT01949168]Phase 230 participants (Anticipated)Interventional2013-09-30Not yet recruiting
A Multicenter, Open-label, Randomized, 3-arm, Phase II Profiling Trial of Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients [NCT01970904]147 participants (Actual)Interventional2013-10-31Completed
Syndrome of Fever Associated With Bleeding of Chinese and Western Medicine Diagnosis and Treatment of Infectious Diseases Plans and Severe Clinical Treatment Research [NCT01973855]Phase 2300 participants (Anticipated)Interventional2012-01-31Recruiting
Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment [NCT01997203]Phase 3100 participants (Actual)Interventional2012-04-30Terminated(stopped due to complete patients samples required)
UMIT-1 Trial: Favipiravir & Ribavirin Phase IB A Randomised Phase Ib Study to Determine the Phase II Dose and to Evaluate the Safety and Efficacy of Intravenous (IV) Favipiravir & Ribavirin [NCT05940545]Phase 1/Phase 224 participants (Anticipated)Interventional2023-07-12Recruiting
Evaluation of Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Adults Chronically Infected With Genotype 2 Hepatitis C Virus: an Open-label, Multicenter Confirmatory Study [NCT03453346]136 participants (Actual)Interventional2016-08-05Completed
Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9: a Phase IV, Randomized, Open-labeled, Multicenter Trial Comparing 24-week vs. 48-week Therapy [NCT00575224]Phase 460 participants (Actual)Interventional2004-10-31Completed
A Phase III, Open-label Trial in Japan to Investigate the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Genotype 1, Hepatitis C-infected Subjects Who Relapsed After Previous IFN-based Therapy [NCT01290731]Phase 349 participants (Actual)Interventional2011-01-31Completed
A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection [NCT01241760]Phase 3744 participants (Actual)Interventional2010-12-31Completed
"Diagnostic Value of Plasma Ribavirin Assay During the Combination Therapy Pegylated Interferon + Ribavirin in Chronic Hepatitis C." [NCT00209755]40 participants Interventional2003-10-31Terminated
Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial [NCT00216268]Phase 2200 participants Interventional2005-07-31Recruiting
Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study [NCT02717949]Phase 41 participants (Actual)Interventional2016-02-25Terminated(stopped due to failure to recruit)
A Prospective, Multicenter, Phase II/III, Open-Label, Controlled, Randomized Trial Evaluating the Efficacy, Safety, and Tolerability of Interferon-alfa-2a Plus Ribavirin Versus PEG-interferon-alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus (HCV) Infe [NCT00008463]Phase 2132 participants Interventional2000-11-30Completed
Treatment of Chronic Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels With Peginterferon α-2a (40 kDa) Plus Ribavirin [NCT00575627]Phase 4150 participants (Anticipated)Interventional2007-09-30Recruiting
Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection [NCT01872936]Phase 220 participants (Anticipated)Interventional2013-06-30Active, not recruiting
A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naïve S [NCT01080222]Phase 2152 participants (Actual)Interventional2010-08-31Terminated(stopped due to Study discontinued)
A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1 [NCT00192647]Phase 4896 participants (Actual)Interventional2004-08-31Completed
An Open-Label Study to Evaluate the Safety and Efficacy of VIRAZOLE® (RIBAVIRIN FOR INHALATION SOLUTION, USP) in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 [NCT04551768]Phase 151 participants (Actual)Interventional2021-02-10Completed
A Multi-centre, Double-blinded, Randomized, Placebo-controlled Trial on the Efficacy and Safety of Lopinavir / Ritonavir Plus Ribavirin in the Treatment of Severe Acute Respiratory Syndrome [NCT00578825]340 participants (Anticipated)InterventionalNot yet recruiting
An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I) [NCT02219490]Phase 31,596 participants (Actual)Interventional2014-10-30Completed
An Open-Label Study to Assess the Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Any Interferon Plus R [NCT01641666]Phase 30 participants (Actual)Interventional2014-05-31Withdrawn
A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection [NCT00707850]Phase 4300 participants (Anticipated)Interventional2007-05-31Completed
Open Multicentre, Phase IV Study to Evaluate Efficacy and Safety of Pegylated Interferon Alpha-2a (40 KD) Plus Ribavirin for Chronic Hepatitis C With Normal Transaminases in Human Immunodeficiency Virus-infected Patients [NCT01684787]Phase 480 participants (Actual)Interventional2006-09-30Completed
Open-label, Multicenter, Non-Comparative, Prospective Observational Study to Evaluate Efficacy and Safety of Combined Ribavirin and Peginterferon Alfa-2a (40 kDa) Therapy in Patients With Chronic Hepatitis C (CHC) or Compensated Liver Cirrhosis in Real Cl [NCT01609049]1,496 participants (Actual)Observational2011-12-07Completed
Post Marketing Observational/Non-Interventional Study Of Retreatment Of Chronic Hepatitis C With Peginterferon Alpha And Ribavirin [NCT01098097]963 participants (Actual)Observational2009-06-30Completed
A Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chr [NCT01314261]Phase 237 participants (Actual)Interventional2011-03-31Completed
A Pilot Study to Assess the Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma [NCT01268579]9 participants (Actual)Interventional2010-12-28Completed
A Phase I/II Study of Ribavirin and Low-dose Cytarabine Arabinoside (Ara-C) in Acute Myeloid Leukemia (AML) M4 and M5 Subtypes, and AML With High eIF4E Expression [NCT01056523]Phase 1/Phase 229 participants (Actual)Interventional2010-01-31Completed
Usefulness of Adding Thalidomide to Peginterferon and Ribavirin in Patients With Hepatitis C and Resistance to Interferon. Phase II [NCT00856804]Phase 210 participants (Anticipated)Interventional2009-03-31Recruiting
[NCT00723242]0 participants Interventional2002-04-30Completed
"PegIntron/REBETOL Combination Therapy Designated Drug Use Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C Excluding Those With IFN Naive Low Viral Load and Genotype [NCT00724230]505 participants (Actual)Observational2006-02-28Completed
Open Multicenter Study of Combination Therapy With Weight-Based PEG-IFN Alfa-2b Plus Ribavirin for Treatment of Mexican naïve Patients With Chronic Hepatitis C Infected With Genotype 1. Impact of the Combination Therapy on Sustained Virological Response a [NCT00724620]Phase 4103 participants (Actual)Interventional2005-06-30Completed
A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 [NCT00895882]Phase 20 participants (Actual)Interventional2010-11-30Withdrawn
Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics [NCT00897312]7 participants (Actual)Observational2006-10-31Terminated(stopped due to slow accrual)
A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study of SD-101 to Assess the Safety, Pharmacodynamics, and Preliminary Evidence of Anti-Viral Effect in Subjects Diagnosed With Chronic Hepatitis C, Genotype 1 [NCT00823862]Phase 134 participants (Actual)Interventional2008-10-31Completed
The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Hepatocellular Carcinoma [NCT00834860]Phase 4179 participants (Actual)Interventional2007-01-31Active, not recruiting
A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1 [NCT00874770]Phase 274 participants (Actual)Interventional2009-06-30Completed
)A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy [NCT00315432]Phase 291 participants (Actual)Interventional2000-09-30Completed
A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With Ribavirin In Interferon Alfa Naive Subjects With Chronic Hepatitis C Gen [NCT00656006]Phase 243 participants (Actual)Interventional2005-11-30Completed
A Randomized, Multicenter, phaseIIIB, Two Arm Study Evaluating the Tolerability of Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Infection co-Infected With Human Immunodeficiency Virus Receiving HAART Versus Not Rece [NCT00296972]Phase 3100 participants Interventional2005-07-31Terminated(stopped due to not funded)
Open, Randomized, Multicenter Phase IV Study to Evaluate Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Patients Genotype 1 and/or 4 [NCT00612755]Phase 443 participants (Actual)Interventional2005-10-31Completed
Open, Randomized and Multicenter Phase IV Study to Compare the Efficacy and Safety of Two Different Treatments Duration 24 Versus 48 Weeks in Chronic Hepatitis C Genotypes 2 and/or 3 co-Infected HIV-HCV Patients. [NCT00611819]Phase 459 participants (Actual)Interventional2005-11-30Active, not recruiting
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hep [NCT00882908]Phase 2386 participants (Actual)Interventional2009-06-30Completed
Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin Who Fail Interferon Alfa or Pegylated Interferon Alfa Monotherapy - a Pilot Study [NCT00491179]Phase 435 participants (Actual)Interventional2006-06-30Completed
Hepatitis C Virus Infection Induced Insulin Resistance: Different Contribution From Liver and Extrahepatic Sites as Inferred by Treating Chronic Hepatitis C Patients With an Interferon-free Antiviral Combination [NCT02760355]17 participants (Actual)Interventional2016-03-31Completed
A Single-Arm Study to Provide Boceprevir Treatment in Subjects With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin in Previous Schering-Plough Boceprevir Studies [NCT00910624]Phase 3168 participants (Actual)Interventional2009-06-22Completed
Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C [NCT00922779]Phase 46,661 participants (Actual)Interventional2002-06-30Completed
A Phase 3 Safety and Efficacy Study of Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin [NCT00845065]Phase 3202 participants (Actual)Interventional2009-02-28Completed
A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy [NCT01170962]Phase 2512 participants (Actual)Interventional2010-08-31Completed
A Prospective Study of Peginterferon Alfa-2a and Ribavirin: Outcomes Assessment in Chronic Hepatitis C Patients [NCT02850289]385 participants (Actual)Observational2006-04-30Completed
Long-Term Therapy With Ribavirin for Chronic Hepatitis C [NCT00001854]Phase 450 participants Interventional1999-02-12Completed
The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma [NCT00630084]Phase 4120 participants (Actual)Interventional2006-08-31Completed
Efficacy and Safety of Pegylated Interferon Plus Ribavirin Combination Therapy in Treating Older Patients With Chronic Hepatitis C [NCT00629824]Phase 4250 participants (Anticipated)Interventional2007-02-28Completed
Efficacy and Safety of High-dose Vitamin C Combined With Traditional Chinese Medicine in the Treatment of Moderate and Severe Coronavirus Pneumonia (COVID-19) [NCT04664010]30 participants (Actual)Interventional2020-02-06Completed
Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-responders to Interferon Alpha Plus Ribavirin [NCT00538811]Phase 2/Phase 340 participants (Anticipated)InterventionalCompleted
Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium [NCT02799355]1,203 participants (Actual)Observational2016-05-31Completed
An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy [NCT00560274]Phase 4190 participants (Actual)Interventional2008-03-31Completed
A Randomized Trial of Telaprevir, Peginterferon, and Ribavirin Versus Peginterferon and Ribavirin for Treatment of Genotype 1 Hepatitis C Virus With Host Interleukin 28B CC Polymorphism [NCT01415141]Phase 40 participants (Actual)Interventional2011-07-31Withdrawn(stopped due to Lack of funding)
A Pilot Study Of Interferon Alpha 2b Plus Ribavirin In The Treatment Of Patients With Chronic Hepatitis B [NCT00275938]Phase 2/Phase 3120 participants Interventional1998-10-31Completed
A Prospective, Randomized, Multi-center, Open-label, Comparative Safety and Efficacy Study of Prophylactically Administered Pegylated Interferon Alfa-2a(Pegasys) Plus Ribavirin vs. No Prophylaxis Following Liver Transplantation for Hepatitis C. [NCT00275548]Phase 412 participants (Actual)Interventional2004-07-31Completed
A Phase 2b Study of Merimepodib in Combination With Pegylated Interferon Alfa-2a (Pegasys®) and Ribavirin in Subjects With Chronic Hepatitis C Non-Responsive to Prior Therapy With Pegylated Interferon Alfa and Ribavirin [NCT00088504]Phase 2315 participants Interventional2004-07-31Completed
Phase 2 Study of Omega Interferon Alone or in Combination With Ribavirin in Subjects With Hepatitis C [NCT00097045]Phase 290 participants Interventional2004-11-30Completed
A Multi-Center, Randomized, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Treatment Experienced Subjects With Chronic [NCT00097435]Phase 2115 participants (Actual)Interventional2004-10-31Completed
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection [NCT01903954]Phase 2283 participants (Actual)Interventional2011-01-31Completed
A Phase II, Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin in Subjects With Genotype 1 Chronic Hepatitis C Infection [NCT01011166]Phase 281 participants (Actual)Interventional2009-11-30Completed
A Phase 2a Study of PPI-668 in Combination With BI 207127 and Faldaprevir, With and Without Ribavirin, in Treatment-Naive Patients With Chronic Hepatitis C (HCV Genotype 1a) [NCT01859962]Phase 238 participants (Actual)Interventional2013-05-31Completed
A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers [NCT01718158]Phase 3444 participants (Actual)Interventional2013-01-31Completed
An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C Patients [NCT04301882]1,000 participants (Anticipated)Observational [Patient Registry]2019-09-01Recruiting
Efficacy and Safety of Interferon Based Therapy and Interferon-free Direct-acting Antivirals in Cirrhotic Patients With Hepatitis C. Impact of Antiviral Therapy on Gastroesophageal Varices. [NCT02758509]237 participants (Actual)Observational2010-01-01Completed
Pilot Evaluation of the Influence of ABT450r, Ombitasvir, Dasabuvir +/- Ribavirin HCV Therapy on Insulin Resistance and Lipid Profile [NCT02734173]Phase 424 participants (Actual)Interventional2015-07-31Completed
Efficacy and Safety of Switching From Pegylated Interferon/Ribavirin (PR) to Direct-acting Antiviral Agents (DAAs) for Chinese With CHC Genotype 1b Infection (SWITCH-1) [NCT02583685]Phase 2160 participants (Anticipated)Interventional2015-05-31Recruiting
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 1 Hepatitis C Who Relapsed After Previous Treatment [NCT00780910]Phase 3109 participants (Actual)Interventional2008-11-30Completed
Clinical Trial of the Efficacy of the Combination of Pegylated Interferon (PEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C [NCT00158496]Phase 3100 participants Interventional2002-08-31Completed
Factors Associated to Success of Hepatitis C Therapy [NCT00514111]100 participants (Actual)Observational2007-08-31Completed
An Open-Label Study to Evaluate Long-Term Outcomes With Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Fertile Women With Genotype 1 and 4 Chronic Hepatitis C Virus (HCV) Infection [NCT02950870]Phase 475 participants (Anticipated)Interventional2016-12-31Not yet recruiting
A Phase III, Randomised, Open Label, Active-controlled Study of an Interferon-free Regimen of BI 207127 in Combination With Faldaprevir and Ribavirin Compared to Telaprevir in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive Patien [NCT01858961]Phase 30 participants (Actual)Interventional2013-05-31Withdrawn
Australian Trial in Acute Hepatitis C [NCT00192569]Phase 4167 participants (Actual)Interventional2004-07-31Completed
A Randomized, Single Center, Comparative Study to Evaluate the Efficacy and Safety of Silibinin (Legalon® SIL) in Combination With Ribavirin or With Peginterferon and Ribavirin, Versus Peginterferon and Ribavirin Based Standard of Care (SoC) in Treatment [NCT01871662]Phase 2/Phase 30 participants (Actual)Interventional2013-08-31Withdrawn
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon α-2a and Ribavirin in Treatment-naïve, Genotype 1 Hepatitis Cinf [NCT01289782]Phase 3395 participants (Actual)Interventional2011-02-28Completed
Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response [NCT00560690]Phase 4140 participants (Actual)Interventional2007-12-31Completed
A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis [NCT01973049]Phase 3202 participants (Actual)Interventional2013-12-31Completed
An Open Label Randomized Controlled Trial To Prevent the Progression of Respiratory Syncytial Virus Upper Respiratory Tract Infection to Lower Respiratory Tract Infection in Patients After Hematopoietic Stem Cell Transplant [NCT01502072]Phase 248 participants (Actual)Interventional2011-12-28Completed
A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) [NCT01471574]Phase 3549 participants (Actual)Interventional2011-12-31Completed
A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1 [NCT03020004]Phase 270 participants (Actual)Interventional2016-01-31Completed
A Multi-centered, Open Label, Phase III Study on Efficacy, Safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1 [NCT03020082]Phase 3141 participants (Actual)Interventional2016-06-30Completed
A Randomized, Phase 2a, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C [NCT01790100]Phase 220 participants (Actual)Interventional2013-02-28Completed
Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C) [NCT00038974]Phase 3401 participants (Actual)Interventional2002-08-31Completed
Phase 4 Study Using Infergen and Ribavirin in Patients With Chronic Hepatitis C Virus Who Achieved Partial Response to Peginterferon-alfa and Ribavirin Therapy [NCT00456248]Phase 45 participants (Actual)Interventional2007-02-28Terminated(stopped due to slow enrollment)
Thalassemia Clinical Research Network - Hepatitis C Clinical Trial [NCT00502788]Phase 221 participants (Actual)Interventional2003-05-31Completed
A Randomized Trial Comparing a Short Course Versus Standard Treatment in Patients With Chronic Hepatitis C Virus Infection [NCT00502970]Phase 4150 participants (Actual)Interventional2004-05-31Completed
Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection [NCT01097395]Phase 435 participants (Actual)Interventional2010-02-28Completed
Open, Multicentre,Randomized Phase IV Trial to Evaluate Efficacy/Safety to Extend Treatment Duration With Peginterferon Alfa-2a+High Dose of Ribavirin Supporting Epo β in Treatment of CHC in HIV-HCV Patients Who Not Clear Virus at Week 4 [NCT00526448]Phase 4384 participants (Anticipated)Interventional2007-06-30Recruiting
Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C [NCT00527540]Phase 360 participants (Anticipated)Interventional2007-02-28Completed
Treatment of Patients With Chronic Hepatitis C Co-infected With HIV Relapsers or Non Responders, Previous Exposed to Sub-optimal Therapies: Open, Pilot Trial [NCT00530972]Phase 450 participants (Actual)Interventional2006-03-31Completed
Retrospective Study to Evaluate the Impact of Using Interferon (Pegylated or Not) in the Treatment of Patients With Chronic Hepatitis C in Brazil (DECISION) [NCT01280656]660 participants (Actual)Observational2010-01-31Completed
Peginterferon Alfa-2a Plus Ribavirin in Patients With Genotype 2 Chronic Hepatitis C: A Randomized Study of Treatment Duration and Ribavirin Dose Stratified by Rapid Virologic Response [NCT00532701]Phase 4880 participants (Actual)Interventional2007-11-30Completed
Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks or Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks in DAA Treatment Naïve HCV Subjects With GT3b, Compensated Cirrhosis in China [NCT05467826]Phase 4100 participants (Anticipated)Interventional2022-09-01Not yet recruiting
Treatment Protocol for Adults With Hemorrhagic Fever With Renal Syndrome (HFRS) With Intravenous (IV) Ribavirin [NCT04283513]Phase 250 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Four Arms, Multicenter, Open Label Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C [NCT00540345]Phase 4300 participants (Actual)Interventional2006-10-31Completed
A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications [NCT01227967]Phase 2881 participants (Actual)Interventional2010-09-30Completed
Randomized, Open-Label, Multicenter Study of Safety, Efficacy, and Tolerability of the Combination of RO5466731, RO5190591, Ritonavir, and Copegus With or Without RO5024048 in HCV Genotype 1 Infected Patients Who Are Either Treatment Naïve or Null Respond [NCT01628094]Phase 2110 participants (Actual)Interventional2012-06-30Completed
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers [NCT01718145]Phase 3258 participants (Actual)Interventional2012-11-30Completed
Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Riba [NCT01425203]Phase 3238 participants (Actual)Interventional2011-11-23Completed
Evaluation of the Health-Related Quality of Life During Combined Treatment of Chronic Hepatitis Due to Hepatitis C Virus Under Habitual Clinical Practise Conditions. [NCT00863109]133 participants (Actual)Observational2009-04-30Completed
Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Daul Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection. A Prospective, Randomized, Multicenter Study [NCT02985281]Phase 2/Phase 341 participants (Anticipated)Interventional2016-12-31Enrolling by invitation
Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection [NCT01389323]Phase 3448 participants (Actual)Interventional2011-09-30Completed
A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1a Chronic Hepatitis [NCT01833533]Phase 3305 participants (Actual)Interventional2013-03-31Completed
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma [NCT03585725]Early Phase 13 participants (Actual)Interventional2018-09-26Terminated(stopped due to low accrual)
Suppressive Long-Term Antiviral Management of Hepatitis C Virus (HCV) and HIV-1 Coinfected Subjects (SLAM-C) [NCT00078403]Phase 2333 participants (Actual)Interventional2004-07-31Completed
A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin Eudra CT2012-003984-23 [NCT01718301]Phase 3128 participants (Actual)Interventional2013-03-31Completed
The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis [NCT02168361]Phase 493 participants (Actual)Interventional2013-12-31Completed
Long-Term Efficacy and Tolerance of Oral Ribavirin Compared to Placebo as a Preventative in Early Stages of Human Immunodeficiency Virus Infection - United States [NCT00002298]0 participants InterventionalTerminated
A Double-Blinded, Randomized Control Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 Chronic Hepatitis C Subjects [NCT01754974]Phase 340 participants (Actual)Interventional2013-03-31Completed
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir [NCT01271790]Phase 2245 participants (Actual)Interventional2010-10-31Completed
Effectiveness and Tolerability of Hepatitis C Treatment in HIV Co-infected Patients in Routine Care Services in Asia: A Pilot Model of Care Project [NCT01838772]Phase 4188 participants (Actual)Interventional2013-12-31Completed
A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients [NCT01318694]Phase 31,081 participants (Actual)Interventional2011-03-31Completed
Effect of Infliximab in Hepatitis-C Genotype 1 Naïve Patients With High TNF-alpha on the Efficacy of Pegylated Interferon Alfa-2b/Ribavirin Therapy [NCT00237484]Phase 389 participants (Actual)Interventional2005-07-18Completed
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 2 Hepatitis C, Who Relapsed After Previous Treatment [NCT01466192]Phase 3108 participants (Actual)Interventional2012-05-31Completed
Phase IV Study of Treatment of Acute Hepatitis C With Pegylated Interferon [NCT00241618]Phase 4180 participants Interventional2002-01-31Completed
An Open-Label, Randomized Study to Determine the Impact of Antiretroviral Treatment in HCV/HIV-Coinfected Subjects With High CD4+ Cell Count on the Efficacy of Hepatitis C Treatment With Pegylated Interferon Alfa-2A and Ribavirin [NCT00100581]2 participants (Actual)InterventionalCompleted
A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C [NCT00262483]Phase 212 participants Interventional2005-12-31Completed
Randomized Placebo-Control Pilot Study Evaluating the Efficacy and Safety of Rosiglitazone Combined With Pegylated Interferon Plus Ribavirin Versus Pegylated Interferon Plus Ribavirin Alone in Genotype 1 Hepatitis C With Steatosis [NCT00274495]Phase 430 participants (Anticipated)Interventional2006-01-31Terminated
Pilot Study to Determine the Efficacy and Safety of Combining Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection [NCT01653236]Phase 340 participants (Anticipated)Interventional2013-12-31Recruiting
Randomized, Controlled Study of Buprenorphine and Methadone in Hepatitis C Patients in Need of Treatment [NCT00279565]Phase 4128 participants Interventional2005-08-31Terminated(stopped due to The trial was terminated because of deviations from the protocol.)
Randomized, Open-Label, Multicenter Study Examining the Effects of Duration of Treatment of PEGASYS® in Combination With Daily COPEGUS® + Amantadine in Patients With Chronic HCV After Relapse to Previous (Peg)IFN + Ribavirin Therapy. [NCT00299923]Phase 3300 participants Interventional2005-11-30Active, not recruiting
A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Pre [NCT00086541]Phase 3515 participants (Actual)Interventional2004-06-30Completed
A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy [NCT00120861]Phase 20 participants Interventional2005-01-31Completed
Chronic Hepatitis C: Treatment of (Peg)Interferon Alpha - Ribavirin Non-Responders With Pegylated Interferon alpha2b, Ribavirin, AdoMet and Betaine [NCT00310336]Phase 2/Phase 330 participants (Anticipated)Interventional2006-08-31Completed
Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and C Hepatitis Who Failed to Active Treatment for HCV. ANRSHC12 Fibrostop [NCT00122616]Phase 352 participants (Actual)Interventional2003-11-30Completed
[NCT01441804]Phase 3200 participants (Anticipated)Interventional2011-05-31Recruiting
A Study to Evaluate the Erythropoietic Response in Hepatitis C Virus (HCV) Patients Receiving Combination Ribavirin (RBV)/Interferon (IFN) Therapy or RBV/PEG IFN [NCT00328549]Phase 2105 participants (Actual)Interventional2001-10-31Completed
Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C [NCT00093093]Phase 3900 participants Interventional2004-06-30Completed
A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C [NCT00332176]Phase 250 participants (Anticipated)Interventional2006-06-30Recruiting
A Pilot Study to Treat Patients With Chronic HCV Genotype 1 and ESRD Receiving Hemodialysis and Naïve to Prior HCV Therapy With Peginterferon Alfa-2b, the Maximally Tolerated Ribavirin Dose and Boceprevir [NCT01731301]Phase 420 participants (Anticipated)Interventional2013-01-31Not yet recruiting
An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons [NCT01054573]Phase 390 participants (Actual)Interventional2010-04-30Completed
An Open-Label Trial of Pegylated Interferon Plus Ribavirin in Combination With CTS-1027 in HCV Null-Responders [NCT01051921]Phase 267 participants (Actual)Interventional2010-01-31Completed
A Pilot Study of Treatment With Pegylated Interferon-Alpha2a, Ribavirin and Insulin Sensitizer Pioglitazone of Insulin Resistance (With the Exception of Diabetes) in Hepatitis C Virus Infection (The INSPIRED HCV Study) [NCT00433069]Phase 25 participants (Actual)Interventional2007-01-31Completed
Pilot, Multicenter, Randomized Study on Lopinavir/Ritonavir-Monotherapy vs Lopinavir/Ritonavir Plus Selected Nucs, in HIV/HCV ARV-Naive Coinfected Patients With Chronic Hepatitis C or Compensated Cirrhosis, Starting Treatment With Ribavirin and Pegylated [NCT00437476]Phase 360 participants (Anticipated)Interventional2007-02-28Recruiting
[NCT00466219]Phase 325 participants Interventional2002-05-31Completed
Individually Adapted Therapy Duration From 24 to 72 Weeks for the Treatment of a Chronic Hepatitis C Genotype 1 Infection With Peginterferon Alfa-2b Plus Ribavirin in Dependence of the Initial Concentration and the Decline of the HCV RNA [NCT00351403]Phase 4390 participants (Anticipated)Interventional2006-07-31Completed
Influence of Marker of Insulin Resistance Upon HCV Treatment Responses to PEG Intron and Rebetol Therapy [NCT00351871]Phase 4400 participants (Actual)Interventional2002-04-30Completed
A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chro [NCT00115908]Phase 2458 participants (Actual)Interventional2005-05-31Completed
An Open Label Study to Evaluate the Safety and Effect on Sustained Virological Response of PEGASYS Plus Ribavirin in Patients With Hemophilia A and Chronic Hepatitis C [NCT00475072]Phase 414 participants (Actual)Interventional2003-06-30Completed
A Pilot Study to Evaluate the Efficacy and Safety of Pegylated Interferon Alfa-2b Plus Ribavirin in the Treatment of Patients With Dual Chronic Hepatitis B and Delta [NCT00117533]Phase 420 participants Interventional2005-09-30Recruiting
An Open Label Non-Randomized Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIV/HCV Coinfected Individuals [NCT00489385]Phase 141 participants (Actual)Interventional2007-06-18Completed
Phase 4 Comparative Study of Pegasys vs Peg-Intron for Treatment of Chronic Hepatitis C Genotype 4 [NCT00502099]Phase 4217 participants (Actual)Interventional2006-01-31Completed
An Open Label, Comparative, Multi-Center Study, to Evaluate the Efficacy and Safety of Peginterferon Alfa-2a Plus Ribavirin in the Treatment of Patients With Chronic Hepatitis C/Hepatitis B Co-Infection and Chronic Hepatitis C [NCT00154869]Phase 3320 participants (Anticipated)Interventional2004-06-30Recruiting
Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (Crimean-Congo Hemorrhagic Fever or Lassa Fever) [NCT02483260]30 participants (Anticipated)Interventional2016-06-16Recruiting
A Multicenter Study Evaluating the Efficacy and Safety of 12 Weeks Versus 24 Weeks Peginterferon Alfa-2a 40KD Combination Therapy With Ribavirin in Interferon Naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection [NCT00143000]Phase 4392 participants (Actual)Interventional2004-04-30Completed
Pilot Study on Interferon Gamma in Association With Peg-Interferon Alpha 2a and Ribavirin Among Patients With a Chronic Hepatitis C and Non Responders to the Association of Peg-Interferon Alpha 2b or 2a and Ribavirin ANRS HC16 Gammatri [NCT00148863]Phase 265 participants Interventional2004-06-30Completed
Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin Versus Pegylated Interferon Alfa-2a Alone for Treatment-naïve Hemodialysis Patients With Chronic Hepatitis C [NCT00491244]Phase 4377 participants (Actual)Interventional2007-06-30Completed
Efficacy of Ombitasvir With Paritaprevir/Ritonavir Plus Ribavirin on the Treatment naïve Patients With Chronic Hepatitis C Virus Genotype 4 [NCT04378608]Phase 1/Phase 2100 participants (Actual)Interventional2017-01-05Completed
A Greek Observational Study on Relapse Rate and Sustained Virological Response in Naive CHC Patients, Treated With Pegylated Interferon Alpha-2b and Ribavirin in Daily Clinical Practice [NCT00724464]332 participants (Actual)Observational2007-12-31Completed
Sustained Viral Response Rate in 100 Subjects With Cirrhosis Due to Hepatitis C Treated With 12 Weeks of Sofosbuvir, Daclatasvir and Ribavirin [NCT02596880]Phase 3100 participants (Actual)Interventional2015-09-30Completed
A Randomized, Multicenter, Double Blinded Study Comparing the Safety and Efficacy of Pegasys® 180 ug Plus Copegus® 1000 or 1200 mg to the Currently Approved Combination of Pegasys® 180 ug Plus Copegus® 800 mg in Interferon-naïve Patients With Chronic Hepa [NCT00353418]Phase 4415 participants (Actual)Interventional2006-06-30Completed
A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Subjects With Genotype 2 Hepatitis C, Who Did Not Respond to Previous Treatment [NCT01468584]Phase 310 participants (Actual)Interventional2011-11-30Completed
A Randomized Phase III Study To Evaluate The Safety And Efficacy Or Ribavirin Inhaled Solution In Preventing Progression Of Upper Respiratory Tract Respiratory Syncytial Virus (RSV) Infection To RSV Pneumonia In Blood And Bone Marrow Transplant (BMT) Reci [NCT00016081]Phase 30 participants Interventional1998-03-31Completed
Early Prediction of Successful Treatment for Chronic Hepatitis C Virus Infection in Taiwan [NCT00543244]300 participants (Anticipated)Observational2006-01-31Recruiting
A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Pre [NCT00162734]Phase 3144 participants (Actual)Interventional2005-02-28Completed
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C Non 2 -3 Genotype naïve Patients Treated With a 12 Weeks Bitherapy of Peginterferon Alpha 2a-Ribavirin, and Followed by a Tritherapy of Peginterferon Alpha 2a-Ribavirin [NCT00199719]Phase 230 participants (Actual)Interventional2003-06-30Completed
Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers [NCT00211848]Phase 2207 participants (Anticipated)Interventional2000-06-30Completed
HRN 003PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy [NCT00215865]Phase 3600 participants InterventionalCompleted
Pilot Study of Addition of IL-2 to Pegylated Interferon Alpha 2a and Ribavirin for the Treatment of Chronic Hepatitis C in HIV-HCV Coinfected Patients Non Responders to Three Months of Therapy With Pegylated Interferon Alpha 2a and Ribavirin. ANRS HC09 SE [NCT00196586]Phase 275 participants Interventional2003-04-30Completed
PEG-Interferon a-2b + Ribavirin for Treatment of Chronic Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon [NCT00215891]Phase 3300 participants InterventionalCompleted
Antiviral Effect of 4 Regimens of PEGASYS Plus Copegus in Patients With Genotype 1 Chronic Hepatitis C Non-responder to Previous Peginterferon Alfa-2a Plus Ribavirin Therapy [NCT00412334]Phase 4104 participants (Actual)Interventional2007-01-31Completed
Randomized Placebo-Controlled Trial of a Triple Therapy Combining Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine Versus Peginterferon Alfa-2a Plus Ribavirin Plus Placebo in Hepatitis C-Infected Patients Non Responders to a First-Line Therapy of Inte [NCT00221624]Phase 3131 participants (Actual)Interventional2001-11-30Completed
COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV [NCT00919633]Phase 2116 participants (Actual)Interventional2009-06-30Completed
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon α-2a and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects [NCT01281839]Phase 3394 participants (Actual)Interventional2011-02-28Completed
A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection [NCT01125189]Phase 2558 participants (Actual)Interventional2010-07-31Completed
Efficacy and Safety of Continuing for a Total of 48 or Prolonging for a Total of 72 Weeks of Combined Treatment of Patients Receiving Pegasys and Copegus Who Are Biochemical Responders But Virological Non-Responders at Week 12 or Week 24 [NCT00336518]Phase 3100 participants Interventional2006-06-30Recruiting
A Pilot, Open Label, Multicenter, Randomized Clinical Trial on Lopinavir/Ritonavir-Monotherapy vs Lopinavir/Ritonavir Plus Selected Nucs, in HIV/HCV Coinfected Patients With Chronic Hepatitis C or Compensated Cirrhosis, Starting Treatment With Ribavirin a [NCT00437684]Phase 350 participants (Anticipated)Interventional2007-02-28Recruiting
Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin β (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens [NCT00470210]Phase 410 participants (Actual)Interventional2007-05-31Completed
Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects With Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Vi [NCT01513941]Phase 3163 participants (Actual)Interventional2012-04-30Completed
24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C, RELAPSERS TO PEG-IFN + RIBAVIRIN TREATMENT. A RANDOMIZED CONTROLLED TRIAL [NCT01517308]Phase 30 participants (Actual)Interventional2012-05-31Withdrawn(stopped due to Time elapsed to require permissions and a recent paper showed a high efficacy of a 48-week regimen in this setting. It seems non-ethical to start this trial)
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland [NCT02582671]101 participants (Actual)Observational2015-11-05Completed
[NCT02556307]270 participants (Actual)Observational2009-03-31Completed
A Pilot, Randomized Study Comparing the Safety, Tolerability and Pharmacokinetics of Combination Therapy (Amantadine, Ribavirin, Oseltamivir) Versus Neuraminidase Inhibitor Monotherapy to Influenza Virus Infected Immunocompromised Patients [NCT00867139]Phase 1/Phase 27 participants (Actual)Interventional2009-03-31Completed
A Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-5172 in Participants With Chronic Hepatitis C [NCT01547312]Phase 10 participants (Actual)Interventional2012-05-31Withdrawn
Peginterferon Alfa-2a and Ribavirin Combination Therapy in Patients With HBeAg-negative Chronic HBV Infection (PARC Study) [NCT00114361]Phase 3138 participants (Actual)Interventional2005-03-31Completed
Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous HCV Non Responders ANRSHC03 BITRI [NCT00122629]Phase 3405 participants Interventional2000-10-31Terminated
A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previo [NCT02094443]Phase 252 participants (Actual)Interventional2014-03-31Completed
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients [NCT01770483]Phase 466 participants (Actual)Interventional2011-07-31Completed
Safety, Efficacy, and Changes in Traditional and Novel Biomarkers of Kidney Function in Patients With Hepatitis C and Advanced Chronic Kidney Disease Treated With Abbvie Viekira Pak or Mavyret Regimen [NCT02946034]Phase 410 participants (Actual)Interventional2017-02-01Completed
[NCT00062816]Phase 1/Phase 222 participants Interventional2003-06-30Completed
A Phase II, Multi-center, Open Label, Randomized Study of Ribavirin and Hedgehog Inhibitor With or Without Decitabine in Acute Myeloid Leukemia (AML) [NCT02073838]Phase 223 participants (Actual)Interventional2015-05-31Completed
A Randomized Phase III Study to Evaluate the Safety and Efficacy of Ribavirin Inhaled Solution in Preventing Progression of Upper Respiratory Tract Respiratory Syncytial Virus Infection to RSV Pneumonia in Blood and Bone Marrow Transplant (BMT) Recipient [NCT00031473]Phase 390 participants Interventional1997-11-30Terminated
An Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C [NCT01833845]Phase 1/Phase 24 participants (Actual)Interventional2013-04-30Terminated(stopped due to due to failure to recruit subjects)
A Prospective Multicenter, Phase II, Open Label, Controlled Trial Evaluating the Response of Hepatitis C Virus (HCV) to Pegylated Interferon Alpha-2A and Ribavirin in Hemophilic Patients With and Without Coinfection With the Human Immunodeficiency Virus ( [NCT00055341]Phase 222 participants Interventional2002-03-31Completed
Pharmacological Interactions Between Zidovudine and Ribavirin in HCV-HIV Co-Infected Patients Treated With Rebetron or Peg-Intron Plus Ribavirin [NCT00059358]Phase 1/Phase 216 participants (Anticipated)Interventional2001-09-30Completed
Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1 [NCT00081770]Phase 34,469 participants (Actual)Interventional2004-03-31Completed
A Multi-Center, Randomized, Open-Label, Phase IIIb Study Investigating the Safety and Efficacy of Peginterferon a-2a Plus Ribavirin for the Treatment of Chronic Hepatitis C Infection in HIV Infected Persons Who Have Failed to Achieve a Sustained Virologic [NCT00215839]Phase 30 participants InterventionalActive, not recruiting
Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs (HI-LO Study) [NCT00399672]370 participants (Actual)Interventional2007-06-30Completed
Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance [NCT01664845]Phase 2/Phase 3120 participants (Anticipated)Interventional2012-08-31Recruiting
HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a Methadone Maintenance Treated (MMT) Opioid Addicted Group. [NCT00147784]Phase 310 participants (Anticipated)Interventional2006-03-31Completed
Randomized Double Blind Trial Comparing the Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin for Initial Treatment of Patients With Hepatitis C With Genotype 1 or 4 and Severe Fibrosis [NCT00148837]Phase 2112 participants (Actual)Interventional2004-09-30Active, not recruiting
Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication [NCT00152581]Phase 440 participants Interventional2002-04-30Completed
A Phase II Study of Adefovir Dipivoxil, Pegylated Interferon Alfa-2A, and Ribavirin Treatment in HBV and HCV Infected Subjects With HIV Disease [NCT00051077]Phase 20 participants (Actual)InterventionalWithdrawn
Tacrolimus Monotherapy in OLT Recipients With HCV Under Preemptive Treatment With Interferon and Ribavirin [NCT00167557]Phase 40 participants (Actual)Interventional2005-01-31Withdrawn(stopped due to The PI left the institution.)
#0810010040: Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus Infection: A Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C [NCT00892697]Phase 215 participants (Actual)Interventional2009-05-31Completed
Safety and Tolerability of Consensus Interferon-Alpha (CIFN) Plus Interferon Gamma-1b (IFN-γ 1b) With or Without Ribavirin (RBV) in the Treatment of Patients With Chronic Hepatitis C Who Are Non-Responders to PEG-IFN-a (2a or 2b) Plus RBV [NCT00084279]Phase 281 participants (Actual)Interventional2004-04-30Completed
Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment [NCT00221650]Phase 217 participants (Actual)Interventional2002-04-30Completed
Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin [NCT01390844]Phase 3282 participants (Actual)Interventional2011-10-21Completed
Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Ch [NCT00394277]Phase 41,175 participants (Actual)Interventional2007-02-28Completed
A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those I [NCT01728324]Phase 3496 participants (Actual)Interventional2012-11-30Completed
Boceprevir/Peginterferon Alfa (PegIFN α)-2b/Ribavirin (Riba) in Difficult-to-Treat Menopausal Women With Chronic Hepatitis C Genotype 1 (Gt 1), Either Deemed Nonresponders to Peginterferon/Ribavirin or Treatment-naives (MEN_BOC) [NCT01457937]Phase 3240 participants (Anticipated)Interventional2011-11-30Recruiting
Study to Evaluate Response Rates in Chronic Hepatitis C (CHC) Patients Genotype 1 With Insulin Resistance and to Assess Prolonged Treatment Duration in Late Virological Responders [NCT00493805]Phase 459 participants (Actual)Interventional2007-04-30Terminated(stopped due to Slow Enrollment)
Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4 [NCT04385407]Phase 2203 participants (Actual)Interventional2015-04-30Completed
A Randomized Study to Evaluate the Safety and Efficacy of Adding Daclatasvir to the Combination of Sofosbuvir (SOF) and Ribavirin (RBV) for 16 Weeks Versus 24 Weeks in Cirrhotic Subjects With Chronic Hepatitis C Infection Genotype 3 [NCT02304159]Phase 439 participants (Actual)Interventional2015-01-31Completed
Evaluation of Satisfaction in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C [NCT00704717]185 participants (Actual)Observational2005-09-30Completed
Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C [NCT00705107]267 participants (Actual)Observational2004-11-30Terminated
An Open-label Randomized Controlled Trial on Lopinavir/ Ritonavir, Ribavirin and Interferon Beta 1b Combination Versus Lopinavir/ Ritonavir Alone, as Treatment for 2019 Novel Coronavirus Infection [NCT04276688]Phase 2127 participants (Actual)Interventional2020-02-10Completed
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients [NCT02631772]Phase 432 participants (Actual)Interventional2016-06-01Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa [NCT01183169]Phase 2459 participants (Actual)Interventional2010-08-31Completed
A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Ribavirin From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fed Conditions [NCT05532306]Phase 136 participants (Actual)Interventional2020-10-11Completed
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in Subjects With Chronic HCV GT1 or GT3 Infection Who Have Failed a Direct [NCT02613403]Phase 294 participants (Actual)Interventional2015-12-10Terminated
A Multi-center, Placebo-controlled, Multiple Dose, Study of the Safety and Pharmacokinetics and Pharmacodynamics of INX-08189 Dosed Either QD, BID or Adjunctively With Ribavirin, and a Study of the Food Effect, in Chronically-infected Genotype 1 HCV, Trea [NCT01445795]Phase 1/Phase 250 participants (Actual)Interventional2011-09-30Completed
A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patient [NCT01057667]Phase 2168 participants (Actual)Interventional2010-02-28Completed
Simeprevir (SMV) + Sofosbuvir (SOF) With or Without Ribavirin (RBV) for Interferon-intolerant or Ineligible (IFN-II) Patients With Chronic Hepatitis C (CHC) [NCT02214420]Phase 424 participants (Actual)Interventional2014-10-31Completed
Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever: A Randomized Controlled Open Label Phase II Clinical Trial [NCT04907682]Phase 240 participants (Actual)Interventional2021-07-30Completed
A Phase I Study of Low Dose Interleukin 2 (IL-2)Monotherapy, Followed by IL-2 Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I Infection [NCT00277758]Phase 118 participants (Actual)Interventional2004-03-31Terminated(stopped due to Insufficient rate of volunteer accrual.)
A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects [NCT00249860]Phase 3257 participants (Actual)Interventional2002-09-30Completed
Direct Acting Antiviral (DAA) Based Therapy for Recently Acquired Hepatitis C [NCT01743521]Phase 414 participants (Actual)Interventional2013-01-31Completed
An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C [NCT01428063]Phase 2276 participants (Actual)Interventional2011-09-30Completed
A Phase 4 Open-Label Pilot Study of the Safety and Tolerability of High Dosage of CIFN Plus RBV Administered Daily for 48 Weeks in HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Pegylated Interferon Alfa Plus RBV Therapy [NCT00266318]Phase 440 participants Interventional2005-12-31Completed
Outcome of Decompensated Hepatitis C Virus-Related Cirrhotic Patients Treated With Peginterferon Alfa-2b and Ribavirin: Results of a Controlled Study [NCT00301509]Phase 2/Phase 30 participants Interventional2002-01-31Completed
A Phase I/II, Open Clinical Trial to Assess the Safety, Tolerability and Efficacy of a Fixed Dose Combination Therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN Alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infe [NCT01272310]Phase 1/Phase 236 participants (Anticipated)Interventional2011-01-31Not yet recruiting
Role of Rapid Virologic Response in Determining Treatment Duration of Peginterferon Alfa-2b/Ribavirin in Chronic Hepatitis C Genotype 4 [NCT00277862]Phase 4280 participants (Actual)Interventional2002-04-30Completed
Comparison of PEG Interferon Alfa-2b Plus Ribavirin Given as a Fixed Dose or on a Weight Optimized Basis for Treatment of Chronic Hepatitis C in Previously Untreated Adult Subjects [NCT00299936]Phase 35,000 participants InterventionalCompleted
14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response [NCT00308048]Phase 3435 participants Interventional2004-03-31Completed
Randomized Study of Nitazoxanide-Peginterferon, Nitazoxanide-Peginterferon-Ribavirin and Peginterferon-Ribavirin in the Treatment of Chronic Hepatitis C [NCT00421434]Phase 2/Phase 3121 participants (Actual)Interventional2006-06-30Completed
Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy [NCT05717400]Phase 415 participants (Anticipated)Interventional2023-02-07Recruiting
Multicenter, Open-label, Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Genotype 1 Chronic Hepatitis C Subjects With Severe Fibrosis and Compensated Cirrhosis [NCT01508286]0 participants Expanded AccessNo longer available
Phase 2b Evaluation of PegIFNα Free Combinations of BMS-986094 (INX-08189) and Daclatasvir, With or Without Ribavirin, in Treatment Naive and Treatment Experienced Patients With Chronic Hepatitis C [NCT01629732]Phase 20 participants (Actual)Interventional2013-03-31Withdrawn
A Pilot Study of Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies [NCT02308241]12 participants (Actual)Interventional2014-12-02Completed
A Randomized, Open-lable, Multicenter, Parallel Group Study to Compare SVR Rate of Pegasys Plus Ribavirin for 48 Weeks vs. 36 Weeks in Patients With Chronic Hepatitis C [NCT01639547]410 participants (Anticipated)Interventional2012-07-31Terminated(stopped due to early termination due to difficult collection of patients)
Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With H [NCT01866930]Phase 3453 participants (Actual)Interventional2013-07-11Terminated(stopped due to Sponsor decision not based on any new unexpected safety findings or efficacy observations.)
PREDICT (Part 2)- Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With HCV Genotype 1 Low Viral Load (HCV LVL 1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A Negativ [NCT01054742]2 participants (Actual)Observational2009-12-31Completed
Vitamin D in Addition to Pegylated Interferon and Ribavirin Compared to Pegylated Interferon and Ribavirin Alone in the Treatment of Chronic Hepatitis C Genotype 4. [NCT01655966]Phase 380 participants (Anticipated)Interventional2012-05-31Active, not recruiting
Cost of Treatment of Chronic Hepatitis C Using Combination of Peginterferon α-2b Plus Ribavirin [NCT00723632]901 participants (Actual)Observational2005-09-30Completed
INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotyp [NCT01278134]Phase 2170 participants (Actual)Interventional2011-02-28Completed
RCT Comparing Different Ribavirin Dosages and Durations of Treatment in Combination With Peginterferon in HCV Genotypes 2 and 3 (WRITE) [NCT01380938]Phase 31,150 participants (Actual)Interventional2018-12-01Completed
A Bioequivalence Study of Ribavirin Oral Solution (RO0209963) Versus the Reference Ribavirin Tablets (Copegus) Following Oral Administration in Healthy Adult Subjects [NCT01697436]Phase 140 participants (Actual)Interventional2012-09-30Completed
A Double Blind Placebo Controlled Randomized Trial of Ribavirin in Patients With Acute on Chronic Liver Failure Due to Hepatitis E Virus [NCT01698723]Phase 240 participants (Anticipated)Interventional2012-09-30Recruiting
Evaluate the Efficacy and Safety of TG-2349 in Combination With Peg-interferon and Ribavirin in Treatment naïve East Asian Subjects With Chronic Hepatitis C Virus Genotype 1b Infection. [NCT02340962]Phase 225 participants (Actual)Interventional2015-05-31Completed
A Phase 2, Multicenter, Dose-Ranging Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C [NCT01726946]Phase 210 participants (Actual)Interventional2012-11-30Completed
A Randomized, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection [NCT01995071]Phase 289 participants (Actual)Interventional2013-11-30Completed
Is Hepcidin a Possible Contributor to Impaired Iron Mobilization and Anaemia in Hepatitis C Patients Treated With Pegylated Interferon Alpha and Ribavirin Therapy? A Pilot Study [NCT01726400]15 participants (Actual)Observational2012-12-31Completed
Effect and Safety of Xiao'er Jiebiao Oral Liquid in Combination With Standard Treatment on Hand-foot-mouth Disease in Pediatric Patients [NCT02328651]Phase 424 participants (Actual)Interventional2014-10-31Completed
STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RITONAVIR-BOOSTED DANOPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS OF ASIAN ORIGIN WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1 W [NCT01749150]Phase 261 participants (Actual)Interventional2013-04-30Completed
Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4) [NCT02319031]Phase 353 participants (Actual)Interventional2015-02-28Completed
An Open Label Study Assessing SVR and Viral Resistance Profile With Boceprevir Plus PEG-IFN Plus Ribavirin Triple Therapy in HCV-1 Infected Patients With Insulin Resistance Who Have Failed PEG-IFN Plus Ribavirin Dual Therapy [NCT01770223]Phase 40 participants (Actual)Interventional2014-01-31Withdrawn
An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection [NCT01779518]0 participants Expanded AccessApproved for marketing
Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus Genotype 1-infected Patients in Taiwan [NCT00495131]Phase 4308 participants (Actual)Interventional2006-06-30Completed
Pharmacovigilance Study of the Interferon α 2b Produced by Bio-Manguinhos / Fiocruz and Used by Genotype 2/3 Chronic Hepatitis C Patients (Estudo de farmacovigilância da Alfainterferona 2b Humana Recombinante Produzida Por Bio-Manguinhos - Fiocruz, Utiliz [NCT01841775]Phase 485 participants (Actual)Interventional2009-05-31Completed
A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1 or Genotype 4 HCV Infection [NCT01846832]Phase 3232 participants (Actual)Interventional2013-09-30Completed
A Phase2/3, Multi-center, Randomized, Double-blind, Placebo-parallel Controlled Study to Investigate the Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Genotype [NCT03362814]Phase 2/Phase 3425 participants (Actual)Interventional2017-07-01Completed
An Open Label,Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1) [NCT01467479]Phase 3185 participants (Actual)Interventional2011-12-31Terminated(stopped due to It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.)
A Phase IV, Open-label, Multicentre, International Trial of Response Guided Treatment With Directly Observed Pegylated Interferon Alfa 2b (PEG-IFN-alfa 2b) and Self Administered Ribavirin (RBV) for Patients With Chronic HCV Genotype 2 or 3 and Injection D [NCT01364090]Phase 493 participants (Actual)Interventional2012-06-30Completed
A Pilot Study on the Efficicay and Safety of Pegylated Interferon, Ribavirin and Telaprevir in Recurrent Hepatitis C Virus (HCV) Infection in Orthotopic Liver Transplant (OLT) Recipients. [NCT01592006]Phase 43 participants (Actual)Interventional2012-04-30Terminated(stopped due to Low accrual)
Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Wee [NCT01606800]Phase 445 participants (Actual)Interventional2013-01-01Terminated(stopped due to The trial was terminated due to change in new standard of therapy during the study period.)
An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/ Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antivira [NCT02399345]Phase 310 participants (Actual)Interventional2015-03-31Completed
A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treat [NCT01648140]Phase 2286 participants (Actual)Interventional2012-08-01Completed
A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection [NCT01717326]Phase 2573 participants (Actual)Interventional2013-02-07Completed
Open-Label, Bridging Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Treatment- Naïve and Treatment-Experienced Russian Subjects With Genotype 1 Chronic Hepatitis C [NCT01498068]Phase 336 participants (Actual)Interventional2012-01-31Completed
A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients [NCT00000699]Phase 120 participants InterventionalCompleted
Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic [NCT01433887]Phase 3535 participants (Actual)Interventional2011-11-30Completed
Study of Parameters of Early Hepatitis C Virus Dynamics for Predicting the Outcome of Standard Interferon Therapy With Chinese Cohort [NCT01434212]40 participants (Anticipated)Observational2010-05-31Active, not recruiting
A Single Center, Prospective Phase IV, Open-Label, Randomized Trial Comparing the Efficacy , Tolerability, and Safety of Quadritherapy Regimen (Reiferon Retard® + Ribavirin + Nitazoxanide + Alfacalcidol ( Bon-One ®) ) Versus Triple Therapy Regimen (Reifer [NCT01896609]Phase 4300 participants (Anticipated)Interventional2013-06-30Recruiting
Directly Observed Hepatitis C Treatment in Methadone Clinics [NCT01442311]80 participants (Actual)Interventional2007-10-31Completed
A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subject [NCT01447394]Phase 30 participants (Actual)Interventional2012-03-31Withdrawn
A Phase II Study of Pembrolizumab (MK-3475) in Hepatitis C Virus Positive and Negative Subjects With Advanced Hepatocellular Carcinoma Who Progressed on or Were Intolerant to First-Line Systemic Therapy [NCT02940496]Phase 212 participants (Actual)Interventional2016-12-09Completed
An Open Labelled, Active Controlled, Three Arm, Parallel- Group Study of the Safety and Efficacy of Renessans Administered Alone and in Combination With Standard Interferon Therapy in Patients Chronic HCV Hepatitis [NCT01463592]Phase 390 participants (Actual)Interventional2010-06-30Active, not recruiting
Pilot Study on the Efficacy of Pegylated Interferon-Ribavirin-Boceprevir Triple Therapy in Patients Infected With Genotype 1 HCV With Cirrhosis and Awaiting Liver Transplantation (ANRS HC 29 BOCEPRETRANSPLANT) [NCT01463956]Phase 258 participants (Actual)Interventional2012-01-06Completed
The Predictive Values of Rapid Virus Response and Complete Early Virus Response for Sustained Virus Response in Chronic Hepatitis C Treated With Individual Therapeutic Programme [NCT01464008]297 participants (Actual)Observational2004-01-31Completed
Pharmacokinetic Interactions of Ribavirin and Abacavir in Hepatitis-C Mono-infected Male Subjects Who Previously Failed Ribavirin-based Treatment [NCT01052701]Phase 126 participants (Actual)Interventional2009-12-31Completed
An Open-Label Study to Evaluate the Safety and Efficacy of VIRAZOLE® (RIBAVIRIN FOR INHALATION SOLUTION, USP) in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 [NCT04356677]Phase 10 participants (Actual)Interventional2021-05-31Withdrawn(stopped due to Due to pandemic status changing in Canada prior to investigative sites being initiated for participation, and that concurrent participant recruitment in the global study BHC-RIB-5401-GL will achieve target enrollment across all countries.)
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Fail [NCT00980330]Phase 2463 participants (Actual)Interventional2009-10-31Completed
Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1 [NCT01012895]Phase 2215 participants (Actual)Interventional2009-12-31Completed
A Prospective, Open-label, Three Phase Pharmacokinetic Study, to Assess the Pharmacokinetic Profile and Safety of Raltegravir 400 mg Twice Daily and Ribavirin 800 mg Once Daily, When Dosed Separately and Together in Healthy Volunteers [NCT00982553]Phase 114 participants (Actual)Interventional2009-09-30Completed
A Phase l b/II a, Multicenter, Randomized, Double-Blinded, and Placebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C-Infection [NCT00911963]Phase 1/Phase 249 participants (Actual)Interventional2009-04-30Completed
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of the Safety, Efficacy, and Pharmacokinetics of ANA598 Administered With Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients With Chronic Hepatit [NCT00978497]Phase 297 participants (Actual)Interventional2009-09-30Completed
A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1 [NCT01500772]Phase 36 participants (Actual)Interventional2012-03-31Terminated
A Randomized, Open Label Trial of the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-INFα2a/RBV) and Boceprevir in Combination With Peg-INFα2a/RBV in African American Treatment-naïve Patients With [NCT01446250]Phase 38 participants (Actual)Interventional2011-12-31Terminated
A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effects of Adding TCM-700C,Botanical Drug, on the Standard Treatment (Peginterferon and Ribavirin) for Subjects With Naive Genotype 1 Hepatitis C Infection [NCT01890200]Phase 30 participants (Actual)Interventional2015-06-30Withdrawn
A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals [NCT00000772]Phase 115 participants InterventionalCompleted
An Open Label, Multicentre, International Pilot Study of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir With or Without Ribavirin or Glecaprevir/Pibrentasvir for People With Recently Acquired Hepatitis C Virus Infection With or Without HIV Co-infection. [NCT02634008]Phase 383 participants (Actual)Interventional2016-06-30Completed
An Open-label, Multicenter, Efficacy and Safety Study of Pegasys® Plus Ribavirin in Patients With Chronic HCV Infection Who Are Unable to Tolerate or Who Do Not Respond to 12 Weeks of Therapy With PEGIntron ® Plus Ribavirin [NCT00087568]Phase 457 participants (Actual)Interventional2003-01-31Completed
A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype [NCT01215643]Phase 2340 participants (Actual)Interventional2010-10-31Completed
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus In [NCT02219477]Phase 336 participants (Actual)Interventional2014-11-24Completed
A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C [NCT01492426]Phase 3605 participants (Actual)Interventional2012-01-31Completed
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute HCV in HIV-1 Infected Individuals (SWIFT-C) [NCT02128217]Phase 144 participants (Actual)Interventional2014-05-30Completed
A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 [NCT00705432]Phase 31,472 participants (Actual)Interventional2008-08-31Completed
Effect of a Combination of Nitazoxanide, Ribavirin and Ivermectin Plus Zinc Supplement on the Clearance of COVID-19: a Pilot Sequential Clinical Trial [NCT04392427]Phase 3100 participants (Anticipated)Interventional2020-10-31Not yet recruiting
Effect of a Combination of Nitazoxanide, Ribavirin and Ivermectin Plus Zinc Supplement on the Clearance of COVID-19: Extension Study [NCT04959786]Phase 2/Phase 3100 participants (Anticipated)Interventional2021-04-01Recruiting
A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype [NCT01459913]Phase 3239 participants (Actual)Interventional2011-11-30Terminated(stopped due to The study was terminated early by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.)
A 2-Part, Open Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected With Genotype 1 Hepatitis C Virus Following Liver Transplantation [NCT01467505]Phase 261 participants (Actual)Interventional2012-02-29Terminated(stopped due to The study was terminated early by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.)
A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Ge [NCT00704405]Phase 2285 participants (Actual)Interventional2009-03-27Completed
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOIS [NCT01704755]Phase 3381 participants (Actual)Interventional2012-10-31Completed
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters [NCT05616598]Phase 2/Phase 3200 participants (Actual)Interventional2022-03-01Completed
A Non-Randomized, Open Label, Study to Assess Hepatitis C Viral Kinetics in Predicting the Clinical Response in Patients With Hepatitis C Infection Coinfected With HIV-1 Treated With Peginterferon Alpha-2b and Ribavirin [NCT00018031]Phase 236 participants (Actual)Interventional2001-06-30Completed
Combination of Pegylated Interferon and Ribavirin as Therapy for Patients With Chronic Hepatitis C With and Without Renal Disease [NCT00028093]Phase 450 participants (Actual)Interventional2001-12-31Completed
An Exploratory Study to Evaluate Immune Restoration Following Removal of Viral Antigen in Treatment-Naïve and Treatment-Experienced Adults With Genotype (GT) 1a Chronic Hepatitis C Virus (HCV) Infection Administered Ombitasvir/ ABT-450/Ritonavir With Dasa [NCT02476617]Phase 325 participants (Actual)Interventional2015-06-30Completed
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium [NCT02581163]314 participants (Actual)Observational2015-10-07Completed
An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chroni [NCT02493855]Phase 246 participants (Actual)Interventional2015-06-30Completed
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II) [NCT02609659]Phase 3105 participants (Actual)Interventional2015-10-28Completed
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Canada (AMBER) [NCT02581189]565 participants (Actual)Observational2015-10-13Completed
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT1 and GT2 Infection [NCT02332707]Phase 2443 participants (Actual)Interventional2015-01-22Completed
A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Fai [NCT02446717]Phase 2/Phase 3141 participants (Actual)Interventional2015-04-30Completed
The Role of DAA in Reducing the Risk of Recurrence After Curative Treatment of HCC in Patients With Chronic Hepatitis C and Early Stage HCC [NCT02959359]Phase 40 participants (Actual)Interventional2016-11-30Withdrawn(stopped due to The supplies of study drug were halted by Gilead Sciences Ltd.)
Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects [NCT01571583]Phase 374 participants (Actual)Interventional2012-02-29Completed
[NCT01579019]Phase 20 participants (Actual)Interventional2012-07-31Withdrawn
A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 [NCT01590225]Phase 30 participants (Actual)Interventional2013-01-28Withdrawn
Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C [NCT01596517]Phase 4272 participants (Actual)Interventional2003-06-30Completed
An Open-Label Safety and Tolerability Study of Nitazoxanide, Pegylated-Interferon Alfa 2a and Ribavirin in HIV/HCV Co-Infected Genotype 1 Prior Treatment Relapsers and Non-Responders [NCT01185028]Phase 1/Phase 28 participants (Actual)Interventional2010-08-31Completed
Prospective, Randomized, Single-blind, Cross-over, Comparative Study for Establishing Comparative Bioavailability of Copegus vs Vilona® in Healthy Volunteers [NCT01615393]Phase 140 participants (Actual)Interventional2011-06-30Completed
Multicenter Open-label Randomized Prospective Clinical Study of Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b) in Comparison With PegIntron (Peginterferon Alfa-2b) in the Combined Treatment of Chronic Hepatitis C [NCT01740089]Phase 2/Phase 3150 participants (Actual)Interventional2011-11-30Completed
Prospective Randomized Pilot Study of Daily Consensus Interferon (CIFN) and Ribavirin for 52 Wks vs Extended Duration 72 Wks Based on Virologic Response for the Initial Treatment of Difficult-to-treat Patients With Chronic HCV Genotype 1 [NCT00211692]Phase 364 participants (Actual)Interventional2005-07-31Completed
Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Participants With HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy (C_ASCENT) [NCT02194998]Phase 246 participants (Actual)Interventional2015-09-16Terminated(stopped due to The study closed to accrual before the planned accrual goal was attained due to the availability of newer directly-acting antiviral (DAA) treatments for HCV.)
An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) in Treatment-Naive Subjects With Genotype 1 Chronic Hepati [NCT01221298]Phase 211 participants (Actual)Interventional2010-10-31Completed
Phase I Study of Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC) [NCT01721525]Phase 110 participants (Actual)Interventional2012-11-30Completed
Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Interest of a Long-term (3 Years) Treatment With Peginterferon Alfa-2b and Ribavirin on Liver Fibrosis in Non-responder Chronic Hepatitis C Patients. [NCT00323804]Phase 2/Phase 3372 participants (Actual)Interventional2006-05-31Completed
A Phase 2a, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Who Have Chronic HCV-1/HIV-1 Co-Infection and Are T [NCT00983853]Phase 262 participants (Actual)Interventional2009-10-31Completed
An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols [NCT01853254]Phase 3272 participants (Actual)Interventional2003-09-30Completed
A Non-Interventional Trial of Pegasys/Copegus in HCV Patients for 12 Months [NCT02515279]463 participants (Actual)Observational2008-11-30Completed
Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients [NCT00000733]Phase 142 participants InterventionalCompleted
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Treatment-Naïve or Treatment-Experienced Adults in Brazil With Genotype 1 Chronic Hepatitis C Virus (HCV) [NCT02442271]Phase 3222 participants (Actual)Interventional2015-04-27Completed
A Multicenter Phase I Clinical Trial of Ribavirin in the Treatment of Patients With AIDS and Advanced AIDS Related Illnesses [NCT00001015]Phase 196 participants InterventionalCompleted
A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome [NCT00001123]130 participants InterventionalCompleted
Randomized Study on the Efficacy and Safety of Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation [NCT00383864]Phase 455 participants Interventional2001-07-31Completed
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1) [NCT02265237]Phase 3184 participants (Actual)Interventional2014-10-28Completed
An Open-label Study to Assess the Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis With HCV Genotype 2 Infection [NCT04774107]Phase 117 participants (Actual)Interventional2020-11-26Completed
A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection [NCT01909804]Phase 2323 participants (Actual)Interventional2013-06-30Completed
Noninterventional Study on the Quality Assurance of the Therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa-2a (Pegasys®) and Ribavirin (e.g. Copegus®) With Main Focus Gastroenterologists - a Project in BNG (Association of German Resident Gastr [NCT02106156]10,228 participants (Actual)Observational2008-01-31Completed
A Phase II Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 + MK-8742 + Ribavirin (R) in Subjects With Chronic Hepatitis C Virus Infection Who Failed Prior Direct Acting Antiviral Therapy [NCT02105454]Phase 279 participants (Actual)Interventional2014-05-23Completed
Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl Alone or in Combination With Ribavirin in Patients With Chronic Hepatitis C [NCT02118012]Phase 1/Phase 224 participants (Actual)Interventional2014-03-20Completed
A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Sofosbuvir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1, 4 [NCT02358044]Phase 3257 participants (Actual)Interventional2015-02-27Completed
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of a Combination Regimen of MK-5172 With/Without MK-8742 and/or Ribavirin (RBV) in Treatment-naive Subjects With Chronic Hepatitis C Genotype 2, 4, 5 and 6 Infection [NCT01932762]Phase 298 participants (Actual)Interventional2013-10-01Completed
Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C [NCT01340573]3 participants (Actual)Observational2007-03-31Terminated(stopped due to Terminated early due to low enrollment.)
A Phase IV, Multisite Study of the Treatment of Chronic Hepatitis C Virus Infection Genotype 1 in a Real World Large Health Maintenance Organization: An Evaluation of Real World Sustained Virological Response and Patient Reported Outcomes [NCT02461745]Phase 4200 participants (Actual)Interventional2015-06-30Completed
Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepato [NCT02504099]Phase 33 participants (Actual)Interventional2015-07-31Terminated(stopped due to Study stopped due to low enrollment)
A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection [NCT02021643]Phase 3687 participants (Actual)Interventional2013-12-10Completed
A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children. [NCT00000833]Phase 120 participants InterventionalCompleted
A Comparative Study of High-dose Interferon Alfa-2a and Pegylated Interferon Alfa-2a for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV [NCT00381953]Phase 333 participants (Actual)Interventional2003-02-28Completed
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With and Without Dasabuvir Coadministered With and Without Ribavirin in Adults With Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immuno [NCT01939197]Phase 2/Phase 3318 participants (Actual)Interventional2013-08-30Completed
Comparison of Standard Therapy,Peginterferon Alpha-2a + Ribavirin for 48 Weeks VS Peginterferon Alph-2a + Ribavirin + Betaine for 12 Weeks Followed by 36 Weeks Standard Therapy in Untreated Adults With Chronic Hepatitis C Genotype 1 [NCT00571714]0 participants (Actual)Interventional2008-04-01Withdrawn(stopped due to lack of enrollment)
Open, Multicentre and Randomised Phase IV Study to Evaluate Viral Kinetics in the First 12 Weeks of Patients With Chronic Hepatitis C Genotypes 1 and 4 Coinfected by the Human Immunodeficiency Virus Treated With Induction Doses of Peginterferon Alpha-2a ( [NCT00356486]Phase 474 participants (Actual)Interventional2005-10-31Completed
Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment: A Pilot Project [NCT02460133]Phase 444 participants (Actual)Interventional2015-07-31Active, not recruiting
Pegintron Induction Therapy in Previous Non-Responders With Chronic HCV: A Dutch Multicenter Randomized Controlled Trial. (PIT-Study) [NCT00363259]Phase 3110 participants Interventional2002-07-31Completed
Directly Observed Therapy for the Delivery of HCV Therapy Among HCV-infected Individuals in Chennai, India [NCT02541409]Phase 250 participants (Actual)Interventional2015-09-30Completed
Phase II Trial of Retreatment Strategies for Difficult-to-Treat Hepatitis C Virus (HCV)-Infected Individuals Who Have Failed Prior Direct Acting Antiviral (DAA)-Based Regimens [NCT02605304]Phase 27 participants (Actual)Interventional2016-02-17Terminated(stopped due to The study experienced enrollment difficulties.)
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal [NCT02207088]Phase 368 participants (Actual)Interventional2014-09-23Completed
Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever [NCT03889106]2 participants (Actual)Observational2019-03-01Terminated(stopped due to insufficient amount of participants)
An Open-label Pilot Study to Determine the Tolerability and Efficacy of Fixed-dose Grazoprevir/Elbasvir Treatment in Hepatitis C Uninfected Recipients of Renal Transplants From Hepatitis C Infected Deceased Donors [NCT02781649]Phase 410 participants (Actual)Interventional2016-07-20Completed
Phase 2 Study To Investigate the Efficacy, Safety And Pharmacokinetics Of Ravidasvir In Combination With Ritonavir-boosted Danoprevir And Ribavirin In Treatment-naive Non-cirrhotic Taiwanese Patients Who Have Chronic Hepatitis C Genotype 1 [NCT03020095]Phase 238 participants (Actual)Interventional2015-08-31Completed
Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma [NCT00375661]Phase 4100 participants (Actual)Interventional2006-09-30Completed
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis C (FOURward Study) [NCT02175966]Phase 235 participants (Actual)Interventional2014-07-28Completed
An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic [NCT01528735]Phase 225 participants (Actual)Interventional2012-02-29Completed
Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam [NCT03537196]Phase 4979 participants (Actual)Interventional2018-11-13Completed
A Prospective, Phase III, Open-Label Study of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in HCV/HIV Coinfected Subjects [NCT01482767]Phase 3262 participants (Actual)Interventional2012-04-30Completed
An Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects [NCT01563536]Phase 212 participants (Actual)Interventional2012-02-29Completed
An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Geno [NCT01458535]Phase 261 participants (Actual)Interventional2011-09-30Completed
A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatm [NCT01464827]Phase 2580 participants (Actual)Interventional2011-10-31Completed
An Open-Label, Multicenter Study to Evaluate Long-term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-II) [NCT02167945]Phase 3615 participants (Actual)Interventional2014-06-12Completed
Sofosbuvir Plus Daclatasvir With or Without Ribavirin for Chronic Hepatitis C Infection: Impact of Drug Concentration on Viral Load Decay [NCT03318887]130 participants (Actual)Observational2014-02-01Completed
Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Slovenia [NCT00705263]113 participants (Actual)Observational2005-10-31Completed
"To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis - A Randomized Open- Label Study" [NCT02464631]62 participants (Actual)Interventional2015-06-30Terminated(stopped due to In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure)
A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C [NCT01628692]Phase 2230 participants (Actual)Interventional2012-07-31Completed
The Diabetes Virus Detection and Intervention Trial [NCT04838145]Phase 296 participants (Actual)Interventional2018-08-30Completed
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic HCV GT3 Infection [NCT02601573]Phase 2101 participants (Actual)Interventional2016-01-05Completed
An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 [NCT02068222]Phase 210 participants (Actual)Interventional2014-04-30Completed
A Phase 3 Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus (EPGCG, Sofosbuvir , Daclatasvir & Ribavirin) Versus Sofosbuvir + Daclatasvir + Ribavirin (Part A) and a Single Dose of Dactavira (EP [NCT03186313]Phase 372 participants (Actual)Interventional2016-09-30Completed
A Phase 2, Randomized, Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination With Ribavirin or GS-9669 250 mg or GS-9669 500 mg in Naive or Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection [NCT01984294]Phase 2101 participants (Actual)Interventional2013-10-31Completed
A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects With Genotype 1b Chronic [NCT01674725]Phase 3187 participants (Actual)Interventional2012-08-31Completed
Randomized, Multicenter Study to Find Optimal Treatment Duration in Patients With Chronic Hepatitis C and Subtype 1 or 4 Depending on HCV RNA Level at Week 8 and Week 12 [NCT02641379]Phase 4737 participants (Actual)Interventional2003-05-31Completed
Impact of Interleukin 28B (rs12979860) Genotype on Virological Responses in Chronic Hepatitis C Treatment [NCT03090035]Phase 398 participants (Actual)Interventional2014-01-01Completed
A Phase III, Open Label, Multicentric Clinical Trial of a Single Arm of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotype 1,4 Who Have Failed to Treat With a [NCT03105349]Phase 40 participants (Actual)Interventional2017-07-01Withdrawn(stopped due to No availability of investigational medication.)
A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment [NCT01440595]Phase 25 participants (Actual)Interventional2011-11-28Terminated(stopped due to Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.)
An Open Label, On-Treatment Trial to Assess the Effect of HIV-1 Coinfection on Therapeutic Responses Using Boceprevir, Peg-Interferon-alfa-2b and Ribavirin in HCV Genotype 1, IFN Treatment-Naive Subjects With or Without HIV-1 [NCT01443923]Phase 44 participants (Actual)Interventional2011-09-30Terminated(stopped due to Unable to complete enrollment due to newly approved treatment options.)
Phase II, Randomized, Double-blind, Placebo-controlled Study of Nitazoxanide in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Hepatitis C [NCT00637923]Phase 2112 participants (Actual)Interventional2008-03-31Completed
A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant [NCT03026023]Phase 40 participants (Actual)Interventional2018-08-01Withdrawn(stopped due to moved forward with another protocol utilizing pan genotypic treatment once it became commercially available and FDA approved)
Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program [NCT01405027]Phase 4197 participants (Actual)Interventional2011-12-31Completed
A Multi-centre, Open Label, Parallel Group Trial to Evaluate the Pharmacokinetic Interactions Between BI 207127 (600 mg t.i.d. or 600 mg b.i.d.) and BI 201335 (120 mg q.d.) Given in Combination With Ribavirin for 24 Weeks, and Their Combined Effect on the [NCT01525628]Phase 172 participants (Actual)Interventional2012-04-30Completed
A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) an [NCT01795911]Phase 2165 participants (Actual)Interventional2013-03-31Completed
Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria [NCT00725751]353 participants (Actual)Observational2007-09-30Completed
An Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Treatment-Naïve and Treatment-Experienced Asian Adults With GT1b Chronic Hepatitis C Virus (HCV) In [NCT02517528]Phase 3104 participants (Actual)Interventional2015-07-20Completed
Treatment Efficacy and Safety of 12 Weeks of Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without Baseline NS5A Resistance-associated Variants (DARING) [NCT03004625]Phase 370 participants (Actual)Interventional2016-11-30Completed
Pilot Study to Assess the Efficacy and Tolerance to a QUadruple Therapy With Asunaprevir , Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a, in HIV-HCV Genotype 1 or 4 Coinfected Patients Previously Null Responders to a Standard Pegylated Interfer [NCT01725542]Phase 275 participants (Actual)Interventional2012-12-31Completed
Telaprevir in Patients With Genotype 3 HCV: Pilot Clinical Study to Evaluate Efficacy and Predictability of Therapy in Patients Who Have Failed to Respond to Pegylated Interferon and Ribavirin [NCT02087111]Phase 414 participants (Actual)Interventional2014-04-30Completed
Viral Kinetic Models of HCV Clearance in Hemophiliacs With Telaprevir [NCT01704521]Phase 15 participants (Actual)Interventional2012-12-31Completed
An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 [NCT02486406]Phase 2/Phase 364 participants (Actual)Interventional2015-10-28Completed
Reversal of Hepatic Impairment by Achieving Sustained Virologic Response (SVR) With 12 Weeks of Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) in Patients With Hepatitis C Virus (HCV) Genotype 1 Infection and Early Decompensation of Cirrhosis (MELD 10 or [NCT02455167]Phase 39 participants (Actual)Interventional2015-05-31Terminated(stopped due to Study stopped due to low accrual and availability of other treatment options)
A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin [NCT01741545]Phase 371 participants (Actual)Interventional2013-03-31Completed
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus [NCT01716585]Phase 3636 participants (Actual)Interventional2012-11-30Completed
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C V [NCT01715415]Phase 3395 participants (Actual)Interventional2012-11-30Completed
A Two-Part, Open-Label, Single-Arm Phase 1/2 Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Aged 3 to 17 Infected With Genotype 1 Hepatitis C Virus [NCT01701063]Phase 1/Phase 242 participants (Actual)Interventional2013-01-31Terminated
A Phase II Randomized, Dose Ranging, Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Different Doses of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment Naïve Subjects With Chronic Hepatiti [NCT01710501]Phase 287 participants (Actual)Interventional2012-12-07Completed
Part A: Drug Interaction Study Between GS-7977 and Antiretroviral Therapy (ARV) Combinations of Efavirenz, Tenofovir and Emtricitabine; Efavirenz, Zidovudine and Lamivudine; Atazanavir/Ritonavir, Tenofovir and Emtricitabine; Darunavir/Ritonavir, Tenofovir [NCT01565889]Phase 1/Phase 252 participants (Actual)Interventional2012-03-31Completed
A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy [NCT00087646]Phase 4948 participants (Actual)Interventional2003-09-30Completed
A Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naive Adults With Genotype 1b Chronic Hepatitis [NCT01767116]Phase 3419 participants (Actual)Interventional2012-12-31Completed
An Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With or Without Sofosbuvir (SOF) and Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Tre [NCT02356562]Phase 229 participants (Actual)Interventional2015-02-03Completed
A Pilot Trial of the Safety and Efficacy of Telaprevir +Peginterferon +Ribavirin +Vitamin D3 Among Treatment-naive Veterans Infected With Genotype 1 Hepatitis C Virus [NCT01890772]Phase 2/Phase 30 participants (Actual)Interventional2013-08-31Withdrawn
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C) [NCT04042740]Phase 245 participants (Actual)Interventional2019-11-15Completed
A Phase IIa, Randomized, Double-blind (Participant and Investigator Blind, Sponsor Open), Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0141625 in Combination With Pegylated Interferon Alpha-2a and Ribav [NCT01180790]Phase 2122 participants (Actual)Interventional2010-09-30Completed
A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection [NCT01732796]Phase 3470 participants (Actual)Interventional2012-12-31Completed
Double-Blind, Randomized, Placebo-Controlled Study to Assess Safety, Efficacy, and Pharmacokinetics (PK) of GSK2336805 in Combination With Peginterferon and Ribavirin in Treatment-naive Chronic Hepatitis C Subjects With Hepatitis C Virus Genotypes 1 or 4 [NCT01439373]Phase 216 participants (Actual)Interventional2011-07-07Completed
A Randomized Study Evaluating Two Different Schedules of Aerosolized Ribavirin For Treatment of RSV Upper Respiratory Infections in Patients With Hematological Malignancies [NCT00500578]Phase 451 participants (Actual)Interventional2003-02-28Completed
TCM-700C Phase II Trial The Effects of Adding a Chinese Formulation (TCM-700C) on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection [NCT00556504]Phase 284 participants (Actual)Interventional2007-07-31Completed
A Phase IIb Open Label Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Patients With Moderate Hepatic Impairment (Child-Pugh B) With Genotype 1b Chronic Hepatitis C Infection [NCT01830127]Phase 235 participants (Actual)Interventional2013-04-30Completed
A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With and Without Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve A [NCT01854697]Phase 3311 participants (Actual)Interventional2013-03-31Completed
Non-interventional, Observational Study on Retreatment of Chronic Hepatitis C Patients Previous Treatment Failure, Using Peginterferon Alfa-2a and Ribavirin Based Regimens [NCT01798576]282 participants (Actual)Observational2012-11-30Terminated
An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects [NCT01609933]Phase 232 participants (Actual)Interventional2012-12-18Completed
Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon [NCT00687544]Phase 411 participants (Actual)Interventional2005-12-31Terminated
Randomized Study for the Assessment of Nitazoxanide in the Treatment of Chronic Hepatitis C Genotype 4 [NCT01276756]Phase 2/Phase 3100 participants (Actual)Interventional2010-12-31Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of TMC435 vs. Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment-Naïve, G [NCT01725529]Phase 3457 participants (Actual)Interventional2012-11-30Completed
ATHENAS - Retrospective Analysis of Compliance to Treatment of Chronic Hepatitis C With Pegylated Interferon Alpha 2b Associated to Ribavirin Until Week 12 and Correlation With Virological Response in Brazil Health Centers [NCT00856024]902 participants (Actual)Observational2008-07-31Terminated
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I) [NCT01685203]Phase 2316 participants (Actual)Interventional2012-08-31Completed
An Open-label, Single-Arm, Phase 2 Study to Evaluate the Combination of ABT-450/r/ABT-267 and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Hepatitis C Virus (HCV) Infection Taking Methadone or Buprenorphine [NCT01911845]Phase 238 participants (Actual)Interventional2013-04-30Completed
Response-guided Triple-therapy Using Boceprevir in Combination With PEGIFN/RBV in HIV/HCV-coinfected Patients [NCT01925183]Phase 46 participants (Actual)Interventional2013-08-31Completed
A Phase IIa, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of a 12 Weeks Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Chronic Genotype 1 Hepatit [NCT01724086]Phase 290 participants (Actual)Interventional2012-10-31Completed
An International, Multicenter, Open-Label Study Evaluating Sustained Virological Response and Safety With Boceprevir in Triple Combination Therapy With Peginterferon Alfa-2a (40KD) and Ribavirin in Treatment-Naïve Patients With Genotype 1 Chronic Hepatiti [NCT01591460]Phase 4165 participants (Actual)Interventional2012-08-31Completed
Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C [NCT00705666]789 participants (Actual)Observational2006-02-28Completed
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Twice-Weekly Peginterferon Alpha 2a and Ribavirin Induction Therapy for Chronic Hepatitis C in Patients Who Are Coinfected With HIV-1 [NCT00085917]Phase 229 participants (Actual)Interventional2004-06-30Completed
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C - An Observational Study in Greece [NCT02725866]216 participants (Actual)Observational2016-04-05Completed
The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial [NCT04695769]Phase 4281 participants (Actual)Interventional2020-11-21Completed
Impact of Patient Support From Medical Staff on the Adherence to Therapy With PegIntron Plus Rebetol [NCT00704964]746 participants (Actual)Observational2005-05-31Completed
An Open-Label, Multi-Center, Randomized, Safety, Feasibility and Tolerability Pilot Study of Pegasys® (Peginterferon Alfa-2a) Plus Copegus® (Ribavirin) in Previous Intravenous Drug Users Who Are Currently Enrolled in a Methadone Maintenance Treatment Prog [NCT00087594]Phase 448 participants (Actual)Interventional2003-11-30Completed
Prospective, Observational Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Patients With Hepatitis C in Georgia [NCT01659567]516 participants (Actual)Observational2011-04-06Completed
Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV [NCT03069001]Phase 490 participants (Actual)Interventional2015-06-30Completed
A Multi-centre Single-arm Study to Evaluate the Efficacy and Safety of BOCEPREVIR 44 Weeks in Addition to Standard of Care (SOC) in Previously Treatment Failure (Relapser, Non-responders, Both Partial and Null) Patients With Chronic Hepatitis C Genotype 1 [NCT01756079]Phase 458 participants (Actual)Interventional2013-02-06Completed
A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon a-2a and Ribavirin in Treatment-Experienced Adult [NCT01854528]Phase 3148 participants (Actual)Interventional2013-06-30Completed
Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C [NCT01447446]4,442 participants (Actual)Observational2011-09-30Completed
An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responder [NCT01466790]Phase 2168 participants (Actual)Interventional2012-01-31Completed
A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4 [NCT01797848]Phase 30 participants (Actual)Interventional2014-06-30Withdrawn
A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of Pegylated Interferon Plus Ribavirin With or Without CTS-1027 in HCV Null-Responders [NCT01273064]Phase 2114 participants (Actual)Interventional2011-01-31Terminated(stopped due to Risk-benefit ratio)
A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Concomitantly Administered With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Relapsed After Previous Treatment [NCT01405937]Phase 351 participants (Actual)Interventional2011-08-29Completed
An Open-label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) Co-administered With Ribavirin (RBV) for 12 or 16 Weeks in Treatment-Naïve and Treatment-Experienced Japanese Adults With Genotype 2 Chronic Hepatitis [NCT02023112]Phase 3171 participants (Actual)Interventional2014-01-31Completed
A Randomized Controlled Study To Assess Safety, Tolerability And Efficacy Of GS-7977 In Combination With Full or Low Dose RBV In HCV Genotype 1, Monoinfected Treatment Naive Participants [NCT01441180]Phase 1/Phase 260 participants (Actual)Interventional2011-09-30Completed
A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin) [NCT01429792]Phase 41,013 participants (Actual)Interventional2008-09-25Completed
Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Subjects With Recurrent Chronic Hepatitis C Genotype 1b Infection [NCT01938625]Phase 235 participants (Actual)Interventional2013-12-12Completed
Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 With ABT-333 and With or Without RBV in HCV Genotype 1 and ABT-450/r/ABT-267 With RBV in HCV GT4-Infected Adult Liver or Renal Transplant Recipie [NCT01782495]Phase 2129 participants (Actual)Interventional2013-02-25Completed
A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection [NCT01858766]Phase 2379 participants (Actual)Interventional2013-04-30Completed
Open, Multicenter Phase IV Study, Evaluating Drop of Hemoglobin in Association to the Rate of Sustained Virological Response in Chronic Hepatitis C Patients Treated With Ribavirin (Copegus®) in Combination With Standard Treatment (ANECO) [NCT01585324]Phase 430 participants (Actual)Interventional2012-01-31Completed
An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turqu [NCT02216422]Phase 336 participants (Actual)Interventional2014-09-30Completed
International, Multicenter, Randomized, Double Blind, Active-controlled, Parallel-group Phase III Study of Narlaprevir/Ritonavir and Pegylated Interferon/Ribavirin in 2 Patient Populations - naïve and Treatment Failure Patients With Genotype 1 Chronic Hep [NCT03833362]Phase 3420 participants (Actual)Interventional2014-05-07Completed
A Quality of Life Study of PEGASYS® (Peginterferon-Alfa2a) in Combination With COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C and Persistently Normal ALT Levels [NCT02726022]114 participants (Actual)Observational2007-02-28Completed
Evaluation of Quality of Life, Neurocognitive Performance, Fatigue, and Emotional State in HCV Patients Before, During, and in the (Long-term) Follow-up of an IFN-free Antiviral Therapy [NCT02469012]30 participants (Anticipated)Interventional2014-10-31Recruiting
A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy With MK-3034 (SCH 503034)/Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Subjects With Chronic HCV Genotype 1 in Asia [NCT01945294]Phase 3257 participants (Actual)Interventional2013-10-10Completed
A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of MK-5172 in Combination With Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection [NCT01716156]Phase 226 participants (Actual)Interventional2013-01-18Completed
An Open-Label Study to Explore the Clinical Efficacy of GS-7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant [NCT01559844]Phase 261 participants (Actual)Interventional2012-03-31Completed
An Open-Label, Phase 4 Study of Telaprevir, Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C Who Have Not Achieved a Sust [NCT01467492]Phase 4121 participants (Actual)Interventional2012-01-31Terminated(stopped due to It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.)
A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Were Non-responders to Previous Treatment [NCT01405560]Phase 342 participants (Actual)Interventional2011-09-02Completed
Efficacy and Safety of Ombitasvir/ Paritaprevir / Ritonavir Plus Ribavirin in Management HCV Genotype 4 and End-stage Kidney Disease With or Without Hemodialysis (An Open Label- Multicenter Prospective Study) [NCT03499639]Phase 4110 participants (Actual)Interventional2018-05-01Completed
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Comparing 24 or 48 Weeks of GS 9190, in Combination With Peginterferon Alfa 2a and Ribavirin, to 48 Weeks of Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic Hepatit [NCT00743795]Phase 2252 participants (Actual)Interventional2008-10-31Completed
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection [NCT01641640]Phase 3328 participants (Actual)Interventional2012-06-30Completed
An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in US Veterans With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-VA) [NCT02442284]Phase 399 participants (Actual)Interventional2015-05-13Completed
A Randomized Clinical Trial Using Fine Needle Aspiration For Evaluation of Hepatic Pharmacokinetics of MK-7009 in Chronic Hepatitis C Patients [NCT01678131]Phase 131 participants (Actual)Interventional2012-10-30Completed
"Real World Administration of Zepatier (Grazoprevir Plus Elvasvir) in Chronic Hemodialysis Patients With Hepatitis C Infection. Strategies for Identification of Patients, Insurance Approval, Treatment , and Laboratory Monitoring" [NCT03365635]Phase 46 participants (Actual)Interventional2019-09-22Completed
THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders [NCT02786537]Phase 41,275 participants (Actual)Interventional2016-06-30Completed
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection [NCT02249182]Phase 2226 participants (Actual)Interventional2014-11-05Completed
Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis [NCT02992457]Phase 410,000 participants (Actual)Interventional2015-01-31Completed
High Dose Ribavirin in Combination With Peginterferon for Patients With Chronic Hepatitis C Genotype 1 Infection Who Have Failed to Respond or Relapsed After Standard Therapy [NCT00735969]Phase 221 participants (Actual)Interventional2008-08-31Completed
A Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers [NCT05229510]Phase 132 participants (Actual)Interventional2021-03-12Completed
A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects [NCT01544920]Phase 3737 participants (Actual)Interventional2012-05-30Completed
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects Who Have Failed Prior Treatment With Pegylated Interferon and Ribavirin (P/R) With Chronic HCV GT1, GT4, and GT6 Infection [NCT02105701]Phase 3420 participants (Actual)Interventional2014-06-05Completed
A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Tre [NCT01598090]Phase 3881 participants (Actual)Interventional2012-06-14Completed
A Phase III Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of TMC435 Plus PegIFNα-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Subjects Who Are Co-infected With Human Immunodeficiency V [NCT01479868]Phase 3109 participants (Actual)Interventional2011-10-31Completed
Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation [NCT01821963]Phase 31 participants (Actual)Interventional2013-04-30Terminated(stopped due to Low referral rate due to new therapeutic options.)
A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4 [NCT01448044]Phase 3152 participants (Actual)Interventional2011-12-31Completed
A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin) [NCT01447420]Phase 4129 participants (Actual)Interventional2011-02-28Completed
Pilot Therapy Using Betaine in Combination With Peginterferon Alpha-2a Plus Ribavirin in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Pegylated Interferon and Ribavirin [NCT00882193]Early Phase 12 participants (Actual)Interventional2009-05-01Terminated(stopped due to new medications with improved response released)
Non-interventional Study to Observe Triple Combination Therapy With Boceprevir or Simeprevir Plus Peginterferon Alfa-2a Plus Ribavirin for Re-treatment of Chronic Hepatitis C in Hungary (IMPERIAL) [NCT02118597]19 participants (Actual)Observational2014-05-31Terminated(stopped due to Study terminated due to the Sponsor's decision.)
A Phase IV Open-label, Multicentre, International Trial of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir ±Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection and Recent Injection Drug Use or Receiving Opioid Substitution Therapy [NCT02498015]Phase 487 participants (Actual)Interventional2016-08-31Completed
A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection [NCT02292706]1,609 participants (Actual)Observational [Patient Registry]2014-12-29Terminated(stopped due to The study stopped early because the study objectives were met.)
Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir [NCT03247296]200 participants (Actual)Observational2017-02-28Active, not recruiting
Pegylated Interferon +/- Ribavirin for Children With Hepatitis C [NCT00100659]Phase 3114 participants (Actual)Interventional2004-12-31Completed
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant [NCT01687270]Phase 240 participants (Actual)Interventional2012-11-30Completed
Response Evaluation of Peginterferon Alfa-2a 180µg 20kDa (Unipeg®) Plus Ribavirin (Ribazole®) in Treatment naïve Pakistani Population With Chronic Hepatitis C Infection [NCT02601976]Phase 464 participants (Actual)Interventional2010-08-31Completed
A Phase 3 Evaluation of Daclatasvir, Sofosbuvir, and Ribavirin in Genotype 1-6 Chronic Hepatitis C Infection Subjects With Cirrhosis Who May Require Future Liver Transplant and Subjects Post-Liver Transplant [NCT02032875]Phase 3116 participants (Actual)Interventional2014-03-31Completed
A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVE [NCT02243293]Phase 2/Phase 3694 participants (Actual)Interventional2014-09-19Completed
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus [NCT02292719]Phase 270 participants (Actual)Interventional2014-12-19Completed
Response to Peg-interferon and Ribavirin for the Treatment of HCV Infection in HIV Co-infected Patients, Implemented in Public Hospitals in Thailand [NCT02247440]Phase 418 participants (Actual)Interventional2014-08-31Completed
A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection [NCT02175758]Phase 2106 participants (Actual)Interventional2014-07-07Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00006164 (15) [back to overview]Development of Hepatocellular Carcinoma (HCC)
NCT00006164 (15) [back to overview]SF-36 Mental Health Summary Score
NCT00006164 (15) [back to overview]Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points
NCT00006164 (15) [back to overview]Ascites
NCT00006164 (15) [back to overview]Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits
NCT00006164 (15) [back to overview]Death From Any Cause
NCT00006164 (15) [back to overview]Hepatic Encephalopathy
NCT00006164 (15) [back to overview]Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies
NCT00006164 (15) [back to overview]Serious Adverse Events
NCT00006164 (15) [back to overview]Spontaneous Bacterial Peritonitis
NCT00006164 (15) [back to overview]Variceal Hemorrhage
NCT00006164 (15) [back to overview]Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.
NCT00006164 (15) [back to overview]SF-36 Vitality Summary Score
NCT00006164 (15) [back to overview]Presumed Hepatocellular Carcinoma (HCC)
NCT00006164 (15) [back to overview]SF-36 Physical Function Summary Score
NCT00018031 (1) [back to overview]Participants With Viral Decline at Day 3 & 28 With Predictors of Post Treatment Response
NCT00028093 (1) [back to overview]Change in Hepatitis C Virus RNA Levels During Phase I
NCT00039871 (3) [back to overview]Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12
NCT00039871 (3) [back to overview]Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12
NCT00039871 (3) [back to overview]Sustained Virologic Response (SVR) Rate
NCT00056862 (5) [back to overview]First Phase Decline in Logarithm of HCV RNA Level
NCT00056862 (5) [back to overview]Slope of Second Phase Decline in HCV Levels
NCT00056862 (5) [back to overview]Time to Negativity
NCT00056862 (5) [back to overview]Virological Response (Intention to Treat)
NCT00056862 (5) [back to overview]Virological Response Category (Per Protocol)
NCT00077636 (7) [back to overview]Percentage of Participants With Marked Laboratory Abnormalities
NCT00077636 (7) [back to overview]Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00077636 (7) [back to overview]Participants With Marked Abnormal Vital Signs
NCT00077636 (7) [back to overview]Number of Participants With Highest Triglyceride Level
NCT00077636 (7) [back to overview]Percentage of Participants With Virological Response at The End of Study Treatment
NCT00077636 (7) [back to overview]Percentage of Participants With Sustained Virological Response (SVR)
NCT00077636 (7) [back to overview]Percentage of Participants Virological Response 12 Weeks Post-Treatment
NCT00077649 (10) [back to overview]Percentage of Participants With Adverse Events and Serious Adverse Events
NCT00077649 (10) [back to overview]Percentage of Participants With Marked Laboratory Abnormalities
NCT00077649 (10) [back to overview]Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period
NCT00077649 (10) [back to overview]Total BDI-II (Beck Depression Inventory) Scores
NCT00077649 (10) [back to overview]Percentage of Participants With Virological Response at the End of the Treatment Period
NCT00077649 (10) [back to overview]HCV RNA Profile During The First 24 Weeks
NCT00077649 (10) [back to overview]Percentage of Participants With Virological Response Over Time to Week 24
NCT00077649 (10) [back to overview]Percentage of Participants With Abnormal Vital Signs
NCT00077649 (10) [back to overview]Percentage of Participants With Predicted Sustained Virological Response
NCT00077649 (10) [back to overview]Percentage of Participants With Sustained Virological Response
NCT00078403 (16) [back to overview]Number of Participants With High-grade Signs and Symptoms or Laboratory Values
NCT00078403 (16) [back to overview]Sustained Virologic Response
NCT00078403 (16) [back to overview]Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations
NCT00078403 (16) [back to overview]Number of Participants With Neutropenia
NCT00078403 (16) [back to overview]Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol
NCT00078403 (16) [back to overview]Number of Participants With Anemia
NCT00078403 (16) [back to overview]Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)
NCT00078403 (16) [back to overview]Weight
NCT00078403 (16) [back to overview]Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
NCT00078403 (16) [back to overview]Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)
NCT00078403 (16) [back to overview]Number of Participants Adherent to Study Medications
NCT00078403 (16) [back to overview]Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)
NCT00078403 (16) [back to overview]Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)
NCT00078403 (16) [back to overview]Number of Participants With Depression and/or Other Psychological Events
NCT00078403 (16) [back to overview]Number of Participants With Thrombocytopenia
NCT00078403 (16) [back to overview]Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)
NCT00081770 (4) [back to overview]Mean Change From Baseline in the Log Viral Load at Treatment Week 4
NCT00081770 (4) [back to overview]Mean Change From Baseline in the Log Viral Load at Treatment Week 2
NCT00081770 (4) [back to overview]Virologic Response Rate at Treatment Week 12
NCT00081770 (4) [back to overview]Sustained Virologic Response (SVR) Rate
NCT00085917 (3) [back to overview]Number of Participants With Sustained Virologic Response (SVR)
NCT00085917 (3) [back to overview]Number of Participants With Adverse Events
NCT00085917 (3) [back to overview]Number of Participants With Normalization of Liver Enzymes
NCT00087568 (10) [back to overview]Mean Score of Beck Depression Inventory Over Time
NCT00087568 (10) [back to overview]Mean Score for Overall Local Injection Site Reaction
NCT00087568 (10) [back to overview]Number of Pegasys and Ribavirin Therapy Completers
NCT00087568 (10) [back to overview]Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
NCT00087568 (10) [back to overview]Number of Participants With Marked Laboratory Abnormalities
NCT00087568 (10) [back to overview]Mean Score of Fatigue Severity Over Time
NCT00087568 (10) [back to overview]Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
NCT00087568 (10) [back to overview]Number of Participants With Serious Adverse Events and Adverse Events
NCT00087568 (10) [back to overview]Number of Participants With Abnormal Vital Signs
NCT00087568 (10) [back to overview]Number of Participants With Individual Flu-like Symptom
NCT00087594 (14) [back to overview]Number of Participants With Marked Laboratory Abnormalities (Biochemistry)
NCT00087594 (14) [back to overview]Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion
NCT00087594 (14) [back to overview]Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation
NCT00087594 (14) [back to overview]Number of Participants With Abnormal Vital Signs
NCT00087594 (14) [back to overview]Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12
NCT00087594 (14) [back to overview]Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits
NCT00087594 (14) [back to overview]Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit
NCT00087594 (14) [back to overview]Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)
NCT00087594 (14) [back to overview]Number of Participants With Degrees of Depression as Defined by the BDI-II Score
NCT00087594 (14) [back to overview]Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion
NCT00087594 (14) [back to overview]Number of Participants With Treatment Completion Rate (TCR)
NCT00087594 (14) [back to overview]Number of Participants With Compliance to the Prescribed Treatment Regimen
NCT00087594 (14) [back to overview]Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)
NCT00087594 (14) [back to overview]Number of Participants With Marked Laboratory Abnormalities (Hematology)
NCT00087607 (15) [back to overview]Weekly Viral Absolute Area Under the HCV RNA Curve Estimated in the Frequent-sampling Cohort for Weeks 1 and 8
NCT00087607 (15) [back to overview]Mean Value of Area Under the HCV-RNA Curve Minus Baseline From Week 1 to Week 12
NCT00087607 (15) [back to overview]Mean Trough Interferon Concentrations at Each Week
NCT00087607 (15) [back to overview]Mean Change From Baseline in Viral Load (log10 Reduction) at Week 4 and Week 8
NCT00087607 (15) [back to overview]The Area Under the HCV-RNA Curve Estimated From the Two Adjacent Pre-dose Assessments at Each Week
NCT00087607 (15) [back to overview]Cumulative Viral Absolute Area Under the HCV RNA Curve Minus Baseline Averaged Over the 12-week Period
NCT00087607 (15) [back to overview]Change From Baseline in Viral Load (log10 Reduction) at Week 12
NCT00087607 (15) [back to overview]Number of Participants With Marked Biochemical Test Abnormalities
NCT00087607 (15) [back to overview]Number of Participants With Adverse Events and Serious Adverse Events
NCT00087607 (15) [back to overview]Area Under the Curve for Interferon in the Frequent-Sampling Cohort
NCT00087607 (15) [back to overview]Percentage of Participants With Undetectable HCV RNA (< 60 International Units/Milliliter) at Each Visit
NCT00087607 (15) [back to overview]Percentage of Participants With a ≥ 2-log10 Decrease or Undetectable (< 60 International Units Per Milliliter) HCV RNA at Each Visit
NCT00087607 (15) [back to overview]Number of Participants With Marked Hematologic Abnormalities
NCT00087607 (15) [back to overview]Number of Participants With Marked Abnormalities in Thyroid Function Tests
NCT00087607 (15) [back to overview]Weekly Viral Load Assessed at Drug Trough
NCT00087646 (8) [back to overview]Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)
NCT00087646 (8) [back to overview]Percentage of Participants With Relapse After End of Treatment
NCT00087646 (8) [back to overview]Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response
NCT00087646 (8) [back to overview]Number of Participants With Sustained Virological Response Rate
NCT00087646 (8) [back to overview]Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)
NCT00087646 (8) [back to overview]Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)
NCT00087646 (8) [back to overview]Percentage of Participants With Undetectable HCV-RNA
NCT00087646 (8) [back to overview]Percentage of Participants With >=2log Drop in HCV-RNA
NCT00100659 (2) [back to overview]Adverse Events
NCT00100659 (2) [back to overview]Sustained Viral Response (SVR)
NCT00104052 (1) [back to overview]Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment
NCT00107653 (21) [back to overview]Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72
NCT00107653 (21) [back to overview]Percentage of Participants With Early Virologic Response at Week 12
NCT00107653 (21) [back to overview]Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72
NCT00107653 (21) [back to overview]Mean Change From Baseline in Fat Score at Week 72
NCT00107653 (21) [back to overview]Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72
NCT00107653 (21) [back to overview]Number of Participants With Any Adverse Events and Serious Adverse Events
NCT00107653 (21) [back to overview]Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72
NCT00107653 (21) [back to overview]Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72
NCT00107653 (21) [back to overview]Percentage of Participants With Early Virologic Response at Week 4
NCT00107653 (21) [back to overview]Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72
NCT00107653 (21) [back to overview]Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time
NCT00107653 (21) [back to overview]Percentage of Participants With Sustained Virologic Response at Week 72
NCT00107653 (21) [back to overview]Percentage of Participants With ISHAK Histological Activity Index Response
NCT00107653 (21) [back to overview]Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities
NCT00107653 (21) [back to overview]Number of Participants With Marked Abnormal Laboratory Parameters
NCT00107653 (21) [back to overview]Percentage of Participants Achieving Virologic Response
NCT00107653 (21) [back to overview]Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score
NCT00107653 (21) [back to overview]Percentage of Participants With Biochemical Response
NCT00107653 (21) [back to overview]Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score
NCT00107653 (21) [back to overview]Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score
NCT00107653 (21) [back to overview]Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score
NCT00136318 (5) [back to overview]Sustained Virologic Response
NCT00136318 (5) [back to overview]Severe Depression Defined as a MADRS Score of 25 or Higher
NCT00136318 (5) [back to overview]Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)
NCT00136318 (5) [back to overview]Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria
NCT00136318 (5) [back to overview]Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher
NCT00160251 (12) [back to overview]Percent of Participants Who Achieved Sustained Virologic Response (SVR)
NCT00160251 (12) [back to overview]Peak Plasma Concentration of Boceprevir (BOC)
NCT00160251 (12) [back to overview]Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA
NCT00160251 (12) [back to overview]Trough Plasma Concentration Level
NCT00160251 (12) [back to overview]Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)
NCT00160251 (12) [back to overview]Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
NCT00160251 (12) [back to overview]Percent of Participants With Virologic Response Prior to Amendment 2
NCT00160251 (12) [back to overview]Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
NCT00160251 (12) [back to overview]Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
NCT00160251 (12) [back to overview]Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
NCT00160251 (12) [back to overview]Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period
NCT00160251 (12) [back to overview]Change in Alanine Aminotransferase (ALT) Levels
NCT00192647 (6) [back to overview]Percentage of Participants With Virological Responses Over Time
NCT00192647 (6) [back to overview]Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response
NCT00192647 (6) [back to overview]Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
NCT00192647 (6) [back to overview]Percentage of Participants With Relapse of End-of-treatment Virological Response
NCT00192647 (6) [back to overview]Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
NCT00192647 (6) [back to overview]Change From Baseline in Log10 HCV RNA Values
NCT00202839 (2) [back to overview]The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.
NCT00202839 (2) [back to overview]The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)
NCT00211692 (4) [back to overview]Overall Number of Serious Adverse Events
NCT00211692 (4) [back to overview]The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.
NCT00211692 (4) [back to overview]Participants Achieving SVR Categorized by Time of Response
NCT00211692 (4) [back to overview]Number of Participants Discontinuing Early From Study Treatment
NCT00255008 (1) [back to overview]Number of Subjects Who Achieved a Sustained Virologic Response (SVR)
NCT00255034 (1) [back to overview]Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy
NCT00265395 (1) [back to overview]Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment.
NCT00302081 (1) [back to overview]The Number of Participants Who Achieve a Sustained Virologic Response (SVR)
NCT00336479 (5) [back to overview]Number of Subjects With Viral Relapse
NCT00336479 (5) [back to overview]Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
NCT00336479 (5) [back to overview]Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00336479 (5) [back to overview]Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
NCT00336479 (5) [back to overview]Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
NCT00353418 (7) [back to overview]Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia
NCT00353418 (7) [back to overview]Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12
NCT00353418 (7) [back to overview]Virological Response at Weeks 4, 12 and 24
NCT00353418 (7) [back to overview]Virological Response at End of Treatment Period
NCT00353418 (7) [back to overview]Sustained Virological Response (SVR)
NCT00353418 (7) [back to overview]Relapse of Virological Response
NCT00353418 (7) [back to overview]Rapid Virological Response (RVR) by Week 4
NCT00372385 (6) [back to overview]Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
NCT00372385 (6) [back to overview]Number of Subjects With Viral Relapse
NCT00372385 (6) [back to overview]Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
NCT00372385 (6) [back to overview]Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
NCT00372385 (6) [back to overview]Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00372385 (6) [back to overview]Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
NCT00378599 (1) [back to overview]A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment
NCT00394277 (4) [back to overview]SVR-24 (Actual Treatment Period)
NCT00394277 (4) [back to overview]SVR-12 (Scheduled Treatment Period)
NCT00394277 (4) [back to overview]SVR-12 (Actual Treatment Period)
NCT00394277 (4) [back to overview]Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
NCT00420784 (6) [back to overview]Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00420784 (6) [back to overview]Number of Subjects With Viral Relapse
NCT00420784 (6) [back to overview]Percentage of Subjects With Undetectable Plasma HCV RNA
NCT00420784 (6) [back to overview]Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
NCT00420784 (6) [back to overview]Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
NCT00420784 (6) [back to overview]Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
NCT00423670 (8) [back to overview]Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR
NCT00423670 (8) [back to overview]Number of Participants Negative for HCV-RNA at FW 12
NCT00423670 (8) [back to overview]Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization
NCT00423670 (8) [back to overview]Number of Participants With SVR Based on Duration of Boceprevir Treatment
NCT00423670 (8) [back to overview]Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR
NCT00423670 (8) [back to overview]Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin
NCT00423670 (8) [back to overview]Number of Participants With Sustained Virologic Response (SVR)
NCT00423670 (8) [back to overview]Number of Participants With an Early Virologic Response (EVR) That Achieved SVR
NCT00423800 (2) [back to overview]Number of Participants With a Virological Relapse
NCT00423800 (2) [back to overview]Number of Participants With a Sustained Virologic Response
NCT00441584 (1) [back to overview]Number of Subjects Who Have Achieved Sustained Virological Response (SVR) at 24 Weeks Post End of Treatment
NCT00446134 (4) [back to overview]Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12.
NCT00446134 (4) [back to overview]Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24
NCT00446134 (4) [back to overview]Relapsers at Follow-Up Visit 24
NCT00446134 (4) [back to overview]Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24
NCT00475176 (2) [back to overview]Improvement in Viral Kinetics During the First 2 Weeks of Therapy
NCT00475176 (2) [back to overview]2-log Decline in HCV RNA by Week 12 (Early Virological Response) and Sustained Eradication of HCV RNA (Sustained Virological Response).
NCT00483938 (3) [back to overview]Percentage of Participants With SVR (Groups C, D, E, and F)
NCT00483938 (3) [back to overview]Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)
NCT00483938 (3) [back to overview]Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)
NCT00491179 (2) [back to overview]Number of Participants With Histologic Response(HR)
NCT00491179 (2) [back to overview]1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs)
NCT00491244 (2) [back to overview]Adverse Event (AE)-Related Withdrawal Rate
NCT00491244 (2) [back to overview]Sustained Virologic Response (SVR)Rate
NCT00493805 (2) [back to overview]Early Virological Response in Participants With and Without Insulin Resistance
NCT00493805 (2) [back to overview]Sustained Virological Response (PCR 24 Weeks After End of Treatment)
NCT00495131 (4) [back to overview]Histologic Response
NCT00495131 (4) [back to overview]Sustained Virologic Response
NCT00495131 (4) [back to overview]Treatment-related Withdrawal Rate
NCT00495131 (4) [back to overview]Sustained Biochemical Response
NCT00495391 (8) [back to overview]End of Treatment Response (HCV RNA Below Lower Limit of Detection)
NCT00495391 (8) [back to overview]Early Virologic Response (HCV RNA Below Lower Limit of Detection)
NCT00495391 (8) [back to overview]Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
NCT00495391 (8) [back to overview]Changes in ALT
NCT00495391 (8) [back to overview]Changes in ALT
NCT00495391 (8) [back to overview]Changes in ALT
NCT00495391 (8) [back to overview]Changes in ALT
NCT00495391 (8) [back to overview]Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
NCT00500578 (1) [back to overview]Occurrences of Pneumonia
NCT00528528 (7) [back to overview]Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)
NCT00528528 (7) [back to overview]Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12
NCT00528528 (7) [back to overview]Percentage of Participants With Virologic Response at Week 12
NCT00528528 (7) [back to overview]Percentage of Participants With Partial Response
NCT00528528 (7) [back to overview]Number of Participants With Viral Breakthrough at End of Treatment (EOT)
NCT00528528 (7) [back to overview]Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
NCT00528528 (7) [back to overview]Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)
NCT00535847 (6) [back to overview]Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
NCT00535847 (6) [back to overview]Percentage of Prior Relapsers With Undetectable HCV RNA
NCT00535847 (6) [back to overview]Percentage of Subjects With End of Treatment Response
NCT00535847 (6) [back to overview]Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
NCT00535847 (6) [back to overview]Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
NCT00535847 (6) [back to overview]Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00537407 (7) [back to overview]Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E)
NCT00537407 (7) [back to overview]log10 Hepatitis C Virus RNA at Day 29
NCT00537407 (7) [back to overview]Percentage of Participants With a Rapid Viral Response at Day 29
NCT00537407 (7) [back to overview]Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96)
NCT00537407 (7) [back to overview]Percentage of Participants With an Early Viral Response at Week 12
NCT00537407 (7) [back to overview]Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72)
NCT00537407 (7) [back to overview]Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C)
NCT00545233 (22) [back to overview]Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
NCT00545233 (22) [back to overview]Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in Leptin Levels at Each Time Point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
NCT00545233 (22) [back to overview]Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
NCT00545233 (22) [back to overview]Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy
NCT00545233 (22) [back to overview]Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only
NCT00545233 (22) [back to overview]Percentage of Participants Achieving Virologic Response
NCT00545233 (22) [back to overview]Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
NCT00545233 (22) [back to overview]Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
NCT00545233 (22) [back to overview]Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks
NCT00545233 (22) [back to overview]Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)
NCT00545233 (22) [back to overview]Change From Baseline in Adiponectin Levels at Each Time Point Assessed
NCT00545233 (22) [back to overview]Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy
NCT00545233 (22) [back to overview]Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period
NCT00556504 (7) [back to overview]Virologic Response
NCT00556504 (7) [back to overview]Immune Cell Normalization
NCT00556504 (7) [back to overview]Sustained Virologic Response (SVR)
NCT00556504 (7) [back to overview]Sustained ALT Response
NCT00556504 (7) [back to overview]Combined ALT and Virologic Response
NCT00556504 (7) [back to overview]ALT Response
NCT00556504 (7) [back to overview]Immune Cell Normalization
NCT00561015 (13) [back to overview]Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15
NCT00561015 (13) [back to overview]Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1
NCT00561015 (13) [back to overview]Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15
NCT00561015 (13) [back to overview]Median Time to Virological Response (HCV RNA Level < 10 IU/ml)
NCT00561015 (13) [back to overview]Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15
NCT00561015 (13) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1
NCT00561015 (13) [back to overview]Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1
NCT00561015 (13) [back to overview]Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15
NCT00561015 (13) [back to overview]Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)
NCT00561015 (13) [back to overview]Percentage of Participants Who Achieved Sustained Virological Response (SVR)
NCT00561015 (13) [back to overview]Percentage of Participants Who Demonstrated Virological Relapse
NCT00561015 (13) [back to overview]Percentage of Participants With Viral Breakthrough
NCT00561015 (13) [back to overview]Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26
NCT00561353 (28) [back to overview]Viral Relapse in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)
NCT00561353 (28) [back to overview]Viral Relapse in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Viral Breakthrough in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1, Panel A and B)
NCT00561353 (28) [back to overview]Viral Breakthrough in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Sustained Virologic Response (SVR) in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)
NCT00561353 (28) [back to overview]Sustained Virologic Response (SVR) in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)
NCT00561353 (28) [back to overview]Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)
NCT00561353 (28) [back to overview]Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)
NCT00561353 (28) [back to overview]Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)
NCT00561353 (28) [back to overview]Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)
NCT00561353 (28) [back to overview]Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)
NCT00561353 (28) [back to overview]Predose Plasma Concentration (C0h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)
NCT00561353 (28) [back to overview]Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)
NCT00561353 (28) [back to overview]Virologic Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Virologic Response Parameters in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)
NCT00561353 (28) [back to overview]Predose Plasma Concentration (C0h) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)
NCT00561353 (28) [back to overview]Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)
NCT00561353 (28) [back to overview]Virologic Response Parameters Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00561353 (28) [back to overview]Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)
NCT00561353 (28) [back to overview]Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)
NCT00561353 (28) [back to overview]Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)
NCT00580801 (12) [back to overview]Maximum Serum Concentration (Cmax) of Telaprevir
NCT00580801 (12) [back to overview]Minimum Serum Concentration (Cmin) of Telaprevir on Day 15
NCT00580801 (12) [back to overview]Median Time to First Viral Response (Undetectable HCV RNA)
NCT00580801 (12) [back to overview]Average Steady-State Serum Concentration (Css,av) of Telaprevir
NCT00580801 (12) [back to overview]Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir
NCT00580801 (12) [back to overview]Percentage of Participants With Viral Response (Undetectable HCV RNA)
NCT00580801 (12) [back to overview]Percentage of Participants With Sustained Viral Response (SVR)
NCT00580801 (12) [back to overview]Number of Participants With Viral Breakthrough (Detectable HCV RNA)
NCT00580801 (12) [back to overview]Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15
NCT00580801 (12) [back to overview]Area Under the Serum Concentration-Time Curve (AUC)
NCT00580801 (12) [back to overview]Pre-Dose Serum Concentration (C[0h]) of Telaprevir
NCT00580801 (12) [back to overview]Percentage of Participants With Relapse
NCT00606086 (1) [back to overview]EVR (Early Virologic Response)
NCT00623428 (7) [back to overview]Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment
NCT00623428 (7) [back to overview]Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment
NCT00623428 (7) [back to overview]Number of Participants With Adverse Events (AEs)
NCT00623428 (7) [back to overview]Percentage of Participants With Virological Response at End of Treatment
NCT00623428 (7) [back to overview]Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
NCT00623428 (7) [back to overview]Percentage of Participants With Virological Relapse
NCT00623428 (7) [back to overview]Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
NCT00627926 (13) [back to overview]Number of Subjects With Undetectable HCV RNA at Week 72
NCT00627926 (13) [back to overview]Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
NCT00627926 (13) [back to overview]Fatigue Severity Scale (FSS) Total Score
NCT00627926 (13) [back to overview]Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment
NCT00627926 (13) [back to overview]Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment
NCT00627926 (13) [back to overview]Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
NCT00627926 (13) [back to overview]Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
NCT00627926 (13) [back to overview]Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
NCT00627926 (13) [back to overview]Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis
NCT00627926 (13) [back to overview]Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00627926 (13) [back to overview]Number of Subjects With Viral Relapse Planned and Viral Relapse Actual
NCT00627926 (13) [back to overview]Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
NCT00627926 (13) [back to overview]Number of Subjects With Undetectable HCV RNA at Week 12
NCT00637923 (8) [back to overview]Changes in ALT
NCT00637923 (8) [back to overview]Changes in ALT
NCT00637923 (8) [back to overview]Early Virologic Response (HCV RNA Below Lower Limit of Detection)
NCT00637923 (8) [back to overview]Changes in ALT
NCT00637923 (8) [back to overview]Changes in ALT
NCT00637923 (8) [back to overview]Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
NCT00637923 (8) [back to overview]Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
NCT00637923 (8) [back to overview]End of Treatment Response (HCV RNA Below Lower Limit of Detection)
NCT00665353 (7) [back to overview]Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)
NCT00665353 (7) [back to overview]Safety and Tolerability
NCT00665353 (7) [back to overview]Safety and Tolerability
NCT00665353 (7) [back to overview]The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2.
NCT00665353 (7) [back to overview]The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2.
NCT00665353 (7) [back to overview]Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides.
NCT00665353 (7) [back to overview]Absolute Change From Entry to Week 24 of Step 1 in AST and ALT.
NCT00686517 (5) [back to overview]Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).
NCT00686517 (5) [back to overview]Virologic Response at the End of Treatment Follow-up (ETR)
NCT00686517 (5) [back to overview]Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
NCT00686517 (5) [back to overview]Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization
NCT00686517 (5) [back to overview]Number of Participants With Rapid Virologic Response (RVR)
NCT00686777 (3) [back to overview]Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT
NCT00686777 (3) [back to overview]Number of Participants Discontinuing Treatment
NCT00686777 (3) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation
NCT00687219 (3) [back to overview]Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)
NCT00687219 (3) [back to overview]Number of Participants With Undetectable HCV-RNA at End of Treatment
NCT00687219 (3) [back to overview]Number of Participants With Undetectable HCV-RNA at Week 24
NCT00687544 (2) [back to overview]Number of Participants Who Died
NCT00687544 (2) [back to overview]Number of Participants Experiencing Adverse Events
NCT00689390 (5) [back to overview]Kaplan-Meier Exposure-adjusted Relapse Rate
NCT00689390 (5) [back to overview]Number of Participants That Discontinued the LTFU Due to SAEs
NCT00689390 (5) [back to overview]Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response)
NCT00689390 (5) [back to overview]Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU
NCT00689390 (5) [back to overview]Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci
NCT00700401 (8) [back to overview]Number of Participants With Any Adverse Events and Any Serious Adverse Events
NCT00700401 (8) [back to overview]Percentage of Participants With Positive Predictive Value
NCT00700401 (8) [back to overview]Percentage of Participants With Rapid Virological Response at Week 4
NCT00700401 (8) [back to overview]Percentage of Participants With Sustained Virological Response at Week 48
NCT00700401 (8) [back to overview]Percentage of Participants With Virological Relapse
NCT00700401 (8) [back to overview]Percentage of Participants With Virological Response at Week 24
NCT00700401 (8) [back to overview]Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
NCT00700401 (8) [back to overview]Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
NCT00703118 (8) [back to overview]Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4
NCT00703118 (8) [back to overview]Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)
NCT00703118 (8) [back to overview]Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)
NCT00703118 (8) [back to overview]Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned
NCT00703118 (8) [back to overview]Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned
NCT00703118 (8) [back to overview]Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4
NCT00703118 (8) [back to overview]Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12
NCT00703118 (8) [back to overview]Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8
NCT00704184 (6) [back to overview]Percentage of Participants Achieving RVR
NCT00704184 (6) [back to overview]Number of Participants With ≥3-log10 Decrease in HCV RNA
NCT00704184 (6) [back to overview]Number of Participants With ≥2-log10 Decrease in HCV RNA
NCT00704184 (6) [back to overview]Number of Participants Discontinuing From Study Therapy Due to AEs
NCT00704184 (6) [back to overview]Mean Log Change From Baseline in HCV RNA
NCT00704184 (6) [back to overview]Number of Participants Experiencing an Adverse Event (AE)
NCT00704405 (6) [back to overview]Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.
NCT00704405 (6) [back to overview]Number of Participants Experiencing an Adverse Event (AE)
NCT00704405 (6) [back to overview]Number of Participants Discontinuing From Study Treatment Due to AEs
NCT00704405 (6) [back to overview]Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.
NCT00704405 (6) [back to overview]Percentage of Participants Achieving cEVR
NCT00704405 (6) [back to overview]Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.
NCT00704522 (2) [back to overview]Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program
NCT00704522 (2) [back to overview]Average Length of Treatment With PegIntron/Rebetol
NCT00704717 (1) [back to overview]Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.
NCT00704964 (2) [back to overview]Number of Participants With Adherence to Therapy According to Physician Approximation
NCT00704964 (2) [back to overview]Number of Participants With Biometrical Adherence to Therapy
NCT00705107 (2) [back to overview]Number of Subjects Who Completed Treatment.
NCT00705107 (2) [back to overview]Average Length of Treatment.
NCT00705224 (5) [back to overview]Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline
NCT00705224 (5) [back to overview]Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline
NCT00705224 (5) [back to overview]Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline
NCT00705224 (5) [back to overview]Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study
NCT00705224 (5) [back to overview]Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline
NCT00705263 (1) [back to overview]Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
NCT00705432 (5) [back to overview]Sustained Virologic Response (SVR) Rate
NCT00705432 (5) [back to overview]Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR
NCT00705432 (5) [back to overview]Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.
NCT00705432 (5) [back to overview]Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)
NCT00705432 (5) [back to overview]Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)
NCT00705666 (1) [back to overview]The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).
NCT00708500 (4) [back to overview]Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.
NCT00708500 (4) [back to overview]Number of Participants With Early Virologic Response.
NCT00708500 (4) [back to overview]Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.
NCT00708500 (4) [back to overview]Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.
NCT00709059 (1) [back to overview]Number of Study Participants Who Had a Virological Response (VR) at Week-72
NCT00709228 (1) [back to overview]Number of HCV LVL G1 Participants Who Relapsed
NCT00723632 (3) [back to overview]Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category
NCT00723632 (3) [back to overview]Average Cost Per Participant With SVR Stratified by Prior Treatment Status
NCT00723632 (3) [back to overview]Average Cost Per Participant With SVR Stratified by Ribavirin Dosage
NCT00723892 (2) [back to overview]the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol
NCT00723892 (2) [back to overview]Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.
NCT00724373 (1) [back to overview]Participants With Treatment Success
NCT00724451 (3) [back to overview]Number of Participants Discontinued From Treatment by Reason for Discontinuation
NCT00724451 (3) [back to overview]Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
NCT00724451 (3) [back to overview]Number of Participants With Treatment Failure by Reason for Failure
NCT00724464 (8) [back to overview]Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline
NCT00724464 (8) [back to overview]Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline
NCT00724464 (8) [back to overview]Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline
NCT00724464 (8) [back to overview]Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline
NCT00724464 (8) [back to overview]Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response
NCT00724464 (8) [back to overview]Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up
NCT00724464 (8) [back to overview]Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
NCT00724464 (8) [back to overview]Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification
NCT00724854 (5) [back to overview]Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR
NCT00724854 (5) [back to overview]Assessment of Baseline Characteristics in Participants With SVR
NCT00724854 (5) [back to overview]Number of Participants With RVR Who Also Achieved SVR
NCT00724854 (5) [back to overview]Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
NCT00724854 (5) [back to overview]Number of Participants Who Achieved Sustained Virologic Response (SVR)
NCT00724893 (49) [back to overview]Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving RVR by Weight (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving RVR by Race (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Weight (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Gender (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Gender (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by EVR Type (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
NCT00724893 (49) [back to overview]The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving EVR Who Achieved SVR (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving EVR (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving EVR (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Weight (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Viral Load (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Race (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving SVR by Race (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving RVR Who Achieved SVR (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving RVR by Gender (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving EVR by Weight (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving EVR by Race (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving EVR by Gender (Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)
NCT00724893 (49) [back to overview]The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
NCT00724893 (49) [back to overview]The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants With End of Treatment (EOT) Response (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)
NCT00724893 (49) [back to overview]Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)
NCT00724893 (49) [back to overview]Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
NCT00724893 (49) [back to overview]The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)
NCT00724893 (49) [back to overview]Relapse Rate by HCV Genotype (Stage 1)
NCT00724893 (49) [back to overview]Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)
NCT00725205 (3) [back to overview]Number of Participants Who Are Triple-80 Compliant
NCT00725205 (3) [back to overview]Number Of Participants Self-Administering Pegylated Interferon Alfa-2b
NCT00725205 (3) [back to overview]Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
NCT00725751 (3) [back to overview]Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy
NCT00725751 (3) [back to overview]Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin
NCT00725751 (3) [back to overview]Number of Participants Who Achieved Sustained Virologic Response (SVR)
NCT00725842 (2) [back to overview]Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment
NCT00725842 (2) [back to overview]Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment
NCT00726557 (2) [back to overview]Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions
NCT00726557 (2) [back to overview]Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week
NCT00727259 (1) [back to overview]Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months
NCT00727311 (4) [back to overview]Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)
NCT00727311 (4) [back to overview]Number of Participants With Early Virologic Response (EVR)
NCT00727311 (4) [back to overview]Number of Participants With Sustained Virologic Response (SVR)
NCT00727311 (4) [back to overview]Number of HCV-RNA Negative Participants at Follow-up
NCT00728494 (6) [back to overview]The Number of Participants Who Relapsed at 6 Months Post-treatment
NCT00728494 (6) [back to overview]The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C
NCT00728494 (6) [back to overview]Average Dosage of Rebetol
NCT00728494 (6) [back to overview]Average Dosage of PegIntron
NCT00728494 (6) [back to overview]Average Length of Treatment
NCT00728494 (6) [back to overview]The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment
NCT00735969 (1) [back to overview]Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.
NCT00758043 (8) [back to overview]Proportion of Randomized Subjects Who Relapse
NCT00758043 (8) [back to overview]Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment
NCT00758043 (8) [back to overview]Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)
NCT00758043 (8) [back to overview]Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00758043 (8) [back to overview]Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
NCT00758043 (8) [back to overview]Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)
NCT00758043 (8) [back to overview]Proportion of Subjects Who Have Undetectable HCV RNA at Week 72
NCT00758043 (8) [back to overview]Proportion of Enrolled Subjects Who Relapse
NCT00761735 (5) [back to overview]Mean Weight Percentiles of Participants Over LTFU
NCT00761735 (5) [back to overview]Mean Height Percentiles of Participants Over LTFU
NCT00761735 (5) [back to overview]Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
NCT00761735 (5) [back to overview]Number of Participants Who Relapsed At End of LTFU Year 5
NCT00761735 (5) [back to overview]Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender
NCT00780416 (1) [back to overview]The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
NCT00780910 (1) [back to overview]The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
NCT00781274 (1) [back to overview]The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
NCT00800735 (1) [back to overview]Percentage of Participants Who Experienced at Least 1 Adverse Event.
NCT00835146 (2) [back to overview]AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)
NCT00835146 (2) [back to overview]Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
NCT00835536 (2) [back to overview]Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
NCT00835536 (2) [back to overview]AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)
NCT00845065 (5) [back to overview]Mean Log Change From Baseline to TW 4 in Viral Load by Visit
NCT00845065 (5) [back to overview]Number of Participants With Undetectable HCV-RNA at Follow-up Week 12
NCT00845065 (5) [back to overview]Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population.
NCT00845065 (5) [back to overview]SVR Rate in the Modified Intent-to-Treat (mITT) Population
NCT00845065 (5) [back to overview]Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR
NCT00845676 (1) [back to overview]Sustained Virologic Response (SVR)
NCT00851890 (14) [back to overview]Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28
NCT00851890 (14) [back to overview]Plasma Concentrations of Ribavirin (RBV)
NCT00851890 (14) [back to overview]Number of Participants With Maximal Phenotypic Resistance to ABT-333 >10 Fold Relative to Baseline Through Day 28
NCT00851890 (14) [back to overview]Number of Participants With Resistance-Associated Variants in Non-structural Viral Protein 5B (NS5B) Through Day 28
NCT00851890 (14) [back to overview]Number of Participants Having Treatment-emergent Adverse Events (AEs)
NCT00851890 (14) [back to overview]Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 or Final Visit
NCT00851890 (14) [back to overview]Time to Maximum Plasma Concentration (Tmax) of ABT-333
NCT00851890 (14) [back to overview]Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 25 IU/mL (the Lower Limit of Quantitation [LLOQ]) at Day 28 or Final Visit
NCT00851890 (14) [back to overview]Maximum Plasma Concentration (Cmax) of ABT-333
NCT00851890 (14) [back to overview]Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 10 IU/mL (Lower Limit of Detection [LLOD]) at Day 28 or Final Visit
NCT00851890 (14) [back to overview]Percentage of Participants With at Least a 2 log10 Maximal Decrease in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Treatment
NCT00851890 (14) [back to overview]Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment
NCT00851890 (14) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC12) of ABT-333
NCT00851890 (14) [back to overview]Serum Concentrations of Pegylated Interferon (pegIFN)
NCT00856024 (3) [back to overview]Percent of Participants Who Achieved Early Virologic Response (EVR)
NCT00856024 (3) [back to overview]Percent of Participants Who Achieved Rapid Virologic Response (RVR)
NCT00856024 (3) [back to overview]Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks
NCT00863109 (7) [back to overview]Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores
NCT00863109 (7) [back to overview]Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)
NCT00863109 (7) [back to overview]Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
NCT00863109 (7) [back to overview]MCID in CLDQ-HCV Scores
NCT00863109 (7) [back to overview]Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
NCT00863109 (7) [back to overview]Minimal Clinically Important Difference (MCID) in SF-36 Scores
NCT00863109 (7) [back to overview]Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)
NCT00867139 (12) [back to overview]Frequency of Confirmed Pneumonia
NCT00867139 (12) [back to overview]Duration of Symptoms
NCT00867139 (12) [back to overview]Duration of Hospitalization
NCT00867139 (12) [back to overview]Days on Supplemental Oxygen
NCT00867139 (12) [back to overview]Number of Deaths
NCT00867139 (12) [back to overview]Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1
NCT00867139 (12) [back to overview]Pharmacokinetics (AUC0-last) of TCAD
NCT00867139 (12) [back to overview]Number of Participants With Viral Resistance as a Function of Drug Exposure
NCT00867139 (12) [back to overview]Number of Participants With Viral Load Decrease as a Function of Time
NCT00867139 (12) [back to overview]Number of Participants With Intubations
NCT00867139 (12) [back to overview]Number of Participants With ICU Admissions
NCT00867139 (12) [back to overview]Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption
NCT00874770 (7) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
NCT00874770 (7) [back to overview]Percentage of Participants With Early Virologic Response (EVR) at Week 12
NCT00874770 (7) [back to overview]Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12
NCT00874770 (7) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
NCT00874770 (7) [back to overview]Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
NCT00874770 (7) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
NCT00874770 (7) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
NCT00880763 (6) [back to overview]Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4
NCT00880763 (6) [back to overview]Number of Participants Who Experienced at Least One Adverse Event
NCT00880763 (6) [back to overview]Number of Participants Who Discontinued Study Drug Due to an Adverse Event
NCT00880763 (6) [back to overview]Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4
NCT00880763 (6) [back to overview]Percentage of Participants Achieving Rapid Viral Response
NCT00880763 (6) [back to overview]Change From Baseline in HCV RNA in log10 at Week 4
NCT00882908 (14) [back to overview]The Percentage of Participants Achieving an Early Virologic Response (EVR)
NCT00882908 (14) [back to overview]The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
NCT00882908 (14) [back to overview]Plasma Concentrations of TMC435
NCT00882908 (14) [back to overview]The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment
NCT00882908 (14) [back to overview]The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up
NCT00882908 (14) [back to overview]The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
NCT00882908 (14) [back to overview]The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
NCT00882908 (14) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)
NCT00882908 (14) [back to overview]Number of Participants With Viral Breakthrough
NCT00882908 (14) [back to overview]The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up
NCT00882908 (14) [back to overview]The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)
NCT00882908 (14) [back to overview]The Number of Participants With Viral Relapse
NCT00882908 (14) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
NCT00882908 (14) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435
NCT00892697 (2) [back to overview]Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir
NCT00892697 (2) [back to overview]Intrahepatic and Plasma HCV Viral Kinetics
NCT00910624 (3) [back to overview]Percentage of Participants With Early Virologic Response (EVR)
NCT00910624 (3) [back to overview]Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL
NCT00910624 (3) [back to overview]Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24);
NCT00919633 (3) [back to overview]Early Virologic Response (EVR)
NCT00919633 (3) [back to overview]Rapid Virologic Response (RVR)
NCT00919633 (3) [back to overview]Viral Load: Incidence of Sustained Virologic Response (SVR)
NCT00922779 (4) [back to overview]Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy
NCT00922779 (4) [back to overview]Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation
NCT00922779 (4) [back to overview]Percentage of Participants With Change in Hemoglobin Level
NCT00922779 (4) [back to overview]Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)
NCT00925990 (2) [back to overview]Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment
NCT00925990 (2) [back to overview]Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
NCT00943761 (4) [back to overview]Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
NCT00943761 (4) [back to overview]Number of Participants Who Experienced a Serious Adverse Event
NCT00943761 (4) [back to overview]Number of Participants Who Experienced an Adverse Event
NCT00943761 (4) [back to overview]Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)
NCT00947349 (33) [back to overview]Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV
NCT00947349 (33) [back to overview]Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy
NCT00947349 (33) [back to overview]Rapid Virological Response (RVR)
NCT00947349 (33) [back to overview]Sustained Virologic Response (SVR)
NCT00947349 (33) [back to overview]t1/2,ss for BI 201335 ZW
NCT00947349 (33) [back to overview]Tmax for BI 201335 ZW
NCT00947349 (33) [back to overview]Tmax for RBV
NCT00947349 (33) [back to overview]Tmax, ss for BI 201335 ZW
NCT00947349 (33) [back to overview]Tmax, ss for RBV
NCT00947349 (33) [back to overview]Week 2 Virological Response (W2VR)
NCT00947349 (33) [back to overview]Week 4 Virological Response (W4VR)
NCT00947349 (33) [back to overview]Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
NCT00947349 (33) [back to overview]Assessment of Tolerability in Triple Combination Therapy
NCT00947349 (33) [back to overview]Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
NCT00947349 (33) [back to overview]Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
NCT00947349 (33) [back to overview]AUCτ,ss of RBV
NCT00947349 (33) [back to overview]AUCτ,1 for BI 201335 ZW
NCT00947349 (33) [back to overview]AUCτ,1 for Ribavirin (RBV)
NCT00947349 (33) [back to overview]AUCτ,ss of BI 201335 ZW
NCT00947349 (33) [back to overview]Cavg for BI 201335 ZW
NCT00947349 (33) [back to overview]Cavg for RBV
NCT00947349 (33) [back to overview]Change From Baseline in HCV Viral Load
NCT00947349 (33) [back to overview]CL/F,ss for BI 201335 ZW
NCT00947349 (33) [back to overview]Cmax of BI 201335 ZW
NCT00947349 (33) [back to overview]Cmax of RBV
NCT00947349 (33) [back to overview]Cmax,ss of BI 201335 ZW
NCT00947349 (33) [back to overview]Cmax,ss of RBV
NCT00947349 (33) [back to overview]Cmin,ss for BI 201335 ZW
NCT00947349 (33) [back to overview]Cmin,ss for RBV
NCT00947349 (33) [back to overview]Complete Early Virological Response (cEVR)
NCT00947349 (33) [back to overview]Day 28 Virologic Response
NCT00947349 (33) [back to overview]Early Virological Response (EVR)
NCT00947349 (33) [back to overview]End of Treatment Response (ETR)
NCT00959699 (6) [back to overview]Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24
NCT00959699 (6) [back to overview]Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)
NCT00959699 (6) [back to overview]Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12)
NCT00959699 (6) [back to overview]Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)
NCT00959699 (6) [back to overview]Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication
NCT00959699 (6) [back to overview]Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound
NCT00980330 (13) [back to overview]The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
NCT00980330 (13) [back to overview]Plasma Concentrations of TMC435
NCT00980330 (13) [back to overview]The Percentage of Participants With Viral Relapse
NCT00980330 (13) [back to overview]The Percentage of Participants With Viral Breakthrough
NCT00980330 (13) [back to overview]The Percentage of Participants Achieving an Early Virologic Response (EVR)
NCT00980330 (13) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)
NCT00980330 (13) [back to overview]The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)
NCT00980330 (13) [back to overview]The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
NCT00980330 (13) [back to overview]The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment
NCT00980330 (13) [back to overview]The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
NCT00980330 (13) [back to overview]The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
NCT00980330 (13) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
NCT00980330 (13) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435
NCT00982553 (4) [back to overview]Ribavirin Minimum Plasma Concentration
NCT00982553 (4) [back to overview]Raltegravir Maximum Plasma Concentration
NCT00982553 (4) [back to overview]Raltegravir Minimum Plasma Concentrations
NCT00982553 (4) [back to overview]Ribavirin Maximum Plasma Concentration
NCT00983853 (6) [back to overview]Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
NCT00983853 (6) [back to overview]Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
NCT00983853 (6) [back to overview]Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
NCT00983853 (6) [back to overview]Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)
NCT00983853 (6) [back to overview]Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)
NCT00983853 (6) [back to overview]Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
NCT00984620 (16) [back to overview]Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)
NCT00984620 (16) [back to overview]Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)
NCT00984620 (16) [back to overview]Viral Load (HCV RNA) at All Visits During Treatment and Follow-up
NCT00984620 (16) [back to overview]Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)
NCT00984620 (16) [back to overview]End of Treatment Response (ETR)
NCT00984620 (16) [back to overview]Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination
NCT00984620 (16) [back to overview]Rapid Virological Response at Week 4 (RVR)
NCT00984620 (16) [back to overview]Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy
NCT00984620 (16) [back to overview]Time to Reach a Plasma HCV RNA Level BLD While on Treatment
NCT00984620 (16) [back to overview]Virological Response at Week 28 (W28VR)
NCT00984620 (16) [back to overview]Virological Response at Week 36 (W36VR)
NCT00984620 (16) [back to overview]Laboratory Test Abnormalities and Study Medication Tolerabilities
NCT00984620 (16) [back to overview]Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)
NCT00984620 (16) [back to overview]Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)
NCT00984620 (16) [back to overview]Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)
NCT00984620 (16) [back to overview]Virological Response at Week 24 (W24VR)
NCT00991289 (11) [back to overview]Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.
NCT00991289 (11) [back to overview]Percent Change in Fasting Insulin Level From Study Entry
NCT00991289 (11) [back to overview]Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry
NCT00991289 (11) [back to overview]Change in Hemoglobin Level From Study Entry
NCT00991289 (11) [back to overview]Percentage of Participants With Early Virologic Response (EVR)
NCT00991289 (11) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR)
NCT00991289 (11) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR)
NCT00991289 (11) [back to overview]Number of Participants With Adverse Events of Grade 2 or Higher
NCT00991289 (11) [back to overview]Number of Participants With HCV Genotype 1
NCT00991289 (11) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR)
NCT00991289 (11) [back to overview]Percent Change in Fasting Glucose Level From Study Entry
NCT01016912 (7) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR)
NCT01016912 (7) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR)
NCT01016912 (7) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
NCT01016912 (7) [back to overview]Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
NCT01016912 (7) [back to overview]Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
NCT01016912 (7) [back to overview]Percentage of Participants With Virologic Failure
NCT01016912 (7) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR)
NCT01017575 (6) [back to overview]Percentage of Participants With a Complete Early Virologic Response (cEVR)
NCT01017575 (6) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR)
NCT01017575 (6) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR)
NCT01017575 (6) [back to overview]Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
NCT01017575 (6) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.
NCT01017575 (6) [back to overview]Number of Participants With Grade 3 to 4 Laboratory Abnormalities
NCT01023035 (2) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR)
NCT01023035 (2) [back to overview]Percentage of Participants Who Discontinued Treatment
NCT01052701 (2) [back to overview]Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations
NCT01052701 (2) [back to overview]Plasma RBV Trough Concentrations
NCT01054573 (10) [back to overview]Percentage of Participants Achieving Rapid Virologic Response (RVR)
NCT01054573 (10) [back to overview]Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)
NCT01054573 (10) [back to overview]Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8
NCT01054573 (10) [back to overview]Percentage of Participants With Viral Breakthrough
NCT01054573 (10) [back to overview]Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
NCT01054573 (10) [back to overview]Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
NCT01054573 (10) [back to overview]The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
NCT01054573 (10) [back to overview]Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
NCT01054573 (10) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)
NCT01054573 (10) [back to overview]Percentage of Participants Who Relapsed During Follow-Up
NCT01054742 (1) [back to overview]Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study
NCT01056523 (5) [back to overview]Overall Response Rate
NCT01056523 (5) [back to overview]Recommended Phase II Dose (RP2D) of Ribavirin When Given in Combination With Low-dose Ara-C
NCT01056523 (5) [back to overview]Partial Response
NCT01056523 (5) [back to overview]Complete Response Rate
NCT01056523 (5) [back to overview]Blast Response
NCT01074008 (24) [back to overview]Maximum Plasma Concentration (Cmax) of ABT-450
NCT01074008 (24) [back to overview]Maximum Plasma Concentration (Cmax) of ABT-333
NCT01074008 (24) [back to overview]Maximum Plasma Concentration (Cmax) of ABT-072
NCT01074008 (24) [back to overview]Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment
NCT01074008 (24) [back to overview]Change From Baseline in SF-36 Physical Component Summary (PCS)
NCT01074008 (24) [back to overview]Change From Baseline in SF-36 Mental Component Summary (MCS)
NCT01074008 (24) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072
NCT01074008 (24) [back to overview]Change From Baseline in Hepatitis C Virus Patient-reported Outcomes (HCV-PRO) Total Score
NCT01074008 (24) [back to overview]Change From Baseline in EQ-5D (3 Level) Health Index Score
NCT01074008 (24) [back to overview]Change From Baseline in ED-5D Visual Analog Scale (ED-5D VAS) Score
NCT01074008 (24) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir
NCT01074008 (24) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450
NCT01074008 (24) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333
NCT01074008 (24) [back to overview]Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)
NCT01074008 (24) [back to overview]Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)
NCT01074008 (24) [back to overview]Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)
NCT01074008 (24) [back to overview]Time to Maximum Plasma Concentration (Tmax) of ABT-072
NCT01074008 (24) [back to overview]Time to Maximum Plasma Concentration (Tmax) of Ritonavir
NCT01074008 (24) [back to overview]Time to Maximum Plasma Concentration (Tmax) of ABT-450
NCT01074008 (24) [back to overview]Time to Maximum Plasma Concentration (Tmax) of ABT-333
NCT01074008 (24) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
NCT01074008 (24) [back to overview]Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12
NCT01074008 (24) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12
NCT01074008 (24) [back to overview]Maximum Plasma Concentration (Cmax) of Ritonavir
NCT01097395 (3) [back to overview]Ribavirin AUC-12 Variability
NCT01097395 (3) [back to overview]Safety - Absolute Hemoglobin Declines
NCT01097395 (3) [back to overview]Sustained Virologic Response (i.e., Cure)
NCT01098097 (6) [back to overview]Incidence of Treatment Discontinuations Due to Adverse Events
NCT01098097 (6) [back to overview]Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)
NCT01098097 (6) [back to overview]Incidence of Particular Adverse Events Resulting in Treatment Discontinuation
NCT01098097 (6) [back to overview]Incidence of Dose Modifications Due to Adverse Events
NCT01098097 (6) [back to overview]Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)
NCT01098097 (6) [back to overview]Incidence of Thrombocytopenia
NCT01125189 (7) [back to overview]Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)
NCT01125189 (7) [back to overview]Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)
NCT01125189 (7) [back to overview]Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)
NCT01125189 (7) [back to overview]Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)
NCT01125189 (7) [back to overview]Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)
NCT01125189 (7) [back to overview]Percentage of Resistant Variants Associated With Virologic Failure
NCT01125189 (7) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died
NCT01132313 (9) [back to overview]Part 2: Time to Virological Response
NCT01132313 (9) [back to overview]Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
NCT01132313 (9) [back to overview]Part 1: Rapid Virological Response (RVR)
NCT01132313 (9) [back to overview]Part 2: Sustained Virological Response (SVR)
NCT01132313 (9) [back to overview]Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
NCT01132313 (9) [back to overview]Part 3 and 4: Sustained Virological Response (SVR)
NCT01132313 (9) [back to overview]Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
NCT01132313 (9) [back to overview]Part 1: Time to Virological Response
NCT01132313 (9) [back to overview]Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
NCT01170962 (9) [back to overview]Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
NCT01170962 (9) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR)
NCT01170962 (9) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR)
NCT01170962 (9) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR)
NCT01170962 (9) [back to overview]Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
NCT01170962 (9) [back to overview]Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
NCT01170962 (9) [back to overview]Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
NCT01170962 (9) [back to overview]Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
NCT01170962 (9) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
NCT01180790 (11) [back to overview]Segment 2: Complete Early Virologic Response (cEVR)
NCT01180790 (11) [back to overview]Segment 2: Safety
NCT01180790 (11) [back to overview]Segment 1: Safety
NCT01180790 (11) [back to overview]Segment 1: Rapid Viral Response At Week 4 (RVR4)
NCT01180790 (11) [back to overview]Segment 2: RVR4
NCT01180790 (11) [back to overview]Segment 1: cEVR
NCT01180790 (11) [back to overview]Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24)
NCT01180790 (11) [back to overview]Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12)
NCT01180790 (11) [back to overview]Segment 1 And Segment 2: HCV RNA Change From Baseline
NCT01180790 (11) [back to overview]Segment 1 And Segment 2: End Of Treatment Response
NCT01180790 (11) [back to overview]Segment 1 And Segment 2: HCV RNA Change From Baseline
NCT01183169 (10) [back to overview]Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
NCT01183169 (10) [back to overview]Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
NCT01183169 (10) [back to overview]Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
NCT01183169 (10) [back to overview]Percentage of Participants With On-treatment Viral Breakthrough
NCT01183169 (10) [back to overview]Percentage of Participants With Viral Relapse
NCT01183169 (10) [back to overview]Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
NCT01183169 (10) [back to overview]Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
NCT01183169 (10) [back to overview]Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
NCT01183169 (10) [back to overview]Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
NCT01183169 (10) [back to overview]Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
NCT01185028 (3) [back to overview]Number of Participants With Adverse Events
NCT01185028 (3) [back to overview]Tolerability of Study Drug Measured as Discontinuation.
NCT01185028 (3) [back to overview]Sustained Viral Response Rate
NCT01215643 (18) [back to overview]Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
NCT01215643 (18) [back to overview]Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
NCT01215643 (18) [back to overview]Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
NCT01215643 (18) [back to overview]Percentage of Participants With On-treatment Viral Breakthrough
NCT01215643 (18) [back to overview]Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
NCT01215643 (18) [back to overview]Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
NCT01215643 (18) [back to overview]Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
NCT01215643 (18) [back to overview]Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
NCT01215643 (18) [back to overview]Percentage of Participants With Viral Relapse
NCT01215643 (18) [back to overview]Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
NCT01215643 (18) [back to overview]Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
NCT01215643 (18) [back to overview]Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
NCT01215643 (18) [back to overview]Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
NCT01215643 (18) [back to overview]Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
NCT01215643 (18) [back to overview]Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
NCT01215643 (18) [back to overview]Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
NCT01215643 (18) [back to overview]Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
NCT01215643 (18) [back to overview]Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
NCT01221298 (7) [back to overview]Time to Virologic Relapse Through 24 Weeks Post-treatment
NCT01221298 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
NCT01221298 (7) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12
NCT01221298 (7) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4
NCT01221298 (7) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
NCT01221298 (7) [back to overview]Time to Failure to Suppress or Rebound During Treatment
NCT01221298 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
NCT01227967 (14) [back to overview]Number of Participants by Virus Detection Status
NCT01227967 (14) [back to overview]qPCR Viral Shedding
NCT01227967 (14) [back to overview]Time to Feeling as Good as Before the Onset of the Influenza Illness
NCT01227967 (14) [back to overview]Percentage of Participants Who Required Hospitalization.
NCT01227967 (14) [back to overview]28-day Mortality
NCT01227967 (14) [back to overview]Time to Resolution of All Symptoms AND Fever
NCT01227967 (14) [back to overview]Time to Return of Physical Function to Pre-illness Leve
NCT01227967 (14) [back to overview]Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen
NCT01227967 (14) [back to overview]Percentage of Participants With Clinical Failure at Day 5
NCT01227967 (14) [back to overview]Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs
NCT01227967 (14) [back to overview]Time to Absence of Fever
NCT01227967 (14) [back to overview]Time to Alleviation of Influenza Clinical Symptoms.
NCT01227967 (14) [back to overview]Time to Return to Pre-influenza Function
NCT01227967 (14) [back to overview]Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.
NCT01241760 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
NCT01241760 (7) [back to overview]Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
NCT01241760 (7) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
NCT01241760 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
NCT01241760 (7) [back to overview]Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
NCT01241760 (7) [back to overview]Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
NCT01241760 (7) [back to overview]Percentage of Participants Who Relapsed During Follow-up Period
NCT01257204 (12) [back to overview]Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
NCT01257204 (12) [back to overview]Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
NCT01257204 (12) [back to overview]Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
NCT01257204 (12) [back to overview]Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
NCT01257204 (12) [back to overview]Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
NCT01257204 (12) [back to overview]Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
NCT01257204 (12) [back to overview]Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
NCT01257204 (12) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
NCT01257204 (12) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
NCT01257204 (12) [back to overview]Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
NCT01257204 (12) [back to overview]Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
NCT01257204 (12) [back to overview]Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
NCT01258101 (11) [back to overview]Number of Participants With Any Adverse Events and Any Serious Adverse Events
NCT01258101 (11) [back to overview]Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment
NCT01258101 (11) [back to overview]Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48
NCT01258101 (11) [back to overview]Mean FSS Scores at Baseline and Weeks 16, 24 and 48
NCT01258101 (11) [back to overview]Median Hemoglobin Levels at End of Treatment
NCT01258101 (11) [back to overview]Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48
NCT01258101 (11) [back to overview]Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48
NCT01258101 (11) [back to overview]Time to Viral Response
NCT01258101 (11) [back to overview]Percentage of Participants With Virological Response at the End of the Treatment
NCT01258101 (11) [back to overview]Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment
NCT01258101 (11) [back to overview]Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48
NCT01276756 (5) [back to overview]Sustained Virologic Response
NCT01276756 (5) [back to overview]Early Virological Response
NCT01276756 (5) [back to overview]Rapid Virological Response
NCT01276756 (5) [back to overview]Safety of Nitazoxanide (Number of Participants Experiencing Adverse Events)
NCT01276756 (5) [back to overview]End-of-treatment Response
NCT01280656 (13) [back to overview]Number of Participants With Any Adverse Events and Any Serious Adverse Events
NCT01280656 (13) [back to overview]Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment
NCT01280656 (13) [back to overview]Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders
NCT01280656 (13) [back to overview]Percentage of Participants With Virologic Response at End of Treatment
NCT01280656 (13) [back to overview]Percentage of Participants With Virologic Relapse up to Week 72
NCT01280656 (13) [back to overview]Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment
NCT01280656 (13) [back to overview]Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment
NCT01280656 (13) [back to overview]Percentage of Participants With Rapid Virologic Response at Week 4
NCT01280656 (13) [back to overview]Percentage of Participants With Null Response or No Responder at End of Treatment
NCT01280656 (13) [back to overview]Percentage of Participants With Early Virologic Response at Week 12
NCT01280656 (13) [back to overview]Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used
NCT01280656 (13) [back to overview]Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home
NCT01280656 (13) [back to overview]Percentage of Participants Who Discontinued Treatment Due to Adverse Events
NCT01281839 (30) [back to overview]The Percentage of Participants With Viral Breakthrough
NCT01281839 (30) [back to overview]The Percentage of Participants With Viral Relapse
NCT01281839 (30) [back to overview]Time From End-of-treatment to Viral Relapse
NCT01281839 (30) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL
NCT01281839 (30) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL
NCT01281839 (30) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable
NCT01281839 (30) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable
NCT01281839 (30) [back to overview]Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
NCT01281839 (30) [back to overview]The Percentage of Participants With On-treatment Virologic Response at All Time Points
NCT01281839 (30) [back to overview]The Percentage of Participants With Viral Breakthrough at Different Time Points
NCT01281839 (30) [back to overview]Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
NCT01281839 (30) [back to overview]Median Time to Normalization of Alanine Aminotransferase (ALT) Levels
NCT01281839 (30) [back to overview]Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4
NCT01281839 (30) [back to overview]Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
NCT01281839 (30) [back to overview]Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)
NCT01281839 (30) [back to overview]Plasma Concentration of TMC435: Systemic Clearance (CL)
NCT01281839 (30) [back to overview]The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
NCT01281839 (30) [back to overview]The Percentage of Participants Achieving a Early Virologic Response (EVR)
NCT01281839 (30) [back to overview]The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)
NCT01281839 (30) [back to overview]The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
NCT01281839 (30) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
NCT01281839 (30) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)
NCT01281839 (30) [back to overview]The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
NCT01281839 (30) [back to overview]The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)
NCT01281839 (30) [back to overview]The Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule
NCT01281839 (30) [back to overview]The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4
NCT01281839 (30) [back to overview]The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)
NCT01281839 (30) [back to overview]The Percentage of Participants With Null Response
NCT01281839 (30) [back to overview]The Percentage of Participants With On-treatment Failure
NCT01281839 (30) [back to overview]The Percentage of Participants With Partial Response
NCT01288209 (11) [back to overview]The Number of Participants With Viral Breakthrough During the Study
NCT01288209 (11) [back to overview]The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)
NCT01288209 (11) [back to overview]Plasma Concentrations of TMC435
NCT01288209 (11) [back to overview]The Number of Participants Demonstrating Viral Relapse During the Study
NCT01288209 (11) [back to overview]The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)
NCT01288209 (11) [back to overview]The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During Treatment for Participants Who Did Not Achieve Undetectable Plasma HCV RNA Levels at Week 12
NCT01288209 (11) [back to overview]The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up
NCT01288209 (11) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435
NCT01288209 (11) [back to overview]The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)
NCT01288209 (11) [back to overview]The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFNα-2a) and Ribavirin (RBV) at Week 24
NCT01288209 (11) [back to overview]The Number Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)
NCT01289782 (34) [back to overview]Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule
NCT01289782 (34) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
NCT01289782 (34) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable
NCT01289782 (34) [back to overview]Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment
NCT01289782 (34) [back to overview]Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
NCT01289782 (34) [back to overview]Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4
NCT01289782 (34) [back to overview]The Percentage of Participants Achieving a Early Virologic Response (EVR)
NCT01289782 (34) [back to overview]The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)
NCT01289782 (34) [back to overview]The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
NCT01289782 (34) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)
NCT01289782 (34) [back to overview]The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
NCT01289782 (34) [back to overview]Time From End-of-treatment to Viral Relapse
NCT01289782 (34) [back to overview]The Percentage of Participants With Viral Breakthrough at Different Time Points
NCT01289782 (34) [back to overview]Percentage of Participants With On-treatment Virologic Response at All Time Points
NCT01289782 (34) [back to overview]Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment
NCT01289782 (34) [back to overview]Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores
NCT01289782 (34) [back to overview]Plasma Concentration of TMC435: Systemic Clearance (CL)
NCT01289782 (34) [back to overview]Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)
NCT01289782 (34) [back to overview]Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
NCT01289782 (34) [back to overview]Percentage of Participants With Viral Relapse
NCT01289782 (34) [back to overview]Percentage of Participants With Viral Breakthrough
NCT01289782 (34) [back to overview]The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4
NCT01289782 (34) [back to overview]Percentage of Participants With Partial Response
NCT01289782 (34) [back to overview]Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
NCT01289782 (34) [back to overview]Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) in Work Productivity and Activity (WPAI) Absenteeism Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment
NCT01289782 (34) [back to overview]The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
NCT01289782 (34) [back to overview]The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)
NCT01289782 (34) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL
NCT01289782 (34) [back to overview]The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)
NCT01289782 (34) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL
NCT01289782 (34) [back to overview]Percentage of Participants With Null Response
NCT01289782 (34) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable
NCT01289782 (34) [back to overview]Median Time to Normalization of Alanine Aminotransferase (ALT) Levels
NCT01289782 (34) [back to overview]Percentage of Participants With On-treatment Failure
NCT01290679 (34) [back to overview]Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)
NCT01290679 (34) [back to overview]Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
NCT01290679 (34) [back to overview]The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)
NCT01290679 (34) [back to overview]Percentage of Participants With Viral Relapse
NCT01290679 (34) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
NCT01290679 (34) [back to overview]Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
NCT01290679 (34) [back to overview]Percentage of Participants With On-treatment Virologic Response at All Time Points
NCT01290679 (34) [back to overview]The Percentage of Participants With Viral Breakthrough at Different Time Points
NCT01290679 (34) [back to overview]Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
NCT01290679 (34) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable
NCT01290679 (34) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable
NCT01290679 (34) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL
NCT01290679 (34) [back to overview]Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL
NCT01290679 (34) [back to overview]Time From End-of-treatment to Viral Relapse
NCT01290679 (34) [back to overview]The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)
NCT01290679 (34) [back to overview]The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
NCT01290679 (34) [back to overview]The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)
NCT01290679 (34) [back to overview]The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4
NCT01290679 (34) [back to overview]The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
NCT01290679 (34) [back to overview]The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)
NCT01290679 (34) [back to overview]The Percentage of Participants Achieving a Early Virologic Response (EVR)
NCT01290679 (34) [back to overview]The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
NCT01290679 (34) [back to overview]Percentage of Participants With Viral Breakthrough
NCT01290679 (34) [back to overview]Percentage of Participants With Partial Response
NCT01290679 (34) [back to overview]Percentage of Participants With On-treatment Failure
NCT01290679 (34) [back to overview]Percentage of Participants With Null Response
NCT01290679 (34) [back to overview]Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4
NCT01290679 (34) [back to overview]Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule
NCT01290679 (34) [back to overview]Median Time to Normalization of Alanine Aminotransferase (ALT) Levels
NCT01290679 (34) [back to overview]Plasma Concentration of TMC435: Systemic Clearance (CL)
NCT01290679 (34) [back to overview]Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment
NCT01290679 (34) [back to overview]Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment
NCT01290679 (34) [back to overview]Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores
NCT01290679 (34) [back to overview]Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment
NCT01290731 (9) [back to overview]The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)
NCT01290731 (9) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 24 Hrs (AUC24h) for TMC435
NCT01290731 (9) [back to overview]The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)
NCT01290731 (9) [back to overview]The Number of Participants With Viral Breakthrough
NCT01290731 (9) [back to overview]The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)
NCT01290731 (9) [back to overview]The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)
NCT01290731 (9) [back to overview]Plasma Concentrations of TMC435
NCT01290731 (9) [back to overview]The Number of Participants Demonstrating Viral Relapse
NCT01290731 (9) [back to overview]The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up
NCT01292239 (10) [back to overview]The Percentage of Participants in the TMC435 Treatment Group Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFN Alpha-2a) and Ribavirin (RBV) at Week 24
NCT01292239 (10) [back to overview]The Number of Participants With Viral Breakthrough
NCT01292239 (10) [back to overview]The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)
NCT01292239 (10) [back to overview]The Percentage of Participants With Undetectable Plasma Levels of Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)
NCT01292239 (10) [back to overview]The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up
NCT01292239 (10) [back to overview]Plasma Concentrations of TMC435
NCT01292239 (10) [back to overview]The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)
NCT01292239 (10) [back to overview]The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)
NCT01292239 (10) [back to overview]The Number of Participants Demonstrating Viral Relapse
NCT01292239 (10) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435
NCT01306617 (12) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
NCT01306617 (12) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
NCT01306617 (12) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12
NCT01306617 (12) [back to overview]Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4
NCT01306617 (12) [back to overview]Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)
NCT01306617 (12) [back to overview]Time to Failure to Suppress or Rebound During Treatment
NCT01306617 (12) [back to overview]Resistance-Associated Variants and Phenotypic Resistance
NCT01306617 (12) [back to overview]Time to Virologic Relapse Post-treatment
NCT01306617 (12) [back to overview]Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants
NCT01306617 (12) [back to overview]Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants
NCT01306617 (12) [back to overview]Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants
NCT01306617 (12) [back to overview]Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants
NCT01314261 (12) [back to overview]Percentage of Participants With Partial Early Virologic Response (pEVR)
NCT01314261 (12) [back to overview]Time to Maximum Plasma Concentration (Tmax) of ABT-267
NCT01314261 (12) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
NCT01314261 (12) [back to overview]Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267
NCT01314261 (12) [back to overview]Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)
NCT01314261 (12) [back to overview]Percentage of Participants With 4-week Rapid Virologic Response (RVR)
NCT01314261 (12) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR)
NCT01314261 (12) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
NCT01314261 (12) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR)
NCT01314261 (12) [back to overview]Plasma Concentrations of Ribavirin (RBV)
NCT01314261 (12) [back to overview]Maximum Plasma Concentration (Cmax) of ABT-267
NCT01314261 (12) [back to overview]Serum Concentrations of Pegylated Interferon (pegIFN)
NCT01318694 (12) [back to overview]Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks
NCT01318694 (12) [back to overview]Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment
NCT01318694 (12) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment
NCT01318694 (12) [back to overview]Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
NCT01318694 (12) [back to overview]Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)
NCT01318694 (12) [back to overview]Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks
NCT01318694 (12) [back to overview]Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment
NCT01318694 (12) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment
NCT01318694 (12) [back to overview]Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks
NCT01318694 (12) [back to overview]Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks
NCT01318694 (12) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks
NCT01318694 (12) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)
NCT01353911 (8) [back to overview]Number of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days
NCT01353911 (8) [back to overview]Median Time to First Achievement of Undetectable HCV RNA During Treatment
NCT01353911 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR24)
NCT01353911 (8) [back to overview]Percentage of Participants Achieving Complete Early Viral Response (cEVR)
NCT01353911 (8) [back to overview]Percentage of Participants Achieving Rapid Viral Response (RVR)
NCT01353911 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of Study Therapy (SVR12)
NCT01353911 (8) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA at Week 72
NCT01353911 (8) [back to overview]Number of Participants Who Discontinued Study Medication Due to AEs During the Treatment Period and First 14 Follow-up Days
NCT01355289 (4) [back to overview]Number of Participants Who Achieved Platelet Response (Greater Than or Equal to 100 x 10^9/L) by Day 21 of Treatment Period A1 of Core Study
NCT01355289 (4) [back to overview]Number of Participants Who Achieved Platelet Count Greater Than 30 X 10^9/L From Baseline to Day 21 During Treatment Period A1 of Core Study
NCT01355289 (4) [back to overview]Change From Baseline of Local Platelet Count by Visit During Treatment Period A1 of Core Study
NCT01355289 (4) [back to overview]Number of Participants Who Initiated Antiviral Treatment by Day 21 of Period A1 of Core Study
NCT01358864 (11) [back to overview]AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
NCT01358864 (11) [back to overview]AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
NCT01358864 (11) [back to overview]AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
NCT01358864 (11) [back to overview]AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
NCT01358864 (11) [back to overview]Early Treatment Success (ETS)
NCT01358864 (11) [back to overview]Sustained Virological Response 12 Weeks Post Treatment (SVR12)
NCT01358864 (11) [back to overview]Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
NCT01358864 (11) [back to overview]ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
NCT01358864 (11) [back to overview]ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
NCT01358864 (11) [back to overview]ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
NCT01358864 (11) [back to overview]ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
NCT01359644 (7) [back to overview]Percentage of Participants With Viral Breakthrough During the Treatment Period
NCT01359644 (7) [back to overview]Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
NCT01359644 (7) [back to overview]Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
NCT01359644 (7) [back to overview]Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
NCT01359644 (7) [back to overview]Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
NCT01359644 (7) [back to overview]Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
NCT01359644 (7) [back to overview]Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
NCT01364090 (1) [back to overview]Treatment Efficacy
NCT01366638 (10) [back to overview]The Area Under the Plasma Concentration-Time Curve (From 0 to 24 Hours) (AUC24h)
NCT01366638 (10) [back to overview]The Number of Participants Demonstrating Viral Relapse
NCT01366638 (10) [back to overview]The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at the End of Treatment (EOT)
NCT01366638 (10) [back to overview]The Number of Participants With Viral Breakthrough
NCT01366638 (10) [back to overview]The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2b (PegIFNα-2b) and Ribavirin (RBV) at Week 24
NCT01366638 (10) [back to overview]Plasma Concentrations of TMC435
NCT01366638 (10) [back to overview]The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up
NCT01366638 (10) [back to overview]The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During Treatment and at the End of Treatment
NCT01366638 (10) [back to overview]The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)
NCT01366638 (10) [back to overview]The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)
NCT01370642 (8) [back to overview]Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)
NCT01370642 (8) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an AE
NCT01370642 (8) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)
NCT01370642 (8) [back to overview]Percentage of Participants Achieving SVR12
NCT01370642 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
NCT01370642 (8) [back to overview]Percentage of Participants Achieving Rapid Virologic Response (RVR)
NCT01370642 (8) [back to overview]Percentage of Participants Achieving Complete Early Virologic Response (cEVR)
NCT01370642 (8) [back to overview]Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study
NCT01389323 (5) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels
NCT01389323 (5) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels
NCT01389323 (5) [back to overview]Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene
NCT01389323 (5) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
NCT01389323 (5) [back to overview]Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)
NCT01390844 (10) [back to overview]Percentage of Participants With an AE of Neutropenia in India
NCT01390844 (10) [back to overview]Percentage of Participants With an AE of Neutropenia in Korea and Taiwan
NCT01390844 (10) [back to overview]Percentage of Participants in India Achieving EVR at Treatment Week 8
NCT01390844 (10) [back to overview]Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population
NCT01390844 (10) [back to overview]Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population
NCT01390844 (10) [back to overview]Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8
NCT01390844 (10) [back to overview]Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population
NCT01390844 (10) [back to overview]Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population
NCT01390844 (10) [back to overview]Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan
NCT01390844 (10) [back to overview]Percentage of Participants With an AE of Anemia in India
NCT01405027 (5) [back to overview]Number of Participants With Adverse Events
NCT01405027 (5) [back to overview]Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.
NCT01405027 (5) [back to overview]Drug Exposure
NCT01405027 (5) [back to overview]Treatment Duration Compliance Rate
NCT01405027 (5) [back to overview]Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
NCT01405560 (8) [back to overview]Percentage of Participants Achieving SVR12
NCT01405560 (8) [back to overview]Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study
NCT01405560 (8) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an AE
NCT01405560 (8) [back to overview]Percentage of Participants Achieving Undetectable HCV Ribonucleic Acid (RNA) at the End of Treatment (EOT)
NCT01405560 (8) [back to overview]Mean Change From Baseline in HCV RNA (Log 10)
NCT01405560 (8) [back to overview]Percentage of Participants Achieving Complete Early Virologic Response (cEVR)
NCT01405560 (8) [back to overview]Percentage of Participants Achieving Rapid Virologic Response (RVR)
NCT01405560 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response (SVR)24
NCT01405937 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
NCT01405937 (8) [back to overview]Percentage of Participants Achieving Rapid Virologic Response (RVR)
NCT01405937 (8) [back to overview]Percentage of Participants Achieving Complete Early Virologic Response (cEVR)
NCT01405937 (8) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an AE
NCT01405937 (8) [back to overview]Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study
NCT01405937 (8) [back to overview]Mean Change From Baseline in HCV RNA (Log 10)
NCT01405937 (8) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)
NCT01405937 (8) [back to overview]Percentage of Participants Achieving SVR12
NCT01425203 (3) [back to overview]Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)
NCT01425203 (3) [back to overview]Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)
NCT01425203 (3) [back to overview]Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8
NCT01428063 (8) [back to overview]Percentage of Participants With End of the Treatment Response (EOTR)
NCT01428063 (8) [back to overview]Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
NCT01428063 (8) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR)
NCT01428063 (8) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR)
NCT01428063 (8) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4
NCT01428063 (8) [back to overview]Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
NCT01428063 (8) [back to overview]Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)
NCT01428063 (8) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study
NCT01429792 (6) [back to overview]Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
NCT01429792 (6) [back to overview]Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
NCT01429792 (6) [back to overview]Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
NCT01429792 (6) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
NCT01429792 (6) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
NCT01429792 (6) [back to overview]Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
NCT01439373 (21) [back to overview]Mean Change From Baseline in Serum HCV RNA Levels at Day 2 and Day 28
NCT01439373 (21) [back to overview]Mean Area Under the Concentration-time Curve (AUC[0-24]), AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK2336805, at Day 1
NCT01439373 (21) [back to overview]Mean Pre-dose Concentration and Concentration at 2 to 4 h Post-dose of GSK2336805 at Days 7, 14, 21, and 28
NCT01439373 (21) [back to overview]Median Serum Alanine Aminotransferase at Baseline, Day 7, 14, 21, 28 and 42
NCT01439373 (21) [back to overview]Mean Serum HCV RNA Levels at Baseline (Day 1), Day 2 and Day 28
NCT01439373 (21) [back to overview]Mean Maximum Plasma Concentration of GSK2336805 (Cmax) and Concentration at 24 h (C24) at Day 1
NCT01439373 (21) [back to overview]Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis
NCT01439373 (21) [back to overview]Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses
NCT01439373 (21) [back to overview]Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period
NCT01439373 (21) [back to overview]Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade Hematology Parameters for Day 1 to Day 28
NCT01439373 (21) [back to overview]Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade for Serum Chemistry Parameters for Day 1 to Day 28
NCT01439373 (21) [back to overview]Number of Participants With Vital Signs of Potential Clinical Concern
NCT01439373 (21) [back to overview]Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses)
NCT01439373 (21) [back to overview]Mean Apparent Clearance (CL/F) of GSK2336805
NCT01439373 (21) [back to overview]Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale
NCT01439373 (21) [back to overview]Change From Baseline in QTcF Interval at Day 2 and 28
NCT01439373 (21) [back to overview]Change From Baseline in Serum Alanine Aminotransferase Levels
NCT01439373 (21) [back to overview]Median Time of Maximal Plasma Concentration (Tmax) of GSK2336805 and Lag Time Before First Observation of Quantifiable Concentration (Tlag) at Day 1
NCT01439373 (21) [back to overview]Number of Participants With Shifts in Urinalysis Parameters From Normal at Baseline to Abnormal
NCT01439373 (21) [back to overview]Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis
NCT01439373 (21) [back to overview]Number of Participants With HCV Genotype 1 With Virologic Response
NCT01441180 (2) [back to overview]Participants With Adverse Events
NCT01441180 (2) [back to overview]Sustained Virologic Response
NCT01447420 (5) [back to overview]Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression
NCT01447420 (5) [back to overview]Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12
NCT01447420 (5) [back to overview]Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment
NCT01447420 (5) [back to overview]Percentage of Participants With Incidence of Anemia
NCT01447420 (5) [back to overview]Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression
NCT01447446 (12) [back to overview]Percentage of Participants With Concomitant Medical Condition at Baseline
NCT01447446 (12) [back to overview]Virological Relapse After End of Treatment
NCT01447446 (12) [back to overview]Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)
NCT01447446 (12) [back to overview]Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)
NCT01447446 (12) [back to overview]Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions
NCT01447446 (12) [back to overview]Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)
NCT01447446 (12) [back to overview]Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)
NCT01447446 (12) [back to overview]Virological Response at Various on Treatment Time Points and End of Treatment (EOT)
NCT01447446 (12) [back to overview]Percentage of Participants With Adverse Events (AE)
NCT01447446 (12) [back to overview]Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)
NCT01447446 (12) [back to overview]Duration of Overall Treatment
NCT01447446 (12) [back to overview]Virological Breakthrough
NCT01448044 (5) [back to overview]Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
NCT01448044 (5) [back to overview]Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
NCT01448044 (5) [back to overview]Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
NCT01448044 (5) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
NCT01448044 (5) [back to overview]Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)
NCT01458535 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
NCT01458535 (7) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT01458535 (7) [back to overview]Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)
NCT01458535 (7) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
NCT01458535 (7) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)
NCT01458535 (7) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]
NCT01458535 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
NCT01459913 (9) [back to overview]Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
NCT01459913 (9) [back to overview]Number of Subjects With Extended Rapid Viral Response (eRVR)
NCT01459913 (9) [back to overview]Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
NCT01459913 (9) [back to overview]Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
NCT01459913 (9) [back to overview]Percentage of Subjects With On-Treatment Virologic Failure
NCT01459913 (9) [back to overview]Number of Subjects With Rapid Viral Response (RVR)
NCT01459913 (9) [back to overview]Percentage of Subjects With Viral Relapse
NCT01459913 (9) [back to overview]Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
NCT01459913 (9) [back to overview]Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01464827 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin
NCT01464827 (6) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01464827 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders
NCT01464827 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin
NCT01464827 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin
NCT01464827 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin
NCT01466192 (1) [back to overview]Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
NCT01466790 (7) [back to overview]Number of Participants With Viral Breakthrough
NCT01466790 (7) [back to overview]Number of Participants With Viral Relapse
NCT01466790 (7) [back to overview]Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)
NCT01466790 (7) [back to overview]Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)
NCT01466790 (7) [back to overview]Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)
NCT01466790 (7) [back to overview]Number of Participants With a Sustained Virologic Response (SVR) at Week 48
NCT01466790 (7) [back to overview]Number of Participants With Inadequate Virologic Response
NCT01467479 (8) [back to overview]Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)
NCT01467479 (8) [back to overview]Percentage of Participants With Rapid Viral Response (RVR)
NCT01467479 (8) [back to overview]Percentage of Participants With Extended Rapid Viral Response (eRVR)
NCT01467479 (8) [back to overview]Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01467479 (8) [back to overview]Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
NCT01467479 (8) [back to overview]Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
NCT01467479 (8) [back to overview]Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
NCT01467479 (8) [back to overview]Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)
NCT01467492 (8) [back to overview]Percentage of Participants With On Treatment Virologic Failure
NCT01467492 (8) [back to overview]Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
NCT01467492 (8) [back to overview]Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
NCT01467492 (8) [back to overview]Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01467492 (8) [back to overview]Percentage of Participants With Extended Rapid Viral Response (eRVR)
NCT01467492 (8) [back to overview]Percentage of Participants With Relapse
NCT01467492 (8) [back to overview]Percentage of Participants With Virologic Breakthrough
NCT01467492 (8) [back to overview]Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
NCT01467505 (6) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01467505 (6) [back to overview]Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
NCT01467505 (6) [back to overview]Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
NCT01467505 (6) [back to overview]Percentage of Participants With Rapid Viral Response (RVR)
NCT01467505 (6) [back to overview]Percentage of Participants With Extended Rapid Viral Response (eRVR)
NCT01467505 (6) [back to overview]Percentage of Participants With On-Treatment Virologic Failure
NCT01468584 (1) [back to overview]Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
NCT01471574 (6) [back to overview]Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation
NCT01471574 (6) [back to overview]Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
NCT01471574 (6) [back to overview]Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
NCT01471574 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
NCT01471574 (6) [back to overview]Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL
NCT01471574 (6) [back to overview]Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)
NCT01479868 (12) [back to overview]Percentage of Participants With Viral Breakthrough
NCT01479868 (12) [back to overview]Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load
NCT01479868 (12) [back to overview]Mean Change From Baseline in CD4+ Cell Count
NCT01479868 (12) [back to overview]Change From Baseline in CD4+ Cell Count in Percentage
NCT01479868 (12) [back to overview]Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)
NCT01479868 (12) [back to overview]Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)
NCT01479868 (12) [back to overview]Percentage of Participants With On-treatment Failure
NCT01479868 (12) [back to overview]Percentage of Participants With Normalized Alanine Aminotransferase Levels
NCT01479868 (12) [back to overview]Percentage of Participants With Viral Relapse
NCT01479868 (12) [back to overview]Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable
NCT01479868 (12) [back to overview]Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
NCT01479868 (12) [back to overview]Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure
NCT01482767 (6) [back to overview]Percentage of Participants With HIV-1 Viral Load <50 Copies/mL
NCT01482767 (6) [back to overview]Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits
NCT01482767 (6) [back to overview]Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)
NCT01482767 (6) [back to overview]Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)
NCT01482767 (6) [back to overview]Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)
NCT01482767 (6) [back to overview]CD4+ T-Cell Count (CD4) Change From Baseline
NCT01492426 (6) [back to overview]Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
NCT01492426 (6) [back to overview]Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4
NCT01492426 (6) [back to overview]Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
NCT01492426 (6) [back to overview]Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)
NCT01492426 (6) [back to overview]Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)
NCT01492426 (6) [back to overview]Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12
NCT01498068 (6) [back to overview]Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
NCT01498068 (6) [back to overview]Number of Participants in Each Specific Category of Treatment Outcome
NCT01498068 (6) [back to overview]Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48
NCT01498068 (6) [back to overview]Number of Participants With Rapid Virologic Response (RVR) at Week 4
NCT01498068 (6) [back to overview]Number of Participants With Extended Rapid Virologic Response (eRVR)
NCT01498068 (6) [back to overview]Number of Participants With Virologic Failure
NCT01502072 (1) [back to overview]Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)
NCT01525628 (24) [back to overview]Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
NCT01525628 (24) [back to overview]C6hr of Deleobuvir (BI 207127)
NCT01525628 (24) [back to overview]Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
NCT01525628 (24) [back to overview]AUC 0-infinity of Tolbutamide
NCT01525628 (24) [back to overview]AUC 0-infinity of Midazolam
NCT01525628 (24) [back to overview]AUC 0-infinity of Caffeine
NCT01525628 (24) [back to overview]AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)
NCT01525628 (24) [back to overview]AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168
NCT01525628 (24) [back to overview]AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
NCT01525628 (24) [back to overview]AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
NCT01525628 (24) [back to overview]Cmax of Deleobuvir (BI 207127)
NCT01525628 (24) [back to overview]C6hr of Deleobuvir Reduction Metabolite CD 6168
NCT01525628 (24) [back to overview]Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)
NCT01525628 (24) [back to overview]Cmax of Deleobuvir Reduction Metabolite CD 6168
NCT01525628 (24) [back to overview]Cmax of Caffeine
NCT01525628 (24) [back to overview]Cmax of Faldaprevir (BI 201335)
NCT01525628 (24) [back to overview]C24hr of Faldaprevir (BI 201335)
NCT01525628 (24) [back to overview]C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)
NCT01525628 (24) [back to overview]Cmax of Midazolam
NCT01525628 (24) [back to overview]Cmax of Tolbutamide
NCT01525628 (24) [back to overview]Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours
NCT01525628 (24) [back to overview]Number of Participants With Sustained Virological Response (SVR12)
NCT01525628 (24) [back to overview]C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)
NCT01525628 (24) [back to overview]AUC 0-6hr of Deleobuvir (BI 207127)
NCT01528735 (42) [back to overview]Maximum Measured Concentration (Cmax) of CD 6168
NCT01528735 (42) [back to overview]Maximum Measured Concentration (Cmax) of CD 6168-AG
NCT01528735 (42) [back to overview]Maximum Measured Concentration (Cmax) of Deleobuvir
NCT01528735 (42) [back to overview]Maximum Measured Concentration (Cmax) of Faldaprevir
NCT01528735 (42) [back to overview]Maximum Measured Concentration (Cmax) of RBV
NCT01528735 (42) [back to overview]Predose Measured Concentration of BI 208333
NCT01528735 (42) [back to overview]Predose Measured Concentration of CD 6168
NCT01528735 (42) [back to overview]Predose Measured Concentration of CD 6168-AG
NCT01528735 (42) [back to overview]AUC Accumulation Ratio of Deleobuvir
NCT01528735 (42) [back to overview]AUC Accumulation Ratio of CD 6168-AG
NCT01528735 (42) [back to overview]Predose Measured Concentration of Deleobuvir
NCT01528735 (42) [back to overview]AUC Accumulation Ratio of BI 208333
NCT01528735 (42) [back to overview]Area Under the Curve (AUC) of RBV
NCT01528735 (42) [back to overview]Area Under the Curve (AUC) of Faldaprevir
NCT01528735 (42) [back to overview]Area Under the Curve (AUC) of Deleobuvir
NCT01528735 (42) [back to overview]Area Under the Curve (AUC) of CD 6168
NCT01528735 (42) [back to overview]Area Under the Curve (AUC) of BI 208333
NCT01528735 (42) [back to overview]Predose Measured Concentration of Faldaprevir
NCT01528735 (42) [back to overview]Predose Measured Concentration of RBV
NCT01528735 (42) [back to overview]Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333
NCT01528735 (42) [back to overview]Percentage of Participants With Virological Response at Week 8
NCT01528735 (42) [back to overview]Percentage of Participants With Virological Response at Week 4
NCT01528735 (42) [back to overview]Number of Patients With Drug-related Adverse Events
NCT01528735 (42) [back to overview]Mean Residence Time (MRTpo,ss) of Deleobuvir
NCT01528735 (42) [back to overview]Cmax Accumulation Ratio (RA,Cmax,57) of RBV
NCT01528735 (42) [back to overview]AUC Accumulation Ratio of RBV
NCT01528735 (42) [back to overview]Apparent Clearance (CL/F,ss) of Faldaprevir
NCT01528735 (42) [back to overview]Apparent Clearance (CL/F,ss) of Deleobuvir
NCT01528735 (42) [back to overview]Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168
NCT01528735 (42) [back to overview]Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG
NCT01528735 (42) [back to overview]Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir
NCT01528735 (42) [back to overview]AUC Accumulation Ratio of CD 6168
NCT01528735 (42) [back to overview]Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir
NCT01528735 (42) [back to overview]Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir
NCT01528735 (42) [back to overview]AUC Accumulation Ratio of Faldaprevir
NCT01528735 (42) [back to overview]Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir
NCT01528735 (42) [back to overview]Time From Last Dosing to the Maximum Concentration (Tmax) of RBV
NCT01528735 (42) [back to overview]Area Under the Curve (AUC) of CD 6168-AG
NCT01528735 (42) [back to overview]Cmax Accumulation Ratio of BI 208333
NCT01528735 (42) [back to overview]Cmax Accumulation Ratio of CD 6168
NCT01528735 (42) [back to overview]Cmax Accumulation Ratio of CD 6168-AG
NCT01528735 (42) [back to overview]Maximum Measured Concentration (Cmax) of BI 208333
NCT01544920 (2) [back to overview]Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24
NCT01544920 (2) [back to overview]Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)
NCT01559844 (8) [back to overview]Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant
NCT01559844 (8) [back to overview]Percentage of Participants With Graft Loss Following Transplant
NCT01559844 (8) [back to overview]HCV RNA and Change From Baseline in HCV RNA Through Week 8
NCT01559844 (8) [back to overview]Number of Participants Who Died
NCT01559844 (8) [back to overview]Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48
NCT01559844 (8) [back to overview]Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
NCT01559844 (8) [back to overview]Proportion of Participants With Virologic Failure Prior to Transplant
NCT01559844 (8) [back to overview]Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48
NCT01563536 (12) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks and 24 Weeks After Combination Therapy
NCT01563536 (12) [back to overview]Percentage of Participants With Rapid Virologic Response
NCT01563536 (12) [back to overview]Percentage of Participants With Extended Rapid Virologic Response
NCT01563536 (12) [back to overview]Percentage of Participants With End-of-Treatment Response
NCT01563536 (12) [back to overview]Mean Maximal Decrease From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During ABT-267 Monotherapy
NCT01563536 (12) [back to overview]Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1
NCT01563536 (12) [back to overview]Time of Maximum Plasma Concentration (Tmax) of ABT-267 Following Monotherapy on Day 1
NCT01563536 (12) [back to overview]Mean Change in Viral Load From Baseline to Pre-dose on Day 2 and Day 3 of ABT-267 Monotherapy
NCT01563536 (12) [back to overview]Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[24]) of ABT-267 Following Monotherapy on Day 1
NCT01563536 (12) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01563536 (12) [back to overview]Resistance-Associated Variants and Phenotypic Resistance
NCT01563536 (12) [back to overview]Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3
NCT01565889 (8) [back to overview]Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
NCT01565889 (8) [back to overview]Part B: On-treatment HIV RNA
NCT01565889 (8) [back to overview]Part B: On-treatment HCV RNA
NCT01565889 (8) [back to overview]Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
NCT01565889 (8) [back to overview]Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
NCT01565889 (8) [back to overview]Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01565889 (8) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
NCT01565889 (8) [back to overview]Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01585324 (7) [back to overview]Number of Participants With Neutropenia Among Participants With or Without SVR
NCT01585324 (7) [back to overview]Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment
NCT01585324 (7) [back to overview]Number of Participants With Thrombocytopenia Among Participants With or Without SVR
NCT01585324 (7) [back to overview]Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR
NCT01585324 (7) [back to overview]Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR
NCT01585324 (7) [back to overview]Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
NCT01585324 (7) [back to overview]Number of Participants With Decrease in Hemoglobin
NCT01591460 (17) [back to overview]HCV RNA Levels
NCT01591460 (17) [back to overview]Percentage of Participants With Virological Response
NCT01591460 (17) [back to overview]Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA
NCT01591460 (17) [back to overview]Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA
NCT01591460 (17) [back to overview]Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason
NCT01591460 (17) [back to overview]Percentage of Participants With a Concomitant Disease Prior to or During the Study
NCT01591460 (17) [back to overview]Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up
NCT01591460 (17) [back to overview]Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir
NCT01591460 (17) [back to overview]Duration of Treatment With PEG-IFN, RBV, and Boceprevir
NCT01591460 (17) [back to overview]Time to Safety-Related Dose Modification
NCT01591460 (17) [back to overview]Percentage of Participants With Virological Relapse Following EOT Response
NCT01591460 (17) [back to overview]Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA
NCT01591460 (17) [back to overview]Percentage of Participants With Virological Breakthrough Following On-Treatment Response
NCT01591460 (17) [back to overview]Percentage of Participants With SVR at 24 Weeks After EOT
NCT01591460 (17) [back to overview]Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)
NCT01591460 (17) [back to overview]Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up
NCT01591460 (17) [back to overview]Number of Participants With a Safety-Related Dose Modification
NCT01592006 (2) [back to overview]The Efficacy of Triple Antiviral Therapy
NCT01592006 (2) [back to overview]Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients
NCT01598090 (11) [back to overview]Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
NCT01598090 (11) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
NCT01598090 (11) [back to overview]Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
NCT01598090 (11) [back to overview]Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
NCT01598090 (11) [back to overview]Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
NCT01598090 (11) [back to overview]Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
NCT01598090 (11) [back to overview]Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
NCT01598090 (11) [back to overview]Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
NCT01598090 (11) [back to overview]Percentage of Participants With Rash
NCT01598090 (11) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
NCT01598090 (11) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
NCT01606800 (1) [back to overview]Number of Participants Achieving Sustained Virologic Response (SVR)
NCT01609933 (4) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
NCT01609933 (4) [back to overview]Number of Participants With Adverse Events
NCT01609933 (4) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR)
NCT01609933 (4) [back to overview]Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24)
NCT01628692 (7) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR)
NCT01628692 (7) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR)
NCT01628692 (7) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
NCT01628692 (7) [back to overview]Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)
NCT01628692 (7) [back to overview]Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died
NCT01628692 (7) [back to overview]Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories
NCT01628692 (7) [back to overview]Percentage of Participants With End of Treatment Response (EOTR)
NCT01641640 (6) [back to overview]Percentage of Participants With Viral Breakthrough
NCT01641640 (6) [back to overview]Percentage of Participants With Viral Relapse
NCT01641640 (6) [back to overview]Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
NCT01641640 (6) [back to overview]Percentage of Participants Achieving Sustained Virologic Response (SVR)12
NCT01641640 (6) [back to overview]Percentage of Participants Achieving SVR24
NCT01641640 (6) [back to overview]Percentage of Participants Achieving SVR4
NCT01648140 (35) [back to overview]Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4
NCT01648140 (35) [back to overview]Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4
NCT01648140 (35) [back to overview]Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Apparent Clearance (CL/F) at Week 4
NCT01648140 (35) [back to overview]Apparent Volume of Distribution (Vz/F) at Week 4
NCT01648140 (35) [back to overview]Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4
NCT01648140 (35) [back to overview]Number of Participants Achieving eRVR
NCT01648140 (35) [back to overview]Number of Participants With Any AEs and Any SAEs After Week 12
NCT01648140 (35) [back to overview]Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12
NCT01648140 (35) [back to overview]Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)
NCT01648140 (35) [back to overview]Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
NCT01648140 (35) [back to overview]Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12
NCT01659567 (14) [back to overview]OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR
NCT01659567 (14) [back to overview]OR for Impact of Baseline Level of Fibrosis (kPa) on SVR
NCT01659567 (14) [back to overview]OR for Impact of Baseline Viral Load Count on SVR
NCT01659567 (14) [back to overview]Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR
NCT01659567 (14) [back to overview]Odds Ratio (OR) for Impact of Age on SVR
NCT01659567 (14) [back to overview]PPV of Complete Early Viral Response (cEVR) on SVR
NCT01659567 (14) [back to overview]Percentage of Participants Achieving Sustained Virological Response (SVR)
NCT01659567 (14) [back to overview]OR for Impact of Overall Duration of Treatment on SVR
NCT01659567 (14) [back to overview]OR for Impact of Gender on SVR
NCT01659567 (14) [back to overview]OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR
NCT01659567 (14) [back to overview]OR for Impact of Body Weight on SVR
NCT01659567 (14) [back to overview]OR for Impact of Duration of Treatment After Achieving RVR on SVR
NCT01659567 (14) [back to overview]OR for Impact of Duration of Treatment After Achieving cEVR on SVR
NCT01659567 (14) [back to overview]OR for Impact of Cumulative Doses of Ribavirin on SVR
NCT01674725 (5) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT01674725 (5) [back to overview]Percentage of Participants With Virologic Relapse After Treatment
NCT01674725 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses
NCT01674725 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses
NCT01674725 (5) [back to overview]Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
NCT01678131 (1) [back to overview]Number of Participants From Whom Detectable Concentrations of Hepatic Vaniprevir Are Obtained by FNA
NCT01685203 (5) [back to overview]Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment
NCT01685203 (5) [back to overview]Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment
NCT01685203 (5) [back to overview]Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events
NCT01685203 (5) [back to overview]Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.
NCT01685203 (5) [back to overview]Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.
NCT01687270 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01687270 (6) [back to overview]HCV RNA and Change From Baseline at Weeks 2, 4, and 8
NCT01687270 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24
NCT01687270 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
NCT01687270 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT01687270 (6) [back to overview]Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
NCT01700179 (1) [back to overview]Sustained Virologic Response At 12 Weeks (SVR12)
NCT01701063 (11) [back to overview]Maximum Plasma Concentration (Cmax) of Telaprevir
NCT01701063 (11) [back to overview]Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
NCT01701063 (11) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01701063 (11) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir
NCT01701063 (11) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir
NCT01701063 (11) [back to overview]Percentage of Participants With Extended Rapid Virologic Response (eRVR)
NCT01701063 (11) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT01701063 (11) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR)
NCT01701063 (11) [back to overview]Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
NCT01701063 (11) [back to overview]Percentage of Participants With Undetectable HCV RNA at Week 12
NCT01701063 (11) [back to overview]Percentage of Participants With Virologic Relapse
NCT01704521 (1) [back to overview]Number of Participants With Sustained Virological Response at Week 12 (SVR12)
NCT01704755 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm
NCT01704755 (4) [back to overview]Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period
NCT01704755 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment
NCT01704755 (4) [back to overview]Percentage of Participants With Virologic Relapse After Treatment
NCT01710501 (8) [back to overview]Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days
NCT01710501 (8) [back to overview]Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days
NCT01710501 (8) [back to overview]Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response
NCT01710501 (8) [back to overview]Percentage of Participants Achieving SVR4
NCT01710501 (8) [back to overview]Percentage of Subjects Achieving SVR24
NCT01710501 (8) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point
NCT01710501 (8) [back to overview]Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point
NCT01710501 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)
NCT01715415 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
NCT01715415 (6) [back to overview]Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
NCT01715415 (6) [back to overview]Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
NCT01715415 (6) [back to overview]Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
NCT01715415 (6) [back to overview]Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
NCT01715415 (6) [back to overview]Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
NCT01716156 (8) [back to overview]Percentage of Participants With Undetectable HCV RNA by Time Point
NCT01716156 (8) [back to overview]Percentage of Participants With HCV RNA <25 IU/mL by Time Point
NCT01716156 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
NCT01716156 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)
NCT01716156 (8) [back to overview]Percentage of Participants Discontinuing Study Therapy Due to an AE
NCT01716156 (8) [back to overview]Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study
NCT01716156 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)
NCT01716156 (8) [back to overview]Time to Achievement of First Undetectable HCV RNA
NCT01716585 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
NCT01716585 (6) [back to overview]Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
NCT01716585 (6) [back to overview]Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
NCT01716585 (6) [back to overview]Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
NCT01716585 (6) [back to overview]Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
NCT01716585 (6) [back to overview]Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
NCT01717326 (12) [back to overview]Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2
NCT01717326 (12) [back to overview]Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days
NCT01717326 (12) [back to overview]Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days
NCT01717326 (12) [back to overview]Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)
NCT01717326 (12) [back to overview]Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12
NCT01717326 (12) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA at Week 2
NCT01717326 (12) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA at Week 12
NCT01717326 (12) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)
NCT01717326 (12) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)
NCT01717326 (12) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
NCT01717326 (12) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA at Week 4
NCT01717326 (12) [back to overview]Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4
NCT01725529 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)
NCT01725529 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24)
NCT01725529 (7) [back to overview]Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72)
NCT01725529 (7) [back to overview]Percentage of Participants With Viral Breakthrough
NCT01725529 (7) [back to overview]Percentage of Participants With On-treatment Normalization of Alanine Aminotransferase Level
NCT01725529 (7) [back to overview]Percentage of Participants With On-treatment Failure
NCT01725529 (7) [back to overview]Percentage of Participants With Viral Relapse
NCT01728324 (5) [back to overview]SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
NCT01728324 (5) [back to overview]Prognostic Value of SVR12 Predicting SVR24
NCT01728324 (5) [back to overview]SVR12 Rates With Historical Control
NCT01728324 (5) [back to overview]SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
NCT01728324 (5) [back to overview]Comparisons of SVR12 Rates Across Treatment Arms
NCT01732796 (4) [back to overview]SVR4
NCT01732796 (4) [back to overview]SVR24
NCT01732796 (4) [back to overview]SVR12 Rates With Historical Control
NCT01732796 (4) [back to overview]Comparisons of SVR12 Rates Across Treatment Arms
NCT01740089 (5) [back to overview]Immunogenicity
NCT01740089 (5) [back to overview]Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.
NCT01740089 (5) [back to overview]Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.
NCT01740089 (5) [back to overview]Number of Randomized Patients Achieving Rapid Virologic Response (RVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.
NCT01740089 (5) [back to overview]Number of Randomized Patients Achieving Sustained Virologic Response (SVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.
NCT01741545 (9) [back to overview]Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)
NCT01741545 (9) [back to overview]Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment
NCT01741545 (9) [back to overview]Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
NCT01741545 (9) [back to overview]Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
NCT01741545 (9) [back to overview]Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment
NCT01741545 (9) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR)
NCT01741545 (9) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR)
NCT01741545 (9) [back to overview]Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12
NCT01741545 (9) [back to overview]Percentage of Participants With End of the Treatment Response (EOTR)
NCT01743521 (10) [back to overview]Undetectable HCV RNA (Week 1)
NCT01743521 (10) [back to overview]Undetectable HCV RNA (Week 3)
NCT01743521 (10) [back to overview]Undetectable HCV RNA (Week 4)
NCT01743521 (10) [back to overview]Decrease in Absolute Neutrophil Count (ANC) ≤0.75
NCT01743521 (10) [back to overview]Change in Hemoglobin at End of Treatment
NCT01743521 (10) [back to overview]Decrease in Platelets <50
NCT01743521 (10) [back to overview]SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)
NCT01743521 (10) [back to overview]SVR24
NCT01743521 (10) [back to overview]Undectectable HCV RNA (Week 2)
NCT01743521 (10) [back to overview]Undetectable HCV RNA (ETR)
NCT01756079 (3) [back to overview]Percentage of Participants With One or More Adverse Events
NCT01756079 (3) [back to overview]Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)
NCT01756079 (3) [back to overview]Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication
NCT01767116 (6) [back to overview]Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
NCT01767116 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate
NCT01767116 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV
NCT01767116 (6) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT01767116 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate
NCT01767116 (6) [back to overview]Percentage of Participants With Virologic Relapse After Treatment
NCT01770483 (2) [back to overview]Normalization of Alanine Transferase Test
NCT01770483 (2) [back to overview]Sustained Viral Response,
NCT01782495 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT01782495 (4) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT01782495 (4) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT01782495 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
NCT01830127 (2) [back to overview]SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
NCT01830127 (2) [back to overview]SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
NCT01833533 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses
NCT01833533 (5) [back to overview]Percentage of Participants With Virologic Relapse After Treatment
NCT01833533 (5) [back to overview]Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
NCT01833533 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses
NCT01833533 (5) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT01833845 (1) [back to overview]Safety: Number of Participants With Adverse Events
NCT01849562 (2) [back to overview]Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants
NCT01849562 (2) [back to overview]Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment
NCT01853254 (1) [back to overview]Percentage of Participants With at Least 1 Adverse Event
NCT01854528 (6) [back to overview]Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)
NCT01854528 (6) [back to overview]Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)
NCT01854528 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment
NCT01854528 (6) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT01854528 (6) [back to overview]Percentage of Participants With Virologic Relapse After Treatment
NCT01854528 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
NCT01854697 (7) [back to overview]Percentage of Participants With SVR12 - Secondary Efficacy Analyses
NCT01854697 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
NCT01854697 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses
NCT01854697 (7) [back to overview]Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)
NCT01854697 (7) [back to overview]Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)
NCT01854697 (7) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT01854697 (7) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT01858766 (4) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01858766 (4) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT01858766 (4) [back to overview]Percentage of Participants With Virologic Failure
NCT01858766 (4) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01866930 (12) [back to overview]Mean Change in Platelet Count From Baseline to End of Treatment
NCT01866930 (12) [back to overview]Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms
NCT01866930 (12) [back to overview]Number of Participants Who Died or Experienced Severe Adverse Events (SAEs), Dose Reductions of Lambda or Discontinuation Due to Adverse Events (AEs)
NCT01866930 (12) [back to overview]Number of Participants With Treatment Emergent Cytopenic Abnormalities
NCT01866930 (12) [back to overview]Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
NCT01866930 (12) [back to overview]Mean Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment
NCT01866930 (12) [back to overview]Mean Percent Change in Total Lymphocyte Count From Baseline to End of Treatment
NCT01866930 (12) [back to overview]Number of Participants With Treatment-emergent Grade 3/4 Lab Abnormalities
NCT01866930 (12) [back to overview]Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR)
NCT01866930 (12) [back to overview]Mean Percent Change in Platelet Count From Baseline to End of Treatment
NCT01866930 (12) [back to overview]Mean Percent Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment
NCT01866930 (12) [back to overview]Mean Change in Total Lymphocyte Count From Baseline to End of Treatment
NCT01909804 (4) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01909804 (4) [back to overview]Percentage of Participants With Virologic Failure
NCT01909804 (4) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01909804 (4) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT01911845 (7) [back to overview]Percentage of Participants With Virologic Relapse Post-treatment
NCT01911845 (7) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT01911845 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment
NCT01911845 (7) [back to overview]Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin
NCT01911845 (7) [back to overview]Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin
NCT01911845 (7) [back to overview]Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin
NCT01911845 (7) [back to overview]Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin
NCT01925183 (2) [back to overview]Proportion of Subjects With Sustained Virologic Response (SVR12)
NCT01925183 (2) [back to overview]Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01932762 (7) [back to overview]Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days
NCT01932762 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)
NCT01932762 (7) [back to overview]Percentage of Participants Achieving SVR4
NCT01932762 (7) [back to overview]Percentage of Participants Achieving SVR24
NCT01932762 (7) [back to overview]Mean Time to First Achievement of Undetectable HCV RNA During Treatment
NCT01932762 (7) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint
NCT01932762 (7) [back to overview]Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint
NCT01938625 (8) [back to overview]Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable
NCT01938625 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks After the End of Treatment (SVR 24)
NCT01938625 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After the End of Treatment (SVR 12)
NCT01938625 (8) [back to overview]Percentage of Participants With HCV RNA (<) 100 IU/mL at Week 4
NCT01938625 (8) [back to overview]Number of Participants With Viral Relapse
NCT01938625 (8) [back to overview]Number of Participants With Viral Breakthrough
NCT01938625 (8) [back to overview]Number of Participants With On-Treatment Failure
NCT01938625 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks After the End of Treatment (SVR 4)
NCT01939197 (14) [back to overview]Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period
NCT01939197 (14) [back to overview]Percentage of Participants in Part 2 With Relapse12
NCT01939197 (14) [back to overview]Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall
NCT01939197 (14) [back to overview]Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
NCT01939197 (14) [back to overview]Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
NCT01939197 (14) [back to overview]Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
NCT01939197 (14) [back to overview]Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12
NCT01939197 (14) [back to overview]Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
NCT01939197 (14) [back to overview]Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period
NCT01939197 (14) [back to overview]Percentage of Participants in Part 1a With Relapse12
NCT01939197 (14) [back to overview]Percentage of Participants in Part 1b Achieving SVR12
NCT01939197 (14) [back to overview]Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period
NCT01939197 (14) [back to overview]Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall
NCT01939197 (14) [back to overview]Percentage of Participants in Part 1a Achieving SVR12
NCT01945294 (8) [back to overview]Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]
NCT01945294 (8) [back to overview]Percentage of Participants With Anemia
NCT01945294 (8) [back to overview]Percentage of Participants With Neutropenia
NCT01945294 (8) [back to overview]Percentage of Participants With Relapse
NCT01945294 (8) [back to overview]Percentage of Participants With Treatment-Related Serious AEs (SAEs)
NCT01945294 (8) [back to overview]Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment
NCT01945294 (8) [back to overview]Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)
NCT01945294 (8) [back to overview]Percentage of Participants With Undetectable HCV RNA Across Treatment
NCT01984294 (5) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT01984294 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01984294 (5) [back to overview]Percentage of Participants Experiencing On-treatment Virologic Failure
NCT01984294 (5) [back to overview]Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)
NCT01984294 (5) [back to overview]Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event
NCT01995071 (4) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT01995071 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT01995071 (4) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT01995071 (4) [back to overview]Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment
NCT02021643 (8) [back to overview]Change From Baseline in HCV RNA (log10 IU/mL)
NCT02021643 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02021643 (8) [back to overview]Change From Baseline in HCV RNA (log10 IU/mL)
NCT02021643 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02021643 (8) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02021643 (8) [back to overview]Percentage of Participants With On-Treatment Virologic Failure
NCT02021643 (8) [back to overview]Percentage of Participants With Viral Relapse
NCT02021643 (8) [back to overview]Change From Baseline in HCV RNA (log10 IU/mL)
NCT02023112 (6) [back to overview]Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations
NCT02023112 (6) [back to overview]Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations
NCT02023112 (6) [back to overview]Percentage of Participants With Post-treatment Relapse Within Different Subpopulations
NCT02023112 (6) [back to overview]Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02023112 (6) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT02023112 (6) [back to overview]Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period
NCT02032875 (8) [back to overview]Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment
NCT02032875 (8) [back to overview]Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
NCT02032875 (8) [back to overview]Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)
NCT02032875 (8) [back to overview]Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death
NCT02032875 (8) [back to overview]Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
NCT02032875 (8) [back to overview]Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24
NCT02032875 (8) [back to overview]Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6
NCT02032875 (8) [back to overview]Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)
NCT02068222 (4) [back to overview]The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
NCT02068222 (4) [back to overview]The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
NCT02068222 (4) [back to overview]The Percentage of Subjects With Post-Treatment Relapse
NCT02068222 (4) [back to overview]The Percentage of Subjects With Virologic Failure During Treatment
NCT02094443 (7) [back to overview]Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
NCT02094443 (7) [back to overview]Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
NCT02094443 (7) [back to overview]Change From Baseline in Alanine Aminotransferase (ALT) at Week 12
NCT02094443 (7) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR)
NCT02094443 (7) [back to overview]Percentage of Participants With End of Treatment Response (ETR)
NCT02094443 (7) [back to overview]Percentage of Participants With Extended Rapid Virologic Response
NCT02094443 (7) [back to overview]Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment
NCT02105454 (4) [back to overview]Percentage of Participants Discontinuing Study Drug Due to an Adverse Event
NCT02105454 (4) [back to overview]Percentage of Participants Experiencing Adverse Events
NCT02105454 (4) [back to overview]Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) Therapy
NCT02105454 (4) [back to overview]Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12)
NCT02105701 (4) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA 12 Weeks After Completing Study Therapy (SVR12)
NCT02105701 (4) [back to overview]Number of Participants Discontinuing Study Treatment Due to an AE
NCT02105701 (4) [back to overview]Percentage of Participants Achieving Undetectable HCV RNA 24 Weeks After the End of All Treatment (SVR24)
NCT02105701 (4) [back to overview]Number of Participants Experiencing Adverse Events (AE)
NCT02106156 (9) [back to overview]Percentage of Participants With End of Treatment (EOT) Response
NCT02106156 (9) [back to overview]Percentage of Participants With Serious Adverse Drug Reactions (SADR)
NCT02106156 (9) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR)
NCT02106156 (9) [back to overview]Percentage of Participants With the Most Frequent Concomitant Medications
NCT02106156 (9) [back to overview]Percentage of Participants With Early Virologic Response (EVR)
NCT02106156 (9) [back to overview]Percentage Cumulative Dose of Ribavirin Received
NCT02106156 (9) [back to overview]Percentage Cumulative Dose of Peginterferon Alfa-2a Received
NCT02106156 (9) [back to overview]Duration of Peginterferon Alfa-2a Therapy
NCT02106156 (9) [back to overview]Percentage of Participants With Rapid Virologic Response (RVR)
NCT02118012 (4) [back to overview]Change in Alanine Aminotransferase (ALT) Levels From Baseline to 28 Days
NCT02118012 (4) [back to overview]Change in Serum HCV RNA Viral Titer From Baseline to 28 Days
NCT02118012 (4) [back to overview]Maximum Chlorcyclizine HCL Weeks 1-4
NCT02118012 (4) [back to overview]Number of Participants Who Tolerated the Drug at the Prescribed Dose for the Duration of Therapy
NCT02118597 (7) [back to overview]Number of Participants With Virological Breakthrough
NCT02118597 (7) [back to overview]Number of Participants With Virological Relapse
NCT02118597 (7) [back to overview]Number of Participants With Adverse Events
NCT02118597 (7) [back to overview]Sustained Virological Response 24 (SVR24) Rate
NCT02118597 (7) [back to overview]Percentage of Participants With Virological Response
NCT02118597 (7) [back to overview]Number of Participants With Treatment Discontinuation Due to Futility
NCT02118597 (7) [back to overview]Number of Participants With Treatment Discontinuation
NCT02128217 (19) [back to overview]Concentration of Tenofovir (TFV) in Plasma
NCT02128217 (19) [back to overview]Concentration of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs)
NCT02128217 (19) [back to overview]Count and Percentage of Participants With an Adverse Event by Type.
NCT02128217 (19) [back to overview]Percentage of Participants With HCV RNA Undetectable After End of Study Treatment
NCT02128217 (19) [back to overview]Percentage of Participants With HCV RNA Undetectable During Study Treatment
NCT02128217 (19) [back to overview]Ribavirin Concentration in Plasma
NCT02128217 (19) [back to overview]Self-reported Adherence to LDV/SOF
NCT02128217 (19) [back to overview]Self-reported Adherence to RBV
NCT02128217 (19) [back to overview]Count of Participants With HIV-1 RNA <50 Copies/mL
NCT02128217 (19) [back to overview]Adherence as Measured by SOF Pill Count
NCT02128217 (19) [back to overview]Adherence as Measured by RBV Pill Count
NCT02128217 (19) [back to overview]Change in CD4+ Cell Count
NCT02128217 (19) [back to overview]Number of Participants Who Had HCV Virologic Relapse
NCT02128217 (19) [back to overview]Percentage of HCV Virologic Failure Participants That Developed SOF- or LDV-Associated Resistance Mutations
NCT02128217 (19) [back to overview]Self-reported Adherence to SOF
NCT02128217 (19) [back to overview]Cellular Concentration of Tenofovir Diphosphate (TFV-DP)
NCT02128217 (19) [back to overview]Percentage of Participants With an Occurrence of a Grade ≥ 2 Adverse Event, Serious AE According to ICH Criteria, or Treatment-limiting AE.
NCT02128217 (19) [back to overview]Percentage of Participants With Sustained Virologic Response 12 (SVR12)
NCT02128217 (19) [back to overview]Adherence as Measured by LDV/SOF Pill Count
NCT02167945 (11) [back to overview]Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
NCT02167945 (11) [back to overview]Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Post-Treatment Week 12 and Post-Treatment Week 24
NCT02167945 (11) [back to overview]Treatment Compliance: Percentage of Tablets Taken Relative to the Total Tablets
NCT02167945 (11) [back to overview]Hepatocellular Carcinoma: Time to Event
NCT02167945 (11) [back to overview]All-Cause Death: Time to Event
NCT02167945 (11) [back to overview]All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
NCT02167945 (11) [back to overview]Liver-Related Death: Time to Event
NCT02167945 (11) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02167945 (11) [back to overview]Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
NCT02167945 (11) [back to overview]Liver Transplantation: Time to Event
NCT02167945 (11) [back to overview]Liver Decompensation: Time to Event
NCT02168361 (2) [back to overview]Serum HCV RNA Level
NCT02168361 (2) [back to overview]Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
NCT02175758 (25) [back to overview]For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
NCT02175758 (25) [back to overview]For the Treatment Phase, Change From Baseline in Height
NCT02175758 (25) [back to overview]For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
NCT02175758 (25) [back to overview]For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF)
NCT02175758 (25) [back to overview]For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
NCT02175758 (25) [back to overview]For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
NCT02175758 (25) [back to overview]For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02175758 (25) [back to overview]For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02175758 (25) [back to overview]For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02175758 (25) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
NCT02175758 (25) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
NCT02175758 (25) [back to overview]For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
NCT02175758 (25) [back to overview]For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
NCT02175758 (25) [back to overview]For the Treatment Phase, Change From Baseline in HCV RNA
NCT02175758 (25) [back to overview]For the Treatment Phase, Change From Baseline in HCV RNA
NCT02175758 (25) [back to overview]For the Treatment Phase, Change From Baseline in Height
NCT02175758 (25) [back to overview]For the Treatment Phase, Change From Baseline in Weight
NCT02175758 (25) [back to overview]For the Treatment Phase, Change From Baseline in Weight
NCT02175758 (25) [back to overview]For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules
NCT02175758 (25) [back to overview]For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
NCT02175758 (25) [back to overview]For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
NCT02175758 (25) [back to overview]For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
NCT02175758 (25) [back to overview]For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
NCT02175758 (25) [back to overview]For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
NCT02175758 (25) [back to overview]For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
NCT02175966 (8) [back to overview]Percentage of Participants With End of Treatment Response (EOTR)
NCT02175966 (8) [back to overview]Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
NCT02175966 (8) [back to overview]Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)
NCT02175966 (8) [back to overview]Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b
NCT02175966 (8) [back to overview]Percentage of Participants Who Achieved HCV RNA
NCT02175966 (8) [back to overview]Percentage of Participants Who Achieved HCV RNA < LLOQ TND
NCT02175966 (8) [back to overview]Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
NCT02175966 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 12 (SVR12)
NCT02194998 (13) [back to overview]Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)
NCT02194998 (13) [back to overview]Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)
NCT02194998 (13) [back to overview]Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher
NCT02194998 (13) [back to overview]Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria
NCT02194998 (13) [back to overview]Levels of Soluble CD14 (sCD14)
NCT02194998 (13) [back to overview]Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.
NCT02194998 (13) [back to overview]Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.
NCT02194998 (13) [back to overview]Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)
NCT02194998 (13) [back to overview]Number of Participants Who Experienced HIV-1 Virologic Failure (VF)
NCT02194998 (13) [back to overview]Levels of IP-10 Concentration.
NCT02194998 (13) [back to overview]Change in Soluble CD14 (sCD14)
NCT02194998 (13) [back to overview]Change in IP-10 Concentration.
NCT02194998 (13) [back to overview]Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)
NCT02207088 (3) [back to overview]Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
NCT02207088 (3) [back to overview]Percentage of Participants With Post-Treatment Relapse
NCT02207088 (3) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02214420 (1) [back to overview]Sustained Viral Response
NCT02216422 (3) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
NCT02216422 (3) [back to overview]Percentage of Participants With On-Treatment Virologic Failure
NCT02216422 (3) [back to overview]Percentage of Participants With Post-Treatment Relapse
NCT02219477 (9) [back to overview]Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12
NCT02219477 (9) [back to overview]Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2
NCT02219477 (9) [back to overview]Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests
NCT02219477 (9) [back to overview]Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest
NCT02219477 (9) [back to overview]Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score
NCT02219477 (9) [back to overview]Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score
NCT02219477 (9) [back to overview]Percentage of Participants With SVR12 in Group 3
NCT02219477 (9) [back to overview]Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure
NCT02219477 (9) [back to overview]Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests
NCT02219490 (8) [back to overview]Liver-Related Death: Time to Event
NCT02219490 (8) [back to overview]Liver Transplantation: Time to Event
NCT02219490 (8) [back to overview]Liver Decompensation: Time to Event
NCT02219490 (8) [back to overview]Hepatocellular Carcinoma: Time to Event
NCT02219490 (8) [back to overview]Change From Baseline in FibroScan Score by SVR12 Status
NCT02219490 (8) [back to overview]All-Cause Death: Time to Event
NCT02219490 (8) [back to overview]All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
NCT02219490 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02243293 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)
NCT02243293 (5) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02243293 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02243293 (5) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT02243293 (5) [back to overview]Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control
NCT02247440 (7) [back to overview]Number of Participants Grouped by HIV-1 RNA Concentrations
NCT02247440 (7) [back to overview]Number of Participants Completed the First 24 and 48 Weeks of Treatment
NCT02247440 (7) [back to overview]Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)
NCT02247440 (7) [back to overview]Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation
NCT02247440 (7) [back to overview]Number of Adverse Events by Severity Grade
NCT02247440 (7) [back to overview]Number of Participants Able to Perform Self-injections of Peg-interferon
NCT02247440 (7) [back to overview]Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
NCT02249182 (26) [back to overview]Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
NCT02249182 (26) [back to overview]For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
NCT02249182 (26) [back to overview]For the Treatment Phase, Change From Baseline in Weight
NCT02249182 (26) [back to overview]For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF
NCT02249182 (26) [back to overview]For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
NCT02249182 (26) [back to overview]Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
NCT02249182 (26) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
NCT02249182 (26) [back to overview]For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
NCT02249182 (26) [back to overview]For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
NCT02249182 (26) [back to overview]For the Treatment Phase, Change From Baseline in HCV RNA
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02249182 (26) [back to overview]For the Treatment Phase, Change From Baseline in HCV RNA
NCT02249182 (26) [back to overview]For the Treatment Phase, Change From Baseline in Height
NCT02249182 (26) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
NCT02249182 (26) [back to overview]For the Treatment Phase, Change From Baseline in Height
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
NCT02249182 (26) [back to overview]For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
NCT02249182 (26) [back to overview]For the Treatment Phase, Change From Baseline in Weight
NCT02265237 (5) [back to overview]Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02265237 (5) [back to overview]Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)
NCT02265237 (5) [back to overview]Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)
NCT02265237 (5) [back to overview]Percentage of Participants in Arms A, B and C With Post-treatment Relapse
NCT02265237 (5) [back to overview]Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure
NCT02292706 (6) [back to overview]Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
NCT02292706 (6) [back to overview]Number of Participants With Detectable HCV Resistance Mutations Through Week 240
NCT02292706 (6) [back to overview]Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240
NCT02292706 (6) [back to overview]Percentage of Participants With Any Liver-Associated Events
NCT02292706 (6) [back to overview]Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240
NCT02292706 (6) [back to overview]Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240
NCT02292719 (3) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02292719 (3) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT02292719 (3) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02304159 (3) [back to overview]Number of Participants With Abnormal Safety Laboratory Tests (ALT and/or Total Bilirubin) That Required Discontinuing Study Drugs
NCT02304159 (3) [back to overview]Number of Participants With Adverse Events
NCT02304159 (3) [back to overview]Number of Participants With Undetectable HCV Virus 12 Weeks After Stopping Study Drugs
NCT02308241 (1) [back to overview]Number of Participants Evaluated for Toxicity
NCT02319031 (3) [back to overview]Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
NCT02319031 (3) [back to overview]Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities
NCT02319031 (3) [back to overview]Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)
NCT02332707 (4) [back to overview]Percentage of Participants Experiencing an Adverse Event (AE)
NCT02332707 (4) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)
NCT02332707 (4) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)
NCT02332707 (4) [back to overview]Percentage of Participants Discontinuing From Study Treatment Due to an AE
NCT02332720 (4) [back to overview]Percentage of HCV GT3-infected Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12)
NCT02332720 (4) [back to overview]Percentage of GT3-infected Participants Achieving SVR at Follow-up Week 24 (SVR24)
NCT02332720 (4) [back to overview]Number of Participants Who Had Study Drug Discontinued Due to an AE
NCT02332720 (4) [back to overview]Number of Participants Experiencing an Adverse Event (AE)
NCT02340962 (8) [back to overview]Mean Absolute Values in HCV RNA (log10 IU/mL)
NCT02340962 (8) [back to overview]Proportion of Subjects Achieving Sustained Viral Response at 4, 8, and 24 Weeks After the End of Treatment (SVR4, SVR8, and SVR24)
NCT02340962 (8) [back to overview]Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)
NCT02340962 (8) [back to overview]Proportion of Subjects Achieving HCV RNA < LLOQ, TND
NCT02340962 (8) [back to overview]Change From Baseline in HCV RNA (log10 IU/mL)
NCT02340962 (8) [back to overview]Proportion of Subjects Achieving Sustained Viral Response at 12 Weeks After the End of Treatment.
NCT02340962 (8) [back to overview]Proportion of Subjects With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at Final Treatment Visit.
NCT02340962 (8) [back to overview]Proportion of Subjects Experiencing Virologic Failure During Treatment and Viral Relapse After the End of Treatment.
NCT02356562 (4) [back to overview]Percentage of Participants With Post-Treatment Relapse
NCT02356562 (4) [back to overview]Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment
NCT02356562 (4) [back to overview]Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
NCT02356562 (4) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02358044 (6) [back to overview]Percentage of Participants Discontinuing Study Treatment Due to an AE
NCT02358044 (6) [back to overview]Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days
NCT02358044 (6) [back to overview]Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12)
NCT02358044 (6) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)
NCT02358044 (6) [back to overview]Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days
NCT02358044 (6) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)
NCT02399345 (3) [back to overview]Percentage of Subjects With On-treatment Virologic Failure
NCT02399345 (3) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
NCT02399345 (3) [back to overview]Percentage of Subjects With Post-treatment Relapse
NCT02442271 (7) [back to overview]Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
NCT02442271 (7) [back to overview](SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
NCT02442271 (7) [back to overview]Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience
NCT02442271 (7) [back to overview]Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening
NCT02442271 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02442271 (7) [back to overview]Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
NCT02442271 (7) [back to overview]Percentage of Participants With SVR12 by Fibrosis Stage
NCT02442284 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders
NCT02442284 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02442284 (4) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT02442284 (4) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT02446717 (4) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02446717 (4) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT02446717 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02446717 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)
NCT02455167 (3) [back to overview]Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: Baseline
NCT02455167 (3) [back to overview]Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: 12 Weeks
NCT02455167 (3) [back to overview]The Sustained Virologic Response (SVR) in Patients Infected With HCV Genotype 1, Cirrhosis, and Early Clinical Decompensation
NCT02461745 (2) [back to overview]Sustained Virological Response (SVR) at Week 4
NCT02461745 (2) [back to overview]Sustained Virological Response (SVR) at Week 12
NCT02476617 (1) [back to overview]Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
NCT02486406 (16) [back to overview]Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV)
NCT02486406 (16) [back to overview]Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV)
NCT02486406 (16) [back to overview]Part 1: Maximum Plasma Concentration (Cmax) of Ritonavir (RTV)
NCT02486406 (16) [back to overview]Parts 1 & 2: Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Actual Dose of Study Drug (SVR24), Summarized by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations
NCT02486406 (16) [back to overview]Parts 1 and 2: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization During Treatment by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations
NCT02486406 (16) [back to overview]Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12)
NCT02486406 (16) [back to overview]Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) Summarized by Formulation, Age and Weight Group, and Across All Subjects on the Adult Formulations
NCT02486406 (16) [back to overview]Part 1: Lowest Plasma Concentration (Ctrough) of Dasabuvir (DSV)
NCT02486406 (16) [back to overview]Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV)
NCT02486406 (16) [back to overview]Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV)
NCT02486406 (16) [back to overview]Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV)
NCT02486406 (16) [back to overview]Part 1: Lowest Plasma Concentration (Ctrough) of Ritonavir (RTV)
NCT02486406 (16) [back to overview]Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV)
NCT02486406 (16) [back to overview]Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV)
NCT02486406 (16) [back to overview]Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV)
NCT02486406 (16) [back to overview]Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ritonavir (RTV)
NCT02493855 (1) [back to overview]Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment
NCT02515279 (3) [back to overview]Percentage of Participants With End of Treatment Response
NCT02515279 (3) [back to overview]Percentage of Participants With Sustained Virologic Response 24 (SVR24)
NCT02515279 (3) [back to overview]Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
NCT02517528 (5) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
NCT02517528 (5) [back to overview]Percentage of Participants With Virologic Relapse by Post-Treatment Week 24
NCT02517528 (5) [back to overview]Percentage of Participants With On Treatment Virologic Failure
NCT02517528 (5) [back to overview]Percentage of Participants With Virologic Relapse
NCT02517528 (5) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
NCT02541409 (4) [back to overview]Sustained Virologic Response (SVR)
NCT02541409 (4) [back to overview]Serious Adverse Events
NCT02541409 (4) [back to overview]Change in Insulin Resistance
NCT02541409 (4) [back to overview]HCV Treatment Completion
NCT02556307 (7) [back to overview]Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment
NCT02556307 (7) [back to overview]Percentage of Participants With Undetectable HCV RNA
NCT02556307 (7) [back to overview]Thrombocyte Values
NCT02556307 (7) [back to overview]Leukocyte Values
NCT02556307 (7) [back to overview]HCV RNA Values
NCT02556307 (7) [back to overview]Hemoglobin Values
NCT02556307 (7) [back to overview]Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism
NCT02557646 (15) [back to overview]Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With Virologic Response
NCT02557646 (15) [back to overview]Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With SVR According to Dose Reduction of Ribavirin
NCT02557646 (15) [back to overview]Percentage of Participants With SVR According to IL-28B Polymorphism
NCT02557646 (15) [back to overview]Percentage of Participants With Viral Relapse or Breakthrough
NCT02557646 (15) [back to overview]Percentage of Participants With SVR According to Starting Dose of Ribavirin
NCT02581163 (8) [back to overview]Percentage of Participants With Virologic Response at End of Treatment (EoT)
NCT02581163 (8) [back to overview]Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
NCT02581163 (8) [back to overview]Percentage of Participants Meeting Relapse Criteria
NCT02581163 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02581163 (8) [back to overview]Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
NCT02581163 (8) [back to overview]Percentage of Participants With Viral Breakthrough
NCT02581163 (8) [back to overview]Percentage of Participants With Relapse
NCT02581163 (8) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02581189 (8) [back to overview]Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
NCT02581189 (8) [back to overview]Percentage of Participants Meeting Relapse Criteria
NCT02581189 (8) [back to overview]Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
NCT02581189 (8) [back to overview]Percentage of Participants With Relapse
NCT02581189 (8) [back to overview]Percentage of Participants With Viral Breakthrough
NCT02581189 (8) [back to overview]Percentage of Participants With Virologic Response at End of Treatment (EoT)
NCT02581189 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02581189 (8) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02582671 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02582671 (8) [back to overview]Percentage of Participants With Virologic Response at End of Treatment (EOT)
NCT02582671 (8) [back to overview]Percentage of Participants Meeting Relapse Criteria
NCT02582671 (8) [back to overview]Percentage of Participants With Viral Breakthrough
NCT02582671 (8) [back to overview]Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
NCT02582671 (8) [back to overview]Percentage of Participants With Relapse
NCT02582671 (8) [back to overview]Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
NCT02582671 (8) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02601573 (4) [back to overview]Percentage of Participants Discontinuing From Study Therapy Due to an AE
NCT02601573 (4) [back to overview]Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy)
NCT02601573 (4) [back to overview]Percentage of Participants Experiencing an Adverse Event (AE)
NCT02601573 (4) [back to overview]Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)
NCT02601976 (5) [back to overview]Number of Participants With Rapid Virological Response (RVR)
NCT02601976 (5) [back to overview]Number of Participants With Sustained Virological Response (SVR)
NCT02601976 (5) [back to overview]Mean of Physical Component Score & Mental Component Score to Determine Quality of Life
NCT02601976 (5) [back to overview]Number of Participants With End Treatment Response
NCT02601976 (5) [back to overview]Number of Participants Who Reported Adverse Events
NCT02605304 (11) [back to overview]Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)
NCT02605304 (11) [back to overview]Percentage of Participants With Protocol-specified Renal Events
NCT02605304 (11) [back to overview]Percentage of Participants With Grade 3 or Higher Adverse Event (AE), Serious AE (SAE), or AE Reported as the Reason for Permanent Discontinuation of Study Treatment
NCT02605304 (11) [back to overview]Number of Participants With Unquantifiable HCV RNA
NCT02605304 (11) [back to overview]Number of Participants With Unquantifiable HCV RNA
NCT02605304 (11) [back to overview]Number of Participants With HIV-1 RNA >50 Copies/mL
NCT02605304 (11) [back to overview]Number of Participants With HIV-1 RNA >50 Copies/mL
NCT02605304 (11) [back to overview]CD4+ T-cell (CD4) Count Change From Baseline
NCT02605304 (11) [back to overview]CD4+ T-cell (CD4) Count Change From Baseline
NCT02605304 (11) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 Weeks After Treatment Discontinuation (SVR4)
NCT02605304 (11) [back to overview]Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)
NCT02609659 (5) [back to overview]Percentage of Participants With Hemoglobin < 10 g/dL During Treatment
NCT02609659 (5) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT02609659 (5) [back to overview]Mean Change in Hemoglobin Values From Baseline to End of Treatment
NCT02609659 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02609659 (5) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02613403 (8) [back to overview]Number of Participants Who Experienced a Non-Overdose Event of Clinical Interest
NCT02613403 (8) [back to overview]Number of Participants Who Experienced a Serious Adverse Event
NCT02613403 (8) [back to overview]Number of Participants Who Experienced a Serious and Drug-Related Adverse Event
NCT02613403 (8) [back to overview]Number of Participants Who Experienced an Adverse Event
NCT02613403 (8) [back to overview]Number of Participants Who Discontinued Study Drug Due to an Adverse Event
NCT02613403 (8) [back to overview]Number of Participants Who Experienced a Drug-Related Adverse Event
NCT02613403 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)
NCT02613403 (8) [back to overview]Number of Participants Who Experienced AST/ALT >5x Upper Limit Normal (ULN)
NCT02631772 (3) [back to overview]Hemoglobin Levels
NCT02631772 (3) [back to overview]Treatment Efficacy
NCT02631772 (3) [back to overview]Number of Participants With Virologic Failure
NCT02641379 (15) [back to overview]Number of Participants With Adverse Events and Serious Adverse Events (Part 2)
NCT02641379 (15) [back to overview]Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
NCT02641379 (15) [back to overview]Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
NCT02641379 (15) [back to overview]Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)
NCT02641379 (15) [back to overview]Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
NCT02641379 (15) [back to overview]Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)
NCT02641379 (15) [back to overview]Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)
NCT02641379 (15) [back to overview]Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)
NCT02641379 (15) [back to overview]Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)
NCT02641379 (15) [back to overview]Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
NCT02641379 (15) [back to overview]Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
NCT02641379 (15) [back to overview]Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
NCT02641379 (15) [back to overview]Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)
NCT02641379 (15) [back to overview]Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
NCT02641379 (15) [back to overview]Number of Participants With Adverse Events and Serious Adverse Events (Part 1)
NCT02716779 (12) [back to overview]Time to Maximum Concentration (Tmax) of Ribavirin
NCT02716779 (12) [back to overview]Maximum Concentration (Cmax) of PEG-IFN
NCT02716779 (12) [back to overview]Time to Maximum Concentration (Tmax) of GPT
NCT02716779 (12) [back to overview]Time to Maximum Concentration (Tmax) of PEG-IFN
NCT02716779 (12) [back to overview]Maximum Concentration (Cmax) of Ribavirin
NCT02716779 (12) [back to overview]Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT)
NCT02716779 (12) [back to overview]Area Under the Concentration-Time Curve (AUC) of Ribavirin
NCT02716779 (12) [back to overview]Maximum Concentration (Cmax) of GPT
NCT02716779 (12) [back to overview]Area Under the Concentration-Time Curve (AUC) of PEG-IFN
NCT02716779 (12) [back to overview]Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action
NCT02716779 (12) [back to overview]Percentage of Participants With Treatment Response
NCT02716779 (12) [back to overview]Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire
NCT02723084 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Non-inferiority of Arm A to Arm B
NCT02723084 (4) [back to overview]Percentage of Participants With Post-Treatment Relapse
NCT02723084 (4) [back to overview]Percentage of Participants With With On-treatment Virologic Failure
NCT02723084 (4) [back to overview]Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02725866 (8) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02725866 (8) [back to overview]Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
NCT02725866 (8) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02725866 (8) [back to overview]Percentage of Participants Meeting Relapse Criteria
NCT02725866 (8) [back to overview]Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
NCT02725866 (8) [back to overview]Percentage of Participants With Relapse
NCT02725866 (8) [back to overview]Percentage of Participants With Viral Breakthrough
NCT02725866 (8) [back to overview]Percentage of Participants With Virologic Response at End of Treatment (EoT)
NCT02726022 (6) [back to overview]Change From Baseline in SF-36 PCS at 24 Weeks After EOT
NCT02726022 (6) [back to overview]Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
NCT02726022 (6) [back to overview]Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
NCT02726022 (6) [back to overview]Change From Baseline in SF-36 MCS at 24 Weeks After EOT
NCT02726022 (6) [back to overview]Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
NCT02726022 (6) [back to overview]Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
NCT02731131 (6) [back to overview]Number of Participants With ALT Normalization at 48 Weeks After End of Treatment
NCT02731131 (6) [back to overview]Number of Participants With Negative HDV RNA at End of Treatment
NCT02731131 (6) [back to overview]Number of Participants With ALT Normalization at End of Treatment
NCT02731131 (6) [back to overview]Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment
NCT02731131 (6) [back to overview]Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment
NCT02731131 (6) [back to overview]Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment
NCT02761629 (8) [back to overview]Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
NCT02761629 (8) [back to overview]Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
NCT02761629 (8) [back to overview]Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment
NCT02761629 (8) [back to overview]Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A
NCT02761629 (8) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR)
NCT02761629 (8) [back to overview]Serum Human Immunodeficiency Virus (HIV) RNA Levels
NCT02761629 (8) [back to overview]Percentage of Participants With Undetectable HCV RNA
NCT02761629 (8) [back to overview]Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
NCT02781649 (6) [back to overview]Kidney Function at 6 Months
NCT02781649 (6) [back to overview]Number of Participants With Grade 3 or Higher Treatment-related Adverse Events as US Department of Health and Human Services Common Terminology of Adverse Events (CTCAE) Version 4
NCT02781649 (6) [back to overview]Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors
NCT02781649 (6) [back to overview]Viral Response
NCT02781649 (6) [back to overview]Antibody Development
NCT02781649 (6) [back to overview]Kidney Function at 12 Months
NCT02786537 (28) [back to overview]Median Change in Headache-Phase 2
NCT02786537 (28) [back to overview]Mean Change in Fatigue PRO -EBR/GZR vs SOF/LDV
NCT02786537 (28) [back to overview]16 Wk EBR/GZR With RBV Efficacy on Patients With HCV RASs
NCT02786537 (28) [back to overview]HCV SVR Durability -No Cirrhosis
NCT02786537 (28) [back to overview]HCV SVR Durability-Patients With Cirrhosis
NCT02786537 (28) [back to overview]Mean Change in Fatigue PRO Score -Phase 1
NCT02786537 (28) [back to overview]Mean Change in HCV- PRO- Phase 1
NCT02786537 (28) [back to overview]Mean Change in HCV-PRO (Functional Well-being) EBR/GZR vs. SOF/LDV Score-Phase 2
NCT02786537 (28) [back to overview]Mean Change in Headache-EBR/GZR and SOF/LDV
NCT02786537 (28) [back to overview]Mean Change in Headache-PRO Scores -Phase 1
NCT02786537 (28) [back to overview]Mean Change in Nausea/Vomiting PRO Score -Phase 1
NCT02786537 (28) [back to overview]Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF
NCT02786537 (28) [back to overview]Median Change in Fatigue -Phase 1
NCT02786537 (28) [back to overview]Median Change in Fatigue-Phase 2
NCT02786537 (28) [back to overview]Median Change in HCV-PRO (Overall Well Being) -Phase 1
NCT02786537 (28) [back to overview]Median Change in Headache -Phase 1
NCT02786537 (28) [back to overview]Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)
NCT02786537 (28) [back to overview]Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation
NCT02786537 (28) [back to overview]Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV
NCT02786537 (28) [back to overview]Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)
NCT02786537 (28) [back to overview]Post-treatment Progression/Regression of Liver Disease-Fib-4
NCT02786537 (28) [back to overview]Treatment Non-Adherence Probability Estimates
NCT02786537 (28) [back to overview]Change in Functional Status (HCV-PRO) Within Treatment
NCT02786537 (28) [back to overview]Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation
NCT02786537 (28) [back to overview]Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2
NCT02786537 (28) [back to overview]Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF
NCT02786537 (28) [back to overview]Median Change in Nausea PROMIS Score-EBR/GZR SOF/LDV
NCT02786537 (28) [back to overview]Median Change in Nausea PRO Score -Phase 1
NCT02803138 (9) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02803138 (9) [back to overview]Percentage of Participants With Viral Breakthrough
NCT02803138 (9) [back to overview]Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment
NCT02803138 (9) [back to overview]Percentage of Participants With Virologic Response at End of Treatment (EoT)
NCT02803138 (9) [back to overview]Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
NCT02803138 (9) [back to overview]Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02803138 (9) [back to overview]Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
NCT02803138 (9) [back to overview]Percentage of Participants Meeting Relapse Criteria
NCT02803138 (9) [back to overview]Percentage of Participants With Relapse
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 10
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 12
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 24
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 3
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 3
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 24
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 20
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 2
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 4
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 5
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 6
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 16
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 12
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 8
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 4
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 16
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 5
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 10
NCT02822794 (29) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02822794 (29) [back to overview]Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02822794 (29) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02822794 (29) [back to overview]Percentage of Participants With Overall Virologic Failure
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 2
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 20
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 1
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 6
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 8
NCT02822794 (29) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 1
NCT02939989 (3) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT02939989 (3) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02939989 (3) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02946034 (8) [back to overview]Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment
NCT02946034 (8) [back to overview]Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment
NCT02946034 (8) [back to overview]Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
NCT02946034 (8) [back to overview]Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)
NCT02946034 (8) [back to overview]Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment
NCT02946034 (8) [back to overview]Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment
NCT02946034 (8) [back to overview]Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)
NCT02946034 (8) [back to overview]Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
NCT02956629 (9) [back to overview]Percentage of Participants With Virologic Failure
NCT02956629 (9) [back to overview]Percentage of Participants Discontinuing Study Therapy Due to an AE
NCT02956629 (9) [back to overview]Percentage of Participants Experiencing a Drug-related AE
NCT02956629 (9) [back to overview]Percentage of Participants With SVR 24 Weeks After Completing Study Therapy (SVR24)
NCT02956629 (9) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Completing Study Therapy (SVR12)
NCT02956629 (9) [back to overview]Percentage of Participants Experiencing an AE of Clinical Importance (ECI)
NCT02956629 (9) [back to overview]Percentage of Participants Experiencing an Adverse Event (AE)
NCT02956629 (9) [back to overview]Percentage of Participants Experiencing a Drug-related SAE
NCT02956629 (9) [back to overview]Percentage of Participants Experiencing a Serious Adverse Event (SAE)
NCT02996682 (9) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02996682 (9) [back to overview]Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02996682 (9) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02996682 (9) [back to overview]Percentage of Participants With Virologic Failure
NCT02996682 (9) [back to overview]Change From Baseline in HCV RNA
NCT02996682 (9) [back to overview]Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event
NCT02996682 (9) [back to overview]Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment
NCT02996682 (9) [back to overview]Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class
NCT02996682 (9) [back to overview]Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
NCT03020004 (1) [back to overview]Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
NCT03020082 (1) [back to overview]Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT03020095 (1) [back to overview]Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
NCT03092375 (7) [back to overview]Difference in SVR12 Rates for 12-wk vs 16 wk
NCT03092375 (7) [back to overview]Comparison of Cirrhotic Participants Achieving SVR 12 After G/P Plus RBV for 12 Wks vs. G/P for 16 Wks
NCT03092375 (7) [back to overview]Tolerability of G/P +/-RBV
NCT03092375 (7) [back to overview]Difference in Relapse Between Arms A & B in Non-cirrhotic Subjects
NCT03092375 (7) [back to overview]Difference in On-Treatment Virologic Failure Between Arms C and D in Cirrhotic Subjects
NCT03092375 (7) [back to overview]Difference in On-Treatment Virologic Failure Between Arms A & B (Non-cirrhotic Subjects)
NCT03092375 (7) [back to overview]Difference in % of Relapse Between Cirrhotic Arms C & D
NCT03365635 (2) [back to overview]Approval for DAA by Third Party Payers
NCT03365635 (2) [back to overview]SVR - Sustained Virologic Response
NCT03760666 (2) [back to overview]Number of Participants With Treatment-Related Adverse Events
NCT03760666 (2) [back to overview]Brequinar Pharmacokinetics - Area Under the Curve (AUC)

Development of Hepatocellular Carcinoma (HCC)

"A diagnosis of development of hepatocellular carcinoma (HCC) was based on either~Histology showing HCC (from a biopsy, surgery, or autopsy) or~A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to > 1,000 ng/ml." (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week13
Standard of Care Followup16

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SF-36 Mental Health Summary Score

Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Mental Health summary score. The SF-36 Mental Health summary score is the sum of 5 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline. (NCT00006164)
Timeframe: 0.5, 1.5, 2.5, and 3.5 years after randomization

,
Interventionunits on a scale (Mean)
0.5 years1.5 years2.5 years3.5 years
Peginterferon Alfa-2a 90 mcg/Week-2.62-2.22-2.65-2.84
Standard of Care Followup-1.08-1.67-2.15-1.85

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Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points

Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week157
Standard of Care Followup157

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Ascites

"Any abdominal fluid which is:~Mild, moderate or marked on ultrasound; or~Progressive on serial physical examinations; or~Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is mild (barely detectable) on physical examination requires ultrasound confirmation that is mild, moderate or marked ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition." (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week32
Standard of Care Followup27

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Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits

Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation) (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week57
Standard of Care Followup52

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Death From Any Cause

(NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week31
Standard of Care Followup22

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Hepatic Encephalopathy

Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause). (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week15
Standard of Care Followup22

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Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies

For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization) (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week71
Standard of Care Followup81

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Serious Adverse Events

"A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following:~Death~Is life threatening (risk of death at the time of the event)~Requires in-patient hospitalization or prolongation of existing hospitalization~Results in persistent or significant disability/incapacity~Congenital abnormality or birth defect~Trial outcomes (except death) were not considered serious adverse events." (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week175
Standard of Care Followup155

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Spontaneous Bacterial Peritonitis

Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability. (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week3
Standard of Care Followup3

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Variceal Hemorrhage

A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week5
Standard of Care Followup11

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Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.

Change in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) by assessment of a liver-biopsy specimen obtained during the study (collected at baseline, Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization) (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

,
Interventionunits on a scale (Mean)
1.5 years3.5 years
Peginterferon Alfa-2a 90 mcg/Week-0.070.12
Standard of Care Followup-0.090.12

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SF-36 Vitality Summary Score

Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Vitality summary score. The SF-36 Vitality summary score is the sum of 4 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline. (NCT00006164)
Timeframe: 0.5, 1.5, 2.5, and 3.5 years after randomization

,
Interventionunits on a scale (Mean)
0.5 years1.5 years2.5 years3.5 years
Peginterferon Alfa-2a 90 mcg/Week-6.05-6.40-5.68-6.69
Standard of Care Followup-1.61-3.24-2.97-3.27

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Presumed Hepatocellular Carcinoma (HCC)

"Presumed HCC was considered when histology was not available and alpha-fetoprotein (AFP) is <1000 ng/ml, if:~A new hepatic lesion was shown on ultrasound and 1 additional imaging showed a hepatic lesion with characteristics of HCC.~AFP> upper limit of normal (ULN) and 2 imaging studies showed a hepatic lesion with characteristics of HCC.~A progressively enlarging hepatic lesion starting as a new defect resulting in patient death.~A new hepatic defect with at least 1 characteristic scan and:~Increase in size over time or~Increasing AFP rising to a level of >200 ng/ml" (NCT00006164)
Timeframe: 1400 days (3.85 years) post randomization

InterventionParticipants (Count of Participants)
Peginterferon Alfa-2a 90 mcg/Week10
Standard of Care Followup9

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SF-36 Physical Function Summary Score

Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Physical Function summary score. The SF-36 Physical Function summary score is the sum of 10 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline. (NCT00006164)
Timeframe: 0.5, 1.5, 2.5, and 3.5 years after randomization

,
Interventionunits on a scale (Mean)
0.5 years1.5 years2.5 years3.5 years
Peginterferon Alfa-2a 90 mcg/Week-1.64-2.41-1.99-3.80
Standard of Care Followup-0.97-1.63-1.68-1.66

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Participants With Viral Decline at Day 3 & 28 With Predictors of Post Treatment Response

"HCV viral kinetics were used to predict rates of sustained virology response (SVR) in HIV/HCV connected subjects.~Measure was determined by analyzing the population of participants with virologic decline of more than 1.0 log at day 3 combined with viral load of less than 5.0 log IU/ml at day 28 to predict sustained virology response" (NCT00018031)
Timeframe: Day 3 and Day 28

Interventionparticipants with post treatment svr (Number)
Peginterferon Alfa-2b, Ribavirin8

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Change in Hepatitis C Virus RNA Levels During Phase I

(NCT00028093)
Timeframe: From day 0 to day 3

Interventionlog(IU/mL) (Median)
Peginterferon+Ribavirin0.50
Peginterferon0.70

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Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12

Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up (NCT00039871)
Timeframe: 24 weeks posttreatment

InterventionParticipants (Number)
PegIntron Plus Rebetol23

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Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12

Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up (NCT00039871)
Timeframe: 24 weeks posttreatment

InterventionParticipants (Number)
PegIntron Plus Rebetol463

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Sustained Virologic Response (SVR) Rate

Number of participants with undetectable hepatitis C virus RNA (HCV-RNA) (NCT00039871)
Timeframe: Assessed at end of 24 weeks posttreatment follow-up

InterventionParticipants (Number)
PegIntron Plus Rebetol497

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First Phase Decline in Logarithm of HCV RNA Level

The 1st phase decline is defined as the log difference between baseline HCV RNA level and the level on day 2 of treatment (see Neumann et al, Science, 1998). (NCT00056862)
Timeframe: 2 days

InterventionlogIU/mL (Mean)
Low Dose Group1.15
Standard Dose Group2.20

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Slope of Second Phase Decline in HCV Levels

The 2nd phase slope is defined as the slope of the logarithmic viral levels from week 1 to week 4 of treatment (see Neumann et al, Science, 1998). (NCT00056862)
Timeframe: day 7 to day 28

InterventionlogIU/mL (Mean)
Low Dose Group1.14
Standard Dose Group1.39

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Time to Negativity

Time from treatment initiation to the first negative HCV RNA test during treatment (NCT00056862)
Timeframe: 24 weeks

Interventiondays (Median)
Low Dose Group42
Standard Dose Group28

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Virological Response (Intention to Treat)

Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped. (NCT00056862)
Timeframe: 6 months after stopping therapy

,
Interventionparticipants (Number)
Sustained Virological Response (SVR)Relapse/breakthroughNonresponseTreatment stopped for adverse eventLost to follow-up
Low Dose Group197301
Standard Dose Group212130

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Virological Response Category (Per Protocol)

Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped. (NCT00056862)
Timeframe: 6 months after therapy

,
Interventionparticipants (Number)
SVRRelapse/breakthroughNonresponse
Low Dose Group1972
Standard Dose Group2021

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Percentage of Participants With Marked Laboratory Abnormalities

Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 μmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 μmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality. (NCT00077636)
Timeframe: Up to Week 40 and Week 48

,
InterventionPercentage of participants (Number)
Hematocrit (fraction)- low n=731,728Hemoglobin (g/dL)- low, n=731,727Platelets(10^9/L)- low,n=731,727Basophils(10^9/L)- high, n=731,727WBC (10^9/L)- low, n=731,727WBC (10^9/L)- high, n=731,727Eosinophils (10^9/L )- high, n=731,727Lymphocytes (10^9/L)- low, n=731,727Monocytes (10^9/L )- low, n=731,727Neutrophils (10^9/L)- low, n=731,727Partial throm.(seconds)- high, n=730,728Liver function: ALAT (SGPT) (U/L)- HIGH n=731,728Albumin (g/L)- low, n=730,728Alk. Phos.(U/L)- high,n=731,728ASAT (SGOT) (U/L)- high,n= 731,727GGT (U/L)- high,n=731,728Total bilirubin (umol/L)- high, n=731,728Total protein (g/L)- high, n=731,728Renal function: bun (mmol/L)- high, n=731,728Chloride (mmol/L)- high, n=731,728Chloride (mmol/L)- low, n=731,728Creatinine (umol/L)- high, n=731,728Potassium (mmol/L)- high, n=731,728Potassium (mmol/L)- low, n=731,728Sodium (mmol/L) - high, n=731,728Sodium (mmol/L)- low,n=731,728Thyroid function: free T4 (pmol/)- high, n=716,715Free T4 (pmol/L)- low, n=716,715TSH (mU/L)- high, n=716,715Miscellaneous: calcium (mmol/L)- low, n= 731,728Cholesterol (mmol/L)- high, n=730,728Phosphate (mmol/L)- high, n=730,728Phosphate (mmol/L)- low, n=730,728Random glucose (mmol/L)- high, n= 731,728Random glucose (mmol/L)- low, n= 731,728Triglycerides (mmol/L)- high, n=730,728Uric acid (umol/L)- high, n=730,728Urinalysis: glycosuria (0 to 4+)- high, n= 721,71Hematuria (0 to 4+) high, n= 721,716Proteinuria (0 to 4+) - high, n= 721,716
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks181524064004906901500151200000000000021021822312040
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks211622071005707501000101000000000000060022110332142

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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. (NCT00077636)
Timeframe: Up to Week 40 and Week 48

,
InterventionPercentage of participants (Number)
Any AEAny SAE
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks975
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks996

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Participants With Marked Abnormal Vital Signs

Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs. (NCT00077636)
Timeframe: Up to Week 40 and Week 48

,
Interventionparticipants (Number)
Diastolic BP, High, n=729,726Systolic BP, High, n=729,726Systolic BP, Low, n=729,726Heart Rate, High, n=728,725Heart Rate, Low, n=728,725
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks42924
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks32234

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Number of Participants With Highest Triglyceride Level

Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed. (NCT00077636)
Timeframe: Up to Week 40 and Week 48

,
Interventionparticipants (Number)
200 - 400 mg/dL>400 - 1000 mg/dL>1000 mg/dL
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks28011717
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks28413814

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Percentage of Participants With Virological Response at The End of Study Treatment

Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group. (NCT00077636)
Timeframe: Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks94
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks92

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Percentage of Participants With Sustained Virological Response (SVR)

SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group. (NCT00077636)
Timeframe: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks65
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks76

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Percentage of Participants Virological Response 12 Weeks Post-Treatment

Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group. (NCT00077636)
Timeframe: Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks59
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks69

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Percentage of Participants With Adverse Events and Serious Adverse Events

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. (NCT00077649)
Timeframe: Up to Week 72

,,,
Interventionpercentage of participants (Number)
Any AESAE
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg1009
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg10013
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg10013
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg10011

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Percentage of Participants With Marked Laboratory Abnormalities

Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 - 20.0 (g/dL),platelets 100 - 700 (10^9/L), lymphocyte 1.00 - 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 - 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 - 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 - 50 (U/L), alkaline phosphatase 0 - 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 - 120 (U/L),Total protein 55 - 87 (g/L),total bilirubin 0 - 34.2 (μmol/L),BUN 0 - 14.3 (mmol/L),creatinine 0 - 154 (μmol/L),chloride 95 - 115 (mmol/L),potassium 3.0 - 6.0 (mmol/L), sodium 130 - 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 - 10.0 (mU/L),triglycerides 0.00 - 2.83 (mmol/L), calcium 2.00 - 2.90 (mmol/L),phosphate 0.75 - 1.60 (mmol/L),Blood Glucose 2.80 - 11.10 (mmol/L),Uric Acid 0 - 600 (μmol/L),proteinuria 0 - 1 (0 to 4+), glycosuria 0 - 1 (0 to 4+), hematuria 0 - 1 (0 to 4+). (NCT00077649)
Timeframe: Up to Week 60

,,,
Interventionpercentage of participants (Number)
Hematocrit (fraction) Low, (n=45,47,46,47)Hemoglobin (g/dl) - Low, (n= 45,47,46,47)Platelets Low, (n= 45,47,46,47)WBC - High, [n= 45,47,46,47]WBC - Low, (n= 45,47,46,47)Lymphocytes High, (n= 45,47,46,47)Lymphocytes Low (n= 45,47,46,47)Neutrophils Low, (n= 45,47,46,47)SGPT High, (n= 45,47,46,47)Albumin Low, (n= 45,47,46,47)Alkaline Phosphate High, (n= 45,47,46,47)SGOT High, (n= 45,47,46,47)GGT High, (n= 45,47,46,47)Total Bilirubin High, (n= 45,47,46,47)Total Protein High, (n= 45,47,46,47)Bun High, (n= 45,47,46,47)Chloride High, (n= 45,47,46,47)Chloride Low (n= 45,47,46,47)Creatinine High, (n= 45,47,46,47)Potassium Low, (n= 45,47,46,47)Sodium High, (n= 45,47,46,47)Sodium Low, (n= 45,47,46,47)TSH High, (n= 45,46,43,46)Calcium Low, (n= 45,47,46,47)Phosphate High, (n= 45,47,46,47)Phosphate Low, (n= 45,47,46,47)Random glucose High, (n= 45,47,46,47)Triglycerides High, (n= 45,47,46,47)Uric acid High (n= 45,47,46,47)Glycosuria High, (n= 44,46,44,45)Hematuria High, (n= 44,46,44,45)Proteinuria High, (n= 44,46,44,45)
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg535726272068791900171960202224074036113811022
PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg4442270760738220001627900000020002312609752
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg4148280700727415222215200200000507204572575
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg64552107427274132026192400200229203064915200

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Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period

Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period. (NCT00077649)
Timeframe: Week 60

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg28.3
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg29.8
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg34.0
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg46.8

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Total BDI-II (Beck Depression Inventory) Scores

The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit. (NCT00077649)
Timeframe: From Baseline (Day 1) to Week 72

,,,
InterventionUnits on a scale (Mean)
Baseline, n=46,46,47,46Week 1, (n=43,44,43,45)Week 2, (n=43,44,43,47)Week 4, (n=42,45,44,45)Week 6, (n=41,41,43,44)Week 8, (n=38,42,42,40)Week 12, (n=44,46,42,44)Week 18, (n=43,44,42,40)Week 24, (n=43,45,41,37)Week 30, (n=38,42,39,34)Week 36, (n=36,42,37,33)Week 42, (n=35,37,35,32)Week 48, (n=34,40,31,29)Week 52, (n=31,36,32,28)Week 60, (n=34,34,31,28)Week 72, (n=28,37,28,29)
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg3.524.244.846.316.326.206.828.047.078.037.507.497.484.564.475.00
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg4.394.454.715.796.496.247.098.317.437.898.638.337.896.625.185.14
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg4.234.815.607.218.198.028.098.628.809.357.828.007.924.223.402.92
PEG-IFN Alfa-2a 270 mcg+ Ribavirin 1600 mg4.433.965.226.076.647.698.098.138.057.749.458.137.934.213.122.80

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Percentage of Participants With Virological Response at the End of the Treatment Period

Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period. (NCT00077649)
Timeframe: Week 48

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg45.7
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg57.4
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg55.3
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg55.3

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HCV RNA Profile During The First 24 Weeks

Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL). (NCT00077649)
Timeframe: Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24

,,,
Interventionlog 10 copies/mL (Mean)
Baseline, (n=46,47,47,47)At Hour 72, (n=41,41,42,46)At Week 1, (n=44,47,45,46)At Week 2, (n=43,45,43,46)At Week 4, (n=44,45,44,46)At Week 12, (n=45,45,41,44)At Week 24, (n=42,45,40,37)
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg6.505.805.745.324.352.992.76
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg6.615.825.815.374.623.102.82
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg6.555.525.424.833.942.522.25
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg6.535.495.454.843.852.752.21

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Percentage of Participants With Virological Response Over Time to Week 24

Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24. (NCT00077649)
Timeframe: 72 hours post-dose, Weeks 1, 2, 4, 12, and 24

,,,
Interventionpercentage of participants (Number)
At Hour 72At Week 1At Week 2At Week 4At Week 12At Week 24
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg0.00.002.18.538.355.3
PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg0.00.000.002.247.856.5
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg0.00.002.110.653.259.6
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg0.00.002.112.851.168.1

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Percentage of Participants With Abnormal Vital Signs

Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline. High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline. Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline. High heart rate is defined as >120 beats/minute and >20% increase from baseline. Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline. (NCT00077649)
Timeframe: Up to Week 72

,,,
Interventionpercentage of participants (Number)
Diastolic BP, High (n=45,47,46,47)Systolic BP High, (n=45,47,46,47)Systolic BP Low, (n=45,47,46,47)Heart Rate Low, (n=45,47,46,47)Heart Rate, High, (n=45,47,46,47)
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg00020
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg02000
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg00200
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg04000

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Percentage of Participants With Predicted Sustained Virological Response

"The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5. The percentage was calculated from the number of participant (N) analyzed under Distribution of the predicted probability of an SVR." (NCT00077649)
Timeframe: Week 4 and 12

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg40.9
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg31.1
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg47.7
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg50.0

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Percentage of Participants With Sustained Virological Response

SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period. (NCT00077649)
Timeframe: Week 72

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg28.3
PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg31.9
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg36.2
PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg46.8

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Number of Participants With High-grade Signs and Symptoms or Laboratory Values

Number of participants with high-grade (Grade 3 or higher) signs and symptoms or laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization. (NCT00078403)
Timeframe: Up to 96 Weeks

,,
InterventionParticipant (Number)
Any Grade 3 or higherGrade 3Grade 4
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)22157
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)20155
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)847311

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Sustained Virologic Response

Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (<60 IU/ml) 24 weeks after treatment discontinuation. (NCT00078403)
Timeframe: 24 weeks after end of treatment

,,
InterventionParticipant (Number)
YesNo
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)044
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)042
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)8881

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Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations

3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized. (NCT00078403)
Timeframe: Up to 96 Weeks

,
InterventionParticipant (Number)
Premature treatment discontinuationTemporarily off treatmentReduced dose
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)1672
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)572933

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Number of Participants With Neutropenia

Number of participants with neutropenia by grade (defined by absolute neutrophil count [ANC] per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm^3; Grade 2 = 750 to 999 /mm^3; Grade 3 = 500 to 749 /mm^3; Grade 4 = below 500 /mm^3. (NCT00078403)
Timeframe: Up to 96 weeks

,,
InterventionParticipant (Number)
Neutropenia >= Grade 2Grade 2Grade 3Grade 4
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)207103
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)10451
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)96383721

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Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol

Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment. (NCT00078403)
Timeframe: Up to 96 weeks

,,
InterventionParticipant (Number)
Number of participants who used megestrolNumber of participants who used dronabinol
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)24
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)14
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)622

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Number of Participants With Anemia

Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl. (NCT00078403)
Timeframe: Up to 96 weeks

,,
InterventionParticipant (Number)
Anemia >= Grade 2Grade 2Grade 3Grade 4
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)1001
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)0000
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)6312

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Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)

Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment (NCT00078403)
Timeframe: At any time after pre-assignment

,,
InterventionParticipant (Number)
Number of participants who used EPONumber of participants who used GCSFNumber of participants who used GM-CSF
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)14170
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)1380
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)70600

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Weight

Participant weight in kilograms. (NCT00078403)
Timeframe: Arms A and B: at entry and weeks 4, 8, 12, 16, 24, 32, 40, 48, 56, 64 and 72; Arm C: at entry and weeks 4, 8, 12, 16, 24, 36, 48, 72, 84 and 96.

,,
Interventionkilograms (Median)
Week 0: Weight (N=43 in A, 42 in B, 169 in C)Week 4: Weight (N=43 in A, 35 in B, 161 in C)Week 8: Weight (N=39 in A, 34 in B, 162 in C)Week 12: Weight (N=42 in A, 30 in B, 157 in C)Week 16: Weight (N=39 in A, 35 in B, 164 in C)Week 24: Weight (N=39 in A, 36 in B, 165 in C)Week 32: Weight (N=37 in A, 35 in B)Week 36: Weight (N=162 in C)Week 40: Weight (N=32 in A, 29 in B)Week 48: Weight (N=33 in A, 31 in B, 153 in C)Week 56: Weight (N=31 in A, 24 in B)Week 64: Weight (N=26 in A, 24 in B)Week 72: Weight (N=26 in A, 27 in B, 141 in C)Week 84: Weight (N=140 in C)Week 96: Weight (N=138)
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)74.974.774.976.377.475.576.5NA75.778.279.778.581.6NANA
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)79.880.480.881.179.979.480.4NA83.180.481.684.085.4NANA
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)75.875.875.876.376.375.8NA75.0NA75.1NANA75.677.078.4

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Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Insulin resistance was evaluated by HOMA-IR, calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing. (NCT00078403)
Timeframe: Arms A and B: at entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 72, 84 and 96.

,,
Interventionmg/dL x uIU/mL (Median)
Week 0: HOMA-IR (N=32 in A, 32 in B, 72 in C)Week 12: HOMA-IR (N=72 in C)Week 24: HOMA-IR (N=34 in A, 30 in B, 73 in C)Week 36: HOMA-IR (N=66 in C)Week 48: HOMA-IR (N=30 in A, 24 in B, 74 in C)Week 72: HOMA-IR (N=67 in C)Week 84: HOMA-IR (N=63 in C)Week 96: HOMA-IR (N=65 in C)
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)3.84NA3.08NA3.534.79NANA
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)2.49NA4.78NA2.844.82NANA
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)2.372.472.582.413.252.692.992.30

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Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)

SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time). (NCT00078403)
Timeframe: Baseline and at week 72 or premature discontinuation

InterventionMetavir units per one year (52 weeks) (Median)
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)0
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)0

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Number of Participants Adherent to Study Medications

A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit. (NCT00078403)
Timeframe: Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.

,
InterventionParticipant (Number)
Week 0: Number of participants with adherence dataWeek 0: Number of participants adherent to medsWeek 12:Number of participants with adherence dataWeek 12:Number of participants adherent to medsWeek 24:Number of participants with adherence dataWeek 24:Number of participants adherent to medsWeek 48:Number of participants with adherence dataWeek 48:Number of participants adherent to medsWeek 60:Number of participants with adherence dataWeek 60:Number of participants adherent to medsWeek 72:Number of participants with adherence dataWeek 72:Number of participants adherent to meds
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)0NA3732322822190NA87
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)1581321501251451181209591790NA

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Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)

Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year. (NCT00078403)
Timeframe: Baseline and at week 72 or premature discontinuation

InterventionIshak units per one year (52 weeks) (Median)
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)0
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)1.31

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Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)

Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than or equal to 60 IU/mL where 60 IU/mL is the lower limit of qualitative assay used in Steps 2 and 3. (NCT00078403)
Timeframe: Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84

,,
InterventionParticipant (Number)
Week 0--Number of participants with HCV RNA dataWeek 0--Number of participants with detectable HCVWeek 12--Number of participants with HCV RNA dataWeek 12-Number of participants with detectable HCVWeek 24--Number of participants with HCV RNA dataWeek 24-Number of participants with detectable HCVWeek 36--Number of participants with HCV RNA dataWeek 36-Number of participants with detectable HCVWeek 48--Number of participants with HCV RNA dataWeek 48-Number of participants with detectable HCVWeek 60--Number of participants with HCV RNA dataWeek 60-Number of participants with detectable HCVWeek 72--Number of participants with HCV RNA dataWeek 72-Number of participants with detectable HCVWeek 84--Number of participants with HCV RNA dataWeek 84-Number of participants with detectable HCV
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)4442424036350NA31310NA27270NA
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)4242343435350NA28280NA22220NA
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)164531583116339158410NA137341355113750

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Number of Participants With Depression and/or Other Psychological Events

Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade. (NCT00078403)
Timeframe: Up to 96 weeks

,,
InterventionParticipant (Number)
Any psychologicalGrade 3Grade 4
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)321
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)110
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)19181

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Number of Participants With Thrombocytopenia

Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm^3; Grade 2 = 50,000 to 74,999 /mm^3; Grade 3 = 20,000 to 49,999 /mm^3; Grade 4 = below 20,000 /mm^3. (NCT00078403)
Timeframe: Up to 96 weeks

,,
InterventionParticipant (Number)
Thrombocytopenia >= Grade 2Grade 2Grade 3Grade 4
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)141040
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)4310
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)312551

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Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)

A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as <50 copies/mL (undetectable) or >=50 copies/mL (detectable). 50 is the lower limit of detection of the assay. (NCT00078403)
Timeframe: Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84

,,
InterventionParticipant (Number)
Week 0: Number of participants with HIV RNA dataWeek 0: No. of participants with undetectable VLWeek 12: Number of participants with HIV RNA dataWeek 12: No. of participants with undetectable VLWeek 24: Number of participants with HIV RNA dataWeek 24: No. of participants with undetectable VLWeek 36: Number of participants with HIV RNA dataWeek 36: No. of participants with undetectable VLWeek 48: Number of participants with HIV RNA dataWeek 48: No. of participants with undetectable VLWeek 60: Number of participants with HIV RNA dataWeek 60: No. of participants with undetectable VLWeek 72: Number of participants with HIV RNA dataWeek 72: No. of participants with undetectable VLWeek 84: Number of participants with HIV RNA dataWeek 84: No. of participants with undetectable VL
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)44320NA39250NA35240NA27190NA
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)42340NA39250NA33250NA27200NA
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)169146164138165141160134150125140113140107136108

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Mean Change From Baseline in the Log Viral Load at Treatment Week 4

The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group. (NCT00081770)
Timeframe: Assessed at Baseline and Treatment Week 4

InterventionLog10 IU/mL (Mean)
PegIntron 1.5 ug/kg/wk Plus REBETOL-2.32
PegIntron 1.0 ug/kg/wk Plus REBETOL-2.02
PEGASYS 180 ug/wk Plus COPEGUS-2.45

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Mean Change From Baseline in the Log Viral Load at Treatment Week 2

The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group. (NCT00081770)
Timeframe: Assessed at Baseline and Treatment Week 2

InterventionLog10 IU/mL (Mean)
PegIntron 1.5 ug/kg/wk Plus REBETOL-1.55
PegIntron 1.0 ug/kg/wk Plus REBETOL-1.30
PEGASYS 180 ug/wk Plus COPEGUS-1.60

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Virologic Response Rate at Treatment Week 12

Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12 (NCT00081770)
Timeframe: Assessed at Treatment Week 12

InterventionPercentage of participants (Number)
PegIntron 1.5 ug/kg/wk Plus REBETOL39.9
PegIntron 1.0 ug/kg/wk Plus REBETOL36.0
PEGASYS 180 ug/wk Plus COPEGUS45.0

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Sustained Virologic Response (SVR) Rate

SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up. (NCT00081770)
Timeframe: Assessed at the end of a 24-week post-treatment follow-up

InterventionPercentage of participants (Number)
PegIntron 1.5 ug/kg/wk Plus REBETOL39.8
PegIntron 1.0 ug/kg/wk Plus REBETOL38.0
PEGASYS 180 ug/wk Plus COPEGUS40.9

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Number of Participants With Sustained Virologic Response (SVR)

SVR [ Sustained virological response] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment. (NCT00085917)
Timeframe: 72 weeks

Interventionparticipants (Number)
Pegasys Single Dose11
Pegasys Double Dose11

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Number of Participants With Adverse Events

"Adverse Events~- Anemia, Neutropenia and Psychiatric adverse events" (NCT00085917)
Timeframe: 48 weeks

Interventionparticipants (Number)
Pegasys Single Dose11
Pegasys Double Dose11

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Number of Participants With Normalization of Liver Enzymes

normalization of liver enzymes :Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) Alanine aminotransferase (ALT): Normal 6 - 41 U/L Aspartate aminotransferase (AST) : Normal 9 - 34 U/L (NCT00085917)
Timeframe: week 24, week 48, week 72

Interventionparticipants (Number)
Pegasys Single Dose11
Pegasys Double Dose11

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Mean Score of Beck Depression Inventory Over Time

The Beck Depression Inventory (BDI-II) is a questionnaire with groups of statements in which the patient is asked to select the statement that most clearly describes the way he/she has felt in the past two weeks, including today. The score for each group is tallied and the ranges of scores are used as guidelines for measuring the degree of depression. For this study, scores are defined as follows: 0 to 15 as minimal, 16 to 21 as mild, 22 to 30 as moderate, and 31 to 63 as severe. The questionnaire was in two areas (changes in sleeping pattern and changes in appetite), selections 1, 2, and 3 contained options for both more and less with respect to the area of interest. Four statements (labelled 0, 1, 2, and 3) were offered that described the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. (NCT00087568)
Timeframe: Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84

,
InterventionUnits on a scale (Mean)
Baseline, (n = 32, 25)Week 4, (n = 31, 24)Week 12, (n = 27, 24)Week 24, (n = 2, 23)Week 36, (n = 3, 19)Week 48, (n = 2, 21)Week 60, (n = 2, 21)Week 84, (n = 2, 0)
Non-Responders10.939.528.633.755.406.153.001.50
Non-Tolerators15.0310.6810.7611.268.654.303.62NA

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Mean Score for Overall Local Injection Site Reaction

Local injection-site reactions were to be given an overall assessment based on pain or discomfort as Grade 0 for no pain or discomfort, Grade 1 for mild tenderness at the injection site, Grade 2 for moderate pain without limitation of usual activities, Grade 3 for severe pain requiring prescription non-topical analgesics or limiting usual activities, Grade 4 for a reaction that resulted in a new hospitalization, prolongation of hospitalization, death, or a persistent or significant disability/incapacity, or was life threatening or medically significant. Adverse events related to the injection site (injection site erythema, hematoma, pain, rash, or reaction) were reported. All of these events were reported as resolved without sequelae. (NCT00087568)
Timeframe: Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60

,
InterventionUnits on a scale (Mean)
Baseline, (n = 32, 25)Week 4, (n = 31, 24)Week 12, (n = 27, 24)Week 24, (n = 2, 23)Week 36, (n = 3, 19)Week 48, n = (2, 0)Week 60, n = (2, 0)
Non-Responders0.250.030.000.000.000.000.00
Non-Tolerators0.480.080.170.090.05NANA

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Number of Pegasys and Ribavirin Therapy Completers

Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12. (NCT00087568)
Timeframe: 36 weeks for Non-Tolerators and 60 weeks for Non-Responders

,
InterventionParticipants (Number)
Completing 36 weeksCompleting 60 weeks
Non-Responders32
Non-Tolerators2323

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Number of Participants With Normal Serum Alanine Transaminase Levels Over Time

The number of participants with serum alanine transaminase (ALT) concentration within the normal range at each time point assessed. Upper limit of normal serum ALT for men is 43 International units per liter (IU/L) and for women is 34 IU/L. (NCT00087568)
Timeframe: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84

,
InterventionParticipants (Number)
BaselineWeek 4Week 12Week 24Week 36Week 48Week 60Week 84
Non-Responders2118963311
Non-Tolerators211919161514150

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Number of Participants With Marked Laboratory Abnormalities

Analysis was performed for hematology, clinical chemistry, thyroid function, and urinalysis. Normal ranges of the parameters were: Haematocrit (fraction): 0.37 - 0.49, Haemoglobin (g/L): 130 - 180 , Platelets (G/L): 150 - 350, White blood cell (G/L): 4.5 - 11.0, Lymphocytes (G/L): 1.00 - 4.80, Neutrophils (G/L): 1.80 - 7.70, Prothrombin Time in Seconds (sec): not defined, Prothrombin Time, normalized (ratio): 0.70 - 1.30, Partial thromboplastin Time (sec): 22.1 - 34.1, Aspartate transaminase (AST) or serum glutamate oxaloacetate transaminase (SGOT) in IU/L: 0 - 40, Alkaline Phosphatase (IU/L): 0 - 115, ALT or serum glutamate pyruvate transaminase (SGPT) in (IU/L): 0-55, Total Bilirubin (umol/L): 0 -17, Thyroxine (T4) (nmol/L): 58 -140, Thyroid-stimulating hormone (TSH, [U/mL]): 0.0 - 5.0, Triglycerides (mmol/L): 0.45 - 1.69, Phosphate (mmol/L): 0.84 - 1.45, Uric Acid (umol/L): 214 - 506 (NCT00087568)
Timeframe: Up to Week 84

,
Interventionparticipants (Number)
Hematocrit (fraction) - Low (n = 32, 25)Hemoglobin-Low (n = 32, 25)Platelets - Low (n = 32, 25)WBC (White blood cells)-High (n = 32, 25)WBC (White blood cells) - Low (n = 32, 25)Lymphocytes - High (n = 32, 25)Lymphocytes - Low (n = 32, 25)Neutrophils - High (n = 32, 25)Neutrophils - Low (n = 32, 25)Partial thromboplastin Time - High (n = 32, 25)Prothrombin time - High (n = 32, 25)SGOT - High (n = 32, 25)SGPT - High (n = 32, 25)Alkaline phosphatase - High (n = 32, 25)Phosphate - High (n = 32, 25)Phosphate - Low (n = 32, 25)Uric acid - High (n = 32, 25)Triglycerides - High (n = 32, 25)Thyroid-T4 - High (n = 32, 25)Thyroid T4 - Low (n = 32, 25)TSH - High (n = 32, 25)
Non-Responders5561111631910149112110623
Non-Tolerators36311305120118901309001

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Mean Score of Fatigue Severity Over Time

"The Fatigue severity score (FSS) scale has a series of questions designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 or 4 weeks by marking on a visual analogue scale labelled at one end with no fatigue ('0' being the best) and at the other end with greater fatigue ('100' being the worst). Longer distance on the scale from no fatigue indicated greater fatigue. FSS values are presented based on questionnaire and visual analog scale." (NCT00087568)
Timeframe: Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84

,
InterventionUnits on a scale (Mean)
Total FSS, Baseline, (n = 32, 25)Total FSS, Week 4, (n = 31, 24)Total FSS, Week 12, (n = 27, 24)Total FSS, Week 24, (n = 2, 23)Total FSS, Week 36,(n = 3, 19)Total FSS, Week 48, (n = 2, 21)Total FSS, Week 60, (n = 2, 20)Total FSS, Week 84, (n = 2, 0)Visual analog based FSS, Baseline, (n = 32, 25)Visual analog based FSS, Week 4, (n = 31, 24)Visual analog based FSS, Week 12, (n = 27, 24)Visual analog based FSS, Week 24, (n = 2, 23)Visual analog based FSS, Week 36, (n = 3, 19)Visual analog based FSS, Week 48, (n = 2, 21)Visual analog based FSS, Week 60, (n = 2, 20Visual analog based FSS, Week 84, (n = 2, 0)
Non-Responders4.664.274.091.332.522.222.441.6148.7247.8752.1554.5047.3326.0031.0021.50
Non-Tolerators5.144.504.724.994.623.172.97NA61.9252.0855.0056.5248.7925.2431.55NA

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Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time

Sustained virological response (SVR) is defined as undetectable Hepatitis C virus-ribonucleic acid (HCV RNA)(<60 International units per milliliter) or HCV RNA for >=2-log10 decrease in viral titre, 24 weeks after the end of treatment. A participant was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at Week 24 post or at any time between Week 24 and completion of antiviral treatment. HCV RNA measured prior to or on the date of the first dose of Pegasys plus ribavirin was used as the baseline in all HCV RNA analyses. (NCT00087568)
Timeframe: Weeks 4, 12, 24, 36, 48, 60, and 84

,
InterventionParticipants (Number)
Week 4Week 12Week 24Week 36Week 48Week 60Week 84
Non-Responders1412121
Non-Tolerators1624212111140

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Number of Participants With Serious Adverse Events and Adverse Events

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An adverse event could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were also to be reported as adverse events. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above. (NCT00087568)
Timeframe: Up to Week 84

,
InterventionParticipants (Number)
any SAEany AE
Non-Responders129
Non-Tolerators123

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Number of Participants With Abnormal Vital Signs

"Abnormal vital signs were defined as~Systolic blood pressure (BP) below 85 mm Hg or above 180 mm Hg with a change from baseline of > 20%~Diastolic BP above 110 mm Hg with a change from baseline of > 20% where systolic and diastolic BP were pressure exerted by blood on the walls of blood vessels during left ventricular systole and diastole respectively.~Pulse rate below 50 beats per minute and above 120 beats per minute, with a change from baseline of > 20%, where pulse represents the palpation of heartbeat" (NCT00087568)
Timeframe: From screening (Day -21 to Day -1) to Week 84

,
InterventionParticipants (Number)
Systolic BP highSystolic BP lowPulse-low
Non-Responders110
Non-Tolerators001

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Number of Participants With Individual Flu-like Symptom

"Participants were asked to complete a flu-like symptom questionnaire at screening, study baseline, and at all subsequent scheduled visits. The yes/no questionnaire evaluated the incidence of headache, fever, myalgia, and chills. If a participant answered yes to the question Has the patient experienced any flu-like symptoms since the last visit? all among headache, fever, muscle aches (myalgia), and chills that applied were to be marked. If any of the experienced symptoms was newly reported or had worsened, a corresponding adverse event was to be reported." (NCT00087568)
Timeframe: Baseline (Week 0); Weeks 12, 36, 60 and 84

,
InterventionParticipants (Number)
Baseline, Headache, (n = 32, 25)Baseline, Fever, (n = 32, 25)Baseline, Muscle aches, (n = 32, 25)Baseline, Chills, (n = 32, 25)Week 12, Headache, (n = 27, 24)Week 12, Fever, (n = 27, 24)Week 12, Muscle aches, (n = 27, 24)Week 12, Chills, (n = 27, 24)Week 36, Headache, (n = 3, 19)Week 36, Fever, (n = 3, 19)Week 36, Muscle aches, (n = 3, 19)Week 36, Chills, (n = 3, 19)Week 60, Headache, (n = 2, 22)Week 60, Fever, (n = 2, 22)Week 60, Muscle aches, (n = 2, 22)Week 60, Chills, (n = 2, 22)Week 84, Headache, (n = 32, 25)Week 84, Fever, (n = 32, 25)Week 84, Muscle aches, (n = 32, 25)Week 84, Chills, (n = 32, 25)
Non-Responders1610171213382211100001910189
Non-Tolerators1914211713510510387102118141915

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Number of Participants With Marked Laboratory Abnormalities (Biochemistry)

"Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal." (NCT00087594)
Timeframe: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)

,
Interventionparticipants (Number)
Aspartate aminotransferase - High (n = 24, 24)Alanine aminotransferase - High (n = 24, 24)Albumin - Low (n = 24, 24)Total protein - High (n = 24, 24)Total protein - Low (n = 24, 24)Chloride - Low (n = 24, 24)Sodium - Low (n = 24, 24)Calcium - Low (n = 24, 24)Phosphate - High (n = 24, 24)Phosphate - Low (n = 24, 24)Glucose random - High (n = 24, 24)Triglycerides - High (n = 24, 24)Thyroxine (T4) - High (n = 22, 22)Thyroid-Stimulating Hormone - High (n = 22, 22)
Direct Observed Therapy22010230161940
Self-Administration Therapy84411325272623

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Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion

Biochemical response is defined as the number of participants with a normal serum alanine aminotransferase (ALT) concentration (i.e., ALT < 30 U/L). EOT for G1 was Week 48 and for G2/3 was Week 24. (NCT00087594)
Timeframe: Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)

,
Interventionparticipants (Number)
Week 12 (G1), (n = 13, 16)Week 24 (G1), (n = 13, 16)Week 48/EOT (G1), (n = 13, 16)12 Weeks after EOT (G1), (n = 13, 16)24 Weeks after EOT (G1), (n = 13, 16)Week 12 (G2/3), (n = 11, 8)Week 24/EOT (G2/3), (n = 11, 8)12 Weeks after EOT (G2/3), (n = 11, 8)24 Weeks after EOT (G2/3), (n = 11, 8)
Direct Observed Therapy3546410101011
Self-Administration Therapy13135872443

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Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Reason for discontinuation was categorized as safety and non-safety, where safety reasons included abnormality of laboratory tests, AEs, and death; and non-safety reasons included insufficient therapeutic response, early improvement, violation of selection criteria at entry, other protocol violation, refused treatment, failure to return and other. Participants who discontinued the study with any reason were recorded. (NCT00087594)
Timeframe: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)

,
Interventionparticipants (Number)
Any AEsAny SAEsAEsStudy discontinuation due to Insufficient ResponseStudy discontinuation due to Refused TreatmentStudy discontinuation due to Failure to Return
Direct Observed Therapy2432240
Self-Administration Therapy2433522

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Number of Participants With Abnormal Vital Signs

Vital Signs included systolic blood pressures (SBP), diastolic blood pressures (DBP), and pulse rate (PR). Abnormal vital signs were reported as low or high abnormal. It was defined as < 85 mm Hg or > 180 mm Hg with a change from baseline of > 20%; DBP as > 110 mm Hg with a change from baseline of > 20%; and PR as < 50 bpm and > 120 bpm with a change from baseline of > 20%. (NCT00087594)
Timeframe: Up to 24 weeks of treatment-free follow-up visit (Week 48 for G2/3 and Week 72 for G1)

,
Interventionparticipants (Number)
SBP - HighSBP - LowDBP - HighPR - Low
Direct Observed Therapy1121
Self-Administration Therapy0001

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Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12

(NCT00087594)
Timeframe: Week 12

,
Interventionparticipants (Number)
Week 12 (G1), (n = 13, 16)Week 12 (G2/3), (n = 11, 8)
Direct Observed Therapy411
Self-Administration Therapy98

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Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits

BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome). (NCT00087594)
Timeframe: Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1)

,
Interventionunits on a scale (Mean)
EOT (Week 24/48), (n = 18, 13)EOS (Week 48/72), (n = 22, 19)
Direct Observed Therapy6.10.4
Self-Administration Therapy13.54.5

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Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit

The HQLQ is a multiple-choice questionnaire includes the eight individual qualify-of-life scales of the Medical Outcomes Study 36-item Short-form Health Survey as: Social functioning (SF), role limitations due to emotional problems (RE), vitality (VT), general mental health (MH), physical functioning (PF), role limitations due to physical problems (RP), freedom from bodily pain (BP), and general health (GH). In addition, two other generic scales (positive well-being [PWB] and health distress [HD]) and two hepatitis-specific scales (limitations because of chronic hepatitis C [HLIM] and health distress because of chronic hepatitis C [HHD]) were included. Scores were scaled to a 0 to 100 range, with 0 = bad and 100 = good. A higher score indicates an improvement. (NCT00087594)
Timeframe: Baseline (Day -30 to -1), 24 weeks after EOT visit (Week 48 for G2/3 and Week 72 for G1)

,
Interventionunits on a scale (Mean)
SF at Baseline (n = 23, 24)SF at EOT, (n = 15, 12)SF at 24 Weeks after EOT, (n = 17, 15)RE at Baseline (n = 23, 24)RE at EOT, (n = 14, 12)RE at 24 Weeks after EOT, (n = 17, 15)MH at Baseline (n = 23, 24)MH at EOT, (n = 15, 12)MH at 24 Weeks after EOT, (n = 17, 15)PF at Baseline (n = 23, 24)PF at EOT, (n = 15, 12)PF at 24 Weeks after EOT, (n = 17, 14)RP at Baseline (n = 23, 24)RP at EOT, (n = 15, 12)RP at 24 Weeks after EOT, (n = 17, 14)BP at Baseline (n = 23, 24)BP at EOT, (n = 14, 12)BP at 24 Weeks after EOT, (n = 17, 15)GH at Baseline (n = 23, 24)GH at EOT, (n = 15, 12)GH at 24 Weeks after EOT, (n = 17, 15)VT at Baseline (n = 23, 24)VT at EOT, (n = 15, 12)VT at 24 Weeks after EOT, (n = 17, 15)HD at Baseline (n = 23, 24)HD at EOT, (n = 15, 12)HD at 24 Weeks after EOT, (n = 17, 15)PWB at Baseline (n = 23, 24)PWB at EOT, (n = 15, 12)PWB at 24 Weeks after EOT, (n = 17, 15)HLIM at Baseline (n = 23, 23)HLIM at EOT, (n = 15, 12)HLIM at 24 Weeks after EOT, (n = 16, 15)HHD at Baseline (n = 23, 23)HHD at EOT, (n = 15, 12)HHD at 24 Weeks after EOT, (n = 16, 15)
Direct Observed Therapy70.750.072.855.147.674.563.753.667.574.659.075.962.026.766.267.055.966.756.354.058.748.029.054.465.762.373.850.065.345.374.559.184.262.858.781.6
Self-Administration Therapy75.535.459.275.036.162.273.551.757.980.052.962.959.416.755.472.247.868.160.837.246.652.720.041.376.943.352.740.263.847.076.840.068.969.850.467.3

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Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)

BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome). (NCT00087594)
Timeframe: Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1).

,
Interventionunits on a scale (Mean)
Baseline, (n = 24, 24)EOT (Week 24/48), (n = 18, 13)EOS (Week 48/72), (n = 22, 19)
Direct Observed Therapy8.713.68.6
Self-Administration Therapy8.622.813.4

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Number of Participants With Degrees of Depression as Defined by the BDI-II Score

Participants with degrees of depression as defined by the BDI-II Score were reported. BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome). (NCT00087594)
Timeframe: Up to Week 72

,
Interventionparticipants (Number)
Baseline, none-mildBaseline, moderateHighest post-baseline, none-mildHighest post-baseline, moderateHighest post-baseline, severeLast post-baseline, none-mildLast post-baseline, moderateLast post-baseline, severe
Direct Observed Therapy22216532031
Self-Administration Therapy24091131832

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Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion

Virological Response Rate is defined as the number of participants with undetectable HCV-RNA (< 10 IU/mL). Treatment completion (end of treatment [EOT]) for G1 was Week 48 and for G2 or 3 was Week 24. (NCT00087594)
Timeframe: Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)

,
Interventionparticipants (Number)
Week 12 (G1), (n = 13, 16)Week 24 (G1), (n = 13, 16)Week 48 (EOT) (G1), (n = 13, 16)12 weeks after EOT (G1), (n = 13, 16)Week 12 (G2/3), (n = 11, 8)Week 24 (EOT) (G2/3), (n = 11, 8)12 Weeks after EOT (G2/3), (n = 11, 8)
Direct Observed Therapy355511119
Self-Administration Therapy5884873

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Number of Participants With Treatment Completion Rate (TCR)

TCR is defined as the number of participants who completed the prescribed duration of the study treatment. TCR for G1 participants is defined as the number of participants who had a missing value or >= 2-log10 decrease in Hepatitis C virus-ribonucleic acid (HCV RNA) at Week 12 and completed 48 weeks of study treatment or had a < 2-log10 decrease from baseline at Week 12 and completed at least 12 weeks of study treatment. TCR for G2/ 3 participants is defined as the number of participants who completed 24 weeks of study treatment. (NCT00087594)
Timeframe: Up to 24 weeks for G2/3; up to 48 weeks for G1

,
Interventionparticipants (Number)
G1 (n = 13, 16)G1, 2 log drop at Week 12 (n = 4, 9)G1, non 2 log drop at Week 12 (n = 4, 4)G1, missing HCV-RNA at Week 12 (n = 5, 3)G2/3 (n = 11, 8)
Direct Observed Therapy944111
Self-Administration Therapy105417

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Number of Participants With Compliance to the Prescribed Treatment Regimen

Participants with compliance to the prescribed treatment regimen for peginterferon alfa-2a and ribavirin was reported. Compliance was calculated as (total cumulative dose taken) / (total cumulative original dose prescribed for the entire study) x 100. Total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (48*7) for G1, total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (24*7) for G2/3. (NCT00087594)
Timeframe: Up to Week 24 for G 2/3; up to Week 48 for G1

,
Interventionparticipants (Number)
Peginterferon alfa-2a, 0-60%Peginterferon alfa-2a, >60-80%Peginterferon alfa-2a, >80-97%Peginterferon alfa-2a, >97%Ribavirin, 0-60%Ribavirin, >60-80%Ribavirin, >80-97%Ribavirin, >97%Total Treatment Duration, 0-60%Total Treatment Duration, >60-80%Total Treatment Duration, >80-97%Total Treatment Duration, >97%
Direct Observed Therapy80115845780115
Self-Administration Therapy814111017681312

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Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)

SVR is defined as the number of participants with undetectable HCV-RNA (< 10 international unit per milliliter [IU/mL]) at 24 weeks post treatment completion. (NCT00087594)
Timeframe: Week 48 for G2/3 and Week 72 for G1

,
Interventionparticipants (Number)
G1 (n = 13, 16)G2/3 (n = 11, 8)
Direct Observed Therapy410
Self-Administration Therapy52

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Number of Participants With Marked Laboratory Abnormalities (Hematology)

"Hematology included hematocrit (fraction), hemoglobin, platelets count, Red blood cells (RBC), White blood cell (WBC), eosinophils, lymphocytes, monocytes, neutrophils, Partial Thromboplastin time (PTT), Prothrombin Time International Normalized Ratio (PT INR). Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal." (NCT00087594)
Timeframe: Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)

,
Interventionparticipants (Number)
Hematocrit (fraction) - Low (n = 24, 24)Hemoglobin - Low (n = 24, 24)Platelets - Low (n = 24, 24)RBC - Low (n = 24, 24)WBC - High (n = 24, 24)WBC - Low (n = 24, 24)Eosinophils - High (n = 24, 24)Lymphocytes - Low (n = 24, 24)Monocytes - High (n = 24, 24)Neutrophils - High (n = 24, 24)Neutrophils - Low (n = 24, 24)PTT - High (n = 22, 23)PT INR (ratio) - High (n = 22, 23)
Direct Observed Therapy1010111401808001920
Self-Administration Therapy11161018119110142032

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Weekly Viral Absolute Area Under the HCV RNA Curve Estimated in the Frequent-sampling Cohort for Weeks 1 and 8

The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. For the frequent-sampling cohort, HCV AUCs over 7 days were calculated for Weeks 1 and 8, with intervals calculated beginning at the dose after which the frequent sampling began (different from the 7-day calendar period used for other AUC calculations). The AUCs for Weeks 1 and 8 in the frequent-sampling cohort (Sparse samples [SS] and frequent samples [FS]) were calculated using the trapezoidal rule. (NCT00087607)
Timeframe: Week 1 and Week 8

,
Interventionlog (IU*week/mL) (Mean)
SS, Week 1; n = 12, 13SS, Week 8; n = 12, 12FS, Week 1; n = 12, 13FS, Week 8; n = 12, 12
Peginterferon Alfa-2a + Ribavirin6.03.45.83.3
Peginterferon Alfa-2b + Ribavirin6.03.55.53.5

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Mean Value of Area Under the HCV-RNA Curve Minus Baseline From Week 1 to Week 12

The HCV AUC was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week -1 HCV AUC (i.e., baseline) from the weekly HCV AUC and presented. (NCT00087607)
Timeframe: Baseline, Week 1 to Week 12

,
Interventionlog (IU*week/mL) (Mean)
Week 1; n = 186, 188Week 2; n = 185, 187Week 3; n = 184, 184Week 4; n = 183, 181Week 5; n = 182, 181Week 6; n = 180, 179Week 7; n = 180, 177Week 8; n = 178, 175Week 9; n = 176, 173Week 10; n = 176, 171Week 11; n = 174, 170Week 12; n = 171, 169
Peginterferon Alfa-2a + Ribavirin0.41.01.41.82.12.42.62.83.03.13.23.2
Peginterferon Alfa-2b + Ribavirin0.41.11.62.02.32.62.82.93.03.13.23.2

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Mean Trough Interferon Concentrations at Each Week

The weekly Interferon (IFN) concentrations were calculated using the trapezoid rule. The trough IFN concentration was analyzed using an enzyme-linked immunosorbent assay (ELISA), with limits of quantification of 250 picograms per milliliter [pg/mL] for Pegasys and 150 pg/mL for PEG-Intron respectively. (NCT00087607)
Timeframe: From Week 1 to Week 12

,
Interventionpg/mL (Mean)
Week 1; n = 137, 179Week 2; n = 152, 182Week 3; n = 152, 181Week 4; n = 152, 178Week 5; n = 150, 177Week 6; n = 150, 173Week 7; n = 150, 175Week 8; n = 146, 174Week 9; n = 144, 171Week 10; n = 145, 168Week 11; n = 144, 165Week 12; n = 144, 168
Peginterferon Alfa-2a + Ribavirin6730953011082120891252912686128521278112781124991268912846
Peginterferon Alfa-2b + Ribavirin119144125150163143162147167156163154

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Mean Change From Baseline in Viral Load (log10 Reduction) at Week 4 and Week 8

The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to week 4 and week 8, expressed in terms of a logarithmic scale with base 10 are presented. (NCT00087607)
Timeframe: Baseline, Week 4 and Week 8

,
Interventionlog (IU/mL) (Mean)
Week 4; n = 181, 178Week 8; n = 178, 175
Peginterferon Alfa-2a + Ribavirin-1.95-2.88
Peginterferon Alfa-2b + Ribavirin-2.22-2.95

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The Area Under the HCV-RNA Curve Estimated From the Two Adjacent Pre-dose Assessments at Each Week

The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The HCV AUC to Week 12 was the sum of the 12 weekly HCV AUCs divided by the time (12 weeks). Summary of weekly HCV AUC values estimated from the two adjacent pre-dose assessments are presented. (NCT00087607)
Timeframe: From Week -1 to Week 12

,
Interventionlog 10 IU/mL (Mean)
Week -1, n = 188, 190Week 1, n = 186, 188Week 2, n = 185, 187Week 3, n = 184, 184Week 4, n = 183, 181Week 5, n = 182, 181Week 6, n = 180, 179Week 7, n = 180, 177Week 8, n = 178, 175Week 9, n = 176, 173Week 10, n = 176, 171Week 11, n = 174, 170Week 12, n = 171, 169
Peginterferon Alfa-2a + Ribavirin6.56.15.55.04.74.34.13.83.63.53.43.33.2
Peginterferon Alfa-2b + Ribavirin6.56.15.44.94.44.13.93.73.63.53.43.33.2

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Cumulative Viral Absolute Area Under the HCV RNA Curve Minus Baseline Averaged Over the 12-week Period

The area under the HCV-RNA curve (HCV AUC) was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week -1 HCV AUC (i.e., baseline) from the weekly HCV AUC. The HCV AUCMB to Week 12 was the sum of the 12 weekly HCV AUCMBs divided by the time (12 weeks). (NCT00087607)
Timeframe: Up to Week 12

Interventionlog10 IU/mL (Mean)
Peginterferon Alfa-2a + Ribavirin26.9
Peginterferon Alfa-2b + Ribavirin28.7

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Change From Baseline in Viral Load (log10 Reduction) at Week 12

The viral load was determined quantitatively and qualitatively by Hepatitis C virus (HCV)-polymerase chain reaction (PCR). HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 international units per milliliter (U/mL), changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to Week 12, expressed in terms of a logarithmic scale with base 10, are presented. (NCT00087607)
Timeframe: From Baseline to Week 12

Interventionlog (IU/mL) (Mean)
Peginterferon Alfa-2a + Ribavirin-3.26
Peginterferon Alfa-2b + Ribavirin-3.27

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Number of Participants With Marked Biochemical Test Abnormalities

Values outside the marked RR for biochemical test parameters that represent a defined, clinically relevant change from baseline are considered marked biochemical test abnormalities. Roche's standard RR for biochemical parameters were used for this analysis. The biochemical test parameters with marked abnormalities were alanine aminotransferase (ALAT) (RR is 0 - 30 units per liter [U/L]), aspartate aminotransferase (ASAT) (RR is 0 - 25 U/L), gamma-glutamyl transferase (GGT) (RR is 0 - 60 U/L), total bilirubin (RR is 0 - 17 micromole/liter [umol/L]), creatinine (RR is 0 - 133 umol/L), total protein (RR is 60 - 80 g/L), triglycerides (RR is 0.45 - 1.70 millimole/liter [mmol/L]), chloride (RR is 100 - 108 mmol/L), potassium (RR is 3.5 - 5.0 mmol/L), sodium (RR is 133 - 145 mmol/L), calcium (RR is 2.10 - 2.60 mmol/L), random glucose (RR is 3.89 - 7.83 mmol/L), uric acid (140 - 500 umol/L). Summary data of number of participants with only marked biochemical test abnormalities are presented. (NCT00087607)
Timeframe: Baseline, up to Week 12

,
Interventionparticipants (Number)
ALAT-HighASAT- HighGG- HighTotal Bilirubin- HighCreatinine- HighTotal Protein- LowTriglycerides- HighChloride- LowPotassium- LowSodium- LowCalcium- LowGlucose Random- HighUric Acid- High
Peginterferon Alfa-2a + Ribavirin5172380189211538
Peginterferon Alfa-2b + Ribavirin121118814985259521

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Number of Participants With Adverse Events and Serious Adverse Events

An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported. (NCT00087607)
Timeframe: Up to Week 12

,
Interventionparticipants (Number)
Any AEAny SAE
Peginterferon Alfa-2a + Ribavirin1855
Peginterferon Alfa-2b + Ribavirin1872

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Area Under the Curve for Interferon in the Frequent-Sampling Cohort

Area Under the Curve (AUC) for Interferon (IFN) for Week 1 and Week 8 in the frequent-sampling cohort were calculated using the trapezoidal rule. (NCT00087607)
Timeframe: Week 1 and Week 8

,
Interventionweek*pg/mL (Mean)
Week 1; n = 8, 4Week 8; n = 7, 5
Peginterferon Alfa-2a + Ribavirin6376.014399.9
Peginterferon Alfa-2b + Ribavirin315.2472.1

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Percentage of Participants With Undetectable HCV RNA (< 60 International Units/Milliliter) at Each Visit

The viral load was determined quantitatively and qualitatively by HCV-polymerase chain reaction (PCR). Qualitative viral titers will be assessed by Roche amplicor HCV Monitor® test v2.0 (< 600 IU/mL). The virological response was determined as the percentage of participants with undetectable HCV RNA at each week. A <60 IU/mL HCV-RNA was measured by amplicor PCR assay. (NCT00087607)
Timeframe: From Week 1 to Week 12

,
Interventionpercentage of participants (Number)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Peginterferon Alfa-2a + Ribavirin0.51.62.67.411.116.922.225.929.634.939.239.2
Peginterferon Alfa-2b + Ribavirin0.52.16.311.515.723.626.729.335.640.341.944.0

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Percentage of Participants With a ≥ 2-log10 Decrease or Undetectable (< 60 International Units Per Milliliter) HCV RNA at Each Visit

The virological response was determined as the proportion/percentage of participants with a ≥ 2-log10 decrease or undetectable HCV RNA at each week. Detection of >= 2-log10 decrease of <60 IU/mL HCV-RNA was done by amplicor PCR assay at each week. Detection of >=2-log10 decrease or undetectable HCV RNA at Week 12 was considered an early virological response (EVR). (NCT00087607)
Timeframe: From Week 1 to Week 12

,
Interventionpercentage of participants (Number)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Peginterferon Alfa-2a + Ribavirin6.920.131.741.846.653.457.161.459.865.665.166.1
Peginterferon Alfa-2b + Ribavirin9.930.442.449.253.455.557.659.257.660.259.763.4

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Number of Participants With Marked Hematologic Abnormalities

The values outside the marked reference range for any hematology parameter that represents a defined, clinically relevant change from baseline are considered marked hematology abnormalities. The Roche standard reference ranges for the hematology parameters for which subjects had marked abnormalities were hematocrit [(RR) is 0.42 - 0.52 (fraction)], hemoglobin (RR is 13.0 - 18.0 gram/deciliter), platelets (RR is 150 - 450 10^9 cells/L), white blood cells (WBC) (RR is 4.3 - 10.8 10^9 cells/L), basophils (RR is 0.00 - 0.15 10^9 cells/L), lymphocytes (RR is 1.50 - 4.00 10^9 cells/L), monocytes (RR is 0.20 - 0.95 10^9 cells/L), neutrophils (RR is 1.83 - 7.25 10^9 cells/L), prothrombin time (PT) (RR is 9 - 13 seconds), partial thromboplastin time (Partial Throm.) (Time) (RR is 25.0 - 38.0 seconds) and PT International normalized ratio (INR) [RR is 0.70 - 1.30 (ratio)]. Summary data of number of participants with only marked hematology abnormalities are presented. (NCT00087607)
Timeframe: Baseline, up to Week 12

,
Interventionparticipants (Number)
Hemoglobin-LowPlatelets-LowHematocrit -LowWBC-HighWBC-LowBasophils-HighLymphocytes-LowMonocytes-LowNeutrophils-LowPartial Throm.-HighPT (ProThrom Time)-HighPT (INR)-High
Peginterferon Alfa-2a + Ribavirin644172212427711363155
Peginterferon Alfa-2b + Ribavirin693190011907511371256

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Number of Participants With Marked Abnormalities in Thyroid Function Tests

Values outside the marked reference ranges for thyroid function test parameters that represent a defined, clinically relevant change from baseline are considered marked thyroid function test abnormalities. Roche's standard reference ranges for thyroid function test parameters were used for the analysis. The thyroid function parameters with marked abnormalities were triiodothyronine (T3) (RR is 1.20 - 3.00 nanomole/liter [nmol/L]), thyroxine (T4) (RR is 51 - 154 nmol/L) and thyroid stimulating hormone (TSH) (RR is 0.0 - 5.0 milliunits per liter [mU/L]). Summary data of number of participants with only marked abnormalities in thyroid function tests are presented. (NCT00087607)
Timeframe: Baseline, up to Week 12

,
Interventionparticipants (Number)
T3-HighT4-HighTSH-High
Peginterferon Alfa-2a + Ribavirin441
Peginterferon Alfa-2b + Ribavirin321

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Weekly Viral Load Assessed at Drug Trough

The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The viral load levels in the serum at baseline and for each week, were expressed in terms of a logarithmic scale with base 10, and averaged for all participants. (NCT00087607)
Timeframe: Baseline, up to Week 12

,
Interventionlog (IU/mL) (Mean)
Baseline; n = 189, 191Week 1; n = 181, 185Week 2; n = 182, 184Week 3; n = 179, 183Week 4; n = 181, 178Week 5; n = 182, 179Week 6; n = 179, 177Week 7; n = 178, 175Week 8; n = 178, 175Week 9; n = 171, 170Week 10; n = 175, 171Week 11; n = 173, 167Week 12; n = 172, 169
Peginterferon Alfa-2a + Ribavirin6.465.695.264.844.514.203.963.733.573.443.313.233.18
Peginterferon Alfa-2b + Ribavirin6.485.705.124.644.254.013.783.643.533.443.343.303.21

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Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)

The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug. (NCT00087646)
Timeframe: At Week 12 and 24

,
InterventionIU/ML (Mean)
HCV RNA Change from BL to Week 12 (n= 424, 421)HCV RNA Change from BL to Week 24 (n= 390, 399)
Group A + Group B-2.75-2.88
Group C + Group D-2.18-2.64

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Percentage of Participants With Relapse After End of Treatment

The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined. (NCT00087646)
Timeframe: Week 96 (Group A and C) and Week 72 (Group B and D)

Interventionpercentage of participants (Number)
Group A49
Group B78
Group C59
Group D67

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Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response

Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment. (NCT00087646)
Timeframe: Week 96 (Group A and C) and Week 72 (Group B and D)

Interventionpercentage of participants (Number)
Group A51
Group B22
Group C41
Group D33

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Number of Participants With Sustained Virological Response Rate

Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end. (NCT00087646)
Timeframe: Up to 72 weeks (Group A) and 48 weeks (Group D)

Interventionparticipants (Number)
Group A52
Group D27

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Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)

SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end. (NCT00087646)
Timeframe: At Week 48 and Week 72

Interventionparticipants (Number)
Group A + Group C74
Group B + Group D38

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Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)

SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end. (NCT00087646)
Timeframe: At Week 48 and Week 72

Interventionparticipants (Number)
Group A + Group B63
Group C + Group D49

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Percentage of Participants With Undetectable HCV-RNA

"The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.~End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days)." (NCT00087646)
Timeframe: At Week 12, 24, 48 and EOT

,
Interventionpercentage of participants (Number)
At Week 12At Week 24At Week 48At EOT
Group A24323231
Group D11272628

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Percentage of Participants With >=2log Drop in HCV-RNA

Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported. (NCT00087646)
Timeframe: At Week 12 and 24

,
Interventionpercentage of participants (Number)
Week 12Week 24
Group A6251
Group D4247

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Adverse Events

Influenza-like, headache, and gastrointestinal symptoms (NCT00100659)
Timeframe: At any time up to 72 weeks

,
InterventionParticipants (Count of Participants)
Influenza-like symptomsHeadacheGastrointestinal symptoms
Pegylated Interferon/Placebo503037
Pegylated Interferon/Ribavirin503431

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Sustained Viral Response (SVR)

SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma (NCT00100659)
Timeframe: at least 24 weeks after stopping treatment.

Interventionparticipants (Number)
PEG/RV29
PEG/Placebo12

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Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment

SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment (NCT00104052)
Timeframe: Up to 48-week treatment duration. Follow-up of 24 weeks.

InterventionParticipants (Number)
PEG-Intron Plus REBETOL70

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Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72

ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) score at week 72. Baseline prognostic factors in the original model include ethnicity, sex, age, baseline ALT quotient, baseline HCV-RNA level, and ISHAK fibrosis and activity scores at baseline. ISHAK modified HAI fibrosis scale by fibrosis grading category as F0= no fibrosis; F1= some portal areas; F2= most portal areas; F3= bridging fibrosis; F4= bridging and portal to central; F5 = marked bridging; F6 = Cirrhosis; where '0' being the best and '6' being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was analysed. (NCT00107653)
Timeframe: From Baseline (Week 0) to Week 72

,
InterventionScore on a scale (Mean)
F5-F6 (n=21,11)F0-F4 (n=136,190)
Latino-1.05-1.49
Non-Latino White-2.64-2.04

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Percentage of Participants With Early Virologic Response at Week 12

Percentage of participants with an early virologic response defined as an HCV-RNA >=2 log10 drop from baseline or undetectable HCV-RNA measurement at Week 12 (lower limit of detection 28 IU/mL). (NCT00107653)
Timeframe: At Week 12

InterventionPercentage of participants (Number)
Latino75.5
Non-Latino White86.0

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Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72

ISHAK modified HAI activity (necroinflammatory) score is a total score of P/B necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each Participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5= zone 3 multiple; 6= panacinar necrosis and Focal necrosis as 0: absent; 1: <= 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was tested using an analysis of covariance (ANCOVA) model with ethnicity and baseline ISHAK HAI score as the fixed effects. (NCT00107653)
Timeframe: From Baseline (Week 0) to Week 72

InterventionScore on a scale (Mean)
Latino-1.4
Non-Latino White-2.1

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Mean Change From Baseline in Fat Score at Week 72

Grading categories for the fat scale were as follows: 1 = <5% hepatocytes; 2 = 6 - 33% hepatocytes; 3 = 34 - 66% hepatocytes; 4 = 67 - 100% hepatocytes. (NCT00107653)
Timeframe: From Baseline (Week 0) to Week 72

InterventionScore on a scale (Mean)
Latino-0.15
Non-Latino White-0.25

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Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72

Fat scores are categorised as Improved: > 1 category decrease in fat scale; stable: no change in fat scale; worsened: >= 1 category increase in fat scale. (NCT00107653)
Timeframe: From Baseline (Week 0) to Week 72

,
InterventionPercentage of participants (Number)
Stable Fat ScoreWorsened Fat ScoreImproved Fat Score
Latino47.820.431.8
Non-Latino White51.216.432.3

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Number of Participants With Any Adverse Events and Serious Adverse Events

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An adverse event could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as adverse events. A serious adverse event (SAE) was any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect. (NCT00107653)
Timeframe: Up to Week 72

,
InterventionParticipants (Number)
Any AEsAny SAEs
Latino26442
Non-Latino White29248

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Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72

"The Fatigue Severity Scale (FSS) is a 10-item self-report questionnaire designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 weeks by marking on a visual analogue scale (VAS) labelled at one end with no fatigue ('0' being the best) and at the other end with greater fatigue ('100' being the worst). Longer distance on the scale from no fatigue indicated greater fatigue. FSS values are presented based on questionnaire and visual analog scale. FSS values at week 48 and 72 are presented based on questionnaire and visual analog scale." (NCT00107653)
Timeframe: Baseline (Week 0), Week 48 and Week 72

,
InterventionScore on a scale (Mean)
FSS Score,From Baseline At Week 48 (n=180,224)FSS Score,From Baseline At Week 72 (n=174,214)FSS VAS Score,From Baseline At Week 48 (n=177,221)FSS VAS Score,From Baseline At Week72 (n=173,212)
Latino0.9-0.114.81.9
Non-Latino White1.50.125.4-2.7

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Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72

The 36-item Short Form Health Survey (SF-36) is a 36-item self-report questionnaire that includes 8 domain scales The 8 domains are incorporated into 2 components: mental and physical. The mental component (MC) includes social functioning, role limitations-emotional, mental health, and vitality. The physical component (PC) includes physical functioning, role limitations-physical, bodily pain, and general health perception. Raw domain scores are transformed to a 0 to 100 scale, [0=worst score (or quality of life) and 100=best score]. Two summary scale scores were computed based on weighted combinations of the 8 domain scores (Physical and the Mental Component) where no minimum or maximum score; higher score indicate better health status. The difference between study groups in change from baseline in SF-36 score at week 48 and 72 was analysed. (NCT00107653)
Timeframe: Baseline (Week 0), Week 48 and Week 72

,
InterventionScore on a scale (Mean)
Standardized PC, At Week 48 (n=178,224)Standardized PC, At Week 72 (n=172,213)Standardized MC, At Week 48 (n=178,224)Standardized MC, At Week 72 (n=172,213)
Latino-4.3-1.4-6.1-1.6
Non-Latino White-8.4-1.8-6.3-0.7

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Percentage of Participants With Early Virologic Response at Week 4

Percentage of participants with an early virologic response defined as an HCVRNA >=1 log10 drop from baseline or undetectable HCV-RNA measurement at Week 4 (lower limit of detection 28 IU/mL). (NCT00107653)
Timeframe: At Week 4

InterventionPercentage of participants (Number)
Latino71.0
Non-Latino White78.7

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Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72

METAVIR activity scores are categorised as histological activity (A) 0 = none; A1 = mild; A2 = moderate; A3 = severe where '0' being 'No activity' and '3' being 'the sever activity'. Changes in liver inflammation defined as Improved: Participants whose METAVIR activity score at up to Month-72 decreases by 1 or more units compared to baseline; stable: Participants whose METAVIR activity score at up to Month-72 is the same as the baseline score; worsened: Participants whose METAVIR activity score at up to Month-72 increases by 1 or more units compared to baseline. METAVIR fibrosis scores are categorised as fibrosis (F) 0 = no fibrosis; F1 = without septa; F 2 = with septa; F3 = many septa; F4 = cirrhosis where; '0' being the best and '4' being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in activity and fibrosis scores based on METAVIR at week 72 was analysed. (NCT00107653)
Timeframe: From Baseline (Week 0) to Week 72

,
InterventionScore on a scale (Mean)
Activity scores based on METAVIRFibrosis scores based on METAVIR
Latino-0.340.04
Non-Latino White-0.51-0.12

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Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time

The table below shows HCV-RNA log10 titers change from baseline values by study week and by study group. Analysis was performed for participants with a baseline and at least 1 post-baseline HCV-RNA assessment. HCV-RNA quantitation was performed using Roche High Pure System/COBAS® TaqMan® HCV Monitor Test. HCV-RNA measurement lower limit of detection was 28 IU/mL. (NCT00107653)
Timeframe: From Baseline (Week 0) to Weeks 4, 12, 24, 48, 60 and 72

,
InterventionLog10 IU/mL (Least Squares Mean)
At Week 4 (n=262, 280)At Week 12 (n=251,279)At Week 24 (n=235, 264)At Week 48 (n=207, 246)At Week 60 (n=181, 217)At Week 72 (n=174, 212)
Latino-2.3-3.9-4.2-4.1-2.7-2.7
Non-Latino White-2.9-4.5-4.8-4.8-3.7-3.6

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Percentage of Participants With Sustained Virologic Response at Week 72

Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test. (NCT00107653)
Timeframe: At Week 72

InterventionPercentage of participants (Number)
Latino33.5
Non-Latino White49.3

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Percentage of Participants With ISHAK Histological Activity Index Response

ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) in the ISHAK modified HAI (necroinflammatory) score at week 72. ISHAK modified HAI activity (necroinflammatory) score is a total score of periportal ± bridging (P/B) necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis grading as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5 = zone 3 multiple; 6 = panacinar necrosis and Focal necrosis grading as 0: absent; 1: < = 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation grading: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal. (NCT00107653)
Timeframe: At Week 72

InterventionPercentage of participants (Number)
Latino47.1
Non-Latino White58.7

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Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities

The table below includes participants with premature withdrawals due to adverse events or laboratory abnormalities. (NCT00107653)
Timeframe: Up to Week 72

,
InterventionParticipants (Number)
Psychiatric disordersGeneral disordersBlood and lymphatic system disordersGastrointestinal disordersNervous system disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersEye disordersMusculoskeletal and connective tissue disordersInvestigationsInfections and infestationsInjury, poisoning and procedural complicationsSocial circumstancesCardiac disordersEndocrine disordersVascular disorders
Latino8432321013100110
Non-Latino White12564333420122001

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Number of Participants With Marked Abnormal Laboratory Parameters

The below table includes participants with marked abnormal lab parameters. Standard reference ranges include: Hematocrit: (fraction) 0.37 - 0.49, Hemoglobin 130 - 180 g/L, Platelets 150 - 350 10^9/L, White Blood Cell (WBC) 4.5 - 11.0 10^9/L, Lymphocytes 1.00 - 4.80 10^9/L, Neutrophils 1.80 - 7.70 10^9/L, Aspartate aminotransferase (AST) 0-40 U/L, ALT 0 - 55 U/L, Total bilirubin 0 - 17 μmol/L, Thyroxine T4 58 - 140 nmol/L, Thyroid Stimulating Hormone (TSH) 0.0 - 5.0 million units (mU)/L, Albumin 35.0 - 55.0 g/L, Chloride 100 - 108 mmol/L, Calcium 2.10 - 2.60 mmol/L, Phosphate 0.84 - 1.45 mmol/L, Uric acid 214 - 506 μmol/L. (NCT00107653)
Timeframe: Up to Week 72

,
InterventionParticipants (Number)
Hematocrit low (n=269,298)Hemoglobin low (n=269,298)Platelets, low (n=269,298)WBC, high (n=269,298)WBC low (n=269,298)Lymphocytes low (n=269,298)Neutrophils, high (n=269,298)Neutrophils, low (n=269,298)AST, high (n=269,296)ALT, high (n=269,296)Total bilirubin, high (n=269,296)T4, high (n=17,16)T4, low (n=17,16)TSH, high (n=64,65)Albumin, low (n=269,296)Chloride, low (n=269,296)Calcium, low (n=269,296)Phosphate, high (n=269,296)Phosphate, low (n=269,296)Uric acid, high (n=269,296)
Latino499978219280720851464286204165112
Non-Latino White67126103725315915261474762411561618509

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Percentage of Participants Achieving Virologic Response

Percentage of participants achieving a virologic response defined as an undetectable HCV-RNA measurement (HCV-RNA <28 IU/mL by Roche High Pure System/COBAS TaqMan HCV Test) (NCT00107653)
Timeframe: At Weeks 4, 12, 24, 48, 60, and 72

,
InterventionPercentage of participants (Number)
At Week 4At Week 12At Week 24At Week 48At Week 60At Week 72
Latino13.848.059.556.133.133.5
Non-Latino White20.063.073.372.750.049.3

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Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score

The Nonalcoholic Steatohepatitis (NASH) included an assessment of sinusoidal fibrosis, Mallory bodies, and hepatocyte ballooning (HB). Grading categories for the NASH scales were as: Sinusoidal fibrosis: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules, without diffuse interstitial sinusoidal collagen deposition; 3 = Involvement of most or all lobules;, with diffuse interstitial fibrosis involving some or most of the lobules Mallory bodies: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules; and Hepatocyte ballooning: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules. (NCT00107653)
Timeframe: At Week 72

,
InterventionPercentage of participants (Number)
Sinusoidal Fibrosis Non-zero NASH Score at Week 72Mallory Bodies Non-zero NASH Score at Week 72HB Non-zero NASH Score at Week 72
Latino19.13.219.7
Non-Latino White18.42.09.5

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Percentage of Participants With Biochemical Response

Biochemical response was defined as normal serum alanine transaminase (ALT) measurement. For ALT measurement the normal range is 5-37 IU/L. (NCT00107653)
Timeframe: At Weeks 4, 12, 24, 48, 60 and 72

,
InterventionPercentage of participants (Number)
At Week 4At Week 12At Week 24At Week 48At Week 60At Week 72
Latino42.856.153.245.735.337.5
Non-Latino White57.072.068.059.753.756.7

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Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score

Overall ISHAK Fibrosis Score is defined as Improved: >= 1 category decrease in fibrosis scale; Stable: no change in fibrosis scale; Worsened: >1 category increase in fibrosis scale. (NCT00107653)
Timeframe: At Week 72

,
InterventionPercentage of participants (Number)
Improved Fibrosis ScoreStable Fibrosis ScoreWorsened Fibrosis Score
Latino24.852.922.3
Non-Latino White42.339.817.9

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Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score

METAVIR activity scale included activity defines as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: > = 1 category increase in activity score. (NCT00107653)
Timeframe: At Week 72

,
InterventionPercentage of participants (Number)
Stable Activity ScoreWorsened Activity ScoreImproved Activity Score
Latino54.17.038.9
Non-Latino White48.83.048.3

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Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score

METAVIR fibrosis score is categorized as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: >= 1 category increase in activity score. (NCT00107653)
Timeframe: At Week 72

,
InterventionPercentage of participants (Number)
Stable Fibrosis ScoreWorsened Fibrosis ScoreImproved Fibrosis Score
Latino71.315.313.4
Non-Latino White66.211.422.4

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Sustained Virologic Response

(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment) (NCT00136318)
Timeframe: assessed 24 weeks after end of antiviral treatment

Interventionpercentage of participants (Number)
Escitalopram56
Placebo46

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Severe Depression Defined as a MADRS Score of 25 or Higher

(NCT00136318)
Timeframe: severe depression during 24 or 48 weeks of antiviral therapy

Interventionpercentage of participants (Number)
Escitalopram1
Placebo12

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Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)

Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression (NCT00136318)
Timeframe: Patients free of depression during 24 or 48 weeks of antiviral therapy

Interventionparticipants (Number)
Escitalopram60
Placebo40

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Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria

(NCT00136318)
Timeframe: major depression during 24 or 48 weeks of antiviral therapy

Interventionpercentage of participants (Number)
Escitalopram8
Placebo17

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Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher

"Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as percentage of participants with MADRS scores > 13 (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)" (NCT00136318)
Timeframe: 50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3

Interventionpercentage of participants (Number)
Escitalopram32
Placebo59

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Percent of Participants Who Achieved Sustained Virologic Response (SVR)

"SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.~All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.~For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.~Arm 1A was not analyzed." (NCT00160251)
Timeframe: Baseline up to Week 73 [24 weeks after end of treatment (EoT)]

InterventionPercent of participants (Number)
Arm 1B: PEG + RBV + BOC 4007.5
Arm 2: PEG + BOC 100 (48 Weeks)2.1
Arm 3: PEG + BOC 200 (48 Weeks)12.2
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)5.2
Arm 5: PEG + RBV + BOC 40014.3
Arm 7: PEG + BOC 8004.6

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Peak Plasma Concentration of Boceprevir (BOC)

All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method. (NCT00160251)
Timeframe: All visits during treatment (baseline to Week 49) except Day 1 of Week 1

Interventionng/mL (Mean)
BOC 100 mg Dose203
BOC 200 mg Dose427
BOC 400 mg Dose704
BOC 800 mg Dose1312

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Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA

Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis. (NCT00160251)
Timeframe: Baseline up to Week 73 [24 weeks after EoT]

InterventionPercent of participants (Number)
0 to ≤ 4 Weeks to First Negative HCV-RNA Group58
>4 to 8 Weeks to First Negative HCV-RNA Group33
>8 to 12 Weeks to First Negative HCV-RNA Group33
>12 to 36 Weeks to First Negative HCV-RNA Group0

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Trough Plasma Concentration Level

All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method. (NCT00160251)
Timeframe: All visits during treatment (baseline to Week 49) except Day 1 of Week 1

Interventionng/mL (Mean)
BOC 100 mg Dose56.7
BOC 200 mg Dose133.0
BOC 400 mg Dose214.0
BOC 800 mg Dose355

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Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)

"Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.~All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.~For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.~Arm 1A was not analyzed." (NCT00160251)
Timeframe: Baseline up to Week 49

InterventionPercent of participants (Number)
Arm 1B: PEG + RBV + BOC 40035.0
Arm 2: PEG + BOC 100 (48 Weeks)6.3
Arm 3: PEG + BOC 200 (48 Weeks)16.3
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)13.4
Arm 5: PEG + RBV + BOC 40020.4
Arm 7: PEG + BOC 80021.5

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Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop

"For each log drop category (<0, 0 to 0.5, 0.5 to <1, 1 to <1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:~Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).~Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group." (NCT00160251)
Timeframe: Week 1 and Week 49

,,
InterventionPercent of participants (Number)
Log drop <0 (Arm2-4,6 n=21/Arm5 n=6/Arm7 n=3)Log drop 0-0.5 (Arm2-4,6 n=55/Arm5 n=17/Arm7 n=16)Log drop 0.5to<1(Arm2-4,6 n=73/Arm5 n=11/Arm7 n=9)Log drop 1to<1.5(Arm2-4,6 n=31/Arm5 n=9/Arm7 n=18)Log drop ≥1.5 (Arm2-4,6 n=12/Arm5 n=4/Arm7 n=18)Missing (Arm2-4,6 n=2/Arm5 n=2/Arm7 n=1)
Arm 5: PEG + RBV + BOC 40016.717.69.133.350.00
Arm 7: PEG + BOC 800118.8016.744.40
Arms 2, 3, 4, 6: PEG + BOC 100, 200, or 4009.51.812.325.833.30

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Percent of Participants With Virologic Response Prior to Amendment 2

Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL. (NCT00160251)
Timeframe: Week 3, Week 5, Week 13

,,,,,
InterventionPercent of participants (Number)
Week 3Week 5Week 13
Arm 1A: PEG + RBV and Arm 1B: PEG + RBV + BOC 4004.14.16.1
Arm 2: PEG + BOC 100 (48 Weeks)0.00.02.1
Arm 3: PEG + BOC 200 (48 Weeks)0.08.214.3
Arm 5: PEG + RBV + BOC 400012.230.6
Arm 7: PEG + BOC 8004.615.40
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)5.29.313.4

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Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])

Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date). (NCT00160251)
Timeframe: From dosing change to end of follow-up (Week 73)(up to 48 weeks)

,,,,,
InterventionParticipants (Number)
Week 3 after dosing changeWeek 6 after dosing changeWeek 9 after dosing changeWeek 12 after dosing changeWeek 18 after dosing changeWeek 24 after dosing changeEnd of treatmentFollow-up Week 4 after dosing changeFollow-up Week 8 after dosing changeFollow-up Week 12 after dosing changeFollow-up Week 24 after dosing changeEnd of follow-up after dosing change
Log Drop ≥5211111111111
Log Drop 0 to <1000011100000
Log Drop 1 to <2000000000000
Log Drop 2 to <3000011100000
Log Drop 3 to <4444444444444
Log Drop 4 to <511119911121186677

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Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)

Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date). (NCT00160251)
Timeframe: From dosing change to end of follow-up (Week 73)(up to 48 weeks)

,,,,
InterventionParticipants (Number)
Week 3 after dosing changeWeek 6 after dosing changeWeek 9 after dosing changeWeek 12 after dosing changeWeek 18 after dosing changeWeek 24 after dosing changeEnd of treatmentFollow-up Week 4 after dosing changeFollow-up Week 8 after dosing changeFollow-up Week 12 after dosing changeFollow-up Week 24 after dosing changeEnd of follow-up after dosing change
Log Drop ≥5100000000000
Log Drop 1 to <2000000000000
Log Drop 2 to <3000000000000
Log Drop 3 to <4333323333233
Log Drop 4 to <5121010965764544

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Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)

Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date). (NCT00160251)
Timeframe: From dosing change to end of follow-up (Week 73) (up to 48 weeks)

,,,,,,,
InterventionParticipants (Number)
Week 3 after dosing changeWeek 6 after dosing changeWeek 9 after dosing changeWeek 12 after dosing changeWeek 18 after dosing changeWeek 24 after dosing changeEnd of treatmentFollow-up Week 4 after dosing changeFollow-up Week 8 after dosing changeFollow-up Week 12 after dosing changeFollow-up Week 24 after dosing changeEnd of follow-up after dosing change
Log Drop <0000000000000
Log Drop ≥5443444410111
Log Drop 0 to <1000000000000
Log Drop 1 to <2000001100000
Log Drop 2 to <3000111100000
Log Drop 3 to <4535454411111
Log Drop 4 to <5757533320111
Missing Data311221100000

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Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period

"All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.~The dosing interval of 8 hours is represented as the hr in the unit of measure." (NCT00160251)
Timeframe: All visits during treatment (baseline to Week 49) except Day 1 of Week 1

Interventionng*hr/mL (Mean)
BOC 100 mg Dose1042
BOC 200 mg Dose2184
BOC 400 mg Dose3633
BOC 800 mg Dose6276

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Change in Alanine Aminotransferase (ALT) Levels

Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline. (NCT00160251)
Timeframe: Baseline up to dosing change (> 25 weeks)

,,,,,,,
InterventionParticipants (Number)
<2.00 x baseline ALT value2.00-2.09 x baseline ALT value2.10-5.09 x baseline ALT value5.10-10.0 x baseline ALT value>10.0 x baseline ALT value
Arm 1A: PEG + RBV141000
Arm 1B: PEG + RBV + BOC 400331000
Arm 2: PEG + BOC 100 (48 Weeks)451200
Arm 3: PEG + BOC 200431300
Arm 5: PEG + RBV + BOC 400470100
Arm 7: PEG + BOC 800610300
Arm 8: PEG + RBV + BOC 80011941811
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)844900

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Percentage of Participants With Virological Responses Over Time

Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week. (NCT00192647)
Timeframe: Weeks 4, 8, 12, and 24

,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 24
PEG-IFN Alfa-2a+Ribavirin - Induction Treatment36.060.574.475.1
PEG-IFN Alfa-2a+Ribavirin - Standard Treatment26.349.861.667.8

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Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response

The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100. (NCT00192647)
Timeframe: Weeks 4, 12, and 72

,
Interventionpercentage of participants (Number)
Week 4: PPV (n= 416, 419)Week 4: NPV (n= 416, 419)Week 12: PPV (n= 412, 413)Week 12: NPV (n= 412, 413)
PEG-IFN Alfa-2a+Ribavirin - Induction Treatment76606687
PEG-IFN Alfa-2a+Ribavirin - Standard Treatment80607287

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Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period

Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period. (NCT00192647)
Timeframe: Week 72

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a+Ribavirin - Induction Treatment53
PEG-IFN Alfa-2a+Ribavirin - Standard Treatment50

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Percentage of Participants With Relapse of End-of-treatment Virological Response

Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis. (NCT00192647)
Timeframe: Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a+Ribavirin - Induction Treatment24
PEG-IFN Alfa-2a+Ribavirin - Standard Treatment22

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Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period

Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48. (NCT00192647)
Timeframe: Weeks 48

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a+Ribavirin - Induction Treatment70
PEG-IFN Alfa-2a+Ribavirin - Standard Treatment66

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Change From Baseline in Log10 HCV RNA Values

The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group. (NCT00192647)
Timeframe: Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)

,
InterventionLog 10 IU/mL (Mean)
Baseline (n=427,431)Change at Week 4 (n=410,412)Change at Week 8 (n=399,406)Change at Week 12 (n=406,407)Change at Week 24 (n=369,369)Change at EoT (n=425,426)
PEG-IFN Alfa-2a+Ribavirin - Induction Treatment6.19-3.42-4.26-4.57-4.58-4.49
PEG-IFN Alfa-2a+Ribavirin - Standard Treatment6.17-2.75-3.68-4.04-4.28-4.13

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The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.

Virologic response was defined as undetectable HCV-RNA level in the blood. (NCT00202839)
Timeframe: 48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)

InterventionPercentage of Participants (Number)
24-Week Treatment57.69
48-Week Treatment67.07

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The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)

Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy (NCT00202839)
Timeframe: 24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy

InterventionPercentage of participants (Number)
24-Week Treatment56.41
48-Week Treatment67.07

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Overall Number of Serious Adverse Events

(NCT00211692)
Timeframe: through end of study up to 72 weeks

Interventionparticipants (Number)
Overall2

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The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.

Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study (NCT00211692)
Timeframe: 24 weeks after the end of treatment

Interventionparticipants (Number)
A (52 Weeks Treatment)11
B (Duration Based on Viral Response)10

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Participants Achieving SVR Categorized by Time of Response

rapid virologic response assessed at 4 weeks, early virologic response assessed at 8-12 weeks, late virologic response assessed at 16-24 weeks (NCT00211692)
Timeframe: 24 weeks after end of treatment

Interventionparticipants (Number)
rapid virologic response (n=20)early virologic response (n=13)late virologic response (n=9)
Overall1542

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Number of Participants Discontinuing Early From Study Treatment

(NCT00211692)
Timeframe: through end of study up to 72 weeks

Interventionparticipants (Number)
Overall26

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Number of Subjects Who Achieved a Sustained Virologic Response (SVR)

SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed. (NCT00255008)
Timeframe: 24 weeks after completion of either up to 24 or 48 weeks of therapy

InterventionParticipants (Number)
Genotype 1 SEA PEG-IFN/RIB 48 w4
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w13
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w7

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Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy

No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target. (NCT00255034)
Timeframe: 24 weeks after completion of either up to 24 or 48 weeks of therapy

InterventionParticipants (Number)
24 Weeks of Therapy55
48 Weeks of Therapy36

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Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment.

LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche) (NCT00265395)
Timeframe: 48 or 72 weeks of treatment plus 24 weeks of follow-up.

InterventionParticipants (Number)
Standard Therapy (48-week Treatment)37
Extended Therapy (72-week Treatment)35

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The Number of Participants Who Achieve a Sustained Virologic Response (SVR)

A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid [HCV-RNA] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable. (NCT00302081)
Timeframe: 24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.

Interventionparticipants (Number)
PEG2b 1.5/R (24 Weeks)153
PEG2b 1.0/R (24 Weeks)144
PEG2b 1.5/R (16 Weeks)129

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Number of Subjects With Viral Relapse

Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00336479)
Timeframe: After last dose of study drug up to antiviral follow-up (up to Week 72)

Interventionparticipants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week8
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week3
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week1
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week3

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Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00336479)
Timeframe: 12 weeks after the completion of study drug dosing (up to Week 60)

Interventionpercentage of participants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week36.0
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week58.2
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week53.2
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week35.3

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Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study." (NCT00336479)
Timeframe: Baseline up to Week 48

,,,
Interventionparticipants (Number)
AEsSAEs
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week754
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week7910
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week173
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week795

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Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir

Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported. (NCT00336479)
Timeframe: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85

Interventionnanogram per milliliter (ng/mL) (Mean)
CmaxCminCavg
Telaprevir3032.482235.512738.46

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Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00336479)
Timeframe: 24 weeks after the completion of study drug dosing (up to Week 72)

Interventionpercentage of participants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week41.3
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week67.1
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week60.8
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week35.3

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Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia

Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia. (NCT00353418)
Timeframe: Up to Week 72

,
InterventionPercentage of participants (Number)
Adverse anemic eventSerious adverse anemic eventPEG-INF alfa-2a dose modification due to anemiaRibavirin dose modification due to anemiaPremature PEG-INF alfa-2a withdrawal due to anemiaPremature ribavirin withdrawal due to anemia
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg32431833
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg24421012

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Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12

EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders. (NCT00353418)
Timeframe: Week 12

,
InterventionPercentage of participants (Number)
Early Virological ResponsePartial Early Virological ResponseComplete Early Virological Response
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg613526
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg512526

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Virological Response at Weeks 4, 12 and 24

Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week. (NCT00353418)
Timeframe: Weeks 4, 12 and 24

,
InterventionPercentage of participants (Number)
Week 4Week 12Week 24
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg72540
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg82533

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Virological Response at End of Treatment Period

Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders. (NCT00353418)
Timeframe: Week 48

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg30
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg35

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Sustained Virological Response (SVR)

SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders. (NCT00353418)
Timeframe: Week 72

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg19
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg22

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Relapse of Virological Response

Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment. (NCT00353418)
Timeframe: Weeks 48 and 72

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg32
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg36

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Rapid Virological Response (RVR) by Week 4

RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders. (NCT00353418)
Timeframe: Week 4

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg8
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg7

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Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00372385)
Timeframe: 12 weeks after the completion of study drug dosing (up to Week 60)

Interventionpercentage of participants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week47.6
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week69.1
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week59.8
Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week37.2

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Number of Subjects With Viral Relapse

Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00372385)
Timeframe: After last dose of study drug up to antiviral follow-up (up to Week 72)

Interventionparticipants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week10
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week8
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week19
Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week22

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Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00372385)
Timeframe: Completion of study drug dosing (up to Week 48)

Interventionpercentage of participants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week54.9
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week70.4
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week80.5
Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week61.5

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Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir

Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported. (NCT00372385)
Timeframe: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85

Interventionnanogram per milliliter (ng/mL) (Mean)
CmaxCminCavg
Telaprevir337025103055

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Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study." (NCT00372385)
Timeframe: Baseline up to Week 48

,,,
Interventionparticipants (Number)
AEsSAEs
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week818
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week8016
Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week789
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week8211

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Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00372385)
Timeframe: 24 weeks after the completion of study drug dosing (up to Week 72)

Interventionpercentage of participants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week46.3
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week69.1
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week59.8
Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week35.9

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A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment

Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV. (NCT00378599)
Timeframe: 24 weeks after completion of up to 48 weeks of therapy

InterventionParticipants (Number)
PEG-Intron Plus Ribavirin36

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SVR-24 (Actual Treatment Period)

SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug. (NCT00394277)
Timeframe: 24 weeks after end of treatment

InterventionPercentage of patients (Number)
PEG-IFN 180 µg + Ribavirin 1200 mg38.2
PEG-IFN 180 µg + Ribavirin 1400/1600 mg43.9
PEG-IFN 360/180 µg + Ribavirin 1200 mg43.5
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg40.7

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SVR-12 (Scheduled Treatment Period)

SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60). (NCT00394277)
Timeframe: 12 weeks after end of treatment

InterventionPercentage of patients (Number)
PEG-IFN 180 µg + Ribavirin 1200 mg40.3
PEG-IFN 180 µg + Ribavirin 1400/1600 mg45.0
PEG-IFN 360/180 µg + Ribavirin 1200 mg44.2
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg41.5

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SVR-12 (Actual Treatment Period)

SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug. (NCT00394277)
Timeframe: 12 weeks after end of treatment

InterventionPercentage of patients (Number)
PEG-IFN 180 µg + Ribavirin 1200 mg40.3
PEG-IFN 180 µg + Ribavirin 1400/1600 mg45.5
PEG-IFN 360/180 µg + Ribavirin 1200 mg44.2
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg42.3

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Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)

SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477). (NCT00394277)
Timeframe: Week 72

InterventionPercentage of patients (Number)
PEG-IFN 180 µg + Ribavirin 1200 mg37.7
PEG-IFN 180 µg + Ribavirin 1400/1600 mg42.9
PEG-IFN 360/180 µg + Ribavirin 1200 mg43.5
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg40.7

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Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study." (NCT00420784)
Timeframe: Baseline up to 2 weeks after last dose of study drug (up to Week 50)

,,,
Interventionparticipants (Number)
AEsSAEs
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week1119
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week1126
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week1056
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week11316

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Number of Subjects With Viral Relapse

Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00420784)
Timeframe: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)

Interventionparticipants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week26
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week10
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week32
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week18

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Percentage of Subjects With Undetectable Plasma HCV RNA

"Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week and at 48 weeks after last dose of study drug for treatment groups Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL)." (NCT00420784)
Timeframe: Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week48.7
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week44.2
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week22.5
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week14.0

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Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00420784)
Timeframe: Completion of study drug dosing (up to Week 48)

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week75.7
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week67.3
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week54.1
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week29.8

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Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00420784)
Timeframe: 24 weeks after the completion of study drug dosing (up to Week 72)

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week51.3
Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week53.1
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week24.3
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week14.0

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Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir

Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported. (NCT00420784)
Timeframe: Week 2, 4, 8, 12, 16, 24

Interventionnanogram per milliliter (ng/mL) (Mean)
CmaxCminCavg
Telaprevir275523352610

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Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR

"Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL." (NCT00423670)
Timeframe: At FW 12 and FW 24 up to EOF

,,,,,,
InterventionParticipants (Number)
HCV-RNA negative at EOFHCV-RNA positive at EOFMissing HCV-RNA at EOF
Arm 1. PEG +RBV for 48 Wks (Part I)3900
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)5820
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)5810
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)6900
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)7600
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)800
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)2010

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Number of Participants Negative for HCV-RNA at FW 12

"Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL." (NCT00423670)
Timeframe: At FW 12

,,,,,,
InterventionParticipants (Number)
HCV-RNA negativeMissing HCV-RNA at FW 12
Arm 1. PEG +RBV for 48 Wks (Part I)3942
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)6013
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)5911
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)6912
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)7614
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)82
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)2117

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Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization

"Participants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL." (NCT00423670)
Timeframe: 72 weeks post randomization

,,,,,,
InterventionParticipants (Number)
HCV-RNA negativeMissing HCV-RNA at 72 weeks post randomization
Arm 1. PEG +RBV for 48 Wks (Part I)3845
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)5325
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)5618
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)6717
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)7620
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)86
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)2022

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Number of Participants With SVR Based on Duration of Boceprevir Treatment

"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL." (NCT00423670)
Timeframe: From FW 24 up to EOF

InterventionParticipants (Number)
Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks)146
Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks)116

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Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR

"Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL." (NCT00423670)
Timeframe: At FW 24 up to EOF and at 72 weeks post randomization

,,,,,,
InterventionParticipants (Number)
HCV-RNA negative at 72 weeks post randomizationHCV-RNA positive at FW 24Missing HCV-RNA at 72 weeks post randomization
Arm 1. PEG +RBV for 48 Wks (Part I)3801
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)5305
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)5602
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)6702
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)7601
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)800
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)2001

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Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin

"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL." (NCT00423670)
Timeframe: From FW 24 up to EOF

InterventionParticipants (Number)
Arm 3 and Arm 5. PEG + RBV + BOC (From Wk 4)135
Arm 2 and Arm 4. PEG + RBV + BOC127

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Number of Participants With Sustained Virologic Response (SVR)

"Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL).~A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR." (NCT00423670)
Timeframe: From follow-up week (FW) 24 up to end of follow-up (EOF)

InterventionParticipants (Number)
Arm 1. PEG +RBV for 48 Wks (Part I)39
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)58
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)58
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)69
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)77
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)8
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)21

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Number of Participants With an Early Virologic Response (EVR) That Achieved SVR

"Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL." (NCT00423670)
Timeframe: At TW 12, and at FW 24 up to EOF

InterventionParticipants (Number)
Arm 1. PEG +RBV for 48 Wks (Part I)32
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)58
Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)58
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)68
Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)77
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)8
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)21

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Number of Participants With a Virological Relapse

"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).~Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment." (NCT00423800)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

,
InterventionParticipants (Number)
Participants with Virological RelapseParticipants with No Virological Relapse
Pegetron® - 24 Weeks03
Pegetron® - 48 Weeks01

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Number of Participants With a Sustained Virologic Response

"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.~Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder." (NCT00423800)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

,
InterventionParticipants (Number)
RespondersNon-responders
Pegetron® - 24 Weeks30
Pegetron® - 48 Weeks11

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Number of Subjects Who Have Achieved Sustained Virological Response (SVR) at 24 Weeks Post End of Treatment

Sustained virologic response is defined as a plasma HCV RNA level below Lower Level of Quantitation at 24 weeks post-treatment, which is < 30 IU/mL in this study. (NCT00441584)
Timeframe: Up to 48 weeks of treatment plus 24 weeks follow up

InterventionParticipants (Number)
PegIntron Plus Rebetol1

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Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12.

The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as <100 copies/mL serum HCV RNA. A PR is defined as < 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group. (NCT00446134)
Timeframe: Treatment Week 12

,,,
InterventionParticipants (Number)
Early Virologic Response (EVR) (less than 100)No EVR (non-responder, Total)Detectable (greater than 100 copies/mL at TW 12)Discontinued (Prior to TW 12)Missing (No value at TW 12)
Ribavirin 800 mg/Day363419150
Taribavirin 20 mg/kg/Day43241770
Taribavirin 25 mg/kg/Day403017121
Taribavirin 30 mg/kg/Day373121100

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Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24

The primary safety endpoint will be the numbers of patients with hemoglobin <10 g/dL (anemia) at any time during the treatment period. The comparison of anemia rates between taribavirin and ribavirin groups will be carried out using the Fisher's exact test or Chi-square test. The 95% confidence interval of the difference in proportion will be analyzed. (NCT00446134)
Timeframe: Treatment Week Follow-Up 24

InterventionParticipants (Number)
Taribavirin 20 mg/kg/Day11
Taribavirin 25 mg/kg/Day11
Taribavirin 30 mg/kg/Day19
Ribavirin 800 mg/Day23

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Relapsers at Follow-Up Visit 24

Includes patients who had undetectable Hepatitis Virus C (HVC) Ribonucleic Acid (RNA) at their last visit on drug. (NCT00446134)
Timeframe: Follow-Up Week 24

InterventionParticipants (Number)
Taribavirin 20 mg/kg/Day10
Taribavirin 25 mg/kg/Day5
Taribavirin 30 mg/kg/Day3
Ribavirin 800 mg/Day5

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Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24

(NCT00446134)
Timeframe: Treatment Week Follow-Up 24

,,,
InterventionParticipants (Number)
Responder Follow-Up Week 24Non-Responder Follow-Up Week 24Detectable HCV RNA Follow-Up Week 24Discontinued Week Follow-Up Week 24
Ribavirin 800 mg/Day19511437
Taribavirin 20 mg/kg/Day19481434
Taribavirin 25 mg/kg/Day19511536
Taribavirin 30 mg/kg/Day19491633

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Improvement in Viral Kinetics During the First 2 Weeks of Therapy

Improvement of slopes of decline in hepatitis C virus Ribonucleic acid in second course compared with first course in days 7 to 14 of therapy (NCT00475176)
Timeframe: Days 7 to 14 of therapy

Interventionparticipants (Number)
Hepatitis C Treated With Peginterferon and Ribavirin14

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2-log Decline in HCV RNA by Week 12 (Early Virological Response) and Sustained Eradication of HCV RNA (Sustained Virological Response).

2-log decline in HCV RNA by week 12 (early virological response) and sustained eradication of HCV RNA (sustained virological response). (NCT00475176)
Timeframe: 12 weeks from start of therapy

Interventionparticipants (Number)
Hepatitis C Treated With Peginterferon and Ribavirin11

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Percentage of Participants With SVR (Groups C, D, E, and F)

SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis. (NCT00483938)
Timeframe: At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)

Interventionpercentage of participants (Number)
Pegylated-interferon Alfa-2a + Ribavirin (Group C)73.3
Pegylated-interferon Alfa-2a + Ribavirin (Group D)74.2
Pegylated-interferon Alfa-2a + Ribavirin (Group E)84.0
Pegylated-interferon Alfa-2a + Ribavirin (Group F)84.0

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Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)

"End of treatment response (ETR) was defined as Success if the HCV-RNA levels were <15 IU/mL at the end of treatment. Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as Success, if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as Success, if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point." (NCT00483938)
Timeframe: Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)

,,,,,
Interventionpercentage of participants (Number)
ETRComplete EVRPartial EVR
Pegylated-interferon Alfa-2a + Ribavirin (Group A)80.500
Pegylated-interferon Alfa-2a + Ribavirin (Group B)76.700
Pegylated-interferon Alfa-2a + Ribavirin (Group C)96.793.30
Pegylated-interferon Alfa-2a + Ribavirin (Group D)90.396.83.2
Pegylated-interferon Alfa-2a + Ribavirin (Group E)92.088.00
Pegylated-interferon Alfa-2a + Ribavirin (Group F)100.092.00

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Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)

SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis. (NCT00483938)
Timeframe: At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)

Interventionpercentage of participants (Number)
Pegylated-interferon Alfa-2a + Ribavirin (Group A)48.8
Pegylated-interferon Alfa-2a + Ribavirin (Group B)39.5

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Number of Participants With Histologic Response(HR)

Number of participants with histologic response (HR): number of patients who had improvement of as least 2 scores at the end of follow-up liver biopsy compared to baseline liver biopsy by Ishak scoring system (the sum of Ishak necroinflammation score (0-18) and Ishak fibrosis score (0-6); the higher the total scores, the severer the histologic changes) (NCT00491179)
Timeframe: 1.5 year

InterventionParticipants (Number)
Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)11
Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)6

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1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs)

"Number of participants with sustained virologic response (SVR): number of patients with undetectable HCV RNA 6 months off therapy by real-time PCR test (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, limit of detection < 25 IU/mL)~Number of participants who droppoed out of the study prematurely due to adverse events (AEs): number of patients who prematurely withdrew from the study due to any adverse events" (NCT00491179)
Timeframe: 1.5 year

,
InterventionParticipants (Number)
Sustained virologic response (SVR)Drop-out
Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)82
Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)137

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Sustained Virologic Response (SVR)Rate

(NCT00491244)
Timeframe: 1.5 year

Interventionparticipants (Number)
Peginterferon and Ribavirin130
Peginterferon72

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Early Virological Response in Participants With and Without Insulin Resistance

Early Virological Response (EVR) defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline in participants with and without insulin resistance. (NCT00493805)
Timeframe: At Week 12 (after start of therapy)

InterventionParticipants (Number)
Non Interventional Arm HOMA IR <= 210
Interventional Arm HOMA IR > 224

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Sustained Virological Response (PCR 24 Weeks After End of Treatment)

Sustained virological response (SVR) was defined as undetectable HCV RNA in serum at the end of follow-up (24 weeks after end of therapy) according to a polymerase chain reaction (PCR) assay. (NCT00493805)
Timeframe: Up to 24 weeks following 48 or 72 weeks of therapy

InterventionParticipants (Number)
Non Interventional Arm HOMA IR <= 21
Interventional Arm HOMA IR > 23

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Histologic Response

Histologic response: improvement of at least 2 grade of scores by Ishak liver histologic classification by end of follow up liver biopsy to baseline liver biopsy (NCT00495131)
Timeframe: 18 months

InterventionParticipants (Number)
Peginterferon and Ribavirin (24 Weeks)71
Peginterferon and Ribavirin (48 Weeks)97

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Sustained Virologic Response

Undetectable HCV RNA 6 months off therapy (NCT00495131)
Timeframe: 18 months

Interventionparticipants (Number)
Peginterferon and Ribavirin (24 Weeks)87
Peginterferon and Ribavirin (48 Weeks)117

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Sustained Biochemical Response

Sustained biochemical response (SBR): alanine aminotransferase (ALT) normalization (NCT00495131)
Timeframe: 18 months

InterventionParticipants (Number)
Peginterferon and Ribavirin (24 Weeks)75
Peginterferon and Ribavirin (48 Weeks)107

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End of Treatment Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders. (NCT00495391)
Timeframe: At end of treatment

,
Interventionparticipants (Number)
RespondersNon-responders
NTZ+PR636
Placebo+PR121

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Early Virologic Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy. (NCT00495391)
Timeframe: After 12 weeks combination treatment

,
Interventionparticipants (Number)
RespondersNon-responders
NTZ+PR339
Placebo+PR022

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Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders. (NCT00495391)
Timeframe: 24 weeks after end of treatment

,
Interventionparticipants (Number)
RespondersNon-responders
NTZ+PR339
Placebo+PR022

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Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up. (NCT00495391)
Timeframe: From baseline to week 8

,
Interventionparticipants (Number)
Remains ElevatedElevated to NormalRemains NormalNormal to Elevated
NTZ+PR14791
Placebo+PR8291

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Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up. (NCT00495391)
Timeframe: From baseline to week 16

,
Interventionparticipants (Number)
Remains ElevatedElevated to NormalRemains NormalNormal to Elevated
NTZ+PR66120
Placebo+PR2261

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Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up. (NCT00495391)
Timeframe: From baseline to end of treatment

,
Interventionparticipants (Number)
Remains ElevatedElevated to NormalRemains NormalNormal to Elevated
NTZ+PR0150
Placebo+PR0010

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Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up. (NCT00495391)
Timeframe: From baseline to end of follow up

,
Interventionparticipants (Number)
Remains ElevatedElevated to NormalRemains NormalNormal to Elevated
NTZ+PR0141
Placebo+PR0010

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Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy. (NCT00495391)
Timeframe: After 4 weeks combination treatment

,
Interventionparticipants (Number)
RespondersNon-responders
NTZ+PR240
Placebo+PR022

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Occurrences of Pneumonia

Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint. (NCT00500578)
Timeframe: 6 Years

InterventionParticipants (Number)
Standard Schedule - Ribavarin4
Modified Schedule - Ribavarin3

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Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)

SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication. (NCT00528528)
Timeframe: EOT (up to Week 48) and up to 24 weeks after EOT

InterventionPercentage of participants (Number)
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet85.0
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule81.0
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet82.5
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule82.1

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Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12

Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration. (NCT00528528)
Timeframe: Baseline (pre-dose), Week 12

,,,
Interventionlog 10 IU/mL (Mean)
BaselineChange from Baseline at Week 12
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet6.4-4.8
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule6.5-5.1
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet6.4-5.2
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule6.5-5.4

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Percentage of Participants With Virologic Response at Week 12

Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). (NCT00528528)
Timeframe: End of treatment (EOT) (up to Week 48)

InterventionPercentage of participants (Number)
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet92.5
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule88.1
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet92.5
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule87.2

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Percentage of Participants With Partial Response

Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples). (NCT00528528)
Timeframe: Baseline (Day 1) up to EOT (up to Week 48)

InterventionPercentage of participants (Number)
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet5
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule0
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet2.5
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule5.1

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Number of Participants With Viral Breakthrough at End of Treatment (EOT)

Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL. (NCT00528528)
Timeframe: EOT (up to Week 48)

InterventionParticipants (Number)
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet1
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule6
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet3
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule4

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Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level

Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). (NCT00528528)
Timeframe: Baseline (Day 1) up to EOT (up to Week 48)

InterventionDays (Median)
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet22
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule22.5
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet22
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule29

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Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)

Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. (NCT00528528)
Timeframe: Baseline (pre-dose), EOT (up to Week 48)

Interventionlog 10 IU/mL (Mean)
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet-5.5
Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule-5.2
Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet-5.4
Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule-5.3

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Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response

Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL. (NCT00535847)
Timeframe: Baseline up to Week 72

,,,
Interventionparticipants (Number)
Prior Null ResponsePrior Partial ResponsePrior Viral BreakthroughPrior Relapse
Achieved eRVR/Achieved SVR1215624
Achieved eRVR/Did Not Achieve SVR5700
Did Not Achieve eRVR/Achieved SVR7104
Did Not Achieve eRVR/Did Not Achieve SVR27621

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Percentage of Prior Relapsers With Undetectable HCV RNA

Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00535847)
Timeframe: 24 weeks after the completion of treatment (up to Week 72)

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week96.0
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week100.0
Other100.0

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Percentage of Subjects With End of Treatment Response

Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00535847)
Timeframe: End of treatment (up to Week 48)

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week72.8
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week64.7
Other100.0

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Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00535847)
Timeframe: 48 weeks after completion of treatment (up to Week 96)

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week83.1
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week70.0

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Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL). (NCT00535847)
Timeframe: 24 weeks after the completion of treatment (up to Week 72)

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week60.5
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week52.9
Other100.0

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Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study." (NCT00535847)
Timeframe: Baseline through Week 48

,,
Interventionparticipants (Number)
AEsSAEs
Other21
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week777
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week313

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Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E)

Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction. (NCT00537407)
Timeframe: Baseline to Day 29

InterventionLog10(IU/mL) (Mean)
Treatment Arm A-0.881
Treatment Arm D-2.321
Treatment Arm E-2.020

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log10 Hepatitis C Virus RNA at Day 29

Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction. (NCT00537407)
Timeframe: Day 29

InterventionLog10(IU/mL) (Mean)
Treatment Arm A5.567
Treatment Arm B6.662
Treatment Arm C5.827
Treatment Arm D4.000
Treatment Arm E4.245

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Percentage of Participants With a Rapid Viral Response at Day 29

A participant had a rapid viral response if their viral RNA was undetectable (< 10 IU/mL). (NCT00537407)
Timeframe: Day 29

Interventionpercentage of participants (Number)
Treatment Arm A0.0
Treatment Arm B0.0
Treatment Arm C0.0
Treatment Arm D10
Treatment Arm E10

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Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96)

A participant had a sustained viral response if their viral RNA was undetectable (< 10 IU/mL). (NCT00537407)
Timeframe: 24 weeks after the end of treatment (Week 72 or 96)

Interventionpercentage of participants (Number)
Treatment Arm A0.0
Treatment Arm B0.0
Treatment Arm C9.1
Treatment Arm D0.0
Treatment Arm E10.0

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Percentage of Participants With an Early Viral Response at Week 12

A participant had an early viral response if their viral RNA had decreased ≥ 2 log10 at Week 12 compared to Baseline. (NCT00537407)
Timeframe: Baseline to Week 12

Interventionpercentage of participants (Number)
Treatment Arm A30.0
Treatment Arm B11.1
Treatment Arm C27.3
Treatment Arm D70.0
Treatment Arm E30.0

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Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72)

A participant had an end-of-treatment response if their viral RNA was undetectable (< 10 IU/mL). (NCT00537407)
Timeframe: End of treatment (Week 48 or 72)

Interventionpercentage of participants (Number)
Treatment Arm A20.0
Treatment Arm B11.1
Treatment Arm C18.2
Treatment Arm D10.0
Treatment Arm E30.0

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Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C)

Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction. (NCT00537407)
Timeframe: Baseline to Day 29

InterventionLog10(IU/mL) (Mean)
Treatment Arm B0.285
Treatment Arm C-0.608

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Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed

"Blood was collected for a fasting Hemoglobin A1C level at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72

,
InterventionPercent (Mean)
Week 4 (n=3, 5)Week 8 (n=4, 28)Week 12 (n=50, 65)Week 16 (n=5, 4)Week 20 (n=1, 4)Week 24 (n=41, 51)Week 28 (n=11, 12)Week 32 (n=2, 2)Week 36 (n=0, 2)Week 40 (n=8, 1)Week 44 (n=7, 0)Week 48 (N=31, 46)Week 60 (N=1, 2)Week 72 (N=29, 38)
PEG-INF Alpha-2a + Ribavirin-0.1-1.0-1.5-1.7-1.3-1.5-1.1-1.7-0.5-1.8NA-1.1-0.1-0.1
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-0.4-0.9-1.1-0.8-0.6-1.0-0.7-1.0NA-0.3-0.7-0.8-0.2-0.1

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Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.

"Blood was collected for fasting insulin levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionpmol/L (Mean)
Week 4 (N=56, 43)Week 8 (N=4, 27)Week 12 (N=52, 65)Week 16 (N=5, 5)Week 20 (N=2, 3)Week 24 (N=42, 60)Week 28 (N=12, 13)Week 32 (N=2, 3)Week 36 (N=0, 2)Week 40 (N=8, 2)Week 44 (N=4, 0)Week 48 (N=32, 46)Week 60 (N=1, 3)Week 72 (N=30, 40)
PEG-INF Alpha-2a + Ribavirin-28.47.3-36.0-162.2180.1-29.1-21.241.741.062.2NA-14.391.0-4.8
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone6.4-40.6-34.4-59.0132.6-38.411.8-47.2NA2.0370.5-38.0-13.2-61.4

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Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed

"Blood was collected for plasma fasting glucose levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionmmol/L (Mean)
Week 4 (n=58, 70)Week 8 (n=57, 68)Week 12 (n=55, 66)Week 16 (n=53, 61)Week 20 (n=46, 57)Week 24 (n=47, 61)Week 28 (n=51, 62)Week 32 (n=39, 47)Week 36 (n=38, 46)Week 40 (n=44, 50)Week 44 (n=37, 43)Week 48 (n=34, 46)Week 60 (n=33, 41)Week 72 (n=30, 38)
PEG-INF Alpha-2a + Ribavirin-0.2-0.1-0.6-0.5-0.3-0.3-0.3-0.5-0.4-0.7-0.2-0.1-0.1-0.1
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-0.4-0.7-0.8-0.8-0.6-0.5-0.4-0.5-0.6-0.4-0.4-0.5-0.6-0.6

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Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed

"Blood was collected for free fatty acids at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionmmol/L (Mean)
Week 4 (n=55, 35)Week 8 (n=2, 2)Week 12 (n=52, 32)Week 16 (n=5, 3)Week 20 (n=2, 3)Week 24 (n=40, 31)Week 28 (n=11, 5)Week 32 (n=2, 1)Week 36 (n=0, 1)Week 40 (n=8, 1)Week 44 (n=4, 0)Week 48 (n=32, 24)Week 60 (n=1, 0)Week 72 (n=30, 19)
PEG-INF Alpha-2a + Ribavirin0.10.00.2-0.10.10.20.1-0.40.2-0.3NA0.0NA0.1
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone0.0-0.1-0.0-0.0-0.5-0.10.00.3NA0.2-0.0-0.20.1-0.2

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Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed

"Blood was collected and assayed for fasting high-density lipoprotein (HDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionmmol/L (Mean)
Week 4 (n=61, 72)Week 8 (n=58, 69)Week 12 (n=56, 68)Week 16 (n=53, 62)Week 20 (n=46, 59)Week 24 (n=47, 61)Week 28 (n=52, 62)Week 32 (n=38, 47)Week 36 (n=38, 46)Week 40 (n=45, 49)Week 44 (n=37, 43)Week 48 (n=34, 46)Week 60 (n=33, 41)Week 72 (n=30, 39)
PEG-INF Alpha-2a + Ribavirin-0.1-0.2-0.2-0.2-0.2-0.2-0.2-0.3-0.3-0.3-0.2-0.2-0.10.1
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-0.1-0.1-0.1-0.2-0.1-0.2-0.1-0.2-0.1-0.1-0.1-0.10.10.2

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Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed

"Insulin resistance (IR) is calculated using the following formula:~HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405.~Baseline for with pioglitazone arm occurred prior to the start of 16 week run-in period and for without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the start of anti-HCV therapy is calculated.~A normal patient can have a HOMA score up to 3. A patient with a score of >3 is definitely IR. Patients scoring 2-3 can be IR but other factors may be causing this without being IR." (NCT00545233)
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72

,
InterventionHOMA Score (Mean)
Week 4 (n=54, 42)Week 8 (n=3, 25)Week 12 (n=51, 63)Week 16 (n=5, 5)Week 20 (n=2, 3)Week 24 (n=42, 60)Week 28 (n=10, 13)Week 32 (n=2, 2)Week 36 (n=0, 2)Week 40 (n=6, 2)Week 44 (n=4, 0)Week 48 (n=30, 44)Week 60 (n=1, 2)Week 72 (n=27, 35)
PEG-INF Alpha-2a + Ribavirin-0.80.6-2.1-9.110.5-1.3-1.04.22.01.0NA-0.35.0-0.1
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone0.6-2.3-2.0-3.24.0-1.80.8-1.8NA0.230.4-1.60.6-2.7

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Change From Baseline in Leptin Levels at Each Time Point Assessed

"Blood was collected for leptin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionng/mL (Mean)
Week 4 (n=56, 39)Week 8 (n=5, 22)Week 12 (n=48, 44)Week 16 (n=5, 4)Week 20 (n=2, 3)Week 24 (n=42, 54)Week 28 (n=11, 11)Week 32 (n=2, 2)Week 36 (n=0, 2)Week 40 (n=7, 1)Week 44 (n=3, 0)Week 48 (n=31, 43)Week 60 (n=1, 2)Week 72 (n=29, 36)
PEG-INF Alpha-2a + Ribavirin-2.4-3.0-3.8-7.9-4.0-5.0-4.1-4.9-1.511.5NA-5.5-0.61.4
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-1.8-1.9-3.1-6.4-2.9-5.8-3.7-4.5NA-4.86.0-4.63.41.3

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Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed

"Blood was collected and assayed for fasting serum low-density lipoprotein (LDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionmmol/L (Mean)
Week 4 (n=58, 70)Week 8 (n=57, 66)Week 12 (n=55, 62)Week 16 (n=53, 58)Week 20 (n=46, 56)Week 24 (n=45, 60)Week 28 (n=52, 60)Week 32 (N=38, 44)Week 36 (n=37, 44)Week 40 (n=44, 49)Week 44 (n=36, 43)Week 48 (n=34, 44)Week 60 (n=33, 39)Week 72 (n=30, 38)
PEG-INF Alpha-2a + Ribavirin-0.5-0.6-0.5-0.6-0.6-0.6-0.6-0.7-0.7-0.7-0.7-0.70.10.0
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-0.3-0.2-0.2-0.2-0.2-0.2-0.2-0.40-0.2-0.3-0.2-0.30.10.2

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Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed

"Blood was collected and assayed for fasting serum triglyceride levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72

,
Interventionmmol/L (Mean)
Week 4 (n=61, 72)Week 8 (n=58, 69)Week 12 (n=56, 68)Week 16 (n=53, 62)Week 20 (n=46, 59)Week 24 (n=47, 61)Week 28 (n=52, 62)Week 32 (n=38, 47)Week 36 (n=38, 46)Week 40 (n=45, 49)Week 44 (n=37, 43)Week 48 (n=34, 46)Week 60 (n=33, 41)Week 72 (n=30, 39)
PEG-INF Alpha-2a + Ribavirin0.40.50.70.60.60.30.40.50.50.40.30.50.30.2
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone0.50.20.20.20.20.50.20.30.10.20.30.2-0.2-0.1

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Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed

"Blood was collected and assayed for fasting serum cholesterol levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionmmol/L (Mean)
Week 4 (n=61, 72)Week 8 (n=58, 69)Week 12 (n=56, 68)Week 16 (n=53, 62)Week 20 (n=46, 59)Week 24 (n=47, 61)Week 28 (n=52, 62)Week 32 (n=38, 47)Week 36 (n=38, 46)Week 40 (n=45, 49)Week 44 (n=37, 43)Week 48 (n=34, 46)Week 60 (n=33, 41)Week 72 (n=30, 39)
PEG-INF Alpha-2a + Ribavirin-0.5-0.6-0.6-0.7-0.6-0.7-0.7-0.8-0.7-0.8-0.8-0.70.10.2
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-0.2-0.2-0.2-0.3-0.3-0.2-0.3-0.4-0.3-0.3-0.2-0.30.00.3

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Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed

"Blood was collected for Transforming Growth Factor beta at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionpg/mL (Mean)
Week 4 (n=56, 41)Week 8 (n=5, 25)Week 12 (n=51, 45)Week 16 (n=5, 4)Week 20 (n=2, 3)Week 24 (n=42, 57)Week 28 (n=12, 12)Week 32 (n=2, 2)Week 36 (n=0, 2)Week 40 (n=7, 1)Week 44 (n=4, 0)Week 48 (n=32, 44)Week 60 (n=1, 2)Week 72 (n=29, 37)
PEG-INF Alpha-2a + Ribavirin-7256-13955-11447-14570-11290-13875-9242-1897387241785NA-10149-3612-1347
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-14891-16224-17666-6164-10653-15976-4071-19750NA-3119-6415-16510-14539-6403

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Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed

"Blood was collected for tumor necrosis factor alpha at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionpg/mL (Mean)
Week 4 (n=56, 41)Week 8 (n=5, 25)Week 12 (n=51, 45)Week 16 (n=5, 4)Week 20 (n=2, 3)Week 24 (n=42, 57)Week 28 (n=12, 12)Week 32 (n=2, 2)Week 36 (n=0, 2)Week 40 (n=7, 1)Week 44 (n=4, 0)Week 48 (n=32, 44)Week 60 (n=1, 2)Week 72 (n=29, 37)
PEG-INF Alpha-2a + Ribavirin-0.91.12.80.6-3.5-1.8-0.1-1.02.73.6NA-1.4-1.4-2.0
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-1.9-3.7-2.0-1.20.7-1.1-0.7-0.8NA-3.3-2.1-2.5-2.4-3.7

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Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy

Serum samples were collected for HCV RNA. The change from Initiation of Pegasys Plus Copegus to Week 24 and Week 48 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment. (NCT00545233)
Timeframe: Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy

,
InterventionIU/mL (Mean)
Week 24 (N=60, 72)Week 48 (N=62, 73)
PEG-INF Alpha-2a + Ribavirin-3.9-3.6
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-4.0-3.5

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Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only

Serum HCV RNA was collected at randomization and during the pioglitazone run-in period at various time points for the with pioglitazone arm only. The change from randomization to each of these time points was calculated. (NCT00545233)
Timeframe: Randomization (Week-16),Weeks -12, -8, -4 and 0

InterventionIU/mL (Mean)
Week -12 (n=74)Week -8 (n=68)Week -4 (n=66)Week 0 (n=64)
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-0.010.000.07-0.03

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Percentage of Participants Achieving Virologic Response

Virologic response was defined as undetectable HCV RNA < 28 IU/mL. Patients with missing HCV RNA values are considered as non-responders. (NCT00545233)
Timeframe: Weeks 4, 12, 24, 48, 60, 72

,
InterventionPercentage of Participants (Number)
Weeks 4Week 12Week 24Week 48Week 60Week 72
PEG-INF Alpha-2a + Ribavirin16.449.363.056.239.738.4
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone6.533.846.839.026.026.0

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Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72

Serum samples were collected for HCV RNA. The percentage of participants with a ≥ 2 log10 decrease in HCV RNA from initiation of Pegasys plus Copegus to time point was calculated. (NCT00545233)
Timeframe: Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72

,
InterventionPercentage of Participants (Number)
Weeks 4Week 12Week 24Week 48Week 60Week 72
PEG-INF Alpha-2a + Ribavirin52.176.772.654.841.137.0
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone41.658.451.939.026.026.0

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Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed

The BDI-FS consisted of seven areas with four statements (labeled 0, 1, 2, and 3) offered to describe the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. The degree of depression was assessed with 0 to 3 indicating minimal depression, 4 to 8 mild depression, 9 to 12 moderate depression and 13 to 21 severe depression. (NCT00545233)
Timeframe: Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72

,
InterventionPercentage of Participants (Number)
Week 4 (n=61, 71)Week 8 (n=57, 69)Week 12 (n=55, 67)Week 16 (n=50, 62)Week 20 (n=46, 59)Week 24 (n=45, 60)Week 28 (n=46, 59)Week 32 (n=37, 46)Week 36 (n=37, 46)Week 40 (n=42, 44)Week 44 (n=36, 40)Week 48 (n=32, 45)Week 60 (n=1, 3)Week 72 (n=30, 39)
PEG-INF Alpha-2a + Ribavirin12.77.211.94.83.410.03.44.36.52.32.5033.37.7
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone6.65.310.96.08.72.28.75.45.44.80003.3

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Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks

Virological breakthrough is a detectable HCV RNA at any time during anti-HCV treatment up to Week 48 after the attainment of undetectable HCV RNA. (NCT00545233)
Timeframe: Up to 48 Weeks

InterventionPercentage of Participants (Number)
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone15.6
PEG-INF Alpha-2a + Ribavirin13.7

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Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)

Virologic relapse was defined as the reappearance of HCV-RNA in serum after PEG-INF alpha 2a therapy is discontinued in a patient who was HCV-RNA undetectable at the completion of anti-HCV therapy. (NCT00545233)
Timeframe: Week 72

InterventionPercentage of Participants (Number)
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone15.6
PEG-INF Alpha-2a + Ribavirin19.2

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Change From Baseline in Adiponectin Levels at Each Time Point Assessed

"Blood was collected for adiponectin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated." (NCT00545233)
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72

,
Interventionμg/mL (Mean)
Week 4 (n=56, 39)Week 8 (n=5, 23)Week 12 (n=49, 45)Week 16 (n=5, 4)Week 20 (n=2, 3)Week 24 (n=41, 55)Week 28 (n=11, 11)Week 32 (n=2, 2)Week 36 (n=0, 2)Week 40 (n=7, 1)Week 44 (n=3, 0)Week 48 (n=31, 44)Week 60 (n=1, 2)Week 72 (n=29, 36)
PEG-INF Alpha-2a + Ribavirin1.6-1.10.3-1.04.00.2-1.01.50.0-4.0NA0.33.0-0.1
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone13.012.210.79.03.012.54.413.0NA2.93.710.8-1.08.2

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Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy

Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment. (NCT00545233)
Timeframe: Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment

InterventionIU/mL (Mean)
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone-3.5
PEG-INF Alpha-2a + Ribavirin-3.7

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Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period

Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment (NCT00545233)
Timeframe: Up to 48 Weeks

InterventionPercentage of Participants (Number)
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone45.5
PEG-INF Alpha-2a + Ribavirin30.1

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Virologic Response

"undetectable HCV RNA at the end of combination drug treatment~Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)." (NCT00556504)
Timeframe: at the end of combination drug treatment (up to 48 weeks)

Interventionparticipants (Number)
TCM-700C34
Placebo31

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Immune Cell Normalization

"Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment~(Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)" (NCT00556504)
Timeframe: at the end of combination drug treatment (up to 48 weeks)

,
Interventionparticipants (Number)
CD4CD8NK cells
Placebo273131
TCM-700C313637

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Sustained Virologic Response (SVR)

"SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..~A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.~If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.~If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.~Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)" (NCT00556504)
Timeframe: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)

InterventionNumber of participants with SVR (Number)
TCM-700C27
Placebo29

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Sustained ALT Response

a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment. (NCT00556504)
Timeframe: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)

Interventionparticipants (Number)
TCM-700C26
Placebo27

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Combined ALT and Virologic Response

Combined ALT and virologic response at the end of combination drug treatment. (NCT00556504)
Timeframe: at the end of combination drug treatment (up to 48 weeks)

Interventionparticipants (Number)
TCM-700C31
Placebo29

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ALT Response

"An ALT response is defined as normalization of ALT at the end of combination drug treatment.~(ALT normalization is defined as ALT level decreases into within the normal range)" (NCT00556504)
Timeframe: at the end of combination drug treatment (up to 48 weeks)

Interventionparticipants (Number)
TCM-700C32
Placebo30

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Immune Cell Normalization

Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment. (NCT00556504)
Timeframe: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)

,
Interventionparticipants (Number)
CD4CD8NK cells
Placebo253031
TCM-700C303436

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Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15

Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology. (NCT00561015)
Timeframe: Baseline, Pre-dose (Day 15)

,,,,,
Interventionlog10 IU/ml (Median)
BaselineChange at Day 15
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 26.15-4.83
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 36.92-4.72
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 26.61-3.66
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 36.65-0.54
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 26.21-5.51
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 36.79-4.85

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Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1

The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml). (NCT00561015)
Timeframe: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])

Interventionng/ml (Mean)
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 21886
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 22462
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 31497
TVR With Peg-IFN-alfa-2a on + RBV (T2/PR24) - Genotype 31588

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Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15

The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml. (NCT00561015)
Timeframe: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)

Interventionng/ml (Mean)
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 23261
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 24318
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 32898
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 33358

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Median Time to Virological Response (HCV RNA Level < 10 IU/ml)

Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. (NCT00561015)
Timeframe: Baseline up to EOT

Interventiondays (Median)
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 231.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 212.0
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 243.0
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 399.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 343.0
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 329.0

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Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15

The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml. (NCT00561015)
Timeframe: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)

Interventionng/ml (Mean)
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 21605
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 22164
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 31800
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 32002

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Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1

The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax. (NCT00561015)
Timeframe: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)

Interventionhr (Median)
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 23.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 24.0
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 34.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 34.0

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Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1

The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. (NCT00561015)
Timeframe: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)

Interventionng*hr/ml (Mean)
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 27980
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 211248
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 36938
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 36979

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Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15

The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. (NCT00561015)
Timeframe: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)

Interventionng*hr/ml (Mean)
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 220144
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 226588
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 318480
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 320895

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Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)

Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable). (NCT00561015)
Timeframe: Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)

,,,,,
Interventionpercentage of participants (Number)
Day 12 (n=8,5,9,8,9,9)Day 15 (n=9,5,9,8,9,9)Week 4 (n=7,5,9,8,9,9)Week 6 (n=7,5,9,8,9,9)Week 14 (n=7,5,9,8,9,9)Week 24/ Week 26 (n=7,5,9,8,7,9)EOT (n=9,5,9,8,9,9)
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 20.0022.244.477.888.988.988.9
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 322.211.166.7100100100100
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 20.000.0071.471.410010088.9
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 30.000.000.0037.575.075.075.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 260.040.080.0100.0100.0100.0100.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 311.122.233.366.7100100100

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Percentage of Participants Who Achieved Sustained Virological Response (SVR)

The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. (NCT00561015)
Timeframe: Week 12, 24 after EOT

,,,,,
Interventionpercentage of participants (Number)
SVR 12SVR 24
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 288.988.9
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 344.444.4
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 266.755.6
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 350.050.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2100100
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 366.766.7

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Percentage of Participants Who Demonstrated Virological Relapse

Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. (NCT00561015)
Timeframe: 24 weeks after EOT

,,,,,
Interventionpercentage of participants (Number)
24 weeks after EOTMissing follow-up
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 20.00.0
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 322.211.1
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 212.50.0
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 333.30.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 20.00.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 333.30.0

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Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. (NCT00561015)
Timeframe: Baseline, Day 12, 15 and Week 24/26

,,,,,
Interventionpercentage of participants (Number)
Day 12Day 15Week 24/ Week 26
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 20.00.011.1
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 30.00.00.0
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 211.166.766.7
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 337.537.537.5
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 20.00.00.0
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 30.00.00.0

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Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26

Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. (NCT00561015)
Timeframe: Baseline and Week 24/26

Interventionlog10 IU/ml (Median)
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2-5.91
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2-5.51
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2-5.45
TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3-5.71
TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3-5.50
Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3-6.22

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Viral Relapse in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)

"The table below shows the number of treatment-naïve participants with viral relapse (defined as having confirmed detectable plasma level of HCV ribonucleic acid [RNA] during the follow-up period in participants with undetectable plasma HCV RNA [less than 25 IU/mL undetectable] at the end of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). See treatment-naïve defined above." (NCT00561353)
Timeframe: Up to Week 72

,,,,
InterventionParticipants (Number)
RelapseNo relapseMissing follow-up
Placebo (Cohort 1, Panel A and B)2100
Placebo (Cohort 2, Panel A and B)050
TMC435 200 mg (Cohort 2, Panel A and B)1130
TMC435 25 mg (Cohort 1, Panel A and B)2121
TMC435 75 mg (Cohort 1, Panel A and B)1170

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Viral Relapse in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows the number of treatment-experienced participants combined (non-responders and relapsers, see defined above) with viral relapse, defined as having confirmed detectable plasma level of HCV ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment who received TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. (NCT00561353)
Timeframe: Up to Week 72

,,,,
InterventionParticipants (Number)
RelapseNo relapse
Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)30
TMC435 150 mg (Cohort 4, Panel C)03
TMC435 200 mg (Cohort 4, Panel C)15
TMC435 200 mg (Cohort 5, Panel D)03
TMC435 75 mg (Cohort 4, Panel C)33

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Viral Breakthrough in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1, Panel A and B)

The table below shows the number of treatment-naïve participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached, or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) after treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on days 8, 15, and 22 (Panel A) and after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). (NCT00561353)
Timeframe: 4 Weeks (Wks), 44 Wks, and 48 Wks

,,,,
InterventionParticipants (Number)
Entire treatment period (48 Wks)During TMC435/Placebo treatment (4 Wks)During treatment with RBV and PegIFNα-2a (44 Wks)
Placebo (Cohort 1, Panels A and B)000
Placebo (Cohort 2, Panels A and B)000
TMC435 200 mg (Cohort 2, Panels A and B)413
TMC435 25 mg (Cohort 1, Panels A and B)321
TMC435 75 mg (Cohort 1, Panels A and B)321

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Viral Breakthrough in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. (NCT00561353)
Timeframe: 4 Weeks (Wks), 44 Wks, and 48 Wks

,,,,
InterventionParticipants (Number)
Entire treatment period (48 Wks)During TMC435/Placebo treatment (4 Wks)During treatment with RBV and PegIFNα-2a (44 Wks)
Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)110
TMC435 150 mg (Cohort 4, Panel C)413
TMC435 200 mg (Cohort 4, Panel C)404
TMC435 200 mg (Cohort 5, Panel D)101
TMC435 75 mg (Cohort 4, Panel C)321

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Sustained Virologic Response (SVR) in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)

"The table below shows the number of treatment-naïve participants with an SVR to treatment (defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively). See treatment-naïve defined above." (NCT00561353)
Timeframe: SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)

,,,,
InterventionParticipants (Number)
SVR4SVR8SVR12SVR24
Placebo (Cohort 1, Panel A and B)11999
Placebo (Cohort 2, Panel A and B)5555
TMC435 200mg (Cohort 2, Panel A and B)12121212
TMC435 25 mg (Cohort 1, Panel A and B)12121210
TMC435 75mg (Cohort 1, Panel A and B)16141515

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Sustained Virologic Response (SVR) in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) in each treatment group in Cohort 4, Panel C and in Cohort 5, Panel D with an SVR to treatment defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of the entire treatment regimen. SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively). (NCT00561353)
Timeframe: SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)

,,,,
InterventionParticipants (Number)
SVR4SVR8SVR12SVR24
Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)1000
TMC435 150 mg (Cohort 4, Panel C)3333
TMC435 200 mg (Cohort 4, Panel C)4455
TMC435 200 mg (Cohort 5, Panel D)3333
TMC435 75 mg (Cohort 4, Panel C)2111

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Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows the mean (standard deviation) Cmax for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right were 8, 8, 10, and 3. (NCT00561353)
Timeframe: Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)

,,,
Interventionng/mL (Mean)
Day 1Day 28
TMC435 150 mg (Cohort 4, Panel C)24224383
TMC435 200 mg (Cohort 4, Panel C)28778452
TMC435 200 mg (Cohort 5, Panel D)387012220
TMC435 75 mg (Cohort 4, Panel C)882.11481

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Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)

"The table below shows the mean (standard deviation) Cmax for treatment-naïve participants at selected time points who were treated with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10." (NCT00561353)
Timeframe: Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)

,,,,,
Interventionng/mL (Mean)
Day 1Day 28
TMC435 200 mg (Cohort 2, Panel A)336911180
TMC435 200 mg (Cohort 2, Panel B)394510900
TMC435 25 mg (Cohort 1, Panel A)251.1307.1
TMC435 25 mg (Cohort 1, Panel B)239.6329.4
TMC435 75 mg (Cohort 1, Panel A)10081058
TMC435 75 mg (Cohort 1, Panel B)958.01609

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Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)

The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants (A treatment-naive participant is someone who has never taken drugs for their HCV infection). (NCT00561353)
Timeframe: Day 7

Interventionlog10 IU/mL (Mean)
TMC435 25 mg (Cohort 1, Panel B)-3.47
TMC435 75 mg (Cohort 1, Panel B)-4.55
Placebo (Cohort 1, Panel B)-1.73
TMC435 200 mg (Cohort 2, Panel B)-4.68
Placebo (Cohort 2, Panel B)-1.64

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Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)

The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection). (NCT00561353)
Timeframe: Day 7

Interventionlog10 IU/mL (Mean)
TMC435 25 mg (Cohort 1, Panel A)-2.63
TMC435 75 mg (Cohort 1, Panel A)-3.48
Placebo (Cohort 1, Panel A)-0.08
TMC435 200 mg (Cohort 2, Panel A)-4.18
Placebo (Cohort 2, Panel A)0.30

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Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up). (NCT00561353)
Timeframe: Day 7

Interventionlog10 IU/mL (Mean)
TMC435 75 mg (Cohort 4, Panel C)-3.80
TMC435 150 mg (Cohort 4, Panel C)-4.68
TMC435 200 mg (Cohort 4, Panel C)-4.49
Placebo (Cohort 4, Panel C)-0.50
TMC435 200 mg (Cohort 5, Panel D)-4.08

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Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)

The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection). (NCT00561353)
Timeframe: Week 4

Interventionlog10 IU/mL (Mean)
TMC435 25 mg (Cohort 1, Panel B)-4.74
TMC435 75 mg (Cohort 1, Panel B)-5.52
Placebo (Cohort 1, Panel B)-3.74
TMC435 200 mg (Cohort 2, Panel B)-5.44
Placebo (Cohort 2, Panel B)-3.26

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Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)

The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo as for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection). (NCT00561353)
Timeframe: Week 4

Interventionlog10 IU/mL (Mean)
TMC435 25 mg (Cohort 1, Panel A)-4.26
TMC435 75 mg (Cohort 1, Panel A)-4.47
Placebo (Cohort 1, Panel A)-2.97
TMC435 200 mg (Cohort 2, Panel A)-4.70
Placebo (Cohort 2, Panel A)-1.92

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Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up). (NCT00561353)
Timeframe: Week 4

Interventionlog10 IU/mL (Mean)
TMC435 75 mg (Cohort 4, Panel C)-4.28
TMC435 150 mg (Cohort 4, Panel C)-5.46
TMC435 200 mg (Cohort 4, Panel C)-5.26
Placebo (Cohort 4, Panel C)-1.53
TMC435 200 mg (Cohort 5, Panel D)-5.86

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Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows mean (standard deviation) of Css,av for TMC435 in treatment-experienced HCV-infected participants (non-responders and relapsers, see defined above) at selected time points following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. (NCT00561353)
Timeframe: Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)

Interventionng/ml (Mean)
TMC435 75 mg (Cohort 4, Panel C)820.8
TMC435 150 mg (Cohort 4, Panel C)2435
TMC435 200 mg (Cohort 4, Panel C)6353
TMC435 200 mg (Cohort 5, Panel D)9613

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Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)

"The table below shows the number of treatment-naive HCV-Infected participants with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above." (NCT00561353)
Timeframe: Day 2 or 3, Day 7, and Day 28

,,,,
InterventionParticipants (Number)
Day 2/3: > or = 2 log10 change from baselineDay 7: > or = 2 log10 change from baselineDay 28: > or = 2 log10 change from baselineDay 2/3: <25 IU/mL detectable or undetectableDay 7: <25 IU/mL detectable or undetectableDay 28: <25 IU/mL detectable or undetectableDay 2/3: <25 IU/mL undetectableDay 7: <25 IU/mL undetectableDay 28: <25 IU/mL undetectableDay 2/3: <100 IU/mLDay 7: <100 IU/mLDay 28: <100 IU/mLDay 2/3: <1000 IU/mLDay 7: <1000 IU/mLDay 28: <1000 IU/mL
Placebo (Cohort 1, Panel B)226003002003004
Placebo (Cohort 2, Panel B)212001000001002
TMC435 200 mg (Cohort 2, Panel B)999039016159699
TMC435 25 (Cohort 1, Panel B)778016003016457
TMC435 75 mg (Cohort 1, Panel B)999019008169599

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Predose Plasma Concentration (C0h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)

"The table below shows mean (standard deviation) of C0h of TMC435 at selected time points following treatment with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) or with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B) in treatment-naïve participants (see treatment-naïve defined above).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 9, 8, 9, 9, and 10." (NCT00561353)
Timeframe: Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)

,,,,,
Interventionng/ml (Mean)
Day 2Day 28
TMC435 200 mg (Cohort 2, Panel A)10536913
TMC435 200 mg (Cohort 2, Panel B)821.74818
TMC435 25 mg (Cohort 1, Panel A)64.5164.78
TMC435 25 mg (Cohort 1, Panel B)65.7395.83
TMC435 75 mg (Cohort 1, Panel A)209.3331.6
TMC435 75 mg (Cohort 1, Panel B)281.6632.8

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Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)

"The table below shows the number of treatment-naïve HCV-infected participants treated with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 who had the following virologic responses: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above." (NCT00561353)
Timeframe: Day 2 or 3, Day 7, and Day 28

,,,,
InterventionParticipants (Number)
Day 2/3: > or = 2 log10 change from baselineDay 7: > or = 2 log10 change from baselineDay 28: > or = 2 log10 change from baselineDay 2/3: <25 IU/mL detectable or undetectableDay 7: <25 IU/mL detectable or undetectableDay 28: <25 IU/mL detectable or undetectableDay 2/3: <25 IU/mL undetectableDay 7: <25 IU/mL undetectableDay 28: <25 IU/mL undetectableDay 2/3: <100 IU/mLDay 7: <100 IU/mLDay 28: <100 IU/mLDay 2/3: <1000 IU/mLDay 7: <1000 IU/mLDay 28: <1000 IU/mL
Placebo (Cohort 1, Panel A)004001001001002
Placebo (Cohort 2, Panel A)001000000000000
TMC435 200 mg (Cohort 2, Panel A)998117007147677
TMC435 25 mg (Cohort 1, Panel A)677115005116237
TMC435 75 mg (Cohort 1, Panel A)999108005138568

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Virologic Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. Note: in the table below, the number of participants (n) analyzed in the TMC435 200 mg (Cohort 4, Panel B) on Day 28 (Week 4) was n=4. (NCT00561353)
Timeframe: Day 2 or 3, Day 7, and Day 28

,,,,
InterventionParticipants (Number)
Day 2/3: > or = 2 log10 change from baselineDay 7: > or = 2 log10 change from baselineDay 28: > or = 2 log10 change from baselineDay 2/3: <25 IU/mL detectable or undetectableDay 7: <25 IU/mL detectable or undetectableDay 28: <25 IU/mL detectable or undetectableDay 2/3: <25 IU/mL undetectableDay 7: <25 IU/mL undetectableDay 28: <25 IU/mL undetectableDay 2/3: <100 IU/mLDay 7: <100 IU/mLDay 28: <100 IU/mLDay 2/3: <1000 IU/mLDay 7: <1000 IU/mLDay 28: <1000 IU/mL
Placebo (Cohort 4, Panel C)102000000000000
TMC435 150 mg (Cohort 4, Panel C)999027005048378
TMC435 200 mg (Cohort 4, Panel C)1010100370030575810
TMC435 200 mg (Cohort 5, Panel D)454004003004034
TMC435 75 mg (Cohort 4, Panel C)888004002026356

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Virologic Response Parameters in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)

The table below shows the number of treatment-naïve participants in the treatment groups for Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined) who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12); a complete EVR (cEVR) defined as a complete EVR having undetectable plasma HCV RNA at Week 12); an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment. (NCT00561353)
Timeframe: Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)

,,,,
InterventionParticipants (Number)
RVREVRcEVReRVRPartial response
Placebo (Cohort 1, Panel A and B)312730
Placebo (Cohort 2, Panel A and B)06501
TMC435 200mg (Cohort 2, Panel A and B)131616130
TMC435 25 mg (Cohort 1, Panel A and B)8161380
TMC435 75mg (Cohort 1, Panel A and B)131917130

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Predose Plasma Concentration (C0h) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows mean (standard deviation) of C0h for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 2 and Day 28 differed as follows: At Day 2, the number of participants in the 4 treatment groups (from left to right) were 8, 7, 10, and 5; the number of participants analyzed at Day 28 in the 4 treatment groups (from left to right) were 9, 8, 10, and 4. (NCT00561353)
Timeframe: Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)

,,,
Interventionng/mL (Mean)
Day 2Day 28
TMC435 150 mg (Cohort 4, Panel C)733.61431
TMC435 200 mg (Cohort 4, Panel C)669.84145
TMC435 200 mg (Cohort 5, Panel D)12805593
TMC435 75 mg (Cohort 4, Panel C)278.4324.3

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Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)

"The table below shows mean (standard deviation)of Css,av for TMC435 in treatment-naïve HCV-infected participants at selected time points administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10." (NCT00561353)
Timeframe: Day 7 (predose); Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel A, Cohorts 1 and 2) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel B, Cohorts 1 and 2)

,,,,,
Interventionng/ml (Mean)
Day 7Day 28
TMC435 200 mg (Cohort 2, Panel B)NA7182
TMC435 25 mg (Cohort 1, Panel A)180.9170.4
TMC435 25 mg (Cohort 1, Panel B)NA186.5
TMC435 75 mg (Cohort 1, Panel A)832.3681.4
TMC435 75 mg (Cohort 1, Panel B)NA986.0
TTMC435 200 mg (Cohort 2, Panel A)57147117

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Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-experienced HCV-infected participants considered non-responders (participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV ribonucleic acid (RNA) levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up at selected time points following treatment with TMC435 coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right was 8, 7, 10, and 3. (NCT00561353)
Timeframe: Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)

,,,
Interventionng.h/mL (Mean)
Day 1Day 28
TMC435 150 mg (Cohort 4, Panel C)3092057440
TMC435 200 mg (Cohort 4, Panel C)34410152600
TMC435 200 mg (Cohort 5, Panel D)51300231300
TMC435 75 mg (Cohort 4, Panel C)1115020150

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Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)

The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-naïve HCV-infected participants administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10. (NCT00561353)
Timeframe: Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)

,,,,,
Interventionng.h/mL (Mean)
Day 1Day 28
TMC435 200 mg (Cohort 2, Panel A)43430167200
TMC435 200 mg (Cohort 2, Panel B)45700169400
TMC435 25 mg (Cohort 1, Panel A)30353961
TMC435 25 mg (Cohort 1, Panel B)28534527
TMC435 75 mg (Cohort 1, Panel A)1224016600
TMC435 75 mg (Cohort 1, Panel B)1279023610

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Virologic Response Parameters Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12; a complete EVR (cEVR) defined as a EVR having undetectable plasma HCV RNA at Week 12; an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment. (NCT00561353)
Timeframe: Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)

,,,,
InterventionParticipants (Number)
RVREVRcEVReRVRPartial response
Placebo (Cohort 4, Panel C)08005
TMC435 150 mg (Cohort 4, Panel C)57441
TMC435 200 mg (Cohort 4, Panel C)38531
TMC435 200 mg (Cohort 5, Panel D)34330
TMC435 75 mg (Cohort 4, Panel C)26420

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Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)

"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. See treatment-naive defined above." (NCT00561353)
Timeframe: Day 2 or 3

InterventionParticipants (Number)
TMC435 25 mg (Cohort 1, Panel B)2
TMC435 75 mg (Cohort 1, Panel B)0
Placebo (Cohort 1, Panel B)5
TMC435 200 mg (Cohort 2, Panel B)0
Placebo (Cohort 2, Panel B)1

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Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)

"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22. See treatment-naive defined above." (NCT00561353)
Timeframe: Day 2 or 3

InterventionParticipants (Number)
TMC435 25 mg (Cohort 1, Panel A)3
TMC435 75 mg (Cohort 1, Panel A)1
Placebo (Cohort 1, Panel A)6
TMC435 200 mg (Cohort 2, Panel A)0
Placebo (Cohort 2, Panel A)3

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Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)

The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with an initial suboptimal response defined as less than 2 log10 change of plasma in plasma level of HCV ribonucleic acid (RNA) at Day 2 or 3 (depending when visit was scheduled) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. (NCT00561353)
Timeframe: Day 2 or 3

InterventionParticipants (Number)
TMC435 75 mg (Cohort 4, Panel C)1
TMC435 150 mg (Cohort 4, Panel C)0
TMC435 200 mg (Cohort 4, Panel C)0
Placebo (Cohort 4, Panel C)8
TMC435 200 mg (Cohort 5, Panel D)1

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Maximum Serum Concentration (Cmax) of Telaprevir

The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). (NCT00580801)
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15

,
InterventionNanogram/milliliter (ng/mL) (Mean)
Cmax: Day 1 (n=8, 8)Cmax: Day 15 (n=7, 7)
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin15982733
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin17093669

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Minimum Serum Concentration (Cmin) of Telaprevir on Day 15

The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here. (NCT00580801)
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15

InterventionNanogram/milliliter (ng/mL) (Mean)
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin1639
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin2100

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Median Time to First Viral Response (Undetectable HCV RNA)

Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected. (NCT00580801)
Timeframe: Up to Week 48/50

InterventionDays (Median)
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin93
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin85.50
Placebo+Pegylated-interferon-alfa-2a+Ribavirin128

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Average Steady-State Serum Concentration (Css,av) of Telaprevir

The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). (NCT00580801)
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15

InterventionNanogram/milliliter (ng/mL) (Mean)
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin2141
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin2896

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Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir

The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test). (NCT00580801)
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15

,
InterventionHours (Median)
tmax: Day 1 (n=8, 8)tmax: Day 15 (n=7, 7)
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin4.022.92
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin4.003.00

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Percentage of Participants With Viral Response (Undetectable HCV RNA)

Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group. (NCT00580801)
Timeframe: Day 15 up to EOT (Week 48/50 or early discontinuation)

,,
InterventionPercentage of participants (Number)
Day 15 (n=7, 8, 8)Week 4/6 (n=7, 8, 8)Week 12/14 (n=7, 8, 7)Week 24/26 (n=6, 8, 8)Week 36/38 (n=6, 8, 5)Week 48/50 (n=4, 7, 5)EOT (n=8, 8, 8)
Placebo+Pegylated-interferon-alfa-2a+Ribavirin012.557.162.510010075.0
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin042.985.710010010087.5
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin12.537.575.087.575.085.775.0

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Percentage of Participants With Sustained Viral Response (SVR)

Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication. (NCT00580801)
Timeframe: Week 12 and 24 after the last dose of study medication

,,
InterventionPercentage of participants (Number)
SVR12SVR24
Placebo+Pegylated-interferon-alfa-2a+Ribavirin62.562.5
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin75.062.5
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin50.050.0

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Number of Participants With Viral Breakthrough (Detectable HCV RNA)

Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group. (NCT00580801)
Timeframe: Day 8, Day 12, Day 15, Week 24/26 and Week 36/38

,,
InterventionParticipants (Number)
Day 8Day 12Day 15Week 24/26Week 36/38
Placebo+Pegylated-interferon-alfa-2a+Ribavirin00011
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin13555
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin00002

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Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15

The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification [LLOQ=25 IU/mL] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology. (NCT00580801)
Timeframe: Baseline and Day 15

,,
Interventionlog 10 IU/mL (Median)
HCV RNA levels: Baseline (n=8,8,8)HCV RNA levels: Change at Day 15 (n=7,8,8)
Placebo+Pegylated-interferon-alfa-2a+Ribavirin5.88-1.58
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin5.83-0.77
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin6.16-4.32

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Area Under the Serum Concentration-Time Curve (AUC)

The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method. (NCT00580801)
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15

,
Interventionnanogram*hour/milliliter (ng*h/mL) (Mean)
AUC : Day 1 (n=8, 7)AUC : Day 15 (n=7, 7)
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin670217120
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin746723320

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Pre-Dose Serum Concentration (C[0h]) of Telaprevir

The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). (NCT00580801)
Timeframe: 0 hour (pre-dose) at Day 15

InterventionNanogram/milliliter (ng/mL) (Mean)
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin1873
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin2806

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Percentage of Participants With Relapse

Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse. (NCT00580801)
Timeframe: Week 24 after EOT (Week 48/50 or early discontinuation)

InterventionPercentage of participants (Number)
Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin14.3
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin33.3
Placebo+Pegylated-interferon-alfa-2a+Ribavirin16.7

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EVR (Early Virologic Response)

Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment. (NCT00606086)
Timeframe: At 12 weeks of treatment

Interventionpercentage of participants (Number)
Arm 1: Peg-IFN/Ribavirin Plus GI-500579.4
Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-500578.5

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Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment

Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders. (NCT00623428)
Timeframe: 12 weeks after actual end of treatment (range from Week 36 to Week 60)

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks52
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks61

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Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment

Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders. (NCT00623428)
Timeframe: 24 weeks after actual end of treatment (range from Week 48 to Week 72).

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks52
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks61

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Number of Participants With Adverse Events (AEs)

"An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as incapacitating with inability to work or perform normal daily activity. A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above." (NCT00623428)
Timeframe: From Week 1 through Week 72.

,
Interventionparticipants (Number)
Any AESevere AEAE related to PEG-IFN alfa-2aAE related to ribavirinSerious AESAE related to PEG-IFN alfa-2aSAE related to ribavirinDeaths
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks811378724000
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks8824868311741

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Percentage of Participants With Virological Response at End of Treatment

Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication. (NCT00623428)
Timeframe: End of Treatment (Week 24 and Week 48 for each treatment group respectively).

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks93
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks90

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Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation

"Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.~Participants without Week 72 measurements were considered non-responders in the analysis." (NCT00623428)
Timeframe: Week 72

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks44
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks57

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Percentage of Participants With Virological Relapse

"Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.~Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.~Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end." (NCT00623428)
Timeframe: End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks41
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks29

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Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment

"Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.~Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis." (NCT00623428)
Timeframe: 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.

Interventionpercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks52
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks57

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Number of Subjects With Undetectable HCV RNA at Week 72

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. (NCT00627926)
Timeframe: Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)

Interventionparticipants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week158
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week243
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week265

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Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels

Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (<1.25*upper limit of normal [ULN]); Grade 1 (mild=1.25 to 2.5*ULN); Grade 2 (moderate=2.6 to 5.0*ULN); Grade 3 (severe= greater than 5.0 to 20.0*ULN); Grade 4 (life-threatening= greater than 20.0*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered. (NCT00627926)
Timeframe: Baseline up to Week 48

,,
Interventionparticipants (Number)
ALT Grade 3 toxicity grade shiftALT Grade 4 toxicity grade shiftAST Grade 3 toxicity grade shiftAST Grade 4 toxicity grade shift
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week120191
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week60100
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week5170

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Fatigue Severity Scale (FSS) Total Score

FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue. (NCT00627926)
Timeframe: Baseline, Week 4, 12, 24, 36, 48, 72

,,
Interventionunits on a scale (Mean)
Baseline (n=343, 351, 346)Week 4 (n=334, 326, 329)Week 12 (n=329, 310, 312)Week 24 (n=317, 307, 304)Week 36 (n=296, 282, 297)Week 48 (n=286, 282, 294)Week 72 (n=296, 270, 289)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week3.04.14.44.34.14.02.9
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week3.04.54.84.33.33.12.6
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week3.24.44.44.33.43.02.6

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Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. (NCT00627926)
Timeframe: 24 weeks after last actual dose of study treatment (up to Week 72)

Interventionparticipants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week158
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week251
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week274

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Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. (NCT00627926)
Timeframe: 12 weeks after last planned dose of study treatment (up to Week 60)

Interventionparticipants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week161
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week255
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week275

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Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. (NCT00627926)
Timeframe: Week 4

Interventionparticipants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week34
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week242
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week246

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Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12. (NCT00627926)
Timeframe: Week 4 and Week 12

Interventionparticipants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week29
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week207
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week212

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Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used. (NCT00627926)
Timeframe: 24 weeks after last planned dose of study treatment (up to Week 72)

,,
Interventionparticipants (Number)
SVR: Protocol DefinedSVR: FDA Guidance
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week158166
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week271285
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week250261

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Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis

FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline. (NCT00627926)
Timeframe: Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)

,,
Interventionparticipants (Number)
SVR achieved (136, 180, 214)SVR not achieved (137, 53, 47)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week3531
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week8412
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week5912

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Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study." (NCT00627926)
Timeframe: Baseline up to Week 48

,,
Interventionparticipants (Number)
AEsSAEs
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week35424
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week36133
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week36231

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Number of Subjects With Viral Relapse Planned and Viral Relapse Actual

Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment. (NCT00627926)
Timeframe: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)

,,
Interventionparticipants (Number)
Viral Relapse PlannedViral Relapse Actual
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week6464
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week2725
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week2828

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Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. (NCT00627926)
Timeframe: End of treatment (up to Week 48)

Interventionparticipants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week229
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week295
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week314

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Number of Subjects With Undetectable HCV RNA at Week 12

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. (NCT00627926)
Timeframe: Week 12

Interventionparticipants (Number)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week146
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week277
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week283

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Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up. (NCT00637923)
Timeframe: From baseline to end of treatment

,
Interventionparticipants (Number)
Remains ElevatedElevated to NormalRemains NormalNormal to Elevated
NTZ+PR428130
Placebo+PR3690

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Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up. (NCT00637923)
Timeframe: From baseline to end of follow up

,
Interventionparticipants (Number)
Remains ElevatedElevated to NormalRemains NormalNormal to Elevated
NTZ+PR923130
Placebo+PR2781

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Early Virologic Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy. (NCT00637923)
Timeframe: After 12 weeks combination treatment

,
Interventionparticipants (Number)
RespondersNon-responders
NTZ+PR4530
Placebo+PR1819

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Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up (NCT00637923)
Timeframe: From baseline to week 16

,
Interventionparticipants (Number)
Remains ElevatedElevated to NormalRemains NormalNormal to Elevated
NTZ+PR1238171
Placebo+PR411151

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Changes in ALT

This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up. (NCT00637923)
Timeframe: From baseline to week 8

,
Interventionparticipants (Number)
Remains ElevatedElevated to NormalRemains NormalNormal to Elevated
NTZ+PR2329163
Placebo+PR511172

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Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders. (NCT00637923)
Timeframe: 24 weeks after end of treatment

,
Interventionparticipants (Number)
RespondersNon-responders
NTZ+PR3243
Placebo+PR1324

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Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy. (NCT00637923)
Timeframe: After 4 weeks combination treatment

,
Interventionparticipants (Number)
RespondersNon-responders
NTZ+PR966
Placebo+PR730

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End of Treatment Response (HCV RNA Below Lower Limit of Detection)

Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders. (NCT00637923)
Timeframe: At end of treatment

,
Interventionparticipants (Number)
RespondersNon-responders
NTZ+PR4629
Placebo+PR1819

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Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)

(NCT00665353)
Timeframe: From Entry to Week 24 of Step 1

Interventionmg/dL x uIU/mL / 405 (Median)
PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)-1.2

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Safety and Tolerability

Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality. (NCT00665353)
Timeframe: Step 1 (Up to 24 to 28 weeks)

Interventionparticipants (Number)
PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)7

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Safety and Tolerability

Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality. (NCT00665353)
Timeframe: Step 2 (Up to 72 weeks)

Interventionparticipants (Number)
PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)13

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The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2.

(NCT00665353)
Timeframe: Week 24 of Step 2

Interventionproportion of participants (Number)
PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)0.158

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The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2.

(NCT00665353)
Timeframe: Week 72 of Step 2

Interventionproportion of participants (Number)
PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)0.053

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Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides.

(NCT00665353)
Timeframe: From Entry to Week 24 of Step 1

Interventionmg/dL (Median)
24 week change in total cholesterol (n=16)24 week change in triglycerides (n=16)
PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)5.528.5

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Absolute Change From Entry to Week 24 of Step 1 in AST and ALT.

(NCT00665353)
Timeframe: From Entry to Week 24 of Step 1

Interventionx ULN (Median)
24 week change in ALT (n=17)24 week change in AST (n=17)
PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)-0.14-0.20

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Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).

LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL. (NCT00686517)
Timeframe: At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).

Interventionparticipants (Number)
PEG-IFN 2420
PEG-IFN 1219
PEG-IFN + RVB 1219

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Virologic Response at the End of Treatment Follow-up (ETR)

"ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks~treatment (depending on treatment arm) was <15 IU/mL." (NCT00686517)
Timeframe: At the end of treatment (either 12 weeks or 24 weeks depending on randomization).

Interventionparticipants (Number)
PEG-IFN 2426
PEG-IFN 1228
PEG-IFN + RVB 1227

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Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period

SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL. (NCT00686517)
Timeframe: Evaluated at the end of 6 months

Interventionparticipants (Number)
PEG-IFN 2423
PEG-IFN 1220
PEG-IFN + RVB 1221

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Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization

ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported. (NCT00686517)
Timeframe: Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.

,,
Interventionparticipants (Number)
End of Treatment6-month Follow-up Period12-month Follow-up Period
PEG-IFN + RVB 12322823
PEG-IFN 12312723
PEG-IFN 24283127

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Number of Participants With Rapid Virologic Response (RVR)

"Participants were considered to have RVR if serum HCV RNA level at 2 or 4~weeks of treatment was below the cut off value of the referring local~laboratory of each participating site." (NCT00686517)
Timeframe: Evaluated at 2 and 4 weeks of treatment

,,
Interventionparticipants (Number)
2 weeks after start of treatment4 weeks after start of treatment
PEG-IFN + RVB 122334
PEG-IFN 122535
PEG-IFN 242428

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Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT

HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result. (NCT00686777)
Timeframe: Measured at 24 weeks of treatment and at EOT (Treatment week 48)

Interventionpercentage of participants (Number)
At 24 Weeks TreatmentAt End of Treatment
PEG-IFN + Ribavirin61.366.7

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Number of Participants Discontinuing Treatment

Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL. (NCT00686777)
Timeframe: From time of first treatment to Week 48

Interventionparticipants (Number)
Due To Decrease in Neutrophil CountDue To Decrease in Neutrophil and Platelet CountDue To ApathyDue To Pleural EffusionDue To Pregnancy of Participant's PartnerDue To No VisitDue To Withdrawal by SubjectTotal Number Discontinued
PEG-IFN + Ribavirin311111210

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Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation

"SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity.~HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result." (NCT00686777)
Timeframe: Measured at 24 weeks after the end of treatment (at the end of follow-up)

Interventionpercentage of participants (Number)
PEG-IFN + Ribavirin30.7

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Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)

Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR) (NCT00687219)
Timeframe: Measured at 24 weeks after 48 weeks treatment (72 weeks)

InterventionParticipants (Number)
Undetectable HCV-RNADetectable HCV-RNAUnknown (data not available)
Peginterferon Alfa-2b + Ribavirin414021

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Number of Participants With Undetectable HCV-RNA at End of Treatment

Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR) (NCT00687219)
Timeframe: Up to 48 weeks

InterventionParticipants (Number)
Undetectable HCV-RNADetectable HCV-RNAUnknown (data not available)
Peginterferon Alfa-2b + Ribavirin59430

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Number of Participants With Undetectable HCV-RNA at Week 24

Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR) (NCT00687219)
Timeframe: Week 24

InterventionParticipants (Number)
Undetectable HCV-RNADetectable HCV-RNAUnknown (data not available)
Peginterferon Alfa-2b + Ribavirin61356

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Number of Participants Who Died

(NCT00687544)
Timeframe: Throughout the study (up to 72 weeks)

Interventionparticipants (Number)
PEG-IFN + RBV0

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Number of Participants Experiencing Adverse Events

An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment. (NCT00687544)
Timeframe: Throughout the study (up to 72 weeks)

Interventionparticipants (Number)
PEG-IFN + RBV10

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Kaplan-Meier Exposure-adjusted Relapse Rate

The distribution of time to relapse was summarized using Kaplan-Meier estimates for all participants who were sustained responders at 24 weeks post-treatment in the previous study. Exposure Adjusted Relapse Rate = 1000 × (number of relapses) / (Total exposure time in years). Total exposure time in years = [(total number of days from last day of treatment to the last follow-up day for all subjects who did not relapse) + (total number of days from last day of treatment to the day of relapse for those who relapsed)] / 365.25 days [for 1 year]. (NCT00689390)
Timeframe: From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)

Interventionrelapses per 1,000 person-years (Number)
Previous SVR on Boceprevir + PR2.3
Previous SVR on Narlaprevir + PR0
Previous SVR on PR Only2.2

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Number of Participants That Discontinued the LTFU Due to SAEs

An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs. (NCT00689390)
Timeframe: From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)

Interventionparticipants (Number)
Participants From Boceprevir Studies19
Participants From Narlaprevir Studies0

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Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU

Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs. (NCT00689390)
Timeframe: From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)

Interventionparticipants (Number)
Participants From Boceprevir Studies136
Participants From Narlaprevir Studies2

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Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci

Plasma samples of all participants receiving at least one dose of study medication in a previous treatment protocol were evaluated by population sequencing and analyzed to detect amino acid variants in the NS3/4A protease known to be associated with reduced susceptibility to boceprevir and narlaprevir. RAVs in the NS3/4A protease gene were evaluated at 12 loci (V36, Q41, F43, T54, V55, V107, R155, A156, V158, D168, I/V170 and M175) on the basis of in vitro studies. A TE-RAV was defined as a RAV not present at baseline and that had not returned to wild type (WT) while the participant was still on treatment. The number of participants with TE-RAVS detected at the EOT in the previous treatment study are reported below, followed by those participants with TE-RAVS that returned to WT during the LTFU (among those with detected TE-RAVS). (NCT00689390)
Timeframe: From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years)

Interventionparticipants (Number)
V36A TE-RAVs detected__V36A TE-RAVs returned to WT (out of 6)V36G TE-RAVs detected__V36G TE-RAVs returned to WT (out of 1)V36L TE-RAVs detected__V36L TE-RAVs returned to WT (out of 9)V36M TE-RAVs detected__V36M TE-RAVs returned to WT (out of 142)F43C TE-RAVs detected__F43C TE-RAVs returned to WT (out of 3)T54A TE-RAVs detected__T54A TE-RAVs returned to WT (out of 40)T54C TE-RAVs detected__T54C TE-RAVs returned to WT (out of 2)T54S TE-RAVs detected__T54S TE-RAVs returned to WT (out of 143)V55A TE-RAVs detected__V55A TE-RAVs returned to WT (out of 5)V107I TE-RAVs detected__V107I TE-RAVs returned to WT (out of 3)R155K TE-RAVs detected__R155K TE-RAVs returned to WT (out of 183)R155T TE-RAVs detected__R155T TE-RAVs returned to WT (out of 22)A156S TE-RAVs detected__A156S TE-RAVs returned to WT (out of 37)A156T TE-RAVs detected__A156T TE-RAVs returned to WT (out of 4)V158I TE-RAVs detected__V158I TE-RAVs returned to WT (out of 16)V158M TE-RAVs detected__V158M TE-RAVs returned to WT (out of 1)D168N TE-RAVs detected__D168N TE-RAVs returned to WT (out of 12)I170T TE-RAVs detected__I170T TE-RAVs returned to WT (out of 3)V170A TE-RAVs detected__V170A TE-RAVs returned to WT (out of 27)M175L TE-RAVs detected__M175L TE-RAVs returned to WT (out of 5)
Participants From Boceprevir Studies With TE-RAVs6611981421353340402214310453321831542220373544181611121133272452

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Number of Participants With Any Adverse Events and Any Serious Adverse Events

An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. (NCT00700401)
Timeframe: Up to 48 weeks

Interventionparticipants (Number)
Any AEsAny SAEs
Peginterferon Alfa-2a + Ribavirin19613

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Percentage of Participants With Positive Predictive Value

Positive predictive value is defined as participants with RVR who did not achieve SVR. (NCT00700401)
Timeframe: At Week 48

Interventionpercentage of participants (Number)
Peginterferon Alfa-2a + Ribavirin85.2

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Percentage of Participants With Rapid Virological Response at Week 4

Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR. (NCT00700401)
Timeframe: At Week 4

InterventionPercentage of participants (Number)
Peginterferon Alfa-2a + Ribavirin56.9

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Percentage of Participants With Sustained Virological Response at Week 48

Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR). (NCT00700401)
Timeframe: At Week 48

InterventionPercentage of participants (Number)
Peginterferon Alfa-2a + Ribavirin52.7

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Percentage of Participants With Virological Relapse

Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR. (NCT00700401)
Timeframe: At week 48

InterventionPercentage of participants (Number)
Peginterferon Alfa-2a + Ribavirin9.4

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Percentage of Participants With Virological Response at Week 24

Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24). (NCT00700401)
Timeframe: At Week 24

InterventionPercentage of participants (Number)
Peginterferon Alfa-2a + Ribavirin56.9

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Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48

Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance. (NCT00700401)
Timeframe: Baseline, Week 4, Week 12, Week 24 and Week 48

InterventionPercent change (Mean)
ALT, Week 4 ( n = 257)ALT, Week 12 (n = 159)ALT, Week 24 (n = 156)ALT, Week 48 (n = 125)AST, Week 4 ( n = 256)AST, Week 12 (n = 159)AST, Week 24 (n = 156)AST, Week 48 (n = 125)Gamma-GT, Week 4 ( n = 243)Gamma-GT, Week 12 (n = 151)Gamma-GT, Week 24 (n = 149)Gamma-GT, Week 48 (n = 121)Fasting cholesterol, Week 4 ( n = 214)Fasting cholesterol, Week 12 (n = 130)Fasting cholesterol, Week 24 (n = 123)Fasting cholesterol, Week 48 (n = 97)Fasting blood glucose, Week 4 ( n = 229)Fasting blood glucose, Week 12 (n = 135)Fasting blood glucose, Week 24 (n = 136)Fasting blood glucose, Week 48 (n = 111)Fasting insulin, Week 4 ( n = 131)Fasting insulin, Week 12 (n = 79)Fasting insulin, Week 24 (n = 74)Fasting insulin, Week 48 (n = 68)Total bilirubin, Week 4 ( n = 234)Total bilirubin, Week 12 (n = 148)Total bilirubin, Week 24 (n = 123)Total bilirubin, Week 48 (n = 108)Creatinine, Week 4 ( n = 239)Creatinine, Week 12 (n = 138)Creatinine, Week 24 (n = 133)Creatinine, Week 48 (n = 116)Fasting triglycerides, Week 4 ( n = 212)Fasting triglycerides, Week 12 (n = 128)Fasting triglycerides, Week 24 (n = 121)Fasting triglycerides, Week 48 (n = 92)HOMA score, Week 4 ( n = 46)HOMA score, Week 12 (n = 37)HOMA score, Week 24 (n = 28)HOMA score, Week 48 (n = 20)PT, Week 4 ( n = 55)PT, Week 12 (n = 31)PT, Week 24 (n = 26)PT, Week 48 (n = 30)INR, Week 4 ( n = 151)INR, Week 12 (n = 73)INR, Week 24 (n = 73)INR, Week 48 (n = 71)
Peginterferon Alfa-2a + Ribavirin-28.5-30.4-30-61.8-19.6-10.2-7.6-47.211.832.569.2-33.4-1-1.40.615.6-3.5-1.81.3-1.222.911.1-12.218.332.819.30-1.7-1.82-2.71-3.555.8944.75658.12212.610.3-14.610.9-1.9-2.6-3.5-4.10.1-1.1-1.5-3.2

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Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48

Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets. (NCT00700401)
Timeframe: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48

InterventionPercent change (Mean)
Hemoglobin, Week 2 ( n =257)Hemoglobin, Week 4 (n=259)Hemoglobin, Week 12 (n=157)Hemoglobin, Week 24 (n=156)Hemoglobin, Week 48 (n=110)Hematocrit, Week 2 ( n = 255)Hematocrit, Week 4 (n = 257)Hematocrit, Week 12 (n = 156)Hematocrit, Week 24 (n = 155)Hematocrit, Week 48 (n=110)Leukocytes, Week 2 ( n = 256)Leukocytes, Week 4 (n = 258)Leukocytes, Week 12 (n = 157)Leukocytes, Week 24 (n = 156)Leukocytes, Week 48 (n = 110)Neutrophils, Week 2 ( n = 256)Neutrophils, Week 4 (n = 258)Neutrophils, Week 12 (n = 157)Neutrophils, Week 24 (n = 156)Neutrophils, Week 48 (n = 110)Platelets, Week 2 ( n = 257)Platelets, Week 4 (n = 259)Platelets, Week 12 (n = 157)Platelets, Week 24 (n = 155)Platelets, Week 48 (n = 110)
Peginterferon Alfa-2a + Ribavirin-8.4-15.7-19.6-20.7-2.2-8.1-14.5-17.7-17.9-2.3-33.2-43.4-48.1-52.10.3-42.9-48-47.3-53.64.5-18.3-20.4-26.7-27.64

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Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4

RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4. (NCT00703118)
Timeframe: Week 4

InterventionParticipants (Number)
T12/PR48152
T12(DS)/PR48188
Pbo/PR483

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Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)

(NCT00703118)
Timeframe: Week 48

InterventionParticipants (Number)
T12/PR48184
T12(DS)/PR48191
Pbo/PR4849

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Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)

Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72). (NCT00703118)
Timeframe: Up to Week 72

InterventionParticipants (Number)
T12/PR4826
T12(DS)/PR4827
Pbo/PR4833

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Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned

SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned). (NCT00703118)
Timeframe: Week 60

InterventionParticipants (Number)
T12/PR48175
T12(DS)/PR48178
Pbo/PR4822

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Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned

SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication. (NCT00703118)
Timeframe: Week 72

InterventionParticipants (Number)
T12/PR48171
T12(DS)/PR48175
Pbo/PR4822

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Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4

(NCT00703118)
Timeframe: Baseline (Day 1) to Week 4

Interventionlog10 IU/mL (Mean)
T12/PR48-5.5
T12(DS)/PR48-2.0
Pbo/PR48-1.9

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Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12

Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels. (NCT00703118)
Timeframe: Week 4 and Week 12

InterventionParticipants (Number)
T12/PR48141
T12(DS)/PR48180
Pbo/PR483

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Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8

Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir. (NCT00703118)
Timeframe: Week 4, Week 6, or Week 8

,
InterventionParticipants (Number)
Week 4Week 6Week 8
T12(DS)/PR481420
T12/PR481652

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Percentage of Participants Achieving RVR

Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4. (NCT00704184)
Timeframe: Week 4

InterventionPercentage of Participants (Number)
Placebo + Peg-IFN/Ribavirin5.6
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin75.0
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin78.9
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin68.8
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin83.3

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Number of Participants With ≥3-log10 Decrease in HCV RNA

The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir. (NCT00704184)
Timeframe: Baseline and Week 4

InterventionNumber of Participants (Number)
Placebo + Peg-IFN/Ribavirin15
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin16
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin19
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin16
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin17

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Number of Participants With ≥2-log10 Decrease in HCV RNA

The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir. (NCT00704184)
Timeframe: Baseline and Week 4

InterventionNumber of Participants (Number)
Placebo + Peg-IFN/Ribavirin16
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin16
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin19
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin16
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin17

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Number of Participants Discontinuing From Study Therapy Due to AEs

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product. (NCT00704184)
Timeframe: Day 1 to Day 28

InterventionParticipants (Number)
Placebo + Peg-IFN/Ribavirin0
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin0
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin0
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin0
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin0

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Mean Log Change From Baseline in HCV RNA

The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4. (NCT00704184)
Timeframe: Baseline and Week 4

InterventionLog10 IU/mL (Mean)
Placebo + Peg-IFN/Ribavirin-3.6
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin-6.1
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin-6.3
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin-6.2
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin-6.3

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Number of Participants Experiencing an Adverse Event (AE)

The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods. (NCT00704184)
Timeframe: Up to Day 42

InterventionParticipants (Number)
Placebo + Peg-IFN/Ribavirin18
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin15
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin18
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin16
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin18

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Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.

The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen. (NCT00704405)
Timeframe: Week 48

InterventionPercentage of participants (Number)
24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV71.1
48-wk PBO + Peg-IFN/RBV36.6

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Number of Participants Experiencing an Adverse Event (AE)

The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product. (NCT00704405)
Timeframe: Up to 73 weeks

InterventionNumber of participants (Number)
24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV38
24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV42
48-wk Vaniprevir 300 mg + Peg-IFN/RBV40
48-wk Vaniprevir 600 mg + Peg-IFN/RBV46
48-wk PBO + Peg-IFN/RBV41

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Number of Participants Discontinuing From Study Treatment Due to AEs

The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. (NCT00704405)
Timeframe: Up to 48 weeks

InterventionNumber of participants (Number)
24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV2
24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV3
48-wk Vaniprevir 300 mg + Peg-IFN/RBV2
48-wk Vaniprevir 600 mg + Peg-IFN/RBV4
48-wk PBO + Peg-IFN/RBV1

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Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.

The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure. (NCT00704405)
Timeframe: Up to 72 weeks

InterventionPercentage of participants (Number)
24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV71.1
24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV84.2
48-wk Vaniprevir 600 mg + Peg-IFN/RBV78.0
48-wk PBO + Peg-IFN/RBV19.0

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Percentage of Participants Achieving cEVR

The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis. (NCT00704405)
Timeframe: Up to Week 60

InterventionPercentage of participants (Number)
24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV92.0
48-wk Vaniprevir 300 mg + Peg-IFN/RBV85.4
PBO + Peg-IFN/RBV9.5

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Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.

The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined. (NCT00704405)
Timeframe: 72 weeks

InterventionPercentage of participants (Number)
48-wk Vaniprevir 300 mg + Peg-IFN/RBV66.7
48-wk PBO + Peg-IFN/RBV19.0

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Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program

(NCT00704522)
Timeframe: 24 or 48 weeks (depending on genotype) and 24 weeks of follow up

InterventionParticipants (Number)
PegIntron Pen/Rebetol Without Patient Assistance Program298
PegIntron Pen/Rebetol With Patient Assistance Program75

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Average Length of Treatment With PegIntron/Rebetol

(NCT00704522)
Timeframe: After start of treatment

InterventionWeeks (Mean)
PegIntron Pen/Rebetol Without Patient Assistance Program28.8
PegIntron Pen/Rebetol With Patient Assistance Program27.3

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Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.

The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen. (NCT00704717)
Timeframe: The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.

InterventionUnits on a scale (Mean)
All Treated Patients6.16

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Number of Participants With Adherence to Therapy According to Physician Approximation

Adherence was based on physiciant's clinical judgment. (NCT00704964)
Timeframe: Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3

InterventionParticipants (Number)
PegIntronRebetol
All Participants615604

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Number of Participants With Biometrical Adherence to Therapy

Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions. (NCT00704964)
Timeframe: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3

InterventionParticipants (Number)
PegIntron + RebetolPegIntronRebetol
All Participants406415413

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Number of Subjects Who Completed Treatment.

(NCT00705107)
Timeframe: Assessed at the end of the 48-week treatment.

InterventionParticipants (Number)
All Treated Patients218

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Average Length of Treatment.

(NCT00705107)
Timeframe: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.

Interventionweeks (Mean)
All Treated Patients43.60

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Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline

SVR was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as Homeostasis model assessment - of insulin-resistance [HOMA-IR] >3) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively. (NCT00705224)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

,
InterventionPercentage of Participants (Number)
Genotype IGenotype IIGenotype IIIOther
HOMA-IR >347.57.545.00
HOMA-IR<=345.714.338.61.4

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Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline

Virological relapse (VR) was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who demonstrated VR. VR was defined as undetectable plasma HCV-RNA (RFT +) at end of treatment (Visit 3- considered Week 24 or Week 48 after treatment start depending on treatment duration), but lost RFT (considered sustained non-Responders) at end of study (Visit 4- considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively). (NCT00705224)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

,
InterventionPercentage of Participants (Number)
Genotype IGenotype IIGenotype IIIOther
HOMA-IR >372.7027.30
HOMA-IR<=383.3016.70

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Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline

Response following treatment (RFT) was assessed at the end of treatment (Visit 3) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the presence or absence of RFT. RFT was defined as undetectable plasma HCV-RNA at end of treatment. Visit 3 was considered Week 24 or Week 48 after treatment start depending on treatment duration. (NCT00705224)
Timeframe: Week 24 or 48 after treatment start

,
InterventionPercentage of Participants (Number)
Genotype IGenotype IIGenotype IIIOther
HOMA-IR >352.95.941.20
HOMA-IR<=350.612.235.91.3

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Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study

Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively. (NCT00705224)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

InterventionPercentage of Participants (Number)
Pegylated Interferon and Ribavirin81.2

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Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline

Early Virological response (EVR) was assessed at 12 weeks after treatment start (Visit 2) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who achieved EVR. EVR was defined as a substantial (greater than 2 log10) decrease in viral load (measured as International Units/milliliter) and/or negative Polymerase chain reaction (PCR)-based viral load qualitative result as assessed at visit 2 of the study. (NCT00705224)
Timeframe: Week 12 after treatment start

,
InterventionPercentage of Participants (Number)
Genotype IGenotype IIGenotype IIIOther
HOMA-IR >354.06.040.00
HOMA-IR<=351.312.734.81.3

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Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.

Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale. (NCT00705263)
Timeframe: After 4 weeks of treatment.

InterventionSatisfied Participants (Number)
Injection technique: correctly injectedNo difficulties injectingOverall impressionSatisfaction with the penEase of setting the doseEase of use of the penConvenience of use of the penEasy injectionCorrect doseHelpfulness of the brochure: instructionsOverall helpfullness of the brochureHelpfulness of the brochure: adviceHelpfulness of the brochure: general informationDifficulty of preparing the penTime required to prepare the pen
Patients Treated With PegIntron Pen Plus Rebetol1041021021021011011019898969491909088

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Sustained Virologic Response (SVR) Rate

"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR." (NCT00705432)
Timeframe: At Follow-up Week (FW) 24

InterventionPercentage of participants (Number)
Cohort I - 1. Placebo + PEG + RBV40.2
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)66.8
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks68.5
Cohort II - 1. Placebo + PEG + RBV23.1
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)42.3
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks52.7

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Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR

"Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL." (NCT00705432)
Timeframe: At Treatment Week 4, 8, 12, 16, 20

,,,,,
InterventionParticipants (Number)
Treatment week 4 (n=28, 18, 20, 2, 1, 0)Treatment week 8 (n=56, 190, 182, 4, 18, 22)Treatment week 12 (n=108, 237, 231, 10, 25, 33)Treatment week 16 (n=138, 231, 237, 15, 26, 36)Treatment week 20 (n=157, 231, 231, 15, 27, 32)
Cohort I - 1. Placebo + PEG + RBV274890106118
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)16170205205201
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks18166204210208
Cohort II - 1. Placebo + PEG + RBV2371212
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)114192021
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks018262626

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Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.

"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL." (NCT00705432)
Timeframe: At FW 12 and at 72 weeks after randomization

,,,,,
InterventionParticipants (Number)
At follow-up week 1272 weeks after randomization
Cohort I - 1. Placebo + PEG + RBV127120
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)209194
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks209205
Cohort II - 1. Placebo + PEG + RBV1111
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)2120
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks2927

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Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)

"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR." (NCT00705432)
Timeframe: At FW 24

InterventionPercentage of participants (Number)
Cohort I - 1. Placebo + PEG + RBV42.1
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)69.6
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks71.2
Cohort II - 1. Placebo + PEG + RBV25.5
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)46.8
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks52.7

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Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)

"Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL." (NCT00705432)
Timeframe: At Treatment Week 2, 4, 8, 12, 16, or 20

,,,,,
InterventionParticipants (Number)
Treatment week 2Treatment week 4Treatment week 8Treatment week 12Treatment week 16Treatment week 20
Cohort I - 1. Placebo + PEG + RBV82856108138157
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)1118190237231231
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks820182231237231
Cohort II - 1. Placebo + PEG + RBV024101515
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)1118252627
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks0022333632

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Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.

"SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment.~This key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009." (NCT00708500)
Timeframe: At Follow-up Week 24

InterventionPercentage of Participants (Number)
Placebo+PEG2b+RBV, x 44 Weeks21.8
Boceprevir+PEG2b+RBV, Response Guided Therapy60.9
Boceprevir+PEG2b+RBV, x 44 Weeks66.9

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Number of Participants With Early Virologic Response.

Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response. (NCT00708500)
Timeframe: At Week 2, 4, 8, or 12

,,
Interventionparticipants (Number)
Week 2Week 4Week 8Week 12
Boceprevir+PEG2b+RBV, Response Guided Therapy0074111
Boceprevir+PEG2b+RBV, x 44 Weeks0284121
Placebo+PEG2b+RBV, x 44 Weeks02723

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Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.

(NCT00708500)
Timeframe: At Follow-up Week 12 and at 72 weeks after randomization

,,
Interventionparticipants (Number)
Follow-Up Week 1272 Weeks Post Randomization
Boceprevir+PEG2b+RBV, Response Guided Therapy9793
Boceprevir+PEG2b+RBV, x 44 Weeks105105
Placebo+PEG2b+RBV, x 44 Weeks1617

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Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.

SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment. (NCT00708500)
Timeframe: At Follow-up Week 24

InterventionPercentage of Participants (Number)
Placebo+PEG2b+RBV, x 44 Weeks21.3
Boceprevir+PEG2b+RBV, Response Guided Therapy58.6
Boceprevir+PEG2b+RBV, x 44 Weeks66.5

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Number of Study Participants Who Had a Virological Response (VR) at Week-72

"VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.~Participants who dropped out or were withdrawn from treatment were considered not to respond." (NCT00709059)
Timeframe: Treatment Week 72

InterventionParticipants (Number)
PegIntron Plus Rebetol176

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Number of HCV LVL G1 Participants Who Relapsed

Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24. (NCT00709228)
Timeframe: Week 24 of follow-up

InterventionParticipants (Number)
PegIntron Plus Rebetol16

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Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category

SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values. (NCT00723632)
Timeframe: From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

InterventionCzech Crown (Mean)
<= 64 kg (n=182)65-85 kg (n=334)>= 85 kg (n=182)
Peginterferon Alfa-2b and Ribavirin28,27131,42934,782

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Average Cost Per Participant With SVR Stratified by Prior Treatment Status

SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values. (NCT00723632)
Timeframe: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

InterventionCzech Crown (Mean)
Treatment-Naive (n=543)Previously Treated (n=155)
Peginterferon Alfa-2b and Ribavirin30,10937,486

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Average Cost Per Participant With SVR Stratified by Ribavirin Dosage

SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values. (NCT00723632)
Timeframe: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

InterventionCzech Crown (Mean)
800 mg/day (n=167)1000 mg/day (n=333)1200 mg/day (n=198)
Peginterferon Alfa-2b and Ribavirin31,11929,30635,621

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the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol

(NCT00723892)
Timeframe: 12 months after onset of treatment

InterventionWeeks (Mean)
PegIntron/Rebetol and Psychotherapy Support Program36.1
PegIntron/Rebetol Alone (no Psychotherapy35.3

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Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.

(NCT00723892)
Timeframe: 12 months after onset of treatment

InterventionParticipants (Number)
PegIntron/Rebetol and Psychotherapy Support Program206
PegIntron/Rebetol Alone (no Psychotherapy)168

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Participants With Treatment Success

Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion). (NCT00724373)
Timeframe: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.

InterventionParticipants (Number)
Genotype 1aGenotype 1bGenotype 1a and 1bGenotype 1cGenotype 1 subgroup unspecified
Participants With Genotype 1 Hepatitis C Virus Infection.117634059

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Number of Participants Discontinued From Treatment by Reason for Discontinuation

Investigators recorded reasons for treatment discontinuation. (NCT00724451)
Timeframe: 24 weeks after the end of treatment (total of 48 to 72 weeks)

Interventionparticipants (Number)
Disease worseningSide effectsNon responseAdverse effectAdministrative reasonVirological responseOther reasons
Participants With Chronic Hepatitis C (CHC)32744325225

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Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility

Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant. (NCT00724451)
Timeframe: Measured at baseline

Interventionparticipants (Number)
AgeMild diseaseSubstance abuse historyTreatment postponedGenotypeComorbidityLiver problemsProblems with previous treatment
Participants With Chronic Hepatitis C (CHC)144771772139414

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Number of Participants With Treatment Failure by Reason for Failure

Investigators recorded reasons for treatment failure whether or not treatment was completed. (NCT00724451)
Timeframe: 24 to 48 weeks

Interventionparticipants (Number)
Disease relapseNon-responder
Participants With Chronic Hepatitis C (CHC)7161

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Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline

SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). (NCT00724464)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

InterventionParticipants (Number)
AbsenceMinimalModerateSignificantMissing
Pegylated Interferon Alpha-2b and Ribavirin8327154157

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Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline

SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). (NCT00724464)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

InterventionParticipants (Number)
Low Viral LoadHigh Viral LoadMissing
Pegylated Interferon Alpha-2b and Ribavirin9915532

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Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline

SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). (NCT00724464)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

InterventionParticipants (Number)
Genotype 1Genotype 2Genotype 3Genotype 4Genotype 2 & 3
Pegylated Interferon Alpha-2b and Ribavirin8128146301

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Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline

SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). (NCT00724464)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

InterventionParticipants (Number)
Normal Baseline ALT levelsElevated Baseline ALT levelsMissing
Pegylated Interferon Alpha-2b and Ribavirin282526

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Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response

SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). (NCT00724464)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

InterventionParticipants (Number)
RVR at Week 4 (+/- 1)Non-RVR at Week 4 (+/- 1)Missing
Pegylated Interferon Alpha-2b and Ribavirin2016250

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Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up

Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up. (NCT00724464)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

InterventionParticipants (Number)
Pegylated Interferon Alpha-2b and Ribavirin23

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Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up

Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). (NCT00724464)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

InterventionParticipants (Number)
Pegylated Interferon Alpha-2b and Ribavirin286

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Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification

SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration). (NCT00724464)
Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

InterventionParticipants (Number)
No Dosage Modification of Study TreatmentAny Dosage Modification of Study Treatment
Pegylated Interferon Alpha-2b and Ribavirin23452

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Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR

Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5. (NCT00724854)
Timeframe: Treatment Week 48 and Treatment Week 72

,
InterventionParticipants (Number)
No SVRSVR
Co-infected With HCV and HIV1319
Mono-infected With HCV251300

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Assessment of Baseline Characteristics in Participants With SVR

Baseline characteristics assessed were age, gender, and genotype. (NCT00724854)
Timeframe: 24 Weeks post-treatment

,
InterventionParticipants (Number)
Age <=40 yearsAge >40 yearsmalefemaleGenotype 1Genotype non-1
Co-infected With HCV and HIV11131771410
Mono-infected With HCV75300203172247128

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Number of Participants With RVR Who Also Achieved SVR

RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment. (NCT00724854)
Timeframe: Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)

InterventionParticipants (Number)
Mono-infected With HCV300
Co-infected With HCV and HIV19

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Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment

Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment. (NCT00724854)
Timeframe: Assessed at Treatment Week 4

InterventionParticipants (Number)
Mono-infected With HCV551
Co-infected With HCV and HIV32

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Number of Participants Who Achieved Sustained Virologic Response (SVR)

SVR was defined as non-detectable HCV RNA 24 weeks post-treatment. (NCT00724854)
Timeframe: Assessed at 24 weeks post-treatment

InterventionParticipants (Number)
Mono-infected With HCV375
Co-infected With HCV and HIV24

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Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)

"EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals." (NCT00724893)
Timeframe: Week 12

InterventionParticipants (Number)
Genotype 1 (n=757)Genotypes 1,4, and 6 (n=780)
Stage 1 Participants461473

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Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)

"EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as not done then EOT was set to no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticpants (Number)
Genotype 1, 4, and 6 (N=780)Genotype 2 and 3 (n=520)Genotype missing (n=2)
Stage 1 Participants4053950

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Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals." (NCT00724893)
Timeframe: Up to 72 weeks

,,,,,
Interventionparticipants (Number)
Genotype 1 (n=757)Genotype 2 (n=172)Genotype 3 (n=348)Genotype 4 (n=21)Genotype 6 (n=2)Unknown Genotype (n=2)
Stage F02148000
Stage F1551713000
Stage F2641313000
Stage F328910020
Stage F42529200
Unknown Stage10581154300

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Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Genotype 1 (n=757)Genotype 2 (n=172)Genotype 3 (n=348)Genotype 4 (n=21)Genotype 5 (n=0)Genotype 6 (n=2)Genotype missing (n=2)
Stage 1 Participants2981262075020

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Number of Participants Achieving RVR by Weight (Stage 2)

"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 4

Interventionparticipants (Number)
40 to <50 kg (n=3)50-<64 kg (n=40)64 to <75 kg (n=83)75 to <85 kg (n=86)>=85 kg (n=169)Weight unknown (n=7)
Stage 2 Participants08911271

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Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly)." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
F0 (n=59)F1 (n=159)F2 (n=216)F3 (n=128)F4 (n=111)Fibrosis stage unknown (n=629)
Stage 1 Participants3385904938343

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Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)

"SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly)." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
F0 (n=66)F1 (n=144)F2 (n=212)F3 (n=99)F4 (n=110)Could not be determined (n=463)Other (n=34)
Stage 2 Participants36729435351879

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Number of Participants Achieving RVR by Race (Stage 2)

"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 4

Interventionparticipants (Number)
Aboriginal peoples/Metis (n=10)Asian (n=19)Black (n=8)Caucasian (n=343)Hispanic (n=1)Other (n=7)
Stage 2 Participants0604703

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Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)

"RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly)." (NCT00724893)
Timeframe: Week 4

Interventionparticipants (Number)
F0 (n=28)F1 (n=30)F2 (n=49)F3 (n=14)F4 (n=27)Could not be determined (n=206)Other (n=34)
Stage 2 Participants49821293

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Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. (NCT00724893)
Timeframe: Up to 48 weeks

InterventionParticipants (Number)
Genotypes 1, 4, and 6 (n=780)Genotype 2 and 3 (n=520)
Stage 1 Participants5224

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Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals." (NCT00724893)
Timeframe: Up to 72 weeks

,,,,
Interventionparticipants (Number)
Genotype 1 (n=757)Genotype 2 (n=172)Genotype 3 (n=348)Genotype 4 (n=21)Genotype 6 (n=2)Genotype unknown (n=2)
>85 kg1185875000
40 to <50 kg451000
50 to <64 kg391131010
64 to <75 kg762653210
75 to <85 kg612647300

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Number of Participants Achieving SVR by Weight (Stage 2)

"SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
40 to <50 kg (n=16)50 to <64 (n=127)64 to <75 kg (n=250)75 to >85 kg (n=238)>=85 kg (n=490)Weight unknown (n=7)
Stage 2 Participants659115931932

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Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
HIV positive (n=11)HIV negative (n=1075)HIV status not done (n=216)
Stage 1 Participants354392

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Number of Participants Achieving SVR by Gender (Stage 2)

"SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Female (n=346)Male (n=782)
Stage 2 Participants167301

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Number of Participants Achieving SVR by Gender (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Female (n=432)Male (n=870)
Stage 1 Participants241397

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Number of Participants Achieving SVR by EVR Type (Stage 1)

"EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
EVR by ≥2 log reduction from baseline (n=78)EVR by HCV-RNA negative (n=389)EVR missing (n=6)
Stage 1 Participants152532

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Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)

"SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Genotype 1a (n=176)Genotype 1b (n=74)Genotype Unknown (n=850)Genotype mixed (n=14)Could not be determined (n=14)
Stage 2 Participants583736454

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Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals." (NCT00724893)
Timeframe: Up to 72 weeks

,,
Interventionparticipants (Number)
Genotype 1 (n=757)Genotype 2 (n=172)Genotype 3 (n=348)Genotype 4 (n=21)Genotype 6 (n=2)Unknown Genotype (n=2)
Viral Load High2225374220
Viral Load Low42414300
Viral Load Missing3469119000

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Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)

"Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 62 weeks

InterventionParticipants (Number)
Stage 1 Participants660

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Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)

"This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 62 weeks

InterventionParticipants (Number)
Stage 1 Participants660

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Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

InterventionParticipants (Number)
Stage 1 Participants638

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The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)

"Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly)." (NCT00724893)
Timeframe: Up to 62 weeks

InterventionParticipants (Number)
F0 (n=59)F1 (n=159)F2 (n=216)F3 (n=128)F4 (n=111)Fibrosis stage unknown (n=629)
Stage 1 Participants3489955140351

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Number of Participants Achieving SVR (Stage 2)

"SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Stage 2 Participants468

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Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)

"This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

InterventionParticipants (Number)
Stage 1 Participants638

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Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)

"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 4

Interventionparticipants (Number)
Stage 2 Participants56

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Number of Participants Achieving EVR Who Achieved SVR (Stage 2)

"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 12

Interventionparticipants (Number)
Stage 2 Participants399

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Number of Participants Achieving EVR (Stage 2)

"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 12

Interventionparticipants (Number)
Stage 2 Participants690

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Number of Participants Achieving EVR (Stage 1)

"EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: From Week 10 to Week 14

Interventionparticipants (Number)
Stage 1 Participants473

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Number of Participants Achieving SVR by Weight (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
40 to <50 kg (n=21)50 to <64 kg (n=160)64 to <75 kg (n=297)75 to <85 kg (n=283)>85 kg (n=541)
Stage 1 Participants1082158137251

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Number of Participants Achieving SVR by Viral Load (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL)." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Viral load high (n=836)Viral load low (n=109)Viral load missing (n=357)
Stage 1 Participants35363222

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Number of Participants Achieving SVR by Race (Stage 2)

"SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Aboriginal peoples/Metis (n=13)Asians (n=54)Black (n=20)Caucasian (n=1002)Hispanic (n=4)Other (n=35)
Stage 2 Participants4375407411

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Number of Participants Achieving SVR by Race (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Asian (n=78)Black (n=18)Caucasian (N=1110)Hispanic (n=11)Other (n=85)
Stage 1 Participants599524442

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Number of Participants Achieving RVR Who Achieved SVR (Stage 2)

"RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 4

Interventionparticipants (Number)
Stage 2 Participants35

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Number of Participants Achieving RVR by Gender (Stage 2)

"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 4

Interventionparticipants (Number)
Female (n=122)Male (n=266)
Stage 2 Participants1937

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Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)

"RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype." (NCT00724893)
Timeframe: Week 4

Interventionparticipants (Number)
Genotype 1a (n=147)Genotype 1b (n=56)Genotype unknown (n=160)Genotype mixed (n=11)Could not be determined (n=14)
Stage 2 Participants1792613

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Number of Participants Achieving EVR by Weight (Stage 2)

"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 12

Interventionparticipants (Number)
40 to <50 kg (n=16)50 to <64 kg (n=127)64 to <75 kg (n=250)75 to <85 kg (n=238)>=85 kg (n=490)Weight unknown (n=7)
Stage 2 Participants9871641432834

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Number of Participants Achieving EVR by Race (Stage 2)

"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 12

Interventionparticipants (Number)
Aboriginal peoples/Metis (n=13)Asian (n=54)Black (n=20)Caucasian (n=1002)Hispanic (n=4)Other (n=35)
Stage 2 Participants6428609421

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Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)

"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly)." (NCT00724893)
Timeframe: Week 12

Interventionparticipants (Number)
F0 (n=66)F1 (n=144)F2 (n=212)F3 (99)F4 (n=110)Could not be determined (n=463)Other (n=34)
Stage 2 Participants4995133625328018

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Number of Participants Achieving EVR by Gender (Stage 2)

"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Week 12

Interventionparticipants (Number)
Female (n=346)Male (n=782)
Stage 2 Participants227463

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Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)

"EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype." (NCT00724893)
Timeframe: Week 12

Interventionparticipants (Number)
Genotype 1a (n=176)Genotype 1b (n=74)Genotype unknown (n=850)Genotype mixed (n=14)Could not be determined (n=14)
Stage 2 Participants1065151887

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The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)

"Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 62 weeks

InterventionParticipants (Number)
Stage 1 Participants679

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The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)

"SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Stage 1 Participants612

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Number of Participants With End of Treatment (EOT) Response (Stage 1)

"EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as not done then EOT was set to no." (NCT00724893)
Timeframe: Up to 48 weeks

Interventionparticipants (Number)
Stage 1 Participants800

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Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment (NCT00724893)
Timeframe: Up to 48 weeks

Interventionparticipants (Number)
Stage 1 Participants76
Stage 2 Participants142

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Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)

"Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

InterventionParticipants (Number)
Stage 1 Participants685

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Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)

"This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Stage 1 Participants685

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The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)

"Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals." (NCT00724893)
Timeframe: Up to 62 weeks

InterventionParticipants (Number)
Genotype 1 (n=757)Genotype 2 (n=172)Genotype 3 (n=348)Genotype 4 (n=21)Genotype 5 (n=0)Genotype 6 (n=2)Genotype unknown (n=2)
Stage 1 Participants3081292156020

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Relapse Rate by HCV Genotype (Stage 1)

"The relapse rate was calculated with these parameters: EOT yes, EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals." (NCT00724893)
Timeframe: Up to 48 weeks

InterventionPercentage of Participants (Number)
Genotype 1 (n=251)Genotype 2 (n=123)Genotype 3 (n=217)Genotype 4 (n=5)Genotype 6 (n=2)
Stage 1 Participants11.53.29.740.00

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Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)

"Compliance was defined as participants taking ≥80% versus <80% of their doses; compliance ≥80% was derived from participants who answered always or most of the time to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen [peginterferon] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no." (NCT00724893)
Timeframe: Up to 72 weeks

Interventionpercentage of participants (Number)
Compliance < 80% (n=10)Compliance ≥80% (n=304)
Stage 2 Participants40.039.1

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Number of Participants Who Are Triple-80 Compliant

Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80. (NCT00725205)
Timeframe: 24 or 48 Weeks

InterventionParticipants (Number)
Peginterferon Alfa-2b and Ribavirin183

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Number Of Participants Self-Administering Pegylated Interferon Alfa-2b

Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering. (NCT00725205)
Timeframe: Up to 48 Weeks

InterventionParticipants (Number)
Peginterferon Alfa-2b and Ribavirin291

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Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up

Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder. (NCT00725205)
Timeframe: 24 Weeks following completion of 24 or 48 weeks of therapy

InterventionParticipants (Number)
Peginterferon Alfa-2b and Ribavirin66

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Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy

This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy. (NCT00725751)
Timeframe: Day 1

Interventionparticipants (Number)
All Participants90

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Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin

For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. (NCT00725751)
Timeframe: 24 to 48 weeks

Interventionparticipants (Number)
PegIFN-2b/Ribavirin With Substitution Therapy56
PegIFN-2b/Ribavirin Without Substitution Therapy150

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Number of Participants Who Achieved Sustained Virologic Response (SVR)

SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24. (NCT00725751)
Timeframe: 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)

Interventionparticipants (Number)
PegIFN-2b/Ribavirin With Substitution Therapy42
PegIFN-2b/Ribavirin Without Substitution Therapy111

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Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment

HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers. (NCT00725842)
Timeframe: 72 weeks post EOT

Interventionparticipants (Number)
Peg-IFN Alfa-2b + Ribavirin3

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Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment

HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers. (NCT00725842)
Timeframe: 24 weeks post end of treatment (EOT)

Interventionparticipants (Number)
Peg-IFN Alfa-2b + Ribavirin13

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Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions

Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid). (NCT00726557)
Timeframe: End of Follow-up (Week 48 or Week 72, depending on genotype)

InterventionParticipants (Number)
Opioid substitution with methadone (n=52)Opioid substitution with levo-methadone (n=13)Opioid substitution with buprenorphine (n=26)Opioid substitution with other medication (n=1)No opioid substitution medication (n=9)
Participants With Negative HCV-RNA at End of Treatment49102309

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Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week

Tolerability of the treatment was measured by number of participants with complete treatment. (NCT00726557)
Timeframe: Assessed at the end of treatment

Interventionparticipants (Number)
Participants Who Tolerated Treatment118

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Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months

Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied). (NCT00727259)
Timeframe: The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.

,
Interventionsatisfaction rating from 0-7 (Mean)
Ease of preparation of the PenSimplicity of adjustment of the injected doseTime required for the preparation of the injectionEase of injectionCharacteristics of the needleOverall satisfaction with the system of injection
After 1 Month of Treatment5.485.745.495.896.145.99
After 3 Months of Treatment5.916.085.846.006.256.04

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Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)

HCV-RNA level was measured by polymerase chain reaction (PCR). (NCT00727311)
Timeframe: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6

InterventionParticipants (Number)
PegIntron + Rebetol1306

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Number of Participants With Early Virologic Response (EVR)

"EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA~negativity from baseline to Week 12" (NCT00727311)
Timeframe: Treatment Week 12

InterventionParticipants (Number)
PegIntron + Rebetol1168

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Number of Participants With Sustained Virologic Response (SVR)

SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT (NCT00727311)
Timeframe: 24 weeks post-treatment (Week 48 or 72, depending on genotype)

InterventionParticipants (Number)
PegIntron + Rebetol888

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Number of HCV-RNA Negative Participants at Follow-up

HCV-RNA was measured by PCR. (NCT00727311)
Timeframe: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype)

InterventionParticipants (Number)
PegIntron + Rebetol887

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The Number of Participants Who Relapsed at 6 Months Post-treatment

Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment (NCT00728494)
Timeframe: Measured at end of treatment and 6 months post-treatment

InterventionParticipants (Number)
Treatment and Patient Assistance Program17
Treatment Alone4

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The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C

Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program (NCT00728494)
Timeframe: At the end of the 48-week treatment period

InterventionParticipants (Number)
Treatment and Patient Assistance Program51
Treatment Alone32

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Average Dosage of Rebetol

Rebetol dosage was expressed in milligrams per kilogram of body weight per day. (NCT00728494)
Timeframe: Up to 48-week treatment duration

Interventionmg/kg/day (Mean)
Treatment and Patient Assistance Program12.63
Treatment Alone12.01

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Average Dosage of PegIntron

Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week (NCT00728494)
Timeframe: Up to 48-week treatment duration

Interventionmicrograms/kg/week (Mean)
Treatment and Patient Assistance Program1.46
Treatment Alone1.45

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Average Length of Treatment

Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment. (NCT00728494)
Timeframe: Maximum 48-week treatment duration

,
InterventionParticipants (Number)
2-12 weeks13-47 weeks48 weeks and one of the drugs at a dose <80%48 weeks and both drugs at a dose >=80%
Treatment Alone52923
Treatment and Patient Assistance Program631338

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The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment

Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment (NCT00728494)
Timeframe: Measured at 6 months post-treatment

InterventionParticipants (Number)
Treatment and Patient Assistance Program29
Treatment Alone7

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Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.

(NCT00735969)
Timeframe: 24 weeks after treatment stop

Interventionparticipants (Number)
Peginterferon and Ribavirin Arm3

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Proportion of Randomized Subjects Who Relapse

Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT). (NCT00758043)
Timeframe: From EOT to Week 48 or Week 72

Interventionparticipants (Number)
T12PR24 (eRVR+)9
T12PR48 (eRVR+)1
T12PR48 (eRVR-)5
Other0

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Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment

SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment. (NCT00758043)
Timeframe: 12 weeks after last dose of study treatment

Interventionparticipants (Number)
T12PR24 (eRVR+)151
T12PR48 (eRVR+)144
T12PR48 (eRVR-)79
Other28

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Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)

SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL). (NCT00758043)
Timeframe: 24 weeks after the last planned dose of study treatment

,,,
Interventionparticipants (Number)
SVR24 (Statistical Analysis 1)SVR24 (Statistical Analysis 2)
Other2327
T12PR24 (eRVR+)149149
T12PR48 (eRVR-)7678
T12PR48 (eRVR+)140144

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Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

(NCT00758043)
Timeframe: Day 1 up to Week 72

,,,
Interventionparticipants (Number)
Subjects With AEsSubjects With SAEs
Other9922
T12PR24 (eRVR+)1614
T12PR48 (eRVR-)1177
T12PR48 (eRVR+)16016

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Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12

Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment). (NCT00758043)
Timeframe: Week 4 and Week 12

Interventionparticipants (Number)
T12PR24 (eRVR+)162
T12PR48 (eRVR+)159
T12PR48 (eRVR-)0
Other31

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Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)

(NCT00758043)
Timeframe: Week 24 or Week 48

Interventionparticipants (Number)
T12PR24 (eRVR+)159
T12PR48 (eRVR+)154
T12PR48 (eRVR-)97
Other59

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Proportion of Subjects Who Have Undetectable HCV RNA at Week 72

SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits. (NCT00758043)
Timeframe: 72 weeks after the last planned dose of study treatment

Interventionparticipants (Number)
T12PR24 (eRVR+)141
T12PR48 (eRVR+)140
T12PR48 (eRVR-)76
Other20

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Proportion of Enrolled Subjects Who Relapse

Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up. (NCT00758043)
Timeframe: From EOT to Week 48 or Week 72

Interventionparticipants (Number)
T12PR24 (eRVR+)9
T12PR48 (eRVR+)4
T12PR48 (eRVR-)11
Other13

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Mean Weight Percentiles of Participants Over LTFU

To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population. (NCT00761735)
Timeframe: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)

,
Interventionpercentile (Mean)
Part 1 Pre-treatment BaselineLTFU Year 1 (n=40, n=44)LTFU Year 2 (n=39, n=39)LTFU Year 3 (n=39, n=44)LTFU Year 4 (n=40, n=38)LTFU Year 5 (n=38, n=42)Last Available LTFU Visit (n=46, n=48)
PEG-IFN + RBV: LTFU (24 Weeks)52.553.6251.7353.1851.7551.1650.15
PEG-IFN + RBV: LTFU (48 Weeks)58.5656.3852.0354.2649.5053.1255.53

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Mean Height Percentiles of Participants Over LTFU

To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population. (NCT00761735)
Timeframe: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)

,
Interventionpercentile (Mean)
Part 1 Pre-treatment BaselineLTFU Year 1 (n=40, n=44)LTFU Year 2 (n=39, n=39)LTFU Year 3 (n=39, n=44)LTFU Year 4 (n=40, n=38)LTFU Year 5 (n=38, n=42)Last Available LTFU Visit (n=46, n=48)
PEG-IFN + RBV: LTFU (24 Weeks)48.9449.2150.5648.0549.6247.6145.96
PEG-IFN + RBV: LTFU (48 Weeks)52.543.3746.2446.0045.2743.5143.56

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Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU

To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population. (NCT00761735)
Timeframe: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)

,
Interventionpercentile (Mean)
Part 1 Pre-treatment BaselineLTFU Year 1 (n=40, n=44)LTFU Year 2 (n=39, n=39)LTFU Year 3 (n=39, n=44)LTFU Year 4 (n=40, n=38)LTFU Year 5 (n=38, n=42)Last Available LTFU Visit (n=46, n=48)
PEG-IFN + RBV: LTFU (24 Weeks)50.451.1548.1152.1448.4448.6148.79
PEG-IFN + RBV: LTFU (48 Weeks)59.7659.9152.8954.9648.6952.3455.38

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Number of Participants Who Relapsed At End of LTFU Year 5

Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU. (NCT00761735)
Timeframe: Part 2 LTFU Year 5

Interventionparticipants (Number)
PEG-IFN + RBV: LTFU (All)0

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Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender

The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported. (NCT00761735)
Timeframe: Last assessment of the Part 2 LTFU (up to 5 years)

,
Interventionyears (Mean)
Age of TS 1 participants (n=4, n=5)Age of TS 2 participants (n=5, n=3)Age of TS 3 participants (n=7, n=1)Age of TS 4 participants (n=4, n=6)Age of TS 5 participants (n=21, n=27)
PEG-IFN + RBV: LTFU (Female)9.7511.8615.2616.0017.37
PEG-IFN + RBV: LTFU (Male)11.0012.5313.6014.7519.18

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The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

(NCT00780416)
Timeframe: After 24 weeks of follow-up

Interventionpercentage of subjects achieving SVR (Number)
TRV/PEG/RBV73.0
PEG/RBV49.2

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The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

(NCT00780910)
Timeframe: After 24 weeks of follow-up

Interventionpercentage of subjects achieving SVR (Number)
MP-42488.1

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The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

(NCT00781274)
Timeframe: After 24 weeks of follow-up

Interventionpercentage of subjects achieving SVR (Number)
MP-42434.4

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Percentage of Participants Who Experienced at Least 1 Adverse Event.

An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT00800735)
Timeframe: Baseline through 24 weeks after the end of treatment (up to 72 weeks)

InterventionPercentage of participants (Number)
Pegylated-interferon Alfa-2a Plus Ribavirin80.0

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AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)

Bioequivalence based on AUC0-72. (NCT00835146)
Timeframe: Blood samples collected over a 72 hour period.

Interventionng*h/mL (Mean)
Test (Ribavirin)5594.145
Reference (Copegus®)5672.088

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Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Cmax. (NCT00835146)
Timeframe: Blood samples collected over a 72 hour period.

Interventionng/mL (Mean)
Test (Ribavirin)518.357
Reference (Copegus®)526.357

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Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Cmax. (NCT00835536)
Timeframe: Blood samples collected over a 72 hour period.

Interventionng/mL (Mean)
Test (Ribavirin)755.154
Reference (Copegus®)749.615

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AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)

Bioequivalence based on AUC0-72. (NCT00835536)
Timeframe: Blood samples collected over a 72 hour period.

Interventionng*h/mL (Mean)
Test (Ribavirin)7902.61
Reference (Copegus®)8041.413

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Mean Log Change From Baseline to TW 4 in Viral Load by Visit

HCV-RNA levels were quantified using the Roche Cobas Taqman 1.0 assay; lower limit of detection of 15 international units [IU]/mL. Changes in HCV-RNA IU/ml were expressed on a log10 scale. (NCT00845065)
Timeframe: From Baseline to TW 4

Interventionlog10 (IU/mL) (Mean)
PEG2a/Ribavirin-2.44
Boceprevir/PEG2a/Ribavirin-2.33

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Number of Participants With Undetectable HCV-RNA at Follow-up Week 12

(NCT00845065)
Timeframe: Follow-up Week 12

InterventionParticipants (Number)
PEG2a/Ribavirin12
Boceprevir/PEG2a/Ribavirin87

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Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population.

SVR rate was the percentage of participants treated with at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo) who had achieved SVR. SVR was defined as undetectable Hepatitis C Virus-Ribonucleic Acid (HCV RNA). (NCT00845065)
Timeframe: Follow-up Week 24

InterventionPercentage of Participants (Number)
PEG2a/Ribavirin20.9
Boceprevir/PEG2a/Ribavirin64.2

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SVR Rate in the Modified Intent-to-Treat (mITT) Population

SVR rate was the percentage of participants treated with at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included in the mITT population. (NCT00845065)
Timeframe: Follow-up Week 24

InterventionPercentage of Participants (Number)
PEG2a/Ribavirin20.9
Boceprevir/PEG2a/Ribavirin66.2

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Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR

EVR was defined as the time to the first undectectable HCV-RNA result at Treatment Week (TW) 2, 4, 8, or 12. Participants with a detectable, but not quantifiable HCV-RNA result at TW 12 may have undergone retesting. Participants with a detectable result on retesting were to be discontinued per the 12-week futility rule. Participants with an undetectable result on retesting were allowed to continue on treatment, and the detectable but not quantifiable result was to be considered a false positive. (NCT00845065)
Timeframe: Day 1 to Treatment Week 12

,
InterventionPercentage of Participants (Number)
<=TW 4 (PEG2a N = 2, Boceprevir N = 3)>TW 4 to TW 8 (PEG2a N = 7, Boceprevir N = 76)>TW 8 to TW 12 (PEG2a N = 9, Boceprevir N = 22)
Boceprevir/PEG2a/Ribavirin100.082.968.2
PEG2a/Ribavirin50.042.988.9

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Sustained Virologic Response (SVR)

Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment (NCT00845676)
Timeframe: 24 weeks

Interventionpercentage of participants (Number)
Experimental: Pegylated Interferon Alfa-2a + Ribavirin62

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Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28

Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during treatment was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level on Day 28. Data are reported as the least squares mean change from nadir ± standard error. (NCT00851890)
Timeframe: Prior to the first dose on Day 1 through Day 28

Interventionlog10 IU/mL (Least Squares Mean)
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV-3.65
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV-3.96
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV-3.59
Placebo + pegIFN/RBV-1.37

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Plasma Concentrations of Ribavirin (RBV)

Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation. (NCT00851890)
Timeframe: Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28

,,,
Interventionng/mL (Mean)
Prior to morning dose on Day 34 hours after morning dose on Day 3Day 4 (n=5, 7, 5, 5)Day 5 (n=6, 6, 8, 5)Day 10 (n=7, 8, 8, 6)Day 17 (n=8, 8, 8, 5)Day 24 (n=8, 7, 8, 5)Day 28 (n=8, 7, 8, 5)
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV0.000.510.290.481.021.321.601.56
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV0.000.460.330.611.051.471.761.76
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV0.000.610.460.691.241.671.912.07
Placebo + pegIFN/RBV0.000.540.360.551.051.341.491.68

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Number of Participants With Maximal Phenotypic Resistance to ABT-333 >10 Fold Relative to Baseline Through Day 28

Phenotypic resistance to ABT-333 was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the corresponding baseline sample, and the maximal fold change in EC50 from baseline over the Day 5-28 period. The resistance sample drawn before the first dose of ABT-333 on Day 1 was defined as the baseline sample. The number of participants with phenotypic resistance in the post-baseline samples are presented. (NCT00851890)
Timeframe: Days 1 through 28

Interventionparticipants (Number)
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV4
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV4
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV5

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Number of Participants With Resistance-Associated Variants in Non-structural Viral Protein 5B (NS5B) Through Day 28

Samples from Days 1, 5, 10, 17, 24 and 28 were analyzed for the presence of resistance-associated amino acids using population sequencing and compared to the baseline non-structural viral protein 5B (NS5B) sequence to assess amino acid changes. The amino acid sequence of NS5B before the first dose of ABT-333 on Day 1 was defined as the baseline sequence. The number of participants with variants at resistance-associated amino acid positions in the post-baseline samples are presented. (NCT00851890)
Timeframe: Days 1, 5, 10, 17, 24 and 28

,,
Interventionparticipants (Number)
Day 1Day 5 (n=6, 8, 7)Day 10 (n=6, 6, 7)Day 17 (n=5, 5, 6)Day 24 (n=3, 3, 2)Day 28 (n=4, 3, 3)
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV012213
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV011232
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV111232

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Number of Participants Having Treatment-emergent Adverse Events (AEs)

"An AE was any untoward medical occurrence that did not have a causal relationship with treatment. An Adverse Drug Reaction (ADR) was any noxious and undesired reaction related to the experimental drug or experiment. A serious adverse event (SAE) was an AE that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in congenital anomaly, was persistent or caused significant disability/incapacity, spontaneous or elective abortion, or required intervention to prevent a serious outcome. AEs were rated for severity as either:~Mild - transient and easily tolerated;~Moderate - caused discomfort and interrupted usual activities;~Severe - caused considerable interference with usual activities, may be incapacitating or life-threatening.~AEs related to direct-acting antiviral agents (DAAs) were assessed as being either probably or possibly related by the investigator." (NCT00851890)
Timeframe: AEs were collected from the time of study drug administration to 30 days after last dose of study drug (8 Weeks)

,,,
Interventionparticipants (Number)
Any AEAny AE at least possibly drug relatedAny severe AEAny serious AEAny AE leading to discontinuation of study drugAny fatal eventsDeaths
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV8200000
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV8410000
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV8300000
Placebo + pegIFN/RBV5100000

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Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 or Final Visit

Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1 and the Day 28 or Final Visit value was the last HCV RNA measurement during the study. Data are reported as the least squares mean change from baseline ± standard error. (NCT00851890)
Timeframe: Day 28 and Final Visit

,,,
Interventionlog10 IU/mL (Least Squares Mean)
Day 28 (n=8, 7, 7, 5)Final Visit
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV-3.24-3.48
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV-3.65-3.65
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV-3.67-3.86
Placebo + pegIFN/RBV-1.45-1.35

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Time to Maximum Plasma Concentration (Tmax) of ABT-333

Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT00851890)
Timeframe: Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2

InterventionHours (Mean)
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV3.80
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV3.50
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV3.50

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Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 25 IU/mL (the Lower Limit of Quantitation [LLOQ]) at Day 28 or Final Visit

Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of quantification (LLOQ) was defined as HCV RNA levels ≤ 25 IU/mL. Data are reported as the percentage of participants. (NCT00851890)
Timeframe: Day 28 or Final Visit

Interventionpercentage of participants (Number)
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV37.5
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV25.0
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV62.5
Placebo + pegIFN/RBV0.00

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Maximum Plasma Concentration (Cmax) of ABT-333

Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT00851890)
Timeframe: Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2

Interventionng/mL (Mean)
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV883
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV1236
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV1975

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Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 10 IU/mL (Lower Limit of Detection [LLOD]) at Day 28 or Final Visit

Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of detection (LLOD) was defined as a HCV RNA level equal to 10 IU/mL. Data are reported as the percentage of participants. (NCT00851890)
Timeframe: Day 28 or Final Visit

Interventionpercentage of participants (Number)
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV37.5
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV0.00
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV12.5
Placebo + pegIFN/RBV0.00

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Percentage of Participants With at Least a 2 log10 Maximal Decrease in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Treatment

Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. Data are reported as the percentage of participants. (NCT00851890)
Timeframe: Prior to the first dose on Day 1 and Day 28

Interventionpercentage of participants (Number)
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV87.5
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV87.5
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV62.5
Placebo + pegIFN/RBV16.7

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Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment

Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during monotherapy was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 3. Data are reported as the least squares mean change from nadir ± standard error. (NCT00851890)
Timeframe: Prior to the first dose on Day 1 to before first dose on Day 3

Interventionlog10 IU/mL (Least Squares Mean)
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV-1.01
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV-0.78
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV-0.68
Placebo + pegIFN/RBV-0.26

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Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC12) of ABT-333

Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) measures the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT00851890)
Timeframe: Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2

Interventionng*hr/mL (Mean)
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV5852
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV7548
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV12411

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Serum Concentrations of Pegylated Interferon (pegIFN)

Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation. (NCT00851890)
Timeframe: Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28

,,,
Interventionng/mL (Mean)
Prior to morning dose on Day 34 hours after morning dose on Day 3 (n=7, 8, 8, 6)Day 4 (n=8, 8, 7, 6)Day 5Day 10Day 17 (n=8, 8, 8, 5)Day 24 (n=8, 7, 8, 5)Day 28 (n=8, 7, 8, 5)
ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV0.000.094.955.574.728.7312.117.0
ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV0.000.706.969.067.9112.312.817.4
ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV0.001.366.517.916.479.2612.117.3
Placebo + pegIFN/RBV0.000.583.424.854.487.058.5814.3

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Percent of Participants Who Achieved Early Virologic Response (EVR)

EVR was defined as HCV RNA negative after 12 weeks of treatment. (NCT00856024)
Timeframe: Week 12

InterventionPercent of participants (Number)
Naïve Participants67.8
Re-treatment46.9
HIV/Hepatitis C Virus (HCV) Co-infected Participants33.3

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Percent of Participants Who Achieved Rapid Virologic Response (RVR)

RVR was defined as HCV RNA negative after 4 weeks of treatment. (NCT00856024)
Timeframe: Week 4

InterventionPercent of participants (Number)
Naïve Participants34.7
Re-treatment18.8
HIV/Hepatitis C Virus (HCV) Co-infected Participants0.0

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Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks

The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment. (NCT00856024)
Timeframe: First 12 weeks of treatment

InterventionPercent of participants (Number)
Naïve Participants98.5
Re-treatment98.5
HIV/Hepatitis C Virus (HCV) Co-infected Participants100.0

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Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores

SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. (NCT00863109)
Timeframe: Baseline, Week 72

Interventionscore on a scale (Mean)
Physical Function-BL (n=123)Physical Function-WK72 (n=45)Physical Function Change from BL (n=45)Physical Role-BL (n=123)Physical Role-WK72 (n=45)Physical Role Change from BL (n=45)Pain-BL (n=126)Pain-WK72 (n=46)Pain Change from BL (n=46)General Health-BL (n=122)General Health-WK72 (n=46)General Health Change from BL (n=46)Vitality-BL (n=121)Vitality-WK72 (n=45)Vitality Change from BL (n=45)Social Function-BL (n=126)Social Function-WK72 (n=46)Social Function Change from BL (n=46)Emotional Role-BL (n=123)Emotional Role-WK72 (n=45)Emotional Role Change from BL (n=45)Mental Health-BL (n=121)Mental Health-WK72 (n=45)Mental Health Change from BL (n=45)PCS-BL (n=121)PCS-WK72 (n=45)PCS Change from BL (n=45)MCS-BL (n=121)MCS-WK72 (n=45)MCS Change from BL (n=45)
PEG + RBV (Standard Clinical Practice)87.2787.33-1.5681.7186.67-0.5677.8882.35-2.2262.2266.241.8667.2068.33-4.3081.5586.962.1779.9587.411.4871.5574.761.1650.4050.73-0.9047.1749.450.54

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Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)

"The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life." (NCT00863109)
Timeframe: Baseline, Week 72

Interventionscore on a scale (Mean)
Activity/Energy-BL (n=125)Activity/Energy-WK72 (n=46)Activity/Energy Change from BL (n=46)Emotional Function-BL (n=125)Emotional Function-WK72 (n=46)Emotional Function Change from BL (n=46)Worry-BL (n=125)Worry-WK72 (n=46)Worry Change from BL (n=46)Systemic Symptoms-BL (n=125)Systemic Symptoms-WK72 (n=46)Systemic Symptoms Change from BL (n=46)CLDQ-HCV Global -BL (n=125)CLDQ-HCV Global-WK72 (n=46)CLDQ-HCV Global Change from BL (n=46)
PEG + RBV (Standard Clinical Practice)5.585.76-0.065.195.350.105.265.650.415.255.570.095.315.560.15

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Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)

"The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life." (NCT00863109)
Timeframe: Baseline, Week 72

,
Interventionscore on a scale (Mean)
Activity/Energy (n=38, n=8)Emotional Function (n=38, n=8)Worry (n=38, n=8)Systemic Symptoms (n=38, n=8)CLDQ-HCV Global (n=38, n=8)
PEG + RBV (Standard Clinical Practice): Completed Treatment0.040.250.610.150.28
PEG + RBV (Standard Clinical Practice): Early End of Treatment-0.50-0.57-0.58-0.23-0.49

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MCID in CLDQ-HCV Scores

"The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (all of the time) and 7 to the minimum (none of the time). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score." (NCT00863109)
Timeframe: From Baseline Visit to Final Visit (up to 72 weeks)

Interventionscore on a scale (Mean)
Activity/EnergyEmotional FunctionWorrySystemic SymptomsCLDQ-HCV Global
PEG + RBV (Standard Clinical Practice)0.000.401.000.000.40

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Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)

SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. (NCT00863109)
Timeframe: Baseline, Week 72

,
Interventionscore on a scale (Mean)
Physical Function (n=37, n=8)Physical Role (n=37, n=8)Pain (n=38, n=8)General Health (n=38, n=8)Vitality (n=37, n=8)Social Function (n=38, n=8)Emotional Role (n=37, n=8)Mental Health (n=37, n=8)PCS (n=37, n=8)MCS (n=37, n=8)
PEG + RBV (Standard Clinical Practice): Completed Treatment-1.08-1.35-3.554.35-1.984.614.503.46-1.232.18
PEG + RBV (Standard Clinical Practice): Early End of Treatment-3.753.134.13-10.00-15.00-9.38-12.50-9.500.59-7.05

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Minimal Clinically Important Difference (MCID) in SF-36 Scores

SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS. (NCT00863109)
Timeframe: From Baseline Visit to Final Visit (up to 72 weeks)

Interventionscore on a scale (Mean)
Physical FunctionPhysical RolePainGeneral HealthVitalitySocial FunctionEmotional RoleMental HealthPCSMCS
PEG + RBV (Standard Clinical Practice)4.293.57-0.676.864.29-5.3614.294.570.192.73

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Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)

Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication. (NCT00863109)
Timeframe: From Baseline Visit to Final Visit (up to 72 weeks)

,
Interventionpercentage of participants (Number)
PEGRBVPEG + RBV
PEG + RBV (Standard Clinical Practice): Completed Treatment98.181.181.1
PEG + RBV (Standard Clinical Practice): Early End of Treatment000

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Frequency of Confirmed Pneumonia

(NCT00867139)
Timeframe: 58 days

Interventionparticipants (Number)
TCAD0
Neuraminidase Inihibitor Monotherapy0
Open-labeled TCAD1

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Duration of Symptoms

"Calculated as the number of days (mean) any persistent symptom lasted per patient as listed below.~overall health, short of breath, chills, cough, diarrhea, ear pain, fatigue, fever, headache, hoarseness, muscle ache, phlegm, runny nose, sinus congestion, sneezing, sore throat, watery eyes, wheezing" (NCT00867139)
Timeframe: from baseline up to 28 days

Interventiondays (Mean)
TCAD4.5
Neuraminidase Inhibitor Monotherapy1
Open-label TCAD4.7

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Duration of Hospitalization

(NCT00867139)
Timeframe: from baseline up to 58 days

Interventiondays (Mean)
TCAD6
Neuraminidase Inihibitor Monotherapy6
Open-labeled TCAD1

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Days on Supplemental Oxygen

(NCT00867139)
Timeframe: 58 days

Interventiondays (Mean)
TCAD2
Neuraminidase Inihibitor Monotherapy0
Open-labeled TCAD0

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Number of Deaths

(NCT00867139)
Timeframe: 58 days

Interventionparticipants (Number)
TCAD0
Neuraminidase Inihibitor Monotherapy0
Open-labeled TCAD0

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Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1

(NCT00867139)
Timeframe: 10 days

,
Interventionparticipants (Number)
Day 5 +/-1Day 10 +/- 1
Neuraminidase Inihibitor Monotherapy00
Open-labeled TCAD01

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Pharmacokinetics (AUC0-last) of TCAD

Only 5 patients had partial pharmacokinetic (PK) data available. Plasma concentration of oseltamivir was measured at several time points in one patient receiving neuraminidase inhibitor monotherapy. Plasma concentration of oseltamivir, amantadine, and ribavirin were measured at several time points in four patients receiving TCAD therapy. Area under the time-concentration curve up to the last measured time point (AUC0-last) was calculated from the plasma concentration-time profiles by non-compartmental analysis. (NCT00867139)
Timeframe: 5 days

Interventionng*hr/mL (Mean)
TCAD304
Neuraminidase Inhibitor Monotherapy1497
Open-lable TCAD2487

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Number of Participants With Viral Resistance as a Function of Drug Exposure

Viral resistance was assessed within 28 days after drug administration by detecting resistance-conferring mutation genes and compared to the value at baseline. (NCT00867139)
Timeframe: 28 days

InterventionNumber of participants (Number)
TCAD0
Neuraminidase Inihibitor Monotherapy1
Open-labeled TCAD0

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Number of Participants With Viral Load Decrease as a Function of Time

Viral loads were measured by quantitative Polymerase Chain Reaction (PCR) on day 1, 3, 5, 7, 9, 15, 20 and 28, if applicable. (NCT00867139)
Timeframe: baseline and 28 days

Interventionnumber of participants (Number)
Neuraminidase Inhibitor Monotherapy0
Open-label TCAD2

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Number of Participants With Intubations

(NCT00867139)
Timeframe: 58 days

Interventionparticipants (Number)
TCAD0
Neuraminidase Inihibitor Monotherapy0
Open-labeled TCAD1

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Number of Participants With ICU Admissions

The number of participants with ICU admissions was evaluated. (NCT00867139)
Timeframe: baseline and up to 58 days

Interventionparticipants (Number)
TCAD0
Neuraminidase Inihibitor Monotherapy0
Open-labeled TCAD1

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Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption

"Abnormal lab data or newly appeared symptoms & signs were considered as AEs.~Examined lab data:~Blood cell count (WBC, differential count, Red Blood Cell (RBC), Hemoglobin, Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), platelets), Chemistry (Cl, bicarbonate (HCO3), K, Na), Renal function test (BUN, Creatinine, Creatinine clearance), Liver function test (AST, Alanine aminotransferase(ALT), T.Bil, gamma-glutamyltransferase)" (NCT00867139)
Timeframe: 30 days after the final dose of study drug

Interventionnumber of participants with AEs (Number)
TCAD1
Neuraminidase Inihibitor Monotherapy1
Open-labeled TCAD1

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Percentage of Participants With Early Virologic Response (EVR) at Week 12

EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL. (NCT00874770)
Timeframe: At Week 12

Interventionpercentage of participants (Number)
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin75
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin100
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin83.3
Placebo + pegIFNα-2a + Ribavirin66.7

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Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12

cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12 (NCT00874770)
Timeframe: At Week 12

Interventionpercentage of participants (Number)
Daclatasvir 3 mg + pegIFNα-2a + Riibavirin58.3
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin83.3
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin83.3
Placebo + pegIFNα-2a + Ribavirin41.7

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Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results

Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L. (NCT00874770)
Timeframe: From screening up to Week 12 (treatment period)

,,,
Interventionparticipants (Number)
Hemoglobin (n= 11,12,12,11)Lymphocytes (n= 11,12,12,12)Neutrophils (n= 11,12,12,12)Platelets (n= 11,12,12,12)ALT (n= 11,12,12,12)AST (n= 11,12,12,12)Total bilirubin (n= 11,12,12,12)WBC (n= 11, 12, 12, 12)
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin03401002
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin11200000
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin13300011
Placebo + pegIFNα-2a + Ribavirin03413302

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Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4. (NCT00874770)
Timeframe: At Week 4

Interventionpercentage of participants (Number)
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin41.7
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin91.7
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin83.3
Placebo + pegIFNα-2a + Ribavirin8.3

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Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12

eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12. (NCT00874770)
Timeframe: A Weeks 4 and 12

Interventionpercentage of participants (Number)
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin41.7
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin83.3
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin75
Placebo + pegIFNα-2a + Ribavirin8.3

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Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4

Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data. (NCT00880763)
Timeframe: Baseline and Week 4

InterventionPercentage of participants (Number)
Vaniprevir 200 mg + Peg-IFN + Ribavirin100
Vaniprevir 600 mg + Peg-IFN + Ribavirin100
Vaniprevir 1200 mg + Peg-IFN + Ribavirin100
Placebo + Peg-IFN + Ribavirin85

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Number of Participants Who Experienced at Least One Adverse Event

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT00880763)
Timeframe: Up to 6 weeks

InterventionParticipants (Number)
Vaniprevir 200 mg + Peg-IFN + Ribavirin23
Vaniprevir 600 mg + Peg-IFN + Ribavirin22
Vaniprevir 1200 mg + Peg-IFN + Ribavirin23
Placebo + Peg-IFN + Ribavirin22

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Number of Participants Who Discontinued Study Drug Due to an Adverse Event

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT00880763)
Timeframe: Up to 6 weeks

InterventionParticipants (Number)
Vaniprevir 200 mg + Peg-IFN + Ribavirin0
Vaniprevir 600 mg + Peg-IFN + Ribavirin0
Vaniprevir 1200 mg + Peg-IFN + Ribavirin0
Placebo + Peg-IFN + Ribavirin0

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Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4

Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data. (NCT00880763)
Timeframe: Baseline and Week 4

InterventionPercentage of participants (Number)
Vaniprevir 200 mg + Peg-IFN + Ribavirin100
Vaniprevir 600 mg + Peg-IFN + Ribavirin100
Vaniprevir 1200 mg + Peg-IFN + Ribavirin100
Placebo + Peg-IFN + Ribavirin95

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Percentage of Participants Achieving Rapid Viral Response

Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data. (NCT00880763)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Vaniprevir 200 mg + Peg-IFN + Ribavirin86.4
Vaniprevir 600 mg + Peg-IFN + Ribavirin95.0
Vaniprevir 1200 mg + Peg-IFN + Ribavirin76.2
Placebo + Peg-IFN + Ribavirin20.0

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Change From Baseline in HCV RNA in log10 at Week 4

Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data. (NCT00880763)
Timeframe: Baseline and Week 4

,,,
InterventionIU/mL in Log10 (Mean)
BaselineChange from Baseline
Placebo + Peg-IFN + Ribavirin6.6-4.7
Vaniprevir 1200 mg + Peg-IFN + Ribavirin6.6-6.3
Vaniprevir 200 mg + Peg-IFN + Ribavirin6.6-6.5
Vaniprevir 600 mg + Peg-IFN + Ribavirin6.6-6.6

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The Percentage of Participants Achieving an Early Virologic Response (EVR)

The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12. (NCT00882908)
Timeframe: Baseline (Day 1) and Week 12

InterventionPercentage of participants (Number)
TMC435 75 mg 12 Wks + PR 24/4897.4
TMC435 75 mg 24 Wks + PR 24/4896.0
TMC435 150 mg 12 Wks + PR 24/4896.1
TMC435 150 mg 24 Wks + PR 24/4896.2
Placebo 24 Wks + PR4889.6

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The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)

The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT. (NCT00882908)
Timeframe: Week 48 or 72

InterventionPercentage of participants (Number)
TMC435 75 mg 12 Wks + PR 24/4882.1
TMC435 75 mg 24 Wks + PR 24/4874.7
TMC435 150 mg 12 Wks + PR 24/4880.5
TMC435 150 mg 24 Wks + PR 24/4886.1
Placebo 24 Wks + PR4864.9

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Plasma Concentrations of TMC435

The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups. (NCT00882908)
Timeframe: Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24

,,,
Interventionng/mL (Median)
CohCss, av
TMC435 150 mg 12 Wks + PR 24/481123.31661.8
TMC435 150 mg 24 Wks + PR 24/481176.71501.6
TMC435 75 mg 12 Wks + PR 24/48240.9413.6
TMC435 75 mg 24 Wks + PR 24/48213.6374.0

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The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment

The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment. (NCT00882908)
Timeframe: Baseline (Day 1) and Weeks, 2, 4, 8, and 12

,,,,
InterventionPercentage of participants (Number)
Week 2Week 4Week 8Week 12
Placebo 24 Wks + PR4840.371.484.489.6
TMC435 150 mg 12 Wks + PR 24/4897.497.497.496.1
TMC435 150 mg 24 Wks + PR 24/4898.793.794.996.2
TMC435 75 mg 12 Wks + PR 24/4893.694.997.497.4
TMC435 75 mg 24 Wks + PR 24/4898.798.797.396.0

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The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up

The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT). (NCT00882908)
Timeframe: Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)

,,,,
InterventionPercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 24Week 36Week 48Week 60Week 72EOT (up to Week 24 or 48)
Placebo 24 Wks + PR482.65.226.055.877.976.674.063.664.979.2
TMC435 150 mg 12 Wks + PR 24/4823.475.392.293.584.481.879.275.377.992.2
TMC435 150 mg 24 Wks + PR 24/4839.274.793.794.987.384.882.383.582.393.7
TMC435 75 mg 12 Wks + PR 24/4839.775.687.291.092.385.979.579.579.592.3
TMC435 75 mg 24 Wks + PR 24/4830.768.090.793.393.381.377.368.070.797.3

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The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)

The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12. (NCT00882908)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 75 mg 12 Wks + PR 24/4891.0
TMC435 75 mg 24 Wks + PR 24/4893.3
TMC435 150 mg 12 Wks + PR 24/4893.5
TMC435 150 mg 24 Wks + PR 24/4894.9
Placebo 24 Wks + PR4855.8

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The Percentage of Participants Achieving a Rapid Virologic Response (RVR)

The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment. (NCT00882908)
Timeframe: Week 4

InterventionPercentage of participants (Number)
TMC435 75 mg 12 Wks + PR 24/4875.6
TMC435 75 mg 24 Wks + PR 24/4868.0
TMC435 150 mg 12 Wks + PR 24/4875.3
TMC435 150 mg 24 Wks + PR 24/4874.7
Placebo 24 Wks + PR485.2

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The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)

The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72. (NCT00882908)
Timeframe: Week 72

InterventionPercentage of participants (Number)
TMC435 75 mg 12 Wks + PR 24/4880.8
TMC435 75 mg 24 Wks + PR 24/4870.7
TMC435 150 mg 12 Wks + PR 24/4877.9
TMC435 150 mg 24 Wks + PR 24/4884.8
Placebo 24 Wks + PR4864.9

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Number of Participants With Viral Breakthrough

The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable). (NCT00882908)
Timeframe: Week 24 or 48

InterventionParticipants (Number)
TMC435 75 mg 12 Wks + PR 24/485
TMC435 75 mg 24 Wks + PR 24/482
TMC435 150 mg 12 Wks + PR 24/486
TMC435 150 mg 24 Wks + PR 24/482
Placebo 24 Wks + PR484

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The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up

The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT). (NCT00882908)
Timeframe: Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)

,,,,
InterventionPercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 24Week 36Week 48Week 60Week 72EOT (up to Week 24 or 48)
Placebo 24 Wks + PR485.215.649.466.280.579.275.364.964.983.1
TMC435 150 mg 12 Wks + PR 24/4875.390.993.596.184.481.879.275.377.992.2
TMC435 150 mg 24 Wks + PR 24/4878.591.193.794.989.984.882.383.583.596.2
TMC435 75 mg 12 Wks + PR 24/4865.485.993.693.692.385.979.579.579.593.6
TMC435 75 mg 24 Wks + PR 24/4866.788.094.794.793.381.377.368.070.797.3

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The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)

The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT. (NCT00882908)
Timeframe: Baseline (Day 1) up to Week 24 or 48

InterventionParticipants (Number)
TMC435 75 mg 12 Wks + PR 24/4839
TMC435 75 mg 24 Wks + PR 24/4837
TMC435 150 mg 12 Wks + PR 24/4839
TMC435 150 mg 24 Wks + PR 24/4835
All TMC435 Treatment Groups150

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The Number of Participants With Viral Relapse

The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment. (NCT00882908)
Timeframe: Up to Week 72

InterventionParticipants (Number)
TMC435 75 mg 12 Wks + PR 24/488
TMC435 75 mg 24 Wks + PR 24/4814
TMC435 150 mg 12 Wks + PR 24/486
TMC435 150 mg 24 Wks + PR 24/486
Placebo 24 Wks + PR4811

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The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)

The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT. (NCT00882908)
Timeframe: Up to Week 36 or 52

InterventionPercentage of participants (Number)
TMC435 75 mg 12 Wks + PR 24/4883.3
TMC435 75 mg 24 Wks + PR 24/4876.0
TMC435 150 mg 12 Wks + PR 24/4880.5
TMC435 150 mg 24 Wks + PR 24/4886.1
Placebo 24 Wks + PR4866.2

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Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435

The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups. Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure). (NCT00882908)
Timeframe: Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24

Interventionng*h/mL (Median)
TMC435 75 mg 12 Wks + PR 24/489926.4
TMC435 75 mg 24 Wks + PR 24/488976.8
TMC435 150 mg 12 Wks + PR 24/4839884.0
TMC435 150 mg 24 Wks + PR 24/4836038.8

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Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir

Intrahepatic and plasma telaprevir concentration ratios (NCT00892697)
Timeframe: Day 1, Day 4, Day 15, Week 8

Interventiontelaprevir liver to plasma conc ratio (Median)
telaprevir liver/plasma conc ratio day 1telaprevir liver/plasma conc ratio day 4telaprevir liver/plasma conc ratio day 15telaprevir liver/plasma conc ratio week 8
Telaprevir/PEG-IFN/RBV0.720.470.570.61

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Intrahepatic and Plasma HCV Viral Kinetics

Intrahepatic viral kinetics, plasma viral kinetics, (NCT00892697)
Timeframe: Day-7, Day 1, Day 4,

Interventionlog transformed copies/ml (Mean)
Plasma HCV RNA predosePlasma HCV RNA 10 hrsPlasma HCV RNA day 4Liver HCV RNA predoseLiver HCV RNA 10 hrsLiver HCV RNA day 4
Telaprevir/Peg-IFN/RBV6.54.93.24.24.03.9

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Percentage of Participants With Early Virologic Response (EVR)

EVR was defined as undetectable HCV-RNA at TW 12 of BOC + PEG/RBV. EVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies. (NCT00910624)
Timeframe: From TW 1 to TW 12

Interventionpercentage of participants (Number)
BOC + PEG/RBV: Prior Null Responders49
BOC + PEG/RBV: Prior Partial Responders76
BOC + PEG/RBV: Prior Relapsers100
BOC + PEG/RBV: All73

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Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24);

SVR24 was defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week (FW) 24. SVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies. (NCT00910624)
Timeframe: From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks)

Interventionpercentage of participants (Number)
BOC + PEG/RBV: Prior Null Responders41
BOC + PEG/RBV: Prior Partial Responders67
BOC + PEG/RBV: Prior Relapsers96
BOC + PEG/RBV: All65

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Early Virologic Response (EVR)

(NCT00919633)
Timeframe: Study week 12

Interventionparticipants (Number)
Group 4: Peginterferon Alfa-2b (1.5 μg/kg)7
Group 1: Interferon Alfa-2b (Dose 1)15
Group 2: Interferon Alfa-2b (Dose 2)13
Group 3: Interferon Alfa-2b (Dose 3)11

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Rapid Virologic Response (RVR)

(NCT00919633)
Timeframe: Study Week 4

Interventionparticipants (Number)
Group 4: Peginterferon Alfa-2b (1.5 μg/kg)2
Group 1: Interferon Alfa-2b (Dose 1)4
Group 2: Interferon Alfa-2b (Dose 2)7
Group 3: Interferon Alfa-2b (Dose 3)11

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Viral Load: Incidence of Sustained Virologic Response (SVR)

(NCT00919633)
Timeframe: 24 weeks after treatment is complete

Interventionparticipants (Number)
Group 4: Peginterferon Alfa-2b (1.5 μg/kg)4
Group 1: Interferon Alfa-2b (Dose 1)7
Group 2: Interferon Alfa-2b (Dose 2)2
Group 3: Interferon Alfa-2b (Dose 3)4

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Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy

SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy. (NCT00922779)
Timeframe: 24 weeks after end of therapy (Week 72)

InterventionPercentage of Participants (Number)
Ribavirin + Peginterferon Alfa-2a50.9

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Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation

HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48. (NCT00922779)
Timeframe: Weeks 12,24 and 48 After Therapy Initiation

InterventionPercentage of Participants (Number)
Week 12Week 24Week 48
Ribavirin + Peginterferon Alfa-2a58.869.724.8

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Percentage of Participants With Change in Hemoglobin Level

"Change in hemoglobin level (compared to baseline) was reported as significant decrease, Normal (no change), Increase, Decrease, and Missing. Significant decrease was defined as per Investigator's discretion." (NCT00922779)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)

InterventionPercentage of Participants (Number)
Week 2, Significant decreaseWeek 2, NormalWeek 2, IncreaseWeek 2, DecreaseWeek 2, MissingWeek 4, Significant decreaseWeek 4, NormalWeek 4, IncreaseWeek 4, DecreaseWeek 4, MissingWeek 8, Significant decreaseWeek 8, NormalWeek 8, IncreaseWeek 8, DecreaseWeek 8, MissingWeek 12, Significant decreaseWeek 12, NormalWeek 12, IncreaseWeek 12, DecreaseWeek 12, MissingWeek 24, Significant decreaseWeek 24, NormalWeek 24, IncreaseWeek 24, DecreaseWeek 24, MissingWeek 36, Significant decreaseWeek 36, NormalWeek 36, IncreaseWeek 36, DecreaseWeek 36, MissingWeek 48, Significant decreaseWeek 48, NormalWeek 48, IncreaseWeek 48, DecreaseWeek 48, MissingFollow-up Week 4, Significant decreaseFollow-up Week 4, NormalFollow-up Week 4, IncreaseFollow-up Week 4, DecreaseFollow-up Week 4, MissingFollow-up Week 12, Significant decreaseFollow-up Week 12, NormalFollow-up Week 12, IncreaseFollow-up Week 12, DecreaseFollow-up Week 12, MissingFollow-up Week 24, Significant decreaseFollow-up Week 24, NormalFollow-up Week 24, IncreaseFollow-up Week 24, DecreaseFollow-up Week 24, Missing
Ribavirin + Peginterferon Alfa-2a13.532.411.732.310.027.921.06.935.19.135.415.35.131.512.838.915.24.730.111.134.913.64.625.421.516.24.11.79.169.013.73.81.77.773.111.518.56.819.643.75.823.010.216.144.84.727.512.215.540.2

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Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs. (NCT00922779)
Timeframe: From signing of informed consent up to end of study (up to Week 72)

InterventionParticipants (Number)
Non Serious AEsSAEs
Ribavirin + Peginterferon Alfa-2a205867

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Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment

"Mean absolute changes in ALT (alanine aminotransferase)in the blood from before treatment (baseline)through 24 weeks of treatment are presented.~Mean absolute change in ALT (IU/ml)= ALT(Week 24) - ALT(baseline)" (NCT00925990)
Timeframe: Baseline and 24 weeks

InterventionIU/mL (Mean)
CTS-1027 + Ribavirin-15.6
CTS-1027 + Placebo-16.5

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Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment

"Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as viral load) levels in the blood from before treatment (baseline) through 24 weeks of treatment.~Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)" (NCT00925990)
Timeframe: Baseline and 24 weeks

Interventionlog (IU/mL) (Mean)
CTS-1027 + Ribavirin-0.48
CTS-1027 + Placebo-0.12

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Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT00943761)
Timeframe: 48 weeks

InterventionParticipants (Number)
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV2
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV1

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Number of Participants Who Experienced a Serious Adverse Event

Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose. (NCT00943761)
Timeframe: up to 72 weeks

InterventionParticipants (Number)
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV4
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV1

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Number of Participants Who Experienced an Adverse Event

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT00943761)
Timeframe: up to 72 weeks

InterventionParticipants (Number)
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV21
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV23

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Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)

SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL. (NCT00943761)
Timeframe: 72 weeks

InterventionPercentage of participants (Number)
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV66.7
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV70.6

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Rapid Virological Response (RVR)

Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4) (NCT00947349)
Timeframe: 4 weeks

Interventionparticipants (Number)
Placebo TN0
BI 201335 NA Low TN5
BI 201335 NA High TN6
BI 201335 NA High TE4

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Sustained Virologic Response (SVR)

Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion (NCT00947349)
Timeframe: 72 weeks

Interventionparticipants (Number)
Placebo TN2
BI 201335 NA Low TN4
BI 201335 NA High TN5
BI 201335 NA High TE3

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t1/2,ss for BI 201335 ZW

terminal half-life of the analyte in plasma at steady state (t1/2,ss) (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Interventionhour(s) (Geometric Mean)
BI 201335 NA Low TN29.3
BI 201335 NA High TN21.2
BI 201335 NA High TE23.0

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Tmax for BI 201335 ZW

Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose

Interventionhour(s) (Median)
BI 201335 NA Low TN4.98
BI 201335 NA High TN5.50
BI 201335 NA High TE7.97

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Tmax for RBV

Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose

Interventionhour(s) (Median)
Placebo TN1.94
BI 201335 NA Low TN3.98
BI 201335 NA High TN3.92
BI 201335 NA High TE4.98

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Tmax, ss for BI 201335 ZW

Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Interventionhour(s) (Median)
BI 201335 NA Low TN3.83
BI 201335 NA High TN2.99
BI 201335 NA High TE3.49

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Tmax, ss for RBV

Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Interventionhour(s) (Median)
Placebo TN2.42
BI 201335 NA Low TN2.92
BI 201335 NA High TN2.90
BI 201335 NA High TE3.92

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Week 2 Virological Response (W2VR)

Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ)) (NCT00947349)
Timeframe: 2 weeks

Interventionparticipants (Number)
Placebo in TN0
BI 201335 NA Low TN5
BI 201335 NA High TN6
BI 201335 NA High TE3

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Week 4 Virological Response (W4VR)

Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ)) (NCT00947349)
Timeframe: 4 weeks

Interventionparticipants (Number)
Placebo TN0
BI 201335 NA Low TN6
BI 201335 NA High TN6
BI 201335 NA High TE5

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Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV

An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV. (NCT00947349)
Timeframe: 44 weeks

,,,
Interventionparticipant(s) (Number)
GoodSatisfactoryNot satisfactoryBad
SOC TE 240 mg3120
SOC TN 120 mg4010
SOC TN 240 mg1212
SOC TN Placebo2200

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Assessment of Tolerability in Triple Combination Therapy

An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV. (NCT00947349)
Timeframe: 4 weeks

,,,
Interventionparticipants (Number)
GoodSatisfactoryNot SatisfactoryBad
Triple TE 240 mg6000
Triple TN 120 mg5100
Triple TN 240 mg5100
Triple TN Placebo3010

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Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV

Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients. (NCT00947349)
Timeframe: 44 weeks

,,,
Interventionparticipant(s) (Number)
Decrease haematocritDecrease haemoglobinDecrease red blood cell ct.Decrease white blood cell ct.Decrease plateletsIncrease eosinophilsDecrease sodiumDecrease potassiumIncrease bicarbonateIncrease uric acidIncrease triglycerideIncrease U. pHIncrease AST/GOT, SGOTIncrease ALT/GPT, SGPT
SOC TE 240 mg45330100002011
SOC TN 120 mg32351000100211
SOC TN 240 mg52450111000000
SOC TN Placebo14030010011000

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Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy

Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients. (NCT00947349)
Timeframe: 4 weeks

,,,
Interventionparticipants (Number)
Decrease HaematocritDecrease HaemoglobinDecrease Red blood cell ct.Decrease White blood cell ct.Decrease PlateletsIncrease EosinophilsDecrease SodiumDecrease PotassiumDecrease BicarbonateIncrease BicarbonateIncrease Bilirubin, totalIncrease Bilirubin, directIncrease Protein, totalIncrease Uric acidIncrease TriglycerideIncrease U. pH
Triple TE 240 mg4424001012540140
Triple TN 120 mg2324102012210201
Triple TN 240 mg3225012101631010
Triple TN Placebo2312001001000200

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AUCτ,ss of RBV

Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state (NCT00947349)
Timeframe: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose

Interventionng*h/mL (Geometric Mean)
Placebo TN27500
BI 201335 NA Low TN25200
BI 201335 NA High TN22400
BI 201335 NA High TE20000

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AUCτ,1 for BI 201335 ZW

Area under the curve (AUC) concentration after the first dose of BI 201335 ZW (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose

Interventionng*h/mL (Geometric Mean)
BI 201335 NA Low TN68900
BI 201335 NA High TN171000
BI 201335 NA High TE233000

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AUCτ,1 for Ribavirin (RBV)

Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a (NCT00947349)
Timeframe: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose

Interventionng*h/mL (Geometric Mean)
Placebo TN5160
BI 201335 NA Low TN4660
BI 201335 NA High TN4620
BI 201335 NA High TE3500

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AUCτ,ss of BI 201335 ZW

AUC at steady state after 4 weeks combination of the last dose (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Interventionng*h/mL (Geometric Mean)
BI 201335 NA Low TN70800
BI 201335 NA High TN361000
BI 201335 NA High TE499000

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Cavg for BI 201335 ZW

average plasma concentration (Cavg) of BI 201335 ZW (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Interventionng/mL (Geometric Mean)
BI 201335 NA Low TN2950
BI 201335 NA High TN15000
BI 201335 NA High TE20800

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Cavg for RBV

average plasma concentration (Cavg) of RBV (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Interventionng/mL (Geometric Mean)
Placebo TN2290
BI 201335 NA Low TN2100
BI 201335 NA High TN1860
BI 201335 NA High TE1670

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Change From Baseline in HCV Viral Load

Change form baseline in HCV viral load (log10) after 4 weeks (NCT00947349)
Timeframe: baseline and week 4

InterventionIU/mL (Mean)
Placebo TN-3.30
BI 201335 NA Low TN-5.88
BI 201335 NA High TN-5.95
BI 201335 NA High TE-5.53

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CL/F,ss for BI 201335 ZW

apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

InterventionmL/min (Geometric Mean)
BI 201335 NA Low TN28.2
BI 201335 NA High TN11.1
BI 201335 NA High TE8.01

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Cmax of BI 201335 ZW

Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose

Interventionng/mL (Geometric Mean)
BI 201335 NA Low TN5500
BI 201335 NA High TN12600
BI 201335 NA High TE15000

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Cmax of RBV

Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a (NCT00947349)
Timeframe: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose

Interventionng/mL (Geometric Mean)
Placebo TN1130
BI 201335 NA Low TN761
BI 201335 NA High TN724
BI 201335 NA High TE509

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Cmax,ss of BI 201335 ZW

Maximum concentration of BI 201335 ZW at steady state (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Interventionng/mL (Geometric Mean)
BI 201335 NA Low TN5880
BI 201335 NA High TN24500
BI 201335 NA High TE29100

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Cmax,ss of RBV

Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state (NCT00947349)
Timeframe: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose

Interventionng/mL (Geometric Mean)
Placebo TN3060
BI 201335 NA Low TN2710
BI 201335 NA High TN2280
BI 201335 NA High TE2130

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Cmin,ss for BI 201335 ZW

Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Interventionng/mL (Geometric Mean)
BI 201335 NA Low TN1550
BI 201335 NA High TN10200
BI 201335 NA High TE16000

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Cmin,ss for RBV

Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state (NCT00947349)
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose

Interventionng/mL (Geometric Mean)
Placebo TN1980
BI 201335 NA Low TN1730
BI 201335 NA High TN1590
BI 201335 NA High TE1400

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Complete Early Virological Response (cEVR)

Number of patients with plasma HCV RNA level BLD at Week 12 (NCT00947349)
Timeframe: 12 weeks

Interventionparticipants (Number)
Placebo TN3
BI 201335 NA Low TN5
BI 201335 NA High TN5
BI 201335 NA High TE6

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Day 28 Virologic Response

Number of patients with HCV viral load reduction >= 2 log10 at Week 4 (NCT00947349)
Timeframe: 4 weeks

Interventionparticipants (Number)
Placebo TN3
BI 201335 NA Low TN6
BI 201335 NA High TN6
BI 201335 NA High TE6

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Early Virological Response (EVR)

Number of patients with reduction >= 2 log10 in plasma HCV RNA level at Week 12 (NCT00947349)
Timeframe: 12 Weeks

Interventionparticipants (Number)
Placebo TN4
BI 201335 NA Low TN5
BI 201335 NA High TN6
BI 201335 NA High TE6

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End of Treatment Response (ETR)

Number of patients with plasma HCV RNA level BLD at week 48 (NCT00947349)
Timeframe: 48 weeks

Interventionparticipants (Number)
Placebo TN3
BI 201335 NA Low TN5
BI 201335 NA High TN4
BI 201335 NA High TE4

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Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24

EVR was defined as undetectable HCV-RNA at Treatment Week (TW) 2, 4, 8, or 12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. (NCT00959699)
Timeframe: Up to Week 12

,
Interventionpercentage of participants (Number)
HCV-RNA undetectable at Week 2 (n=0, 0)HCV-RNA undetectable at Week 4 (n=3, 3)HCV-RNA undetectable at Week 8 (n=5, 27)HCV-RNA undetectable at Week 12 (n=8, 38)
PegIFN-2b + RBV010010087.5
PegIFN-2b + RBV + Boceprevir010092.692.1

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Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)

This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. (NCT00959699)
Timeframe: Baseline and Week 4

,
Interventionparticipants (Number)
Participants with <1 positive log dropParticipants with >= 1 positive log dropParticipants with undetectable HCV-RNAParticipants with missing data
PegIFN-2b + RBV151630
PegIFN-2b + RBV + Boceprevir283231

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Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12)

The virologic response at FW12 was considered SVR12 with an additional rule for handling missing data: participants with missing HCV-RNA assessment at FW12 but having non-missing, undetectable HCV-RNA assessments at both FW4 and FW24, were assumed to be responders for SVR12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. (NCT00959699)
Timeframe: Up to Week 60

Interventionpercentage of participants (Number)
PegIFN-2b + RBV26.5
PegIFN-2b + RBV + Boceprevir62.5

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Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)

SVR24 is defined as undetectable plasma HCV-RNA 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from FW12 was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. (NCT00959699)
Timeframe: Up to Week 72

Interventionpercentage of participants (Number)
PegIFN-2b + RBV30.3
PegIFN-2b + RBV + Boceprevir64.5

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Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication

SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. (NCT00959699)
Timeframe: Up to Week 72

Interventionpercentage of participants (Number)
PegIFN-2b + RBV29.4
PegIFN-2b + RBV + Boceprevir62.5

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Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound

Virologic breakthrough is defined as achieving undetectable HCV-RNA and subsequently having an HCV-RNA level of >1000 IU/mL. Incomplete Virologic Response/Rebound is defined as having a one log10 increase in HCV-RNA from the participant's nadir, with an HCV-RNA >1000 IU/mL. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. (NCT00959699)
Timeframe: Up to Week 72

,
Interventionpercentage of participants (Number)
Virologic breakthroughIncomplete response
PegIFN-2b + RBV017.6
PegIFN-2b + RBV + Boceprevir6.39.4

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The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up

The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (EOT). (NCT00980330)
Timeframe: Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)

,,,,,,
InterventionPercentage of Participants (Number)
Week 2Week 4Week 8Week 12Week 24Week 36Week 48Week 60Week 72EOT (up to Week 48)
Placebo 48Wks + PR483.03.012.134.850.043.940.922.722.747.0
TMC435 100mg 12 Wks + PR4860.678.887.987.984.881.883.371.269.786.4
TMC435 100mg 24 Wks + PR4855.472.381.581.578.573.873.867.766.281.5
TMC435 100mg 48 Wks + PR4854.581.884.883.380.378.874.260.660.681.8
TMC435 150mg 12 Wks + PR4863.686.487.989.486.481.878.866.766.789.4
TMC435 150mg 24 Wks + PR4860.382.489.788.286.886.882.472.173.589.7
TMC435 150mg 48 Wks + PR4866.286.287.789.289.284.681.578.580.089.2

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Plasma Concentrations of TMC435

The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for TMC435 for participants in each of the 6 TMC435 treatment groups. (NCT00980330)
Timeframe: 0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48

,,,,,
Interventionng/mL (Median)
C0hCss,av
TMC435 100mg 12 Wks + PR48380.5691.1
TMC435 100mg 24 Wks + PR48411.3770.5
TMC435 100mg 48 Wks + PR48529.8892.0
TMC435 150mg 12 Wks + PR481323.51960.9
TMC435 150mg 24 Wks + PR481074.01792.3
TMC435 150mg 48 Wks + PR48886.11606.9

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The Percentage of Participants With Viral Relapse

The table below shows the percentage of participants in the overall population who had viral relapse, defined as confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with HCV RNA less than 25 IU/mL undetectable at end of treatment. (NCT00980330)
Timeframe: Up to Week 72

InterventionPercentage of participants (Number)
TMC435 100mg 12 Wks + PR489.3
TMC435 100mg 24 Wks + PR4813.7
TMC435 100mg 48 Wks + PR4818.0
TMC435 150mg 12 Wks + PR4811.8
TMC435 150mg 24 Wks + PR4814.0
TMC435 150mg 48 Wks + PR485.5
Placebo 48Wks + PR4844.4

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The Percentage of Participants With Viral Breakthrough

The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of > 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable). (NCT00980330)
Timeframe: EOT (up to Week 48)

InterventionPercentage of participants (Number)
TMC435 100mg 12 Wks + PR4810.6
TMC435 100mg 24 Wks + PR4813.8
TMC435 100mg 48 Wks + PR4813.6
TMC435 150mg 12 Wks + PR489.1
TMC435 150mg 24 Wks + PR4810.3
TMC435 150mg 48 Wks + PR487.7
Placebo 48Wks + PR481.5

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The Percentage of Participants Achieving an Early Virologic Response (EVR)

The table below shows the percentage of participants who achieved an EVR, defined as having a greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline at Week 12. (NCT00980330)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 100mg 12 Wks + PR4890.9
TMC435 100mg 24 Wks + PR4887.7
TMC435 100mg 48 Wks + PR4884.8
TMC435 150mg 12 Wks + PR4892.4
TMC435 150mg 24 Wks + PR4891.2
TMC435 150mg 48 Wks + PR4892.3
Placebo 48Wks + PR4860.6

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The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)

The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT. (NCT00980330)
Timeframe: Week 72

InterventionPercentage of participants (Number)
TMC435 100mg 12 Wks + PR4869.7
TMC435 100mg 24 Wks + PR4866.2
TMC435 100mg 48 Wks + PR4860.6
TMC435 150mg 12 Wks + PR4866.7
TMC435 150mg 24 Wks + PR4872.1
TMC435 150mg 48 Wks + PR4880.0
Placebo 48Wks + PR4822.7

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The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)

The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48). (NCT00980330)
Timeframe: EOT (up to Week 48)

InterventionPercentage of participants (Number)
TMC435 100mg 12 Wks + PR4826
TMC435 100mg 24 Wks + PR4837
TMC435 100mg 48 Wks + PR4831
TMC435 150mg 12 Wks + PR4823
TMC435 150mg 24 Wks + PR4831
TMC435 150mg 48 Wks + PR4833
All TMC435181

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The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)

The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma levels of Hepatitis C virus ribonucleic acid at Week 12. (NCT00980330)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 100mg 12 Wks + PR4881.8
TMC435 100mg 24 Wks + PR4873.8
TMC435 100mg 48 Wks + PR4872.7
TMC435 150mg 12 Wks + PR4880.3
TMC435 150mg 24 Wks + PR4885.3
TMC435 150mg 48 Wks + PR4883.1
Placebo 48Wks + PR4819.7

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The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment

The table below shows the percentage of participants in each treatment group who achieved a greater than 2 log10 drop in plasma levels of HCV RNA at selected time points during treatment. (NCT00980330)
Timeframe: Weeks, 2, 4, 8, and 12

,,,,,,
InterventionPercentage of participants (Number)
Week 2Week 4Week 8Week 12
Placebo 48Wks + PR4824.236.457.660.6
TMC435 100mg 12 Wks + PR4897.092.492.490.9
TMC435 100mg 24 Wks + PR4893.893.889.287.7
TMC435 100mg 48 Wks + PR4897.092.489.484.8
TMC435 150mg 12 Wks + PR48100.097.093.992.4
TMC435 150mg 24 Wks + PR4895.691.291.291.2
TMC435 150mg 48 Wks + PR4896.996.995.492.3

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The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up

The table below shows the percentage of participants in each treatment who achieved plasma HCV RNA levels of <25 IU/mL undetectable at selected time points during treatment and follow-up and at the end of treatment (EOT). (NCT00980330)
Timeframe: Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)

,,,,,,
InterventionPercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 24Week 36Week 48Week 60Week 72EOT (up to Week 48)
Placebo 48Wks + PR480.01.57.619.742.439.437.922.722.740.9
TMC435 100mg 12 Wks + PR4822.766.777.381.881.878.881.869.769.780.3
TMC435 100mg 24 Wks + PR4818.558.575.473.875.473.873.867.766.278.5
TMC435 100mg 48 Wks + PR4815.253.077.372.778.878.874.259.160.680.3
TMC435 150mg 12 Wks + PR4824.262.184.880.383.380.375.866.766.780.3
TMC435 150mg 24 Wks + PR4832.467.683.885.386.883.880.972.173.583.8
TMC435 150mg 48 Wks + PR4827.766.283.183.186.281.581.576.980.086.2

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The Percentage of Participants Achieving a Rapid Virologic Response (RVR)

The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having an undetectable plasma Hepatitis C virus ribonucleic acid level after receiving 4 weeks of treatment. (NCT00980330)
Timeframe: Week 4

InterventionPercentage of participants (Number)
TMC435 100mg 12 Wks + PR4866.7
TMC435 100mg 24 Wks + PR4858.5
TMC435 100mg 48 Wks + PR4853.0
TMC435 150mg 12 Wks + PR4862.1
TMC435 150mg 24 Wks + PR4867.6
TMC435 150mg 48 Wks + PR4866.2
Placebo 48Wks + PR481.5

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The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)

The table below shows the percentage of participants in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT. (NCT00980330)
Timeframe: Week 60

InterventionPercentage of participants (Number)
TMC435 100mg 12 Wks + PR4869.7
TMC435 100mg 24 Wks + PR4867.7
TMC435 100mg 48 Wks + PR4860.6
TMC435 150mg 12 Wks + PR4866.7
TMC435 150mg 24 Wks + PR4872.1
TMC435 150mg 48 Wks + PR4880.0
Placebo 48Wks + PR4822.7

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Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435

The table below shows the median (range) AUC24h values for TMC435 for participants in each TMC435 treatment group. (NCT00980330)
Timeframe: 0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48

Interventionng.h/mL (Median)
TMC435 100mg 12 Wks + PR4816587.0
TMC435 100mg 24 Wks + PR4818492.5
TMC435 100mg 48 Wks + PR4821409.0
TMC435 150mg 12 Wks + PR4847061.8
TMC435 150mg 24 Wks + PR4843015.0
TMC435 150mg 48 Wks + PR4838564.5

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Ribavirin Minimum Plasma Concentration

Ribavirin minimum plasma concentration by pharmacokinetic analyses (NCT00982553)
Timeframe: Day 20

Interventionng/mL (Geometric Mean)
Phase1_Ribavirin184.71
Phase3_ribovarin and Raltegravir186.98

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Raltegravir Maximum Plasma Concentration

(NCT00982553)
Timeframe: Day 20

Interventionng/mL (Geometric Mean)
Phase2_Raltegravir2227.41
Phase3_ribovarin and Raltegravir2591.19

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Raltegravir Minimum Plasma Concentrations

Raltegravir minimum plasma concentrations by pharmacokinetic analyses (NCT00982553)
Timeframe: Day 20

Interventionng/mL (Geometric Mean)
Phase2_Raltegravir83.97
Phase3_ribovarin and Raltegravir68.91

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Ribavirin Maximum Plasma Concentration

Pharmacokinetic analyses of blood samples (NCT00982553)
Timeframe: Day 20

Interventionng/mL (Geometric Mean)
Phase1_ribavirin630.09
Phase3_ribovarin and Raltegravir496.71

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Proportion of Subjects Achieving Undetectable HCV RNA at Week 12

(NCT00983853)
Timeframe: 12 weeks after first dose of study drug

Interventionparticipants (Number)
Part A: T/PR6
Part A: Pbo/PR2
Part B: EFV-based HAART + T/PR14
Part B: EFV-based HAART + Pbo/PR2
Part B: ATV/R-based HAART + T/PR10
Part B: ATV/R-based HAART + Pbo/PR2

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Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment

(NCT00983853)
Timeframe: 12 weeks after last dose of study drug

,,,,,
Interventionparticipants (Number)
SVR12SVR24
Part A: Pbo/PR22
Part A: T/PR55
Part B: ATV/R-based HAART + Pbo/PR44
Part B: ATV/R-based HAART + T/PR1212
Part B: EFV-based HAART + Pbo/PR44
Part B: EFV-based HAART + T/PR1111

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Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12

number of subjects with undetectable HCV RNA (NCT00983853)
Timeframe: 4 and 12 weeks after the first dose of study drug

,,,,,
Interventionparticipants (Number)
Week 4 (RVR)Weeks 4 and 12 (eRVR)
Part A: Pbo/PR00
Part A: T/PR54
Part B: ATV/R-based HAART + Pbo/PR00
Part B: ATV/R-based HAART + T/PR97
Part B: EFV-based HAART + Pbo/PR00
Part B: EFV-based HAART + T/PR1212

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Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)

Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference) (NCT00983853)
Timeframe: through 12 weeks after first dose of study drug

,
Interventionratio (test/reference) (Median)
EfavirenzTenofovir
Pbo/PR0.790.64
T/PR0.941.06

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Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)

Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference) (NCT00983853)
Timeframe: through 12 weeks after first dose of study drug

,
Interventionratio (test/reference) (Median)
Atazanavir (N=12 T/PR, N=6 Pbo/PR)Tenofovir (N=13 T/PR, N=7 Pbo/PR)Ritonavir (N=9 T/PR, N=7 Pbo/PR)
Pbo/PR1.030.930.74
T/PR1.160.750.72

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Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure

(NCT00983853)
Timeframe: through 12 weeks after first dose of study drug

,
Interventionratio (test/reference) (Least Squares Mean)
CminCavgCmax
ATV/R-based (Test, N=13) vs No HAART (Reference, N=7)1.30591.09301.0075
EFV-based (Test, N=15) vs No HAART (Reference, N=7)0.88420.96101.0061

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Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)

Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase. (NCT00984620)
Timeframe: baseline and 48 weeks

,
InterventionU/L (Mean)
AST/GOT (U/L), CFB, Day 1(N=74, N=75)AST/GOT (U/L), CFB, wk2 (N=75, N=78)AST/GOT (U/L), CFB, wk4 (N=74, N=76)AST/GOT (U/L), CFB, wk8 (N=74, N=76)AST/GOT (U/L), CFB, wk12 (N=74, N=76)AST/GOT (U/L), CFB, wk18 (N=67, N=70)AST/GOT (U/L), CFB, wk24 (N=12, N=4)AST/GOT (U/L), CFB, wk28 (N=5, N=3)AST/GOT (U/L), CFB, wk36 (N=4, N=2)AST/GOT (U/L), CFB, EoT (N=66, N=71)ALT/GPT (U/L), CFB, day1 (N=76, N=75)ALT/GPT (U/L), CFB, wk2 (N=75, N=78)ALT/GPT (U/L), CFB, wk4 (N=74, N=77)ALT/GPT (U/L), CFB, wk8 (N=74, N=76)ALT/GPT (U/L), CFB, wk12 (N=74, N=76)ALT/GPT (U/L), CFB, wk18 (N=67, N=70)ALT/GPT (U/L), CFB, wk24 (N=12, N=4)ALT/GPT (U/L), CFB, wk28 (N=5, N=3)ALT/GPT (U/L), CFB, wk36 (N=4, N=2)ALT/GPT (U/L), CFB, EoT (N=66, N=71)Alka. phosphatase (U/L), CFB, day1 (n=77, N=75)Alka. phosphatase (U/L), CFB, wk2 (n=76, N=78)Alka. phosphatase (U/L), CFB, wk4 (n=76, N=77)Alka. phosphatase (U/L), CFB, wk8 (n=75, N=76)Alka. phosphatase (U/L), CFB, wk12 (n=75, N=76)Alka. phosphatase (U/L), CFB, wk18 (n=68, N=70)Alka. phosphatase (U/L), CFB, wk24 (n=12, N=4)Alka. phosphatase (U/L), CFB, wk28 (n=5, N=3)Alka. phosphatase (U/L), CFB, wk36 (n=4, N=2)Alka. phosphatase (U/L), CFB, EoT (n=67, N=73)GGT (U/L), CFB, day1 (N=77, N=75)GGT (U/L), CFB, wk2 (N=76, N=78)GGT (U/L), CFB, wk4 (N=76, N=77)GGT (U/L), CFB, wk8 (N=75, N=76)GGT (U/L), CFB, wk12 (N=75, N=76)GGT (U/L), CFB, wk18 (N=68, N=70)GGT (U/L), CFB, wk24 (N=12, N=4)GGT (U/L), CFB, wk28 (N=5, N=3)GGT (U/L), CFB, wk36 (N=4, N=2)GGT (U/L), CFB, EoT (N=67, N=73)Creatine kinase (U/L), CFB, day1 (N=76, N=75)Creatine kinase (U/L), CFB, wk2 (N=75, N=78)Creatine kinase (U/L), CFB, wk4 (N=74, N=77)Creatine kinase (U/L), CFB, wk8 (N=74, N=76)Creatine kinase (U/L), CFB, wk12 (N=74, N=75)Creatine kinase (U/L), CFB, wk18 (N=67, N=70)Creatine kinase (U/L), CFB, wk24 (N=12, N=4)Creatine kinase (U/L), CFB, wk28 (N=5, N=3)Creatine kinase (U/L), CFB, wk36 (N=4, N=2)Creatine kinase (U/L), CFB, EoT (N=66, N=71)Lipase (U/L). CFB, day1 (N=77, N=75)Lipase (U/L). CFB, wk2 (N=76, N=78)Lipase (U/L). CFB, wk4 (N=76, N=76)Lipase (U/L). CFB, wk8 (N=75, N=76)Lipase (U/L). CFB, wk12 (N=75, N=75)Lipase (U/L). CFB, wk18 (N=68, N=70)Lipase (U/L). CFB, wk24 (N=12, N=4)Lipase (U/L). CFB, wk28 (N=5, N=3)Lipase (U/L). CFB, wk36 (N=4, N=2)Lipase (U/L). CFB, EoT (N=67, N=73)Amylase (U/L), CFB, day1 (N=77, N=75)Amylase (U/L), CFB, wk2 (N=76, N=78)Amylase (U/L), CFB, wk4 (N=76, N=77)Amylase (U/L), CFB, wk8 (N=75, N=76)Amylase (U/L), CFB, wk12 (N=75, N=75)Amylase (U/L), CFB, wk18 (N=68, N=70)Amylase (U/L), CFB, wk24 (N=12, N=4)Amylase (U/L), CFB, wk28 (N=5, N=3)Amylase (U/L), CFB, wk36 (N=4, N=2)Amylase (U/L), CFB, EoT (N=67, N=73)
Faldaprevir 120mg (12 Weeks)0-24-25-22-24-25-23-20-21-251-37-37-36-37-41-40-45-47-4215775-2-14-2-51-5-34-59-76-71-62-118-52-23-39-2-59-69-92-98-93-69-48-68-89-25-1-11-12-132-1-4-6152-5-10-7-14-21-350
Faldaprevir 120mg (24 Weeks)-5-29-29-27-27-30-10-1611-27-2-34-34-35-36-42-24-22-6-4217109651315185-5-38-60-70-69-64-131-113-14-5930-41-62-75-84-60-42-32-37-21269624-4-170-15-5735-2-4-7-16-8-19-4

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Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)

Change from baseline (CFB) in PT-INR (ratio). (NCT00984620)
Timeframe: baseline and 48 weeks

,
Interventionratio (Mean)
PT-INR (ratio), CFB, Day 1(N=77, N=72)PT-INR (ratio), CFB, wk2 (N=76, N=78)PT-INR (ratio), CFB, wk4(N=74, N=76)PT-INR (ratio), CFB, wk8(N=73, N=75)PT-INR (ratio), CFB, wk12(N=74, N=72)PT-INR (ratio), CFB, wk18(N=69, N=70)PT-INR (ratio), CFB, wk24(N=12, N=4)PT-INR (ratio), CFB, wk28(N=5, N=3)PT-INR (ratio), CFB, wk36(N=4, N=2)PT-INR (ratio), CFB, EoT(N=68, N=73)
Faldaprevir 120mg (12 Weeks)0.00.00.00.00.00.00.0-0.10.00.0
Faldaprevir 120mg (24 Weeks)0.00.00.00.00.00.00.10.0-0.10.0

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Viral Load (HCV RNA) at All Visits During Treatment and Follow-up

Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits. (NCT00984620)
Timeframe: From baseline to 72 weeks

,
InterventionIU/mL (Mean)
week 2, change from baseline (N=76, N=78)week 4, change from baseline (N=76, N=77)week 8, change from baseline (N=75, N=76)week 12, change from baseline (N=76, N=76)week 16, change from baseline (N=18, N=13)week 20, change from baseline (N=52, N=57)week 24, change from baseline (N=12, N=8)week 28, change from baseline (N=4, N=4)week 36, change from baseline (N=4, N=2)End of TRT, change from baseline (N=80, N=78)4 wks after TRT, change from baseline (N=75, N=77)12 wks after TRT, change from baseline (N=75,N=75)24 wks after TRT, change from baseline (N=73,N=75)
Faldaprevir 120 mg (12 Weeks)-4.724-4.993-5.128-5.117-5.363-5.056-4.176-5.723-5.624-4.910-4.296-4.154-4.103
Faldaprevir 120 mg (24 Weeks)-4.866-5.081-5.088-5.107-5.262-5.366-4.740-4.369-5.958-5.017-4.367-4.353-4.250

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Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)

Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose. (NCT00984620)
Timeframe: baseline and 48 weeks

,
Interventionmmol/L (Mean)
Sodium (mmol/L) CFB, Day 1(N=77, N=74)Sodium (mmol/L) CFB, wk2 (N=76, N=78)Sodium (mmol/L) CFB, wk4 (N=76, N=77)Sodium (mmol/L) CFB, wk8 (N=73, N=76)Sodium (mmol/L) CFB, wk12 (N=75, N=76)Sodium (mmol/L) CFB, wk18 (N=68, N=70)Sodium (mmol/L) CFB, wk24 (N=12, N=4)Sodium (mmol/L) CFB, wk28 (N=5, N=3)Sodium (mmol/L) CFB, wk36 (N=4, N=2)Sodium (mmol/L) CFB, EoT (N=67, N=73)Bicarbonate (mmol/L), CFB, day1 (N=76, N=75)Bicarbonate (mmol/L), CFB, wk2 (N=75, N=78)Bicarbonate (mmol/L), CFB, wk4 (N=74, N=77)Bicarbonate (mmol/L), CFB, wk8 (N=74, N=76)Bicarbonate (mmol/L), CFB, wk12 (N=74, N=76)Bicarbonate (mmol/L), CFB, wk18 (N=66, N=69)Bicarbonate (mmol/L), CFB, wk24 (N=12, N=4)Bicarbonate (mmol/L), CFB, wk28 (N=4, N=3)Bicarbonate (mmol/L), CFB, wk36 (N=4, N=2)Bicarbonate (mmol/L), CFB, EoT (N=64, N=71)Cholesterol tot. (mmol/L), CFB, day1 (n=77, N=75)Cholesterol tot. (mmol/L), CFB, wk2 (n=76, N=78)Cholesterol tot. (mmol/L), CFB, wk4 (n=76, N=77)Cholesterol tot. (mmol/L), CFB, wk8 (n=75, N=76)Cholesterol tot. (mmol/L), CFB, wk12 (n=75, N=76)Cholesterol tot. (mmol/L), CFB, wk18 (n=68, N=70)Cholesterol tot. (mmol/L), CFB, wk24 (n=12, N=4)Cholesterol tot. (mmol/L), CFB, wk28 (n=5, N=3)Cholesterol tot. (mmol/L), CFB, wk36 (n=4, N=2)Cholesterol tot. (mmol/L), CFB, EoT (n=67, N=73)Triglyceride (mmol/L), CFB, day1 (N=77, N=75)Triglyceride (mmol/L), CFB, wk2 (N=76, N=78)Triglyceride (mmol/L), CFB, wk4 (N=76, N=77)Triglyceride (mmol/L), CFB, wk8 (N=75, N=76)Triglyceride (mmol/L), CFB, wk12 (N=75, N=76)Triglyceride (mmol/L), CFB, wk18 (N=68, N=70)Triglyceride (mmol/L), CFB, wk24 (N=12, N=4)Triglyceride (mmol/L), CFB, wk28 (N=5, N=3)Triglyceride (mmol/L), CFB, wk36 (N=4, N=2)Triglyceride (mmol/L), CFB, EoT (N=67, N=73)Glucose (mmol/L), CFB, day1 (N=76, N=75)Glucose (mmol/L), CFB, wk2 (N=75, N=78)Glucose (mmol/L), CFB, wk4 (N=74, N=77)Glucose (mmol/L), CFB, wk8 (N=74, N=76)Glucose (mmol/L), CFB, wk12 (N=73, N=76)Glucose (mmol/L), CFB, wk18 (N=67, N=70)Glucose (mmol/L), CFB, wk24 (N=12, N=4)Glucose (mmol/L), CFB, wk28 (N=5, N=3)Glucose (mmol/L), CFB, wk36 (N=4, N=2)Glucose (mmol/L), CFB, EoT (N=66, N=71)
Faldaprevir 120mg (12 Weeks)000100-1-2-100.1-0.2-0.1-0.1-0.3-0.3-0.4-1.2-2.6-0.20.03-0.48-0.51-0.58-0.64-0.51-0.360.10-0.35-0.43-0.10.10.10.10.10.0-0.20.0-0.30.1-0.1-0.1-0.2-0.1-0.3-0.4-0.7-0.4-0.1-0.4
Faldaprevir 120mg (24 Weeks)1001100-1-100.20.0-0.10.0-0.4-0.4-0.5-0.2-1.0-0.1-0.05-0.54-0.67-0.60-0.74-0.80-0.37-0.09-0.23-0.74-0.10.10.20.10.10.20.20.40.10.10.20.10.10.1-0.1-0.1-0.40.1-0.1-0.1

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End of Treatment Response (ETR)

End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy. (NCT00984620)
Timeframe: up to 48 weeks

Interventionparticipants (Number)
Faldaprevir 120 mg (12 Weeks)65
Faldaprevir 120 mg (24 Weeks)67

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Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination

No number of participants with clinically relevant abnormalities in vital signs and physical examination. (NCT00984620)
Timeframe: 48 weeks

Interventionparticipants with abnormality (Number)
Faldaprevir 120mg (12 Weeks)0
Faldaprevir 120mg (24 Weeks)0

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Rapid Virological Response at Week 4 (RVR)

Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4. (NCT00984620)
Timeframe: 4 weeks

Interventionparticipants (Number)
Faldaprevir 120 mg (12 Weeks)48
Faldaprevir 120 mg (24 Weeks)56

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Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy

Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy. (NCT00984620)
Timeframe: 72 weeks

Interventionparticipants (Number)
Faldaprevir 120 mg (12 Weeks)54
Faldaprevir 120 mg (24 Weeks)58

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Time to Reach a Plasma HCV RNA Level BLD While on Treatment

Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment (NCT00984620)
Timeframe: 48 weeks

Interventionweek (Median)
Faldaprevir 120 mg (12 Weeks)4.1
Faldaprevir 120 mg (24 Weeks)4.1

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Virological Response at Week 28 (W28VR)

Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28. (NCT00984620)
Timeframe: 28 weeks

Interventionparticipants (Number)
Faldaprevir 120 mg (12 Weeks)61
Faldaprevir 120 mg (24 Weeks)60

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Virological Response at Week 36 (W36VR)

Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36. (NCT00984620)
Timeframe: 36 weeks

Interventionparticipants (Number)
Faldaprevir 120 mg (12 Weeks)55
Faldaprevir 120 mg (24 Weeks)58

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Laboratory Test Abnormalities and Study Medication Tolerabilities

Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic. (NCT00984620)
Timeframe: 48 weeks

,
Interventionparticipants (Number)
Red blood cell count: low (N=81, N=79)haematocrit: low (N=81, N=79)haematocrit: high(N=81, N=79)white blood cell count: low(N=81, N=79)platelets: low(N=81, N=78)eosinophils: high (N=81, N=79)PT-INR: high (N=81, N=79)sodium: low (N=81, N=79)bicarbonate: low (N=79, N=74)bicarbonate: high (N=79, N=74)AST/GOT, SGOT: high (N=75, N=71)ALT/GPT, SGPT: high (N=68, N=64)alkaline phosphatase: high (N=80, N=79)GGT: high (N=74, N=72)creatine kinase: high (N=80, N=79)lipase: high (N=79, N=79)amylase: high (N=81, N=79)glucose: low (N=80, N=79)cholesterol, total: high (N=80, N=75)triglyceride: high (N=74, N=71)
Faldaprevir 120 mg (12 Weeks)93005651116133140110613
Faldaprevir 120 mg (24 Weeks)821160251111135083322218

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Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)

Change from baseline (CFB) in Red blood cells. (NCT00984620)
Timeframe: baseline and 48 weeks

,
Intervention10^12 cells/L (Mean)
Red blood cell (10^12cells/L) CFB,Day 1(N=77,N=75)Red blood cell (10^12cells/L) CFB, wk2 (N=75,N=77)Red blood cell (10^12cells/L) CFB, wk4(N=74, N=76)Red blood cell (10^12cells/L) CFB, wk8(N=75, N=74)Red blood cell (10^12cells/L) CFB, wk12(N=74,N=74)Red blood cell (10^12cells/L) CFB, wk18(N=66,N=69)Red blood cell (10^12cells/L) CFB, wk24(N=12, N=4)Red blood cell (10^12cells/L) CFB, wk28(N=4, N=3)Red blood cell (10^12cells/L) CFB, wk36(N=4, N=2)Red blood cell (10^12cells/L) CFB, EoT(N=67, N=73)
Faldaprevir 120mg (12 Weeks)0.0-0.3-0.8-1.0-1.1-1.2-1.2-1.1-0.9-1.2
Faldaprevir 120mg (24 Weeks)-0.1-0.4-0.8-1.0-1.2-1.2-0.9-0.9-1.4-1.2

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Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)

Change from baseline (CFB) in haematocrit and Eosinophils. (NCT00984620)
Timeframe: baseline and 48 weeks

,
Intervention% of laboratory test substance (Mean)
haematocrit (%) CFB, Day1 (N=77, N=75)haematocrit (%) CFB, wk2 (N=75, N=77)haematocrit (%) CFB, wk4 (N=74, N=76)haematocrit (%) CFB, wk8 (N=75, N=74)haematocrit (%) CFB, wk12 (N=72, N=74)haematocrit (%) CFB, wk18 (N=66, N=69)haematocrit (%) CFB, wk24 (N=11, N=4)haematocrit (%) CFB, wk28 (N=4, N=3)haematocrit (%) CFB, wk36 (N=4, N=2)haematocrit (%) CFB, EoT (N=66, N=70)Eosinophils(%), CFB, day1 (N=77, N=75)Eosinophils(%), CFB, wk2 (N=75, N=76)Eosinophils(%), CFB, wk4 (N=73, N=74)Eosinophils(%), CFB, wk8 (N=74, N=73)Eosinophils(%), CFB, wk12 (N=72, N=72)Eosinophils(%), CFB, wk18 (N=62, N=65)Eosinophils(%), CFB, wk24 (N=12, N=4)Eosinophils(%), CFB, wk28 (N=4, N=3)Eosinophils(%), CFB, wk36 (N=4, N=2)Eosinophils(%), CFB, EoT (N=66, N=70)
Faldaprevir 120mg (12 Weeks)-0.9-4.3-8.0-8.4-8.5-7.3-6.6-3.8-3.0-6.000-1000-1-1-10
Faldaprevir 120mg (24 Weeks)-1.3-4.7-7.9-7.1-7.8-6.5-2.7-1.2-3.6-6.0000000-1-2-11

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Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)

Change from baseline (CFB) in Platelets and white blood cells. (NCT00984620)
Timeframe: baseline and 48 weeks

,
Intervention10^9 cells/L (Mean)
Platelets CFB, Day 1 (N=77, N=73)Platelets CFB, wk2 (N=74, N=74)Platelets CFB, wk4 (N=73, N=74)Platelets CFB, wk8 (N=73, N=71)Platelets CFB, wk12 (N=72, N=72)Platelets CFB, wk18 (N=66, N=68)Platelets CFB, wk24 (N=12, N=3)Platelets CFB, wk28 (N=4, N=2)Platelets CFB, wk36 (N=4, N=2)Platelets CFB, EoT (N=67, N=71)white blood cell CFB, day1 (N=77, N=75)white blood cell CFB, wk2 (N=75, N=77)white blood cell CFB, wk4 (N=74, N=76)white blood cell CFB, wk8 (N=75, N=74)white blood cell CFB, wk12 (N=74, N=74)white blood cell CFB, wk18 (N=66, N=69)white blood cell CFB, wk24 (N=12, N=4)white blood cell CFB, wk28 (N=4, N=3)white blood cell CFB, wk36 (N=4, N=2)white blood cell CFB, EoT (N=67, N=73)
Faldaprevir 120mg (12 Weeks)3-35-35-55-61-55-46-22-47-59-0.1-2.2-2.6-3.2-3.4-3.2-4.0-2.8-2.5-3.4
Faldaprevir 120mg (24 Weeks)2-35-39-48-50-51-50-83-85-500.3-1.8-2.6-2.9-2.8-3.1-2.0-1.9-3.0-3.1

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Virological Response at Week 24 (W24VR)

virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24. (NCT00984620)
Timeframe: 24 weeks

Interventionparticipants (Number)
Faldaprevir 120 mg (12 Weeks)59
Faldaprevir 120 mg (24 Weeks)63

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Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.

Change in log10 HCV viral load was calculated as log10-transformed HCV viral load at Week 4 minus log10-transformed HCV viral load at study entry. HCV viral load testing was done using Cobas AmpliPrep/Taqman HCV Test. (NCT00991289)
Timeframe: Weeks 0, 4

Interventionlog10 IU/mL (Median)
NTZ/PEG/RBV-0.12

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Percent Change in Fasting Insulin Level From Study Entry

Percent Change in fasting insulin (FINS) was calculated as FINS at later time point (16, 28, 52, 76) minus FINS at study entry, divided by FINS at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin testing. (NCT00991289)
Timeframe: Weeks 0, 16, 28, 52, and 76

Interventionpercentage of FINS at study entry (Median)
Percent change in FINS at Week 16Percent change in FINS at Week 28Percent change in FINS at Week 52Percent change in FINS at Week 76
NTZ/PEG/RBV08.828.28.3

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Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry

HOMA-IR was calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Percent Change in HOMA-IR was calculated as HOMA-IR at later time point (16, 28, 52, 76) minus HOMA-IR at study entry, divided by HOMA-IR at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing. (NCT00991289)
Timeframe: Weeks 0, 16, 28, 52, and 76

Interventionpercentage of HOMA-IR at study entry (Median)
Percent change in HOMA-IR at Week 16 (n=56)Percent change in HOMA-IR at Week 28 (n=39)Percent change in HOMA-IR at Week 52 (n=27)Percent change in HOMA-IR at Week 76 (n=22)
NTZ/PEG/RBV-13.0-6.323.29.5

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Change in Hemoglobin Level From Study Entry

Change in hemoglobin (HGB) was calculated as HGB at later time point (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76) minus HGB at study entry. (NCT00991289)
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76.

Interventiong/dL (Median)
Change in HGB at Week 4Change in HGB at Week 8Change in HGB at Week 12Change in HGB at Week 16Change in HGB at Week 20Change in HGB at Week 24Change in HGB at Week 28Change in HGB at Week 32Change in HGB at Week 36Change in HGB at Week 40Change in HGB at Week 44Change in HGB at Week 48Change in HGB at Week 52Change in HGB at Week 76
NTZ/PEG/RBV-0.1-2.1-2.5-2.5-2.5-2.4-2.5-2.7-2.5-2.6-2.6-2.7-2.9-0.9

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Percentage of Participants With Early Virologic Response (EVR)

Early virologic response (EVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 16 or at least a 2-log10 decrease in HCV viral load from study entry at Week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). (NCT00991289)
Timeframe: Weeks 0, 16

Interventionpercentage of participants (Number)
NTZ/PEG/RBV65.7

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Percentage of Participants With Sustained Virologic Response (SVR)

Sustained virologic response (SVR) was defined as undetectable HCV viral load (<43 IU/ml) at 24 weeks after treatment discontinuation, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). Participants who failed to achieve EVR or had detectable HCV RNA at Week 28 and per protocol discontinued study, and participants without HCV RNA from 24 weeks after treatment discontinuation, were considered non-responders. (NCT00991289)
Timeframe: 24 weeks after treatment discontinuation

Interventionpercentage of participants (Number)
NTZ/PEG/RBV32.8

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Percentage of Participants With Rapid Virologic Response (RVR)

Rapid virologic response (RVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 8 where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). (NCT00991289)
Timeframe: Week 8

Interventionpercentage of participants (Number)
NTZ/PEG/RBV10.4

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Number of Participants With Adverse Events of Grade 2 or Higher

Number of participants who experienced an adverse event of Grade 2 or higher at any time after study entry. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. (NCT00991289)
Timeframe: From study entry to up to week 76

Interventionparticipants (Number)
NTZ/PEG/RBV65

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Number of Participants With HCV Genotype 1

Confirmatory HCV genotyping was performed on stored plasma from entry using VERSANT HCV Genotype assay v2.0 (LiPA, RUO, Siemens Healthcare Diagnostics Inc., Tarrytown, NY). (NCT00991289)
Timeframe: Week 0

Interventionparticipants (Number)
NTZ/PEG/RBV67

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Percentage of Participants With Complete Early Virologic Response (cEVR)

Complete early virologic response (cEVR) was defined as undetectable HCV viral load (<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). (NCT00991289)
Timeframe: Week 16

Interventionpercentage of participants (Number)
NTZ/PEG/RBV38.8

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Percent Change in Fasting Glucose Level From Study Entry

Percent Change in fasting glucose (FGLUC) was calculated as FGLUC at later time point (16, 28, 52, 76) minus FGLUC at study entry, divided by FGLUC at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting glucose testing. (NCT00991289)
Timeframe: Weeks 0, 16, 28, 52, and 76

Interventionpercentage of FGLUC at study entry (Median)
Percent change in FGLUC at Week 16Percent change in FGLUC at Week 28Percent change in FGLUC at Week 52Percent change in FGLUC at Week 76
NTZ/PEG/RBV-3.2-5.31.10

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Percentage of Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory (NCT01016912)
Timeframe: At Week 12 on treatment

Interventionpercentage of participants (Number)
Placebo + pegIFNα + Ribavirin (Treatment-naive)62.5
Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)77.8
Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)100.0
Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders)55.6
Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)55.6

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Percentage of Participants With Extended Rapid Virologic Response (eRVR)

eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory. (NCT01016912)
Timeframe: At Weeks 4 and 12 on treatment

Interventionpercentage of participants (Number)
Placebo + pegIFNα + Ribavirin (Treatment-naive)0
Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)66.7
Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment Naive)80.0
Daclatasvir 10- mg + pegINFα + Ribavirin (Nonresponders)55.6
Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)22.2

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Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results

Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN. (NCT01016912)
Timeframe: From baseline to 30 days after last dose of study drug

,,,,
Interventionparticipants (Number)
HemoglobinLymphocytesNeutrophilsWBCALTASTTotal bilirubin
Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders)3322000
Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)0241111
Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)0200110
Daclatasvir 60- mg + pegIFNα- + Ribavirin (Treatment-naive)1320000
Placebo + pegIFNα + Ribavirin (Treatment-naive)1221000

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Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24

SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory . (NCT01016912)
Timeframe: Follow-up Weeks 4, 12, and 24

,,,,
Interventionpercentage of participants (Number)
SVR4: Follow-up Week 4SVR12: Follow-up Week 12SVR24: Follow-up Week 24
Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)22.222.222.2
Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)66.766.766.7
Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)33.333.333.3
Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)90.090.090.0
Placebo + pegIFNα + Ribavirin (Treatment-naive)75.062.562.5

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Percentage of Participants With Virologic Failure

Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment. (NCT01016912)
Timeframe: From on-treatment Week 1 to Follow-up Week 24

,,,,
Interventionpercentage of participants (Number)
Virologic failureVirologic breakthroughRelapse
Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)77.844.433.3
Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)33.311.111.1
Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive)10.00.010.0
Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)66.744.422.2
Placebo + pegIFNα + Ribavirin (Treatment-naive)37.512.525.0

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Percentage of Participants With Rapid Virologic Response (RVR)

RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory . (NCT01016912)
Timeframe: At Week 4 on treatment

Interventionpercentage of participants (Number)
Placebo + pegIFNα + Ribavirin (Treatment-naive)0
Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)77.8
Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)80.0
Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)55.6
Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)33.3

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Percentage of Participants With a Complete Early Virologic Response (cEVR)

cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12. (NCT01017575)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)62.5
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)88.9
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)100
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)87.5
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)88.9

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Percentage of Participants With Extended Rapid Virologic Response (eRVR)

eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12. (NCT01017575)
Timeframe: From Week 4 up to Week 12

Interventionpercentage of participants (Number)
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)12.5
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)66.7
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)62.5
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)62.5
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)77.8

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Percentage of Participants With Rapid Virologic Response (RVR)

RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4. (NCT01017575)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)12.5
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)77.8
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)62.5
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)62.5
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)88.9

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Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24

SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24. (NCT01017575)
Timeframe: Follow up Week 12, Follow up Week 24

,,,,
Interventionpercentage of participants (Number)
SVR12SVR24
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)5050
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)88.988.9
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)77.877.8
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)100100
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)7575

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Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT01017575)
Timeframe: From Baseline up to 30 days after last dose of study drug

,,,,
Interventionparticipants (Number)
SAEsDiscontinuations due to AEsDeath
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)000
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)210
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)020
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)000
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)000

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Number of Participants With Grade 3 to 4 Laboratory Abnormalities

Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN. (NCT01017575)
Timeframe: From screening up to Week 12 (treatment period)

,,,,
InterventionParticipants (Number)
HemoglobinLymphocytesNeutrophilsPlateletsWBCASTLipase
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)0532210
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)2240101
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)2320200
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)1430200
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)0540300

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Percentage of Participants With Sustained Virologic Response (SVR)

SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24 (NCT01023035)
Timeframe: At Follow-up Week 24

Interventionpercentage of participants (Number)
Ribavirin Dose Reduction Arm71.5
Erythropoietin Use Arm70.9

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Percentage of Participants Who Discontinued Treatment

Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification [LLQ] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up). (NCT01023035)
Timeframe: From Study Day 1 up to Study Treatment Week 48

Interventionpercentage of participants (Number)
Ribavirin Dose Reduction Arm29
Erythropoietin Use Arm34
Treated/Not Randomized63

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Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations

Ribavirin Triphosphate (RBV-TP) intracellular concentrations. (NCT01052701)
Timeframe: Day 56

Interventionpicomoles per 10^6 cells (Mean)
Ribavirin Plus Abacavir15.87
Ribavirin Alone15.93

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Plasma RBV Trough Concentrations

Plasma RBV trough concentrations. (NCT01052701)
Timeframe: Day 56

Interventionmicrograms per milliliter (Mean)
Ribavirin Plus Abacavir2.54
Ribavirin Alone2.60

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Percentage of Participants Achieving Rapid Virologic Response (RVR)

The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment). (NCT01054573)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Phase 3: T12(Q8h)/PR - Prior Null Responder37.5
Phase 3: T12(Q8h)/PR - Prior Partial Responder77.3
Phase 3: T12(Q8h)/PR - Prior Relapser85.2
Phase 1: T12(Q8h)/PR33.3

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Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)

The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment). (NCT01054573)
Timeframe: Weeks 4 and 12

InterventionPercentage of participants (Number)
Phase 3: T12(Q8h)/PR - Prior Null Responder34.4
Phase 3: T12(Q8h)/PR - Prior Partial Responder72.7
Phase 3: T12(Q8h)/PR - Prior Relapser85.2
Phase 1: T12(Q8h)/PR33.3

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Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8

The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL. (NCT01054573)
Timeframe: Week 4, Week 8

InterventionPercentage of participants (Number)
Phase 3: T12(Q8h)/PR - Prior Null Responder28.1
Phase 3: T12(Q8h)/PR - Prior Partial Responder4.5
Phase 3: T12(Q8h)/PR - Prior Relapser3.7
Phase 1: T12(Q8h)/PR11.1

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Percentage of Participants With Viral Breakthrough

The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase. (NCT01054573)
Timeframe: Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)

,,,
InterventionPercentage of participants (Number)
Week 48 (Period After Telaprevir Intake)Week 12 (Telaprevir Treatment Phase)
Phase 1: T12(Q8h)/PR11.111.1
Phase 3: T12(Q8h)/PR - Prior Null Responder25.015.6
Phase 3: T12(Q8h)/PR - Prior Partial Responder9.14.5
Phase 3: T12(Q8h)/PR - Prior Relapser3.70.0

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Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36

The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL. (NCT01054573)
Timeframe: Week 12 or Weeks 24 or 36

,,,
InterventionPercentage of participants (Number)
Week 12Week 24Week 36
Phase 1: T12(Q8h)/PR11.111.10
Phase 3: T12(Q8h)/PR - Prior Null Responder31.29.49.4
Phase 3: T12(Q8h)/PR - Prior Partial Responder4.59.10
Phase 3: T12(Q8h)/PR - Prior Relapser03.70

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Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time

The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time. (NCT01054573)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 48

,,,
InterventionLog 10 IU/mL (Median)
Baseline (n=32, 22, 27, and 9)Week 4 (n=32, 22, 26, and 9)Week 8 (n=32, 22, 26, and 9)Week 12 (n=31, 22, 26, and 9)Week 24 (n=23, 20, 26, and 8)Week 36 (n=18, 19, 23, and 7)Week 48 (n=16, 16, 21, and 7)
Phase 1: T12(Q8h)/PR6.761.240.700.700.700.700.70
Phase 3: T12(Q8h)/PR - Prior Null Responder6.631.240.700.700.700.700.70
Phase 3: T12(Q8h)/PR - Prior Partial Responder6.720.700.700.700.700.700.70
Phase 3: T12(Q8h)/PR - Prior Relapser6.480.700.700.700.700.700.70

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The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points

The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values. (NCT01054573)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)

,,,
InterventionPercentage of participants with response (Number)
BaslineWeek 4Week 8Week 12Week 24Week 36Week 48End of Treatment
Phase 1: T12(Q8h)/PR033.366.766.766.777.877.877.8
Phase 3: T12(Q8h)/PR - Prior Null Responder037.556.359.450.043.843.843.8
Phase 3: T12(Q8h)/PR - Prior Partial Responder077.386.490.977.381.872.786.4
Phase 3: T12(Q8h)/PR - Prior Relapser085.292.692.685.285.285.292.6

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Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level

The table below shows change from baseline in log 10 plasma HCV RNA values measured over time. (NCT01054573)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48

,,,
Interventionlog 10 IU/ml (Median)
Week 4 (n=32, 22, 26, and 9)Week 8 (n=32, 22, 26, and 9)Week 12 (n=31, 22, 26, 9)Week 24 (n=23, 20, 24, and 8)Week 36 (n=18, 19, 23, and 7)Week 48 (n=15, 16, 21, and 7)
Phase 1: T12(Q8h)/PR-5.55-5.96-5.96-5.87-6.07-6.07
Phase 3: T12(Q8h)/PR - Prior Null Responder-5.39-5.51-5.40-5.89-5.95-6.03
Phase 3: T12(Q8h)/PR - Prior Partial Responder-5.83-5.88-5.88-5.72-5.86-5.88
Phase 3: T12(Q8h)/PR - Prior Relapser-5.59-5.62-5.62-5.75-5.78-5.71

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The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)

The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure. (NCT01054573)
Timeframe: End of trial (24 weeks after last dose, administerd at 48 weeks)

InterventionPercentage of participants with response (Number)
Phase 3: T12(Q8h)/PR - Prior Null Responder34.4
Phase 3: T12(Q8h)/PR - Prior Partial Responder72.7
Phase 3: T12(Q8h)/PR - Prior Relapser81.5
Phase 1: T12(Q8h)/PR44.4

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Percentage of Participants Who Relapsed During Follow-Up

The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment). (NCT01054573)
Timeframe: During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)

InterventionPercentage of participants (Number)
Phase 3: T12(Q8h)/PR - Prior Null Responder21.4
Phase 3: T12(Q8h)/PR - Prior Partial Responder5.3
Phase 3: T12(Q8h)/PR - Prior Relapser4.0
Phase 1: T12(Q8h)/PR28.6

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Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study

A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA. (NCT01054742)
Timeframe: From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2]

Interventionparticipants (Number)
Day 1, Study Part 2Treatment Week 12, Study Part 2Treatment Week 24, Study Part 2Treatment Week 48, Study Part 2Follow-up Week 24, Study Part 2
Standard of Care PegIntron Plus Ribavirin [Part 2]02222

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Overall Response Rate

Overall response rate comprises complete response (<5% blasts in the bone marrow, and in the peripheral blood Hgb more than or equal to 100 g/L, platelets more than or equal to 100x10-9/L, and neutrophils more than or equal to 1x10-9/L), partial response (5 to 25% blasts in the bone marrow and same peripheral blood parameters) and blast response (a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days). (NCT01056523)
Timeframe: 2-3 years

InterventionParticipants (Count of Participants)
Ribavirin and Cytarabine5

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Partial Response

Partial response was defined as 5 to 25% blasts in the bone marrow and Hgb >100g/L, platelets >100,000/ul and neutrophils >1000/ul. (NCT01056523)
Timeframe: 2-3 years

InterventionParticipants (Count of Participants)
Ribavirin and Cytarabine1

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Complete Response Rate

Defined as <5% blasts in the bone marrow and a hgb 100 g/L, platelets 100,000/uL, neutrophils 1000/uL. (NCT01056523)
Timeframe: 2-3 years

InterventionParticipants (Count of Participants)
Ribavirin and Cytarabine2

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Blast Response

Blast response was defined as a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days. (NCT01056523)
Timeframe: 2-3 years

InterventionParticipants (Count of Participants)
Ribavirin and Cytarabine2

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Maximum Plasma Concentration (Cmax) of ABT-450

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Interventionng/mL (Mean)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV34.4
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV165
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV2923

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Maximum Plasma Concentration (Cmax) of ABT-333

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Interventionng/mL (Mean)
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV800
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV1201

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Maximum Plasma Concentration (Cmax) of ABT-072

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Interventionng/mL (Mean)
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV390
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV1218
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV1748

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Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment

Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Prior to dosing on Day 1 to before the morning dose on Day 4

Interventionlog10 IU/mL (Mean)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV-4.07
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV-3.91
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV-4.11
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV-1.14
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV-1.07
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV-1.57
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV-1.08
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV-0.95
Placebo + pegIFN/RBV-0.36

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Change From Baseline in SF-36 Physical Component Summary (PCS)

The Physical Component Summary (PCS) of the SF-36 was used to measure the overall physical health status of a participant. The aggregated score of the SF-36 PCS score was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better physical function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation. (NCT01074008)
Timeframe: Baseline and Post-treatment Week 24

Interventionunits on a scale (Mean)
ABT-450/r (Regardless of Dose) + pegIFN/RBV3.01
ABT-072 (Regardless of Dose) + pegIFN/RBV-1.92
ABT-333 (Regardless of Dose) + pegIFN/RBV4.08
Placebo (Regardless of Dose) + pegIFN/RBV-2.84

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Change From Baseline in SF-36 Mental Component Summary (MCS)

The Mental Component Summary (MCS) of the SF-36 was used to measure the overall mental health status of participants. The aggregated score of the SF-36 MPS was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better mental function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation. (NCT01074008)
Timeframe: Baseline and Post-treatment Week 24

Interventionunits on a scale (Mean)
ABT-450/r (Regardless of Dose) + pegIFN/RBV-2.77
ABT-072 (Regardless of Dose) + pegIFN/RBV-0.41
ABT-333 (Regardless of Dose) + pegIFN/RBV-4.37
Placebo (Regardless of Dose) + pegIFN/RBV-10.29

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Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Interventionng*hr/mL (Mean)
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV3678
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV9413
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV14126

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Change From Baseline in Hepatitis C Virus Patient-reported Outcomes (HCV-PRO) Total Score

The Hepatitis C Virus Patient-report Outcomes (HCV-PRO, formerly known as HCV Quality of Life) survey was used to assess disease-specific function and well-being on a scale from 0 to 100; a higher score indicated relatively good function and well-being of treated participants. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are reported as the group mean change from baseline ± standard deviation. (NCT01074008)
Timeframe: Baseline up to Post-treatment Week 24

Interventionunits on a scale (Mean)
ABT-450/r (Regardless of Dose) + pegIFN/RBV-0.78
ABT-072 (Regardless of Dose) + pegIFN/RBV-0.37
ABT-333 (Regardless of Dose) + pegIFN/RBV-3.25
Placebo (Regardless of Dose) + pegIFN/RBV-9.04

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Change From Baseline in EQ-5D (3 Level) Health Index Score

The EQ-5D was a health state questionnaire used to measure five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The combination of responses from all five dimensions were derived into an index score ranging from 0 to 1; a higher score indicated a more preferable health utility value from the societal perspectives. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation. (NCT01074008)
Timeframe: Baseline and Post-treatment Week 24

Interventionunits on a scale (Mean)
ABT-450/r (Regardless of Dose) + pegIFN/RBV-0.06
ABT-072 (Regardless of Dose) + pegIFN/RBV-0.06
ABT-333 (Regardless of Dose) + pegIFN/RBV-0.02
Placebo (Regardless of Dose) + pegIFN/RBV-0.09

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Change From Baseline in ED-5D Visual Analog Scale (ED-5D VAS) Score

The ED-5D VAS was a self-rating survey used to capture the current health status of a participant and ranged from 0 (the worst imaginable health state) to 100 (best imaginable health state). Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation. (NCT01074008)
Timeframe: Baseline and Post-treatment Week 24

Interventionunits on a scale (Mean)
ABT-450/r (Regardless of Dose) + pegIFN/RBV-5.91
ABT-072 (Regardless of Dose) + pegIFN/RBV-2.38
ABT-333 (Regardless of Dose) + pegIFN/RBV11.18
Placebo (Regardless of Dose) + pegIFN/RBV-9.00

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Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Interventionng*hr/mL (Mean)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV4518
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV7638
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV8663

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Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Interventionng*hr/mL (Mean)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV250
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV1122
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV17351

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Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333

Blood samples were collected immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1

Interventionng*hr/mL (Mean)
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV4315
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV6431

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Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)

Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-450 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-450 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented. (NCT01074008)
Timeframe: Baseline and Day 4

,,
Interventionparticipants (Number)
Baseline Variants in NS3Baseline Resistance to ABT-450 >10-foldDay 4 Variants in NS3 (n=3, 2, 3)Day 4: Resistance to ABT-450 >10-fold (n=3, 2, 3)
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV0021
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV0010
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV0021

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Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)

Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-333 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented. (NCT01074008)
Timeframe: Baseline and Day 4

,
Interventionparticipants (Number)
Baseline Variants in NS5BBaseline Resistance to ABT-333 >10-fold NS5BDay 4: Variants in NS5B (n=7, 8)Day 4: Resistance to ABT-333 >10-fold (n=7, 8)
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV1030
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV2130

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Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)

Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-072 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-072 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented. (NCT01074008)
Timeframe: Baseline and Day 4

,,
Interventionparticipants (Number)
Baseline Variants in NS5BBaseline Resistance to ABT-072 >10-foldDay 4: Variants in NS5B (n=6, 7, 6)Day 4: Resistance to ABT-072 >10-fold (n=6, 7, 6)
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV0010
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV1120
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV0011

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Time to Maximum Plasma Concentration (Tmax) of ABT-072

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

InterventionHours (Mean)
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV4.5
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV2.8
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV3.1

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Time to Maximum Plasma Concentration (Tmax) of Ritonavir

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

InterventionHours (Mean)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV4.8
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV5.3
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV4.5

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Time to Maximum Plasma Concentration (Tmax) of ABT-450

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

InterventionHours (Mean)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV2.5
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV4.8
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV3.0

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Time to Maximum Plasma Concentration (Tmax) of ABT-333

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

InterventionHours (Mean)
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV4.5
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV7.0

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Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Rapid virologic response was defined as HCV RNA level < LLOQ (< 25 IU/mL) at Week 4. Data are reported as the percentage of participants with RVR. (NCT01074008)
Timeframe: Week 4

Interventionpercentage of participants (Number)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV87.5
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV75.0
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV100.0
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV37.5
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV12.5
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV42.9
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV50.0
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV50.0
Placebo + pegIFN/RBV9.1

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Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. Partial early virologic response (EVR) was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline. The baseline value was the last measurement before the first dose on Day 1. Data are reported as the percentage of participants with partial EVR. (NCT01074008)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV100.0
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV87.5
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV100.0
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV100.0
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV62.5
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV100.0
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV100.0
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV100.0
Placebo + pegIFN/RBV36.4

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Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Complete EVR was defined as HCV RNA levels < LLOQ (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR. (NCT01074008)
Timeframe: Week 12

Interventionpercentage of participants (Number)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV87.5
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV87.5
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV100.0
ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV75.0
ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV50.0
ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV85.7
ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV87.5
ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV62.5
Placebo + pegIFN/RBV18.2

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Maximum Plasma Concentration (Cmax) of Ritonavir

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01074008)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Interventionng/mL (Mean)
ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV563
ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV851
ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV1098

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Ribavirin AUC-12 Variability

Demonstrate that concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposure with reduced variability in the steady-state area-under-the-concentration-time curve (AUC0-12) compared with standard weight-based ribavirin dosing (NCT01097395)
Timeframe: steady state (~weeks 9-10)

Interventionng*hr/mL (Mean)
Standard Weight-Based Ribavirin Dosing34425
Concentration-Controlled Ribavirin Dosing40903

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Safety - Absolute Hemoglobin Declines

(NCT01097395)
Timeframe: from baseline through end of treatment, up to 48 weeks

Interventiong/dL (Mean)
Standard Weight-Based Ribavirin Dosing2.6
Concentration-Controlled Ribavirin Dosing3.6

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Sustained Virologic Response (i.e., Cure)

Compare proportions with SVR in standard weight-based vs. concentration-guided ribavirin dosing groups. Number of participants with sustained virologic response is reported. (NCT01097395)
Timeframe: assessed 12 weeks after stopping treatment

InterventionParticipants (Count of Participants)
Standard Weight-Based Ribavirin Dosing8
Concentration-Controlled Ribavirin Dosing12

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Incidence of Treatment Discontinuations Due to Adverse Events

All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs. (NCT01098097)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
Treatment stopped - any AEDose reduced, then treatment stopped - any AE
Peginterferon Alpha and Ribavirin2.60.1

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Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes. (NCT01098097)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
Clinically significant adverse eventSerious adverse event
Peginterferon Alpha and Ribavirin33.61.9

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Incidence of Particular Adverse Events Resulting in Treatment Discontinuation

"All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS).~The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)" (NCT01098097)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
TS - AnemiaTS - LeucopeniaTS - NeutropeniaTS - ThrombocytopeniaTS - Esophageal varicesTS - SplenomegalyTS -Portal hypertensive gastropathyTS - HepatomegalyDR/TS - AnemiaDR/TS - LeucopeniaDR/TS - NeutropeniaDR/TS - ThrombocytopeniaDR/TS - Esophageal varicesDR/TS - SplenomegalyDR/TS - Portal hypertensive gastropathyDR/TS - Hepatomegaly
Peginterferon Alpha and Ribavirin0.60.20.20.10.00.00.00.00.10.00.00.00.00.00.00.0

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Incidence of Dose Modifications Due to Adverse Events

All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs. (NCT01098097)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
Dose ReducedDose Reduced, then Treatment StoppedDose Reduced, Treatment Suspended and Restarted
Peginterferon Alpha and Ribavirin9.70.10.3

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Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)

Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL. (NCT01098097)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Peginterferon Alpha and Ribavirin42.4

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Incidence of Thrombocytopenia

Thrombocytopenia is a low blood platelet count (NCT01098097)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
Peginterferon Alpha and Ribavirin3.8

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Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)

RVR was defined as undetectable RNA (HCV RNA NCT01125189)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin59.9
Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin56.8
Placebo + Peg-interferon Alfa-2a + Ribavirin15.3

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Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)

SVR24 was defined as HCV NCT01125189)
Timeframe: Follow-up Week 24

Interventionpercentage of participants (Number)
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin59.2
Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin59.6
Placebo + Peg-interferon Alfa-2a + Ribavirin37.5

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Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)

eRVR was defined as HCV RNA NCT01125189)
Timeframe: Weeks 4 and 12

Interventionpercentage of participants (Number)
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin54.4
Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin54.1
Placebo + Peg-interferon Alfa-2a + Ribavirin13.9

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Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as undetectable RNA (HCV RNA NCT01125189)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin77.6
Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin75.3
Placebo + Peg-interferon Alfa-2a + Ribavirin43.1

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Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)

SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and NCT01125189)
Timeframe: Follow-up Week 12

Interventionpercentage of participants (Number)
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin64.6
Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin60.3
Placebo + Peg-interferon Alfa-2a + Ribavirin36.1

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Percentage of Resistant Variants Associated With Virologic Failure

"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA NCT01125189)
Timeframe: Follow-up Week 48

,,
Interventionpercentage of participants (Number)
Virologic BreakthroughWeek 4 Futility RuleDetectable HCV RNA at EOTOther CriteriaRelapse
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin8.22.07.51.418.5
Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin10.32.16.80.119.0
Placebo + Peg-interferon Alfa-2a + Ribavirin2.825.05.66.922.0

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Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died

SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT01125189)
Timeframe: From start of study treatment (day 1) up to follow-up Week 48

,,
Interventionparticipants (Number)
SAEsDiscontinuations Due to AEsDeath
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin1272
Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin1370
Placebo + Peg-interferon Alfa-2a + Ribavirin680

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Part 2: Time to Virological Response

Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure. (NCT01132313)
Timeframe: From drug administration until end of drug administration, up to 40 weeks

,,,,
InterventionPercentage of participants (Number)
Day 0 (N=81, 80, 77, 78, 46)Day 8(N=75, 72, 72, 75, 44)Day 15 (N=62, 61, 63, 60, 33)Day 29 (N=29, 32, 27, 32, 21)Day 43 (N=16, 12, 13, 18, 12)Day 57 (N=9, 8, 9, 11, 9)Day 85 (N=9, 7, 8, 11, 9)Day 113 (N=9, 7, 8, 11, 8)Day 141 (N=9, 7, 8, 11, 8)Day 169 (N=9, 7, 8, 11, 8)Day 197 (N=9, 7, 8, 11, 8)
Part 2: 600mg DBV and 120mg FDV - 16w0.03.819.461.578.888.188.188.188.188.188.1
Part 2: 600mg DBV and 120mg FDV - 40w0.01.49.959.480.585.186.886.886.886.886.8
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w0.02.219.348.670.778.078.080.480.480.480.4
Part 2: 600mg DBV BID and 120mg FDV - 28w0.02.622.157.776.285.585.585.585.585.585.5
Part 2: 600mg DBV TID and 120mg FDV - 28w0.07.720.755.583.388.990.390.390.390.390.3

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Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4

Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4 (NCT01132313)
Timeframe: 4 weeks

InterventionPercentage of participants (Number)
Part 1: 400mg DBV and 120mg FDV - 4w20.0
Part 1: 600mg DBV and 120mg FDV - 4w70.6
Part 2: 600mg DBV and 120mg FDV - 16w65.4
Part 2: 600mg DBV TID and 120mg FDV - 28w60.0
Part 2: 600mg DBV and 120mg FDV - 40w63.6
Part 2: 600mg DBV BID and 120mg FDV - 28w56.4
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w50.0

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Part 1: Rapid Virological Response (RVR)

Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment (NCT01132313)
Timeframe: 4 weeks

InterventionPercentage of participants (Number)
Part 1: 400mg DBV and 120mg FDV - 4w73.3
Part 1: 600mg DBV and 120mg FDV - 4w100.0

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Part 2: Sustained Virological Response (SVR)

Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment (NCT01132313)
Timeframe: From drug administration until 12 weeks after end of treatment, up to 52 weeks

InterventionPercentage of participants (Number)
Part 2: 600mg DBV and 120mg FDV - 16w59.3
Part 2: 600mg DBV TID and 120mg FDV - 28w58.8
Part 2: 600mg DBV and 120mg FDV - 40w51.9
Part 2: 600mg DBV BID and 120mg FDV - 28w69.2
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w39.1

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Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment

Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment (NCT01132313)
Timeframe: Week 4 and 12

InterventionPercentage of participants (Number)
Part 3: 600mg DBV and 120mg FDV - 16w75.0
Part 3: 800mg DBV and 120mg FDV - 24w26.9
Part 3: 600mg DBV and 120mg FDV - 24w32.0
Part 4: 600 mg DBV and 120mg FDV - 16wNA
Part 4: 600 mg DBV and 120mg FDV - 24wNA

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Part 3 and 4: Sustained Virological Response (SVR)

Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment (NCT01132313)
Timeframe: From drug administration until 12 weeks after end of treatment, up to 36 weeks

InterventionPercentage of participants (Number)
Part 3: 600mg DBV and 120mg FDV - 16w65.6
Part 3: 800mg DBV and 120mg FDV - 24w19.2
Part 3: 600mg DBV and 120mg FDV - 24w12.0
Part 4: 600 mg DBV and 120mg FDV - 16wNA
Part 4: 600 mg DBV and 120mg FDV - 24wNA

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Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment

Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment (NCT01132313)
Timeframe: up to 28 weeks

InterventionPercentage of participants (Number)
Part 3: 600mg DBV and 120mg FDV - 16w75.0
Part 3: 800mg DBV and 120mg FDV - 24w19.2
Part 3: 600mg DBV and 120mg FDV - 24w12.0
Part 4: 600 mg DBV and 120mg FDV - 16wNA
Part 4: 600 mg DBV and 120mg FDV - 24wNA

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Part 1: Time to Virological Response

Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure. (NCT01132313)
Timeframe: From drug administration until end of drug administration, up to 4 weeks

,
InterventionPercentage of participants (Number)
<= 2 weeks<= 4 weeks<= 8 weeks<= 12 weeks<= 16 weeks<= 28 weeks<= 32 weeks<= 40 weeks> 40 weeksNever
Part 1: 400mg DBV and 120mg FDV - 4w6.720.053.30.06.70.06.70.00.06.7
Part 1: 600mg DBV and 120mg FDV - 4w11.847.141.20.00.00.00.00.00.00.0

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Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment

Part 2: Sustained virological response at 4 and 24 weeks after end of treatment (NCT01132313)
Timeframe: 4 weeks and 24 weeks after the end of treatment, up to 64 weeks

,,,,
InterventionPercentage of participants (Number)
SVR4SVR24
Part 2: 600mg DBV and 120mg FDV - 16w60.558.0
Part 2: 600mg DBV and 120mg FDV - 40w54.549.4
Part 2: 600mg DBV and 120mg FDV, no RBV - 28w43.539.1
Part 2: 600mg DBV BID and 120mg FDV - 28w69.269.2
Part 2: 600mg DBV TID and 120mg FDV - 28w62.558.8

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Percentage of Participants With 24-week Sustained Virologic Response (SVR24)

SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA NCT01170962)
Timeframe: Follow-up Week 24

Interventionpercentage of participants (Number)
Daclatasvir (20 mg): Prior Null Responders18.8
Daclatasvir (60 mg): Prior Null Responders22.0
Daclatasvir (20 mg): Prior Partial Responders24.3
Daclatasvir (60 mg): Prior Partial Responders43.3
Placebo: Prior Partial Responders0

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Percentage of Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA NCT01170962)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Daclatasvir (20 mg): Prior Null Responders30.1
Daclatasvir (60 mg): Prior Null Responders34.1
Daclatasvir (20 mg): Prior Partial Responders44.3
Daclatasvir (60 mg): Prior Partial Responders56.7
Placebo: Prior Partial Responders0

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Percentage of Participants With Extended Rapid Virologic Response (eRVR)

eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT01170962)
Timeframe: Week 4, Week 12

Interventionpercentage of participants (Number)
Daclatasvir (20 mg): Prior Null Responders18.0
Daclatasvir (60 mg): Prior Null Responders19.7
Daclatasvir (20 mg): Prior Partial Responders25.7
Daclatasvir (60 mg): Prior Partial Responders35.8
Placebo: Prior Partial Responders0

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Percentage of Participants With Rapid Virologic Response (RVR)

RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA NCT01170962)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Daclatasvir (20 mg): Prior Null Responders21.8
Daclatasvir (60 mg): Prior Null Responders21.2
Daclatasvir (20 mg): Prior Partial Responders25.7
Daclatasvir (60 mg): Prior Partial Responders38.8
Placebo: Prior Partial Responders0

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Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)

SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA NCT01170962)
Timeframe: Follow-up Week 12

Interventionpercentage of participants (Number)
Daclatasvir (20 mg): Prior Null Responders19.5
Daclatasvir (60 mg): Prior Null Responders23.5
Daclatasvir (20 mg): Prior Partial Responders25.7
Daclatasvir (60 mg): Prior Partial Responders47.8
Placebo: Prior Partial Responders0

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Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures

Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C. (NCT01170962)
Timeframe: Baseline to follow-up Week 48

,,,
Interventionparticipants (Number)
M28: L/T/V: Baseline (n=78,84,49,36)M28: L/T/V: On-Treatment (n= 60,57,34,22)M28: L/T/V: Relapsers (n=10,12,7,3)Q30: H: Baseline (n=78,0,0,36)Q30: H: On-Treatment (n= 60,0,0,22)Q30: H:Relapsers (n=10,0,0,3)L31: M: Baseline (n=78,84,49,36)L31: M: On-Treatment (n= 60,57,34,22)L31: M: Relapsers (n=10,12,7,3)H54: Y: Baseline (n=0,84,49,0)H54: Y: On-Treatment (n=0,57,34,0)H54: Y: Relapsers (n=0,12,7,0)H58: C/D/N/P/Q: Baseline (n=78,84,49,0)H58: C/D/N/P/Q: On-Treatment (n= 60,57,34,0)H58: C/D/N/P/Q: Relapsers (n=10,12,7,3)E62: D: Baseline (n=78,84,49,0)E62: D: On-Treatment (n= 60,57,34,0)E62: D: Relapsers (n=10,12,7,0)Y93: C: Baseline (n=0,84,49,0)Y93: C: On-Treatment (n= 0,57,34,0)Y93: C: Relapsers (n=0,12,7,0)
Daclatasvir (20 mg): Prior Null Responders220110550NANANA440110NANANA
Daclatasvir (20 mg): Prior Partial Responders110NANANA101110310210101
Daclatasvir (60 mg): Prior Null Responders330NANANA110220330321110
Daclatasvir (60 mg): Prior Partial Responders320100220NANANANANANANANANANANANA

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Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures

Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H. (NCT01170962)
Timeframe: Baseline to follow-up Week 48

,,,
Interventionparticipants (Number)
L28: M/V: Baseline (n=43,37,19,0)L28: M/V: On-Treatment (n=19,20,6,0)L28: M/V: Relapsers (n=7,6,2,0)R30: H/Q: Baseline (n=43,37,19,27)R30: H/Q: On-Treatment (n=19,20,6,5)R30: H/Q: Relapsers (n=7,6,2,9)L31: M: Baseline (n=43,37,19,27)L31: M: On-Treatment (n=19,20,6,5)L31: M: Relapsers (n=7,6,2,9)Q54: H/N/Y: Baseline (n=43,37,19,27)Q54: H/N/Y: On-Treatment (n=19,20,6,5)Q54: H/N/Y: Relapsers (n=7,6,2,9)P58: A/Q/S: Baseline (n=43,37,19,27)P58: A/Q/S: On-Treatment (n=19,20,6,5)P58: A/Q/S: Relapsers (n=7,6,2,9)Q62: E/K/N/R/S: Baseline (n=43,37,19,27)Q62: E/K/N/R/S: On-Treatment (n=19,20,6,5)Q62: E/K/N/R/S: Relapsers (n=7,6,2,9)A92: T/V: Baseline (n=43,37,19,0)A92: T/V: On-Treatment (n=0,20,6,0)A92: T/V: Relapsers (n=0,6,2,0)Y93: F/H: Baseline (n=43,37,0,27)Y93: F/H: On-Treatment (n=0,20,0,5)Y93: F/H: Relapsers (n=0,6,0,9)
Daclatasvir (20 mg): Prior Null Responders11044042118953205302NANA1NANA
Daclatasvir (20 mg): Prior Partial Responders100101101950210210310NANANA
Daclatasvir (60 mg): Prior Null Responders11053254020121732110320541
Daclatasvir (60 mg): Prior Partial RespondersNANANA101101822301101NANANA302

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Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT01170962)
Timeframe: From day 8 post last dose of treatment up-to Week 72

,,
Interventionparticipants (Number)
SAEsDeath
Daclatasvir (20 mg): Prior Null and Partial Responders62
Daclatasvir (60 mg): Prior Null and Partial Responders72
Placebo: Prior Partial Responders00

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Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT01170962)
Timeframe: From first dose to last dose plus 7 days, up to 49 weeks

,,
Interventionparticipants (Number)
SAEsAEs Leading to Discontinuation of TreatmentDeath
Daclatasvir (20 mg): Prior Null and Partial Responders14110
Daclatasvir (60 mg): Prior Null and Partial Responders11120
Placebo: Prior Partial Responders331

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Segment 2: Complete Early Virologic Response (cEVR)

The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12. (NCT01180790)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Segment 2: 200 mg ACH-0141625100.0
Segment 2: 400 mg ACH-014162594.0
Segment 2: 800 mg ACH-0141625100.00

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Segment 2: Safety

Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01180790)
Timeframe: 12 weeks

,,
Interventionpercentage of participants (Number)
Adverse Events (%)Abnormal Laboratories (%)Dose Reductions (%)Dose Interruptions (%)Dose Discontinuations (%)
Segment 2: 200 mg ACH-014162594.7100.0006.0
Segment 2: 400 mg ACH-014162585.095.00020.0
Segment 2: 800 mg ACH-0141625100.0100.0000

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Segment 1: Safety

Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01180790)
Timeframe: 4 weeks

,,,
Interventionpercentage of participants (Number)
Adverse Events (%)Abnormal Laboratories (%)Dose Reductions (%)Dose Interruptions (%)Dose Discontinuations (%)
Segment 1: 200 mg ACH-0141625100.0100.0006.0
Segment 1: 400 mg ACH-014162593.8100.0000
Segment 1: 800 mg ACH-0141625100.094.0006.0
Segment 1: Placebo93.3100.0000

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Segment 1: Rapid Viral Response At Week 4 (RVR4)

The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus [HCV] ribonucleic acid (RNA) less than or equal to the limit of quantitation [LOQ] at the Week 4 visit). (NCT01180790)
Timeframe: 4 weeks

,,,
Interventionpercentage of participants (Number)
Rapid Virologic Response (%)No Rapid Virologic Response (%)
Segment 1: 200 mg ACH-014162575.025.0
Segment 1: 400 mg ACH-014162575.025.0
Segment 1: 800 mg ACH-014162576.523.5
Segment 1: Placebo20.080.0

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Segment 2: RVR4

For Segment 2, the percentage of participants in the virology population who achieved RVR4, defined as HCV RNA less than or equal to the LOQ at the Week 4 visit. (NCT01180790)
Timeframe: 4 weeks

Interventionpercentage of participants (Number)
Segment 2: 200 mg ACH-014162578.9
Segment 2: 400 mg ACH-014162588.8
Segment 2: 800 mg ACH-014162589.5

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Segment 1: cEVR

For Segment 1, the percentage of participants in the virology population who achieved cEVR, defined as undetectable HCV RNA at Week 12. (NCT01180790)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Segment 1: 200 mg ACH-014162562.5
Segment 1: 400 mg ACH-014162575.0
Segment 1: 800 mg ACH-014162570.6
Segment 1: Placebo33.3

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Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24)

The percentage of virology population participants who achieved SVR, defined as HCV RNA less than the LOQ, 6 months post-dosing. (NCT01180790)
Timeframe: 6 months post-dosing

Interventionpercentage of participants (Number)
Segment 1: 200 mg ACH-014162562.5
Segment 1: 400 mg ACH-014162556.3
Segment 1: 800 mg ACH-014162535.3
Segment 1: Placebo40.0
Segment 2: 200 mg ACH-014162570.0
Segment 2: 400 mg ACH-014162576.9
Segment 2 : 800 mg ACH-014162583.3

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Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12)

The percentage of virology population participants who achieved sustained virologic response (SVR), defined as HCV RNA less than the LOQ, at 12 weeks (3 months) post-dosing. (NCT01180790)
Timeframe: 3 months post-dosing

Interventionpercentage of participants (Number)
Segment 1: 200 mg ACH-014162556.3
Segment 1: 400 mg ACH-014162556.3
Segment 1: 800 mg ACH-014162535.3
Segment 1: Placebo40.0
Segment 2: 200 mg ACH-014162580.0
Segment 2: 400 mg ACH-014162576.9
Segment 2: 800 mg ACH-014162584.5

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Segment 1 And Segment 2: HCV RNA Change From Baseline

Change from baseline in log10 HCV RNA level by visit. (NCT01180790)
Timeframe: Week 12

Interventionlog10 HCV RNA level (Mean)
Segment 1: 200 mg ACH-0141625-5.13
Segment 1: 400 mg ACH-0141625-4.51
Segment 1: 800 mg ACH-0141625-4.67
Segment 1: Placebo-3.48
Segment 2: 200 mg ACH-0141625-4.90
Segment 2: 400 mg ACH-0141625-5.08
Segment 2: 800 mg ACH-0141625-4.58

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Segment 1 And Segment 2: End Of Treatment Response

The percentage of virology population participants who were reported as undetectable HCV RNA at the completion of treatment. (NCT01180790)
Timeframe: Week 48 (Segment 1); Week 24 (Segment 2)

Interventionpercentage of participants (Number)
Segment 1: 200 mg ACH-014162575.0
Segment 1: 400 mg ACH-014162575.0
Segment 1: 800 mg ACH-014162564.7
Segment 1: Placebo53.3
Segment 2: 200 mg ACH-0141625100.0
Segment 2: 400 mg ACH-014162592.3
Segment 2: 800 mg ACH-0141625100.0

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Segment 1 And Segment 2: HCV RNA Change From Baseline

The mean change from baseline in log10 HCV RNA level by visit for the virology population (NCT01180790)
Timeframe: Week 4

Interventionlog10 HCV RNA Level (Mean)
Segment 1: 200 mg ACH-0141625-4.94
Segment 1: 400 mg ACH-0141625-4.60
Segment 1: 800 mg ACH-0141625-4.94
Segment 1: Placebo-2.22
Segment 2: 200 mg ACH-0141625-4.74
Segment 2: 400 mg ACH-0141625-5.04
Segment 2: 800 mg ACH-0141625-4.51

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Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End

(NCT01183169)
Timeframe: Up to 48 weeks

,,,,,
Interventionpercentage of participants (Number)
End of Treatment (n = 53,49,60,53,14,7)End of Study (n = 49,42,18,46,13,6)
Treatment A77.454.7
Treatment B77.661.2
Treatment C59.018.0
Treatment C1A35.721.4
Treatment C2A28.628.6
Treatment D83.067.9

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Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD

RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch. (NCT01183169)
Timeframe: after 4 weeks of treatment

,,,,,
Interventionpercentage of participants (Number)
RVR-LOQRVR-LOD
Treatment A20.99.1
Treatment B25.08.3
Treatment C7.32.7
Treatment C1A39.418.2
Treatment C2A56.750.0
Treatment D41.322.9

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Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)

cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch. (NCT01183169)
Timeframe: after 12 weeks of treatment

Interventionpercentage of participants (Number)
Treatment A48.2
Treatment B61.1
Treatment C35.5
Treatment D74.3
Treatment C1A45.5
Treatment C2A80.0

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Percentage of Participants With On-treatment Viral Breakthrough

"On-treatment viral breakthrough was defined as either:~Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or~HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOQ) during treatment" (NCT01183169)
Timeframe: within 48 weeks

Interventionpercentage of participants (Number)
Treatment A12.7
Treatment B9.3
Treatment C5.5
Treatment D2.8
Treatment C1A6.1
Treatment C2A10.0

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Percentage of Participants With Viral Relapse

Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment. (NCT01183169)
Timeframe: within 24 weeks after treatment

Interventionpercentage of participants (Number)
Treatment A19.1
Treatment B18.5
Treatment C17.3
Treatment D12.8
Treatment C1A30.3
Treatment C2A13.3

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Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD

SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively. (NCT01183169)
Timeframe: 12 weeks after treatment

,,,,,
Interventionpercentage of participants (Number)
SVR12-LOQSVR12-LOD
Treatment A42.740.9
Treatment B51.950.9
Treatment C14.514.5
Treatment C1A18.218.2
Treatment C2A53.353.3
Treatment D65.163.3

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Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD

SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively. (NCT01183169)
Timeframe: 24 weeks after treatment

,,,,,
Interventionpercentage of participants (Number)
SVR24-LOQSVR24-LOD
Treatment A41.840.0
Treatment B51.950.0
Treatment C14.514.5
Treatment C1A18.218.2
Treatment C2A53.353.3
Treatment D65.163.3

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Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD

ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively. (NCT01183169)
Timeframe: within 48 weeks

,,,,,
Interventionpercentage of participants (Number)
ETR-LOQETR-LOD
Treatment A68.261.8
Treatment B74.170.4
Treatment C33.631.8
Treatment C1A51.536.4
Treatment C2A73.366.7
Treatment D82.678.9

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Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD

pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch. (NCT01183169)
Timeframe: after 12 weeks of treatment

,,,,,
Interventionpercentage of participants (Number)
pEVR-LOQpEVR-LOD
Treatment A38.247.3
Treatment B28.748.1
Treatment C31.846.4
Treatment C1A3.09.1
Treatment C2A6.713.3
Treatment D11.927.5

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Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)

cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch. (NCT01183169)
Timeframe: after 12 weeks of treatment

Interventionpercentage of participants (Number)
Treatment A39.1
Treatment B41.7
Treatment C20.9
Treatment D58.7
Treatment C1A39.4
Treatment C2A73.3

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Number of Participants With Adverse Events

Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table. (NCT01185028)
Timeframe: 1 year and 2 months

Interventionparticipants (Number)
Nitazoxanide With Pegylated Interferon And Ribavirin8

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Tolerability of Study Drug Measured as Discontinuation.

Proportion of individuals that discontinued study drug due to intolerability. (NCT01185028)
Timeframe: 1 year and 2 mos

InterventionParticipants (Count of Participants)
Nitazoxanide With Pegylated Interferon And Ribavirin0

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Sustained Viral Response Rate

Proportion of participants that are HCV negative 6 months after treatment completion (NCT01185028)
Timeframe: 1 year and 2 mos

Interventionparticipants (Number)
Nitazoxanide With Pegylated Interferon And Ribavirin8

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Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)

(NCT01215643)
Timeframe: 12 weeks after the end of treatment

,,,,
Interventionpercentage of participants (Number)
SVR12LOQSVR12LOD
ALV 1000 mg78.378.3
ALV 600 mg+PEG72.772.7
ALV 600 mg+RBV76.776.7
ALV 800 mg+RBV76.976.9
PEG+RBV61.553.8

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Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)

(NCT01215643)
Timeframe: 24 weeks after the end of treatment

,,,,
Interventionpercentage of participants (Number)
SVR24LOQSVR24LOD
ALV 1000 mg80.280.2
ALV 600 mg+PEG79.579.5
ALV 600 mg+RBV84.584.5
ALV 800 mg+RBV80.679.6
PEG+RBV57.557.5

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Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)

ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued. (NCT01215643)
Timeframe: at end of treatment, within 24 weeks

,,,,
Interventionpercentage of participants (Number)
ETR24LOQETR24LOD
ALV 1000 mg95.192.6
ALV 600 mg+PEG94.992.3
ALV 600 mg+RBV96.494.0
ALV 800 mg+RBV95.792.5
PEG+RBV87.582.5

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Percentage of Participants With On-treatment Viral Breakthrough

"Viral breakthrough was defined as either:~Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or~HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment" (NCT01215643)
Timeframe: within 24 weeks of treatment

Interventionpercentage of participants (Number)
ALV 1000 mg2.5
ALV 600 mg+RBV3.6
ALV 800 mg+RBV2.2
ALV 600 mg+PEG5.1
PEG+RBV0.0

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Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)

RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment. (NCT01215643)
Timeframe: after 4 weeks of treatment

Interventionpercentage of participants (Number)
ALV 1000 mg28.4
ALV 600 mg+RBV36.9
ALV 800 mg+RBV41.9
ALV 600 mg+PEG84.6
PEG+RBV72.5

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Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)

(NCT01215643)
Timeframe: after 12 weeks of treatment

,,,,
Interventionpercentage of participants (Number)
cEVR12LOQcEVR12LOD
ALV 1000 mg100.0100.0
ALV 600 mg+PEG100.090.9
ALV 600 mg+RBV96.783.3
ALV 800 mg+RBV80.880.8
PEG+RBV84.684.6

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Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)

cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively. (NCT01215643)
Timeframe: after 12 weeks of treatment

,,,,
Interventionpercentage of participants (Number)
cEVR12LOQcEVR12LOD
ALV 1000 mg93.891.4
ALV 600 mg+PEG94.984.6
ALV 600 mg+RBV95.286.9
ALV 800 mg+RBV90.390.3
PEG+RBV85.082.5

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Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)

(NCT01215643)
Timeframe: at end of treatment, within 24 weeks

,,,,
Interventionpercentage of participants (Number)
ETR24LOQETR24LOD
ALV 1000 mg100.0100.0
ALV 600 mg+PEG100.0100.0
ALV 600 mg+RBV96.796.7
ALV 800 mg+RBV84.676.9
PEG+RBV92.384.6

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Percentage of Participants With Viral Relapse

Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment. (NCT01215643)
Timeframe: within 24 weeks after the end of treatment

,,,,
Interventionpercentage of participants (Number)
0 to 12 weeks after the end of treatment12 to 24 weeks after the end of treatment
ALV 1000 mg9.91.2
ALV 600 mg+PEG10.30.0
ALV 600 mg+RBV8.30.0
ALV 800 mg+RBV6.50.0
PEG+RBV20.05.0

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Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)

(NCT01215643)
Timeframe: 12 weeks after the end of treatment

,,,,
Interventionpercentage of participants (Number)
SVR12LOQSVR12LOD
ALV 1000 mg82.881.0
ALV 600 mg+PEG78.675.0
ALV 600 mg+RBV88.988.9
ALV 800 mg+RBV82.182.1
PEG+RBV63.063.0

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Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)

(NCT01215643)
Timeframe: 24 weeks after the end of treatment

,,,,
Interventionpercentage of participants (Number)
SVR24LOQSVR24LOD
ALV 1000 mg81.081.0
ALV 600 mg+PEG82.182.1
ALV 600 mg+RBV88.988.9
ALV 800 mg+RBV82.180.6
PEG+RBV59.359.3

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Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)

(NCT01215643)
Timeframe: after 12 weeks of treatment

,,,,
Interventionpercentage of participants (Number)
cEVR12LOQcEVR12LOD
ALV 1000 mg91.487.9
ALV 600 mg+PEG92.982.1
ALV 600 mg+RBV94.488.9
ALV 800 mg+RBV94.094.0
PEG+RBV85.281.5

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Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)

(NCT01215643)
Timeframe: after 4 weeks of treatment

,,,,
Interventionpercentage of participants (Number)
RVR4LOQRVR4LOD
ALV 1000 mg21.713.0
ALV 600 mg+PEG81.863.6
ALV 600 mg+RBV23.310.0
ALV 800 mg+RBV46.226.9
PEG+RBV76.953.8

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Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)

(NCT01215643)
Timeframe: after 4 weeks of treatment

,,,,
Interventionpercentage of participants (Number)
RVR4LOQRVR4LOD
ALV 1000 mg31.020.7
ALV 600 mg+PEG85.771.4
ALV 600 mg+RBV44.416.7
ALV 800 mg+RBV40.322.4
PEG+RBV70.463.0

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Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)

SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively. (NCT01215643)
Timeframe: 12 weeks after the end of treatment

,,,,
Interventionpercentage of participants (Number)
SVR12LOQSVR12LOD
ALV 1000 mg81.580.2
ALV 600 mg+PEG76.974.4
ALV 600 mg+RBV84.584.5
ALV 800 mg+RBV80.680.6
PEG+RBV62.560.0

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Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)

(NCT01215643)
Timeframe: at end of treatment, within 24 weeks

,,,,
Interventionpercentage of participants (Number)
ETR24LOQETR24LOD
ALV 1000 mg93.189.7
ALV 600 mg+PEG92.989.3
ALV 600 mg+RBV96.392.6
ALV 800 mg+RBV100.098.5
PEG+RBV85.281.5

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Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)

RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment. (NCT01215643)
Timeframe: after 4 weeks of treatment

Interventionpercentage of participants (Number)
ALV 1000 mg18.5
ALV 600 mg+RBV14.3
ALV 800 mg+RBV23.7
ALV 600 mg+PEG69.2
PEG+RBV60.0

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Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)

(NCT01215643)
Timeframe: 24 weeks after the end of treatment

,,,,
Interventionpercentage of participants (Number)
SVR24LOQSVR24LOD
ALV 1000 mg78.378.3
ALV 600 mg+PEG72.772.7
ALV 600 mg+RBV76.776.7
ALV 800 mg+RBV76.976.9
PEG+RBV53.853.8

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Time to Virologic Relapse Through 24 Weeks Post-treatment

Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. (NCT01221298)
Timeframe: Post-treatment Day 1 to Post-treatment Week 24

InterventionDays (Mean)
ABT-450/r and ABT-072, Plus Ribavirin (RBV)84

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Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment

Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. (NCT01221298)
Timeframe: Post-treatment Day 1 to Post-treatment Week 12

Interventionpercentage of participants (Number)
ABT-450/r and ABT-072, Plus Ribavirin (RBV)90.9

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Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). (NCT01221298)
Timeframe: Week 4 through Week 12

Interventionpercentage of participants (Number)
ABT-450/r and ABT-072, Plus Ribavirin (RBV)100

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Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4

Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). (NCT01221298)
Timeframe: Week 4

Interventionpercentage of participants (Number)
ABT-450/r and ABT-072, Plus Ribavirin (RBV)100

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Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)

Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. (NCT01221298)
Timeframe: Week 2

Interventionpercentage of participants (Number)
ABT-450/r and ABT-072, Plus Ribavirin (RBV)100

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Time to Failure to Suppress or Rebound During Treatment

The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD. (NCT01221298)
Timeframe: Day 1 through Week 12

InterventionDays (Mean)
ABT-450/r and ABT-072, Plus Ribavirin (RBV)NA

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Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment

Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. (NCT01221298)
Timeframe: Post-treatment Day 1 to Post-treatment Week 24

Interventionpercentage of participants (Number)
ABT-450/r and ABT-072, Plus Ribavirin (RBV)90.9

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Number of Participants by Virus Detection Status

Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ (NCT01227967)
Timeframe: At Day 0, 3 and 7.

InterventionParticipants (Count of Participants)
Day 072298058Day 072298059Day 372298059Day 372298058Day 772298058Day 772298059
>=LOD, Missing>=LLOQ
Combination Therapy221
Oseltamivir Monotherapy200
Oseltamivir Monotherapy9
Combination Therapy5
Oseltamivir Monotherapy15
Combination Therapy0
Oseltamivir Monotherapy0
Combination Therapy65
Oseltamivir Monotherapy87
Combination Therapy22
Oseltamivir Monotherapy25
Combination Therapy134
Oseltamivir Monotherapy104
Combination Therapy9
Oseltamivir Monotherapy8
Combination Therapy19
Oseltamivir Monotherapy24
Combination Therapy4
Oseltamivir Monotherapy7
Combination Therapy193
Oseltamivir Monotherapy184
Combination Therapy14

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qPCR Viral Shedding

Median, 25% and 75% percentile of the value of viral shedding (Results = LOD, NCT01227967)
Timeframe: At Day 0, 3 and 7

,
InterventionLog10 copies/mL (Median)
Day 0Day 3Day 7
Combination Therapy6.43.43.2
Oseltamivir Monotherapy6.73.93.2

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Time to Feeling as Good as Before the Onset of the Influenza Illness

Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered. (NCT01227967)
Timeframe: From treatment initiation to Day 28

InterventionDays (Median)
Combination Therapy7.5
Oseltamivir Monotherapy6.5

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Percentage of Participants Who Required Hospitalization.

The percentage of participants hospitalized by 28 days was estimated from the Kaplan-Meier curves. (NCT01227967)
Timeframe: From treatment initiation to Day 28

Interventionpercentage of participants analyzed (Number)
Combination Therapy4.28
Oseltamivir Monotherapy0.98

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28-day Mortality

Number of deaths (NCT01227967)
Timeframe: From treatment initiation to Day 28

Interventionparticipants (Number)
Combination Therapy0
Oseltamivir Monotherapy1

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Time to Resolution of All Symptoms AND Fever

The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever >=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated. (NCT01227967)
Timeframe: From treatment initiation to Day 28

InterventionDays (Median)
Combination Therapy4.5
Oseltamivir Monotherapy4.5

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Time to Return of Physical Function to Pre-illness Leve

Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment).For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated. (NCT01227967)
Timeframe: From treatment initiation to Day 28

InterventionDays (Median)
Combination Therapy7.0
Oseltamivir Monotherapy6.0

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Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen

Percentage of participants who required new or increased use of supplemental oxygen (NCT01227967)
Timeframe: From treatment initiation to Day 28

Interventionpercentage of participants analyzed (Number)
Combination Therapy1.91
Oseltamivir Monotherapy1.6

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Percentage of Participants With Clinical Failure at Day 5

Clinical failure at Day 5 is defined as the need for continued (non-study) antiviral use after Day 5. (NCT01227967)
Timeframe: From treatment initiation to Day 28

Interventionpercentage of participants analyzed (Number)
Combination Therapy7.0
Oseltamivir Monotherapy7.7

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Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs

The central laboratory performed a qualitative PCR test on the NP sample from Day 0 in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding. (NCT01227967)
Timeframe: At Day 3

Interventionpercentage of participants analyzed (Number)
Combination Therapy40
Oseltamivir Monotherapy50

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Time to Absence of Fever

Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated. (NCT01227967)
Timeframe: From treatment initiation to Day 28

InterventionDays (Median)
Combination Therapy0.5
Oseltamivir Monotherapy0.5

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Time to Alleviation of Influenza Clinical Symptoms.

The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1 (mild). A measurement is considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements are obtained per day) and then the daily assessment thereafter. Time will then be calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfy this criterion, then the duration will be set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated. (NCT01227967)
Timeframe: From treatment initiation to Day 28

InterventionDays (Median)
Combination Therapy4.5
Oseltamivir Monotherapy4.0

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Time to Return to Pre-influenza Function

Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered. (NCT01227967)
Timeframe: From treatment initiation to Day 28

InterventionDays (Median)
Combination Therapy7.0
Oseltamivir Monotherapy6.0

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Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.

Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above. (NCT01227967)
Timeframe: From treatment initiation to Day 28

,
Interventionpercentage of participants analyzed (Number)
SinustisOtitis MediaBronchitis BronchiolitisPneumoniaAntibiotic use for other reasonsAt least one complication and/or use of antibiotic
Combination Therapy4.50.35.72.28.616.6
Oseltamivir Monotherapy4.51.03.51.99.315.4

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Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)

The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between). (NCT01241760)
Timeframe: End of trial, 72 weeks after the start of study medication

Interventionpercentage of participants with response (Number)
T12(q8h)/PR69.0
T12(b.i.d.)/PR70.2

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Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs

The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL. (NCT01241760)
Timeframe: Week 4, 12, 24, 32, 40

Interventionpercentage of participants (Number)
T12(q8h)/PR9.7
T12(b.i.d.)/PR10.3

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)

The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). (NCT01241760)
Timeframe: End of trial, 12 weeks after last planned dose

Interventionpercentage of participants with response (Number)
T12(q8h)/PR72.8
T12(b.i.d.)/PR74.3

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Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)

The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12. (NCT01241760)
Timeframe: End of trial, 24 weeks after last planned dose

Interventionpercentage of participants with response (Number)
T12(q8h)/PR72.8
T12(b.i.d.)/PR74.8

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Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)

The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned. (NCT01241760)
Timeframe: End of trial, 12 weeks after the last planned dose

,
Interventionpercentage of participants with response (Number)
CC genotype (n = 108; n = 103)CT genotype (n = 207; n = 207)TT genotype (n = 56; n = 59)
T12(b.i.d.)/PR92.467.565.5
T12(q8h)/PR86.867.864.9

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Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.

The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study. (NCT01241760)
Timeframe: Baseline, Week 4 and Week 4+12.

,
Interventionpercentage of participants with response (Number)
Baselineat Week 4at Week 4 and Week 12
T12(b.i.d.)/PR069.466.1
T12(q8h)/PR067.463.1

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Percentage of Participants Who Relapsed During Follow-up Period

The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment). (NCT01241760)
Timeframe: During Follow-Up (24 weeks after the last dose of study drug)

Interventionpercentage of participants (Number)
T12(q8h)/PR7.2
T12(b.i.d.)/PR7.7

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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2

SVR12 was defined as undetectable HCV RNA (HCV RNA NCT01257204)
Timeframe: Follow-up Week 12

Interventionpercentage of participants (Number)
Daclatasvir, 60 mg, 12-Week Cohort87.5
Daclatasvir, 60 mg, 16-Week Cohort82.6
Placebo70.8

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Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3

RVR was defined as undetectable HCV RNA (HCV RNA NCT01257204)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Daclatasvir, 60 mg, 12-Week Cohort84.6
Daclatasvir, 60 mg, 16-Week Cohort74.1
Placebo37.0

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Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2

RVR was defined as undetectable HCV RNA (HCV RNA NCT01257204)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Daclatasvir, 60 mg, 12-Week Cohort87.5
Daclatasvir, 60 mg, 16-Week Cohort73.9
Placebo41.7

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Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3

cEVR was defined as undetectable HCV RNA (HCV RNA NCT01257204)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Daclatasvir, 60 mg, 12-Week Cohort80.8
Dacalatasvir, 60 mg, 16-Week Cohort88.9
Placebo59.3

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Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2

cEVR was defined as undetectable HCV RNA (HCV RNA NCT01257204)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Daclatasvir, 60 mg, 12-Week Cohort91.7
Daclatasvir, 60 mg, 16-Week Cohort82.6
Placebo75.0

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Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3

"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA NCT01257204)
Timeframe: Baseline up to Week 48

,,
Interventionparticipants (Number)
Virologic breakthrough (n=26,27,27)<1 log10 decrease in HCV RNA at Week4 (n=26,27,27)HCV RNA ≥LLOQ or Relapse (n=25,24,21)
Daclatasvir, 60 mg, 12-Week Cohort0016
Daclatasvir, 60 mg, 16-Week Cohort0126
Placebo1333

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Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2

"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA NCT01257204)
Timeframe: Baseline up to Week 48

,,
Interventionparticipants (Number)
Virologic breakthrough (n=24,23,24)<1 log10 decrease in HCV RNA at Week4 (n=24,23,24)HCV RNA ≥LLOQ or Relapse (n=23,21,22)
Daclatasvir, 60 mg, 12-Week Cohort0011
Daclatasvir, 60 mg, 16-Week Cohort1120
Placebo1012

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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT01257204)
Timeframe: From end of treatment period up to Week 48 (follow-up period)

,,
Interventionparticipants (Number)
AEsSAEsDeaths
Daclatasvir, 60 mg, 12-Week Cohort: Follow-up1620
Daclatasvir, 60 mg, 16-Week Cohort: Follow-up1200
Placebo: Follow-up1100

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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3

SVR24 was defined as undetectable HCV RNA (HCV RNA NCT01257204)
Timeframe: Follow-up Week 24

Interventionpercentage of participants (Number)
Daclatasvir, 60 mg, 12-Week Cohort69.2
Daclatasvir, 60 mg, 16-Week Cohort66.7
Placebo59.3

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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2

SVR24 was defined as undetectable HCV RNA (HCV RNA NCT01257204)
Timeframe: Follow-up Week 24

Interventionpercentage of participants (Number)
Daclatasvir, 60 mg, 12-Week Cohort83.3
Daclatasvir, 60 mg, 16-Week Cohort82.6
Placebo62.5

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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3

SVR12 was defined as undetectable HCV RNA (HCV RNA NCT01257204)
Timeframe: Follow-up Week 12

Interventionpercentage of participants (Number)
Daclatasvir, 60 mg, 12-Week Cohort69.2
Daclatasvir, 60 mg, 16-Week Cohort77.8
Placebo51.9

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Number of Participants With Any Adverse Events and Any Serious Adverse Events

An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT01258101)
Timeframe: Up to Week 48

,,,
InterventionNumber of Participants (Number)
Any AEAny SAE
Peginterferon/Ribavirin 400 mg (16 Weeks)452
Peginterferon/Ribavirin 400 mg (24 Weeks)13818
Peginterferon/Ribavirin 800 mg (16 Weeks)290
Peginterferon/Ribavirin 800 mg (24 Weeks)13912

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Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment

Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24. (NCT01258101)
Timeframe: At Week 16 and Week 24

,,,
InterventionPercentage of participants (Number)
G2, W16, Virologic Response (n=14,13,3,3)G2, W24, Virologic Response (n=14,13,3,3)G3, W16,Virologic Response (n=101,97,18,23)G3, W24,Virologic Response (n=101,97,18,23)
Peginterferon/Ribavirin 400 mg (16 Weeks)1000.01000.0
Peginterferon/Ribavirin 400 mg (24 Weeks)0.01000.096.9
Peginterferon/Ribavirin 800 mg (16 Weeks)66.70.01000.0
Peginterferon/Ribavirin 800 mg (24 Weeks)0.092.90.099.0

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Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48

Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0. (NCT01258101)
Timeframe: At Baseline (Week 0) and Weeks 16, 24 and 48

,,,
InterventionScore on a scale (Mean)
G2, BS, Physical Functioning (n=14,13,3,3)G2, W16, Physical Functioning (n=14,13,3,3)G2, W24 Physical Functioning (n=14,13,3,3)G2,W48, Physical Functioning, (n=14,13,3,3)G3, BS, Physical Functioning (n=101,97,18,23)G3, W16, Physical Functioning (n=101,97,18,23)G3, W24, Physical Functioning (n=101,97,18,23)G3, W48, Physical Functioning (n=101,97,18,23)G2, BS,Role Functioning Physical (n=14,13,3,3)G2,W16,Role Functioning Physical (n=14,13,3,3)G2,W24,Role Functioning Physical (n=14,13,3,3)G2,W48,Role Functioning Physical (n=14,13,3,3)G3, BS,Role Functioning Physical (n=101,97,18,23)G3,W16,Role Functioning Physical (n=101,97,18,23)G3,W24,Role Functioning Physical (n=101,97,18,23)G3,W48,Role Functioning Physical (n=101,97,18,23)G2, BS, Bodily Pain (n=14,13,3,3)G2,W16, Bodily Pain (n=14,13,3,3)G2, W24, Bodily Pain (n=14,13,3,3)G2, W48, Bodily Pain (n=14,13,3,3)G3, BS, Bodily Pain (n=101,97,18,23)G3, W16, Bodily Pain (n=101,97,18,23)G3, W24, Bodily Pain(n=101,97,18,23)G3,W48, Bodily Pain (n=101,97,18,23)G2,BS, General Health (n=14,13,3,3)G2,W16,General Health (n=14,13,3,3)G2, W24, General Health (n=14,13,3,3)G2,W48, General Health (n=14,13,3,3)G3, BS, General Health (n=101,97,18,23)G3, W16, General Health (n=101,97,18,23)G3, W24, General Health (n=101,97,18,23)G3, W48, General Health (n=101,97,18,23)G2, BS, Vitality (n=14,13,3,3)G2,W16, Vitality (n=14,13,3,3)G2, W24, Vitality (n=14,13,3,3)G2,W48, Vitality (n=14,13,3,3)G3,BS, Vitality (n=101,97,18,23)G3,W16, Vitality (n=101,97,18,23)G3,W24, Vitality (n=101,97,18,23)G3, W48, Vitality (n=101,97,18,23)G2, BS, Social Functioning (n=14,13,3,3)G2, W16, Social Functioning (n=14,13,3,3)G2,W24, Social Functioning (n=14,13,3,3)G2,W48, Social Functioning (n=14,13,3,3)G3,BS, Social Functioning (n=101,97,18,23)G3, W16, Social Functioning (n=101,97,18,23)G3,W24, Social Functioning (n=101,97,18,23)G3, W48, Social Functioning (n=101,97,18,23)G2, BS, Role Functioning Emotional (n=14,13,3,3)G2,W16, Role Functioning Emotional (n=14,13,3,3)G2,W24, Role Functioning Emotional (n=14,13,3,3)G2,W48, Role Functioning Emotional (n=14,13,3,3)G3,BS,Role Functioning Emotional (n=101,97,18,23)G3,W16,Role Functioning Emotional (n=101,97,18,23)G3,W24,Role Functioning Emotional (n=101,97,18,23)G3,W48,Role Functioning Emotional (n=101,97,18,23)G2,BS, Mental Health (n=14,13,3,3)G2,W16, Mental Health (n=14,13,3,3)G2,W24, Mental Health (n=14,13,3,3)G2,W48, Mental Health (n=14,13,3,3)G3,BS, Mental Health (n=101,97,18,23)G3,W16, Mental Health (n=101,97,18,23)G3,W24, Mental Health (n=101,97,18,23)G3, W48, Mental Health (n=101,97,18,23)G2,BS,Reported Health Transition (n=14,13,3,3)G2,W16,Reported Health Transition (n=14,13,3,3)G2,W24,Reported Health Transition (n=14,13,3,3)G2,W48,Reported Health Transition (n=14,13,3,3)G3,BS,Reported Health Transition (n=101,97,18,23)G3,W16,Reported Health Transition (n=101,97,18,23)G3,W24,Reported Health Transition (n=101,97,18,23)G3,W48,Reported Health Transition (n=101,97,18,23)
Peginterferon/Ribavirin 400 mg (16 Weeks)69.463.3NA85.077.969.8NA87.950.041.7NA87.575.061.8NA81.361.054.3NA81.083.670.2NA81.951.049.0NA43.561.163.6NA63.035.030.6NA45.049.443.5NA60.156.358.3NA81.384.766.9NA78.750.044.4NA83.368.560.8NA79.258.049.3NA70.059.655.5NA64.13.03.0NA2.52.82.9NA2.2
Peginterferon/Ribavirin 400 mg (24 Weeks)87.9NA79.081.085.9NA79.889.788.9NA50.088.973.9NA63.685.583.0NA55.584.082.9NA71.587.766.3NA67.276.061.7NA59.570.562.2NA39.563.951.9NA45.558.793.8NA76.386.177.2NA72.181.688.9NA43.385.273.2NA57.484.273.2NA64.876.167.8NA63.268.83.0NA3.71.92.9NA2.71.9
Peginterferon/Ribavirin 800 mg (16 Weeks)76.763.3NA82.587.281.1NA88.975.016.7NA87.583.361.1NA91.771.061.3NA81.073.069.6NA84.162.342.3NA53.556.958.3NA70.243.325.0NA57.551.746.1NA70.675.050.0NA81.386.163.9NA87.577.833.3NA100.070.463.0NA88.957.342.7NA58.563.656.4NA68.03.74.0NA2.02.93.3NA2.3
Peginterferon/Ribavirin 800 mg (24 Weeks)87.8NA73.580.690.6NA79.691.672.2NA57.556.381.2NA60.490.578.6NA74.076.185.5NA76.789.560.4NA63.276.367.2NA68.173.958.1NA38.558.155.8NA46.963.480.6NA63.889.183.8NA68.886.674.1NA56.760.483.1NA61.090.966.5NA59.266.369.2NA63.070.52.7NA2.61.82.8NA3.01.7

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Mean FSS Scores at Baseline and Weeks 16, 24 and 48

The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0. (NCT01258101)
Timeframe: At Baseline (Week 0) and Weeks 16, 24 and 48

,,,
InterventionScore on a scale (Mean)
G2, BS (n=14,13,3,3)G2, W16 (n=14,13,3,3)G2, W24 (n=14,13,3,3)G2, W48 (n=14,13,3,3)G3,BS(n=101,97,18,23)G3, W16, (n=101,97,18,23)G3, W24 (n=101,97,18,23)G3, W48 (n=101,97,18,23)
Peginterferon/Ribavirin 400 mg (16 Weeks)3.93.7NA3.23.54.3NA3.7
Peginterferon/Ribavirin 400 mg (24 Weeks)3.4NA4.43.53.8NA4.13.2
Peginterferon/Ribavirin 800 mg (16 Weeks)4.96.2NA4.53.44.0NA2.4
Peginterferon/Ribavirin 800 mg (24 Weeks)3.5NA4.43.43.6NA4.13.0

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Median Hemoglobin Levels at End of Treatment

Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was >=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day. (NCT01258101)
Timeframe: At Week 16 and Week 24

,,,
Interventiong/L (Median)
At Week 16At Week 24
Peginterferon/Ribavirin 400 mg (16 Weeks)131.00NA
Peginterferon/Ribavirin 400 mg (24 Weeks)131.00130.00
Peginterferon/Ribavirin 800 mg (16 Weeks)129.50NA
Peginterferon/Ribavirin 800 mg (24 Weeks)123.00124.00

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Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48

"Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0." (NCT01258101)
Timeframe: At Baseline (Week 0) and Weeks 16, 24 and 48

,,,
InterventionScore on a scale (Mean)
G2 ,BL, BS (n=14,13,3,3)G2, BL,W4 (n=14,13,3,3)G2, BL, W8 (n=14,13,3,3)G2, BL, W12 (n=14,13,3,3)G2, BL,W24 (n=14,13,3,3)G2, BL,W48 (n=14,13,3,3)G3, BL,BS(n=101,97,18,23)G3, BL,W4 (n=101,97,18,23)G3, BL,W8 (n=101,97,18,23)G3, BL,W12 (n=101,97,18,23)G3,BL,W24 (n=101,97,18,23)G3,BL,W48 (n=101,97,18,23)
Peginterferon/Ribavirin 400 mg (16 Weeks)NA3.8NANANA4.03.3NA3.73.0NA3.3
Peginterferon/Ribavirin 400 mg (24 Weeks)3.43.33.63.33.23.43.33.03.03.13.23.5
Peginterferon/Ribavirin 800 mg (16 Weeks)3.0NANA3.0NA3.23.2NA2.63.2NA3.4
Peginterferon/Ribavirin 800 mg (24 Weeks)3.33.13.43.52.93.43.33.43.33.23.23.6

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Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48

For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0. (NCT01258101)
Timeframe: At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48

,,,
InterventionScore on a scale (Mean)
G2,BDI,BS (n=14,13,3,3)G2,BDI,W4 (n=14,13,3,3)G2,BDI,W8 (n=14,13,3,3)G2,BDI,W12 (n=14,13,3,3)G2,BDI,W24 (n=14,13,3,3)G2,BDI,W48 (n=14,13,3,3)G3,BDI,BS (n=101,97,18,23)G3,BDI,W4 (n=101,97,18,23)G3,BDI,W8 (n=101,97,18,23)G3,BDI,W12 (n=101,97,18,23)G3,BDI,W24 (n=101,97,18,23)G3,BDI,W48 (n=101,97,18,23)
Peginterferon/Ribavirin 400 mg (16 Weeks)NA3.0NANANA1.07.0NANA15.0NA6.6
Peginterferon/Ribavirin 400 mg (24 Weeks)5.48.83.08.57.64.08.910.812.711.49.06.7
Peginterferon/Ribavirin 800 mg (16 Weeks)9.0NANA8.0NA4.08.0NA20.04.8NA5.4
Peginterferon/Ribavirin 800 mg (24 Weeks)8.210.710.08.011.53.87.17.98.27.88.03.6

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Time to Viral Response

Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 [in days]. Mean of number of days to viral response for overall population were reported. (NCT01258101)
Timeframe: Up to Week 48

InterventionDays (Mean)
Peginterferon/Ribavirin 800 mg (24 Weeks)165.1
Peginterferon/Ribavirin 400 mg (24 Weeks)165.0
Peginterferon/Ribavirin 800 mg (16 Weeks)114.5
Peginterferon/Ribavirin 400 mg (16 Weeks)122.8

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Percentage of Participants With Virological Response at the End of the Treatment

Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24. (NCT01258101)
Timeframe: At Week 16 and Week 24

InterventionPercentage of participants (Number)
Peginterferon/Ribavirin 800 mg (24 Weeks)98.3
Peginterferon/Ribavirin 400 mg (24 Weeks)97.3
Peginterferon/Ribavirin 800 mg (16 Weeks)95.2
Peginterferon/Ribavirin 400 mg (16 Weeks)100

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Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment

Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment. (NCT01258101)
Timeframe: Up to Week 48 (24 weeks post completion of the treatment)

InterventionPercentage of participants (Number)
Peginterferon/Ribavirin 800 mg (24 Weeks)80.9
Peginterferon/Ribavirin 400 mg (24 Weeks)78.2
Peginterferon/Ribavirin 800 mg (16 Weeks)81.0
Peginterferon/Ribavirin 400 mg (16 Weeks)61.5

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Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48

Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively. (NCT01258101)
Timeframe: At Week 24 and Week 48

,,,
InterventionPercentage of participants (Number)
G2, W24, HCV-RNA Positive (n=14,13,3,3)G2, W24, HCV-RNA Negative (n=14,13,3,3)G2, W48, HCV-RNA Positive (n=14,13,3,3)G2, W48, HCV-RNA Negative (n=14,13,3,3)G3, W24, HCV-RNA Positive (n=101,97,18,23)G3, W24, HCV-RNA Negative (n=101,97,18,23)G3, W48, HCV-RNA Positive (n=101,97,18,23)G3, W48, HCV-RNA Negative (n=101,97,18,23)
Peginterferon/Ribavirin 400 mg (16 Weeks)0.00.033.366.70.00.039.160.9
Peginterferon/Ribavirin 400 mg (24 Weeks)0.010023.176.93.196.921.678.4
Peginterferon/Ribavirin 800 mg (16 Weeks)0.00.066.733.30.00.011.188.9
Peginterferon/Ribavirin 800 mg (24 Weeks)7.192.97.192.91.099.020.879.2

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Sustained Virologic Response

sustained virological response is defined as a negative HCV PCR at 180 days after the end of treatment (End of treatment being at 48 weeks for Group A, 52 weeks for Group B). For any patient who stopped treatment prematurely (e.g. due to adverse events) SVR was defined as a negative HCV PCR (polymerase chain reaction) at 180 days after the last dose of all medications (interferon, ribavirin and nitazoxanide) (NCT01276756)
Timeframe: 180 days (+- 7 days) after the end of treatment. (48 weeks for Group A, 52 weeks for Group B, or after the last dose of treatment for patients who stopped prematurely).

Interventionparticipants (Number)
Standard of Care24
Triple Therapy25

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Early Virological Response

"A complete early virologic response is defined as a negative HCV PCR 90 days after the start of pegylated interferon.~A partial early virologic response is defined as a decrease of 2 or more log in HCV PCR at 90 days after the start of pegylated interferon" (NCT01276756)
Timeframe: 90 ± 7 days from the start of pegylated interferon and ribavirin

,
Interventionparticipants (Number)
Complete early virologic responsePartial early virologic responseNo early virologic response response
Standard of Care35510
Triple Therapy36014

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Rapid Virological Response

A rapid virologic response is defined as a negative HCV PCR 4 weeks after treatment (NCT01276756)
Timeframe: 28 - 33 days after start of Pegylated interferon and ribavirin

Interventionparticipants (Number)
Standard of Care30
Triple Therapy25

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Safety of Nitazoxanide (Number of Participants Experiencing Adverse Events)

The occurence of adverse events that could be linked temporally and reasonably to the administration of the tested drug. (NCT01276756)
Timeframe: throughout the period of treatment and up to 90 days after end of triple therapy

Interventionparticipants (Number)
Standard of Care50
Triple Therapy47

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End-of-treatment Response

An end-of-treatment response is defined as a negative HCV PCR at 48 weeks after the start of pegylated interferon and ribavirin (NCT01276756)
Timeframe: 48 weeks +- 7 days after starting pegylated interferon and ribavirin

Interventionparticipants (Number)
Standard of Care31
Triple Therapy29

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Number of Participants With Any Adverse Events and Any Serious Adverse Events

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. (NCT01280656)
Timeframe: Up to Week 72

,,
Interventionparticipants (Number)
any AEany SAE
Conventional Interferon Plus Ribavirin572
Peginterferon Alfa-2a Plus Ribavirin28515
Peginterferon Alfa-2b Plus Ribavirin2649

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Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment

The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy. (NCT01280656)
Timeframe: Up to Week 48

,,
Interventionpercentage of participants (Number)
At the site (n=0,98,126)At home (n=55,204,137)
Conventional Interferon Plus RibavirinNA5.5
Peginterferon Alfa-2a Plus Ribavirin17.411.8
Peginterferon Alfa-2b Plus Ribavirin17.521.9

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Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders

The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders. (NCT01280656)
Timeframe: Up to Week 72

,,
Interventionmean percentage reduction of hemoglobin (Mean)
Responders (n=0,19,15)Non-responders (n=10,54,48)
Conventional Interferon Plus RibavirinNA18.3
Peginterferon Alfa-2a Plus Ribavirin14.49.8
Peginterferon Alfa-2b Plus Ribavirin15.812.6

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Percentage of Participants With Virologic Response at End of Treatment

Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48. (NCT01280656)
Timeframe: At Week 48

Interventionpercentage of participants (Number)
Conventional Interferon Plus Ribavirin25.8
Peginterferon Alfa-2a Plus Ribavirin40.4
Peginterferon Alfa-2b Plus Ribavirin35.3

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Percentage of Participants With Virologic Relapse up to Week 72

Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser. (NCT01280656)
Timeframe: Up to Week 72

Interventionpercentage of participants (Number)
Conventional Interferon Plus Ribavirin37.5
Peginterferon Alfa-2a Plus Ribavirin22.2
Peginterferon Alfa-2b Plus Ribavirin22.8

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Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment

SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy. (NCT01280656)
Timeframe: At Week 72

Interventionpercentage of participants (Number)
Conventional Interferon Plus Ribavirin62.5
Peginterferon Alfa-2a Plus Ribavirin74.6
Peginterferon Alfa-2b Plus Ribavirin72.3

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Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment

Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy. (NCT01280656)
Timeframe: At Week 60

Interventionpercentage of participants (Number)
Conventional Interferon Plus Ribavirin0
Peginterferon Alfa-2a Plus Ribavirin7.1
Peginterferon Alfa-2b Plus Ribavirin20.8

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Percentage of Participants With Rapid Virologic Response at Week 4

Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period. (NCT01280656)
Timeframe: At Week 4

Interventionpercentage of participants (Number)
Conventional Interferon Plus Ribavirin6.5
Peginterferon Alfa-2a Plus Ribavirin21.2
Peginterferon Alfa-2b Plus Ribavirin20.3

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Percentage of Participants With Null Response or No Responder at End of Treatment

Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48. (NCT01280656)
Timeframe: At Week 48

Interventionpercentage of participants (Number)
Conventional Interferon Plus Ribavirin74.2
Peginterferon Alfa-2a Plus Ribavirin59.6
Peginterferon Alfa-2b Plus Ribavirin64.7

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Percentage of Participants With Early Virologic Response at Week 12

An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period. (NCT01280656)
Timeframe: At Week 12

Interventionpercentage of participants (Number)
Conventional Interferon Plus Ribavirin14.5
Peginterferon Alfa-2a Plus Ribavirin37.2
Peginterferon Alfa-2b Plus Ribavirin35.0

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Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used

The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported (NCT01280656)
Timeframe: At Week 24

Interventionparticipants (Number)
Conventional Interferon Plus Ribavirin1
Peginterferon Alfa-2a Plus Ribavirin9
Peginterferon Alfa-2b Plus Ribavirin29

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Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home

The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented. (NCT01280656)
Timeframe: At Week 60 (SVR 12) and Week 72 (SVR 24)

,,
Interventionpercentage of participants (Number)
SVR-12, treated at IAC (n=0, 40, 35)SVR-12, treated at home (n=14, 81, 57)SVR-24, treated at IAC (n=0, 40, 35)SVR-24, treated at home (n=14, 81, 57)
Conventional Interferon Plus RibavirinNA0NA64.3
Peginterferon Alfa-2a Plus Ribavirin5.08.680.075.3
Peginterferon Alfa-2b Plus Ribavirin2.933.377.168.4

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Percentage of Participants Who Discontinued Treatment Due to Adverse Events

The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented. (NCT01280656)
Timeframe: Up to Week 48

Interventionpercentage of participants (Number)
Conventional Interferon Plus Ribavirin1.6
Peginterferon Alfa-2a Plus Ribavirin4.5
Peginterferon Alfa-2b Plus Ribavirin4.6

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The Percentage of Participants With Viral Breakthrough

The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable). (NCT01281839)
Timeframe: Up to Week 48

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/480.0
PBO 12Wks PR482.3

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The Percentage of Participants With Viral Relapse

The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment. (NCT01281839)
Timeframe: Up to Week 72

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4818.9
PBO 12Wks PR4850.5

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Time From End-of-treatment to Viral Relapse

The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment. (NCT01281839)
Timeframe: Up to Week 72

InterventionDays (Mean)
TMC435 150mg 12Wks PR24/48284.09
PBO 12Wks PR48115.22

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL

The table below shows mean time in days to reach HCV RNA levels <100 IU/mL. (NCT01281839)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/488
PBO 12Wks PR4885

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL

The table below shows mean time in days to reach HCV RNA levels <1000 IU/mL. (NCT01281839)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/484
PBO 12Wks PR4857

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable

The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable. (NCT01281839)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/4828
PBO 12Wks PR48141

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable

The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable. (NCT01281839)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/4814
PBO 12Wks PR48110

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Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

The table below shows change from baseline in log10 HCV RNA levels. (NCT01281839)
Timeframe: Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48

,
Interventionlog10 IU/mL (Mean)
Day 3Week 1Week 4Week 12Week 24Week 48
PBO 12Wks PR48-1.039-1.099-2.638-4.476-5.373-5.473
TMC435 150mg 12Wks PR24/48-3.537-4.535-5.295-5.404-5.449-5.635

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The Percentage of Participants With On-treatment Virologic Response at All Time Points

The table below shows the percentage of participants with HCV ribonucleic acid (RNA plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA. (NCT01281839)
Timeframe: Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42

,
InterventionPercentage of Participants (Number)
Day 3:<25 IU/mL undetectableWeek 1:<25 IU/mL undetectableWeek 2:<25 IU/mL undetectableWeek 8:<25 IU/mL undetectableWeek 16:<25 IU/mLWeek 20:<25 IU/mLWeek 28:<25 IU/mLWeek 36:<25 IU/mLWeek 42:<25 IU/mLDay 3:<25 IU/mL undetectable/detectableWeek 1:<25 IU/mL undetectable/detectableWeek 2:<25 IU/mL undetectable/detectableWeek 8:<25 IU/mL undetectable/detectableWeek 16:<25 IU/mL undetectable/detectableWeek 20:<25 IU/mL undetectable/detectableWeek 28:<25 IU/mL undetectable/detectableWeek 36:<25 IU/mL undetectable/detectableWeek 42:<25 IU/mL undetectable/detectableDay 3:<100 IU/mLWeek 1:<100 IU/mLWeek 2:<100 IU/mLWeek 8:<100 IU/mLWeek 16:<100 IU/mLWeek 20:<100 IU/mLWeek 28:<100 IU/mLWeek 36:<100 IU/mLWeek 42:<100 IU/mLDay 3:> or = 2 log10 change from baselineWeek 1:> or = 2 log10 change from baselineWeek 2:> or = 2 log10 change from baselineWeek 8:> or = 2 log10 change from baselineWeek 16:> or = 2 log10 change from baselineWeek 20:> or = 2 log10 change from baselineWeek 28:> or = 2 log10 change from baselineWeek 36:> or = 2 log10 change from baselineWeek 42:> or = 2 log10 change from baseline
PBO 12Wks PR480.800.815.047.465.584.591.991.70.80.81.527.677.689.4100.099.097.90.80.82.337.084.593.8100.0100.0100.014.113.735.487.4100.0100.0100.0100.0100.0
TMC435 150mg 12Wks PR24/4803.928.395.798.499.688.990.0100.03.135.982.698.0100.099.6100.090.0100.09.162.292.298.0100.099.6100.090.0100.097.699.699.698.4100.0100.0100.0100.0100.0

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The Percentage of Participants With Viral Breakthrough at Different Time Points

The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable). (NCT01281839)
Timeframe: Up to Week 48

,
InterventionPercentage of Participants (Number)
=<12 weeks>12-=<24 weeks>24 weeks
PBO 12Wks PR480.00.00.0
TMC435 150mg 12Wks PR24/481.90.010.0

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Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

The table below shows actual values of log10 HCV RNA levels. From Week 4 onwards, most participants in TMC 435 150mg 12Wks PR24/48 group had plasma HCV RNA levels below the limit of detection of the HCV RNA assay. (NCT01281839)
Timeframe: Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48

,
Interventionlog10 IU/mL (Mean)
Day 3Week 1Week 4Week 12Week 24Week 48
PBO 12Wks PR485.4455.3763.8382.0051.1080.995
TMC435 150mg 12Wks PR24/482.8841.8891.1281.0180.9560.954

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Median Time to Normalization of Alanine Aminotransferase (ALT) Levels

The table below shows the median time to normalization of ALT levels. (NCT01281839)
Timeframe: Up to Week 48

InterventionWeeks (Median)
TMC435 150mg 12Wks PR24/487.86
PBO 12Wks PR488.00

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Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4

The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4. (NCT01281839)
Timeframe: Week 4

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/481.9
PBO 12Wks PR4869.9

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Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)

The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours (AUC 24hr) after dosing for TMC435. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then the median of AUC value across visits for each participant was used to calculate the mean AUC 24 hr for the study. (NCT01281839)
Timeframe: From the time of administration up to 24 hours after dosing through Week 12

Interventionng*h/mL (Mean)
TMC435 150mg 12Wks PR24/4860987

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Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)

The table below shows mean (standard deviation) of C0h values of TMC435. To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then the median of C0h values across visits for each participant was used to calculate the mean C0h for the study. (NCT01281839)
Timeframe: Before administration of TMC435 through Week 12

Interventionng/mL (Mean)
TMC435 150mg 12Wks PR24/482081

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Plasma Concentration of TMC435: Systemic Clearance (CL)

The table below shows mean (standard deviation) of CL values of TMC435. To calculate the mean CL for the study, CL values were derived for each participant at each visit and then the median of CL values across visits for each participant was used to calculate the mean CL for the study. (NCT01281839)
Timeframe: From the time of administration through Week 12

InterventionL/h (Mean)
TMC435 150mg 12Wks PR24/484.92

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The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)

The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12. (NCT01281839)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4898.0
PBO 12Wks PR4827.4

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The Percentage of Participants Achieving a Early Virologic Response (EVR)

The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12. (NCT01281839)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4898.8
PBO 12Wks PR4895.2

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The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)

The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12. (NCT01281839)
Timeframe: Week 4 and Week 12

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4877.6
PBO 12Wks PR481.6

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The Percentage of Participants Achieving a Rapid Virologic Response (RVR)

The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment. (NCT01281839)
Timeframe: Week 4

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4877.2
PBO 12Wks PR483.1

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The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)

The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment. (NCT01281839)
Timeframe: Week 36 or Week 60

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4879.2
PBO 12Wks PR4836.1

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The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)

The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72. (NCT01281839)
Timeframe: Week 72

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4876.5
PBO 12Wks PR4833.8

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The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)

The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment. (NCT01281839)
Timeframe: Week 48 or Week 72

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4877.3
PBO 12Wks PR4833.8

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The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)

The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment. (NCT01281839)
Timeframe: Week 28 or Week 52

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4888.5
PBO 12Wks PR4848.1

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The Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule

The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks. (NCT01281839)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4890.0
PBO 12Wks PR480

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The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4

The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4. (NCT01281839)
Timeframe: Week 4

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/480.8
PBO 12Wks PR489.3

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The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)

The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 156 of 260 participants in the TMC435 treatment group and 84 of 133 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range. (NCT01281839)
Timeframe: Up to Week 48

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4869.9
PBO 12Wks PR4869.0

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The Percentage of Participants With Null Response

The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline. (NCT01281839)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/481.2
PBO 12Wks PR484.8

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The Percentage of Participants With On-treatment Failure

The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment. (NCT01281839)
Timeframe: Week 48

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/483.1
PBO 12Wks PR4827.1

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The Percentage of Participants With Partial Response

The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment. (NCT01281839)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
TMC435 150mg 12Wks PR24/4810.5
PBO 12Wks PR480

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The Number of Participants With Viral Breakthrough During the Study

The table below shows the number of all participants in each treatment group who experienced viral breakthrough during the treatment period in the study (Baseline to end of treatment [EOT], ie, Week 24 or 48). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in all participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable. (NCT01288209)
Timeframe: Up to EOT (Week 24 or 48)

InterventionParticipants (Number)
TMC435 100 mg 12 Wks + PR24/487
TMC435 100 mg 24 Wks + PR24/486

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The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)

The table below shows the observed percentage of participants in each treatment group with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72). (NCT01288209)
Timeframe: EOT (Week 24 or 48) and Week 48 or 72

InterventionPercentage of participants (Number)
TMC435 100 mg 12 Wks + PR24/4850.9
TMC435 100 mg 24 Wks + PR24/4835.8

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Plasma Concentrations of TMC435

"The table below shows median (range) TMC435 predose plasma concentration (C0h) values and TMC435 maximum plasma concentration (Cmax) values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of Overall representes the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the Number of Participants Analyzed." (NCT01288209)
Timeframe: Week 12, Week 24, and Overall (Weeks 4, 12, and 24)

,
Interventionng/mL (Median)
C0h (Week 12) (n=47; n=44)C0h (Week 24) (n=0; n=40)C0h (Overall) (n=53; n=53)Cmax (Week 12) (n=47; n=44)Cmax (Week 24) (n=0; n=40)Cmax (Overall) (n=53; n=53)
TMC435 100 mg 12 Wks + PR24/481844NA17843408NA3401
TMC435 100 mg 24 Wks + PR24/48910866906247624432488

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The Number of Participants Demonstrating Viral Relapse During the Study

The table below shows the number of participants in each treatment group who demonstrated viral relapse during the study. Viral relapse is defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at EOT and detectable HCV RNA during follow-up or detectable HCV RNA at the time points for a sustained viral response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement. (NCT01288209)
Timeframe: Up to 72 weeks

InterventionParticipants (Number)
TMC435 100 mg 12 Wks + PR24/4817
TMC435 100 mg 24 Wks + PR24/4823

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The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)

The table below shows the percentage of participants with undetectable HCV RNA (<1.2 log10 IU/mL) during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (Week 24 or 48). (NCT01288209)
Timeframe: Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT

,
InterventionPercentage of participants (Number)
Week 4Week 12Week 24Week 36Week 48Week 60Week 72EOT
TMC435 100 mg 12 Wks + PR24/4858.584.979.252.850.950.950.983.0
TMC435 100 mg 24 Wks + PR24/4850.979.271.735.835.835.835.884.9

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The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During Treatment for Participants Who Did Not Achieve Undetectable Plasma HCV RNA Levels at Week 12

"The table below shows the percentage of participants with undetectable HCV RNA at Weeks 24, 48, end of treatment (EOT), at the time of assessment for a sustained virologic response (SVR) 12 weeks after the last planned dose (SVR12) (Week 36 or 60), and SVR24 (Week 48 or 72) who did not achieve undetectable HCV RNA levels at Week 12. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the Number of Participants Analyzed. Results are not available for Weeks 24, 48, and EOT because there were no participants who met the criteria for a SVR at those time points." (NCT01288209)
Timeframe: Weeks 24, 48, EOT (Weeks 24 or 48), SVR12 (Weeks 36 or 60), and SVR24 (Weeks 48 or 72)

,
InterventionPercentage of participants (Number)
SVR12 (Weeks 36 or 60) (n=6; n=8)SVR24 (Weeks 48 or 72) (n=6; n=8)Week 24Week 48EOT
TMC435 100 mg 12 Wks + PR24/480.00.0NANANA
TMC435 100 mg 24 Wks + PR24/480.00.0NANANA

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The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up

The table below shows the percentage of participants in each treatment group with a greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in HCV RNA at each time point during treatment and post-treatment follow-up. (NCT01288209)
Timeframe: Day 3, Day 7, and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and Follow-up (FU) Weeks 4, 12, and 24

,
InterventionPercentage of participants (Number)
Day 3Day 7Week 2Week 3Week 4Week 8Week 12Week 16Week 20Week 24Week 28week 36Week 48Week 60Week 72EOTFU Week 4FU Week 12FU Week 24
TMC435 100 mg 12 Wks + PR24/4896.210010010010088.788.784.984.984.975.552.850.950.950.988.777.452.850.9
TMC435 100 mg 24 Wks + PR24/4896.210096.294.390.690.686.883.079.275.569.841.537.735.835.890.681.139.635.8

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Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435

"The table below shows the median (range) AUC24h values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of Overall represents the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the Number of Participants Analyzed." (NCT01288209)
Timeframe: Week 12, Week 24, and Overall (Weeks 4, 12, and 24)

,
Interventionng.h/mL (Median)
AUC24h (Week 12) (n=47; n=44)AUC24h (Week 24) (n=0; n=40)Overall (n=53; n=53)
TMC435 100 mg 12 Wks + PR24/4862993NA62313
TMC435 100 mg 24 Wks + PR24/48398673893140014

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The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)

The table below shows the observed percentage of participants in each treatment group with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60). (NCT01288209)
Timeframe: EOT (Week 24 or 48) and Week 36 or 60

InterventionPercentage of participants (Number)
TMC435 100 mg 12 Wks + PR24/4852.8
TMC435 100 mg 24 Wks + PR24/4835.8

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The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFNα-2a) and Ribavirin (RBV) at Week 24

The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2a and RBV at Week 24. Participants in the TMC435 treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48. (NCT01288209)
Timeframe: Week 24

InterventionPercentage of participants (Number)
TMC435 100 mg 12 Wks + PR24/4881.1
TMC435 100 mg 24 Wks + PR24/4873.6

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The Number Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)

The table below shows the number of participants in each treatment group with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at the EOT. At Baseline, 34/53 participants in the TMC435 100 mg 12 Wks PR 24/48 treatment group and 35/53 participants in the TMC435 100 mg 24 Wks PR 24/48 treatment group had abnormal ALT levels. (NCT01288209)
Timeframe: EOT (Week 24 or 48)

InterventionParticipants (Number)
TMC435 100 mg 12 Wks + PR24/4820
TMC435 100 mg 24 Wks + PR24/4828

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Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule

The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks. (NCT01289782)
Timeframe: Week 24

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4883
PBO 12Wks PR48NA

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The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)

The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment. (NCT01289782)
Timeframe: Week 36 or Week 60

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4879.5
PBO 12Wks PR4850

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable

The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable. (NCT01289782)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/4814
PBO 12Wks PR4885

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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment

Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants during study visits throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). An area under the curve (AUC) analysis compared the overall WPAI Overall Work Productivity Scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the WPAI Overall Work Productivity Scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI Work Productivity Scores and the statistical comparison between treatment groups. (NCT01289782)
Timeframe: Baseline to Week 60 and Week 72

,
Interventionscores on a scale*weeks (Least Squares Mean)
Week 60Week 72
PBO 12Wks PR481785.6681966.449
TMC435 150mg 12Wks PR24/481555.2041718.241

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Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

The table below shows actual values of log10 HCV RNA levels. (NCT01289782)
Timeframe: Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48

,
Interventionlog10 IU/mL (Mean)
Day 3Week 1Week 4Week 12Week 24Week 48
PBO 12Wks PR485.3515.2023.7232.1111.3340.961
TMC435 150mg 12Wks PR24/482.9141.9731.2231.0901.1130.993

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Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4

The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4. (NCT01289782)
Timeframe: Week 4

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/484.5
PBO 12Wks PR4863.8

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The Percentage of Participants Achieving a Early Virologic Response (EVR)

The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12. (NCT01289782)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4899.2
PBO 12Wks PR4885.2

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The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)

The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12. (NCT01289782)
Timeframe: Week 4 and 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4878.9
PBO 12Wks PR4811.7

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The Percentage of Participants Achieving a Rapid Virologic Response (RVR)

The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment. (NCT01289782)
Timeframe: Week 4

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4879.5
PBO 12Wks PR4811.8

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The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)

The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72. (NCT01289782)
Timeframe: Week 72

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4878.4
PBO 12Wks PR4849.2

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The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)

The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment. (NCT01289782)
Timeframe: Week 48 or Week 72

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4879.5
PBO 12Wks PR4849.2

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Time From End-of-treatment to Viral Relapse

The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment. (NCT01289782)
Timeframe: Up to Week 72

InterventionDays (Mean)
TMC435 150mg 12Wks PR24/48100.96
PBO 12Wks PR48146.04

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The Percentage of Participants With Viral Breakthrough at Different Time Points

The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable). (NCT01289782)
Timeframe: Up to Week 48

,
InterventionPercentage of participants (Number)
< 12 WeeksWeek 12 - Week 24> Week 24
PBO 12Wks PR481.56.81.2
TMC435 150mg 12Wks PR24/482.72.50

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Percentage of Participants With On-treatment Virologic Response at All Time Points

The table below shows the percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, < 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA. (NCT01289782)
Timeframe: Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42

,
InterventionPercentage of participants (Number)
Day 3:<25 IU/mL undetectableWeek 1:<25 IU/mL undetectableWeek 2:<25 IU/mL undetectableWeek 8:<25 IU/mL undetectableWeek 16:<25 IU/mL undetectableWeek 20:<25 IU/mL undetectableWeek 28:<25 IU/mL undetectableWeek 36:<25 IU/mL undetectableWeek 42:<25 IU/mL undetectableDay 3:<25 IU/mL undetectable/detectableWeek 1:<25 IU/mL undetectable/detectableWeek 2:<25 IU/mL undetectable/detectableWeek 8:<25 IU/mL undetectable/detectableWeek 16:<25 IU/mL undetectable/detectableWeek 20:<25 IU/mL undetectable/detectableWeek 28:<25 IU/mL undetectable/detectableWeek 36:<25 IU/mL undetectable/detectableWeek 42:<25 IU/mL undetectable/detectableDay 3:<100 IU/mLWeek 1:<100 IU/mLWeek 2:<100 IU/mLWeek 8:<100 IU/mLWeek 16:<100 IU/mLWeek 20:<100 IU/mLWeek 28:<100 IU/mLWeek 36:<100 IU/mLWeek 42:<100 IU/mLDay 3:> or = 2 log10 change from baselineWeek 1:> or = 2 log10 change from baselineWeek 2:> or = 2 log10 change from baselineWeek 8:> or = 2 log10 change from baselineWeek 16:> or = 2 log10 change from baselineWeek 20:> or = 2 log10 change from baselineWeek 28:> or = 2 log10 change from baselineWeek 36:> or = 2 log10 change from baselineWeek 42:> or = 2 log10 change from baseline
PBO 12Wks PR480.80.82.326.269.278.296.3100.098.70.82.36.340.582.784.298.8100.0100.01.63.17.846.084.686.198.8100.0100.013.320.235.280.299.097.097.598.798.7
TMC435 150mg 12Wks PR24/480.46.635.890.093.893.490.990.990.92.436.876.794.095.495.0100.0100.0100.011.462.885.294.896.796.7100.0100.0100.095.398.198.898.4100.098.3100.0100.0100.0

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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment

Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. Scores ranged from 0 (no effect on activities) to 10 (completely prevented me from doing my daily activities). An area under the curve (AUC) analysis compared the impairment in daily activity scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in impairment in daily activity scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in the impairment in daily activity scores and the statistical comparison between treatment groups. (NCT01289782)
Timeframe: Baseline to Week 60 and Week 72

,
Interventionscores on a scale*weeks (Least Squares Mean)
Week 60Week 72
PBO 12Wks PR481792.4601975.457
TMC435 150mg 12Wks PR24/481514.4001667.735

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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores

Study participants completed FSS questionnaires during study visits before treatment began and throughout treatment and follow-up to rate the severity and impact of fatigue they experienced in the preceding 2 weeks on their daily lives. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst possible fatigue]. An area under the curve (AUC) analysis compared the overall severity of fatigue in each treatment group from baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the amount of fatigue participants experienced throughout the study resulting in equal AUC from baseline to Week 72 (AUC72) for FSS total scores. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups. (NCT01289782)
Timeframe: Baseline to Week 60 and Week 72

,
Interventionscores on a scale*weeks (Least Squares Mean)
Week 60Week 72
PBO 12Wks PR48235.586274.322
TMC435 150mg 12Wks PR24/48214.907250.522

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Plasma Concentration of TMC435: Systemic Clearance (CL)

The table below shows the mean (standard deviation) values for the CL of TMC435.To calculate the mean CL for all participants in the study, CL values were first derived for each participant at each visit and then a median CL value calculated across visits for each participant. The median CL value for each participant was used to calculate the mean CL for all participants in the study. (NCT01289782)
Timeframe: Across Weeks 2, 4, 8, and 12

InterventionL/h (Mean)
TMC435 150mg 12Wks PR24/485.05

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Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)

The table below shows the mean (standard deviation) values for the C0h of TMC435.To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then a median C0H value calculated across visits for each participant. The median COh value for each participant across all visits was used to calculate the mean C0h for the study. (NCT01289782)
Timeframe: Before administration of TMC435 at Weeks 2, 4, 8, and 12

Interventionng/mL (Mean)
TMC435 150mg 12Wks PR24/481825

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Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)

The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 for all participants. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then a median AUC value calcuated across all visits for each participant. The median AUC value across all visits for each participant was used to calculate the mean AUC 24 hr all participants in the study. (NCT01289782)
Timeframe: Fom the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12

Interventionng*h/mL (Mean)
TMC435 150mg 12Wks PR24/4854795

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Percentage of Participants With Viral Relapse

The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment. (NCT01289782)
Timeframe: Up to Week 72

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/489.0
PBO 12Wks PR4822.6

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Percentage of Participants With Viral Breakthrough

The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable). (NCT01289782)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/484.9
PBO 12Wks PR487.7

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The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4

The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4. (NCT01289782)
Timeframe: Week 4

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/480
PBO 12Wks PR4815.7

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Percentage of Participants With Partial Response

The table below shows the percentage of participants with partial response, defined as greater than or equal to 2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment. (NCT01289782)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/483.2
PBO 12Wks PR4813.1

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Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

The table below shows the change from baseline in log10 HCV RNA levels. (NCT01289782)
Timeframe: Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48

,
Interventionlog10 IU/mL (Mean)
Day 3Week 1Week 4Week 12Week 24Week 48
PBO 12Wks PR48-0.93-1.08-2.56-4.18-4.89-5.23
TMC435 150mg 12Wks PR24/48-3.52-4.47-5.22-5.34-5.32-5.33

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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) in Work Productivity and Activity (WPAI) Absenteeism Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment

Time missed from work in hours because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work, question #2). The number of hours missed from work because of HCV was divided by the total number of hours supposed to work, and expressed as a percentage. An area under the curve (AUC) analysis compared the WPAI absenteeism scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms WPAI absenteeism scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI absenteeism scores and the statistical comparison between treatment groups. (NCT01289782)
Timeframe: Baseline to Week 60 and Week 72

,
Interventionscores on a scale*weeks (Least Squares Mean)
Week 60Week 72
PBO 12Wks PR48400.771430.285
TMC435 150mg 12Wks PR24/48447.170487.449

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The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)

The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12. (NCT01289782)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4892.8
PBO 12Wks PR4850.8

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The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)

The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 158 of 264 participants in the TMC435 treatment group and 89 of 130 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range. (NCT01289782)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4881.0
PBO 12Wks PR4877.5

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL

The table below shows median time in days to reach HCV RNA levels <100 IU/mL. (NCT01289782)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/4828
PBO 12Wks PR4884

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The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)

The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment. (NCT01289782)
Timeframe: Week 28 or Week 52

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4882.2
PBO 12Wks PR4856.2

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL

The table below shows median time in days to reach HCV RNA levels <1000 IU/mL. (NCT01289782)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/484
PBO 12Wks PR4856.5

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Percentage of Participants With Null Response

The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline. (NCT01289782)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/480.8
PBO 12Wks PR4814.8

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable

The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable. (NCT01289782)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/4828
PBO 12Wks PR48111

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Median Time to Normalization of Alanine Aminotransferase (ALT) Levels

The table below shows the median time in weeks to normalization of ALT levels. (NCT01289782)
Timeframe: Up to Week 48

InterventionWeeks (Median)
TMC435 150mg 12Wks PR24/482.14
PBO 12Wks PR488.14

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Percentage of Participants With On-treatment Failure

The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment. (NCT01289782)
Timeframe: Week 48

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/489.1
PBO 12Wks PR4833.8

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Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)

The table below shows the mean (standard deviation) of C0h values of TMC435. NOTE: the timing of collection of blood samples post-dose for analysis at Week 2, 4, 8, and 12 was not specifed; only the interval was between blood samples was specified (ie, 2 samples collected 2 hours apart at Week 2, 4, 8, and 12). (NCT01290679)
Timeframe: Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12

Interventionng/mL (Mean)
TMC435 150mg 12Wks PR24/481902

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Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)

The table below shows the mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435. (NCT01290679)
Timeframe: At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12

Interventionng*h/mL (Mean)
TMC435 150mg 12Wks PR24/4856611

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The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)

The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 164 of 257 participants in the TMC435 treatment group and 79 of 134 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range. (NCT01290679)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4879.9
PBO 12Wks PR4881.0

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Percentage of Participants With Viral Relapse

The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment. (NCT01290679)
Timeframe: Up to Week 72

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4812.3
PBO 12Wks PR4823.9

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The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)

The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment. (NCT01290679)
Timeframe: Week 36 or Week 60

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4881.3
PBO 12Wks PR4850.0

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Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

The table below shows changes from baseline in log10 HCV RNA. (NCT01290679)
Timeframe: Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48

,
Interventionlog10 IU/mL (Mean)
Day 3Week 1Week 4Week 12Week 24Week 48
PBO 12Wks PR48-1.22-1.21-2.72-4.21-4.93-5.28
TMC435 150mg 12Wks PR24/48-3.60-4.52-5.28-5.34-5.27-5.83

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Percentage of Participants With On-treatment Virologic Response at All Time Points

The table below shows the percentage of participants with Hepatitis C Virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of HCV-Infected participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA. (NCT01290679)
Timeframe: Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42

,
InterventionPercentage of participants (Number)
Day 3:<25 IU/mL undetectableWeek 1:<25 IU/mL undetectableWeek 2:<25 IU/mL undetectableWeek 8:<25 IU/mL undetectableWeek 16:<25 IU/mL undetectableWeek 20:<25 IU/mL undetectableWeek 28:<25 IU/mL undetectableWeek 36:<25 IU/mL undetectableWeek 42:<25 IU/mL undetectableDay 3:<25 IU/mL detectable or undetectableWeek 1:<25 IU/mL detectable or undetectableWeek 2:<25 IU/mL detectable or undetectableWeek 8:<25 IU/mL detectable or undetectableWeek 16:<25 IU/mL detectable or undetectableWeek 20:<25 IU/mL detectable or undetectableWeek 28:<25 IU/mL detectable or undetectableWeek 36:<25 IU/mL detectable or undetectableWeek 42:<25 IU/mL detectable or undetectableDay 3:<100 IU/mLWeek 1:<100 IU/mLWeek 2:<100 IU/mLWeek 8:<100 IU/mLWeek 16:<100 IU/mLWeek 20:<100 IU/mLWeek 28:<100 IU/mLWeek 36:<100 IU/mLWeek 42:<100 IU/mLDay 3:> or = 2 log 10 change from baselineWeek 1:> or =2 log 10 change from baselineWeek 2:> or =2 log 10 change from baselineWeek 8:> or =2 log 10 change from baselineWeek 16:> or =2 log 10 change from baselineWeek 20:> or =2 log 10 change from baselineWeek 28:> or =2 log 10 change from baselineWeek 36:> or =2 log 10 change from baselineWeek 42:> or =2 log 10 change from baseline
PBO 12Wks PR4801.53.831.365.568.288.095.395.002.312.045.073.579.197.898.8100.01.56.014.350.477.083.697.898.8100.020.824.139.880.297.393.6100.098.8100.0
TMC435 150mg 12Wks PR24/480.46.331.793.796.395.966.7100.0100.04.737.080.798.098.097.177.8100.0100.015.365.792.098.898.898.077.8100.0100.096.999.699.699.699.298.888.9100.0100.0

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The Percentage of Participants With Viral Breakthrough at Different Time Points

The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable). (NCT01290679)
Timeframe: Up to Week 48

,
InterventionPercentage of participants (Number)
< 12 WeeksWeek 12 - Week 24> Week 24
PBO 12Wks PR483.76.42.1
TMC435 150mg 12Wks PR24/481.23.312.5

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Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

The table below shows actual values of log10 HCV RNA levels. (NCT01290679)
Timeframe: Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48

,
Interventionlog10 IU/mL (Mean)
Day 3Week 1Week 4Week 12Week 24Week 48
PBO 12Wks PR485.1655.1713.6572.1571.3880.960
TMC435 150mg 12Wks PR24/482.7771.8521.0931.0271.0941.015

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable

The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable. (NCT01290679)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/4814
PBO 12Wks PR4885

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable

The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable. (NCT01290679)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/4829
PBO 12Wks PR48113

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL

The table below shows the median time in days to reach HCV RNA levels <1000 IU/mL. (NCT01290679)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/484
PBO 12Wks PR4857

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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL

The table below shows the median time in days to reach HCV RNA levels <100 IU/mL. (NCT01290679)
Timeframe: Up to Week 48

InterventionDays (Median)
TMC435 150mg 12Wks PR24/488
PBO 12Wks PR4871

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Time From End-of-treatment to Viral Relapse

The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment. (NCT01290679)
Timeframe: Up to Week 72

InterventionDays (Mean)
TMC435 150mg 12Wks PR24/48229.77
PBO 12Wks PR4877.74

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The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)

The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72. (NCT01290679)
Timeframe: Week 72

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4878.6
PBO 12Wks PR4850.0

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The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)

The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment. (NCT01290679)
Timeframe: Week 48 or Week 72

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4880.5
PBO 12Wks PR4850.0

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The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)

The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment. (NCT01290679)
Timeframe: Week 28 or Week 52

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4884.8
PBO 12Wks PR4853.0

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The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4

The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4. (NCT01290679)
Timeframe: Week 4

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/480.4
PBO 12Wks PR4817.3

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The Percentage of Participants Achieving a Rapid Virologic Response (RVR)

The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment. (NCT01290679)
Timeframe: Week 4

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4879.2
PBO 12Wks PR4812.8

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The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)

The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12. (NCT01290679)
Timeframe: Weeks 4 and 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4878.3
PBO 12Wks PR4813.4

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The Percentage of Participants Achieving a Early Virologic Response (EVR)

The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12. (NCT01290679)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4898.8
PBO 12Wks PR4889.8

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The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)

The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12. (NCT01290679)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4896.8
PBO 12Wks PR4844.9

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Percentage of Participants With Viral Breakthrough

The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable). (NCT01290679)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/484.7
PBO 12Wks PR4810.4

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Percentage of Participants With Partial Response

The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment. (NCT01290679)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/480.4
PBO 12Wks PR4817.3

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Percentage of Participants With On-treatment Failure

The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment. (NCT01290679)
Timeframe: Week 48

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/487.0
PBO 12Wks PR4832.1

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Percentage of Participants With Null Response

The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline. (NCT01290679)
Timeframe: Week 12

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/481.2
PBO 12Wks PR4810.2

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Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4

The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4. (NCT01290679)
Timeframe: Week 4

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/481.2
PBO 12Wks PR4861.2

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Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule

The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks. (NCT01290679)
Timeframe: Week 24

InterventionPercentage of participants (Number)
TMC435 150mg 12Wks PR24/4889.5
PBO 12Wks PR48NA

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Median Time to Normalization of Alanine Aminotransferase (ALT) Levels

The table below shows the median time in weeks to normalization of ALT levels. (NCT01290679)
Timeframe: Up to Week 48

InterventionWeeks (Median)
TMC435 150mg 12Wks PR24/482.14
PBO 12Wks PR484.14

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Plasma Concentration of TMC435: Systemic Clearance (CL)

The table below shows the mean (standard deviation) of CL values of TMC435. NOTE: the pre-dose CL values taken at Weeks, 2, 4, 8, and 12 were averaged and then the mean values from all participants were averaged to provide the final value reported below. (NCT01290679)
Timeframe: At protocol-specified time points at Weeks 2, 4, 8, and 12

InterventionL/h (Mean)
TMC435 150mg 12Wks PR24/485.23

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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment

Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. The possible impairment in WPAI daily activity score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in daily activities. The average WPAI impairment in daily activity score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI impairment in daily activity score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment arms in the AUC for the change from baseline to Week 72 (AUC72) in WPAI impairment in daily activity scores. The Table below shows the WPAI Impairment in daily activity scores at Week 72 (as well as at Week 60) and the statistical analysis between treatment groups. (NCT01290679)
Timeframe: Baseline to Week 60 and Week 72

,
InterventionScores on a scale*weeks (Least Squares Mean)
Week 60Week 72
PBO 12Wks PR481863.0712056.283
TMC435 150mg 12Wks PR24/481580.6351727.079

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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment

Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). The average WPAI score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment groups in the AUC for the change from baseline to Week 72 (AUC72) in WPAI Productivity Scores. The Table below shows WPAI Productivity Scores at Week 72 (as well as at Week 60) from the model used to calculate the AUC and the statistical comparison between treatment groups. (NCT01290679)
Timeframe: Baseline to Week 60 and Week 72

,
InterventionScores on a scale*weeks (Least Squares Mean)
Week 60Week 72
PBO 12Wks PR481910.2352106.131
TMC435 150mg 12Wks PR24/481628.0751781.768

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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores

Study participants completed FSS questionnaires during study visits before treatment and throughout follow-up to rate the severity and impact of fatigue experienced in the preceding 2 weeks. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst fatigue]; the possible score range from baseline to Week 60 would be 60-420 and to Week 72 would be 72-504. The average FSS total score from baseline to Week 60 and to Week 72 was calculated for each participant and then the average of those values were calculated to show the average FSS total score for each treatment group. The null hypothesis was that there would be no difference between the treatment arms in the FSS total score. The Table below shows the lease squares (LS) mean estimates of the area under the curve (AUC) at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups. (NCT01290679)
Timeframe: Baseline to Week 60 and Week 72

,
InterventionScores on a scale*weeks (Least Squares Mean)
Week 60Week 72
PBO 12Wks PR48225.194259.532
TMC435 150mg 12Wks PR24/48208.418240.695

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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment

Hours missed from work because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work). The possible WPAI WPAI absenteeism score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in WPAI absenteeism. The average WPAI absenteeism score from baseline to Week 60/72 was calculated for each participant and then the average of those values calculated for each treatment group. The area under the curve (AUC60/AUC72) over time from baseline to Week 60/72 was derived from a piecewise-linear model allowing the slopes to change at Week 4, 12, 24, 36, 48 and 60. The null hypothesis was there is no statistically significant difference between the treatment arms in the area under the curve (AUC) from baseline to Week 72 (AUC72) in WPAI absenteeism score. (NCT01290679)
Timeframe: Baseline to Week 60 and Week 72

,
InterventionScores on a scale*weeks (Least Squares Mean)
Week 60Week 72
PBO 12Wks PR48840.495886.425
TMC435 150mg 12Wks PR24/48653.642698.223

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The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)

The table below shows the percentage of participants with undetectable HCV RNA (defined as less than 1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT [Week 24 or 48]). (NCT01290731)
Timeframe: Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT

InterventionPercentage of participants (Number)
Week 4Week 12Week 24Week 36Week 48Week 60Week 72EOT
TMC435 100 mg 12 Wks + PR24/4881.6100.095.991.889.889.889.8100.0

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Area Under the Plasma Concentration-time Curve From 0 to 24 Hrs (AUC24h) for TMC435

"The table below shows the median (range) AUC24h values for TMC435 for all participants who received TMC435 for up to 12 weeks. Overall is the median exposure estimate using all available data for each participant in the study. Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)." (NCT01290731)
Timeframe: Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)

Interventionng.h/mL (Median)
TMC435 100 mg 12 Wks + PR24/4863261

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The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)

The table below shows the number of participants with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels (defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT). At baseline, 15/49 participants had abnormal ALT levels. (NCT01290731)
Timeframe: EOT (Week 24 or 48)

InterventionParticipants (Number)
TMC435 100 mg 12 Wks + PR24/4811

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The Number of Participants With Viral Breakthrough

Viral breakthrough was defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in particpants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The table below shows that no viral breakthrough was noted in any participants during the treatment period of the study. (NCT01290731)
Timeframe: Day 1 until end of treatment (EOT [Week 24 or 48])

InterventionParticipants (Number)
TMC435 100 mg 12 Wks + PR24/480

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The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)

The table below shows the percentage of participants with an SVR12 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) 12 weeks after the last dose of treatment (Week 36 or 60). (NCT01290731)
Timeframe: Week 36 or 60

InterventionPercentage of participants (Number)
TMC435 100 mg 12 Wks + PR24/4895.9

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The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)

The table below shows the percentage of participants with a SVR24 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72). (NCT01290731)
Timeframe: Week 48 or 60

InterventionPercentage of participants (Number)
TMC435 100 mg 12 Wks + PR24/4889.8

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Plasma Concentrations of TMC435

"The table below shows median (range) TMC435 predose plasma concentration (C0h) values and the TMC435 maximum plasma concentration (Cmax) values for all participants who received TMC435 for up to 12 weeks. Overall is the median exposure estimate using all available data for each participant in the study.Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)." (NCT01290731)
Timeframe: Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)

Interventionng/mL (Median)
C0hCmax
TMC435 100 mg 12 Wks + PR24/4818223440

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The Number of Participants Demonstrating Viral Relapse

The table below shows the number of participants who demonstrated viral relapse, defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at end of treatment (EOT) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of sustained virologic response (SVR) assessment . The incidence of viral relapse was calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement. (NCT01290731)
Timeframe: Up to 72 weeks

InterventionParticipants (Number)
TMC435 100 mg 12 Wks + PR24/484

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The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up

The table below shows the percentage of participants with greater than or equal to 2 log10 IU/mL drop from baseline in plasma HCV RNA at each time point during treatment, at the end of treatment (Week 24 or 48), and post-treatment follow-up. (NCT01290731)
Timeframe: Days 3 and 7, Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and follow-up (FU) Weeks 4, 12, and 24

InterventionPercentage of participants (Number)
Day 3Day 7Week 2Week 3Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 36Week 48Week 60Week 72EOTFU Week 4FU Week 12FU Week 24
TMC435 100 mg 12 Wks + PR24/4893.9100.0100.098.0100.0100.0100.098.0100.095.9100.093.989.889.889.810010095.991.8

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The Percentage of Participants in the TMC435 Treatment Group Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFN Alpha-2a) and Ribavirin (RBV) at Week 24

The table below shows the percentage of participants in the TMC435 treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with pegIFN alpha 2a and RBV at Week 24. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group continued treatment with PegIFN alpha 2a and RBV to Week 48. (NCT01292239)
Timeframe: Week 24

InterventionPercentage of participants (Number)
TMC435 100 mg 12 Wks + PR 24/4891.9

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The Number of Participants With Viral Breakthrough

Viral breakthrough was defined as a confirmed increase of > 1 log10 IU/mL in plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA)l from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period (up to the end of treatment [EOT]). (NCT01292239)
Timeframe: Up to EOT (up to Week 24 or 48)

InterventionParticipants (Number)
TMC435 100 mg 12 Wks + PR 24/481
PBO 12 Wks + PR 482

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The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)

The table below shows the observed percentage of participants with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60). (NCT01292239)
Timeframe: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)

InterventionPercentage of participants (Number)
TMC435 100 mg 12 Wks + PR 24/4888.6
PBO 12 Wks + PR 4861.7

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The Percentage of Participants With Undetectable Plasma Levels of Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)

The table below shows the percentage of participants with undetectable plasma levels of HCV RNA <1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at the EOT (up to Week 24 or 48). (NCT01292239)
Timeframe: Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)

,
InterventionPercentage of participants (Number)
Week 4Week 12Week 24Week 36Week 48Week 60Week 72EOT (up to Week 24 or 48)
PBO 12 Wks + PR 4813.363.373.371.775.061.756.788.3
TMC435 100 mg 12 Wks + PR 24/4883.796.791.987.086.288.688.699.2

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The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up

The table below shows the percentage of participants with greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in plasma levels of HCV RNA at each time point during treatment and post-treatment follow-up (FU). (NCT01292239)
Timeframe: Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60, 72, EOT (up to Week 24 or 48), FU Week 4, 12, and 24

,
InterventionPercentage of participants (Number)
Day 3Day 7Week 2Week 3Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 36Week 42Week 48Week 52Week 60Week 72EOT (up to Week 24 or 48)FU Week 4FU Week 12FU Week 24
PBO 12 Wks + PR 4826.746.758.371.776.788.388.388.386.783.380.080.076.775.071.765.058.396.783.365.058.3
TMC435 100 mg 12 Wks + PR 24/4898.499.2100.0100.099.2100.097.695.195.992.794.387.82.486.20.088.688.699.296.789.488.6

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Plasma Concentrations of TMC435

"The table below shows median (range) predose plasma concentration (C0h) values and median (range) maximum plasma concentration (Cmax) values for TMC435 for all participants in the TMC435 treatment group. The time frame of Overall (up to Week 12) represents the median exposure estimate using all available data for each participant in the study." (NCT01292239)
Timeframe: Overall (ie, Up to Week 12)

Interventionng/mL (Median)
C0hCmax
TMC435 100 mg 12 Wks + PR 24/4810052601

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The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)

The table below shows the observed percentage of participants with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT, defined as up to Week 24 or 48) and at 24 weeks after the last dose of treatment (up to Week 48 or 72). (NCT01292239)
Timeframe: EOT (up to Week 24 or 48) and 24 weeks after the after the last dose of treatment (up to Week 48 or 72)

InterventionPercentage of participants (Number)
TMC435 100 mg 12 Wks + PR 24/4888.6
PBO 12 Wks + PR 4856.7

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The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)

The table below shows the number of participants with abnormal ALT levels at Baseline (Day 1) who achieved normal ALT levels at the EOT (up to Week 24 or 48). At Baseline, 61/123 participants in the TMC435 treatment group and 25/60 participants in the Placebo treatment group had abnormal ALT levels. At the EOT, 47 (77.0%) participants in the TMC435 treatment group and 18 (72.0%) participants in the Placebo treatment group had ALT levels that returned to normal (or normalization of ALT levels defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT.). (NCT01292239)
Timeframe: Baseline (Day 1) to EOT (up to Week 24 or 48)

InterventionParticipants (Number)
TMC435 100 mg 12 Wks + PR 24/4847
PBO 12 Wks + PR 4818

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The Number of Participants Demonstrating Viral Relapse

The table below shows the number of participants who demonstrated viral relapse, defined as undetectable plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) at the End of Treatment (EOT) (up to Week 24 or 48) and detectable HCV RNA during follow-up or detectable plasma levels of HCV RNA at the time points of sustained virologic response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable plasma levels of HCV RNA at the EOT and with at least one follow-up HCV RNA. measurement. (NCT01292239)
Timeframe: Up to Week 72

InterventionParticipants (Number)
TMC435 100 mg 12 Wks + PR 24/489
PBO 12 Wks + PR 4815

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Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435

"The table below shows the median (range) AUC24h values for TMC435 for all participants in the TMC435 treatment group who received TMC435 for up to 12 weeks. The time frame of Overall (up to Week 12) represents the median exposure estimate using all available data for each participant in the study." (NCT01292239)
Timeframe: Overall (Up to Week 12)

Interventionng.h/mL (Median)
TMC435 100 mg 12 Wks + PR 24/4842721

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Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment

Sustained virologic response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. (NCT01306617)
Timeframe: Post-treatment Day 1 to Post-treatment Week 24

Interventionpercentage of participants (Number)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve94.7
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve85.7
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders47.1

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Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment

Sustained virologic response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. (NCT01306617)
Timeframe: Post-treatment Day 1 to Post-treatment Week 12

Interventionpercentage of participants (Number)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve94.7
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve92.9
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders47.1

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Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (< 15 IU/mL). (NCT01306617)
Timeframe: Week 4 through Week 12

Interventionpercentage of participants (Number)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve89.5
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve78.6
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders58.8

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Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4

Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). (NCT01306617)
Timeframe: Week 4

Interventionpercentage of participants (Number)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve100
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve92.9
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders88.2

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Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)

Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. (NCT01306617)
Timeframe: Week 2

Interventionpercentage of participants (Number)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve100
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve92.9
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders100

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Time to Failure to Suppress or Rebound During Treatment

Time to failure to achieve a 2 log10 IU/mL HCV RNA decrease at Week 1, failure to achieve HCV RNA < Lower Limit of Detection (LLOD) at Week 6, or a confirmed increase of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of quantitation (LLOQ) for participants who previously achieved HCV RNA < LLOQ. (NCT01306617)
Timeframe: Day 1 through Week 12

Interventiondays (Mean)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve43.0
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïveNA
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders62.6

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Resistance-Associated Variants and Phenotypic Resistance

Baseline samples were analyzed for resistance-associated amino acid variants using population sequencing. Phenotypic resistance to ABT-450 or ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Participants not achieving SVR12 were analyzed for resistance-associated variants at the time of failure using population sequencing and were compared with the baseline and appropriate reference sequences to assess amino acid changes. Phenotypic resistance to ABT-450 or ABT-333 at the time of failure was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at baseline and at the time of failure are presented. (NCT01306617)
Timeframe: Day 1 to post-treatment week 48

,,
Interventionparticipants (Number)
Baseline Variants in NS3; n=49Baseline Resistance to ABT-450 >10-fold; n=40Baseline Variants in NS5B; n=49Baseline Resistance to ABT-333 >10-fold; n=49Post-treatment resistant variants in NS3; n=11Post-treatment resistance to ABT-450 >10-fold; n=9Post-treatment resistant variants in NS5B; n=11Post-treatment resistance to ABT-333 >10-fold;n=11
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders11008688
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve00210000
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve00200000

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Time to Virologic Relapse Post-treatment

Time to the first of 2 consecutive measurements of confirmed HCV RNA ≥ lower limit of quantitation (LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. (NCT01306617)
Timeframe: Post-treatment Day 1 to post-treatment week 48

Interventiondays (Mean)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïveNA
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïveNA
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders15.8

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Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose. (NCT01306617)
Timeframe: Day 1 to Week 12

Interventionnanograms (ng) per milliliter (mL) (Geometric Mean)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve43.92
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve42.35
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders44.21

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Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose. (NCT01306617)
Timeframe: Day 1 to Week 12

Interventionnanograms (ng) per milliliter (mL) (Geometric Mean)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve2480
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve2280
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders2000

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Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose. (NCT01306617)
Timeframe: Day 1 to Week 12

Interventionnanograms (ng) per milliliter (mL) (Geometric Mean)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve148.44
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve162.57
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders166.15

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Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants

Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose. (NCT01306617)
Timeframe: Day 1 to Week 12

Interventionnanograms (ng) per milliliter (mL) (Geometric Mean)
ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve53.21
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve16.81
ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders16.15

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Percentage of Participants With Partial Early Virologic Response (pEVR)

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR. (NCT01314261)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
ABT-267 (5 mg) Once Daily + pegIFN/RBV100.0
ABT-267 (50 mg) Once Daily + pegIFN/RBV88.9
ABT-267 (200 mg) Once Daily + pegIFN/RBV90.0
Placebo + pegIFN/RBV77.8

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Time to Maximum Plasma Concentration (Tmax) of ABT-267

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01314261)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

InterventionHours (Mean)
ABT-267 (5 mg) Once Daily + pegIFN/RBV3.3
ABT-267 (50 mg) Once Daily + pegIFN/RBV3.8
ABT-267 (200 mg) Once Daily + pegIFN/RBV4.2

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Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24. (NCT01314261)
Timeframe: 24 weeks after the last dose of pegIFN/RBV

Interventionpercentage of participants (Number)
ABT-267 (5 mg) Once Daily + pegIFN/RBV55.6
ABT-267 (50 mg) Once Daily + pegIFN/RBV44.4
ABT-267 (200 mg) Once Daily + pegIFN/RBV50.0
Placebo + pegIFN/RBV22.2

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Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01314261)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12

Interventionng*hr/mL (Mean)
ABT-267 (5 mg) Once Daily + pegIFN/RBV115
ABT-267 (50 mg) Once Daily + pegIFN/RBV2200
ABT-267 (200 mg) Once Daily + pegIFN/RBV6130

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Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels < the lower limit of quantification (< 25 IU/mL). Data are reported as the median number of days. (NCT01314261)
Timeframe: Approximately 12 weeks

InterventionDays (Median)
ABT-267 (5 mg) Once Daily + pegIFN/RBV27.0
ABT-267 (50 mg) Once Daily + pegIFN/RBV16.0
ABT-267 (200 mg) Once Daily + pegIFN/RBV21.5
Placebo + pegIFN/RBV84.0

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Percentage of Participants With 4-week Rapid Virologic Response (RVR)

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR. (NCT01314261)
Timeframe: Week 4

Interventionpercentage of participants (Number)
ABT-267 (5 mg) Once Daily + pegIFN/RBV33.3
ABT-267 (50 mg) Once Daily + pegIFN/RBV55.6
ABT-267 (200 mg) Once Daily + pegIFN/RBV70.0
Placebo + pegIFN/RBV22.2

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Percentage of Participants With Complete Early Virologic Response (cEVR)

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA < the lower limit of quantification (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR. (NCT01314261)
Timeframe: Week 12

Interventionpercentage of participants (Number)
ABT-267 (5 mg) Once Daily + pegIFN/RBV100.0
ABT-267 (50 mg) Once Daily + pegIFN/RBV88.9
ABT-267 (200 mg) Once Daily + pegIFN/RBV80.0
Placebo + pegIFN/RBV66.7

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Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12. (NCT01314261)
Timeframe: 12 weeks after the last dose of pegIFN/RBV

Interventionpercentage of participants (Number)
ABT-267 (5 mg) Once Daily + pegIFN/RBV66.7
ABT-267 (50 mg) Once Daily + pegIFN/RBV66.7
ABT-267 (200 mg) Once Daily + pegIFN/RBV60.0
Placebo + pegIFN/RBV33.3

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Percentage of Participants With Extended Rapid Virologic Response (eRVR)

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels < the lower level of quantification (< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR. (NCT01314261)
Timeframe: Week 4 through Week 12

Interventionpercentage of participants (Number)
ABT-267 (5 mg) Once Daily + pegIFN/RBV77.8
ABT-267 (50 mg) Once Daily + pegIFN/RBV77.8
ABT-267 (200 mg) Once Daily + pegIFN/RBV80.0
Placebo + pegIFN/RBV22.2

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Plasma Concentrations of Ribavirin (RBV)

Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range). (NCT01314261)
Timeframe: At each study visit from Week 1 to Week 12

,,,
Interventionng/mL (Median)
Week 1Week 2Week 4 (n=8, 8, 10, 9)Week 6 (n=8, 9, 9, 9)Week 8 (n=8, 9, 9, 9)Week 12 (n=8, 9, 9, 9)
ABT-267 (200 mg) Once Daily + pegIFN/RBV106014201580178016501800
ABT-267 (5 mg) Once Daily + pegIFN/RBV133018901900200020802510
ABT-267 (50 mg) Once Daily + pegIFN/RBV147016401680151017101740
Placebo + pegIFN/RBV119013601950190022801940

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Maximum Plasma Concentration (Cmax) of ABT-267

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. (NCT01314261)
Timeframe: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Interventionng/mL (Mean)
ABT-267 (5 mg) Once Daily + pegIFN/RBV10.7
ABT-267 (50 mg) Once Daily + pegIFN/RBV148
ABT-267 (200 mg) Once Daily + pegIFN/RBV535

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Serum Concentrations of Pegylated Interferon (pegIFN)

Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range). (NCT01314261)
Timeframe: At each study visit from Week 1 to Week 12

,,,
Interventionng/mL (Median)
Week 1Week 2Week 4 (n=9, 9, 10, 9)Week 6 (n=8, 9, 9, 9)Week 8 (n=8, 9, 9, 9)Week 12 (n=8, 9, 9, 9)
ABT-267 (200 mg) Once Daily + pegIFN/RBV4.307.528.2314.612.115.2
ABT-267 (5 mg) Once Daily + pegIFN/RBV7.508.7511.810.99.9114.4
ABT-267 (50 mg) Once Daily + pegIFN/RBV6.129.227.729.3510.16.16
Placebo + pegIFN/RBV4.836.878.7610.911.08.91

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Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks

ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued). (NCT01318694)
Timeframe: at treatment end within 48 weeks

Interventionpercentage of participants (Number)
Treatment Arm A88.2
Treatment Arm B87.7
Treatment Arm C87.5
Treatment Arm D80.0

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Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment

EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment. (NCT01318694)
Timeframe: after 12 weeks of treatment

Interventionpercentage of participants (Number)
Treatment Arm A97.7
Treatment Arm B98.3
Treatment Arm C99.6
Treatment Arm D89.8

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Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment

cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment. (NCT01318694)
Timeframe: after 12 weeks of treatment

Interventionpercentage of participants (Number)
Treatment Arm A89.6
Treatment Arm B96.3
Treatment Arm C89.1
Treatment Arm D70.3

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Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)

SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment. (NCT01318694)
Timeframe: 24 weeks after the end of treatment

Interventionpercentage of participants (Number)
Treatment Arm A68.5
Treatment Arm B69.0
Treatment Arm C68.3
Treatment Arm D51.7

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Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)

SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment. (NCT01318694)
Timeframe: 12 weeks after the end of treatment

Interventionpercentage of participants (Number)
Treatment Arm A68.6
Treatment Arm B68.9
Treatment Arm C69.4
Treatment Arm D52.5

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Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks

Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category. (NCT01318694)
Timeframe: within 48 weeks

,,,
Interventionpercentage of participants (Number)
Grade 3Grade 4
Treatment Arm A6.70.0
Treatment Arm B21.91.1
Treatment Arm C12.50.0
Treatment Arm D1.90.0

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Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment

pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment. (NCT01318694)
Timeframe: after 12 weeks of treatment

Interventionpercentage of participants (Number)
Treatment Arm A8.1
Treatment Arm B2.1
Treatment Arm C10.5
Treatment Arm D19.5

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Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment

eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12. (NCT01318694)
Timeframe: from 4 to 12 weeks of treatment

Interventionpercentage of participants (Number)
Treatment Arm A60.2
Treatment Arm B71.1
Treatment Arm C56.7
Treatment Arm D28.1

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Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks

Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category. (NCT01318694)
Timeframe: within 48 weeks

,,,
Interventionpercentage of participants (Number)
Grade 3Grade 4
Treatment Arm A24.44.4
Treatment Arm B24.78.0
Treatment Arm C23.17.2
Treatment Arm D12.92.7

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Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks

"Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).~Participants with multiple abnormalities were counted only once in the worst category." (NCT01318694)
Timeframe: within 48 weeks

,,,
Interventionpercentage of participants (Number)
Grade 3Grade 4
Treatment Arm A1.80.0
Treatment Arm B3.40.4
Treatment Arm C0.80.0
Treatment Arm D1.90.0

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Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks

"ALT abnormalities were summarized as participants who had either:~ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline~ALT > 3 x ULN during the study and > 2 x ULN at baseline" (NCT01318694)
Timeframe: within 48 weeks

,,,
Interventionpercentage of participants (Number)
> 2 x ULN and > 2 x baseline> 3 x ULN and > 2 x baseline
Treatment Arm A1.50.7
Treatment Arm B0.40.0
Treatment Arm C1.91.5
Treatment Arm D1.50.8

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Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)

RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment. (NCT01318694)
Timeframe: after 4 weeks of treatment

Interventionpercentage of participants (Number)
Treatment Arm A60.1
Treatment Arm B72.5
Treatment Arm C56.6
Treatment Arm D28.4

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Number of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01353911)
Timeframe: Treatment period plus the first 14 days of follow-up (up to 50 weeks)

Interventionparticipants (Number)
OL Grazoprevir 100 mg34
Grazoprevir 100 mg65
Grazoprevir 200 mg66
Grazoprevir 400 mg23
Grazoprevir 800 mg28
Grazoprevir 400 mg/100 mg42
Grazoprevir 800 mg/100 mg35
Boceprevir 800 mg64

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Median Time to First Achievement of Undetectable HCV RNA During Treatment

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm. (NCT01353911)
Timeframe: From first dose of study medication until first achievement of undetectable HCV RNA (up to 48 weeks of treatment)

Interventiondays (Median)
OL Grazoprevir 100 mg22.0
Grazoprevir 100 mg15.0
Grazoprevir 200 mg28.0
Grazoprevir 400 mg16.0
Grazoprevir 800 mg16.5
Grazoprevir 400 mg/100 mg27.0
Grazoprevir 800 mg/100 mg29.0
Boceprevir 800 mg57.0

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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR24)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (TND) HCV RNA at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01353911)
Timeframe: 24 weeks after the end of all treatment (up to 72 weeks)

Interventionpercentage of participants (Number)
OL Grazoprevir 100 mg72.2
Grazoprevir 100 mg86.4
Grazoprevir 200 mg92.6
Grazoprevir 400 mg87.5
Grazoprevir 800 mg79.3
Grazoprevir 400 mg/100 mg93.0
Grazoprevir 800 mg/100 mg91.7
Boceprevir 800 mg57.6

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Percentage of Participants Achieving Complete Early Viral Response (cEVR)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). cEVR was defined as undetectable HCV RNA (target not detected [TND]) at Week 12. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01353911)
Timeframe: After 12 weeks of treatment with grazoprevir/boceprevir

Interventionpercentage of participants (Number)
OL Grazoprevir 100 mg94.4
Grazoprevir 100 mg80.3
Grazoprevir 200 mg85.3
Grazoprevir 400 mg87.5
Grazoprevir 800 mg75.9
Grazoprevir 400 mg/100 mg86.0
Grazoprevir 800 mg/100 mg86.1
Boceprevir 800 mg69.7

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Percentage of Participants Achieving Rapid Viral Response (RVR)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). RVR was defined as undetectable (TND) HCV RNA at Week 4 of study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01353911)
Timeframe: After 4 weeks of treatment with grazoprevir/boceprevir

Interventionpercentage of participants (Number)
OL Grazoprevir 100 mg72.2
Grazoprevir 100 mg90.9
Grazoprevir 200 mg91.2
Grazoprevir 400 mg87.5
Grazoprevir 800 mg86.2
Grazoprevir 400 mg/100 mg81.4
Grazoprevir 800 mg/100 mg83.3
Boceprevir 800 mg59.1

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of Study Therapy (SVR12)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (TND) HCV RNA at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01353911)
Timeframe: 12 weeks after the end of all treatment (up to 60 weeks)

Interventionpercentage of participants (Number)
OL Grazoprevir 100 mg72.2
Grazoprevir 100 mg89.4
Grazoprevir 200 mg91.2
Grazoprevir 400 mg87.5
Grazoprevir 800 mg79.3
Grazoprevir 400 mg/100 mg93.0
Grazoprevir 800 mg/100 mg91.7
Boceprevir 800 mg60.6

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Percentage of Participants Achieving Undetectable HCV RNA at Week 72

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01353911)
Timeframe: Week 72

Interventionpercentage of participants (Number)
OL Grazoprevir 100 mg69.4
Grazoprevir 100 mg80.3
Grazoprevir 200 mg86.8
Grazoprevir 400 mg87.5
Grazoprevir 800 mg75.9
Grazoprevir 400 mg/100 mg79.1
Grazoprevir 800 mg/100 mg83.3
Boceprevir 800 mg54.5

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Number of Participants Who Discontinued Study Medication Due to AEs During the Treatment Period and First 14 Follow-up Days

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01353911)
Timeframe: Treatment period plus the first 14 days of follow-up (up to 50 weeks)

Interventionparticipants (Number)
OL Grazoprevir 100 mg2
Grazoprevir 100 mg3
Grazoprevir 200 mg4
Grazoprevir 400 mg2
Grazoprevir 800 mg3
Grazoprevir 400 mg/100 mg4
Grazoprevir 800 mg/100 mg2
Boceprevir 800 mg9

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Number of Participants Who Achieved Platelet Response (Greater Than or Equal to 100 x 10^9/L) by Day 21 of Treatment Period A1 of Core Study

A responder was defined as a participant having a platelet count of greater than or equal to 100x10^9/L by Day 21 starting from an average baseline platelet count of greater than 20 x 10^9/L to less than or equal to 70 x 10^9/L. (NCT01355289)
Timeframe: Baseline to Day 21

,,,
InterventionParticipants (Count of Participants)
YesNo
Avatrombopag 10 mg (Core Study)610
Avatrombopag 20 mg (Core Study)126
Avatrombopag 30 mg (Core Study)95
Placebo (Core Study)116

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Number of Participants Who Achieved Platelet Count Greater Than 30 X 10^9/L From Baseline to Day 21 During Treatment Period A1 of Core Study

Blood draws were taken to monitor platelet counts. (NCT01355289)
Timeframe: Baseline to Day 21

,,,
InterventionParticipants (Count of Participants)
YesNo
Avatrombopag 10 mg (Core Study)97
Avatrombopag 20 mg (Core Study)162
Avatrombopag 30 mg (Core Study)113
Placebo (Core Study)116

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Change From Baseline of Local Platelet Count by Visit During Treatment Period A1 of Core Study

Missing platelet counts were imputed using last observation carried forward (LOCF) approach for subjects who achieved platelet response at prior visits. (NCT01355289)
Timeframe: Day 7 and Day 14

,,,
Interventioncells x 10^9/L (Mean)
Day 7Day 14
Avatrombopag 10 mg (Core Study)19.829.2
Avatrombopag 20 mg (Core Study)26.557.2
Avatrombopag 30 mg (Core Study)30.955.4
Placebo (Core Study)-0.1-0.2

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Number of Participants Who Initiated Antiviral Treatment by Day 21 of Period A1 of Core Study

Blood draws were taken to monitor platelet counts during the first 21 days of study treatment. When a platelet count of greater than or equal to 100 X 10^9/L was attained, antiviral treatment was initiated. (NCT01355289)
Timeframe: Baseline to Day 21

,,,
InterventionParticipants (Count of Participants)
YesNo
Avatrombopag 10 mg (Core Study)610
Avatrombopag 20 mg (Core Study)135
Avatrombopag 30 mg (Core Study)95
Placebo (Core Study)116

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AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES

The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline (NCT01358864)
Timeframe: 12 weeks post treatment, up to 60 weeks

,,,,,,,
Interventionparticipants (Number)
SVR12=YESBL normal to SVR12 normalBL elevated to SVR12 normalNo AST data available at SVR12 visit
Null:Faldaprevir 12 Weeks4916281
Null:Faldaprevir 24 Weeks4617250
Partial:Faldaprevir 12 Weeks3316160
Partial:Faldaprevir 24 Weeks251380
Partial:Placebo1010
Relapser:Faldaprevir 12 Weeks6936291
Relapser:Faldaprevir 24 Weeks7241280
Relapser:Placebo7241

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AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline (NCT01358864)
Timeframe: End of treatment, up to 48 weeks

,,,,,,,
Interventionparticipants (Number)
SVR12=NOBL normal to EoT normalBL elevated to EoT normal
Null:Faldaprevir 12 Weeks961824
Null:Faldaprevir 24 Weeks942128
Partial:Faldaprevir 12 Weeks24314
Partial:Faldaprevir 24 Weeks3056
Partial:Placebo2849
Relapser:Faldaprevir 12 Weeks30165
Relapser:Faldaprevir 24 Weeks31129
Relapser:Placebo42195

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AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline (NCT01358864)
Timeframe: End of treatment, up to 48 weeks

,,,,,,,
Interventionparticipants (Number)
SVR12=YESBL normal to EoT normalBL elevated to EoT normalNo EoT data available for AST
Null:Faldaprevir 12 Weeks4915211
Null:Faldaprevir 24 Weeks4616200
Partial:Faldaprevir 12 Weeks3313100
Partial:Faldaprevir 24 Weeks251091
Partial:Placebo1010
Relapser:Faldaprevir 12 Weeks6935240
Relapser:Faldaprevir 24 Weeks7239220
Relapser:Placebo7241

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AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO

The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline (NCT01358864)
Timeframe: 12 weeks post treatment, up to 60 weeks

,,,,,,,
Interventionparticipants (Number)
SVR12=NOBL normal to SVR12 normalBL elevated to SVR12 normalNo AST data available at SVR12 visit
Null:Faldaprevir 12 Weeks9613627
Null:Faldaprevir 24 Weeks9414330
Partial:Faldaprevir 12 Weeks24366
Partial:Faldaprevir 24 Weeks30336
Partial:Placebo280023
Relapser:Faldaprevir 12 Weeks301427
Relapser:Faldaprevir 24 Weeks311063
Relapser:Placebo420233

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Early Treatment Success (ETS)

Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8. (NCT01358864)
Timeframe: Week 4 and Week 8

Interventionpercentage of participants (Number)
Relapser:Placebo4.1
Relapser:Faldaprevir 12 Weeks85.9
Relapser:Faldaprevir 24 Weeks87.4
Partial:Placebo3.4
Partial:Faldaprevir 12 Weeks66.7
Partial:Faldaprevir 24 Weeks76.4
Null:Faldaprevir 12 Weeks58.6
Null:Faldaprevir 24 Weeks51.4

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Sustained Virological Response 12 Weeks Post Treatment (SVR12)

Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration. (NCT01358864)
Timeframe: 12 weeks post treatment, up to 60 weeks

Interventionpercentage of participants (Number)
Relapser & Partial: Placebo10.3
Relapser & Partial: Faldaprevir 12 Weeks65.4
Relapser & Partial: Faldaprevir 24 Weeks61.4
Null:Faldaprevir 12 Weeks33.8
Null:Faldaprevir 24 Weeks32.9

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Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)

Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. (NCT01358864)
Timeframe: 24 weeks post treatment, up to 72 weeks

Interventionpercentage of participants (Number)
Relapser & Partial: Placebo10.3
Relapser & Partial: Faldaprevir 12 Weeks63.5
Relapser & Partial: Faldaprevir 24 Weeks59.5
Null:Faldaprevir 12 Weeks33.8
Null:Faldaprevir 24 Weeks32.9

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ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES

The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline (NCT01358864)
Timeframe: 12 weeks post treatment, up to 60 weeks

,,,,,,,
Interventionparticipants (Number)
SVR12=YESBL normal to SVR12 normalBL elevated to SVR12 normalNo ALT data available at SVR12 visit
Null:Faldaprevir 12 Weeks4913321
Null:Faldaprevir 24 Weeks4610350
Partial:Faldaprevir 12 Weeks3313200
Partial:Faldaprevir 24 Weeks2510110
Partial:Placebo1010
Relapser:Faldaprevir 12 Weeks6931351
Relapser:Faldaprevir 24 Weeks7231380
Relapser:Placebo7331

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ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO

The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline (NCT01358864)
Timeframe: 12 weeks post treatment, up to 60 weeks

,,,,,,,
Interventionparticipants (Number)
SVR12=NOBL normal to SVR12 normalBL elevated to SVR12 normalNo ALT data available at SVR12 visit
Null:Faldaprevir 12 Weeks9611727
Null:Faldaprevir 24 Weeks946930
Partial:Faldaprevir 12 Weeks24246
Partial:Faldaprevir 24 Weeks30435
Partial:Placebo280023
Relapser:Faldaprevir 12 Weeks30967
Relapser:Faldaprevir 24 Weeks31663
Relapser:Placebo420133

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ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO

The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline (NCT01358864)
Timeframe: End of treatment, up to 48 weeks

,,,,,,,
Interventionparticipants (Number)
SVR12=NOBL normal to EoT normalBL elevated to EoT normalNo EoT data available for ALT
Null:Faldaprevir 12 Weeks9615341
Null:Faldaprevir 24 Weeks9414380
Partial:Faldaprevir 12 Weeks244140
Partial:Faldaprevir 24 Weeks30461
Partial:Placebo28390
Relapser:Faldaprevir 12 Weeks309100
Relapser:Faldaprevir 24 Weeks316140
Relapser:Placebo429151

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ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES

The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline (NCT01358864)
Timeframe: End of treatment, up to 48 weeks

,,,,,,,
Interventionparticipants (Number)
SVR12=YESBL normal to EoT normalBL elevated to EoT normal
Null:Faldaprevir 12 Weeks491223
Null:Faldaprevir 24 Weeks46927
Partial:Faldaprevir 12 Weeks331014
Partial:Faldaprevir 24 Weeks2588
Partial:Placebo101
Relapser:Faldaprevir 12 Weeks693029
Relapser:Faldaprevir 24 Weeks723026
Relapser:Placebo734

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Percentage of Participants With Viral Breakthrough During the Treatment Period

Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8. (NCT01359644)
Timeframe: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)

,,
InterventionPercentage of participants (Number)
DCV/SOF with ribavirin (n=56, 14, 20)DCV/SOF without ribavirin (n=70, 30, 21)
Telaprevir or Boceprevir Failures With Genotype 100
Treatment-naive Participants With Genotype 100
Treatment-naive Participants With Genotype 2 or 303.3

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Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24

Change from baseline in log10 HCV RNA at scheduled sampling time. (NCT01359644)
Timeframe: Baseline, Follow-up week 24

,,,,,,,,,
InterventionIU/mL (Mean)
BaselineChange at Follow-up week 24
Treatment A: Sofosbuvir + Daclatasvir1.28-5.19
Treatment B: Sofosbuvir + Daclatasvir0.95-5.23
Treatment C: Sofosbuvir + Daclatasvir0.95-5.67
Treatment D: Sofosbuvir + Daclatasvir0.98-5.83
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin0.95-5.77
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin0.95-5.61
Treatment G: Sofosbuvir + Daclatasvir0.95-5.19
Treatment H: Sofosbuvir + Daclatasvir + Ribavirin0.95-5.48
Treatment I: Sofosbuvir + Daclatasvir0.95-5.39
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin0.95-5.36

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Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe. (NCT01359644)
Timeframe: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)

,,,
InterventionParticipants (Number)
DeathsSAEsAEs leading to discontinuationGr 3 PhosporusGr 3 Fasting serum glucoseGr 3 Serum glucoseGr 3 Total cholesterolGr 3 Uric acid
Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)01030011
Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)06111200
Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)01001000
Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)07112110

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Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)

SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir. (NCT01359644)
Timeframe: Follow-up Week 12

,,
InterventionPercentage of participants (Number)
DCV/SOF with ribavirin (n=56, 14, 20)DCV/SOF without ribavirin (n=70, 30, 21)DCF/SOF All
Telaprevir or Boceprevir Failures With Genotype 195.0100.097.6
Treatment-naive Participants With Genotype 196.4100.098.4
Treatment-naive Participants With Genotype 2 or 385.793.390.9

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Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)

SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir. (NCT01359644)
Timeframe: Follow-up Week 24

,,
InterventionPercentage of participants (Number)
DCV/SOF with ribavirin (n=56, 14, 20)DCV/SOF without ribavirin (n=70, 30, 21)DCV/SOF All
Telaprevir/Boceprevir Failures With Genotype 1100.0100.0100.0
Treatment-naive Participants With Genotype 194.695.795.2
Treatment-naive Participants With Genotype 2 or 392.993.393.2

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Percentage of Participants Who Experienced Viral Relapse During Follow-up Period

Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment. (NCT01359644)
Timeframe: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)

,,
InterventionPercentage of participants (Number)
DCV/SOF with ribavirin (n=56, 14, 20)DCV/SOF without ribavirin (n=70, 30, 21)
Telaprevir or Boceprevir Failures With Genotype 100
Treatment-naive Participants With Genotype 101.4
Treatment-naive Participants With Genotype 2 or 303.3

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Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe (NCT01359644)
Timeframe: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)

,,,
InterventionParticipants (Number)
DeathsSAEsGrade 3-4 Lab Abnormalities: Serum glucose
Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)021
Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)040
Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)020
Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)040

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Treatment Efficacy

The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy. (NCT01364090)
Timeframe: 36 weeks

InterventionParticipants (Count of Participants)
Standard Treatment Duration (24 Weeks)10
Shortened Treatment Duration (12 Weeks)51
Discontinued Prior to RVR0

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The Area Under the Plasma Concentration-Time Curve (From 0 to 24 Hours) (AUC24h)

"The table below shows the median (range) AUC24h values for TMC435 for all participants in each TMC435 treatment group who received TMC435 for up to 12 weeks. Overall is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: Overall (Up to Week 12)

Interventionng·h/mL (Median)
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/4835448
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/4868130
Prior Non-Responder: TMC435 100 mg 12 Wks+PR 4840645

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The Number of Participants Demonstrating Viral Relapse

"The table below shows the number of participants in each treatment group who demonstrated viral relapse, defined as having undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at end of treatment (EOT [Week 24 or 48]) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of an assessment of sustained virologic response (SVR). The number of participants analyzed in each treatment group below are those with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: Up to 72 weeks

InterventionParticipants (Number)
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/482
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/481
Prior Non-Responder: TMC435 100 mg 12 Wks+PR 484

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The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at the End of Treatment (EOT)

"The table below shows the number of participants in each treatment group with abnormal ALT levels at Baseline who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at EOT. At Baseline, 15 treatment-naïve participants, 13 prior relapsers, and 13 prior non-responders had abnormal ALT levels at Baseline. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/4813
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/488
Prior Non-Responder: TMC435 100 mg 12 Wks+PR 488

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The Number of Participants With Viral Breakthrough

"The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period. Viral breakthrough is defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of greater than 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: Up to 48 Weeks

InterventionParticipants (Number)
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/480
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/480
Prior Non-Responder: TMC435 100 mg 12 Wks+PR 482

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The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2b (PegIFNα-2b) and Ribavirin (RBV) at Week 24

"The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2b and RBV at Week 24. Participants in the TMC435 Treatment-Naïve and TMC435 Prior Relapser treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48 (does not apply to the TMC435 Non-responder treatment group because the specified treatment duration was 48 weeks and RGT criteria was not assessed at Week 24). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: Week 24 or 48

InterventionPercentage of participants (Number)
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/4891.7
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/4896.6

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Plasma Concentrations of TMC435

"The table below shows the median (range) TMC435 predose plasma concentrations (C0h) and maximum concentration (Cmax) values for participants in each treatment group. Overall is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: Overall (Up to Week 12)

,,
Interventionng/mL (Median)
CmaxC0h
Prior Non-Responder: TMC435 100 mg 12 Wks+PR 482521921
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/4836432015
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/482304735

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The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up

"The table below shows the percentage of participants in each treatment group with greater than or equal to 2 log10 IU/mL drop from baseline in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at each time point during treatment and post-treatment follow-up. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT (up to Week 24 or 48), follow-up (FU) Week 4, 12, and 24

,,
InterventionPercentage of participants (Number)
Day 3Day 7Week 2Week 3Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 36Week 48Week 60Week 72EOTFU Week 4FU Week 12FU Week 24
Prior Non-Responder: TMC435 100 mg 12 Wks+PR 4888.510010096.296.292.384.676.976.973.169.265.461.542.338.580.846.242.338.5
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/4810010010010010010010096.610096.696.696.696.696.696.610010010096.6
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/4810010010010010010010010095.810091.787.583.391.791.710095.891.791.7

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The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During Treatment and at the End of Treatment

"The table below shows the percentage of participants in each treatment group with undetectable HCV RNA less than 1.2 log10 IU/mL during treatment and at end of treatment (EOT). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: Weeks 4, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)

,,
InterventionPercentage of participants (Number)
Week 4Week 12Week 24Week 36Week 48Week 60Week 72EOT
Prior Non-Responder: TMC435 100 mg 12 Wks+PR 4857.776.965.457.753.838.538.557.7
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/4886.210096.696.696.696.696.6100
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/4879.210010087.583.391.791.7100

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The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)

"The table below shows the percentage of participants in each treatment group with a SVR24 defined as participants with undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment and at 24 weeks after the last dose of treatment (Week 48 or 72). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: 24 weeks after the last dose of treatment (Week 48 or 72)

InterventionPercentage of participants (Number)
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/4891.7
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/4896.6
Prior Non-Responder: TMC435 100 mg 12 Wks+PR 4838.5

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The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)

"The table below shows the percentage of participants in each treatment group with an SVR12 defined as participants with undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma HCV RNA 12 weeks after the last dose of treatment (Week 36 or 60). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)." (NCT01366638)
Timeframe: Week 36 or 60

InterventionPercentage of Participants (Number)
Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/4891.7
Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48100.0
Prior Non-Responder: TMC435 100 mg 12 Wks+PR 4838.5

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Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)

"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable." (NCT01370642)
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24

,,
InterventionLog IU/ml (Least Squares Mean)
Change From BL at Week 2Change From BL at Week 4Change From BL at Week 8Change From BL at Week 12Change From BL at Week 24
Control Arm-2.0-3.0-4.2-4.8-5.3
Vaniprevir 12 Week Arm-5.3-6.0-6.1-6.1-6.0
Vaniprevir 24 Week Arm-5.5-6.1-6.2-6.2-6.1

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Percentage of Participants Who Discontinued Study Drug Due to an AE

An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. (NCT01370642)
Timeframe: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm7.1
Vaniprevir 24 Week Arm3.1
Control Arm11.2

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Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)

Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. (NCT01370642)
Timeframe: At Week 24 or 48

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm95.9
Vaniprevir 24 Week Arm97.9
Control Arm79.6

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Percentage of Participants Achieving SVR12

SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. (NCT01370642)
Timeframe: 12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm83.7
Vaniprevir 24 Week Arm84.5
Control Arm54.1

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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)

SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. (NCT01370642)
Timeframe: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm83.7
Vaniprevir 24 Week Arm84.5
Control Arm55.1

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Percentage of Participants Achieving Rapid Virologic Response (RVR)

RVR was defined as having an undetectable HCV RNA level at Week 4. (NCT01370642)
Timeframe: At Week 4

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm86.7
Vaniprevir 24 Week Arm85.6
Control Arm9.2

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Percentage of Participants Achieving Complete Early Virologic Response (cEVR)

cEVR was defined as having an undetectable HCV RNA level at Week 12. (NCT01370642)
Timeframe: At Week 12

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm94.9
Vaniprevir 24 Week Arm96.9
Control Arm46.9

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Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study

"An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted Tier 1 safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea)." (NCT01370642)
Timeframe: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)

,,
Interventionpercentage of participants (Number)
With ≥1 Tier 1 AEsanaemiabilirubin increasedGI AEsneutropenia
Control Arm85.764.370146.951.0
Vaniprevir 12 Week Arm89.860.27.162.259.2
Vaniprevir 24 Week Arm83.551.512.452.651.5

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Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels

The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort. (NCT01389323)
Timeframe: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Both Weeks 4 and 12EOTPost-treatment Week 12Post-treatment Week 24
Black/African American Cohort6.328.164.168.870.364.155.571.150.846.9
Latino Cohort12.127.168.275.773.874.858.978.555.155.1
White Non-Latino Cohort6.730.050.066.766.766.743.393.363.363.3

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Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels

The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels NCT01389323)
Timeframe: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Both Weeks 4 and 12EOTPost-treatment Week 24
Black/African American Cohort32.864.177.376.676.671.168.073.446.9
Latino Cohort44.972.085.081.381.380.477.679.457.0
White Non-Latino Cohort33.360.066.780.076.776.756.793.363.3

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Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene

SVR12 was defined as Hepatitis C Virus (HCV) RNA levels NCT01389323)
Timeframe: Post-treatment Week 12

,,
Interventionpercentage of participants (Number)
Wild Type (CC) (n=20, 24, 10)Heterozygous (CT) (n=58, 69, 17)Minor Homozygous (TT) (n=50, 14, 3)
Black/African American Cohort80.053.436.0
Latino Cohort70.850.764.3
White Non-Latino Cohort80.058.866.7

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Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)

SVR12 was defined as Hepatitis C Virus (HCV) RNA levels NCT01389323)
Timeframe: Post-treatment Week 12

Interventionpercentage of participants (Number)
Black/African American Cohort50.8
Latino Cohort57.0
White Non-Latino Cohort66.7

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Percentage of Participants With an AE of Neutropenia in India

Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant. (NCT01390844)
Timeframe: Up to 96 weeks

,
InterventionPercentage of Participants (Number)
Grade 1 (1.0 to 1.5x10^9/L of neutrophils)Grade 2 (0.75 to <1.0x10^9/L of neutrophils)Grade 3 (0.5 to <0.75x10^9/L of neutrophils)Grade 4 (<0.5x10^9/L of neutrophils)
Boceprevir - India51.112.86.42.1
Control - India29.24.200

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Percentage of Participants With an AE of Neutropenia in Korea and Taiwan

Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant. (NCT01390844)
Timeframe: Up to 96 weeks

,
InterventionPercentage of Participants (Number)
Grade 1 (1.0 to 1.5x10^9/L of neutrophils)Grade 2 (0.75 to <1.0x10^9/L of neutrophils)Grade 3 (0.5 to <0.75x10^9/L of neutrophils)Grade 4 (<0.5x10^9/L of neutrophils)
Boceprevir - Korea+Taiwan30.124.822.63.8
Control - Korea+Taiwan41.520.012.30.0

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Percentage of Participants in India Achieving EVR at Treatment Week 8

Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8) (NCT01390844)
Timeframe: Treatment Week 8

InterventionPercentage of Participants (Number)
Boceprevir - India59.57
Control - India25.00

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Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population

SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR. (NCT01390844)
Timeframe: Follow-up Week 24

InterventionPercentage of Participants (Number)
Boceprevir - India53.19
Control - India20.83

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Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population

SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR. (NCT01390844)
Timeframe: Follow-up Week 24

InterventionPercentage of Participants (Number)
Boceprevir - India53.19
Control - India21.74

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Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8

Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8) (NCT01390844)
Timeframe: Treatment Week 8

InterventionPercentage of Participants (Number)
Boceprevir - Korea+Taiwan73.68
Control - Korea+Taiwan44.62

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Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population

SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR. (NCT01390844)
Timeframe: Follow-up Week 24

InterventionPercentage of Participants (Number)
Boceprevir - Korea+Taiwan60.90
Control - Korea+Taiwan26.15

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Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population

SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR. (NCT01390844)
Timeframe: Follow-up Week 24

InterventionPercentage of Participants (Number)
Boceprevir - Korea+Taiwan61.83
Control - Korea+Taiwan26.56

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Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan

Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters). (NCT01390844)
Timeframe: Up to 96 weeks

,
InterventionPercentage of Participants (Number)
Grade 1 (9.5 to <11 g/dL of hemoglobin)Grade 2 (8.0 to <9.5 g/dL of hemoglobin)Grade 3 (6.5 to <8.0 g/dL of hemoglobin)Grade 4 (<6.5 g/dL of hemoglobin)
Boceprevir - Korea+Taiwan34.629.34.50.0
Control - Korea+Taiwan43.17.70.00.0

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Percentage of Participants With an AE of Anemia in India

Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters). (NCT01390844)
Timeframe: Up to 96 weeks

,
InterventionPercentage of Participants (Number)
Grade 1 (9.5 to <11 g/dL of hemoglobin)Grade 2 (8.0 to <9.5 g/dL of hemoglobin)Grade 3 (6.5 to <8.0 g/dL of hemoglobin)Grade 4 (<6.5 g/dL of hemoglobin)
Boceprevir - India25.546.810.60
Control - India33.38.300

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Number of Participants With Adverse Events

Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs (NCT01405027)
Timeframe: Throughout entire study, at end of treatment and follow up week 24

Interventionparticipants (Number)
Group A - HCEE77
Group B - Community Sites95

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Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.

Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. (NCT01405027)
Timeframe: Follow-up week 24

,
Interventionpercentage of participants (Number)
Negative (percent)Positive (percent)Missing (percent)
Group A - HCEE48.823.827.4
Group B - Community Sites46.026.527.4

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Drug Exposure

Total number of patients receiving treatment over specified time intervals. (NCT01405027)
Timeframe: End of treatment up to treatment week 48

,
Interventionparticipants (Number)
Days 1-7Days 8-14Days 15-28Days 29-56Days 57-84Days 85-168Days 169-252Days >252
Group A - HCEE8484838178734926
Group B - Community Sites113112110108100917530

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Treatment Duration Compliance Rate

The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B). (NCT01405027)
Timeframe: End of treatment up to treatment week 48

InterventionPercentage of compliance (Mean)
Group A - HCEE85.4
Group B - Community Sites83.8

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Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)

"Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs.~Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life." (NCT01405027)
Timeframe: Baseline, end of treatment, follow-up week 24

,
Interventionscore (Mean)
Physical Component Score - baselinePhysical Component Score - End of treatmentPhysical Component Score - Follow-up weekMental Component Score - BaselineMental Component Score - End of treatmentMental Component Score - Follow-up weekPhysical Functioning - BaselinePhysical Functioning - End of treatmentPhysical Functioning - Follow-up weekPhysical Role Functioning - BaselinePhysical Role Functioning - End of treatmentPhysical Role Functioning - Follow-up weekBodily Pain - BaselineBodily Pain - End of treatmentBodily Pain - Follow-up weekGeneral Health - BaselineGeneral Health - End of treatmentGeneral Health - Follow-up weekVitality - BaselineVitality - End of treatmentVitality - Follow-up weekSocial Functioning - BaselineSocial Functioning - End of treatmentSocial Functioning - Follow-up weekEmotional Role Functioning - BaselineEmotional Role Functioning - End of treatmentEmotional Role Functioning - Follow-up weekMental Health - BaselineMental Health - End of treatmentMental Health - Follow-up week
Group A - HCEE44.642.949.252.245.354.876.168.384.271.047.180.763.165.176.767.765.974.657.544.671.782.466.089.886.661.185.676.469.583.3
Group B - Community Sites45.543.749.451.445.251.977.170.382.368.047.081.868.966.073.865.769.074.058.243.065.782.867.987.280.364.282.076.668.577.2

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Percentage of Participants Achieving SVR12

SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405560)
Timeframe: 12 weeks after 24 weeks of study therapy (up to 36 weeks)

Interventionpercentage of participants (Number)
Vaniprevir 24 Week Arm61.9

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Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405560)
Timeframe: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)

Interventionpercentage of participants (Number)
With ≥1 specific AEsanaemiabilirubin increasedGI AEsneutropenia
Vaniprevir 24 Week Arm78.640.57.152.440.5

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Percentage of Participants Who Discontinued Study Drug Due to an AE

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. (NCT01405560)
Timeframe: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)

Interventionpercentage of participants (Number)
Vaniprevir 24 Week Arm2.4

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Percentage of Participants Achieving Undetectable HCV Ribonucleic Acid (RNA) at the End of Treatment (EOT)

Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405560)
Timeframe: At Week 24

Interventionpercentage of participants (Number)
Vaniprevir 24 Week Arm95.2

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Mean Change From Baseline in HCV RNA (Log 10)

"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable." (NCT01405560)
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24

InterventionLog IU/ml (Mean)
Change From BL at Week 2 (n=42)Change From BL at Week 4 (n=42)Change From BL at Week 8 (n=42)Change From BL at Week 12 (n=41)Change From BL at Week 24 (n=39)
Vaniprevir 24 Week Arm-5.5-6.1-6.5-6.5-6.6

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Percentage of Participants Achieving Complete Early Virologic Response (cEVR)

cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405560)
Timeframe: At Week 12

Interventionpercentage of participants (Number)
Vaniprevir 24 Week Arm95.2

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Percentage of Participants Achieving Rapid Virologic Response (RVR)

RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405560)
Timeframe: At Week 4

Interventionpercentage of participants (Number)
Vaniprevir 24 Week Arm57.1

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Percentage of Participants Achieving Sustained Virologic Response (SVR)24

SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405560)
Timeframe: 24 weeks after 24 weeks of study therapy (up to 48 weeks)

Interventionpercentage of participants (Number)
Vaniprevir 24 Week Arm61.9

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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)

SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405937)
Timeframe: 24 weeks after 24 weeks of study therapy (up to 48 weeks)

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm92.0
Vaniprevir 24 Week Arm96.2

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Percentage of Participants Achieving Rapid Virologic Response (RVR)

RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405937)
Timeframe: At Week 4

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm88.0
Vaniprevir 24 Week Arm88.5

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Percentage of Participants Achieving Complete Early Virologic Response (cEVR)

cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405937)
Timeframe: At Week 12

InterventionPercentage of participants (Number)
Vaniprevir 12 Week Arm100.0
Vaniprevir 24 Week Arm100.0

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Percentage of Participants Who Discontinued Study Drug Due to an AE

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. (NCT01405937)
Timeframe: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm4.0
Vaniprevir 24 Week Arm0.0

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Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal (GI) adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405937)
Timeframe: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)

,
Interventionpercentage of participants (Number)
With ≥1 specific AEsanaemiabilirubin increasedGI AEsneutropenia
Vaniprevir 12 Week Arm88.056.08.064.040.0
Vaniprevir 24 Week Arm84.661.53.865.442.3

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Mean Change From Baseline in HCV RNA (Log 10)

"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable." (NCT01405937)
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24

,
InterventionLog IU/ml (Mean)
Change From BL at Week 2 (n=25, 26)Change From BL at Week 4 (n=25, 26)Change From BL at Week 8 (n=25, 26)Change From BL at Week 12 (n=25, 26)Change From BL at Week 24 (n=24, 26)
Vaniprevir 12 Week Arm-5.7-6.5-6.6-6.6-6.7
Vaniprevir 24 Week Arm-5.7-6.3-6.5-6.5-6.5

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Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)

Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405937)
Timeframe: At Week 24

InterventionPercentage of participants (Number)
Vaniprevir 12 Week Arm100.0
Vaniprevir 24 Week Arm100.0

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Percentage of Participants Achieving SVR12

SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen. (NCT01405937)
Timeframe: 12 weeks after 24 weeks of study therapy (up to 36 weeks)

Interventionpercentage of participants (Number)
Vaniprevir 12 Week Arm88.0
Vaniprevir 24 Week Arm92.3

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Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)

SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder. (NCT01425203)
Timeframe: Follow-up Week 24 (up to 72 weeks)

Interventionpercentage of participants (Number)
RGT BOC + PR74.8
PBO + PR (Control)46.2

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Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)

SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder. (NCT01425203)
Timeframe: Follow-up Week 24 (up to 72 weeks)

Interventionpercentage of participants (Number)
RGT BOC + PR76.3
PBO + PR (Control)46.8

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Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8

EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8. (NCT01425203)
Timeframe: Treatment Week 8

Interventionpercentage of participants (Number)
RGT BOC + PR87.4
PBO + PR (Control)42.3

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Percentage of Participants With End of the Treatment Response (EOTR)

EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment. (NCT01428063)
Timeframe: End of the study (Week 24)

InterventionPercentage of participants (Number)
Daclatasvir + Asunaprevir85.9
DCV + ASV + pegIFN-2a+ Ribavirin97.9
DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)90.0
DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)100.0
DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)90.9
DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)92.3
DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)84.0
DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)88.9
DCV + pegIFN-2a+ RBV83.3

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Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)

SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. (NCT01428063)
Timeframe: Week 12 (Follow-up period)

InterventionPercentage of participants (Number)
Daclatasvir + Asunaprevir85.9
DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4)90.0
DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)40.0
DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)100.0
DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)90.9
DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)76.9
DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)84.0
DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)88.9
DCV + pegIFN-2a+ RBV50.0

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Percentage of Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12. (NCT01428063)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Daclatasvir + Asunaprevir87.9
DCV + ASV + pegIFN-2a+ Ribavirin95.8
DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)90.0
DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)100.0
DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)90.9
DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)92.3
DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)76.0
DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)88.9
DCV + pegIFN-2a+ RBV83.3

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Percentage of Participants With Extended Rapid Virologic Response (eRVR)

eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12. (NCT01428063)
Timeframe: Week 4 and 12

InterventionPercentage of participants (Number)
Daclatasvir + Asunaprevir67.7
DCV + ASV + pegIFN-2a+ Ribavirin87.5
DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)70.0
DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)83.3
DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)81.8
DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)76.9
DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)64.0
DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)88.9
DCV + pegIFN-2a+ RBV83.3

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Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4

RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4. (NCT01428063)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Daclatasvir + Asunaprevir72.7
DCV + ASV + pegIFN-2a+ Ribavirin91.7
DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)70.0
DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)83.3
DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)90.9
DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)76.9
DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)76.0
DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)88.9
DCV + pegIFN-2a+ RBV83.3

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Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)

SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24. (NCT01428063)
Timeframe: Week 24 (Follow-up)

InterventionPercentage of participants (Number)
Daclatasvir + Asunaprevir84.8
DCV + ASV + pegIFN-2a+ Ribavirin95.8
DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)40.0
DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)100.0
DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)90.9
DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)76.9
DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)84.0
DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)88.9
DCV + pegIFN-2a+ RBV50.0

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Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)

SVR12 defined as HCV RNANCT01428063)
Timeframe: Week 12 (Follow-up period)

InterventionPercentage of participants (Number)
Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR)94.6

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Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT01428063)
Timeframe: For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation

,,,,,,,,
InterventionParticipants (Number)
SAEsAEs leading to discontinuation of therapyDeath
Daclatasvir + Asunaprevir420
DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)000
DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)010
DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)200
DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)000
DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)000
DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)120
DCV + ASV + pegIFN-2a+ Ribavirin020
DCV + pegIFN-2a+ RBV000

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Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment

The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment. (NCT01429792)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Pegylated Interferon Alfa 2a (Peginterferon)51.97

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Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24

The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment (NCT01429792)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Pegylated Interferon Alfa 2a (Peginterferon)15.6

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Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment

The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12. (NCT01429792)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Pegylated Interferon Alfa 2a (Peginterferon)15.7

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Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment. (NCT01429792)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Pegylated Interferon Alfa 2a (Peginterferon)48.03

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Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment

The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment (NCT01429792)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Pegylated Interferon Alfa 2a (Peginterferon)50.8

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Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24

The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study. (NCT01429792)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Pegylated Interferon Alfa 2a (Peginterferon)6.9

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Mean Change From Baseline in Serum HCV RNA Levels at Day 2 and Day 28

Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. (NCT01439373)
Timeframe: Baseline (Day 1, Pre -dose ) and Day 2 (24 h, post-dose), Day 28

,
InterventionLog IU/mL (Mean)
Day 2, 24 h post-doseDay 28, Pre or Post AM dose
GSK2336805 60 mg + PEG + RIBA-2.38-4.78
Placebo + PEG + RIBA-0.11-1.99

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Mean Area Under the Concentration-time Curve (AUC[0-24]), AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK2336805, at Day 1

AUC values were determined using the linear-up, log-down trapezoidal rule. The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were below quantification limit (BLQ) before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters. (NCT01439373)
Timeframe: 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2)

InterventionNanogram (ng)*h/mL (Geometric Mean)
AUC (0-24)AUC(0-inf)
GSK2336805 60 mg (Part A)2977.793284.90

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Mean Pre-dose Concentration and Concentration at 2 to 4 h Post-dose of GSK2336805 at Days 7, 14, 21, and 28

The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters. (NCT01439373)
Timeframe: 0 (pre-dose), 0 to 2 h, > 2 h up to 4 h, > 4 h up to 6 h, or > 6 h up to 10 h on Days 7, 14, 21 and 28

Interventionng/ml (Geometric Mean)
Day 7, PredoseDay 7, >2 to 4 hDay 7, >4 to 6 hDay 14, PredoseDay 14, >0 to 2 hDay 14, >2 to 4 hDay 14, >4 to 6 hDay 21, PredoseDay 21, >2 to 4 hDay 21, >4 to 6 hDay 21, >6 to 10 hDay 28, PredoseDay 28, >0 to 2 hDay 28, >2 to 4 h
GSK2336805 60 mg (Part A)37.80621.40314.19121.57518.82364.75304.03484.18346.00546.72317.4916.95607.02402.05

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Median Serum Alanine Aminotransferase at Baseline, Day 7, 14, 21, 28 and 42

Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels. (NCT01439373)
Timeframe: Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42

,
InterventionU/L (Median)
BaselineDay 7Day 14Day 21Day 28Follow-up (Day 42)
GSK2336805 60 mg + PEG + RIBA56.041.528.027.028.029.0
Placebo + PEG + RIBA43.537.048.539.048.027.0

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Mean Serum HCV RNA Levels at Baseline (Day 1), Day 2 and Day 28

Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. (NCT01439373)
Timeframe: Baseline (Day 1, pre-dose), Day 2 (24 h, Post-dose) and Day 28

,
InterventionLog IU/mL (Mean)
Day 1, Pre-dose,Day 2, 24 h post-doseDay 28, Pre or Post ante meridian (AM) dose
GSK2336805 60 mg + PEG + RIBA6.614.231.80
Placebo + PEG + RIBA5.435.333.44

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Mean Maximum Plasma Concentration of GSK2336805 (Cmax) and Concentration at 24 h (C24) at Day 1

The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by non-compartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters. (NCT01439373)
Timeframe: 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1)

Interventionng/mL (Geometric Mean)
CmaxC24
GSK2336805 60 mg (Part A)404.8426.98

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Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis

The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed by nominal analysis was reported. (NCT01439373)
Timeframe: Day 28

InterventionPosterior probability (Mean)
GSK2336805 60 mg + PEG + RIBA0.67
Placebo + PEG + RIBA0.21

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Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses

The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed was reported. (NCT01439373)
Timeframe: Day 28

InterventionPosterior probability (Mean)
GSK2336805 60 mg + PEG + RIBA0.62
Placebo + PEG + RIBA0.21

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Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period

AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (NCT01439373)
Timeframe: Up to Day 28

,
InterventionParticipants (Count of Participants)
Any AEAny SAE
GSK2336805 60 mg + PEG + RIBA110
Placebo + PEG + RIBA40

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Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade Hematology Parameters for Day 1 to Day 28

Laboratory abnormalities were graded according to the modified division of AIDS ( DAIDS)version 1.0. Shift from Baseline to worst post baseline toxicity grade (where applicable) were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Hematology parameters were red blood cell, hemoglobin, hematocrit, platelet white blood cell count with differential leukocyte count, mean corpuscular volume, prothrombin time and international normalized ratio. (NCT01439373)
Timeframe: Baseline (Day 1) to Day 28

,
InterventionParticipants (Count of Participants)
Hemoglobin, No toxicityHemoglobin, Grade 1Hemoglobin, Grade 2International normalized ratio, No toxicityInternational normalized ratio, Grade 1Lymphocytes absolute, No toxicityLymphocytes absolute, Grade 4Platelet count, No toxicityPlatelet count, Grade 1Platelet count, Grade 2Prothrombin time, No toxicityProthrombin time, Grade 1Total neutrophils, absolute, No toxicityTotal neutrophils, absolute, Grade 1Total neutrophils, absolute, Grade 2Total neutrophils, absolute, Grade 3White cell count, No toxicityWhite cell count, Grade 1White cell count, Grade 2
GSK2336805 60 mg + PEG + RIBA73110110110101017121821
Placebo + PEG + RIBA3103140301312200310

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Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade for Serum Chemistry Parameters for Day 1 to Day 28

Abnormalities were graded according to the modified DAIDS version 1.0. Shift from Baseline to worst post Baseline toxicity grade were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Clinical chemistry parameters were alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, creatine phosphokinase, total CO2, chloride, creatinine, glucose, sodium, phosphate, potassium, total albumin, total bilirubin, and direct bilirubin. Only participants with change in toxicity grades are reported. (NCT01439373)
Timeframe: Baseline (Day 1) and 28

,
InterventionParticipants (Count of Participants)
Alanine aminotransferase, No toxicityAlanine aminotransferase, Grade 1Albumin, No toxicityAlbumin, Grade 1Aspartate aminotransferase, No toxicityAspartate aminotransferase, Grade 1Aspartate aminotransferase, Grade 2Total Bilirubin, No toxicityTotal Bilirubin, Grade 1Total Bilirubin, Grade 2Carbon dioxide, No toxicityCarbon dioxide, Grade 1Creatine phosphokinase, No toxicityCreatine phosphokinase, Grade 1Glucose, No toxicityGlucose, Grade 1Glucose, Grade 2Phosphorus, inorganic, No toxicityPhosphorus, inorganic, Grade 1Phosphorus, inorganic, Grade 2Potassium, No toxicityPotassium, Grade 1Sodium, No toxicitySodium, Grade 2
GSK2336805 60 mg + PEG + RIBA1101108109208110154182110192
Placebo + PEG + RIBA213111130111404004003040

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Number of Participants With Vital Signs of Potential Clinical Concern

The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported. (NCT01439373)
Timeframe: Up to 42 days

InterventionParticipants (Count of Participants)
GSK2336805 60 mg + PEG + RIBA0
Placebo + PEG + RIBA0

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Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses)

RVR was defined as the proportion of participants LOD <18 IU/mL for HCV RNA after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure. Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants. The primary and supportive analysis differs from the nominal analysis as supportive analysis is assessed at Day 28 ± 2 (2 days visit window) whereas, the nominal analysis was assessed at Day 28. (NCT01439373)
Timeframe: Day 28

,
InterventionParticipants (Count of Participants)
Undetectable HCV RNAHCV RNA >= LLOQ
GSK2336805 60 mg + PEG + RIBA74
Placebo + PEG + RIBA13

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Mean Apparent Clearance (CL/F) of GSK2336805

The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters (NCT01439373)
Timeframe: 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1)

InterventionL/h (Geometric Mean)
GSK2336805 60 mg18.27

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Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale

Blood samples for determination of HCV RNA levels were collected at immediately prior to and 1, 2, 4, 6, and 8 and 24 h after the first dose in Part 1 (Day 1). Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value. Virus RNA levels reported as <43 are undetectable levels. If the result for HCV RNA (IU/ML) was <43, then change from Baseline was calculated using 42, and the change from Baseline on the log scale was calculated using log (42). (NCT01439373)
Timeframe: Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h)

,
InterventionLog IU/mL (Mean)
1 h post-dose2 h post-dose4 h post-dose6 h post-dose8 h post-dose24 h post-dose
GSK2336805 60 mg (Part A)0.02-0.03-0.70-1.37-1.83-2.38
Placebo (Part A)-0.01-0.00-0.070.080.07-0.11

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Change From Baseline in QTcF Interval at Day 2 and 28

Single 12-lead electrocardiogram (ECG) was obtained. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. QTc Interval was calculated using Frederica correction formula: QTcF = QT / (RR)^1/3. Change from Baseline was calculated by subtracting the Baseline assessment value from post Baseline visit value. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. The change from Baseline in QTc Interval at Day 2 and 28 were reported. (NCT01439373)
Timeframe: Baseline (Day 1, Pre-dose ), Day 2 and Day 28

,
Interventionmsec (Mean)
DAY 2DAY 28
GSK2336805 60 mg + PEG + RIBA0.01-5.15
Placebo + PEG + RIBA0.829.13

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Change From Baseline in Serum Alanine Aminotransferase Levels

Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value. (NCT01439373)
Timeframe: Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42

,
InterventionUnits per litre (U/L) (Mean)
Day 7Day 14Day 21Day 28Follow-up (Day 42)
GSK2336805 60 mg + PEG + RIBA-15.3-25.7-25.9-24.4-19.5
Placebo + PEG + RIBA-15.0-0.5-10.07.0-19.5

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Median Time of Maximal Plasma Concentration (Tmax) of GSK2336805 and Lag Time Before First Observation of Quantifiable Concentration (Tlag) at Day 1

The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters (NCT01439373)
Timeframe: 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2)

Interventionh (Median)
TmaxTlag
GSK2336805 60 mg (Part A)2.000.00

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Number of Participants With Shifts in Urinalysis Parameters From Normal at Baseline to Abnormal

The urinalysis parameters analyzed were Leukocyte esterase, bilirubin, occult blood, glucose, ketones, nitrite, pH, specific gravity and dipstick assessments. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important urinalysis findings at specified visit were reported. Visits where no abnormal values were observed not reported. (NCT01439373)
Timeframe: Day 14, 28, Follow-up (Day 42)

,
InterventionParticipants (Count of Participants)
Occult blood, Day 14Occult blood, Follow-upKetone, Day 14Nitrate, Day 14Leukocytes, Day 14
GSK2336805 60 mg + PEG + RIBA00111
Placebo + PEG + RIBA11211

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Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis

RVR was defined as the proportion of participants below the assay lower limit of detection (LOD) <18 International units per milliliter (IU/mL) for Hepatitis C virus (HCV) ribonucleic acid (RNA) after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure . Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants. (NCT01439373)
Timeframe: Day 28

,
InterventionParticipants (Count of Participants)
HCV RNA >= Low Limit of Quantification (LLOQ)Undetectable HCV RNA
GSK2336805 60 mg + PEG + RIBA38
Placebo + PEG + RIBA31

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Number of Participants With HCV Genotype 1 With Virologic Response

Serum for determination of HCV genotype was collected at the screening visit. Genotype was determined by the VERSANT HCV genotype 2.0 Assay (LiPA). Number of participants with HCV genotype 1 were reported. (NCT01439373)
Timeframe: Day 7, 14 and 21

,
InterventionParticipants (Count of Participants)
Day 7, Undetectable HCV RNADay 7, Detectable HCV RNA but < LLOQDay 7, HCV RNA >= LLOQDay 14, Undetectable HCV RNADay 14, Detectable HCV RNA but < LLOQDay 14, HCV RNA >= LLOQDay 21, Undetectable HCV RNADay 21, Detectable HCV RNA but < LLOQDay 21, HCV RNA >= LLOQ
GSK2336805 60 mg + PEG + RIBA119425713
Placebo + PEG + RIBA004004004

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Participants With Adverse Events

Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability. (NCT01441180)
Timeframe: 24 weeks

,,
Interventionpartipants (Number)
Any grade 3-4 eventAny Serious Adverse EventDeathDiscontinuation owing to an adverse event
Phase 11000
Phase 2 Arm A (Sofosbuvir + Weight Based RBV)1000
Phase 2 Arm B (Sofosbuvir + Low-dose RBV)5100

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Sustained Virologic Response

Sustained virology response at 24 weeks post treatment completion (NCT01441180)
Timeframe: 24 weeks post treatment completion

Interventionpercentage of total participants (Number)
Phase 1100
Phase 2 Arm A71
Phase 2 Arm B55

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Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression

Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders. (NCT01447420)
Timeframe: At Week 72

InterventionPercentage of participants (Number)
Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC63.2
Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT26.4
Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT33.3

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Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12

Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: < 1.0 log IU/ml; >= 1.0 and < 2.0 log IU/ml; >= 2.0 and < 3.0 log IU/ml; >= 3.0 and <4.0 log IU/ml; >= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively. (NCT01447420)
Timeframe: From Baseline (Week 0) to Week 12

,,
Interventionparticipants (Number)
Week 0 - Week 4 (<1.0 log10 UI / ml)Week 0 - Week 4 (>=1.0 e < 2.0 log10 UI / ml)Week 0 - Week 4 (>=2.0 e < 3.0 log10 UI / ml)Week 0 - Week 4 (>=3.0 e < 4.0 log10 UI / ml)Week 0 - Week 4 (>=4.0 log10 UI / ml)Week 0 - Week 12 (<1.0 log10 UI / ml)Week 0 - Week 12 (>=1.0 e < 2.0 log10 UI / ml)Week 0 - Week 12 (>=2.0 e < 3.0 log10 UI / ml)Week 0 - Week 12 (>=3.0 e < 4.0 log10 UI / ml)Week 0 - Week 12 (>=4.0 log10 UI / ml)
Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC049138035522
Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT2624132319112226
Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT10511035334

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Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment

Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported. (NCT01447420)
Timeframe: Up to Week 72

,,
Interventionparticipants (Number)
SVR with No anemia (n = 15, 20, 6)In the first month of treatment (n = 10, 15, 2)After the first month of treatment (n = 13, 37,10)
Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC969
Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT4312
Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT204

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Percentage of Participants With Incidence of Anemia

Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb < 11 gram per decilitre (g/dL) for women and Hb < 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population. (NCT01447420)
Timeframe: Up to Week 72

InterventionPercentage of participants (Number)
Peginterferon Alfa-2a Plus Ribavirin67.4

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Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression

Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a >= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT. (NCT01447420)
Timeframe: Weeks 4, 12, 24, 48, 60 and 72

,,
Interventionparticipants (Number)
RVR rate, Week 4 (n = 14)pEVR rate, Week 12 (n = 33)cEVR rate, Week 12 (n = 72)VR rate, Week 24 (n = 87)VR rate, EOT (Week 48) (n = 74)VR rate, 12 weeks post-treatment (n = 50)SVR rate, 24 weeks or more post-treatment (n = 49)
Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC1143131282524
Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT3243646371919
Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT05510966

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Percentage of Participants With Concomitant Medical Condition at Baseline

(NCT01447446)
Timeframe: Baseline

Interventionpercentage of participants (Number)
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin48.1
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin50.4
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin65.8
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin68.8
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin67.2
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin41.9

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Virological Relapse After End of Treatment

Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL). (NCT01447446)
Timeframe: Up to 24 weeks after EOT (up to 118 weeks)

Interventionpercentage of participants (Number)
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin18.4
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin19.7
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin21.0
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin20.6
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin13.8
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin7.5

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Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)

Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA). (NCT01447446)
Timeframe: Up to 72 weeks of treatment

,,,
Interventionpercentage of participants (Number)
Discontinued DAA During Week 1 to Week 2Discontinued DAA During Week 3 to Week 4Discontinued DAA During Week 5 to Week 12Discontinued DAA During Week 13 to Week 24Discontinued DAA During Week 25 to Week 48
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin6.82.113.416.159.2
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin7.51.18.618.364.5
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin1.71.524.771.70.4
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin4.74.722.168.60.0

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Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)

Participants who prolonged the treatment period from 72 weeks were not reported. (NCT01447446)
Timeframe: Up to 72 weeks of treatment

,,,,,
Interventionpercentage of participants (Number)
Discontinued PEG-IFN During Week 1 to Week 12Discontinued RBV During Week 1 to Week 12Discontinued PEG-IFN During Week 13 to Week 24Discontinued RBV During Week 13 to Week 24Discontinued PEG-IFN During Week 25 to Week 48Discontinued RBV During Week 25 to Week 48Discontinued PEG-IFN During Week 49 to Week 72Discontinued RBV During Week 49 to Week 72
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin5.76.313.522.141.743.036.226.6
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin8.39.117.122.441.346.632.121.0
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin9.29.616.817.130.141.141.129.1
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin9.710.814.016.129.041.947.331.2
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin9.910.810.213.941.044.938.930.3
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin11.612.812.819.843.041.932.625.6

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Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions

SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days. (NCT01447446)
Timeframe: Up to first 12 weeks of treatment

,,,,,
Interventionpercentage of participants (Number)
SVR at Week 12 After EOTSVR at Week 24 EOT
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin37.135.3
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin27.324.2
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin20.717.2
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin14.314.3
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin35.434.2
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin44.444.4

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Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)

SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period. (NCT01447446)
Timeframe: 24 weeks after end of treatment (up to 118 weeks)

Interventionpercentage of participants (Number)
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin52.1
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin49.4
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin46.6
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin50.5
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin57.7
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin47.7

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Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)

SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period. (NCT01447446)
Timeframe: 12 weeks after end of treatment (up to 118 weeks)

Interventionpercentage of participants (Number)
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin54.3
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin51.0
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin50.0
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin53.8
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin62.0
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin57.0

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Virological Response at Various on Treatment Time Points and End of Treatment (EOT)

Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants. (NCT01447446)
Timeframe: Week 4, 12 and End of treatment (EOT) (up to 96 weeks)

,,,,,
Interventionpercentage of participants (Number)
VR by Week 4VR by Week 12VR by EOT
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin39.571.373.6
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin40.167.770.6
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin9.956.867.1
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin9.759.172.0
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin49.880.874.9
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin51.273.366.3

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Percentage of Participants With Adverse Events (AE)

An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment. (NCT01447446)
Timeframe: Up to 118 weeks

Interventionpercentage of participants (Number)
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin60.3
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin65.7
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin76.7
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin88.2
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin90.7
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin87.2

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Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)

Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir. (NCT01447446)
Timeframe: Up to 98 weeks

Interventionpercentage of participants (Number)
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin37.7
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin32.3
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin45.6
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin47.7

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Duration of Overall Treatment

Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks. (NCT01447446)
Timeframe: Up to 118 weeks

InterventionWeeks (Mean)
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin34.2
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin31.3
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin35.2
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin35.3
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin33.2
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin31.2

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Virological Breakthrough

Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation. (NCT01447446)
Timeframe: Up to EOT (up to 118 weeks)

Interventionpercentage of participants (Number)
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin5.4
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin4.8
Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin8.7
Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin15.9
Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin15.0
Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin21.6

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Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels

Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. (NCT01448044)
Timeframe: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Weeks 4 and 12 (VR 4 & 12)EOTPost treatment Week 24Post treatment Week 48
Daclatasvir + PegIFNα2a + Ribavirin14.645.185.480.587.884.179.390.278.081.8
Placebo + PegIFNα2a + Ribavirin0.09.511.916.738.147.611.964.340.5NA

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Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene

Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively. (NCT01448044)
Timeframe: Post Treatment Weeks 12, 24

,
InterventionPercentage of participants (Number)
IL28B Genotype CC (SVR12) (n=22, 9)IL28B Genotype CT (SVR12) (n=40, 27)IL28B Genotype TT (SVR12) (n=20, 6)IL28B Genotype CC (SVR24) (n=22, 9)IL28B Genotype CT (SVR24) (n=40, 27)IL28B Genotype TT (SVR24) (n=20, 6)
Daclatasvir + PegIFNα2a + Ribavirin95.575.080.095.572.580.0
Placebo + PegIFNα2a + Ribavirin100.033.30.088.933.30.0

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Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)

Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. (NCT01448044)
Timeframe: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Weeks 4 and 12End of TreatmentPost treatment Week 24Post treatment Week 48
Daclatasvir + PegIFNα2a + Ribavirin53.789.091.584.187.885.484.192.780.583.6
Placebo + PegIFNα2a + Ribavirin4.811.919.040.547.659.519.064.340.5NA

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Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation. (NCT01448044)
Timeframe: From Day 1 (start of study treatment) up to Follow-up Week 4

,
Interventionparticipants (Number)
AEs leading to discontinuation of study drugSAEsDeath
Daclatasvir + PegIFNα2a + Ribavirin480
Placebo + PegIFNα2a + Ribavirin320

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Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)

Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12. (NCT01448044)
Timeframe: Week 12 (Follow-up period)

InterventionPercentage of participants (Number)
Daclatasvir + PegIFNα2a + Ribavirin81.7
Placebo + PegIFNα2a + Ribavirin42.9

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Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment

Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures. (NCT01458535)
Timeframe: Post-treatment Day 1 to Post-treatment Week 24

Interventionpercentage of participants (Number)
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants100
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants80.0
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants40.0
ABT-450/r and ABT-267 in Genotype 1 Participants60.0
ABT-450/r and ABT-267 in Genotype 2 Participants60.0
ABT-450/r and ABT-267 in Genotype 3 Participants9.1

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Percentage of Participants With Virologic Failure During Treatment

Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment). (NCT01458535)
Timeframe: Day 1 through Week 12

,,,,,
Interventionpercentage of participants (Number)
Participant ReboundsParticipants who fail to Suppress
ABT-450/r and ABT-267 in Genotype 1 Participants10.00
ABT-450/r and ABT-267 in Genotype 2 Participants10.00
ABT-450/r and ABT-267 in Genotype 3 Participants72.70
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants00
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants10.00
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants30.00

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Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)

Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures. (NCT01458535)
Timeframe: Post-treatment Day 1 to Post-treatment Week 48

Interventionpercentage of participants (Number)
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants0
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants0
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants28.6
ABT-450/r and ABT-267 in Genotype 1 Participants22.2
ABT-450/r and ABT-267 in Genotype 2 Participants22.2
ABT-450/r and ABT-267 in Genotype 3 Participants50.0

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Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)

Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures. (NCT01458535)
Timeframe: Week 2

Interventionpercentage of participants (Number)
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants100
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants100
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants100
ABT-450/r and ABT-267 in Genotype 1 Participants100
ABT-450/r and ABT-267 in Genotype 2 Participants100
ABT-450/r and ABT-267 in Genotype 3 Participants100

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Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)

Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures. (NCT01458535)
Timeframe: Week 4

Interventionpercentage of participants (Number)
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants100
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants100
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants90.0
ABT-450/r and ABT-267 in Genotype 1 Participants100
ABT-450/r and ABT-267 in Genotype 2 Participants90.0
ABT-450/r and ABT-267 in Genotype 3 Participants27.3

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Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures. (NCT01458535)
Timeframe: Week 4 through Week 12

Interventionpercentage of participants (Number)
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants100
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants90.0
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants70.0
ABT-450/r and ABT-267 in Genotype 1 Participants90.0
ABT-450/r and ABT-267 in Genotype 2 Participants80.0
ABT-450/r and ABT-267 in Genotype 3 Participants18.2

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Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment

Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures. (NCT01458535)
Timeframe: Post-treatment Day 1 to Post-treatment Week 12

Interventionpercentage of participants (Number)
ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants100
ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants80.0
ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants50.0
ABT-450/r and ABT-267 in Genotype 1 Participants60.0
ABT-450/r and ABT-267 in Genotype 2 Participants60.0
ABT-450/r and ABT-267 in Genotype 3 Participants9.1

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Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)

"SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups." (NCT01459913)
Timeframe: 4 weeks after last planned dose of study drug (up to Week 28)

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)89.6
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)98.1

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Number of Subjects With Extended Rapid Viral Response (eRVR)

"The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups." (NCT01459913)
Timeframe: Week 4 and Week 12

Interventionparticipants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)105
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)51

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Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)

"SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups." (NCT01459913)
Timeframe: 24 weeks after last planned dose of study drug (up to Week 48)

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)85.8
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)92.3

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Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

"SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups." (NCT01459913)
Timeframe: 12 weeks after last planned dose of study drug (up to Week 36)

Interventionpercentage of participants (Number)
Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)88.7
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)96.2

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Percentage of Subjects With On-Treatment Virologic Failure

On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well. (NCT01459913)
Timeframe: Baseline up to Week 48

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)0
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)0
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)0
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)3.3
Telaprevir+Peg-IFN-alfa-2a, RBV (Total)0.8

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Number of Subjects With Rapid Viral Response (RVR)

"The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups." (NCT01459913)
Timeframe: Week 4

Interventionparticipants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)106
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)52

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Percentage of Subjects With Viral Relapse

"Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups." (NCT01459913)
Timeframe: After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up

,
Interventionpercentage of participants (Number)
4 Weeks12 Weeks24 Weeks
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)1.97.510.4
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)0.00.00.0

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Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)

"SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups." (NCT01459913)
Timeframe: Week 72

Interventionpercentage of participants (Number)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)72.4
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)86.5

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Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study." (NCT01459913)
Timeframe: Baseline up to Week 48

,,,
Interventionparticipants (Number)
AEsSAEs
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)1045
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)6113
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)193
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)514

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Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin

This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 [Group B] or ABT-450/ritonavir plus ABT-267 [Groups C + D + J]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L). (NCT01464827)
Timeframe: Post-Treatment Week 24

Interventionpercentage of participants (Number)
Group B82.9
Groups C + D + J88.7
Groups F + G + K + L95.2

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Number of Participants With Adverse Events (AEs)

"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either:~Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention." (NCT01464827)
Timeframe: From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).

,,,,,,,,
Interventionparticipants (Number)
Any adverse eventAny adverse event at least possibly DAA-relatedAny severe adverse eventAny serious adverse eventAny AE leading to discontinuation of study drugAny AE leading to interruption of study drugAny AE leading to ribavirin dose modificationAny fatal adverse events
Group A6758301020
Group B3629000120
Group C + D7153320240
Group E6851520100
Group F + G7157313090
Group H + I77683131100
Group J4235101030
Group K + L3930100010
Group M + N3728121030

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Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders

This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N). (NCT01464827)
Timeframe: Post-Treatment Week 24

Interventionpercentage of participants (Number)
Groups F + G + H + I93.7
Groups K + L + M + N94.3

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Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin

"The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G)." (NCT01464827)
Timeframe: Post Treatment Week 24

Interventionpercentage of participants (Number)
Group A87.5
Group B82.9
Group C84.6
Group D92.5
Group E88.6
Group F97.4
Group G95.0
Group H92.5
Group I90.0
Group J88.9
Group K91.3
Group L95.5
Group M91.3
Group N100.0

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Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin

This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N). (NCT01464827)
Timeframe: Post-Treatment Week 24

Interventionpercentage of participants (Number)
Group A87.5
Groups F + G + K + L95.2
Groups H + I + M + N92.7

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Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin

This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with or without ribavirin (Group E versus Groups F + G + K + L). (NCT01464827)
Timeframe: Post-Treatment Week 24

Interventionpercentage of participants (Number)
Group E88.6
Groups F + G + K + L95.2

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Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

(NCT01466192)
Timeframe: After 24 weeks of follow-up

Interventionpercentage of subjects achieving SVR (Number)
MP-42488.0

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Number of Participants With Viral Breakthrough

Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions. (NCT01466790)
Timeframe: Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]

InterventionParticipants (Number)
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks0
Cohort 1: TMC435 and PSI-7977 for 24 Weeks0
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks0
Cohort 1: TMC435 and PSI-7977 for 12 Weeks0
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks0
Cohort 2: TMC435 and PSI-7977 for 24 Weeks0
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks0
Cohort 2: TMC435 and PSI-7977 for 12 Weeks0

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Number of Participants With Viral Relapse

Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period. (NCT01466790)
Timeframe: During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]

InterventionParticipants (Number)
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks1
Cohort 1: TMC435 and PSI-7977 for 24 Weeks0
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks1
Cohort 1: TMC435 and PSI-7977 for 12 Weeks1
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks0
Cohort 2: TMC435 and PSI-7977 for 24 Weeks0
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks2
Cohort 2: TMC435 and PSI-7977 for 12 Weeks1

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Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)

Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment. (NCT01466790)
Timeframe: Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)

InterventionParticipants (Number)
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks19
Cohort 1: TMC435 and PSI-7977 for 24 Weeks14
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks26
Cohort 1: TMC435 and PSI-7977 for 12 Weeks13
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks28
Cohort 2: TMC435 and PSI-7977 for 24 Weeks16
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks25
Cohort 2: TMC435 and PSI-7977 for 12 Weeks13

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Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)

Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment. (NCT01466790)
Timeframe: Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)

InterventionParticipants (Number)
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks19
Cohort 1: TMC435 and PSI-7977 for 24 Weeks14
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks26
Cohort 1: TMC435 and PSI-7977 for 12 Weeks13
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks28
Cohort 2: TMC435 and PSI-7977 for 24 Weeks16
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks25
Cohort 2: TMC435 and PSI-7977 for 12 Weeks13

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Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)

Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment. (NCT01466790)
Timeframe: Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)

InterventionParticipants (Number)
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks20
Cohort 1: TMC435 and PSI-7977 for 24 Weeks14
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks26
Cohort 1: TMC435 and PSI-7977 for 12 Weeks13
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks28
Cohort 2: TMC435 and PSI-7977 for 24 Weeks16
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks26
Cohort 2: TMC435 and PSI-7977 for 12 Weeks14

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Number of Participants With a Sustained Virologic Response (SVR) at Week 48

Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48. (NCT01466790)
Timeframe: Week 48

InterventionParticipants (Number)
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks19
Cohort 1: TMC435 and PSI-7977 for 24 Weeks14
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks26
Cohort 1: TMC435 and PSI-7977 for 12 Weeks13
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks27
Cohort 2: TMC435 and PSI-7977 for 24 Weeks16
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks24
Cohort 2: TMC435 and PSI-7977 for 12 Weeks13

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Number of Participants With Inadequate Virologic Response

Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition. (NCT01466790)
Timeframe: Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]

InterventionParticipants (Number)
Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks0
Cohort 1: TMC435 and PSI-7977 for 24 Weeks0
Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks0
Cohort 1: TMC435 and PSI-7977 for 12 Weeks0
Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks0
Cohort 2: TMC435 and PSI-7977 for 24 Weeks0
Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks0
Cohort 2: TMC435 and PSI-7977 for 12 Weeks0

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Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)

SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (NCT01467479)
Timeframe: 24 weeks after last planned dose of study drug (up to Week 72)

,,
Interventionpercentage of participants (Number)
Treatment Naïve (n= 23, 38, 29)Prior Relapser (n=8, 11, 4)Prior Null Responder (n= 15, 9, 14)Prior Partial Responder (n= 7, 8, 9)Total (n= 53, 66, 56)
T/PR + HAART Regimen (ATV/r-Based)65.275.033.314.350.9
T/PR + HAART Regimen (EFV-Based)57.954.522.275.054.5
T/PR + HAART Regimen (RAL-Based)51.710035.755.651.8

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Percentage of Participants With Rapid Viral Response (RVR)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (NCT01467479)
Timeframe: Week 4

,,
Interventionpercentage of participants (Number)
Treatment Naïve (n= 24, 39, 31)Prior Relapser (n=8, 11, 4)Prior Null Responder (n= 15, 11, 15)Prior Partial Responder (n= 7, 8, 9)Total (n= 54, 69, 59)
T/PR + HAART Regimen (ATV/r-Based)50.062.526.742.944.4
T/PR + HAART Regimen (EFV-Based)53.872.754.550.056.5
T/PR + HAART Regimen (RAL-Based)74.210053.344.466.1

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Percentage of Participants With Extended Rapid Viral Response (eRVR)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (NCT01467479)
Timeframe: Week 4 and Week 12

,,
Interventionpercentage of participants (Number)
Treatment Naïve (n= 24, 39, 31)Prior Relapser (n=8, 11, 4)Prior Null Responder (n= 15, 11, 15)Prior Partial Responder (n= 7, 8, 9)Total (n= 54, 69, 59)
T/PR + HAART Regimen (ATV/r-Based)50.062.526.714.340.7
T/PR + HAART Regimen (EFV-Based)53.872.754.550.056.5
T/PR + HAART Regimen (RAL-Based)61.310053.344.459.3

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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. (NCT01467479)
Timeframe: Up to Week 52

,,
Interventionpercentage of participants (Number)
AEsSAEs
T/PR + HAART Regimen (ATV/r-Based)10013.0
T/PR + HAART Regimen (EFV-Based)95.711.6
T/PR + HAART Regimen (RAL-Based)94.915.3

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Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment. (NCT01467479)
Timeframe: Baseline, follow-up (Week 96)

Interventionparticipants (Number)
Baseline (n = 180)Follow-up (n = 26)
T/PR + HAART Regimen211

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Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)

Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir. (NCT01467479)
Timeframe: Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir

,,
Interventionnanogram per milliliter (ng/mL) (Mean)
ATV: Day -14 to Day -1, Cmax(n=46, 0, 0)ATV: Day -14 to Day -1, Cmin(n=46, 0, 0)ATV: Day -14 to Day -1, Cavg(n=41, 0, 0)ATV: Week 1, Cmax (n=42, 0, 0)ATV: Week 1, Cmin (n=42, 0, 0)ATV: Week 1, Cavg (n=30, 0, 0)EFV: Day -14 to Day -1, Cmax(n=0, 60, 0)EFV: Day -14 to Day -1, Cmin(n=0, 60, 0)EFV: Day -14 to Day -1, Cavg(n=0, 51, 0)EFV: Week 1, Cmax (n=0, 51, 0)EFV: Week 1, Cmin (n=0, 51, 0)EFV: Week 1, Cavg (n=0, 47, 0)RAL: Day -14 to Day -1, Cmax(n=0, 0, 52)RAL: Day -14 to Day -1, Cmin(n=0, 0, 52)RAL: Day -14 to Day -1, Cavg(n=0, 0, 35)RAL: Week 1, Cmax (n=0, 0, 49)RAL: Week 1, Cmin (n=0, 0, 49)RAL: Week 1, Cavg (n=0, 0, 34)Telaprevir: Week 1, Cmax(n=49, 59, 54)Telaprevir: Week 1, Cmin(n=49, 59, 54)Telaprevir: Week 1, Cavg(n=30, 32, 26)
T/PR + HAART Regimen (ATV/r-Based)28709911100282012801320NANANANANANANANANANANANA316016502320
T/PR + HAART Regimen (EFV-Based)NANANANANANA380025602150334022901920NANANANANANA378017502430
T/PR + HAART Regimen (RAL-Based)NANANANANANANANANANANANA19001964832320281643347018402520

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Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (NCT01467479)
Timeframe: 12 weeks after last planned dose of study drug (up to Week 60)

,,
Interventionpercentage of participants (Number)
Treatment Naïve (n= 24, 39, 31)Prior Relapser (n=8, 11, 4)Prior Null Responder (n= 15, 11, 15)Prior Partial Responder (n= 7, 8, 9)Total (n= 54, 69, 59)
T/PR + HAART Regimen (ATV/r-Based)66.775.04014.353.7
T/PR + HAART Regimen (EFV-Based)59.054.536.487.558.0
T/PR + HAART Regimen (RAL-Based)61.31004055.657.6

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Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (NCT01467479)
Timeframe: EOT (up to Week 48)

Interventionpercentage of participants (Number)
T/PR + HAART Regimen (ATV/r-Based)55.6
T/PR + HAART Regimen (EFV-Based)63.8
T/PR + HAART Regimen (RAL-Based)61.0

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Percentage of Participants With On Treatment Virologic Failure

On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category. (NCT01467492)
Timeframe: Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48

,
Interventionpercentage of participants (Number)
Prior Null Response, Week 2Prior Null Response, Week 4Prior Null Response, Week 8Prior Null Response, Week 12Prior Null Response, Week 16Prior Null Response, Week 24Prior Null Response, Week 28Prior Null Response, Week 36Prior Null Response, Week 40Prior Null Response, Week 48Prior Partial Response, Week 2Prior Partial Response, Week 4Prior Partial Response, Week 8Prior Partial Response, Week 12Prior Partial Response, Week 16Prior Partial Response, Week 24Prior Partial Response, Week 28Prior Partial Response, Week 36Prior Partial Response, Week 40Prior Partial Response, Week 48Prior Relapse, Week 2Prior Relapse, Week 4Prior Relapse, Week 8Prior Relapse, Week 12Prior Relapse, Week 16Prior Relapse, Week 24Prior Relapse, Week 28Prior Relapse, Week 36Prior Relapse, Week 40Prior Relapse, Week 48Total, Week 2Total, Week 4Total, Week 8Total, Week 12Total, Week 16Total, Week 24Total, Week 28Total, Week 36Total, Week 40Total, Week 48
Group A - Black04.98.512.219.523.223.225.628.029.302.42.44.94.96.16.17.37.37.30001.21.21.21.21.21.21.207.311.018.325.630.530.534.136.637.8
Group B - Non-Black02.67.97.97.910.513.213.213.213.200002.67.910.510.510.510.5000002.62.62.65.35.302.67.97.910.521.126.326.328.928.9

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Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)

SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (NCT01467492)
Timeframe: 12 weeks after last actual dose of study drug (up to Week 60)

,
Interventionpercentage of participants (Number)
Prior Null Response (n = 41, 10)Prior Partial Response (n= 20, 6)Prior Relapse ( n= 21, 22)Total (n= 82, 38)
Group A - Black26.840.066.740.2
Group B - Non-Black20.033.359.144.7

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Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response. (NCT01467492)
Timeframe: up to Week 72

Interventionparticipants (Number)
All Participants47

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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. (NCT01467492)
Timeframe: Up to Week 52

,
Interventionpercentage of participants (Number)
AESAE
Group A - Black96.38.5
Group B - Non-Black100.015.8

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Percentage of Participants With Extended Rapid Viral Response (eRVR)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (NCT01467492)
Timeframe: Week 4 and Week 12

,
Interventionpercentage of participants (Number)
Prior Null Response (n = 41, 10)Prior Partial Response (n= 20, 6)Prior Relapse ( n= 21, 22)Total (n= 82, 38)
Group A - Black24.445.066.740.2
Group B - Non-Black30.066.768.257.9

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Percentage of Participants With Relapse

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (=lower limit of quantification) during follow-up. (NCT01467492)
Timeframe: 4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT

,
Interventionpercentage of participants (Number)
Prior Null Response, 4 Wk After EOT (n=17,3)Prior Null Response, 12 Wk After EOT (n=17,3)Prior Null Response, 24 Wk After EOT (n=17,3)Prior Partial Response, 4Wk After EOT (n=13,4)Prior Partial Response, 12 Wk After EOT (n=13,4)Prior Partial Response, 24 Wk After EOT (n=13,4)Prior Relapse, 4 Wk After EOT (n=18,19)Prior Relapse, 12 Wk After EOT (n=18,19)Prior Relapse, 24 Wk After EOT (n=18,19)Total, 4 Wk After EOT (n=48,26)Total, 12 Wk After EOT (n=48,26)Total, 24 Wk After EOT (n=48,26)
Group A - Black23.523.529.415.423.123.111.111.111.116.718.820.8
Group B - Non-Black33.333.333.350.050.050.015.826.326.323.130.830.8

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Percentage of Participants With Virologic Breakthrough

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (NCT01467492)
Timeframe: Week 2, 4, 8, and 12

,
Interventionpercentage of participants (Number)
Prior Null Response, Week 2Prior Null Response, Week 4Prior Null Response, Week 8Prior Null Response, Week 12Prior Partial Response, Week 2Prior Partial Response, Week 4Prior Partial Response, Week 8Prior Partial Response, Week 12Prior Relapse, Week 2Prior Relapse, Week 4Prior Relapse, Week 8Prior Relapse, Week 12Total, Week 2Total, Week 4Total, Week 8Total, Week 12
Group A - Black01.23.76.102.42.42.40001.203.73.79.8
Group B - Non-Black02.65.35.30000000002.65.35.3

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Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)

SVR24 was defined as an undetectable HCV RNA Levels (NCT01467492)
Timeframe: 24 weeks after last actual dose of study drug (up to Week 72)

,
Interventionpercentage of participants (Number)
Prior Null Response (n = 41, 10)Prior Partial Response (n= 20, 6)Prior Relapse ( n= 21, 22)Total (n= 82, 38)
Group A - Black19.530.061.932.9
Group B - Non-Black20.016.750.036.8

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

"Any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study." (NCT01467505)
Timeframe: Baseline up to Week 52

,
Interventionparticipants (Number)
AEsSAEs
T/PR + Immunosuppressant Regimen (Cyclosporine)103
T/PR + Immunosuppressant Regimen (Tacrolimus)5111

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Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)

SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. (NCT01467505)
Timeframe: 24 weeks after last planned dose of study drug (up to Week 72)

,
Interventionpercentage of participants (Number)
Naive (n= 5,1)Prior Relapser (n= 4,1)Prior Null Responder (n=10, 4)Prior Partial Responder (n= 0, 1)Uncategorized (n= 5, 0)Total (n= 24, 7)
T/PR + Immunosuppressant Regimen (Cyclosporine)0050.0100.0042.9
T/PR + Immunosuppressant Regimen (Tacrolimus)60.025.020.0020.029.2

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Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (NCT01467505)
Timeframe: 12 weeks after last planned dose of study drug (up to Week 60)

,
Interventionpercentage of participants (Number)
Naive (n= 16, 2)Prior Relapser (n= 10, 2)Prior Null Responder (n=16, 4)Prior Partial Responder (n= 3, 1)Uncategorized (n= 6, 1)Total (n= 51, 10)
T/PR + Immunosuppressant Regimen (Cyclosporine)50.0100.050.0100.0100.070.0
T/PR + Immunosuppressant Regimen (Tacrolimus)75.060.037.566.750.056.9

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Percentage of Participants With Rapid Viral Response (RVR)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. (NCT01467505)
Timeframe: Week 4

,
Interventionpercentage of participants (Number)
Naive (n= 16, 2)Prior Relapser (n= 10, 2)Prior Null Responder (n=16, 4)Prior Partial Responder (n= 3, 1)Uncategorized (n= 6, 1)Total (n= 51, 10)
T/PR + Immunosuppressant Regimen (Cyclosporine)050.025.0100.0030.0
T/PR + Immunosuppressant Regimen (Tacrolimus)68.850.043.866.733.352.9

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Percentage of Participants With Extended Rapid Viral Response (eRVR)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. (NCT01467505)
Timeframe: Week 4 and Week 12

,
Interventionpercentage of participants (Number)
Naive (n= 16, 2)Prior Relapser (n= 10, 2)Prior Null Responder (n=16, 4)Prior Partial Responder (n= 3, 1)Uncategorized (n= 6, 1)Total (n= 51, 10)
T/PR + Immunosuppressant Regimen (Cyclosporine)050.025.0100.0030.0
T/PR + Immunosuppressant Regimen (Tacrolimus)68.850.037.566.733.351.0

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Percentage of Participants With On-Treatment Virologic Failure

On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response. (NCT01467505)
Timeframe: Baseline up to Week 48

Interventionpercentage of participants (Number)
T/PR + Immunosuppressant Regimen (Tacrolimus)0
T/PR + Immunosuppressant Regimen (Cyclosporine)0

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Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

(NCT01468584)
Timeframe: After 24 weeks of follow-up

Interventionpercentage of subjects achieving SVR (Number)
MP-42450.0

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Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation

Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: From Day 1 to 7 days post last dose of study treatment (up to Week 48)

,,,,
InterventionParticipants (Number)
DeathsSAEsGrade 3 to 4 AEsAEs leading to discontinuation
HAART Therapy: Daclatasvir 30 or 60 or 90 mg2249317
HAART Therapy: Daclatasvir, 30 mg + 60 mg06356
HAART Therapy: Daclatasvir, 60 mg16124
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg012467
Non-HAART Therapy: Daclatasvir, 60 mg0041

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Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Follow-up Week 12

InterventionPercentage of participants (Number)
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg75
HAART Therapy: Daclatasvir, 60 mg71.8
HAART: Daclatasvir, 30 mg + 60 mg71.7
HAART Therapy: Daclatasvir 30 or 60 or 90 mg73.3
Non-HAART Therapy: Daclatasvir, 60 mg87.5

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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)

Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Weeks 4 and 12End of treatmentFollow-up Week 12Follow-up Week 24
HAART Therapy: Daclatasvir 30 or 60 or 90 mg933.964.374.47881.261.484.873.370.4
Non-HAART Therapy: Daclatasvir, 60 mg16.75091.787.595.891.787.595.887.583.3

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Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene

Percentages calculated as number of responders/number who received treatment. (NCT01471574)
Timeframe: Follow-up Week 12

,,,,
InterventionPercentage of participants (Number)
CC Genotype (n=36, 14, 39, 89, 6)CT Genotype (n=72, 22, 50,144, 15)TT Genotype (n=22, 3, 12, 37, 2)Not reported (n=2, 0, 5, 7, 1)
HAART Therapy: Daclatasvir 30, 60 or 90 mg87.667.462.271.4
HAART Therapy: Daclatasvir, 30 mg + 60 mg79.570.058.360.0
HAART Therapy: Daclatasvir, 60 mg92.963.633.30.0
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg94.466.768.2100.0
Non-HAART Therapy: Daclatasvir, 60 mg100.093.350.00.0

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Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL

Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined. (NCT01471574)
Timeframe: End of treatment (up to Week 48)

,,,
InterventionPercentage of participants (Number)
HIV RNA <40 copies/mLHIV RNA ≥400 copies/mL
HAART Therapy: Daclatasvir 30 or 60 or 90 mg90.60.4
HAART Therapy: Daclatasvir, 30mg + 60 mg93.40.0
HAART Therapy: Daclatasvir, 60 mg89.72.6
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg88.60.0

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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)

Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Weeks 4 and 12End of treatmentFollow-up Week 12Follow-up Week 24
HAART Therapy: Daclatasvir 30 or 60 or 90 mg39.771.582.784.184.185.278.784.873.370.4
Non-HAART Therapy: Daclatasvir, 60 mg41.791.795.887.595.891.791.795.887.583.3

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Percentage of Participants With Viral Breakthrough

Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy. (NCT01479868)
Timeframe: Week 1 to 48

Interventionpercentage of participants (Number)
TMC435 150mg 12Wks PR24/4811.4

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Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load

(NCT01479868)
Timeframe: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72

Interventioncopies per milliliter (Mean)
Baseline (n=93)Change at Week 2 (n=91)Change at Week 4 (n=93)Change at Week 8 (n=92)Change at Week 12 (n=90)Change at Week 16 (n=88)Change at Week 20 (n=86)Change at Week 24 (n=88)Change at Week 28 (n=82)Change at Week 36 (n=85)Change at Week 42 (n=35)Change at Week 48 (n=79)Change at Week 52 (n=36)Change at Week 60 (n=40)Change at Week 72 (n=38)Change at End of study (n=93)
TMC435 150mg 12Wks PR24/481.3726-0.0724-0.0704-0.0442-0.0655-0.0829-0.0847-0.0689-0.05640.0004-0.0623-0.00410.0011-0.0184-0.02650.0099

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Mean Change From Baseline in CD4+ Cell Count

(NCT01479868)
Timeframe: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72

Interventioncell counts per microliter (Mean)
Baseline (n=93)Change at Week 2 (n=89)Change at Week 4 (n=91)Change at Week 8 (n=92)Change at Week 12 (n=91)Change at Week 16 (n=88)Change at Week 20 (n=84)Change at Week 24 (n=89)Change at Week 28 (n=82)Change at Week 36 (n=83)Change at Week 42 (n=33)Change at Week 48 (n=77)Change at Week 52 (n=35)Change at Week 60 (n=40)Change at Week 72 (n=38)Change at End of Study (n=93)
TMC435 150mg 12Wks PR24/48640.3-95.0-171.5-244.2-271.7-275.5-283.5-288.8-252.3-198.7-336.8-166.6-202.7-90.6-62.9-51.1

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Change From Baseline in CD4+ Cell Count in Percentage

(NCT01479868)
Timeframe: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72

Interventionpercentage of lymphocyte (Mean)
Baseline (n=93)Change at Week 2 (n=89)Change at Week 4 (n=91)Change at Week 8 (n=92)Change at Week 12 (n=91)Change at Week 16 (n=88)Change at Week 20 (n=84)Change at Week 24 (n=89)Change at Week 28 (n=82)Change at Week 36 (n=83)Change at Week 42 (n=33)Change at Week 48 (n=77)Change at Week 52 (n=35)Change at Week 60 (n=40)Change at Week 72 (n=38)Change at End of study (n=93)
TMC435 150mg 12Wks PR24/4831.650.422.503.853.935.475.275.503.792.756.412.093.260.250.700.13

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Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)

The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment. (NCT01479868)
Timeframe: 24 weeks after end of treatment (Week 24 or 48)

Interventionpercentage of participants (Number)
TMC435 150mg 12Wks PR24/4872.6

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Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)

The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 12 Weeks after end of treatment. (NCT01479868)
Timeframe: 12 weeks after end of treatment (Week 24 or 48)

Interventionpercentage of participants (Number)
TMC435 150mg 12Wks PR24/4873.6

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Percentage of Participants With On-treatment Failure

Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels. (NCT01479868)
Timeframe: Week 1 to 48

Interventionpercentage of participants (Number)
TMC435 150mg 12Wks PR24/4817

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Percentage of Participants With Normalized Alanine Aminotransferase Levels

Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline. (NCT01479868)
Timeframe: Baseline up to Week 72

Interventionpercentage of participants (Number)
TMC435 150mg 12Wks PR24/4881.5

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Percentage of Participants With Viral Relapse

Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL. (NCT01479868)
Timeframe: Week 1 to 72

Interventionpercentage of participants (Number)
TMC435 150mg 12Wks PR24/4810.3

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Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable

Percentage of participants with HCV RNA less than (<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed. (NCT01479868)
Timeframe: Week 4, 12, 24, 36, and 48

Interventionpercentage of participants (Number)
Week 4: < 25 IU/mL HCV-RNA undet. (n=105)Week 4:< 25 IU/mL HCV-RNA det./undet. (n=105)Week 12:< 25 IU/mL HCV-RNA undet. (n=97)Week 12:< 25 IU/mL HCV-RNA det./undet. (n=97)Week 24:< 25 IU/mL HCV-RNA undet. (n=90)Week 24:< 25 IU/mL HCV-RNA det./undet. (n=90)Week 48:< 25 IU/mL HCV-RNA undet. (n=20)Week 48:< 25 IU/mL HCV-RNA det./undet. (n=20)
TMC435 150mg 12Wks PR24/4865.788.694.897.990.093.3100100

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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state. (NCT01479868)
Timeframe: Week 1 to Week 72

Interventionparticipants (Number)
TEAEsTESAEs
TMC435 150mg 12Wks PR24/481026

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Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure

Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL. (NCT01479868)
Timeframe: Baseline to Week 72.

Interventionpercentage of participants (Number)
Greater than or equal to 50 copies/mLGreater than or equal to 200 copies/mL
TMC435 150mg 12Wks PR24/485.42.2

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Percentage of Participants With HIV-1 Viral Load <50 Copies/mL

HIV-1 RNA testing was performed with Abbott RealTime HIV-1 assay (LLOQ=40 copies/mL) or with Roche COBAS AmpliPrep/Taqman HIV-1 assay (LLOQ=20 copies/mL). (NCT01482767)
Timeframe: Entry and weeks (W) 4, 8, 12, 24, 28, 40, 48, 52, 60, 72

,
Interventionpercentage of participants (Number)
W0 HIV-1 RNA (A: n=133, B: n=122)W4 HIV-1 RNA (A: n=123, B: n=114)W8 HIV-1 RNA (A: n=117, B: n=104)W12 HIV-1 RNA (A: n=108, B: n=99)W24 HIV-1 RNA (A: n=62, B: n=52)W28 HIV-1 RNA: (A: n=54, B: n=45)W40 HIV-1 RNA (A: n=52, B: n=38)W48 HIV-1 RNA (A: n=23, B: n=33)W52 HIV-1 RNA (A: n=24, B: n=0)W60 HIV-1 RNA (A: n=40, B: n=36)W72 HIV-1 RNA (A: n=34, B: n=27)
HCV Treatment-Experienced (Group B)92.696.596.298.0100.0100.0100.0100.0NA97.2100.0
HCV Treatment-Naive (Group A)100.098.4100.098.1100.098.192.3100.0100.0100.097.1

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Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits

Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0. (NCT01482767)
Timeframe: Weeks (W) 4, 8, 12

,
Interventionparticipants (Number)
W4 HCV RNA (A: n=122, B: n=116)W8 HCV RNA (A: n=117, B: n=104)W12 HCV RNA (A: n=109, B: n=99)
HCV Treatment-Experienced (Group B)32843
HCV Treatment-Naive (Group A)94868

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Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)

SVR12 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 12 weeks after treatment discontinuation. Participants without HCV RNA for SVR12 determination were considered not to have achieved SVR12. (NCT01482767)
Timeframe: 12 weeks after treatment discontinuation

Interventionpercentage of participants (Number)
HCV Treatment-Naive (Group A)35.6
HCV Treatment-Experienced (Group B)30.3

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Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)

Number of participants who experienced an AE (sign or symptom or laboratory abnormality) of Grade 3 or higher at any time after baseline while on study. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. (NCT01482767)
Timeframe: From study treatment dispensation to Week 72

Interventionpercentage of participants (Number)
HCV Treatment-Naive (Group A)74.1
HCV Treatment-Experienced (Group B)73.8

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Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)

SVR24 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 24 weeks after treatment discontinuation. Participants without HCV RNA for SVR24 determination were considered not to have achieved SVR24. (NCT01482767)
Timeframe: 24 weeks after treatment discontinuation

Interventionpercentage of participants (Number)
HCV Treatment-Naive (Group A)34.8
HCV Treatment-Experienced (Group B)25.4

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CD4+ T-Cell Count (CD4) Change From Baseline

Change in CD4 T-cell count was calculated as value at the post entry visit minus the value at entry. (NCT01482767)
Timeframe: Entry and weeks (W) 8, 12, 24, 28, 40, 48, 52, 60, 72

,
Interventioncells/mm^3 (Median)
W8 CD4 change (A: n=115, B: n=101)W12 CD4 change (A: n=106, B: n=95)W24 CD4 change (A: n=61, B: n=52)W28 CD4 change (A: n=53, B: n=44)W40 CD4 change (A: n=50, B: n=37)W48 CD4 change (A: n=22, B: n=35)W52 CD4 change (A: n=23, B: n=0)W60 CD4 change (A: n=39, B: n=36)W72 CD4 change (A: n=33, B: n=27)
HCV Treatment-Experienced (Group B)-170-202-263-284-276-237NA-79-15
HCV Treatment-Naive (Group A)-174-194-277-304-128-220-24-348

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Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment. (NCT01492426)
Timeframe: Week 12 (Follow-up period)

InterventionPercentage of participants (Number)
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin64.9
Telaprevir + PEG-IFN Alpha-2a + Ribavirin69.7

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Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4

RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment. (NCT01492426)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin77.2
Telaprevir + PEG-IFN Alpha-2a + Ribavirin79.1

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Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12. (NCT01492426)
Timeframe: Week 12 (Follow-up period)

InterventionPercentage of participants (Number)
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin85.1
Telaprevir + PEG-IFN Alpha-2a + Ribavirin81.3

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Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)

SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment. (NCT01492426)
Timeframe: Week 24 (Follow-up period)

InterventionPercentage of participants (Number)
Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin84.3
Telaprevir + PEG-IFN Alpha-2a + Ribavirin80.6

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Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment. (NCT01492426)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin90.7
Telaprevir + PEG-IFN Alpha-2a + Ribavirin90.03

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Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12

eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment. (NCT01492426)
Timeframe: Week 4, Week 12

InterventionPercentage of participants (Number)
Daclatasvir + PEG-IFN Alpha-2a + Ribavirin75.0
Telaprevir + PEG-IFN Alpha-2a + Ribavirin73.1

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Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

Changes from baseline in log10 HCV RNA levels were calculated. (NCT01498068)
Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48

,
InterventionLog 10 IU/mL (Median)
Baseline (n=16, 20)Week 4 (n=16, 20)Week 8 (n=16,19)Week 12 (n=15,19)Week 24 (n=14, 19)Week 32 (n=2, 12)Week 40 (n=2, 12)Week 48 (n=2, 12)
Treatment-experienced6.10-5.33-5.39-5.39-5.39-5.46-5.46-5.46
Treatment-naïve6.20-5.47-5.50-5.46-5.53-5.30-5.30-3.14

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Number of Participants in Each Specific Category of Treatment Outcome

Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =>25 IU/mL during follow-up period after previous HCV RNA<25 IU/mL at planned end of treatment(EOT)[Week 24 or Week 48] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase >1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA has previously become <25 IU/mL during treatment).Stopping rule defined as HCV RNA value >1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA <25 IU/mL at actual EOT and never HCV RNA =>25 IU/mL thereafter. (NCT01498068)
Timeframe: From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)

,
InterventionParticipants (Number)
SVR12RelapseOn treatment virologic failureOther
Treatment-experienced16121
Treatment-naïve14011

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Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48

The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks. (NCT01498068)
Timeframe: Weeks 8, 12, 24, 32, 40 and 48

,
InterventionParticipants (Number)
Week 8 (n=16, 20)Week 12 (n=16, 20)Week 24 (n=16, 20)Week 32 (n=3, 14)Week 40 (n=3, 14)Week 48 (n=3, 14)
Treatment-experienced191918121212
Treatment-naïve161515221

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Number of Participants With Rapid Virologic Response (RVR) at Week 4

A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4 (NCT01498068)
Timeframe: Week 4

InterventionParticipants (Number)
Treatment-naïve14
Treatment-experienced18

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Number of Participants With Extended Rapid Virologic Response (eRVR)

A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment. (NCT01498068)
Timeframe: Week 4 and Week 12

InterventionParticipants (Number)
Treatment-naïve13
Treatment-experienced18

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Number of Participants With Virologic Failure

Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40. (NCT01498068)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40

InterventionParticipants (Number)
Treatment-naïve1
Treatment-experienced2

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Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)

Patient who developed signs of lower respiratory tract infection (NCT01502072)
Timeframe: 14 days

Interventionpercentage of participants (Number)
Oral Ribavirin8
Inhaled Ribavirin30
No Ribavirin10

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Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA596386
Group B2031130806

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C6hr of Deleobuvir (BI 207127)

Concentration of an analyte in plasma at 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 14)
Group ANA179005080
Group B58002080010100

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Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA127003790
Group B5620202006550

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AUC 0-infinity of Tolbutamide

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=13, 17)Day 17 (N=14, 18)Day 66 (N=12, 15)
Group A1940000180000015200001330000
Group B2220000194000014100001390000

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AUC 0-infinity of Midazolam

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A79.711712775.5
Group B10713014095.6

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AUC 0-infinity of Caffeine

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionng*h/mL (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 15)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A549004210071900120000
Group B77500142000170000159000

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AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 13)
Group A23.624.223.518.3
Group B26.028.522.820.8

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AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA4170019300
Group B133006220039100

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AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA29801620
Group B89357003510

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AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA6180015000
Group B243009880027600

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Cmax of Deleobuvir (BI 207127)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA2700010100
Group B109003140016000

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C6hr of Deleobuvir Reduction Metabolite CD 6168

Concentration of an analyte in plasma at 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 14)
Group ANA69803360
Group B2250102007460

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Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A5.576.506.465.05
Group B6.686.525.024.67

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Cmax of Deleobuvir Reduction Metabolite CD 6168

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA85204510
Group B3040124008880

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Cmax of Caffeine

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionng/mL (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A5170489048305590
Group B5340722065306450

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Cmax of Faldaprevir (BI 201335)

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionng/mL (Geometric Mean)
Day 9 (N=15,0)Day 17 (N=14,14)Day 66 (N=13,15)
Group A352087804410
Group BNA99506690

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C24hr of Faldaprevir (BI 201335)

Concentration of an analyte in plasma at 24 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionng/mL (Geometric Mean)
Day 9 (N=15,0)Day 17 (N=14,19)Day 66 (N=13,14)
Group A98336701140
Group BNA54102580

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C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)

Concentration of an analyte in plasma at 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 14)
Group ANA112002740
Group B4330175005780

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Cmax of Midazolam

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A21.129.931.921.3
Group B23.829.828.823.2

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Cmax of Tolbutamide

Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=16, 19)Day 9 (N=15, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group A152000146000130000110000
Group B170000158000126000127000

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Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionng*h/mL (Geometric Mean)
Day 9 (N=15,0)Day 17 (N=14,19)Day 66 (N=13,15)
Group A4560013800056200
Group BNA17300097300

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Number of Participants With Sustained Virological Response (SVR12)

Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12. (NCT01525628)
Timeframe: 12 weeks post treatment

InterventionParticipants (Number)
Group A13
Group B13
Group C11
Group D10
Group E3

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C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)

Concentration of an analyte in plasma at 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 14)
Group ANA508295
Group B159962712

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AUC 0-6hr of Deleobuvir (BI 207127)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.

,
Interventionnmol*h/L (Geometric Mean)
Day 9 (N=0, 17)Day 17 (N=14, 19)Day 66 (N=13, 15)
Group ANA11900036200
Group B4110013500059200

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Maximum Measured Concentration (Cmax) of CD 6168

Maximum measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir19202340021000
600mg Deleobuvir and 80mg Faldaprevir1640122007150

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Maximum Measured Concentration (Cmax) of CD 6168-AG

Maximum measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). AG=acylglucuronide. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir10620201780
600mg Deleobuvir and 80mg Faldaprevir73.7691455

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Maximum Measured Concentration (Cmax) of Deleobuvir

Maximum measured concentration of BI 207127 (Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir188005030041900
600mg Deleobuvir and 80mg Faldaprevir128003010018800

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Maximum Measured Concentration (Cmax) of Faldaprevir

Maximum measured concentration of Faldaprevir (BI 201335 ZW) in plasma following the morning dose of Nth day (Cmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionng/mL (Geometric Mean)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir64402040018700
600mg Deleobuvir and 80mg Faldaprevir338085304750

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Maximum Measured Concentration (Cmax) of RBV

Maximum measured concentration of ribavirin (RBV) in plasma following the morning dose of Nth day (Cmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57

,
Interventionng/mL (Geometric Mean)
Day 1 (N=9, 13)Day 57 (N=9, 11)
600mg Deleobuvir and 120mg Faldaprevir6012740
600mg Deleobuvir and 80mg Faldaprevir5372560

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Predose Measured Concentration of BI 208333

Predose measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57

,
Interventionnmol/L (Geometric Mean)
Cpre,11 (N=9, 13)Cpre,ss (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir1680010700
600mg Deleobuvir and 80mg Faldaprevir74501630

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Predose Measured Concentration of CD 6168

Predose measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57

,
Interventionnmol/L (Geometric Mean)
Cpre,11 (N=9, 13)Cpre,ss (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir1760013100
600mg Deleobuvir and 80mg Faldaprevir96103190

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Predose Measured Concentration of CD 6168-AG

Predose measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). AG=acylglucuronide. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57

,
Interventionnmol/L (Geometric Mean)
Cpre,11 (N=9, 13)Cpre,ss (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir16301350
600mg Deleobuvir and 80mg Faldaprevir566211

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AUC Accumulation Ratio of Deleobuvir

Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of Deleobuvir versus itself (RA,AUC,Met,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA,AUC,11 (N=11, 12)RA,AUC,57 (N=10, 13)RA,AUC,tau,Met,ss (N=10, 13)
600mg Deleobuvir and 120mg Faldaprevir3.432.741.00
600mg Deleobuvir and 80mg Faldaprevir2.601.211.00

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AUC Accumulation Ratio of CD 6168-AG

Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168-AG versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). AG=acylglucuronide. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA,AUC,11 (N=11, 8)RA,AUC,57 (N=9, 8)RA,AUC,tau,Met,ss (N=10, 12)
600mg Deleobuvir and 120mg FaldaprevirNANA0.0557
600mg Deleobuvir and 80mg Faldaprevir16.78.060.0369

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Predose Measured Concentration of Deleobuvir

Predose measured concentration of BI 207127 (Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57

,
Interventionnmol/L (Geometric Mean)
Cpre,11 (N=9, 12)Cpre,ss (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir2350016599
600mg Deleobuvir and 80mg Faldaprevir107003280

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AUC Accumulation Ratio of BI 208333

Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of BI 208333 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA,AUC,11 (N=11, 12)RA,AUC,57 (N=110 13)RA,AUC,tau,Met,ss (N=10, 13)
600mg Deleobuvir and 120mg Faldaprevir8.104.920.431
600mg Deleobuvir and 80mg Faldaprevir4.161.480.345

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Area Under the Curve (AUC) of RBV

Area under the concentration time curve (AUC) of ribavirin (RBV) in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57

,
Interventionng*h/mL (Geometric Mean)
Day 1 (N=9, 13)Day 57 (N=8, 10)
600mg Deleobuvir and 120mg Faldaprevir373027600
600mg Deleobuvir and 80mg Faldaprevir341025700

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Area Under the Curve (AUC) of Faldaprevir

Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionng*h/mL (Geometric Mean)
Day 1 (N=9, 9)Day 11 (N=11, 10)Day 57 (N=10, 11)
600mg Deleobuvir and 120mg Faldaprevir107000360000291000
600mg Deleobuvir and 80mg Faldaprevir4290011900058700

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Area Under the Curve (AUC) of Deleobuvir

Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionnmol*h/L (Geometric Mean)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=10, 13)
600mg Deleobuvir and 120mg Faldaprevir118000404000326000
600mg Deleobuvir and 80mg Faldaprevir77500216000111000

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Area Under the Curve (AUC) of CD 6168

Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionnmol*h/L (Geometric Mean)
Day 1 (N=8, 10)Day 11 (N=11, 12)Day 57 (N=10, 12)
600mg Deleobuvir and 120mg Faldaprevir13200234000191000
600mg Deleobuvir and 80mg Faldaprevir1120011100061400

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Area Under the Curve (AUC) of BI 208333

Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionnmol*h/L (Geometric Mean)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=10, 13)
600mg Deleobuvir and 120mg Faldaprevir26000210000141000
600mg Deleobuvir and 80mg Faldaprevir199009420038400

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Predose Measured Concentration of Faldaprevir

Predose measured concentration of Faldaprevir (BI 201335 ZW) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57

,
Interventionng/mL (Geometric Mean)
Cpre,11 (N=9, 12)Cpre,ss (N=11, 12)
600mg Deleobuvir and 120mg Faldaprevir138009980
600mg Deleobuvir and 80mg Faldaprevir42501540

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Predose Measured Concentration of RBV

Predose measured concentration of ribavirin (RBV) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57

,
Interventionng/mL (Geometric Mean)
Cpre,11 (N=9, 13)Cpre,ss (N=10, 12)
600mg Deleobuvir and 120mg Faldaprevir12902110
600mg Deleobuvir and 80mg Faldaprevir14002080

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Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333

Time from last dosing to the maximum concentration of BI 208333 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionhours (Median)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir7.803.995.98
600mg Deleobuvir and 80mg Faldaprevir6.005.905.97

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Percentage of Participants With Virological Response at Week 8

Percentage of participants with plasma HCV RNA (hepatitis C virus ribonucleic acid ) level <25 IU/mL (undetected or detected) at week 8. (NCT01528735)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
600mg Deleobuvir and 80mg Faldaprevir91.7
600mg Deleobuvir and 120mg Faldaprevir100.0

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Percentage of Participants With Virological Response at Week 4

Percentage of participants with plasma HCV RNA (hepatitis C virus (HCV) ribonucleic acid (RNA)) level <25 IU/mL (undetected or detected) at week 4. (NCT01528735)
Timeframe: 4 weeks

Interventionpercentage of participants (Number)
600mg Deleobuvir and 80mg Faldaprevir91.7
600mg Deleobuvir and 120mg Faldaprevir92.3

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Mean Residence Time (MRTpo,ss) of Deleobuvir

Mean residence time of BI 207127 (Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57

Interventionhours (Geometric Mean)
600mg Deleobuvir and 80mg Faldaprevir6.65
600mg Deleobuvir and 120mg Faldaprevir12.6

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Cmax Accumulation Ratio (RA,Cmax,57) of RBV

Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the 57th day and after the first dose (RA,Cmax,57). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57

InterventionRatio (Geometric Mean)
600mg Deleobuvir and 80mg Faldaprevir5.05
600mg Deleobuvir and 120mg Faldaprevir4.89

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AUC Accumulation Ratio of RBV

Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the 57th day and after the first dose (RA,AUC,57). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57

InterventionRatio (Geometric Mean)
600mg Deleobuvir and 80mg Faldaprevir8.03
600mg Deleobuvir and 120mg Faldaprevir6.89

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Apparent Clearance (CL/F,ss) of Faldaprevir

Apparent clearance of Faldaprevir (BI 201335 ZW) in plasma following extravascular administration on the 57th day (CL/F,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57

InterventionmL/min (Geometric Mean)
600mg Deleobuvir and 80mg Faldaprevir22.7
600mg Deleobuvir and 120mg Faldaprevir6.87

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Apparent Clearance (CL/F,ss) of Deleobuvir

Apparent clearance of BI 207127 (Deleobuvir) in plasma following extravascular administration on the 57th day (CL/F,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57

InterventionLitres per hour (Geometric Mean)
600mg Deleobuvir and 80mg Faldaprevir8.25
600mg Deleobuvir and 120mg Faldaprevir2.81

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Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168

Time from last dosing to the maximum concentration of CD 6168 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionhours (Median)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir9.813.944.10
600mg Deleobuvir and 80mg Faldaprevir8.003.955.83

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Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG

Time from last dosing to the maximum concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). AG=acylglucuronide. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionhours (Median)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir9.934.966.08
600mg Deleobuvir and 80mg Faldaprevir8.005.905.85

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Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir

Time from last dosing to the maximum concentration of Deleobuvir (BI 207127) in plasma after the morning dose of Nth day (Tmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionhours (Median)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir5.033.943.98
600mg Deleobuvir and 80mg Faldaprevir3.973.924.00

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AUC Accumulation Ratio of CD 6168

Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA,AUC,11 (N=10, 10)RA,AUC,57 (N=9, 11)RA,AUC,tau,Met,ss (N=10, 12)
600mg Deleobuvir and 120mg Faldaprevir17.014.20.600
600mg Deleobuvir and 80mg Faldaprevir9.575.140.552

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Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir

Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA,Cmax,11 (N=11, 12)RA,Cmax,57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir3.173.00
600mg Deleobuvir and 80mg Faldaprevir2.721.51

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Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir

Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of Deleobuvir versus itself (RA,Cmax,Met,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA,Cmax,11 (N=11, 12)RA,Cmax,57 (N=11, 13)RA,Cmax,Met,ss (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir2.682.201.00
600mg Deleobuvir and 80mg Faldaprevir2.331.461.00

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AUC Accumulation Ratio of Faldaprevir

Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA, AUC,11 (N=11, 9)RA,AUC,57 (N=10, 9)
600mg Deleobuvir and 120mg Faldaprevir3.312.26
600mg Deleobuvir and 80mg Faldaprevir2.881.28

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Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir

Time from last dosing to the maximum concentration of Faldaprevir (BI 201335 ZW) in plasma after the morning dose of Nth day (Tmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionhours (Median)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir5.984.003.97
600mg Deleobuvir and 80mg Faldaprevir3.973.923.92

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Time From Last Dosing to the Maximum Concentration (Tmax) of RBV

Time from last dosing to the maximum concentration of ribavirin (RBV) in plasma after the morning dose of Nth day (Tmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57

,
Interventionhours (Median)
Day 1 (N=9, 13)Day 57 (N=9, 11)
600mg Deleobuvir and 120mg Faldaprevir3.952.03
600mg Deleobuvir and 80mg Faldaprevir2.002.08

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Area Under the Curve (AUC) of CD 6168-AG

Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. AG=acylglucuronide. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionnmol*h/L (Geometric Mean)
Day 1Day 11 (N=11, 12)Day 57 (N=10, 12)
600mg Deleobuvir and 120mg FaldaprevirNA2070017700
600mg Deleobuvir and 80mg FaldaprevirNA64604110

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Cmax Accumulation Ratio of BI 208333

Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of BI 208333 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA,Cmax,11 (N=11, 12)RA,Cmax,57 (N=11, 13)RA,Cmax,Met,ss (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir5.733.990.349
600mg Deleobuvir and 80mg Faldaprevir3.821.600.345

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Cmax Accumulation Ratio of CD 6168

Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA,Cmax,11 (N=10, 12)RA,Cmax,57 (N=11, 13)RA,Cmax,Met,ss (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir12.210.90.500
600mg Deleobuvir and 80mg Faldaprevir8.344.900.380

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Cmax Accumulation Ratio of CD 6168-AG

Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168-AG versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). AG=acylglucuronide. (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57

,
InterventionRatio (Geometric Mean)
RA,Cmax,11 (N=11, 8)RA,Cmax,57 (N=11, 13)RA,Cmax,Met,ss (N=11, 13)
600mg Deleobuvir and 120mg FaldaprevirNA17.20.0424
600mg Deleobuvir and 80mg Faldaprevir10.87.110.0242

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Maximum Measured Concentration (Cmax) of BI 208333

Maximum measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). (NCT01528735)
Timeframe: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57

,
Interventionnmol/L (Geometric Mean)
Day 1 (N=9, 12)Day 11 (N=11, 12)Day 57 (N=11, 13)
600mg Deleobuvir and 120mg Faldaprevir36302080014600
600mg Deleobuvir and 80mg Faldaprevir2600111004630

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Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24

SVR24 rates were determined for only participants that had undetectable HCV RNA at Week 4 of treatment (Arm 1a and Arm 2a). HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL. (NCT01544920)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
Arm 1a: Peg-IFN + RBV 24 Weeks87.0
Arm 2a: BOC + Peg-IFN + RBV 24 Weeks97.2

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Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)

SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL. (NCT01544920)
Timeframe: Up to Week 74

InterventionPercentage of participants (Number)
Arm 1: Peg-IFN + RBV86.7
Arm 2: BOC + Peg-IFN + RBV88.3

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Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant

(NCT01559844)
Timeframe: Up to 48 weeks prior to transplant

Interventionpercentage of participants (Number)
SOF+RBV3.3

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Percentage of Participants With Graft Loss Following Transplant

(NCT01559844)
Timeframe: Up to 48 weeks following transplant

Interventionpercentage of participants (Number)
SOF+RBV6.5

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HCV RNA and Change From Baseline in HCV RNA Through Week 8

(NCT01559844)
Timeframe: Up to 8 weeks prior to transplant

Interventionlog10 IU/mL (Mean)
Week 1 (N = 59)Week 2 (N = 61)Week 3 (N = 60)Week 4 (N = 58)Week 8 (N = 53)
SOF+RBV-3.87-4.43-4.64-4.69-4.66

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Number of Participants Who Died

"Treatment-emergent deaths were those that occurred while taking study drug or to the minimum of 1) date of transplantation, 2) retreatment 1st dose date, or 3) last dose date + 30 days.~Only those participants who underwent liver transplantation were analyzed for death post-transplantation." (NCT01559844)
Timeframe: Up to 48 weeks following transplant

Interventionparticipants (Number)
All DeathsTreatment-Emergent Death (N = 61)Death Following Transplant (N = 46)Death Not Meeting Either Criteria (N = 61)
SOF+RBV5131

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Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48

(NCT01559844)
Timeframe: Up to 48 weeks prior to transplant

Interventionpercentage of participants (Number)
Week 1 (N = 61)Week 2 (N = 61)Week 3 (N = 60)Week 4 (N = 58)Week 8 (N = 54)Week 12 (N = 48)Week 24 (N = 30)Week 36 (N = 9)Week 48 (N = 8)
SOF+RBV13.157.481.793.190.793.8100.0100.0100.0

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Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12

pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant. (NCT01559844)
Timeframe: Posttransplant Week 12

Interventionpercentage of participants (Number)
Transplant after ≥ 12 weeks of treatment (N=32)Transplant after any duration of treatment (N=43)
SOF+RBV75.069.8

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Proportion of Participants With Virologic Failure Prior to Transplant

"Virologic failure (VF) in the pretransplant phase was defined by:~Breakthrough (HCV RNA ≥ 25 IU/ml after having previously had HCV RNA < 25 IU/ml, while on treatment)~Rebound (breakthrough or > 1 log10 IU/ml increase in HCV RNA from nadir while on treatment)~Non-response (HCV RNA ≥ 25 IU/ml through 8 weeks of treatment)~Pre-transplant relapse (HCV RNA ≥ 25 IU/ml during the Pre-Transplant off-treatment follow-up period after having achieved HCV RNA < 25 IU/ml at last observed HCV RNA on treatment)" (NCT01559844)
Timeframe: Up to 48 weeks prior to transplant

Interventionpercentage of participants (Number)
On-treatment VF (N = 61)Posttreatment/Pretransplant VF - 24 Weeks (N = 15)Posttreatment/Pretransplant VF - 48 Weeks (N = 8)
SOF+RBV8.273.337.5

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Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48

pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at the relevant time point after transplant. (NCT01559844)
Timeframe: Up to 48 weeks following transplant

Interventionpercentage of participants (Number)
Posttransplant Week 1 (N = 32)Posttransplant Week 2 (N = 32)Posttransplant Week 4 (N = 32)Posttransplant Week 8 (N = 32)Posttransplant Week 24 (N = 32)Posttransplant Week 48 (N = 30)
SOF+RBV87.581.375.075.075.066.7

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Percentage of Participants With Sustained Virologic Response 12 Weeks and 24 Weeks After Combination Therapy

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 and 24 weeks after the last dose of combination study drug. The LLOQ for the assay was 25 IU/mL. (NCT01563536)
Timeframe: 12 and 24 weeks after last dose of combination study drug

,
Interventionpercentage of participants (Number)
12 Weeks Post-treatment24 Weeks Post-treatment
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV83.383.3
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV83.383.3

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Percentage of Participants With Rapid Virologic Response

The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) after 4 weeks of combination therapy. (NCT01563536)
Timeframe: 4 weeks

Interventionpercentage of participants (Number)
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV83.3
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV100

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Percentage of Participants With Extended Rapid Virologic Response

The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at Weeks 4 through 12 of combination therapy. (NCT01563536)
Timeframe: Weeks 4 to 12

Interventionpercentage of participants (Number)
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV83.3
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV83.3

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Percentage of Participants With End-of-Treatment Response

The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at the end of combination therapy (12 weeks). (NCT01563536)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV83.3
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV83.3

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Mean Maximal Decrease From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During ABT-267 Monotherapy

The baseline value was the last measurement before the first dose of ABT-267 monotherapy (Day 1). The maximal decrease during monotherapy was the change from baseline to the lowest log10 IU/mL HCV RNA level any time from the first dose of ABT-267 on Day 1 to the last log10 HCV RNA level before the first dose of ABT-267 combination therapy (Study Day 3). (NCT01563536)
Timeframe: Pre-dose on Days 1, 2, and 3

Interventionlog10 IU/mL (Least Squares Mean)
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV-1.6
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV-3.1

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Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1

Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was estimated using noncompartmental analyses. (NCT01563536)
Timeframe: Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)

Interventionng/mL (Mean)
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV1.66
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV41.0

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Time of Maximum Plasma Concentration (Tmax) of ABT-267 Following Monotherapy on Day 1

Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Time of maximum plasma concentration (Tmax; measured in hours) was estimated using noncompartmental analyses. (NCT01563536)
Timeframe: Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)

Interventionhours (Mean)
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV3.67
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV3.67

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Mean Change in Viral Load From Baseline to Pre-dose on Day 2 and Day 3 of ABT-267 Monotherapy

The relationship between ABT-267 dose, ABT-267 concentration, and response was analyzed as the change in viral load (measured as log10 IU/mL) from baseline (pre-dose on Day 1) to pre-dose on Days 2 and 3. Plasma concentrations of ABT-267 pre-dose on Days 2 and 3 are presented above in 4. Primary Outcome: Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3. (NCT01563536)
Timeframe: Predose on Days 1, 2, and 3

,
Interventionlog10 IU/mL (Mean)
Day 2 Mean change in Viral Load from BaselineDay 3 Mean change in Viral Load from Baseline
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV-1.95-1.96
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV-2.85-3.10

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Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[24]) of ABT-267 Following Monotherapy on Day 1

Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[24]; measured in ng multiplied by hour/mL) was estimated using noncompartmental analyses. (NCT01563536)
Timeframe: Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)

Interventionng*hr/mL (Mean)
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV18.0
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV467

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Number of Participants With Adverse Events (AEs)

"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs), and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention." (NCT01563536)
Timeframe: All AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks).

,
Interventionparticipants (Number)
Any AEAny AE at least possibly related to DAAsAny severe AEAny serious AEAny AE leading to discontinuation of study drugAny AE leading to interruption of study drugAny AE leading to RBV dose modificationAny fatal AEDeaths
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV330000000
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV541210100

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Resistance-Associated Variants and Phenotypic Resistance

Baseline (pre-dose on Day 1) samples were analyzed for resistance-associated amino acid (AA) variants using population sequencing. Phenotypic resistance to ABT-267 at Baseline was assessed by calculating the fold difference in the the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Day 3 samples were analyzed using population sequencing and were compared with the baseline and appropriate prototypic reference sequences to assess AA changes. Phenotypic resistance at Day 3 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding Baseline sample. The number of participants with variants at resistance-associated AA positions and phenotypic resistance at Baseline and Day 3 are presented. (NCT01563536)
Timeframe: Day 1 Pre-dose (Baseline) and Day 3 Pre-dose

,
Interventionparticipants (Number)
Baseline Variants in NS5A (n=5, 6)Baseline Resistance >10-fold (n=5, 6)Day 3 Variants in NS5A (n=5, 2)Day 3 Resistance >10-fold (n=5, 2)
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV2161
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV0022

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Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3

Blood samples were collected pre-dose on Day 2 (prior to second dose of ABT-267 monotherapy) and pre-dose on Day 3 (prior to first dose of combination therapy). The samples were analyzed for ABT-267 using validated analytical methods. Pre-dose plasma concentrations on Day 2 and Day 3 (Ctrough, measured in ng/mL) are reported. (NCT01563536)
Timeframe: Day 2 (pre-dose) and Day 3 (pre-dose)

,
Interventionng/mL (Mean)
Day 2 CtroughDay 3 Ctrough
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV00.228
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV5.26.62

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Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse

"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.~Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.~Data for this outcome measure were collected for participants in Part B only." (NCT01565889)
Timeframe: Posttreatment Weeks 4 and 24

Interventionpercentage of participants (Number)
Viral breakthroughViral relapse
Part B: SOF+PEG+RBV08.7

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Part B: On-treatment HIV RNA

Data for this outcome measure were collected for participants in Part B only. (NCT01565889)
Timeframe: Up to 8 weeks

Interventioncopies/mL (Mean)
Baseline (n = 23)Week 1 (n = 20)Week 2 (n = 22)Week 4 (n = 22)Week 6 (n = 22)Week 8 (n = 21)
Part B: SOF+PEG+RBV252020191919

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Part B: On-treatment HCV RNA

Data for this outcome measure were collected for participants in Part B only. (NCT01565889)
Timeframe: Up to 8 weeks

Interventionlog10 IU/mL (Mean)
Baseline (n = 23)Week 1 (n = 20)Week 2 (n = 22)Week 4 (n = 23)Week 6 (n = 23)Week 8 (n = 21)
Part B: SOF+PEG+RBV6.591.651.381.381.381.38

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Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7

"Cmax: maximum observed concentration of drug in plasma.~Data for this outcome measure were collected for participants in Part A only." (NCT01565889)
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

,,,,
Interventionng/mL (Mean)
Pharmacokinetics of SOF (Cmax at Day 7)Pharmacokinetics of EFV (Cmax at Day 7)Pharmacokinetics of TFV (Cmax at Day 7)Pharmacokinetics of FTC (Cmax at Day 7)
Part A: SOF+EFV/FTC/TDF (Cohort 1)635.05423.8372.51533.1
Part A: SOF+EFV+ZDV/3TC (Cohort 2)285.13469.5NANA
Part A: SOF+RAL+FTC/TDF (Cohort 5)1189.2NA388.12079.5
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)1228.9NA519.81797.9
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)828.2NA441.81808.2

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Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7

"AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).~Data for this outcome measure were collected for participants in Part A only." (NCT01565889)
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose

,,,,
Interventionh*ng/mL (Mean)
Pharmacokinetics of SOF (AUCtau at Day 7)Pharmacokinetics of EFV (AUCtau at Day 7)Pharmacokinetics of TFV (AUCtau at Day 7)Pharmacokinetics of FTC (AUCtau at Day 7)
Part A: SOF+EFV/FTC/TDF (Cohort 1)867.595094.42351.210144.8
Part A: SOF+EFV+ZDV/3TC (Cohort 2)627.653770.7NANA
Part A: SOF+RAL+FTC/TDF (Cohort 5)1687.1NA2657.110622.8
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)2269.4NA3793.011564.9
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)1421.5NA3996.813091.2

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Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.~Data for this outcome measure were collected for participants in Part B only." (NCT01565889)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Part B: SOF+PEG+RBV91.3

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Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

The percentage of participants discontinuing any study drug due to an adverse event was summarized. (NCT01565889)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
Part A: SOF+EFV/FTC/TDF (Cohort 1)0
Part A: SOF+EFV+ZDV/3TC (Cohort 2)0
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)0
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)0
Part A: SOF+RAL+FTC/TDF (Cohort 5)0
Part B: SOF+PEG+RBV8.7

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Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

"SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.~Data for this outcome measure were collected for participants in Part B only." (NCT01565889)
Timeframe: Posttreatment Weeks 4 and 24

Interventionpercentage of participants (Number)
SVR4SVR24
Part B: SOF+PEG+RBV91.391.3

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Number of Participants With Neutropenia Among Participants With or Without SVR

(NCT01585324)
Timeframe: Week 12

Interventionparticipants (Number)
Participants With SVR0
Participants Without SVR0

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Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment

SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment. (NCT01585324)
Timeframe: 24 weeks after the end of treatment (72 weeks)

Interventionpercentage of participants (Number)
Peginterferon Alpha-2a + Ribavirin83.3

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Number of Participants With Thrombocytopenia Among Participants With or Without SVR

(NCT01585324)
Timeframe: Week 12

Interventionparticipants (Number)
Participants With SVR1
Participants Without SVR0

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Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR

Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR. (NCT01585324)
Timeframe: Baseline and Week 12

Interventiongrams per liter (g/L) (Mean)
Participants With SVR-23.0
Participants Without SVR-32.4

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Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR

The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR. (NCT01585324)
Timeframe: Week 12

Interventiong/L (Mean)
Participants With SVR124.24
Participants Without SVR126.60

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Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR

(NCT01585324)
Timeframe: Week 12

Interventionparticipants (Number)
Participants With SVR1
Participants Without SVR0

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Number of Participants With Decrease in Hemoglobin

The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than [>] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR. (NCT01585324)
Timeframe: Week 12

,
Interventionparticipants (Number)
Up to 20 g/L20-40 g/L>40 g/L
Participants With SVR9142
Participants Without SVR032

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HCV RNA Levels

HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL. (NCT01591460)
Timeframe: At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)

,,,,,
Interventionlog10 IU/mL (Mean)
Baseline (n=165,20,24,24,78,19)Week 2 (n=159,18,24,23,76,18)Week 4 (n=158,20,24,22,75,17)Week 6 (n=151,18,24,21,73,15)Week 8 (n=160,20,24,24,77,15)Week 12 (n=160,20,24,24,77,15)Week 16 (n=156,19,22,24,78,13)Week 24 (n=152,17,23,24,78,10)Week 28 (n=143,15,19,23,76,10)Week 36 (n=71,16,21,24,3,7)EOT (n=162,20,24,23,78,17)12 weeks after EOT (n=152,19,24,23,74,12)24 weeks after EOT (n=159,20,23,24,78,14)
Cirrhotics6.345.064.302.011.691.411.341.801.181.541.582.532.66
Early Responders6.184.273.251.251.181.181.181.181.182.601.181.401.42
Late Responders6.465.384.601.911.521.251.191.181.181.331.381.481.77
Others6.344.904.242.181.841.741.322.211.481.912.733.834.05
Poor Responders6.406.075.782.701.951.691.461.831.452.001.872.482.39
Total Population6.294.864.061.751.471.351.251.411.231.691.521.922.00

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Percentage of Participants With Virological Response

HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as [number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)

,,,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 6Week 8Week 12Week 16Week 24Week 28Week 36EOT
Cirrhotics003545657080807580
Early Responders61471100100100100999599
Late Responders00406796100969696
Others552653535842423747
Poor Responders00013757179797579
Total Population474161828788878387

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Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA

Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as [number of participants meeting one of the above criteria divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: At 12 and 24 weeks

,,,,,
Interventionpercentage of participants (Number)
Week 12Week 24
Cirrhotics105
Early Responders00
Late Responders00
Others1111
Poor Responders138
Total Population43

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Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA

HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as [number of participants with log reduction divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: At Weeks 2, 4, 6, 8, 12, 16, 24, and 28

,,,,,
Interventionpercentage of participants (Number)
3-log, Week 23-log, Week 43-log, Week 63-log, Week 83-log, Week 123-log, Week 163-log, Week 243-log, Week 282-log, Week 22-log, Week 42-log, Week 62-log, Week 82-log, Week 122-log, Week 162-log, Week 242-log, Week 281-log, Week 21-log, Week 41-log, Week 61-log, Week 81-log, Week 121-log, Week 161-log, Week 241-log, Week 28
Cirrhotics5208595100958080205095100100958080607595100100958080
Early Responders19479710010010010010042769910010010010010073100100100100100100100
Late Responders08921001001001009683396100100100100965410010010010010010096
Others162663687468535326377474746853534284848474685853
Poor Responders007583888883790096100888883790010010096888879
Total Population122988939594908827519597959490885581989896949188

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Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason

Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: Up to 48 weeks (from Baseline until EOT)

,,,,,
Interventionpercentage of participants (Number)
PEG-IFN, Any reason (n=165,20,24,24,78,19)PEG-IFN, Anemia (n=165,20,24,24,78,19)PEG-IFN, Asthenia (n=165,20,24,24,78,19)PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19)PEG-IFN, Neutropenia (n=165,20,24,24,78,19)PEG-IFN, Rash (n=165,20,24,24,78,19)PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19)PEG-IFN, Safety/other (n=165,20,24,24,78,19)PEG-IFN, Poor efficacy (n=165,20,24,24,78,19)PEG-IFN, Not specified (n=165,20,24,24,78,19)RBV, Any reason (n=165,20,24,24,78,19)RBV, Anemia (n=165,20,24,24,78,19)RBV, Asthenia (n=165,20,24,24,78,19)RBV, Nausea/vomiting (n=165,20,24,24,78,19)RBV, Neutropenia (n=165,20,24,24,78,19)RBV, Rash (n=165,20,24,24,78,19)RBV, Safety/other (n=165,20,24,24,78,19)RBV, Poor efficacy (n=165,20,24,24,78,19)RBV, Not specified (n=165,20,24,24,78,19)Boceprevir, Any reason (n=164,20,24,24,78,18)Boceprevir, Anemia (n=164,20,24,24,78,18)Boceprevir, Asthenia (n=164,20,24,24,78,18)Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18)Boceprevir, Neutropenia (n=164,20,24,24,78,18)Boceprevir, Rash (n=164,20,24,24,78,18)Boceprevir, Safety/other (n=164,20,24,24,78,18)Boceprevir, Poor efficacy (n=164,20,24,24,78,18)Boceprevir, Not specified (n=164,20,24,24,78,18)
Cirrhotics600003053510150655000051515045100005101510
Early Responders4210136010086253100030812010000010
Late Responders460403300134134638004013482140040408
Others845004700021428926011215162142890011286171728
Poor Responders540403804421867460000821829000000218
Total Population52110.6360.65481264460.613188112820.61414712

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Percentage of Participants With a Concomitant Disease Prior to or During the Study

The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as [number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here. (NCT01591460)
Timeframe: Up to 76 weeks (from Screening until 24 weeks after EOT)

Interventionpercentage of participants (Number)
Any diseaseHypertensionDiabetes mellitusHypothyroidismVitamin D deficiency
Total Population5318865

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Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up

Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. Medication classes reported by >10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here. (NCT01591460)
Timeframe: Up to 72 weeks (from Baseline until 24 weeks after EOT)

Interventionpercentage of participants (Number)
Any medicationAnalgesicsNSAIDsAntihistaminesCorticosteroidsProton pump inhibitorsVitamins and mineralsBeta-adrenoceptor blocking agents
Total Population7929221919171211

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Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir

The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of <60%, 60 to <80%, 80 to <95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as [number of participants in each range divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: Up to 48 weeks (from Baseline until EOT)

,,,,
Interventionpercentage of participants (Number)
PEG-IFN, <60%PEG-IFN, 60 to <80%PEG-IFN, 80 to <95%PEG-IFN, 95% or moreRBV, <60%RBV, 60 to <80%RBV, 80 to <95%RBV, 95% or moreBoceprevir, <60%Boceprevir, 60 to <80%Boceprevir, 80 to <95%Boceprevir, 95% or more
Cirrhotics2505702501065305560
Early Responders004961049510396
Late Responders0417794488380488
Poor Responders250075250075250075
Total Population80.758690.7586100.7386

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Duration of Treatment With PEG-IFN, RBV, and Boceprevir

The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks. (NCT01591460)
Timeframe: Up to 48 weeks (from Baseline until EOT)

,,,,,
Interventionweeks (Median)
PEG-IFN (n=165,20,24,24,78,19)RBV (n=165,20,24,24,78,19)Boceprevir (n=164,20,24,24,78,18)
Cirrhotics48.048.044.0
Early Responders28.028.024.0
Late Responders48.048.032.0
Others26.027.010.0
Poor Responders48.048.044.0
Total Population28.028.024.0

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Percentage of Participants With Virological Relapse Following EOT Response

Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: Up to 72 weeks (at 12 and 24 weeks after EOT)

Interventionpercentage of participants (Number)
Total Population7
Cirrhotics13
Poor Responders5
Late Responders9
Early Responders4
Others25

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Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA

Virological rebound was defined as an HCV RNA viral load >1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)

Interventionpercentage of participants (Number)
Total Population6
Cirrhotics5
Poor Responders17
Late Responders4
Early Responders0
Others22

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Percentage of Participants With Virological Breakthrough Following On-Treatment Response

Virological breakthrough was defined as an HCV RNA viral load greater than (>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)

Interventionpercentage of participants (Number)
Total Population3
Cirrhotics0
Poor Responders0
Late Responders4
Early Responders0
Others23

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Percentage of Participants With SVR at 24 Weeks After EOT

SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: At 24 weeks after EOT (up to 72 weeks)

Interventionpercentage of participants (Number)
Total Population80
Cirrhotics70
Poor Responders71
Late Responders88
Early Responders95
Others32

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Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)

SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: At 12 weeks after EOT (up to 60 weeks)

Interventionpercentage of participants (Number)
Total Population81
Cirrhotics70
Poor Responders75
Late Responders88
Early Responders95
Others32

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Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up

Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. (NCT01591460)
Timeframe: Up to 72 weeks (from Baseline until 24 weeks after EOT)

Interventionpercentage of participants (Number)
Total Population6

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The Efficacy of Triple Antiviral Therapy

To evaluate the efficacy of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C. This will be measured and reported by sustained virologic response (defined as undetectable HCV RNA in the blood 24 weeks after completing therapy [SVR24]) (NCT01592006)
Timeframe: 3 years from start of study

Interventionpercentage of participants (Number)
HCV, LT, Pegasys, Ribavirin, Telaprevir100

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Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients

Tolerability and Safety will be measured and reported by serious adverse events. (NCT01592006)
Timeframe: 6 years from the start of the study

Interventionparticipants (Number)
HCV, LT, Pegasys, Ribavirin, Telaprevir0

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Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B

Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain. (NCT01598090)
Timeframe: After Day 1 of treatment up to Week 48

,
InterventionPercentage of participants (Number)
Flu-Like SymptomsMusculoskeletal symptoms
Part B: Peginterferon Alfa-2a + RBV + TVR36.430.6
Part B: Peginterferon Lambda-1a + RBV + TVR14.421.4

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Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B

SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). (NCT01598090)
Timeframe: Follow-up Week 12

InterventionPercentage of participants (Number)
Part B: Peginterferon Lambda-1a + RBV + TVR73.6
Part B: Peginterferon Alfa-2a + RBV + TVR81.9

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Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A

SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. (NCT01598090)
Timeframe: Follow up week 24

InterventionPercentage of participants (Number)
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)40.7

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Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B

Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3. (NCT01598090)
Timeframe: After Day 1 of treatment up to Week 48

InterventionPercentage of participants (Number)
Part B: Peginterferon Lambda-1a + RBV + TVR11.7
Part B: Peginterferon Alfa-2a + RBV + TVR55.8

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Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B

SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). (NCT01598090)
Timeframe: Follow-up Week 12

InterventionPercentage of participants (Number)
Part B: Peginterferon Lambda-1a + RBV + TVR76.2
Part B: Peginterferon Alfa-2a + RBV + TVR82

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Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A

SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL). (NCT01598090)
Timeframe: Follow-up Week 12

InterventionPercentage of participants (Number)
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)48.1

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Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B

SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). (NCT01598090)
Timeframe: Follow-up Week 24

InterventionPercentage of participants (Number)
Part B: Peginterferon Lambda-1a + RBV + TVR83
Part B: Peginterferon Alfa-2a + RBV + TVR87

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Percentage of Participants With Rash

All skin reactions involving rash or rash-like events that occurred on treatment were reported. (NCT01598090)
Timeframe: After Day 1 of treatment up to Week 48

InterventionPercentage of participants (Number)
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)63
Part B: Peginterferon Lambda-1a + RBV + TVR36.3
Part B: Peginterferon Alfa-2a + RBV + TVR38.3

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Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B

eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). (NCT01598090)
Timeframe: Week 4 and Week 12

InterventionPercentage of participants (Number)
Part B: Peginterferon Lambda-1a + RBV + TVR64
Part B: Peginterferon Alfa-2a + RBV + TVR70.9

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Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A

eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). (NCT01598090)
Timeframe: Assessed at Week 4 and Week 12, week 12 reported

InterventionPercentage of participants (Number)
Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)51.9

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Number of Participants Achieving Sustained Virologic Response (SVR)

SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy. (NCT01606800)
Timeframe: At 24 weeks after the completion of therapy (up to 72 weeks)

InterventionParticipants (Number)
44 Weeks of PEG-IFN Alfa-2b + RBV13
20 Weeks of PEG-IFN Alfa-2b + RBV22

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12)

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than lower limit of quantitation [LLOQ] 12 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV). (NCT01609933)
Timeframe: 12 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 36 weeks after subject's initial dose of study drug in Substudy 1

Interventionpercentage of participants (Number)
2-DAA + PegIFN/RBV81.3

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Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after initiation of study drug through 30 days post-DAA dosing. For more details on AEs, see the AE section. (NCT01609933)
Timeframe: From first dose of study drug through 30 days after last dose of study drug (DAAs plus pegIFN alpha-2a and RBV) (up to 28 weeks).

Interventionparticipants (Number)
2-DAA TEAE2-DAA TESAE
2-DAA + PegIFN/RBV291

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Percentage of Participants With Extended Rapid Virologic Response (eRVR)

eRVR was defined as HCV RNA level < LLOQ at Substudy 1 treatment weeks 4 through 12 without a confirmed HCV RNA >= LLOQ (NCT01609933)
Timeframe: Treatment weeks 4 through 12 of Substudy 1 (DAAs plus pegIFN alpha-2a and RBV)

Interventionpercentage of participants (Number)
2-DAA + PegIFN/RBV87.5

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Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24)

SVR24 was defined as HCV RNA level less than the LLOQ 24 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV). (NCT01609933)
Timeframe: 24 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 48 weeks after subject's initial dose of study drug in Substudy 1

Interventionpercentage of participants (Number)
2-DAA + PegIFN/RBV78.1

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Percentage of Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as hepatitis C virus (HCV) RNA levels to be NCT01628692)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Genotype 1b: Daclatasvir + Simeprevir (Naive)84.9
Genotype 1b: Daclatasvir + Simeprevir (Null)73.9
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)82.4
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)90
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)66.7
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)11.1

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Percentage of Participants With Extended Rapid Virologic Response (eRVR)

eRVR were defined as hepatitis C virus (HCV) RNA levels to be NCT01628692)
Timeframe: Week 4 and Week 12

InterventionPercentage of participants (Number)
Genotype 1b: Daclatasvir + Simeprevir (Naive)71.7
Genotype 1b: Daclatasvir + Simeprevir (Null)60.9
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)62.7
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)75
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)58.3
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)11.1

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Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

RVR was defined as hepatitis C virus (HCV) RNA levels to be NCT01628692)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Genotype 1b: Daclatasvir + Simeprevir (Naive)79.2
Genotype 1b: Daclatasvir + Simeprevir (Null)69.6
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)68.6
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)85
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)75
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)33.3

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Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)

SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be NCT01628692)
Timeframe: Post Treatment Week 12 (Follow-up period)

InterventionPercentage of participants (Number)
Genotype 1b: Daclatasvir + Simeprevir (Naive)84.9
Genotype 1b: Daclatasvir + Simeprevir (Null)69.6
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)74.5
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)95
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)66.7
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)0

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Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT01628692)
Timeframe: From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)

,,
InterventionParticipants (Number)
SAEsAEs Leading to DiscontinuationDeath
Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)721
Genotype1a: Daclatasvir +Simeprevir + Ribavirin(Naive + Null)100
Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)320

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Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories

Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT01628692)
Timeframe: Baseline, post-treatment Week 12 (Follow-up period)

,,,,,
InterventionPercentage of participants (Number)
IL28B Genotype CC type (n= 16,1,13,1,3,0)IL28B Genotype CT type (n= 22,15, 28,10,9,8)IL28B Genotype TT type (n= 12,6,10,7,0,1)
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)66.766.7NA
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)NA00
Genotype 1b: Daclatasvir + Simeprevir (Naive)87.595.566.7
Genotype 1b: Daclatasvir + Simeprevir (Null)1006083.3
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)84.682.140
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)10090100

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Percentage of Participants With End of Treatment Response (EOTR)

EOTR were defined as hepatitis C virus (HCV) RNA levels NCT01628692)
Timeframe: End of treatment (Week 24)

InterventionPercentage of participants (Number)
Genotype 1b: Daclatasvir + Simeprevir (Naive)88.7
Genotype 1b: Daclatasvir + Simeprevir (Null)78.3
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)78.4
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)95
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)66.7
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)0

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Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. (NCT01641640)
Timeframe: Baseline to Week 12

Interventionpercentage of participants (Number)
Sofosbuvir+PEG+RBV0.0

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Percentage of Participants With Viral Relapse

Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. (NCT01641640)
Timeframe: End of treatment to post-treatment Week 24

Interventionpercentage of participants (Number)
Sofosbuvir+PEG+RBV8.6

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Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug

The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments. (NCT01641640)
Timeframe: Baseline to Week 12

Interventionparticipants (Number)
AnaemiaHaemolytic anaemiaNeutropeniaVision blurredBlood creatinine increasedHaemoglobin abnormalDermatitis
Sofosbuvir+PEG+RBV2111111

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Percentage of Participants Achieving Sustained Virologic Response (SVR)12

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy. (NCT01641640)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Sofosbuvir+PEG+RBV91

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Percentage of Participants Achieving SVR24

SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy (NCT01641640)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
Sofosbuvir+PEG+RBV90.5

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Percentage of Participants Achieving SVR4

SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy (NCT01641640)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
Sofosbuvir+PEG+RBV92.4

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Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionMilliliter per minute (mL/min) (Mean)
Creatinine Clearance; Week1; n=40, 39, 15, 13Creatinine Clearance; Week2; n=41, 38,14,13Creatinine Clearance; Week4; n=41, 39,14,13Creatinine Clearance; Week6; n=41, 38,13,13Creatinine Clearance; Week8; n=40, 39,13,13Creatinine Clearance; Week12; n=38,35,12,13
GSK2336805 40 mg, Genotype 1 HCV1.53.352.71.9-0.2
GSK2336805 60 mg, Genotype 1 HCV-2.14.71.9-0.73.42.2
GSK2336805 60 mg, Genotype 4 HCV5.7-1.84.51.5-31.2
Telaprevir, Genotype 1 HCV-9.5-9-9.1-19.1-17.8-14.3

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Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionmL/min (Mean)
Creatinine clearance; Week 18; n=38, 34, 13, 12Creatinine clearance; Week 24; n=35, 33, 12, 11Creatinine clearance; Week 30; n=13,10,3,2Creatinine clearance; Week 36; n=10,7,2,2Creatinine clearance; Week 42; n=9, 6,1,2Creatinine clearance; Week 48; n=6, 6,0,2Creatinine clearance; PT Week 4; n=33,34,11,11
GSK2336805 40 mg, Genotype 1 HCV-0.1-1.9-4.8-11-6.13.2-1.5
GSK2336805 60 mg, Genotype 1 HCV-1.1-1-10.4-8.1-13.3-15.8-1.3
GSK2336805 60 mg, Genotype 4 HCV-4.3-6.171.5-1.5-4-5.3
Telaprevir, Genotype 1 HCV-2.5-4.1-3.7-19NA-2.7

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Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionMillimoles per liter (Mean)
Chloride; Week 18; n=38, 34, 13, 12Chloride; Week 24; n=35, 33, 12, 11Chloride; Week 30; n=13, 10, 3, 2Chloride; Week 36; n=10, 7, 2, 2Chloride; Week 42; n=9, 6, 1, 2Chloride; Week 48; n=6, 6, 0, 2Chloride; PT Week 4; n=33, 34, 11, 11Bicarbonate; Week 18; n=38, 34, 13,12Bicarbonate; Week 24; n=35, 33, 12,11Bicarbonate; Week 30; n=13, 10, 3, 2Bicarbonate; Week 36; n=10, 7, 2, 2Bicarbonate; Week 42; n=9, 6, 1, 2Bicarbonate; Week 48; n=6, 6, 0, 2Bicarbonate; PT Week 4; n=33, 34, 11,11Glucose; Week 18; n=38, 34, 13, 12Glucose; Week 24; n=35, 33, 12, 11Glucose; Week 30; n=13, 10, 3, 2Glucose; Week 36; n=10, 7, 2, 2Glucose; Week 42; n=9, 6, 1, 2Glucose; Week 48; n=6, 6, 0, 2Glucose; PT Week 4; n=33, 34, 11, 11Potassium; Week 18; n=38, 34, 13, 12Potassium; Week 24; n=35, 33, 12, 11Potassium; Week 30; n=13, 10, 3, 2Potassium; Week 36; n=10, 7, 2, 2Potassium; Week 42; n=9, 6, 1, 2Potassium; Week 48; n=6, 6, 0, 2Potassium; PT Week 4; n=33, 34, 11,11Sodium; Week 18; n=38, 34, 13, 12Sodium; Week 24; n=35, 33, 12, 11Sodium; Week 30; n=13, 10, 3, 2Sodium; Week 36; n=10, 7, 2, 2Sodium; Week 42; n=9, 6, 1, 2Sodium; Week 48; n=6, 6, 0, 2Sodium; PT Week 4; n=33, 34, 11, 11Inorganic phosphorus; Week 18; n=38,34,13,12Inorganic phosphorus; Week 24; n=35,33,12,11Inorganic phosphorus; Week 30; n=13,10,3,2Inorganic phosphorus; Week 36; n=10,7,2,2Inorganic phosphorus; Week 42; n=9,6,1,2Inorganic phosphorus; Week 48; n=6,6,0,2Inorganic phosphorus; PT Week 4;n=33,34,11,11Urea/BUN; Week 18; n=38, 34, 13, 12Urea/BUN; Week 24; n=35, 33, 12, 11Urea/BUN; Week 30; n=13, 10, 3, 2Urea/BUN; Week 36; n=10, 7, 2, 2Urea/BUN; Week 42; n=9, 6, 1, 2Urea/BUN; Week 48; n=6, 6, 0, 2Urea/BUN; PT Week 4; n=33, 34, 11,11
GSK2336805 40 mg, Genotype 1 HCV1.921.91.31.31.30.5-0.3-10.4-0.9-0.7-1-0.7-0.28-0.330.03-0.38-0.280.250.24-0.19-0.13-0.030.24-0.10.1-0.160.70.41.10.40.4-0.2-0.1-0.161-0.139-0.156-0.121-0.08-0.167-0.084-0.19-0.220.690.650.340.670.35
GSK2336805 60 mg, Genotype 1 HCV10.70.3-0.10-10.2-1-1.2-2.20.1-0.2-1.3-0.5-0.130.27-0.26-0.37-0.12-0.30.18-0.24-0.12-0.23-0.1-0.2-0.3-0.130.1-0.1-1.4-0.7-0.5-1.20.1-0.13-0.13-0.118-0.167-0.108-0.108-0.003-0.23-0.55-0.160.040.50.4-0.19
GSK2336805 60 mg, Genotype 4 HCV0.5-0.2310.50-1.50-0.4-2-1.5-1-0.51-0.23-0.220.9-0.7-0.154.55-0.07-0.2-0.32-0.10.20.10.05-0.10.40.40-0.5-1.5-2.5-0.5-0.111-0.107-0.225-0.125-0.1-0.35-0.085-0.250.02-0.5-0.25-0.5-0.5-0.47
Telaprevir, Genotype 1 HCV1.82.95.34.510NA0.6-1.2-1.8-1.3-2.5-4NA-0.9-0.06-0.23-0.13-0.10.4NA-0.12-0.41-0.34-0.10.15-0.1NA-0.250.71.51.323NA1.1-0.092-0.119-0.267-0.195-0.15NA0.009-0.49-0.43-0.5-0.150.5NA-0.62

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Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionRatio (Mean)
Hematocrit; Week 18; n=38, 34, 13, 12Hematocrit; Week 24; n=35, 33, 12, 11Hematocrit; Week 30; n=13, 10, 2, 2Hematocrit; Week 36; n=12, 7, 1, 2Hematocrit; Week 42; n=10, 6, 2, 2Hematocrit; Week 48; n=9, 6, 1, 2Hematocrit; PT Week 4; n=32, 34, 11,11
GSK2336805 40 mg, Genotype 1 HCV-0.083-0.0782-0.0713-0.0567-0.0623-0.0624-0.0293
GSK2336805 60 mg, Genotype 1 HCV-0.0622-0.0635-0.0397-0.069-0.0802-0.0753-0.0135
GSK2336805 60 mg, Genotype 4 HCV-0.0699-0.0823-0.1125-0.0895-0.111-0.1095-0.0354
Telaprevir, Genotype 1 HCV-0.0776-0.0808-0.0955-0.087-0.0535-0.047-0.0362

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Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12

Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12

,,,
InterventionBeats per minute (Mean)
Heart Rate; Day2; n=41, 40, 17, 13Heart Rate; Week1; n=41, 39, 15, 13Heart Rate; Week2; n=41, 39, 14, 13Heart Rate; Week4; n=41, 39, 14, 13Heart Rate; Week6; n=41, 39, 13, 13Heart Rate; Week8; n=41, 39, 13, 13Heart Rate; Week12; n=38, 35, 12, 13
GSK2336805 40 mg, Genotype 1 HCV6.51.53.86.884.77
GSK2336805 60 mg, Genotype 1 HCV5.43.14.24.256.85.3
GSK2336805 60 mg, Genotype 4 HCV3.87.77.85.510.212.88.4
Telaprevir, Genotype 1 HCV9.38.18.710.713.814.211

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Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12

The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1 and 12

,,,
InterventionBeats per minute (Mean)
Week 1, n=41, 40, 15, 12Week 12, n=38, 35, 12, 13
GSK2336805 40 mg, Genotype 1 HCV3.38.3
GSK2336805 60 mg, Genotype 1 HCV0.85.1
GSK2336805 60 mg, Genotype 4 HCV4.88.5
Telaprevir, Genotype 1 HCV4.19.3

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Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionMillimoles per liter (Mean)
Chloride; Week1; n=40, 39, 15, 13Chloride; Week2; n=41, 38, 14, 13Chloride; Week4; n=41, 39, 14, 13Chloride; Week6; n=41, 38, 13, 13Chloride; Week8; n=40, 39, 13, 13Chloride; Week12; n=37, 35, 12, 13Bicarbonate; Week1; n=40, 39, 15, 13Bicarbonate; Week2; n=41, 38, 14, 13Bicarbonate; Week4; n=41, 39, 14, 13Bicarbonate; Week6; n=41, 38, 13, 13Bicarbonate; Week8; n=40, 39, 13, 13Bicarbonate; Week12; n=37, 35, 12, 13Glucose; Week1; n=40, 39, 15, 13Glucose; Week2; n=41, 38, 14, 13Glucose; Week4; n=41, 39, 14, 13Glucose; Week6; n=41, 38, 13, 13Glucose; Week8; n=40, 39, 13, 13Glucose; Week12; n=38, 35, 12, 13Potassium; Week1; n=40, 39, 15, 13Potassium; Week2; n=41, 38, 14, 13Potassium; Week4; n=41, 39, 14, 13Potassium; Week6; n=41, 38, 13, 13Potassium; Week8; n=40, 39, 13, 13Potassium; Week12; n=37, 35, 12, 13Sodium; Week1; n=40, 39, 15, 13Sodium; Week2; n=41, 38, 14, 13Sodium; Week4; n=41, 39, 14, 13Sodium; Week6; n=41, 38, 13, 13Sodium; Week8; n=40, 39, 13, 13Sodium; Week12; n=37, 35, 12, 13Inorganic Phosphorus; Week1; n=40, 39, 15, 13Inorganic Phosphorus; Week2; n=41,38,14,13Inorganic Phosphorus; Week4; n=41,39,14,13Inorganic Phosphorus; Week6; n=41,38,13,13Inorganic Phosphorus; Week8; n=40,39,13,13Inorganic Phosphorus; Week12; n=37,35,12,13Urea/BUN; Week1; n=40, 39, 15, 13Urea/BUN; Week2; n=41, 38, 14, 13Urea/BUN; Week4; n=41, 39, 14, 13Urea/BUN; Week6; n=41, 38, 13, 13Urea/BUN; Week8; n=40, 39, 13, 13Urea/BUN; Week12; n=37, 35, 12, 13
GSK2336805 40 mg, Genotype 1 HCV0.50.71.71.621.50-0.3-0.9-0.4-0.7-0.6-0.37-0.22-0.03-0.15-0.05-0.3-0.02-0.1-0.16-0.15-0.11-0.15-0.4-0.10.10.20.30.1-0.13-0.141-0.151-0.171-0.169-0.1720.240.20.03-0.04-0.16-0.08
GSK2336805 60 mg, Genotype 1 HCV-0.40.110.80.70.1-0.9-0.8-0.8-0.7-0.8-0.9-0.34-0.170.02-0.18-0.06-0.39-0.06-0.12-0.11-0.16-0.19-0.21-0.8-0.6-0.1-0.3-0.6-0.3-0.086-0.108-0.125-0.181-0.23-0.1680.04-0.13-0.4-0.29-0.46-0.31
GSK2336805 60 mg, Genotype 4 HCV-0.2-0.70.1-0.1-0.81.2-0.7-0.2-0.50.60-0.50.360.13-0.48-0.55-0.36-0.45-0.02-0.02-0.05-0.21-0.14-0.1-0.8-1.3-0.80-0.60.5-0.087-0.105-0.078-0.159-0.14-0.136-0.01-0.12-0.88-1.02-0.85-0.64
Telaprevir, Genotype 1 HCV0.60.51.60.82.21.9-1.2-1.5-1.4-1.5-1.2-1.1-0.030.11-0.110.180.04-0.23-0.11-0.39-0.34-0.45-0.51-0.38-0.200.40.21.10.8-0.122-0.081-0.077-0.121-0.112-0.1170.190.080.11-0.39-0.07-0.11

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Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionGiga cells per liter (Mean)
Basophils; Week1; n=38, 38, 14, 11Basophils; Week2; n=40, 38, 14, 10Basophils; Week4; n=41, 38, 14, 13Basophils; Week6; n=41, 37, 12, 12Basophils; Week8; n=38, 39, 13, 13Basophils; Week12; n=37, 36, 12, 12Eosinophils; Week1; n=38, 38, 14, 11Eosinophils; Week2; n=40, 38, 14, 10Eosinophils; Week4; n=41, 38, 14, 13Eosinophils; Week6; n=41, 37, 12, 12Eosinophils; Week8; n=38, 39, 13, 13Eosinophils; Week12; n=37, 36, 12, 12Lymphocytes; Week1; n=38, 38, 14, 11Lymphocytes; Week2; n=40, 38, 14, 10Lymphocytes; Week4; n=41, 38, 14, 13Lymphocytes; Week6; n=41, 37, 12, 12Lymphocytes; Week8; n=38, 39, 13, 13Lymphocytes; Week12; n=37, 36, 12, 12Monocytes; Week1; n=38, 38, 14, 11Monocytes; Week2; n=40, 38, 14, 10Monocytes; Week4; n=41, 38, 14, 13Monocytes; Week6; n=41, 37, 12, 12Monocytes; Week8; n=38, 39, 13, 13Monocytes; Week12; n=37, 36, 12, 12Total Neutrophils; Week1; n=38, 38, 14, 11Total Neutrophils; Week 2; n=40, 38, 14, 10Total Neutrophils; Week4; n=41, 38, 14, 13Total Neutrophils; Week6; n=41, 37, 12, 12Total Neutrophils; Week8; n=38, 39, 13, 13Total Neutrophils; Week12; n=37, 36, 12, 12Platelet Count; Week1; n=38, 39, 14, 11Platelet Count; Week2; n=41, 38, 14, 11Platelet Count; Week4; n=41, 38, 14, 13Platelet Count; Week6; n=41, 38, 12, 13Platelet Count; Week8; n=39, 39, 13, 13Platelet Count; Week12; n=38, 34, 12, 12White Blood Cell count; Week1; n=38, 38, 14, 11White Blood Cell count; Week2; n=40, 38, 14, 10White Blood Cell count; Week4; n=41, 38, 14, 13White Blood Cell count; Week6; n=41, 37, 12, 12White Blood Cell count; Week8; n=38, 39, 13, 13White Blood Cell count; Week12; n=37, 36, 12, 12
GSK2336805 40 mg, Genotype 1 HCV-0.011-0.014-0.017-0.015-0.019-0.018-0.051-0.08-0.105-0.117-0.121-0.118-0.319-0.448-0.787-0.963-0.953-1.118-0.103-0.122-0.151-0.182-0.229-0.185-2.338-2.114-2.487-2.51-2.706-2.894-58.5-58-54.4-66.8-74.9-73.4-2.83-2.77-3.55-3.78-4.03-4.33
GSK2336805 60 mg, Genotype 1 HCV-0.011-0.01-0.012-0.013-0.016-0.013-0.075-0.111-0.132-0.134-0.134-0.112-0.282-0.603-0.854-1.043-1.061-1.074-0.056-0.061-0.129-0.171-0.165-0.183-1.871-2.121-2.333-2.247-2.168-2.188-51.4-57.8-55.9-71.9-75.7-85.3-2.3-2.92-3.47-3.62-3.55-3.58
GSK2336805 60 mg, Genotype 4 HCV-0.013-0.009-0.015-0.013-0.012-0.012-0.085-0.114-0.108-0.109-0.104-0.102-0.371-0.553-0.773-0.93-0.964-1.048-0.025-0.034-0.055-0.135-0.124-0.133-1.378-1.468-1.603-1.683-1.613-1.483-33.1-34.4-33.8-46-52.6-53-1.87-2.17-2.55-2.85-2.8-2.77
Telaprevir, Genotype 1 HCV-0.012-0.009-0.01-0.013-0.009-0.011-0.059-0.059-0.079-0.113-0.13-0.106-0.608-0.675-0.989-1.334-1.256-1.4380.034-0.091-0.126-0.245-0.185-0.219-1.158-1.186-1.412-1.413-1.222-1.649-59.5-41.4-56.2-71.3-60.1-58.8-1.81-2.01-2.61-3.09-2.8-3.42

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Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionInternational units per liter (Mean)
ALP; Week 18; n=38, 34, 13, 12ALP; Week 24; n=35, 33, 12, 11ALP; Week 30; n=13, 10, 3, 2ALP; Week 36; n=10, 7, 2, 2ALP; Week 42; n=9, 6, 1, 2ALP; Week 48; n=6, 6, 0, 2ALP; PT Week 4; n=33, 34, 11, 11ALT; Week 18; n=38, 34, 13, 12ALT; Week 24; n=35, 33, 12, 11ALT; Week 30; n=13, 10, 3, 2ALT; Week 36; n=10, 7, 2, 2ALT; Week 42; n=9, 6, 1, 2ALT; Week 48; n=6, 6, 0, 2ALT; PT Week 4; n=33, 34, 11, 11AST; Week 18; n=38, 34, 13, 12AST; Week 24; n=35, 33, 12, 11AST; Week 30; n=13, 10, 3, 2AST; Week 36; n=10, 7, 2, 2AST; Week 42; n=9, 6, 1, 2AST; Week 48; n=6, 6, 0, 2AST; PT Week 4; n=33, 34, 11, 11CK; Week 18; n=38, 34, 13, 12CK; Week 24; n=35, 33, 12, 11CK; Week 30; n=13, 10, 3, 2CK; Week 36; n=10, 7, 2, 2CK; Week 42; n=9, 6, 1, 2CK; Week 48; n=6, 6, 0, 2CK; PT Week 4; n=33, 34, 11, 11GGT; Week 18; n=38, 34, 13, 12GGT; Week 24; n=35, 33, 12, 11GGT; Week 30; n=13, 10, 3, 2GGT; Week 36; n=10, 7, 2, 2GGT; Week 42; n=9, 6, 1, 2GGT; Week 48; n=6, 6, 0, 2GGT; PT Week 4; n=33, 34, 11, 11
GSK2336805 40 mg, Genotype 1 HCV2.50.81.825.39.8-4.9-38.9-43.9-34.8-30.2-34.3-38.8-45.5-13.1-16.5-15.1-11.8-14.2-12.8-19.5-44-34.5-33-18.9-0.210.5-17.9-37.3-38.3-44.2-51.5-44.6-37.8-43.4
GSK2336805 60 mg, Genotype 1 HCV1.13.3-6.42.73.34.2-6.3-22.9-31.3-45.1-16.6-14.3-10.8-33.3-3.5-11.8-18.7-7.3-5.8-2.2-15.6-28.3-18.7-15.8-26.7-29.722.3-26.4-12.3-12.5-32.8-19.7-19.7-16.8-17.7
GSK2336805 60 mg, Genotype 4 HCV6.44.522.51817.530-3.9-38.4-41.7-26-20.5-28-26.5-43.9-16.3-15.7-6.5-2.5-9-6.5-16-60.760.1-78.5-69-81-82.5258.7-34.2-35.7-12-10-9-9.5-41.4
Telaprevir, Genotype 1 HCV2.22.1-82.5-2NA-7-38.6-39.7-57.7-69-122NA-31.5-18.8-23.8-27.7-27.5-54NA-17.7-38.7-39-30-37.5-32NA-21.7-30.2-37.4-38.7-40.5-17NA-30.7

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Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionInternational units per liter (Mean)
ALP; Week1; n=40, 39, 15, 13ALP; Week2; n=41, 38, 14, 13ALP; Week4; n=41, 39, 14, 13ALP; Week6; n=41, 38, 13, 13ALP; Week8; n=40, 39, 13, 13ALP; Week12; n=37, 35, 12, 13ALT; Week1; n=40, 39, 15, 13ALT; Week2; n=41, 38, 14, 13ALT; Week4; n=41, 39, 14, 13ALT; Week6; n=41, 38, 13, 13ALT; Week8; n=40, 39, 13, 13ALT; Week12; n=37, 35, 12, 13AST; Week1; n=40, 39, 15, 13AST; Week2; n=41, 38, 14, 13AST; Week4; n=41, 39, 14, 13AST; Week6; n=41, 38, 13, 13AST; Week8; n=40, 39, 13, 13AST; Week12; n=37, 35, 12, 13CK; Week1; n=40, 39, 15, 13CK; Week2; n=41, 38, 14, 13CK; Week4; n=41, 39, 14, 13CK; Week6; n=41, 38, 13, 13CK; Week8; n=40, 39, 13, 13CK; Week12; n=37, 35, 12, 13GGT; Week1; n=40, 39, 15, 13GGT; Week2; n=41, 38, 14, 13GGT; Week4; n=41, 39, 14, 13GGT; Week6; n=41, 38, 13, 13GGT; Week8; n=40, 39, 13, 13GGT; Week12; n=37, 35, 12, 13
GSK2336805 40 mg, Genotype 1 HCV04.68.69.16.96.7-26.8-28.2-32.5-36-36.8-38.9-12.3-10-12.8-13.8-13.1-14.418.2-0.74.5-26-21.3-36.3-3.7-11.7-24.5-28.1-32.1-29.7
GSK2336805 60 mg, Genotype 1 HCV1.53.87.17.26.56.4-24.4-24.9-25.3-30.3-25.4-23.5-15.2-11.6-10.6-13.8-7.6-6.5-10.9-22.6-32.156.1-33.2-33.9-2-17.1-25.5-30.5-27.2-20.7
GSK2336805 60 mg, Genotype 4 HCV-0.23.87.26.65.67.3-25.6-26.8-33-38.4-39.5-36.8-13.9-10.2-15.8-19.5-18.6-17.3-43.5-28.5-47.7-64.5-66.8-48.5-6.4-7.2-16.2-23.8-28.5-30
Telaprevir, Genotype 1 HCV3.99.411.716.615.511.7-30.7-35.4-40.4-40.8-39.9-43.7-18.1-18.4-20.9-21.6-21.8-25.7-3.3-9.6-14.4-21.5-30.3-20.9-10.3-19.9-27.7-30.5-30.5-33.6

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Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionGrams per liter (Mean)
Albumin; Week1; n=40, 39, 15, 13Albumin; Week2; n=41, 38, 14, 13Albumin; Week4; n=41, 39, 14, 13Albumin; Week6; n=41, 38, 13, 13Albumin; Week8; n=40, 39, 13, 13Albumin; Week12; n=37, 35, 12, 13
GSK2336805 40 mg, Genotype 1 HCV-0.6-1.3-1.9-2.2-2.6-2.1
GSK2336805 60 mg, Genotype 1 HCV-0.3-1.5-1.5-1.5-1.7-1.3
GSK2336805 60 mg, Genotype 4 HCV-1-0.2-1.2-2.1-1.5-1.6
Telaprevir, Genotype 1 HCV-1.1-2-3-3.5-3.7-3.3

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Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionGrams per liter (Mean)
Albumin; Week 18; n=38, 34, 13, 12Albumin; Week 24; n=35, 33, 12, 11Albumin; Week 30; n=13, 10, 3, 2Albumin; Week 36; n=10, 7, 2, 2Albumin; Week 42; n=9, 6, 1, 2Albumin; Week 48; n=6, 6, 0, 2Albumin; PT Week 4; n=33, 34, 11, 11
GSK2336805 40 mg, Genotype 1 HCV-2.3-2.1-1.8-1.7-1.3-1.3-0.7
GSK2336805 60 mg, Genotype 1 HCV-1.4-1.6-0.7-1.1-1.3-0.3-0.2
GSK2336805 60 mg, Genotype 4 HCV-1-1.1-4.5-2-3-4-0.7
Telaprevir, Genotype 1 HCV-1.8-2.3-32-1NA0.5

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Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose. (NCT01648140)
Timeframe: Week 4 (24 h post dose)

,
Interventionng/mL (Geometric Mean)
Cmax, n=11, 10Ctau, n=11, 10
GSK2336805 40 mg, Genotype 1 HCV335.3531.37
GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV618.7549.31

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Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose. (NCT01648140)
Timeframe: Week 4 (24 h post dose)

Interventionhour (Median)
GSK2336805 40 mg, Genotype 1 HCV2
GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV2

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Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionGiga cells per liter (Mean)
Basophils; Week18; n=37, 33, 13, 12Basophils; Week24; n=34, 32, 12, 11Basophils; Week30; n=13, 10, 2, 2Basophils; Week36; n=12, 7, 1, 2Basophils; Week42; n=10, 6, 2, 2Basophils; Week48; n=7, 6, 1, 2Basophils; PT Week4; n=32, 34, 11, 11Eosinophils; Week18; n=37, 33, 13, 12Eosinophils; Week24; n=34, 32, 12, 11Eosinophils; Week30; n=13, 10, 2, 2Eosinophils; Week36; n=12, 7, 1, 2Eosinophils; Week42; n=10, 6, 2, 2Eosinophils; Week48; n=8, 6, 1, 2Eosinophils; PT Week4; n=32, 34, 11,11Lymphocytes; Week18; n=37, 33, 13,12Lymphocytes; Week24; n=34, 32, 12,11Lymphocytes; Week30; n=13, 10, 2, 2Lymphocytes; Week36; n=12, 7, 1, 2Lymphocytes; Week42; n=10, 6, 2, 2Lymphocytes; Week48; n=7, 6, 1, 2Lymphocytes; PT Week4; n=32, 34, 11,11Monocytes; Week18; n=37, 33, 13, 12Monocytes; Week24; n=34, 32, 12, 11Monocytes; Week30; n=13, 10, 2, 2Monocytes; Week36; n=12, 7, 1, 2Monocytes; Week42; n=10, 6, 2, 2Monocytes; Week48; n=7, 6, 1, 2Monocytes; PT Week4; n=32, 34, 11,11Total Neutrophils; Week18; n=37, 33,13,12Total Neutrophils; Week24; n=34, 32,12,11Total Neutrophils; Week30; n=13, 10,2,2Total Neutrophils; Week36; n=12, 7, 1,2Total Neutrophils; Week42; n=10, 6, 2,2Total Neutrophils; Week48; n=7, 6, 1, 2Total Neutrophils; PT Week4; n=32, 34,11,11Platelet Count; Week18; n=38, 34, 13,12Platelet Count; Week24; n=35, 33, 12,11Platelet Count; Week30; n=13, 10, 1, 2Platelet Count; Week36; n=12, 7, 1, 2Platelet Count; Week42; n=10, 6, 2, 2Platelet Count; Week48; n=9, 6, 1, 2Platelet Count; PT Week4; n=32, 34,11,11White Blood Cell count; Week18; n=37,33,13,12White Blood Cell count ; Week24; n=34,32,12,11White Blood Cell count ; Week30; n=13,10,2,2White Blood Cell count ; Week36; n=12,7,1,2White Blood Cell count ; Week42; n=10,6,2,2White Blood Cell count; Week48; n=7,6,1,2White Blood Cell count; PT Week4;n=32,34,11,11
GSK2336805 40 mg, Genotype 1 HCV-0.019-0.018-0.018-0.02-0.015-0.007-0.007-0.119-0.128-0.124-0.081-0.105-0.071-0.069-1.081-1.181-1.225-1.267-1.135-0.779-0.681-0.186-0.206-0.151-0.255-0.184-0.066-0.047-2.702-2.527-2.402-2.503-2.23-1.129-1.158-73.7-67.5-70-64.1-56.1-37.7-20.4-4.1-4.06-3.92-4.13-3.67-2.09-1.97
GSK2336805 60 mg, Genotype 1 HCV-0.01-0.01-0.012-0.006-0.005-0.007-0.003-0.127-0.131-0.116-0.123-0.1-0.11-0.085-1.157-1.092-1.085-1.286-1.22-1.4-0.7-0.141-0.156-0.135-0.18-0.093-0.147-0.031-2.378-2.187-2.252-2.777-3.085-2.488-0.808-87.5-78.8-71.9-75.7-67.3-68.8-28.9-3.81-3.58-3.59-4.39-4.52-4.17-1.64
GSK2336805 60 mg, Genotype 4 HCV-0.012-0.013-0.02-0.01-0.0150.005-0.003-0.068-0.041-0.04-0.05-0.04-0.05-0.018-0.973-1.057-1.845-1.92-1.93-2.2-0.737-0.143-0.121-0.060.015-0.01-0.085-0.053-1.463-1.3-2.085-1.63-1.815-1.445-0.671-52.1-51.9-36.5-34-22-14-12.9-2.65-2.52-4.05-3.55-3.8-3.8-1.45
Telaprevir, Genotype 1 HCV-0.014-0.013-0.02-0.0200.02-0.001-0.087-0.118-0.13-0.06-0.020.13-0.07-0.999-1.405-1.905-1.97-1.1250.09-0.756-0.088-0.151-0.4-0.2-0.0250.020.032-1.652-1.308-2.24-1.61-0.5650.02-0.744-55.7-60.3-112-115-11233-12.4-2.84-3-4.7-3.9-1.750.2-1.54

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Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12

Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0), Weeks 2 and 12

,,,
InterventionParticipants (Number)
Week 2, UBIL, BL MIS to PBL MIS, n=1,0,0,0Week 12, UBIL, BL MIS to PBL MIS,n=37,34,12,13Week 2, UGLU, BL MIS to PBL MIS, n=1,0,0,0Week 12, UGLU, BL MIS to PBL MIS,n=37,34,12,13Week 2, UKET, BL MIS to PBL MIS, n=1,0,0,0Week 12, UKET, BL MIS to PBL MIS,n=37,34,12,13Week 2, ULET, BL MIS to PBL MIS, n=1,0,0,0Week 12, ULET, BL MIS to PBL MIS,n=37,34,12,13Week 12, UMBT, BL MIS to PBL MIS,n=1,1,0,0Week 12, UMRBC, BL MIS to PBL MIS,n=4,5,2,2Week 12, UMWBC, BL MIS to PBL MIS, n=4,5,2,2Week 2, UNIT, BL MIS to PBL MIS, n=1,0,0,0Week 12, UNIT, BL MIS to PBL MIS,n=37,34,12,13Week 2, UOB, BL MIS to PBL MIS, n=1,0,0,0Week 12, UOB, BL MIS to PBL MIS,n=37,34,12,13Week 2, UPH, BL NL to PBL NL, n=1, 0,0,0Week 12, UPH, BL NL to PBL NL, n=37,34,12,13Week 12, UPH, BL NL to PBL ANL, n=37,34,12,13Week 2, USG, BL NL to PBL NL, n=1, 0,0,0Week 12, USG, BL NL to PBL NL, n=37,34,12,13Week 12, USG, BL NL to PBL ANL,n=37,34,12,13
GSK2336805 40 mg, Genotype 1 HCV13713713713714413713713611370
GSK2336805 60 mg, Genotype 1 HCV03403403403415503403403400340
GSK2336805 60 mg, Genotype 4 HCV01301301301302201301301300121
Telaprevir, Genotype 1 HCV01201201201202201201201200120

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Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionTrillion cells per liter (Mean)
Red Blood Cell count; Week1; n=38, 39, 14, 12Red Blood Cell count; Week2; n=41, 38, 14, 12Red Blood Cell count; Week4; n=41, 38, 14, 13Red Blood Cell count; Week6; n=41, 38, 12, 13Red Blood Cell count; Week8; n=39, 39, 13, 13Red Blood Cell count; Week12; n=38, 36, 12, 12
GSK2336805 40 mg, Genotype 1 HCV-0.15-0.48-0.88-0.97-1.01-1.08
GSK2336805 60 mg, Genotype 1 HCV-0.04-0.44-0.64-0.78-0.82-0.79
GSK2336805 60 mg, Genotype 4 HCV-0.13-0.28-0.72-0.86-0.85-0.92
Telaprevir, Genotype 1 HCV-0.18-0.57-1.03-1.28-1.45-1.61

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Apparent Clearance (CL/F) at Week 4

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau). (NCT01648140)
Timeframe: Week 4 (24 h post dose)

InterventionLiter per hour (L/hr) (Geometric Mean)
GSK2336805 40 mg, Genotype 1 HCV14.63
GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV12.13

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Apparent Volume of Distribution (Vz/F) at Week 4

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC[0-tau] lambda z) where lambda z is the terminal phase rate constant. (NCT01648140)
Timeframe: Week 4 (24 h post dose)

InterventionLiter per hour (L/hr) (Geometric Mean)
GSK2336805 40 mg, Genotype 1 HCV172.81
GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV125.09

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Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4

Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. (NCT01648140)
Timeframe: Week 4 (24 h post dose)

Interventionhour*nanogram per milliliter(hr*ng/mL) (Geometric Mean)
GSK2336805 40 mg, Genotype 1 HCV2733.34
GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV4948.23

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Number of Participants Achieving eRVR

eRVR is defined as plasma HCV ribonucleic acid (RNA) NCT01648140)
Timeframe: Week 4 and Week 12

InterventionParticipants (Number)
GSK2336805 40 mg, Genotype 1 HCV23
GSK2336805 60 mg, Genotype 1 HCV21
Telaprevir, Genotype 1 HCV9
GSK2336805 60 mg, Genotype 4 HCV9

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Number of Participants With Any AEs and Any SAEs After Week 12

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. (NCT01648140)
Timeframe: From Week 12 up to PT Week 24 FU

,,,
InterventionParticipants (Number)
Any AEAny SAE
GSK2336805 40 mg, Genotype 1 HCV212
GSK2336805 60 mg, Genotype 1 HCV221
GSK2336805 60 mg, Genotype 4 HCV90
Telaprevir, Genotype 1 HCV80

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Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. (NCT01648140)
Timeframe: From the start of study treatment up to Week 12

,,,
InterventionParticipants (Number)
Any AEAny SAE
GSK2336805 40 mg, Genotype 1 HCV390
GSK2336805 60 mg, Genotype 1 HCV372
GSK2336805 60 mg, Genotype 4 HCV131
Telaprevir, Genotype 1 HCV173

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Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)

Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA NCT01648140)
Timeframe: From the start of the treatment up to PT FU Week 24

,,,
InterventionParticipants (Number)
vRVRRVRcEVRSVR12SVR24SVR24 with RGT
GSK2336805 40 mg, Genotype 1 HCV82333302717
GSK2336805 60 mg, Genotype 1 HCV122330262517
GSK2336805 60 mg, Genotype 4 HCV6913000
Telaprevir, Genotype 1 HCV8101110109

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Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12

Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour [h]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose [20-28h]), Week 4 (Predose [20-28h], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose [20-28h]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. (NCT01648140)
Timeframe: Day 1, Day 2, Week 4, and Week 12

,
Interventionnanograms per milliliter (ng/mL) (Mean)
Day 1 (0h-1h), n=1, 3Day 1 (1h-4h), n=35, 42Day 1 (4h-8h), n=0, 3Day 1 (8h-20h), n=0, 1Day 2 Predose (20-28h), n=36, 43Week 4 Predose (20-28h), n=33, 42Week 4 (0h-1h), n=2, 6Week 4 (1h-4h), n=46, 52Week 4 (4h-8h), n=22, 19Week 4 (8h-20h), n=1, 2Week 4 (20h-28h), n=11, 10Week 12 (Predose [20-28h]), n=26, 35
GSK2336805 40 mg, Genotype 1 HCVNA290.39NANA53.7981.18198.4392.78215.55NA51.2445.99
GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV604445.18221.33NA123.89146.85553591.07411.68192.566.29142.59

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Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionMicromoles per liter (Mean)
Total bilirubin; Week 18; n=38, 34, 13, 12Total bilirubin; Week 24; n=35, 33, 12,11Total bilirubin; Week 30; n=13, 10, 3, 2Total bilirubin; Week 36; n=10, 7, 2, 2Total bilirubin; Week 42; n=9, 6, 1, 2Total bilirubin; Week 48; n=6, 6, 0, 2Total bilirubin PT Week 4; n=33, 34, 11,11Creatinine; Week 24; n=35, 33, 12, 11Creatinine; Week 18; n=38, 34, 13, 12Creatinine; Week 30; n=13, 10, 3, 2Creatinine; Week 36; n=10, 7, 2, 2Creatinine; Week 42; n=9, 6, 1, 2Creatinine; Week 48; n=6, 6, 0, 2Creatinine; PT Week 4; n=33, 34, 11,11
GSK2336805 40 mg, Genotype 1 HCV0.5-0.1-0.200.1-0.7-4.6-1.55-2.240.662.331.23-2.351.23
GSK2336805 60 mg, Genotype 1 HCV1.710.81.91.53.5-2.4-2.4-1.972.822.994.9710.07-0.34
GSK2336805 60 mg, Genotype 4 HCV0.61.3-4-3-4-4-2.21.310.09-8.85-8-7.55-7.1-1.25
Telaprevir, Genotype 1 HCV-1.4-1.3-2.3-3-14NA-0.4-3.12-1.75-8.47-5.5-14.3NA-1.7

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Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12

Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) up to 12-week treatment period

,,,
InterventionMillimeters of mercury (mmHg) (Mean)
DBP; Day2; n=41, 40, 17, 13DBP; Week1; n=41, 39, 15, 13DBP; Week2; n=41, 39, 14, 13DBP; Week4; n=41, 39, 14, 13DBP; Week6; n=41, 39, 13, 13DBP; Week8; n=41, 39, 13, 13DBP; Week12; n=38, 35, 12, 13SBP; Day2; n=41, 40, 17, 13SBP; Week1; n=41, 39, 15, 13SBP; Week2; n=41, 39, 14, 13SBP; Week4; n=41, 39, 14, 13SBP; Week6; n=41, 39, 13, 13SBP; Week8; n=41, 39, 13, 13SBP; Week12; n=38, 35, 12, 13
GSK2336805 40 mg, Genotype 1 HCV-1.2-0.4-0.4-1.2-1.2-2.10.3-1.40.9-2-3.6-0.4-3.7-1.9
GSK2336805 60 mg, Genotype 1 HCV-1-2.2-1.7-4.4-4.8-2.9-4.4-0.8-3-0.7-4.2-3.8-1.5-1.4
GSK2336805 60 mg, Genotype 4 HCV-1.5-1-2.80.8-1.6-2.4-1-1.3-2.6-4.2-5.20.2-4.2-2.6
Telaprevir, Genotype 1 HCV-31-0.3-3.9-5.9-4.4-3.5-3.3-4.5-4.1-3.8-5.9-2.9-5.2

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Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionMicromoles per liter (Mean)
Total Bilirubin; Week1; n=40, 39, 15, 13Total Bilirubin; Week2; n=41, 38, 14, 13Total Bilirubin; Week4; n=41, 39, 14, 13Total Bilirubin; Week6; n=41, 38, 13, 13Total Bilirubin; Week8; n=40, 39, 13, 13Total Bilirubin; Week12; n=37, 35, 12, 13Direct Bilirubin; Week1; n=1, 1, 1, 1Direct Bilirubin; Week2; n=1, 1, 1, 1Direct Bilirubin; Week4; n=1, 1, 0, 0Direct Bilirubin; Week6; n=1, 1, 0, 0Creatinine; Week1; n=40, 39, 15, 13Creatinine; Week2; n=41, 38, 14, 13Creatinine; Week4; n=41, 39, 14, 13Creatinine; Week6; n=41, 38, 13, 13Creatinine; Week8; n=40, 39, 13, 13Creatinine; Week12; n=38, 35, 12, 13
GSK2336805 40 mg, Genotype 1 HCV6.95.82.21.51.40.40000-1.41-2.47-3.4-2.15-1.88-1.49
GSK2336805 60 mg, Genotype 1 HCV6.75.52.92.72.31.420200.23-2.78-1.33-0.34-0.51-1.99
GSK2336805 60 mg, Genotype 4 HCV4.26.52.52.11.81.2-11NANA-3.85-1.17-3.57-2.05-0.08-2.41
Telaprevir, Genotype 1 HCV8.15.60.7-0.5-0.3-2.8-8-14NANA5.124.135.357.19.436.85

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Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionTrillion cells per liter (Mean)
Red Blood Cell count; Week 18; n=38, 34, 13, 12Red Blood Cell count; Week 24; n=35, 33, 12, 11Red Blood Cell count; Week 30; n=13,10,2,2Red Blood Cell count; Week 36; n=12,7,1,2Red Blood Cell count; Week 42; n=10,6,2,2Red Blood Cell count; Week 48; n=9, 6,1,2Red Blood Cell count; PT Week 4; n=32,34,11,11
GSK2336805 40 mg, Genotype 1 HCV-1.13-1.13-1.05-0.88-0.91-0.83-0.57
GSK2336805 60 mg, Genotype 1 HCV-0.88-0.94-0.75-1.06-1.17-1.03-0.37
GSK2336805 60 mg, Genotype 4 HCV-0.99-1.14-1.45-1.3-1.45-1.5-0.65
Telaprevir, Genotype 1 HCV-1.19-1.19-1.45-1-0.55-0.4-0.66

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Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12

The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1 and 12

,,,
InterventionMilliseconds (Mean)
PR interval, Week 1, n=41, 40, 15, 12PR interval, Week 12, n=38, 35, 12, 13QRS duration, Week 1, n=41, 40, 15,12QRS duration, Week 12, n=38, 35, 12,13Uncorrected QT Interval, Week 1, n=41,40,15,12Uncorrected QT interval, Week 12,n=38,35,12,13QTcB interval, Week 1, n=41,40,15,12QTcB interval, Week 12,n=38,35,12,13QTcF interval, Week 1, n=41,40,15,12QTcF interval, Week 12,n=38,35,12,13
GSK2336805 40 mg, Genotype 1 HCV0.52.9-6.6-8.2-2.3-11.87.708711.55124.19953.3516
GSK2336805 60 mg, Genotype 1 HCV1.23.20.4-1.8-2.6-120.24911.7615-0.7151-3.1442
GSK2336805 60 mg, Genotype 4 HCV-1.60.20.4-25.9-4.619.887918.994314.918710.7637
Telaprevir, Genotype 1 HCV2.75.52.90.4-2.1-179.811211.28015.76761.6147

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Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionFemtoliters (Mean)
Mean corpuscle volume; Week1; n=38, 39, 14, 12Mean corpuscle volume; Week2; n=41, 38, 14, 12Mean corpuscle volume; Week4; n=41, 38, 14, 13Mean corpuscle volume; Week6; n=41, 38, 12, 13Mean corpuscle volume; Week8; n=39, 39, 13, 13Mean corpuscle volume; Week12; n=38, 34, 12, 12
GSK2336805 40 mg, Genotype 1 HCV-1.1-20.32.33.85.7
GSK2336805 60 mg, Genotype 1 HCV-0.8-1.40.21.834.2
GSK2336805 60 mg, Genotype 4 HCV-0.7-1.5-0.21.42.23.8
Telaprevir, Genotype 1 HCV-0.4-1.4-0.8-0.23.15.3

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Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionFemtoliters (Mean)
Mean Corpuscle Volume ; Week 18;n=38,34,13,12Mean Corpuscle Volume ; Week 24;n=35,33,12,11Mean Corpuscle Volume ; Week 30; n=13,10,2,2Mean Corpuscle Volume ; Week 36; n=12,7,1,2Mean Corpuscle Volume ; Week 42;n=10,6,2,2Mean Corpuscle Volume ; Week 48;n=9,6,1,2Mean Corpuscle Volume; PT Week 4; n=32,34,11,11
GSK2336805 40 mg, Genotype 1 HCV7.58.57.88.16.95.26.1
GSK2336805 60 mg, Genotype 1 HCV6.27.59.511.410.795.1
GSK2336805 60 mg, Genotype 4 HCV5.35.835.5455.3
Telaprevir, Genotype 1 HCV8.57.611.521-15.8

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Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionGrams per liter (Mean)
Hemoglobin; Week1; n=38, 39, 14, 12Hemoglobin; Week2; n=41, 38, 14, 12Hemoglobin; Week4; n=41, 38, 14, 13Hemoglobin; Week6; n=41, 38, 12, 13Hemoglobin; Week8; n=39, 39, 13, 13Hemoglobin; Week12; n=38, 36, 12, 12
GSK2336805 40 mg, Genotype 1 HCV-5.2-16.7-28.6-30.1-30.5-33
GSK2336805 60 mg, Genotype 1 HCV-2.3-14.9-22.1-24.7-25.5-24.1
GSK2336805 60 mg, Genotype 4 HCV-5.3-9.9-22.5-25.2-25.2-27.6
Telaprevir, Genotype 1 HCV-6.6-20.5-34.4-40.8-44.9-47.4

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Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12

Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4

,,,
InterventionGrams per liter (Mean)
Hemoglobin; Week 18; n=38, 34, 13, 12Hemoglobin; Week 24; n=35, 33, 12,11Hemoglobin; Week 30; n=13, 10, 2, 2Hemoglobin; Week 36; n=12, 7, 1, 2Hemoglobin; Week 42; n=10, 6, 2, 2Hemoglobin; Week 48; n=9, 6, 1, 2Hemoglobin; PT Week 4; n=32, 34, 11,11
GSK2336805 40 mg, Genotype 1 HCV-33.6-33.4-30.2-26.7-27.1-25.9-16.5
GSK2336805 60 mg, Genotype 1 HCV-26.7-28-21-30-31.7-29.3-11.7
GSK2336805 60 mg, Genotype 4 HCV-29-32.3-40-35-40-41-16.8
Telaprevir, Genotype 1 HCV-35-35.6-40-37-25-18-21.4

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Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12

Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. (NCT01648140)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12

,,,
InterventionRatio (Mean)
Hematocrit; Week1; n=38, 39, 14, 12Hematocrit; Week2; n=41, 38, 14, 12Hematocrit; Week4; n=41, 38, 14, 13Hematocrit; Week6; n=41, 38, 12, 13Hematocrit; Week8; n=39, 39, 13, 13Hematocrit; Week12; n=38, 36, 12, 12
GSK2336805 40 mg, Genotype 1 HCV-0.0196-0.0539-0.0848-0.0859-0.0838-0.0843
GSK2336805 60 mg, Genotype 1 HCV-0.0069-0.0465-0.0621-0.0685-0.0663-0.0589
GSK2336805 60 mg, Genotype 4 HCV-0.0166-0.0335-0.0668-0.074-0.07-0.0688
Telaprevir, Genotype 1 HCV-0.0201-0.0609-0.0999-0.1203-0.1235-0.1318

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OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin0.12

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OR for Impact of Baseline Level of Fibrosis (kPa) on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin0.53

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OR for Impact of Baseline Viral Load Count on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin1.07

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Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR

RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

Interventionpercentage of participants (Number)
Pegylated Interferon Alfa-2a and Ribavirin93.1

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Odds Ratio (OR) for Impact of Age on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin0.21

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PPV of Complete Early Viral Response (cEVR) on SVR

cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

Interventionpercentage of participants (Number)
Pegylated Interferon Alfa-2a and Ribavirin60.3

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Percentage of Participants Achieving Sustained Virological Response (SVR)

SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported. (NCT01659567)
Timeframe: At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks

Interventionpercentage of participants (Number)
Pegylated Interferon Alfa-2a and Ribavirin79.1

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OR for Impact of Overall Duration of Treatment on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin1.05

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OR for Impact of Gender on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin0.48

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OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin0.99

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OR for Impact of Body Weight on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin1.01

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OR for Impact of Duration of Treatment After Achieving RVR on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin1.04

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OR for Impact of Duration of Treatment After Achieving cEVR on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin2.77

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OR for Impact of Cumulative Doses of Ribavirin on SVR

The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). (NCT01659567)
Timeframe: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

Interventionodds ratio (Number)
Pegylated Interferon Alfa-2a and Ribavirin0.99

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Percentage of Participants With Virologic Failure During Treatment

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). (NCT01674725)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

,
Interventionpercentage of participants (Number)
ReboundFailure to Suppress
ABT-450/r/ABT-267 and ABT-33300
ABT-450/r/ABT-267 and ABT-333, Plus RBV00

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Percentage of Participants With Virologic Relapse After Treatment

Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (NCT01674725)
Timeframe: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV0
ABT-450/r/ABT-267 and ABT-3330

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses

"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV." (NCT01674725)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV97.7
ABT-450/r/ABT-267 and ABT-333100

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses

"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV." (NCT01674725)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV97.7
ABT-450/r/ABT-267 and ABT-333100

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Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment

The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment. (NCT01674725)
Timeframe: Baseline (Day 1) and Week 12 (End of Treatment)

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV42.0
ABT-450/r/ABT-267 and ABT-3335.5

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Number of Participants From Whom Detectable Concentrations of Hepatic Vaniprevir Are Obtained by FNA

Liver samples were collected by FNA at 3 of 5 of the following specified postdose timepoints: 3, 12, 24, 48 and 72 hours after a single vaniprevir dose on Day 7. The technical success of the FNA procedure was established for a participant if vaniprevir was detected from at least 2 of the 3 FNA collection timepoints. (NCT01678131)
Timeframe: Day 7 up to Day 10 at 3 of the following timepoints: 3, 12, 24, 48 and 72 hours postdose

InterventionParticipants (Number)
600 mg Vaniprevir10
300 mg Vaniprevir + PegIFN/RBV9
600 mg Vaniprevir + PegIFN/RBV10

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Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [NCT01685203)
Timeframe: 12 weeks after the last actual dose of study drug

InterventionPercentage of participants (Number)
Group 190.9
Group 295.2
Group 390.0
Group 4100
Group 6100
Group 797.9
Group 898.1

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Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [NCT01685203)
Timeframe: 24 weeks after the last actual dose of study drug

InterventionPercentage of participants (Number)
Group 186.4
Group 292.9
Group 390.0
Group 4100.0
Group 6100.0
Group 797.9
Group 898.1

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Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events

Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug. (NCT01685203)
Timeframe: From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.

InterventionPercentage of participants (Number)
Group 177.3
Group 273.8
Group 380.0
Group 488.1
Group 685.7
Group 785.1
Group 871.2

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Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). (NCT01685203)
Timeframe: Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8

InterventionPercentage of participants (Number)
Group 12.3
Group 20
Group 32.5
Group 40
Group 60
Group 70
Group 80

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Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. (NCT01685203)
Timeframe: Within 12 weeks after the last dose of study drug

InterventionPercentage of participants (Number)
Group 14.8
Group 20
Group 37.7
Group 40
Group 60
Group 70
Group 81.9

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug. (NCT01687270)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV70.0

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HCV RNA and Change From Baseline at Weeks 2, 4, and 8

(NCT01687270)
Timeframe: Baseline; Weeks 2, 4, and 8

Interventionlog10 IU/mL (Mean)
Week 2 (n = 39)Change from baseline at Week 2 (n = 39)Week 4 (n = 40)Change from baseline at Week 4 (n = 40)Week 8 (n = 40)Change from baseline at Week 8 (n = 40)
SOF+RBV1.65-4.891.38-5.171.38-5.17

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Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24

(NCT01687270)
Timeframe: Weeks 12 and 24

Interventionpercentage of participants (Number)
Week 12 (n = 40)Week 24 (n = 38)
SOF+RBV100.00100.00

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Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)

SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively. (NCT01687270)
Timeframe: Posttreatment Weeks 4, 24, and 48

Interventionpercentage of participants (Number)
SVR4SVR24SVR48
SOF+RBV72.570.070.0

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment~Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)" (NCT01687270)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
On-treatment virologic failureVirologic relapse
SOF+RBV030.0

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Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event

(NCT01687270)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
SOF+RBV5.0

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Sustained Virologic Response At 12 Weeks (SVR12)

To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point. (NCT01700179)
Timeframe: 12 weeks following the last dose

Interventionpercentage of participants (Number)
ACH-0143102 Plus Ribavirin50

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Maximum Plasma Concentration (Cmax) of Telaprevir

Cmax was measured for telaprevir only. (NCT01701063)
Timeframe: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7

Interventionnanogram per milliliter (ng/mL) (Mean)
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV4310
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV5050
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV4060

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Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by age. (NCT01701063)
Timeframe: Baseline, On treatment (up to Week 48)

Interventionparticipants (Number)
Baseline (n = 41)On treatment (n = 6)
Overall Participants26

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

"AE: any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study." (NCT01701063)
Timeframe: Baseline up to Week 52

,,
Interventionparticipants (Number)
Participants with SAEsParticipants with AEs
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV013
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV018
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV110

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Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir

AUC was measured for telaprevir only. AUC 0-t last was defined as the area under the concentration-time curve from the time of dosing to the last measurable concentration. AUC 0-12 hour (AUC 0-12h) was calculated by respecifying predose concentrations as 12 hour concentrations. AUC 0-24h was calculated as AUC 0-12h multiplied by 2. Dose adjusted AUC (AUC 0-24h_Adj) was calculated by multiplying AUC 0-24h by the dose adjustment factor to obtain projected exposures in participants who were misdosed. Data were presented for AUC 0-t last, AUC 0-12h, AUC 0-24h, AUC 0-24h_Adj. (NCT01701063)
Timeframe: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7

,,
Interventionhours*nanogram per milliliter (h*ng/mL) (Mean)
AUC 0-t lastAUC 0-12hAUC 0-24hAUC 0-24h_Adj
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV39900399007990095700
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV43300441008810088600
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV35300353007060076300

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Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir

Tmax was measured for telaprevir only. (NCT01701063)
Timeframe: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7

Interventionhours (h) (Median)
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV4.00
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV4.00
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV4.00

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Percentage of Participants With Extended Rapid Virologic Response (eRVR)

The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. eRVR was defined as an undetectable HCV RNA (NCT01701063)
Timeframe: Week 4 and Week 12

Interventionpercentage of participants (Number)
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV61.5
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV73.7
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV60.0

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Percentage of Participants With On-treatment Virologic Failure

On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Futility rules: 1) HCV RNA >1000 IU/mL at Week 4; 2) HCV RNA >1000 IU/mL at Week 12; 3) Detectable HCV RNA after Week 12 to end of treatment. (NCT01701063)
Timeframe: Baseline up to Week 48

Interventionpercentage of participants (Number)
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV15.4
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV5.3
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV30.0

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Percentage of Participants With Rapid Virologic Response (RVR)

The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. RVR was defined as an undetectable HCV RNA (NCT01701063)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV69.2
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV73.7
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV70.0

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Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (less than [<] lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/High Pure System (HPS) RNA assay version 2.0. The lower limit of quantification was 25 international units per milliliter (IU/mL). (NCT01701063)
Timeframe: 12 weeks after last planned dose of study drug (up to Week 60)

Interventionpercentage of participants (Number)
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV69.2
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV89.5
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV40.0

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Percentage of Participants With Undetectable HCV RNA at Week 12

The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. (NCT01701063)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV69.2
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV89.5
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV70.0

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Percentage of Participants With Virologic Relapse

The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Viral relapse was defined as having detectable HCV at follow-up in participants who had HCV RNA less than (<) lower limit of quantification (LLOQ) at planned EOT. (NCT01701063)
Timeframe: 12 weeks after planned EOT (up to Week 60)

Interventionpercentage of participants (Number)
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV0
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV0
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV0

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Number of Participants With Sustained Virological Response at Week 12 (SVR12)

"Viral kinetic assessment using SVR 12 to either lead-in 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment." (NCT01704521)
Timeframe: Post-treatment at week 12

Interventionparticipants (Number)
Lead-In2
No Lead-in2

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm

A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug. (NCT01704755)
Timeframe: 12 weeks after the last actual dose of study drug

InterventionPercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks91.8
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks96.5

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Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). (NCT01704755)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

InterventionPercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks0.5
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks1.7

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01704755)
Timeframe: 12 weeks after the last actual dose of study drug

InterventionPercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks91.8
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks96.5

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Percentage of Participants With Virologic Relapse After Treatment

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. (NCT01704755)
Timeframe: within 12 weeks after the last dose of study drug

InterventionPercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks5.9
ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks0.6

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Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. (NCT01710501)
Timeframe: Up to 24 weeks

Interventionparticipants (Number)
Grazoprevir 25 mg + PEG-IFN + RBV1
Grazoprevir 50 mg + PEG-IFN + RBV1
Grazoprevir 100 mg + PEG-IFN + RBV1

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Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. (NCT01710501)
Timeframe: 14 days following last dose of study drug (up to 26 weeks)

Interventionparticipants (Number)
Grazoprevir 25 mg + PEG-IFN + RBV28
Grazoprevir 50 mg + PEG-IFN + RBV28
Grazoprevir 100 mg + PEG-IFN + RBV28

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Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response

Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available. (NCT01710501)
Timeframe: From Day 1 up to Follow-up Week 24 (up to 48 weeks total)

Interventionparticipants (Number)
Grazoprevir 25 mg + PEG-IFN + RBV9
Grazoprevir 50 mg + PEG-IFN + RBV5
Grazoprevir 100 mg + PEG-IFN + RBV3

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Percentage of Participants Achieving SVR4

HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy. (NCT01710501)
Timeframe: 4 weeks after end of treatment (up to 28 weeks total)

Interventionpercentage of participants (Number)
Grazoprevir 25 mg + PEG-IFN + RBV76.9
Grazoprevir 50 mg + PEG-IFN + RBV88.0
Grazoprevir 100 mg + PEG-IFN + RBV92.3

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Percentage of Subjects Achieving SVR24

HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy. (NCT01710501)
Timeframe: 24 weeks after end of treatment (up to 48 weeks total)

Interventionpercentage of participants (Number)
Grazoprevir 25 mg + PEG-IFN + RBV54.2
Grazoprevir 50 mg + PEG-IFN + RBV84.0
Grazoprevir 100 mg + PEG-IFN + RBV84.6

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Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point

HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA < 9.3 IU/mL. (NCT01710501)
Timeframe: From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)

,,
Interventionpercentage of participants (Number)
Week 2 (n=29, 25, 29)Week 4 (n=28, 26, 29)Week 12 (n=28, 26, 28)End of All Therapy (n=26, 25, 26)
Grazoprevir 100 mg + PEG-IFN + RBV55.289.7100.0100.0
Grazoprevir 25 mg + PEG-IFN + RBV34.582.196.492.3
Grazoprevir 50 mg + PEG-IFN + RBV32.076.992.392.0

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Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point

HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. (NCT01710501)
Timeframe: From TW 2 through end of treatment (up to 24 weeks)

,,
Interventionpercentage of participants (Number)
Week 2 (n=29, 25, 29)Week 4 (n=28, 26, 29)Week 12 (n=28, 26, 28)End of all Therapy (n=26, 25, 26)
Grazoprevir 100 mg + PEG-IFN + RBV96.6100.0100.0100.0
Grazoprevir 25 mg + PEG-IFN + RBV86.296.496.492.3
Grazoprevir 50 mg + PEG-IFN + RBV88.0100.0100.0100.0

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Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)

Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy. (NCT01710501)
Timeframe: 12 weeks after end of treatment (up to 36 weeks total)

Interventionpercentage of participants (Number)
Grazoprevir 25 mg + PEG-IFN + RBV54.2
Grazoprevir 50 mg + PEG-IFN + RBV84.0
Grazoprevir 100 mg + PEG-IFN + RBV88.5

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01715415)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV96.3

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Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. (NCT01715415)
Timeframe: Within 12 weeks post-treatment

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV2.4

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Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period

Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline. (NCT01715415)
Timeframe: At 12 weeks

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV96.9
Placebo12.8

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Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01715415)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV96.7

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Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm

Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment. (NCT01715415)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV0

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Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01715415)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV96.0

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Percentage of Participants With Undetectable HCV RNA by Time Point

HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: From Week 2 through end of treatment (up to 24 weeks)

,,
InterventionPercentage of participants (Number)
Week 2Week 4; Grazoprevir 100 mg + RBV 24 Weeks, n=11Week 12; Grazoprevir 100 mg + RBV 24 Weeks, n=11End of all therapy
Grazoprevir 100 mg + RBV 12 Weeks50.0100.0100.0100.0
Grazoprevir 100 mg + RBV 12 Weeks Extended0.00.075.075.0
Grazoprevir 100 mg + RBV 24 Weeks41.781.881.891.7

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Percentage of Participants With HCV RNA <25 IU/mL by Time Point

HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: From Week 2 through end of treatment (up to 24 weeks)

,,
InterventionPercentage of participants (Number)
Week 2Week 4; Grazoprevir 100 mg + RBV 24 Weeks, n=11Week 12; Grazoprevir 100 mg + RBV 24 Weeks, n=11End of all therapy
Grazoprevir 100 mg + RBV 12 Weeks100.0100.0100.0100.0
Grazoprevir 100 mg + RBV 12 Weeks Extended75.0100.075.075.0
Grazoprevir 100 mg + RBV 24 Weeks100.0100.090.991.7

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)

SVR12 was defined as HCV RNA <25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: Up to Week 36

InterventionPercentage of participants (Number)
Grazoprevir 100 mg + RBV 12 Weeks58.3
Grazoprevir 100 mg + RBV 24 Weeks90.0

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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)

HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL 24 weeks after the end of all study therapy. (NCT01716156)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
Grazoprevir 100 mg + RBV 12 Weeks62.5
Grazoprevir 100 mg + RBV 12 Weeks Extended50.0
Grazoprevir 100 mg + RBV 24 Weeks80.0

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Percentage of Participants Discontinuing Study Therapy Due to an AE

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment. (NCT01716156)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
Grazoprevir 100 mg + RBV: up to 12 Weeks0
Grazoprevir 100 mg + RBV: Beyond 12 Weeks0

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Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment. (NCT01716156)
Timeframe: Fourteen days following last dose of study drug (up to 26 weeks)

InterventionPercentage of participants (Number)
Grazoprevir 100 mg + RBV: up to 12 Weeks72.7
Grazoprevir 100 mg + RBV: Beyond 12 Weeks86.7

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Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)

HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL 4 weeks after the end of all study therapy. (NCT01716156)
Timeframe: Up to Week 28

InterventionPercentage of participants (Number)
Grazoprevir 100 mg + RBV 12 Weeks87.5
Grazoprevir 100 mg + RBV 12 Weeks Extended75.0
Grazoprevir 100 mg + RBV 24 Weeks90.9

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Time to Achievement of First Undetectable HCV RNA

The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: Up to Week 24

InterventionDays (Mean)
Grazoprevir 100 mg + RBV HCV GT1a27.1
Grazoprevir 100 mg + RBV HCV GT1non-a19.7

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01716585)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV96.4

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Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01716585)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV95.7

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Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01716585)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV98.0

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Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period

Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline. (NCT01716585)
Timeframe: At 12 weeks

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV97.0
Placebo15.8

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Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm

Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment. (NCT01716585)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV0.2

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Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. (NCT01716585)
Timeframe: Within 12 weeks post-treatment

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV1.5

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Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 2

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk91.3
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk92.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk91.7
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk86.2
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk73.3
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk77.4
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk60.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk79.3
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk78.1
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk67.7
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk77.4
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk66.7
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk57.6
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk62.5
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk89.7
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk76.7
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk76.7
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk61.3
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk70.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk85.0

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Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01717326)
Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk88.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk85.7
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk91.7
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk90.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk72.7
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk87.1
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk77.4
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk65.5
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk87.5
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk83.9
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk81.3
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk78.8
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk97.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk81.3
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk65.5
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk53.3
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk73.3
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk54.8
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk85.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk90.5

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Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01717326)
Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk0.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk0.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk0.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk0.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk0.0
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk6.3
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk0.0
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk3.1
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk0.0
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk0.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk0.0
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk0.0
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk0.0
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk0.0
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk0.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk4.8

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Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA. (NCT01717326)
Timeframe: From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)

Interventiondays (Mean)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk21.7
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk19.2
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk23.4
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk27.9
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk30.7
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk32.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk37.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk33.2
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk33.1
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk33.7
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk31.9
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk37.4
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk37.4
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk42.7
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk27.6
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk29.0
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk23.7
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk34.5
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk30.1
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk19.8

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Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 12

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk93.3
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk100.0
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk100.0
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk92.9
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk47.4
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk75.0

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Percentage of Participants Achieving Undetectable HCV RNA at Week 2

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 2

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk52.2
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk44.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk41.7
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk44.8
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk20.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk16.1
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk6.7
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk10.3
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk25.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk16.1
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk12.9
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk6.1
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk6.1
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk6.3
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk37.9
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk40.0
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk46.7
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk12.9
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk40.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk70.0

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Percentage of Participants Achieving Undetectable HCV RNA at Week 12

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 12

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk93.3
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk96.6
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk100.0
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk93.8
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk93.1
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk92.9
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk47.7
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk65.0

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Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 4 weeks after end of therapy (up to 22 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk95.8
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk93.3
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk96.8
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk96.7
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk96.6
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.8
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk93.9
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk96.6
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk93.1
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk93.1
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk96.8
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk50.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk61.1

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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 24 weeks after end of therapy (up to 42 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk95.8
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk78.6
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk96.8
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk90.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk96.6
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk93.1
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk90.9
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk96.6
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk88.9
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk93.1
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk93.5
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk47.4
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk58.8

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 12 weeks after end of therapy (up to 30 weeks)

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk95.8
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk82.8
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk96.8
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk90.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk96.6
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk93.5
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk90.9
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk96.9
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk96.6
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk92.9
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk93.1
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk93.5
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk47.4
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk61.1

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Percentage of Participants Achieving Undetectable HCV RNA at Week 4

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 4

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk73.9
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk91.7
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk75.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk73.3
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk83.3
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk77.4
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk60.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk79.3
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk71.9
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk71.0
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk83.3
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk68.8
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk69.7
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk53.1
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk75.9
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk78.6
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk86.7
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk74.2
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk50.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk77.8

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Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 4

Interventionpercentage of participants (Number)
A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk100.0
A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk90.0
B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk100.0
B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk100.0
B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk90.3
B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk100.0
B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk96.9
B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk97.0
B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk93.8
B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk100.0
B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk100.0
C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk100.0
C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk96.8
D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk65.0
D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk83.3

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Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)

Participants considered to have achieved SVR12 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 12 weeks after the planned end of study drug treatment. (NCT01725529)
Timeframe: 12 weeks after the end of treatment (EOT: Week 24 or 48)

InterventionPercentage of participants (Number)
Placebo75.7
Simeprevir (TMC435) 100mg88.9
Simeprevir (TMC435) 150mg90.8

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Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24)

Participants considered to have achieved SVR24 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ;25 IU/mL) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 24 weeks after the planned end of study drug treatment. (NCT01725529)
Timeframe: 24 weeks after the end of treatment (EOT: Week 24 or 48)

Interventionpercentage of participants (Number)
Placebo75.0
Simeprevir (TMC435) 100mg88.9
Simeprevir (TMC435) 150mg90.8

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Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72)

(NCT01725529)
Timeframe: Week 72

Interventionpercentage of participants (Number)
Placebo75.0
Simeprevir (TMC435) 100mg87.6
Simeprevir (TMC435) 150mg90.1

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Percentage of Participants With Viral Breakthrough

The number of patients who experience viral breakthrough will be determined by measuring Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in plasma. Viral breakthrough was defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in subjects whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment. (NCT01725529)
Timeframe: Week 24 or 48 (End of Treatment)

Interventionpercentage of participants (Number)
Placebo2.0
Simeprevir (TMC435) 100mg2.6
Simeprevir (TMC435) 150mg2.6

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Percentage of Participants With On-treatment Normalization of Alanine Aminotransferase Level

Percentage of participants with on-treatment normalization of alanine aminotransferase level were assessed. (NCT01725529)
Timeframe: 72 weeks after the EOT (Week 24 or 48)

Interventionpercentage of participants (Number)
Placebo85.7
Simeprevir (TMC435) 100mg86.1
Simeprevir (TMC435) 150mg89.9

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Percentage of Participants With On-treatment Failure

A participant with on-treatment failure refers to a participant with confirmed detectable HCV RNA at the end of treatment. (NCT01725529)
Timeframe: End of Treatment (EOT: Week 24 or 48)

Interventionpercentage of participants (Number)
Placebo12.5
Simeprevir (TMC435) 100mg3.3
Simeprevir (TMC435) 150mg3.3

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Percentage of Participants With Viral Relapse

Viral relapse was defined as undetectable HCV RNA at the actual end of treatment and last HCV RNA measurement during follow-up ≥25 IU/mL. (NCT01725529)
Timeframe: 72 weeks after the EOT (Week 24 or 48)

Interventionpercentage of participants (Number)
Placebo11.5
Simeprevir (TMC435) 100mg1.4
Simeprevir (TMC435) 150mg2.8

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SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.

Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT. (NCT01728324)
Timeframe: 4 weeks (after End Of Treatment)

Interventionpercentage of participants (Number)
24-wk Non-cirrhotic (NC) Treatment Group81.0
16-wk Non-cirrhotic (NC) Treatment Group74.2
24-wk Cirrhotic (CR) Treatment Group72.2

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Prognostic Value of SVR12 Predicting SVR24

The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed. (NCT01728324)
Timeframe: 24 Week (post-treatment)

InterventionPercentage of participants (Number)
24-wk Non-cirrhotic (NC) Treatment Group99.0
16-wk Non-cirrhotic (NC) Treatment Group99.0
24-wk Cirrhotic (CR) Treatment Group98.0

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SVR12 Rates With Historical Control

"Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.~The number of participants analyzed are actually adjusted number of participant analyzed." (NCT01728324)
Timeframe: 12 Week (post-treatment)

,
Interventionpercentage of participants (Number)
PegIFN eligiblePegIFN ineligible
16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group76.6870.78
24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group79.9588.28

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SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.

Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT. (NCT01728324)
Timeframe: 4 weeks (after End Of Treatment)

Interventionpercentage of participants (Number)
24-wk Non-cirrhotic (NC) Treatment Group83.9
16-wk Non-cirrhotic (NC) Treatment Group80.3
24-wk Cirrhotic (CR) Treatment Group77.8

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Comparisons of SVR12 Rates Across Treatment Arms

Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint. (NCT01728324)
Timeframe: 12 Week (post-treatment)

InterventionPercentage of participants (Number)
24-wk Non-cirrhotic (NC) Treatment Group82.0
16-wk Non-cirrhotic (NC) Treatment Group75.6
24-wk Cirrhotic (CR) Treatment Group73.6

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SVR4

Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4). (NCT01732796)
Timeframe: 4 Week (post-treatment)

,,
InterventionPercentage of participants (Number)
Percentage of patients with responsePositive predicted value
16 wk NC FDV+DBV+RBV78.494.0
24 wk CR FDV+DBV+RBV76.595.0
24 wk NC FDV+DBV+RBV84.498.0

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SVR24

Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24). (NCT01732796)
Timeframe: 24 Week (post-treatment)

,,
InterventionPercantage of participants (Number)
Percentage of patients with responsePositive predicted value
16 wk NC FDV+DBV+RBV70.797.0
24 wk CR FDV+DBV+RBV72.5100.0
24 wk NC FDV+DBV+RBV80.699.0

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SVR12 Rates With Historical Control

Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint (NCT01732796)
Timeframe: 12 Week (post-treatment)

,
InterventionPercentage of participants (Number)
non-cirrhotic (N=174, 149)cirrhotic (N=37, 37)
16 wk FDV+DBV+RBV71.672.5
24 wk FDV+DBV+RBV82.572.5

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Comparisons of SVR12 Rates Across Treatment Arms

Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint. (NCT01732796)
Timeframe: 12 Week (post-treatment)

InterventionPercentage of participants (Number)
16 wk NC FDV+DBV+RBV71.6
24 wk NC FDV+DBV+RBV82.5
24 wk CR FDV+DBV+RBV72.5

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Immunogenicity

Number of randomized patients with neutralizing antibodies to IFN alfa on weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment. (NCT01740089)
Timeframe: Weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment

Interventionparticipants (Number)
Algeron (n=100)0
PegIntron (n=50)0

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Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.

(NCT01740089)
Timeframe: After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.

Interventionparticipants (Number)
Algeron (n=100)88
PegIntron (n=50)38

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Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.

(NCT01740089)
Timeframe: 12 weeks

Interventionparticipants (Number)
Algeron 1.5 μg/kg47
Algeron 2.0 μg/kg47
PegIntron44

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Number of Randomized Patients Achieving Rapid Virologic Response (RVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.

(NCT01740089)
Timeframe: 4 weeks

Interventionparticipants (Number)
Algeron 1.5 μg/kg32
Algeron 2.0 μg/kg28
PegIntron33

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Number of Randomized Patients Achieving Sustained Virologic Response (SVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.

(NCT01740089)
Timeframe: 24 weeks after last dose of study treatment

Interventionparticipants (Number)
Algeron (n=100)75
PegIntron (n=50)34

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Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)

SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24. (NCT01741545)
Timeframe: Follow-up Week 24

InterventionPercentage of participants (Number)
Cohort A66.7
Cohort B30.8

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Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment

Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) <10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) <750 mm^3, and/or thrombocytopenia: platelets <50,000 mm^3. (NCT01741545)
Timeframe: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

InterventionPercentage of participants (Number)
Cohort A0
Cohort B0

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Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities

Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): >2.0*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : >5*ULN; Aspartate aminotransferase (AST): >5*ULN; Prothrombin Time (PT): >1.50*ULN; Bilirubin (Total): >2.5*ULN; Triglycerides (fasting): >750 mg/dL. (NCT01741545)
Timeframe: After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

,
InterventionParticipants (Count of Participants)
INRALTASTPTBilirubinTriglycerides
Cohort A020020
Cohort B112171

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Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death

AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug. (NCT01741545)
Timeframe: From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)

,
InterventionPercentage of participants (Number)
AEs on treatmentSAEsDeathAE leading to discontinuationDose reduction - LambdaDose reduction - RBV
Cohort A1000100
Cohort B3840312

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Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment

Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain. (NCT01741545)
Timeframe: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

,
InterventionPercentage of participants (Number)
Flu-like symptomsMusculoskeletal symptoms
Cohort A8.30
Cohort B12.815.4

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Percentage of Participants With Rapid Virologic Response (RVR)

RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4. (NCT01741545)
Timeframe: Treatment Week 4

InterventionPercentage of participants (Number)
Cohort A91.7
Cohort B76.9

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Percentage of Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12. (NCT01741545)
Timeframe: Treatment Week 12

InterventionPercentage of participants (Number)
Cohort A91.7
Cohort B92.3

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Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12

SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. (NCT01741545)
Timeframe: Follow-up Week 12

InterventionPercentage of participants (Number)
Cohort A91.7
Cohort B89.7

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Percentage of Participants With End of the Treatment Response (EOTR)

EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment. (NCT01741545)
Timeframe: End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)

InterventionPercentage of participants (Number)
Cohort A100
Cohort B100

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Undetectable HCV RNA (Week 1)

To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy. (NCT01743521)
Timeframe: Week 1 of therapy

Interventionpercentage of participants (Number)
Group A - 8 Weeks Total Therapy71.43
Group B - 12 Weeks Total Therapy0
Group C - 24 Weeks Total Therapy0

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Undetectable HCV RNA (Week 3)

To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy. (NCT01743521)
Timeframe: Week 3 of therapy

Interventionpercentage of participants (Number)
Group A - 8 Weeks Total Therapy100
Group B - 12 Weeks Total Therapy33.33
Group C - 24 Weeks Total Therapy0

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Undetectable HCV RNA (Week 4)

To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy. (NCT01743521)
Timeframe: Week 4 of therapy

Interventionpercentage of participants (Number)
Group A - 8 Weeks Total Therapy100
Group B - 12 Weeks Total Therapy66.67
Group C - 24 Weeks Total Therapy0

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Decrease in Absolute Neutrophil Count (ANC) ≤0.75

(NCT01743521)
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

Interventionparticipants (Number)
Group A - 8 Weeks Total Therapy1
Group B - 12 Weeks Total Therapy1
Group C - 24 Weeks Total Therapy0

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Change in Hemoglobin at End of Treatment

To evaluate indicators of toxicity during telaprevir based therapy (NCT01743521)
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

Interventiong/L (Median)
Group A - 8 Weeks Total Therapy-31
Group B - 12 Weeks Total Therapy-53
Group C - 24 Weeks Total Therapy-17.5

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Decrease in Platelets <50

(NCT01743521)
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

Interventionparticipants (Number)
Group A - 8 Weeks Total Therapy0
Group B - 12 Weeks Total Therapy0
Group C - 24 Weeks Total Therapy0

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SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)

Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion) (NCT01743521)
Timeframe: 12 weeks post-treatment

Interventionpercentage of participants (Number)
Group A - 8 Weeks Total Therapy71
Group B - 12 Weeks Total Therapy100
Group C - 24 Weeks Total Therapy100

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SVR24

To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24) (NCT01743521)
Timeframe: 24 weeks post-treatment

Interventionpercentage of participants (Number)
Group A - 8 Weeks Total Therapy43
Group B - 12 Weeks Total Therapy100
Group C - 24 Weeks Total Therapy100

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Undectectable HCV RNA (Week 2)

To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy. (NCT01743521)
Timeframe: Week 2 of therapy

Interventionpercentage of participants (Number)
Group A - 8 Weeks Total Therapy100
Group B - 12 Weeks Total Therapy0
Group C - 24 Weeks Total Therapy0

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Undetectable HCV RNA (ETR)

To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR) (NCT01743521)
Timeframe: Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

Interventionpercentage of participants (Number)
Group A - 8 Weeks Total Therapy100
Group B - 12 Weeks Total Therapy100
Group C - 24 Weeks Total Therapy100

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Percentage of Participants With One or More Adverse Events

Adverse events were monitored during the Lead-in and Treatment Periods (NCT01756079)
Timeframe: Up to 48 weeks (Lead-in and Treatment Periods)

InterventionPercentage of participants (Number)
Overall Participants98.1

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Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)

Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period. (NCT01756079)
Timeframe: Week 72 (24 weeks after end of treatment)

InterventionPercentage of participants (Number)
Overall Participants35.2

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Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication

Adverse events were monitored during the Lead-in and Treatment Periods (NCT01756079)
Timeframe: Up to 48 weeks (Lead-in and Treatment Periods)

InterventionPercentage of participants (Number)
Overall Participants9.3

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Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment

The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment. (NCT01767116)
Timeframe: Baseline (Day 1) and Week 12 (End of Treatment)

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV51.2
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV3.4

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate

"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN)." (NCT01767116)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV99.5
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV100.0

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV

"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV." (NCT01767116)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV99.5
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV100

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Percentage of Participants With Virologic Failure During Treatment

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). (NCT01767116)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

,
Interventionpercentage of participants (Number)
ReboundFailure to suppress
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV00
ABT-450/r/ABT-267 and ABT-333, Plus RBV0.50

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate

"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV." (NCT01767116)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of particpants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV99.5
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV100

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Percentage of Participants With Virologic Relapse After Treatment

Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (NCT01767116)
Timeframe: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV0
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV0

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Normalization of Alanine Transferase Test

Liver function test,showing resolution of the inflammation of liver parenchyma (NCT01770483)
Timeframe: 48week

Interventionparticipants (Number)
Control Group11
Study Group11

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Sustained Viral Response,

Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment. (NCT01770483)
Timeframe: 48 WEEK

Interventionparticipants (Number)
Control Group13
Study Group11

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT01782495)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A97.1
Arm B96.3
Arm C100
Arm D100
Arm E100
Arm F95.5
Arm G100
Arm H66.7
Arm I100
Arm J100
Arm K100

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or confirmed HCV RNA ≥ LLOQ at any point during treatment after HCV RNA < LLOQ, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. (NCT01782495)
Timeframe: Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)

Interventionpercentage of participants (Number)
Arm A0
Arm B3.7
Arm C0
Arm D0
Arm E0
Arm F0
Arm G0
Arm H0
Arm I0
Arm J0
Arm K0

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Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT01782495)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
Arm A3.0
Arm B0
Arm C0
Arm D0
Arm E0
Arm F4.8
Arm G0
Arm H0
Arm I0
Arm J0
Arm K0

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Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)

SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT01782495)
Timeframe: 24 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A97.1
Arm B96.3
Arm C100
Arm D100
Arm E100
Arm F95.5
Arm G100
Arm H66.7
Arm I100
Arm J100
Arm K100

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SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)

Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage. (NCT01830127)
Timeframe: 4 weeks after End of Treatment

InterventionPercentage of participants (Number)
Arm1: Child-Pugh A72.2
Arm2: Child-Pugh B76.5

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SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)

Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage. (NCT01830127)
Timeframe: 12 weeks after End of Treatment

InterventionPercentage of participants (Number)
Arm1: Child-Pugh A61.1
Arm2: Child-Pugh B52.9

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses

"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV." (NCT01833533)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV97.0
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV90.2

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Percentage of Participants With Virologic Relapse After Treatment

Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (NCT01833533)
Timeframe: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV1.0
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV5.2

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Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment

The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment. (NCT01833533)
Timeframe: Baseline (Day 1) and Week 12 (End of Treatment)

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV42.0
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV3.9

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses

"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV." (NCT01833533)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV97.0
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV90.2

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Percentage of Participants With Virologic Failure During Treatment

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). (NCT01833533)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

,
Interventionpercentage of participants (Number)
ReboundFailure to suppress
ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV2.90
ABT-450/r/ABT-267 and ABT-333, Plus RBV1.00

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Safety: Number of Participants With Adverse Events

Safety was assessed throughout study by collection of adverse event and concomitant medication data, and routine monitoring of lab safety tests, physical exams, ophthalmic examination, vital signs and 12 lead electrocardiograms. (NCT01833845)
Timeframe: all 24 weeks

Interventionparticipants (Number)
Ribavirin+HCQ4

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Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants

To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs). (NCT01849562)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
Discontinuations due to AEsTreatment Emergent G3/G4 AEsTreatment Emergent G3/G4 AbnormalitiesClinically Significant ECGs
Placebo0000
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg0030
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-2000 mg0020

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Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment

Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo. (NCT01849562)
Timeframe: Four weeks after the completion of treatment

InterventionPercentage of participants with SVR4 (Number)
Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg50
Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000-1200 mg70
Placebo0

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Percentage of Participants With at Least 1 Adverse Event

(NCT01853254)
Timeframe: From Baseline to the end of the study (up to 72 weeks)

InterventionPercentage of participants (Number)
Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin38.2

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Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)

The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being). (NCT01854528)
Timeframe: Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)

Interventionunits on a scale (Mean)
3-DAA/RBV0.4
TPV/RBV-7.7

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Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)

The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being). (NCT01854528)
Timeframe: Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)

Interventionunits on a scale (Mean)
3-DAA/RBV-1.3
TPV/RBV-9.8

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Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. (NCT01854528)
Timeframe: 24 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
3-DAA/RBV99.0
TPV/RBV66.0

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Percentage of Participants With Virologic Failure During Treatment

Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment. (NCT01854528)
Timeframe: Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV)

Interventionpercentage of participants (Number)
3-DAA/RBV0
TPV/RBV19.1

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Percentage of Participants With Virologic Relapse After Treatment

Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (NCT01854528)
Timeframe: Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment)

Interventionpercentage of participants (Number)
3-DAA/RBV0
TPV/RBV6.3

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. (NCT01854528)
Timeframe: 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
3-DAA/RBV100.0
TPV/RBV66.0

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Percentage of Participants With SVR12 - Secondary Efficacy Analyses

The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug. (NCT01854697)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
Arm A: 3-DAA + RBV in GT1a97.1
Arm B: TPV/PR in GT1a82.4
Arm C: 3-DAA + RBV in GT1b98.8
Arm D: 3-DAA in GT1b97.6
Arm E: TPV/PR in GT1b78.0

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Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)

The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug. (NCT01854697)
Timeframe: 24 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
Arm A: 3-DAA + RBV in GT1a95.7
Arm B: TPV/PR in GT1a82.4
Arm C: 3-DAA + RBV in GT1b97.6
Arm D: 3-DAA in GT1b97.6
Arm E: TPV/PR in GT1b78.0

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01854697)
Timeframe: 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
Arm A: 3-DAA + RBV in GT1a97.1
Arm B: TPV/PR in GT1a82.4
Arm C: 3-DAA + RBV in GT1b98.8
Arm D: 3-DAA in GT1b97.6
Arm E: TPV/PR in GT1b78.0

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Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)

SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL). (NCT01854697)
Timeframe: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E

Interventionunits on a scale (Mean)
Arm A: 3-DAA + RBV in GT1a-4.2
Arm B: TPV/PR in GT1a-5.8
Arm C: 3-DAA + RBV in GT1b-0.3
Arm D: 3-DAA in GT1b-0.1
Arm E: TPV/PR in GT1b-6.4

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Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)

SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL). (NCT01854697)
Timeframe: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E

Interventionunits on a scale (Mean)
Arm A: 3-DAA + RBV in GT1a0.5
Arm B: TPV/PR in GT1a-5.5
Arm C: 3-DAA + RBV in GT1b0.4
Arm D: 3-DAA in GT1b2.2
Arm E: TPV/PR in GT1b-5.5

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Percentage of Participants With Post-treatment Relapse

Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment. (NCT01854697)
Timeframe: Within 24 weeks post treatment

Interventionpercentage of participants (Number)
Arm A: 3-DAA + RBV in GT1a0
Arm B: TPV/PR in GT1a0
Arm C: 3-DAA + RBV in GT1b1.2
Arm D: 3-DAA in GT1b0
Arm E: TPV/PR in GT1b6.3

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Percentage of Participants With Virologic Failure During Treatment

"Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy:~Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment~Failure to achieve HCV RNA < LLOQ by Week 6 or~Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ.~Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows:~HCV RNA > 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV~HCV RNA > 1000 IU/mL at Week 12, discontinue pegIFN and RBV~Confirmed HCV RNA > lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV~Confirmed HCV RNA > LLOD at Week 36, discontinue pegIFN and RBV." (NCT01854697)
Timeframe: 12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E

Interventionpercentage of participants (Number)
Arm A: 3-DAA + RBV in GT1a2.9
Arm B: TPV/PR in GT1a5.9
Arm C: 3-DAA + RBV in GT1b0
Arm D: 3-DAA in GT1b1.2
Arm E: TPV/PR in GT1b12.2

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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT01858766)
Timeframe: Posttreatment Weeks 4 and 24

,,,,,,,,,,,,,,,,,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+VEL 100 mg + RBV 8 Weeks (GT1)87.180.6
SOF+VEL 100 mg + RBV 8 Weeks (GT2)88.588.5
SOF+VEL 100 mg 12 Weeks (GT1)100.0100.0
SOF+VEL 100 mg 12 Weeks (GT2)100.0100.0
SOF+VEL 100 mg 12 Weeks (GT3)100.092.6
SOF+VEL 100 mg 12 Weeks (GT4)85.785.7
SOF+VEL 100 mg 12 Weeks (GT6)100.0100.0
SOF+VEL 100 mg 8 Weeks (GT1)93.189.7
SOF+VEL 100 mg 8 Weeks (GT2)92.388.5
SOF+VEL 25 mg + RBV 8 Weeks (GT1)83.383.3
SOF+VEL 25 mg + RBV 8 Weeks (GT2)88.088.0
SOF+VEL 25 mg 12 Weeks (GT1)96.392.6
SOF+VEL 25 mg 12 Weeks (GT2)90.990.9
SOF+VEL 25 mg 12 Weeks (GT3)92.692.6
SOF+VEL 25 mg 12 Weeks (GT4)100.0100.0
SOF+VEL 25 mg 12 Weeks (GT5)100.0100.0
SOF+VEL 25 mg 12 Weeks (GT6)100.0100.0
SOF+VEL 25 mg 8 Weeks (GT1)86.786.7
SOF+VEL 25 mg 8 Weeks (GT2)88.576.9

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT01858766)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF+VEL 25 mg 12 Weeks0
SOF+VEL 100 mg 12 Weeks0
SOF+VEL 25 mg 8 Weeks1.8
SOF+VEL 25 mg + RBV 8 Weeks0
SOF+VEL 100 mg 8 Weeks0
SOF+VEL 100 mg + RBV 8 Weeks0

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01858766)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+VEL 25 mg 12 Weeks (GT1)3.7
SOF+VEL 100 mg 12 Weeks (GT1)0
SOF+VEL 25 mg 12 Weeks (GT2)0
SOF+VEL 100 mg 12 Weeks (GT2)0
SOF+VEL 25 mg 12 Weeks (GT3)7.4
SOF+VEL 100 mg 12 Weeks (GT3)7.4
SOF+VEL 25 mg 12 Weeks (GT4)0
SOF+VEL 100 mg 12 Weeks (GT4)0
SOF+VEL 25 mg 12 Weeks (GT5)0
SOF+VEL 25 mg 12 Weeks (GT6)0
SOF+VEL 100 mg 12 Weeks (GT6)0
SOF+VEL 25 mg 8 Weeks (GT1)10.0
SOF+VEL 25 mg + RBV 8 Weeks (GT1)16.7
SOF+VEL 100 mg 8 Weeks (GT1)10.3
SOF+VEL 100 mg + RBV 8 Weeks (GT1)16.1
SOF+VEL 25 mg 8 Weeks (GT2)23.1
SOF+VEL 25 mg + RBV 8 Weeks (GT2)8.0
SOF+VEL 100 mg 8 Weeks (GT2)11.5
SOF+VEL 100 mg + RBV 8 Weeks (GT2)11.5

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT01858766)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+VEL 25 mg 12 Weeks (GT1)96.3
SOF+VEL 100 mg 12 Weeks (GT1)100.0
SOF+VEL 25 mg 12 Weeks (GT2)90.9
SOF+VEL 100 mg 12 Weeks (GT2)100.0
SOF+VEL 25 mg 12 Weeks (GT3)92.6
SOF+VEL 100 mg 12 Weeks (GT3)92.6
SOF+VEL 25 mg 12 Weeks (GT4)100.0
SOF+VEL 100 mg 12 Weeks (GT4)85.7
SOF+VEL 25 mg 12 Weeks (GT5)100.0
SOF+VEL 25 mg 12 Weeks (GT6)100.0
SOF+VEL 100 mg 12 Weeks (GT6)100.0
SOF+VEL 25 mg 8 Weeks (GT1)86.7
SOF+VEL 25 mg + RBV 8 Weeks (GT1)83.3
SOF+VEL 100 mg 8 Weeks (GT1)89.7
SOF+VEL 100 mg + RBV 8 Weeks (GT1)80.6
SOF+VEL 25 mg 8 Weeks (GT2)76.9
SOF+VEL 25 mg + RBV 8 Weeks (GT2)88.0
SOF+VEL 100 mg 8 Weeks (GT2)88.5
SOF+VEL 100 mg + RBV 8 Weeks (GT2)88.5

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Mean Change in Platelet Count From Baseline to End of Treatment

All treated participants were monitored for change in Platelet Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants (units of measurement = x10^9 cells/L). (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

Intervention10^9 cells/L (Mean)
Cohort A: HCV GT-2 or GT-332.7
Cohort B: HCV GT-1 or GT-433.3

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Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms

All treated participants were monitored for IFN-associated Flu-like and Musculoskeletal symptoms. Flu-like symptoms were defined as pyrexia, chills, or pain. Musculoskeletal symptoms were defined as arthralgia, myalgia, or back pain. Subjects were monitored throughout the treatment period during the treatment period (After day 1 up to week 24, or After day 1 up to week 48 for subjects requiring those visits). (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48

,
InterventionParticipants (Count of Participants)
Musculoskeletal symptomsFlu-like symptoms
Cohort A: HCV GT-2 or GT-366
Cohort B: HCV GT-1 or GT-42119

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Number of Participants Who Died or Experienced Severe Adverse Events (SAEs), Dose Reductions of Lambda or Discontinuation Due to Adverse Events (AEs)

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that. at any dose, results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48

,
InterventionParticipants (Count of Participants)
DeathsSAEsLambda Dose ReductionDiscontinuation due to AEs
Cohort A: HCV GT-2 or GT-30644
Cohort B: HCV GT-1 or GT-43121913

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Number of Participants With Treatment Emergent Cytopenic Abnormalities

All treated participants were monitored for treatment emergent cytopenic abnormalities (anemia as defined by hemoglobin (Hb) < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000/mm3) during the treatment period (Weeks 1, 2, 4, 6, 8, 12, 20, and 24, and at Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits). (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48

InterventionParticipants (Count of Participants)
Cohort A: HCV GT-2 or GT-34
Cohort B: HCV GT-1 or GT-415

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Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)

SVR12 was defined as HCV RNA less than lower limit of quantification (< LLOQ) (25 IU/mL; target detected or not detected) at follow-up week 12. (NCT01866930)
Timeframe: Follow-up week 12

InterventionParticipants (Count of Participants)
Cohort A: HCV GT-2 or GT-388
Cohort B: HCV GT-1 or GT-4149

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Mean Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment

All treated participants were monitored for change in Absolute CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionCells/uL (Mean)
Cohort A: HCV GT-2 or GT-3-42.4
Cohort B: HCV GT-1 or GT-4-104.9

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Mean Percent Change in Total Lymphocyte Count From Baseline to End of Treatment

All treated participants were monitored for percent change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionPercent change (Mean)
Cohort A: HCV GT-2 or GT-3-15.33
Cohort B: HCV GT-1 or GT-4-22.95

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Number of Participants With Treatment-emergent Grade 3/4 Lab Abnormalities

Grade 3/4 treatment-emergent lab abnormalities that occurred in >=5% of subjects in either cohort are reported. The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AST = Aspartate aminotransferase, ALT = Alanine aminotransferase. (NCT01866930)
Timeframe: After Day 1 to end of treatment; up to Weeks 24 or 48

,
InterventionParticipants (Count of Participants)
Total BilirubinASTALT
Cohort A: HCV GT-2 or GT-326102
Cohort B: HCV GT-1 or GT-4631310

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Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR)

RVR is defined as HCV RNA < LLOQ target not detected at Week 4 and eRVR defined as HCV RNA < LLOQ target not detected at Weeks 4 and 12 (NCT01866930)
Timeframe: Treatment weeks 4 and 12

,
InterventionParticipants (Count of Participants)
RVReRVR
Cohort A: HCV GT-2 or GT-38280
Cohort B: HCV GT-1 or GT-4149138

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Mean Percent Change in Platelet Count From Baseline to End of Treatment

All treated participants were monitored for percent change in Platelet Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionPercent change (Mean)
Cohort A: HCV GT-2 or GT-316.9
Cohort B: HCV GT-1 or GT-420.1

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Mean Percent Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment

All treated participants were monitored for percent change in CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionPercent change (Mean)
Cohort A: HCV GT-2 or GT-3-4.0
Cohort B: HCV GT-1 or GT-4-13.4

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Mean Change in Total Lymphocyte Count From Baseline to End of Treatment

All treated participants were monitored for change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. (NCT01866930)
Timeframe: Day 1 to end of treatment; up to week 24 or week 48

InterventionCells/µL (Mean)
Cohort A: HCV GT-2 or GT-3-0.38
Cohort B: HCV GT-1 or GT-4-0.50

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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT01909804)
Timeframe: Posttreatment Weeks 4 and 24

,,,,,,,,,,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+VEL 100 mg (GT1)100.0100.0
SOF+VEL 100 mg (GT3 Cirrhotic)88.592.3
SOF+VEL 100 mg (GT3 Non-Cirrhotic)100.0100.0
SOF+VEL 100 mg + RBV (GT1)96.496.4
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)96.296.2
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)100.0100.0
SOF+VEL 25 mg (GT1)100.0100.0
SOF+VEL 25 mg (GT3 Cirrhotic)61.557.7
SOF+VEL 25 mg (GT3 Non-Cirrhotic)88.584.6
SOF+VEL 25 mg + RBV (GT1)96.696.6
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)84.084.0
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)96.496.4

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01909804)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+VEL 25 mg (GT3 Non-Cirrhotic)15.4
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)3.6
SOF+VEL 100 mg (GT3 Non-Cirrhotic)0
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)0
SOF+VEL 25 mg (GT3 Cirrhotic)42.3
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)12.0
SOF+VEL 100 mg (GT3 Cirrhotic)11.5
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)3.8
SOF+VEL 25 mg (GT1)0
SOF+VEL 25 mg + RBV (GT1)3.4
SOF+VEL 100 mg (GT1)0
SOF+VEL 100 mg + RBV (GT1)3.6

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT01909804)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+VEL 25 mg (GT3 Non-Cirrhotic)84.6
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)96.4
SOF+VEL 100 mg (GT3 Non-Cirrhotic)100.0
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)100.0
SOF+VEL 25 mg (GT3 Cirrhotic)57.7
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)84.0
SOF+VEL 100 mg (GT3 Cirrhotic)88.5
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)96.2
SOF+VEL 25 mg (GT1)100.0
SOF+VEL 25 mg + RBV (GT1)96.6
SOF+VEL 100 mg (GT1)100.0
SOF+VEL 100 mg + RBV (GT1)96.4

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT01909804)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF+VEL 25 mg0
SOF+VEL 25 mg + RBV1.2
SOF+VEL 100 mg0
SOF+VEL 100 mg + RBV0

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Percentage of Participants With Virologic Relapse Post-treatment

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. Completion of treatment was defined as a study drug duration ≥ 77 days. (NCT01911845)
Timeframe: From the end of treatment through 12 weeks after the last actual dose of study drug

InterventionPercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV0

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Percentage of Participants With Virologic Failure During Treatment

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks [≥ 36 days] of treatment. (NCT01911845)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

InterventionPercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV0

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment

The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01911845)
Timeframe: 12 weeks after the last actual dose of study drug

InterventionPercentage of participants (Number)
ABT-450/r/ABT-267 and ABT-333, Plus RBV97.4

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Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng*hr/mL)] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

,
Interventionng*hr/mL (Mean)
ABT-450RitonavirABT-267ABT-333ABT-333 M1 metaboliteRibavirin
Buprenorphine ± Naloxone27438.9414303.271523.485666.153086.7333362.24
Methadone37174.8911375.381486.725021.412950.3633499.39

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Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

,
Interventionng/mL (Mean)
ABT-450RitonavirABT-267ABT-333ABT-333 M1 metaboliteRibavirin
Buprenorphine ± Naloxone3269.501261.92102.00805.08469.923389.17
Methadone2973.30888.7095.98671.90439.643232.00

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Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

,
Interventionhours (Mean)
ABT-450RitonavirABT-267ABT-333ABT-333 M1 metaboliteRibavirin
Buprenorphine ± Naloxone4.384.184.694.254.403.72
Methadone6.817.015.264.054.655.83

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Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

,
Interventionng/mL (Mean)
ABT-450RitonavirABT-267ABT-333ABT-333 M1 metaboliteRibavirin
Buprenorphine ± Naloxone170.01167.3533.75223.7686.982555.83
Methadone458.53136.8732.78147.9571.102632.00

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Proportion of Subjects With Sustained Virologic Response (SVR12)

Defined as HCV-RNA negativity by a sensitive assay (NCT01925183)
Timeframe: Follow-up week 12 (FU12)

InterventionParticipants (Count of Participants)
28 Weeks of Treatment Duration3
48 Weeks of Treatment Duration2

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Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

(NCT01925183)
Timeframe: Baseline (BL) to Follow-up week 12 (FU12)

,
InterventionParticipants (Count of Participants)
Adverse events (AEs)Serious adverse events (SAEs)
28 Weeks of Treatment Duration30
48 Weeks of Treatment Duration31

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Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)

SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) <25 IU/mL, either target detected but unquantifiable (TD[u]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population. (NCT01932762)
Timeframe: 12 weeks after end of all therapy (Study Week 24)

Interventionpercentage of participants (Number)
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)85.2
GT2: Grazoprevir + RBV (Arm B1)75.0
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)94.1
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)76.9

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Percentage of Participants Achieving SVR4

SVR4 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population. (NCT01932762)
Timeframe: 4 weeks after end of all therapy (Study Week 16)

Interventionpercentage of participants (Number)
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)88.9
GT2: Grazoprevir + RBV (Arm B1)83.3
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)94.1
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)78.6

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Percentage of Participants Achieving SVR24

SVR24 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population. (NCT01932762)
Timeframe: 24 weeks after end of all therapy (Study Week 36)

Interventionpercentage of participants (Number)
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)84.6
GT2: Grazoprevir + RBV (Arm B1)75.0
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)94.1
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)76.9

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Mean Time to First Achievement of Undetectable HCV RNA During Treatment

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS). (NCT01932762)
Timeframe: From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)

Interventiondays (Mean)
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)25.2
GT2: Grazoprevir + RBV (Arm B1)26.9
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)27.4
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)21.3

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Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population. (NCT01932762)
Timeframe: From TW 2 through TW 12 (up to 12 weeks)

,,,
Interventionpercentage of participants (Number)
Week 2 (n=28, 24, 16, 15)Week 4 (n=28, 24, 17, 15)Week 12 (n=28, 24, 17, 14)
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)53.380.078.6
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)50.088.2100.0
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)42.985.796.4
GT2: Grazoprevir + RBV (Arm B1)50.079.283.3

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Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels <25 IU/ml (either TD[u] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population. (NCT01932762)
Timeframe: From TW 2 through TW 12 (up to 12 weeks)

,,,
Interventionpercentage of participants (Number)
Week 2 (n=28, 24, 16, 15)Week 4 (n=28, 24, 17, 15)Week 12 (n=28, 24, 17, 14)
GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)93.393.385.7
GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)87.5100.0100.0
GT2: Grazoprevir + Elbasvir + RBV (Arm A1)96.4100.096.4
GT2: Grazoprevir + RBV (Arm B1)79.291.787.5

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Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable

Percentage of participants with detectable and undetectable HCV RNA (<) 25 IU/mL during treatment at Weeks 2,4, 12, and 24 were reported. (NCT01938625)
Timeframe: Weeks 2, 4, 12, and 24

,
Interventionpercentage of participants (Number)
Week 2: <25 IU/mL detectableWeek 2: <25 IU/mL undetectableWeek 4: <25 IU/mL detectableWeek 4: <25 IU/mL undetectableWeek 12: <25 IU/mL detectableWeek 12: <25 IU/mL undetectableWeek 24: <25 IU/mL detectableWeek 24: <25 IU/mL undetectable
Cyclosporine3010307001000100
Tacrolimus361224680960100

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Percentage of Participants With Sustained Virologic Response 24 Weeks After the End of Treatment (SVR 24)

Participants were considered to have achieved SVR 24 if hepatitis C virus ribonucleic acid (HCV RNA) levels were (<) 25 IU/mL detectable or undetectable at 24 weeks after the end of treatment. (NCT01938625)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cyclosporine100
Tacrolimus88

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Percentage of Participants With Sustained Virologic Response 12 Weeks After the End of Treatment (SVR 12)

Participants were considered to have achieved SVR12 if hepatitis C virus ribonucleic acid (HCV RNA) levels were less than (<) 25 international unit per milliliter (IU/mL) detectable or undetectable at 12 weeks after the end of treatment. (NCT01938625)
Timeframe: Week 36

Interventionpercentage of participants (Number)
Cyclosporine100
Tacrolimus88

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Percentage of Participants With HCV RNA (<) 100 IU/mL at Week 4

Percentage of participants with HCV RNA (<) 100 IU/mL at week 4 were reported. (NCT01938625)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Cyclosporine100
Tacrolimus100

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Number of Participants With Viral Relapse

Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up. (NCT01938625)
Timeframe: Up to Week 24 after actual EOT (week 24)

Interventionparticipants (Number)
Cyclosporine0
Tacrolimus0

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Number of Participants With Viral Breakthrough

Viral breakthrough is defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in participants whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment. (NCT01938625)
Timeframe: Up to week 24

Interventionparticipants (Number)
Cyclosporine0
Tacrolimus3

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Number of Participants With On-Treatment Failure

On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been NCT01938625)
Timeframe: Up to Week 24 after actual EOT (week 24)

Interventionparticipants (Number)
Cyclosporine0
Tacrolimus3

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Percentage of Participants With Sustained Virologic Response 4 Weeks After the End of Treatment (SVR 4)

Participants were considered to have achieved SVR4 if HCV RNA levels were (<) 25 IU/mL detectable or undetectable at 4 weeks after the end of treatment. (NCT01938625)
Timeframe: Week 28

Interventionpercentage of participants (Number)
Cyclosporine100
Tacrolimus88

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Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period

Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment. (NCT01939197)
Timeframe: up to 12 or 24 weeks, based on treatment duration

Interventionpercentage of participants (Number)
Part 2: GT1 Analysis Group0.5
Part 2: Arm E0
Part 2: Arm F25.0
Part 2: Arm I0
Part 2: Arm J0
Part 2: GT4 Analysis Group0
Group 2: Arm K0

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Percentage of Participants in Part 2 With Relapse12

Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA < LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution. (NCT01939197)
Timeframe: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug

Interventionpercentage of participants (Number)
Part 2: GT1 Analysis Group0.5
Part 2: Arm E0
Part 2: Arm F0
Part 2: Arm I0.8
Part 2: Arm J0
Part 2: GT4 Analysis Group0
Group 2: Arm K0

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Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall

SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. (NCT01939197)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
Part 2: GT4 Analysis Group96.4
Part 2: Arm K96.4

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Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment

HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL). (NCT01939197)
Timeframe: End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126)

,
Interventionpercentage of participants (Number)
End of TreatmentPost-Treatment Week 12
Part 1a: Arm A93.596.8
Part 1a: Arm B90.693.8

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Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment

HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL). (NCT01939197)
Timeframe: End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)

,,
Interventionpercentage of participants (Number)
End of TreatmentPost-Treatment Week 12
Part 1b Total90.986.4
Part 1b: Arm C100100
Part 1b: Arm D83.375.0

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Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment

HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL). (NCT01939197)
Timeframe: End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)

,,,,,,
Interventionpercentage of participants (Number)
End of TreatmentPost-Treatment Week 12
Group 2: Arm K85.792.9
Part 2: Arm E90.597.6
Part 2: Arm F100100
Part 2: Arm I89.691.9
Part 2: Arm J78.989.5
Part 2: GT1 Analysis Group8993
Part 2: GT4 Analysis Group85.792.9

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Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12

SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. (NCT01939197)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
Part 2: Arm F75.0
Part 2: Arm G80.0

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Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)

"SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution.~The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%)." (NCT01939197)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Part 2: GT1 Analysis Group97.0

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Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period

Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment. (NCT01939197)
Timeframe: up to 12 or 24 weeks, based on treatment duration

Interventionpercentage of participants (Number)
Part 1a: Arm A0
Part 1a: Arm B3.1

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Percentage of Participants in Part 1a With Relapse12

Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution. (NCT01939197)
Timeframe: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug

Interventionpercentage of participants (Number)
Part 1a: Arm A3.3
Part 1a: Arm B0

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Percentage of Participants in Part 1b Achieving SVR12

SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. (NCT01939197)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
Part 1b: Arm C100
Part 1b: Arm D100
Part 1b: Total100

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Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period

Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment. (NCT01939197)
Timeframe: up to 12 weeks

Interventionpercentage of participants (Number)
Part 1b: Arm C0
Part 1b: Arm D0
Part 1b: Total0

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Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall

Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution. (NCT01939197)
Timeframe: up to 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Part 1b: Arm C0
Part 1b: Arm D0
Part 1b: Total0

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Percentage of Participants in Part 1a Achieving SVR12

SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution. (NCT01939197)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
Part 1a: Arm A93.5
Part 1a: Arm B90.6

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Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]

SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA < Lower Limit of Quantification [LLoQ]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL. (NCT01945294)
Timeframe: Follow-up Week (FW) 12 (up to 40 weeks)

InterventionPercentage of Participants (Number)
Arm 1: 16-week Treatment Arm70.6
Arm 2: 28-week Treatment Arm81.9

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Percentage of Participants With Anemia

The percentage of participants with anemia (hemoglobin [Hgb] <10 g/dL) was determined in each arm. (NCT01945294)
Timeframe: Up to 60 weeks

InterventionPercentage of Participants (Number)
Arm 1: 16-week Treatment Arm33.3
Arm 2: 28-week Treatment Arm43.8
Arm 3: 48-week Treatment Arm26.0

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Percentage of Participants With Neutropenia

The percentage of participants with neutropenia (neutrophil count <0.75 x10^9/L) is summarized for each arm. (NCT01945294)
Timeframe: Up to 60 weeks

InterventionPercentage of Participants (Number)
Arm 1: 16-week Treatment Arm10.8
Arm 2: 28-week Treatment Arm12.4
Arm 3: 48-week Treatment Arm4.0

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Percentage of Participants With Relapse

The percentage of viral relapse (defined as confirmed HCV RNA >15 IU/mL after End-of-Treatment [EOT]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL. (NCT01945294)
Timeframe: From EOT to FW12 (up to 12 weeks)

InterventionPercentage of Participants (Number)
Arm 1: 16-week Treatment Arm20.4
Arm 2: 28-week Treatment Arm1.1
Arm 3: 48-week Treatment Arm0.0

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Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment

The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA NCT01945294)
Timeframe: TW4, TW8, and TW12

,,
InterventionPercentage of Participants (Number)
% Undetectable HCV RNA at TW4 (n=25, 18, 0)% Undetectable HCV RNA at TW8 (n=101, 104, 0)% Undetectable HCV RNA at TW12 (n=100, 103, 20)
Arm 1: 16-week Treatment Arm24.569.668.6
Arm 2: 28-week Treatment Arm14.381.080.0
Arm 3: 48-week Treatment Arm0.00.041.4

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Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported. (NCT01945294)
Timeframe: From TW1 through TW48

,,
InterventionPercentage of Participants (Number)
Discontinued from BOCDiscontinued from BOC + RDiscontinued from all Study Medication
Arm 1: 16-week Treatment Arm2.90.00.0
Arm 2: 28-week Treatment Arm7.65.75.7
Arm 3: 48-week Treatment Arm16.08.08.0

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Percentage of Participants With Undetectable HCV RNA Across Treatment

The percentage of participants with undetectable HCV RNA (HCV RNA NCT01945294)
Timeframe: TW4, TW8, and TW12

,,
InterventionPercentage of Participants (Number)
TW4TW8TW12
Arm 1: 16-week Treatment Arm24.8100.099.0
Arm 2: 28-week Treatment Arm17.1100.0100.0
Arm 3: 48-week Treatment Arm0.00.069.0

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Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. (NCT01984294)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF+RBV11.4
LDV/SOF+GS-9669 250 mg9.4
LDV/SOF+GS-9669 500 mg18.2

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug. (NCT01984294)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF+RBV88.6
LDV/SOF+GS-9669 250 mg90.6
LDV/SOF+GS-9669 500 mg81.8

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Percentage of Participants Experiencing On-treatment Virologic Failure

"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)" (NCT01984294)
Timeframe: Up to 8 weeks

Interventionpercentage of participants (Number)
LDV/SOF+RBV0
LDV/SOF+GS-9669 250 mg0
LDV/SOF+GS-9669 500 mg0

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Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)

SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively. (NCT01984294)
Timeframe: Posttreatment Weeks 2, 4, 8, and 24

,,
Interventionpercentage of participants (Number)
SVR2SVR4SVR8SVR24
LDV/SOF+GS-9669 250 mg100.090.690.690.6
LDV/SOF+GS-9669 500 mg97.084.881.881.8
LDV/SOF+RBV100.091.488.688.6

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Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event

(NCT01984294)
Timeframe: Up to 8 weeks

Interventionpercentage of participants (Number)
LDV/SOF+RBV0
LDV/SOF+GS-9669 250 mg3.1
LDV/SOF+GS-9669 500 mg0

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Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT01995071)
Timeframe: From the end of treatment through 12 weeks after the last dose of combination study drug

Interventionpercentage of participants (Number)
Arm 1 Non-cirrhotic0
Arm 2 Non-cirrhotic0
Arm 3 Non-cirrhotic0
Arm 4 Non-cirrhotic0
Arm 5 Compensated Cirrhotic0
Arm 6 Non-cirrhotic0
Arm 7 Non-cirrhotic0
Arm 8 Non-cirrhotic0
Arm 9 Non-cirrhotic0
Arm 10 Compensated Cirrhotic0
Arm 11 Non-cirrhotic0

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT01995071)
Timeframe: 12 weeks after last actual dose of combination study drug

Interventionpercentage of participants (Number)
Arm 1 Non-cirrhotic87.5
Arm 2 Non-cirrhotic100
Arm 3 Non-cirrhotic87.5
Arm 4 Non-cirrhotic100
Arm 5 Compensated Cirrhotic100
Arm 6 Non-cirrhotic100
Arm 7 Non-cirrhotic87.5
Arm 8 Non-cirrhotic87.5
Arm 9 Non-cirrhotic100
Arm 10 Compensated Cirrhotic100
Arm 11 Non-cirrhotic100

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment. (NCT01995071)
Timeframe: Up to 87 days

Interventionparticipants (Number)
Arm 1 Non-cirrhotic0
Arm 2 Non-cirrhotic0
Arm 3 Non-cirrhotic0
Arm 4 Non-cirrhotic0
Arm 5 Compensated Cirrhotic0
Arm 6 Non-cirrhotic0
Arm 7 Non-cirrhotic12.5
Arm 8 Non-cirrhotic0
Arm 9 Non-cirrhotic0
Arm 10 Compensated Cirrhotic0
Arm 11 Non-cirrhotic0

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Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment

Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1. (NCT01995071)
Timeframe: Day 1 through prior to first dose of the combination regimen on Study Day 4

InterventionLog10 IU/mL (Mean)
Arm 1 Non-cirrhotic-4.11
Arm 2 Non-cirrhotic-4.02
Arm 3 Non-cirrhotic-4.31
Arm 4 Non-cirrhotic + Arm 5 Compensated Cirrhotic-4.06
Arm 6 Non-cirrhotic-3.38
Arm 7 Non-cirrhotic + Arm 10 Compensated Cirrhotic-4.21
Arm 8 Non-cirrhotic-4.25
Arm 9 Non-cirrhotic-4.08
Arm 11 Non-cirrhotic-3.79

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Change From Baseline in HCV RNA (log10 IU/mL)

(NCT02021643)
Timeframe: Up to 24 weeks

,,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 8Change at Week 10Change at Week 12
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)-4.81-5.11-5.12-5.12-5.12-5.12-5.12
SOF+RBV 12 Weeks (GT1 and GT6)-4.59-4.89-4.89-4.89-4.89-4.89-4.89
SOF+RBV 12 Weeks (GT2)-4.46-4.78-4.81-4.80-4.83-4.83-4.83

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Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02021643)
Timeframe: Posttreatment Weeks 4 and 24

,,,,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)96.895.5
SOF+RBV 12 Weeks (GT1 and GT6)100100
SOF+RBV 12 Weeks (GT2)97.596.8
SOF+RBV 16 Weeks (GT1 and GT6)10090.9
SOF+RBV 24 Weeks (GT1 and GT6)94.294.2
SOF+RBV 24 Weeks (GT3)97.695.2

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Change From Baseline in HCV RNA (log10 IU/mL)

(NCT02021643)
Timeframe: Up to 24 weeks

Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 8Change at Week 10Change at Week 12Change at Week 16
SOF+RBV 16 Weeks (GT1 and GT6)-4.36-4.79-4.82-4.82-4.82-4.82-4.82-4.82

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug. (NCT02021643)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)95.5
SOF+RBV 12 Weeks (GT1 and GT6)100
SOF+RBV 16 Weeks (GT1 and GT6)100
SOF+RBV 24 Weeks (GT1 and GT6)94.2
SOF+RBV 12 Weeks (GT2)96.8
SOF+RBV 24 Weeks (GT3)95.2

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02021643)
Timeframe: Up to 24 weeks

InterventionParticipants (Count of Participants)
SOF+PEG+RBV 12 Weeks1
SOF+RBV 12 Weeks1
SOF+RBV 16 Weeks0
SOF+RBV 24 Weeks2

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Percentage of Participants With On-Treatment Virologic Failure

Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment. (NCT02021643)
Timeframe: Up to 24 weeks

InterventionParticipants (Count of Participants)
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)0
SOF+RBV 12 Weeks (GT1 and GT6)0
SOF+RBV 16 Weeks (GT1 and GT6)0
SOF+RBV 24 Weeks (GT1 and GT6)0
SOF+RBV 12 Weeks (GT2)1
SOF+RBV 24 Weeks (GT3)0

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Percentage of Participants With Viral Relapse

Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. (NCT02021643)
Timeframe: Up to Posttreatment Week 24

InterventionParticipants (Count of Participants)
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)7
SOF+RBV 12 Weeks (GT1 and GT6)0
SOF+RBV 16 Weeks (GT1 and GT6)0
SOF+RBV 24 Weeks (GT1 and GT6)6
SOF+RBV 12 Weeks (GT2)6
SOF+RBV 24 Weeks (GT3)6

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Change From Baseline in HCV RNA (log10 IU/mL)

(NCT02021643)
Timeframe: Up to 24 weeks

,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 8Change at Week 10Change at Week 12Change at Week 16Change at Week 20Change at Week 24
SOF+RBV 24 Weeks (GT1 and GT6)-4.61-5.04-5.12-5.12-5.12-5.12-5.12-5.12-5.14-5.14
SOF+RBV 24 Weeks (GT3)-4.52-4.86-4.87-4.87-4.87-4.87-4.84-4.87-4.87-4.87

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Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations

"The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.~On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment)." (NCT02023112)
Timeframe: 12 or 16 weeks (end of treatment period)

,
Interventionpercentage of participants (Number)
All Participants: Overall; n=85, 86All Participants: Rebound; n=85, 86All Participants: Failure to Suppress; n=85, 86Noncirrhotic: Overall; n=80, 80Noncirrhotic: Rebound; n=80, 80Noncirrhotic: Failure to Suppress; n=80, 80Noncirrhotic T-exp: Overall; n=32, 33Noncirrhotic T-exp: Rebound; n=32, 33Noncirrhotic T-exp: Failure to Suppress; n=32, 33Cirrhotic: Overall; n=5, 6Cirrhotic: Rebound; n=5, 6Cirrhotic: Failure to Suppress; n=5, 6
ABT-450/r/ABT-267 Plus RBV for 12 Weeks15.315.34.715.015.03.825.025.09.420.020.020.0
ABT-450/r/ABT-267 Plus RBV for 16 Weeks16.315.14.713.812.53.821.218.29.150.050.016.7

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Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations

The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis. (NCT02023112)
Timeframe: 12 weeks after last dose of study drug

,
Interventionpercentage of participants (Number)
All participants; n=85, 86Noncirrhotic participants; n=80, 80Noncirrhotic T-exp; n=32, 33Noncirrhotic T-exp Relapser; n=15, 16Noncirrhotic T-exp Nonresponder; n=5, 6Noncirrhotic T-exp IFN-intolerant; n=12, 11Cirrhotic Participants; n=5, 6
ABT-450/r/ABT-267 Plus RBV for 12 Weeks72.972.568.880.040.066.780.0
ABT-450/r/ABT-267 Plus RBV for 16 Weeks81.485.075.893.850.063.633.3

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Percentage of Participants With Post-treatment Relapse Within Different Subpopulations

"The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.~Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm." (NCT02023112)
Timeframe: within 12 weeks after the last dose of study drug

,
Interventionpercentage of participants (Number)
All Participants; n=69, 70Noncirrhotic Participants; n=65, 68Noncirrhotic T-exp Participants; n=24, 25Cirrhotic Participants; n=4, 2
ABT-450/r/ABT-267 Plus RBV for 12 Weeks10.110.88.30
ABT-450/r/ABT-267 Plus RBV for 16 Weeks0000

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Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT02023112)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 Plus RBV for 12 Weeks75.0
ABT-450/r/ABT-267 Plus RBV for 16 Weeks91.5

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Percentage of Participants With Post-treatment Relapse

Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm. (NCT02023112)
Timeframe: within 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 Plus RBV for 12 Weeks12.2
ABT-450/r/ABT-267 Plus RBV for 16 Weeks0

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Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period

On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment). (NCT02023112)
Timeframe: 12 or 16 weeks (end of treatment period)

,
Interventionpercentage of participants (Number)
OverallReboundFailure to suppress
ABT-450/r/ABT-267 Plus RBV for 12 Weeks8.38.30
ABT-450/r/ABT-267 Plus RBV for 16 Weeks8.58.50

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Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment

Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit. (NCT02032875)
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12End of treatment
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin1.711.753.376.793.393.396.7
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin3.813.256.684.998.198.1100.0

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Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)

SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. (NCT02032875)
Timeframe: Post-treatment follow-up Week 12

InterventionPercentage of participants (Number)
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin82.2

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Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)

SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (NCT02032875)
Timeframe: Post-treatment follow-up Week 12

InterventionPercentage of participants (Number)
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin95.1

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Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities

Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50-7.4 g/dL for grade 3 and/or < 6.5 g/dL for grade 4, Platelet count as 25*10^9-50*10^9 /L for grade 3 and/or < 25.000*10^9 /L for grade 4, International normalized ratio as 2.1-3.0*upper limit of normal (ULN) > 3.0*ULN for grade 3 and/or > 3.0*ULN for grade 4, Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and/or <1.0*10^9/L for grade 4, Lymphocytes (Absolute) as 0.350*109-0.499*10^9 /L for grade 3 and/or < 0.350*10^9 /L for grade 4, Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Alkaline phosphatase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Bilirubin (Total) as 2.6-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, Albumin as < 20 g/L, Lipase (Total) as 3.1-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, and Creatinine as 1.9-3.4*ULN for grade 3 and/or ≥ 3.5*ULN for grade 4. (NCT02032875)
Timeframe: From start of study treatment up to 7 days post last dose of study treatment

,
Interventionparticipants (Number)
HemoglobinPlatelet countInternational normalized ratioLeukocytesLymphocytes (Absolute)Alanine aminotransferaseAspartate aminotransferaseAlkaline phosphataseBilirubin (Total)AlbuminLipase (Total)Creatinine
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin541062309132
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin200230012022

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Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24

Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit. (NCT02032875)
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12End of treatmentFollow-up Week 4 (SVR4)Follow-up Week 8 (SVR8)Follow-up Week 24 (SVR24)
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin15.045.095.091.795.093.396.788.386.780.0
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin22.667.994.396.298.198.1100.098.196.294.3

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Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6

SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. (NCT02032875)
Timeframe: Post-treatment follow-up Week 12

,
InterventionPercentage of participants (Number)
All Genotypes (n =53, 60)HCV Genotype 2 (n =0, 5)HCV Genotype 3 (n =11, 6)HCV Genotype 4 (n =0, 4)HCV Genotype 6 (n =1, 0)
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin83.38083.3100NA
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin94.3NA90.9NA100

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Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)

Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be NCT02032875)
Timeframe: Post-treatment follow-up Week 12

,
InterventionPercentage of participants (Number)
CC type (n = 13, 13)Non-CC type (n = 40, 47)
Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin84.678.7
Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin10092.5

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The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)

SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. (NCT02068222)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r and ABT-530 Plus RBV90

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The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)

SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug. (NCT02068222)
Timeframe: 24 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r and ABT-530 Plus RBV90

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The Percentage of Subjects With Post-Treatment Relapse

Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment. (NCT02068222)
Timeframe: Within 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r and ABT-530 Plus RBV0

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The Percentage of Subjects With Virologic Failure During Treatment

Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment. (NCT02068222)
Timeframe: Up to Treatment Week 12

Interventionpercentage of participants (Number)
ABT-450/r and ABT-530 Plus RBV10

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Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End

ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L. (NCT02094443)
Timeframe: Up to 24 weeks

,
Interventionpercentage of participants (Number)
End of TreatmentEnd of Study
Alisporivir 300 mg BID73.138.5
Alisporivir 400 mg BID61.542.3

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Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12

The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12. (NCT02094443)
Timeframe: Baseline, Week 12

,
Interventionlog10 IU/mL (Mean)
BaselineChange from baseline
Alisporivir 300 mg BID6.323-3.935
Alisporivir 400 mg BID6.343-3.855

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Change From Baseline in Alanine Aminotransferase (ALT) at Week 12

ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage. (NCT02094443)
Timeframe: Baseline, Week 12

,
InterventionU/L (Mean)
BaselineChange from baseline
Alisporivir 300 mg BID77.3-67.4
Alisporivir 400 mg BID67.9-58.2

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Percentage of Participants With Rapid Virologic Response (RVR)

eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment (NCT02094443)
Timeframe: 4 weeks

Interventionpercentage of participants (Number)
Alisporivir 300 mg BID3.8
Alisporivir 400 mg BID15.4

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Percentage of Participants With End of Treatment Response (ETR)

ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued). (NCT02094443)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Alisporivir 300 mg BID46.2
Alisporivir 400 mg BID50.0

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Percentage of Participants With Extended Rapid Virologic Response

Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment (NCT02094443)
Timeframe: 2 weeks

Interventionpercentage of participants (Number)
Alisporivir 300 mg BID0.0
Alisporivir 400 mg BID3.8

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Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment

SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively. (NCT02094443)
Timeframe: Up to 24 weeks posttreatment

,
Interventionpercentage of participants (Number)
SVR4SVR12SVR24
Alisporivir 300 mg BID30.819.219.2
Alisporivir 400 mg BID38.526.926.9

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Percentage of Participants Discontinuing Study Drug Due to an Adverse Event

Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. (NCT02105454)
Timeframe: Up to 12 weeks

InterventionPercentage of participants (Number)
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks1.3

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Percentage of Participants Experiencing Adverse Events

Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. (NCT02105454)
Timeframe: Up to 40 weeks (from Day 1 [post-dose] through 24 [-12/+4] weeks following last dose of study drug)

InterventionPercentage of participants (Number)
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks79.7

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Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) Therapy

SVR12 is defined as participants having HCV RNA level lower than the LLoQ (<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. Prior DAA therapy regimen included boceprevir, telaprevir, simeprevir, or sofosbuvir taken concomitantly with peginterferon and ribavirin. Below categories specify with our without resistance-associated variants (RAVs) of the hepatitis C virus. (NCT02105454)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
Boceprevir with signature baseline RAVs, n=9Boceprevir without signature baseline RAVs, n=16Telaprevir with signature baseline RAVs, n=18Telaprevir without signature baseline RAVs, n=22Simeprevir with signature baseline RAVs, n=4Simeprevir without signature baseline RAVs, n=1
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks88.9100.094.4100.0100.0100.0

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Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12)

SVR12 is defined as participants having hepatitis C virus ribonucleic acid (HCV RNA) level lower than the limit of quantification (LLoQ, <15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. (NCT02105454)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
GZR 100 mg + EBR 50 mg + RBV for 12 Weeks97.1

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Percentage of Participants Achieving Undetectable HCV RNA 12 Weeks After Completing Study Therapy (SVR12)

HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. (NCT02105701)
Timeframe: 12 weeks after the end of all study treatment (up to 28 weeks)

InterventionPercentage of participants (Number)
Grazoprevir + Elbasvir 12 Weeks92.4
Grazoprevir + Elbasvir + RBV 12 Weeks94.2
Grazoprevir + Elbasvir 16 Weeks92.4
Grazoprevir + Elbasvir + RBV 16 Weeks98.1

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Number of Participants Discontinuing Study Treatment Due to an AE

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02105701)
Timeframe: Up to 16 weeks

InterventionNumber of participants (Number)
Grazoprevir + Elbasvir 12 Weeks1
Grazoprevir + Elbasvir + RBV 12 Weeks1
Grazoprevir + Elbasvir 16 Weeks0
Grazoprevir + Elbasvir + RBV 16 Weeks5

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Percentage of Participants Achieving Undetectable HCV RNA 24 Weeks After the End of All Treatment (SVR24)

HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. (NCT02105701)
Timeframe: 24 weeks after the end of all study treatment (up to 40 weeks)

InterventionPercentage of participants (Number)
Grazoprevir + Elbasvir 12 Weeks91.4
Grazoprevir + Elbasvir + RBV 12 Weeks94.2
Grazoprevir + Elbasvir 16 Weeks89.5
Grazoprevir + Elbasvir + RBV 16 Weeks95.3

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Number of Participants Experiencing Adverse Events (AE)

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02105701)
Timeframe: Up to 18 weeks

InterventionNumber of participants (Number)
Grazoprevir + Elbasvir 12 Weeks74
Grazoprevir + Elbasvir + RBV 12 Weeks85
Grazoprevir + Elbasvir 16 Weeks77
Grazoprevir + Elbasvir + RBV 16 Weeks95

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Percentage of Participants With End of Treatment (EOT) Response

EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment. (NCT02106156)
Timeframe: Up to Week 72

Interventionpercentage of participants (Number)
Main Analysis Set59.2
Elastography Analysis Set: Treated51.1

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Percentage of Participants With Serious Adverse Drug Reactions (SADR)

(NCT02106156)
Timeframe: Up to Week 96

Interventionpercentage of participants (Number)
Main Analysis Set3.5
Elastography Analysis Set: Treated3.3

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Percentage of Participants With Sustained Virologic Response (SVR)

SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment. (NCT02106156)
Timeframe: Up to Week 96

Interventionpercentage of participants (Number)
Main Analysis Set41.4
Elastography Analysis Set: Treated36.7

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Percentage of Participants With the Most Frequent Concomitant Medications

Most frequent concomitant medications were defined as those, which were observed in >1 % of participants. (NCT02106156)
Timeframe: At Baseline (Day 1)

Interventionpercentage of participants (Number)
AnilidesSelective serotonin reuptake inhibitorsProton pump inhibitorsPropionic acid derivativesPropulsivesOther antidepressantsAngiotensin-converting-enzyme (ACE) inhibitorsThyroid hormonesCorticosteroids, potent (group III)Benzodiazepine related drugsPyrazolonesBeta blocking agents, selectiveNon-selective monoamine reuptake inhibitors
Main Analysis Set10.69.95.34.72.32.32.01.81.71.51.41.31.2

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Percentage of Participants With Early Virologic Response (EVR)

EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12. (NCT02106156)
Timeframe: At Week 12

Interventionpercentage of participants (Number)
Main Analysis Set71.2
Elastography Analysis Set: Treated77.8

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Percentage Cumulative Dose of Ribavirin Received

Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period. (NCT02106156)
Timeframe: Up to Week 96

Interventionpercentage of cumulated dose (Median)
Main Analysis Set100.00
Elastography Analysis Set: Treated97.92

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Percentage Cumulative Dose of Peginterferon Alfa-2a Received

Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period. (NCT02106156)
Timeframe: Up to Week 96

Interventionpercentage of cumulated dose (Median)
Main Analysis Set97.9
Elastography Analysis Set: Treated94.8

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Duration of Peginterferon Alfa-2a Therapy

Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented. (NCT02106156)
Timeframe: Up to Week 72

Interventionweeks (Median)
Main Analysis Set27.3
Elastography Analysis Set: Treated29.3

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Percentage of Participants With Rapid Virologic Response (RVR)

RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4. (NCT02106156)
Timeframe: At Week 4

Interventionpercentage of participants (Number)
Main Analysis Set40.0
Elastography Analysis Set: Treated41.7

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Change in Alanine Aminotransferase (ALT) Levels From Baseline to 28 Days

(NCT02118012)
Timeframe: Baseline and 28 days

InterventionU/L (Median)
Chlorcyclizine and RBV26
Chlorcyclizine HCl Only6

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Change in Serum HCV RNA Viral Titer From Baseline to 28 Days

(NCT02118012)
Timeframe: Baseline and 28 days

Interventionlog IU/ml (Median)
Chlorcyclizine and RBV-0.46
Chlorcyclizine HCl Only-0.11

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Maximum Chlorcyclizine HCL Weeks 1-4

Chlorcyclizine HCL concentration was measured once a week in the morning. This outcome is the maximum over the four weeks. (NCT02118012)
Timeframe: Weeks 1-4

Interventionng/ml (Median)
Chlorcyclizine and RBV211
Chlorcyclizine HCl Only251

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Number of Participants Who Tolerated the Drug at the Prescribed Dose for the Duration of Therapy

(NCT02118012)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Chlorcyclizine and RBV12
Chlorcyclizine HCl Only11

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Number of Participants With Virological Breakthrough

Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir. (NCT02118597)
Timeframe: Up to Week 48

Interventionparticipants (Number)
Triple Combination Therapy1

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Number of Participants With Virological Relapse

Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment. (NCT02118597)
Timeframe: Week 49 up to Week 72

Interventionparticipants (Number)
Triple Combination Therapy1

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Number of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02118597)
Timeframe: Up to 72 weeks

Interventionparticipants (Number)
Triple Combination Therapy17

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Sustained Virological Response 24 (SVR24) Rate

The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up. (NCT02118597)
Timeframe: 24 weeks after end of treatment (EOT) at Week 72

Interventionpercentage of participants (Number)
Triple Combination Therapy0

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Percentage of Participants With Virological Response

Virological response is defined as HCV RNA <15 IU/mL. (NCT02118597)
Timeframe: Weeks 4, 8, 12, and 24

Interventionpercentage of participants (Number)
Week 4 (n=3)Week 8 (n=18)Week 12 (n=17)Week 24 (n=16)
Triple Combination Therapy0.073.773.778.9

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Number of Participants With Treatment Discontinuation Due to Futility

Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24. (NCT02118597)
Timeframe: Up to Week 48

Interventionparticipants (Number)
Triple Combination Therapy2

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Number of Participants With Treatment Discontinuation

Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24. (NCT02118597)
Timeframe: Up to Week 48

Interventionparticipants (Number)
Sponsor's decisionAdverse eventFutility rule
Triple Combination Therapy742

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Concentration of Tenofovir (TFV) in Plasma

Concentration of tenofovir (TFV) in plasma among participants who took TFV for treatment of HIV infection. (NCT02128217)
Timeframe: Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.

,
Interventionng/mL (Geometric Mean)
BaselineEnd of treatment12 Weeks after end of HCV study treatment
Cohort 1: SOF+Weight-based RBV for 12 Wks989694
Cohort 2: LDV/SOF for 8 Wks8715576

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Concentration of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs)

Concentration of tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs). This outcome is measured in Cohort 1 only. (NCT02128217)
Timeframe: Baseline (before SOF + RBV dosing), EOT (end of study treatment), 12 weeks after end of HCV study treatment.

Interventionfmol/10^6 cells (Geometric Mean)
BaselineEnd of treatment12 Weeks after end of HCV study treatment
Cohort 1: SOF+Weight-based RBV for 12 Wks7914981

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Count and Percentage of Participants With an Adverse Event by Type.

The adverse events considered were Grade 2 or higher adverse events (primary diagnosis, primary sign and symptom, or a primary lab), SAE according to ICH criteria, or treatment-limiting adverse events. Participants may experience more than one type of adverse event. (NCT02128217)
Timeframe: Any time from start of treatment to 28 days after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.

,
InterventionParticipants (Count of Participants)
Primary DiagnosisPrimary Sign/SymptomPrimary LabSerious Adverse EventTreatment-Limiting Adverse Event
Cohort 1: SOF+Weight-based RBV for 12 Wks05500
Cohort 2: LDV/SOF for 8 Wks24610

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Percentage of Participants With HCV RNA Undetectable After End of Study Treatment

"HCV RNA undetectable is defined as an HCV RNA measurement NCT02128217)
Timeframe: 2, 4, 8 and 24 weeks after last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.

,
InterventionPercentage of participants (Number)
SVR2SVR4SVR8SVR24
Cohort 1: SOF+Weight-based RBV for 12 Wks64.758.858.864.7
Cohort 2: LDV/SOF for 8 Wks100.096.396.396.3

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Percentage of Participants With HCV RNA Undetectable During Study Treatment

"HCV RNA undetectable was defined as an HCV RNA measurement NCT02128217)
Timeframe: 1, 2, 4, 8 and, for the 12-week regimen, 12 weeks after starting study treatment.

,
InterventionPercentage of participants (Number)
On-treatment Week 1On Treatment Week 2On-treatment Week 4On-treatment Week 8On-treatment Week 12
Cohort 1: SOF+Weight-based RBV for 12 Wks11.829.470.6100.0100.0
Cohort 2: LDV/SOF for 8 Wks18.544.481.592.6NA

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Ribavirin Concentration in Plasma

Ribavirin concentration in plasma. This outcome was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 4, 8, and 12 weeks after starting study treatment.

Interventionng/mL (Geometric Mean)
Week 4week 8Week 12
Cohort 1: SOF+Weight-based RBV for 12 Wks180321222013

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Self-reported Adherence to LDV/SOF

Count and percentage of participants who reported having taken all doses of LDV/SOF. This outcome measure was evaluated in Cohort 2 only. (NCT02128217)
Timeframe: 1, 2, 4, and 8 weeks after starting study treatment.

InterventionParticipants (Count of Participants)
Week 1Week 2Week 4Week 8
Cohort 2: LDV/SOF for 8 Wks25252718

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Self-reported Adherence to RBV

Count and percentage of participants who reported having taken all doses of RBV. This outcome measure was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 1, 2, 4, 8 and 12 weeks after starting study treatment.

InterventionParticipants (Count of Participants)
Week 1Week 2Week 4Week 8Week 12
Cohort 1: SOF+Weight-based RBV for 12 Wks1615151615

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Count of Participants With HIV-1 RNA <50 Copies/mL

Because all except one participant had HIV-1 RNA < 50 copies/mL, participants were categorized according to whether or not their HIV-1 RNA was <5 copies/mL at each follow-up evaluation. (NCT02128217)
Timeframe: 4 and 12 weeks after start of study treatment for Cohort 1. 4 and 8 weeks after start of study treatment for the 8-week regimen used in Cohort 2)

InterventionParticipants (Count of Participants)
On-treatment Week 471972119On-treatment Week 471972120On-treatment Week 871972119On-treatment Week 871972120On-treatment Week 1271972119On-treatment Week 1271972120
≥50 copies/mL<50 copies/mL
Cohort 1: SOF+Weight-based RBV for 12 Wks17
Cohort 2: LDV/SOF for 8 Wks27
Cohort 2: LDV/SOF for 8 Wks0
Cohort 1: SOF+Weight-based RBV for 12 Wks0
Cohort 2: LDV/SOF for 8 Wks23

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Adherence as Measured by SOF Pill Count

The count and percentage of participants who had a pill count consistent with 100% of SOF doses taken. This outcome measure was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 12 weeks after starting study treatment.

InterventionParticipants (Count of Participants)
Pill count not availablePill count consistent with 100% of doses takenPill count indicates <100% of doses taken
Cohort 1: SOF+Weight-based RBV for 12 Wks1241

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Adherence as Measured by RBV Pill Count

The count and percentage of participants who had a pill count consistent with 100% of RBV doses taken. This outcome measure was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 12 weeks after starting study treatment.

InterventionParticipants (Count of Participants)
Pill count not availablePill count consistent with 100% of doses takenPill count indicates <100% of doses taken
Cohort 1: SOF+Weight-based RBV for 12 Wks1214

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Change in CD4+ Cell Count

The change in CD4+ cell count from baseline to 12 weeks after the end of study treatment. (NCT02128217)
Timeframe: Baseline to 12 weeks after end of study treatment. Duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.

Interventioncells/mm^3 (Mean)
Cohort 1: SOF+Weight-based RBV for 12 Wks11
Cohort 2: LDV/SOF for 8 Wks61

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Number of Participants Who Had HCV Virologic Relapse

HCV virologic relapse was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable. (NCT02128217)
Timeframe: From end of study treatment through to 24 weeks after end of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort 1: SOF+Weight-based RBV for 12 Wks7
Cohort 2: LDV/SOF for 8 Wks0

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Percentage of HCV Virologic Failure Participants That Developed SOF- or LDV-Associated Resistance Mutations

Percentage of participants who developed SOF- or LDV-associated resistance mutation found within HCV Virologic Failure participants. HCV virologic failure was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable. (NCT02128217)
Timeframe: At time of HCV virologic failure; any time from start of study treatment to 24 weeks after end of study treatment. Duration of study treatment for Cohort 1 and 2 were 12 and 8 weeks, respectively.

InterventionPercentage of participants (Number)
Cohort 1: SOF+Weight-based RBV for 12 Wks0.00

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Self-reported Adherence to SOF

Count and percentage of participants who reported having taken all doses of SOF. This outcome measure was evaluated in Cohort 1 only. (NCT02128217)
Timeframe: 1, 2, 4, 8 and 12 weeks after starting study treatment.

InterventionParticipants (Count of Participants)
Week 1Week 2Week 4Week 8Week 12
Cohort 1: SOF+Weight-based RBV for 12 Wks1716161615

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Cellular Concentration of Tenofovir Diphosphate (TFV-DP)

Cellular concentration of tenofovir diphosphate (TFV-DP) from dried blood spot samples. (NCT02128217)
Timeframe: Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.

,
Interventionfmol/punch (Geometric Mean)
BaselineEnd of treatment12 Weeks after end of HCV study treatment
Cohort 1: SOF+Weight-based RBV for 12 Wks168766072100
Cohort 2: LDV/SOF for 8 Wks1516268461644

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Percentage of Participants With an Occurrence of a Grade ≥ 2 Adverse Event, Serious AE According to ICH Criteria, or Treatment-limiting AE.

"Any adverse event occurring after initiation of study treatment through to 28 days after the date of last dose of study treatment was included (except that an event that was ongoing at the same grade from before start of study treatment was excluded). Adverse events consisted of Grade ≥ 2 primary diagnosis, primary sign/symptoms, and primary laboratory abnormality. It also included any serious adverse event according to ICH criteria and any treatment-limiting AE (ie, an AE reported as the reason for permanent discontinuation of study treatment).~A two-sided 90% confidence interval was calculated for the percentage using the Blyth-Still-Casella method." (NCT02128217)
Timeframe: From initiation of study treatment to 28 days after last dose of study treatment. The duration for study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.

InterventionPercentage of participants (Number)
Cohort 1: SOF+Weight-based RBV for 12 Wks47.1
Cohort 2: LDV/SOF for 8 Wks33.3

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Percentage of Participants With Sustained Virologic Response 12 (SVR12)

"SVR12 was defined as HCV RNA undetectable less than the lower limit of quantification, Target Not Detected (NCT02128217)
Timeframe: At 12 weeks after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.

InterventionPercentage of participants (Number)
Cohort 1: SOF+Weight-based RBV for 12 Wks58.8
Cohort 2: LDV/SOF for 8 Wks100.0

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Adherence as Measured by LDV/SOF Pill Count

The count and percentage of participants who had a pill count consistent with 100% of LDV/SOF doses taken.. This outcome measure was evaluated in Cohort 2 only. (NCT02128217)
Timeframe: 8 weeks after starting study treatment.

InterventionParticipants (Count of Participants)
Pill count not availablePill count consistent with 100% of doses takenPill count indicates <100% of doses taken
Cohort 2: LDV/SOF for 8 Wks7173

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Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24

The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of 4 weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health. Positive numbers indicate improvement from baseline. (NCT02167945)
Timeframe: From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24

,,,
Interventionunits on a scale (Mean)
At Post-treatment Week 12At Post-treatment Week 24
Baseline Fibrosis Stage F0-F12.73.2
Baseline Fibrosis Stage F21.01.9
Baseline Fibrosis Stage F30.91.5
Baseline Fibrosis Stage F40.30.4

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Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Post-Treatment Week 12 and Post-Treatment Week 24

The FACIT-F is a symptom specific instrument with a focus on measuring fatigue in a variety of chronic diseases or health conditions. It was originally developed from interviews with oncology patients and clinical experts to assess anemia-associated fatigue. Its 13-item-version assesses peripheral, central, or mixed fatigue with a recall period of 7 days and yields a summed total score ranging between 0 and 52. Higher FACIT-F scores indicate a lesser degree of fatigue. Positive numbers indicate improvement from baseline. (NCT02167945)
Timeframe: From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24

,,,
Interventionunits on a scale (Mean)
At Post-treatment Week 12At Post-treatment Week 24
Baseline Fibrosis Stage F0-F13.93.9
Baseline Fibrosis Stage F22.03.1
Baseline Fibrosis Stage F32.02.3
Baseline Fibrosis Stage F43.02.6

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Treatment Compliance: Percentage of Tablets Taken Relative to the Total Tablets

Treatment compliance was calculated as the percentage of tablets taken (presumed as [tablets dispensed-tablets returned]) relative to the total tablets, respectively, expected to be taken. Study drug interruptions due to an adverse event or other planned interruptions recorded on the electronic case report form (eCRF) were to be subtracted from the duration. For compliance to ribavirin (RBV), RBV dose modifications due to adverse events, toxicity management, or weight changes as recorded on the RBV Dose Modifications eCRF were to be used to modify the total number of tablets that should have been taken. A participant is considered to be compliant if the percentage is between 80% and 120%. (NCT02167945)
Timeframe: Up to Treatment Week 24

Interventionpercentage of tablets taken (Mean)
ABT-450/r/ABT-267 Plus ABT-333100.22
Weight-based Ribavirin (RBV)99.86

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Hepatocellular Carcinoma: Time to Event

Time to hepatocellular carcinoma was defined as number of days from the 1st day of study drug dosing for the participant to date of hepatocellular carcinoma. All hepatocellular carcinoma was to be included, whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for hepatocellular carcinoma. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490). (NCT02167945)
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260

,
Interventionpercentage of participants (Number)
Kaplan-Meier estimate at PT Week 52Kaplan-Meier estimate at PT Week 104Kaplan-Meier estimate at PT Week 156Kaplan-Meier estimate at PT Week 208Kaplan-Meier estimate at PT Week 260
Participants in Studies M14-222 and M14-423 Who Achieved SVR120.20.40.50.60.9
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR1200000

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All-Cause Death: Time to Event

Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490). (NCT02167945)
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260

,
Interventionpercentage of participants (Number)
Kaplan-Meier estimate at PT Week 52Kaplan-Meier estimate at PT Week 104Kaplan-Meier estimate at PT Week 156Kaplan-Meier estimate at PT Week 208Kaplan-Meier estimate at PT Week 260
Participants in Studies M14-222 and M14-423 Who Achieved SVR120.10.71.21.52.0
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR128.38.38.38.38.3

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. (NCT02167945)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)95.3

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Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24

The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of 4 weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health. Positive numbers indicate improvement from baseline. (NCT02167945)
Timeframe: From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24

,,,
Interventionunits on a scale (Mean)
At Post-treatment Week 12At Post-treatment Week 24
Baseline Fibrosis Stage F0-F11.21.1
Baseline Fibrosis Stage F20.00.5
Baseline Fibrosis Stage F31.82.3
Baseline Fibrosis Stage F41.41.8

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Liver Transplantation: Time to Event

Time to liver transplantation was defined as number of days from the 1st day of study drug dosing for the participant to date of liver transplantation. All liver transplantation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490). (NCT02167945)
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260

,
Interventionpercentage of participants (Number)
Kaplan-Meier estimate at PT Week 52Kaplan-Meier estimate at PT Week 104Kaplan-Meier estimate at PT Week 156Kaplan-Meier estimate at PT Week 208Kaplan-Meier estimate at PT Week 260
Participants in Studies M14-222 and M14-423 Who Achieved SVR12000.10.10.2
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR1200000

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Liver Decompensation: Time to Event

Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490). (NCT02167945)
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260

,
Interventionpercentage of participants (Number)
Kaplan-Meier estimate at PT Week 52Kaplan-Meier estimate at PT Week 104Kaplan-Meier estimate at PT Week 156Kaplan-Meier estimate at PT Week 208Kaplan-Meier estimate at PT Week 260
Participants in Studies M14-222 and M14-423 Who Achieved SVR120.20.20.30.30.5
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR124.54.54.54.54.5

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Serum HCV RNA Level

(NCT02168361)
Timeframe: 4 and 12 weeks into therapy

,
InterventionIU/ml (Median)
Serum HCV RNA level at 4 weeksSerum HCV RNA level at 8 weeks
All Oral Therapy15431
Interferon-containing Arm880740

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Proportion of Participants With Sustained Virologic Response 12 (SVR-12)

Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy (NCT02168361)
Timeframe: 12 weeks post-therapy

Interventionparticipants (Number)
All Oral Therapy54
Interferon-containing Arm18

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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development

Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02175758)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

InterventionParticipants (Count of Participants)
End of Treatment71966064End of Treatment71966065End of Treatment71966066Posttreatment Week 1271966064Posttreatment Week 1271966065Posttreatment Week 1271966066Posttreatment Week 2471966064Posttreatment Week 2471966065Posttreatment Week 2471966066
No ChangeIncreaseDecrease
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks24
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks11
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks7
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks0
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks0
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks21
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks10
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks9
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks1
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks0
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks20
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks9
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks3
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks11
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks2

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For the Treatment Phase, Change From Baseline in Height

(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

,,
Interventioncentimeters (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24
12 to < 18 Years Old - SOF+RBV 24 Weeks0.0-0.10.20.20.30.40.50.80.91.31.8
3 to < 6 Years Old - SOF+RBV 24 Weeks0.30.30.50.81.71.82.52.73.54.05.7
6 to < 12 Years Old - SOF+RBV 24 Weeks0.00.00.40.40.71.11.62.12.63.85.1

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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair

Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02175758)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

InterventionParticipants (Count of Participants)
End of Treatment71966064End of Treatment71966065End of Treatment71966066Posttreatment Week 1271966064Posttreatment Week 1271966065Posttreatment Week 1271966066Posttreatment Week 2471966064Posttreatment Week 2471966065Posttreatment Week 2471966066
No ChangeIncreaseDecrease
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks23
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks10
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks8
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks1
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks0
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks0
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks10
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks0
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks20
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks9
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks3
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks11
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks2

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For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT02175758)
Timeframe: 6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7

Interventionh*ng/mL (Mean)
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks9106.0
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks7651.2
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks10293.7

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For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough

Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment. (NCT02175758)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
12 to < 18 Years Old - SOF+RBV 12 Weeks0
12 to < 18 Years Old - SOF+RBV 24 Weeks0
6 to < 12 Years Old - SOF+RBV 12 Weeks0
6 to < 12 Years Old - SOF+RBV 24 Weeks0
3 to < 6 Years Old - SOF+RBV 12 Weeks0
3 to < 6 Years Old - SOF+RBV 24 Weeks0

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For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT02175758)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
12 to < 18 Years Old - SOF+RBV 12 Weeks0
12 to < 18 Years Old - SOF+RBV 24 Weeks0
6 to < 12 Years Old - SOF+RBV 12 Weeks0
6 to < 12 Years Old - SOF+RBV 24 Weeks0
3 to < 6 Years Old - SOF+RBV 12 Weeks0
3 to < 6 Years Old - SOF+RBV 24 Weeks0

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For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02175758)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
12 to < 18 Years Old - SOF+RBV 12 Weeks100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks100.0
6 to < 12 Years Old - SOF+RBV 12 Weeks100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks100.0
3 to < 6 Years Old - SOF+RBV 12 Weeks80.0
3 to < 6 Years Old - SOF+RBV 24 Weeks100.0

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For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02175758)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
12 to < 18 Years Old (Total) - SOF+RBV 12 or 24 Weeks98.1
3 to < 12 Years Old (Total) - SOF+RBV 12 or 24 Weeks98.1
12 to < 18 Years Old - SOF+RBV 12 Weeks100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks97.4
6 to < 12 Years Old - SOF+RBV 12 Weeks100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks100.0
3 to < 6 Years Old - SOF+RBV 12 Weeks80.0
3 to < 6 Years Old - SOF+RBV 24 Weeks100.0

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For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02175758)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
12 to < 18 Years Old - SOF+RBV 12 Weeks100.0
12 to < 18 Years Old - SOF+RBV 24 Weeks97.4
6 to < 12 Years Old - SOF+RBV 12 Weeks100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks100.0
3 to < 6 Years Old - SOF+RBV 12 Weeks80.0
3 to < 6 Years Old - SOF+RBV 24 Weeks100.0

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase

(NCT02175758)
Timeframe: Up to Day 7

Interventionpercentage of participants (Number)
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks0
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks0
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks0

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase

(NCT02175758)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
12 to < 18 Years Old - SOF+RBV 12 Weeks0
12 to < 18 Years Old - SOF+RBV 24 Weeks0
6 to < 12 Years Old - SOF+RBV 12 Weeks0
6 to < 12 Years Old - SOF+RBV 24 Weeks0
3 to < 6 Years Old - SOF+RBV 12 Weeks20.0
3 to < 6 Years Old - SOF+RBV 24 Weeks0

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For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA

(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks-3.98-4.84-4.84-4.84-4.84
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks-4.12-4.31-4.42-4.52-4.52
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks-3.82-4.92-4.92-4.92-4.92

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For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA

(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks-4.23-4.34-4.34-4.34-4.34-4.34-4.34-4.34
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks-3.53-3.94-3.97-3.97-3.97-3.97-3.97-3.97
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks-3.78-4.56-4.60-4.61-4.61-4.61-4.61-4.61

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For the Treatment Phase, Change From Baseline in HCV RNA

(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12
12 to < 18 Years Old - SOF+RBV 12 Weeks-4.25-4.74-4.74-4.74-4.74
3 to < 6 Years Old - SOF+RBV 12 Weeks-4.12-4.31-4.42-4.52-4.52
6 to < 12 Years Old - SOF+RBV 12 Weeks-4.12-4.55-4.68-4.68-4.68

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For the Treatment Phase, Change From Baseline in HCV RNA

(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
12 to < 18 Years Old - SOF+RBV 24 Weeks-4.12-4.86-5.01-5.02-5.02-5.02-5.02-5.02
3 to < 6 Years Old - SOF+RBV 24 Weeks-3.53-3.94-3.97-3.97-3.97-3.97-3.97-3.97
6 to < 12 Years Old - SOF+RBV 24 Weeks-3.88-4.51-4.56-4.54-4.57-4.57-4.57-4.57

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For the Treatment Phase, Change From Baseline in Height

(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

,,
Interventioncentimeters (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24
12 to < 18 Years Old - SOF+RBV 12 Weeks0.10.10.20.30.50.51.41.6
6 to < 12 Years Old - SOF+RBV 12 Weeks0.00.10.31.00.81.42.44.2
3 to < 6 Years Old - SOF+RBV 12 Weeks0.30.70.90.91.51.62.85.0

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For the Treatment Phase, Change From Baseline in Weight

(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

,,
Interventionkilograms (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24
12 to < 18 Years Old - SOF+RBV 24 Weeks-0.4-0.3-0.10.0-0.10.20.10.50.92.13.0
3 to < 6 Years Old - SOF+RBV 24 Weeks-0.2-0.1-0.10.00.10.10.40.40.70.91.7
6 to < 12 Years Old - SOF+RBV 24 Weeks0.00.00.10.10.50.60.91.21.32.23.5

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For the Treatment Phase, Change From Baseline in Weight

(NCT02175758)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

,,
Interventionkilograms (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24
12 to < 18 Years Old - SOF+RBV 12 Weeks-0.7-0.2-0.2-0.5-0.4-0.30.92.5
3 to < 6 Years Old - SOF+RBV 12 Weeks0.20.50.00.30.30.51.01.3
6 to < 12 Years Old - SOF+RBV 12 Weeks0.20.30.40.60.91.22.13.8

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For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules

Participants were asked if they were able to taste the SOF oral granules. (NCT02175758)
Timeframe: Day 1

,,
Interventionpercentage of participants (Number)
Able to Taste SOF Granules: YesAble to Taste SOF Granules: No
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks0100.0
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks75.025.0
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks42.957.1

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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization

ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data. (NCT02175758)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4

,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Posttreatment Week 4
12 to < 18 Years Old - SOF+RBV 12 Weeks50.0100.0100.0100.0100.0100.0
6 to < 12 Years Old - SOF+RBV 12 Weeks25.0100.0100.0100.0100.0100.0

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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization

ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data. (NCT02175758)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16Week 20Week 24Posttreatment Week 4
12 to < 18 Years Old - SOF+RBV 24 Weeks63.690.995.595.5100.0100.0100.0100.0100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks100.0100.0100.0100.0100.0100.0100.0100.0100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks75.093.3100.0100.0100.0100.0100.0100.0100.0

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For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment

(NCT02175758)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
12 to < 18 Years Old - SOF+RBV 12 Weeks30.8100.0100.0100.0100.0
3 to < 6 Years Old - SOF+RBV 12 Weeks50.075.075.0100.0100.0
6 to < 12 Years Old - SOF+RBV 12 Weeks46.276.9100.0100.0100.0

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For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment

(NCT02175758)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16Week 20Week 24
12 to < 18 Years Old - SOF+RBV 24 Weeks30.874.492.3100.0100.0100.0100.0100.0
3 to < 6 Years Old - SOF+RBV 24 Weeks37.587.5100.0100.0100.0100.0100.0100.0
6 to < 12 Years Old - SOF+RBV 24 Weeks39.378.696.496.4100.0100.0100.0100.0

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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development

Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02175758)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

InterventionParticipants (Count of Participants)
End of Treatment71966068End of Treatment71966069End of Treatment71966067Posttreatment Week 1271966068Posttreatment Week 1271966069Posttreatment Week 1271966067Posttreatment Week 2471966069Posttreatment Week 2471966067Posttreatment Week 2471966068
No ChangeIncreaseDecrease
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks20
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks24
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks8
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks1
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks5
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks0
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks1
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks17
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks3
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks0
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks16
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks19
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks4
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks11
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks0

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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair

Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02175758)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

InterventionParticipants (Count of Participants)
End of Treatment71966067End of Treatment71966068End of Treatment71966069Posttreatment Week 1271966067Posttreatment Week 1271966068Posttreatment Week 1271966069Posttreatment Week 2471966068Posttreatment Week 2471966069Posttreatment Week 2471966067
No ChangeIncreaseDecrease
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks20
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks24
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks8
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks1
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks6
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks0
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks0
3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks0
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks18
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks23
12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks2
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks22
6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks8

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Percentage of Participants With End of Treatment Response (EOTR)

EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment. (NCT02175966)
Timeframe: End of the treatment

InterventionPercentage of participants (Number)
4 Weeks DCV 3DAA + SOF92.9
6 Weeks DCV 3DAA + SOF100.0

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Number of Participants With Selected Grade 3/4 Laboratory Abnormalities

Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. (NCT02175966)
Timeframe: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)

InterventionParticipants (Count of Participants)
4 Weeks DCV 3DAA + SOF0
6 Weeks DCV 3DAA + SOF0

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Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)

Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported. (NCT02175966)
Timeframe: Post-treatment Week 12

,
InterventionPercentage of Participants (Number)
CC genotypeNon-CC Genotype
4 Weeks DCV 3DAA + SOF40.022.2
6 Weeks DCV 3DAA + SOF66.750.0

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Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b

Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b (NCT02175966)
Timeframe: Post-treatment Week 12

,
InterventionPercentage of Participants (Number)
Genotype 1aGenotype 1b
4 Weeks DCV 3DAA + SOF27.333.3
6 Weeks DCV 3DAA + SOF54.566.7

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Percentage of Participants Who Achieved HCV RNA

Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24). (NCT02175966)
Timeframe: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)

,
InterventionPercentage of Participants (Number)
Week 1Week 2Week 4Week 6Follow-Up Week 2Follow-Up Week 4Follow-Up Week 12Follow-Up Week 24
4 Weeks DCV 3DAA + SOF35.778.6100.0NA78.642.928.628.6
6 Weeks DCV 3DAA + SOF71.4100.0100.0100.0100.078.657.157.1

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Percentage of Participants Who Achieved HCV RNA < LLOQ TND

Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24). (NCT02175966)
Timeframe: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Follow-Up Week 2Follow-Up Week 4Follow-Up Week 12Follow-Up Week 24
4 Weeks DCV 3DAA + SOF21.442.992.9NA71.442.928.628.6
6 Weeks DCV 3DAA + SOF7.164.3100.0100.092.971.457.157.1

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Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment

SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect. (NCT02175966)
Timeframe: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)

,
InterventionParticipants (Count of Participants)
DeathSerious Adverse EventsAEs Leading to Discontinuation
4 Weeks DCV 3DAA + SOF010
6 Weeks DCV 3DAA + SOF000

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Percentage of Participants With Sustained Virologic Response 12 (SVR12)

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach. (NCT02175966)
Timeframe: 12 Weeks after treatment discontinuation (Follow-up Week 12)

InterventionPercentage of participants (Number)
4 Weeks DCV 3DAA + SOF28.6
6 Weeks DCV 3DAA + SOF57.1

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Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)

"SVR12 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 12 weeks post HCV treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method.~For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome." (NCT02194998)
Timeframe: At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Interventionpercentage of participants (Number)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]95.2
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]60
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]100
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]100

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Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)

Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome. (NCT02194998)
Timeframe: At confirmation of HIV-1 virologic failure.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

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Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher

"Participants with signs/symptoms of grade 3 or higher post treatment initiation.~Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0." (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]2
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]3
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

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Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria

Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment. (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]1
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]1
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]2
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

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Levels of Soluble CD14 (sCD14)

Levels of sCD14. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

,,,
Interventionng/mL (Median)
sCD14 at BaselinesCD14 at EOTsCD14 at 12 weeks post EOT
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]1,832.02,126.51,977.3
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]2,226.81,132.81,367.4
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]3,157.02,421.13,424.5
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]3,092.02,801.32,608.3

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Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.

"Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation.~If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0." (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]5
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]3
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]3
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

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Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.

Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation. (NCT02194998)
Timeframe: From treatment initiation to end of study follow-up at 48 weeks.The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively. The duration for ARV treatment for all cohorts was 48 weeks.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]1
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

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Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)

HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA NCT02194998)
Timeframe: From treatment initiation to either 24 weeks (for Cohort A and C) or 12 weeks (for Cohort B and D). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]1
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]1
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0

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Number of Participants Who Experienced HIV-1 Virologic Failure (VF)

HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL. (NCT02194998)
Timeframe: From treatment initiation to 4 weeks after last dose of HCV study treatment. HIV-1 RNA was measured at weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. The durations for HCV study treatment for Cohorts A/C and Cohorts B/D were 24 and 12 weeks, respectively.

InterventionParticipants (Count of Participants)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]0
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]0
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]1

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Levels of IP-10 Concentration.

Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

,,,
Interventionpg/mL (Median)
IP-10 at baselineIP-10 at EOTIP-10 at 12 weeks post EOT
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]379100.994.6
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]120.260.485.5
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]225.576.682.5
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]196.4182.6159.5

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Change in Soluble CD14 (sCD14)

Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

,,,
Interventionng/mL (Median)
Change from baseline to EOTChange from baseline to 12 weeks post EOT
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]307.6145.2
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]-1,063.2-894.2
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]-380.3-22.6
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]318.2-987.0

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Change in IP-10 Concentration.

Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

,,,
Interventionpg/mL (Median)
Change from baseline to EOTChange from baseline to 12 weeks post EOT
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]-244.4-127
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]-22.2-29.1
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]-116-83.1
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]-61.1-114.9

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Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)

"SVR24 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 24 weeks post treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson.~For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome." (NCT02194998)
Timeframe: At 24 weeks after the date of last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Interventionpercentage of participants (Number)
Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]90.5
Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]60
Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]93.3
Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]100

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Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (NCT02207088)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
3-DAA ± RBV94.1

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Percentage of Participants With Post-Treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. (NCT02207088)
Timeframe: Within 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
3-DAA ± RBV1.5

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. (NCT02207088)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
3-DAA ± RBV0

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Sustained Viral Response

Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured. (NCT02214420)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
SMV+SOF13
SMV+SOF+RBV8

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Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment

Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures. (NCT02216422)
Timeframe: Post-treatment Day 1 to Post-treatment Week 12

Interventionpercentage of participants (Number)
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV100

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Percentage of Participants With On-Treatment Virologic Failure

On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment. (NCT02216422)
Timeframe: Day 1 through Week 12

Interventionpercentage of participants (Number)
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV0

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Percentage of Participants With Post-Treatment Relapse

Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment. (NCT02216422)
Timeframe: Post-treatment Day 1 to Post-treatment Week 12

Interventionpercentage of participants (Number)
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV0

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Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12

Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method. (NCT02219477)
Timeframe: Up to 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Group 1: GT1B0
Group 2: GT1 Non-B0
Group 3: GT40

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Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2

SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method. (NCT02219477)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Group 1: GT1B100
Group 2: GT1 Non-B95.8

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Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests

"Improvement was defined as:~increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin~decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin~decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein~increase of more than 15*10^9/L from baseline to post-treatment Week 12 in platelet count~decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio." (NCT02219477)
Timeframe: Up to post-treatment Week 12

Interventionpercentage of participants (Number)
AlbuminBilirubinAlpha-fetoproteinPlatelet countInternational normalized ratio
Group 1: GT1B77.866.733.322.20

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Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest

The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12. (NCT02219477)
Timeframe: Up to post-treatment Week 12

Interventionpercentage of participants (Number)
Group 1: GT1B0
Group 2: GT1 Non-B9.1
Group 3: GT450.0

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Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score

The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12. (NCT02219477)
Timeframe: Up to post-treatment Week 12

Interventionpercentage of participants (Number)
Group 1: GT1B66.7
Group 2: GT1 Non-B54.5
Group 3: GT450.0

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Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score

MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12. (NCT02219477)
Timeframe: Up to post-treatment Week 12

Interventionpercentage of participants (Number)
Group 1: GT1B87.5
Group 2: GT1 Non-B61.9
Group 3: GT4100

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Percentage of Participants With SVR12 in Group 3

SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. (NCT02219477)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Group 3: GT466.7

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Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure

On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. (NCT02219477)
Timeframe: Up to 24 weeks during treatment

Interventionpercentage of participants (Number)
Group 1: GT1B0
Group 2: GT1 Non-B0
Group 3: GT40

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Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests

"Improvement was defined as:~increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin~decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin~decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein~increase of more than 15*10^9/L from baseline to post-treatment Week 12 in platelet count~decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio." (NCT02219477)
Timeframe: Up to post-treatment Week 12

,
Interventionpercentage of participants (Number)
AlbuminBilirubinPlatelet countInternational normalized ratio
Group 2: GT1 Non-B77.372.714.30
Group 3: GT450.010000

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Liver Transplantation: Time to Event

Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). (NCT02219490)
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260

,
Interventionpercentage of participants (Number)
Kaplan-Meier estimate at PT Week 52Kaplan-Meier estimate at PT Week 104Kaplan-Meier estimate at PT Week 156Kaplan-Meier estimate at PT Week 208Kaplan-Meier estimate at PT Week 260
Participants in Studies M14-222 and M14-423 Who Achieved SVR12000.10.10.2
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR1200000

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Liver Decompensation: Time to Event

Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). (NCT02219490)
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260

,
Interventionpercentage of participants (Number)
Kaplan-Meier estimate at PT Week 52Kaplan-Meier estimate at PT Week 104Kaplan-Meier estimate at PT Week 156Kaplan-Meier estimate at PT Week 208Kaplan-Meier estimate at PT Week 260
Participants in Studies M14-222 and M14-423 Who Achieved SVR120.20.20.30.30.5
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR124.54.54.54.54.5

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Hepatocellular Carcinoma: Time to Event

Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). (NCT02219490)
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260

,
Interventionpercentage of participants (Number)
Kaplan-Meier estimate at PT Week 52Kaplan-Meier estimate at PT Week 104Kaplan-Meier estimate at PT Week 156Kaplan-Meier estimate at PT Week 208Kaplan-Meier estimate at PT Week 260
Participants in Studies M14-222 and M14-423 Who Achieved SVR120.20.40.50.60.9
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR1200000

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Change From Baseline in FibroScan Score by SVR12 Status

The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis. (NCT02219490)
Timeframe: At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260

,
InterventionkPa (Mean)
At the final treatment visitPost-Treatment Week 12Post-Treatment Week 24Post-Treatment Week 52Post-Treatment Week 104Post-Treatment Week 156Post-Treatment Week 208Post-Treatment Week 260
Participants in Study M14-423 Who Achieved SVR12-1.41-1.76-1.98-2.46-2.80-2.92-3.08-3.08
Participants in Study M14-423 Who Did Not Achieve SVR12-2.55-1.81-1.26-0.30-0.35-0.37-0.88-1.31

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All-Cause Death: Time to Event

Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). (NCT02219490)
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260

,
Interventionpercentage of participants (Number)
Kaplan-Meier estimate at PT Week 52Kaplan-Meier estimate at PT Week 104Kaplan-Meier estimate at PT Week 156Kaplan-Meier estimate at PT Week 208Kaplan-Meier estimate at PT Week 260
Participants in Studies M14-222 and M14-423 Who Achieved SVR120.10.71.21.52.0
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR128.38.38.38.38.3

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures. (NCT02219490)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)97.0

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Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)

SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02243293)
Timeframe: 4 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A96.0
Arm B100.0
Arm C100.0
Arm D93.3
Arm E93.3
Arm F93.5
Arm G93.3
Arm J98.1
Arm L96.2
Arm O96.4
Arm P100.0
Arm Q197.5
Arm Q295.5
Arm R195.5
Arm R295.7
Arm S197.9
Arm S298.3

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02243293)
Timeframe: Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment

Interventionpercentage of participants (Number)
Arm A0
Arm B0
Arm C0
Arm D0
Arm E0
Arm F3.2
Arm G3.3
Arm J0
Arm L1.9
Arm O0
Arm P0
Arm Q10
Arm Q20
Arm R10
Arm R22.1
Arm S10
Arm S20

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02243293)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A96.0
Arm B100.0
Arm C100.0
Arm D93.3
Arm E93.3
Arm F93.5
Arm G83.3
Arm J98.1
Arm L94.3
Arm O96.4
Arm P100.0
Arm Q197.5
Arm Q290.9
Arm R195.5
Arm R295.7
Arm S197.9
Arm S293.1

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Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. (NCT02243293)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
Arm A0.0
Arm B0.0
Arm C0.0
Arm D3.4
Arm E6.7
Arm F0.0
Arm G7.1
Arm J0.0
Arm L2.0
Arm O3.6
Arm P0.0
Arm Q10
Arm Q29.1
Arm R14.5
Arm R22.2
Arm S11.4
Arm S20

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Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02243293)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm S198.5

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Number of Participants Grouped by HIV-1 RNA Concentrations

Number of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected). (NCT02247440)
Timeframe: At time of treatment discontinuation (whatever its date) and 6 months thereafter

InterventionParticipants (Count of Participants)
HIV-1 RNA not detectedHIV-1 RNA detectedMissing
PegINF-ribavirin1611

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Number of Participants Completed the First 24 and 48 Weeks of Treatment

Number of participants completed the first 24 and 48 weeks of treatment. (NCT02247440)
Timeframe: From initiation of treatment to the first 48 weeks of treatment

InterventionParticipants (Count of Participants)
Completed the first 24 weeks of treatmentCompleted the first 48 weeks of treatment
PegINF-ribavirin1414

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Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)

Number of participants with at least a serious adverse events associated with study treatment (peg-interferon and ribavirin). (NCT02247440)
Timeframe: From initiation of treatment to 6 months after treatment discontinuation

InterventionParticipants (Count of Participants)
PegINF-ribavirin1

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Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation

Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation, (NCT02247440)
Timeframe: 6 months after end of treatment, i.e. 1.5 years after treatment initiation

InterventionParticipants (Count of Participants)
PegINF-ribavirin10

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Number of Adverse Events by Severity Grade

Number of adverse events (AE) by severity grade. The severity grading scale is based on the DAIDS grading table, the grading scale ranging from grades 1 to 5: Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, and Grade 5 indicates death. (NCT02247440)
Timeframe: From initiation of treatment to 6 months after treatment discontinuation

Interventionevents (Number)
AE grade 1AE grade 2AE grade 3
PegINF-ribavirin1871

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Number of Participants Able to Perform Self-injections of Peg-interferon

Number of participants able to perform self-injections of peg-interferon. (NCT02247440)
Timeframe: From initiation of treatment to the first 48 weeks of treatment

InterventionParticipants (Count of Participants)
Week 0 to Week 1271963978Week 12 to Week 1671963978Week 16 to Week 2871963978Week 28 to Week 3271963978Week 32 to Week 4871963978
PegINF not injectedPegINF injected
PegINF-ribavirin17
PegINF-ribavirin0
PegINF-ribavirin16
PegINF-ribavirin1
PegINF-ribavirin15
PegINF-ribavirin13
PegINF-ribavirin14

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Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%

Number of participants with ribavirin compliance at ≥ 95%, 80% - 95%, and < 80%. (NCT02247440)
Timeframe: From initiation of treatment to the first 48 weeks of treatment

InterventionParticipants (Count of Participants)
Week 0 to Week 271963978Week 2 to Week 471963978Week 4 to Week 1271963978Week 12 to Week 1671963978Week 16 to Week 2071963978Week 20 to Week 2471963978Week 24 to Week 2871963978Week 28 to Week 3271963978Week 32 to Week 3671963978Week 36 to Week 4471963978Week 44 to Week 4871963978
Compliance < 80%Compliance ≥ 95%Compliance 80% - 95%
PegINF-ribavirin0
PegINF-ribavirin1
PegINF-ribavirin17
PegINF-ribavirin16
PegINF-ribavirin15
PegINF-ribavirin2
PegINF-ribavirin13
PegINF-ribavirin14

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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization

ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. (NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Posttreatment Week 4
12 to < 18 Years Old - LDV/SOF 12 Weeks72.389.893.891.393.390.2
3 to < 6 Years Old - LDV/SOF 12 Weeks63.084.096.092.091.791.3
6 to < 12 Years Old - LDV/SOF 12 Weeks75.784.893.190.195.598.4

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For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment. (NCT02249182)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
12 to < 18 Years Old - LDV/SOF 12 Weeks98.0
6 to < 12 Years Old - LDV/SOF 12 Weeks98.9
6 to < 12 Years Old - LDV/SOF 24 Weeks100.0
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks100.0
3 to < 6 Years Old - LDV/SOF 12 Weeks97.1

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For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02249182)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
12 to < 18 Years Old - LDV/SOF 12 Weeks98.0
6 to < 12 Years Old - LDV/SOF 12 Weeks98.9
6 to < 12 Years Old - LDV/SOF 24 Weeks100.0
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks100.0
3 to < 6 Years Old - LDV/SOF 12 Weeks97.1

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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization

ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. (NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16Week 20Week 24
6 to < 12 Years Old - LDV/SOF 24 Weeks0000100.0100.0100.0100.0

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For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization

ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. (NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16Week 20Week 24Posttreatment Week 4
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks50.050.0100.0100.0100.0100.0100.0100.0100.0

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For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment

(NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
12 to < 18 Years Old - LDV/SOF 12 Weeks40.075.097.0100.0100.0
3 to < 6 Years Old - LDV/SOF 12 Weeks29.478.897.0100.0100.0
6 to < 12 Years Old - LDV/SOF 12 Weeks30.371.996.6100.0100.0

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For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment

(NCT02249182)
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16Week 20Week 24
6 to < 12 Years Old - LDV/SOF 24 Weeks0100.0100.0100.0100.0100.0100.0100.0
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks100.0100.0100.0100.0100.0100.0100.0100.0

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Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1

Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score > 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to < 40. (NCT02249182)
Timeframe: Day 1

Interventionpercentage of participants (Number)
Did not taste the study drugTasted drug with score > 60 to 100Tasted drug with score 40 to 60Tasted drug with score of 0 to < 40
3 to < 6 Years Old - LDV/SOF 12 Weeks41.217.611.829.4

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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair

Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02249182)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

InterventionParticipants (Count of Participants)
End of Treatment71908380End of Treatment71908381End of Treatment71908379Posttreatment Week 1271908380Posttreatment Week 1271908379Posttreatment Week 1271908381Posttreatment Week 2471908379Posttreatment Week 2471908380Posttreatment Week 2471908381
No ChangeIncreaseDecrease
12 to < 18 Years Old - LDV/SOF 12 Weeks52
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks34
3 to < 6 Years Old - LDV/SOF 12 Weeks21
12 to < 18 Years Old - LDV/SOF 12 Weeks9
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks2
12 to < 18 Years Old - LDV/SOF 12 Weeks1
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks0
3 to < 6 Years Old - LDV/SOF 12 Weeks0
12 to < 18 Years Old - LDV/SOF 12 Weeks45
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks31
3 to < 6 Years Old - LDV/SOF 12 Weeks22
12 to < 18 Years Old - LDV/SOF 12 Weeks15
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks3
12 to < 18 Years Old - LDV/SOF 12 Weeks40
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks27
12 to < 18 Years Old - LDV/SOF 12 Weeks21
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks8
12 to < 18 Years Old - LDV/SOF 12 Weeks0

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For the Treatment Phase, Change From Baseline in Weight

(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

,
Interventionkilograms (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24
6 to < 12 Years Old - LDV/SOF 24 Weeks-0.50.00.51.32.11.62.23.11.83.14.5
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks0.30.30.70.60.91.21.82.42.23.75.7

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For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT02249182)
Timeframe: Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10

,,
Interventionh*ng/mL (Mean)
GS-331007 (metabolite of SOF)LDVSOF
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks12682.510202.42175.7
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks11688.99316.32495.2
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks8210.37288.31754.4

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For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA

(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12

,,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks-4.34-4.71-4.73-4.73-4.73
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks-4.32-4.87-4.92-4.92-4.92
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks-4.29-4.55-4.75-4.76-4.76

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Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1

Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to < 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to < 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet. (NCT02249182)
Timeframe: Day 1

,
Interventionpercentage of participants (Number)
Able to Swallow 90/400 mg Placebo TabletUnable to Swallow 90/400 mg Placebo TabletAble to Swallow 22.5/100 mg Placebo TabletUnable to Swallow 22.5/100 mg Placebo Tablet
12 to < 18 Years Old - LDV/SOF 12 Weeks89.011.072.727.3
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks100.0098.81.2

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase

(NCT02249182)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
12 to < 18 Years Old - LDV/SOF 12 Weeks0
6 to < 12 Years Old - LDV/SOF 12 Weeks0
6 to < 12 Years Old - LDV/SOF 24 Weeks0
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks0
3 to < 6 Years Old - LDV/SOF 12 Weeks2.9

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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair

Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02249182)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

InterventionParticipants (Count of Participants)
End of Treatment71908377End of Treatment71908376End of Treatment71908378Posttreatment Week 1271908377Posttreatment Week 1271908376Posttreatment Week 1271908378Posttreatment Week 2471908378Posttreatment Week 2471908376Posttreatment Week 2471908377
No ChangeIncreaseDecrease
12 to < 18 Years Old - LDV/SOF 12 Weeks35
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks52
3 to < 6 Years Old - LDV/SOF 12 Weeks10
12 to < 18 Years Old - LDV/SOF 12 Weeks1
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks1
12 to < 18 Years Old - LDV/SOF 12 Weeks32
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks51
12 to < 18 Years Old - LDV/SOF 12 Weeks3
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks2
12 to < 18 Years Old - LDV/SOF 12 Weeks28
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks48
3 to < 6 Years Old - LDV/SOF 12 Weeks9
12 to < 18 Years Old - LDV/SOF 12 Weeks7
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks4
3 to < 6 Years Old - LDV/SOF 12 Weeks1
12 to < 18 Years Old - LDV/SOF 12 Weeks0
3 to < 6 Years Old - LDV/SOF 12 Weeks0

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For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development

Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02249182)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

InterventionParticipants (Count of Participants)
End of Treatment71908379End of Treatment71908380End of Treatment71908381Posttreatment Week 1271908380Posttreatment Week 1271908381Posttreatment Week 1271908379Posttreatment Week 2471908380Posttreatment Week 2471908381Posttreatment Week 2471908379
IncreaseDecreaseNo Change
12 to < 18 Years Old - LDV/SOF 12 Weeks53
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks31
12 to < 18 Years Old - LDV/SOF 12 Weeks8
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks5
3 to < 6 Years Old - LDV/SOF 12 Weeks0
12 to < 18 Years Old - LDV/SOF 12 Weeks1
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks0
12 to < 18 Years Old - LDV/SOF 12 Weeks49
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks25
3 to < 6 Years Old - LDV/SOF 12 Weeks21
12 to < 18 Years Old - LDV/SOF 12 Weeks11
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks8
12 to < 18 Years Old - LDV/SOF 12 Weeks0
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks1
12 to < 18 Years Old - LDV/SOF 12 Weeks43
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks21
12 to < 18 Years Old - LDV/SOF 12 Weeks18
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks14
3 to < 6 Years Old - LDV/SOF 12 Weeks1

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For the Treatment Phase, Change From Baseline in HCV RNA

(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12
12 to < 18 Years Old - LDV/SOF 12 Weeks-4.34-4.74-4.84-4.85-4.85
3 to < 6 Years Old - LDV/SOF 12 Weeks-4.25-4.80-4.85-4.86-4.86
6 to < 12 Years Old - LDV/SOF 12 Weeks-4.27-4.73-4.87-4.89-4.89

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For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. (NCT02249182)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
12 to < 18 Years Old - LDV/SOF 12 Weeks98.0
6 to < 12 Years Old - LDV/SOF 12 Weeks98.9
6 to < 12 Years Old - LDV/SOF 24 Weeks100.0
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks100.0
3 to < 6 Years Old - LDV/SOF 12 Weeks97.1

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For the Treatment Phase, Change From Baseline in HCV RNA

(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)

,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
6 to < 12 Years Old - LDV/SOF 24 Weeks-4.30-5.09-5.09-5.09-5.09-5.09-5.09-5.09
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks-4.54-4.54-4.54-4.54-4.54-4.54-4.54-4.54

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For the Treatment Phase, Change From Baseline in Height

(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

,
Interventioncentimeters (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24
6 to < 12 Years Old - LDV/SOF 24 Weeks0.30.51.21.32.13.24.34.34.35.07.6
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks0.70.50.60.81.11.41.62.52.43.45.6

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase

(NCT02249182)
Timeframe: Up to Day 10

Interventionpercentage of participants (Number)
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks0
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks0
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks5.9

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For the Treatment Phase, Change From Baseline in Height

(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

,,
Interventioncentimeters (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24
12 to < 18 Years Old - LDV/SOF 12 Weeks0.10.00.10.40.50.81.21.8
3 to < 6 Years Old - LDV/SOF 12 Weeks0.20.30.71.01.62.13.34.7
6 to < 12 Years Old - LDV/SOF 12 Weeks0.10.30.50.81.31.82.74.1

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For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT02249182)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
12 to < 18 Years Old - LDV/SOF 12 Weeks0
6 to < 12 Years Old - LDV/SOF 12 Weeks1.1
6 to < 12 Years Old - LDV/SOF 24 Weeks0
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks0
3 to < 6 Years Old - LDV/SOF 12 Weeks0

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For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough

Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment. (NCT02249182)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
12 to < 18 Years Old - LDV/SOF 12 Weeks0
6 to < 12 Years Old - LDV/SOF 12 Weeks0
6 to < 12 Years Old - LDV/SOF 24 Weeks0
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks0
3 to < 6 Years Old - LDV/SOF 12 Weeks0

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For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development

Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. (NCT02249182)
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24

InterventionParticipants (Count of Participants)
End of Treatment71908376End of Treatment71908377End of Treatment71908378Posttreatment Week 1271908377Posttreatment Week 1271908376Posttreatment Week 1271908378Posttreatment Week 2471908376Posttreatment Week 2471908377Posttreatment Week 2471908378
DecreaseNo ChangeIncrease
12 to < 18 Years Old - LDV/SOF 12 Weeks34
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks52
12 to < 18 Years Old - LDV/SOF 12 Weeks1
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks1
12 to < 18 Years Old - LDV/SOF 12 Weeks33
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks50
3 to < 6 Years Old - LDV/SOF 12 Weeks9
12 to < 18 Years Old - LDV/SOF 12 Weeks2
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks4
12 to < 18 Years Old - LDV/SOF 12 Weeks0
12 to < 18 Years Old - LDV/SOF 12 Weeks29
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks47
3 to < 6 Years Old - LDV/SOF 12 Weeks10
12 to < 18 Years Old - LDV/SOF 12 Weeks6
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks6
6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks0
3 to < 6 Years Old - LDV/SOF 12 Weeks0

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For the Treatment Phase, Change From Baseline in Weight

(NCT02249182)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24

,,
Interventionkilograms (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24
12 to < 18 Years Old - LDV/SOF 12 Weeks0.10.30.40.50.60.91.63.2
3 to < 6 Years Old - LDV/SOF 12 Weeks0.10.20.30.50.61.11.22.0
6 to < 12 Years Old - LDV/SOF 12 Weeks0.30.40.50.81.11.42.13.5

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Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (NCT02265237)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A96.6
Arm B100.0
Arm C93.4

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Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02265237)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A96.6
Arm B100

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Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02265237)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm B100
Arm C93.4

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Percentage of Participants in Arms A, B and C With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment. (NCT02265237)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
Arm A0
Arm B0
Arm C0

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Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA >= LLOQ with at least 6 weeks of treatment. (NCT02265237)
Timeframe: Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment

Interventionpercentage of participants (Number)
Arm A1.7
Arm B0
Arm C0

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Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240

Reinfection was defined as HCV RNA > LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study. (NCT02292706)
Timeframe: Enrollment up to 240 weeks

InterventionParticipants (Count of Participants)
SOF+RBV0
LDV/SOF0
LDV/SOF+RBV0
SOF/VEL1
SOF/VEL+RBV0
SOF/VEL/VOX1
Other SOF-Based0

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Number of Participants With Detectable HCV Resistance Mutations Through Week 240

(NCT02292706)
Timeframe: Enrollment up to 240 weeks

InterventionParticipants (Count of Participants)
SOF+RBV0
LDV/SOF0
LDV/SOF+RBV1
SOF/VEL0
SOF/VEL+RBV0
SOF/VEL/VOX1
Other SOF-Based0

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Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240

(NCT02292706)
Timeframe: Enrollment up to 240 weeks

InterventionParticipants (Count of Participants)
SOF+RBV0
LDV/SOF0
LDV/SOF+RBV0
SOF/VEL0
SOF/VEL+RBV0
SOF/VEL/VOX0
Other SOF-Based0

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Percentage of Participants With Any Liver-Associated Events

The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model. (NCT02292706)
Timeframe: Enrollment up to 240 weeks

Interventionpercentage of participants (Number)
SOF+RBV18.7
LDV/SOF15.0
LDV/SOF+RBV24.8
SOF/VEL18.1
SOF/VEL+RBV37.6
SOF/VEL/VOX16.1
Other SOF-Based18.2

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Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240

Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model. (NCT02292706)
Timeframe: Enrollment up to 240 weeks

Interventionpercentage of participants (Number)
SOF+RBV11.8
LDV/SOF5.01
LDV/SOF+RBV10.8
SOF/VEL10.8
SOF/VEL+RBV15.3
SOF/VEL/VOX12.4
Other SOF-Based11.2

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Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240

SVR at Week 240 was defined as HCV RNA< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter [IU/mL]) or last available HCV RNA< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model. (NCT02292706)
Timeframe: Week 240

Interventionpercentage of participants (Number)
SOF+RBV98.9
LDV/SOF100
LDV/SOF+RBV99.6
SOF/VEL99.7
SOF/VEL+RBV100
SOF/VEL/VOX99.6
Other SOF-Based100

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment. (NCT02292719)
Timeframe: Up to Week 12

Interventionpercentage of participants (Number)
Arm A (Genotype [GT]3, Noncirrhotic)0
Arm B (GT3, Noncirrhotic)0
Arm C (GT2, Noncirrhotic)0
Arm D (GT2, Noncirrhotic)0
Arm E (GT3, Cirrhotic)0
Arm F (GT3, Noncirrhotic)0

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Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02292719)
Timeframe: Up to 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
Arm A (Genotype [GT]3, Noncirrhotic)0
Arm B (GT3, Noncirrhotic)0
Arm C (GT2, Noncirrhotic)10.0
Arm D (GT2, Noncirrhotic)55.6
Arm E (GT3, Cirrhotic)0
Arm F (GT3, Noncirrhotic)0

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02292719)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A (Genotype [GT]3, Noncirrhotic)100
Arm B (GT3, Noncirrhotic)90.9
Arm C (GT2, Noncirrhotic)90.0
Arm D (GT2, Noncirrhotic)44.4
Arm E (GT3, Cirrhotic)100
Arm F (GT3, Noncirrhotic)100

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Number of Participants With Abnormal Safety Laboratory Tests (ALT and/or Total Bilirubin) That Required Discontinuing Study Drugs

This field states the number of participants who had an abnormal ALT that required discontinuing study drugs and/or abnormal Total Bilirubin that required discontinuing study drugs. (NCT02304159)
Timeframe: From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.

InterventionParticipants (Count of Participants)
Group A - 16 Weeks0
Group B - 24 Weeks0

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Number of Participants With Adverse Events

This field states the number of participants who had an adverse event (NCT02304159)
Timeframe: From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.

InterventionParticipants (Count of Participants)
Group A - 16 Weeks21
Group B - 24 Weeks18

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Number of Participants With Undetectable HCV Virus 12 Weeks After Stopping Study Drugs

Sustained Virologic Response (SVR) defined as undetectable HCV RNA 12 weeks after stopping study drugs. (NCT02304159)
Timeframe: From baseline (start of study drugs) until 12 weeks after stopping study drugs

InterventionParticipants (Count of Participants)
Group A - 16 Weeks19
Group B - 24 Weeks16

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Number of Participants Evaluated for Toxicity

will be tabulated using NCI CTCAE version 4, (NCT02308241)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Ribavirin12

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Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)

SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up. (NCT02319031)
Timeframe: Follow-up Week 12

Interventionpercentage of participants (Number)
Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)87.5
Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)92.3

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Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities

Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria. (NCT02319031)
Timeframe: Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)

,
Interventionparticipants (Number)
DeathSAEsDiscontinuation due to AEsGrade 3/4 AEsGrade 3/4 Laboratory Abnormalities
Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)12021
Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)03022

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Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)

SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up. (NCT02319031)
Timeframe: Follow-up Weeks 4 and 24

,
Interventionpercentage of participants (Number)
Follow-up Week 4 (SVR4)Follow-up Week 24 (SVR24)
Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)87.587.5
Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)96.292.3

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Percentage of Participants Experiencing an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02332707)
Timeframe: Up to 18 weeks

InterventionPercentage of Participants (Number)
A1: GT1 NC GZR+UPR+EBR (8 Weeks)60.9
A2: GT1 NC GZR+UPR+RZR (8 Weeks)83.3
A3: GT2 NC GZR+UPR+EBR (8 Weeks)56.3
A4: GT2 NC GZR+UPR+RZR (8 Weeks)71.4
A5: GT1 NC GZR+UPR+EBR (8 Weeks)73.9
A6: GT1 NC GZR+UPR+RZR (8 Weeks)60.9
B6: GT1 NC GZR+UPR+RVR (8 Weeks)62.3
A7: GT2 NC GZR+UPR+EBR (8 Weeks)86.7
A8: GT2 NC GZR+UPR+RZR (8 Weeks)75.0
B8: GT2 NC GZR+UPR+RZR (8 Weeks)68.8
B9: GT1 NC GZR+UPR+RZR (12 Weeks)72.9
B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV80.6
B11: GT2 NC GZR+UPR+RZR (12 Weeks)71.0
B12: GT1 C GZR+UPR+RZR (8 Weeks)57.1
B13: GT1 C GZR+UPR+RZR (12 Weeks)72.5
B14: GT2 C GZR+UPR+RZR (12 Weeks)53.3
B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV81.3
16: GT2 C GZR+UPR+RZR (16 Weeks)69.2

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)

The percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) < Lower Limit of Quantification (LLoQ) 12 weeks after completing treatment (i.e., SVR12) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL. (NCT02332707)
Timeframe: Up to 28 weeks

InterventionPercentage of Participants (Number)
A1: GT1 NC GZR+UPR+EBR (8 Weeks)100.0
A2: GT1 NC GZR+UPR+RZR (8 Weeks)100.0
A3: GT2 NC GZR+UPR+EBR (8 Weeks)68.8
A4: GT2 NC GZR+UPR+RZR (8 Weeks)71.4
A5: GT1 NC GZR+UPR+EBR (8 Weeks)100.0
A6: GT1 NC GZR+UPR+RZR (8 Weeks)91.3
B6: GT1 NC GZR+UPR+RVR (8 Weeks)100.0
A7: GT2 NC GZR+UPR+EBR (8 Weeks)60.0
A8: GT2 NC GZR+UPR+RZR (8 Weeks)93.8
B8: GT2 NC GZR+UPR+RZR (8 Weeks)87.5
B9: GT1 NC GZR+UPR+RZR (12 Weeks)100.0
B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV83.3
B11: GT2 NC GZR+UPR+RZR (12 Weeks)100.0
B12: GT1 C GZR+UPR+RZR (8 Weeks)97.1
B13: GT1 C GZR+UPR+RZR (12 Weeks)100.0
B14: GT2 C GZR+UPR+RZR (12 Weeks)100.0
B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV100.0
16: GT2 C GZR+UPR+RZR (16 Weeks)100.0

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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)

The percentage of participants with HCV RNA < LLoQ 24 weeks after completing treatment (i.e., SVR24) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL. (NCT02332707)
Timeframe: Up to 40 weeks

InterventionPercentage of Participants (Number)
A1: GT1 NC GZR+UPR+EBR (8 Weeks)100.0
A2: GT1 NC GZR+UPR+RZR (8 Weeks)100.0
A3: GT2 NC GZR+UPR+EBR (8 Weeks)68.8
A4: GT2 NC GZR+UPR+RZR (8 Weeks)71.4
A5: GT1 NC GZR+UPR+EBR (8 Weeks)100.0
A6: GT1 NC GZR+UPR+RZR (8 Weeks)90.9
B6: GT1 NC GZR+UPR+RVR (8 Weeks)100.0
A7: GT2 NC GZR+UPR+EBR (8 Weeks)60.0
A8: GT2 NC GZR+UPR+RZR (8 Weeks)93.8
B8: GT2 NC GZR+UPR+RZR (8 Weeks)87.5
B9: GT1 NC GZR+UPR+RZR (12 Weeks)100.0
B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV83.3
B11: GT2 NC GZR+UPR+RZR (12 Weeks)100.0
B12: GT1 C GZR+UPR+RZR (8 Weeks)97.1
B13: GT1 C GZR+UPR+RZR (12 Weeks)100.0
B14: GT2 C GZR+UPR+RZR (12 Weeks)100.0
B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV100.0
16: GT2 C GZR+UPR+RZR (16 Weeks)100.0

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Percentage of Participants Discontinuing From Study Treatment Due to an AE

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02332707)
Timeframe: Up to 16 weeks

InterventionPercentage of Participants (Number)
A1: GT1 NC GZR+UPR+EBR (8 Weeks)0
A2: GT1 NC GZR+UPR+RZR (8 Weeks)0
A3: GT2 NC GZR+UPR+EBR (8 Weeks)0
A4: GT2 NC GZR+UPR+RZR (8 Weeks)0
A5: GT1 NC GZR+UPR+EBR (8 Weeks)0
A6: GT1 NC GZR+UPR+RZR (8 Weeks)0
B6: GT1 NC GZR+UPR+RVR (8 Weeks)0
A7: GT2 NC GZR+UPR+EBR (8 Weeks)0
A8: GT2 NC GZR+UPR+RZR (8 Weeks)0
B8: GT2 NC GZR+UPR+RZR (8 Weeks)0
B9: GT1 NC GZR+UPR+RZR (12 Weeks)0
B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV6.5
B11: GT2 NC GZR+UPR+RZR (12 Weeks)0
B12: GT1 C GZR+UPR+RZR (8 Weeks)0
B13: GT1 C GZR+UPR+RZR (12 Weeks)2.5
B14: GT2 C GZR+UPR+RZR (12 Weeks)0
B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV12.5
16: GT2 C GZR+UPR+RZR (16 Weeks)0

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Percentage of HCV GT3-infected Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 is defined as HCV ribonucleic acid (RNA) less than the lower limit of quantification (NCT02332720)
Timeframe: Up to 20 weeks (Part A), up to 28 weeks (Part B)

InterventionPercentage of participants (Number)
A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)90.5
A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)95.2
A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)86.4
A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)90.9
A4+B4: GT3 NC TN MK-3682B (8 Weeks)92.1
B4: GT3 NC TN MK-3682B (8 Weeks)93.8
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)100.0
B6: GT3 NC TN MK-3682B (12 Weeks)97.2
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)100.0
B8: GT3 NC TE MK-3682B (8 Weeks)100.0
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)92.9
B10: GT3 NC TE MK-3682B (12 Weeks)100.0
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)93.3
B12: GT3 NC TE MK-3682B (16 Weeks)93.8
B13: GT3 C TN MK-3682B (12 Weeks)92.3
B14: GT3 C TN MK-3682B + RBV (12 Weeks)100.0
B15: GT3 C TN MK-3682B (16 Weeks)100.0
B16: GT3 C TE MK-3682B (12 Weeks)100.0
B17: GT3 C TE MK-3682B + RBV (12 Weeks)100.0
B18: GT3 C TE MK-3682B (16 Weeks)100.0
B19: GT3 C TE MK-3682B + RBV (16 Weeks)96.0

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Percentage of GT3-infected Participants Achieving SVR at Follow-up Week 24 (SVR24)

SVR24 is defined as HCV RNA NCT02332720)
Timeframe: Up to 40 weeks

InterventionPercentage of participants (Number)
A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)90.0
A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)95.2
A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)86.4
A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)90.9
A4+B4: GT3 NC TN MK-3682B (8 Weeks)92.1
B4: GT3 NC TN MK-3682B (8 Weeks)93.8
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)100.0
B6: GT3 NC TN MK-3682B (12 Weeks)97.2
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)100.0
B8: GT3 NC TE MK-3682B (8 Weeks)100.0
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)92.9
B10: GT3 NC TE MK-3682B (12 Weeks)100.0
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)93.3
B12: GT3 NC TE MK-3682B (16 Weeks)93.8
B13: GT3 C TN MK-3682B (12 Weeks)92.3
B14: GT3 C TN MK-3682B + RBV (12 Weeks)100.0
B15: GT3 C TN MK-3682B (16 Weeks)100.0
B16: GT3 C TE MK-3682B (12 Weeks)100.0
B17: GT3 C TE MK-3682B + RBV (12 Weeks)100.0
B18: GT3 C TE MK-3682B (16 Weeks)100.0
B19: GT3 C TE MK-3682B + RBV (16 Weeks)96.0

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Number of Participants Who Had Study Drug Discontinued Due to an AE

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks. (NCT02332720)
Timeframe: Up to 16 weeks

InterventionParticipants (Count of Participants)
A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)0
A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)0
A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)0
A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)0
A4+ B4: GT3 NC TN MK-3682B (8 Weeks)0
B4: GT3 NC TN MK-3682B (8 Weeks)0
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)0
B6: GT3 NC TN MK-3682B (12 Weeks)0
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)1
B8: GT3 NC TE MK-3682B (8 Weeks)0
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)0
B10: GT3 NC TE MK-3682B (12 Weeks)0
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)0
B12: GT3 NC TE MK-3682B (16 Weeks)0
B13: GT3 C TN MK-3682B (12 Weeks)0
B14: GT3 C TN MK-3682B + RBV (12 Weeks)1
B15: GT3 C TN MK-3682B (16 Weeks)1
B16: GT3 C TE MK-3682B (12 Weeks)0
B17: GT3 C TE MK-3682B + RBV (12 Weeks)0
B18: GT3 C TE MK-3682B (16 Weeks)1
B19: GT3 C TE MK-3682B + RBV (16 Weeks)0
B20: GT4 NC TN MK-3682B (8 Weeks)0
B22: GT6 NC TN MK-3682B (12 Weeks)0
Part C: GT3 NC TN: MK-3682B + RBV (16 Weeks)0

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Number of Participants Experiencing an Adverse Event (AE)

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks. (NCT02332720)
Timeframe: Up to 40 weeks

InterventionParticipants (Count of Participants)
A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)18
A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)14
A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks)16
A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks)17
A4+ B4: GT3 NC TN MK-3682B (8 Weeks)26
B4: GT3 NC TN MK-3682B (8 Weeks)9
B5: GT3 NC TN MK-3682B + RBV (8 Weeks)30
B6: GT3 NC TN MK-3682B (12 Weeks)25
B7: GT3 NC TN MK-3682B + RBV (12 Weeks)33
B8: GT3 NC TE MK-3682B (8 Weeks)12
B9: GT3 NC TE MK-3682B + RBV (8 Weeks)12
B10: GT3 NC TE MK-3682B (12 Weeks)9
B11: GT3 NC TE MK-3682B + RBV (12 Weeks)13
B12: GT3 NC TE MK-3682B (16 Weeks)13
B13: GT3 C TN MK-3682B (12 Weeks)9
B14: GT3 C TN MK-3682B + RBV (12 Weeks)14
B15: GT3 C TN MK-3682B (16 Weeks)12
B16: GT3 C TE MK-3682B (12 Weeks)12
B17: GT3 C TE MK-3682B + RBV (12 Weeks)12
B18: GT3 C TE MK-3682B (16 Weeks)16
B19: GT3 C TE MK-3682B + RBV (16 Weeks)21
B20: GT4 NC TN MK-3682B (8 Weeks)3
B22: GT6 NC TN MK-3682B (12 Weeks)3
Part C: GT3 NC TN: MK-3682B + RBV (16 Weeks)7

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Mean Absolute Values in HCV RNA (log10 IU/mL)

(NCT02340962)
Timeframe: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)

,
Interventionlog10 IU/mL (Mean)
BaselineDay 4Week 1Day 10Week 2Week 3Week 4Week 6Week 8Week 10Week 12Post-Treatment Week 4Post-Treatment Week 8Post-Treatment Week 12Post-Treatment Week 24
200 mg TG-23495.81.91.41.21.00.70.50.40.00.20.00.00.20.50.1
400 mg TG-23495.92.01.41.11.00.40.40.10.10.00.10.80.91.00.0

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Proportion of Subjects Achieving Sustained Viral Response at 4, 8, and 24 Weeks After the End of Treatment (SVR4, SVR8, and SVR24)

(NCT02340962)
Timeframe: 4, 8, 24 weeks after the end of treatment (SVR4, 8, 24), after 12-week treatments

,
InterventionParticipants (Count of Participants)
SVR4SVR8SVR24
200 mg TG-2349121111
400 mg TG-2349101010

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Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)

(NCT02340962)
Timeframe: The whole treatment period, 12 weeks

,
InterventionParticipants (Count of Participants)
BaselineDay 4Week 1Day 10Week 2Week 3Week 4Week 6Week 8Week 10Week 12
200 mg TG-234901369111211111111
400 mg TG-2349004810101111111111

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Proportion of Subjects Achieving HCV RNA < LLOQ, TND

(NCT02340962)
Timeframe: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)

,
InterventionParticipants (Count of Participants)
BaselineDay 4Week 1Day 10Week 2Week 3Week 4Week 6Week 8Week 10Week 12Post-Treatment Week 4Post-Treatment Week 8Post-Treatment Week 12Post-Treatment Week 24
Group I001024671191112111110
Group II0013499101011101010910

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Change From Baseline in HCV RNA (log10 IU/mL)

(NCT02340962)
Timeframe: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)

,
Interventionlog10 IU/mL (Mean)
Day 4Week 1Day 10Week 2Week 3Week 4Week 6Week 8Week 10Week 12Post-Treatment Week 4Post-Treatment Week 8Post-Treatment Week 12Post-Treatment Week 24
200 mg TG-2349-3.8-4.4-4.6-4.8-5.0-5.2-5.4-5.8-5.6-5.8-5.8-5.6-5.2-5.6
400 mg TG-2349-3.9-4.5-4.8-4.9-5.5-5.5-5.7-5.7-5.8-5.7-5.1-5.0-4.8-5.8

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Proportion of Subjects Achieving Sustained Viral Response at 12 Weeks After the End of Treatment.

Proportion of subjects with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at 12 weeks after the end of treatment (SVR12) in the Full Analysis Set (FAS) population, which include subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs. (NCT02340962)
Timeframe: 12 weeks after the end of treatment (SVR12), after 12-week treatments

InterventionParticipants (Count of Participants)
200 mg TG-234911
400 mg TG-234910

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Proportion of Subjects With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at Final Treatment Visit.

(NCT02340962)
Timeframe: From baseline (day 1) to the final treatment visit (week 12 or week 24)

,
InterventionParticipants (Count of Participants)
ALT > ULN at baselineALT normalization
200 mg TG-234972
400 mg TG-234975

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Proportion of Subjects Experiencing Virologic Failure During Treatment and Viral Relapse After the End of Treatment.

(NCT02340962)
Timeframe: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)

,
InterventionParticipants (Count of Participants)
Virologic failureOn-Treatment failurePost-Treatment relapse
200 mg TG-2349101
400 mg TG-2349211

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Percentage of Participants With Post-Treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. (NCT02356562)
Timeframe: Within 12 weeks after the last actual dose of active study drug

Interventionpercentage of participants (Number)
Part 1, 3-DAA With SOF With or Without RBV4.8
Part 2, 3-DAA With RBV0.0

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Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02356562)
Timeframe: 12 weeks after the last dose of active drug

Interventionpercentage of participants (Number)
Part 1, 3-DAA With SOF With or Without RBV95.5

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Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment

SVR12 was defined as plasma HCV RNA level NCT02356562)
Timeframe: 12 weeks after the last dose of active drug

Interventionpercentage of participants (Number)
Part 2, 3-DAA With RBV85.7

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. (NCT02356562)
Timeframe: Up to week 24

Interventionpercentage of participants (Number)
Part 1, 3-DAA With SOF With or Without RBV0.0
Part 2, 3-DAA With RBV14.3

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Percentage of Participants Discontinuing Study Treatment Due to an AE

"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.~The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial." (NCT02358044)
Timeframe: Up to Week 12

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir0.8
SOF + PR0.8

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Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm. (NCT02358044)
Timeframe: Treatment + First 14 days of follow-up (Up to Week 14)

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir51.9
SOF + PR93.7

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Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12)

Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (NCT02358044)
Timeframe: 12 weeks after end of all therapy (Study Week 24)

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir99.2
SOF + PR90.5

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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)

HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR24 was defined as HCV RNA NCT02358044)
Timeframe: 24 weeks after end of all therapy (Study Week 36)

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir98.4
SOF + PR89.7

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Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days

Tier 1 safety events were pre-specified by the protocol to evaluate safety and test the safety superiority hypothesis. Tier 1 safety events were chosen to assess broad tolerability, hematological side effects and liver-related laboratory abnormalities. For this study, Tier 1 safety events included: any serious drug-related AE, any drug-related AE leading to permanent discontinuation (DC) of all study drugs, neutrophil count <0.75 x 10^9/L, hemoglobin <10 g/dL, severe depression, hepatic events of clinical interest (defined by abnormal increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]), or events meeting stopping rule criteria for DC from trial (due to abnormal increases of ALT, AST, or ALP with/without pre-specified related AEs). The percentage of participants who experienced each individual event that was defined as a Tier 1 safety event during the study treatment period was reported for each treatment arm. (NCT02358044)
Timeframe: Treatment + First 14 days of follow-up (Up to Week 14)

,
Interventionpercentage of participants (Number)
Total Tier 1 AEsTier 1 AE: Serious drug-related AETier 1 AE: DC due to drug-related AETier 1 AE: Neutrophil count <0.75 x 10^9/LTier 1 AE: Hemoglobin <10 g/dLTier 1 AE: Severe depressionTier 1 AE: Hepatic event of clinical interestTier 1 AE: Trial DC due to stopping rule
Grazoprevir + Elbasvir0.80.00.00.00.80.00.00.0
SOF + PR27.82.40.812.714.30.00.00.0

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Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)

HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR4 was defined as HCV RNA NCT02358044)
Timeframe: 4 weeks after end of all therapy (Study Week 16)

Interventionpercentage of participants (Number)
Grazoprevir + Elbasvir99.2
SOF + PR92.1

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Percentage of Subjects With On-treatment Virologic Failure

Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment). (NCT02399345)
Timeframe: 6 weeks

Interventionpercentage of participants (Number)
Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV0

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Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. (NCT02399345)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV80

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Percentage of Subjects With Post-treatment Relapse

Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment (NCT02399345)
Timeframe: Up to 12 weeks after last actual dose of active study drug

Interventionpercentage of participants (Number)
Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV20

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Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug

The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score. Scores range from 0 to 100. A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening. If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing. (NCT02442271)
Timeframe: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug

,
Interventionunits on a scale (Mean)
SVR12 Not AchievedSVR12 Achieved
Fibrosis Stage F30.53.8
Fibrosis Stage F40.84.2

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(SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug

The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain was missing. (NCT02442271)
Timeframe: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug

,
Interventionunits on a scale (Mean)
SVR12 Not AchievedSVR12 Achieved
Fibrosis Stage F32.42.4
Fibrosis Stage F4-0.62.5

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Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience

SVR12 was defined as HCV RNA level NCT02442271)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Treatment-Naive96.1
Pegylated Interferon (PegIFN)/RBV Null Responders95.5
Pegylated Interferon (PegIFN)//RBV Partial Responders100
Pegylated Interferon (PegIFN)/RBV Non-Responders100
Pegylated Interferon (PegIFN)/RBV Relapser97.1
Pegylated Interferon (PegIFN)/RBV Breakthrough100
IFN Interolerant85.7
Other91.7

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Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening

SVR12 was defined as HCV RNA level NCT02442271)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Interferon (IFN)-Ineligible, Treatment-Naive90.0
Interferon (IFN)-Eligible, Treatment-Naive96.7
Interferon (IFN)-Ineligible, Treatment-Experienced85.7
Interferon (IFN)-Eligible, Treatment-Experienced97.3

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02442271)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
3-DAA ± RBV96.4

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Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug

The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain (NCT02442271)
Timeframe: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug

,
Interventionunits on a scale (Mean)
SVR12 Not AchievedSVR12 Achieved
Fibrosis Stage F3-0.50.1
Fibrosis Stage F41.32.1

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Percentage of Participants With SVR12 by Fibrosis Stage

SVR12 was defined as plasma HCV RNA level NCT02442271)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Fibrosis Stage F396.6
Fibrosis Stage F496.2

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02442284)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
3-DAA ± RBV for 12 or 24 Weeks95.8

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02442284)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
3-DAA ± RBV for 12 or 24 Weeks93.9

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Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02442284)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
3-DAA ± RBV for 12 or 24 Weeks2.2

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Percentage of Participants With Virologic Failure During Treatment

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment. (NCT02442284)
Timeframe: up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group

Interventionpercentage of participants (Number)
3-DAA ± RBV for 12 or 24 Weeks1.0

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02446717)
Timeframe: Day 3, Treatment Weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment for 12-week treatment arms), and 16 (end of treatment for 16-week treatment arm) or premature discontinuation from treatment

Interventionpercentage of participants (Number)
ARM A0.0
ARM B0.0
ARM C4.5
ARM D2.3
ARM E8.5

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Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. (NCT02446717)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
ARM A0.0
ARM B4.8
ARM C0.0
ARM D9.3
ARM E0.0

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02446717)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
ARM A100
ARM B95.5
ARM C86.4
ARM D88.6
ARM E91.5

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Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)

SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02446717)
Timeframe: 4 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
ARM A100.0
ARM B95.5
ARM C95.5
ARM D90.9
ARM E91.5

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Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: Baseline

Liver function as assessed via MELD score. The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome. (NCT02455167)
Timeframe: Baseline

Interventionscore on a scale (Mean)
HCV Positive Group8

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Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: 12 Weeks

Liver function as assessed via MELD score. The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome. (NCT02455167)
Timeframe: 12 Weeks

Interventionscore on a scale (Mean)
HCV Positive Group7.25

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The Sustained Virologic Response (SVR) in Patients Infected With HCV Genotype 1, Cirrhosis, and Early Clinical Decompensation

"Number of participants who cleared Hepatitis C (HCV) after 12 weeks was collected (HCV RNA level was Not Detected." (NCT02455167)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
HCV Positive Group4

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Sustained Virological Response (SVR) at Week 4

Percentage of study participants achieving sustained virological response (SVR) at Week 4 per protocol among subjects who completed 12-week course of treatment in the study. (NCT02461745)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Genotype 1a116
Genotype 1b65

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Sustained Virological Response (SVR) at Week 12

Percentage of study participants achieving sustained virological response (SVR) at Week 12 per protocol among study participants who completed 12-week course of treatment. (NCT02461745)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Genotype 1a116
Genotype 1b66

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Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12

The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (NCT02476617)
Timeframe: Week 0 to Post-Treatment Week 12

InterventionFold change (Mean)
CXCL10ISG15CXCL11MX1IFI27OAS2DDX60IFIT3IFI44STAT1CXCL9IFIT1HERC5IRF7OAS1PLSCR1IRF9IFIH1TRIM14IRF1IRF3STAT2IFNGIFNL1IFNL2IFNL3IFNL4IFNGR1ADARALG10BCHECCL2CCL4CD163CXCL5CXCR3DDIT4DDX58DPP4EIF2AK2GBP1GCKRGUCY1B3HELZ2HERC6IFI35IFI44LIFI6IFIT2IFIT5IFITM1IFITM2IFITM3IFNAIFNBIL10IL18IRF2ISG20MAP3K14MOV10MS4A4AMX2MYST1NOS2ANT5C3OASLPPP3CBRNASELRSAD2SLC27A2SOCS1SOCS3USP18
Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + RBV-0.464-0.148-0.611-0.399-0.462-0.168-0.016-0.543-0.467-0.301-0.552-0.440-0.358-0.1710.284-0.255-0.205-0.3210.022-0.1300.044-0.0510.516-0.361-0.199-0.205-0.228-0.046-0.212-0.083-0.1010.2000.6380.5561.0850.3080.0290.3880.869-0.317-0.2880.0090.350-0.232-0.074-0.023-0.554-0.464-0.365-0.291-0.0660.158-0.423-0.202-0.1670.202-0.0780.3110.156-0.072-0.185-0.005-0.101-0.0570.2490.017-0.2330.0110.395-0.4060.0221.3130.025-0.288

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Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2

Interventionng/mL (Geometric Mean)
15 - 29 kg Body Weight99.6
30 - 44 kg Body Weight116
≥ 45 kg Body Weight83.7

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Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2

Interventionng/mL (Geometric Mean)
15 - 29 kg Body Weight294
30 - 44 kg Body Weight1540
≥ 45 kg Body Weight870

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Part 1: Maximum Plasma Concentration (Cmax) of Ritonavir (RTV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2

Interventionng/mL (Geometric Mean)
15 - 29 kg Body Weight1090
30 - 44 kg Body Weight1830
≥ 45 kg Body Weight1180

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Parts 1 & 2: Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Actual Dose of Study Drug (SVR24), Summarized by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations

SVR24 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 24 weeks after the last actual dose of study drug. (NCT02486406)
Timeframe: 24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)

Interventionpercentage of participants (Number)
Participants in Parts 1 and 2 of the Study96.9
Adult Tablet, 12-17 YR, ≥ 45 kg100
Mini-tablet, 9-11 YR, 15 to 29 kg100.0
Mini-tablet, 9-11 YR, 30 to 44 kg88.9
Mini-tablet, 9-11 YR, ≥ 45 kg100.0
Mini-tablet, 3-8 YR, 15 to 29 kg92.9
Mini-tablet Total92.3

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Parts 1 and 2: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization During Treatment by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations

Alanine aminotransferase (ALT) normalization during treatment is defined as ALT ≤ the upper limit of normal (ULN) at the final treatment visit for participants with ALT > ULN at baseline. (NCT02486406)
Timeframe: 12 or 24 weeks after starting study drug, depending on treatment duration

Interventionpercentage of participants (Number)
Adult Tablet,12-17 YR, ≥ 45 kg, ALT Normalization87.5
Mini-tablet, 9-11 YR, 15 to 29 kg, ALT Normalization100
Mini-tablet, 9-11 YR, 30 to 44 kg, ALT Normalization100
Mini-tablet, 3-8 YR, 15 to 29 kg, ALT Normalization80.0
Mini-tablet Total, ALT Normalization87.5
Participants in Parts 1 and 2 of the Study, ALT Normalization87.5

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Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12)

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. (NCT02486406)
Timeframe: 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)

Interventionpercentage of participants (Number)
All Participants, Total98.4

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Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) Summarized by Formulation, Age and Weight Group, and Across All Subjects on the Adult Formulations

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. (NCT02486406)
Timeframe: 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)

Interventionpercentage of participants (Number)
Adult Tablet, 12-17 YR, ≥ 45 kg100
Mini-tablet, 9-11 YR, 15 to 29 kg100
Mini-tablet, 9-11 YR, 30 to 44 kg100
Mini-tablet, 9-11 YR, ≥ 45 kg100
Mini-tablet, 3-8 YR, 15 to 29 kg92.9
Mini-tablet Total96.2

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Part 1: Lowest Plasma Concentration (Ctrough) of Dasabuvir (DSV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8

,,
Interventionng/mL (Geometric Mean)
Week 2Week 8
≥ 45 kg Body Weight165191
15 - 29 kg Body Weight110168
30 - 44 kg Body Weight215264

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Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8

,,
Interventionng/mL (Geometric Mean)
Week 2Week 8
≥ 45 kg Body Weight21.820.9
15 - 29 kg Body Weight24.729.6
30 - 44 kg Body Weight28.230.4

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Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV)

Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2

Interventionng/mL (Geometric Mean)
15 - 29 kg Body Weight579
30 - 44 kg Body Weight830
≥ 45 kg Body Weight671

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Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8

,,
Interventionng/mL (Geometric Mean)
Week 2Week 8
≥ 45 kg Body Weight18.023.5
15 - 29 kg Body Weight9.8617.3
30 - 44 kg Body Weight16.118.4

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Part 1: Lowest Plasma Concentration (Ctrough) of Ritonavir (RTV)

Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8

,,
Interventionng/mL (Geometric Mean)
Week 2Week 8
≥ 45 kg Body Weight29.858.2
15 - 29 kg Body Weight16.191.8
30 - 44 kg Body Weight32.138.1

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Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of paritaprevir present was measured up to 24 hours after dosing. (NCT02486406)
Timeframe: At Week 2

Interventionng•h/mL (Geometric Mean)
15 - 29 kg Body Weight2180
30 - 44 kg Body Weight8640
≥ 45 kg Body Weight5770

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Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ombitasvir present was measured up to 24 hours after dosing. (NCT02486406)
Timeframe: At Week 2

Interventionng•h/mL (Geometric Mean)
15 - 29 kg Body Weight1270
30 - 44 kg Body Weight1490
≥ 45 kg Body Weight1060

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Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of dasabuvir present was measured up to 12 hours after dosing. For two subjects in the 15-29 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. For one subject in the 30-44 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. (NCT02486406)
Timeframe: At Week 2

Interventionng•h/mL (Geometric Mean)
15 - 29 kg Body Weight3960
30 - 44 kg Body Weight5960
≥ 45 kg Body Weight4630

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Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ritonavir (RTV)

AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ritonavir present was measured up to 24 hours after dosing. (NCT02486406)
Timeframe: At Week 2

Interventionng•h/mL (Geometric Mean)
15 - 29 kg Body Weight6570
30 - 44 kg Body Weight14100
≥ 45 kg Body Weight8900

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Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment

HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm. (NCT02493855)
Timeframe: From Week 0 to Week 2

Intervention1/day (Median)
Arm A: Ribavirin Full Dose for Last 10 Weeks0.0036
Arm B: Ribavirin Full Dose for 12 Weeks0.0046
Arm C: Ribavirin Low-dose for 12 Weeks0.0051

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Percentage of Participants With End of Treatment Response

Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported. (NCT02515279)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Participants with negative PCRParticipants with positive PCR
Participants With Hepatitis C83.89.7

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Percentage of Participants With Sustained Virologic Response 24 (SVR24)

Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment. (NCT02515279)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Participants With Hepatitis C26.6

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Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs. (NCT02515279)
Timeframe: Up to 6 years

Interventionpercentage of participants (Number)
AEsSAEs
Participants With Hepatitis C44.283.9

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. (NCT02517528)
Timeframe: 12 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 + ABT-333 + Ribavirin100

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Percentage of Participants With Virologic Relapse by Post-Treatment Week 24

Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 24 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. (NCT02517528)
Timeframe: Within 24 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 + ABT-333 + Ribavirin0

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Percentage of Participants With On Treatment Virologic Failure

On treatment virologic failure is defined as confirmed HCV RNA greater than or equal to the LLOQ at any point during treatment after HCV RNA less than LLOQ, confirmed increase from the lowest value post-baseline in HCV RNA (two consecutive HCV RNA measurements greater than 1 log10 IU/mL above the lowest value post-baseline) at any time point during treatment, or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks (greater than or equal to 36 days) of treatment. 95% CI is calculated using Wilson's score method. (NCT02517528)
Timeframe: Within 12 weeks after first dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 + ABT-333 + Ribavirin0

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Percentage of Participants With Virologic Relapse

Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. (NCT02517528)
Timeframe: Within 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 + ABT-333 + Ribavirin0

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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)

SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China. (NCT02517528)
Timeframe: 24 weeks after last dose of study drug

Interventionpercentage of participants (Number)
ABT-450/r/ABT-267 + ABT-333 + Ribavirin100

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Sustained Virologic Response (SVR)

The percentage of participants who achieve SVR as assessed by undetectable HCV RNA measured 12 weeks after treatment completion (NCT02541409)
Timeframe: 24 weeks from baseline for SOF+PEG+RBV and 36 weeks from baseline for SOF+RBV

InterventionParticipants (Count of Participants)
SOF+PEG+RBV22
SOF+RBV15

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Serious Adverse Events

Number of participants with treatment-related serious adverse events by laboratory tests and physician examination (NCT02541409)
Timeframe: 24 weeks from baseline SOF+PEG+RBV and 36 weeks from baseline for SOF+RBV

InterventionParticipants (Count of Participants)
SOF+PEG+RBV0
SOF+RBV0

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Change in Insulin Resistance

Change in insulin resistance while on treatment by the homeostasis model assessment - insulin resistance (HOMA-IR). HOMA-IR is calculated according to the formula (fasting insulin (microU/L)+fasting glucose (nmol/L)/22.5. Fasting insulin and glucose measurements are obtained using whole blood. (NCT02541409)
Timeframe: Difference from entry to 24 weeks for SOF+PEG+RBV and difference from entry to 36 weeks for SOF+RBV

InterventionHOMA-IR (Median)
SOF+PEG+RBV1.2
SOF+RBV0.2

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HCV Treatment Completion

The percentage of subjects that complete their course of treatment (NCT02541409)
Timeframe: 12 weeks from baseline for SOF+PEG+RBV and 24 weeks from baselne for SOF+RBV

InterventionParticipants (Count of Participants)
SOF+PEG+RBV22
SOF+RBV22

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Percentage of Participants With Undetectable HCV RNA

Undetectable HCV RNA=a single last HCV RNA <20 IU/mL (NCT02556307)
Timeframe: Weeks 4, 12 and at end of treatment (up to 99.6 weeks)

Interventionpercentage of participants (Number)
Week 4Week 12End of treatment
Peginterferon Alfa-2a + Ribavirin642179

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Thrombocyte Values

(NCT02556307)
Timeframe: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Interventionbillion cells per liter (Mean)
Baseline (n=265)Week 4 (n=260)Week 12 (n=217)End of treatment (n=224)6 months post treatment (n=198)
Peginterferon Alfa-2a + Ribavirin206143125140207

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Leukocyte Values

(NCT02556307)
Timeframe: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Interventionbillion cells per liter (Mean)
Baseline (n=265)Week 4 (n=260)Week 12 (n=217)End of treatment (n=224)6 months post treatment (n=198)
Peginterferon Alfa-2a + Ribavirin7.03.83.43.67.1

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HCV RNA Values

(NCT02556307)
Timeframe: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

InterventionIU/mL (Mean)
Baseline (n=267)Week 4 (n=262)Week 12 (n=219)End of treatment (n=224)6 months post treatment (n=195)
Peginterferon Alfa-2a + Ribavirin328192244174213423943693414

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Hemoglobin Values

(NCT02556307)
Timeframe: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Interventiongram per liter (Mean)
Baseline (n=265)Week 4 (n=260)Week 12 (n=260)End of treatment (n=224)6 months post treatment (n=198)
Peginterferon Alfa-2a + Ribavirin147129129122143

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Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin

(NCT02556307)
Timeframe: Up to 99.6 Weeks

Interventionweeks (Mean)
Peginterferon alfa-2aRibavirin
Peginterferon Alfa-2a + Ribavirin31.031.3

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Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and >20 mg/kg/day) is presented. (NCT02557646)
Timeframe: Up to 24 weeks after EOT (maximum up to 96 weeks)

Interventionpercentage of participants (Number)
Ribavirin dose <5mg/kg/day: None (n=2)Ribavirin dose <5mg/kg/day: Relapse (n=2)Ribavirin dose <5mg/kg/day: Breakthrough (n=2)Ribavirin dose = 5-10 mg/kg/day: None (n=28)Ribavirin dose = 5-10 mg/kg/day: Relapse (n=28)Ribavirin dose = 5-10mg/kg/day: Breakthrough(n=28)Ribavirin dose = 10-15 mg/kg/day: None (n=249)Ribavirin dose = 10-15 mg/kg/day: Relapse (n=249)Ribavirin dose =10-15mg/kg/day:Breakthrough(n=249)Ribavirin dose = 15-20 mg/kg/day: None (n=151)Ribavirin dose = 15-20 mg/kg/day: Relapse (n=151)Ribavirin dose=15-20mg/kg/day: Breakthrough(n=151)Ribavirin dose >20 mg/kg/day: None (n=12)Ribavirin dose >20 mg/kg/day: Relapse (n=12)Ribavirin dose >20 mg/kg/day: Breakthrough (n=12)
Peginterferon Alfa-2a + Ribavirin0.00100.000.0060.7135.713.5760.6430.528.8476.8220.532.6583.3316.670.00

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Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day [mg/kg/day]) dose group is presented. (NCT02557646)
Timeframe: Up to EOT (maximum up to 72 weeks)

Interventionpercentage of participants (Number)
Ribavirin dose <5mg/kg/day (n=5)Ribavirin dose = 5-10 mg/kg/day (n=33)Ribavirin dose = 10-15 mg/kg/day (n=383)Ribavirin dose = 15-20 mg/kg/day (n=251)Ribavirin dose >20mg/kg/day (n=19)
Peginterferon Alfa-2a + Ribavirin40.0090.9168.9364.9468.42

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Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (<60%, 60-69%, 70-79%, 80-89%, and >90%) is reported. (NCT02557646)
Timeframe: Up to 24 weeks after EOT (maximum up to 96 weeks)

Interventionpercentage of participants (Number)
Cumulative dose <60%: None (n=33)Cumulative dose <60%: Relapse (n=33)Cumulative dose <60%: Breakthrough (n=33)Cumulative dose = 60-69%: None (n=21)Cumulative dose = 60-69%: Relapse (n=21)Cumulative dose = 60-69%: Breakthrough (n=21)Cumulative dose = 70-79%: None (n=32)Cumulative dose = 70-79%: Relapse (n=32)Cumulative dose = 70-79%: Breakthrough (n=32)Cumulative dose = 80-89%: None (n=50)Cumulative dose = 80-89%: Relapse (n=50)Cumulative dose = 80-89%: Breakthrough (n=50)Cumulative dose >90%: None (n=257)Cumulative dose >90%: Relapse (n=257)Cumulative dose >90%: Breakthrough (n=257)
Peginterferon Alfa-2a + Ribavirin57.5839.393.0366.6733.330.0053.1340.636.2552.0038.0010.0070.9823.925.10

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Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented. (NCT02557646)
Timeframe: Up to EOT (maximum up to 72 weeks)

Interventionpercentage of participants (Number)
Starting dose of ribavirin = 200mg (n=1)Starting dose of ribavirin = 400mg (n=2)Starting dose of ribavirin = 600mg (n=3)Starting dose of ribavirin = 800mg (n=35)Starting dose of ribavirin = 1000mg (n=277)Starting dose of ribavirin = 1200mg (n=332)Starting dose of ribavirin = 1400mg (n=40)
Peginterferon Alfa-2a + Ribavirin0.0050.0066.6777.1467.1568.6767.50

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Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented. (NCT02557646)
Timeframe: Up to EOT (maximum up to 72 weeks)

Interventionpercentage of participants (Number)
CC Allele (n = 26)CT Allele (n = 52)TT Allele (n = 19)
Peginterferon Alfa-2a + Ribavirin84.6265.3873.68

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Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented. (NCT02557646)
Timeframe: Up to EOT (maximum up to 72 weeks)

Interventionpercentage of participants (Number)
None (n=443)Within 12 weeks (n = 140)After 12 weeks (n = 78)Not Specified (n =32)
Peginterferon Alfa-2a + Ribavirin67.4965.7179.4962.50

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Percentage of Participants With Virologic Response

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. (NCT02557646)
Timeframe: Week 4, 12, 24 and at EOT (maximum up to 72 weeks)

Interventionpercentage of participants (Number)
Week 4Week 12Week 24EOT
Peginterferon Alfa-2a + Ribavirin18.732.714.81.8

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Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented. (NCT02557646)
Timeframe: Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)

Interventionpercentage of participants (Number)
Starting dose = 600mg: None (n=2)Starting dose = 600mg: Relapse (n=2)Starting dose = 600mg: Breakthrough (n=2)Starting dose = 800mg: None (n=25)Starting dose = 800mg: Relapse (n=25)Starting dose = 800mg: Breakthrough (n=25)Starting dose = 1000mg: None (n=171)Starting dose = 1000mg: Relapse (n=171)Starting dose = 1000mg: Breakthrough (n=171)Starting dose = 1200mg: None (n=217)Starting dose = 1200mg: Relapse (n=217)Starting dose = 1200mg: Breakthrough (n=217)Starting dose = 1400mg: None (n=26)Starting dose = 1400mg: Relapse (n=26)Starting dose = 1400mg: Breakthrough (n=26)
Peginterferon Alfa-2a + Ribavirin100.000.000.0080.008.0012.0066.0829.824.0966.3627.196.4557.6930.7711.54

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Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented. (NCT02557646)
Timeframe: Up to 24 weeks after EOT (maximum up to 96 weeks)

Interventionpercentage of participants (Number)
No Dose Reduction: None (n=278)No Dose Reduction: Relapse (n=278)No Dose Reduction: Breakthrough (n=278)Within 12 weeks: None (n=87)Within 12 weeks: Relapse (n=87)Within 12 weeks: Breakthrough (n=87)After 12 weeks: None (n=57)After 12 weeks: Relapse (n=57)After 12 weeks: Breakthrough (n=57)Not specified: None (n=19)Not specified: Relapse (n=19)Not specified: Breakthrough (n=19)
Peginterferon Alfa-2a + Ribavirin70.0023.576.4357.4735.636.9063.1633.333.5168.4226.325.26

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Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin

Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. (NCT02557646)
Timeframe: 24 weeks after EOT (maximum up to 96 Weeks)

Interventionpercentage of participants (Number)
Cumulative dose of ribavirin <60% (n=35)Cumulative dose of ribavirin = 60-69% (n=23)Cumulative dose of ribavirin = 70-79% (n=32)Cumulative dose of ribavirin = 80-89% (n=52)Cumulative dose of ribavirin >90% (n=264)
Peginterferon Alfa-2a + Ribavirin54.2960.8753.1350.0068.56

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Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented. (NCT02557646)
Timeframe: 24 weeks after EOT (maximum up to 96 weeks)

Interventionpercentage of participants (Number)
Ribavirin dose <5mg/kg/day (n=5)Ribavirin dose = 5-10 mg/kg/day (n=31)Ribavirin dose = 10-15 mg/kg/day (n=368)Ribavirin dose = 15-20 mg/kg/day (n=239)Ribavirin dose >20mg/kg/day (n=18)
Peginterferon Alfa-2a + Ribavirin0.0054.8441.0348.5455.56

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Percentage of Participants With SVR According to Dose Reduction of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented. (NCT02557646)
Timeframe: 24 weeks after EOT (maximum up to 96 weeks)

Interventionpercentage of participants (Number)
None (n=280)Within 12 weeks (n = 87)After 12 weeks (n = 57)Not Specified (n =19)
Peginterferon Alfa-2a + Ribavirin70.0057.4763.1668.42

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Percentage of Participants With SVR According to IL-28B Polymorphism

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented. (NCT02557646)
Timeframe: 24 weeks after EOT (maximum up to 96 Weeks)

Interventionpercentage of participants (Number)
CC Allele (n = 25)CT Allele (n = 51)TT Allele (n = 18)
Peginterferon Alfa-2a + Ribavirin64.0039.2233.33

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Percentage of Participants With Viral Relapse or Breakthrough

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported. (NCT02557646)
Timeframe: Up to 24 weeks after EOT (maximum up to 96 weeks)

Interventionpercentage of participants (Number)
NoneRelapseBreakthrough
Peginterferon Alfa-2a + Ribavirin66.527.36.0

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Percentage of Participants With SVR According to Starting Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented. (NCT02557646)
Timeframe: 24 weeks after EOT (maximum up to 96 weeks)

Interventionpercentage of participants (Number)
Starting dose of ribavirin = 200mg (n=1)Starting dose of ribavirin = 400mg (n=1)Starting dose of ribavirin = 600mg (n=3)Starting dose of ribavirin = 800mg (n=33)Starting dose of ribavirin = 1000mg (n=262)Starting dose of ribavirin = 1200mg (n=321)Starting dose of ribavirin = 1400mg (n=39)
Peginterferon Alfa-2a + Ribavirin0.000.0066.6760.6143.1344.8638.46

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Percentage of Participants With Virologic Response at End of Treatment (EoT)

Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02581163)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 492.9

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Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria

The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 45.8

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Percentage of Participants Meeting Relapse Criteria

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 41.9

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

"SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Core population (CP)CPSFU12
Participants With HCV Genotype 1 or 487.793.8

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Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria

Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 41.6

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Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02581163)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 40.3

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Percentage of Participants With Relapse

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02581163)
Timeframe: Up to 48 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 42.3

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 41.6

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Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria

Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 42.1

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Percentage of Participants Meeting Relapse Criteria

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 42.1

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Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria

The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 46.6

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Percentage of Participants With Relapse

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02581189)
Timeframe: Up to 48 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 42.6

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Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02581189)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 40.9

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Percentage of Participants With Virologic Response at End of Treatment (EoT)

Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02581189)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 493.8

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

"SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Core population (CP)CPSFU12
Participants With HCV Genotype 1 or 486.694.1

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 41.3

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

"SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02582671)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Core population (CP)CPSFU12
Participants With HCV Genotype 197.098.0

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Percentage of Participants With Virologic Response at End of Treatment (EOT)

Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02582671)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
Participants With HCV Genotype 197.0

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Percentage of Participants Meeting Relapse Criteria

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02582671)
Timeframe: Up to 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 10

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Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02582671)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 10

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Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria

The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. (NCT02582671)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 11.0

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Percentage of Participants With Relapse

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02582671)
Timeframe: From the end of treatment through the end of study (maximum of 48 weeks post-treatment)

Interventionpercentage of participants (Number)
Participants With HCV Genotype 10

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Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria

Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02582671)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 12.0

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02582671)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 10

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Percentage of Participants Discontinuing From Study Therapy Due to an AE

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02601573)
Timeframe: Up to 16 weeks

InterventionPercentage of Participants (Number)
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks0.0
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks0.0
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks0.0
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks0.0
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks5.6

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Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy)

The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid [RNA] < Lower Limit of Quantification [LLOQ] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. (NCT02601573)
Timeframe: Up to Week 28

InterventionPercentage of Participants (Number)
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks91.3
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks100.0
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks100.0
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks100.0
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks94.4

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Percentage of Participants Experiencing an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02601573)
Timeframe: Up to 18 weeks (up to 2 weeks after completion of study treatment)

InterventionPercentage of Participants (Number)
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks87.0
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks87.5
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks82.4
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks94.4
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks94.4

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Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)

The percentage of participants achieving SVR24 (i.e., HCV RNA < LLOQ 24 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. (NCT02601573)
Timeframe: Up to Week 40

InterventionPercentage of Participants (Number)
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks91.3
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks100.0
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks100.0
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks100.0
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks93.8

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Number of Participants With Rapid Virological Response (RVR)

To evaluate the Rapid Virological Response (RVR) of all patients treated with PegInterferon Alfa-2a plus Ribavirin at 4 weeks of treatment (NCT02601976)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
PegInterferon Alfa-2a and Ribavirin48

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Number of Participants With Sustained Virological Response (SVR)

To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR (NCT02601976)
Timeframe: Post treatment Week 24

InterventionParticipants (Count of Participants)
PegInterferon Alfa-2a and Ribavirin49

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Mean of Physical Component Score & Mental Component Score to Determine Quality of Life

To determine and compare the changes in quality of life (QOL) from baseline to end of the treatment. Health-Related Quality of Life (HRQOL) Questionnaire (SF-36) was used to measure the quality of life. The SF-36 is a widely used questionnaire, and consists of 36 questions measuring eight concepts: Physical Function (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Function (SF), Role Emotional (RE), and Mental Health (MH). The scoring of the SF-36 questionnaire in our study was conducted upon a 0-100 scale, with higher scores reflecting better health status. (NCT02601976)
Timeframe: Upto 48 weeks

Interventionscore on a scale (Mean)
Physical Component ScoreMental Component Score
PegInterferon Alfa-2a and Ribavirin50.6254.89

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Number of Participants With End Treatment Response

To determine the End Treatment Response (ETR) rate of all patients treated with PegInterferon alfa-2a plus Ribavirin (NCT02601976)
Timeframe: Upto 48 weeks

InterventionParticipants (Count of Participants)
PegInterferon Alfa-2a and Ribavirin56

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Number of Participants Who Reported Adverse Events

To determine the number of patients treated with PegInterferon Alfa-2a plus Ribavirin who experience any adverse drug reaction. All ADR are reported as per patient information leaflet (NCT02601976)
Timeframe: Upto 48 weeks

InterventionParticipants (Count of Participants)
PegInterferon Alfa-2a and Ribavirin10

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Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)

SVR24 was defined as HCV RNA below the LLOQ of the assay (either TD or TND) at 24 weeks after treatment discontinuation. The sample from a visit greater than 20 weeks after treatment discontinuation which was closest to the targeted week (24 weeks post treatment), not followed by any HCV RNA result ≥LLOQ, was used. If there was no HCV RNA sample within this window, then the participant was considered not to have achieved SVR24. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). Wilson (score) method was used for confidence intervals. (NCT02605304)
Timeframe: At 24 weeks after treatment discontinuation (i.e., at 36 weeks after study entry in Arm A and at 48 weeks after study entry in Arm B).

Interventionpercentage of participants (Number)
Arm A: LDV/SOF + RBV100.0
Arm B: LDV/SOF100.0

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Percentage of Participants With Protocol-specified Renal Events

The study protocol defined renal events as (1) ≥Grade 2 creatinine clearance (CRCL) after study entry, or (2) new urinalysis proteinuria and/or glucosuria, defined as ≥1+ or an increase ≥1+ from baseline. The percentage of participants who experienced any renal event, and the percentages of participants who experienced each component of the outcome are provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple events. Each participant is counted at most once within category, and in the overall summary line. (NCT02605304)
Timeframe: From study entry to study completion (Week 36 in Arm A, Week 48 in Arm B)

,
Interventionpercentage of participants (Number)
Overall (any renal event)CRCL ≥ Grade 2ProteinuriaGlucosuria
Arm A: LDV/SOF + RBV25.025.025.00
Arm B: LDV/SOF33.333.300

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Percentage of Participants With Grade 3 or Higher Adverse Event (AE), Serious AE (SAE), or AE Reported as the Reason for Permanent Discontinuation of Study Treatment

Percentage of participants who experienced an AE (diagnosis, sign/symptom or laboratory abnormality) of ≥Grade 3, SAE according to International Conference on Harmonisation (ICH) criteria, or AE reported as the reason for permanent study treatment discontinuation, during study treatment and up to 30 days after study treatment. Events that were ongoing at the same grade from prior to study treatment initiation were excluded. AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (V2.0) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. The percentage of participants who experienced any event (overall), and the percentage of participants who experienced each component of the outcome are provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple events. Each participant is counted at most once within category, and in the overall summary line. (NCT02605304)
Timeframe: From study treatment initiation to 30 days after study treatment discontinuation. Duration of treatment was 12 weeks in Arm A and 24 weeks in Arm B.

,
Interventionpercentage of participants (Number)
Overall (any event)Diagnosis ≥ Grade 3Laboratory event ≥ Grade 3Sign/symptom ≥ Grade 3SAEAE that led to treatment discontinuation
Arm A: LDV/SOF + RBV50.0050.0000
Arm B: LDV/SOF000000

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Number of Participants With Unquantifiable HCV RNA

Unquantifiable HCV was defined as HCV RNA below the LLOQ of the assay (15 IU/mL), either TD or TND. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). (NCT02605304)
Timeframe: Entry (Week 0); at 1, 4, 8, 12 (and 16, 20, 24 in Arm B) weeks after study entry

InterventionParticipants (Count of Participants)
Week 0: unquantifiable HCV RNAWeek 1: unquantifiable HCV RNAWeek 4: unquantifiable HCV RNAWeek 8: unquantifiable HCV RNAWeek 12: unquantifiable HCV RNAWeek 16: unquantifiable HCV RNAWeek 20: unquantifiable HCV RNAWeek 24: unquantifiable HCV RNA
Arm B: LDV/SOF00332333

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Number of Participants With Unquantifiable HCV RNA

Unquantifiable HCV was defined as HCV RNA below the LLOQ of the assay (15 IU/mL), either TD or TND. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). (NCT02605304)
Timeframe: Entry (Week 0); at 1, 4, 8, 12 (and 16, 20, 24 in Arm B) weeks after study entry

InterventionParticipants (Count of Participants)
Week 0: unquantifiable HCV RNAWeek 1: unquantifiable HCV RNAWeek 4: unquantifiable HCV RNAWeek 8: unquantifiable HCV RNAWeek 12: unquantifiable HCV RNA
Arm A: LDV/SOF + RBV01444

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Number of Participants With HIV-1 RNA >50 Copies/mL

HIV-1 RNA testing was performed at a central laboratory using Abbott RealTime HIV-1 assay (Abbott Laboratories, Lake Bluff, IL, USA). (NCT02605304)
Timeframe: Entry (Week 0); at 4, 12 (and 24 in Arm B) weeks after study entry, and at 4 weeks after treatment discontinuation

InterventionParticipants (Count of Participants)
Week 0: HIV-1 RNA >50 copies/mLWeek 4: HIV-1 RNA >50 copies/mLWeek 12: HIV-1 RNA >50 copies/mLWeek 24: HIV-1 RNA >50 copies/mLPost treatment Week 4: HIV-1 RNA >50 copies/mL
Arm B: LDV/SOF00000

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Number of Participants With HIV-1 RNA >50 Copies/mL

HIV-1 RNA testing was performed at a central laboratory using Abbott RealTime HIV-1 assay (Abbott Laboratories, Lake Bluff, IL, USA). (NCT02605304)
Timeframe: Entry (Week 0); at 4, 12 (and 24 in Arm B) weeks after study entry, and at 4 weeks after treatment discontinuation

InterventionParticipants (Count of Participants)
Week 0: HIV-1 RNA >50 copies/mLWeek 4: HIV-1 RNA >50 copies/mLWeek 12: HIV-1 RNA >50 copies/mLPost treatment Week 4: HIV-1 RNA >50 copies/mL
Arm A: LDV/SOF + RBV0000

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CD4+ T-cell (CD4) Count Change From Baseline

Change in CD4 count was calculated as value at the post entry visit minus the value at study entry. (NCT02605304)
Timeframe: Entry and at 12 (and 24 in Arm B) weeks after study entry

Interventioncells/mm^3 (Median)
Week 12: CD4 changeWeek 24: CD4 change
Arm B: LDV/SOF365138

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CD4+ T-cell (CD4) Count Change From Baseline

Change in CD4 count was calculated as value at the post entry visit minus the value at study entry. (NCT02605304)
Timeframe: Entry and at 12 (and 24 in Arm B) weeks after study entry

Interventioncells/mm^3 (Median)
Week 12: CD4 change
Arm A: LDV/SOF + RBV-102

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Percentage of Participants With Sustained Virologic Response at 4 Weeks After Treatment Discontinuation (SVR4)

SVR4 was defined as HCV RNA below the LLOQ of the assay (either TD or TND) at 4 weeks after treatment discontinuation. The sample within the visit window, closest to the targeted time was used. If there was no HCV RNA sample within visit window, then the participant was considered not to have achieved SVR4, unless there were preceding and subsequent HCV RNA measurements that were both NCT02605304)
Timeframe: At 4 weeks after treatment discontinuation (i.e., at 16 weeks after study entry in Arm A and at 28 weeks after study entry in Arm B).

Interventionpercentage of participants (Number)
Arm A: LDV/SOF + RBV100.0
Arm B: LDV/SOF100.0

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Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)

SVR12 was defined as HCV RNA below the LLOQ of the assay (either target detected [TD] or target not detected [TND]) at 12 weeks after treatment discontinuation. The sample within the visit window, closest to the targeted time was used. If there was no HCV RNA sample within visit window, then the participant was considered not to have achieved SVR12, unless there were preceding and subsequent HCV RNA measurements that were both NCT02605304)
Timeframe: At 12 weeks after treatment discontinuation (i.e., at 24 weeks after study entry in Arm A and at 36 weeks after study entry in Arm B).

Interventionpercentage of participants (Number)
Arm A: LDV/SOF + RBV100.0
Arm B: LDV/SOF100.0

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Percentage of Participants With Hemoglobin < 10 g/dL During Treatment

The percentage of participants with hemoglobin <10 g/dL during treatment is provided. (NCT02609659)
Timeframe: up to 12 weeks

Interventionpercentage of participants (Number)
3-DAA + RBV 600 mg0

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Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug, excluding reinfection, among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02609659)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
3-DAA + RBV 600 mg4.1

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Mean Change in Hemoglobin Values From Baseline to End of Treatment

The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided. (NCT02609659)
Timeframe: Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)

Interventiong/L (Mean)
Week 2Week 4Week 8Week 12Final Treatment Visit
3-DAA + RBV 600 mg-6.4-8.9-11.2-12.4-12.1

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02609659)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
3-DAA + RBV 600 mg89.5

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment. (NCT02609659)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
3-DAA + RBV 600 mg1.0

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Number of Participants Who Experienced a Non-Overdose Event of Clinical Interest

The number of participants experiencing a non-overdose event of clinical interest (ECI) was determined. Non-overdose ECIs, assessed from initiation of study therapy through 14 days following study treatment cessation, included the following: 1) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >500 IU/L; or 2) AST or ALT >3x nadir value and >3X upper limit normal (ULN). (NCT02613403)
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)

InterventionParticipants (Count of Participants)
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV0
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B1
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV0
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B0

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Number of Participants Who Experienced a Serious Adverse Event

The number of participants experiencing a serious adverse event (SAE) was assessed. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention. (NCT02613403)
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)

InterventionParticipants (Count of Participants)
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV3
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B4
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV0
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B1

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Number of Participants Who Experienced an Adverse Event

The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE. (NCT02613403)
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)

InterventionParticipants (Count of Participants)
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV31
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B27
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV9
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B12

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Number of Participants Who Discontinued Study Drug Due to an Adverse Event

The number of participants discontinuing study drug due to an AE was assessed. (NCT02613403)
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)

InterventionParticipants (Count of Participants)
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV0
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B0
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV0
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B0

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)

The percentage of participants achieving SVR12 was determined, defined as having a plasma HCV ribonucleic acid (RNA) level below the lower limit of quantification (LLOQ) 12 weeks after the end of study therapy. Plasma HCV RNA level was measured using the Roche COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay with a LLOQ of 15 IU/mL. (NCT02613403)
Timeframe: 12 weeks following final dose of study treatment ([MK-3682B + RBV Groups]: Study Week 28; [MK-3682B Groups]: Study Week 36)

InterventionPercentage (Number)
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV97.1
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B100.0
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV100.0
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B100.0

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Number of Participants Who Experienced AST/ALT >5x Upper Limit Normal (ULN)

The number of participants experiencing AST / ALT >5 times ULN from study week 4 until 2 weeks following completion of study therapy was determined. (NCT02613403)
Timeframe: From Study Week 4 up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)

InterventionParticipants (Count of Participants)
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV0
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B0
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV0
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B0

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Hemoglobin Levels

Change in hemoglobin levels over the course of the study (NCT02631772)
Timeframe: Week 4, Week 8, Week 12, Week 16

,
Interventiong/dL (Mean)
Hemoglobin levels at Week 4Hemoglobin levels at Week 8Hemoglobin levels at Week 12Hemoglobin levels at Week 16
Late Cohort, Arm 113.113.313.713.6
Late Cohort, Arm 212.911.212.013.1

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Treatment Efficacy

Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen (NCT02631772)
Timeframe: 12 Weeks

Intervention% of participants (Number)
Late Cohort, Arm 188
Late Cohort, Arm 275

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Number of Participants With Virologic Failure

Number of participants who had a nonresponse to treatment or a relapse of disease under study. (NCT02631772)
Timeframe: 12 weeks

,
InterventionParticipants (Count of Participants)
NonresponseRelapse
Late Cohort, Arm 101
Late Cohort, Arm 212

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Number of Participants With Adverse Events and Serious Adverse Events (Part 2)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT02641379)
Timeframe: Up to Week 96

,,,,,
InterventionNumber of participants (Number)
Number of participants with any AENumber of participants with any SAE
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)71
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)405
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)192
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)361
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)437
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)253

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Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)

Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented. (NCT02641379)
Timeframe: Baseline (Day 1)

,,,,
InterventionNumber of participants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)11630
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)1757581014
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)820231511
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)1138641811
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)1540681316

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Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)

Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented. (NCT02641379)
Timeframe: Baseline (Day 1)

,,,,
InterventionNumber of participants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)481010
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)12651
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)56455
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)39815
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)43424

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Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)

The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented. (NCT02641379)
Timeframe: Up to Week 96

,,
InterventionPercentage of participants (Number)
Genotype I, n = 33, 23, 39Genotype IV, n = 3, 2, 6
PEG-IFN Alfa 2a + Ribavirin 48 Weeks (Group A1) (Part 2)30.333.3
PEG-IFN Alfa 2a + Ribavirin 72 Weeks (Group B1) (Part 2)34.80.0
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)64.150.0

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Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)

Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented. (NCT02641379)
Timeframe: Up to Week 96

,
InterventionPercentage of participants (Number)
Genotype I, Week 4 response < 600 U/ml,n= 130, 136Genotype I,Week 4 response >=600 U/ml, n =130, 136Genotype IV, Week 4 response < 600 U/ml, n =12, 16Genotype IV, Week 4 response >=600 U/ml, n =12, 16
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)22.052.70.080.0
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)8.330.042.980.0

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Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)

The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D. (NCT02641379)
Timeframe: Up to Week 96

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)45.1
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)48.0
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)6.4
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)73.7

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Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)

The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D. (NCT02641379)
Timeframe: Up to Week 96

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)0.0
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)73.8

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Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)

Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1. (NCT02641379)
Timeframe: Up to Week 96

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)41.2
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)38.5

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Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)

ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result < 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D. (NCT02641379)
Timeframe: Up to Week 72

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)47.2
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)52.0
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)5.0
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)90.5

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Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)

The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B). (NCT02641379)
Timeframe: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96

,
Interventionscores on a scale (Mean)
Baseline, n = 104, 114Week 24, n = 69, 77Week 48, n = 59, 63Week 72, n = 58, 62Week 96, n = 0, 57
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)3.64.54.73.0NA
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)3.44.74.74.33.4

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Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)

The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). (NCT02641379)
Timeframe: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96

,,
Interventionscores on a scale (Mean)
Baseline, n = 22, 17, 15Week 24, n = 17, 15, 9Week 48, n = 11, 7, 0Week 72, n = 8, 7, 1Week 96, n = 0, 7, 0
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)3.94.8NA5.3NA
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)3.74.24.03.9NA
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)3.84.94.53.84.5

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Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)

The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening. (NCT02641379)
Timeframe: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96

,
Interventionscores on a scale (Mean)
Physical Functioning, Baseline, n = 106, 121Physical Functioning, Week 24, n = 77, 90Physical Functioning, Week 48, n = 67, 77Physical Functioning, Week 72, n = 65, 68Physical Functioning, Week 96, n = 0, 59Role Functioning - Physical, Baseline,n = 105, 120Role Functioning - Physical, Week 24, n = 77, 88Role Functioning - Physical, Week 48, n = 66, 76Role Functioning - Physical, Week 72, n = 65, 67Role Functioning - Physical, Week 96, n = 0, 58Bodily Pain, Baseline, n = 103, 120Bodily Pain, Week 24, n = 76, 91Bodily Pain, Week 48, n = 67, 77Bodily Pain, Week 72, n = 64, 70Bodily Pain, Week 96, n = 0, 61General Health, Baseline, n = 102, 119General Health, Week 24, n = 75, 83General Health, Week 48, n = 63, 74General Health, Week 72, n = 65, 62General Health, Week 96, n = 0, 59Vitality, Baseline, n = 103, 116Vitality, Week 24, n = 75, 88Vitality, Week 48, n = 66, 77Vitality, Week 72, n = 63, 67Vitality, Week 96, n = 0, 59Social Functioning, Baseline, n = 105, 121Social Functioning, Week 24, n = 77, 91Social Functioning, Week 48, n = 67, 78Social Functioning, Week 72, n = 65, 70Social Functioning, Week 96, n = 0, 61Role Functioning - Emotional,Baseline,n = 104, 120Role Functioning - Emotional, Week 24, n = 76, 88Role Functioning - Emotional, Week 48, n = 66, 74Role Functioning - Emotional, Week 72, n = 65, 66Role Functioning - Emotional, Week 96, n = 0, 58Mental Health, Baseline, n = 103, 115Mental Health, Week 24, n = 76, 88Mental Health, Week 48, n = 66, 77Mental Health, Week 72, n = 63, 67Mental Health, Week 96, n = 0, 59Reported Health Transition, Baseline, n = 105, 123Reported Health Transition, Week 24, n = 77, 90Reported Health Transition, Week 48, n = 67, 77Reported Health Transition, Week 72, n = 65, 69Reported Health Transition, Week 96, n = 0, 61
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)86.961.866.189.8NA74.739.040.781.5NA82.368.269.585.4NA64.558.958.171.7NA56.840.340.666.9NA79.864.471.686.3NA71.536.841.780.5NA69.660.762.676.3NA3.13.53.21.6NA
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)87.069.266.870.387.076.245.742.247.484.583.570.066.867.390.266.355.156.360.170.358.940.641.243.562.981.664.157.263.883.475.843.942.843.484.571.957.959.660.872.33.03.23.02.31.3

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Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)

End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D. (NCT02641379)
Timeframe: Up to Week 72

InterventionPercentage of participants (Number)
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)74.6
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)64.5
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)9.0
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)92.3

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Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)

The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening. (NCT02641379)
Timeframe: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96

,,
Interventionscores on a scale (Mean)
Physical functioning, Baseline, n = 22, 18, 15Physical functioning, Week 24, n = 17, 13, 9Physical functioning, Week 48, n = 13, 8, 0Physical functioning, Week 72, n = 10, 7, 1Physical functioning, Week 96, n = 0, 6, 0Role Functioning- Physical, Baseline,n =22, 18, 15Role Functioning - Physical, Week 24, n= 17, 13, 8Role Functioning - Physical, Week 48, n = 13, 8, 0Role Functioning - Physical,, Week 72, n= 10, 7,1Role Functioning - Physical, Week 96, n = 0, 5, 0Bodily Pain, Baseline, n = 21, 19, 15Bodily Pain, Week 24, n = 17, 13, 8Bodily Pain, Week 48, n = 13, 8, 0Bodily Pain, Week 72, n = 10, 7, 1Bodily Pain, Week 96, n = 0, 6, 0General Health, Baseline, n = 22, 16, 14General Health, Week 24, n = 17, 11, 8General Health, Week 48, n = 12, 8, 0General Health, Week 72, n = 10, 7, 1General Health, Week 96, n = 0, 6, 0Vitality, Baseline, n = 21, 18, 15Vitality, Week 24, n = 17, 11, 8Vitality, Week 48, n = 13, 8, 0Vitality, Week 72, n = 9, 7, 1Vitality, Week 96, n = 0, 6, 0Social Functioning, Baseline, n = 22, 19, 15Social Functioning, Week 24, n = 17, 13, 8Social Functioning, Week 48, n = 13, 8, 0Social Functioning, Week 72, n = 10, 7, 1Social Functioning, Week 96, n = 0, 6, 0Role Functioning -Emotional,Baseline,n =22, 18, 15Role Functioning-Emotional, Week 24, n=17, 13, 8Role Functioning - Emotional, Week 48, n= 13, 8, 0Role Functioning - Emotional, Week 72, n= 10, 7, 1Role Functioning - Emotional, Week 96, n = 0, 5, 0Mental Health, Baseline, n = 21, 18, 15Mental Health, Week 24, n = 17, 11, 8Mental Health, Week 48, n = 13, 8, 0Mental Health, Week 72, n = 9, 7, 1Mental Health, Week 96, n = 0, 6, 0Reported Health Transition,Baseline, n =22, 19, 15Reported Health Transition, Week 24, 17, 13, 9Reported Health Transition, Week 48, n = 13, 8, 0Reported Health Transition, Week 72, n = 10, 7, 1Reported Health Transition, Week 96, n = 0, 6, 0
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)78.572.2NA45.0NA53.343.8NA0.0NA66.554.9NA62.0NA53.457.1NA35.0NA45.043.1NA40.0NA72.565.6NA25.0NA53.345.8NA0.0NA62.162.0NA36.0NA3.33.2NA4.0NA
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)82.561.866.577.0NA75.041.241.060.0NA75.357.966.471.1NA61.852.854.455.0NA54.037.843.247.2NA84.764.762.577.5NA71.243.143.656.7NA71.658.857.466.7NA3.03.82.92.8NA
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)83.151.276.380.785.862.015.456.382.170.076.345.954.670.474.556.737.156.359.952.852.531.248.160.256.978.956.778.178.683.362.020.554.281.060.062.946.261.066.958.32.93.52.92.62.0

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Number of Participants With Adverse Events and Serious Adverse Events (Part 1)

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. (NCT02641379)
Timeframe: Up to Week 96

,,,,
InterventionNumber of participants (Number)
Number of participants with any AENumber of participants with any SAE
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)102
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)15314
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)768
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)14022
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)14928

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Time to Maximum Concentration (Tmax) of Ribavirin

Tmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42. (NCT02716779)
Timeframe: From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.

Interventionweeks (Median)
Pegylated Interferon (PEG-IFN) Alfa-2a6.0
Placebo8.0
Ribavirin6.4

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Maximum Concentration (Cmax) of PEG-IFN

Cmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42. (NCT02716779)
Timeframe: From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126

Interventionng/ml (Median)
Pegylated Interferon (PEG-IFN) Alfa-2a28.77
Placebo20.36
Ribavirin19.8

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Time to Maximum Concentration (Tmax) of GPT

Tmax was obtained directly from the concentration-time data. (NCT02716779)
Timeframe: From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.

Interventiondays (Median)
Pegylated Interferon (PEG-IFN) Alfa-2a2.8
Placebo14.0
Ribavirin3.0

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Time to Maximum Concentration (Tmax) of PEG-IFN

Tmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42. (NCT02716779)
Timeframe: From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126

Interventionweeks (Median)
Pegylated Interferon (PEG-IFN) Alfa-2a6.3
Placebo12.0
Ribavirin6.0

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Maximum Concentration (Cmax) of Ribavirin

Cmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42. (NCT02716779)
Timeframe: From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.

Interventionmcg/ml (Median)
Pegylated Interferon (PEG-IFN) Alfa-2a2.95
Placebo2.83
Ribavirin3.37

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Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT)

(NCT02716779)
Timeframe: From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.

Intervention(Units/liter)*day ([U/L]*d) (Median)
Pegylated Interferon (PEG-IFN) Alfa-2a5078.3
Placebo7233.5
Ribavirin5231.3

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Area Under the Concentration-Time Curve (AUC) of Ribavirin

Evaluation of ribavirin arm after Day 0. Evaluation of placebo and PEG-IFN arms after Day 42. (NCT02716779)
Timeframe: From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.

Intervention(microgram/milliliter)*day ([mcg/ml]*d) (Median)
Pegylated Interferon (PEG-IFN) Alfa-2a186.6
Placebo179.4
Ribavirin290.1

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Maximum Concentration (Cmax) of GPT

Cmax was obtained directly from the concentration-time data. (NCT02716779)
Timeframe: From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.

InterventionU/L (Median)
Pegylated Interferon (PEG-IFN) Alfa-2a68.5
Placebo88.0
Ribavirin75.0

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Area Under the Concentration-Time Curve (AUC) of PEG-IFN

Evaluation of PEG-IFN arm after Day 0. Evaluation of ribavirin and placebo arms after Day 42. (NCT02716779)
Timeframe: From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126

Intervention(nanogram/milliliter)*day ([ng/ml]*d) (Median)
Pegylated Interferon (PEG-IFN) Alfa-2a2097.9
Placebo1270.4
Ribavirin1164.9

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Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action

To investigate possible action mechanisms, three different models were fitted to viruskinetic data and evaluated using related log-likelihood function values. These models were designed assuming individual effects with respect to infectiousness (model 1), virus production (model 2) or degradation of infected cells rate (model 3). The following viruskinetic parameters were fitted in each model: initial viral load, loss rate of infected cells (delta), effectivity of interferon with respect to a pharmacokinetic-pharmacodynamic model. A lower log likelihood function value indicates a lesser fit for the model. (NCT02716779)
Timeframe: Up to Day 126

,,
Interventionlog likelihood function value (Median)
Model 1= infectiousnessModel 2= virus productionModel 3= degradation rate
Pegylated Interferon (PEG-IFN) Alfa-2a-27.0-28.2-27.1
Ribavirin-21.4-23.8-20.7
Total Participant Group-22.2-23.9-23.1

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Percentage of Participants With Treatment Response

HCV-RNA level was measured at each visit by a central laboratory. Treatment response was estimated applying the following definitions of response/non-response: 1) Adequate first phase decline: HCV RNA decline ≥ 0.5 log10 International Units/milliliter (IU/mL) from time 0 to 48 hours of PEG-IFN treatment (PEG-IFN arm: day 0 - day 2; placebo and ribavirin arm: day 42-day 44), 2) Rapid virologic response: HCV RNA < 15 IU/mL (=detection limit) on day 70, 3) Complete early virologic response: HCV RNA < 15 IU/mL on day 126, 4) Partial early virologic response (log decrease): HCV RNA decrease ≥ 2 log10 IU/mL from day 0 to day 126, 5) Partial early virologic response (cut off): HCV RNA <30000 IU/mL on day 126, 6) Non-response: HCV RNA decrease <2 log10 IU/mL from day 0 to day 126, 7) Null-response: HCV RNA decrease <1 log10 IU/mL from day 0 to day 28 and from day 0 to day 70 for PEG-IFN arm and placebo / ribavirin arm, respectively. (NCT02716779)
Timeframe: Up to Day 126

,,
Interventionpercentage of participants (Number)
Adequate first phase declineRapid virologic responseComplete early virologic responsePartial early virologic response (log decrease)Partial early virologic response (cut off)Non-responseNull responder
Pegylated Interferon (PEG-IFN) Alfa-2a79436479792136
Placebo65304878782226
Ribavirin72207284841612

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Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire

"SF-36 is a psychometric scale to quantify health conditions. This psychometric scale has 8 dimensions of the subjective health status and consists of 36 individual items that have a varying number of related item scores (ranging from yes/no up to a 6-point scale). At first the raw scores were determined by summation over all items and weighted accordingly. Afterwards the raw scores were transformed to ranges of 0-100 with 100 being the highest level of health and compared to published reference scales. The following eight dimensions of subjective health conditions were considered: physical functioning index, role physical index, pain, general health perception, vitality, social functioning index, role emotional index and mental health index. The SF36 questionnaire had to be answered by the patients at screening before monotherapy, after monotherapy and at the end of the study (=end of combination therapy)." (NCT02716779)
Timeframe: At screening (Days -56 to -1), at end of monotherapy (Week 6) and at end of combination therapy (Week 18)

,,
Interventionunits on a scale (Mean)
Physical functioning index: ScreeningPhysical functioning index: End of monotherapyPhysical functioning index: End of comb. therapyRole physical index: ScreeningRole physical index: End of monotherapyRole physical index: End of combination therapyPain: ScreeningPain: End of monotherapyPain: End of combination therapyGeneral health perception: ScreeningGeneral health perception: End of monotherapyGeneral health perception: End of comb. therapyVitality: ScreeningVitality: End of monotherapyVitality: End of combination therapySocial functioning index: ScreeningSocial functioning index: End of monotherapySocial functioning index: End of comb. therapyRole emotional index: ScreeningRole emotional index: End of monotherapyRole emotional index: End of combination therapyMental health index: ScreeningMental health index: End of monotherapyMental health index: End of combination therapy
Pegylated Interferon (PEG-IFN) Alfa-2a95.690.867.175.066.725.089.373.272.358.658.260.054.245.040.875.072.968.855.655.633.368.561.372.2
Placebo76.572.373.055.656.840.070.361.556.053.659.255.252.844.132.579.268.261.366.769.750.063.162.861.6
Ribavirin79.768.453.462.550.529.770.066.060.162.954.347.150.941.839.883.880.156.362.553.335.464.561.547.7

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Non-inferiority of Arm A to Arm B

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02723084)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A97.8
Arm B93.5

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Percentage of Participants With Post-Treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. 95% CI was calculated using the Wilson score method. (NCT02723084)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
Arm A0
Arm B4.4

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Percentage of Participants With With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method. (NCT02723084)
Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for arm A), and 12 (end of treatment for arm B) or premature discontinuation from treatment

Interventionpercentage of participants (Number)
Arm A0
Arm B0

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Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02723084)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A97.8

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

"SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Core population (CP)CPSFU12
Participants With HCV Genotype 1 or 491.195.6

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Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria

The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response was documented. (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 43.8

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as breakthrough (at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 40.5

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Percentage of Participants Meeting Relapse Criteria

Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 40.9

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Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria

Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 42.3

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Percentage of Participants With Relapse

Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02725866)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 40.9

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Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02725866)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 40.0

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Percentage of Participants With Virologic Response at End of Treatment (EoT)

Virologic response was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02725866)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 493.9

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Change From Baseline in SF-36 PCS at 24 Weeks After EOT

SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). (NCT02726022)
Timeframe: Baseline, 24 weeks after EOT (up to 72 weeks)

Interventionunits on a scale (Mean)
Gender: MaleGender: FemaleDrug Addiction: YesDrug Addiction: No
Chronic Hepatitis C Participants0.115.86.78.4

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Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT

SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). (NCT02726022)
Timeframe: Baseline, EOT (up to 48 weeks)

Interventionunits on a scale (Mean)
Gender: MaleGender: FemaleDrug Addiction: YesDrug Addiction: No
Chronic Hepatitis C Participants-0.70.17-0.4-0.1

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Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). (NCT02726022)
Timeframe: Baseline, EOT (up to 48 weeks)

Interventionunits on a scale (Mean)
Gender: MaleGender: FemaleDrug Addiction: YesDrug Addiction: No
Chronic Hepatitis C Participants-5.10-3.47-9.4-2.1

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Change From Baseline in SF-36 MCS at 24 Weeks After EOT

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). (NCT02726022)
Timeframe: Baseline, 24 weeks after EOT (up to 72 weeks)

Interventionunits on a scale (Mean)
Gender: MaleGender: FemaleDrug Addiction: YesDrug Addiction: No
Chronic Hepatitis C Participants-3.26.54.40.9

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Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no). (NCT02726022)
Timeframe: Baseline, 24 weeks after EOT (up to 72 weeks)

Interventionunits on a scale (Mean)
Gender: MaleGender: FemaleDrug Addiction: YesDrug Addiction: No
Chronic Hepatitis C Participants0.315.48.47.6

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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no). (NCT02726022)
Timeframe: Baseline, EOT (up to 48 weeks)

Interventionunits on a scale (Mean)
Gender: MaleGender: FemaleDrug Addiction: YesDrug Addiction: No
Chronic Hepatitis C Participants-3.2-3.0-7.4-1.2

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Number of Participants With ALT Normalization at 48 Weeks After End of Treatment

Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported. (NCT02731131)
Timeframe: Week 96

Interventionparticipants (Number)
Group A: Monotherapy With Peginterferon Alfa-2a3
Group B: Combination With Peginterferon Alfa-2a + Ribavirin1

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Number of Participants With Negative HDV RNA at End of Treatment

Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported. (NCT02731131)
Timeframe: Week 48

Interventionparticipants (Number)
Group A: Monotherapy With Peginterferon Alfa-2a1
Group B: Combination With Peginterferon Alfa-2a + Ribavirin2

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Number of Participants With ALT Normalization at End of Treatment

Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported. (NCT02731131)
Timeframe: Week 48

Interventionparticipants (Number)
Group A: Monotherapy With Peginterferon Alfa-2a1
Group B: Combination With Peginterferon Alfa-2a + Ribavirin0

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Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment

Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported. (NCT02731131)
Timeframe: Week 96

Interventionparticipants (Number)
Group A: Monotherapy With Peginterferon Alfa-2a0
Group B: Combination With Peginterferon Alfa-2a + Ribavirin1

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Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment

Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported. (NCT02731131)
Timeframe: Week 96

Interventionparticipants (Number)
Group A: Monotherapy With Peginterferon Alfa-2a0
Group B: Combination With Peginterferon Alfa-2a + Ribavirin1

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Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment

Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported. (NCT02731131)
Timeframe: Week 48

Interventionparticipants (Number)
Group A: Monotherapy With Peginterferon Alfa-2a0
Group B: Combination With Peginterferon Alfa-2a + Ribavirin0

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Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96

Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). (NCT02761629)
Timeframe: "For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Baseline, Weeks 4, 12, 24, 48, and 72; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96"

,
InterventionCells per cubic millimeter (cells/mm^3) (Mean)
Baseline (n=78, 81)Change at Week 4 (n=69, 74)Change at Week 12 (n=68, 75)Change at Week 24 (n=69, 68)Change at Week 48 (n=61, 67)Change at Week 72 (n=58, 55)Change at Week 96 (n=0, 62)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks578.7-148.2-185.4-206.7-209.49.5NA
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks546.2-88.0-164.5-178.4-196.4-167.5-15.1

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Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96

Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). (NCT02761629)
Timeframe: "For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Baseline, Weeks 4, 12, 24, 48, and 72; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96"

,
InterventionRatio (Mean)
Baseline (n=78, 81)Change at Week 4 (n=69, 74)Change at Week 12 (n=68, 75)Change at Week 24 (n=69, 68)Change at Week 48 (n=61, 67)Change at Week 72 (n=58, 55)Change at Week 96 (n=0, 62)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks0.670.110.220.360.430.12NA
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks0.680.090.200.290.300.360.09

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Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment

"SVR was defined as having undetectable HCV RNA levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Percentage of participants without SVR among participants with undetectable HCV RNA at the end of treatment was reported (end of treatment = Week 48 for Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm and Week 72 for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm)." (NCT02761629)
Timeframe: "24 weeks after completion of study treatment (up to Week 72 for Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm and up to Week 96 for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm)"

Interventionpercentage of participants (Number)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks52.6
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks24.3

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Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A

HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Participants with detectable HCV RNA or without measurement at the end of 12 weeks after the last dose of Peg-IFN-Alpha-2A were considered as non-responders. (NCT02761629)
Timeframe: "12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm and up to Week 84 for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm)"

Interventionpercentage of participants (Number)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks23.8
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks36.5

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Percentage of Participants With Sustained Virologic Response (SVR)

SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter [IU/mL]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders. (NCT02761629)
Timeframe: "24 weeks after completion of study treatment (up to Week 72 for Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm and up to Week 96 for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm)"

Interventionpercentage of participants (Number)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks23.8
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks36.5

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Serum Human Immunodeficiency Virus (HIV) RNA Levels

HIV RNA levels were measured using Roche AMPLICOR MONITOR HIV-1 Test (limit of detection: 400 HIV-1 RNA copies/mL). Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). (NCT02761629)
Timeframe: "For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Weeks 4, 12, 24, 48, and 72; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Weeks 4, 12, 24, 48, 72, and 96"

,
InterventionLog10 copies per milliliter (Mean)
Baseline (n=12, 23)Week 4 (n=6, 16)Week 24 (n=9, 20)Week 48 (n=11, 17)Week 72 (n=10, 9)Week 96 (n=0, 13)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks4.233.943.964.024.08NA
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks4.643.984.214.414.514.22

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Percentage of Participants With Undetectable HCV RNA

HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). (NCT02761629)
Timeframe: "For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Weeks 4, 12, 24, and 48; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Weeks 4, 12, 24, 48, and 72"

,
Interventionpercentage of participants (Number)
Week 4 (n=73, 83)Week 12 (n=73, 81)Week 24 (n=73, 78)Week 48 (n=68, 71)Week 72 (n=0, 65)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks2.723.352.155.9NA
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks12.028.453.864.856.9

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Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories

ALT levels were classified as: Normal Limit (NL) (as per laboratory standard), >1-2 Upper Normal Limit (ULN), >2-5 ULN, >5-10 ULN, and >10 ULN. Percentage of participants in each of these ALT level categories was reported. Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm). (NCT02761629)
Timeframe: "For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Weeks 4, 12, 24, 48, and 72; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Weeks 4, 12, 24, 48, 72, and 96"

,
Interventionpercentage of participants (Number)
Week 4, NL (n=70, 78)Week 4, >1-2 ULN (n=70, 78)Week 4, >2-5 ULN (n=70, 78)Week 4, >5-10 ULN (n=70, 78)Week 4, >10 ULN (n=70, 78)Week 12, NL (n=76, 77)Week 12, >1-2 ULN (n=76, 77)Week 12, >2-5 ULN (n=76, 77)Week 12, >5-10 ULN (n=76, 77)Week 12, >10 ULN (n=76, 77)Week 24, NL (n=74, 74)Week 24, >1-2 ULN (n=74, 74)Week 24, >2-5 ULN (n=74, 74)Week 24, >5-10 ULN (n=74, 74)Week 24, >10 ULN (n=74, 74)Week 48, NL (n=65, 71)Week 48, >1-2 ULN (n=65, 71)Week 48, >2-5 ULN (n=65, 71)Week 48, >5-10 ULN (n=65, 71)Week 48, >10 ULN (n=65, 71)Week 72, NL (n=59, 61)Week 72, >1-2 ULN (n=59, 61)Week 72, >2-5 ULN (n=59, 61)Week 72, >5-10 ULN (n=59, 61)Week 72, >10 ULN (n=59, 61)Week 96, NL (n=0, 62)Week 96, >1-2 ULN (n=0, 62)Week 96, >2-5 ULN (n=0, 62)Week 96, >5-10 ULN (n=0, 62)Week 96, >10 ULN (n=0, 62)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks50.040.010.00.00.061.827.610.50.00.070.327.02.70.00.067.724.67.70.00.052.527.120.30.00.0NANANANANA
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks52.638.59.00.00.062.329.95.21.31.363.528.46.80.01.469.026.82.81.40.068.927.93.30.00.050.035.512.91.60.0

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Kidney Function at 6 Months

Serum creatinine mg/dL at 6 months following transplantation (NCT02781649)
Timeframe: 6 months following transplantation

Interventionmg/dL (Median)
Donor Genotype 1a no Resistance or 1b1.12
Donor Genotype 2 or 30.9

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Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors

"Number of participants with NS5A resistance mutations in the HCV population from the deceased donors.~Number of donors with NS5A resistance mutations" (NCT02781649)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
Donor Genotype 1a no Resistance or 1b0
Donor Genotype 1a With Resistance0
Donor Genotype 2 or 30

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Viral Response

This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 12 (NCT02781649)
Timeframe: 12 weeks after completing treatment

InterventionParticipants (Count of Participants)
Donor Genotype 1a no Resistance or 1b7
Donor Genotype 1a With Resistance0
Donor Genotype 2 or 33

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Antibody Development

Number of kidney transplant recipients who become reactive for HCV antibody (NCT02781649)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Donor Genotype 1a no Resistance or 1b3
Donor Genotype 1a With Resistance0
Donor Genotype 2 or 32

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Kidney Function at 12 Months

Serum creatinine mg/dL at 12 months following transplantation (NCT02781649)
Timeframe: 12 months following transplantation

Interventionmg/dL (Median)
Donor Genotype 1a no Resistance or 1b1.0
Donor Genotype 2 or 31.3

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Median Change in Headache-Phase 2

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of median change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: Baseline -on Treatment (12-16 weeks)

Interventionunits on a scale (Median)
EBR/GZR With RBV-1.0
EBR/GZR0.0
SOF/LDV With RBV0.5
SOF/LDV-0.5

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Mean Change in Fatigue PRO -EBR/GZR vs SOF/LDV

Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline and Average On-Treatment Score

Interventionscore on a scale (Mean)
EBR/GZR With RBV-1.0
EBR/GZR-2.1
SOF/LDV With RBV-3.7
SOF/LDV-2.2

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16 Wk EBR/GZR With RBV Efficacy on Patients With HCV RASs

"Efficacy of Hepatitis C Virus (HCV) Treatment with Zepatier (Elbasvir/Grazobevir) with Ribavirin (RBV) for 16 weeks when used in Genotype 1a patients with Baseline RASs (NS5a Resistance Associated Substitutions or RAPs -Resistance Associated Polymorphisms).~Efficacy defined as HCV RNA undetectable 12 weeks post treatment. Table excludes Genotype 1b patients." (NCT02786537)
Timeframe: 12 weeks post treatment

InterventionParticipants (Count of Participants)
EBR/GZR With RBV-16 Weeks34

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HCV SVR Durability -No Cirrhosis

Number/Percentage of patients with persistence of viral cure, SVR (SVR = Sustained Virologic Response)- defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. (NCT02786537)
Timeframe: 24 weeks post-end of treatment up to 153 weeks

InterventionParticipants (Count of Participants)
EBR/GZR255
EBR/GZR With Ribavirin17
SOF/LDV146
SOF/LDV With RBV2
PrOD14
PrOD With RBV36

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HCV SVR Durability-Patients With Cirrhosis

Percentage of Cirrhotic patients with persistence of viral cure, SVR, (SVR= Sustained Virologic Response) defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. (NCT02786537)
Timeframe: Up to 132 weeks post HCV treatment

InterventionParticipants (Count of Participants)
EBR/GZR43
EBR/GZR With RBV7
SOF/LDV35
SOF/LDV With RBV7
PrOD6
PrOD With RBV7

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Mean Change in Fatigue PRO Score -Phase 1

Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline to On-treatment

Interventionunits on a scale (Mean)
EBR/GZR With RBV1.5
EBR/GZR-1.2
SOF/LDV With RBV-7.2
SOF/LDV-2.0
PrOD With RBV-1.9
PrOD-3.0

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Mean Change in HCV- PRO- Phase 1

"HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'overall functioning and well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Baseline to End of Treatment

Interventionunits on a scale (Mean)
EBR/GZR With RBV-0.9
EBR/GZR5.6
SOF/LDV With RBV2.5
SOF/LDV6.9
PrOD With RBV3.2
PrOD9.9

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Mean Change in HCV-PRO (Functional Well-being) EBR/GZR vs. SOF/LDV Score-Phase 2

"HCV-PRO, a survey designed to assess functional status of patients with HCV and measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered. End of Treatment -Baseline were used to calculate CHANGE in outcome. Number of subjects reflects participants from both Phase 1 and 2." (NCT02786537)
Timeframe: End of Treatment - Baseline

Interventionscore on a scale (Mean)
EBR/GZR With RBV3.2
EBR/GZR6.1
SOF/LDV With RBV6.3
SOF/LDV6.8

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Mean Change in Headache-EBR/GZR and SOF/LDV

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: Baseline to On-Treatment

Interventionunits on a scale (Mean)
EBR/GZR With RBV-0.8
EBR/GZR-0.7
SOF/LDV With RBV0.4
SOF/LDV-0.8

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Mean Change in Headache-PRO Scores -Phase 1

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement in symptom. (NCT02786537)
Timeframe: Baseline to On-Treatment

Interventionunits on a scale (Mean)
EBR/GZR With Ribavirin (RBV)0.0
EBR/GZR Regimen-0.8
SOF/LDV With RBV-0.7
SOF/LDV-0.5
PrOD With RBV Regimen-0.2
PrOD-2.2

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Mean Change in Nausea/Vomiting PRO Score -Phase 1

"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.~The estimates of mean change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes. The model expressed mean score as a function of DAA regimen, cirrhosis status, HCV genotype, sex, age, race, and previous treatment status." (NCT02786537)
Timeframe: Baseline to On-Treatment

Interventionunits on a scale (Mean)
EBR/GZR With RBV1.3
EBR/GZR-1.4
SOF/LDV With RBV-3.9
SOF/LDV-0.7
PrOD With RBV2.5
PrOD0.7

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Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF

"Participants completed the Patient Reported Outcomes surveys (PROs) 'PROMIS Nausea/Vomiting -4 Short Form' at baseline and during treatment. Raw scores are converted to standardized T-scores with a range of 45.0-80.1. Higher scores indicate worse nausea/vomiting.~Results presented as mean difference from baseline to average of on Treatment Scores (highest/worst) score during treatment.~A negative (-) PROMIS change score is suggestive of symptom improvement or lack of drug side effect. Estimates of mean change were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline and Average On-Treatment Score

Interventionunits on a scale (Mean)
EBR/GZR With RBV-0.3
EBR/GZR-0.6
SOF/LDV With RBV-1.6
SOF/LDV-0.4

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Median Change in Fatigue -Phase 1

Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline to End of Treatment

Interventionunits on a scale (Median)
EBR/GZR With RBV2.2
EBR/GZR Regimen-0.9
SOF/LDV With RBV-10.2
SOF/LDV-3.4
PrOD Regimen With RBV-0.2
PrOD-4.1

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Median Change in Fatigue-Phase 2

Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline-On Treatment (up to 16 weeks)

Interventionunits on a scale (Median)
EBR/GZR With RBV-1.3
EBR/GZR-1.2
SOF/LDV With RBV-2.4
SOF/LDV-1.4

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Median Change in HCV-PRO (Overall Well Being) -Phase 1

"HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'Overall Functioning and Well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Baseline to End of Treatment

Interventionscore on a scale (Median)
EBR/GZR With RBV0.0
EBR/GZR4.3
SOF/LDV With RBV4.7
SOF/LDV4.7
PrOD With RBV3.1
PrOD8.6

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Median Change in Headache -Phase 1

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: 12 weeks (Baseline and Average On-treatment Score)

Interventionunits on a scale (Median)
EBR/GZR (Elbasvir/Grazoprevir) With RBV0.0
EBR/GZR (Elbasvir/Grazoprevir)0.0
SOF/LDV (Sofosbuvir/Ledipasvir) With RBV-2.0
SOF/LDV (Sofosbuvir/Ledipasvir)-1.0
PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) With RBV (Phase 1 Only)0.0
PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir)-1.0

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Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)

"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~Number of subjects reflects participants randomized during Phase 1 only." (NCT02786537)
Timeframe: 12 -24 weeks post-treatment

InterventionParticipants (Count of Participants)
EBR/GZR With RBV9
EBR/GZR108
SOF/LDV With RBV6
SOF/LDV88
PrOD With RBV77
PrOD (Phase 1 Only)42

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Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation

"SVR (Sustained Virologic Response) 12 will be defined as patients who have undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~mITT with imputation (missing=failure). Total number of subjects reflects participants from Phase 1 only." (NCT02786537)
Timeframe: 12 weeks post-treatment

InterventionParticipants (Count of Participants)
EBR/GZR With RBV9
EBR/GZR108
SOF/LDV With RBV6
SOF/LDV88
PrOD With RBV77
PrOD42

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Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV

"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation at discretion of provider).~mITT with imputation (missing=failure). Total number of subjects reflects participants from EBR/GZR with or without RBV and SOF/LDV with or without RBV randomized during Phase 1 and Phase 2." (NCT02786537)
Timeframe: 12 weeks post-treatment

InterventionParticipants (Count of Participants)
EBR/GZR With RBV40
EBR/GZR516
SOF/LDV With RBV14
SOF/LDV335

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Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)

"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~Number of subjects reflects participants who started EBR/GZR or SOF/LDV- based treatment (with or without RBV) during Phase 1 and 2." (NCT02786537)
Timeframe: 12-24 weeks post HCV treatment

InterventionParticipants (Count of Participants)
EBR/GZR With RBV40
EBR/GZR516
SOF/LDV With RBV14
SOF/LDV335

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Post-treatment Progression/Regression of Liver Disease-Fib-4

Mean change (delta) in FIB-4, an indirect non-invasive measure of liver fibrosis, calculated as baseline median -long term follow up median, following SVR after any of the study treatment regimens. Change in FIB-4 where negative values indicate improvement in liver fibrosis score and positive values indicate worsening of fibrosis score. There is no upper or lower limit for change. FIB-4 = age (years) * AST(IU/L)/Platelets (10^3/L) * ALT^.5(IU/L). In general, Score of 0-1.29 is low risk for advanced fibrosis, 1.30-1.67: intermediate risk for advanced liver fibrosis, >2.67: high risk for advanced fibrosis. (NCT02786537)
Timeframe: Baseline to up to 3 years post treatment discontinuation

Interventionscore on a scale (Median)
EBR/GZR, SOF/LDV or PrOD Based HCV Treatment-1.36

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Treatment Non-Adherence Probability Estimates

"The Voils Medication Adherence Survey (VMAS) was used to evaluate medication adherence during HCV treatment. Participants responded to three questions about the extent of adherence during the past seven days of treatment (during early and late on-treatment occasions). Participants responded using a five-point ordinal scale of missed dosing from 1 (none of the time) to 5 (all of the time). On each occasion participants were coded as being Non-adherent if any response was > 1, otherwise they were coded as Adherent. Probability estimates of percentage of patients reporting non-adherence were calculated per HCV treatment (Direct Acting Antiviral-DAA) regimen: 1)EBR/GZV (elbasvir/grazoprevir, 2)SOF/LDV (sofosbuvir/ledipasvir), 3)PrOD" (NCT02786537)
Timeframe: 12-16 weeks of HCV treatment

Interventionpercentage of patients (Number)
EBR/GZR23
SOF/LDV19
PrOD26

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Change in Functional Status (HCV-PRO) Within Treatment

"HCV-PRO score, a validated PROMIS survey used to evaluate overall functioning and well-being in HCV patients, was utilized to compare long-term 'within treatment' changes of functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive estimate (Post treatment to baseline) suggests baseline functional well-being improvement.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Treatment start date up to 2 years post-treatment

,
Interventionscore on a scale (Mean)
9 months post treatment20 months post treatment
EBR/GZR Regimen8.029.87
SOF/LDV Regimen9.9011.54

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Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation

Change in HCV-associated symptoms was calculated as the mean differences of mean scores from multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)-- Fatigue, nausea, belly pain, sleep disturbance, and diarrhea) and functional status (well-being) when comparing baseline to early post-treatment and late post treatment surveys. Mean change scores were calculated by comparing baseline to early post-treatment (1 yr) and late post-treatment (approximately 3 years) surveys. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.Negative numbers suggest better symptoms (improvement in HCV-associated symptoms). PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.HCV-PRO positive estimates suggest baseline functional well-being improvement. (NCT02786537)
Timeframe: 1 year post treatment discontinuation (Early post-tx)

,
Interventionunits on a scale (Mean)
NauseaBelly PainDiarrheaFatigueSleep DisturbanceCognitive ImpairmentHCV-PRO
EBR/GZR Regimen0.00-0.82-1.12-2.080.65-0.548.02
SOF/LDV Regimen-4.99-6.47-5.77-7.59-1.72-4.489.90

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Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2

Number of participants who achieved SVR (sustained virologic response), defined as undetectable HCV RNA 12 weeks post-treatment with RASs (Resistant Associated Substitutions) after treatment with EBR/GZR or SOF/LDV regimen (NCT02786537)
Timeframe: 12 weeks post HCV treatment

,
InterventionParticipants (Count of Participants)
With NS5a RASWithout NS5a RAS
EBR/GZR Regimen47485
SOF/LDV Regimen42286

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Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF

The number of participants with adverse events that led to early treatment discontinuation (defined as duration less than originally prescribed treatment regimen) (NCT02786537)
Timeframe: Treatment start date through treatment completion (up to 24 weeks)

InterventionParticipants (Count of Participants)
EBR/GZR Regimen12
SOF/LDV Regimen4

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Median Change in Nausea PROMIS Score-EBR/GZR SOF/LDV

"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for change represent improvement.~The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline- On Treatment (up to 16 weeks)

Interventionscore on a scale (Median)
EBR/GZR With RBV0.0
EBR/GZR0.0
SOF/LDV With RBV0.0
SOF/LDV0.0

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Median Change in Nausea PRO Score -Phase 1

"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.~The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline to end of treatment

Interventionunits on a scale (Median)
EBR/GZR With RBV0.4
EBR/GZR0.0
SOF/LDV With RBV-6.1
SOF/LDV0.0
PrOD With RBV0.0
PrOD0.0

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Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 41.3

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Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02803138)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 40.0

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Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment

"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02803138)
Timeframe: 12 weeks (at least 70 days) after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 495.8

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Percentage of Participants With Virologic Response at End of Treatment (EoT)

Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02803138)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 482.0

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Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria

The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 425.9

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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 470.6

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Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria

Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 41.8

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Percentage of Participants Meeting Relapse Criteria

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 40

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Percentage of Participants With Relapse

Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02803138)
Timeframe: Up to 48 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Participants With HCV Genotype 1 or 40.0

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Percentage of Participants With HCV RNA < LLOQ at Week 10

(NCT02822794)
Timeframe: Week 10

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks100.0
SOF/VEL+RBV 24 Weeks100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 12

(NCT02822794)
Timeframe: Week 12

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks100.0
SOF/VEL+RBV 24 Weeks100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 24

(NCT02822794)
Timeframe: Week 24

Interventionpercentage of participants (Number)
SOF/VEL+RBV 24 Weeks100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 3

(NCT02822794)
Timeframe: Week 3

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks91.1
SOF/VEL+RBV 24 Weeks90.0

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Change From Baseline in HCV RNA at Week 3

(NCT02822794)
Timeframe: Baseline; Week 3

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 12 Weeks-5.07
SOF/VEL+RBV 24 Weeks-5.02

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Change From Baseline in HCV RNA at Week 24

(NCT02822794)
Timeframe: Baseline; Week 24

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 24 Weeks-5.06

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Change From Baseline in HCV RNA at Week 20

(NCT02822794)
Timeframe: Baseline; Week 20

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 24 Weeks-5.06

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Change From Baseline in HCV RNA at Week 2

(NCT02822794)
Timeframe: Baseline; Week 2

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 12 Weeks-4.91
SOF/VEL+RBV 24 Weeks-4.89

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Percentage of Participants With HCV RNA < LLOQ at Week 4

(NCT02822794)
Timeframe: Week 4

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks98.2
SOF/VEL+RBV 24 Weeks98.3

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Percentage of Participants With HCV RNA < LLOQ at Week 5

(NCT02822794)
Timeframe: Week 5

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks98.2
SOF/VEL+RBV 24 Weeks98.3

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Percentage of Participants With HCV RNA < LLOQ at Week 6

(NCT02822794)
Timeframe: Week 6

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks100.0
SOF/VEL+RBV 24 Weeks98.3

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Change From Baseline in HCV RNA at Week 16

(NCT02822794)
Timeframe: Baseline; Week 16

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 24 Weeks-5.06

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Change From Baseline in HCV RNA at Week 12

(NCT02822794)
Timeframe: Baseline; Week 12

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 12 Weeks-5.13
SOF/VEL+RBV 24 Weeks-5.06

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Percentage of Participants With HCV RNA < LLOQ at Week 8

(NCT02822794)
Timeframe: Week 8

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks100.0
SOF/VEL+RBV 24 Weeks100.0

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Change From Baseline in HCV RNA at Week 4

(NCT02822794)
Timeframe: Baseline; Week 4

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 12 Weeks-5.12
SOF/VEL+RBV 24 Weeks-5.04

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Percentage of Participants With HCV RNA < LLOQ at Week 16

(NCT02822794)
Timeframe: Week 16

Interventionpercentage of participants (Number)
SOF/VEL+RBV 24 Weeks100.0

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Change From Baseline in HCV RNA at Week 5

(NCT02822794)
Timeframe: Baseline; Week 5

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 12 Weeks-5.13
SOF/VEL+RBV 24 Weeks-5.05

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Change From Baseline in HCV RNA at Week 10

(NCT02822794)
Timeframe: Baseline; Week 10

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 12 Weeks-5.13
SOF/VEL+RBV 24 Weeks-5.06

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02822794)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks (GT1)85.1
SOF/VEL+RBV 12 Weeks (GT2)70.0
SOF/VEL+RBV 24 Weeks (GT1)97.9
SOF/VEL+RBV 24 Weeks (GT2)91.7

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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02822794)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks82.5
SOF/VEL+RBV 24 Weeks96.7

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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02822794)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks86.0
SOF/VEL+RBV 24 Weeks98.3

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Percentage of Participants With Overall Virologic Failure

"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02822794)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks15.8
SOF/VEL+RBV 24 Weeks3.3

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Percentage of Participants With HCV RNA < LLOQ at Week 2

(NCT02822794)
Timeframe: Week 2

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks64.3
SOF/VEL+RBV 24 Weeks70.0

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Percentage of Participants With HCV RNA < LLOQ at Week 20

(NCT02822794)
Timeframe: Week 20

Interventionpercentage of participants (Number)
SOF/VEL+RBV 24 Weeks100.0

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Change From Baseline in HCV RNA at Week 1

(NCT02822794)
Timeframe: Baseline; Week 1

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 12 Weeks-4.40
SOF/VEL+RBV 24 Weeks-4.36

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Change From Baseline in HCV RNA at Week 6

(NCT02822794)
Timeframe: Baseline; Week 6

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 12 Weeks-5.13
SOF/VEL+RBV 24 Weeks-5.05

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Change From Baseline in HCV RNA at Week 8

(NCT02822794)
Timeframe: Baseline; Week 8

Interventionlog10 IU/mL (Mean)
SOF/VEL+RBV 12 Weeks-5.13
SOF/VEL+RBV 24 Weeks-5.06

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02822794)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks1.8
SOF/VEL+RBV 24 Weeks3.3

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Percentage of Participants With HCV RNA < LLOQ at Week 1

(NCT02822794)
Timeframe: Week 1

Interventionpercentage of participants (Number)
SOF/VEL+RBV 12 Weeks21.1
SOF/VEL+RBV 24 Weeks25.0

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Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed. (NCT02939989)
Timeframe: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).

Interventionpercentage of participants (Number)
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks0
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks3.6
Total3.0

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Percentage of Participants With On-treatment Virologic Failure

"On-treatment virologic failure was defined as meeting one of the following:~confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the treatment period; or~confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or~HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment." (NCT02939989)
Timeframe: 12 or 16 weeks depending on the treatment regimen

Interventionpercentage of participants (Number)
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks0
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks0
Total0

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug. (NCT02939989)
Timeframe: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.

Interventionpercentage of participants (Number)
Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks100
Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks96.4
Total97.0

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Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment

"Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.~To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below." (NCT02946034)
Timeframe: 52 Weeks 52 Weeks 52 weeks

Interventionpg/mL (Mean)
Viekira Pak ± Ribavirin or Mavyret-394.57

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Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment

"Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.~To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below." (NCT02946034)
Timeframe: 52 weeks

Interventionpg/mL (Mean)
Viekira Pak ± Ribavirin or Mavyret2.01

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Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment

"Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.~To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below." (NCT02946034)
Timeframe: 52 Weeks

Interventionng/g (Mean)
Viekira Pak ± Ribavirin or Mavyret-0.05

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Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment

"Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.~To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below." (NCT02946034)
Timeframe: 52 weeks

Interventionng/g (Mean)
Viekira Pak ± Ribavirin or Mavyret5.73

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Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment

"Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.~To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below." (NCT02946034)
Timeframe: 52 weeks

Interventionpg/mL (Mean)
Viekira Pak ± Ribavirin or Mavyret-3.94

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Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)

Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose. (NCT02946034)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Viekira Pak ± Ribavirin or Mavyret8

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Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment

"Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.~To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below." (NCT02946034)
Timeframe: 52 weeks

Interventionpg/mL (Mean)
Viekira Pak ± Ribavirin or Mavyret6.67

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Percentage of Participants With Virologic Failure

Virologic failure is the detection of HCV RNA among participants who do not discontinue study for non-treatment-related reasons, either due to on-treatment failure defined as either non-response where HCV RNA is detected at end of treatment without HCV RNA 1 log10 IU/mL increase in HCV RNA from nadir while on treatment and confirmed from a separate blood draw within 2 weeks; or virologic breakthrough which is confirmed HCV RNA ≥LLOQ (target detected, quantifiable [TD(q)]) after being NCT02956629)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
HCV GT13.8
HCV GT22.1
HCV GT323.0
HCV GT40
HCV GT50
HCV GT613.6

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Percentage of Participants Discontinuing Study Therapy Due to an AE

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02956629)
Timeframe: Up to Week 12

InterventionPercentage of participants (Number)
HCV GT11.3
HCV GT22.1
HCV GT31.6
HCV GT41.8
HCV GT50
HCV GT64.5

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Percentage of Participants With SVR 24 Weeks After Completing Study Therapy (SVR24)

Plasma levels of HCV RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR24 is the absence of detectable RNA of the hepatitis C virus (NCT02956629)
Timeframe: 24 weeks after completing study therapy (Week 36)

InterventionPercentage of participants (Number)
HCV GT189.7
HCV GT285.1
HCV GT372.1
HCV GT496.4
HCV GT5100.0
HCV GT681.8

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Completing Study Therapy (SVR12)

Plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR12 is the absence of detectable RNA of the hepatitis C virus, (NCT02956629)
Timeframe: 12 weeks after completing study therapy (Week 24)

InterventionPercentage of participants (Number)
HCV GT192.3
HCV GT291.5
HCV GT373.8
HCV GT498.2
HCV GT5100.0
HCV GT690.9

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Percentage of Participants Experiencing an AE of Clinical Importance (ECI)

Adverse events of clinical importance, excluding overdoses include, but is not limited to, significant changes in alanine aminotransferase, aspartate aminotransferase, blood creatinine, glomerular filtration rate or hepatitis B reactivation. (NCT02956629)
Timeframe: Up to Week 14

InterventionPercentage of participants (Number)
HCV GT11.3
HCV GT22.1
HCV GT31.6
HCV GT43.6
HCV GT50
HCV GT60

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Percentage of Participants Experiencing an Adverse Event (AE)

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02956629)
Timeframe: Up to Week 14

InterventionPercentage of participants (Number)
HCV GT160.3
HCV GT261.7
HCV GT357.4
HCV GT455.4
HCV GT577.8
HCV GT677.3

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Percentage of Participants Experiencing a Serious Adverse Event (SAE)

A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose. (NCT02956629)
Timeframe: Up to Week 14

InterventionPercentage of participants (Number)
HCV GT13.8
HCV GT22.1
HCV GT31.6
HCV GT43.6
HCV GT50
HCV GT60

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02996682)
Timeframe: Posttreatment Week 12

InterventionPercentage of participants (Number)
SOF/VEL92.2
SOF/VEL + RBV92.2

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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02996682)
Timeframe: Posttreatment Week 24

InterventionPercentage of participants (Number)
SOF/VEL92.2
SOF/VEL + RBV92.2

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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02996682)
Timeframe: Posttreatment Week 4

InterventionPercentage of participants (Number)
SOF/VEL94.1
SOF/VEL + RBV96.1

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)." (NCT02996682)
Timeframe: Up to Posttreatment Week 24

InterventionPercentage of participants (Number)
SOF/VEL7.8
SOF/VEL + RBV3.9

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Change From Baseline in HCV RNA

(NCT02996682)
Timeframe: Baseline and up to 12 weeks

,
Interventionlog10 IU/mL (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12
SOF/VEL-4.14-4.55-4.56-4.56
SOF/VEL + RBV-4.33-4.65-4.70-4.70

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Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event

(NCT02996682)
Timeframe: Up to 12 weeks

,
InterventionPercentage of participants (Number)
Discontinuation of SOF/VELDiscontinuation of RBV
SOF/VEL0NA
SOF/VEL + RBV3.917.6

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Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment

(NCT02996682)
Timeframe: Up to 12 weeks

,
InterventionPercentage of participants (Number)
Week 2Week 4Week 8Week 12
SOF/VEL45.196.1100.0100.0
SOF/VEL + RBV51.090.296.1100.0

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Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class

CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. CPT scores were calculated using prothrombin activation percentage for the coagulation parameter per Japan's standard. (NCT02996682)
Timeframe: Baseline to Posttreatment Week 24

,
InterventionPercentage of participants (Number)
Improved CPT ClassWorsened CPT Class
SOF/VEL36.24.3
SOF/VEL + RBV39.12.2

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Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score

"MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. No change was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; Decrease was assigned for differences that were less than or equal to -2; and Increase was assigned for values that were greater than or equal to 2." (NCT02996682)
Timeframe: Baseline to Posttreatment Week 24

,
InterventionPercentage of participants (Number)
Decrease (Improvement)No ChangeIncrease (Worsening)
SOF/VEL38.353.28.5
SOF/VEL + RBV21.754.323.9

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Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment

SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration (NCT03020004)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Danoprevir,Ritonavir, Peg-IFN,RBV66

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Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

(NCT03020082)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Danoprevir, Ritonavir, Peg-IFN,RBV136

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Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment

SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration. (NCT03020095)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Ravidasvir,Danoprevir/r,RBV38

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Difference in SVR12 Rates for 12-wk vs 16 wk

Difference in proportions of SVR 12 rates will be determined for 12-week vs. 16-week treatment durations using contrasts within a logistic regression model with cirrhosis status and HCV genotype (1b vs non-1b) as factors (NCT03092375)
Timeframe: 28 weeks

InterventionParticipants (Count of Participants)
Arm A: G/P 300 mg/120 mg QD for 12 Wks70
Arm B: G/P 300 mg/120 mg QD for 16 Wks46
Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks18
Arm D: G/P 300 mg/120 mg QD for 16 Wks28

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Comparison of Cirrhotic Participants Achieving SVR 12 After G/P Plus RBV for 12 Wks vs. G/P for 16 Wks

Number of cirrhotic participants who are treatment experienced with a NS5A inhibitor + SOF +/RBV with undetectable HCV RNA 12 weeks after completing G/P plus RBV for 12 wks vs. G/P for 16 Wks (NCT03092375)
Timeframe: Up to 28 weeks

,
InterventionParticipants (Count of Participants)
Virologic ResponseVirologic Failure
Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks183
Arm D: G/P 300 mg/120 mg QD for 16 Wks281

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Tolerability of G/P +/-RBV

Number of subjects who discontinued G/P due to adverse events (NCT03092375)
Timeframe: Up to 16 weeks

InterventionParticipants (Count of Participants)
Arm A: G/P 300 mg/120 mg QD for 12 Wks0
Arm B: G/P 300 mg/120 mg QD for 16 Wks0
Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks0
Arm D: G/P 300 mg/120 mg QD for 16 Wks0

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Difference in Relapse Between Arms A & B in Non-cirrhotic Subjects

Difference in Post-treatment relapse (defined as confirmed HCV RNA>= Lower limit of quantification (LLOQ) between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment as planned with HCV RNA < LLOQ at end of treatment, excluding subjects with subjects with reinfection) (NCT03092375)
Timeframe: Up to 28 weeks

InterventionParticipants (Count of Participants)
Arm A: G/P 300 mg/120 mg QD for 12 Wks5
Arm B: G/P 300 mg/120 mg QD for 16 Wks2

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Difference in On-Treatment Virologic Failure Between Arms C and D in Cirrhotic Subjects

Difference in percentage of cirrhotic subjects experiencing on-treatment virologic failure (confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment) after 12 weeks of G/P with or without RBV for 12 weeks versus 16 weeks of G/P (NCT03092375)
Timeframe: Up to 28 weeks

InterventionParticipants (Count of Participants)
Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks2
Arm D: G/P 300 mg/120 mg QD for 16 Wks0

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Difference in On-Treatment Virologic Failure Between Arms A & B (Non-cirrhotic Subjects)

Difference in % of subjects with on-treatment virologic failure further defined as either 1)Breakthrough a)Confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < Lower Limit of Quantification (LLOQ) at some point during the Treatment Period or confirmed increase from nadir in HCV RNA (two consecutive measurements > 1 log10 IU/mL above nadir) at any time point during the Treatment Period, or b) a single value indicating viral breakthrough (≥ 100 IU/mL or > 1 log10 above nadir), followed by patient status of 'Lost to Follow-up', the latter not requiring confirmation by a proximate measurement) or 2) End of Treatment Failure defined as HCV RNA ≥ LLOQ at end of treatment and following at least 6 weeks of treatment. (NCT03092375)
Timeframe: Up to 28 weeks

InterventionParticipants (Count of Participants)
Arms A G/P 300 mg/120 mg QD for 12 Weeks1
Arm B G/P 300/120mg Once Daily for 16 Weeks1

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Difference in % of Relapse Between Cirrhotic Arms C & D

Difference in the percentage of compensated cirrhotic subjects with post-treatment relapse (defined as confirmed HCV RNA>=Lower limit of quantification (LLOQ) between end of treatment and 12 weeks after last dose of study drug among subjects who completed treatment as planned with HCV RNANCT03092375)
Timeframe: Up to 28 weeks

InterventionParticipants (Count of Participants)
Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks1
Arm D: G/P 300 mg/120 mg QD for 16 Wks1

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Approval for DAA by Third Party Payers

The number of participants for whom their third party insurance approved payment of the DAA (study drug) (NCT03365635)
Timeframe: Within one month of last patient enrolled

InterventionParticipants (Count of Participants)
Genotype 1a -Rx Naive -no NS5A Polymorph0
Genotype 1b - Rx Naive0

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SVR - Sustained Virologic Response

Absence of HCV by viral RNA quantitation at 12 weeks post treatment (NCT03365635)
Timeframe: 12 weeks after completion of Elbasivir/Grazoprevir treatment

InterventionParticipants (Count of Participants)
Genotype 1a -Rx Naive -no NS5A Polymorph3
Genotype 1a, Rx Naive + NS5A Polymorph0
Genotype 1b - Rx Naive1
Genotype 1a/1b -Prior INF or NS3/4A0
Genotype4 - Treatment Naive0

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Brequinar Pharmacokinetics - Area Under the Curve (AUC)

The plot of drug concentration in blood plasma vs. time. (NCT03760666)
Timeframe: First day of dosing: baseline (pre-dose), 1 hour, 2 hours, 4 hours, 6 hours.

Interventionmicrograms.hr/mL (Mean)
Cohort 1501.0
Cohort 2546.5
Cohort 3130.5

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