Page last updated: 2024-12-07

sofosbuvir

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Description

Sofosbuvir is a nucleotide analog antiviral medication used to treat chronic hepatitis C virus (HCV) infection. It was discovered by Pharmasset, Inc. and is marketed by Gilead Sciences under the trade name Sovaldi. Sofosbuvir is a prodrug that is converted in the liver to an active metabolite, which inhibits the HCV NS5B RNA polymerase. This enzyme is essential for HCV replication, and inhibiting it prevents the virus from multiplying. Sofosbuvir is typically administered in combination with other antiviral medications, such as ribavirin and pegylated interferon, and is highly effective in treating HCV infection. It has revolutionized HCV treatment, significantly reducing the duration of treatment and improving cure rates. Sofosbuvir is studied extensively because of its high efficacy and safety profile. Research continues to explore its potential benefits for different patient populations and treatment regimens, including its use in combination with other antiviral agents and its potential for the treatment of other viral infections.'

Sofosbuvir: A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

sofosbuvir : A nucleotide conjugate that is used in combination with ledipasvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection. [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]

5-carboxycytosine: a 5-formylcystosine oxidation product; structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

5-carboxycytosine : A nucleobase analogue that is cytosine in which the hydrogen at position 5 is replaced by a carboxy group. [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]

Cross-References

ID SourceID
PubMed CID45375808
CHEMBL ID1259059
CHEBI ID85083
SCHEMBL ID2010114
MeSH IDM0551450
PubMed CID45375806
CHEMBL ID1258950
SCHEMBL ID2003999
MeSH IDM0551450
PubMed CID77213
CHEBI ID76793
SCHEMBL ID4359910
MeSH IDM0551450

Synonyms (141)

Synonym
HY-15005
gs7977
chebi:85083 ,
CHEMBL1259059
sofosbuvir
gs-7977
hepcvir
hepcinat
sovaldi
sovihep
l-alanine, n-((p(s),2'r)-2'-deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl)-, 1-methylethyl ester
unii-wj6ca3zu8b
resof
2-((5-(2,4-dioxo-3,4-dihydro-2h-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-ylmethoxy)phenoxyphosphorylamino)propionic acid isopropyl ester
gs 7977
psi 7977
sofosbuvir [usan:inn]
wj6ca3zu8b ,
hsdb 8226
sofosbuvir (jan/usan)
D10366
sovaldi (tn)
isopropyl ((s)-(((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-l-alaninate
AM84279
CS-0554
S2794
gi-7977
gtpl7368
propan-2-yl (2s)-2-[[[(2r,3r,4r,5r)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy-phenoxyphosphoryl]amino]propanoate
sofosbuvir component of epclusa
(s)-isopropyl 2-((s)-(((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)-(phenoxy)phosphorylamino)propanoate
sofosbuvir [vandf]
vosevi component sofosbuvir
sofosbuvir [inn]
sofosbuvir [orange book]
sofosbuvir component of harvoni
sofosbuvir [who-dd]
sofosbuvir [usan]
sofosbuvir [jan]
sofosbuvir component of vosevi
sofosbuvir [mi]
harvoni component sofosbuvir
epclusa component sofosbuvir
DB08934
s)-isopropyl 2-((s)-(((2r,3r,4r,5r)-5-(2,4-dioxo-3,4- dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)- (phenoxy)phosphorylamino)propanoate
SCHEMBL2010114
isopropyl (2s)-2-{[(s)-{[(2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate
gi 7977
psi7977
AKOS024464753
EX-A389
sofosbuvir (psi-7977, gs-7977)
SW219116-1
sofosbuvirpsi7977gs-7977
(s)-isopropyl 2-((s)-(((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphorylamino)propanoate
wg6 ,
sofosbuvir(psi-7977)
Q2502747
sofosbuvir (psi-7977; gs-7977)
(s)-isopropyl 2-(((s)-(((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-h
CCG-269909
sofosbuvir (gs-7977)
BS165550
DTXSID701027632
propan-2-yl (2s)-2-{[(s)-{[(2r,3r,4r,5r)-5-(2,4-dioxo-1,2,3,4-tetrahydropyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate
EN300-19897652
sofosbuvirum
isopropyl (2s)-2-(((s)-(((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)amino)propanoate
j05ap08
sovaldi access
1-methylethyl n-((s)-(((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)phenoxyphosphoryl)-l-alaninate
Z2235802138
propan-2-yl (2s)-2-{[(s)-{[(2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate (non-preferred name)
propan-2-yl (2s)-2-{[{[(2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate (non-preferred name)
isopropyl (2s)-2-[[[(2r,3r,4r,5r)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate
psi-7851
CHEMBL1258950
psi-7977
SCHEMBL2003999
mfcd18782704
isopropyl ((((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-l-alaninate
AC-27382
AKOS025401925
gs-9851
unii-3s5s1851ov
n-((2'r)-2'-deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl)-l-alanine 1-methylethyl ester
1064684-44-1
l-alanine, n-((2'r)-2'-deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl)-, 1-methylethyl ester
3s5s1851ov ,
psi 7851
EN300-187117
propan-2-yl (2s)-2-[({[(2r,3r,4r,5r)-5-(2,4-dioxo-1,2,3,4-tetrahydropyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy}(phenoxy)phosphoryl)amino]propanoate
1221574-17-9
1190308-01-0
(2s)-isopropyl 2-(((((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)amino)propanoate
AS-19600
(s)-isopropyl 2-(((s)-(((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)a
Q27257971
A898985
nsc-791959
nsc791959
CS-0164665
(2s)-isopropyl 2-(((((2r,3r,4r,5r)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)amino)propanoate? (sofosbuvir impurity pound(c)
BB 0248369
6-amino-2-oxo-1,2-dihydro-pyrimidine-5-car boxylic acid
760cu98b9k ,
unii-760cu98b9k
einecs 222-890-1
cytosine-5-carboxylic acid
nsc 9309
nsc-9309
3650-93-9
nsc9309
AKOS005143089
AKOS006345200
SCHEMBL4359910
6-amino-2-oxo-1h-pyrimidine-5-carboxylic acid
4-amino-2-hydroxypyrimidine-5-carboxylic acid
4-amino-2-hydroxy-5-pyrimidinecarboxylic acid
1rt ,
FT-0684109
5-carboxycytosine
5-carboxylcytosine
4-amino-2-oxopyrimidine-5-carboxylic acid
CHEBI:76793
4-amino-2-oxo-1,2-dihydropyrimidine-5-carboxylic acid
5-pyrimidinecarboxylic acid, 6-amino-1,2-dihydro-2-oxo-
5-pyrimidinecarboxylic acid, 4-amino-1,2-dihydro-2-oxo-
4-amino-2-oxo-1,2-dihydro-pyrimidine-5-carboxylic acid, aldrichcpr
DTXSID70190003
mfcd00047368
4-amino-2-hydroxypyrimidine-5-carboxylic acid hydrobromide
CS-0045904
STL513101
Q27146335
A874338
D94964
SB57388
STL582075
AS-76797
EN300-7691553

Research Excerpts

Toxicity

Sofosbuvir was safe and effective in the treatment of hepatitis C virus genotype 1, 2, 3, or 4 infections. Low-dose Sofos Buvir and full-dose Daclatasvir are safe andeffective in treating CHC in patients with CKD with eGFR less than 30 mL/min/1.

ExcerptReferenceRelevance
" However, this combination is often contraindicated and associated with severe adverse events that limit its use in clinical practice."( Efficacy and Safety of Sofosbuvir in the Treatment of Chronic Hepatitis C: The Dawn of a New Era.
Borgia, F; Borgia, G; Buonomo, AR; Castaldo, G; Gentile, I; Spera, AM; Zappulo, E, 2014
)
0.4
"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
" Data were extracted on virological responses including sustained virological response at post-treatment Week 12 (SVR12), relapse, treatment discontinuation due to an adverse event (AE), virological breakthrough during treatment, and AEs."( Efficacy and safety of sofosbuvir-based therapy for the treatment of chronic hepatitis C in treatment-naïve and treatment-experienced patients.
Chang, H; Han, Q; Li, N; Liu, X; Liu, Z; Lv, Y; Wang, Y; Zhang, G; Zhu, Q, 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
" 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
" 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
" Daclastavir is generally safe and well tolerated, with a low barrier to resistance and low potential for drug-drug interaction."( Review article: the efficacy and safety of daclatasvir in the treatment of chronic hepatitis C virus infection.
Bunchorntavakul, C; Reddy, KR, 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
" This drug reduces adverse events associated with IFN therapy."( Safety analysis of sofosbuvir and ledipasvir for treating hepatitis C.
Fazel, Y; Golabi, P; Lam, B; Younossi, Z, 2015
)
0.42
"In trials enrolling more than 3000 patients, LDV/SOF is well tolerated with a good safety and side-effect profile in diverse cohorts, including previous direct-acting antiviral (DAA) treatment failures, liver transplant recipients, decompensated cirrhosis and HIV/HCV co-infection."( Safety analysis of sofosbuvir and ledipasvir for treating hepatitis C.
Fazel, Y; Golabi, P; Lam, B; Younossi, Z, 2015
)
0.42
" During the eight clinical studies, adverse events were observed in 83."( Meta-analysis of the efficacy and safety of sofosbuvir for the treatment of hepatitis C virus infection.
Ryoo, JY; Yang, HJ; Yoo, BK, 2015
)
0.42
"Sofosbuvir was safe and effective in the treatment of hepatitis C virus genotype 1, 2, 3, or 4 infections."( Meta-analysis of the efficacy and safety of sofosbuvir for the treatment of hepatitis C virus infection.
Ryoo, JY; Yang, HJ; Yoo, BK, 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
" The aim of this study was to evaluate the rates of sustained virological response (SVR) and adverse events in a cohort of patients with nosocomially acquired HCV genotype-1b following 12 weeks of therapy with fixed-dose combination (FDC) ledipasvir/sofosbuvir (LDV/SOF)."( The safety and efficacy of ledipasvir/sofosbuvir for the treatment of a nosocomial outbreak of HCV in patients with significant cardiovascular disease.
Brainard, DM; Chung, RT; Doehle, B; Gustafson, J; Kim, AY; Lauer, GM; Liu, L; McHutchison, JG; Mo, H; Pang, PS; Simon, TG; Stamm, LM, 2016
)
0.43
" The most commonly reported adverse events were gastrointestinal illness and upper respiratory viral-type illness."( The safety and efficacy of ledipasvir/sofosbuvir for the treatment of a nosocomial outbreak of HCV in patients with significant cardiovascular disease.
Brainard, DM; Chung, RT; Doehle, B; Gustafson, J; Kim, AY; Lauer, GM; Liu, L; McHutchison, JG; Mo, H; Pang, PS; Simon, TG; Stamm, LM, 2016
)
0.43
"In this open-label, uncontrolled, pilot study enrolling patients with HCV genotype-1b and significant CVD, administration of a fixed-dose, oral combination of LDV and SOF for 12 weeks was associated with high rates of SVR and minimal adverse events."( The safety and efficacy of ledipasvir/sofosbuvir for the treatment of a nosocomial outbreak of HCV in patients with significant cardiovascular disease.
Brainard, DM; Chung, RT; Doehle, B; Gustafson, J; Kim, AY; Lauer, GM; Liu, L; McHutchison, JG; Mo, H; Pang, PS; Simon, TG; Stamm, LM, 2016
)
0.43
" In the phase 3 ION program, the single-tablet regimen of the NS5A inhibitor ledipasvir and NS5B nucleotide polymerase inhibitor sofosbuvir was shown to be safe and highly effective in the general population."( Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.
Afdhal, N; Gitlin, N; Howell, C; Jeffers, LJ; Kowdley, K; McHutchison, JG; Muir, AJ; Pang, PS; Poulos, J; Ravendhran, N; Reddy, KR; Shiffman, ML; Sulkowski, MS; Wilder, JM; Workowski, K; Yang, JC; Zhu, Y, 2016
)
0.43
" The addition of ribavirin did not appear to increase SVR12 but was associated with higher rates of adverse events."( Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.
Afdhal, N; Gitlin, N; Howell, C; Jeffers, LJ; Kowdley, K; McHutchison, JG; Muir, AJ; Pang, PS; Poulos, J; Ravendhran, N; Reddy, KR; Shiffman, ML; Sulkowski, MS; Wilder, JM; Workowski, K; Yang, JC; Zhu, Y, 2016
)
0.43
" The tolerance to anti-HCV therapy was excellent and no adverse event was observed."( Efficacy and Safety of Sofosbuvir-Based Antiviral Therapy to Treat Hepatitis C Virus Infection After Kidney Transplantation.
Alric, L; Barange, K; Cointault, O; Del Bello, A; Esposito, L; Izopet, J; Kamar, N; Lavayssière, L; Marion, O; Métivier, S; Ribes, D; Rostaing, L, 2016
)
0.43
" To better understand the mechanism for adverse events, clinically relevant HCV NI were characterized in biochemical and cellular assays, including assays of decreased viability in multiple cell lines and primary cells, interaction with human DNA and RNA polymerases, and inhibition of mitochondrial protein synthesis and respiration."( Role of Mitochondrial RNA Polymerase in the Toxicity of Nucleotide Inhibitors of Hepatitis C Virus.
Ahmadyar, S; Babusis, D; Barauskas, O; Feng, JY; McCutcheon, K; Park, Y; Perron, M; Perry, JK; Ray, AS; Sakowicz, R; Schultz, BE; Stepan, G; Xu, Y; Yu, H, 2016
)
0.43
" 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
"To review adverse events (AEs) uniquely associated with DAA therapy across a broad spectrum of patient populations."( Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy.
Banerjee, D; Reddy, KR, 2016
)
0.43
"Full dose sofosbuvir/simeprevir or sofosbuvir/ledipasvir therapy for HCV-infected patients with end stage renal disease was well tolerated with no discontinuation owing to side effects and no significant adverse events."( Sofosbuvir-based treatment is safe and effective in patients with chronic hepatitis C infection and end stage renal disease: a case series.
Alkhouri, N; Anthony, S; Guirguis, J; Hanouneh, IA; Rivas, J; Singh, T, 2016
)
0.43
" However, these patients had higher rates of anaemia, worsening renal dysfunction and serious adverse events regardless of use of RBV."( Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function.
Chung, RT; Fried, MW; Koraishy, FM; Liapakis, A; Lim, JK; Nelson, DR; Saxena, V; Schmidt, M; Sise, ME; Terrault, NA, 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
" 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
" Hepatic decompensation and other serious adverse events were investigated in an observational cohort study of 511 patients treated with regimens containing sofosbuvir, December 2013-June 2014."( High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in HCV-infected patients treated with sofosbuvir-containing regimens.
Bichoupan, K; Branch, AD; Chang, C; Dieterich, DT; Grewal, P; Harty, A; Khaitova, V; Ku, L; Liu, L; Motamed, D; Patel, N; Perumalswami, PV; Schiano, TD; Woodward, M; Yalamanchili, R, 2016
)
0.43
" No discontinuations were attributed to treatment-related adverse events."( 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens.
Ackerman, P; Bhore, R; Luetkemeyer, AF; McDonald, C; Noviello, S; Ramgopal, M, 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
" 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
" We postulate that this adverse drug reaction may have been secondary to the known interaction between ledipasvir and TDF, which results in increased TDF exposure."( Nephrotoxicity Associated with Concomitant Use of Ledipasvir-Sofosbuvir and Tenofovir in a Patient with Hepatitis C Virus and Human Immunodeficiency Virus Coinfection.
Bunnell, KL; Gallagher, MA; Glowacki, RC; Huhn, G; Osei, AM; Vibhakar, S, 2016
)
0.43
" Demographic, clinical and virological data as well as adverse outcomes were collected."( Efficacy and safety of sofosbuvir plus simeprevir therapy in Egyptian patients with chronic hepatitis C: a real-world experience.
El-Amin, H; El-Khayat, HR; Fouad, YM; Maher, M; Muhammed, H, 2017
)
0.46
" 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
" 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
"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
" Fatal adverse events occurred in 23/6211 cases (0."( Real life Egyptian experience of efficacy and safety of Simeprevir/Sofosbuvir therapy in 6211 chronic HCV genotype IV infected patients.
Abdel Rehim, S; Abdo, M; Doss, W; El Kassas, M; El Raziky, M; El Serafy, M; El-Sayed, MH; Elakel, W; Elbaz, T; Eletreby, R; ElShazly, Y; Esmat, G; Fouad, R; Gamal Eldeen, H; Korany, M; Said, M; Seif, S; Waked, I; Yosry, A; Zaky, S, 2017
)
0.46
"" Sustained virologic response at 12 weeks after the end of treatment (SVR12) rate, incidence of serious adverse events (SAEs) and/or adverse events, discontinuation rate with 95% confidence intervals (CI) were pooled with random-effects model."( Efficacy and safety of sofosbuvir-based interferon-free therapies for hepatitis C in liver transplant recipients.
Guo, Y; Li, T; Qu, Y; Sun, C; Wang, L; Yang, B; Ye, Q, 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
"There is no known reason to suspect an adverse drug interaction between dolutegravir-based antiretroviral therapy and sofosbuvir, simeprevir, or ledipasvir."( Clinical experience with dolutegravir/abacavir/lamivudine in HIV-HCV co-infected patients treated with a sofosbuvir-based regimen-safety and efficacy.
Bhattarai, S; Fallon, JP; Galang, H; Habeeb, R; Johnson, TM; Shukla, PP; Sison, R; Slim, J, 2016
)
0.43
" No patients ended therapy secondary to adverse events."( Clinical experience with dolutegravir/abacavir/lamivudine in HIV-HCV co-infected patients treated with a sofosbuvir-based regimen-safety and efficacy.
Bhattarai, S; Fallon, JP; Galang, H; Habeeb, R; Johnson, TM; Shukla, PP; Sison, R; Slim, J, 2016
)
0.43
" The most common adverse events were fatigue (one [17%] of six patients receiving sofosbuvir, ledipasvir, and asunaprevir; one [17%] of six patients receiving sofosbuvir, daclatasvir, and simeprevir; and two [33%] of six patients receiving sofosbuvir, daclatasvir, and asunaprevir) and headache (one [17%] patient in each group)."( Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study.
Bassit, L; Benhamou, Y; Chen, G; Chen, J; Hou, J; Hsiao, HM; Ji, D; Jiang, Y; Ke, R; Lau, G; Li, B; Li, F; Li, J; Liu, J; Perelson, AS; Schinazi, RF; Shao, Q; Sun, J; Tao, S; Tsang, ST; Wang, C; Wang, Y; Wong, A; Wong, CL; Wu, V, 2016
)
0.43
" By shortening the duration of therapy from the currently recommended 12 weeks to 3 weeks, we could drastically reduce the cost of therapy and the rate of adverse events."( Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study.
Bassit, L; Benhamou, Y; Chen, G; Chen, J; Hou, J; Hsiao, HM; Ji, D; Jiang, Y; Ke, R; Lau, G; Li, B; Li, F; Li, J; Liu, J; Perelson, AS; Schinazi, RF; Shao, Q; Sun, J; Tao, S; Tsang, ST; Wang, C; Wang, Y; Wong, A; Wong, CL; Wu, V, 2016
)
0.43
" 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
" The three most commonly reported adverse events were headache (27% of patients), diarrhea (14%), and fatigue (13%)."( The safety and effectiveness of ledipasvir-sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection.
Balistreri, WF; Bansal, S; Brainard, DM; German, P; Gonzalez-Peralta, RP; Jonas, MM; Kanwar, B; Kersey, K; Lin, CH; Massetto, B; Murray, KF; Rosenthal, P; Schwarz, K; Svarovskaia, E; Wen, J; Zhu, Y, 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 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
" 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
" After a median follow-up period of 26 months (interquartile range, 20-30 mo), no patients had a serious adverse event or relapse of vasculitis."( Efficacy and Safety of Sofosbuvir Plus Daclatasvir for Treatment of HCV-Associated Cryoglobulinemia Vasculitis.
Alric, L; Bouyer, AS; Cacoub, P; Comarmond, C; de Saint Martin, L; Ferfar, Y; Hezode, C; Musset, L; Pol, S; Poynard, T; Resche Rigon, M; Saadoun, D; Si Ahmed, SN, 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
" Some have hypothesized that the active metabolites of toxic ribonucleoside analogs, the triphosphate forms, inadvertently target human mitochondrial RNA polymerase (POLRMT), thus inhibiting mitochondrial RNA transcription and protein synthesis."( Structure-activity relationship analysis of mitochondrial toxicity caused by antiviral ribonucleoside analogs.
Behera, I; Beigelman, L; Chaudhuri, S; Deval, J; Dyatkina, N; Jekle, A; Jin, Z; Kinkade, A; Rajwanshi, VK; Smith, DB; Symons, JA; Tucker, K; Wang, G, 2017
)
0.46
" Adverse events were mild with all-oral therapy."( Safety and efficacy of sofosbuvir-based direct-acting antiviral regimens for hepatitis C virus genotypes 1-4 and 6 in Myanmar: Real-world experience.
Aung, ST; Bwa, AH; Hlaing, NKT; Kyaw, AMM; Mitrani, RA; Phyo, WW; Reddy, KR; Serper, M; Win, KM, 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
" 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 use of IFN-free regimens is safe and effective in the treatment of most HCV-related rheumatologic EHM."( Efficacy and safety of sofosbuvir-based, interferon-free therapy : The Management of rheumatologic extrahepatic manifestations associated with chronic hepatitis C virus infection.
Amer, SA; Said, M; Shahin, AA; Zayed, HS, 2018
)
0.48
" 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
" Tolerance was satisfactory, with mainly grade 1 or 2 adverse events."( Efficacy, safety and patient-reported outcomes of ledipasvir/sofosbuvir in NS3/4A protease inhibitor-experienced individuals with hepatitis C virus genotype 1 and HIV coinfection with and without cirrhosis (ANRS HC31 SOFTRIH study).
Allegre, T; Alric, L; Amri, I; Aumaitre, H; Bailly, F; Bellissant, E; Billaud, E; Bourlière, M; Carrieri, MP; Chas, J; Chevaliez, S; Cotte, L; De Truchis, P; Dominguez, S; Dupon, M; Fougerou-Leurent, C; Garraffo, R; Girard, PM; Jeantils, V; Lacombe, K; Leroy, V; Marcellin, F; Metivier, S; Molina, JM; Morlat, P; Naqvi, A; Neau, D; Pabic, EL; Pageaux, GP; Pailhé, A; Perré, P; Piroth, L; Poizot-Martin, I; Pol, S; Raffi, F; Renault, A; Reynes, J; Rosenthal, E; Salmon-Ceron, D; Teicher, E; Tual, C; Valantin, MA; Yazdanpanah, Y; Zucman, D, 2018
)
0.48
" Adverse events were reported in 63."( Efficacy and safety of 6 or 8 weeks of simeprevir, daclatasvir, sofosbuvir for HCV genotype 1 infection.
Beumont, M; Corregidor, AM; Feld, JJ; Felizarta, F; Gamil, M; Ghalib, R; Kakuda, TN; Khalid, O; Lawitz, E; Luo, D; Ouwerkerk-Mahadevan, S; Smith, WB; Sulkowski, MS; Van Eygen, V; Van Remoortere, P; Vijgen, L, 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
" Headache was the most common side effect in all patients (20%)."( The effectiveness and safety of ledipasvir plus sofosbuvir in adolescents with chronic hepatitis C virus genotype 4 infection: a real-world experience.
Attia, D; Ayoub, H; El Sheemy, RY; El-Khayat, HR; El-Sayed, MH; El-Shabrawi, M; Fouad, YM; Kamal, EM; Maher, M; RizK, A, 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
"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
" One patient showed an increase in ALT of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 severity that returned to the normal range following treatment of his HCV infection with ledipasvir 90 mg/sofosbuvir 400 mg."( Safety and efficacy of anti-PD-1 therapy for metastatic melanoma and non-small-cell lung cancer in patients with viral hepatitis: a case series.
Khattak, MA; Kothapalli, A, 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
"Low-dose Sofosbuvir and full-dose Daclatasvir are safe and effective in treating CHC in patients with CKD with eGFR less than 30 mL/min/1."( Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease.
Chawla, Y; De, A; Dhiman, RK; Duseja, A; Gupta, KL; Kohli, HS; Kumar, V; Mehta, M; Ramachandran, R; Taneja, S, 2018
)
0.48
" 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
" We assessed the rate of sustained virological response at 12 weeks post-treatment (SVR12), incidence of adverse events, and serum markers of hepatocellular carcinoma (HCC)."( Real-world efficacy and safety of ledipasvir and sofosbuvir in patients with hepatitis C virus genotype 1 infection: a nationwide multicenter study by the Japanese Red Cross Liver Study Group.
Akahane, T; Hasebe, C; Itakura, J; Izumi, N; Joko, K; Kimura, H; Kobashi, H; Kojima, Y; Kondou, M; Kurosaki, M; Kusakabe, A; Mitsuda, A; Mori, N; Nakata, R; Narita, R; Ogawa, C; Sohda, T; Takaki, S; Takezawa, J; Tamada, T; Tsuji, K; Uchida, Y; Yagisawa, H, 2018
)
0.48
" Adverse events were rare and not associated with age."( Real-world efficacy and safety of ledipasvir and sofosbuvir in patients with hepatitis C virus genotype 1 infection: a nationwide multicenter study by the Japanese Red Cross Liver Study Group.
Akahane, T; Hasebe, C; Itakura, J; Izumi, N; Joko, K; Kimura, H; Kobashi, H; Kojima, Y; Kondou, M; Kurosaki, M; Kusakabe, A; Mitsuda, A; Mori, N; Nakata, R; Narita, R; Ogawa, C; Sohda, T; Takaki, S; Takezawa, J; Tamada, T; Tsuji, K; Uchida, Y; Yagisawa, H, 2018
)
0.48
"LDV/SOF therapy is highly effective and safe in elderly Japanese patients with HCV GT1, even in the presence of cirrhosis or NS5A RASs."( Real-world efficacy and safety of ledipasvir and sofosbuvir in patients with hepatitis C virus genotype 1 infection: a nationwide multicenter study by the Japanese Red Cross Liver Study Group.
Akahane, T; Hasebe, C; Itakura, J; Izumi, N; Joko, K; Kimura, H; Kobashi, H; Kojima, Y; Kondou, M; Kurosaki, M; Kusakabe, A; Mitsuda, A; Mori, N; Nakata, R; Narita, R; Ogawa, C; Sohda, T; Takaki, S; Takezawa, J; Tamada, T; Tsuji, K; Uchida, Y; Yagisawa, H, 2018
)
0.48
"Treatment of severe psoriasis in HCV positive patients is challenging, because several psoriasis medications have a toxic effect on the liver, and interferon alpha, used to treat hepatitis, can induce worsening of psoriatic lesions."( Safety and efficacy of HCV eradication during etanercept treatment for severe psoriasis.
Di Cesare, A; Lazzeri, L; Pescitelli, L; Prignano, F; Ricceri, F; Tripo, L, 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
"DAA in adult dosage are safe and effective for treatment of chronic hepatitis C (genotype 3) in pediatric β-thalassemic major population."( Efficacy and Safety of Direct Acting Antiviral Therapy for Chronic Hepatitis C in Thalassemic Children.
Garg, K; Gupta, GK; Maharshi, S; Nijhawan, S; Padhi, S, 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
" The endpoints were sustained virological response 12- and 24-weeks after the cessation of therapy (SVR12 and SVR24), the adverse events (AEs) and the severe adverse events (SAEs)."( Efficacy and safety of sofosbuvir-containing regimens in chronic hepatitis C patients with genotype 2 and 3: a comprehensive analysis of 18 randomized controlled trials.
Fan, H; Feng, Y; Huang, P; Tian, T; Wang, J; Wu, J; Xia, X; Yu, R; Yue, M; Zhang, Y, 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
"DAAs appear to be safe and effective for HCV treatment in patients with a history of liver and/or kidney transplantation."( Safety and effectiveness of direct acting antivirals for treatment of hepatitis C virus in patients with solid organ transplantation.
Hill, L; Kerr, J; Mansour, M, 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
" For the 182 treated with the 8-week LDV/SOF treatment, there were no serious adverse events requiring hospitalization or signs of liver failure requiring transplantation."( Eight-Week Hepatitis C Treatment with New Direct Acting Antivirals Has a Better Safety Profile While Being Effective in the Treatment-Naïve Geriatric Population Without Liver Cirrhosis and Hepatitis C Virus-RNA < 6 Million IU/mL.
Aziz, A; Durazo, F; Hanna, RM; Latt, N; Mikhail, MM; Mitry, A; Saab, S; Sahota, A; Yanny, B, 2018
)
0.48
" 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
"No adverse cardiovascular events were observed in this group of HCV infected children and adolescents treated with sofosbuvir/ledipasvir."( Is sofosbuvir/ledipasvir safe for the hearts of children with hepatitis C virus?
Abdullatif, H; El-Karaksy, H; Ghobrial, C; Mogahed, E; Sobhy, R, 2019
)
0.51
" Combined SOF/DCV was found to be effective and safe for treating HCV Genotype 4-infected children, 8 years of age and above."( Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4.
Abdel Gawad, M; Abdel Ghaffar, A; Abdel Ghaffar, TY; El Naghi, S; Helmy, S; Moafy, M; Yousef, M, 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
" Patients' outcome and Adverse effects (AE) were evaluated."( Efficacy and safety of sofosbuvir-based therapy in hepatitis C virus recurrence post living donor liver transplant: A real life egyptian experience.
Abdelaziz, A; Abdelmoniem, R; Doss, W; El-Serafy, M; Elakel, W; Esmat, G; Gamal Eldeen, H; Kaddah, M; Medhat, E; Mehrez, M; Yosry, A; Zayed, N, 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
" 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
" Clinical, adverse events, and virological data were collected throughout treatment and post-treatment follow-up."( Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort.
Abergel, A; Alric, L; Bourliere, M; Bronowicki, JP; Cales, P; Carrat, F; Causse, X; Chazouilleres, O; Diallo, A; Dorival, C; Fontaine, H; Ganne-Carrie, N; Geist, C; Guyader, D; Haour, G; Hezode, C; Larrey, D; Laurain, A; Loustaud-Ratti, V; Luzivika-Nzinga, C; Marcellin, P; Mathurin, P; Metivier, S; Petrov-Sanchez, V; Pol, S; Riachi, G; Samuel, D; Thabut, D; Tran, A; Zarski, JP; Zoulim, F, 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
" Efficacy was defined as HCV RNA below the lower limit of detection 12 weeks after the end of treatment (SVR12), while safety endpoints included the incidence of grade 3 and 4 adverse events (AEs) following treatment, and the proportion of patients who stopped treatment prematurely due to AEs."( A pilot study of safety and efficacy of HCV retreatment with sofosbuvir/velpatasvir/voxilaprevir in patients with or without HIV (RESOLVE STUDY).
Chua, J; Comstock, E; Covert, E; Emmanuel, B; Hoffmann, J; Husson, J; Kattakuzhy, S; Kottilil, S; Masur, H; Mathur, P; Price, A; Rosenthal, E; Tang, L; Wilson, E, 2019
)
0.51
"Retreatment with 12 weeks of SOF/VEL/VOX was safe and effective in patients with relapsed HCV following initial combination DAA-based treatment."( A pilot study of safety and efficacy of HCV retreatment with sofosbuvir/velpatasvir/voxilaprevir in patients with or without HIV (RESOLVE STUDY).
Chua, J; Comstock, E; Covert, E; Emmanuel, B; Hoffmann, J; Husson, J; Kattakuzhy, S; Kottilil, S; Masur, H; Mathur, P; Price, A; Rosenthal, E; Tang, L; Wilson, E, 2019
)
0.51
"Twelve weeks of the combination of direct-acting antivirals (SOF/VEL/VOX) was safe and effective in patients with relapsed hepatitis C virus infection who had previously received combination therapy with direct-acting antivirals."( A pilot study of safety and efficacy of HCV retreatment with sofosbuvir/velpatasvir/voxilaprevir in patients with or without HIV (RESOLVE STUDY).
Chua, J; Comstock, E; Covert, E; Emmanuel, B; Hoffmann, J; Husson, J; Kattakuzhy, S; Kottilil, S; Masur, H; Mathur, P; Price, A; Rosenthal, E; Tang, L; Wilson, E, 2019
)
0.51
" Adverse effects were mild and non-specific."( Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs.
Antonio Carrión, J; Arenas, J; Arencibia, A; Badia, E; Bernal, V; Buti, M; Cachero, A; Carmona, I; Conde, I; Delgado, M; Diago, M; Esteban, R; Fernández, I; Fernández-Bermejo, M; Fernández-Rodríguez, C; Figueruela, B; García-Samaniego, J; Gea, F; González-Santiago, JM; Hernández-Guerra, M; Iñarrairaegui, M; Lens, S; Llaneras, J; Llerena, S; Luis Calleja, J; María Morillas, R; Mariño, Z; Montoliu, S; Pascasio, JM; Riveiro-Barciela, M; Rosales, JM; Torras, X; Turnes, J, 2019
)
0.51
"Real-world data show that SOF/VEL/VOX is an effective, safe rescue therapy for patients with prior DAA treatment failure despite the presence of resistance-associated substitutions."( Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs.
Antonio Carrión, J; Arenas, J; Arencibia, A; Badia, E; Bernal, V; Buti, M; Cachero, A; Carmona, I; Conde, I; Delgado, M; Diago, M; Esteban, R; Fernández, I; Fernández-Bermejo, M; Fernández-Rodríguez, C; Figueruela, B; García-Samaniego, J; Gea, F; González-Santiago, JM; Hernández-Guerra, M; Iñarrairaegui, M; Lens, S; Llaneras, J; Llerena, S; Luis Calleja, J; María Morillas, R; Mariño, Z; Montoliu, S; Pascasio, JM; Riveiro-Barciela, M; Rosales, JM; Torras, X; Turnes, J, 2019
)
0.51
" Treatment with SOF/VEL/VOX is an effective and safe rescue therapy due to its high efficacy and very good safety profile."( Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs.
Antonio Carrión, J; Arenas, J; Arencibia, A; Badia, E; Bernal, V; Buti, M; Cachero, A; Carmona, I; Conde, I; Delgado, M; Diago, M; Esteban, R; Fernández, I; Fernández-Bermejo, M; Fernández-Rodríguez, C; Figueruela, B; García-Samaniego, J; Gea, F; González-Santiago, JM; Hernández-Guerra, M; Iñarrairaegui, M; Lens, S; Llaneras, J; Llerena, S; Luis Calleja, J; María Morillas, R; Mariño, Z; Montoliu, S; Pascasio, JM; Riveiro-Barciela, M; Rosales, JM; Torras, X; Turnes, J, 2019
)
0.51
" We collected data on on-treatment adverse events (AEs), severe AEs, and laboratory abnormalities."( Efficacy and safety of direct-acting antiviral agents for HCV in mild-to-moderate chronic kidney disease.
Aoufi-Rabih, S; Dixit, V; Fabrizi, F; Garcia-Agudo, R; Mendizabal, M; Ridruejo, E; Silva, M,
)
0.13
" Most frequent adverse events included fatigue (6%), hyperbilirubinemia (6%) and anemia (4%)."( Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure.
Aghemo, A; Alberti, A; Bonfanti, P; Carolo, G; Carriero, C; Centenaro, R; Degasperi, E; Fabris, P; Faggiano, G; Fagiuoli, S; Gatti, F; Giorgini, A; Grossi, G; Lampertico, P; Landonio, S; Lombardi, A; Lomonaco, L; Maggiolo, F; Noventa, F; Paolucci, S; Paon, V; Pasin, F; Pasulo, L; Pozzoni, P; Puoti, M; Romano, A; Rossi, MC; Rovere, P; Russo, FP; Soffredini, R; Soria, A; Spinetti, A; Vario, A; Vinci, M; Zoncada, A, 2019
)
0.51
"SOF/VEL/VOX is an effective and safe retreatment for patients with HCV who have failed on a previous DAA course in a real-life setting."( Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure.
Aghemo, A; Alberti, A; Bonfanti, P; Carolo, G; Carriero, C; Centenaro, R; Degasperi, E; Fabris, P; Faggiano, G; Fagiuoli, S; Gatti, F; Giorgini, A; Grossi, G; Lampertico, P; Landonio, S; Lombardi, A; Lomonaco, L; Maggiolo, F; Noventa, F; Paolucci, S; Paon, V; Pasin, F; Pasulo, L; Pozzoni, P; Puoti, M; Romano, A; Rossi, MC; Rovere, P; Russo, FP; Soffredini, R; Soria, A; Spinetti, A; Vario, A; Vinci, M; Zoncada, A, 2019
)
0.51
" Demographics, HCV viral load, lipid and sugar profiles, and adverse events were recorded and reviewed."( Real-world effectiveness and safety of ledipasvir/sofosbuvir for genotype 6 chronic hepatitis C patients in Taiwan.
Chen, JJ; Cheng, PN; Chiu, HC; Chiu, YC; Lee, PL; Tung, HD, 2020
)
0.56
" Serious adverse events (SAEs) were reported in 2 patients and were not related to coblopasvir and sofosbuvir."( Safety and efficacy of coblopasvir and sofosbuvir in patients with genotypes 1, 2, 3 and 6 HCV infections without or with compensated cirrhosis.
Guan, Y; Guo, X; Jia, J; Jiang, X; Li, C; Li, G; Mao, Q; Ning, J; Pan, H; Qin, H; Rao, H; Song, G; Wang, C; Wei, L; Wu, X; Yang, Y; Zhang, Y, 2020
)
0.56
" 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
" Nevertheless, there are many reports in which these patients have been treated with sofosbuvir-containing regiments without important adverse events."( The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment.
Afshar, B; Agah, S; Amiriani, T; Fattahi Abdizadeh, M; Fattahi, MR; Hormati, A; Khoshnia, M; Latifnia, M; Majd Jabbari, S; Maleki, I; Malekzadeh, R; Malekzadeh, Z; Mansour-Ghanaei, F; Merat, D; Merat, S; Minakari, M; Moini, M; Mokhtare, M; Poustchi, H; Roozbeh, F; Sharifi, AH; Shayesteh, AA; Shayesteh, E; Sofian, M; Sohrabi, M; Somi, MH, 2020
)
0.56
" No adverse events leading to discontinuation of medicine was observed."( The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment.
Afshar, B; Agah, S; Amiriani, T; Fattahi Abdizadeh, M; Fattahi, MR; Hormati, A; Khoshnia, M; Latifnia, M; Majd Jabbari, S; Maleki, I; Malekzadeh, R; Malekzadeh, Z; Mansour-Ghanaei, F; Merat, D; Merat, S; Minakari, M; Moini, M; Mokhtare, M; Poustchi, H; Roozbeh, F; Sharifi, AH; Shayesteh, AA; Shayesteh, E; Sofian, M; Sohrabi, M; Somi, MH, 2020
)
0.56
"The combination of sofosbuvir and daclatasvir is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis."( The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment.
Afshar, B; Agah, S; Amiriani, T; Fattahi Abdizadeh, M; Fattahi, MR; Hormati, A; Khoshnia, M; Latifnia, M; Majd Jabbari, S; Maleki, I; Malekzadeh, R; Malekzadeh, Z; Mansour-Ghanaei, F; Merat, D; Merat, S; Minakari, M; Moini, M; Mokhtare, M; Poustchi, H; Roozbeh, F; Sharifi, AH; Shayesteh, AA; Shayesteh, E; Sofian, M; Sohrabi, M; Somi, MH, 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
"A shortened 8-week regimen of LED/SOF (45/200 mg) is safe and effective with 100% SVR12 in treatment-naïve children with cirrhosis aged 4-10 years with chronic HCV infection genotype 4."( Safety and Efficacy of 8 Weeks Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 4 in Children Aged 4-10 Years.
Ayoub, BA; Basiouny, HM; Behairy, BE; El-Araby, HA; El-Guindi, MA; Fouad, OA; Marei, AM; Sira, MM, 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
" Plasma pharmacokinetic parameters were estimated by using noncompartmental models, and safety was assessed through clinical evaluation and monitoring of adverse events."( Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects.
Ding, Y; Kersey, K; Li, C; Li, X; Shen, G; Zhang, H; Zhu, X, 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
" We concluded that sofosbuvir while looking toxic and pro-oxidant in lower concentrations, acts as protective and antioxidant in higher concentrations."( Contrasting Role of Dose Increase in Modulating Sofosbuvir-Induced Hepatocyte Toxicity.
Nabavi, N; Pourahmad, J; Yousefsani, BS, 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
" These findings provide reassurance that the combination of TAF, boosted PIs and ledipasvir/sofosbuvir is safe in HIV/HCV-coinfected populations."( Pharmacokinetics and renal safety of tenofovir alafenamide with boosted protease inhibitors and ledipasvir/sofosbuvir.
Anderson, PL; Blum, J; Brooks, KM; Bushman, LR; Castillo-Mancilla, JR; Cendali, F; Choi, YJ; Gomez, J; Haas, H; Ibrahim, ME; Johnson, B; Kiser, JJ; MaWhinney, S; Morrow, M; Roon, L; Rowan, SE; Wyles, DL; Zheng, JH, 2020
)
0.56
" The most frequent adverse event was fatigue with a pooled prevalence of 16% (95% CI 5-29%), followed by anemia 15% (95% CI 3-31%), and nausea or vomiting 14% (95% CI 4-27%)."( Efficacy and safety of sofosbuvir in the treatment of hep C among patients on hemodialysis: a systematic review and meta-analysis.
Byrd, K; D'Agata, EMC; Kalligeros, M; Martin, P; Mylonakis, E; Shehadeh, F; Shemin, D, 2020
)
0.56
"As patients with chronic hepatitis C virus (HCV) tend to be older and/or have advanced liver disease in Japan, real-world data are needed to evaluate safe and effective treatment options."( Real-world safety and effectiveness of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C virus genotype 1 in Japan.
Fujiyama, N; Hedskog, C; Littman, M; Liu, LJ; Mizokami, M; Ng, LJ; Sekiya, T; Yuan, J, 2021
)
0.62
" Secondary outcome was frequency of adverse events (AE)."( Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics.
Ahlenstiel, G; Bowden, S; Dore, GJ; Douglas, M; Doyle, J; Farrell, G; Fisher, L; George, J; Haque, M; Hazeldine, S; Hellard, M; Levy, M; MacQuillan, G; McGarity, B; New, K; O'Beirne, J; O'Keefe, J; Papaluca, T; Prewett, E; Roberts, SK; Sawhney, R; Sievert, W; Sinclair, M; Sood, S; Stoove, M; Strasser, SI; Stuart, KA; Thomas, J; Thompson, AJ; Tse, E; Valaydon, Z; Valiozis, I; Wade, AJ; Weltman, M; Wigg, A; Wilson, M; Woodward, A, 2021
)
0.62
" 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
"Sofosbuvir plus Velpatasvir fixed-dose combination is safe and effective in treating CHC in patients with ESRD on MHD."( Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end-stage renal disease on maintenance haemodialysis.
De, A; Dhiman, RK; Duseja, A; Kohli, HS; Kumar, V; Mehta, M; Premkumar, M; Ramachandran, R; Ratho, RK; Singh, MP; Singh, V; Taneja, S; Verma, N, 2021
)
0.62
" There were no adverse events related to the use of Sof-Vel, with no major fluctuations in cyclosporine levels."( Safety and efficacy of Sofosbuvir and Velpatasvir in children with active hepatitis C virus infection undergoing haploidentical transplantation.
Bhakuni, P; Chakrabarti, S; Gupta, M; Jaiswal, SR; Soni, M; Thatai, A, 2021
)
0.62
" 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
"SOF-based pangenotypic DAAs including SOF plus DCV and SOF plus VEL, were effective and safe for CHC patients without GT determination in this study."( Efficacy and safety of sofosbuvir-based pangenotypic direct-acting antiviral agents for chronic hepatitis C patients without genotype determination: Real-world experience of a retrospective study.
Chen, EQ; Chen, XB; Jiang, W; Li, J; Tao, YC; Wang, ML; Wang, YH; Wu, DB; Xiao, GB, 2020
)
0.56
"Treatment was safe and well-tolerated and there were no drug discontinuations due to DAA-related adverse events."( Real-world efficacy and safety of direct-acting antiviral drugs in patients with chronic hepatitis C and inherited blood disorders.
Ahmed-Belkacem, A; Chevaliez, S; Demontant, V; Donati, F; Fourati, S; François, M; N'Debi, M; Pawlotsky, JM; Poiteau, L; Rodriguez, C; Ruiz, I; Scoazec, G; Soulier, A, 2021
)
0.62
" 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
" No severe adverse events (AEs) were reported, and there was no dose reduction or interruption due to AE."( Efficacy and safety of ledipasvir/sofosbuvir in 5,028 Mongolian patients infected with genotype 1 hepatitis C virus: A multicenter study.
Ahn, SH; Amarsanaa, J; Baatarkhuu, O; Badamsuren, D; Batbayar, P; Choijamts, N; Enkhtuya, D; Gantuul, C; Gegeebadrakh, B; Han, KH; Kim, DY; Lee, JS; Naranzul, N; Otgonbayar, R; Otgonbold, J; Saruul, BU; Tuvshinbayar, N; Ulzmaa, G, 2021
)
0.62
" We conclude that sofosbuvir-based DAA therapy is safe and highly effective in HCV-HIV patients with decompensated liver disease and post-LT, with post-LT survival rates comparable to other indications."( Retrospective-prospective study of safety and efficacy of sofosbuvir-based direct-acting antivirals in HIV/HCV-coinfected participants with decompensated liver disease pre- or post-liver transplant.
Amara, D; Blumberg, E; Dove, L; Durand, CM; Emond, J; Fishbein, T; Florman, S; Grab, J; Haydel, B; Huprikar, S; Husson, J; Kottilil, S; Luetkemeyer, AF; Masur, H; Olthoff, K; Peters, MG; Rogers, R; Smith, C; Stock, PG; Sulkowski, MS; Terrault, N, 2021
)
0.62
" No adverse effects leading to drug discontinuation occurred."( Efficacy and safety of sofosbuvir/ ledipasvir in treatment of patients with COVID-19; A randomized clinical trial.
Ahmadinejad, Z; Dehghan Manshadi, SA; Emadi Kouchak, H; Jafari, S; Kebriaeezadeh, A; Khalili, H; Nourian, A; Rasolinejad, M, 2020
)
0.56
" No significant adverse event was detected."( Efficacy and safety of sofosbuvir/ ledipasvir in treatment of patients with COVID-19; A randomized clinical trial.
Ahmadinejad, Z; Dehghan Manshadi, SA; Emadi Kouchak, H; Jafari, S; Kebriaeezadeh, A; Khalili, H; Nourian, A; Rasolinejad, M, 2020
)
0.56
" The most common adverse events were fatigue (12."( Real-world efficacy and safety of Ledipasvir + Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience.
Akarca, US; Akarsu, M; Akbulut, S; Akın, M; Aladağ, M; Albayrak, B; Alkım, H; Atalay, R; Balkan, A; Balkan, Y; Çoban, M; Coşar, AM; Danış, N; Değertekin, B; Demir, M; Demircan, M; Dinçer, D; Doğanay, L; Dursun, H; Erarslan, E; Göktürk, HS; Gündüz, F; Güneş, Ş; Gürel, S; Güzelbulut, F; Harputluoğlu, M; İnci, İ; Irak, K; Kaçar, S; Kani, HT; Kartal, A; Kefeli, A; Koklu, H; Mert, A; Nuriyev, K; Özakyol, A; Özdoğan, O; Öztaşkın, S; Sen, İ; Şimşek, H; Soylu, A; Sümer, H; Temel, T; Üçbilek, E; Uğurlu, ÇB; Uyanıkoğlu, A; Vatansever, S; Yalçın, K; Yaras, S; Yıldırım, E, 2020
)
0.56
" The most common treatment-emergent adverse events were pyrexia (35 [12%]), cough (26 [9%]), upper respiratory tract infection (23 [8%]), and headache (20 [7%])."( Efficacy and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis C infection without cirrhosis or with compensated cirrhosis (STORM-C-1): interim analysis of a two-stage, open-label, multicentre, single arm, phase 2/3 trial.
Andrieux-Meyer, I; Avihingsanon, A; Bompart, F; Chan, WK; Cressey, TR; Goyal, V; Hassan, MRA; Khemnark, S; Kumar, S; Menétrey, C; Murad, S; Ngo-Giang-Huong, N; Omar, H; Pécoul, B; Said, HRHM; Salvadori, N; Simon, F; Siva, S; Swanson, A; Tan, SS; Tee, HP; Thanprasertsuk, S; Thetket, K; Thongsawat, S; Yerly, S, 2021
)
0.62
" Exploratory studies to identify potential rare adverse drug events associated with DAAs to optimize their use are scarce."( Global adverse events reported for direct-acting antiviral therapies for the treatment of hepatitis C: an analysis of the World Health Organization VigiBase.
Burden, AM; Burkard, T; Hayes, KN; Tadrous, M; Weiler, S, 2021
)
0.62
"We aimed to describe the most common serious DAA-associated adverse drug reaction (ADR) reports overall and by DAA regimen."( Global adverse events reported for direct-acting antiviral therapies for the treatment of hepatitis C: an analysis of the World Health Organization VigiBase.
Burden, AM; Burkard, T; Hayes, KN; Tadrous, M; Weiler, S, 2021
)
0.62
" Adverse events were evaluated in all patients who started their assigned treatment."( Efficacy and safety of sofosbuvir/velpatasvir versus the standard of care in adults hospitalized with COVID-19: a single-centre, randomized controlled trial.
Afsharian, M; Bozorgomid, A; Janbakhsh, A; Khodarahmi, R; Khosravi Shadmani, F; Mansouri, F; Miladi, R; Mohseni Afshar, Z; Najafi, F; Rahimi, Z; Salimi, M; Sayad, B; Shirvani, M; Vaziri, S; Zamanian, MH, 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
"LDV/SOF is a safe and relatively effective treatment for hepatitis C in drug users."( Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysis.
Pang, L; Tang, H; Tang, Y; Xu, D; Xu, P; Yang, X; Zhang, G, 2021
)
0.62
"DCV 30 mg OD was predicted to achieve effective and safe exposures in children 14 to <35 kg, perhaps down to 10 kg."( Effective and Safe Daclatasvir Drug Exposures Predicted in Children Using Adult Formulations.
Abbassi, M; Al-Nahari, M; Cressey, TR; Easterbrook, P; El-Sayed, MH; Farid, S; Indolfi, G; Lallemant, M; Penazzato, M, 2021
)
0.62
" Subjective adverse events were reported by 42."( Sofosbuvir-based antiviral therapy provided highly treatment efficacy, safety, and good tolerability for Taiwanese chronic hepatitis C patients with decompensated cirrhosis.
Chu, CJ; Hou, MC; Huang, YH; Lee, FY; Lee, SD; Lin, CC; Su, CW; Su, PS; Wang, YJ; Wu, SH, 2022
)
0.72
"HCV-infected patients can be treated well with an interferon-free SOF/DAC regimen, tolerated with generally mild adverse effects with a higher SVR."( Diagnostic approach to elucidate the efficacy and side effects of direct-acting antivirals in HCV infected patients.
Alsrhani, A; Alzahrani, B; Ejaz, H; Gohar, UF; Junaid, K; Mukhtar, H; Qamar, MU; Younas, S, 2021
)
0.62
"A 12 week course of sofosbuvir-velpatasvir-voxilaprevir is safe and efficacious for the re-treatment of individuals infected with HCV genotype 4 non-a/d subtypes with frequent baseline NS5A resistance-associated substitutions, following failure of previous direct-acting antiviral treatment."( Safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trial.
Camus, G; Grant, PM; Gupta, N; Kabihizi, J; Kateera, F; Makuza, JD; Manirambona, L; Mukabatsinda, C; Murangwa, A; Musabeyezu, E; Muvunyi, CM; Nsanzimana, S; Serumondo, J; Shumbusho, F, 2022
)
0.72
"A 12-week regimen of sofosbuvir-velpatasvir is safe and efficacious in treating chronic HCV genotype 4 infection in patients in Rwanda."( Safety and efficacy of sofosbuvir-velpatasvir to treat chronic hepatitis C virus infection in treatment-naive patients in Rwanda (SHARED-3): a single-arm trial.
Camus, G; Grant, PM; Gupta, N; Kabakambira, JD; Kabihizi, J; Kateera, F; Makuza, JD; Manirambona, L; Murangwa, A; Muvunyi, CM; Nsanzimana, S; Serumondo, J; Shumbusho, F; Sylvain, H, 2022
)
0.72
" Therefore, there is a need for effective and safe antiviral."( Efficacy and safety of the sofosbuvir/velpatasvir combination for the treatment of patients with early mild to moderate COVID-19.
Adinolfi, LE; De Lucia Sposito, P; Fusco, R; Gaglione, P; Izzi, A; Lumino, P; Maggi, P; Marrone, A; Messina, V; Nevola, R; Rega, R; Rinaldi, L; Sasso, FC; Simeone, F, 2022
)
0.72
" Demographic information, HCV viral load (VL), profiles of lipid and sugar, and adverse events were recorded and reviewed."( Real-world effectiveness and safety of sofosbuvir/velpatasvir and glecaprevir/pibrentasvir for genotype 6 chronic hepatitis C.
Chen, JJ; Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC; Lee, PL; Tung, HD, 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
" No mortality or serious adverse events were recorded."( Sofosbuvir/ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: A randomized controlled trial for repurposing antivirals.
Abd Elghafar, MS; Abd-Elsalam, S; Abdelghaffar, H; Abdelghaffar, K; Al Shafie, A; Badr, M; El-Kassas, M; Esmael, HE; Ezz Eldin, AM; Ezzat, S; Hassany, SM; Kamal, DT; Karam-Allah, H; Medhat, MA; Moaz, I; Moustafa, E; Ossimi, A; Salama, M; Sayed, H; Shamseldeen, A, 2022
)
0.72
" These drugs represent a safe and affordable treatment for COVID-19."( Sofosbuvir/ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: A randomized controlled trial for repurposing antivirals.
Abd Elghafar, MS; Abd-Elsalam, S; Abdelghaffar, H; Abdelghaffar, K; Al Shafie, A; Badr, M; El-Kassas, M; Esmael, HE; Ezz Eldin, AM; Ezzat, S; Hassany, SM; Kamal, DT; Karam-Allah, H; Medhat, MA; Moaz, I; Moustafa, E; Ossimi, A; Salama, M; Sayed, H; Shamseldeen, A, 2022
)
0.72
"Ledipasvir/sofosbuvir fixed-dose combination is a safe and highly effective therapeutic option in Egyptian children aged ≥ 12 years, with chronic HCV infection, genotype 4, either without or with comorbidities."( Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Treatment-Naïve Children without and with Comorbidities.
AbouBakr, O; El Sayed Zaki, M; Ezz El Regal, M; Noaman, A; Sarhan, AA, 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
"Gastrointestinal adverse drug reactions (GADRs) of direct-acting antiviral agents (DAAs) in patients with chronic hepatitis C are underestimated."( Direct-acting antiviral agent use and gastrointestinal safety in patients with chronic hepatitis C: a pharmacovigilance study based on FDA Adverse Event Reporting System.
Li, J; Wang, L; Xie, W; Zhou, Y; Zhu, X, 2023
)
0.91
"The US FDA Adverse Event Reporting System database was searched for GADR cases reported from 01 to 2012 to 30 September 2021."( Direct-acting antiviral agent use and gastrointestinal safety in patients with chronic hepatitis C: a pharmacovigilance study based on FDA Adverse Event Reporting System.
Li, J; Wang, L; Xie, W; Zhou, Y; Zhu, X, 2023
)
0.91
" Serious adverse events (SAE) were registered."( Real World Efficacy and Safety of Sofosbuvir + Velpatasvir + Voxilaprevir in Romanian Patients with Genotype 1b HCV Infection Non-reponders to DAAs Therapy.
Diculescu, MM; Gheorghe, L; Iacob, SM; Iliescu, L; Istratescu, D; Manuc, M; Manuc, T; Popescu, CP; Preda, C; Stanciu, C; Stroie, TG; Tieranu, CG; Trifan, A, 2022
)
0.72
" Serious adverse events related to therapy were reported in 1/143(0."( Real World Efficacy and Safety of Sofosbuvir + Velpatasvir + Voxilaprevir in Romanian Patients with Genotype 1b HCV Infection Non-reponders to DAAs Therapy.
Diculescu, MM; Gheorghe, L; Iacob, SM; Iliescu, L; Istratescu, D; Manuc, M; Manuc, T; Popescu, CP; Preda, C; Stanciu, C; Stroie, TG; Tieranu, CG; Trifan, A, 2022
)
0.72
" Researchers assessed treatment-emergent adverse events (TEAEs) and laboratory abnormalities in patients randomized to SOF/VEL or placebo for 12 weeks in ASTRAL-1 and SOF/VEL for 12 weeks in ASTRAL-2 and ASTRAL-3."( The tolerability of sofosbuvir/velpatasvir for 12 weeks in patients treated in the ASTRAL 1, 2 and 3 studies: A pooled safety analysis.
Bourgeois, S; Foster, GR; Gerken, G; Hernandez, C; Jacobson, IM; Mathurin, P; Osinusi, A; Ryder, SD; Scherbakovsky, S; Tedesco, D; Thuluvath, P; Vanstraelen, K, 2023
)
0.91
" 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
" No grade III/IV adverse events were reported, and there was no worsening of blood counts, liver or renal function test parameters."( Efficacy and safety of pan-genotypic sofosbuvir and velpatasvir in patients with hepatitis C and HIV coinfection on dolutegravir-based antiretroviral therapy.
Bhagat, N; Charak, S; De, A; Duseja, A; Goel, K; Premkumar, M; Rathi, S; Sharma, A; Singh, V; Taneja, S; Verma, N, 2023
)
0.91
" The average incidence of adverse reactions during treatment was approximately 10%."( Treatment effectiveness and side effects of patients with hepatitis C in the prisons of Southern Taiwan: a real-life retrospective analysis.
Hsin, YH; Huang, CW; Ko, CY; Tsai, QZ; Tsai, YC; Yu, ML, 2023
)
0.91
" Thirty-three reported adverse events (AEs) were considered related to the administration of SOF/VEL, all of them were mild or moderate."( Efficacy and safety of treatment with sofosbuvir/velpatasvir in patients aged 6-18 years with chronic hepatitis C-Results of the PANDAA-PED study.
Aniszewska, M; Dobrzeniecka, A; Indolfi, G; Marczyńska, M; Pluta, M; Pokorska-Śpiewak, M; Talarek, E, 2023
)
0.91
" Overall, sofosbuvir-velpatasvir and sofosbuvir-velpatasvir-voxilaprevir were safe and well tolerated."( Efficacy and safety of sofosbuvir-velpatasvir and sofosbuvir-velpatasvir-voxilaprevir for hepatitis C in Korea: a Phase 3b study.
Ahn, SH; Byun, KS; Cho, JY; Heo, J; Jang, BK; Jang, JW; Jeong, SH; Jung, YJ; Kim, HJ; Kim, IH; Kim, JH; Kim, YJ; Kwon, JH; Kwon, KM; Lee, BS; Lee, SW; Lee, YJ; Lim, YS; Paik, SW; Park, NH; Suri, V; Tak, WY; Wu, P; Yang, SH; Yoon, KT, 2023
)
0.91
"Treatment with sofosbuvir-velpatasvir or sofosbuvir-velpatasvir-voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients."( Efficacy and safety of sofosbuvir-velpatasvir and sofosbuvir-velpatasvir-voxilaprevir for hepatitis C in Korea: a Phase 3b study.
Ahn, SH; Byun, KS; Cho, JY; Heo, J; Jang, BK; Jang, JW; Jeong, SH; Jung, YJ; Kim, HJ; Kim, IH; Kim, JH; Kim, YJ; Kwon, JH; Kwon, KM; Lee, BS; Lee, SW; Lee, YJ; Lim, YS; Paik, SW; Park, NH; Suri, V; Tak, WY; Wu, P; Yang, SH; Yoon, KT, 2023
)
0.91
"Due to concerns over potential interactions between some hepatitis C direct-acting antivirals (DAAs) and opioids, we describe adverse event (AE) reports of concomitant use of opioids and DAAs."( Reported adverse events related to use of hepatitis C virus direct-acting antivirals with opioids: 2017-2021.
Collins, M; Conway, B; Dylla, DE; Khan, T; Marcinak, J; Martinez, A; Saget, B, 2023
)
0.91

Pharmacokinetics

Physiological changes in pregnancy alter the pharmacokinetics of some medications. In this pharmacokinetic study, sofosbuvir full dose (400mg once daily) administered every day with another direct antiviral agent did not accumulate in hemodialysis patients.

ExcerptReferenceRelevance
" 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
" This was a 112-day, open-label, fixed-sequence pharmacokinetic (PK) study in healthy female subjects that included a lead-in cycle (OC only; N = 21), cycle 1 (OC only; N = 15), cycle 2 (OC + sofosbuvir; N = 15), and cycle 3 (OC + ledipasvir; N = 15)."( Lack of a clinically important pharmacokinetic interaction between sofosbuvir or ledipasvir and hormonal oral contraceptives norgestimate/ethinyl estradiol in HCV-uninfected female subjects.
German, P; Mathias, A; Moorehead, L; Pang, P; Vimal, M, 2014
)
0.4
" The method was successfully applied to a pharmacokinetic study of ledipasvir, sofosbuvir and GS-331007 in rats."( Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study.
Chen, W; Chen, Y; Jin, L; Lin, W; Pan, C; Pan, Z; Zheng, Y; Zhou, G, 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
" This novelty allows us to measure serum concentrations of the drug for a longer time postdose and provides more opportunity for pharmacokinetic studies of sofosbuvir."( Quantification of sofosbuvir in human serum by liquid chromatography with negative ionization mass spectrometry using the parent peak and its source-induced fragment: Application to a bioequivalence study.
Babaei, A; Bahrami, G; Bahrami, MT; Ghaheri, M; Miraghaei, S; Mohammadi, B, 2016
)
0.43
" Areas covered: This article reviews the pharmacokinetic and pharmacodynamic properties of the SOF/LDV fixed dose combination for the treatment of HCV."( Pharmacokinetics and pharmacodynamics of sofosbuvir and ledipasvir for the treatment of hepatitis C.
Cuenca-Lopez, F; Rivero, A; Rivero-Juárez, A, 2017
)
0.46
" Following approval in 2016, new pharmacokinetic and pharmacodynamic data were reported, which led to important clinical applications."( Pharmacokinetic drug evaluation of velpatasvir plus sofosbuvir for the treatment of hepatitis C virus infection.
Brieva, T; Rivero, A; Rivero-Juarez, A, 2017
)
0.46
" 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
" 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
"The purpose of this study was to investigate the safety, tolerability, and pharmacokinetic profile of sofosbuvir and its metabolites after a single dose of sofosbuvir 400mg and once daily dosing of sofosbuvir 400mg for 7days in healthy Chinese subjects."( Pharmacokinetics, Safety, and Tolerability of the Direct-acting Hepatitis C Antiviral Sofosbuvir in HealthyChineseSubjects.
Brainard, DM; Chen, G; Chen, H; Ding, Y; Li, X; Massetto, B; Niu, J; Shen, G; Zhang, H; Zhu, X, 2018
)
0.48
" The pharmacokinetic properties of sofosbuvir, GS-556500, and GS-311007 were found to be broadly similar in healthy Chinese subjects compared with non-Chinese subjects in previous sofosbuvir studies."( Pharmacokinetics, Safety, and Tolerability of the Direct-acting Hepatitis C Antiviral Sofosbuvir in HealthyChineseSubjects.
Brainard, DM; Chen, G; Chen, H; Ding, Y; Li, X; Massetto, B; Niu, J; Shen, G; Zhang, H; Zhu, X, 2018
)
0.48
"Limited data exist on the pharmacokinetic profile of novel direct-acting antivirals in kidney transplant recipients."( Pharmacokinetics of Daclatasvir, Sofosbuvir, and GS-331007 in a Prospective Cohort of Hepatitis C Virus-Positive Kidney Transplant Recipients.
Algharably, E; Budde, K; Duerr, M; Glander, P; Halleck, F; Hoffmann, F; Jaeger, C; Kreutz, R; Lisec, J; Schrezenmeier, E; Schrezenmeier, J, 2019
)
0.51
" This study provides the rationale for future studies investigating the pharmacokinetic profile of sofosbuvir-based HCV treatment in kidney transplant recipients with an eGFR <30 mL/min."( Pharmacokinetics of Daclatasvir, Sofosbuvir, and GS-331007 in a Prospective Cohort of Hepatitis C Virus-Positive Kidney Transplant Recipients.
Algharably, E; Budde, K; Duerr, M; Glander, P; Halleck, F; Hoffmann, F; Jaeger, C; Kreutz, R; Lisec, J; Schrezenmeier, E; Schrezenmeier, J, 2019
)
0.51
"A series of deuterated sofosbuvir analogs were designed and prepared with the aim of improving their pharmacokinetic properties."( Synthesis and biological evaluation of deuterated sofosbuvir analogs as HCV NS5B inhibitors with enhanced pharmacokinetic properties.
Ao, W; Lin, Y; Ma, X; Song, W; Wang, Q; Wang, X; Xu, H; Zhang, X; Zhang, Y, 2019
)
0.51
" Pharmacokinetic study was successfully applied and proved the possibility of co-administration of SOF with PAR and MET."( Determination of sofosbuvir with two co-administered drugs; paracetamol and DL-methionine by two chromatographic methods. Application to a pharmacokinetic study.
Abdel-Rahman, HM; Abdelrahman, MM; Abdelwahab, NS; Fares, MY, 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
" Although both have been approved in China, there are currently no data on their pharmacokinetic profiles in Chinese individuals."( Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects.
Ding, Y; Kersey, K; Li, C; Li, X; Shen, G; Zhang, H; Zhu, X, 2020
)
0.56
" Plasma pharmacokinetic parameters were estimated by using noncompartmental models, and safety was assessed through clinical evaluation and monitoring of adverse events."( Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects.
Ding, Y; Kersey, K; Li, C; Li, X; Shen, G; Zhang, H; Zhu, X, 2020
)
0.56
" The pharmacokinetic parameters for sofosbuvir, GS-566500, GS-331007, and ledipasvir or velpatasvir were similar to historical values in non-Chinese subjects."( Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects.
Ding, Y; Kersey, K; Li, C; Li, X; Shen, G; Zhang, H; Zhu, X, 2020
)
0.56
"Overall, ledipasvir/sofosbuvir and sofosbuvir/velpatasvir exhibited pharmacokinetic and safety profiles in healthy Chinese subjects similar to those in non-Chinese subjects in historical studies, supporting their use in the Chinese population with HCV infection."( Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects.
Ding, Y; Kersey, K; Li, C; Li, X; Shen, G; Zhang, H; Zhu, X, 2020
)
0.56
" This study was to evaluate the pharmacokinetic characteristics and effectiveness of daclatasvir/sofosbuvir (DAC/SOF) and ledipasvir/SOF (LDV/SOF) in HD patients."( Effect of Hemodialysis on Efficacy and Pharmacokinetics of Sofosbuvir Coformulated with Either Daclatasvir or Ledipasvir in Patients with End-Stage Renal Disease.
Feng, Z; Gao, H; Huang, R; Li, Z; Liang, X; Lin, T; Liu, S; Ma, J; Wang, X; Xu, L; Zhang, L, 2020
)
0.56
" Pharmacokinetic sampling, urine biomarker collection [urine protein (UPCR), retinol binding protein (RBP) and β2 microglobulin (β2M) normalized to creatinine] and safety assessments occurred at the end of each phase."( Pharmacokinetics and renal safety of tenofovir alafenamide with boosted protease inhibitors and ledipasvir/sofosbuvir.
Anderson, PL; Blum, J; Brooks, KM; Bushman, LR; Castillo-Mancilla, JR; Cendali, F; Choi, YJ; Gomez, J; Haas, H; Ibrahim, ME; Johnson, B; Kiser, JJ; MaWhinney, S; Morrow, M; Roon, L; Rowan, SE; Wyles, DL; Zheng, JH, 2020
)
0.56
" Physiological changes in pregnancy alter the pharmacokinetics of some medications; thus, our aim was to compare the pharmacokinetic parameters of ledipasvir 90 mg plus sofosbuvir 400 mg during pregnancy with non-pregnant women."( Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study.
Bogen, DL; Bunge, KE; Chappell, CA; Gaggar, A; Hillier, SL; Kirby, BJ; Krans, EE; Macio, IS; Meyn, LA; Scarsi, KK; Suri, V, 2020
)
0.56
" A reference group of women who had participated in pharmacokinetic studies of ledipasvir-sofosbuvir during phase 2 and 3 trials was used."( Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study.
Bogen, DL; Bunge, KE; Chappell, CA; Gaggar, A; Hillier, SL; Kirby, BJ; Krans, EE; Macio, IS; Meyn, LA; Scarsi, KK; Suri, V, 2020
)
0.56
" This study aimed to evaluate the pharmacokinetic interaction of atorvastatin and fixed-dose combination of sofosbuvir/ledipasvir "FDCSL" with rationalization to the underlying mechanism."( Pharmacokinetic interaction between atorvastatin and fixed-dose combination of sofosbuvir/ledipasvir in healthy male Egyptian volunteers.
Abdelaziz, AE; Abdelkawy, KS; Ali, AA; Belal, F; Elbarbry, F; Elmekawy, HA, 2021
)
0.62
" This calls for a deep investigation of CMD effects on the pharmacokinetic parameters of these drugs to ensure their safety and efficacy."( In-depth investigation of the Silymarin effect on the pharmacokinetic parameters of sofosbuvir, GS-331007 and ledipasvir in rat plasma using LC-MS.
Abdine, HH; Aboras, SI; El-Yazbi, AF; Korany, MA; Ragab, MAA, 2022
)
0.72
" For this reason, inhibitors, or inducers of intestinal P-gp may alter the plasma concentration of sofosbuvir and increase or decrease its efficacy causing a significant change in its pharmacokinetic parameters."( Effects of aged garlic and ginkgo biloba extracts on the pharmacokinetics of sofosbuvir in rats.
El-Demerdash, E; Saeed, NM; Wahdan, SA; Wasef, AK, 2022
)
0.72
"This case report describes a pharmacokinetic drug-drug interaction between crizotinib, a tyrosine kinase inhibitor, and sofosbuvir/velpatasvir, a direct-acting antiviral drug, leading to cardiac toxicity."( Cardiac toxicity associated with pharmacokinetic drug-drug interaction between crizotinib and sofosbuvir/velpatasvir: A case report.
Batista, R; Blanchet, B; Cabanes, L; Chouchana, L; Goldwasser, F; Huillard, O; Khoudour, N; Monribot, A; Pallet, N; Préta, LH; Sogni, P; Thomas-Schoemann, A, 2023
)
0.91

Compound-Compound Interactions

Daclatasvir (DCV) is a potent, pangenotypic nonstructural protein 5A inhibitor with demonstrated antiviral efficacy. Study was to report on possible drug-drug interactions between ledipasvir/sofosbuvir and other medications received by children and adolescents with hepatitis C virus.

ExcerptReferenceRelevance
" 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
"The objectives were to (1) compare the frequency of contraindicated drug-drug interactions (XDDI) when simeprevir (SIM)- and sofosbuvir (SOF)-containing regimens are theoretically added to a patient's medication profile; (2) identify which hepatitis C (HCV) regimen is associated with the lowest frequency of XDDIs within different types of antiretroviral treatment (ART) regimens; and (3) determine the risk factors for XDDIs with each regimen."( Prevalence of drug-drug interactions upon addition of simeprevir- or sofosbuvir-containing treatment to medication profiles of patients with HIV and hepatitis C coinfection.
Amin, R; Koroglu, A; McGuey, L; McNutt, LA; Miller, C; Nasiri, M; Patel, N; Roman, M, 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
" This phase 1, drug-drug interaction, open-label, multiple-dose study enrolled 32 healthy subjects to receive the 3D or 2D regimen in combination with sofosbuvir."( Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir.
Awni, WM; Cohen, D; Ding, B; Dutta, S; King, JR; Menon, RM; Podsadecki, TJ, 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
" health agencies issued warning letters in response to 9 reported clinical cases of severe bradycardia/bradyarrhythmia in hepatitis C virus (HCV)-infected patients treated with sofosbuvir (SOF) in combination with other direct acting antivirals (DAAs) and the antiarrhythmic drug, amiodarone (AMIO)."( Assessment of the clinical cardiac drug-drug interaction associated with the combination of hepatitis C virus nucleotide inhibitors and amiodarone in guinea pigs and rhesus monkeys.
DeGeorge, JJ; Fitzgerald, K; Gerenser, P; Gruver, S; Morissette, P; Regan, CP; Regan, HK; Sannajust, FJ; Travis, JJ; Wen, J, 2016
)
0.43
" Here, we evaluated the ability of human induced pluripotent stem cell derived cardiomyocytes (hiPSC-CMs) to recapitulate the interaction between sofosbuvir and amiodarone in vitro, and more generally assessed the feasibility of hiPSC-CMs as a model system for drug-drug interactions."( Identification of Drug-Drug Interactions In Vitro: A Case Study Evaluating the Effects of Sofosbuvir and Amiodarone on hiPSC-Derived Cardiomyocytes.
Anson, BD; Aoyama, N; Becker, N; Carlson, CB; Fertig, N; Goetze, TA; January, CT; Juhasz, K; Millard, DC; Ross, JD; Stoelzle-Feix, S; Strock, CJ, 2016
)
0.43
"To evaluate the plasma trough concentrations ( C trough ) of dolutegravir and rilpivirine used in combination with simeprevir and sofosbuvir in HIV/hepatitis C virus (HCV)-coinfected patients with liver cirrhosis."( Pharmacokinetics of dolutegravir and rilpivirine in combination with simeprevir and sofosbuvir in HIV/hepatitis C virus-coinfected patients with liver cirrhosis.
Ariaudo, A; Bonora, S; Castagna, A; D'Avolio, A; Galli, L; Hasson, H; Lazzarin, A; Marinaro, L; Merli, M; Messina, E; Uberti-Foppa, C, 2017
)
0.46
"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
" MBL-HCV1, a neutralizing human monoclonal antibody (mAb) targeting the HCV envelope, was combined with a licensed oral direct-acting antiviral (DAA) to prevent HCV recurrence post-transplant in an open-label exploratory efficacy trial."( Prevention of allograft HCV recurrence with peri-transplant human monoclonal antibody MBL-HCV1 combined with a single oral direct-acting antiviral: A proof-of-concept study.
Boucher, E; Chapman, W; Cheslock, P; Chung, RT; Curry, MP; Mantry, P; Molrine, DC; Schiano, TD; Smith, HL; Wang, Y, 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
" No clinically relevant differences in the pharmacokinetics (PK) of SOF, SOF metabolite GS-331007, or VEL were observed other than an approximate 50% decrease in VEL exposure when administered with EFV/FTC/TDF."( Drug-Drug Interaction Studies Between Hepatitis C Virus Antivirals Sofosbuvir/Velpatasvir and Boosted and Unboosted Human Immunodeficiency Virus Antiretroviral Regimens in Healthy Volunteers.
Brainard, DM; Ling, KHJ; Mathias, A; Mogalian, E; Osinusi, A; Shen, G; Stamm, LM, 2018
)
0.48
"While direct-acting antivirals have been approved for treating hepatitis C, the guidelines highlight the importance of considering potential drug-drug interactions between DAAs and concomitant medications."( Comorbidities, concomitant medications and potential drug-drug interactions with interferon-free direct-acting antiviral agents in hepatitis C patients in Taiwan.
Brooks-Rooney, C; Chen, CY; Chen, JJ; Cheng, PN; Hsieh, TY; Huang, YH; Kao, JH; Lin, CL; Liu, CH; Lo, CC; Ma, Q; Peng, CY; Su, WW; Yu, ML, 2018
)
0.48
"To assess comorbidity prevalence, concomitant medication use and potential drug-drug interactions between DAAs and concomitant medications for hepatitis C patients in Taiwan."( Comorbidities, concomitant medications and potential drug-drug interactions with interferon-free direct-acting antiviral agents in hepatitis C patients in Taiwan.
Brooks-Rooney, C; Chen, CY; Chen, JJ; Cheng, PN; Hsieh, TY; Huang, YH; Kao, JH; Lin, CL; Liu, CH; Lo, CC; Ma, Q; Peng, CY; Su, WW; Yu, ML, 2018
)
0.48
" The potential drug-drug interactions between these concomitant medications and DAA regimens differed, with the fewest potential interactions with sofosbuvir-based regimens."( Comorbidities, concomitant medications and potential drug-drug interactions with interferon-free direct-acting antiviral agents in hepatitis C patients in Taiwan.
Brooks-Rooney, C; Chen, CY; Chen, JJ; Cheng, PN; Hsieh, TY; Huang, YH; Kao, JH; Lin, CL; Liu, CH; Lo, CC; Ma, Q; Peng, CY; Su, WW; Yu, ML, 2018
)
0.48
" The aim of this study was to report on possible drug-drug interactions between ledipasvir/sofosbuvir and other medications received by children and adolescents with hepatitis C virus, in addition to suggested management for these drug-drug interactions."( Drug-Drug Interactions in Children and Adolescents Receiving Ledipasvir/Sofosbuvir for the Treatment of Hepatitis C Virus Infection.
Abdullatif, HM; El Rasheed Abd El Zaher, BA; El Raziky, MS; El-Karaksy, HM; Ghobrial, CM; Mogahed, EA; Ramzi, R, 2019
)
0.51
" Medications were reviewed by the Kasr Alainy Drug Information Center to identify possible drug-drug interactions with prescribed ledipasvir/sofosbuvir and their management."( Drug-Drug Interactions in Children and Adolescents Receiving Ledipasvir/Sofosbuvir for the Treatment of Hepatitis C Virus Infection.
Abdullatif, HM; El Rasheed Abd El Zaher, BA; El Raziky, MS; El-Karaksy, HM; Ghobrial, CM; Mogahed, EA; Ramzi, R, 2019
)
0.51
"Early identification and prompt response to drug-drug interactions with the aid of pharmacists optimize the pharmacotherapeutic outcome and eliminate possible morbidities when using direct-acting antivirals in children and adolescents with hepatitis C virus."( Drug-Drug Interactions in Children and Adolescents Receiving Ledipasvir/Sofosbuvir for the Treatment of Hepatitis C Virus Infection.
Abdullatif, HM; El Rasheed Abd El Zaher, BA; El Raziky, MS; El-Karaksy, HM; Ghobrial, CM; Mogahed, EA; Ramzi, R, 2019
)
0.51
" The last wave of DAAs is also characterized by a lesser tendency to generate or being victim of drug-drug interactions."( Drug-drug interactions in anti-HCV therapy: a comparison among options available in Italy.
Cariti, G; Di Perri, G, 2019
)
0.51
" Nevertheless, the complicated comedications and their potential drug-drug interactions (DDIs) with DAAs might limit clinical practice in this special population."( Comedications and potential drug-drug interactions with direct-acting antivirals in hepatitis C patients on hemodialysis.
Chang, JM; Chen, SC; Chiu, YW; Chuang, WL; Dai, CY; Hsieh, MH; Hsieh, MY; Hsu, CT; Hsu, PY; Huang, CF; Huang, CI; Huang, JC; Huang, JF; Hwang, SJ; Jang, TY; Lee, JJ; Liang, PC; Lin, YH; Lin, ZY; Niu, SW; Wei, YJ; Yeh, ML; Yu, ML, 2021
)
0.62
"The increasing number of direct-acting antiviral (DAA) regimens along with limited number of subjects and co-medications involved in clinical trials results in drug-drug interactions (DDIs) with DAAs is to be determined."( Drug-drug interactions between direct-acting antivirals and co-medications: a territory-wide cohort study.
Au, CL; Chan, HL; Hui, VW; Lai, JC; Lam, ASM; Tse, YK; Wong, GL; Wong, VW; Yip, TC, 2022
)
0.72
"This case report describes a pharmacokinetic drug-drug interaction between crizotinib, a tyrosine kinase inhibitor, and sofosbuvir/velpatasvir, a direct-acting antiviral drug, leading to cardiac toxicity."( Cardiac toxicity associated with pharmacokinetic drug-drug interaction between crizotinib and sofosbuvir/velpatasvir: A case report.
Batista, R; Blanchet, B; Cabanes, L; Chouchana, L; Goldwasser, F; Huillard, O; Khoudour, N; Monribot, A; Pallet, N; Préta, LH; Sogni, P; Thomas-Schoemann, A, 2023
)
0.91

Bioavailability

A high-fat meal appeared to promote the bioavailability of sofosbuvir and the metabolite GS-566500. The increase in sofasbuvir bioavailability was more pronounced after atorvastatin intake.

ExcerptReferenceRelevance
"The present study describes synthesis of amino-decorated mesoporous silica nanoparticles (MSNs) for sustained delivery and enhanced bioavailability of sofosbuvir."( Amino-decorated mesoporous silica nanoparticles for controlled sofosbuvir delivery.
Asghar, S; Asif, M; Hussain, T; Khalid, I; Khalid, SH; Khan, IU; Khan, RU; Mehmood, Y; Shah, SU; Shahzad, Y; Yousaf, AM, 2020
)
0.56
" A high-fat meal appeared to promote the bioavailability of sofosbuvir and the metabolite GS-566500."( Evaluation of the pharmacokinetics and food intake effect of generic sofosbuvir in healthy Chinese subjects
.
Li, X; Li, Y; Liu, L; Liu, Y; Wang, Y; Xu, B; Zhang, P, 2020
)
0.56
" The increase in sofosbuvir bioavailability was more pronounced after atorvastatin intake."( Statins Increase the Bioavailability of Fixed-Dose Combination of Sofosbuvir/Ledipasvir by Inhibition of P-glycoprotein.
Abdelaziz, A; Abdelgaied, MY; Abdelkawy, KS; Belal, F; El-Khodary, NM; Elmekawy, HA, 2022
)
0.72
" This formulation would be a good alternate for the management of viral diseases with better dissolution profile, stability and improved bioavailability for the patients."( Formulation and evaluation of antiviral drug sofosbuvir fast dissolving tablets using natural super disintegrants.
Aamir, MN; Akbar Sheikh, F; Khalid, N; Khurram Syed, S; Madni, A; Munir, F; Shirazi, JH, 2022
)
0.72

Dosage Studied

In the 194 subjects treated with sofosbuvir/ribavirin, median initial ribavirin dosage was 13. Harvoni(®) dosed once daily is recommended for 24 weeks for treatment-experienced genotype 1 patients with cirrhosis.

ExcerptRelevanceReference
" Among HCV protease inhibitors, the safety, potency, and convenient dosing of simeprevir, asunaprevir, faldaprevir, and ABT-450/r were particularly highlighted."( Hepatitis C therapy: highlights from the 2012 annual meeting of the European Association for the Study of the Liver.
Barreiro, P; Fernández-Montero, JV; Poveda, E; Soriano, V; Vispo, E, 2013
)
0.39
" In addition, after oral dosing of several phosphoramidate derivatives of compound 21 to rats, substantial hepatic levels of the active triphosphate metabolite were found."( Nucleotide prodrugs of 2'-deoxy-2'-spirooxetane ribonucleosides as novel inhibitors of the HCV NS5B polymerase.
Berke, JM; Fanning, G; Hu, L; Jonckers, TH; Lachau-Durand, S; Leclercq, L; Lin, TI; Nilsson, M; Raboisson, P; Rosenquist, Å; Samuelsson, B; Simmen, K; Stoops, B; Tahri, A; Van Hoof, S; Vandekerckhove, L; Vandyck, K; Vijgen, L, 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
" 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
" Harvoni(®), a combination tablet of sofosbuvir and ledipasvir, dosed once daily is recommended for 24 weeks for treatment-experienced genotype 1 patients with cirrhosis, but 12 weeks of therapy is sufficient for all other populations."( Changing the face of hepatitis C management - the design and development of sofosbuvir.
Besur, SV; deLemos, AS; Noell, BC, 2015
)
0.42
" When surveying the DAA regimens available, efficacy, safety and tolerability of LDV/SOF is comparable or better, and LDV/SOF provides an option with convenient single-tablet, once daily, ribavirin-free dosing with relatively few significant drug-drug interactions."( Safety analysis of sofosbuvir and ledipasvir for treating hepatitis C.
Fazel, Y; Golabi, P; Lam, B; Younossi, Z, 2015
)
0.42
"Simeprevir and sofasbuvir have advantages in response rates and convenient dosage forms and frequency compared with other HCV treatments; however, they are more expensive than previous HCV therapies."( Simeprevir and sofosbuvir for treatment of hepatitis C infection.
Chopp, S; Hult, A; Klepser, M; Vanderwall, R, 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
"A once-daily dosage of ledipasvir/sofosbuvir was similarly effective in black and non-black patients with genotype 1 HCV infection."( Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.
Afdhal, N; Gitlin, N; Howell, C; Jeffers, LJ; Kowdley, K; McHutchison, JG; Muir, AJ; Pang, PS; Poulos, J; Ravendhran, N; Reddy, KR; Shiffman, ML; Sulkowski, MS; Wilder, JM; Workowski, K; Yang, JC; Zhu, Y, 2016
)
0.43
" Strategies for the management of expected and observed drug interactions consequent to the addition of simeprevir to preexisting complex medication regimens included modifications of HIV antiretroviral regimens (n = 4) and tacrolimus dosing (n = 4) and frequent monitoring of tacrolimus trough levels."( Successful sofosbuvir-based therapy in HIV/hepatitis C virus coinfected liver transplant recipients with recurrent hepatitis C virus infection.
Abecassis, MM; Brooks, H; Grant, JL; Hawkins, C; Koppe, SW; Palella, FJ; Stosor, V, 2016
)
0.43
" 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
" 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
" 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
" The efficacy of selected DAAs was determined in dose-response assays, in which the number of HCV-infected cells was measured after incubation with different concentrations of the specific DAA."( Robust HCV Genotype 3a Infectious Cell Culture System Permits Identification of Escape Variants With Resistance to Sofosbuvir.
Bukh, J; Gottwein, JM; Mikkelsen, LS; Ramirez, S, 2016
)
0.43
" Tacrolimus dosing required adjustment during and after ledipasvir-sofosbuvir therapy but antiretroviral regimens did not."( Successful Posttransplant Treatment of Hepatitis C With Ledipasvir-Sofosbuvir in HIV+ Kidney Transplant Recipients.
Blumberg, EA; Doyle, AM; Lee, DH; Sawinski, D, 2017
)
0.46
"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
" 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
" Simple, sensitive, and rapid spectrophotometric methods are presented for the determination of sofosbuvir and ledipasvir in their combined dosage form."( Spectrophotometric Methods for Simultaneous Determination of Sofosbuvir and Ledipasvir (HARVONI Tablet): Comparative Study with Two Generic Products.
Abo-Talib, NF; El-Ghobashy, MR; Tammam, MH, 2017
)
0.46
" 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
" Furthermore this method was successfully applied to the analysis of ledipasvir in pharmaceutical dosage form without interference from sofosbuvir and other additives and the results were statistically compared to a reported method and found no significant difference."( Spectroflurimetric estimation of the new antiviral agent ledipasvir in presence of sofosbuvir.
Abolmagd, E; Abouserie, AA; Attia, KA; El-Olemy, A; Salama, FM, 2018
)
0.48
" Pharmaceutical dosage form was quantified by developed methods and the results were compared with the High Performance Liquid Chromatography (HPLC) reference method."( Chemometric simultaneous determination of Sofosbuvir and Ledipasvir in pharmaceutical dosage form.
Khalili, M; Mirzabeygi, V; Sohrabi, MR; Torabi Ziaratgahi, N, 2018
)
0.48
" Geometric least squares means ratios (coadministration:alone) and 90% confidence intervals were constructed for area under the plasma concentration-time curve over the dosing interval, maximum concentration, and trough, for all analytes."( Drug-Drug Interaction Studies Between Hepatitis C Virus Antivirals Sofosbuvir/Velpatasvir and Boosted and Unboosted Human Immunodeficiency Virus Antiretroviral Regimens in Healthy Volunteers.
Brainard, DM; Ling, KHJ; Mathias, A; Mogalian, E; Osinusi, A; Shen, G; Stamm, LM, 2018
)
0.48
" 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
"DAA in adult dosage are safe and effective for treatment of chronic hepatitis C (genotype 3) in pediatric β-thalassemic major population."( Efficacy and Safety of Direct Acting Antiviral Therapy for Chronic Hepatitis C in Thalassemic Children.
Garg, K; Gupta, GK; Maharshi, S; Nijhawan, S; Padhi, S, 2018
)
0.48
"The purpose of this study was to investigate the safety, tolerability, and pharmacokinetic profile of sofosbuvir and its metabolites after a single dose of sofosbuvir 400mg and once daily dosing of sofosbuvir 400mg for 7days in healthy Chinese subjects."( Pharmacokinetics, Safety, and Tolerability of the Direct-acting Hepatitis C Antiviral Sofosbuvir in HealthyChineseSubjects.
Brainard, DM; Chen, G; Chen, H; Ding, Y; Li, X; Massetto, B; Niu, J; Shen, G; Zhang, H; Zhu, X, 2018
)
0.48
" Steady state of the major metabolite GS-331007 was achieved after 4days of consecutive dosing with sofosbuvir 400mg once daily."( Pharmacokinetics, Safety, and Tolerability of the Direct-acting Hepatitis C Antiviral Sofosbuvir in HealthyChineseSubjects.
Brainard, DM; Chen, G; Chen, H; Ding, Y; Li, X; Massetto, B; Niu, J; Shen, G; Zhang, H; Zhu, X, 2018
)
0.48
" We evaluated non-adherence (<90% adherent) as measured by electronic blister-pack assessed using logistic regression and generalised estimating equations (continuous) with detailed analyses of dosing dynamics."( Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use: The SIMPLIFY study.
Amin, J; Applegate, TL; Bruggmann, P; Bruneau, J; Conway, B; Cooper, C; Cunningham, EB; Dalgard, O; Dillon, JF; Dore, GJ; Dunlop, AJ; Feld, JJ; Fraser, C; Gane, E; Grebely, J; Hajarizadeh, B; Hellard, M; Litwin, AH; Marks, P; Matthews, GV; Norton, B; Powis, J; Quiene, S; Read, P; Shaw, D; Siriragavan, S; Thurnheer, MC; Weltman, M, 2018
)
0.48
"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
" The PK parameters of sofosbuvir and its metabolite (GS-331007) in both blood and urine samples were analyzed after dosing by the established liquid chromatography tandem mass spectrometry analytical method."( Pharmacokinetic Profile of a Generic Formulation of Sofosbuvir and Its Metabolite GS-331007 in Healthy Chinese Subjects.
Chen, G; Chen, H; Ding, Y; Li, X; Niu, J; Shen, Z; Zhang, H; Zhu, X, 2019
)
0.51
"Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population."( Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis.
Agarwal, K; Ampuero, J; Ben-Ari, Z; Borgia, SM; Brown, A; Bruck, R; Calleja, JL; Cooper, C; Cramp, ME; Dearden, J; Dvory-Sobol, H; Esteban, R; Fox, R; Foxton, M; Gane, EJ; Haider, S; Hyland, R; Kirby, BJ; Lu, S; Lurie, Y; Markova, S; Meng, A; Osinusi, AO; Rodriguez, CF; Ryder, SD; Shafran, SD; Shaw, D; Willems, B; Yoshida, EM, 2019
)
0.51
" Despite the lack of dosing recommendations, sofosbuvir-containing regimens (including sofosbuvir/velpatasvir) are frequently used for HCV-infected patients undergoing dialysis."( Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis.
Agarwal, K; Ampuero, J; Ben-Ari, Z; Borgia, SM; Brown, A; Bruck, R; Calleja, JL; Cooper, C; Cramp, ME; Dearden, J; Dvory-Sobol, H; Esteban, R; Fox, R; Foxton, M; Gane, EJ; Haider, S; Hyland, R; Kirby, BJ; Lu, S; Lurie, Y; Markova, S; Meng, A; Osinusi, AO; Rodriguez, CF; Ryder, SD; Shafran, SD; Shaw, D; Willems, B; Yoshida, EM, 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
" The method was validated according to International Conference on Harmonization guidelines, and it was successively applied for the determination of the studied drugs in their different pharmaceutical dosage forms and gave excellent percent of recovery."( Silver Nanoparticles Synthesis for Sensitive Spectrophotometric Determination of Sofosbuvir, Lamivudine, and Ritonavir in Pure Forms and Pharmaceutical Dosage Forms.
Elhenawee, M; Saleh, H; Saraya, RE, 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
"Hepatitis C direct-acting antiviraltherapy may decrease calcineurin inhibitor levels, but this was not associated with clinically different dosing requirements or rejection rates."( Effects of Sofosbuvir-Based Hepatitis C Treatment Regimens on Calcineurin Inhibitor Dosing in Liver and Kidney Transplant Recipients.
Berg, C; Byrns, J; Harris, M; Laub, M; Sanoff, S, 2021
)
0.62
"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
" Although 1 had a favorable in vitro activity profile in HCV replicons, oral dosing in dog resulted in low levels of the active 5'-triphosphate (TP) in liver."( Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
Bow, DAJ; Carr, RA; Chen, HJ; Chris Krueger, A; DeGoey, DA; Dekhtyar, T; Heyman, HR; Irvin, M; Krishnan, P; Li, T; Peterkin, V; Randolph, JT; Stolarik, D; Van Handel, C; Wagner, R, 2020
)
0.56
" Repeated dosing did not result in drug accumulation in the blood."( Evaluation of the pharmacokinetics and food intake effect of generic sofosbuvir in healthy Chinese subjects
.
Li, X; Li, Y; Liu, L; Liu, Y; Wang, Y; Xu, B; Zhang, P, 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
" The validated HPLC method was successfully used to analyze the abovementioned drugs in their pure and dosage forms without interference from common excipients present in commercial formulations."( Validated Reversed-Phase Liquid Chromatographic Method with Gradient Elution for Simultaneous Determination of the Antiviral Agents: Sofosbuvir, Ledipasvir, Daclatasvir, and Simeprevir in Their Dosage Forms.
Abo-Talib, NF; Almehizia, AA; Amr, AEE; Asiri, YA; Ezzeldin, E; Tammam, MH, 2020
)
0.56
"Two chemometric assisted spectrophotometric models were applied for the quantitative analysis of velpatasvir and sofosbuvir in their newly FDA approved pharmaceutical dosage form."( Simultaneous spectrophotometric quantitative analysis of velpatasvir and sofosbuvir in recently approved FDA pharmaceutical preparation using artificial neural networks and genetic algorithm artificial neural networks.
Abdelazim, AH; Attia, KAM; El-Abasawi, NM; El-Olemy, A; Goda, AI; Shahin, M; Zeid, AM, 2021
)
0.62
"Four chemometric assisted spectrophotometric models were developed for the quantitative analysis of velpatasvir and sofosbuvir, in their newly FDA approved pharmaceutical dosage form."( Application of different chemometric assisted models for spectrophotometric quantitative analysis of velpatasvir and sofosbuvir.
Abdelazim, AH; Abu-Khadra, AS; Shahin, M, 2021
)
0.62
" The suggested methodology has been effectively employed for the determination of the mentioned drugs in their pure forms and their pharmaceutical dosage forms as well as human plasma without significant interference of the pharmaceutical excipients or plasma components."( Feasible TLC-Spectro-Densitometry Technique for Simultaneous Determination of Two Hepatitis C Antiviral Drugs, Sofosbuvir and Simeprevir: Application to Combined Pharmaceutical Dosage Forms and Human Plasma.
Derayea, SM; Hamad, AE; Mohammed, BS, 2021
)
0.62
" 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
" This valor is even more important in the case of the combined dosage form (Darvoni® tablets) to the pharmaceutical market."( HPLC-UV and TLC-Densitometry Methods for Simultaneous Determination of Sofosbuvir and Daclatasvir: Application to Darvoni® Tablet.
Eissa, MS; Fayed, AS; Hegazy, MA; Kamel, EB, 2022
)
0.72
" This work critically reviews the recent advances in chromatographic methods for the analysis of sofosbuvir and/or its metabolites in pure samples, pharmaceutical dosage forms, and in the presence of other co-administered drugs to highlight the current status and future perspectives to enhance its determination in different matrixes."( Recent advances in the chromatographic determination of the most commonly used anti-hepatitis C drug sofosbuvir and its co-administered drugs in human plasma.
Abd El-Moghny, MG; Abdel-Tawab, MA; El Nashar, RM, 2022
)
0.72
" For this purpose, simple, sensitive, rapid, and smart spectrophotometric methods were developed and validated for the determination of these drugs in their combined dosage form."( Three Smart and Original Spectrophotometric Data Processing Ratio Techniques for Resolving the Partial Overlapped Spectra of the Binary Antiviral Mixture Daclatasvir/Sofosbuvir: Application to Combined Dosage Form Darvoni® Tablets.
Eissa, MS; Fayed, AS; Hegazy, MA; Kamel, EB, 2022
)
0.72
"Development of smart, sensitive, low-cost spectrophotometric methods for the determination of DCV and SFV in their combined dosage form."( Three Smart and Original Spectrophotometric Data Processing Ratio Techniques for Resolving the Partial Overlapped Spectra of the Binary Antiviral Mixture Daclatasvir/Sofosbuvir: Application to Combined Dosage Form Darvoni® Tablets.
Eissa, MS; Fayed, AS; Hegazy, MA; Kamel, EB, 2022
)
0.72
" They were tested on their tablet dosage form, and a good recovery was obtained."( Three Smart and Original Spectrophotometric Data Processing Ratio Techniques for Resolving the Partial Overlapped Spectra of the Binary Antiviral Mixture Daclatasvir/Sofosbuvir: Application to Combined Dosage Form Darvoni® Tablets.
Eissa, MS; Fayed, AS; Hegazy, MA; Kamel, EB, 2022
)
0.72
" This benefit is even more important in the case of the combined dosage form (Darvoni® tablets) for the pharmaceutical market."( Three Smart and Original Spectrophotometric Data Processing Ratio Techniques for Resolving the Partial Overlapped Spectra of the Binary Antiviral Mixture Daclatasvir/Sofosbuvir: Application to Combined Dosage Form Darvoni® Tablets.
Eissa, MS; Fayed, AS; Hegazy, MA; Kamel, EB, 2022
)
0.72
" Using in vitro short-term dose-response assays, these polymorphisms do not cause any reduction in sofosbuvir potency, suggesting an indirect mechanism of action in decreasing sofosbuvir efficacy."( Viral genome wide association study identifies novel hepatitis C virus polymorphisms associated with sofosbuvir treatment failure.
Ansari, MA; Barnes, E; Bowden, R; Bukh, J; Chaturvedi, N; Fellay, J; Fernandez-Antunez, C; Foster, GR; Irving, WL; Magri, A; McLauchlan, J; Pedergnana, V; Ramirez, S; Simmonds, P; Smith, DA, 2021
)
0.62
"Sofosbuvir-based direct-acting antiviral agents have no protective effects against the development of severe illness in patients with COVID-19 with the current dosing regimen."( Clinical outcomes of sofosbuvir-based antivirals in patients with COVID-19: a systematic review and meta-analysis of randomized trials.
Hasan, SS; Javed, A; Kow, CS; Ramachandram, D, 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
"A smooth, exceptionally sensitive, correct, and extra reproducible RP-HPLC technique was developed and demonstrated to estimate Sofosbuvir (SOF) in pharmaceutical dosage formulations."( RP-HPLC Method Development, Validation, and Drug Repurposing of Sofosbuvir Pharmaceutical Dosage Form: A Multidimensional Study.
Chanihoon, GQ; Jafar, TH; Khalid, Z; Maneengam, A; Mangrio, GR; Nassani, R; Unar, A, 2022
)
0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
antiviral drugA substance used in the prophylaxis or therapy of virus diseases.
hepatitis C protease inhibitorAn inhibitor of hepatitis C protease, an enzyme required for production of proteins needed for viral assembly.
metaboliteAny intermediate or product resulting from metabolism. The term 'metabolite' subsumes the classes commonly known as primary and secondary metabolites.
[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 (9)

ClassDescription
L-alanyl esterAny alpha-amino acid ester that results from the formal condensation of the carboxylic acid group of L-alanine with an alcohol.
phosphoramidate esterA phosphoric ester (phosphate) that has an NR2 instead of an OH group.
nucleotide conjugate
organofluorine compoundAn organofluorine compound is a compound containing at least one carbon-fluorine bond.
isopropyl esterAny carboxylic ester resulting from the formal condensation of a carboxylic acid with the hydroxy group of propan-2-ol.
aminopyrimidineA member of the class of pyrimidines that is pyrimidine substituted by at least one amino group and its derivatives.
nucleobase analogueA molecule that can substitute for a normal nucleobase in nucleic acids.
pyrimidoneA pyrimidine carrying one or more oxo substituents.
aromatic carboxylic acidAny carboxylic acid in which the carboxy group is directly bonded to an aromatic ring.
[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 (3)

PathwayProteinsCompounds
Gene expression (Transcription)90249
Epigenetic regulation of gene expression11717
Oxidative demethylation of DNA49

Protein Targets (8)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Cereblon isoform 4Magnetospirillum gryphiswaldenseKi24.50000.64203.94289.6000AID1685002; AID1685006
Cytochrome P450 1A2Homo sapiens (human)IC50 (µMol)100.00000.00011.774010.0000AID1449550
Cytochrome P450 3A4Homo sapiens (human)IC50 (µMol)8.40000.00011.753610.0000AID1449548
Cytochrome P450 2D6Homo sapiens (human)IC50 (µMol)100.00000.00002.015110.0000AID1449551
Cytochrome P450 2C9 Homo sapiens (human)IC50 (µMol)60.00000.00002.800510.0000AID1449549
Protein cereblonHomo sapiens (human)IC50 (µMol)1,000.00000.28601.70663.0000AID1685005
[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)15.51000.00870.54751.3000AID1558369; AID1558370
Cytochrome P450 2C9 Homo sapiens (human)EC50 (µMol)0.23000.00080.41702.3000AID1666939
RNA-directed RNA polymerase EC50 (µMol)0.14540.00180.23482.8000AID1392412; AID1445766; AID1576087; AID1614291; AID1614292; AID1614293; AID1614294; AID1614296; AID1614301; AID1614302; AID1666938; AID1666939
[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)
RNA-directed RNA polymerase EC90 (µMol)0.83430.13001.96759.9000AID1614291; AID1614292; AID1614293; AID1614294; AID1614296; AID1614301; AID1614302
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (48)

Processvia Protein(s)Taxonomy
steroid catabolic processCytochrome P450 1A2Homo sapiens (human)
porphyrin-containing compound metabolic processCytochrome P450 1A2Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 1A2Homo sapiens (human)
cholesterol metabolic processCytochrome P450 1A2Homo sapiens (human)
estrogen metabolic processCytochrome P450 1A2Homo sapiens (human)
toxin biosynthetic processCytochrome P450 1A2Homo sapiens (human)
post-embryonic developmentCytochrome P450 1A2Homo sapiens (human)
alkaloid metabolic processCytochrome P450 1A2Homo sapiens (human)
regulation of gene expressionCytochrome P450 1A2Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 1A2Homo sapiens (human)
dibenzo-p-dioxin metabolic processCytochrome P450 1A2Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 1A2Homo sapiens (human)
lung developmentCytochrome P450 1A2Homo sapiens (human)
methylationCytochrome P450 1A2Homo sapiens (human)
monocarboxylic acid metabolic processCytochrome P450 1A2Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 1A2Homo sapiens (human)
retinol metabolic processCytochrome P450 1A2Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 1A2Homo sapiens (human)
cellular respirationCytochrome P450 1A2Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 1A2Homo sapiens (human)
hydrogen peroxide biosynthetic processCytochrome P450 1A2Homo sapiens (human)
oxidative demethylationCytochrome P450 1A2Homo sapiens (human)
cellular response to cadmium ionCytochrome P450 1A2Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 1A2Homo sapiens (human)
lipid hydroxylationCytochrome P450 3A4Homo sapiens (human)
lipid metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid catabolic processCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid metabolic processCytochrome P450 3A4Homo sapiens (human)
cholesterol metabolic processCytochrome P450 3A4Homo sapiens (human)
androgen metabolic processCytochrome P450 3A4Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A4Homo sapiens (human)
alkaloid catabolic processCytochrome P450 3A4Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 3A4Homo sapiens (human)
calcitriol biosynthetic process from calciolCytochrome P450 3A4Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D metabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D catabolic processCytochrome P450 3A4Homo sapiens (human)
retinol metabolic processCytochrome P450 3A4Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A4Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 3A4Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 3A4Homo sapiens (human)
oxidative demethylationCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2D6Homo sapiens (human)
steroid metabolic processCytochrome P450 2D6Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2D6Homo sapiens (human)
estrogen metabolic processCytochrome P450 2D6Homo sapiens (human)
coumarin metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid catabolic processCytochrome P450 2D6Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2D6Homo sapiens (human)
isoquinoline alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2D6Homo sapiens (human)
retinol metabolic processCytochrome P450 2D6Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2D6Homo sapiens (human)
negative regulation of bindingCytochrome P450 2D6Homo sapiens (human)
oxidative demethylationCytochrome P450 2D6Homo sapiens (human)
negative regulation of cellular organofluorine metabolic processCytochrome P450 2D6Homo sapiens (human)
arachidonic acid metabolic processCytochrome P450 2D6Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C9 Homo sapiens (human)
steroid metabolic processCytochrome P450 2C9 Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2C9 Homo sapiens (human)
estrogen metabolic processCytochrome P450 2C9 Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C9 Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
urea metabolic processCytochrome P450 2C9 Homo sapiens (human)
monocarboxylic acid metabolic processCytochrome P450 2C9 Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C9 Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
amide metabolic processCytochrome P450 2C9 Homo sapiens (human)
icosanoid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
oxidative demethylationCytochrome P450 2C9 Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
protein ubiquitinationProtein cereblonHomo sapiens (human)
positive regulation of Wnt signaling pathwayProtein cereblonHomo sapiens (human)
negative regulation of protein-containing complex assemblyProtein cereblonHomo sapiens (human)
positive regulation of protein-containing complex assemblyProtein cereblonHomo sapiens (human)
negative regulation of monoatomic ion transmembrane transportProtein cereblonHomo sapiens (human)
locomotory exploration behaviorProtein cereblonHomo sapiens (human)
proteasome-mediated ubiquitin-dependent protein catabolic processProtein cereblonHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (35)

Processvia Protein(s)Taxonomy
monooxygenase activityCytochrome P450 1A2Homo sapiens (human)
iron ion bindingCytochrome P450 1A2Homo sapiens (human)
protein bindingCytochrome P450 1A2Homo sapiens (human)
electron transfer activityCytochrome P450 1A2Homo sapiens (human)
oxidoreductase activityCytochrome P450 1A2Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 1A2Homo sapiens (human)
enzyme bindingCytochrome P450 1A2Homo sapiens (human)
heme bindingCytochrome P450 1A2Homo sapiens (human)
demethylase activityCytochrome P450 1A2Homo sapiens (human)
caffeine oxidase activityCytochrome P450 1A2Homo sapiens (human)
aromatase activityCytochrome P450 1A2Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 1A2Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 1A2Homo sapiens (human)
hydroperoxy icosatetraenoate dehydratase activityCytochrome P450 1A2Homo sapiens (human)
monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
steroid bindingCytochrome P450 3A4Homo sapiens (human)
iron ion bindingCytochrome P450 3A4Homo sapiens (human)
protein bindingCytochrome P450 3A4Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
oxidoreductase activityCytochrome P450 3A4Homo sapiens (human)
oxygen bindingCytochrome P450 3A4Homo sapiens (human)
enzyme bindingCytochrome P450 3A4Homo sapiens (human)
heme bindingCytochrome P450 3A4Homo sapiens (human)
vitamin D3 25-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
caffeine oxidase activityCytochrome P450 3A4Homo sapiens (human)
quinine 3-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1-alpha,25-dihydroxyvitamin D3 23-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
aromatase activityCytochrome P450 3A4Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1,8-cineole 2-exo-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
monooxygenase activityCytochrome P450 2D6Homo sapiens (human)
iron ion bindingCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activityCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2D6Homo sapiens (human)
heme bindingCytochrome P450 2D6Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
iron ion bindingCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
caffeine oxidase activityCytochrome P450 2C9 Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
aromatase activityCytochrome P450 2C9 Homo sapiens (human)
heme bindingCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C9 Homo sapiens (human)
protein bindingProtein cereblonHomo sapiens (human)
transmembrane transporter bindingProtein cereblonHomo sapiens (human)
metal ion bindingProtein cereblonHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (11)

Processvia Protein(s)Taxonomy
endoplasmic reticulum membraneCytochrome P450 1A2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 1A2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 1A2Homo sapiens (human)
cytoplasmCytochrome P450 3A4Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A4Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 3A4Homo sapiens (human)
mitochondrionCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulumCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2D6Homo sapiens (human)
cytoplasmCytochrome P450 2D6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C9 Homo sapiens (human)
plasma membraneCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
cytoplasmCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
nucleusProtein cereblonHomo sapiens (human)
cytoplasmProtein cereblonHomo sapiens (human)
cytosolProtein cereblonHomo sapiens (human)
membraneProtein cereblonHomo sapiens (human)
perinuclear region of cytoplasmProtein cereblonHomo sapiens (human)
Cul4A-RING E3 ubiquitin ligase complexProtein cereblonHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (331)

Assay IDTitleYearJournalArticle
AID1783408Effect on formation of DENV replication complex in human Huh-7 cells assessed as reduction in expression of NS5 at 100 uM measured after 8 to 24 hrs by DAPI staining based confocal microscopy analysis2021European 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.
AID1614308Selectivity ratio of EC50 for HCV genotype 1b NS5B polymerase S282T mutant to EC50 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614323Mitochondrial toxicity in human HepG2 cells assessed as inhibition of nuclear ribosomal-DNA level followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1449506Cytotoxicity against African green monkey Vero cells assessed as inhibition of cell proliferation after 3 days by MTT assay2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1401643Antiviral activity against Hepatitis C virus JFH-1 infected in human HuH7 cells assessed as inhibition of viral RNA replication after 3 days by quantitative real-time RT-PCR analysis2018European journal of medicinal chemistry, Jan-01, Volume: 143Synthesis and biological evaluation of a novel β-D-2'-deoxy-2'-α-fluoro-2'-β-C-(fluoromethyl)uridine phosphoramidate prodrug for the treatment of hepatitis C virus infection.
AID1650027Stability in human plasma assessed as parent compound remaining after 4 hrs2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1614377Selectivity ratio of EC90 for HCV genotype 1a NS5B polymerase to EC90 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614298Cytotoxicity against human PBMC assessed reduction in cell viability after 5 days by MTT assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1449508Antiviral activity against HCV genotype 1b infected in human HuH7 cells assessed as inhibition of viral RNA replication after 96 hrs by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1071249Ratio of EC90 for Hepatitis C virus harboring NS5B polymerase S282T mutant gene to EC90 for Hepatitis C virus harboring wild type NS5B polymerase2014Journal of medicinal chemistry, Mar-13, Volume: 57, Issue:5
Nucleotide prodrugs of 2'-deoxy-2'-spirooxetane ribonucleosides as novel inhibitors of the HCV NS5B polymerase.
AID1614363Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA level at 12.5 uM followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1649893Half life in human2019European journal of medicinal chemistry, Mar-01, Volume: 165Hepatitis C - New drugs and treatment prospects.
AID517723Antiviral activity against HCV infected in human clone A cells2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1467745Drug recovery in human urine at 100 to 800 mg2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
The ProTide Prodrug Technology: From the Concept to the Clinic.
AID517747Cytotoxicity against human CEM cells assessed as inhibition of ribosomal DNA up to 100 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1666941Intrinsic clearance in human hepatocytes2020Bioorganic & medicinal chemistry letters, 04-01, Volume: 30, Issue:7
Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
AID1366663Cytotoxicity against human CEM cells assessed as reduction in cell viability after 6 days by trypan blue exclusion assay2017Bioorganic & medicinal chemistry letters, 12-01, Volume: 27, Issue:23
Synthesis and anti-HCV activity of a series of β-d-2'-deoxy-2'-dibromo nucleosides and their corresponding phosphoramidate prodrugs.
AID1328887Cytotoxicity against human Huh7.5.1 cells after 48 hrs by luciferase reporter gene assay2016ACS medicinal chemistry letters, Dec-08, Volume: 7, Issue:12
Discovery of 2'-α-C-Methyl-2'-β-C-fluorouridine Phosphoramidate Prodrugs as Inhibitors of Hepatitis C Virus.
AID1819072Antiviral activity against HCVcc infected in human Huh7.5 cells assessed as inhibition of viral replication2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
AID1697211Cytotoxicity against human HuH-7-Luc/Neo-ET cells2020Bioorganic & medicinal chemistry letters, 12-01, Volume: 30, Issue:23
Synthesis and biological evaluation of 5'-C-methyl nucleotide prodrugs for treating HCV infections.
AID1666942Prodrug conversion in human hepatocytes assessed as nucleotide triphosphate level at 100 uM after 4 hrs2020Bioorganic & medicinal chemistry letters, 04-01, Volume: 30, Issue:7
Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
AID1650025Aqueous solubility of compound in pH 7.4 phosphate buffer2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1614369Mitochondrial toxicity in human HepG2 cells assessed as lactic acid production at 12.5 uM followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1401642Cytotoxicity against human HuH7 cells after 72 hrs by CellTiter 96 AQueous one solution cell proliferation assay2018European journal of medicinal chemistry, Jan-01, Volume: 143Synthesis and biological evaluation of a novel β-D-2'-deoxy-2'-α-fluoro-2'-β-C-(fluoromethyl)uridine phosphoramidate prodrug for the treatment of hepatitis C virus infection.
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.
AID1650030Intrinsic clearance in dog hepatocytes2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1449523Selectivity ratio of EC90 for HCV genotype 1b harboring NS5B S282T mutant to EC90 for HCV genotype 1b harboring wild type NS5B2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
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.
AID1650021Prodrug conversion in human primary hepatocytes assessed as nucleotide triphosphate level at 100 uM incubated for 4 hrs followed by compound wash-out for 20 hrs and measured following 4 hrs incubation period by LC-MS/MS analysis2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1449548Inhibition of human CYP3A4 using ketoconazole as substrate2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1614307Selectivity ratio of EC50 for HCV genotype 1b/5a chimeric replicon NS5B polymerase to EC50 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614299Cytotoxicity against human CCRF-CEM assessed reduction in cell viability after 4 days by MTT assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1366660Antiviral activity against HCV genotype 1b infected in human HuH7 cells assessed as inhibition of viral RNA replication after 5 days by RT-PCR method2017Bioorganic & medicinal chemistry letters, 12-01, Volume: 27, Issue:23
Synthesis and anti-HCV activity of a series of β-d-2'-deoxy-2'-dibromo nucleosides and their corresponding phosphoramidate prodrugs.
AID1576087Inhibition of HCV genotype 1b NS5B RNA dependent RNA polymerase2019MedChemComm, Jun-01, Volume: 10, Issue:6
Scaffold hybridization strategy towards potent hydroxamate-based inhibitors of
AID1650012Antiviral activity against HCV genotype 4a expressing wild type NS5B infected in human HuH7 replicon cells assessed as inhibition of viral replication after 4 days by luciferase reporter gene based assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1614530Cytotoxicity against human HuH7 cells infected with HCV genotype 1b replicon after 72 hrs by CellTiter-Fluor reagent based fluorescence assay2019Bioorganic & medicinal chemistry, 03-01, Volume: 27, Issue:5
Discovery of pyrimidine nucleoside dual prodrugs and pyrazine nucleosides as novel anti-HCV agents.
AID1449551Inhibition of human CYP2D6 using quinidine as substrate2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1449510Antiviral activity against HCV genotype 2b infected in human HuH7 cells assessed as inhibition of viral RNA replication after 96 hrs by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1449521Antiviral activity against HCV genotype 1b harboring NS5B S282T mutant infected in human HuH7 cells assessed as inhibition of viral RNA replication after 4 days by luciferase reporter gene assay2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1449522Selectivity ratio of EC50 for HCV genotype 1b harboring NS5B S282T mutant to EC50 for HCV genotype 1b harboring wild type NS5B2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1614301Inhibition of NS5B polymerase in HCV genotype 1b/5a chimeric replicon infected in human HuH7 replicon cells after 5 days by RT-PCR analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1654878Antiviral activity against wild type HCV by qRT-PCR analysis based by Reed-Muench method2020Journal 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.
AID1449525Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA levels at 50 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1819075Cytotoxicity against human Huh7.5 cells carrying HCV subgenomic replicons assessed as reduction in cell viability incubated for 96 hrs by MTT assay2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
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.
AID1650009Antiviral activity against HCV genotype 2a expressing NS5B S282T mutant infected in human HuH7 replicon cells assessed as inhibition of viral replication after 4 days by luciferase reporter gene based assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1449529Mitochondrial toxicity in human HepG2 cells assessed as cytochrome c oxidase subunit 2 DNA levels at 10 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1614328Cytotoxicity against human primary hepatocytes assessed as reduction in cell viability after 72 hrs by MTT assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1366662Cytotoxicity against human PBMC assessed as reduction in cell viability after 6 days by trypan blue exclusion assay2017Bioorganic & medicinal chemistry letters, 12-01, Volume: 27, Issue:23
Synthesis and anti-HCV activity of a series of β-d-2'-deoxy-2'-dibromo nucleosides and their corresponding phosphoramidate prodrugs.
AID517759Antiviral activity against HCV expressing NS5B polymerase S282T mutation infected in clone A cells2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1614302Inhibition of NS5B polymerase S282T mutant in HCV genotype 1b infected in human Huh7 replicon cells after 5 days by RT-PCR assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614389Cytotoxicity against human PBMC after 6 days by trypan blue exclusion method2019Bioorganic & medicinal chemistry, 02-15, Volume: 27, Issue:4
Synthesis and anti-HCV activity of β-d-2'-deoxy-2'-α-chloro-2'-β-fluoro and β-d-2'-deoxy-2'-α-bromo-2'-β-fluoro nucleosides and their phosphoramidate prodrugs.
AID1507860Antiviral activity against CSFV infected in SK6 cells assessed as reduction of pseudo-plaque formation after 2 days by immunoperoxidase monolayer assay2017European journal of medicinal chemistry, Sep-08, Volume: 137Novel thioglycosyl analogs of glycosyltransferase substrates as antiviral compounds against classical swine fever virus and hepatitis C virus.
AID1666938Inhibition of NS5B polymerase in HCV genotype 1a H77 infected in human HuH7 replicon cells assessed as inhibition of viral replication after 3 days by luciferase reporter gene assay2020Bioorganic & medicinal chemistry letters, 04-01, Volume: 30, Issue:7
Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
AID517748Cytotoxicity against human CEM cells assessed as inhibition of mitochondrial DNA up to 100 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1614364Mitochondrial toxicity in human HepG2 cells assessed as inhibition of nuclear ribosomal-DNA level at 12.5 uM followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
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.
AID1449504Cytotoxicity against human PBMC assessed as inhibition of cell proliferation after 5 days by MTT assay2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1654848Selectivity index, ratio of CC50 for cytotoxicity in human Huh7.5 cells assessed as reduction in cell viability incubated for 96 hrs by MTT assay to EC50 for antiviral activity against HCV J6/JFH/JC1 infected in human Huh7.5 cells incubated for 72 hrs by 2020Journal 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.
AID1819070Selectivity index, ratio of CC50 for cytotoxicity against human Huh7.5.1 cells to EC50 for antiviral activity against HCV infected in human Huh7.5.1 cells2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
AID1614300Cytotoxicity against African green monkey Vero cells assessed reduction in cell viability after 3 days by MTT assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1558370Inhibition of RNA-dependent RNA polymerase in Zika virus infected in human NPC assessed as antiviral activity by DAPI-staining based assay2020Journal of medicinal chemistry, 01-23, Volume: 63, Issue:2
Drugs for the Treatment of Zika Virus Infection.
AID1614321Mitochondrial toxicity in human HepG2 cells assessed as inhibition of nuclear ribosomal-DNA level at 50 uM followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1463884Dose normalized AUC (0 to 24 hrs) in mouse plasma assessed as 2'-C-MeU level at 10 mg/kg, po administered as single dose2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
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.
AID1328886Antiviral activity against HCV JFH-1 infected in human HuH7.5.1 cells after 48 hrs by luciferase reporter gene assay2016ACS medicinal chemistry letters, Dec-08, Volume: 7, Issue:12
Discovery of 2'-α-C-Methyl-2'-β-C-fluorouridine Phosphoramidate Prodrugs as Inhibitors of Hepatitis C Virus.
AID1599418Antiviral activity against DENV2 infected in human Huh7 cells assessed as reduction in virus yield by qRT-PCR analysis2019European journal of medicinal chemistry, Aug-15, Volume: 176Recent update on anti-dengue drug discovery.
AID1449505Cytotoxicity against human CEM cells assessed as inhibition of cell proliferation after 4 days by MTT assay2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1650007Antiviral activity against HCV genotype 1b Con1 expressing NS5B S282T mutant infected in human HuH7 replicon cells assessed as inhibition of viral replication after 4 days by luciferase reporter gene based assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1467742Fraction absorbed in po dosed portal vein cannulated dog2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
The ProTide Prodrug Technology: From the Concept to the Clinic.
AID1507864Cytotoxicity against human Huh7.5 cells assessed as reduction in cell viability after 72 hrs by MTT method2017European journal of medicinal chemistry, Sep-08, Volume: 137Novel thioglycosyl analogs of glycosyltransferase substrates as antiviral compounds against classical swine fever virus and hepatitis C virus.
AID1328888Antiviral activity against HCV infected in human Huh7 cells assessed as reduction in viral RNA replication after 4 days2016ACS medicinal chemistry letters, Dec-08, Volume: 7, Issue:12
Discovery of 2'-α-C-Methyl-2'-β-C-fluorouridine Phosphoramidate Prodrugs as Inhibitors of Hepatitis C Virus.
AID1614291Inhibition of NS5B polymerase in HCV genotype 1b/3a chimeric replicon infected in human HuH7 replicon cells after 5 days by RT-PCR analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1650003Antiviral activity against HCV genotype 1a H77 infected in human HuH7 replicon cells assessed as inhibition of viral replication after 3 days by luciferase reporter gene assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID517760Selectivity, ratio of EC90 for HCV expressing NS5B polymerase S282T mutation to EC90 for HCV expressing wild type NS5B polymerase2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1445770Half life in human liver S9 fraction at 10 uM by LC/MS/MS analysis2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Discovery of Novel Nucleotide Prodrugs with Improved Potency Against HCV Variants Carrying NS5B S282T Mutation.
AID1497245Cytotoxicity against human HepG2 cells after 96 hrs by CCK-8 assay2018Bioorganic & medicinal chemistry letters, 07-15, Volume: 28, Issue:13
Structure-activity relationship of uridine-based nucleoside phosphoramidate prodrugs for inhibition of dengue virus RNA-dependent RNA polymerase.
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.
AID1783406Effect on formation of DENV replication complex in human Huh-7 cells assessed as reduction in expression of NS3 at 100 uM measured after 8 to 24 hrs by DAPI staining based confocal microscopy analysis2021European 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.
AID1449507Antiviral activity against HCV genotype 1a infected in human HuH7 cells assessed as inhibition of viral RNA replication after 96 hrs by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1614306Selectivity ratio of EC50 for HCV genotype 1b/4a chimeric replicon NS5B polymerase to EC50 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614303Selectivity ratio of EC50 for HCV genotype 1a NS5B polymerase to EC50 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1445769Half life in human plasma at 200 uM by LC/MS/MS analysis2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Discovery of Novel Nucleotide Prodrugs with Improved Potency Against HCV Variants Carrying NS5B S282T Mutation.
AID1463883Selectivity index, ratio of CC50 for human Huh-7 cells to EC50 for HCV genotype 1b Con1 expressing NS3 protease2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1449511Antiviral activity against HCV genotype 3a infected in human HuH7 cells assessed as inhibition of viral RNA replication after 96 hrs by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1449550Inhibition of human CYP1A2 using alpha-naphthoflavone as substrate2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1449502Antiviral activity against HCV genotype 1b harboring wild type NS5B infected in human HuH7 cells assessed as inhibition of viral RNA replication after 5 days by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1666939Inhibition of NS5B polymerase in HCV genotype 1b Con1 infected in human HuH7 replicon cells assessed as inhibition of viral replication after 3 days by luciferase reporter gene assay2020Bioorganic & medicinal chemistry letters, 04-01, Volume: 30, Issue:7
Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
AID1614330Cardiotoxicity against human embryonic stem cell-induced ventricular cardiomyocytes administered on day 7 and measured on day 10 after 30 mins incubation by CellTiter Glo assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID517761Antiviral activity against HCV infected in human ET-lunet cells2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
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.
AID1650029Unbound drug level in human plasma2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
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.
AID1650026Stability in dog plasma assessed as parent compound remaining after 4 hrs2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1312842Antiviral activity against HCV genotype 3a infected in homozygous cDNA-uPA chimeric SCID mouse bearing humanized hepatocytes assessed as reduction in HCV RNA level in serum administered through oral gavage twice daily daily for 7 days by RT-PCR method2016Journal of medicinal chemistry, 06-23, Volume: 59, Issue:12
Discovery of 1-((2R,4aR,6R,7R,7aR)-2-Isopropoxy-2-oxidodihydro-4H,6H-spiro[furo[3,2-d][1,3,2]dioxaphosphinine-7,2'-oxetan]-6-yl)pyrimidine-2,4(1H,3H)-dione (JNJ-54257099), a 3'-5'-Cyclic Phosphate Ester Prodrug of 2'-Deoxy-2'-Spirooxetane Uridine Triphosp
AID1714220Antiviral activity against wild-type HCV J6/JFH/JC1 infected in human Huh7.5 cells assessed as inhibition of viral replication measured after 72 hrs by qRT-PCR analysis2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Design and Synthesis of Cajanine Analogues against Hepatitis C Virus through Down-Regulating Host Chondroitin Sulfate N-Acetylgalactosaminyltransferase 1.
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.
AID1650028Unbound drug level in dog plasma2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1654847Antiviral activity against HCV J6/JFH/JC1 infected in human Huh7.5 cells incubated for 72 hrs by In-Cell Western 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.
AID1650005Cytotoxicity against human HuH7 cells assessed as reduction in cell viability2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1463866Antiviral activity against HCV genotype 1b Con1 expressing NS3 protease infected in human Huh-7 cells assessed as reduction in viral RNA replication after 72 hrs by luciferase reporter gene assay2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1445764Inhibition of wild type NS5B in HCV genotype 1b replicon expressed in human HuH7 cells after 72 hrs by bright Glo-luciferase reporter gene assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Discovery of Novel Nucleotide Prodrugs with Improved Potency Against HCV Variants Carrying NS5B S282T Mutation.
AID1507880Antiviral activity against HCV infected in human Huh7-J17 cells assessed as inhibition of viral RNA replication after 72 hrs by bright-glo luciferase reporter assay2017European journal of medicinal chemistry, Sep-08, Volume: 137Novel thioglycosyl analogs of glycosyltransferase substrates as antiviral compounds against classical swine fever virus and hepatitis C virus.
AID1614527Antiviral activity against HCV genotype 1b replicon infected in human HuH7 cells at 20 uM after 72 hrs by bright-glo luciferase reporter gene assay relative to control2019Bioorganic & medicinal chemistry, 03-01, Volume: 27, Issue:5
Discovery of pyrimidine nucleoside dual prodrugs and pyrazine nucleosides as novel anti-HCV agents.
AID1614317Drug metabolism in human primary hepatocytes assessed as Tmax for NTP formation at 10 uM after 2 to 48 hrs by LC-MS/MS analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1467727Protein binding in human plasma2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
The ProTide Prodrug Technology: From the Concept to the Clinic.
AID1449530Mitochondrial toxicity in human HepG2 cells assessed as cytochrome c oxidase subunit 2 DNA levels at 50 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID517763Selectivity, ratio of EC90 for HCV expressing NS5B polymerase S282T mutation to EC90 for HCV expressing wild type NS5B polymerase in ET-Lunet cells2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
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.
AID1312838Antiviral activity against HCV genotype 3a infected in homozygous cDNA-uPA chimeric SCID mouse bearing humanized hepatocytes assessed as change in HCV RNA level in serum at 100 mg/kg, po qd administered through gavage for 7 days by RT-PCR method2016Journal of medicinal chemistry, 06-23, Volume: 59, Issue:12
Discovery of 1-((2R,4aR,6R,7R,7aR)-2-Isopropoxy-2-oxidodihydro-4H,6H-spiro[furo[3,2-d][1,3,2]dioxaphosphinine-7,2'-oxetan]-6-yl)pyrimidine-2,4(1H,3H)-dione (JNJ-54257099), a 3'-5'-Cyclic Phosphate Ester Prodrug of 2'-Deoxy-2'-Spirooxetane Uridine Triphosp
AID1714217Antiviral activity against HCV J6/JFH/JC1 harboring S282T mutant infected in human Huh7.5 cells assessed as inhibition of viral replication measured after 72 hrs by qRT-PCR analysis2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Design and Synthesis of Cajanine Analogues against Hepatitis C Virus through Down-Regulating Host Chondroitin Sulfate N-Acetylgalactosaminyltransferase 1.
AID1650023Antiviral activity against HCV genotype 1b Con1 over expressing CES1 infected in human HuH7 replicon cells assessed as inhibition of viral replication after 3 days by luciferase reporter gene assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1614293Inhibition of NS5B polymerase in HCV genotype 2a infected in human HuH7 replicon cells after 5 days by RT-PCR analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614388Cytotoxicity against human HuH7 cells assessed as reduction in rRNA levels after 5 days by RT-PCR analysis2019Bioorganic & medicinal chemistry, 02-15, Volume: 27, Issue:4
Synthesis and anti-HCV activity of β-d-2'-deoxy-2'-α-chloro-2'-β-fluoro and β-d-2'-deoxy-2'-α-bromo-2'-β-fluoro nucleosides and their phosphoramidate prodrugs.
AID1449528Cytotoxicity against human HepG2 cells assessed as inhibition of nuclear DNA levels measured on day 14 by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1599373Antiviral activity against DENV2 New Guinea C/PUO-218 by qRT-PCR analysis2019European journal of medicinal chemistry, Aug-15, Volume: 176Recent update on anti-dengue drug discovery.
AID1449526Cytotoxicity against human HepG2 cells assessed as inhibition of nuclear DNA levels at 50 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1366664Cytotoxicity against African green monkey Vero cells assessed as reduction in cell viability after 6 days by trypan blue exclusion assay2017Bioorganic & medicinal chemistry letters, 12-01, Volume: 27, Issue:23
Synthesis and anti-HCV activity of a series of β-d-2'-deoxy-2'-dibromo nucleosides and their corresponding phosphoramidate prodrugs.
AID1819089Selectivity index, ratio of CC50 for cytotoxicity against human Huh7.5 cells infected with HCVcc to EC50 for antiviral activity against HCVcc infected in human Huh7.5 cells2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
AID1650004Antiviral activity against HCV genotype 1b Con1 infected in human HuH7 replicon cells assessed as inhibition of viral replication after 3 days by luciferase reporter gene assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1614319Half life in human HuH7 cells at 10 uM pretreated for 24 hrs followed by change of media by LC-MS/MS analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1463892AUC (0 to t) in human hepatocytes assessed as ((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methyl tetrahydrogen triphosphate level per 10'6 cells at 10 uM after 48 to 96 hrs2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1614379Selectivity ratio of EC90 for HCV genotype 1b/3a chimeric replicon NS5B polymerase to EC90 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1312841Antiviral activity against HCV genotype 3a infected in homozygous cDNA-uPA chimeric SCID mouse bearing humanized hepatocytes assessed as reduction in HCV RNA level in serum administered through oral gavage once daily for 7 days by RT-PCR method2016Journal of medicinal chemistry, 06-23, Volume: 59, Issue:12
Discovery of 1-((2R,4aR,6R,7R,7aR)-2-Isopropoxy-2-oxidodihydro-4H,6H-spiro[furo[3,2-d][1,3,2]dioxaphosphinine-7,2'-oxetan]-6-yl)pyrimidine-2,4(1H,3H)-dione (JNJ-54257099), a 3'-5'-Cyclic Phosphate Ester Prodrug of 2'-Deoxy-2'-Spirooxetane Uridine Triphosp
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.
AID1463888Drug metabolism assessed as CES1 (unknown origin)-mediated monophosphate formation after 21 hrs relative to control2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1685006Binding affinity to Magnetospirillum gryphiswaldense cereblon isoform 4 by measuring baseline corrected normalized fluorescence by MST based assay2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Sweet and Blind Spots in E3 Ligase Ligand Space Revealed by a Thermophoresis-Based Assay.
AID1538367Antiviral activity against HCV JFH-1 harboring K78E/E2-G451R/NS3-M260K/NS5A-T462I mutant infected in human Huh7.5.1 cells after 2 days by renilla luciferase reporter gene assay2019Journal of medicinal chemistry, 04-25, Volume: 62, Issue:8
Discovery, Optimization, and Target Identification of Novel Potent Broad-Spectrum Antiviral Inhibitors.
AID1650006Antiviral activity against HCV genotype 1b Con1 expressing wild type NS5B infected in human HuH7 replicon cells assessed as inhibition of viral replication after 4 days by luciferase reporter gene based assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1666956Lipophilicity, log D of compound2020Bioorganic & medicinal chemistry letters, 04-01, Volume: 30, Issue:7
Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
AID1467741Oral bioavailability in portal vein cannulated dog2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
The ProTide Prodrug Technology: From the Concept to the Clinic.
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.
AID1650010Antiviral activity against HCV genotype 3a expressing wild type NS5B infected in human HuH7 replicon cells assessed as inhibition of viral replication after 4 days by luciferase reporter gene based assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1614381Selectivity ratio of EC90 for HCV genotype 1b/5a chimeric replicon NS5B polymerase to EC90 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1449524Cytotoxicity against human HepG2 cells assessed as inhibition of nuclear DNA levels at 10 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1497239Antiviral activity against Dengue virus 2 infected in human PBMC after 2 days post infection by plaque assay2018Bioorganic & medicinal chemistry letters, 07-15, Volume: 28, Issue:13
Structure-activity relationship of uridine-based nucleoside phosphoramidate prodrugs for inhibition of dengue virus RNA-dependent RNA polymerase.
AID1614297Cytotoxicity against human HuH7 cells assessed reduction in cell viability after 3 to 5 days by MTT assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614292Inhibition of NS5B polymerase in HCV genotype 1b/4a chimeric replicon infected in human HuH7 replicon cells after 5 days by RT-PCR analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
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.
AID1697212Therapeutic index, ratio of TC50 for human HuH-7-Luc/Neo-ET cells to EC50 for HCV infected in human HuH7-Luc/Neo-ET cells2020Bioorganic & medicinal chemistry letters, 12-01, Volume: 30, Issue:23
Synthesis and biological evaluation of 5'-C-methyl nucleotide prodrugs for treating HCV infections.
AID1366661Cytotoxicity against human HuH7 cells assessed as reduction in cell viability by MTT assay2017Bioorganic & medicinal chemistry letters, 12-01, Volume: 27, Issue:23
Synthesis and anti-HCV activity of a series of β-d-2'-deoxy-2'-dibromo nucleosides and their corresponding phosphoramidate prodrugs.
AID1649894Oral bioavailability in human2019European journal of medicinal chemistry, Mar-01, Volume: 165Hepatitis C - New drugs and treatment prospects.
AID517732Antiviral activity against HCV infected in human clone A cells assessed as inhibition of cellular rRNA replication at 50 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
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.
AID1614305Selectivity ratio of EC50 for HCV genotype 1b/3a chimeric replicon NS5B polymerase to EC50 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614526Antiviral activity against HCV genotype 1b replicon infected in human HuH7 cells after 72 hrs by bright-glo luciferase reporter gene assay2019Bioorganic & medicinal chemistry, 03-01, Volume: 27, Issue:5
Discovery of pyrimidine nucleoside dual prodrugs and pyrazine nucleosides as novel anti-HCV agents.
AID1463873AUC (0 to t) in human cardiomyocytes assessed as ((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methyl tetrahydrogen triphosphate level per 10'6 cells at 10 uM after 24 to 168 hrs2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1614329Nephrotoxicity in human HK2 cells after 72 hrs by Hoechst 33342/HCS live/dead green dye-based assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1449509Antiviral activity against HCV genotype 2a/k infected in human HuH7 cells assessed as inhibition of viral RNA replication after 96 hrs by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1467743Fraction absorbed in human2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
The ProTide Prodrug Technology: From the Concept to the Clinic.
AID1650011Antiviral activity against HCV genotype 3a expressing NS5B S282T mutant infected in human HuH7 replicon cells assessed as inhibition of viral replication after 4 days by luciferase reporter gene based assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1558283Cytotoxicity against African green monkey Vero cells2020Journal of medicinal chemistry, 01-23, Volume: 63, Issue:2
Drugs for the Treatment of Zika Virus Infection.
AID1614320Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA level at 50 uM followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1819073Antiviral activity against HCV infected in human Huh7.5 cells carrying HCV subgenomic replicons assessed as inhibition of viral replication2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
AID1449549Inhibition of human CYP2C9 using sulfaphenazole as substrate2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1467726Protein binding in plasma of patient with end stage renal disease2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
The ProTide Prodrug Technology: From the Concept to the Clinic.
AID1614391Cytotoxicity against African green monkey Vero cells after 3 days by hemocytometric method2019Bioorganic & medicinal chemistry, 02-15, Volume: 27, Issue:4
Synthesis and anti-HCV activity of β-d-2'-deoxy-2'-α-chloro-2'-β-fluoro and β-d-2'-deoxy-2'-α-bromo-2'-β-fluoro nucleosides and their phosphoramidate prodrugs.
AID1614362Half life in human hepatocytes cells at 10 uM pretreated for 12 hrs followed by change of media by LC-MS/MS analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614294Inhibition of NS5B polymerase in HCV genotype 1a infected in human HuH7 replicon cells after 5 days by RT-PCR analysis2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614380Selectivity ratio of EC90 for HCV genotype 1b/4a chimeric replicon NS5B polymerase to EC90 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1449512Antiviral activity against HCV genotype 4 infected in human HuH7 cells assessed as inhibition of viral RNA replication after 96 hrs by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1614296Inhibition of NS5B polymerase in wild type HCV genotype 1b infected in human Huh7 replicon cells after 5 days by RT-PCR assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1685005Binding affinity to human CRBN-thalidomide binding domain expressed in Escherichia coli by measuring baseline corrected normalized fluorescence by MST based assay2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Sweet and Blind Spots in E3 Ligase Ligand Space Revealed by a Thermophoresis-Based Assay.
AID1392412Inhibition of Hepatitis C virus genotype 1b NS5B RNA-dependent-RNA polymerase assessed as reduction in viral replication after 72 hrs by indirect immunofluorescence assay2018Bioorganic & medicinal chemistry, 05-15, Volume: 26, Issue:9
Design, synthesis, and structure-activity relationships of novel imidazo[4,5-c]pyridine derivatives as potent non-nucleoside inhibitors of hepatitis C virus NS5B.
AID1449552Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA levels at 25 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1654843Antiviral activity against HCV J6/JFH/JC1 infected in human Huh7.5 cells assessed as reduction in viral RNA levels incubated for 72 hrs by qRT-PCR analysis2020Journal 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.
AID1654849Selectivity index, ratio of CC50 for cytotoxicity in human Huh7.5 cells assessed as reduction in cell viability incubated for 96 hrs by MTT assay to EC50 antiviral activity against HCV J6/JFH/JC1 infected in human Huh7.5 cells assessed as reduction in vir2020Journal 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.
AID1507862Selectivity index, ratio of CC50 for SK6 cells to IC50 for CSFV2017European journal of medicinal chemistry, Sep-08, Volume: 137Novel thioglycosyl analogs of glycosyltransferase substrates as antiviral compounds against classical swine fever virus and hepatitis C virus.
AID1071250Antiviral activity against Hepatitis C virus harboring NS5B polymerase S282T mutant gene2014Journal of medicinal chemistry, Mar-13, Volume: 57, Issue:5
Nucleotide prodrugs of 2'-deoxy-2'-spirooxetane ribonucleosides as novel inhibitors of the HCV NS5B polymerase.
AID1467720Prodrug activation in human urine assessed as 2'-deoxy-2'-fluoro-2'-C-methyluridine formation at 100 to 800 mg2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
The ProTide Prodrug Technology: From the Concept to the Clinic.
AID1463889Drug metabolism assessed as CatA (unknown origin)-mediated monophosphate formation after 18 hrs relative to control2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1445766Inhibition of NS5B S282T mutant in HCV genotype 1b replicon expressed in human HuH7 cells after 72 hrs by bright Glo-luciferase reporter gene assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Discovery of Novel Nucleotide Prodrugs with Improved Potency Against HCV Variants Carrying NS5B S282T Mutation.
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.
AID517762Antiviral activity against HCV expressing NS5B polymerase S282T mutation infected in human ET-lunet cells2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1614382Selectivity ratio of EC90 for HCV genotype 1b NS5B polymerase S282T mutant to EC90 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1463891AUC (0 to t) in human Huh-7 cells assessed as ((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methyl tetrahydrogen triphosphate level per 10'6 cells at 10 uM after 24 to 72 hrs2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1666957Cytotoxicity against human HuH7 cells assessed as reduction in cell viability2020Bioorganic & medicinal chemistry letters, 04-01, Volume: 30, Issue:7
Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
AID1666943Prodrug conversion in human hepatocytes assessed as nucleotide triphosphate level at 100 uM incubated for 4 hrs followed by compound washout and further incubated in fresh media for 24 hrs2020Bioorganic & medicinal chemistry letters, 04-01, Volume: 30, Issue:7
Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
AID1614290Mitochondrial toxicity in human HepG2 cells assessed as lactic acid production at 50 uM followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1685002Binding affinity to Magnetospirillum gryphiswaldense cereblon isoform by FRET assay2021ACS medicinal chemistry letters, Jan-14, Volume: 12, Issue:1
Sweet and Blind Spots in E3 Ligase Ligand Space Revealed by a Thermophoresis-Based Assay.
AID1614322Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA level followed by medium plus drugs replenishment every 3 to 4 days for 14 days relative to control2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1614304Selectivity ratio of EC50 for HCV genotype 2a NS5B polymerase to EC50 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C 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.
AID1819069Antiviral activity against HCV infected in human Huh7.5 cells incubated for 72 hrs by in-cell western assay2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
AID1614327Cytotoxicity in human HepaRG cells assessed as reduction in cell viability incubated for 14 days by CellTiter-Glo assay2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1697210Antiviral activity against HCV subtype 1b infected in human HuH-7-Luc/Neo-ET cells by luciferase replicon-reporter gene assay2020Bioorganic & medicinal chemistry letters, 12-01, Volume: 30, Issue:23
Synthesis and biological evaluation of 5'-C-methyl nucleotide prodrugs for treating HCV infections.
AID1449554Mitochondrial toxicity in human HepG2 cells assessed as cytochrome c oxidase subunit 2 DNA levels at 25 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1666940Aqueous solubility of compound at pH 7.42020Bioorganic & medicinal chemistry letters, 04-01, Volume: 30, Issue:7
Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
AID517765Cytotoxicity against human HepG2 cells assessed as inhibition of ribosomal DNA2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
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.
AID1449527Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA levels measured on day 14 by RT-PCR method2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1445765Cytotoxicity against human HuH7 cells assessed as reduction in cell viability up to 100 uM after 72 hrs by Cell Titer-Fluor Cell assay2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Discovery of Novel Nucleotide Prodrugs with Improved Potency Against HCV Variants Carrying NS5B S282T Mutation.
AID1507865Selectivity index, ratio of CC50 for Huh7.5 cells to IC50 for HCV Jc1/JFH2017European journal of medicinal chemistry, Sep-08, Volume: 137Novel thioglycosyl analogs of glycosyltransferase substrates as antiviral compounds against classical swine fever virus and hepatitis C virus.
AID1650013Antiviral activity against HCV genotype 6a expressing wild type NS5B infected in human HuH7 replicon cells assessed as inhibition of viral replication after 4 days by luciferase reporter gene based assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
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.
AID1819080Binding affinity to HCV E1 protein at 12.5 to 200 uM by SPR analysis2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
AID1650022Prodrug conversion in human primary hepatocytes assessed as nucleotide triphosphate level at 100 uM incubated for 4 hrs and followed by compound washout for 20 hrs and measured following 24 hrs incubation period by LC-MS/MS analysis2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1614378Selectivity ratio of EC90 for HCV genotype 2a NS5B polymerase to EC90 for wild type HCV genotype 1b NS5B polymerase2019Journal of medicinal chemistry, 02-28, Volume: 62, Issue:4
Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.
AID1783348Selectivity 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 direct yield reduction ass2021European 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.
AID1449553Cytotoxicity against human HepG2 cells assessed as inhibition of nuclear DNA levels at 25 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1463886Antiviral activity against HCV genotype 1b Con1 infected in human Huh-7 cells over-expressing CES12017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1463887Drug metabolism assessed as CES1 (unknown origin)-mediated monophosphate formation after 3 hrs relative to control2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1650008Antiviral activity against HCV genotype 2a expressing wild type NS5B infected in human HuH7 replicon cells assessed as inhibition of viral replication after 4 days by luciferase reporter gene based assay2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
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.
AID1650024Distribution coefficient, logD of compound by HT-LCMS analysis2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
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.
AID1649892Inhibition of HCV NS3/4a protease2019European journal of medicinal chemistry, Mar-01, Volume: 165Hepatitis C - New drugs and treatment prospects.
AID1312834Antiviral activity against HCV genotype 1a infected in homozygous cDNA-uPA chimeric SCID mouse bearing humanized hepatocytes assessed as change in HCV RNA level in serum at 100 mg/kg, po qd administered through gavage for 7 days by RT-PCR method2016Journal of medicinal chemistry, 06-23, Volume: 59, Issue:12
Discovery of 1-((2R,4aR,6R,7R,7aR)-2-Isopropoxy-2-oxidodihydro-4H,6H-spiro[furo[3,2-d][1,3,2]dioxaphosphinine-7,2'-oxetan]-6-yl)pyrimidine-2,4(1H,3H)-dione (JNJ-54257099), a 3'-5'-Cyclic Phosphate Ester Prodrug of 2'-Deoxy-2'-Spirooxetane Uridine Triphosp
AID1071252Antiviral activity against Hepatitis C virus genotype 1b in human Huh7-luc clone ET replicon cells assessed as inhibition of replicon replication after 3 days by luciferase assay2014Journal of medicinal chemistry, Mar-13, Volume: 57, Issue:5
Nucleotide prodrugs of 2'-deoxy-2'-spirooxetane ribonucleosides as novel inhibitors of the HCV NS5B polymerase.
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.
AID1558369Inhibition of RNA-dependent RNA polymerase in Zika virus infected in African green monkey Vero cells assessed as antiviral activity by DAPI-staining based assay2020Journal of medicinal chemistry, 01-23, Volume: 63, Issue:2
Drugs for the Treatment of Zika Virus Infection.
AID517764Cytotoxicity against human HepG2 cells assessed as inhibition of mitochondrial DNA2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1650031Intrinsic clearance in human hepatocytes2020Bioorganic & medicinal chemistry, 01-01, Volume: 28, Issue:1
Synthesis and evaluation of 2'-dihalo ribonucleotide prodrugs with activity against hepatitis C virus.
AID1463885Dose normalized AUC (0 to 24 hrs) in mouse liver assessed as 2'-C-MeUTP level at 10 mg/kg, po administered as single dose2017Bioorganic & medicinal chemistry letters, 09-15, Volume: 27, Issue:18
The discovery of IDX21437: Design, synthesis and antiviral evaluation of 2'-α-chloro-2'-β-C-methyl branched uridine pronucleotides as potent liver-targeted HCV polymerase inhibitors.
AID1666937Half life in human hepatocytes2020Bioorganic & medicinal chemistry letters, 04-01, Volume: 30, Issue:7
Discovery of 2-aminoisobutyric acid ethyl ester (AIBEE) phosphoramidate prodrugs for delivering nucleoside HCV NS5B polymerase inhibitors.
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.
AID1614387Antiviral activity against HCV genotype 1b subgenomic replicon infected in human HuH7 clone B cells assessed as inhibition of viral RNA replication after 5 days by RT-PCR method2019Bioorganic & medicinal chemistry, 02-15, Volume: 27, Issue:4
Synthesis and anti-HCV activity of β-d-2'-deoxy-2'-α-chloro-2'-β-fluoro and β-d-2'-deoxy-2'-α-bromo-2'-β-fluoro nucleosides and their phosphoramidate prodrugs.
AID1714214Resistance ratio of EC50 for antiviral activity against HCV J6/JFH/JC1 harboring S282T mutant infected in human Huh7.5 cells to EC50 for antiviral activity against wild-type HCV J6/JFH/JC1 infected in human Huh7.5 cells2016Journal of medicinal chemistry, 11-23, Volume: 59, Issue:22
Design and Synthesis of Cajanine Analogues against Hepatitis C Virus through Down-Regulating Host Chondroitin Sulfate N-Acetylgalactosaminyltransferase 1.
AID1819090Antiviral activity against HCV infected in human Huh7.5 cells assessed as reduction in HCV core protein expression at 6.4 nM incubated for 72 hrs by in-cell western assay2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
AID1654881Antiviral activity against HCV expressing NS5B S282T mutant by qRT-PCR analysis based by Reed-Muench method2020Journal 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.
AID1467746Renal clearance in human at 100 to 800 mg2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
The ProTide Prodrug Technology: From the Concept to the Clinic.
AID1783410Effect on formation of DENV replication complex in human Huh-7 cells assessed as reduction in NS5 translocation into nucleus at 100 uM measured after 16 to 24 hrs by DAPI staining based confocal microscopy analysis2021European 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.
AID1449516Mitochondrial toxicity in human HepG2 cells assessed as inhibition of cytochrome c oxidase subunit 2 DNA levels at 10 uM measured on day 14 by RT-PCR method relative to nuclear beta-actin DNA levels2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1445767Ratio of EC50 for HCV genotype 1b replicon NS5B S282T mutant to EC50 for wild type HCV genotype 1b replicon NS5B2017Journal of medicinal chemistry, 07-27, Volume: 60, Issue:14
Discovery of Novel Nucleotide Prodrugs with Improved Potency Against HCV Variants Carrying NS5B S282T Mutation.
AID1783411Effect on formation of DENV replication complex in human Huh-7 cells assessed as reduction NS3 translocation into cytoplasm at 100 uM measured after 16 to 24 hrs by DAPI staining based confocal microscopy analysis2021European 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.
AID1507863Antiviral activity against HCV Jc1/JFH infected in human Huh7.5 cells assessed as reduction of pseudo-plaque formation after 72 hrs by immunoperoxidase monolayer assay2017European journal of medicinal chemistry, Sep-08, Volume: 137Novel thioglycosyl analogs of glycosyltransferase substrates as antiviral compounds against classical swine fever virus and hepatitis C virus.
AID1507881Cytotoxicity against human Huh7-J17 cells assessed as decrease in cell viability after 72 hrs by MTT assay2017European journal of medicinal chemistry, Sep-08, Volume: 137Novel thioglycosyl analogs of glycosyltransferase substrates as antiviral compounds against classical swine fever virus and hepatitis C virus.
AID1819074Cytotoxicity against human Huh7.5 cells infected with HCVcc assessed as reduction in cell viability incubated for 96 hrs by MTT assay2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
AID1654845Cytotoxicity in human Huh7.5 cells assessed as reduction in cell viability incubated for 96 hrs by MTT 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.
AID1879226Antiviral activity against HCV by replicon assay2022Bioorganic & medicinal chemistry letters, 04-01, Volume: 61Design, chemical synthesis and antiviral evaluation of 2'-deoxy-2'-fluoro-2'-C-methyl-4'-thionucleosides.
AID1558371Cytotoxicity against human Neural progenitor cells2020Journal of medicinal chemistry, 01-23, Volume: 63, Issue:2
Drugs for the Treatment of Zika Virus Infection.
AID1449503Cytotoxicity against human HuH7 cells assessed as inhibition of cell proliferation after 4 days by MTS assay2017Journal of medicinal chemistry, 07-13, Volume: 60, Issue:13
2'-Chloro,2'-fluoro Ribonucleotide Prodrugs with Potent Pan-genotypic Activity against Hepatitis C Virus Replication in Culture.
AID1467744Tmax in po dosed human2018Journal of medicinal chemistry, 03-22, Volume: 61, Issue:6
The ProTide Prodrug Technology: From the Concept to the Clinic.
AID1507861Cytotoxicity against SK6 cells assessed as reduction in cell viability after 2 days by MTS method2017European journal of medicinal chemistry, Sep-08, Volume: 137Novel thioglycosyl analogs of glycosyltransferase substrates as antiviral compounds against classical swine fever virus and hepatitis C virus.
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.
AID1819068Cytotoxicity against human Huh7.5 cells assessed as reduction in cell viability incubated for 96 hrs by MTT assay2022Journal of medicinal chemistry, 02-10, Volume: 65, Issue:3
Design, Synthesis, and Biological Evaluation of 2-((4-Bisarylmethyl-piperazin-1-yl)methyl)benzonitrile Derivatives as HCV Entry Inhibitors.
AID1614390Cytotoxicity against human CEM cells after 6 days by trypan blue exclusion method2019Bioorganic & medicinal chemistry, 02-15, Volume: 27, Issue:4
Synthesis and anti-HCV activity of β-d-2'-deoxy-2'-α-chloro-2'-β-fluoro and β-d-2'-deoxy-2'-α-bromo-2'-β-fluoro nucleosides and their phosphoramidate prodrugs.
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.
AID1402276Antiviral activity against HCV infected in human GS4.3 cells assessed as inhibition of viral core protein levels at 0.8 uM treated with fresh media containing compound every 2 days measured after 6 days by Western blot method2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery and evolution of aloperine derivatives as a new family of HCV inhibitors with novel mechanism.
AID517741AUC (0 to infinity) in cynomolgus monkey plasma at 50 mg/kg, po qd for 4 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547055Antiviral activity against West Nile virus New York by neutral red assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517726Cmax in rat liver assessed as 2'-F-2'-C-Methyluridine-5''-TP level at 50 mg/kg, po2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517734Tmax in dog plasma at 50 mg/kg, po qd for 4 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547296Antiviral activity against Hepatitis C virus assessed as clearance of HCV from replicon cells at 2 uM2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547285Antiviral activity against Hepatitis C virus harboring wild-type NS5B infected in human lunet cells by luciferase-based replicon assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547048Antiviral activity against Hepatitis C virus Con1 infected in human lunet cells assessed as inhibition of viral RNA replication after 4 days by luciferase reporter gene assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547076Cytotoxicity against human CEM cells assessed as effect on ribosome RNA gene level at up to 100 uM after 14 days by quantitative real-time PCR assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547290Antiviral activity against Hepatitis C virus assessed as log reduction in viral RNA at 1 uM after 3 weeks2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517731Half life in simulated gastric fluid at pH 1.2 at 50 ug/mL2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1595513Cytotoxicity against human HuH7 cells infected with HCV con1 subgenomic replicon assessed as reduction in cell viability measured after 3 days by CellTiter-blue cell viability assay2019Journal of medicinal chemistry, 05-09, Volume: 62, Issue:9
Synthesis and Anti-HCV Activities of 4'-Fluoro-2'-Substituted Uridine Triphosphates and Nucleotide Prodrugs: Discovery of 4'-Fluoro-2'- C-methyluridine 5'-Phosphoramidate Prodrug (AL-335) for the Treatment of Hepatitis C Infection.
AID517740Tmax in cynomolgus monkey plasma at 50 mg/kg, po qd for 4 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517737AUC (0 to t) in dog plasma at 50 mg/kg, po qd for 4 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1402257Antiviral activity against HCV J6/JFH/JC-1 infected in human Huh7.5 cells assessed as inhibition of NS3/4A S282T mutant levels at 0.01 to 1 uM treated with fresh media containing compound every 2 days by Western blot method2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery and evolution of aloperine derivatives as a new family of HCV inhibitors with novel mechanism.
AID1402293Antiviral activity against 22.5 to 90 IU/cell of HCV J6/JFH/JC-1 infected in human Huh7.5 cells assessed as inhibition of viral core protein levels at 0.05 uM treated with fresh media containing compound every 2 days by Western blot method2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery and evolution of aloperine derivatives as a new family of HCV inhibitors with novel mechanism.
AID1535562Cytotoxicity against human Huh7.5 cells after 72 hrs by MTT assay2019Bioorganic & medicinal chemistry, 02-01, Volume: 27, Issue:3
Harzianoic acids A and B, new natural scaffolds with inhibitory effects against hepatitis C virus.
AID547081Cytotoxicity against human erythroid progenitor cells after 14 to 16 days by colony formation assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517753Cytotoxicity against human myeloid progenitor cells after 14 to 16 hrs2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517729Half life in simulated intestinal fluid of pH 7.5 at 50 ug/mL2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547052Antiviral activity against Hepatitis C virus H77 harboring Htat protein assessed as viral RNA level by quantitative real-time PCR2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517746Cytotoxicity against HuH7 cells at 100 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1402260Antiviral activity against HCV J6/JFH/JC-1 infected in human Huh7.5 cells harboring NS3/4A S282T mutant assessed as inhibition of viral core protein levels at 0.01 to 1 uM treated with fresh media containing compound every 2 days by Western blot method2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery and evolution of aloperine derivatives as a new family of HCV inhibitors with novel mechanism.
AID547054Antiviral activity against Hepatitis C virus H772010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547063Cytotoxicity against human HepG2 cells assessed as effect on cellular GAPDH RNA level after 8 days by quantitative real-time PCR2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547091Antiviral activity against Hepatitis C virus harboring NS5B polymerase S96T/N142T mutant gene infected in human lunet cells by luciferase-based replicon assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517723Antiviral activity against HCV infected in human clone A cells2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517735AUC (0 to infinity) in dog plasma at 50 mg/kg, po qd for 4 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547051Antiviral activity against Hepatitis C virus genotype 1b harboring Ntat protein assessed as viral RNA level by quantitative real-time PCR2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID1535561Antiviral activity against HCV genotype 2a JFH/JC1 infected in human Huh7.5 cells assessed as inhibition of viral RNA replication after 72 hrs by qRT-PCR analysis2019Bioorganic & medicinal chemistry, 02-01, Volume: 27, Issue:3
Harzianoic acids A and B, new natural scaffolds with inhibitory effects against hepatitis C virus.
AID547293Antiviral activity against Hepatitis C virus assessed as inhibition of viral rebound at 2 uM after 3 weeks in presence of G4182010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547050Antiviral activity against Hepatitis C virus isolate Con1 harboring Btat protein assessed as viral RNA level by quantitative real-time PCR2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547283Antiviral activity against Hepatitis C virus harboring NS5B polymerase S282T mutant gene infected in human HuH7 cells by luciferase-based replicon assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547060Antiviral activity against Hepatitis B virus infected in human HepAD38 cells by quantitative real-time PCR2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547282Antiviral activity against Hepatitis C virus harboring wild-type NS5B infected in human HuH7 cells by luciferase-based replicon assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547080Cytotoxicity against human CEM cells assessed as inhibition of mitochondrial DNA synthesis2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547291Antiviral activity against Hepatitis C virus assessed as log reduction in viral RNA at 2 uM after 3 weeks2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547068Cytotoxicity against human HeLaP4 cells2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547077Cytotoxicity against human HepG2 cells2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547284Selectivity ratio of EC90 for Hepatitis C virus harboring NS5B polymerase S282T mutant gene to EC90 for Hepatitis C virus harboring wild-type NS5B polymerase2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID1402275Antiviral activity against HCV infected in human GS4.3 cells assessed as inhibition of NS3/4A levels at 0.8 uM treated with fresh media containing compound every 2 days measured after 6 days by Western blot method2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery and evolution of aloperine derivatives as a new family of HCV inhibitors with novel mechanism.
AID517751Cytotoxicity against human CEM cells at 100 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1535563Selectivity index, ratio of CC50 for human Huh7.5 cells to EC50 for antiviral activity against HCV genotype 2a JFH/JC1 infected in human Huh7.5 cells2019Bioorganic & medicinal chemistry, 02-01, Volume: 27, Issue:3
Harzianoic acids A and B, new natural scaffolds with inhibitory effects against hepatitis C virus.
AID517754Toxicity in rat assessed as mortality at 50 to 1800 mg/kg, po after 14 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547065Cytotoxicity against human CEM cells assessed as effect on cellular GAPDH RNA level after 8 days by quantitative real-time PCR2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517738Metabolic stability in dog liver assessed as 2'-F-2'-C-Methyluridine-5''-triphosphate level at 50 mg/kg, po2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID1595512Antiviral activity against HCV con1 subgenomic replicon infected in human HuH7 cells assessed as reduction in viral RNA replication by qRT-PCR analysis2019Journal of medicinal chemistry, 05-09, Volume: 62, Issue:9
Synthesis and Anti-HCV Activities of 4'-Fluoro-2'-Substituted Uridine Triphosphates and Nucleotide Prodrugs: Discovery of 4'-Fluoro-2'- C-methyluridine 5'-Phosphoramidate Prodrug (AL-335) for the Treatment of Hepatitis C Infection.
AID547062Cytotoxicity against human HuH7 cells assessed as effect on cellular GAPDH RNA level after 8 days by quantitative real-time PCR2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547053Antiviral activity against Hepatitis C virus JFH1 assessed as viral RNA level by quantitative real-time PCR2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547082Cytotoxicity against human myeloid progenitor cells after 14 to 16 days by colony formation assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547064Cytotoxicity against human BxPC3 cells assessed as effect on cellular GAPDH RNA level after 8 days by quantitative real-time PCR2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547056Antiviral activity against Yellow fever virus 17D by neutral red assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517727Tmax in rat liver assessed as 2'-F-2'-C-Methyluridine-5''-TP level at 50 mg/kg, po2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517725AUC (0 to t) in rat liver assessed as 2'-F-2'-C-Methyluridine-5''-TP level at 50 mg/kg, po2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547066Cytotoxicity against HFF2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517742AUC (0 to t) in cynomolgus monkey plasma at 50 mg/kg, po qd for 4 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517755Toxicity in rat assessed as change in body weight at 50 to 1800 mg/kg, po after 14 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547286Antiviral activity against Hepatitis C virus harboring NS5B polymerase S96T mutant gene infected in human lunet cells by luciferase-based replicon assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547049Antiviral activity against Hepatitis C virus isolate Con1 infected in human HuH-7 cells assessed as inhibition of viral RNA replication after 4 days by luciferase reporter gene assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517733Cmax in dog plasma at 50 mg/kg, po qd for 4 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517743Metabolic stability in cynomolgus monkey liver assessed as prodrug level at 50 mg/kg, po2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517745Permeability by PAMPA assay2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547289Antiviral activity against Hepatitis C virus assessed as log reduction in viral RNA at 0.1 uM after 3 weeks2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547292Antiviral activity against Hepatitis C virus assessed as inhibition of viral rebound at 1 uM after 3 weeks in presence of G4182010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517752Cytotoxicity against human erythroid progenitor cells after 14 to 16 hrs2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547057Antiviral activity against Influenza A virus (A/Brisbane/59/2007 (H1N1)) infected in HFF by neutral red assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517724AUC (0 to infinity) in rat liver assessed as 2'-F-2'-C-Methyluridine-5''-TP level at 50 mg/kg, po2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547079Cytotoxicity against human HepG2 cells assessed as inhibition of mitochondrial DNA synthesis2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547078Cytotoxicity against human CEM cells2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517757Toxicity in rat assessed as change in kidney weight at 50 to 1800 mg/kg, po after 14 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517750Cytotoxicity against human BxPC3 cells at 100 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517728Half life in human liver S9 fraction at 100 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517730Half life in human plasma at 100 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517744Metabolic stability in cynomolgus monkey liver assessed as 2'-F-2'-C-Methyluridine-5''-triphosphate level at 50 mg/kg, po2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID517758Toxicity in rat assessed as change in macroscopic pathology at 50 to 1800 mg/kg, po after 14 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547295Antiviral activity against Hepatitis C virus assessed as clearance of HCV from replicon cells at 1 uM2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517732Antiviral activity against HCV infected in human clone A cells assessed as inhibition of cellular rRNA replication at 50 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547089Inhibition of human RNA polymerase at 2 uM2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547061Antiviral activity against HIV infected in human HeLaP4 cells by beta-galactosidase-based reporter gene assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID1294756Antiviral activity against HCV subtype 1b by replicon assay2016European journal of medicinal chemistry, Jun-10, Volume: 115Design, synthesis and biological evaluation of pyrido[2,3-d]pyrimidin-7-(8H)-ones as HCV inhibitors.
AID517736Metabolic stability in dog liver assessed as prodrug level at 50 mg/kg, po2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547073Mitochondrial toxicity in human HepG2 cells assessed as effect on mitochondrial cytochrome c oxidase subunit 2 gene level up to 100 uM after 14 days by real-time PCR assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517739Cmax in cynomolgus monkey plasma at 50 mg/kg, po qd for 4 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547075Cytotoxicity against human HepG2 cells assessed as effect on ribosome RNA gene level at up to 100 uM after 14 days by quantitative real-time PCR assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID1402292Antiviral activity against 22.5 to 90 IU/cell of HCV J6/JFH/JC-1 infected in human Huh7.5 cells assessed as inhibition of NS3/4A levels at 0.05 uM treated with fresh media containing compound every 2 days by Western blot method2018European journal of medicinal chemistry, Jan-01, Volume: 143Discovery and evolution of aloperine derivatives as a new family of HCV inhibitors with novel mechanism.
AID547058Antiviral activity against Influenza A virus (A/Viet Nam/1203/2004(H5N1)) infected in HFF by neutral red assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517756Toxicity in rat assessed as change in liver weight at 50 to 1800 mg/kg, po after 14 days2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547059Antiviral activity against Influenza A virus (A/Brisbane/10/2007(H3N2)) infected in HFF by neutral red assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547074Mitochondrial toxicity in human CEM cells assessed as effect on mitochondrial cytochrome c oxidase subunit 2 gene level up to 100 uM after 14 days by quantitative real-time PCR assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID547287Selectivity ratio of EC90 for Hepatitis C virus harboring NS5B polymerase S96T mutant gene to EC90 for HCV harboring wild type NS5B polymerase2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
AID517749Cytotoxicity against human HepG2 cells at 100 uM2010Journal of medicinal chemistry, Oct-14, Volume: 53, Issue:19
Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.
AID547067Cytotoxicity against human HepAD38 cells2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
PSI-7851, a pronucleotide of beta-D-2'-deoxy-2'-fluoro-2'-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,186)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's1615 (73.88)24.3611
2020's571 (26.12)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 79.73

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index79.73 (24.57)
Research Supply Index4.77 (2.92)
Research Growth Index4.56 (4.65)
Search Engine Demand Index138.51 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (79.73)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials318 (14.70%)5.53%
Trials0 (0.00%)5.53%
Trials0 (0.00%)5.53%
Reviews243 (11.23%)6.00%
Reviews0 (0.00%)6.00%
Reviews16 (13.68%)6.00%
Case Studies239 (11.04%)4.05%
Case Studies0 (0.00%)4.05%
Case Studies0 (0.00%)4.05%
Observational146 (6.75%)0.25%
Observational0 (0.00%)0.25%
Observational0 (0.00%)0.25%
Other1,218 (56.28%)84.16%
Other6 (100.00%)84.16%
Other101 (86.32%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (322)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Lung Transplantation Using Hepatitis C Positive Donors to Hepatitis C Negative Recipients: A Pilot Study [NCT03112044]Early Phase 126 participants (Actual)Interventional2017-09-19Active, not recruiting
The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4 [NCT03743727]Phase 425 participants (Anticipated)Interventional2018-08-01Recruiting
A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study [NCT03236506]Phase 2129 participants (Actual)Interventional2018-01-19Completed
Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (CUTTS HepC): a Non-randomised, Quasiexperimental, Prospective Comparative Trial [NCT06159504]Early Phase 13,040 participants (Anticipated)Interventional2024-03-31Not yet recruiting
Management of Hepatitis C Virus (HCV) Infection in Pregnant Women With Opioid Use Disorder (OUD): the Potential of an Integrated Medical Home Model: Phase IV Trial of Sofosbuvir/Velpatasvir (SOF/VEL) in Postpartum Women With Chronic HCV [NCT03057847]Phase 432 participants (Actual)Interventional2018-01-30Completed
Pharmacokinetics of Low-dose Sofosbuvir in Dialysis-dependent Patients With Hepatitis C Virus Infection [NCT03883698]Phase 330 participants (Actual)Interventional2019-03-15Completed
Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection [NCT03646396]40 participants (Anticipated)Interventional2018-08-01Recruiting
Role of Pegylated Interferon in Combination With Direct Acting Antivirals (DAAs) to Cure Hepatitis C As Soon As Possible (ASAP) - Hepatitis C [ASAP-C] [NCT03480932]Phase 2/Phase 3150 participants (Actual)Interventional2018-02-02Completed
Evaluation of the Natural History and Vertical Transmission of Chronic Hepatitis C Virus Infection in Pregnancy With Targeted Elimination by Postpartum Treatment [NCT03570112]150 participants (Anticipated)Observational2018-06-08Recruiting
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 Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations Who Are HCV Treatment Naïve With Evidence of Active HCV Infection: The MINMON Stud [NCT03512210]Phase 4400 participants (Actual)Interventional2018-10-22Completed
A Phase 3 Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection and Compensated Cirrhosis [NCT04112303]Phase 337 participants (Actual)Interventional2019-10-16Completed
The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia [NCT03169348]50 participants (Anticipated)Interventional2017-11-01Recruiting
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis [NCT02994056]Phase 232 participants (Actual)Interventional2017-01-23Completed
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
A Randomized Study of a Rapid HCV Treatment Initiation Strategy (HCV Seek, Test and Rapid Treatment) Compared to Standard Care in Young People Who Inject Drugs [NCT03627546]Phase 439 participants (Actual)Interventional2018-09-18Completed
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease [NCT03036852]Phase 259 participants (Actual)Interventional2017-03-22Completed
A Multicenter, Open-label Study of Harvoni ® (Sofosbuvir Ledipasvir Fixed Dose Combination) in Subjects Infected With Chronic Hepatitis C and Advanced Heart Failure or Lung Disease [NCT02858180]Phase 415 participants (Actual)Interventional2016-12-31Completed
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection [NCT03074331]Phase 3130 participants (Actual)Interventional2017-03-23Completed
Bridging Care to HCV Treatment Among Opiate Dependent Patients on Buprenorphine/Naloxone Maintenance Therapy: A Pilot Study of Treating HCV With Epclusa at a Psychiatrist-staffed Outpatient Addiction Clinic [NCT03235154]Phase 411 participants (Actual)Interventional2017-10-11Completed
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
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
Multicenter Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir Fix Dose combination_The HepNet Acute HCV-V Study [NCT03818308]Phase 220 participants (Actual)Interventional2019-05-28Completed
Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital [NCT03965286]80 participants (Anticipated)Observational2019-06-01Not yet recruiting
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
Outcome of New Direct Acting Agents For Hepatitis C [NCT02485262]340 participants (Anticipated)Observational [Patient Registry]2013-11-30Recruiting
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
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
The Relationship Between Direct Acting Antiviral Treatment Effect and Myeloid-Derived Suppressor Cells and NK Cells Activity in Chronic Hepatitis C [NCT03188276]Early Phase 152 participants (Actual)Interventional2016-02-01Completed
A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of an 8-Week and 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection With and Witho [NCT02253550]Phase 230 participants (Anticipated)Interventional2014-10-31Completed
Evaluation of Vitamin D and Iron Status in Chronic Hepatitis C Virus Patients Before and After Treatment [NCT03166280]87 participants (Anticipated)Observational2017-06-30Not yet recruiting
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects With Genotype 1, 4, 5 and 6 Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease [NCT03036839]Phase 295 participants (Actual)Interventional2017-06-27Completed
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection [NCT03022981]Phase 2216 participants (Actual)Interventional2017-01-26Completed
A Multicenter, Single-arm, Open-label Study to Investigate the Efficacy and Safety of Yimitasvir Phosphate (DAG181)/Sofosbuvir(SOF) Combination for 12 Weeks in Subjects With Chronic Genotype 1 HCV Infection [NCT03487107]Phase 3362 participants (Actual)Interventional2018-04-17Completed
Does Directly Acting Antivirals Usage Affect HCV Related Hepatocellular Carcinoma Recurrence After Percutaneous Ablation: A Randomized Controlled Trial [NCT04653818]Phase 484 participants (Actual)Interventional2020-10-05Completed
Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet [NCT03389061]Phase 40 participants (Actual)Interventional2018-04-01Withdrawn(stopped due to Lack of patients who are eligible for inclusion: less patients on treatment and not using epclusa.)
Efficacy of a Fixed-Dose Combination Pill of Sofosbuvir and Daclatasvir in Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus [NCT03369327]Phase 3232 participants (Actual)Interventional2017-01-01Completed
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
Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir (GS-5885) Fixed-dose Combination in NS3/4A Protease Inhibitor-experienced Subjects With HCV Genotype 1 Infection and HIV Co-infection [NCT02125500]Phase 268 participants (Actual)Interventional2014-08-31Completed
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Switch Followed by Sofosbuvir/Velpatasvir (SOF/VEL) Antiviral HCV Therapy Followed by Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Simplification in HIV-HCV [NCT03549312]Phase 425 participants (Anticipated)Interventional2018-02-01Recruiting
Monitoring of Hepatitis C Therapy Using Telemedicine in a Simplified Protocol With Pangenotypic Regimen in Non-cirrhotic Patients - a Single Group Clinical Trial in the National Public Health System in Brazil [NCT04039698]144 participants (Actual)Interventional2019-08-23Active, not recruiting
A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis [NCT02781558]Phase 2204 participants (Actual)Interventional2016-07-29Completed
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infect [NCT02639338]Phase 3220 participants (Actual)Interventional2015-12-23Completed
An Open Label, Pilot Study to Investigate the Safety and Efficacy of 12 Weeks of Simeprevir and Sofosbuvir, for HIV-infected, HCV Genotype 1 Patients With Advanced Fibrosis [NCT02206932]Phase 40 participants (Actual)Interventional2014-08-31Withdrawn(stopped due to never opened)
The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin [NCT01329978]Phase 2332 participants (Actual)Interventional2011-03-31Completed
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
Effect of Direct-acting Antiviral Drugs on Erectile Function Among Hepatitis c Patients [NCT03444272]Phase 3105 participants (Anticipated)Interventional2018-01-01Recruiting
Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine [NCT04038320]868 participants (Actual)Observational2018-03-26Completed
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs [NCT03981211]60 participants (Anticipated)Interventional2021-02-12Recruiting
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
Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study) [NCT05016609]Phase 41,800 participants (Anticipated)Interventional2022-03-09Recruiting
Open Label Study to Evaluate the Safety and Pharmacokinetics of Elpida® in Healthy Subjects and Patients With Hepatic Impairment, as Well as to Assess the Impact of Food Intake and Drug-Drug Interactions in Case of Co-administration With Other Antiviral D [NCT03706898]Phase 136 participants (Actual)Interventional2018-10-01Completed
Measuring Inflammation Cells (CD163 and CD206) With the Purpose of Examining Reduction of Fibrosis in the Liver of Chronic Hepatitis C Patients Following Treatment With the Medication Sofosbuvir [NCT02528461]71 participants (Actual)Observational2015-01-31Completed
Evaluation of Efficacy and Safety of KW-136 Capsule Combined With Sofosbuvir Tablet for Treatment of Adult Chronic Hepatitis C: an Open-label, Multi-center, Phase 3 Study [NCT03995485]Phase 3371 participants (Actual)Interventional2017-06-07Completed
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
PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver [NCT03619837]Phase 4122 participants (Actual)Interventional2018-07-15Completed
Efficacy of Adding Sofosbuvir/Ledipasvir Combination, or Nitazoxanide to the Standard of Care in Treatment of COVID-19: A Randomized Controlled Trial [NCT04498936]Phase 4240 participants (Actual)Interventional2020-07-15Completed
Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents [NCT03343444]Phase 380 participants (Anticipated)Interventional2017-04-15Enrolling by invitation
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination Therapy in Treatment of Chronic Hepatitis C Infection in Egyptian Children With Gaucher Disease [NCT03721627]Phase 410 participants (Anticipated)Interventional2018-04-03Recruiting
An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient [NCT03801707]Phase 2/Phase 354 participants (Actual)Interventional2019-03-22Completed
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland) [NCT02491450]Phase 124 participants (Actual)Interventional2015-02-28Completed
Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients [NCT02480686]Phase 432 participants (Actual)Interventional2015-01-31Completed
Effect of Triple Direct Acting Antiviral Agents (DAAs) for Non-cirrhotic Subjects With Chronic HCV G1b Infection [NCT02470858]Phase 218 participants (Actual)Interventional2015-01-31Completed
Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers [NCT03313414]Phase 40 participants (Actual)Interventional2019-08-13Withdrawn(stopped due to No participant enrollment, funding withdrawn.)
Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients [NCT03377478]Phase 110 participants (Actual)Interventional2019-07-30Completed
Phase I Pharmacokinetic and Safety Trial of Ledipasvir/Sofosbuvir Fixed Dose Combination in Pregnant Women With Chronic Hepatitis C Virus Infection [NCT02683005]Phase 19 participants (Actual)Interventional2016-09-30Completed
Direct Observed Therapy With Ledipasvir/Sofosbuvir in Treatment-naïve Patients With Chronic Genotype 1 HCV (Hepatitis C Virus) Infection Receiving Opiate Substitution Therapy [NCT02638233]Phase 440 participants (Anticipated)Interventional2015-09-30Recruiting
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 Multicenter Study to Evaluate the Anti-viral Activity of an Interferon-free Treatment With Ledipasvir/Sofosbuvir (G1 and G4) and Sofosbuvir/Velpatasvir (G2 and G3) for Patients With Hepatitis C Virus-associated Indolent B-cell Lymphomas [NCT02836925]Phase 240 participants (Actual)Interventional2016-03-31Completed
A Prospective, Non-Interventional Cohort Study of Approved Sofosbuvir-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice [NCT02783976]25 participants (Actual)Observational2016-10-28Completed
A Phase IV Open-label Multicentre International Pilot Study of 4-week Treatment With Sofosbuvir (400 mg) Plus Glecaprevir/Pibrentasvir (300mg/120mg) in Chronic HCV Treatment naïve Patients With Early Liver Disease [NCT03855917]Phase 430 participants (Anticipated)Interventional2020-02-11Recruiting
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
The Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Naïve Children [NCT05091008]Phase 250 participants (Actual)Interventional2018-03-01Completed
Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 2 Infection [NCT02482077]Phase 4112 participants (Actual)Interventional2015-01-31Completed
Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children From 3 to Less Than 18 Years of Age With GT-1 to -6 Chronic Hepatitis C (CHC) Infection [NCT03487848]Phase 25 participants (Actual)Interventional2018-06-25Terminated(stopped due to Business objectives have changed)
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection [NCT02472886]Phase 3153 participants (Actual)Interventional2015-06-17Completed
A Pilot Study to Assess the Feasibility of Hepatitis C Virus (HCV) Treatment as Prevention With Interferon-free Direct Acting Antivirals (DAAs) in the Prison Setting [NCT02064049]Phase 43,692 participants (Actual)Interventional2014-10-31Completed
Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient [NCT03093740]Phase 40 participants (Actual)Interventional2018-10-01Withdrawn(stopped due to Withdrew IRB application, never approved and no subjects enrolled)
The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China : a Mutil-center,Prospective,Single-arm,Open-label [NCT04997564]Phase 4120 participants (Anticipated)Interventional2021-08-31Recruiting
Security and Efficacy of Triple Therapy Including Direct-Acting Antivirals Against Chronic Hepatitis C Infection In HIV-Coinfected Patients In Real-Life Conditions: The Prospective HEPAVIR Cohort. [NCT02057003]1,000 participants (Anticipated)Observational2012-01-31Recruiting
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subje [NCT02607800]Phase 3943 participants (Actual)Interventional2015-11-16Completed
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
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Subjects With Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects With Chronic Hepatitis C Recurrence [NCT02161939]0 participants Expanded AccessNo longer available
Therapy for Hepatitis C Virus (HCV) in Primary Treatment Failure in Pakistan [NCT05248919]318 participants (Anticipated)Interventional2023-06-01Enrolling by invitation
Transplantation of Livers of Hepatitis C (HCV) Seropositive Donors to HCV Seronegative Recipients With Subsequent Therapy With Sofosbuvir/Velpatasvir (Epclusa®) [NCT03819322]Phase 273 participants (Actual)Interventional2019-08-15Active, not recruiting
The Treatment And Prevention (TAP) Study: Treating People Who Inject Drugs (PWID) in Community-based Settings Using a Social Network Approach [NCT02363517]Phase 3420 participants (Anticipated)Interventional2015-02-28Recruiting
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
Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy [NCT03903185]Phase 1/Phase 224 participants (Actual)Interventional2019-03-01Completed
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
Metabolic Changes in Chronic Hepatitis C Virus Patients Receiving Direct Acting Antivirals [NCT04211844]100 participants (Anticipated)Observational [Patient Registry]2019-10-01Recruiting
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods [NCT02657694]10,000 participants (Anticipated)Observational [Patient Registry]2015-07-01Enrolling by invitation
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
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC [NCT02771405]Phase 3150 participants (Anticipated)Interventional2016-03-31Recruiting
Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection [NCT02576314]Phase 348 participants (Actual)Interventional2015-05-31Completed
A Multi-center, Randomised, Open Label Study of Nitazoxanide (NTZ), or Sofosbuvir and Daclatasvir (SOF/DCV), Compared to no Pharmacological Intervention for the Prevention of COVID-19 Disease in Healthcare Workers and Inner City Inhabitants at High Risk o [NCT04561063]Phase 21,950 participants (Actual)Interventional2020-12-08Completed
A Prospective Multicenter Cohort Study: the Efficacy of Vosevi in Treating Direct Antiviral Agent Therapy Failure Patients [NCT06180590]200 participants (Anticipated)Observational2023-02-28Recruiting
A Multicenter, Prospective, Observational, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Patients With Chronic Hepatitis C Virus Infection in India [NCT02592057]532 participants (Actual)Observational2015-11-30Completed
Randomized Clinical Trial to Assess the Effectiveness of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1 (TNT-1 Study) [NCT02624063]Phase 4121 participants (Actual)Interventional2015-12-31Completed
A Phase IIa, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 2,3,6 Hepatitis C Virus Infection [NCT04111367]Phase 236 participants (Anticipated)Interventional2019-04-03Recruiting
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
Pharmacokinetics of Sofosbuvir and Ledipasvir in Hepatitis C Virus - Infected Adolescent Patients With Haematological Disorders [NCT04353986]Phase 324 participants (Anticipated)Interventional2018-06-11Recruiting
Clinical Pharmacokinetics, Safety and Efficacy Study of Daclatasvir/Sofosbuvir in Adolescents Aged 12 to 18 Years Old With Hepatitis C Virus: A Preliminary Study [NCT03540212]Phase 2/Phase 350 participants (Anticipated)Interventional2017-12-10Recruiting
Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients [NCT02555943]Phase 2/Phase 323 participants (Actual)Interventional2015-02-28Completed
Comparative Open-label,Randomized, Fasting, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Scien [NCT02953535]Phase 136 participants (Actual)Interventional2016-05-31Completed
Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon (Hepatitis Eradication Accuracy Trial of Sofosbuvir): An Observational Non-interventional Real Life Trial [NCT02804386]Phase 4573 participants (Actual)Interventional2016-06-30Completed
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience [NCT02745535]Phase 277 participants (Actual)Interventional2016-05-31Completed
Safety, Tolerability, and Outcomes of Velpatasvir/SofosbuviR in Treatment of Chronic Hepatitis C Virus During Pregnancy (STORC) [NCT05140941]Phase 4100 participants (Anticipated)Interventional2022-04-04Recruiting
Transplantation of Kidneys of Hepatitis C (HCV) Seropositive Donors to HCV Seronegative Recipients With Subsequent Therapy With Sofosbuvir/Velpatasvir (Epclusa) [NCT03809533]Phase 230 participants (Actual)Interventional2019-05-29Active, not recruiting
A Phase Ib/IIa, Single Center, Randomized, Open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability, Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects [NCT04202952]Phase 1/Phase 224 participants (Actual)Interventional2020-07-06Completed
Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria. JAILFREE-C [NCT02768961]Phase 464 participants (Actual)Interventional2016-05-10Completed
A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 1 Hepatitis C Virus Infection. [NCT04001608]Phase 3206 participants (Actual)Interventional2018-10-17Active, not recruiting
Evolution of Estimated Glomerular Filtration Rate in Chronic Hepatitis C Patients Receiving Sofosbuvir-based or Sofosbuvir-free Direct Acting Antivirals [NCT04047680]441 participants (Actual)Observational2015-02-28Completed
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 Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1) [NCT02556086]Phase 20 participants (Actual)Interventional2015-12-31Withdrawn
Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication [NCT03823911]Phase 487 participants (Actual)Interventional2018-11-18Completed
Evaluation of Liver Fibrosis by Serum Hyalornic Acid Measurement in β-Thalassemic Children Infected With Hepatitis C Virus Before and After Direct-Acting Antiviral Therapy [NCT03961828]Phase 450 participants (Actual)Interventional2017-10-01Completed
Open Label Phase II/III, Multicenter, Trial to Assess the Efficacy, Safety, Tolerance, and Pharmacokinetics of Sofosbuvir Plus Ravidasvir in HCV (+/- HIV) Chronically Infected Adults With no or Compensated Cirrhosis in Thailand and Malaysia [NCT02961426]Phase 2/Phase 3603 participants (Actual)Interventional2016-09-30Active, not recruiting
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
Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects With Chronic Hepatitis C [NCT03118674]Phase 223 participants (Actual)Interventional2017-09-06Completed
A Phase IV, Single Arm, Open-Label Study to Determine the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF) in Treatment-Naive Alcoholic Subjects With Chronic Genotype 1 Hepatitis C Infection [NCT02759861]Phase 416 participants (Actual)Interventional2016-08-01Completed
A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 Hepatitis C Infect [NCT02278419]Phase 263 participants (Actual)Interventional2014-12-31Completed
Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment [NCT04530422]Phase 3250 participants (Actual)Interventional2020-04-15Completed
Phase 2, Exploratory, Single Center, Randomized, Open Label, Adaptive Clinical Trial to Compare Safety and Efficacy of Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19 [NCT04532931]Phase 2192 participants (Actual)Interventional2020-09-03Completed
Expanding the Pool in Orthotopic Heart Transplantation: The Use of Hepatitis C Positive Donor Hearts in Hepatitis C Negative Recipients [NCT03222531]Phase 220 participants (Anticipated)Interventional2017-08-01Active, not recruiting
The Effects of Anti-Viral Therapy on the Clinical Status, Quality of Life, and Survival of Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection [NCT02597166]Phase 314 participants (Actual)Interventional2016-01-31Completed
Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection [NCT04063839]300 participants (Anticipated)Observational2015-01-31Recruiting
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 Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Na [NCT01260350]Phase 2292 participants (Actual)Interventional2010-12-31Completed
The Renal Safety and Rates of Acute Kidney Injury (AKI) in Patients With Chronic HCV Undergoing Sofosbuvir Containing Direct Acting Antiviral Therapy [NCT04169464]Phase 4200 participants (Anticipated)Interventional2019-04-01Enrolling by invitation
Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection [NCT04159246]30 participants (Anticipated)Observational2019-02-10Active, not recruiting
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
Transplanting Organs From Hepatitis C Positive Donors to Hepatitis C Uninfected Recipients [NCT03086044]Phase 4148 participants (Anticipated)Interventional2017-03-01Recruiting
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
Comparative Open-label,Randomized, Fasting, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (G [NCT02605798]Phase 124 participants (Actual)Interventional2015-08-31Completed
Pharmacokinetics, Safety, Efficacy and Acceptability Study of Daclatasvir/Sofosbuvir in Children Weighing 14-35 Kilograms With Chronic Hepatitis C Virus Infection [NCT05854511]Phase 330 participants (Anticipated)Interventional2022-06-05Recruiting
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
Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C [NCT03402165]Phase 41,200 participants (Anticipated)Interventional2017-01-01Recruiting
Drug Interaction Between RDV and SOF in ASC18 Tablets (RDV/SOF Compound Tablets) and the Influence of Food Effect on the Pharmacokinetics of ASC18 Tablets Were Evaluated in Healthy Subjects. Comparison of the Pharmacokinetic Parameters of ASC18 Tablets(Ra [NCT04358523]Phase 150 participants (Actual)Interventional2020-03-20Completed
A Multicenter, Randomized, Parallel Assigned, Open-label Study to Investigate the Efficacy and Safety of Yimitasvir Phosphate (DAG181)/Sofosbuvir(SOF) Combination for 12 Weeks in Subjects With Chronic Genotype 1 HCV Infection [NCT03458481]Phase 2129 participants (Actual)Interventional2017-07-31Completed
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
A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials [NCT02510300]461 participants (Actual)Observational [Patient Registry]2015-10-21Terminated(stopped due to The study stopped early because the study objectives were met.)
A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patie [NCT01188772]Phase 2147 participants (Actual)Interventional2010-08-31Completed
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Harvoni Treatment Regimen in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea [NCT02951364]1,081 participants (Actual)Observational2016-12-05Completed
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
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
A Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in People Who Inject Drugs and People With HIV Coinfection. [NCT02625909]Phase 3222 participants (Actual)Interventional2017-03-09Completed
A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection [NCT02250807]Phase 340 participants (Actual)Interventional2015-01-31Completed
A Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Standard of Care [NCT01054729]Phase 264 participants (Actual)Interventional2010-01-31Completed
Phase 1 Pharmacokinetic Trial of Sofosbuvir/Velpatasvir in Pregnant Women With Chronic Hepatitis C Virus Infection [NCT04382404]Phase 111 participants (Actual)Interventional2020-10-22Completed
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
SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China [NCT04948801]150 participants (Anticipated)Observational2018-12-08Recruiting
A Phase 2 Open- Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naïve Patients With Chronic HCV Genotype 3 Infection [NCT02413593]Phase 2111 participants (Actual)Interventional2015-04-30Completed
Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection [NCT02457611]Phase 226 participants (Actual)Interventional2015-06-30Completed
Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 [NCT04246723]Phase 285 participants (Actual)Interventional2019-05-06Completed
A Pilot Study to Evaluate the Safety and Efficacy of Multiple Anti-HCV Combination Therapy in Chronically Infected Hepatitis C Patients [NCT01805882]Phase 2229 participants (Actual)Interventional2013-01-31Completed
The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4 [NCT03080415]Phase 340 participants (Actual)Interventional2017-03-18Completed
Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World [NCT02964091]Phase 4300 participants (Actual)Interventional2016-10-31Completed
A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamid [NCT02707601]Phase 3150 participants (Actual)Interventional2016-04-01Completed
A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Non-Genotype 1 HCV Infection [NCT02378961]Phase 2128 participants (Actual)Interventional2015-02-16Completed
Eliminación de la infección Por el Virus de la Hepatitis C en PWID en Los Estados Del Norte de México [NCT05503979]1,000 participants (Anticipated)Observational2022-11-15Not yet recruiting
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
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
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
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination [NCT03776760]600 participants (Anticipated)Observational2019-05-28Recruiting
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
Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia [NCT02825212]Phase 2/Phase 310 participants (Actual)Interventional2016-02-29Completed
Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19) [NCT04535869]Phase 350 participants (Anticipated)Interventional2020-12-28Recruiting
A Non-randomized Trial to Evaluate a TEst and Treat Intervention Integrating Novel Point-of-care Hepatitis C RNA Testing, Linkage to Nursing Care, and Peer-supported Delivery of HCV Testing and Treatment aMong Current People Who Inject Drugs With HCV Atte [NCT03492112]101 participants (Actual)Interventional2019-09-10Completed
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting [NCT02350569]Phase 217 participants (Actual)Interventional2015-05-22Completed
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
An Open-Label Study to Characterize the Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of PSI-7977 or PSI-352938 in HCV-infected Subjects With Varying Degrees of Hepatic Impairment [NCT01497327]Phase 124 participants (Actual)Interventional2011-07-31Completed
A Phase 4, Multicenter, Open Label Study to Investigate the Efficacy and Safety of an All Oral Combination of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis VALOR-HCV: Veterans Affairs alL Oral Regimen of SOF+RBV in GT2 HCV [NCT02128542]Phase 466 participants (Actual)Interventional2014-06-30Completed
Efficacy and Safety of Treatment Against Hepatitis C Virus Infection Based on Direct-acting Antivirals in Real-life Conditions: The GEHEP Cohort [NCT02333292]1,128 participants (Actual)Observational2014-12-31Completed
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection [NCT02032901]Phase 3173 participants (Actual)Interventional2014-01-31Completed
A Phase 2b, Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 and Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 Weeks in Genotype 1 or 4 HCV Infected Subjects With Renal Insufficiency [NCT01958281]Phase 238 participants (Actual)Interventional2013-10-07Completed
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
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial. [NCT04497649]Phase 2/Phase 3100 participants (Anticipated)Interventional2020-07-01Recruiting
A Phase 2, Single-Center, Open-Label Pilot Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfe [NCT02480387]Phase 220 participants (Actual)Interventional2015-05-31Completed
An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection [NCT01924949]Phase 25 participants (Actual)Interventional2013-07-31Completed
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
Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients [NCT04391985]Phase 1/Phase 2113 participants (Actual)Interventional2017-03-01Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection [NCT01604850]Phase 3202 participants (Actual)Interventional2012-06-30Completed
An Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Subjects With Sickle Cell Disease [NCT02301936]Phase 210 participants (Actual)Interventional2015-03-02Completed
Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study [NCT02717949]Phase 41 participants (Actual)Interventional2016-02-25Terminated(stopped due to failure to recruit)
A Phase 2, Randomized, Open-label Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 6 or 8 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Subjects With Chronic Hepatitis C Virus Genotype 1 I [NCT02349048]Phase 268 participants (Actual)Interventional2015-01-31Completed
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection [NCT01910636]Phase 3153 participants (Actual)Interventional2013-02-28Completed
The Immunologic Effects of HCV Therapy With Fixed Dose Combination Ledipasvir/Sofosbuvir (HARVONI) in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs. [NCT02347345]Phase 434 participants (Actual)Interventional2016-11-15Completed
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 3b Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection [NCT04211909]Phase 387 participants (Actual)Interventional2020-01-03Completed
An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Stud [NCT01987453]Phase 2100 participants (Actual)Interventional2014-07-31Completed
Efficacy of Decentralized Care in the Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model [NCT03488485]50,000 participants (Anticipated)Interventional2016-06-18Recruiting
Benefits of Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination [NCT03490097]Phase 2/Phase 3100 participants (Actual)Interventional2017-12-01Completed
A Phase 2b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders [NCT02120300]Phase 2122 participants (Actual)Interventional2014-04-30Completed
A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection. [NCT01896193]Phase 3127 participants (Actual)Interventional2013-06-30Completed
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
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (ECF/TAF) Switch Followed by Ledipasvir-Sofosbuvir HCV Therapy in HIV-HCV Co-Infection: A CIHR Canadian HIV Trials Network-Gilead Pilot Trial Proposal [NCT02660905]Phase 325 participants (Actual)Interventional2016-04-30Completed
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
Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure. [NCT03063879]Phase 495 participants (Actual)Interventional2017-04-01Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection. [NCT01682720]Phase 3421 participants (Actual)Interventional2012-09-30Completed
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters [NCT05616598]Phase 2/Phase 3200 participants (Actual)Interventional2022-03-01Completed
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection. [NCT01701401]Phase 3870 participants (Actual)Interventional2012-09-30Completed
Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study [NCT03949764]Phase 4374 participants (Actual)Interventional2019-09-23Active, not recruiting
Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients: An Open-label, Randomized, Multicenter Study in Malaysia [NCT04885855]Phase 2/Phase 3316 participants (Anticipated)Interventional2021-03-23Recruiting
Association of Serum Interleukin -6 and Transforming Growth Factor Beta Levels With Response to Antiviral Therapy for Chronic Hepatitis c Patients [NCT03882307]Early Phase 140 participants (Anticipated)Interventional2022-10-31Recruiting
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.)
The Pulmonary Safety of the New Oral Antihepatitis C Treatment [NCT04122066]50 participants (Anticipated)Observational2020-06-30Not yet recruiting
Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study) [NCT04773756]Phase 454 participants (Actual)Interventional2020-11-01Completed
A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection [NCT02081079]Phase 285 participants (Actual)Interventional2014-03-31Completed
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis [NCT02201901]Phase 3268 participants (Actual)Interventional2014-07-31Completed
A Phase 2, Single-Center, Double-Blind, Placebo-Controlled, Randomized Study to Investigate the Effect of Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Subjects With Chr [NCT02219685]Phase 240 participants (Actual)Interventional2014-08-31Completed
A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection [NCT02378935]Phase 2205 participants (Actual)Interventional2015-02-17Completed
A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen [NCT02536313]Phase 249 participants (Actual)Interventional2015-07-29Completed
A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection a [NCT02114151]Phase 3103 participants (Actual)Interventional2014-04-30Completed
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
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
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 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 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection. [NCT01838590]Phase 3103 participants (Actual)Interventional2013-03-31Completed
A Phase 2, Open-Label Study of Sofosbuvir in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3 [NCT01808248]Phase 247 participants (Actual)Interventional2013-02-28Completed
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects [NCT01783678]Phase 3275 participants (Actual)Interventional2013-01-31Completed
An Open Label Trial to Assess Safety, Tolerability, and Efficacy of the Fixed Dose Combination of GS-7977 and GS-5885 in HCV Genotype 1 Subjects Coinfected With HIV [NCT01878799]Phase 250 participants (Actual)Interventional2013-06-30Completed
Open-Label Study to Evaluate the Safety and Tolerability of Telaprevir in Combination With Sofosbuvir in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotype 1 [NCT01994486]Phase 220 participants (Actual)Interventional2013-12-31Completed
Safety, Tolerability, and Efficacy of Simeprevir 150 mg Daily Plus Sofosbuvir 400 mg Daily for 24 Weeks in Patients With Chronic Hepatitis C Genotype 1 With CPT Score of 6 or Lower Who Are IFN-Intolerant or Unwilling to be Treated With IFN [NCT02485080]Phase 40 participants (Actual)Interventional2015-09-30Withdrawn(stopped due to Withdrawn due to lack of resources)
A Phase II Open-Label Study of Ledipasvir/Sofosbuvir for 12 Weeks in Subjects With Hepatitis B Virus Infection [NCT03312023]Phase 221 participants (Actual)Interventional2018-02-01Completed
Pilot Therapeutic Study of DAA Treatment for Children and Adolescents With Active HCV Infection in Cambodia [NCT05992077]36,600 participants (Anticipated)Interventional2023-08-07Not yet recruiting
Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C: Multi-center, Prospective, Observational Real-world Study in EASTERN China [NCT04952207]300 participants (Anticipated)Observational [Patient Registry]2019-03-06Recruiting
A Phase 2, 2-panel, Open-label Randomized Study in Hepatitis C Virus Infected Subjects to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir and Ledipasvir in Treatmen [NCT02421211]Phase 241 participants (Actual)Interventional2015-05-19Completed
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.)
Effect of Ledipasvir and Sofosbuvir on Proteinuria and Estimated Glomerular Filtration Rate in Patients With Early Stage (1-3) Hepatitis C Associated Chronic Kidney Disease [NCT02503735]14 participants (Actual)Interventional2015-07-15Terminated(stopped due to Unable to meet enrollment goal)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV [NCT02201940]Phase 3741 participants (Actual)Interventional2014-07-31Completed
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection [NCT02722837]Phase 3119 participants (Actual)Interventional2016-04-04Completed
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant [NCT02781571]Phase 279 participants (Actual)Interventional2016-07-27Completed
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
A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Subjects Undergoing Cancer Chemotherapy [NCT02868242]Phase 219 participants (Actual)Interventional2016-08-28Completed
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
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV [NCT02671500]Phase 3375 participants (Actual)Interventional2016-04-19Completed
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects [NCT01667731]Phase 3224 participants (Actual)Interventional2012-07-31Completed
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
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
Efficacy and Safety of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection [NCT02473211]Phase 2/Phase 3106 participants (Actual)Interventional2015-01-31Completed
"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)
Dynamic Changes of the Frequency of Classic and Inflammatory Monocytes Subsets and Natural Killer Cells in Chronic Hepatitis C Patients Treated by Direct-acting Antiviral Agents [NCT03063723]25 participants (Actual)Observational2016-01-01Completed
A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HC [NCT02607735]Phase 3416 participants (Actual)Interventional2015-11-11Completed
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 Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies [NCT01625338]Phase 3534 participants (Actual)Interventional2012-06-30Completed
A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV) [NCT02032888]Phase 3238 participants (Actual)Interventional2014-02-28Completed
deLIVER: Direct Acting Antiviral Effects on the Liver [NCT02938013]Phase 415 participants (Actual)Interventional2017-01-31Completed
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection [NCT02021656]Phase 3384 participants (Actual)Interventional2013-12-10Completed
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 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligib [NCT01542788]Phase 3278 participants (Actual)Interventional2012-03-31Completed
Assessment of Haematological and Biochemical Effect After New Direct Acting Antiviral Drugs in Chronic Hepatitis c Virus Egyptian Patients in Assiut Province [NCT03163849]Phase 350 participants (Anticipated)Interventional2019-09-01Active, not recruiting
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 Sofosbuvir-based Quadruple Regimen is Highly Effective in HCV Type 4-infected Egyptian Patients With DAA Treatment Failure [NCT04387539]Phase 1/Phase 294 participants (Actual)Interventional2017-03-01Completed
A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection [NCT02613871]Phase 3111 participants (Actual)Interventional2015-12-22Completed
A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection [NCT02487030]Phase 3255 participants (Actual)Interventional2015-09-07Completed
Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial [NCT03032666]Phase 47 participants (Actual)Interventional2017-05-01Completed
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)
Sofosbuvir Based Regimens in Treatment of COVID 19 Patients [NCT04460443]Phase 2/Phase 360 participants (Anticipated)Interventional2020-08-01Recruiting
An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection [NCT02346721]Phase 3111 participants (Actual)Interventional2015-02-23Completed
An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study [NCT02300103]Phase 269 participants (Actual)Interventional2014-12-01Completed
A Phase 2, Multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 48 Weeks in Patients Infected With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensatio [NCT01687257]Phase 250 participants (Actual)Interventional2012-07-31Completed
A Phase IV Pilot Study to Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia [NCT02339038]Phase 4600 participants (Actual)Interventional2015-01-07Completed
Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection: Real-world Effectiveness and Safety in Taiwan [NCT05092074]100 participants (Anticipated)Observational2021-10-01Recruiting
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection [NCT01713283]Phase 260 participants (Actual)Interventional2012-10-31Completed
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant [NCT01938430]Phase 2339 participants (Actual)Interventional2013-09-30Completed
Comparative Open-label,Randomized, Fed, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sci [NCT03062423]Phase 136 participants (Actual)Interventional2016-10-31Completed
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Subjects Who Have Failed Prior Treatment With Sofosbuvir-based Therapies [NCT02600351]Phase 387 participants (Actual)Interventional2015-11-11Terminated(stopped due to Due to lack of feasibility of enrolling participants, the study was terminated early.)
A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in Adults With Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3) [NCT02640157]Phase 3506 participants (Actual)Interventional2015-12-31Completed
Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV [NCT03069001]Phase 490 participants (Actual)Interventional2015-06-30Completed
Treatment of Recent Injection Drug Use With Chronic HCV Infection in U.S. Liver Referral Clinics: A Prospective, Observational Cohort Study And Contemporaneous Therapy Cohort Without Injection Drug Use [NCT05895448]Phase 4125 participants (Anticipated)Interventional2018-03-01Active, not recruiting
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naive Subjects W [NCT01851330]Phase 3647 participants (Actual)Interventional2013-05-31Completed
A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection [NCT02480712]Phase 3107 participants (Actual)Interventional2015-07-01Completed
Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4 [NCT04387526]Phase 2/Phase 3946 participants (Actual)Interventional2016-04-01Completed
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 Phase 3b, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 1 HCV Infection [NCT01975675]Phase 3341 participants (Actual)Interventional2013-10-31Completed
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Sovaldi in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea [NCT02907996]2,033 participants (Actual)Observational2016-09-09Completed
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection [NCT01826981]Phase 2359 participants (Actual)Interventional2013-04-30Completed
A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir Fixed Dose Combination Administered for Four Weeks in Patients Infected With Chronic HCV in the Peri-Operative Liver Transplantation Setting [NCT02728206]Phase 29 participants (Actual)Interventional2016-06-12Completed
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
HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE) [NCT03282474]Phase 210 participants (Actual)Interventional2017-12-07Completed
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
A Clinical and Pharmacokinetic Study of the Effectiveness of Hepatitis C Treatment (Sofosbuvir+Daclatasvir) in HIV Co-infected and Non HIV Co-infected Patients at the Level of Non-hospital Based Management in Myanmar [NCT03158857]0 participants (Actual)Observational2022-01-31Withdrawn(stopped due to Long local IRB process to meet with the treatment deadline)
A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 [NCT01497366]Phase 3527 participants (Actual)Interventional2011-12-31Completed
A Phase II, Open-label, Single Arm, Multicentre, International Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use [NCT02336139]Phase 2103 participants (Actual)Interventional2016-03-16Completed
Investigation of Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816 [NCT02468648]Phase 272 participants (Actual)Interventional2015-06-09Completed
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
A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection [NCT02738333]Phase 3239 participants (Actual)Interventional2016-04-12Completed
Evaluation of Efficacy and Safety of KW-136 Plus Sofosbuvir for Treatment-naive Adults Chronically Infected With Hepatitis C Virus: a Randomized, Open-label, Multicenter Phase 2 Trial [NCT03416491]Phase 2110 participants (Actual)Interventional2017-02-15Completed
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
A Phase 3b, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection [NCT02074514]Phase 3117 participants (Actual)Interventional2014-03-31Completed
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infec [NCT02073656]Phase 3335 participants (Actual)Interventional2014-02-28Completed
A Phase II Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172, MK-8742, and Sofosbuvir in Treatment-Naïve Subjects With Chronic HCV GT1 or GT3 Infection [NCT02133131]Phase 2143 participants (Actual)Interventional2014-06-13Completed
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
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
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of a 12- or 8-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve and -Experienced Subjects With Chronic Genotype 1 Hepatitis C [NCT02114177]Phase 3310 participants (Actual)Interventional2014-04-30Completed
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrho [NCT01965535]Phase 2155 participants (Actual)Interventional2013-10-31Completed
Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT) [NCT02478229]Phase 31 participants (Actual)Interventional2015-06-30Terminated(stopped due to difficulty recruiting patients)
Efficacy and Safety of Anti-hepatitis C Drugs in the Treatment of COVID-19 [NCT04443725]Phase 2/Phase 3100 participants (Anticipated)Interventional2020-07-31Not yet recruiting
A Pilot Phase II Study of New Direct-Acting Antiviral Agent, HARVONI® (Ledipasvir/Sofosbuvir), for the Treatment of Genotype 1 or 2 HCV-Associated Indolent B-Cell Non- Hodgkin's Lymphoma [NCT03261349]Phase 221 participants (Anticipated)Interventional2017-09-01Not yet recruiting
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant [NCT02010255]Phase 2334 participants (Actual)Interventional2014-01-31Completed
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjec [NCT02639247]Phase 3333 participants (Actual)Interventional2015-12-23Completed
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
[NCT03200184]Phase 41,448 participants (Actual)Interventional2016-09-01Completed
A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis [NCT02226549]Phase 247 participants (Actual)Interventional2014-07-31Completed
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 Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection. [NCT01962441]Phase 3601 participants (Actual)Interventional2013-09-24Completed
A Phase 2, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection [NCT02251717]Phase 2114 participants (Actual)Interventional2014-10-14Completed
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection [NCT02201953]Phase 3558 participants (Actual)Interventional2014-07-31Completed
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
A Phase 2 Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of 12 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir, Followed by a 5-Year Post-treatment Long-term Follow-up, in Treatment-naïve and Treatment-experienced [NCT02262728]Phase 240 participants (Actual)Interventional2014-09-30Completed
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection [NCT02202980]Phase 2273 participants (Actual)Interventional2014-08-04Completed
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection [NCT02220998]Phase 3269 participants (Actual)Interventional2014-09-30Completed
A Phase II Open-Label Study of the Clinical Effectiveness of a Human Monoclonal Antibody Against Hepatitis C Virus E2 Glycoprotein (MBL-HCV1) Combined With Oral Direct-Acting Antivirals in Hepatitis C Infected Patients Undergoing Liver Transplantation [NCT01532908]Phase 211 participants (Actual)Interventional2012-11-21Terminated(stopped due to The study was terminated due to funding constraints)
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
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of GS-331007: Cmax at Day 27
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of GS-566500: Cmax at Day 27
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of GS-566500: Cmax at Day 0
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of GS-331007: Cmax at Day 0
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0
NCT01054729 (17) [back to overview]Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27
NCT01054729 (17) [back to overview]Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0
NCT01054729 (17) [back to overview]Percentage of Participants With Rapid Virologic Response at Week 4
NCT01054729 (17) [back to overview]Percentage of Participants Who Developed Resistance to Sofosbuvir
NCT01054729 (17) [back to overview]Change in Circulating HCV RNA at Week 4
NCT01054729 (17) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment
NCT01188772 (14) [back to overview]Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)
NCT01188772 (14) [back to overview]Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)
NCT01188772 (14) [back to overview]Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
NCT01188772 (14) [back to overview]Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)
NCT01188772 (14) [back to overview]Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)
NCT01188772 (14) [back to overview]Percentage of Participants With Virologic Response at the End of Treatment
NCT01188772 (14) [back to overview]Percentage of Participants With Rapid Virologic Response at Week 4
NCT01188772 (14) [back to overview]Percentage of Participants With Extended Rapid Virologic Response
NCT01188772 (14) [back to overview]Percentage of Participants With Complete Early Virologic Response at Week 12
NCT01188772 (14) [back to overview]Percentage of Participants Who Developed Resistance to Sofosbuvir
NCT01188772 (14) [back to overview]Change in HCV RNA From Baseline to Week 12
NCT01188772 (14) [back to overview]Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)
NCT01188772 (14) [back to overview]Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)
NCT01188772 (14) [back to overview]Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)
NCT01260350 (9) [back to overview]Percentage of Participants With HCV RNA < LOD at Week 12
NCT01260350 (9) [back to overview]Percentage of Participants With HCV RNA < LOD at Week 6
NCT01260350 (9) [back to overview]Percentage of Participants With Virologic Failure
NCT01260350 (9) [back to overview]Percentage of Participants Who Experienced Adverse Events
NCT01260350 (9) [back to overview]Change From Baseline in HCV RNA at Week 8
NCT01260350 (9) [back to overview]Change From Baseline in HCV RNA at Week 6
NCT01260350 (9) [back to overview]Change From Baseline in HCV RNA at Week 12
NCT01260350 (9) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
NCT01260350 (9) [back to overview]Percentage of Participants With HCV RNA < LOD at Week 8
NCT01329978 (17) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
NCT01329978 (17) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
NCT01329978 (17) [back to overview]Percentage of Participants With HCV RNA Below < LOD at Week 8
NCT01329978 (17) [back to overview]Percentage of Participants With HCV RNA Below < LOD at Week 4
NCT01329978 (17) [back to overview]Percentage of Participants With HCV RNA Below < LOD at Week 24
NCT01329978 (17) [back to overview]Percentage of Participants With HCV RNA Below < LOD at Week 12
NCT01329978 (17) [back to overview]Percentage of Participants With HCV RNA < LOD at Week 2
NCT01329978 (17) [back to overview]Percentage of Participants With ALT Normalization at Week 12
NCT01329978 (17) [back to overview]Percentage of Participants With ALT Normalization at Post-treatment Week 4
NCT01329978 (17) [back to overview]Change in HCV RNA at Week 8
NCT01329978 (17) [back to overview]Change in HCV RNA at Week 4
NCT01329978 (17) [back to overview]Percentage of Participants With ALT Normalization at Week 24
NCT01329978 (17) [back to overview]Change in HCV RNA at Week 2
NCT01329978 (17) [back to overview]Change in HCV RNA at Week 12
NCT01329978 (17) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT01329978 (17) [back to overview]Percentage of Participants Who Experienced Adverse Events
NCT01329978 (17) [back to overview]Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).
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]Percentage of Participants With Viral Breakthrough During the Treatment Period
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 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
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]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
NCT01359644 (7) [back to overview]Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
NCT01441180 (2) [back to overview]Participants With Adverse Events
NCT01441180 (2) [back to overview]Sustained Virologic Response
NCT01466790 (7) [back to overview]Number of Participants With Viral Relapse
NCT01466790 (7) [back to overview]Number of Participants With Viral Breakthrough
NCT01466790 (7) [back to overview]Number of Participants With Inadequate Virologic Response
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 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) 24 Weeks After the Planned End of Treatment (EOT)
NCT01466790 (7) [back to overview]Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)
NCT01497366 (7) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT01497366 (7) [back to overview]Change From Baseline in HCV RNA
NCT01497366 (7) [back to overview]Percentage of Participants With Virologic Failure During Treatment
NCT01497366 (7) [back to overview]Percentage of Participants With Viral Relapse Following Treatment
NCT01497366 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)
NCT01497366 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
NCT01497366 (7) [back to overview]Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
NCT01532908 (6) [back to overview]Number of Subjects With Undetectable HCV RNA at Day 56 Post Liver Transplantation
NCT01532908 (6) [back to overview]Change in Viral Load Between Baseline Pre-transplant HCV RNA Levels and Study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98 in Liver Transplant Recipients
NCT01532908 (6) [back to overview]Safety and Tolerability of Study Treatment by Number of Adverse Events Reported
NCT01532908 (6) [back to overview]Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 10, 14, 28, 35, 42, 49, 70, 84 and 98 in Liver Transplant Recipients and for Those Subjects Receiving an Additional 4 Weeks of Treatment at Study Day 105, 112 and 126
NCT01532908 (6) [back to overview]Number of Subjects With Sustained Virologic Response (SVR) at Week 12 and Week 24
NCT01532908 (6) [back to overview]Number of Participants With HCV Resistance-associated Variants to MBL-HCV1 and Oral Direct-acting Antivirals Before and After Receipt of Study Treatment
NCT01542788 (6) [back to overview]Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
NCT01542788 (6) [back to overview]Percentage of Participants Achieving SVR12
NCT01542788 (6) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT01542788 (6) [back to overview]Percentage of Participants Experiencing Viral Breakthrough
NCT01542788 (6) [back to overview]Percentage of Participants Achieving SVR4
NCT01542788 (6) [back to overview]Percentage of Participants Achieving SVR24
NCT01559844 (8) [back to overview]Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48
NCT01559844 (8) [back to overview]Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
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 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]Proportion of Participants With Virologic Failure Prior to Transplant
NCT01604850 (6) [back to overview]Percentage of Participants Achieving SVR24
NCT01604850 (6) [back to overview]Percentage of Participants Achieving SVR12
NCT01604850 (6) [back to overview]Adverse Events Leading to Permanent Discontinuation of Study Drug
NCT01604850 (6) [back to overview]Percentage of Participants Achieving SVR4
NCT01604850 (6) [back to overview]Percentage of Participants With Viral Breakthrough
NCT01604850 (6) [back to overview]Percentage of Participants With Viral Relapse
NCT01625338 (5) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01625338 (5) [back to overview]Percentage of Participants With Viral Relapse
NCT01625338 (5) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT01625338 (5) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT01625338 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01641640 (6) [back to overview]Percentage of Participants Achieving SVR4
NCT01641640 (6) [back to overview]Percentage of Participants Achieving SVR24
NCT01641640 (6) [back to overview]Percentage of Participants Achieving Sustained Virologic Response (SVR)12
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 With Viral Relapse
NCT01641640 (6) [back to overview]Percentage of Participants With Viral Breakthrough
NCT01667731 (10) [back to overview]Change From Baseline in HCV RNA at Week 4
NCT01667731 (10) [back to overview]Change From Baseline in HCV RNA at Week 2
NCT01667731 (10) [back to overview]Change From Baseline in HCV RNA at Week 1
NCT01667731 (10) [back to overview]Change From Baseline in HCV RNA at Week 6
NCT01667731 (10) [back to overview]Change From Baseline in HCV RNA at Week 8
NCT01667731 (10) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
NCT01667731 (10) [back to overview]Percentage of Participants Experiencing On-treatment Virologic Failure
NCT01667731 (10) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT01667731 (10) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01667731 (10) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01682720 (4) [back to overview]Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
NCT01682720 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01682720 (4) [back to overview]Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
NCT01682720 (4) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01687257 (7) [back to overview]Percentage of Participants Experiencing On-Treatment Virologic Failure
NCT01687257 (7) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT01687257 (7) [back to overview]Change From Baseline in Child-Pugh-Turcotte (CPT) Score
NCT01687257 (7) [back to overview]Change From Baseline in Model for End Stage Liver Disease (MELD) Scores
NCT01687257 (7) [back to overview]Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
NCT01687257 (7) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01687257 (7) [back to overview]Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment
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 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 Who Discontinue Study Drug Due to an Adverse Event
NCT01687270 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT01701401 (10) [back to overview]Percentage of Participants With Virologic Failure
NCT01701401 (10) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug
NCT01701401 (10) [back to overview]Change From Baseline in HCV RNA at Week 2
NCT01701401 (10) [back to overview]Change From Baseline in HCV RNA at Week 4
NCT01701401 (10) [back to overview]Change From Baseline in HCV RNA at Week 8
NCT01701401 (10) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
NCT01701401 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 2
NCT01701401 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 4
NCT01701401 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 8
NCT01701401 (10) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)
NCT01713283 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01713283 (5) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01713283 (5) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
NCT01713283 (5) [back to overview]Percentage of Participants Experiencing On-treatment Virologic Failure
NCT01713283 (5) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT01783678 (9) [back to overview]HCV RNA Change From Baseline at Week 6
NCT01783678 (9) [back to overview]HCV RNA Change From Baseline at Week 4
NCT01783678 (9) [back to overview]HCV RNA Change From Baseline at Week 2
NCT01783678 (9) [back to overview]HCV RNA Change From Baseline at Week 1
NCT01783678 (9) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
NCT01783678 (9) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01783678 (9) [back to overview]Percentage of Participants Experiencing Virologic Failure
NCT01783678 (9) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01783678 (9) [back to overview]HCV RNA Change From Baseline at Week 8
NCT01805882 (1) [back to overview]The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
NCT01808248 (5) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01808248 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01808248 (5) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT01808248 (5) [back to overview]Percentage of Participants Experiencing On-treatment Virologic Failure
NCT01808248 (5) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
NCT01826981 (11) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01826981 (11) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT01826981 (11) [back to overview]Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
NCT01826981 (11) [back to overview]Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
NCT01826981 (11) [back to overview]Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
NCT01826981 (11) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT01826981 (11) [back to overview]Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
NCT01826981 (11) [back to overview]Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
NCT01826981 (11) [back to overview]Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
NCT01826981 (11) [back to overview]Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
NCT01826981 (11) [back to overview]For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
NCT01838590 (5) [back to overview]Percentage of Participants Experiencing On-treatment Virologic Failure
NCT01838590 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01838590 (5) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT01838590 (5) [back to overview]Percentage of Participants Experiencing Virologic Relapse
NCT01838590 (5) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01851330 (10) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01851330 (10) [back to overview]Percentage of Participants Experiencing Virologic Failure
NCT01851330 (10) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01851330 (10) [back to overview]Change From Baseline in HCV RNA at Week 4
NCT01851330 (10) [back to overview]Change From Baseline in HCV RNA at Week 2
NCT01851330 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 8
NCT01851330 (10) [back to overview]Change From Baseline in HCV RNA at Week 8
NCT01851330 (10) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
NCT01851330 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 2
NCT01851330 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 4
NCT01878799 (1) [back to overview]Percentage of Participants With Achieved SVR12 (HCV RNA
NCT01896193 (5) [back to overview]Percentage of Participants Experiencing Virologic Relapse
NCT01896193 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01896193 (5) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01896193 (5) [back to overview]Percentage of Participants Experiencing On-treatment Virologic Failure
NCT01896193 (5) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
NCT01910636 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01910636 (5) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01910636 (5) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT01910636 (5) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
NCT01910636 (5) [back to overview]Percentage of Participants Experiencing Viral Breakthrough
NCT01924949 (6) [back to overview]Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event
NCT01924949 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01924949 (6) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01924949 (6) [back to overview]HCV RNA Change From Baseline
NCT01924949 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT01924949 (6) [back to overview]Percentage of Participants Experiencing Virologic Failure
NCT01938430 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 24
NCT01938430 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 20
NCT01938430 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 2
NCT01938430 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 16
NCT01938430 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 12
NCT01938430 (25) [back to overview]Percentage of Participants With Virologic Failure
NCT01938430 (25) [back to overview]HCV RNA and Change From Baseline at Week 1
NCT01938430 (25) [back to overview]HCV RNA and Change From Baseline at Week 8
NCT01938430 (25) [back to overview]HCV RNA and Change From Baseline at Week 6
NCT01938430 (25) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
NCT01938430 (25) [back to overview]Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
NCT01938430 (25) [back to overview]Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
NCT01938430 (25) [back to overview]HCV RNA and Change From Baseline at Week 2
NCT01938430 (25) [back to overview]HCV RNA and Change From Baseline at Week 12
NCT01938430 (25) [back to overview]Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
NCT01938430 (25) [back to overview]Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
NCT01938430 (25) [back to overview]Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
NCT01938430 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 1
NCT01938430 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 4
NCT01938430 (25) [back to overview]HCV RNA and Change From Baseline at Week 4
NCT01938430 (25) [back to overview]Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
NCT01938430 (25) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01938430 (25) [back to overview]Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
NCT01938430 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 8
NCT01938430 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 6
NCT01958281 (35) [back to overview]PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
NCT01958281 (35) [back to overview]PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
NCT01958281 (35) [back to overview]PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
NCT01958281 (35) [back to overview]PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
NCT01958281 (35) [back to overview]PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
NCT01958281 (35) [back to overview]Pharmacokinetic (PK) Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT01958281 (35) [back to overview]Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT01958281 (35) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01958281 (35) [back to overview]Percentage of Participants With Overall Virologic Failure
NCT01958281 (35) [back to overview]Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
NCT01958281 (35) [back to overview]Percentage of Participants Experiencing Treatment-Emergent Adverse Events Associated With Vital Sign Abnormalities
NCT01958281 (35) [back to overview]Percentage of Participants Experiencing Treatment-Emergent Adverse Events
NCT01958281 (35) [back to overview]Percentage of Participants Experiencing Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
NCT01958281 (35) [back to overview]PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
NCT01958281 (35) [back to overview]PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
NCT01958281 (35) [back to overview]PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
NCT01958281 (35) [back to overview]PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
NCT01958281 (35) [back to overview]PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)
NCT01958281 (35) [back to overview]PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)
NCT01962441 (10) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT01962441 (10) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01962441 (10) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01962441 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
NCT01962441 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
NCT01962441 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
NCT01962441 (10) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT01962441 (10) [back to overview]HCV RNA at Weeks 1, 2, 4, 8, and 12
NCT01962441 (10) [back to overview]Percentage of Participants Experiencing On-Treatment Virologic Failure
NCT01962441 (10) [back to overview]Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
NCT01965535 (5) [back to overview]Percentage of Participants With Virologic Failure
NCT01965535 (5) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01965535 (5) [back to overview]Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
NCT01965535 (5) [back to overview]Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
NCT01965535 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01975675 (5) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01975675 (5) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT01975675 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants
NCT01975675 (5) [back to overview]Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01975675 (5) [back to overview]Percentage of Participants Experiencing Virologic Failure
NCT01987453 (6) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT01987453 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01987453 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT01987453 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01987453 (6) [back to overview]Change in HCV RNA From Baseline
NCT01987453 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment
NCT01994486 (6) [back to overview]Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007
NCT01994486 (6) [back to overview]Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose
NCT01994486 (6) [back to overview]Proportion of Subjects With Viral Relapse
NCT01994486 (6) [back to overview]Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen
NCT01994486 (6) [back to overview]Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks
NCT01994486 (6) [back to overview]Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir
NCT02010255 (25) [back to overview]Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
NCT02010255 (25) [back to overview]Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02010255 (25) [back to overview]Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02010255 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 1
NCT02010255 (25) [back to overview]HCV RNA Levels and Change From Baseline at Week 4
NCT02010255 (25) [back to overview]HCV RNA Levels and Change From Baseline at Week 6
NCT02010255 (25) [back to overview]HCV RNA Levels and Change From Baseline at Week 8
NCT02010255 (25) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
NCT02010255 (25) [back to overview]Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
NCT02010255 (25) [back to overview]Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
NCT02010255 (25) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02010255 (25) [back to overview]Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
NCT02010255 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 8
NCT02010255 (25) [back to overview]Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
NCT02010255 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 6
NCT02010255 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 4
NCT02010255 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 24
NCT02010255 (25) [back to overview]HCV RNA Levels and Change From Baseline at Week 2
NCT02010255 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 20
NCT02010255 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 2
NCT02010255 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 16
NCT02010255 (25) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 12
NCT02010255 (25) [back to overview]HCV RNA Levels and Change From Baseline at Week 12
NCT02010255 (25) [back to overview]HCV RNA Levels and Change From Baseline at Week 1
NCT02010255 (25) [back to overview]Percentage of Participants With Virologic Failure
NCT02021643 (8) [back to overview]Percentage of Participants With Viral Relapse
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 With On-Treatment Virologic Failure
NCT02021643 (8) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
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]Change From Baseline in HCV RNA (log10 IU/mL)
NCT02021656 (6) [back to overview]Percentage of Participants Experiencing Viral Breakthrough
NCT02021656 (6) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02021656 (6) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT02021656 (6) [back to overview]Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
NCT02021656 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02021656 (6) [back to overview]HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only
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]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]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)
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 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 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]Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities
NCT02032888 (10) [back to overview]Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
NCT02032888 (10) [back to overview]Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
NCT02032888 (10) [back to overview]Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
NCT02032888 (10) [back to overview]Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels
NCT02032888 (10) [back to overview]Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be
NCT02032888 (10) [back to overview]Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
NCT02032888 (10) [back to overview]Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
NCT02032888 (10) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period
NCT02032888 (10) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period
NCT02032888 (10) [back to overview]Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)
NCT02032901 (10) [back to overview]Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
NCT02032901 (10) [back to overview]Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
NCT02032901 (10) [back to overview]Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)
NCT02032901 (10) [back to overview]Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
NCT02032901 (10) [back to overview]Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
NCT02032901 (10) [back to overview]Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
NCT02032901 (10) [back to overview]Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
NCT02032901 (10) [back to overview]Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)
NCT02032901 (10) [back to overview]Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)
NCT02032901 (10) [back to overview]Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
NCT02073656 (12) [back to overview]Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24
NCT02073656 (12) [back to overview]For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8
NCT02073656 (12) [back to overview]For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24
NCT02073656 (12) [back to overview]For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
NCT02073656 (12) [back to overview]For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure
NCT02073656 (12) [back to overview]Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment
NCT02073656 (12) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02073656 (12) [back to overview]Percentage of Participants With Virologic Failure
NCT02073656 (12) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
NCT02073656 (12) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02073656 (12) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02073656 (12) [back to overview]Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8
NCT02074514 (4) [back to overview]Percentage of Participants With Virologic Failure and Viral Relapse
NCT02074514 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02074514 (4) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02074514 (4) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02081079 (5) [back to overview]Percentage of Patients With Virologic Failure
NCT02081079 (5) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02081079 (5) [back to overview]Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
NCT02081079 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02081079 (5) [back to overview]Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event
NCT02114151 (12) [back to overview]Percentage of Participants With On-treatment Virologic Response
NCT02114151 (12) [back to overview]Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24
NCT02114151 (12) [back to overview]Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12
NCT02114151 (12) [back to overview]Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24
NCT02114151 (12) [back to overview]Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24
NCT02114151 (12) [back to overview]Percentage of Participants With Viral Relapse
NCT02114151 (12) [back to overview]Percentage of Participants With Viral Breakthrough
NCT02114151 (12) [back to overview]Percentage of Participants With On-treatment Failure
NCT02114151 (12) [back to overview]Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)
NCT02114151 (12) [back to overview]Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)
NCT02114151 (12) [back to overview]Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)
NCT02114151 (12) [back to overview]Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)
NCT02114177 (10) [back to overview]Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)
NCT02114177 (10) [back to overview]Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
NCT02114177 (10) [back to overview]Percentage of Participants With Viral Breakthrough
NCT02114177 (10) [back to overview]Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24
NCT02114177 (10) [back to overview]Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale
NCT02114177 (10) [back to overview]Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores
NCT02114177 (10) [back to overview]Percentage of Participants With Viral Relapse
NCT02114177 (10) [back to overview]Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS)
NCT02114177 (10) [back to overview]Percentage of Participants Achieving a On-treatment Virologic Response
NCT02114177 (10) [back to overview]Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)
NCT02120300 (8) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02120300 (8) [back to overview]Percentage of Participants With Virologic Failure
NCT02120300 (8) [back to overview]Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
NCT02120300 (8) [back to overview]Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)
NCT02120300 (8) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
NCT02120300 (8) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02120300 (8) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02120300 (8) [back to overview]Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)
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]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
NCT02128217 (19) [back to overview]Adherence as Measured by RBV Pill Count
NCT02128217 (19) [back to overview]Adherence as Measured by SOF Pill Count
NCT02128217 (19) [back to overview]Cellular Concentration of Tenofovir Diphosphate (TFV-DP)
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]Self-reported Adherence to SOF
NCT02128217 (19) [back to overview]Count of Participants With HIV-1 RNA <50 Copies/mL
NCT02128542 (6) [back to overview]Percentage of Participants Experiencing Viral Relapse
NCT02128542 (6) [back to overview]Percentage of Participants Experiencing Viral Breakthrough
NCT02128542 (6) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02128542 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy
NCT02128542 (6) [back to overview]Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment
NCT02128542 (6) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02133131 (3) [back to overview]Number of Participants Discontinuing Study Therapy Due to an AE
NCT02133131 (3) [back to overview]Number of Participants Experiencing at Least 1 Adverse Event (AE)
NCT02133131 (3) [back to overview]Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)
NCT02168361 (2) [back to overview]Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
NCT02168361 (2) [back to overview]Serum HCV RNA Level
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 HCV RNA
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 HCV RNA < LLOQ While On Treatment
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, 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, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
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]For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
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 the Treatment Phase, Number of Female 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, Change From Baseline in HCV RNA
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, Percentage of Participants With HCV RNA < LLOQ While On Treatment
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 Height
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
NCT02175966 (8) [back to overview]Percentage of Participants With End of Treatment Response (EOTR)
NCT02175966 (8) [back to overview]Percentage of Participants Who Achieved HCV RNA
NCT02175966 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 12 (SVR12)
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 Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b
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)
NCT02201901 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02201901 (8) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
NCT02201901 (8) [back to overview]Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score
NCT02201901 (8) [back to overview]Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
NCT02201901 (8) [back to overview]Percentage of Participants With Virologic Failure
NCT02201901 (8) [back to overview]Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score
NCT02201901 (8) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02201901 (8) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02201940 (6) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02201940 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
NCT02201940 (6) [back to overview]Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
NCT02201940 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT02201940 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02201940 (6) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02201953 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
NCT02201953 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02201953 (6) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02201953 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT02201953 (6) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02201953 (6) [back to overview]Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
NCT02202980 (10) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02202980 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
NCT02202980 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
NCT02202980 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
NCT02202980 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
NCT02202980 (10) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02202980 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
NCT02202980 (10) [back to overview]Percentage of Participants With Virologic Failure
NCT02202980 (10) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02202980 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
NCT02214420 (1) [back to overview]Sustained Viral Response
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Motor
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Memory T Score
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Attention Scaled Score
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Motor
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Attention Scaled Score
NCT02219685 (22) [back to overview]Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by WPAI: Hepatitis C - Activity Impairment
NCT02219685 (22) [back to overview]Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Memory T Score
NCT02219685 (22) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
NCT02219685 (22) [back to overview]Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Hopelessness Scale (BHS)
NCT02219685 (22) [back to overview]Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Depression Inventory-II (BDI-II)
NCT02219685 (22) [back to overview]Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol
NCT02219685 (22) [back to overview]Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline
NCT02219685 (22) [back to overview]Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG
NCT02219685 (22) [back to overview]Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Work Productivity and Activity Impairment Questionnaire, Hepatitis C (WPAI: Hepatitis C) - Overall Work Impairment
NCT02219685 (22) [back to overview]Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Short Form 36 (SF-36) Health Survey Scale - Physical Component Score
NCT02219685 (22) [back to overview]Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by SF-36 Health Survey Scale - Mental Component Score
NCT02219685 (22) [back to overview]Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
NCT02219685 (22) [back to overview]Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Chronic Liver Disease Questionnaire - HCV (CLDQ-HCV)
NCT02220998 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
NCT02220998 (6) [back to overview]Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
NCT02220998 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT02220998 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02220998 (6) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02220998 (6) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02226549 (3) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02226549 (3) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02226549 (3) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02249182 (26) [back to overview]For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
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, 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 Alanine Aminotransferase (ALT) Normalization
NCT02249182 (26) [back to overview]For the Treatment Phase, Change From Baseline in Weight
NCT02249182 (26) [back to overview]For the Treatment Phase, Change From Baseline in Weight
NCT02249182 (26) [back to overview]For the Treatment Phase, Change From Baseline in Height
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]For the Treatment Phase, Change From Baseline in HCV RNA
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]Acceptability of LDV/SOF Granules as Measured by Palatability 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
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 SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
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, 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, Percentage of Participants With HCV RNA < LLOQ While On Treatment
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 Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
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, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
NCT02250807 (7) [back to overview]Percentage of Participants With On-Treatment Failure
NCT02250807 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
NCT02250807 (7) [back to overview]Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
NCT02250807 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)
NCT02250807 (7) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)
NCT02250807 (7) [back to overview]Percentage of Participants With Viral Breakthrough
NCT02250807 (7) [back to overview]Percentage of Participants With Viral Relapse
NCT02251717 (4) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02251717 (4) [back to overview]Percentage of Participants With Virologic Failure
NCT02251717 (4) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02251717 (4) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02262728 (11) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
NCT02262728 (11) [back to overview]Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
NCT02262728 (11) [back to overview]Percentage of Participants With On-treatment Failure
NCT02262728 (11) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)
NCT02262728 (11) [back to overview]Percentage of Participants With SVR12 Who Maintained to Have HCV RNA
NCT02262728 (11) [back to overview]Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
NCT02262728 (11) [back to overview]Percentage of Participants With On-Treatment Virologic Response
NCT02262728 (11) [back to overview]Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
NCT02262728 (11) [back to overview]Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
NCT02262728 (11) [back to overview]Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)
NCT02262728 (11) [back to overview]Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)
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]Number of Participants With Detectable HCV Resistance Mutations Through Week 240
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
NCT02292706 (6) [back to overview]Percentage of Participants With Any Liver-Associated Events
NCT02292706 (6) [back to overview]Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
NCT02292719 (3) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02292719 (3) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02292719 (3) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT02300103 (6) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02300103 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT02300103 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02300103 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ On-treatment
NCT02300103 (6) [back to overview]HCV RNA Change From Baseline
NCT02300103 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02301936 (14) [back to overview]Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
NCT02301936 (14) [back to overview]Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
NCT02301936 (14) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02301936 (14) [back to overview]HCV RNA Change From Baseline
NCT02301936 (14) [back to overview]HCV RNA Change From Baseline
NCT02301936 (14) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02301936 (14) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02301936 (14) [back to overview]Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
NCT02301936 (14) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02301936 (14) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02301936 (14) [back to overview]Percentage of Participants With Virologic Failure
NCT02301936 (14) [back to overview]Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
NCT02301936 (14) [back to overview]Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
NCT02301936 (14) [back to overview]Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
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
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)
NCT02319031 (3) [back to overview]Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
NCT02339038 (1) [back to overview]Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
NCT02346721 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT02346721 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02346721 (6) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02346721 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02346721 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment
NCT02346721 (6) [back to overview]HCV RNA Change From Baseline
NCT02347345 (5) [back to overview]Gene Expression Profiles
NCT02347345 (5) [back to overview]sCD14 (ng/mL)
NCT02347345 (5) [back to overview]Virologic Response to Therapy as Measured by HCV RNA
NCT02347345 (5) [back to overview]Gene Expression Profiles
NCT02347345 (5) [back to overview]sCD14 (ng/mL)
NCT02349048 (8) [back to overview]Percentage of Participants With On-treatment Virologic Response
NCT02349048 (8) [back to overview]Percentage of Participants With On-Treatment Failure
NCT02349048 (8) [back to overview]Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment
NCT02349048 (8) [back to overview]Number of Participants With Late Viral Relapse
NCT02349048 (8) [back to overview]Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR
NCT02349048 (8) [back to overview]Number of Participants With Viral Relapse
NCT02349048 (8) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12)
NCT02349048 (8) [back to overview]Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR
NCT02350569 (5) [back to overview]Percentage of Participants With Virologic Failure
NCT02350569 (5) [back to overview]Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event
NCT02350569 (5) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28
NCT02350569 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02350569 (5) [back to overview]Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
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 Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment
NCT02356562 (4) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02356562 (4) [back to overview]Percentage of Participants With Post-Treatment Relapse
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]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]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 Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)
NCT02378935 (10) [back to overview]HCV RNA Change From Baseline
NCT02378935 (10) [back to overview]HCV RNA Change From Baseline
NCT02378935 (10) [back to overview]Percentage of Participants With Virologic Failure
NCT02378935 (10) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02378935 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02378935 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02378935 (10) [back to overview]Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02378935 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02378935 (10) [back to overview]HCV RNA Change From Baseline
NCT02378935 (10) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02378961 (10) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02378961 (10) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02378961 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02378961 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02378961 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02378961 (10) [back to overview]HCV RNA Change From Baseline
NCT02378961 (10) [back to overview]HCV RNA Change From Baseline
NCT02378961 (10) [back to overview]HCV RNA Change From Baseline
NCT02378961 (10) [back to overview]Percentage of Participants With Virologic Failure
NCT02378961 (10) [back to overview]Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
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 On-treatment Virologic Failure
NCT02399345 (3) [back to overview]Percentage of Subjects With Post-treatment Relapse
NCT02413593 (6) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02413593 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02413593 (6) [back to overview]Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
NCT02413593 (6) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02413593 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT02413593 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12
NCT02421211 (19) [back to overview]Percentage of Participants With Viral Relapse
NCT02421211 (19) [back to overview]Percentage of Participants With On-treatment Failure
NCT02421211 (19) [back to overview]Minimum Plasma Concentration (Cmin) of Simeprevir (SMV)
NCT02421211 (19) [back to overview]Minimum Plasma Concentration (Cmin) of Ledipasvir (LDV)
NCT02421211 (19) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT02421211 (19) [back to overview]Maximum Plasma Concentration (Cmax) of Simeprevir
NCT02421211 (19) [back to overview]Maximum Plasma Concentration (Cmax) of Ledipasvir
NCT02421211 (19) [back to overview]Fluctuation Index (FI) of Simeprevir
NCT02421211 (19) [back to overview]Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Ledipasvir
NCT02421211 (19) [back to overview]Percentage of Participants With On-treatment Virologic Response
NCT02421211 (19) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks After the Actual EOT (SVR4) and 12 Weeks After the Actual EOT (SVR12)
NCT02421211 (19) [back to overview]Fluctuation Index (FI) of Ledipasvir
NCT02421211 (19) [back to overview]Average Plasma Concentration at Steady State (Cavg,ss) of Simeprevir
NCT02421211 (19) [back to overview]Average Plasma Concentration at Steady State (Cavg,ss) of Ledipasvir
NCT02421211 (19) [back to overview]Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Simeprevir
NCT02421211 (19) [back to overview]Trough Plasma Concentration (Ctrough) of Simeprevir
NCT02421211 (19) [back to overview]Trough Plasma Concentration (Ctrough) of Ledipasvir
NCT02421211 (19) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir
NCT02421211 (19) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of Ledipasvir
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]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]The Sustained Virologic Response (SVR) in Patients Infected With HCV Genotype 1, Cirrhosis, and Early Clinical Decompensation
NCT02457611 (9) [back to overview]Percentage of Participants With Virologic Failure
NCT02457611 (9) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02457611 (9) [back to overview]Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
NCT02457611 (9) [back to overview]Change From Baseline in HCV RNA at Weeks 2, 4, and 6
NCT02457611 (9) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)
NCT02457611 (9) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)
NCT02457611 (9) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02457611 (9) [back to overview]Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.
NCT02457611 (9) [back to overview]Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4
NCT02468648 (4) [back to overview]Number of Participants Who Sustained Virologic Response
NCT02468648 (4) [back to overview]Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)
NCT02468648 (4) [back to overview]Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)
NCT02468648 (4) [back to overview]Number of Participants With Sustained Virologic Response
NCT02472886 (8) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)
NCT02472886 (8) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02472886 (8) [back to overview]Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
NCT02472886 (8) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02472886 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02472886 (8) [back to overview]Percentage of Participants With Virologic Failure
NCT02472886 (8) [back to overview]For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4
NCT02472886 (8) [back to overview]HCV RNA Change From Day 1
NCT02480712 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02480712 (8) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02480712 (8) [back to overview]Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
NCT02480712 (8) [back to overview]HCV RNA Change From Baseline/Day 1
NCT02480712 (8) [back to overview]Percentage of Participants With Virologic Failure
NCT02480712 (8) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02480712 (8) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02480712 (8) [back to overview]Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12
NCT02487030 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02487030 (4) [back to overview]Percentage of Participants With Overall Virologic Failure
NCT02487030 (4) [back to overview]Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)
NCT02487030 (4) [back to overview]Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02503735 (6) [back to overview]The Percent Change in Proteinuria
NCT02503735 (6) [back to overview]Change in Urinary β-2microglobulin Levels After Therapy
NCT02503735 (6) [back to overview]Number of Participants With ≥25% Reduction in Proteinuria
NCT02503735 (6) [back to overview]Median Change in eGFR From Baseline to Timepoint Week 52
NCT02503735 (6) [back to overview]Median Change in eGFR From Baseline to Timepoint Week 24
NCT02503735 (6) [back to overview]Mean Time in Weeks to Maximum Reduction in Proteinuria
NCT02536313 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02536313 (6) [back to overview]HCV RNA Change From Baseline/Day 1 Through Week 12
NCT02536313 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT02536313 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)
NCT02536313 (6) [back to overview]Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event
NCT02536313 (6) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02541409 (4) [back to overview]HCV Treatment Completion
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
NCT02600351 (6) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation of Therapy (SVR12)
NCT02600351 (6) [back to overview]Percentage of Participants With Viral Breakthrough
NCT02600351 (6) [back to overview]Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment
NCT02600351 (6) [back to overview]Percentage of Participants With Viral Relapse
NCT02600351 (6) [back to overview]Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event
NCT02600351 (6) [back to overview]Number of Participants With Emerging Resistance
NCT02601573 (4) [back to overview]Percentage of Participants Experiencing an Adverse Event (AE)
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 Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)
NCT02605304 (11) [back to overview]Number of Participants With HIV-1 RNA >50 Copies/mL
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]Percentage of Participants With Protocol-specified Renal Events
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)
NCT02605304 (11) [back to overview]CD4+ T-cell (CD4) Count Change From Baseline
NCT02605304 (11) [back to overview]Number of Participants With HIV-1 RNA >50 Copies/mL
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]Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)
NCT02607735 (11) [back to overview]Change From Baseline in HCV RNA (Primary Study)
NCT02607735 (11) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
NCT02607735 (11) [back to overview]Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
NCT02607735 (11) [back to overview]Change From Baseline in HCV RNA (Deferred Treatment Substudy)
NCT02607735 (11) [back to overview]Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)
NCT02607735 (11) [back to overview]Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
NCT02607735 (11) [back to overview]Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)
NCT02607735 (11) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)
NCT02607735 (11) [back to overview]Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)
NCT02607735 (11) [back to overview]Percentage of Participants With Virologic Failure (Primary Study)
NCT02607735 (11) [back to overview]Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
NCT02607800 (8) [back to overview]Change From Baseline in HCV RNA
NCT02607800 (8) [back to overview]Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
NCT02607800 (8) [back to overview]Percentage of Participants With HCV RNA < LLOQ On Treatment
NCT02607800 (8) [back to overview]Percentage of Participants With HCV RNA < LLOQ On Treatment
NCT02607800 (8) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02607800 (8) [back to overview]Percentage of Participants With Virologic Failure
NCT02607800 (8) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02607800 (8) [back to overview]Change From Baseline in HCV RNA
NCT02613871 (16) [back to overview]Percentage of Participants With Virologic Failure
NCT02613871 (16) [back to overview]HCV RNA Change From Baseline While on Treatment
NCT02613871 (16) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
NCT02613871 (16) [back to overview]Plasma HBV DNA Change From Baseline While on Treatment
NCT02613871 (16) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment
NCT02613871 (16) [back to overview]Serum LOXL-2 Level Change From Baseline While on Treatment
NCT02613871 (16) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02613871 (16) [back to overview]Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
NCT02613871 (16) [back to overview]Percentage of Participants That Required HBV Therapy During the Study
NCT02613871 (16) [back to overview]Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
NCT02613871 (16) [back to overview]Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study
NCT02613871 (16) [back to overview]Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
NCT02613871 (16) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02613871 (16) [back to overview]HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
NCT02613871 (16) [back to overview]HBsAg Level Change From Baseline While on Treatment
NCT02613871 (16) [back to overview]Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
NCT02625909 (4) [back to overview]Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population
NCT02625909 (4) [back to overview]Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Modified Intention-to-treat (ITT) Population
NCT02625909 (4) [back to overview]Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Per Protocol (PP) Population
NCT02625909 (4) [back to overview]Number of Participants With Undetectable HCV RNA at End of Treatment (ETR) of SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population
NCT02631772 (3) [back to overview]Number of Participants With Virologic Failure
NCT02631772 (3) [back to overview]Treatment Efficacy
NCT02631772 (3) [back to overview]Hemoglobin Levels
NCT02639247 (6) [back to overview]Percentage of Participants With HCV RNA < LLOQ On Treatment
NCT02639247 (6) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02639247 (6) [back to overview]Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
NCT02639247 (6) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02639247 (6) [back to overview]Percentage of Participants With Virologic Failure
NCT02639247 (6) [back to overview]Change From Baseline in HCV RNA
NCT02639338 (8) [back to overview]Percentage of Participants With HCV RNA < LLOQ On Treatment
NCT02639338 (8) [back to overview]Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02639338 (8) [back to overview]Change From Baseline in HCV RNA
NCT02639338 (8) [back to overview]Change From Baseline in HCV RNA
NCT02639338 (8) [back to overview]Percentage of Participants With HCV RNA < LLOQ On Treatment
NCT02639338 (8) [back to overview]Percentage of Participants With Virologic Failure
NCT02639338 (8) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02639338 (8) [back to overview]Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
NCT02640157 (5) [back to overview]Percentage of Participants With On-treatment Virologic Failure
NCT02640157 (5) [back to overview]Percentage of Participants With Post-treatment Relapse
NCT02640157 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B
NCT02640157 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A
NCT02640157 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B
NCT02671500 (7) [back to overview]Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02671500 (7) [back to overview]Change From Baseline in HCV RNA
NCT02671500 (7) [back to overview]Percentage of Participants With HCV RNA < LLOQ On Treatment
NCT02671500 (7) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02671500 (7) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02671500 (7) [back to overview]Percentage of Participants With Overall Virologic Failure
NCT02671500 (7) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02707601 (4) [back to overview]Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm
NCT02707601 (4) [back to overview]Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)
NCT02707601 (4) [back to overview]Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment
NCT02707601 (4) [back to overview]Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)
NCT02722837 (15) [back to overview]Change From Baseline in HCV RNA at Week 8
NCT02722837 (15) [back to overview]Change From Baseline in HCV RNA at Week 12
NCT02722837 (15) [back to overview]Change From Baseline in HCV RNA at Week 1
NCT02722837 (15) [back to overview]Change From Baseline in HCV RNA at Week 2
NCT02722837 (15) [back to overview]Change From Baseline in HCV RNA at Week 4
NCT02722837 (15) [back to overview]Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
NCT02722837 (15) [back to overview]Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02722837 (15) [back to overview]Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02722837 (15) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12
NCT02722837 (15) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2
NCT02722837 (15) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4
NCT02722837 (15) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8
NCT02722837 (15) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02722837 (15) [back to overview]Percentage of Participants With Virologic Failure
NCT02722837 (15) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1
NCT02723084 (4) [back to overview]Percentage of Participants With With On-treatment Virologic Failure
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 in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
NCT02728206 (5) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02728206 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02728206 (5) [back to overview]Percentage of Participants With Overall Virologic Failure
NCT02728206 (5) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02728206 (5) [back to overview]Percentage of Participants With HCV RNA < LLOQ On Treatment
NCT02738333 (23) [back to overview]Change From Baseline in HCV RNA at Week 10
NCT02738333 (23) [back to overview]Change From Baseline in HCV RNA at Week 1
NCT02738333 (23) [back to overview]Change From Baseline in HCV RNA at Week 12
NCT02738333 (23) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02738333 (23) [back to overview]Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02738333 (23) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02738333 (23) [back to overview]Percentage of Participants With Overall Virologic Failure
NCT02738333 (23) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 8
NCT02738333 (23) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 6
NCT02738333 (23) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 5
NCT02738333 (23) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 4
NCT02738333 (23) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 3
NCT02738333 (23) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 2
NCT02738333 (23) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 12
NCT02738333 (23) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 10
NCT02738333 (23) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 1
NCT02738333 (23) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02738333 (23) [back to overview]Change From Baseline in HCV RNA at Week 8
NCT02738333 (23) [back to overview]Change From Baseline in HCV RNA at Week 6
NCT02738333 (23) [back to overview]Change From Baseline in HCV RNA at Week 5
NCT02738333 (23) [back to overview]Change From Baseline in HCV RNA at Week 4
NCT02738333 (23) [back to overview]Change From Baseline in HCV RNA at Week 3
NCT02738333 (23) [back to overview]Change From Baseline in HCV RNA at Week 2
NCT02745535 (5) [back to overview]Number of Participants Who Achieve End of Treatment Virologic Response (ETR) at Completion of Therapy.
NCT02745535 (5) [back to overview]Number of Participants Who Achieve Sustained Virologic Response (SVR) 12 Weeks After Completion of Therapy (SVR12)
NCT02745535 (5) [back to overview]Number of Participants Who Achieve Sustained Virologic Response (SVR) 24 Weeks After Completion of Therapy.
NCT02745535 (5) [back to overview]Number of Participants Who Achieve Sustained Virologic Response (SVR) 4 Weeks After Completion of Therapy.
NCT02745535 (5) [back to overview]Number of Participants With Grade 3 and 4 Adverse Events
NCT02759861 (2) [back to overview]Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR
NCT02759861 (2) [back to overview]The Number of Subjects Who Achieve Negative RNA in Alcoholics
NCT02781558 (16) [back to overview]HCV RNA at Week 2
NCT02781558 (16) [back to overview]HCV RNA at Week 12
NCT02781558 (16) [back to overview]Change From Baseline in HCV RNA at Week 8
NCT02781558 (16) [back to overview]Change From Baseline in HCV RNA at Week 4
NCT02781558 (16) [back to overview]Change From Baseline in HCV RNA at Week 2
NCT02781558 (16) [back to overview]Change From Baseline in HCV RNA at Week 12
NCT02781558 (16) [back to overview]Percentage of Participants With Virologic Failure
NCT02781558 (16) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
NCT02781558 (16) [back to overview]HCV RNA at Week 4
NCT02781558 (16) [back to overview]Percentage of Participants Who Have HCV RNA < LLOQ at Week 8
NCT02781558 (16) [back to overview]Percentage of Participants Who Have HCV RNA < LLOQ at Week 4
NCT02781558 (16) [back to overview]Percentage of Participants Who Have HCV RNA < LLOQ at Week 2
NCT02781558 (16) [back to overview]Percentage of Participants Who Have HCV RNA < LLOQ at Week 12
NCT02781558 (16) [back to overview]Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
NCT02781558 (16) [back to overview]HCV RNA at Week 8
NCT02781558 (16) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
NCT02781571 (16) [back to overview]Change From Baseline in HCV RNA at Week 4
NCT02781571 (16) [back to overview]Change From Baseline in HCV RNA at Week 2
NCT02781571 (16) [back to overview]Change From Baseline in HCV RNA at Week 12
NCT02781571 (16) [back to overview]Percentage of Participants With Virologic Failure
NCT02781571 (16) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
NCT02781571 (16) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
NCT02781571 (16) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 8
NCT02781571 (16) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 4
NCT02781571 (16) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 2
NCT02781571 (16) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 12
NCT02781571 (16) [back to overview]Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
NCT02781571 (16) [back to overview]HCV RNA at Week 8
NCT02781571 (16) [back to overview]HCV RNA at Week 4
NCT02781571 (16) [back to overview]HCV RNA at Week 2
NCT02781571 (16) [back to overview]HCV RNA at Week 12
NCT02781571 (16) [back to overview]Change From Baseline in HCV RNA at Week 8
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]Kidney Function at 12 Months
NCT02781649 (6) [back to overview]Kidney Function at 6 Months
NCT02781649 (6) [back to overview]Antibody Development
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]Median Change in Fatigue-Phase 2
NCT02786537 (28) [back to overview]Median Change in Fatigue -Phase 1
NCT02786537 (28) [back to overview]Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF
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]Mean Change in Nausea/Vomiting PRO Score -Phase 1
NCT02786537 (28) [back to overview]Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2
NCT02786537 (28) [back to overview]Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation
NCT02786537 (28) [back to overview]Change in Functional Status (HCV-PRO) Within Treatment
NCT02786537 (28) [back to overview]Treatment Non-Adherence Probability Estimates
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]Post-treatment Progression/Regression of Liver Disease-Fib-4
NCT02786537 (28) [back to overview]Phase 1/2 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]Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)
NCT02786537 (28) [back to overview]Mean Change in Headache-PRO Scores -Phase 1
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
NCT02786537 (28) [back to overview]Mean Change in Headache-EBR/GZR and SOF/LDV
NCT02786537 (28) [back to overview]Median Change in Headache -Phase 1
NCT02786537 (28) [back to overview]Median Change in HCV-PRO (Overall Well Being) -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 HCV- PRO- Phase 1
NCT02786537 (28) [back to overview]Median Change in Headache-Phase 2
NCT02786537 (28) [back to overview]Mean Change in Fatigue PRO Score -Phase 1
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
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 16
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]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]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]Percentage of Participants With HCV RNA < LLOQ at Week 8
NCT02822794 (29) [back to overview]Percentage of Participants With Overall Virologic Failure
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]Change From Baseline in HCV RNA at Week 1
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 10
NCT02822794 (29) [back to overview]Change From Baseline in HCV RNA at Week 12
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 2
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 24
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 4
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 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
NCT02822794 (29) [back to overview]Percentage of Participants With HCV RNA < LLOQ at Week 10
NCT02825212 (2) [back to overview]Response in Patients With Mixed Cryoglobulinemia (MC)
NCT02825212 (2) [back to overview]Sustained Virologic Response (SVR)
NCT02858180 (4) [back to overview]Number of Subjects With Sustained Virologic Response (SVR) 4
NCT02858180 (4) [back to overview]Number of Subjects With Sustained Virologic Response (SVR) 12
NCT02858180 (4) [back to overview]Number of Subjects Who Completed 24 Weeks of Therapy
NCT02858180 (4) [back to overview]Discontinuation for Adverse Events and Serious Adverse Events
NCT02868242 (7) [back to overview]Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
NCT02868242 (7) [back to overview]Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02868242 (7) [back to overview]Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02868242 (7) [back to overview]Percentage of Participants With Virologic Failure
NCT02868242 (7) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02868242 (7) [back to overview]HCV RNA Change From Baseline/Day 1
NCT02868242 (7) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Treatment
NCT02938013 (4) [back to overview]Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
NCT02938013 (4) [back to overview]Reduction Over the First Week in Plasma HCV RNA
NCT02938013 (4) [back to overview]Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
NCT02938013 (4) [back to overview]Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
NCT02939989 (3) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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
NCT02994056 (10) [back to overview]Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
NCT02994056 (10) [back to overview]Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
NCT02994056 (10) [back to overview]Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event
NCT02994056 (10) [back to overview]Absolute HCV RNA Level Through Week 12
NCT02994056 (10) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
NCT02994056 (10) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02994056 (10) [back to overview]Number of Participants With Virologic Failure
NCT02994056 (10) [back to overview]Change From Baseline in HCV RNA
NCT02994056 (10) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02994056 (10) [back to overview]Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class
NCT03022981 (22) [back to overview]Treatment Phase: Percentage of Participants With Virologic Failure
NCT03022981 (22) [back to overview]Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT03022981 (22) [back to overview]Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT03022981 (22) [back to overview]Treatment Phase: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT03022981 (22) [back to overview]Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE)
NCT03022981 (22) [back to overview]Treatment Phase: Growth and Development as Measured by Parental Height
NCT03022981 (22) [back to overview]PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE)
NCT03022981 (22) [back to overview]PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL)
NCT03022981 (22) [back to overview]PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF)
NCT03022981 (22) [back to overview]PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of GS-331007 (Metabolite of SOF)
NCT03022981 (22) [back to overview]Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment
NCT03022981 (22) [back to overview]Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline
NCT03022981 (22) [back to overview]Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey
NCT03022981 (22) [back to overview]Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment
NCT03022981 (22) [back to overview]Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12
NCT03022981 (22) [back to overview]Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1
NCT03022981 (22) [back to overview]Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline
NCT03022981 (22) [back to overview]Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12
NCT03022981 (22) [back to overview]Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles
NCT03022981 (22) [back to overview]Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles
NCT03022981 (22) [back to overview]Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age
NCT03022981 (22) [back to overview]PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7
NCT03036839 (20) [back to overview]PK Parameter: AUCtau of SOF
NCT03036839 (20) [back to overview]PK Parameter: Cmax of SOF
NCT03036839 (20) [back to overview]HCV RNA
NCT03036839 (20) [back to overview]HCV RNA
NCT03036839 (20) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT03036839 (20) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT03036839 (20) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT03036839 (20) [back to overview]Change From Baseline in HCV RNA
NCT03036839 (20) [back to overview]Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
NCT03036839 (20) [back to overview]Change From Baseline in HCV RNA
NCT03036839 (20) [back to overview]Change From Baseline in HCV RNA
NCT03036839 (20) [back to overview]Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT03036839 (20) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT03036839 (20) [back to overview]Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT03036839 (20) [back to overview]Percentage of Participants With Virologic Failure
NCT03036839 (20) [back to overview]Pharmacokinetics (PK) Parameter: AUCtau of LDV
NCT03036839 (20) [back to overview]PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
NCT03036839 (20) [back to overview]HCV RNA
NCT03036839 (20) [back to overview]PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
NCT03036839 (20) [back to overview]PK Parameter: Cmax of LDV
NCT03036852 (15) [back to overview]Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
NCT03036852 (15) [back to overview]Percentage of Participants With Virologic Failure
NCT03036852 (15) [back to overview]Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
NCT03036852 (15) [back to overview]Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
NCT03036852 (15) [back to overview]Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT03036852 (15) [back to overview]PK Parameter: Cmax of SOF
NCT03036852 (15) [back to overview]PK Parameter: Cmax of VEL
NCT03036852 (15) [back to overview]PK Parameter: Ctau of VEL
NCT03036852 (15) [back to overview]Change From Baseline in HCV RNA
NCT03036852 (15) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT03036852 (15) [back to overview]Pharmacokinetic (PK) Parameter: AUCtau of SOF
NCT03036852 (15) [back to overview]PK Parameter: AUCtau of VEL
NCT03036852 (15) [back to overview]PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
NCT03036852 (15) [back to overview]Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
NCT03036852 (15) [back to overview]PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
NCT03057847 (6) [back to overview]Number of Participants Achieving Sustained Virologic Response (SVR)
NCT03057847 (6) [back to overview]Number of Missed Treatment Doses
NCT03057847 (6) [back to overview]Number of Participants Reporting Treatment Side Effects
NCT03057847 (6) [back to overview]Intravenous Drug Use Recidivism
NCT03057847 (6) [back to overview]Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment
NCT03057847 (6) [back to overview]HCV Reinfection
NCT03074331 (3) [back to overview]Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT03074331 (3) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT03074331 (3) [back to overview]Percentage of Participants With Virologic Failure
NCT03118674 (4) [back to overview]Number of Participants With Resolution of Active PCT by 7 Months After Start of Therapy
NCT03118674 (4) [back to overview]Number of Participants With Complete Biochemical Remission of PCT
NCT03118674 (4) [back to overview]Number of Participants With Cure of CHC
NCT03118674 (4) [back to overview]Time to Resolution of Active PCT
NCT03235154 (3) [back to overview]Adherence to Study Treatment
NCT03235154 (3) [back to overview]Health-Related Quality of Life
NCT03235154 (3) [back to overview]Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment (SVR-12)
NCT03236506 (1) [back to overview]Adherence as Assessed by the Total Percentage of Tablets Taken (Out of Those Dispensed) During the Treatment Period
NCT03312023 (3) [back to overview]Change of Serum Hepatitis B Surface Antigen (HBsAg as Measured in log10 IU/mL) Level as an Indicator of Antiviral Activity of Ledipasvir and/or Sofosbuvir in Subjects With Chronic Hepatitis B From Baseline to End of 12 Weeks Treatment.
NCT03312023 (3) [back to overview]Changes in Serum Hepatitis B Virus DNA Levels (HBV DNA as Measured in IU/mL) With Treatment of Ledipasvir and/or Sofosbuvir From Baseline to End of 12 Weeks of Treatment in Subjects With Chronic Hepatitis B Infection.
NCT03312023 (3) [back to overview]Incidence of Adverse Events Leading to Permanent Discontinuation of Ledipasvir and/or Sofosbuvir Treatment in Subjects With Chronic Hepatitis B Infection.
NCT03480932 (3) [back to overview]Medication Adherence
NCT03480932 (3) [back to overview]Serious Adverse Events
NCT03480932 (3) [back to overview]SVR12
NCT03487848 (9) [back to overview]Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12
NCT03487848 (9) [back to overview]Apparent Total Body Clearance (CLT/F) for Daclatasvir
NCT03487848 (9) [back to overview]Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir
NCT03487848 (9) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Daclatasvir
NCT03487848 (9) [back to overview]Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis
NCT03487848 (9) [back to overview]Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir
NCT03487848 (9) [back to overview]Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis
NCT03487848 (9) [back to overview]Number of Participants Experiencing Adverse Events
NCT03487848 (9) [back to overview]Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir
NCT03512210 (5) [back to overview]Percentage of Participants Who Prematurely Discontinued HCV Study Medications
NCT03512210 (5) [back to overview]Percentage of Participants With Sustained Virologic Response 12 (SVR12)
NCT03512210 (5) [back to overview]Percentage of Participants With at Least One Unplanned Clinic Visit Prior to SVR12 Evaluation
NCT03512210 (5) [back to overview]Percentage of Participants With an Occurrence of Serious Adverse Events According to International Council for Harmonization (ICH) Criteria
NCT03512210 (5) [back to overview]Percentage of Participants With an Occurrence of One or More Non-serious, Grade >= 3 Adverse Event (AE), or Treatment Limiting AE.
NCT03619837 (3) [back to overview]Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)
NCT03619837 (3) [back to overview]Survival Rate of Patients and Their Allografts 6 Months Post Transplant
NCT03619837 (3) [back to overview]Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment
NCT03801707 (4) [back to overview]Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant
NCT03801707 (4) [back to overview]Graft Survival at 6 and 12 Months
NCT03801707 (4) [back to overview]Patient's Survival at 6 and 12 Months
NCT03801707 (4) [back to overview]Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment
NCT03823911 (1) [back to overview]Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein
NCT04112303 (5) [back to overview]Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug
NCT04112303 (5) [back to overview]Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)
NCT04112303 (5) [back to overview]Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)
NCT04112303 (5) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)
NCT04112303 (5) [back to overview]Percentage of Participants With Virologic Failure
NCT04211909 (7) [back to overview]Number of Participants With Alanine Aminotransferase (ALT) Normalization
NCT04211909 (7) [back to overview]Change From Baseline in HCV RNA
NCT04211909 (7) [back to overview]Percentage of Participants With Virologic Failure
NCT04211909 (7) [back to overview]Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment
NCT04211909 (7) [back to overview]Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment
NCT04211909 (7) [back to overview]Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT04211909 (7) [back to overview]Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event

Plasma Pharmacokinetics of GS-331007: Cmax at Day 27

The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

Interventionng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV233.79
Sofosbuvir 200 mg+PEG+RBV357.38
Sofosbuvir 400 mg+PEG+RBV717.23

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Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0

"The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir.~Cmax is defined as the maximum concentration of drug." (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

Interventionng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV218.08
Sofosbuvir 200 mg+PEG+RBV332.26
Sofosbuvir 400 mg+PEG+RBV1257.50

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Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27

"The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir).~AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval." (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

Interventionh*ng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV375.70
Sofosbuvir 200 mg+PEG+RBV732.27
Sofosbuvir 400 mg+PEG+RBV2011.23

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Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0

"The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir).~AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time." (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

Interventionh*ng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV280.19
Sofosbuvir 200 mg+PEG+RBV585.56
Sofosbuvir 400 mg+PEG+RBV1867.24

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Plasma Pharmacokinetics of GS-566500: Cmax at Day 27

The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

Interventionng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV64.75
Sofosbuvir 200 mg+PEG+RBV132.72
Sofosbuvir 400 mg+PEG+RBV237.46

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Plasma Pharmacokinetics of GS-566500: Cmax at Day 0

The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

Interventionng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV69.99
Sofosbuvir 200 mg+PEG+RBV145.51
Sofosbuvir 400 mg+PEG+RBV293.35

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Plasma Pharmacokinetics of GS-331007: Cmax at Day 0

The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

Interventionng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV197.32
Sofosbuvir 200 mg+PEG+RBV357.33
Sofosbuvir 400 mg+PEG+RBV662.13

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Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27

The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir. (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

Interventionng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV253.54
Sofosbuvir 200 mg+PEG+RBV475.14
Sofosbuvir 400 mg+PEG+RBV1355.65

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Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27

The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir). (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

Interventionh*ng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV262.00
Sofosbuvir 200 mg+PEG+RBV571.95
Sofosbuvir 400 mg+PEG+RBV1072.91

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Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0

The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir). (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

Interventionh*ng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV266.22
Sofosbuvir 200 mg+PEG+RBV645.95
Sofosbuvir 400 mg+PEG+RBV1315.94

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Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period

Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event. (NCT01054729)
Timeframe: Baseline to Week 4

,,,
Interventionpercentage of participants (Number)
Any AEDrug-related AEGrade 3 or higher AEAE leading to drug discontinuation/interruptionSerious AE
Placebo+PEG+RBV85.742.90.00.00.0
Sofosbuvir 100 mg+PEG+RBV87.512.50.00.00.0
Sofosbuvir 200 mg+PEG+RBV83.327.80.00.00.0
Sofosbuvir 400 mg+PEG+RBV86.733.30.00.00.0

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Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27

The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir). (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

Interventionh*ng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV2256.81
Sofosbuvir 200 mg+PEG+RBV3389.23
Sofosbuvir 400 mg+PEG+RBV7398.99

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Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0

The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir). (NCT01054729)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

Interventionh*ng/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV2173.18
Sofosbuvir 200 mg+PEG+RBV3984.88
Sofosbuvir 400 mg+PEG+RBV7559.91

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Percentage of Participants With Rapid Virologic Response at Week 4

Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4. (NCT01054729)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Sofosbuvir 100 mg+PEG+RBV87.5
Sofosbuvir 200 mg+PEG+RBV94.4
Sofosbuvir 400 mg+PEG+RBV93.3
Placebo+PEG+RBV21.4

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Percentage of Participants Who Developed Resistance to Sofosbuvir

(NCT01054729)
Timeframe: Baseline to Week 4

Interventionpercentage of participants (Number)
Sofosbuvir 100 mg+PEG+RBV0.0
Sofosbuvir 200 mg+PEG+RBV0.0
Sofosbuvir 400 mg+PEG+RBV0.0

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Change in Circulating HCV RNA at Week 4

(NCT01054729)
Timeframe: Baseline to Week 4

Interventionlog10 IU/mL (Mean)
Sofosbuvir 100 mg+PEG+RBV-5.323
Sofosbuvir 200 mg+PEG+RBV-5.081
Sofosbuvir 400 mg+PEG+RBV-5.346
Placebo+PEG+RBV-2.8

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Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment

SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV). (NCT01054729)
Timeframe: Post-treatment Weeks 12 and 24

,,,
Interventionpercentage of participants (Number)
SVR12SVR24
Placebo+PEG+RBV50.042.9
Sofosbuvir 100 mg+PEG+RBV56.356.3
Sofosbuvir 200 mg+PEG+RBV72.283.3
Sofosbuvir 400 mg+PEG+RBV86.780.0

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Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)

The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose

Interventionng•h/mL (Mean)
Sofosbuvir 200 mg (Genotype 1)3020.30
Sofosbuvir 400 mg (Genotype 1)8620.07
Sofosbuvir 400 mg (Genotype 2/3)5738.61

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Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)

SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively. (NCT01188772)
Timeframe: Post-treatment Weeks 12 and 24

,,,
Interventionpercentage of participants (Number)
SVR12SVR24
Placebo (Genotype 1)57.757.7
Sofosbuvir 200 mg (Genotype 1)89.689.6
Sofosbuvir 400 mg (Genotype 1)91.591.5
Sofosbuvir 400 mg (Genotype 2/3)92.092.0

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Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period

Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event. (NCT01188772)
Timeframe: Baseline to Week 12 plus 30 days

,,,
Interventionpercentage of participants (Number)
Any AEDrug-related AEGrade 3 or higher AEAE leading to drug discontinuationSerious AE
Placebo (Genotype 1)100.0100.011.511.53.8
Sofosbuvir 200 mg (Genotype 1)97.997.910.44.22.1
Sofosbuvir 400 mg (Genotype 1)97.995.721.36.46.4
Sofosbuvir 400 mg (Genotype 2/3)96.096.012.00.00.0

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Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)

The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose

Interventionng/mL (Mean)
Sofosbuvir 200 mg (Genotype 1)331.48
Sofosbuvir 400 mg (Genotype 1)750.78
Sofosbuvir 400 mg (Genotype 2/3)518.18

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Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)

The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose

Interventionng/mL (Mean)
Sofosbuvir 200 mg (Genotype 1)285.77
Sofosbuvir 400 mg (Genotype 1)897.41
Sofosbuvir 400 mg (Genotype 2/3)574.13

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Percentage of Participants With Virologic Response at the End of Treatment

End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at the last on-treatment visit. (NCT01188772)
Timeframe: Week 48 (genotype 1) or Week 12 (genotype 2/3)

Interventionpercentage of participants (Number)
Sofosbuvir 200 mg (Genotype 1)93.8
Sofosbuvir 400 mg (Genotype 1)100.0
Placebo (Genotype 1)61.5
Sofosbuvir 400 mg (Genotype 2/3)100.0

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Percentage of Participants With Rapid Virologic Response at Week 4

Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) (NCT01188772)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Sofosbuvir 200 mg (Genotype 1)97.9
Sofosbuvir 400 mg (Genotype 1)97.9
Placebo (Genotype 1)19.2
Sofosbuvir 400 mg (Genotype 2/3)96.0

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Percentage of Participants With Extended Rapid Virologic Response

Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12. (NCT01188772)
Timeframe: Week 4 to Week 12

Interventionpercentage of participants (Number)
Sofosbuvir 200 mg (Genotype 1)97.9
Sofosbuvir 400 mg (Genotype 1)91.5
Placebo (Genotype 1)19.2
Sofosbuvir 400 mg (Genotype 2/3)96.0

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Percentage of Participants With Complete Early Virologic Response at Week 12

Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 12 (NCT01188772)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Sofosbuvir 200 mg (Genotype 1)100.0
Sofosbuvir 400 mg (Genotype 1)91.5
Placebo (Genotype 1)61.5
Sofosbuvir 400 mg (Genotype 2/3)96.0

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Percentage of Participants Who Developed Resistance to Sofosbuvir

Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24. (NCT01188772)
Timeframe: Baseline to Week 12

Interventionpercentage of participants (Number)
Sofosbuvir 200 mg (Genotype 1)0.0
Sofosbuvir 400 mg (Genotype 1)0.0
Sofosbuvir 400 mg (Genotype 2/3)0.0

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Change in HCV RNA From Baseline to Week 12

(NCT01188772)
Timeframe: Baseline to Week 12

Interventionlog10 IU/mL (Mean)
Sofosbuvir 200 mg (Genotype 1)-5.39
Sofosbuvir 400 mg (Genotype 1)-5.20
Placebo (Genotype 1)-4.16
Sofosbuvir 400 mg (Genotype 2/3)-4.95

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Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)

The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose

Interventionng•h/mL (Mean)
Sofosbuvir 200 mg (Genotype 1)2789.62
Sofosbuvir 400 mg (Genotype 1)9191.86
Sofosbuvir 400 mg (Genotype 2/3)5874.52

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Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)

The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose

Interventionng•h/mL (Mean)
Sofosbuvir 200 mg (Genotype 1)3178.53
Sofosbuvir 400 mg (Genotype 1)11245.43
Sofosbuvir 400 mg (Genotype 2/3)5465.41

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Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)

The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. (NCT01188772)
Timeframe: 1, 2, 4, 8, and 12 hours postdose

Interventionng/mL (Mean)
Sofosbuvir 200 mg (Genotype 1)269.93
Sofosbuvir 400 mg (Genotype 1)1087.21
Sofosbuvir 400 mg (Genotype 2/3)515.13

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Percentage of Participants With HCV RNA < LOD at Week 12

Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. (NCT01260350)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN100.0
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN100.0
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN100.0
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN100.0
Group 5: SOF 12 wk: GT 2 or 3, TN100.0
Group 7: SOF+RBV 12 wk: GT 1, TE100.0
Group 8: SOF+RBV 12 wk: GT 1, TN100.0
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE100.0
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN100.0
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE100.0
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN100.0
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE100.0
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN100.0
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis100.0
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis100.0
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN100.0
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac100.0

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Percentage of Participants With HCV RNA < LOD at Week 6

(NCT01260350)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN100.0
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN100.0
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN100.0
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN100.0
Group 5: SOF 12 wk: GT 2 or 3, TN100.0
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN100.0
Group 7: SOF+RBV 12 wk: GT 1, TE100.0
Group 8: SOF+RBV 12 wk: GT 1, TN100.0
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE100.0
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN100.0
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN100.0
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE100.0
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN100.0
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE100.0
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN100.0
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis100.0
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis100.0
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN100.0
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac100.0
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN100.0

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Percentage of Participants With Virologic Failure

"The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.~On-treatment virologic failure was defined as:~Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment),~Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or~Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)~Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit." (NCT01260350)
Timeframe: Up to Posttreatment Week 24

,,,,,,,,,,,,,,,,,,,
Interventionpercentage of participants (Number)
On-treatment virologic failureViral relapse
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN0.00.0
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN0.036.0
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN0.040.0
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE0.00.0
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN0.00.0
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE0.00.0
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN0.08.0
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis0.030.0
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis0.00.0
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN0.020.0
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN0.00.0
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac0.00.0
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN0.032.0
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN0.00.0
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN0.00.0
Group 5: SOF 12 wk: GT 2 or 3, TN0.040.0
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN0.00.0
Group 7: SOF+RBV 12 wk: GT 1, TE0.090.0
Group 8: SOF+RBV 12 wk: GT 1, TN0.016.0
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE0.032.0

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Percentage of Participants Who Experienced Adverse Events

Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. (NCT01260350)
Timeframe: Up to 12 weeks plus 30 days

,,,,,,,,,,,,,,,,,,,
InterventionPercentage of participants (Number)
Any AEDrug-related AEGrade 3 or higher AEAE leading to drug discontinuationSerious AE
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN108001
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN2521102
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN107000
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE99000
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN2424312
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE1010000
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN2521200
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis75000
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis88100
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN76000
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN99200
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac1312132
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN2219020
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN1010000
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN1111110
Group 5: SOF 12 wk: GT 2 or 3, TN107000
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN1010301
Group 7: SOF+RBV 12 wk: GT 1, TE1010000
Group 8: SOF+RBV 12 wk: GT 1, TN2525101
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE2420000

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Change From Baseline in HCV RNA at Week 8

Data are not presented for Group 21 which ended treatment after Week 6. (NCT01260350)
Timeframe: Baseline to Week 8

Interventionlog10 IU/mL (Mean)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN-5.52
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN-5.44
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN-5.23
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN-5.20
Group 5: SOF 12 wk: GT 2 or 3, TN-4.59
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN-4.94
Group 7: SOF+RBV 12 wk: GT 1, TE-5.70
Group 8: SOF+RBV 12 wk: GT 1, TN-4.95
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE-5.38
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN-4.92
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN-5.01
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE-5.74
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN-4.80
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE-5.84
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN-5.19
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis-5.36
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis-5.18
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN-4.93
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac-5.35

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Change From Baseline in HCV RNA at Week 6

(NCT01260350)
Timeframe: Baseline to Week 6

Interventionlog10 IU/mL (Mean)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN-5.52
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN-5.44
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN-5.23
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN-5.20
Group 5: SOF 12 wk: GT 2 or 3, TN-6.23
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN-4.94
Group 7: SOF+RBV 12 wk: GT 1, TE-5.70
Group 8: SOF+RBV 12 wk: GT 1, TN-4.95
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE-5.38
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN-4.92
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN-5.01
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE-5.74
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN-4.80
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE-5.84
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN-5.19
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis-5.36
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis-5.18
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN-4.93
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac-5.35
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN-5.39

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Change From Baseline in HCV RNA at Week 12

Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules. (NCT01260350)
Timeframe: Baseline to Week 12

Interventionlog10 IU/mL (Mean)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN-5.52
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN-5.44
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN-5.23
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN-5.20
Group 5: SOF 12 wk: GT 2 or 3, TN-4.59
Group 7: SOF+RBV 12 wk: GT 1, TE-5.70
Group 8: SOF+RBV 12 wk: GT 1, TN-4.95
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE-5.39
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN-2.01
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE-5.74
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN-4.85
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE-5.84
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN-5.19

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Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)

SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug. (NCT01260350)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN100.0
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN100.0
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN100.0
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN100.0
Group 5: SOF 12 wk: GT 2 or 3, TN60.0
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN100.0
Group 7: SOF+RBV 12 wk: GT 1, TE10.0
Group 8: SOF+RBV 12 wk: GT 1, TN84.0
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE68.0
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN64.0
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN60.0
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE100.0
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN100.0
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE100.0
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN92.0
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis70.0
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis100.0
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN80.0
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac100.0
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN68.0

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Percentage of Participants With HCV RNA < LOD at Week 8

Data are not presented for Group 21 which ended treatment after Week 6. (NCT01260350)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN100.0
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN100.0
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN100.0
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN100.0
Group 5: SOF 12 wk: GT 2 or 3, TN100.0
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN100.0
Group 7: SOF+RBV 12 wk: GT 1, TE100.0
Group 8: SOF+RBV 12 wk: GT 1, TN100.0
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE100.0
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN100.0
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN100.0
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE100.0
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN100.0
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE100.0
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN100.0
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis100.0
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis100.0
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN100.0
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac100.0

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Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)

SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug. (NCT01329978)
Timeframe: Post-treatment Week 24

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks90.4
SOF+PEG+RBV 24 Weeks92.7
SOF+PEG+RBV 12 Week/Rerandomization Group91.0
SOF Rerandomization Group93.3
SOF+RBV Rerandomization Group94.7

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Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)

SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug. (NCT01329978)
Timeframe: Post-treatment Week 12

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks90.4
SOF+PEG+RBV 24 Weeks92.0
SOF+PEG+RBV 12 Week/Rerandomization Group91.0
SOF Rerandomization Group93.3
SOF+RBV Rerandomization Group94.7

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Percentage of Participants With HCV RNA Below < LOD at Week 8

(NCT01329978)
Timeframe: Week 8

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks100.0
SOF+PEG+RBV 24 Weeks100.0
SOF+PEG+RBV 12 Week/Rerandomization Group99.3

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Percentage of Participants With HCV RNA Below < LOD at Week 4

(NCT01329978)
Timeframe: Week 4

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks98.0
SOF+PEG+RBV 24 Weeks100.0
SOF+PEG+RBV 12 Week/Rerandomization Group98.7

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Percentage of Participants With HCV RNA Below < LOD at Week 24

(NCT01329978)
Timeframe: Week 24

Interventionpercentage of participants (Number)
SOF+PEG+RBV 24 Weeks100.0
SOF Rerandomization Group100.0
SOF+RBV Rerandomization Group98.6

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Percentage of Participants With HCV RNA Below < LOD at Week 12

(NCT01329978)
Timeframe: Week 12

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks100.0
SOF+PEG+RBV 24 Weeks100.0
SOF+PEG+RBV 12 Week/Rerandomization Group100.0

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Percentage of Participants With HCV RNA < LOD at Week 2

(NCT01329978)
Timeframe: Week 2

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks68.6
SOF+PEG+RBV 24 Weeks85.5
SOF+PEG+RBV 12 Week/Rerandomization Group77.1

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Percentage of Participants With ALT Normalization at Week 12

ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12. (NCT01329978)
Timeframe: Baseline (Day 1) to Week 12

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks78.3
SOF+PEG+RBV 24 Weeks76.6
SOF+PEG+RBV 12 Week/Rerandomization Group67.6

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Percentage of Participants With ALT Normalization at Post-treatment Week 4

ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4. (NCT01329978)
Timeframe: Baseline (Day 1) to Post-treatment Week 4

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks89.5
SOF+PEG+RBV 24 Weeks87.2
SOF+PEG+RBV 12 Week/Rerandomization Group95.2
SOF Rerandomization Group91.7
SOF+RBV Rerandomization Group100.0

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Change in HCV RNA at Week 8

(NCT01329978)
Timeframe: Baseline (Day 1) to Week 8

Interventionlog10 IU/mL (Mean)
SOF+PEG+RBV 12 Weeks-5.34
SOF+PEG+RBV 24 Weeks-5.17
SOF+PEG+RBV 12 Week/Rerandomization Group-5.25

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Change in HCV RNA at Week 4

(NCT01329978)
Timeframe: Baseline (Day 1) to Week 4

Interventionlog10 IU/mL (Mean)
SOF+PEG+RBV 12 Weeks-5.33
SOF+PEG+RBV 24 Weeks-5.19
SOF+PEG+RBV 12 Week/Rerandomization Group-5.24

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Percentage of Participants With ALT Normalization at Week 24

ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24. (NCT01329978)
Timeframe: Baseline (Day 1) to Week 24

Interventionpercentage of participants (Number)
SOF+PEG+RBV 24 Weeks78.9
SOF Rerandomization Group94.3
SOF+RBV Rerandomization Group100.0

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Change in HCV RNA at Week 2

(NCT01329978)
Timeframe: Baseline (Day 1) to Week 2

Interventionlog10 IU/mL (Mean)
SOF+PEG+RBV 12 Weeks-5.12
SOF+PEG+RBV 24 Weeks-5.07
SOF+PEG+RBV 12 Week/Rerandomization Group-5.13

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Change in HCV RNA at Week 12

(NCT01329978)
Timeframe: Baseline (Day 1) to Week 12

Interventionlog10 IU/mL (Mean)
SOF+PEG+RBV 12 Weeks-5.36
SOF+PEG+RBV 24 Weeks-5.20
SOF+PEG+RBV 12 Week/Rerandomization Group-5.25

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Percentage of Participants With Virologic Failure During Treatment

"Virologic failure was defined as either~HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or~HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)~Baseline was Day 1 for all groups." (NCT01329978)
Timeframe: Baseline (Day 1) to Week 24

,,,,
Interventionpercentage of participants (Number)
Viral breakthroughViral reboundNon-response
SOF Rerandomization Group0.00.00.0
SOF+PEG+RBV 12 Week/Rerandomization Group0.00.00.0
SOF+PEG+RBV 12 Weeks0.00.00.0
SOF+PEG+RBV 24 Weeks0.00.00.0
SOF+RBV Rerandomization Group0.00.00.0

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Percentage of Participants Who Experienced Adverse Events

Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. (NCT01329978)
Timeframe: Baseline (Day 1) to post-treatment Day 30

,,,,
Interventionpercentage of participants (Number)
Any AEDrug-related AEGrade 3 or higher AEAE leading to drug discontinuationSerious AE
SOF Rerandomization Group98.798.714.75.32.7
SOF+PEG+RBV 12 Week/Rerandomization Group98.797.414.24.52.6
SOF+PEG+RBV 12 Weeks98.196.215.45.83.8
SOF+PEG+RBV 24 Weeks96.894.417.616.04.8
SOF+RBV Rerandomization Group100.097.313.34.02.7

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Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).

Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement. (NCT01329978)
Timeframe: End of treatment to Post-treatment Week 24

Interventionpercentage of participants (Number)
SOF+PEG+RBV 12 Weeks5.9
SOF+PEG+RBV 24 Weeks1.6
SOF+PEG+RBV 12 Week/Rerandomization Group3.9
SOF Rerandomization Group2.7
SOF+RBV Rerandomization Group2.7

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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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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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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 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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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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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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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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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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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 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 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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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 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) 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) 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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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT01497366)
Timeframe: Up to 12 Weeks

,
Interventionpercentage of participants (Number)
Week 1 (SOF+RBV, n = 252; PEG+RBV, n = 243)Week 2 (SOF+RBV, n = 251; PEG+RBV, n = 241)Week 4 (SOF+RBV, n = 250; PEG+RBV, n = 236)Week 8 (SOF+RBV, n = 248; PEG+RBV, n = 231)Week 12 (SOF+RBV, n = 244; PEG+RBV, n = 224)
PEG+RBV6.631.566.985.792.4
Sofosbuvir+RBV43.792.099.699.699.2

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Change From Baseline in HCV RNA

(NCT01497366)
Timeframe: Baseline to Week 12

,
Interventionlog10 IU/mL (Mean)
Week 1 (SOF+RBV, n = 239; PEG+RBV, n = 236)Week 2 (SOF+RBV, n = 246; PEG+RBV, n = 233)Week 4 (SOF+RBV, n = 250; PEG+RBV, n = 235)Week 8 (SOF+RBV, n = 248; PEG+RBV, n = 228)Week 12 (SOF+RBV, n = 243; PEG+RBV, n = 222)
PEG+RBV-2.19-3.19-4.04-4.42-4.45
Sofosbuvir+RBV-4.26-4.60-4.64-4.63-4.65

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Percentage of Participants With Virologic Failure During Treatment

"Virologic failure was defined as either~Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement~Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)" (NCT01497366)
Timeframe: Baseline up to Week 24

Interventionpercentage of participants (Number)
Sofosbuvir+RBV0.4
PEG+RBV7.4

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Percentage of Participants With Viral Relapse Following Treatment

Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement. (NCT01497366)
Timeframe: Up to Post-treatment Week 24

Interventionpercentage of participants (Number)
Sofosbuvir+RBV30.5
PEG+RBV22.6

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Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)

SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation. (NCT01497366)
Timeframe: Post-treatment Week 24

Interventionpercentage of participants (Number)
Sofosbuvir+RBV66.8
PEG+RBV65.4

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation. (NCT01497366)
Timeframe: Post-treatment Week 12

Interventionpercentage of participants (Number)
Sofosbuvir+RBV67
PEG+RBV67

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Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities

(NCT01497366)
Timeframe: Up to 24 weeks plus 30 days following the last dose of study drug

,
Interventionparticipants (Number)
AEs leading to discontinuation of any study drugSerious AEsGrade 3 laboratory abnormalitiesGrade 4 laboratory abnormalitiesDeaths
PEG+RBV29380210
Sofosbuvir+RBV373331

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Number of Subjects With Undetectable HCV RNA at Day 56 Post Liver Transplantation

The primary outcome was to determine if MBL-HCV1 in combination with the oral direct-acting antiviral could reduce HCV viral RNA to undetectable at day 56 post transplant and prevent the new liver from becoming productively infected. Undetectable HCV RNA was defined as the level below the lower limit of detection (LLOD) of an FDA-approved polymerase chain reaction (PCR) assay. HCV RNA was quantified by PCR (e.g., COBAS®AmpliPrep/ COBAS® TaqMan® HCV Test manufactured by Roche or equivalent) at each study site (NCT01532908)
Timeframe: Day 56

InterventionParticipants (Count of Participants)
Part 1: MBL-HCV1 and Telaprevir4
Part 2: MBL-HCV1 and Sofosbuvir2

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Change in Viral Load Between Baseline Pre-transplant HCV RNA Levels and Study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98 in Liver Transplant Recipients

"Serum HCV RNA was measured by quantitative RT-PCR. The change in log 10 IU/mL HCV viral load from baseline was compared with pre-transplant HCV RNA level and evaluated for each subject at each study visit.~Change in the level of HCV RNA in serum, log10(IU/mL), is defined as the difference between the level measured at Baseline and the specified time point. If HCV RNA was not detected by the PCR assay, the lower level of detection of the PCR assay was used for the calculation" (NCT01532908)
Timeframe: Baseline pre-transplant and study Day 7, 10, 14, 28, 35, 42, 49, 56, 70, 84 and 98

,
InterventionLog10 IU/mL (Mean)
Day 7Day 10Day 14Day 28Day 35Day 42Day 49Day 56Day 70Day 84Day 98
Part 1: MBL-HCV1 and Telaprevir-2.97-3.35-3.58-2.94-3.01-2.94-2.89-2.28-2.62-2.53-0.76
Part 2: MBL-HCV1 and Sofosbuvir-3.46-3.99-4.32-5.29-5.29-5.29-5.29-5.29-5.29-5.29-5.29

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Safety and Tolerability of Study Treatment by Number of Adverse Events Reported

Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Abnormal laboratory values constituted adverse events only if they induced clinical signs or symptoms and/or required therapy that was new or enhanced from baseline. Solicited adverse reactions included the occurrence of the following during or immediately after the infusion: arthralgia, chills, dyspnea, fatigue, fever, headache, nausea, hives, or rash. The presence of any of these symptoms (new or worsening from baseline) was documented as an adverse event. In addition, subjects were asked at all scheduled study visits to report any other adverse events. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 14.1) (NCT01532908)
Timeframe: Day 0 start of first infusion through Day 56 or six weeks after last dose of study treatment whichever is later, up to approximately 126 days

,
InterventionEvents (Number)
Blood And Lymphatic System DisordersCardiac DisordersEye DisordersGastrointestinal DisordersGeneral Disorders And Administration Site ConditionsHepatobiliary DisordersImmune System DisordersInfections And InfestationsInjury, Poisoning And Procedural ComplicationsInvestigationsMetabolism And Nutrition DisordersMusculoskeletal And Connective Tissue DisordersNeoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)Nervous System DisordersPsychiatric DisordersRenal And Urinary DisordersReproductive System And Breast DisordersRespiratory, Thoracic And Mediastinal DisordersSkin And Subcutaneous Tissue DisordersSurgical And Medical ProceduresVascular Disorders
Part 1: MBL-HCV1 and Telaprevir6019123261131410651110205
Part 2: MBL-HCV1 and Sofosbuvir010300121121112020111

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Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 10, 14, 28, 35, 42, 49, 70, 84 and 98 in Liver Transplant Recipients and for Those Subjects Receiving an Additional 4 Weeks of Treatment at Study Day 105, 112 and 126

"The number of subjects with undetectable HCV RNA by study visit day was analyzed utilizing a last value carried forward (LVCF) strategy so that each study visit day had data from (8 subjects in Part 1 and 2 subjects in Part 2), effectively imputing the information for the subjects who had missing data due to a missed study visit, HCV RNA measured with a non-FDA approved assay, or completion of all required post-treatment study visits. The last recorded HCV RNA status for a subject (detectable vs undetectable) was used for the next missing level (in ascending visit number order) until a new HCV RNA level was recorded at a later visit. Serum HCV RNA was measured by Quantitative RT-PCR using an FDA-approved quantitative assay" (NCT01532908)
Timeframe: Day 7, 10, 14, 28, 35, 42, 49, 70, 84, 98, 105, 112 and 126

,
Interventionparticipants (Number)
Day 7Day 10Day 14Day 28Day 35Day 42Day 49Day 70Day 84Day 98Day 105Day 112Day 126
Part 1: MBL-HCV1 and Telaprevir0224555322222
Part 2: MBL-HCV1 and Sofosbuvir0002222222222

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Number of Subjects With Sustained Virologic Response (SVR) at Week 12 and Week 24

"Number of subjects with sustained virologic response (defined as HCV RNA concentration below the limit of detection) at 12 and 24 weeks post-treatment was examined as an exploratory endpoint in subjects whose HCV RNA remained undetectable at the 6 week post-treatment safety follow-up visit.~Those subjects that had detectable HCV RNA at the end of safety follow-up period were not assessed for SVR 12 and SVR 24. Those subjects achieving an SVR12 were assessed for the durability of the response at 24 weeks after the end of treatment" (NCT01532908)
Timeframe: 12 weeks after the end of treatment (SVR12) and 24 weeks after the end of treatment 12 weeks and 24 weeks post-treatment

,
Interventionparticipants (Number)
Post Treatment Week 12Post Treatment Week 24
Part 1: MBL-HCV1 and Telaprevir11
Part 2: MBL-HCV1 and Sofosbuvir22

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Number of Participants With HCV Resistance-associated Variants to MBL-HCV1 and Oral Direct-acting Antivirals Before and After Receipt of Study Treatment

Conventional sequencing was performed on HCV RNA isolated from a subset of serum samples obtained at baseline, at the time of viral rebound, and at the end of study in subjects who did not achieve a sustained virologic response. The targets of both the MBL-HCV1 antibody (E1/E2 glycoprotein) and telaprevir (NS3) were sequenced. The data displays the number of subjects with > 20% resistance associated variants (RAV) reported for the target MBL-HCV1 and/or Direct-acting Antiviral (DAA) (NCT01532908)
Timeframe: Pre-transplant, time of viral rebound (assessed from Day 7-Day 56 of treatment), end of study (up to day 126) in subjects who did not achieve a sustained virologic response (SVR)

,
InterventionParticipants with > 20 % RAV (Number)
Pre-transplantViral ReboundEnd of Study
Part 1: MBL-HCV1 and Telaprevir447
Part 2: MBL-HCV1 and SofosbuvirNANANA

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Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug

The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. (NCT01542788)
Timeframe: Baseline to Week 12

,
Interventionparticipants (Number)
No adverse event leading to discontinuationAbdominal pain upperAlanine aminotransferase increasedAnaemiaAnxietyChest discomfortInjuryInsomniaMuscle spasmsOedema peripheralPancreatitisRashRoad traffic accident
Placebo68010000001110
SOF+RBV202101111110001

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Percentage of Participants Achieving SVR12

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy (NCT01542788)
Timeframe: Post-treatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV78
Placebo0

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Percentage of Participants Experiencing 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 (NCT01542788)
Timeframe: End of treatment to post-treatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV20.5

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Percentage of Participants Experiencing 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 (NCT01542788)
Timeframe: Baseline to Week 12

Interventionpercentage of participants (Number)
SOF+RBV0.0
Placebo0.0

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Percentage of Participants Achieving SVR4

SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy (NCT01542788)
Timeframe: Post-treatment Week 4

Interventionpercentage of participants (Number)
SOF+RBV83.1
Placebo0.0

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Percentage of Participants Achieving SVR24

SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy (NCT01542788)
Timeframe: Post-treatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV77.8
Placebo0.0

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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 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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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 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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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 Achieving SVR24

"SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV+Placebo50.0
SOF+RBV71.6

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Percentage of Participants Achieving SVR12

"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV+Placebo51.0
SOF+RBV72.6

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Adverse Events Leading to Permanent Discontinuation of Study Drug

Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment. (NCT01604850)
Timeframe: Baseline to Week 16

Interventionparticipants (Number)
SOF+RBV+Placebo1
SOF+RBV0

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Percentage of Participants Achieving SVR4

"SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF+RBV+Placebo56.0
SOF+RBV76.8

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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.~For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: Up to 16 weeks

Interventionpercentage of participants (Number)
SOF+RBV+Placebo0.0
SOF+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.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)." (NCT01604850)
Timeframe: End of treatment to posttreatment Week 24

Interventionparticipants (Number)
SOF+RBV+Placebo47
SOF+RBV26

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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. (NCT01625338)
Timeframe: Posttreatment Weeks 4 and 24

,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+RBV 12 Weeks73.771.9
SOF+RBV 24 Weeks81.576.0
SOF+RBV+Peg-IFN 12 Weeks87.282.6

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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. (NCT01625338)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV 12 Weeks25.7
SOF+RBV 24 Weeks20.6
SOF+RBV+Peg-IFN 12 Weeks16.4

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT01625338)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 12 Weeks0.9
SOF+RBV 24 Weeks1.0
SOF+RBV+Peg-IFN 12 Weeks3.7

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Percentage of Participants With 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)" (NCT01625338)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 12 Weeks0.9
SOF+RBV 24 Weeks0.5
SOF+RBV+Peg-IFN 12 Weeks0

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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, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01625338)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV 12 Weeks71.9
SOF+RBV 24 Weeks77.5
SOF+RBV+Peg-IFN 12 Weeks82.6

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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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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 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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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 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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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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Change From Baseline in HCV RNA at Week 4

(NCT01667731)
Timeframe: Baseline; Week 4

Interventionlog10 IU/mL (Mean)
SOF+RBV 12 Wk GT 2 TN-5.04
SOF+RBV 12 Wk GT 3 TN-4.86
SOF+RBV 24 Wk GT 2 TE-5.16
SOF+RBV 24 Wk GT 3 TE-5.06
SOF+RBV 24 Wk GT 1 TN-5.12

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Change From Baseline in HCV RNA at Week 2

(NCT01667731)
Timeframe: Baseline; Week 2

Interventionlog10 IU/mL (Mean)
SOF+RBV 12 Wk GT 2 TN-5.11
SOF+RBV 12 Wk GT 3 TN-4.84
SOF+RBV 24 Wk GT 2 TE-5.15
SOF+RBV 24 Wk GT 3 TE-5.06
SOF+RBV 24 Wk GT 1 TN-5.00

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Change From Baseline in HCV RNA at Week 1

(NCT01667731)
Timeframe: Baseline; Week 1

Interventionlog10 IU/mL (Mean)
SOF+RBV 12 Wk GT 2 TN-4.69
SOF+RBV 12 Wk GT 3 TN-4.52
SOF+RBV 24 Wk GT 2 TE-4.63
SOF+RBV 24 Wk GT 3 TE-4.78
SOF+RBV 24 Wk GT 1 TN-4.42

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Change From Baseline in HCV RNA at Week 6

(NCT01667731)
Timeframe: Baseline; Week 6

Interventionlog10 IU/mL (Mean)
SOF+RBV 12 Wk GT 2 TN-5.13
SOF+RBV 12 Wk GT 3 TN-4.86
SOF+RBV 24 Wk GT 2 TE-5.16
SOF+RBV 24 Wk GT 3 TE-5.06
SOF+RBV 24 Wk GT 1 TN-5.20

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Change From Baseline in HCV RNA at Week 8

(NCT01667731)
Timeframe: Baseline; Week 8

Interventionlog10 IU/mL (Mean)
SOF+RBV 12 Wk GT 2 TN-5.13
SOF+RBV 12 Wk GT 3 TN-4.83
SOF+RBV 24 Wk GT 2 TE-5.16
SOF+RBV 24 Wk GT 3 TE-5.06
SOF+RBV 24 Wk GT 1 TN-5.20

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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. (NCT01667731)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 12 Wk GT 2/3 TN4.4
SOF+RBV 24 Wk GT 2/3 TE2.4
SOF+RBV 24 Wk GT 1 TN2.6

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Percentage of Participants Experiencing On-treatment Virologic Failure

"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment" (NCT01667731)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 12 Wk GT 2 TN3.8
SOF+RBV 12 Wk GT 3 TN0
SOF+RBV 24 Wk GT 2 TE0
SOF+RBV 24 Wk GT 3 TE0
SOF+RBV 24 Wk GT 1 TN0.9

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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. (NCT01667731)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV 12 Wk GT 2 TN0
SOF+RBV 12 Wk GT 3 TN28.6
SOF+RBV 24 Wk GT 2 TE4.2
SOF+RBV 24 Wk GT 3 TE5.9
SOF+RBV 24 Wk GT 1 TN22.1

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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. (NCT01667731)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV 12 Wk GT 2 TN88.5
SOF+RBV 12 Wk GT 3 TN66.7
SOF+RBV 24 Wk GT 2 TE91.7
SOF+RBV 24 Wk GT 3 TE94.1
SOF+RBV 24 Wk GT 1 TN76.3

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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01667731)
Timeframe: Posttreatment Weeks 4 and 24

,,,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+RBV 12 Wk GT 2 TN88.588.5
SOF+RBV 12 Wk GT 3 TN71.466.7
SOF+RBV 24 Wk GT 1 TN80.775.4
SOF+RBV 24 Wk GT 2 TE95.891.7
SOF+RBV 24 Wk GT 3 TE94.188.2

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Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed. (NCT01682720)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Placebo 12 Weeks (GT2/3)1.2
SOF 12 Weeks (GT2/3)1.2
SOF 24 Weeks (GT3)0.4

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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. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group. (NCT01682720)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF 12 Weeks (GT2)93.2
SOF 12 Weeks (GT3)27.3
SOF 24 Weeks (GT3)85.2

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Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse

"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) 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 was not collected for the Placebo 12 Weeks (GT2/3) group." (NCT01682720)
Timeframe: Up to Posttreatment Week 24

,,
Interventionpercentage of participants (Number)
Viral breakthroughViral relapse
SOF 12 Weeks (GT2)06.8
SOF 12 Weeks (GT3)054.5
SOF 24 Weeks (GT3)0.414.0

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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 was not collected for the Placebo 12 Weeks (GT2/3) group. (NCT01682720)
Timeframe: Posttreatment Weeks 4 and 24

,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF 12 Weeks (GT2)93.293.2
SOF 12 Weeks (GT3)45.527.3
SOF 24 Weeks (GT3)87.284.4

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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)" (NCT01687257)
Timeframe: Up to 48 weeks

Interventionpercentage of participants (Number)
SOF+RBV (Group 1)8.0
SOF+RBV (Group 2)0

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Percentage of Participants Experiencing 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. (NCT01687257)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV (Group 1)17.4
SOF+RBV (Group 2)23.8

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Change From Baseline in Child-Pugh-Turcotte (CPT) Score

"CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. Data are presented as improvement, no change, or worsening in CPT scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in CPT score was defined as having a decrease in CPT score from baseline, no change in CPT score was defined as having no change in CPT score from baseline, and worsening in CPT score was defined as having an increase in CPT score from baseline.~Baseline values were the last available values on or prior to first dose date of any study drug." (NCT01687257)
Timeframe: Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)

,,,
Interventionpercentage of participants (Number)
Improvement in CPT ScoreNo Change in CPT ScoreWorsening in CPT Score
All SOF+RBV (Groups 1 and 2)53.736.69.8
Observation Period (Group 2)10.075.015.0
SOF+RBV (Group 1)65.226.18.7
SOF+RBV (Group 2)38.950.011.1

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Change From Baseline in Model for End Stage Liver Disease (MELD) Scores

"MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. Data are presented as improvement, no change, or worsening in MELD scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in MELD score was defined as having a baseline MELD score of 11-15 or 16-20 that changed to 0-10, or a baseline MELD score of 16-20 that changed to 11-15; no change in MELD score was defined as having no change in score group (0-10, 11-15, or 16-20) from baseline; and worsening in MELD score was defined as having a baseline MELD score of 0-10 that changed to 11-15 or 16-20, or a baseline MELD score of 11-15 that changed to 16-20.~Baseline values were the last available values on or prior to first dose date of any study drug." (NCT01687257)
Timeframe: Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)

,,,
Interventionpercentage of participants (Number)
Improvement in MELD ScoreNo Change in MELD ScoreWorsening in MELD Score
All SOF+RBV (Groups 1 and 2)22.068.39.8
Observation Period (Group 2)20.075.05.0
SOF+RBV (Group 1)33.354.212.5
SOF+RBV (Group 2)5.988.25.9

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Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)

SVR4, SVR24, and SVR48 were defined as HCV RNA < LLOQ at 4, 24, and 48 weeks after stopping study treatment, respectively. (NCT01687257)
Timeframe: Posttreatment Weeks 4, 24, and 48

,
Interventionpercentage of participants (Number)
SVR4 (Group 1: N = 25; Group 2: N = 21)SVR24 (Group 1: N = 25; Group 2: N = 21)SVR48 (Group 1: N = 17; Group 2: N = 13)
SOF+RBV (Group 1)72.068.094.1
SOF+RBV (Group 2)76.271.4100.0

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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, 25 IU/mL) at 12 weeks after stopping study treatment. For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA < LLOQ for 12 consecutive weeks, any time during the observational period. (NCT01687257)
Timeframe: Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)

Interventionpercentage of participants (Number)
SOF+RBV (Group 1)72.0
Observation Period (Group 2)0
SOF+RBV (Group 2)71.4

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Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment

HVPG closely reflects the degree of portal hypertension in patients with cirrhosis. The end of treatment for the Observation group was defined as the end of the observation period. The treatment period for Group 2 was defined as the end of the observation period to the end of the treatment. Baseline values were the last available values on or prior to first dose date of any study drug. (NCT01687257)
Timeframe: Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)

InterventionmmHg (Mean)
SOF+RBV (Group 1)-1.6
Observation Period (Group 2)0.5
SOF+RBV (Group 2)-0.4
All SOF+RBV (Groups 1 and 2)-1.0

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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 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 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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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 With Virologic Failure

"On-treatment virologic failure was defined as:~Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR~Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment~Virologic 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" (NCT01701401)
Timeframe: Baseline to posttreatment Week 24

,,,
Interventionpercentage of participants (Number)
On-treatment virologic failureVirologic relapse
LDV/SOF 12 Weeks00.5
LDV/SOF 24 Weeks0.50.5
LDV/SOF+RBV 12 Weeks00
LDV/SOF+RBV 24 Weeks00

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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug

SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively. (NCT01701401)
Timeframe: Posttreatment Weeks 4 and 24

,,,
Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF 12 Weeks98.698.6
LDV/SOF 24 Weeks99.198.2
LDV/SOF+RBV 12 Weeks98.297.2
LDV/SOF+RBV 24 Weeks99.199.1

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Change From Baseline in HCV RNA at Week 2

(NCT01701401)
Timeframe: Baseline; Week 2

Interventionlog10 IU/mL (Mean)
LDV/SOF 12 Weeks-4.90
LDV/SOF+RBV 12 Weeks-4.94
LDV/SOF 24 Weeks-4.86
LDV/SOF+RBV 24 Weeks-4.89

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Change From Baseline in HCV RNA at Week 4

(NCT01701401)
Timeframe: Baseline; Week 4

Interventionlog10 IU/mL (Mean)
LDV/SOF 12 Weeks-4.99
LDV/SOF+RBV 12 Weeks-5.02
LDV/SOF 24 Weeks-4.93
LDV/SOF+RBV 24 Weeks-4.96

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Change From Baseline in HCV RNA at Week 8

(NCT01701401)
Timeframe: Baseline; Week 8

Interventionlog10 IU/mL (Mean)
LDV/SOF 12 Weeks-4.99
LDV/SOF+RBV 12 Weeks-5.02
LDV/SOF 24 Weeks-4.91
LDV/SOF+RBV 24 Weeks-4.96

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Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug

The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized. (NCT01701401)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks0
LDV/SOF+RBV 12 Weeks0.5
LDV/SOF 24 Weeks1.8
LDV/SOF+RBV 24 Weeks3.7

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Percentage of Participants With HCV RNA < LLOQ at Week 2

(NCT01701401)
Timeframe: Week 2

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks82.2
LDV/SOF+RBV 12 Weeks83.4
LDV/SOF 24 Weeks82.9
LDV/SOF+RBV 24 Weeks82.9

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Percentage of Participants With HCV RNA < LLOQ at Week 4

(NCT01701401)
Timeframe: Week 4

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks100
LDV/SOF+RBV 12 Weeks99.1
LDV/SOF 24 Weeks100
LDV/SOF+RBV 24 Weeks100

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Percentage of Participants With HCV RNA < LLOQ at Week 8

(NCT01701401)
Timeframe: Week 8

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks99.5
LDV/SOF+RBV 12 Weeks100
LDV/SOF 24 Weeks99.5
LDV/SOF+RBV 24 Weeks100

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)

SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug. (NCT01701401)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks98.6
LDV/SOF+RBV 12 Weeks97.2
LDV/SOF 24 Weeks98.2
LDV/SOF+RBV 24 Weeks99.1

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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. (NCT01713283)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV 12 Wk TN78.6
SOF+RBV 12 Wk TE58.8
SOF+RBV 24 Wk TN100.0
SOF+RBV 24 Wk TE86.7

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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01713283)
Timeframe: Posttreatment Weeks 4 and 24

,,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+RBV 12 Wk TE58.858.8
SOF+RBV 12 Wk TN78.678.6
SOF+RBV 24 Wk TE93.386.7
SOF+RBV 24 Wk TN100.0100.0

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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. (NCT01713283)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 12 Wk0
SOF+RBV 24 Wk3.4

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Percentage of Participants Experiencing On-treatment Virologic Failure

"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment" (NCT01713283)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 12 Wk TN7.1
SOF+RBV 12 Wk TE0
SOF+RBV 24 Wk TN0
SOF+RBV 24 Wk TE0

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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. (NCT01713283)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV 12 Wk TN15.4
SOF+RBV 12 Wk TE41.2
SOF+RBV 24 Wk TN0
SOF+RBV 24 Wk TE13.3

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HCV RNA Change From Baseline at Week 6

(NCT01783678)
Timeframe: Baseline; Week 6

Interventionlog10 IU/mL (Mean)
Genotype 2 Treatment-naive-5.33
All Genotype 1 Treatment-naive-4.95
Genotype 1a Treatment-naive-5.01
Genotype 1b Treatment-naive-4.55
Genotype 2 Treatment-experienced-5.05
Genotype 3 Treatment-naive-4.89
Genotype 3 Treatment-experienced-4.91
Genotype 4 Treatment-naive-4.57

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HCV RNA Change From Baseline at Week 4

(NCT01783678)
Timeframe: Baseline; Week 4

Interventionlog10 IU/mL (Mean)
Genotype 2 Treatment-naive-5.33
All Genotype 1 Treatment-naive-4.95
Genotype 1a Treatment-naive-5.01
Genotype 1b Treatment-naive-4.55
Genotype 2 Treatment-experienced-5.05
Genotype 3 Treatment-naive-4.89
Genotype 3 Treatment-experienced-4.84
Genotype 4 Treatment-naive-4.57

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HCV RNA Change From Baseline at Week 2

(NCT01783678)
Timeframe: Baseline; Week 2

Interventionlog10 IU/mL (Mean)
Genotype 2 Treatment-naive-5.29
All Genotype 1 Treatment-naive-4.92
Genotype 1a Treatment-naive-4.97
Genotype 1b Treatment-naive-4.55
Genotype 2 Treatment-experienced-4.98
Genotype 3 Treatment-naive-4.86
Genotype 3 Treatment-experienced-4.89
Genotype 4 Treatment-naive-4.52

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HCV RNA Change From Baseline at Week 1

(NCT01783678)
Timeframe: Baseline; Week 1

Interventionlog10 IU/mL (Mean)
Genotype 2 Treatment-naive-4.72
All Genotype 1 Treatment-naive-4.54
Genotype 1a Treatment-naive-4.57
Genotype 1b Treatment-naive-4.35
Genotype 2 Treatment-experienced-4.34
Genotype 3 Treatment-naive-4.41
Genotype 3 Treatment-experienced-4.33
Genotype 4 Treatment-naive-4.21

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Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized. (NCT01783678)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Genotype 2 Treatment-naive0
Genotype 2/3 Treatment-experienced1.8
Genotype 1/3/4 Treatment-naive3.5

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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively. (NCT01783678)
Timeframe: Posttreatment Weeks 4 and 24

,,,,,,,
Interventionpercentage of participants (Number)
SVR4SVR24
All Genotype 1 Treatment-naive87.583.0
Genotype 1a Treatment-naive87.082.0
Genotype 1b Treatment-naive90.990.9
Genotype 2 Treatment-experienced83.383.3
Genotype 2 Treatment-naive89.589.5
Genotype 3 Treatment-experienced87.883.7
Genotype 3 Treatment-naive91.291.2
Genotype 4 Treatment-naive90.380.6

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Percentage of Participants Experiencing Virologic Failure

"On-treatment virologic failure was defined as either:~Virologic 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~Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).~Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01783678)
Timeframe: Baseline up to Posttreatment Week 24

,,,,,,,
Interventionpercentage of participants (Number)
On-Treatment Virologic FailureVirologic Relapse
All Genotype 1 Treatment-naive012.5
Genotype 1a Treatment-naive013.0
Genotype 1b Treatment-naive09.1
Genotype 2 Treatment-experienced016.7
Genotype 2 Treatment-naive05.3
Genotype 3 Treatment-experienced2.012.5
Genotype 3 Treatment-naive07.0
Genotype 4 Treatment-naive016.1

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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) 12 weeks following the last dose of study drug. (NCT01783678)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Genotype 2 Treatment-naive89.5
All Genotype 1 Treatment-naive84.8
Genotype 1a Treatment-naive84.0
Genotype 1b Treatment-naive90.9
Genotype 2 Treatment-experienced83.3
Genotype 3 Treatment-naive91.2
Genotype 3 Treatment-experienced85.7
Genotype 4 Treatment-naive83.9

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HCV RNA Change From Baseline at Week 8

(NCT01783678)
Timeframe: Baseline; Week 8

Interventionlog10 IU/mL (Mean)
Genotype 2 Treatment-naive-5.33
All Genotype 1 Treatment-naive-4.95
Genotype 1a Treatment-naive-5.01
Genotype 1b Treatment-naive-4.55
Genotype 2 Treatment-experienced-5.05
Genotype 3 Treatment-naive-4.88
Genotype 3 Treatment-experienced-4.86
Genotype 4 Treatment-naive-4.57

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The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs

The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification. (NCT01805882)
Timeframe: 12 weeks after stop of treatment

Interventionpercentage of subjects (Number)
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir100
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-966995
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-945195
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir91.2
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir100
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir95
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-945176
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-945140
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-966920

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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01808248)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
Genotype 295.795.7
Genotype 387.583.3

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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, < 15 IU/mL) at 12 weeks after stopping study treatment. (NCT01808248)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Genotype 295.7
Genotype 383.3

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Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. (NCT01808248)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
Genotype 20
Genotype 38.7

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Percentage of Participants Experiencing On-treatment Virologic Failure

"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment" (NCT01808248)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
Genotype 20
Genotype 30

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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. (NCT01808248)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF+PEG+RBV8.5

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment. (NCT01826981)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)100
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)90
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)100
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease100
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)64.0
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)100
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)96.0
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)82.0
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)65.0
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)100
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)87.5
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)96.3
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)100.0
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)75
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)100

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Percentage of Participants With 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)" (NCT01826981)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)0
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)0
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)0
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease0
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)0
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)0
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)0
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)0
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)0
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)0
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)0
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)0
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)0
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)0
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)0

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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

(NCT01826981)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)100.0
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)100.0
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)100.0
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease100.0
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)100.0
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)100.0
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)100.0
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)98.0
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)100.0
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)100.0
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)100.0

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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

(NCT01826981)
Timeframe: Week 10

Interventionpercentage of participants (Number)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)100.0
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)100.0
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)100.0
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease100.0
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)100.0
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)100.0
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)100.0
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)98.0
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)100.0
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)100.0
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)100.0

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Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

(NCT01826981)
Timeframe: Up to 24 weeks plus 30 days

InterventionPercentage of participants (Number)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)0
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)0
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)4.0
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease0
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)4.0
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)0
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)0
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)2.0
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)0
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)0
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)4.2
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)0
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)3.8
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)5.0
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)0

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Percentage of Participants Experiencing Viral Relapse

Viral relapse is 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. (NCT01826981)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)0
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)10.0
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)0
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease0
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)33.3
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)0
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)4.0
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)16.3
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)35.0
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)0
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)8.7
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)0
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)0
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)15.0
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)0

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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

(NCT01826981)
Timeframe: Weeks 1 and 2

,,,,,,,,,,,,,,
Interventionpercentage of participants (Number)
Week 1Week 2
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)15.863.2
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)30.050.0
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)4.044.0
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease11.553.8
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)20.064.0
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)11.561.5
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)12.056.0
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)12.052.0
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)025.0
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)33.370.4
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)4.266.7
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)26.965.4
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)19.269.2
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)15.045.0
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)12.575.0

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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

(NCT01826981)
Timeframe: Weeks 4, 6, and 8

,,,,,,,,,,,,,,
Interventionpercentage of participants (Number)
Week 4Week 6Week 8
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)100.0100.0100.0
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)100.0100.0100.0
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)84.0100.0100.0
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease92.3100.0100.0
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)95.8100.0100.0
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)88.5100.0100.0
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)96.096.0100.0
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)96.0100.0100.0
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)75.0100.0100.0
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)96.3100.0100.0
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)95.7100.0100.0
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)92.3100.0100.0
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)96.2100.0100.0
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)75.090.090.0
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)87.5100.0100.0

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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

(NCT01826981)
Timeframe: Weeks 16, 20, and 24

Interventionpercentage of participants (Number)
Week 16Week 20Week 24
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)100.0100.0100.0

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Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)

(NCT01826981)
Timeframe: Posttreatment Weeks 2, 4, 8, and 24

,,,,,,,,,,,,,,
Interventionpercentage of participants (Number)
SVR2SVR4SVR8SVR24
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)100.0100.0100.0100.0
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)100.0100.090.090.0
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)100.084.0100.0100.0
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease100.092.3100.0100.0
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)72.095.864.064.0
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)100.088.5100.0100.0
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)100.096.096.096.0
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)90.096.082.082.0
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)95.075.065.065.0
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)100.096.3100.0100.0
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)87.595.787.587.5
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)96.392.396.396.3
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)100.096.2100.0100.0
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)95.075.080.075.0
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)100.087.5100.0100.0

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For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)

(NCT01826981)
Timeframe: Posttreatment Weeks 16 and 20

Interventionpercentage of participants (Number)
SVR16SVR20
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)100100

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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)" (NCT01838590)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 12 Weeks, TN0
SOF+RBV 12 Weeks, TE0
SOF+RBV 24 Weeks, TN0
SOF+RBV 24 Weeks, TE0

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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. (NCT01838590)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV 12 Weeks, TN84.0
SOF+RBV 12 Weeks, TE70.4
SOF+RBV 24 Weeks, TN91.7
SOF+RBV 24 Weeks, TE88.9

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT01838590)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 12 Weeks0
SOF+RBV 24 Weeks0

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Percentage of Participants Experiencing Virologic Relapse

Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT01838590)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV 12 Weeks, TN16.0
SOF+RBV 12 Weeks, TE29.6
SOF+RBV 24 Weeks, TN4.2
SOF+RBV 24 Weeks, TE11.1

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Percentage of Participants With Sustained Virologic Response 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 following the last dose of study drug, respectively. (NCT01838590)
Timeframe: Posttreatment Weeks 4 and 24

,,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+RBV 12 Weeks, TE74.170.4
SOF+RBV 12 Weeks, TN88.084.0
SOF+RBV 24 Weeks, TE88.988.9
SOF+RBV 24 Weeks, TN91.791.7

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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. (NCT01851330)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 8 Week94.0
LDV/SOF+RBV 8 Week93.1
LDV/SOF 12 Week96.3

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Percentage of Participants Experiencing Virologic Failure

"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~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) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01851330)
Timeframe: Baseline to posttreatment Week 24

,,
Interventionpercentage of participants (Number)
On-treatment virologic failureVirologic relapse
LDV/SOF 12 Week01.4
LDV/SOF 8 Week05.1
LDV/SOF+RBV 8 Week04.2

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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01851330)
Timeframe: Posttreatment Weeks 4 and 24

,,
Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF 12 Week96.396.3
LDV/SOF 8 Week96.394.0
LDV/SOF+RBV 8 Week94.993.1

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Change From Baseline in HCV RNA at Week 4

(NCT01851330)
Timeframe: Baseline; Week 4

Interventionlog10 IU/mL (Mean)
LDV/SOF 8 Week-5.12
LDV/SOF+RBV 8 Week-5.05
LDV/SOF 12 Week-5.05

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Change From Baseline in HCV RNA at Week 2

(NCT01851330)
Timeframe: Baseline; Week 2

Interventionlog10 IU/mL (Mean)
LDV/SOF 8 Week-5.06
LDV/SOF+RBV 8 Week-5.01
LDV/SOF 12 Week-4.99

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Percentage of Participants With HCV RNA < LLOQ at Week 8

(NCT01851330)
Timeframe: Week 8

Interventionpercentage of participants (Number)
LDV/SOF 8 Week100.0
LDV/SOF+RBV 8 Week100.0
LDV/SOF 12 Week99.5

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Change From Baseline in HCV RNA at Week 8

(NCT01851330)
Timeframe: Baseline; Week 8

Interventionlog10 IU/mL (Mean)
LDV/SOF 8 Week-5.12
LDV/SOF+RBV 8 Week-5.05
LDV/SOF 12 Week-5.04

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Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug

The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized. (NCT01851330)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF 8 Week0
LDV/SOF+RBV 8 Week0.9
LDV/SOF 12 Week0.9

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Percentage of Participants With HCV RNA < LLOQ at Week 2

(NCT01851330)
Timeframe: Week 2

Interventionpercentage of participants (Number)
LDV/SOF 8 Week88.4
LDV/SOF+RBV 8 Week91.1
LDV/SOF 12 Week91.2

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Percentage of Participants With HCV RNA < LLOQ at Week 4

(NCT01851330)
Timeframe: Week 4

Interventionpercentage of participants (Number)
LDV/SOF 8 Week100.0
LDV/SOF+RBV 8 Week99.1
LDV/SOF 12 Week100.0

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Percentage of Participants With Achieved SVR12 (HCV RNA

The primary end point was sustained virologic response [plasma HCV RNA level <12 IU/mL by real-time HCV assay (Abbott)] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study. (NCT01878799)
Timeframe: 12 weeks after completion of treatment

Interventionpercentage of participants (Number)
Subjects With HIV and HCV on Antiretroviral Agents97
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents100

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Percentage of Participants Experiencing Virologic Relapse

Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT01896193)
Timeframe: Up to Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV 16 Weeks, GT150.0
SOF+RBV 24 Weeks, GT123.5
SOF+RBV 16 Weeks, GT313.3
SOF+RBV 24 Weeks, GT39.7

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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. (NCT01896193)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV 16 Weeks, GT150.0
SOF+RBV 24 Weeks, GT176.5
SOF+RBV 16 Weeks, GT386.7
SOF+RBV 24 Weeks, GT390.3

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Percentage of Participants With Sustained Virologic Response 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 following the last dose of study drug, respectively. (NCT01896193)
Timeframe: Posttreatment Weeks 4 and 24

,,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+RBV 16 Weeks, GT153.146.9
SOF+RBV 16 Weeks, GT390.086.7
SOF+RBV 24 Weeks, GT176.576.5
SOF+RBV 24 Weeks, GT390.390.3

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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)" (NCT01896193)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 16 Weeks, GT10
SOF+RBV 24 Weeks, GT10
SOF+RBV 16 Weeks, GT30
SOF+RBV 24 Weeks, GT30

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Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized. (NCT01896193)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 16 Weeks, GT10
SOF+RBV 24 Weeks, GT10
SOF+RBV 16 Weeks, GT30
SOF+RBV 24 Weeks, GT30

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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. (NCT01910636)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV Treatment Naive97.8
SOF+RBV Treatment Experienced95.2

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Percentage of Participants With Sustained Virologic Response 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 following the last dose of study drug, respectively. (NCT01910636)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+RBV Treatment Experienced95.295.2
SOF+RBV Treatment Naive98.997.8

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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. (NCT01910636)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV Treatment Naive2.2
SOF+RBV Treatment Experienced4.8

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Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized. (NCT01910636)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF+RBV0

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Percentage of Participants Experiencing Viral Breakthrough

Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values. (NCT01910636)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF+RBV Treatment Naive0
SOF+RBV Treatment Experienced0

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Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event

(NCT01924949)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks0

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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. (NCT01924949)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks100.0

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Percentage of Participants With Sustained Virologic Response 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. (NCT01924949)
Timeframe: Posttreatment Weeks 4 and 24

Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF 12 Weeks100.0100.0

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HCV RNA Change From Baseline

(NCT01924949)
Timeframe: Baseline; Weeks 1, 4, and 8

Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 4Change at Week 8
LDV/SOF 12 Weeks-4.36-4.56-4.56

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT01924949)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
Week 1Week 4Week 8Week 12
LDV/SOF 12 Weeks60.0100.0100.0100.0

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Percentage of Participants Experiencing 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." (NCT01924949)
Timeframe: Baseline to posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks0

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Percentage of Participants With HCV RNA < LLOQ at Week 24

(NCT01938430)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 20

(NCT01938430)
Timeframe: Week 20

Interventionpercentage of participants (Number)
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 2

(NCT01938430)
Timeframe: Week 2

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)36.7
Cohort A, Group 1 (24 wk): CPT Class B (7-9)41.4
Cohort A, Group 2 (12 wk): CPT Class C (10-12)39.1
Cohort A, Group 2 (24 wk): CPT Class C (10-12)38.5
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis49.1
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis41.8
Cohort B, Group 4 (12 wk): CPT Class A (5-6)34.6
Cohort B, Group 4 (24 wk): CPT Class A (5-6)28.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)8.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)42.3
Cohort B, Group 6 (12 wk): CPT Class C (10-12)40.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)25.0
Cohort B, Group 7 (12 wk): FCH50.0
Cohort B, Group 7 (24 wk): FCH0.0

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Percentage of Participants With HCV RNA < LLOQ at Week 16

(NCT01938430)
Timeframe: Week 16

Interventionpercentage of participants (Number)
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 12

(NCT01938430)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)100.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)96.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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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 on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01938430)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)10.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)3.7
Cohort A, Group 2 (12 wk): CPT Class C (10-12)4.5
Cohort A, Group 2 (24 wk): CPT Class C (10-12)8.7
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis3.6
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis0.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)0.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)0.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)3.8
Cohort B, Group 5 (24 wk): CPT Class B (7-9)0.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)40.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)25.0
Cohort B, Group 7 (12 wk): FCH3.6
Cohort B, Group 7 (24 wk): FCH0.0

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HCV RNA and Change From Baseline at Week 1

(NCT01938430)
Timeframe: Baseline; Week 1

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 1Change at Week 1
Cohort A, Group 1 (12 wk): CPT Class B (7-9)2.26-3.59
Cohort A, Group 1 (24 wk): CPT Class B (7-9)2.49-3.34
Cohort A, Group 2 (12 wk): CPT Class C (10-12)2.11-3.47
Cohort A, Group 2 (24 wk): CPT Class C (10-12)2.46-3.32
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis2.33-4.14
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis2.42-3.98
Cohort B, Group 4 (12 wk): CPT Class A (5-6)2.40-3.80
Cohort B, Group 4 (24 wk): CPT Class A (5-6)2.86-3.86
Cohort B, Group 5 (12 wk): CPT Class B (7-9)2.84-3.41
Cohort B, Group 5 (24 wk): CPT Class B (7-9)2.56-3.68
Cohort B, Group 6 (12 wk): CPT Class C (10-12)2.76-3.75
Cohort B, Group 6 (24 wk): CPT Class C (10-12)2.75-3.52
Cohort B, Group 7 (12 wk): FCH2.28-4.22
Cohort B, Group 7 (24 wk): FCH4.30-2.76

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HCV RNA and Change From Baseline at Week 8

(NCT01938430)
Timeframe: Baseline; Week 8

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 8Change at Week 8
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.15-4.70
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.15-4.67
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.15-4.47
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.16-4.61
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.15-5.33
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.15-5.25
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.15-5.05
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.15-5.60
Cohort B, Group 5 (12 wk): CPT Class B (7-9)1.15-5.11
Cohort B, Group 5 (24 wk): CPT Class B (7-9)1.15-5.10
Cohort B, Group 6 (12 wk): CPT Class C (10-12)1.15-5.21
Cohort B, Group 6 (24 wk): CPT Class C (10-12)1.15-5.12
Cohort B, Group 7 (12 wk): FCH1.15-5.36
Cohort B, Group 7 (24 wk): FCH1.22-5.83

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HCV RNA and Change From Baseline at Week 6

(NCT01938430)
Timeframe: Baseline; Week 6

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 6Change at Week 6
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.15-4.70
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.15-4.69
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.15-4.47
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.15-4.61
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.15-5.32
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.15-5.25
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.15-5.05
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.15-5.60
Cohort B, Group 5 (12 wk): CPT Class B (7-9)1.15-5.10
Cohort B, Group 5 (24 wk): CPT Class B (7-9)1.15-5.09
Cohort B, Group 6 (12 wk): CPT Class C (10-12)1.15-5.21
Cohort B, Group 6 (24 wk): CPT Class C (10-12)1.15-5.12
Cohort B, Group 7 (12 wk): FCH1.15-5.36
Cohort B, Group 7 (24 wk): FCH1.15-5.28

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Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

(NCT01938430)
Timeframe: Up to 24 weeks

,,,,,,,,,,,,,
Interventionpercentage of participants (Number)
Discontinued LDV/SOFDiscontinued Any Study Drug
Cohort A, Group 1 (12 wk): CPT Class B (7-9)0.00.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)6.913.8
Cohort A, Group 2 (12 wk): CPT Class C (10-12)4.313.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)7.734.6
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis0.010.9
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis3.617.9
Cohort B, Group 4 (12 wk): CPT Class A (5-6)3.815.4
Cohort B, Group 4 (24 wk): CPT Class A (5-6)0.08.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)7.723.1
Cohort B, Group 5 (24 wk): CPT Class B (7-9)11.534.6
Cohort B, Group 6 (12 wk): CPT Class C (10-12)0.040.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)0.025.0
Cohort B, Group 7 (12 wk): FCH0.025.0
Cohort B, Group 7 (24 wk): FCH0.00.0

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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score

CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline. (NCT01938430)
Timeframe: Baseline to Posttreatment Week 4

,,,,,,,,,,
Interventionpercentage of participants (Number)
DecreaseNo ChangeIncrease
Cohort A: Baseline CPT Class A (24 wk)0.00.0100.0
Cohort A: Baseline CPT Class B (12 wk)63.323.313.3
Cohort A: Baseline CPT Class B (24 wk)50.038.511.5
Cohort A: Baseline CPT Class C (12 wk)89.510.50.0
Cohort A: Baseline CPT Class C (24 wk)72.227.80.0
Cohort B: Baseline CPT Class A (12 wk)18.268.213.6
Cohort B: Baseline CPT Class A (24 wk)47.852.20.0
Cohort B: Baseline CPT Class B (12 wk)56.534.88.7
Cohort B: Baseline CPT Class B (24 wk)59.131.89.1
Cohort B: Baseline CPT Class C (12 wk)50.050.00.0
Cohort B: Baseline CPT Class C (24 wk)100.00.00.0

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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score

Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. (NCT01938430)
Timeframe: Baseline to Posttreatment Week 4

,,,,,,,,,
Interventionpercentage of participants (Number)
DecreaseNo ChangeIncrease
Cohort A, Group 1 (12 wk): CPT Class B (7-9)60.717.921.4
Cohort A, Group 1 (24 wk): CPT Class B (7-9)68.020.012.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)61.99.528.6
Cohort A, Group 2 (24 wk): CPT Class C (10-12)80.015.05.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)30.439.130.4
Cohort B, Group 4 (24 wk): CPT Class A (5-6)52.016.032.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)66.719.014.3
Cohort B, Group 5 (24 wk): CPT Class B (7-9)70.05.025.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)40.020.040.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)66.70.033.3

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HCV RNA and Change From Baseline at Week 2

(NCT01938430)
Timeframe: Baseline; Week 2

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 2Change at Week 2
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.60-4.25
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.67-4.16
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.49-4.09
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.82-3.98
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.64-4.83
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.59-4.79
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.73-4.48
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.91-4.84
Cohort B, Group 5 (12 wk): CPT Class B (7-9)2.03-4.22
Cohort B, Group 5 (24 wk): CPT Class B (7-9)1.76-4.47
Cohort B, Group 6 (12 wk): CPT Class C (10-12)1.80-4.56
Cohort B, Group 6 (24 wk): CPT Class C (10-12)2.00-4.26
Cohort B, Group 7 (12 wk): FCH1.66-4.85
Cohort B, Group 7 (24 wk): FCH1.61-4.81

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HCV RNA and Change From Baseline at Week 12

(NCT01938430)
Timeframe: Baseline; Week 12

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 12Change at Week 12
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.15-4.70
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.15-4.70
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.15-4.44
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.15-4.62
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.15-5.33
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.15-5.25
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.15-5.09
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.15-5.60
Cohort B, Group 5 (12 wk): CPT Class B (7-9)1.15-5.14
Cohort B, Group 5 (24 wk): CPT Class B (7-9)1.15-5.10
Cohort B, Group 6 (12 wk): CPT Class C (10-12)1.15-5.21
Cohort B, Group 6 (24 wk): CPT Class C (10-12)1.15-5.12
Cohort B, Group 7 (12 wk): FCH1.15-5.36
Cohort B, Group 7 (24 wk): FCH1.15-5.91

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Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)

SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment. (NCT01938430)
Timeframe: Posttreatment Week 8

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)86.7
Cohort A, Group 1 (24 wk): CPT Class B (7-9)88.9
Cohort A, Group 2 (12 wk): CPT Class C (10-12)86.4
Cohort A, Group 2 (24 wk): CPT Class C (10-12)95.7
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis96.4
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis98.2
Cohort B, Group 4 (12 wk): CPT Class A (5-6)96.2
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)88.5
Cohort B, Group 5 (24 wk): CPT Class B (7-9)88.5
Cohort B, Group 6 (12 wk): CPT Class C (10-12)60.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)75.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT01938430)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)90.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)88.9
Cohort A, Group 2 (12 wk): CPT Class C (10-12)90.9
Cohort A, Group 2 (24 wk): CPT Class C (10-12)95.7
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis96.4
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis98.2
Cohort B, Group 4 (12 wk): CPT Class A (5-6)96.2
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)88.5
Cohort B, Group 5 (24 wk): CPT Class B (7-9)92.3
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)75.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT01938430)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)86.7
Cohort A, Group 1 (24 wk): CPT Class B (7-9)88.9
Cohort A, Group 2 (12 wk): CPT Class C (10-12)85.7
Cohort A, Group 2 (24 wk): CPT Class C (10-12)87.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis96.4
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis98.2
Cohort B, Group 4 (12 wk): CPT Class A (5-6)96.2
Cohort B, Group 4 (24 wk): CPT Class A (5-6)96.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)84.6
Cohort B, Group 5 (24 wk): CPT Class B (7-9)88.5
Cohort B, Group 6 (12 wk): CPT Class C (10-12)60.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)75.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 1

(NCT01938430)
Timeframe: Week 1

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)6.7
Cohort A, Group 1 (24 wk): CPT Class B (7-9)6.9
Cohort A, Group 2 (12 wk): CPT Class C (10-12)13.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)3.8
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis16.4
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis12.5
Cohort B, Group 4 (12 wk): CPT Class A (5-6)15.4
Cohort B, Group 4 (24 wk): CPT Class A (5-6)4.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)3.8
Cohort B, Group 5 (24 wk): CPT Class B (7-9)7.7
Cohort B, Group 6 (12 wk): CPT Class C (10-12)0.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)0.0
Cohort B, Group 7 (12 wk): FCH25.0
Cohort B, Group 7 (24 wk): FCH0.0

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Percentage of Participants With HCV RNA < LLOQ at Week 4

(NCT01938430)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)83.3
Cohort A, Group 1 (24 wk): CPT Class B (7-9)82.8
Cohort A, Group 2 (12 wk): CPT Class C (10-12)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)84.6
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis87.3
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis90.9
Cohort B, Group 4 (12 wk): CPT Class A (5-6)88.5
Cohort B, Group 4 (24 wk): CPT Class A (5-6)80.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)72.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)88.5
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH50.0

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HCV RNA and Change From Baseline at Week 4

(NCT01938430)
Timeframe: Baseline; Week 4

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 4Change at Week 4
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.20-4.65
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.21-4.63
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.15-4.44
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.23-4.56
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.24-5.23
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.16-5.24
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.18-5.01
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.23-5.52
Cohort B, Group 5 (12 wk): CPT Class B (7-9)1.24-5.01
Cohort B, Group 5 (24 wk): CPT Class B (7-9)1.18-5.05
Cohort B, Group 6 (12 wk): CPT Class C (10-12)1.15-5.21
Cohort B, Group 6 (24 wk): CPT Class C (10-12)1.15-5.12
Cohort B, Group 7 (12 wk): FCH1.15-5.36
Cohort B, Group 7 (24 wk): FCH1.67-5.39

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Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)

SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment. (NCT01938430)
Timeframe: Posttreatment Week 2

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)96.7
Cohort A, Group 1 (24 wk): CPT Class B (7-9)92.6
Cohort A, Group 2 (12 wk): CPT Class C (10-12)95.5
Cohort A, Group 2 (24 wk): CPT Class C (10-12)95.8
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis98.2
Cohort B, Group 4 (12 wk): CPT Class A (5-6)96.2
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)88.5
Cohort B, Group 5 (24 wk): CPT Class B (7-9)92.3
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)75.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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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. (NCT01938430)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)86.7
Cohort A, Group 1 (24 wk): CPT Class B (7-9)88.9
Cohort A, Group 2 (12 wk): CPT Class C (10-12)86.4
Cohort A, Group 2 (24 wk): CPT Class C (10-12)87.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis96.4
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis98.2
Cohort B, Group 4 (12 wk): CPT Class A (5-6)96.2
Cohort B, Group 4 (24 wk): CPT Class A (5-6)96.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)84.6
Cohort B, Group 5 (24 wk): CPT Class B (7-9)88.5
Cohort B, Group 6 (12 wk): CPT Class C (10-12)60.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)75.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12

pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant. (NCT01938430)
Timeframe: Posttransplant Week 12

Interventionpercentage of participants (Number)
All LDV/SOF+RBV85.7

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Percentage of Participants With HCV RNA < LLOQ at Week 8

(NCT01938430)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)100.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)96.6
Cohort A, Group 2 (12 wk): CPT Class C (10-12)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)92.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)96.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)96.2
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH50.0

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Percentage of Participants With HCV RNA < LLOQ at Week 6

(NCT01938430)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)100.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)96.2
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis96.4
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH50.0

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PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)

Ctau is defined as the observed drug concentration at the end of the dosing interval. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Interventionng/mL (Mean)
SOFGS-566500GS-331007LDV
LDV/SOF (Cohort 3)2.959.32568.2705.0

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PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)

Cmax is defined as the maximum concentration of drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

,
Interventionng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)575.9308.31750.01373.1
SOF 400 mg + RBV 200 mg (Cohort 2)976.8538.32721.41373.8

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PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)

Cmax is defined as the maximum concentration of drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

,
Interventionng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)903.9352.21727.02458.8
SOF 400 mg + RBV 200 mg (Cohort 2)1422.9509.12645.02589.4

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PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)

Cmax is defined as the maximum concentration of drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Interventionng/mL (Mean)
SOFGS-566500GS-331007LDV
LDV/SOF (Cohort 3)2018.11021.63570.0903.4

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PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)

Clast is defined as the last observable concentration of drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

,
Interventionng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)68.037.61023.0759.1
SOF 400 mg + RBV 200 mg (Cohort 2)21.335.81736.1818.8

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PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)

Clast is defined as the last observable concentration of drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

,
Interventionng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)100.772.2952.51741.3
SOF 400 mg + RBV 200 mg (Cohort 2)22.732.11412.92040.9

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PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)

Clast is defined as the last observable concentration of drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Interventionng/mL (Mean)
SOFGS-566500GS-331007LDV
LDV/SOF (Cohort 3)56.370.52570.6700.6

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PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

,
Interventionh*ng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)1302.72223.231078.345341.9
SOF 400 mg + RBV 200 mg (Cohort 2)1571.33213.946810.150471.2

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PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Interventionh*ng/mL (Mean)
SOFGS-566500GS-331007LDV
LDV/SOF (Cohort 3)3536.87716.671463.318460.1

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PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)

AUClast is defined as the concentration of drug from time zero to the last observable concentration. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

,
Interventionh*ng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)885.01973.331859.422253.9
SOF 400 mg + RBV 200 mg (Cohort 2)1607.73965.751989.623595.5

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PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)

AUClast is defined as the concentration of drug from time zero to the last observable concentration. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

,
Interventionh*ng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)1177.71867.131078.345341.9
SOF 400 mg + RBV 200 mg (Cohort 2)1548.13133.046810.150471.2

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PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)

AUClast is defined as the concentration of drug from time zero to the last observable concentration. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Interventionh*ng/mL (Mean)
SOFGS-566500GS-331007LDV
LDV/SOF (Cohort 3)3519.37657.669177.718044.3

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Pharmacokinetic (PK) Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

,
Interventionh*ng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)1093.92120.231859.422253.9
SOF 400 mg + RBV 200 mg (Cohort 2)1630.54026.251989.623595.5

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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. (NCT01958281)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF 200 mg + RBV 200 mg (Cohort 1)40.0
SOF 400 mg + RBV 200 mg (Cohort 2)60.0
LDV/SOF (Cohort 3)100.0

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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR4 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT01958281)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF 200 mg + RBV 200 mg (Cohort 1)40.0
SOF 400 mg + RBV 200 mg (Cohort 2)60.0
LDV/SOF (Cohort 3)100.0

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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. (NCT01958281)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF 200 mg + RBV 200 mg (Cohort 1)40.0
SOF 400 mg + RBV 200 mg (Cohort 2)60.0
LDV/SOF (Cohort 3)100.0

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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." (NCT01958281)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF 200 mg + RBV 200 mg (Cohort 1)50.0
SOF 400 mg + RBV 200 mg (Cohort 2)40.0
LDV/SOF (Cohort 3)0

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Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any time postbaseline up to the date of last dose of study drug plus 30 days. (NCT01958281)
Timeframe: Up to 24 weeks plus 30 days

Interventionpercentage of participants (Number)
SOF 200 mg + RBV 200 mg (Cohort 1)100.0
SOF 400 mg + RBV 200 mg (Cohort 2)100.0
LDV/SOF (Cohort 3)100.0

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Percentage of Participants Experiencing Treatment-Emergent Adverse Events Associated With Vital Sign Abnormalities

(NCT01958281)
Timeframe: Up to 24 weeks plus 30 days

Interventionpercentage of participants (Number)
SOF 200 mg + RBV 200 mg (Cohort 1)10.0
SOF 400 mg + RBV 200 mg (Cohort 2)0
LDV/SOF (Cohort 3)0

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Percentage of Participants Experiencing Treatment-Emergent Adverse Events

(NCT01958281)
Timeframe: Up to 24 weeks plus 30 days

Interventionpercentage of participants (Number)
SOF 200 mg + RBV 200 mg (Cohort 1)100.0
SOF 400 mg + RBV 200 mg (Cohort 2)90.0
LDV/SOF (Cohort 3)72.2

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Percentage of Participants Experiencing Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities

(NCT01958281)
Timeframe: Up to 24 weeks plus 30 days

Interventionpercentage of participants (Number)
SOF 200 mg + RBV 200 mg (Cohort 1)0
SOF 400 mg + RBV 200 mg (Cohort 2)0
LDV/SOF (Cohort 3)5.6

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PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)

Tmax is defined as the time (observed time point) of Cmax. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Interventionhours (Median)
SOFGS-566500GS-331007LDV
LDV/SOF (Cohort 3)1.002.004.026.00

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PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)

λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

,
Intervention1/hour (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)1.04190.20780.02750.0165
SOF 400 mg + RBV 200 mg (Cohort 2)1.01550.17710.02730.0141

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PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)

λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

,
Intervention1/hour (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)1.40020.22320.03320.0124
SOF 400 mg + RBV 200 mg (Cohort 2)1.21540.18180.03130.0085

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PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)

λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Intervention1/hour (Mean)
SOFGS-566500GS-331007LDV
LDV/SOF (Cohort 3)0.60330.17050.02140.0305

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PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)

Tmax is defined as the time (observed time point) of Cmax. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

,
Interventionhours (Median)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)1.002.174.002.00
SOF 400 mg + RBV 200 mg (Cohort 2)1.504.006.002.00

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PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)

Tmax is defined as the time (observed time point) of Cmax. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

,
Interventionhours (Median)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)1.042.175.112.00
SOF 400 mg + RBV 200 mg (Cohort 2)0.502.005.001.50

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PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)

Tlast is defined as the time (observed time point) of Clast. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

,
Interventionhours (Median)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)4.0012.0024.0024.00
SOF 400 mg + RBV 200 mg (Cohort 2)6.0024.0024.0024.00

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PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)

Tlast is defined as the time (observed time point) of Clast. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

,
Interventionhours (Median)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)4.0012.0024.0024.00
SOF 400 mg + RBV 200 mg (Cohort 2)4.0324.0024.0024.00

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PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)

Tlast is defined as the time (observed time point) of Clast. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Interventionhours (Median)
SOFGS-566500GS-331007LDV
LDV/SOF (Cohort 3)12.0024.0024.0024.00

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PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)

Ctau is defined as the observed drug concentration at the end of the dosing interval. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

,
Interventionng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)NA3.71023.0759.1
SOF 400 mg + RBV 200 mg (Cohort 2)NA20.81736.1818.8

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PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)

t1/2 is defined as the estimate of the terminal elimination half-life of the drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2

,
Interventionhours (Median)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)0.673.3130.5346.89
SOF 400 mg + RBV 200 mg (Cohort 2)0.673.8829.0556.43

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PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)

t1/2 is defined as the estimate of the terminal elimination half-life of the drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

,
Interventionhours (Median)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)0.483.0322.0361.25
SOF 400 mg + RBV 200 mg (Cohort 2)0.573.8833.5491.62

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PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)

t1/2 is defined as the estimate of the terminal elimination half-life of the drug. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4

Interventionhours (Median)
SOFGS-566500GS-331007LDV
LDV/SOF (Cohort 3)1.184.0239.3025.96

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PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)

Ctau is defined as the observed drug concentration at the end of the dosing interval. (NCT01958281)
Timeframe: Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12

,
Interventionng/mL (Mean)
SOFGS-566500GS-331007RBV
SOF 200 mg + RBV 200 mg (Cohort 1)NA2.3952.51567.5
SOF 400 mg + RBV 200 mg (Cohort 2)NA10.41356.01968.6

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT01962441)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 16 Weeks1.5
SOF+RBV 24 Weeks1.5
SOF+RBV+Peg-IFN 12 Weeks1.5

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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. (NCT01962441)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF+RBV 16 Weeks71.9
SOF+RBV 24 Weeks85.4
SOF+RBV+Peg-IFN 12 Weeks92.9

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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. (NCT01962441)
Timeframe: Posttreatment Weeks 4 and 24

,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF+RBV 16 Weeks73.071.9
SOF+RBV 24 Weeks85.984.4
SOF+RBV+Peg-IFN 12 Weeks95.993.4

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

(NCT01962441)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16Week 20Week 24
SOF+RBV 24 Weeks20.153.591.999.598.599.599.5100.0

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

(NCT01962441)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16
SOF+RBV 16 Weeks14.853.386.699.5100.099.0

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

(NCT01962441)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
SOF+RBV+Peg-IFN 12 Weeks25.967.097.499.5100.0

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Percentage of Participants Experiencing Viral Relapse

Viral relapse is 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. (NCT01962441)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF+RBV 16 Weeks26.7
SOF+RBV 24 Weeks12.3
SOF+RBV+Peg-IFN 12 Weeks4.6

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HCV RNA at Weeks 1, 2, 4, 8, and 12

(NCT01962441)
Timeframe: Weeks 1, 2, 4, 8, and 12

,,
Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 8Week 12
SOF+RBV 16 Weeks2.131.441.191.151.15
SOF+RBV 24 Weeks2.081.451.211.151.17
SOF+RBV+Peg-IFN 12 Weeks1.811.321.161.151.15

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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)" (NCT01962441)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF+RBV 16 Weeks0
SOF+RBV 24 Weeks1.5
SOF+RBV+Peg-IFN 12 Weeks0

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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

(NCT01962441)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12

,,
Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 8Week 12
SOF+RBV 16 Weeks-4.18-4.86-5.11-5.16-5.15
SOF+RBV 24 Weeks-4.15-4.78-5.02-5.08-5.05
SOF+RBV+Peg-IFN 12 Weeks-4.46-4.96-5.12-5.12-5.12

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Percentage of Participants With Virologic Failure

"Virologic failure is 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." (NCT01965535)
Timeframe: Baseline to Posttreatment Week 24

,
Interventionpercentage of participants (Number)
On-Treatment Virologic FailureVirologic Relapse
LDV/SOF02.6
LDV/SOF + RBV03.9

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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT01965535)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF97.497.4
LDV/SOF + RBV97.496.1

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Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24

(NCT01965535)
Timeframe: Weeks 1, 2, 4, 8, 12, and 24

,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 24
LDV/SOF7.850.697.498.7100.0100.0
LDV/SOF + RBV9.159.797.4100.0100.0100.0

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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

(NCT01965535)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12

,
Interventionlog10 IU/mL (Mean)
Week 1 (LDV/SOF: n = 75; LDV/SOF + RBV: n = 75)Week 2 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)Week 4 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)Week 8 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)Week 12 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)
LDV/SOF-4.10-4.74-5.10-5.11-5.11
LDV/SOF + RBV-4.27-4.94-5.19-5.20-5.20

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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, < 25 IU/mL) 12 weeks following the last dose of study drug.~1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set.~1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set)." (NCT01965535)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF97.4
LDV/SOF + RBV96.1

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Percentage of Participants With Sustained Virologic Response 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. (NCT01975675)
Timeframe: Posttreatment Weeks 4 and 24

,,,
Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF (Treatment Experienced)100.0100.0
LDV/SOF (Treatment Naive)100.0100.0
LDV/SOF+RBV (Treatment Experienced)100.0100.0
LDV/SOF+RBV (Treatment Naive)96.496.4

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT01975675)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF0
LDV/SOF+RBV1.8

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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT01975675)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF (Treatment Naive)100.0
LDV/SOF+RBV (Treatment Naive)97.2

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Percentage of Participants With Sustained Virologic Response 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. (NCT01975675)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF (Treatment Naive)100.0
LDV/SOF+RBV (Treatment Naive)96.4
LDV/SOF (Treatment Experienced)100.0
LDV/SOF+RBV (Treatment Experienced)100.0

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Percentage of Participants Experiencing 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." (NCT01975675)
Timeframe: Up to Posttreatment Week 24

,,,
Interventionpercentage of participants (Number)
On-treatment virologic failureVirologic relapse
LDV/SOF (Treatment Experienced)00
LDV/SOF (Treatment Naive)00
LDV/SOF+RBV (Treatment Experienced)00
LDV/SOF+RBV (Treatment Naive)01.2

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT01987453)
Timeframe: Up to 24 Weeks

InterventionPercentage of participants (Number)
LDV/SOF + RBV 12 Weeks (Group 1)5.9
LDV/SOF 24 Weeks (Group 2)0
LDV/SOF + RBV 24 Weeks (Group 3)0

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Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively. (NCT01987453)
Timeframe: Posttreatment Weeks 4 and 24

,,
InterventionPercentage of participants (Number)
SVR4SVR24
LDV/SOF + RBV 12 Weeks (Group 1)98.098.0
LDV/SOF + RBV 24 Weeks (Group 3)100.0100.0
LDV/SOF 24 Weeks (Group 2)73.270.7

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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 confirmed with 2 consecutive values or last available posttreatment measurement" (NCT01987453)
Timeframe: Up to posttreatment Week 24

,,
InterventionPercentage of participants (Number)
On treatment Virologic FailureRelapse
LDV/SOF + RBV 12 Weeks (Group 1)02.0
LDV/SOF + RBV 24 Weeks (Group 3)00
LDV/SOF 24 Weeks (Group 2)2.427.5

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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) 12 weeks following the last dose of study treatment. (NCT01987453)
Timeframe: Post-treatment Week 12

InterventionPercentage of participants (Number)
LDV/SOF + RBV 12 Weeks (Group 1)98.0
LDV/SOF 24 Weeks (Group 2)70.7
LDV/SOF + RBV 24 Weeks (Group 3)100.0

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Change in HCV RNA From Baseline

(NCT01987453)
Timeframe: Baseline to Week 8

,,
Interventionlog10 IU/mL (Mean)
Week 1Week 4Week 8
LDV/SOF + RBV 12 Weeks (Group 1)-4.47-5.07-5.09
LDV/SOF + RBV 24 Weeks (Group 3)-3.75-4.47-4.47
LDV/SOF 24 Weeks (Group 2)-4.40-5.06-5.08

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Percentage of Participants With HCV RNA < LLOQ While on Treatment

(NCT01987453)
Timeframe: Baseline to Week 24

,,
InterventionPercentage of participants (Number)
Week 1Week 4Week 8Week 12Week 16Week 20Week 24
LDV/SOF + RBV 12 Weeks (Group 1)23.598.0100.0100.0NANANA
LDV/SOF + RBV 24 Weeks (Group 3)0100.0100.0100.0100.0100.0100.0
LDV/SOF 24 Weeks (Group 2)31.795.1100.0100.097.697.6100.0

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Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007

Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir. (NCT01994486)
Timeframe: 1/17/2014-3/26/2014

Interventionng/mL (Geometric Mean)
Pre-Dose Trough Level Metabolite GS-331007 Wk 2Pre-Dose Trough Level GS-331007 Wk 10
Telaprevir and Sofosbuvir593619

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Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose

Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment (NCT01994486)
Timeframe: 4/22/2014-5/6/2014

Interventionparticipants (Number)
Telaprevir and Sofosbuvir19

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Proportion of Subjects With Viral Relapse

Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point. (NCT01994486)
Timeframe: 1/3/2014-9/8/2014

Interventionparticipants (Number)
Telaprevir and Sofosbuvir1

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Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen

Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL) (NCT01994486)
Timeframe: 6/16/2014-7/2/2014

Interventionparticipants (Number)
Telaprevir and Sofosbuvir19

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Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks

The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period. (NCT01994486)
Timeframe: 1/3/2014-4/10/2014

Interventionparticipants (Number)
Telaprevir and Sofosbuvir1

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Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir

Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported. (NCT01994486)
Timeframe: 12 weeks-January 3, 2014- April 10, 2014

Interventionparticipants (Number)
Telaprevir and Sofosbuvir0

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Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)

SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment. (NCT02010255)
Timeframe: Posttreatment Week 8

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)84.6
Cohort A, Group 1 (24 wk): CPT Class B (7-9)96.2
Cohort A, Group 2 (12 wk): CPT Class C (10-12)81.8
Cohort A, Group 2 (24 wk): CPT Class C (10-12)80.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis94.2
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)97.1
Cohort B, Group 4 (24 wk): CPT Class A (5-6)97.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)95.5
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)33.3
Cohort B, Group 6 (24 wk): CPT Class C (10-12)80.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02010255)
Timeframe: Posttreatment Week 4

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)88.5
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)90.9
Cohort A, Group 2 (24 wk): CPT Class C (10-12)80.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis94.2
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)97.1
Cohort B, Group 4 (24 wk): CPT Class A (5-6)97.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)95.5
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)80.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02010255)
Timeframe: Posttreatment Week 24

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)84.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)96.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)80.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)76.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis94.2
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)97.1
Cohort B, Group 4 (24 wk): CPT Class A (5-6)97.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)95.5
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)33.3
Cohort B, Group 6 (24 wk): CPT Class C (10-12)80.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 1

(NCT02010255)
Timeframe: Week 1

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)3.8
Cohort A, Group 1 (24 wk): CPT Class B (7-9)3.7
Cohort A, Group 2 (12 wk): CPT Class C (10-12)12.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)3.8
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis9.6
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis6.1
Cohort B, Group 4 (12 wk): CPT Class A (5-6)5.9
Cohort B, Group 4 (24 wk): CPT Class A (5-6)3.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)0.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)8.7
Cohort B, Group 6 (12 wk): CPT Class C (10-12)0.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)0.0
Cohort B, Group 7 (12 wk): FCH0.0
Cohort B, Group 7 (24 wk): FCH0.0

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HCV RNA Levels and Change From Baseline at Week 4

(NCT02010255)
Timeframe: Baseline; Week 4

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 4Change at Week 4
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.26-4.78
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.20-4.66
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.23-4.45
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.18-4.52
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.23-5.13
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.18-5.32
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.29-5.05
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.21-5.25
Cohort B, Group 5 (12 wk): CPT Class B (7-9)1.25-4.88
Cohort B, Group 5 (24 wk): CPT Class B (7-9)1.32-4.87
Cohort B, Group 6 (12 wk): CPT Class C (10-12)1.15-4.89
Cohort B, Group 6 (24 wk): CPT Class C (10-12)1.56-4.91
Cohort B, Group 7 (12 wk): FCH1.15-6.16
Cohort B, Group 7 (24 wk): FCH1.15-4.89

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HCV RNA Levels and Change From Baseline at Week 6

(NCT02010255)
Timeframe: Baseline; Week 6

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 6Change at Week 6
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.15-4.90
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.15-4.72
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.17-4.51
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.15-4.56
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.15-5.21
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.15-5.35
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.15-5.19
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.15-5.31
Cohort B, Group 5 (12 wk): CPT Class B (7-9)1.15-4.98
Cohort B, Group 5 (24 wk): CPT Class B (7-9)1.15-5.05
Cohort B, Group 6 (12 wk): CPT Class C (10-12)1.15-4.89
Cohort B, Group 6 (24 wk): CPT Class C (10-12)1.15-5.33
Cohort B, Group 7 (12 wk): FCH1.15-6.16
Cohort B, Group 7 (24 wk): FCH1.15-4.89

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HCV RNA Levels and Change From Baseline at Week 8

(NCT02010255)
Timeframe: Baseline; Week 8

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 8Change at Week 8
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.15-4.90
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.15-4.72
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.15-4.53
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.15-4.60
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.15-5.21
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.15-5.35
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.15-5.19
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.15-5.31
Cohort B, Group 5 (12 wk): CPT Class B (7-9)1.15-4.98
Cohort B, Group 5 (24 wk): CPT Class B (7-9)1.15-5.05
Cohort B, Group 6 (12 wk): CPT Class C (10-12)1.15-4.89
Cohort B, Group 6 (24 wk): CPT Class C (10-12)1.15-5.33
Cohort B, Group 7 (12 wk): FCH1.15-6.16
Cohort B, Group 7 (24 wk): FCH1.15-4.89

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Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

(NCT02010255)
Timeframe: Up to 24 weeks

,,,,,,,,,,,,,
Interventionpercentage of participants (Number)
Discontinued LDV/SOFDiscontinued Any Study Drug
Cohort A, Group 1 (12 wk): CPT Class B (7-9)3.63.6
Cohort A, Group 1 (24 wk): CPT Class B (7-9)3.67.1
Cohort A, Group 2 (12 wk): CPT Class C (10-12)0.016.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)7.723.1
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.95.8
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis0.06.1
Cohort B, Group 4 (12 wk): CPT Class A (5-6)0.00.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)3.015.2
Cohort B, Group 5 (12 wk): CPT Class B (7-9)0.018.2
Cohort B, Group 5 (24 wk): CPT Class B (7-9)0.017.4
Cohort B, Group 6 (12 wk): CPT Class C (10-12)0.033.3
Cohort B, Group 6 (24 wk): CPT Class C (10-12)20.020.0
Cohort B, Group 7 (12 wk): FCH0.00.0
Cohort B, Group 7 (24 wk): FCH0.00.0

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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score

CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline. (NCT02010255)
Timeframe: Baseline to Posttreatment Week 4

,,,,,,,,,
Interventionpercentage of participants (Number)
DecreaseNo ChangeIncrease
Cohort A: Baseline CPT Class B (12 wk)64.328.67.1
Cohort A: Baseline CPT Class B (24 wk)87.013.00.0
Cohort A: Baseline CPT Class C (12 wk)82.411.85.9
Cohort A: Baseline CPT Class C (24 wk)73.726.30.0
Cohort B: Baseline CPT Class A (12 wk)28.668.62.9
Cohort B: Baseline CPT Class A (24 wk)23.561.814.7
Cohort B: Baseline CPT Class B (12 wk)61.133.35.6
Cohort B: Baseline CPT Class B (24 wk)85.010.05.0
Cohort B: Baseline CPT Class C (12 wk)100.00.00.0
Cohort B: Baseline CPT Class C (24 wk)80.020.00.0

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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score

Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. (NCT02010255)
Timeframe: Baseline to Posttreatment Week 4

,,,,,,,,,
Interventionpercentage of participants (Number)
DecreaseNo ChangeIncrease
Cohort A, Group 1 (12 wk): CPT Class B (7-9)70.812.516.7
Cohort A, Group 1 (24 wk): CPT Class B (7-9)77.39.113.6
Cohort A, Group 2 (12 wk): CPT Class C (10-12)81.014.34.8
Cohort A, Group 2 (24 wk): CPT Class C (10-12)70.05.025.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)28.131.340.6
Cohort B, Group 4 (24 wk): CPT Class A (5-6)62.518.818.8
Cohort B, Group 5 (12 wk): CPT Class B (7-9)66.714.319.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)65.217.417.4
Cohort B, Group 6 (12 wk): CPT Class C (10-12)50.050.00.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)75.00.025.0

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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. (NCT02010255)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)84.6
Cohort A, Group 1 (24 wk): CPT Class B (7-9)96.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)81.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)76.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis94.2
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)97.1
Cohort B, Group 4 (24 wk): CPT Class A (5-6)97.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)95.5
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)33.3
Cohort B, Group 6 (24 wk): CPT Class C (10-12)80.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12

pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant. (NCT02010255)
Timeframe: Posttreatment Week 12

InterventionPercentage of participants (Number)
All LDV/SOF+RBV100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 8

(NCT02010255)
Timeframe: Week 8

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)100.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)96.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)96.9
Cohort B, Group 5 (12 wk): CPT Class B (7-9)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)

SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment. (NCT02010255)
Timeframe: Posttreatment Week 2

Interventionpercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)96.2
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)91.3
Cohort A, Group 2 (24 wk): CPT Class C (10-12)80.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis98.1
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)97.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)95.5
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)80.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 6

(NCT02010255)
Timeframe: Week 6

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)100.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)91.7
Cohort A, Group 2 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis98.1
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)97.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 4

(NCT02010255)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)76.9
Cohort A, Group 1 (24 wk): CPT Class B (7-9)81.5
Cohort A, Group 2 (12 wk): CPT Class C (10-12)80.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)84.6
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis84.6
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis91.8
Cohort B, Group 4 (12 wk): CPT Class A (5-6)67.6
Cohort B, Group 4 (24 wk): CPT Class A (5-6)81.8
Cohort B, Group 5 (12 wk): CPT Class B (7-9)72.7
Cohort B, Group 5 (24 wk): CPT Class B (7-9)82.6
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100
Cohort B, Group 6 (24 wk): CPT Class C (10-12)25
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 24

(NCT02010255)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (24 wk): FCH100.0

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HCV RNA Levels and Change From Baseline at Week 2

(NCT02010255)
Timeframe: Baseline; Week 2

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 2Change at Week 2
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.76-4.29
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.70-4.17
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.71-3.92
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.72-3.99
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.62-4.74
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.49-5.00
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.92-4.42
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.97-4.48
Cohort B, Group 5 (12 wk): CPT Class B (7-9)1.86-4.26
Cohort B, Group 5 (24 wk): CPT Class B (7-9)2.00-4.20
Cohort B, Group 6 (12 wk): CPT Class C (10-12)2.08-3.95
Cohort B, Group 6 (24 wk): CPT Class C (10-12)2.81-3.66
Cohort B, Group 7 (12 wk): FCH1.85-5.46
Cohort B, Group 7 (24 wk): FCH1.65-4.38

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Percentage of Participants With HCV RNA < LLOQ at Week 20

(NCT02010255)
Timeframe: Week 20

InterventionPercentage of participants (Number)
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 2

(NCT02010255)
Timeframe: Week 2

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)26.9
Cohort A, Group 1 (24 wk): CPT Class B (7-9)37.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)40.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)38.5
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis48.1
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis44.9
Cohort B, Group 4 (12 wk): CPT Class A (5-6)26.5
Cohort B, Group 4 (24 wk): CPT Class A (5-6)21.2
Cohort B, Group 5 (12 wk): CPT Class B (7-9)31.8
Cohort B, Group 5 (24 wk): CPT Class B (7-9)30.4
Cohort B, Group 6 (12 wk): CPT Class C (10-12)0.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)0.0
Cohort B, Group 7 (12 wk): FCH33.3
Cohort B, Group 7 (24 wk): FCH0.0

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Percentage of Participants With HCV RNA < LLOQ at Week 16

(NCT02010255)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (24 wk): FCH100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 12

(NCT02010255)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)100.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)100.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)100.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis100.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)100.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)100.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)95.5
Cohort B, Group 5 (24 wk): CPT Class B (7-9)100.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)100.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)100.0
Cohort B, Group 7 (12 wk): FCH100.0
Cohort B, Group 7 (24 wk): FCH100.0

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HCV RNA Levels and Change From Baseline at Week 12

(NCT02010255)
Timeframe: Baseline; Week 12

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 12Change at Week 12
Cohort A, Group 1 (12 wk): CPT Class B (7-9)1.15-4.90
Cohort A, Group 1 (24 wk): CPT Class B (7-9)1.15-4.72
Cohort A, Group 2 (12 wk): CPT Class C (10-12)1.15-4.53
Cohort A, Group 2 (24 wk): CPT Class C (10-12)1.15-4.60
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.15-5.21
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis1.15-5.35
Cohort B, Group 4 (12 wk): CPT Class A (5-6)1.15-5.19
Cohort B, Group 4 (24 wk): CPT Class A (5-6)1.15-5.30
Cohort B, Group 5 (12 wk): CPT Class B (7-9)1.15-4.98
Cohort B, Group 5 (24 wk): CPT Class B (7-9)1.15-5.05
Cohort B, Group 6 (12 wk): CPT Class C (10-12)1.15-4.89
Cohort B, Group 6 (24 wk): CPT Class C (10-12)1.15-5.33
Cohort B, Group 7 (12 wk): FCH1.15-6.16
Cohort B, Group 7 (24 wk): FCH1.15-4.89

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HCV RNA Levels and Change From Baseline at Week 1

(NCT02010255)
Timeframe: Baseline; Week 1

,,,,,,,,,,,,,
Interventionlog10 IU/mL (Mean)
Week 1Change at Week 1
Cohort A, Group 1 (12 wk): CPT Class B (7-9)2.44-3.60
Cohort A, Group 1 (24 wk): CPT Class B (7-9)2.47-3.39
Cohort A, Group 2 (12 wk): CPT Class C (10-12)2.32-3.28
Cohort A, Group 2 (24 wk): CPT Class C (10-12)2.50-3.20
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis2.38-3.98
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis2.38-4.12
Cohort B, Group 4 (12 wk): CPT Class A (5-6)2.64-3.70
Cohort B, Group 4 (24 wk): CPT Class A (5-6)2.81-3.65
Cohort B, Group 5 (12 wk): CPT Class B (7-9)2.63-3.50
Cohort B, Group 5 (24 wk): CPT Class B (7-9)2.75-3.44
Cohort B, Group 6 (12 wk): CPT Class C (10-12)2.97-3.06
Cohort B, Group 6 (24 wk): CPT Class C (10-12)3.73-2.74
Cohort B, Group 7 (12 wk): FCH2.91-4.40
Cohort B, Group 7 (24 wk): FCH2.28-3.76

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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 on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02010255)
Timeframe: Up to Posttreatment Week 24

InterventionPercentage of participants (Number)
Cohort A, Group 1 (12 wk): CPT Class B (7-9)15.4
Cohort A, Group 1 (24 wk): CPT Class B (7-9)4.0
Cohort A, Group 2 (12 wk): CPT Class C (10-12)9.5
Cohort A, Group 2 (24 wk): CPT Class C (10-12)4.0
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis1.9
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis0.0
Cohort B, Group 4 (12 wk): CPT Class A (5-6)0.0
Cohort B, Group 4 (24 wk): CPT Class A (5-6)0.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)0.0
Cohort B, Group 5 (24 wk): CPT Class B (7-9)0.0
Cohort B, Group 6 (12 wk): CPT Class C (10-12)33.3
Cohort B, Group 6 (24 wk): CPT Class C (10-12)0.0
Cohort B, Group 7 (12 wk): FCH0.0
Cohort B, Group 7 (24 wk): FCH0.0

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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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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 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 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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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 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 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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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 Experiencing Viral Breakthrough

Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). (NCT02021656)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF: China0
LDF/SOF: Overall0

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Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02021656)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
LDF/SOF: Overall99.299.0
LDV/SOF: China100.0100.0

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Percentage of Participants Experiencing Viral Relapse

Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR. (NCT02021656)
Timeframe: Week 12 to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF: China0
LDF/SOF: Overall0.5

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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

(NCT02021656)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF: China0
LDV/SOF: Overall0.5

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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 in Korea and Taiwan and < 15 IU/mL in China) 12 weeks following the last dose of study drug. (NCT02021656)
Timeframe: Posttreatment Week 12

InterventionPercentage of participants (Number)
LDV/SOF: China100.0
LDV/SOF: Overall99.2

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HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only

(NCT02021656)
Timeframe: Baseline; Week 12

Interventionlog10 IU/mL (Mean)
BaselineChange at Week 12
LDV/SOF: China6.31-5.16

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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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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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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 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 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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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 Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as HCV RNANCT02032888)
Timeframe: At follow-up Week 12

InterventionPercentage of participants (Number)
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks75.6

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Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as HCV RNA NCT02032888)
Timeframe: At follow-up Week 12

InterventionPercentage of participants (Number)
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks97.7

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Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as HCV RNA NCT02032888)
Timeframe: At follow-up Week 12

InterventionPercentage of participants (Number)
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks96.4

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Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels

Participants with HCV RNA levels NCT02032888)
Timeframe: At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment

,,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12End of treatment
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks5.823.163.594.2100.098.1100.0
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks9.933.770.389.198.096.099.0
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks6.034.078.090.096.0NA100.0

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Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be

Participants with hepatitis C virus CV) levels to be NCT02032888)
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24

,,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12End of treatmentFollow-up Week 4Follow-up Week 24
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks34.671.292.398.1100.098.1100.096.292.3
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks34.777.293.199.098.096.099.098.092.1
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks44.078.098.098.096.0NA100.082.072.0

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Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR is defined as hepatitis C virus RNA NCT02032888)
Timeframe: At Follow-up Week 12

,,
InterventionPercentage of participants (Number)
CC Genotype (n=28,13,13)Non-CC Genotype (n=73,37, 39)
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks100.097.4
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks100.095.9
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks69.278.4

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Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results

Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. (NCT02032888)
Timeframe: From screening up to week 24 of post treatment follow--up

,,
InterventionParticipants (Number)
International normalized ratioLeukocytesAspartate aminotransferaseBilirubin (total)Lipase (total)Alanine aminotransferase
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks111211
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks100550
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks001111

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Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)

SVR12 was defined as HCV RNA levels NCT02032888)
Timeframe: At follow-up Week 12

InterventionPercentage of participants (Number)
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks97.0
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks76.0
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks98.1

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Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)

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. (NCT02032901)
Timeframe: From Day 1 first dose to last dose plus 7 days

,
InterventionParticipants (Number)
SAEsDiscontinuations Due to AEs
Daclatasvir + Sofosbuvir in Treatment-experienced Participants00
Daclatasvir + Sofosbuvir in Treatment-naive Participants10

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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)

Percentage of participants who achieved HCV RNA NCT02032901)
Timeframe: Week 1, 2, 6, 8 (treatment period)

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 6Week 8
Daclatasvir + Sofosbuvir in Treatment-experienced Participants2.029.490.298.0
Daclatasvir + Sofosbuvir in Treatment-naive Participants11.934.786.195.0

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Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)

Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12 (Follow-up period)

,
InterventionPercentage of participants (Number)
Genotype: CC (n=40, 20)Genotype: Non-CC (n=61, 31)
Daclatasvir + Sofosbuvir in Treatment-experienced Participants95.080.6
Daclatasvir + Sofosbuvir in Treatment-naive Participants90.090.2

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Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)

SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse. (NCT02032901)
Timeframe: Baseline, Week 12 (Follow-up period)

,
InterventionPercentage of participants (Number)
With cirrhosis (n= 19, 13)Without cirrhosis (n= 75, 34)
Daclatasvir + Sofosbuvir in Treatment-experienced Participants69.294.1
Daclatasvir + Sofosbuvir in Treatment-naive Participants57.997.3

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Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)

SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12 (Follow-up period)

InterventionPercentage of participants (Number)
Daclatasvir + Sofosbuvir in Treatment-naive Participants90.1

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Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)

SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, 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. (NCT02032901)
Timeframe: Week 12 (Follow-up period)

Interventionpercentage of participants (Number)
Daclatasvir + Sofosbuvir in Treatment-experienced Participants86.3

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Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)

RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 4

InterventionPercentage of participants (Number)
Daclatasvir + Sofosbuvir in Treatment-naive Participants63.4
Daclatasvir + Sofosbuvir in Treatment-experienced Participants72.5

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Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)

EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Up to the end of treatment (up to 24 weeks)

Interventionpercentage of participants (Number)
Daclatasvir + Sofosbuvir in Treatment-naive Participants99.0
Daclatasvir + Sofosbuvir in Treatment-experienced Participants100.0

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Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)

cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Daclatasvir + Sofosbuvir in Treatment-naive Participants98.0
Daclatasvir + Sofosbuvir in Treatment-experienced Participants100.0

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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)

Percentage of participants who achieved HCV RNA NCT02032901)
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)

,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12End of treatmentFollow-up Week 4Follow-up Week 24
Daclatasvir + Sofosbuvir in Treatment-experienced Participants23.568.698.098.0100.0100.0100.086.382.4
Daclatasvir + Sofosbuvir in Treatment-naive Participants39.677.294.1100.0100.098.099.091.189.1

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Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24

(NCT02073656)
Timeframe: Baseline; Week 12, Posttreatment Weeks 12 and 24

Interventionmg/dL (Mean)
Change at Week 12 (N = 320)Change at Posttreatment Week 12 (N = 325)Change at Posttreatment Week 24 (N = 313)
LDV/SOF 12 Weeks0.050.03-0.02

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For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8

(NCT02073656)
Timeframe: Baseline; Weeks 2, 4, and 8 of Retreatment Substudy

Interventionlog10 IU/mL (Mean)
Change at Week 2 RetreatmentChange at Week 4 RetreatmentChange at Week 8 Retreatment
LDV/SOF+RBV 24 Weeks (Retreatment Substudy)-5.01-5.04-5.04

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For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24

(NCT02073656)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy

Interventionpercentage of participants (Number)
Week 2 RetreatmentWeek 4 RetreatmentWeek 8 RetreatmentWeek 12 RetreatmentWeek 16 RetreatmentWeek 20 RetreatmentWeek 24 Retreatment
LDV/SOF+RBV 24 Weeks (Retreatment Substudy)88.9100.0100.0100.0100.0100.0100.0

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For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)

SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively. (NCT02073656)
Timeframe: Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy

Interventionpercentage of participants (Number)
SVR4SVR12SVR24
LDV/SOF+RBV 24 Weeks (Retreatment Substudy)88.988.988.9

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For Participants in the Retreatment Substudy, 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." (NCT02073656)
Timeframe: Up to Posttreatment Week 24 of Retreatment Substudy

Interventionpercentage of participants (Number)
On-Treatment Virologic FailureVirologic Relapse
LDV/SOF+RBV 24 Weeks (Retreatment Substudy)011.1

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Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment

(NCT02073656)
Timeframe: Weeks 4, 8, and 12

Interventionpercentage of participants (Number)
Week 4 (N = 335)Week 8 (N = 334)Week 12 (N = 334)
LDV/SOF 12 Weeks98.598.297.9

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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. (NCT02073656)
Timeframe: Posttreatment Weeks 4 and 24

Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF 12 Weeks96.796.1

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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." (NCT02073656)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
On-Treatment Virologic Failure (N = 335)Virologic Relapse (N = 333)
LDV/SOF 12 Weeks0.63.0

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12

(NCT02073656)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12

Interventionpercentage of participants (Number)
Week 1 (N = 335)Week 2 (N = 335)Week 4 (N = 335)Week 6 (N = 335)Week 8 (N = 334)Week 10 (N = 332)Week 12 (N = 332)
LDV/SOF 12 Weeks29.381.298.899.199.4100.0100.0

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02073656)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks0

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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, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT02073656)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks96.1

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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8

(NCT02073656)
Timeframe: Baseline; Weeks 1, 2, 4, 6, and 8

Interventionlog10 IU/mL (Mean)
Change at Week 1 (N = 331)Change at Week 2 (N = 334)Change at Week 4 (N = 335)Change at Week 6 (N = 334)Change at Week 8 (N = 333)
LDV/SOF 12 Weeks-4.68-5.21-5.30-5.30-5.33

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Percentage of Participants With Virologic Failure and Viral Relapse

"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." (NCT02074514)
Timeframe: Up to Posttreatment Week 24

,,,
Interventionpercentage of participants (Number)
Overall Virologic FailureRelapse
SOF + RBV 16 Weeks GT110.010.0
SOF + RBV 16 Weeks GT300
SOF + RBV 24 Weeks GT13.63.6
SOF + RBV 24 Weeks GT33.33.3

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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, 15 IU/mL) 12 weeks following the last dose of study drug. (NCT02074514)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF + RBV 16 Weeks GT190
SOF + RBV 24 Weeks GT196.4
SOF + RBV 16 Weeks GT3100.0
SOF + RBV 24 Weeks GT393.3

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Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02074514)
Timeframe: Posttreatment Weeks 4 and 24

,,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF + RBV 16 Weeks GT190.090.0
SOF + RBV 16 Weeks GT3100.0100.0
SOF + RBV 24 Weeks GT196.496.4
SOF + RBV 24 Weeks GT396.793.3

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02074514)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF + RBV 16 Weeks0
SOF + RBV 24 Weeks3.4

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Percentage of Patients With Virologic Failure

"Virologic failure was defined as either:~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); or~Relapse:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment" (NCT02081079)
Timeframe: Up to posttreatment Week 24

,,,
Interventionpercentage of participants (Number)
On-treatment Virologic FailureRelapse
Genotype 4: Treatment-experienced09.1
Genotype 4: Treatment-naive04.5
Genotype 5: Treatment-experienced05.0
Genotype 5: Treatment-naive04.8

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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. (NCT02081079)
Timeframe: Posttreatment Weeks 4 and 24

,,,
Interventionpercentage of participants (Number)
SVR4SVR24
Genotype 4: Treatment-experienced90.990.9
Genotype 4: Treatment-naive95.595.5
Genotype 5: Treatment-experienced95.095.0
Genotype 5: Treatment-naive95.295.2

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Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12

(NCT02081079)
Timeframe: Baseline; Weeks 2, 4, 8, and 12

,,,
Interventionlog10 IU/mL (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12
Genotype 4: Treatment-experienced-4.77-5.17-5.18-5.18
Genotype 4: Treatment-naive-4.65-4.86-4.88-4.88
Genotype 5: Treatment-experienced-4.94-5.39-5.45-5.45
Genotype 5: Treatment-naive-4.97-5.07-5.07-5.07

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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. (NCT02081079)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Genotype 4: Treatment-naive95.5
Genotype 4: Treatment-experienced90.9
Genotype 5: Treatment-naive95.2
Genotype 5: Treatment-experienced95.0

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Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event

(NCT02081079)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
Genotype 40
Genotype 50

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Percentage of Participants With On-treatment Virologic Response

On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. NCT02114151)
Timeframe: Week 2, 4 and End of Treatment (Week 12)

InterventionPercentage of Participants (Number)
Week 2: < 100 IU/mL (n=102)Week 2: < 25 IU/mL (n=102)Week 2: < 25 IU/mL Detectable (n=102)Week 2: < 25 IU/mL Undetectable (n=102)Week 4: < 100 IU/mL (n=102)Week 4: < 25 IU/mL (n=102)Week 4: < 25 IU/mL Detectable (n=102)Week 4: < 25 IU/mL Undetectable (n=102)EOT (Week 12): < 100 IU/mL (n=103)EOT (Week 12): < 25 IU/mL (n=103)EOT (Week 12): < 25 IU/mL Detectable (n=103)EOT (Week 12): < 25 IU/mL Undetectable (n=103)
Simeprevir Plus Sofosbuvir90.268.644.124.599.099.015.783.397.197.1097.1

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Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24

Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants. (NCT02114151)
Timeframe: Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24

InterventionParticipants (Number)
HCV NS3NS5B
Simeprevir Plus Sofosbuvir130

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Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12

The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively. (NCT02114151)
Timeframe: Baseline, Week 4, Week 12 and Follow-Up Week 12

InterventionUnits on a Scale (Mean)
Baseline (n=98)Change at Week 4 (n=96)Change at Week 12 (n=89)Change at Follow-up Week 12 (n=94)
Simeprevir Plus Sofosbuvir17.4-4.9-4.7-5.8

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Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24

The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue. (NCT02114151)
Timeframe: Baseline, Week 12, Follow-up Week 12 and 24

InterventionUnits on a Scale (Mean)
Baseline (n=96)Change at Week 12 (n=86)Change at Follow-up Week 12 (n=92)Change at Follow-up Week 24 (n=86)
Simeprevir Plus Sofosbuvir3.4-0.4-0.6-0.8

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Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24

"The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health)." (NCT02114151)
Timeframe: Baseline, Follow-up Week 12 and 24

InterventionUnits on a Scale (Mean)
Baseline (n=96)Change at Follow-up Week 12 (n=92)Change at Follow-up Week 24 (n=86)
Simeprevir Plus Sofosbuvir70.19.89.5

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Percentage of Participants With Viral Relapse

Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period. (NCT02114151)
Timeframe: During the Follow-up (Week 24)

InterventionPercentage of Participants (Number)
Simeprevir Plus Sofosbuvir13.1

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Percentage of Participants With Viral Breakthrough

Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL). (NCT02114151)
Timeframe: Up to End of Treatment (Week 12)

InterventionPercentage of Participants (Number)
Simeprevir Plus Sofosbuvir1.9

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Percentage of Participants With On-treatment Failure

On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. (NCT02114151)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
Simeprevir Plus Sofosbuvir2.9

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Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)

Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment. (NCT02114151)
Timeframe: Week 16

InterventionPercentage of Participants (Number)
Simeprevir Plus Sofosbuvir86.4

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Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)

Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment. (NCT02114151)
Timeframe: Week 36

InterventionPercentage of Participants (Number)
Simeprevir Plus Sofosbuvir82.5

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Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)

Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment. (NCT02114151)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
Simeprevir Plus Sofosbuvir83.5

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Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)

The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness. (NCT02114151)
Timeframe: Baseline, Week 12, Follow-up Week 12 and 24

InterventionPercentage of Participants (Number)
Baseline: No Depression (n=96)Baseline: Mild to Moderate Depression (n=96)Baseline: Severe Depression (n=96)Week 12: No Depression (n=88)Week 12: Mild to Moderate Depression (n=88)Week 12: Severe Depression (n=88)Follow-up Week 12: No Depression (n=94)Follow-up Week12:Mild to Moderate Depression(n=94)Follow-up Week 12: Severe Depression (n=94)Follow-up Week 24: No Depression (n=88)Follow-up Week24:Mild to Moderate Depression(n=88)Follow-up Week 24: Severe Depression (n=88)
Simeprevir Plus Sofosbuvir67.716.715.677.315.96.879.86.413.879.510.210.2

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Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)

Participants considered to have achieved SVR24, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 24 weeks after the Actual end of study drug treatment. (NCT02114177)
Timeframe: 24 weeks after the end of treatment (EOT) (Week 32 or Week 36)

InterventionPercentage of participants (Number)
Simeprevir and Sofosbuvir for 8 Weeks82.6
Simeprevir and Sofosbuvir for 12 Weeks96.8

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Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)

Participants considered to have achieved SVR4, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 4 weeks after the actual end of study drug treatment. (NCT02114177)
Timeframe: 4 weeks after the end of treatment (EOT) (Week 12 or Week 16)

InterventionPercentage of Participants (Number)
Simeprevir and Sofosbuvir for 8 Weeks83.9
Simeprevir and Sofosbuvir for 12 Weeks96.8

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Percentage of Participants With Viral Breakthrough

Percentage of participants with greater than 1 log10 IU/mL increase in plasma Hepatitis C virus ribonucleic acid 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 less than 25 IU/mL. (NCT02114177)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
Simeprevir and Sofosbuvir for 8 Weeks0
Simeprevir and Sofosbuvir for 12 Weeks0

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Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24

The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue. (NCT02114177)
Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24

,
Interventionunits on a scale (Mean)
Baseline (n=144, 149)Change at Week 4 (n=142, 142)Change at Week 8 (n=142, 144)Change at Week 12 (n=0, 140)Change at Follow-up Week 4 (n=141, 148)Change at Follow-up Week 12 (n=140, 145)Change at Follow-up Week 24 (n=132, 143)
Simeprevir and Sofosbuvir for 12 Weeks3.2-0.1-0.2-0.1-0.4-0.4-0.5
Simeprevir and Sofosbuvir for 8 Weeks2.9-0.1-0.1NA-0.4-0.5-0.6

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Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale

"The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening." (NCT02114177)
Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24

,
Interventionunits on a scale (Mean)
Baseline (N=144, 149)Change at Week 4 (n=142, 141)Change at Week 8 (n=142, 144)Change at Week 12 (n=0, 140)Change at Follow-up Week 4 (n=141, 148)Change at Follow-up Week 12 (n=138, 145)Change at Follow-up Week 24 (n=131, 143)
Simeprevir and Sofosbuvir for 12 Weeks76.72.42.72.54.43.95.3
Simeprevir and Sofosbuvir for 8 Weeks79.34.64.0NA6.95.56.2

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Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores

The CES-D scale assesses how often during the past week participants experienced 20 symptoms commonly associated with major depression. CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5-7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores greater than or equal to 23 indicate probable major depressive illness. (NCT02114177)
Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24

,
Interventionunits on a scale (Mean)
Baseline (n=144, 149)Change at Week 4 (n=139, 140)Change at Week 8 (n=141, 144)Change at Week 12 (n=141, 144)Change at Follow-up Week 4 (n=141, 148)Change at Follow-up Week 12 (n=140, 145)Change at Follow-up Week 24 (n=131, 143)
Simeprevir and Sofosbuvir for 12 Weeks10.2-0.8-0.31.0-0.6-0.1-1.0
Simeprevir and Sofosbuvir for 8 Weeks8.8-0.6-0.6NA-2.6-1.5-2.8

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Percentage of Participants With Viral Relapse

Percentage of participants who did not achieve sustained virologic response 12, have less than 25 IU/mL undetectable plasma HCV RNA at end of treatment, and greater than or equal to 25 IU/mL plasma HCV RNA during the follow-up phase. (NCT02114177)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
Simeprevir and Sofosbuvir for 8 Weeks17.4
Simeprevir and Sofosbuvir for 12 Weeks2.6

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Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS)

HCVSIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively. (NCT02114177)
Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24

,
Interventionunits on a scale (Mean)
Baseline (n=145, 149)Change at Week 4 (n=145, 146)Change at Week 8 (n=144, 146)Change at Week 12 (n=0, 141)Change at Follow-up Week 4 (n=142, 148)Change at Follow-up Week 12 (n=141, 145)Change at Follow-up Week 24 (n=133, 143)
Simeprevir and Sofosbuvir for 12 Weeks13.3-0.9-0.40.1-3.0-3.5-4.4
Simeprevir and Sofosbuvir for 8 Weeks10.8-0.4-0.2NA-3.5-2.0-3.6

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Percentage of Participants Achieving a On-treatment Virologic Response

Ontreatment virologic response was determined by HCV RNA results satisfying a specified threshold. NCT02114177)
Timeframe: Day 14, Day 28, End of treatment (Week 8 or Week 12)

,
InterventionPercentage of participants (Number)
Day 14: < 100 IU/mL (n=154, 152)Day 14: < 25 IU/mL (n=154, 152)Day 14: < 25 IU/mL detectable (n=154, 152)Day 14: < 25 IU/mL undetectable (n=154, 152)Day 28: < 100 IU/mL (n=154, 153)Day 28: < 25 IU/mL (n=154, 153)Day 28: < 25 IU/mL detectable (n=154, 153)Day 28: < 25 IU/mL undetectable (n=154, 153)EOT: < 100 IU/mL (n=155, 155)EOT: < 25 IU/mL (n=155, 155)EOT: < 25 IU/mL undetectable (n=155, 155)
Simeprevir and Sofosbuvir for 12 Weeks93.479.645.434.210098.711.187.6100100100
Simeprevir and Sofosbuvir for 8 Weeks90.977.9240.2637.6610098.716.282.5100100100

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Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)

Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the actual end of study drug treatment. (NCT02114177)
Timeframe: 12 weeks after the end of treatment (EOT) (Week 20 or Week 24)

InterventionPercentage of participants (Number)
Simeprevir and Sofosbuvir for 8 Weeks82.6
Simeprevir and Sofosbuvir for 12 Weeks96.8

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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. (NCT02120300)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks GT1 or GT499.0
LDV/SOF 24 Weeks GT1 (TE)100.0
SOF+RBV 12 Weeks GT2100.0
SOF+RBV 24 Weeks GT383.3

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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." (NCT02120300)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks GT1 or GT40
LDV/SOF 24 Weeks GT1 (TE)0
SOF+RBV 12 Weeks GT20
SOF+RBV 24 Weeks GT316.7

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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

(NCT02120300)
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24

,,,
Interventionlog10 IU/mL (Mean)
BaselineWeek 1 (LDV/SOF 12 Weeks: n= 98)Week 2 (LDV/SOF 24 Week: n=4)Week 4Week 8Week 12 (LDV/SOF 12 Weeks: n= 98)Week 16Week 20Week 24
LDV/SOF 12 Weeks GT1 or GT46.21-4.41-4.87-5.05-5.06-5.06NANANA
LDV/SOF 24 Weeks GT1 (TE)6.02-4.32-4.65-4.87-4.87-4.87-4.87-4.87-4.87
SOF+RBV 12 Weeks GT26.20-4.39-5.01-5.05-5.05-5.05NANANA
SOF+RBV 24 Weeks GT36.6-3.95-4.76-5.26-5.45-5.45-5.45-5.45-5.45

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Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)

(NCT02120300)
Timeframe: Baseline; Weeks 12, 24, and Posttreatment Week 12

,,
Interventionmg/dL (Mean)
BaselineWeek 12Week 24Posttreatment Week12
LDV/SOF 12 Weeks GT1 or GT40.940.04NA-0.01
SOF+RBV 12 Weeks GT21.01-0.03NA-0.08
SOF+RBV 24 Weeks GT30.94-0.03-0.08-0.02

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

(NCT02120300)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24

,,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16Week 20Week 24
LDV/SOF 12 Weeks GT1 or GT428.368.794.9100.099.0NANANA
LDV/SOF 24 Weeks GT1 (TE)20.040.0100.0100.0100.0100.0100.0100.0
SOF+RBV 12 Weeks GT220.070.0100.0100.0100.0NANANA
SOF+RBV 24 Weeks GT316.733.366.7100.0100.0100.0100.0100.0

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02120300)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks GT1 or GT40
LDV/SOF 24 Weeks GT1 (TE)0
SOF+RBV 12 Weeks GT20
SOF+RBV 24 Weeks GT30

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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. (NCT02120300)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks GT1 or GT499.0
LDV/SOF 24 Weeks GT1 (TE)100.0
SOF+RBV 12 Weeks GT2100.0
SOF+RBV 24 Weeks GT383.3

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Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)

(NCT02120300)
Timeframe: Weeks 4, 8, 12, 16, 20, and 24

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24
LDV/SOF 12 Weeks GT1 or GT4100100100NANANA
SOF+RBV 12 Weeks GT2100100100NANANA
SOF+RBV 24 Weeks GT310010010010010066.7

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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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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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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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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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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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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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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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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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Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment. (NCT02128542)
Timeframe: Up to Posttreatment Week 12

InterventionPercentage of participants (Number)
SOF+RBV 12 Weeks (TN)17.4
SOF+RBV 12 Weeks (TE)15.8

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Percentage of Participants Experiencing Viral Breakthrough

"Viral breakthrough was defined as either:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment~HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values" (NCT02128542)
Timeframe: Up to Posttreatment Weak 12

InterventionPercentage of participants (Number)
SOF+RBV 12 Weeks (TN)0
SOF+RBV 12 Weeks (TE)0

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Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug. (NCT02128542)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF+RBV 12 Weeks (TN)78.7
SOF+RBV 12 Weeks (TE)89.5

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. (NCT02128542)
Timeframe: Posttreatment Week 12

InterventionPercentage of participants (Number)
SOF+RBV 12 Weeks (TN)76.6
SOF+RBV 12 Weeks (TE)84.2

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Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment

Deep sequencing of the HCV NS5B gene was attempted for all participants who had virologic failure at pretreatment and posttreatment time points if the level of HCV RNA in the plasma sample was ≥ 1000 IU/L. (NCT02128542)
Timeframe: Pretreatment and Posttreatment Week 12

Interventionparticipants (Number)
NS5B NI RAV PretreatmentNS5B NI RAV PosttreatmentNS5B RBV RAV PretreatmentNS5B RBV RAV Posttreatment
SOF+RBV 12 Weeks (All)2500

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02128542)
Timeframe: Up to 12 weeks

InterventionPercentage of participants (Number)
SOF+RBV 12 Weeks (All)4.5

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Number 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. (NCT02133131)
Timeframe: Up to Week 12

InterventionNumber of participants (Number)
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks0
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks0
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks0
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks1
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks0
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks0
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks0

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Number of Participants Experiencing at Least 1 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. (NCT02133131)
Timeframe: Up to Week 14

InterventionNumber of participants (Number)
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks5
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks7
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks7
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks4
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks4
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks3
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks3

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Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)

The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0. (NCT02133131)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks33.3
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks89.3
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks80.0
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks89.5
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks93.3
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks100.0
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks90.9

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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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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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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, 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 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 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 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, 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, 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, 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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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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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 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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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 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, 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 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 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, 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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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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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 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 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 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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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 With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02201901)
Timeframe: Posttreatment Weeks 4 and 24

,,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF/VEL 12 Weeks (Group 1)92.283.3
SOF/VEL 24 Weeks (Group 3)90.087.8
SOF/VEL+RBV 12 Weeks (Group 2)95.494.3

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

(NCT02201901)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

,,
Interventionpercentage of participants (Number)
Wk 1(Group 1: N=90; Group 2: N=87; Group 3: N=90)Wk 2 (Group 1: N=90; Group 2: N=87;Group 3: N=89)Wk 4 (Group 1: N=90; Group 2: N=87; Group 3: N=89)Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88)Wk 8(Group 1: N=89; Group 2: N=84; Group 3: N=87)Wk 10(Group 1: N=89; Group 2: N=84; Group 3: N=87)Wk 12(Group 1: N=89; Group 2: N=83; Group 3: N=87)Wk 16(Group 1: N=0; Group 2: N=0; Group 3: N=86)Wk 20(Group 1: N=0; Group 2: N=0;Group 3: N=84)Wk 24(Group 1: N=0; Group 2: N=0; Group 3: N=84)
SOF/VEL 12 Weeks (Group 1)2.234.481.198.998.9100.0100.0NANANA
SOF/VEL 24 Weeks (Group 3)11.139.391.098.9100.0100.097.797.7100.0100.0
SOF/VEL+RBV 12 Weeks (Group 2)14.949.480.597.698.898.898.8NANANA

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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score

Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. (NCT02201901)
Timeframe: Baseline to Posttreatment Week 24

,,
Interventionpercentage of participants (Number)
Decrease (Improvement)No ChangeIncrease (Worsening)
SOF/VEL 12 Weeks (Group 1)55.120.324.6
SOF/VEL 24 Weeks (Group 3)50.721.727.5
SOF/VEL+RBV 12 Weeks (Group 2)49.325.325.3

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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

(NCT02201901)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

,,
Interventionlog10 IU/mL (Mean)
Wk 1(Group 1: N=89; Group 2: N=83; Group 3: N=88)Wk 2(Group 1: N=89; Group 2: N=87; Group 3: N=88)Wk 4(Group 1: N=88; Group 2: N=86; Group 3: N=88)Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88)Wk 8(Group 1: N=89; Group 2: N=83; Group 3: N=87)Wk 10(Group 1: N=89; Group 2: N=84; Group 3, N=87)Wk 12(Group 1: N=89; Group 2: N=82; Group 3: N=86)Wk 16 (Group 1: N=0; Group 2: N=0; Group 3: N=85)Wk 20 (Group 1: N=0; Group 2: N=0; Group 3: N =84)Wk 24 (Group 1: N=0; Group 2: N=0; Group 3: N =84)
SOF/VEL 12 Weeks (Group 1)-3.51-4.24-4.78-4.87-4.87-4.87-4.87NANANA
SOF/VEL 24 Weeks (Group 3)-3.72-4.38-4.70-4.74-4.76-4.76-4.75-4.76-4.77-4.77
SOF/VEL+RBV 12 Weeks (Group 2)-3.63-4.17-4.58-4.68-4.68-4.67-4.68NANANA

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~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" (NCT02201901)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks (Group 1)12.2
SOF/VEL+RBV 12 Weeks (Group 2)3.4
SOF/VEL 24 Weeks (Group 3)8.9

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Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score

CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease. (NCT02201901)
Timeframe: Baseline to Posttreatment Week 24

,,
Interventionpercentage of participants (Number)
Decrease (Improvement)No ChangeIncrease (Worsening)
SOF/VEL 12 Weeks (Group 1)44.943.511.6
SOF/VEL 24 Weeks (Group 3)63.827.58.7
SOF/VEL+RBV 12 Weeks (Group 2)53.337.39.3

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02201901)
Timeframe: Up to 24 weeks plus 30 days

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks (Group 1)1.1
SOF/VEL+RBV 12 Weeks (Group 2)16.1
SOF/VEL 24 Weeks (Group 3)4.4

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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) 12 weeks following the last dose of study drug. (NCT02201901)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks (Group 1)83.3
SOF/VEL+RBV 12 Weeks (Group 2)94.3
SOF/VEL 24 Weeks (Group 3)87.8

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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. (NCT02201940)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
Placebo00
SOF/VEL99.299.0

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12

(NCT02201940)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12

,
Interventionpercentage of participants (Number)
Week 1 (SOF/VEL: N = 624; Placebo: N = 116)Week 2 (SOF/VEL: N = 624; Placebo: N = 116)Week 4 (SOF/VEL: N = 623; Placebo: N = 116)Week 6 (SOF/VEL: N = 623; Placebo: N = 115)Week 8 (SOF/VEL: N = 622; Placebo: N = 114)Week 10 (SOF/VEL: N = 622; Placebo: N = 114)Week 12 (SOF/VEL: N = 622; Placebo: N = 113)
Placebo0000000
SOF/VEL18.856.990.598.999.7100.0100.0

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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12

(NCT02201940)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12

,
Interventionlog10 IU/mL (Mean)
Change at Wk 1 (SOF/VEL: N= 617; Placebo: N= 114)Change at Wk 2 (SOF/VEL: N= 622; Placebo: N= 116)Change at Wk 4 (SOF/VEL: N= 617; Placebo: N= 114)Change at Wk 6 (SOF/VEL: N= 623; Placebo: N= 115)Change at Wk 8 (SOF/VEL: N= 622; Placebo: N= 113)Change at Wk 10 (SOF/VEL: N= 622; Placebo: N= 112)Change at Wk 12 (SOF/VEL: N= 622; Placebo: N= 111)
Placebo-0.050.01-0.010.070.050.05-0.06
SOF/VEL-4.29-4.82-5.08-5.11-5.11-5.12-5.12

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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." (NCT02201940)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL0.3
Placebo100

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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. (NCT02201940)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL99.0
Placebo0

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02201940)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL0.2
Placebo1.7

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

(NCT02201953)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

,
Interventionpercentage of participants (Number)
Week 1 (SOF/VEL: N = 277; SOF+RBV: N = 275)Week 2 (SOF/VEL: N = 276; SOF+RBV: N = 274)Week 4 (SOF/VEL: N = 276; SOF+RBV: N = 272)Week 6 (SOF/VEL: N = 276; SOF+RBV: N = 269)Week 8 (SOF/VEL: N = 276; SOF+RBV: N = 269)Week 10 (SOF/VEL: N = 276; SOF+RBV: N = 268)Week 12 (SOF/VEL: N = 275; SOF+RBV: N = 265)Week 16 (SOF/VEL: N = 0; SOF+RBV: N = 262)Week 20 (SOF/VEL: N = 0; SOF+RBV: N = 260)Week 24 (SOF/VEL: N = 0; SOF+RBV: N = 255)
SOF/VEL 12 Weeks18.462.091.796.799.6100.0100.0NANANA
SOF+RBV 24 Weeks17.550.088.298.999.399.399.698.999.6100.0

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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. (NCT02201953)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks95.3
SOF+RBV 24 Weeks80.7

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02201953)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks0
SOF+RBV 24 Weeks3.3

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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." (NCT02201953)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks4.0
SOF+RBV 24 Weeks14.2

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Percentage of Participants With SVR at 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. (NCT02201953)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF/VEL 12 Weeks96.895.3
SOF+RBV 24 Weeks82.280.7

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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

(NCT02201953)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

,
Interventionlog10 IU/mL (Mean)
Change at Wk 1 (SOF/VEL: N =272; SOF+RBV: N =268)Change at Wk 2 (SOF/VEL: N =274; SOF+RBV: N =272)Change at Wk 4 (SOF/VEL: N =276; SOF+RBV: N =270)Change at Wk 6 (SOF/VEL: N =275; SOF+RBV: N =269)Change at Wk 8 (SOF/VEL: N =276; SOF+RBV: N =269)Change at Wk 10 (SOF/VEL: N =276; SOF+RBV: N =267)Change at Wk 12 (SOF/VEL: N =275; SOF+RBV: N =264)Change at Wk 16 (SOF/VEL: N = 0; SOF+RBV: N = 262)Change at Wk 20 (SOF/VEL: N = 0; SOF+RBV: N = 259)Change at Wk 24 (SOF/VEL: N = 0; SOF+RBV: N = 255)
SOF/VEL 12 Weeks-4.26-4.82-5.02-5.06-5.07-5.07-5.08NANANA
SOF+RBV 24 Weeks-4.16-4.79-5.09-5.13-5.13-5.14-5.14-5.11-5.14-5.14

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02202980)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)7.1
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)0
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)0
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)0
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)0
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)0
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)0
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)0
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)0
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)0
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)0
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)0
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)0
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)0

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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit

(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)7.440.792.696.3

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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit

(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)9.453.187.5100.0100.0
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)28.060.092.0100.0100.0
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)7.77.784.6100.0100.0

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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit

(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

,,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)26.766.7100.0100.0
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)26.766.7100.0100.0
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)13.343.393.396.7
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)16.788.9100.0100.0

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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit

(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

Interventionpercentage of participants (Number)
Week 1Week 2Week 4
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)26.753.3100.0

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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. (NCT02202980)
Timeframe: Posttreatment Weeks 4 and 24

,,,,,,,,,,,,,
Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)100.0100.0
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)96.296.2
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)76.976.9
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)81.574.1
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)92.992.9
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)73.320.0
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)100.093.3
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)86.786.7
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)86.766.7
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)88.983.3
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)100.0100.0
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)92.989.3
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)100.0100.0
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)100.0100.0

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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit

(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

,,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)5.941.276.5100.0100.0
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)7.160.785.796.4100.0
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)5.342.184.294.7100.0
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)025.0100.0100.0100.0

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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." (NCT02202980)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)7.1
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)0
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)22.2
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)0
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)23.1
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)6.7
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)73.3
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)13.3
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)11.1
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)0
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)0
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)10.7
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)30.0
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)0

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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. (NCT02202980)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)92.9
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)96.2
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)74.1
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)100.0
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)76.9
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)93.3
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)26.7
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)86.7
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)83.3
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)100.0
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)100.0
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)89.3
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)66.7
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)100.0

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Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit

(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16Week 20Week 24
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)7.164.3100.0100.0100.092.992.9100.0

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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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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Motor

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF-10.00
Blinded Phase: Placebo-6.00

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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Memory T Score

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF-3.88
Blinded Phase: Placebo7.93

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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF-13.04
Blinded Phase: Placebo-12.43

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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF1.96
Blinded Phase: Placebo4.00

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Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Attention Scaled Score

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF0.73
Blinded Phase: Placebo1.43

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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Motor

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF-9.21

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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF-16.67

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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF4.00

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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Attention Scaled Score

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF1.42

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Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Memory T Score

"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory." (NCT02219685)
Timeframe: Baseline; Posttreatment Week 24

Interventionunits on a scale (Mean)
Blinded Phase: LDV/SOF-17.42

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Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)

SVR4, SVR12, and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4, 12, and 24 weeks after stopping study treatment with LDV/SOF, respectively. (NCT02219685)
Timeframe: Posttreatment Weeks 4, 12, and 24

,
Interventionpercentage of participants (Number)
SVR4SVR12SVR24
Blinded Phase: LDV/SOF96.292.392.3
Open-Label Phase: LDV/SOF100.0100.0100.0

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Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol

MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal myoinositol was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure. (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4

,
Interventionratio (Mean)
Basal GangliaFrontal CortexDorsolateral Prefrontal Cortex
Blinded Phase: LDV/SOF0.02-0.01-0.02
Blinded Phase: Placebo0.000.080.00

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Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline

MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal choline was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure. (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4

,
Interventionratio (Mean)
Basal GangliaFrontal CortexDorsolateral Prefrontal Cortex
Blinded Phase: LDV/SOF-0.010.010.00
Blinded Phase: Placebo0.000.000.01

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Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG

MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal N-acetylaspartate (NAA) + N-acetylaspartylglutamate (NAAG) was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure. (NCT02219685)
Timeframe: Baseline; Posttreatment Week 4

,
Interventionratio (Mean)
Basal GangliaFrontal CortexDorsolateral Prefrontal Cortex
Blinded Phase: LDV/SOF-0.03-0.030.00
Blinded Phase: Placebo-0.01-0.09-0.01

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12

(NCT02220998)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12

,
Interventionpercentage of participants (Number)
Week 1 (SOF/VEL: N = 133; SOF+RBV: N = 132)Week 2 (SOF/VEL: N = 133; SOF+RBV: N = 132)Week 4 (SOF/VEL: N = 133; SOF+RBV: N = 132)Week 6 (SOF/VEL: N = 133; SOF+RBV: N = 132)Week 8 (SOF/VEL: N = 133; SOF+RBV: N = 132)Week 10 (SOF/VEL: N = 133; SOF+RBV: N = 132)Week 12 (SOF/VEL: N = 133; SOF+RBV: N = 131)
SOF/VEL12.857.190.297.7100.0100.0100.0
SOF+RBV22.759.890.299.2100.0100.0100.0

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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12

(NCT02220998)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12

,
Interventionlog10 IU/mL (Mean)
Change at Wk 1 (SOF/VEL: N= 132; SOF+RBV: N= 131)Change at Wk 2 (SOF/VEL: N= 132; SOF+RBV: N= 131)Change at Wk 4 (SOF/VEL: N= 132; SOF+RBV: N= 131)Change at Wk 6 (SOF/VEL: N= 133; SOF+RBV: N= 131)Change at Wk 8 (SOF/VEL: N= 133; SOF+RBV: N= 132)Change at Wk 10 (SOF/VEL: N= 133; SOF+RBV: N= 132)Change at Wk 12 (SOF/VEL: N= 133; SOF+RBV: N= 131)
SOF/VEL-4.51-5.08-5.29-5.31-5.32-5.32-5.32
SOF+RBV-4.51-5.04-5.24-5.27-5.27-5.27-5.26

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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." (NCT02220998)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL0
SOF+RBV4.5

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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. (NCT02220998)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL99.3
SOF+RBV93.9

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02220998)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL0.7
SOF+RBV0

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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. (NCT02220998)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF/VEL99.399.3
SOF+RBV96.293.9

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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. (NCT02226549)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
LDV/SOF+VDV95.5
LDV/SOF+VDV+RBV95.8

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02226549)
Timeframe: Up to 8 weeks

Interventionpercentage of participants (Number)
LDV/SOF+VDV0
LDV/SOF+VDV+RBV8.3

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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. (NCT02226549)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF+VDV95.5
LDV/SOF+VDV+RBV87.5

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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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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, 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 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 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, 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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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 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, 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, 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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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 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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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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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, 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 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 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, 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, 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, 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 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, 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, 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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Percentage of Participants With On-Treatment Failure

Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., =LLOQ. (NCT02250807)
Timeframe: through 12 weeks (EOT)

Interventionpercentage of participants (Number)
SMV+SOF 12 Weeks0

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Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)

SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT. (NCT02250807)
Timeframe: 12 weeks after EOT

Interventionpercentage of participants (Number)
SMV+SOF 12 Weeks100

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Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

Percentage of participants with HCV RNA less than (<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed. (NCT02250807)
Timeframe: Week 2, 3, 4, 12 and EOT

Interventionpercentage of participants (Number)
Week 2: < 100 IU/mLWeek 2: < 15 IU/mL undetectable/detectableWeek 2: < 15 IU/mL undetectableWeek 3: < 100 IU/mLWeek 3: < 15 IU/mL undetectable/detectableWeek 3: < 15 IU/mL undetectableWeek 4: < 100 IU/mLWeek 4: < 15 IU/mL undetectable/detectableWeek 4: < 15 IU/mL undetectable (RVR)Week 12: < 100 IU/mLWeek 12: < 15 IU/mL undetectable/detectableWeek 12: < 15 IU/mL undetectableEnd of Treatment (EOT): < 100 IU/mLEOT: < 15 IU/mL undetectable/detectableEOT: < 15 IU/mL undetectable
SMV+SOF 12 Weeks87.540.017.5100.082.540.0100.087.565.0100.0100.0100.0100.0100.0100.0

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Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)

Participants were considered to have reached SVR24, if at the time point of SVR24 (that is [i.e.], 24 weeks after the end of treatment [EOT]) the following condition has been met: HCV RNA < lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable. (NCT02250807)
Timeframe: At 24 weeks after EOT

Interventionpercentage of participants (Number)
SMV+SOF 12 Weeks100

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Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)

SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 4 weeks after actual EOT. (NCT02250807)
Timeframe: 4 weeks after EOT

Interventionpercentage of participants (Number)
SMV+SOF 12 Weeks100

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Percentage of Participants With Viral Breakthrough

Participants with confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA NCT02250807)
Timeframe: Up to follow-up Week 24

Interventionpercentage of participants (Number)
SMV+SOF 12 Weeks0

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Percentage of Participants With Viral Relapse

Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (>=)LLOQ. (NCT02250807)
Timeframe: Up to follow-up week 24

Interventionpercentage of participants (Number)
SMV+SOF 12 Weeks0

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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02251717)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF 12 Weeks100.0100.0
LDV/SOF 24 Weeks100.0100.0

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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." (NCT02251717)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks0
LDV/SOF 24 Weeks0

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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. (NCT02251717)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks100.0
LDV/SOF 24 Weeks100.0

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02251717)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks1.8
LDV/SOF 24 Weeks0

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Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

Tmax is the time to reach maximum observed plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,
InterventionHours (Median)
Simeprevir: Week 2Simeprevir: Week 8Daclatasvir: Week 2Daclatasvir: Week 8Sofosbuvir: Week 2Sofosbuvir: Week 8GS-331007: Week 2GS-331007: Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A6.006.003.002.501.001.754.004.00
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B8.008.004.004.002.002.004.004.00

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Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

The C0h is the pre-dose plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,
Interventionnanogram/milliliter (ng/mL) (Mean)
Simeprevir : Week 2Simeprevir : Week 8Daclatasvir : Week 2Daclatasvir : Week 8Sofosbuvir : Week 2Sofosbuvir : Week 8GS-331007 : Week 2GS-331007 : Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A35773160494492NANA484478
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B52188577646824NANA490572

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Percentage of Participants With On-treatment Failure

On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. (NCT02262728)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A0
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B0

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Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)

Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment. (NCT02262728)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A100
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B100

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Percentage of Participants With SVR12 Who Maintained to Have HCV RNA

Percentage of participants with SVR12 who maintained to have HCV RNA NCT02262728)
Timeframe: Week 24 post treatment until the end of 3-year follow-up

InterventionPercentage of participants (Number)
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A78.9
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B85.7

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Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

The Cmax is the maximum observed plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,
Interventionnanogram per milliliter (ng/mL) (Mean)
Simeprevir : Week 2 (reference)Simeprevir : Week 8 (test)Daclatasvir : Week 2Daclatasvir : Week 8Sofosbuvir : Week 2Sofosbuvir : Week 8GS-331007 : Week 2GS-331007 : Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A69766029118710721571127614031404
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B772610498114512101615152715611594

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Percentage of Participants With On-Treatment Virologic Response

On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point: NCT02262728)
Timeframe: Week 1, 2, 4, 6, 8, 10, 12

,
InterventionPercentage of Participants (Number)
Week 1 : >= 15 IU/mLWeek 1 : < 100 IU/mLWeek 1: < 15 IU/mL undetect/detectableWeek 1 : < 15 IU/mL detectableWeek 1 : < 15 IU/mL UndetectableWeek 2 : >= 15 IU/mLWeek 2 : < 100 IU/mLWeek 2: < 15 IU/mL undetect/detectableWeek 2 : < 15 IU/mL detectableWeek 2: < 15 IU/mL undetectable (vRVR)Week 4 : >= 15 IU/mLWeek 4 : < 100 IU/mLWeek 4: < 15 IU/mL undetect/detectableWeek 4 : < 15 IU/mL detectableWeek 4 : < 15 IU/mL undetectable (RVR)Week 6 : >= 15 IU/mLWeek 6 : < 100 IU/mLWeek 6: < 15 IU/mL undetect/detectableWeek 6 : < 15 IU/mL detectableWeek 6 : < 15 IU/mL undetectableWeek 8 : >= 15 IU/mLWeek 8 : < 100 IU/mLWeek 8: < 15 IU/mL undetect/detectableWeek 8 : < 15 IU/mL detectableWeek 8 : < 15 IU/mL undetectableWeek 10 : >= 15 IU/mLWeek 10 : < 100 IU/mLWeek 10: < 15 IU/mL undetect/detectableWeek 10 : < 15 IU/mL detectableWeek 10 : < 15 IU/mL undetectableWeek 12 : >= 15 IU/mLWeek 12 :< 100 IU/mLWeek 12: < 15 IU/mL undetect/detectableWeek 12 : < 15 IU/mL detectableWeek 12 : < 15 IU/mL undetectable
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A72.261.127.811.116.710.594.789.536.852.60100.0100.05.694.40100.0100.05.394.70100.0100.00100.00100.0100.00100.00100.0100.00100.0
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B76.238.123.819.04.847.671.452.419.033.39.5100.090.528.661.90100.0100.020.080.00100.0100.04.895.20100.0100.00100.00100.0100.00100.0

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Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

The Cmin is the minimum observed plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,
Interventionng/mL (Mean)
Simeprevir : Week 2Simeprevir : Week 8Daclatasvir : Week 2Daclatasvir : Week 8Sofosbuvir : Week 2Sofosbuvir : Week 8GS-331007 : Week 2GS-331007 : Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A31332639414442NANA419443
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B43636955519660NANA441523

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Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

The AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after dosing. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,
Interventionng.h/mL (Mean)
Simeprevir : Week 2Simeprevir : Week 8Daclatasvir : Week 2Daclatasvir : Week 8Sofosbuvir : Week 2Sofosbuvir : Week 8GS-331007 : Week 2GS-331007 : Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A113835985681648715574287027461790018132
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B1421622072211785820787391539332111822829

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Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)

(NCT02262728)
Timeframe: Follow-up Week 24 (Week 36)

,
InterventionUnits per Liter (U/L) (Mean)
Baseline : ALTBaseline : ASTFollow-Up Week 24 : ALTFollow-Up Week 24 : AST
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A137.8119.134.839.2
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B60.983.532.335.0

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Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)

Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was NCT02262728)
Timeframe: Week 16 and Week 36

,
InterventionPercentage of Participants (Number)
SVR 4SVR 24
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A100100
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B100100

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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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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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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 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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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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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 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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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 Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02300103)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
SOF/VEL+RBV5.8

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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" (NCT02300103)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL+RBV7.2

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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. (NCT02300103)
Timeframe: Posttreatment Weeks 4 and 24

Interventionpercentage of participants (Number)
SVR4SVR24
SOF/VEL+RBV92.889.9

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Percentage of Participants With HCV RNA < LLOQ On-treatment

(NCT02300103)
Timeframe: Baseline to Week 24

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Week 16Week 20Week 24
SOF/VEL+RBV15.960.991.398.597.198.5100.0100.0100.0

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HCV RNA Change From Baseline

(NCT02300103)
Timeframe: Baseline to Week 24

Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 6Week 8Week 12Week 16Week 20Week 24
SOF/VEL+RBV-4.45-5.04-5.18-5.23-5.23-5.23-5.23-5.23-5.23

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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 quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02300103)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL+RBV91.3

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02301936)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks0
LDV/SOF 24 Weeks0

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HCV RNA Change From Baseline

(NCT02301936)
Timeframe: Up to 24 weeks

Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12
LDV/SOF 12 Weeks-4.20-3.86-3.98-4.47-4.61

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HCV RNA Change From Baseline

(NCT02301936)
Timeframe: Up to 24 weeks

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
LDV/SOF 24 Weeks-3.86-4.63-5.05-5.05-5.05-5.05-5.05-5.05

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02301936)
Timeframe: Weeks 1, 2, 4, 8,12, 16, 20, and 24

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
LDV/SOF 12 Weeks33.366.788.988.9100.0

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02301936)
Timeframe: Weeks 1, 2, 4, 8,12, 16, 20, and 24

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12Week 16Week 20Week 24
LDV/SOF 24 Weeks00100.0100.0100.0100.0100.0100.0

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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) 12 weeks following the last dose of study drug. (NCT02301936)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks88.9
LDV/SOF 24 Weeks100.0

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Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < the LLOQ 4 weeks following the last dose of study drug. (NCT02301936)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks88.9
LDV/SOF 24 Weeks100.0

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~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" (NCT02301936)
Timeframe: Up to Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks11.1
LDV/SOF 24 Weeks0

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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 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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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 Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs

The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (<15IU/mL). (NCT02339038)
Timeframe: At least 12 weeks after completion of medication

InterventionParticipants (Count of Participants)
Standard of Care516

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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." (NCT02346721)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks0.9

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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) 12 weeks following the last dose of study drug. (NCT02346721)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks97.3

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02346721)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks0.9

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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 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02346721)
Timeframe: Posttreatment Weeks 4 and 24

Interventionpercentage of participants (Number)
SVR4SVR24
SOF/VEL 12 Weeks98.297.3

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Percentage of Participants With HCV RNA < LLOQ While on Treatment

(NCT02346721)
Timeframe: Baseline to Week 12

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12
SOF/VEL 12 Weeks18.055.094.699.1100.0100.0100.0

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HCV RNA Change From Baseline

(NCT02346721)
Timeframe: Baseline to Week 12

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/VEL 12 Weeks-4.23-4.79-5.10-5.11-5.11-5.11-5.11

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Gene Expression Profiles

Gene expression profiles in PBMC will be determined using RNA Seq (NCT02347345)
Timeframe: 24 weeks

InterventionRNA seq different from active IDU (Number)
baseline
Healthy Volunteers12

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sCD14 (ng/mL)

Marker of immune activation as measured by levels of soluble CD14. Note that the levels of sCD14 were only measured at baseline in the Healthy Volunteers group and therefore there are no data for weeks 4, 12, or 24 entered. (NCT02347345)
Timeframe: 24 weeks

,
Interventionng/mL (Mean)
baselineweek 4week 12week 24
Active Injection Drug Use (IDU)1986206020361973
Former Injection Drug Use (Former IDU)1918180517821819

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Virologic Response to Therapy as Measured by HCV RNA

HCV RNA levels in plasma (IU/mL) (NCT02347345)
Timeframe: 24 weeks

,
InterventionHCV RNA copies/mL plasma (Mean)
baselineweek 12week 24
Active Injection Drug Use (IDU)778114800
Former Injection Drug Use (Former IDU)232002600

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Gene Expression Profiles

Gene expression profiles in PBMC will be determined using RNA Seq (NCT02347345)
Timeframe: 24 weeks

,
InterventionRNA seq different from active IDU (Number)
baseline4 weeks12 weeks24 weeks
Active Injection Drug Use (IDU)9999
Former Injection Drug Use (Former IDU)11111111

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sCD14 (ng/mL)

Marker of immune activation as measured by levels of soluble CD14. Note that the levels of sCD14 were only measured at baseline in the Healthy Volunteers group and therefore there are no data for weeks 4, 12, or 24 entered. (NCT02347345)
Timeframe: 24 weeks

Interventionng/mL (Mean)
baseline
Healthy Volunteers1542

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Percentage of Participants With On-treatment Virologic Response

"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: NCT02349048)
Timeframe: Day 2, Day 3, Week 1, 2, 3, 4, 6 (for Arm A) and 8 (for Arm B only)

,
InterventionPercentage of Participants (Number)
Day 2 : >= 15 IU/mL (n = 56, 9)Day 2 : < 100 IU/mL (n = 56, 9)Day 2 : < 15 IU/mL undetect/detectable (n = 56, 9)Day 2 : < 15 IU/mL detectable (n = 56, 9)Day 2: < 15 IU/mL undetectable (n = 56, 9)Day 3 : >= 15 IU/mL (n = 58, 9)Day 3 : < 100 IU/mL (n = 58, 9)Day 3 : < 15 IU/mL undetect/detectable (n = 58, 9)Day 3 : < 15 IU/mL detectable (n = 58, 9)Day 3 : < 15 IU/mL undetectable (n = 58, 9)Week 1: >= 15 IU/mL (n = 58, 9)Week 1: < 100 IU/mL (n = 58, 9)Week 1: < 15 IU/mL undetect/detectable (n = 58, 9)Week 1 : < 15 IU/mL detectable (n = 58, 9)Week 1 : < 15 IU/mL undetectable (n = 58, 9)Week 2 : >= 15 IU/mL (n = 56, 9)Week 2: < 100 IU/mL (n = 56, 9)Week 2: < 15 IU/mL undetect/detectable (n = 56, 9)Week 2 : < 15 IU/mL detectable (n = 56, 9)Week 2: < 15 IU/mL undetectable (vRVR) (n = 56, 9)Week 3: >= 15 IU/mL (n = 56, 9)Week 3: < 100 IU/mL (n = 56, 9)Week 3: < 15 IU/mL undetect/detectable (n = 56, 9)Week 3 : < 15 IU/mL detectable (n = 56, 9)Week 3 : < 15 IU/mL undetectable (n = 56, 9)Week 4 : >= 15 IU/mL (n = 58, 9)Week 4: < 100 IU/mL (n = 58, 9)Week 4: < 15 IU/mL undetect/detectable (n = 58, 9)Week 4 : < 15 IU/mL detectable ( n = 58, 9)Week 4 : < 15 IU/mL undetectable (RVR) (n = 58, 9)Week 6 : >= 15 IU/mL (n = 58, 9)Week 6: < 100 IU/mL ( n = 58, 9)Week 6: < 15 IU/mL undetect/detectable (n = 58, 9)Week 6 : < 15 IU/mL detectable (n = 58, 9)Week 6 : < 15 IU/mL undetectable (n= 58, 9)Week 8 : >= 15 IU/ml (n = 0, 9)Week 8: < 100 IU/mL (n = 0, 9)Week 8: < 15 IU/mL undetect/detectable (n = 0, 9)Week 8: < 15 IU/mL detectable (n = 0, 9)Week 8: < 15 IU/mL undetectable (n = 0, 9)
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks96.47.13.63.6094.819.05.25.2058.675.941.436.25.219.694.680.441.139.37.110092.921.471.43.498.396.68.687.901001006.993.1NANANANANA
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks100000010011.100066.733.333.333.3066.777.833.3033.333.310066.722.244.411.110088.933.355.60100100010001001000100

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Percentage of Participants With On-Treatment Failure

Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. Includes participants with: 1) viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA 2) confirmed detectable HCV RNA at the actual end of treatment (example, completed treatment, discontinued due to adverse events, withdrawal of consent) of >100 IU/mL in participants whose HCV RNA had previously been NCT02349048)
Timeframe: Baseline up to End of Treatment (Week 6 for Arm A and Week 8 for Arm B)

InterventionPercentage of Participants (Number)
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks1.7
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks0

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Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment

Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was NCT02349048)
Timeframe: 4 weeks after end of study drug treatment (week 10 for Arm A and 12 for Arm B); 24 weeks after end of study drug treatment (week 30 for Arm A and 32 for Arm B)

,
InterventionPercentage of Participants (Number)
SVR4SVR24
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks93.284.7
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks100100

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Number of Participants With Late Viral Relapse

Late Viral Relapse: Participant who achieved SVR12 and the post treatment HCV RNA measurement fulfilled 1 the following conditions: a) at least 2 consecutive measurements not lesser than (<)15 IU/mL undetectable, of which at least the second measurement was >=15 IU/mL quantifiable or b) the last available measurement was >=15 IU/mL quantifiable. (NCT02349048)
Timeframe: From Week 18 to Week 30 (for Arm A), From Week 20 to Week 32 (for Arm B)

InterventionParticipants (Number)
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks1
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks0

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Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR

The Q80K polymorphism, associated with low level SMV in vitro resistance. Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported. (NCT02349048)
Timeframe: up to Week 30 for Arm A and Week 32 for Arm B

,
InterventionPercentage of Participants (Number)
With NS3 Q80K polymorphism at baseline (n=25,9)Without NS3 Q80K polymorphism at baseline (n=23,9)
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks88.078.3
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks100100

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Number of Participants With Viral Relapse

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 followup. (NCT02349048)
Timeframe: From Week 6 to Week 18 (for Arm A) and From Week 8 to Week 20 (for Arm B)

InterventionParticipants (Number)
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks7
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks0

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Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12)

Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment. (NCT02349048)
Timeframe: 12 weeks after end of study drug treatment (week 18 for Arm A and week 20 for Arm B)

InterventionPercentage of Participants (Number)
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks86.4
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks100

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Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR

Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify preexisting sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. (NCT02349048)
Timeframe: Up to Week 30 for Arm A and up to Week 32 for Arm B

InterventionParticipants (Number)
Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks8
Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks0

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as:~End of treatment virologic failure:~Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment HCV RNA measurement." (NCT02350569)
Timeframe: Up to Posttreatment Week 12

Interventionpercentage of participants (Number)
Main Study (LDV/SOF 4 Weeks)6.3

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Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event

(NCT02350569)
Timeframe: Up to 4 weeks

Interventionpercentage of participants (Number)
Main Study (LDV/SOF 4 Weeks)0

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Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28

(NCT02350569)
Timeframe: Days 1, 3, 5, 7, 14, 21, and 28

Interventionpercentage of participants (Number)
Day 1Day 3Day 5Day 7Day 14Day 21Day 28
Main Study (LDV/SOF 4 Weeks)012.518.833.393.3100.0100.0

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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. (NCT02350569)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Main Study (LDV/SOF 4 Weeks)87.5

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Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02350569)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
Main Study (LDV/SOF 4 Weeks)87.5

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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 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 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 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 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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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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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 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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HCV RNA Change From Baseline

(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

,,
Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 8
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic-4.15-4.57-4.81-4.84-4.85
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic-4.60-4.98-5.06-5.08-5.08
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic-4.31-4.85-5.17-5.16-5.16

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HCV RNA Change From Baseline

(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 6
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic-4.64-5.00-5.07-5.07

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Percentage of Participants With Virologic Failure

"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." (NCT02378935)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic29.4
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic6.1
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic19.4
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic0
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic0
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)0

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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) 12 weeks following the last dose of study treatment. (NCT02378935)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic70.6
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic100.0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic93.9
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic80.6
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic100
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic100.0
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)100.0

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)12.575.0100.0100.0100.0100.0100.0
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic28.162.596.9100.0100.0100.0100.0
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic22.658.193.5100.0100.0100.0100.0

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic33.363.690.997.0100.0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic38.975.094.4100.0100.0
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic16.154.896.8100.0100.0

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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 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02378935)
Timeframe: Posttreatment Weeks 4 and 24

,,,,,,
Interventionpercentage of participants (Number)
SVR4SVR24
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)100.0100.0
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic100.0100.0
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic100.0100.0
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic88.270.6
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic93.993.9
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic100.0100.0
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic87.180.6

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic23.579.4100.0100.0

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HCV RNA Change From Baseline

(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

,,
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
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic-4.19-4.66-4.84-4.84-4.84-4.84-4.84
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic-4.40-4.97-5.22-5.24-5.24-5.24-5.24
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)-4.71-5.27-5.35-5.35-5.35-5.35-5.35

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02378935)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic0
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic6.5
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic0
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic0
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)0

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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) 12 weeks following the last dose of study treatment. (NCT02378961)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic87.9
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic93.3
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic96.6

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02378961)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic0
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic6.7
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic3.4

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic33.381.8100.0100.0

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic20.073.3100.0100.0100.0

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic10.58.689.796.6100.0100.0100.0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic33.372.288.997.2100.0100.0100.0

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HCV RNA Change From Baseline

(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 6
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic-4.51-4.91-5.01-5.01

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HCV RNA Change From Baseline

(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 8
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic-4.28-4.84-4.99-4.99-4.98

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HCV RNA Change From Baseline

(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)

,
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
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic-4.24-4.96-5.25-5.29-5.30-5.30-5.32
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic-4.51-4.95-5.14-5.19-5.19-5.19-5.19

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Percentage of Participants With Virologic Failure

"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." (NCT02378961)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic12.1
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic6.7
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic0
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic3.4

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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 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively. (NCT02378961)
Timeframe: Posttreatment Weeks 4 and 24

,,,
Interventionpercentage of participants (Number)
SVR4SVR24
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic100.096.6
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic100.0100.0
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic90.987.9
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic96.793.3

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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 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 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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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02413593)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF+RBV0.9

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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. (NCT02413593)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF+RBV89.2

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Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

(NCT02413593)
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
LDV/SOF+RBV-4.33-4.85-5.05-5.06-5.06

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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. (NCT02413593)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
LDV/SOF+RBV91.9

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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." (NCT02413593)
Timeframe: Up to Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF+RBV7.2

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Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12

(NCT02413593)
Timeframe: Weeks 1, 2, 4, 8, and 12

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
LDV/SOF+RBV20.764.997.3100.099.1

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Percentage 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. (NCT02421211)
Timeframe: Up to Week 12 follow-up phase after EOT

Interventionpercentage of participants (Number)
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])0
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)0

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Percentage 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 NCT02421211)
Timeframe: Day 70 in Panel 1 and Day 56 in Panel 2

Interventionpercentage of participants (Number)
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])0
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)0

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Minimum Plasma Concentration (Cmin) of Simeprevir (SMV)

The Cmin is the minimum observed plasma concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionnanogram per Milliliters (ng/mL) (Mean)
Panel 1: SMV 150 mg + SOF 400 mg (Day 14)2411
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)6701

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Minimum Plasma Concentration (Cmin) of Ledipasvir (LDV)

The Cmin is the minimum observed plasma concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionng/mL (Mean)
Panel 2: LDV 90mg/SOF 400mg (Day 14)319
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)557

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

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is 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. (NCT02421211)
Timeframe: Up to 10 Weeks for Panel 1 and 8 Weeks for Panel 2

,
Interventionnumber of participants (Number)
Adverse eventsSerious adverse events
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])172
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)150

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Maximum Plasma Concentration (Cmax) of Simeprevir

The Cmax is the maximum observed plasma concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionng/mL (Mean)
Panel 1: SMV 150 mg + SOF 400 mg (Day 14)6767
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)13691

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Maximum Plasma Concentration (Cmax) of Ledipasvir

The Cmax is the maximum observed plasma concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionng/mL (Mean)
Panel 2: LDV 90mg/SOF 400mg (Day 14)556
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)930

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Fluctuation Index (FI) of Simeprevir

Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg). (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionpercentage fluctuation (Mean)
Panel 1: SMV 150 mg + SOF 400 mg (Day 14)144
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)84.4

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Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Ledipasvir

AUCtau is defined as area under the analyte concentration versus time curve during dosing interval tau, calculated by linear-linear trapezoidal summation. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionng*h/mL (Mean)
Panel 2: LDV 90mg/SOF 400mg (Day 14)9868
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)17435

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Percentage of Participants With On-treatment Virologic Response

"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: less than (<) lower limit of quantification (LLOQ) undetectable, NCT02421211)
Timeframe: Week 1, up to EOT (Week 10 in Panel 1 and Week 8 in Panel 2)

,
Interventionpercentage of participants (Number)
Week 1: >= 15 IU/mLWeek 1: < 15 IU/mL undetectable/detectableWeek 1: < 15 IU/mL detectableWeek 1: < 15 IU/mL undetectableWeek 2: >= 15 IU/mLWeek 2: < 15 IU/mL undetectable/detectableWeek 2: < 15 IU/mL detectableWeek 2: < 15 IU/mL undetectable (vRVR)Week 4: >= 15 IU/mLWeek 4: < 15 IU/mL undetectable/detectableWeek 4: < 15 IU/mL detectableWeek 4: < 15 IU/mL undetectable (RVR)Week 6: >= 15 IU/mLWeek 6: < 15 IU/mL undetectable/detectableWeek 6: < 15 IU/mL detectableWeek 6: < 15 IU/mL undetectableWeek 8: >= 15 IU/mLWeek 8: < 15 IU/mL undetectable/detectableWeek 8: < 15 IU/mL detectableWeek 8: < 15 IU/mL undetectableWeek 10: >= 15 IU/mLWeek 10: < 15 IU/mL undetectable/detectableWeek 10: < 15 IU/mL detectableWeek 10: < 15 IU/mL undetectable
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])65.035.015.020.025.075.030.045.00100.015.085.00100.00100.00100.00100.00100.00100.0
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)60.040.035.05.035.065.030.035.05.095.05.090.00100.05.095.00100.00100.0NANANANA

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Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks After the Actual EOT (SVR4) and 12 Weeks After the Actual EOT (SVR12)

SVR4 or SVR12 is defined as sustained virologic response 4 or 12 weeks after the actual EOT the participant has HCV RNA NCT02421211)
Timeframe: 4 weeks after EOT (Week 4 of follow-up phase in Panel 1 and Panel 2) and 12 weeks after EOT (Week 12 of follow-up phase in Panel 1 and Panel 2)

,
Interventionpercentage of participants (Number)
SVR4SVR12
Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])100100
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)100100

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Fluctuation Index (FI) of Ledipasvir

Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg). (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionpercentage fluctuation (Mean)
Panel 2: LDV 90mg/SOF 400mg (Day 14)60.6
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)51.2

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Average Plasma Concentration at Steady State (Cavg,ss) of Simeprevir

The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau). (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionng/mL (Mean)
Panel 1: SMV 150 mg + SOF 400 mg (Day 14)4196
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)10139

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Average Plasma Concentration at Steady State (Cavg,ss) of Ledipasvir

The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau). (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionng/mL (Mean)
Panel 2: LDV 90mg/SOF 400mg (Day 14)411
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)725

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Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Simeprevir

The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionnanogram hour per Milliliters (ng*h/mL) (Mean)
Panel 1: SMV 150 mg + SOF 400 mg (Day 14)100492
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)243564

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Trough Plasma Concentration (Ctrough) of Simeprevir

The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen. (NCT02421211)
Timeframe: Pre-dose on Day 14 and Day 28

Interventionnanogram per Milliliters (ng/mL) (Mean)
Panel 1: SMV 150 mg + SOF 400 mg (Day 14)3059
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)8453

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Trough Plasma Concentration (Ctrough) of Ledipasvir

The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen. (NCT02421211)
Timeframe: Pre-dose on Day 14 and Day 28

Interventionng/mL (Mean)
Panel 2: LDV 90mg/SOF 400mg (Day 14)376
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)659

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Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir

The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

Interventionhour (H) (Median)
Panel 1: SMV 150 mg + SOF 400 mg (Day 14)6.00
Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)6.00

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Time to Reach Maximum Plasma Concentration (Tmax) of Ledipasvir

The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. (NCT02421211)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28

InterventionHour (Median)
Panel 2: LDV 90mg/SOF 400mg (Day 14)4.07
Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)6.00

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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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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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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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Percentage of Participants With Virologic Failure

"Virologic failure was defined as:~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),~HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse)~Relapse~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" (NCT02457611)
Timeframe: Up to Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF15.4

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02457611)
Timeframe: Weeks 2, 4, and 6

Interventionpercentage of participants (Number)
Week 2Week 4Week 6
LDV/SOF73.188.596.2

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Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4

(NCT02457611)
Timeframe: Weeks 2, 4, 6, and Posttreatment Week 4

Interventionpercentage of participants (Number)
Week 2Week 4Week 6Posttreatment Week 4
LDV/SOF100.0100.095.2100.0

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Change From Baseline in HCV RNA at Weeks 2, 4, and 6

(NCT02457611)
Timeframe: Baseline; Weeks 2, 4, and 6

Interventionlog10 IU/mL (Mean)
Change at Week 2Change at Week 4Change at Week 6
LDV/SOF-4.01-4.16-4.17

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Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)

SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug. (NCT02457611)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
LDV/SOF84.6

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Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02457611)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF76.9

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02457611)
Timeframe: Up to 6 weeks

Interventionpercentage of participants (Number)
LDV/SOF0

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Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.

Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates. (NCT02457611)
Timeframe: Day 1; Week 6

InterventionParticipants (Count of Participants)
LDV/SOF0

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Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4

(NCT02457611)
Timeframe: Baseline; Week 6; Posttreatment Week 4

Interventionpercent change (Mean)
Change at Week 6Change at Posttreatment Week 4
LDV/SOF-0.30.4

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Number of Participants Who Sustained Virologic Response

Absence of detectable virus 24 weeks after completion of antiviral therapy (NCT02468648)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Combination of Sofosbuvir and GS-581670

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Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)

(NCT02468648)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Combination of Sofosbuvir and GS-581655

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Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)

(NCT02468648)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Combination of Sofosbuvir and GS-581670

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Number of Participants With Sustained Virologic Response

Absence of detectable virus 12 weeks after completion of antiviral therapy (NCT02468648)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Combination of Sofosbuvir and GS-581670

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Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)

(NCT02472886)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF 8 Weeks (TN, HCV-monoinfected)0
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)0
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)0

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02472886)
Timeframe: Up to 12 weeks

,,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)3.759.388.9100.0100.0
LDV/SOF 8 Weeks (TN, HCV-monoinfected)20.965.7100.0100.0NA
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)39.069.596.698.3NA

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Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4

(NCT02472886)
Timeframe: Up to Posttreatment Week 4

Interventionpercentage of participants (Number)
Week 4Week 8Posttreatment Week 4
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)100.0100.097.2

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Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02472886)
Timeframe: Posttreatment Weeks 4 and 24

,,
Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)96.396.3
LDV/SOF 8 Weeks (TN, HCV-monoinfected)100.0100.0
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)96.696.6

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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) 12 weeks following the last dose of study drug. (NCT02472886)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 8 Weeks (TN, HCV-monoinfected)100.0
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)96.6
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)96.3

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)~Relapse~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" (NCT02472886)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF 8 Weeks (TN, HCV-monoinfected)0
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)3.4
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)3.7

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For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4

(NCT02472886)
Timeframe: Up to Posttreatment Week 4

,
Interventioncells/µL (Mean)
Change at Week 4Change at Week 8Change at Posttreatment Week 4
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV Experienced)159202172
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV- Naive)474574

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HCV RNA Change From Day 1

(NCT02472886)
Timeframe: Up to 12 weeks

,,
Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 8Week 12
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)-4.12-4.83-5.08-5.11-5.11
LDV/SOF 8 Weeks (TN, HCV-monoinfected)-3.97-4.50-4.74-4.74NA
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)-4.34-4.76-4.89-4.91NA

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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 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02480712)
Timeframe: Posttreatment Weeks 4 and 24

Interventionpercentage of participants (Number)
SVR4SVR24
SOF/VEL 12 Weeks95.395.3

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02480712)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12
SOF/VEL 12 Weeks25.768.092.299.0100.0100.0100.0

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Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment

(NCT02480712)
Timeframe: Up to 12 Weeks

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)94.496.396.2
SOF/VEL 12 Weeks (Non TDF Containing Regimens)10010092.9
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)97.197.1100

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HCV RNA Change From Baseline/Day 1

(NCT02480712)
Timeframe: Baseline to Week 12

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/VEL 12 Weeks-4.47-4.97-5.15-5.18-5.17-5.17-5.17

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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" (NCT02480712)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks1.9

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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) 12 weeks following the last dose of study drug. (NCT02480712)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks95.3

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02480712)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks1.9

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Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12

(NCT02480712)
Timeframe: Week 12; Posttreatment Week 12

,,
Interventionmg/dL (Mean)
Change at Week 12Change at Posttreatment Week 12
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)0.090.04
SOF/VEL 12 Weeks (Non TDF Containing Regimens)0.00-0.06
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)0.040.02

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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) 12 weeks following the last dose of study drug. (NCT02487030)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 8 wk TN (Cohort 1, Group 1)95.3
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)90.5
LDV/SOF 12 wk TN (Cohort 1, Group 3)97.7
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)97.6
LDV/SOF 12 wk TE (Cohort 3, Group 1)94.4
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)100.0
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)100.0

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Percentage of Participants With Overall Virologic Failure

"Virologic failure was defined as~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)~Relapse~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" (NCT02487030)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF 8 wk TN (Cohort 1, Group 1)4.7
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)9.5
LDV/SOF 12 wk TN (Cohort 1, Group 3)2.3
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)0.0
LDV/SOF 12 wk TE (Cohort 3, Group 1)2.8
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)0.0
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)0.0

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Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)

(NCT02487030)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF 8 Weeks0
LDV/SOF + RBV 8 Weeks0
LDV/SOF 12 Weeks0
LDV/SOF + RBV 12 Weeks1.1

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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 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively. (NCT02487030)
Timeframe: Posttreatment Weeks 4 and 24

,,,,,,
Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)100.0100.0
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)100.0100.0
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)97.697.6
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)95.290.5
LDV/SOF 12 wk TE (Cohort 3, Group 1)100.094.4
LDV/SOF 12 wk TN (Cohort 1, Group 3)97.797.7
LDV/SOF 8 wk TN (Cohort 1, Group 1)95.395.3

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The Percent Change in Proteinuria

% change in proteinuria from baseline (timepoint week 0) through timepoint week 24, which was 12 weeks after completion of Harvoni. (NCT02503735)
Timeframe: Baseline and 24 weeks (12 weeks after completion of Harvoni)

Interventionpercentage change from baseline (Median)
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)-14

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Change in Urinary β-2microglobulin Levels After Therapy

"Change in urinary β-2microglobulin levels after therapy with ledipasvir/sofosbuvir fixed dose combination pill~β-2microglobulin (mcg/L) levels were assessed at baseline (timepoint week 0) and at timepoint week 24. Change was recorded for each patient, and presented as a median with IQR." (NCT02503735)
Timeframe: 24 weeks

Interventionmcg/L (Median)
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)57

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Number of Participants With ≥25% Reduction in Proteinuria

Number of participants with at least -25% change in proteinuria, calculated from baseline (timepoint week 0) to timepoint week 24, which is 12 weeks after completion of Harvoni. (NCT02503735)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)3

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Median Change in eGFR From Baseline to Timepoint Week 52

"Median change from baseline (timepoint week 0) to timepoint week 52, which was 40 weeks after completion of Harvoni.~Median change in eGFR was calculated using the creatinine and cystatin C-based estimating equation.~eGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 [if female] × 1.08 [if black]" (NCT02503735)
Timeframe: 52 weeks

InterventionmL/min/1.73m^2 (Median)
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)-4

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Median Change in eGFR From Baseline to Timepoint Week 24

"Median change from baseline (timepoint week 0) to timepoint week 24, which was 12 weeks after completion of Harvoni.~Median change in eGFR was calculated using the creatinine and cystatin C-based estimating equation.~eGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 [if female] × 1.08 [if black]" (NCT02503735)
Timeframe: 24 weeks

InterventionmL/min/1.73m^2 (Median)
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)1

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Mean Time in Weeks to Maximum Reduction in Proteinuria

This outcome evaluated all post-baseline proteinuria values through the 52 week followup, and determined which demonstrated the greatest negative change (reduction) from baseline. We then calculate the mean time to maximum reduction of proteinuria. (NCT02503735)
Timeframe: 52 weeks

Interventionweeks (Mean)
12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)39.4

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT02536313)
Timeframe: Weeks 1, 2, 4, 8 and 12

,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
SOF/VEL/VOX54.279.2100100.0100.0
SOF/VEL/VOX + RBV4060.092.0100.0100.0

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HCV RNA Change From Baseline/Day 1 Through Week 12

(NCT02536313)
Timeframe: 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
SOF/VEL/VOX-4.63-4.97-5.10-5.10-5.10
SOF/VEL/VOX + RBV-4.53-4.95-5.14-5.18-5.18

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Percentage of Participants With Virologic Failure

"Virologic failure is 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." (NCT02536313)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL/VOX0
SOF/VEL/VOX + RBV4.0

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)

SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02536313)
Timeframe: Posttreatment Week 12

Interventionpercentage of particpants (Number)
SOF/VEL/VOX100.0
SOF/VEL/VOX + RBV96.0

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Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event

(NCT02536313)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL/VOX0
SOF/VEL/VOX + RBV0

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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 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02536313)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF/VEL/VOX100.0100.0
SOF/VEL/VOX + RBV96.096.0

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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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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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Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation 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. (NCT02600351)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks, Without Cirrhosis81.3
LDV/SOF + RBV 12 Weeks, Without Cirrhosis100.0
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis80.0
LDV/SOF 24 Weeks, With Compensated Cirrhosis91.7

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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. (NCT02600351)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks, Without Cirrhosis0
LDV/SOF + RBV 12 Weeks, Without Cirrhosis0
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis0
LDV/SOF 24 Weeks, With Compensated Cirrhosis0

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Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02600351)
Timeframe: Posttreatment Weeks 4 and 24

,,,
Interventionpercentage of participants (Number)
SVR4SVR24
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis88.080.0
LDV/SOF + RBV 12 Weeks, Without Cirrhosis100.0100.0
LDV/SOF 12 Weeks, Without Cirrhosis93.881.3
LDV/SOF 24 Weeks, With Compensated Cirrhosis95.891.7

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Percentage of Participants With Viral Relapse

Viral relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA NCT02600351)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks, Without Cirrhosis18.8
LDV/SOF + RBV 12 Weeks, Without Cirrhosis0
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis20.0
LDV/SOF 24 Weeks, With Compensated Cirrhosis8.3

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Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event

(NCT02600351)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
LDV/SOF 12 Weeks, Without Cirrhosis0
LDV/SOF + RBV 12 Weeks, Without Cirrhosis0
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis0
LDV/SOF 24 Weeks, With Compensated Cirrhosis0

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Number of Participants With Emerging Resistance

The full-length NS3, NS5A, and NS5B coding regions were deep sequenced at pretreatment (baseline) for all participants included in the Full Analysis Set, and at posttreatment for all participants who relapsed. (NCT02600351)
Timeframe: Up to Posttreatment Week 24

InterventionParticipants (Count of Participants)
LDV/SOF 12 Weeks, Without Cirrhosis3
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis5
LDV/SOF 24 Weeks, With Compensated Cirrhosis2

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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 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 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 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 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 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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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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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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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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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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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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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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Change From Baseline in HCV RNA (Primary Study)

(NCT02607735)
Timeframe: Baseline; Weeks 1, 2, 4, 8 and 12

,
Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 8Week 12
Placebo (Primary Study)0.020.02-0.010.050.03
SOF/VEL/VOX (Primary Study)-4.20-4.81-5.07-5.11-5.10

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02607735)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL/VOX (Primary Study)96.2

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Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)

(NCT02607735)
Timeframe: Weeks 1, 2, 4, 8 and 12

,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
Placebo (Primary Study)00000
SOF/VEL/VOX (Primary Study)15.656.792.7100.099.6

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Change From Baseline in HCV RNA (Deferred Treatment Substudy)

(NCT02607735)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)

Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 8Week 12
SOF/VEL/VOX (Deferred Treatment Substudy)-4.30-4.93-5.16-5.20-5.20

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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)

(NCT02607735)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL/VOX (Primary Study)0.4
Placebo (Primary Study)2.0

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Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)

SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively. (NCT02607735)
Timeframe: Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)

Interventionpercentage of participants (Number)
SVR4SVR12SVR24
SOF/VEL/VOX (Deferred Treatment Substudy)98.697.397.3

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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02607735)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL/VOX (Primary Study)96.2

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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment, respectively. (NCT02607735)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF/VEL/VOX (Primary Study)97.7
Placebo (Primary Study)0

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Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)

"Virologic failure is 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." (NCT02607735)
Timeframe: Up to Posttreatment Week 24 (Deferred Treatment Substudy)

Interventionpercentage of participants (Number)
SOF/VEL/VOX (Deferred Treatment Substudy)2.7

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Percentage of Participants With Virologic Failure (Primary Study)

"Virologic failure is 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." (NCT02607735)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL/VOX (Primary Study)2.7

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Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)

(NCT02607735)
Timeframe: Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
SOF/VEL/VOX (Deferred Treatment Substudy)14.362.693.2100.0100.0

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Change From Baseline in HCV RNA

(NCT02607800)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12

Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 8Week 12
SOF/VEL 12 Weeks-4.24-4.77-4.99-5.03-5.03

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Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event

(NCT02607800)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL/VOX 8 Weeks0
SOF/VEL 12 Weeks0.5

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Percentage of Participants With HCV RNA < LLOQ On Treatment

(NCT02607800)
Timeframe: Weeks 1, 2, 4, 8, and 12

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8
SOF/VEL/VOX 8 Weeks24.865.992.499.2

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Percentage of Participants With HCV RNA < LLOQ On Treatment

(NCT02607800)
Timeframe: Weeks 1, 2, 4, 8, and 12

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
SOF/VEL 12 Weeks22.761.392.099.899.8

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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. (NCT02607800)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR 24
SOF/VEL 12 Weeks98.998.0
SOF/VEL/VOX 8 Weeks96.495.0

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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" (NCT02607800)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL/VOX 8 Weeks4.2
SOF/VEL 12 Weeks0.7

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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) at 12 weeks after stopping study treatment. (NCT02607800)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL/VOX 8 Weeks95.2
SOF/VEL 12 Weeks98.2

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Change From Baseline in HCV RNA

(NCT02607800)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12

Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 8
SOF/VEL/VOX 8 Weeks-4.23-4.75-4.95-4.99

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as :~Breakthrough (confirmed HCV RNA ≥ LLOQ [15 IU/mL] 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)" (NCT02613871)
Timeframe: First dose date up to Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF FDC0

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HCV RNA Change From Baseline While on Treatment

(NCT02613871)
Timeframe: 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
LDV/SOF FDC-4.14-4.63-4.73-4.73-4.73

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Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

LLOQ = 15 IU/mL (NCT02613871)
Timeframe: Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

Interventionpercentage of participants (Number)
Posttreatment Week 24Posttreatment Week 36Posttreatment Week 48Posttreatment Week 60Posttreatment Week 72Posttreatment Week 84Posttreatment Week 96Posttreatment Week 108
LDV/SOF FDC100100100100100100100100

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Plasma HBV DNA Change From Baseline While on Treatment

(NCT02613871)
Timeframe: 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
LDV/SOF FDC-0.060.080.370.510.24

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Percentage of Participants With HCV RNA < LLOQ While on Treatment

LLOQ = 15 IU/mL (NCT02613871)
Timeframe: Weeks 1, 2, 4, 8, and 12

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
LDV/SOF FDC33.382.0100.0100.0100.0

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Serum LOXL-2 Level Change From Baseline While on Treatment

(NCT02613871)
Timeframe: Weeks 1, 2, 4, 8, and 12

Interventionpg/mL (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12
LDV/SOF FDC-2-6-15-22-27

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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 quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02613871)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
Genotype 1Genotype 2Total
LDV/SOF FDC100.0100.0100.0

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Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug

(NCT02613871)
Timeframe: First dose date up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF FDC0.0

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Percentage of Participants That Required HBV Therapy During the Study

(NCT02613871)
Timeframe: First dose date up to Posttreatment Week 108

Interventionpercentage of participants (Number)
LDV/SOF FDC7.2

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Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

(NCT02613871)
Timeframe: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

Interventionlog10 IU/mL (Mean)
Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24Change at Posttreatment Week 36Change at Posttreatment Week 48Change at Posttreatment Week 60Change at Posttreatment Week 72Change at Posttreatment Week 84Change at Posttreatment Week 96Change at Posttreatment Week 108
LDV/SOF FDC0.490.660.560.670.680.700.550.500.410.38

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Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study

(NCT02613871)
Timeframe: First dose date up to Posttreatment Week 108

Interventionpercentage of participants (Number)
LDV/SOF FDC0.0

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Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36

(NCT02613871)
Timeframe: Posttreatment Weeks 4, 12, and 36

Interventionpg/mL (Mean)
Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 36
LDV/SOF FDC-30-32-41

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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment. (NCT02613871)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
LDV/SOF FDC100.0

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HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

(NCT02613871)
Timeframe: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

Interventionlog10 IU/mL (Mean)
Change at Posttreatment Week 4Change at Posttreatment Week 12Change at Posttreatment Week 24Change at Posttreatment Week 36Change at Posttreatment Week 48Change at Posttreatment Week 60Change at Posttreatment Week 72Change at Posttreatment Week 84Change at Posttreatment Week 96Change at Posttreatment Week 108
LDV/SOF FDC-0.16-0.01-0.02-0.07-0.10-0.16-0.20-0.25-0.32-0.37

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HBsAg Level Change From Baseline While on Treatment

(NCT02613871)
Timeframe: 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
LDV/SOF FDC-0.14-0.18-0.25-0.41-0.47

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Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108

"FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:~Presence of cirrhosis = FibroScan result of > 12.5 kPa~Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa" (NCT02613871)
Timeframe: Posttreatment Weeks 12, 60, and 108

InterventionkPa (Mean)
Posttreatment Week 12Posttreatment Week 60Posttreatment Week 108
LDV/SOF FDC8.07.27.1

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Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population

To evaluate the proportion of participants with HCV RNA below the level of quantification at 12 weeks post treatment following SOF/VEL for 6 weeks as compared with 12 weeks in people with recent HCV infection- among intention-to-treat (ITT) population The ITT population included all randomized participants, with loss to follow-up deemed treatment failure. (NCT02625909)
Timeframe: 12 weeks post treatment

InterventionParticipants (Count of Participants)
Drug: SOF/VEL for 6 Weeks76
Drug: SOF/VEL for 12 Weeks86

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Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Modified Intention-to-treat (ITT) Population

To evaluate the proportion of participants with HCV RNA below the level of quantification at 12 weeks post treatment following SOF/VEL for 6 weeks as compared with 12 weeks in people with recent HCV infection- among modified intention-to-treat (ITT) population The modified ITT population included participants in the ITT population, but excluded those with non-virological reasons for treatment failure (including death and loss to follow-up) and reinfection. (NCT02625909)
Timeframe: 12 Weeks Post End of Treatment

InterventionParticipants (Count of Participants)
Drug: SOF/VEL for 6 Weeks76
Drug: SOF/VEL for 12 Weeks86

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Number of Participants With Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) Following SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Per Protocol (PP) Population

To evaluate the proportion of participants with HCV RNA below the level of quantification at 12 weeks post treatment following SOF/VEL for 6 weeks as compared with 12 weeks in people with recent HCV infection- among Per Protocol (PP) population The per protocol population included participants who received >90% of scheduled treatment for >90% of the scheduled treatment period with follow-up virologic data at SVR12 (excluding reinfection and retreatments) (NCT02625909)
Timeframe: 12 weeks post treatment

InterventionParticipants (Count of Participants)
Drug: SOF/VEL for 6 Weeks69
Drug: SOF/VEL for 12 Weeks77

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Number of Participants With Undetectable HCV RNA at End of Treatment (ETR) of SOF/VEL for 6 Weeks as Compared With 12 Weeks in People With Recent HCV Infection- Among Intention-to-treat (ITT) Population

To evaluate the proportion of participants with HCV RNA below the level of quantification at end of treatment of SOF/VEL for 6 Weeks as compared With 12 Weeks in People With Recent HCV Infection The ITT population included all randomized participants, with loss to follow-up deemed treatment failure. (NCT02625909)
Timeframe: End of treatment - week 6 of the shortened treatment duration arm, and week 12 of the standard treatment duration arm

InterventionParticipants (Count of Participants)
Drug: SOF/VEL for 6 Weeks85
Drug: SOF/VEL for 12 Weeks87

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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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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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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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Percentage of Participants With HCV RNA < LLOQ On Treatment

(NCT02639247)
Timeframe: Weeks 1, 2, 4, 8 and 12

,
Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
SOF/VEL 12 Weeks17.256.390.798.799.3
SOF/VEL/VOX 12 Weeks15.962.688.5100.098.9

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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02639247)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participcants (Number)
SVR4SVR24
SOF/VEL 12 Weeks91.490.1
SOF/VEL/VOX 12 Weeks98.497.8

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Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event

(NCT02639247)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL/VOX 12 Weeks0
SOF/VEL 12 Weeks0.7

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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) at 12 weeks after stopping study treatment. (NCT02639247)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL/VOX 12 Weeks97.8
SOF/VEL 12 Weeks90.1

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Percentage of Participants With Virologic Failure

"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." (NCT02639247)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL/VOX 12 Weeks0.5
SOF/VEL 12 Weeks9.9

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Change From Baseline in HCV RNA

(NCT02639247)
Timeframe: 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
SOF/VEL 12 Weeks-4.17-4.78-5.06-5.08-5.09
SOF/VEL/VOX 12 Weeks-4.29-4.93-5.13-5.17-5.17

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Percentage of Participants With HCV RNA < LLOQ On Treatment

(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8Week 12
SOF/VEL 12 Weeks10.150.985.299.1100.0

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Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02639338)
Timeframe: Posttreatment Weeks 4 and 24

,
Interventionpercentage of participants (Number)
SVR4SVR24
SOF/VEL 12 Weeks97.296.3
SOF/VEL/VOX 8 Weeks97.396.4

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Change From Baseline in HCV RNA

(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12

Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 8
SOF/VEL/VOX 8 Weeks-4.06-4.60-4.84-4.90

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Change From Baseline in HCV RNA

(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12

Interventionlog10 IU/mL (Mean)
Week 1Week 2Week 4Week 8Week 12
SOF/VEL 12 Weeks-4.09-4.73-5.00-5.09-5.14

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Percentage of Participants With HCV RNA < LLOQ On Treatment

(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12

Interventionpercentage of participants (Number)
Week 1Week 2Week 4Week 8
SOF/VEL/VOX 8 Weeks17.356.487.397.3

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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), or~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02639338)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL/VOX 8 Weeks1.8
SOF/VEL 12 Weeks1.8

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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) at 12 weeks after stopping study treatment. (NCT02639338)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL/VOX 8 Weeks96.4
SOF/VEL 12 Weeks96.3

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Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event

(NCT02639338)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL/VOX 8 Weeks0
SOF/VEL 12 Weeks0.9

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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 in 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. (NCT02640157)
Timeframe: Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment

Interventionpercentage of participants (Number)
Arm A0.4
Arm B0
Arm C0.6

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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. (NCT02640157)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Interventionpercentage of participants (Number)
Arm A1.4
Arm B0.9
Arm C3.3

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority 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 [NCT02640157)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A95.3
Arm B96.5

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A

SVR12 was defined as plasma HCV RNA level NCT02640157)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A95.3
Arm C94.9

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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B

SVR12 was defined as plasma HCV RNA level NCT02640157)
Timeframe: 12 weeks after the last actual dose of study drug

Interventionpercentage of participants (Number)
Arm A95.3
Arm B96.5

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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. (NCT02671500)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL96.5

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Change From Baseline in HCV RNA

(NCT02671500)
Timeframe: Baseline and up to Week 12

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/VEL-4.38-4.89-5.02-5.03-5.03-5.03-5.03

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Percentage of Participants With HCV RNA < LLOQ On Treatment

(NCT02671500)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12

InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12
SOF/VEL27.773.895.599.7100.0100.0100.0

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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. (NCT02671500)
Timeframe: Posttreatment Week 4

InterventionPercentage of participants (Number)
SOF/VEL97.1

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02671500)
Timeframe: Up to 12 weeks

InterventionPercentage of participants (Number)
SOF/VEL0

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Percentage of Participants With Overall Virologic Failure

Virologic failure was defined as: (1) 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) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT02671500)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL3.2

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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) at 12 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 12

InterventionPercentage of participants (Number)
SOF/VEL (Overall)96.5
SOF/VEL (China - Region 1)96.2
SOF/VEL (Southeast Asia - Region 2)97.3

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Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02707601)
Timeframe: 24 weeks after start of HIV treatment

Interventionpercentage of participants (Number)
E/C/F/TAF + LDV/SOF1.4
F/R/TAF + LDV/SOF1.4

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Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment. (NCT02707601)
Timeframe: HCV Posttreatment Week 4

Interventionpercentage of participants (Number)
E/C/F/TAF + LDV/SOF98.6
F/R/TAF + LDV/SOF98.6

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Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment

(NCT02707601)
Timeframe: Up to 32 weeks plus 30 days

Interventionpercentage of participants (Number)
E/C/F/TAF + LDV/SOF (Co-administration: Week 8 to Week 20)62.5
F/R/TAF + LDV/SOF (Co-administration: Week 8 to Week 20)69.4
E/C/F/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV Week 12)83.8
F/R/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV to Week 12)79.7

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Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)

Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment. (NCT02707601)
Timeframe: HCV Posttreatment Week 12

Interventionpercentage of participants (Number)
E/C/F/TAF + LDV/SOF98.6
F/R/TAF + LDV/SOF95.8

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Change From Baseline in HCV RNA at Week 8

(NCT02722837)
Timeframe: Baseline (Day 1); Week 8

Interventionlog10 IU/mL (Mean)
SOF/VEL-4.93

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Change From Baseline in HCV RNA at Week 12

(NCT02722837)
Timeframe: Baseline (Day 1); Week 12

Interventionlog10 IU/mL (Mean)
SOF/VEL-4.93

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Change From Baseline in HCV RNA at Week 1

(NCT02722837)
Timeframe: Baseline (Day 1); Week 1

Interventionlog10 IU/mL (Mean)
SOF/VEL-4.17

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Change From Baseline in HCV RNA at Week 2

(NCT02722837)
Timeframe: Baseline (Day 1); Week 2

Interventionlog10 IU/mL (Mean)
SOF/VEL-4.70

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Change From Baseline in HCV RNA at Week 4

(NCT02722837)
Timeframe: Baseline (Day 1); Week 4

Interventionlog10 IU/mL (Mean)
SOF/VEL-4.90

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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

(NCT02722837)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL0

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Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02722837)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL99.2

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Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02722837)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF/VEL100.0

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Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12

(NCT02722837)
Timeframe: Week 12

Interventionpercentage of participants (Number)
SOF/VEL100.0

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Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2

(NCT02722837)
Timeframe: Week 2

Interventionpercentage of participants (Number)
SOF/VEL64.7

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Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4

(NCT02722837)
Timeframe: Week 4

Interventionpercentage of participants (Number)
SOF/VEL96.6

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Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8

(NCT02722837)
Timeframe: Week 8

Interventionpercentage of participants (Number)
SOF/VEL100.0

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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) at 12 weeks after stopping study treatment. (NCT02722837)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL99.2

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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)" (NCT02722837)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL0.8

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Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1

(NCT02722837)
Timeframe: Week 1

Interventionpercentage of participants (Number)
SOF/VEL21.0

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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 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 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 With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02728206)
Timeframe: Posttreatment Week 4

InterventionPercentage of participants (Number)
SOF/VEL88.9

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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. (NCT02728206)
Timeframe: Posttreatment Week 12

InterventionPercentage of participants (Number)
SOF/VEL77.8

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Percentage of Participants With Overall Virologic Failure

Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA ≥ 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA ≥ 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA < 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. (NCT02728206)
Timeframe: Up to Posttreatment Week 12

InterventionPercentage of participants (Number)
SOF/VEL0

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02728206)
Timeframe: Up to Week 4

InterventionPercentage of participants (Number)
SOF/VEL11.1

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Percentage of Participants With HCV RNA < LLOQ On Treatment

(NCT02728206)
Timeframe: Days 3, 5, 7, 14, 21, and 28

InterventionPercentage of participants (Number)
Day 3Day 5Day 7Day 14Day 21Day 28
SOF/VEL00033.385.785.7

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Change From Baseline in HCV RNA at Week 10

(NCT02738333)
Timeframe: Baseline; Week 10

Interventionlog10 IU/mL (Mean)
LDV/SOF (Cohort 1)-4.92
SOF+RBV (Cohort 1)-4.93
LDV/SOF (Cohort 2)-4.76

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Change From Baseline in HCV RNA at Week 1

(NCT02738333)
Timeframe: Baseline; Week 1

Interventionlog10 IU/mL (Mean)
LDV/SOF (Cohort 1)-4.18
SOF+RBV (Cohort 1)-4.34
LDV/SOF (Cohort 2)-4.24

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Change From Baseline in HCV RNA at Week 12

(NCT02738333)
Timeframe: Baseline; Week 12

Interventionlog10 IU/mL (Mean)
LDV/SOF (Cohort 1)-4.92
SOF+RBV (Cohort 1)-4.92
LDV/SOF (Cohort 2)-4.76

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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. (NCT02738333)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)97.2
SOF+RBV (Cohort 1)98.1
LDV/SOF (Cohort 2)96.0

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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. (NCT02738333)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)96.2
SOF+RBV (Cohort 1)95.4
LDV/SOF (Cohort 2)96.0

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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. (NCT02738333)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)96.2
SOF+RBV (Cohort 1)95.4
LDV/SOF (Cohort 2)96.0

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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." (NCT02738333)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)2.8
SOF+RBV (Cohort 1)3.7
LDV/SOF (Cohort 2)4.0

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Percentage of Participants With HCV RNA < LLOQ at Week 8

(NCT02738333)
Timeframe: Week 8

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)100.0
SOF+RBV (Cohort 1)100.0
LDV/SOF (Cohort 2)100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 6

(NCT02738333)
Timeframe: Week 6

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)99.0
SOF+RBV (Cohort 1)99.1
LDV/SOF (Cohort 2)100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 5

(NCT02738333)
Timeframe: Week 5

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)98.1
SOF+RBV (Cohort 1)99.1
LDV/SOF (Cohort 2)100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 4

(NCT02738333)
Timeframe: Week 4

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)98.1
SOF+RBV (Cohort 1)96.3
LDV/SOF (Cohort 2)100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 3

(NCT02738333)
Timeframe: Week 3

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)90.6
SOF+RBV (Cohort 1)90.7
LDV/SOF (Cohort 2)96.0

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Percentage of Participants With HCV RNA < LLOQ at Week 2

(NCT02738333)
Timeframe: Week 2

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)73.6
SOF+RBV (Cohort 1)76.6
LDV/SOF (Cohort 2)76.0

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Percentage of Participants With HCV RNA < LLOQ at Week 12

(NCT02738333)
Timeframe: Week 12

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)100.0
SOF+RBV (Cohort 1)100.0
LDV/SOF (Cohort 2)100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 10

(NCT02738333)
Timeframe: Week 10

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)100.0
SOF+RBV (Cohort 1)100.0
LDV/SOF (Cohort 2)100.0

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Percentage of Participants With HCV RNA < LLOQ at Week 1

(NCT02738333)
Timeframe: Week 1

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)24.5
SOF+RBV (Cohort 1)31.5
LDV/SOF (Cohort 2)32.0

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT02738333)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
LDV/SOF (Cohort 1)0.9
SOF+RBV (Cohort 1)1.9
LDV/SOF (Cohort 2)0

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Change From Baseline in HCV RNA at Week 8

(NCT02738333)
Timeframe: Baseline; Week 8

Interventionlog10 IU/mL (Mean)
LDV/SOF (Cohort 1)-4.92
SOF+RBV (Cohort 1)-4.93
LDV/SOF (Cohort 2)-4.76

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Change From Baseline in HCV RNA at Week 6

(NCT02738333)
Timeframe: Baseline; Week 6

Interventionlog10 IU/mL (Mean)
LDV/SOF (Cohort 1)-4.91
SOF+RBV (Cohort 1)-4.92
LDV/SOF (Cohort 2)-4.76

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Change From Baseline in HCV RNA at Week 5

(NCT02738333)
Timeframe: Baseline; Week 5

Interventionlog10 IU/mL (Mean)
LDV/SOF (Cohort 1)-4.91
SOF+RBV (Cohort 1)-4.92
LDV/SOF (Cohort 2)-4.76

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Change From Baseline in HCV RNA at Week 4

(NCT02738333)
Timeframe: Baseline; Week 4

Interventionlog10 IU/mL (Mean)
LDV/SOF (Cohort 1)-4.89
SOF+RBV (Cohort 1)-4.91
LDV/SOF (Cohort 2)-4.76

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Change From Baseline in HCV RNA at Week 3

(NCT02738333)
Timeframe: Baseline; Week 3

Interventionlog10 IU/mL (Mean)
LDV/SOF (Cohort 1)-4.87
SOF+RBV (Cohort 1)-4.89
LDV/SOF (Cohort 2)-4.75

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Change From Baseline in HCV RNA at Week 2

(NCT02738333)
Timeframe: Baseline; Week 2

Interventionlog10 IU/mL (Mean)
LDV/SOF (Cohort 1)-4.76
SOF+RBV (Cohort 1)-4.81
LDV/SOF (Cohort 2)-4.64

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Number of Participants Who Achieve End of Treatment Virologic Response (ETR) at Completion of Therapy.

Per protocol analysis. End of Treatment Virologic Response as measure by an undetectable HCV RNA level completion of therapy. (NCT02745535)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
SOF/VEL/VOX71

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Number of Participants Who Achieve Sustained Virologic Response (SVR) 12 Weeks After Completion of Therapy (SVR12)

Intention to treat (ITT) analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 12 weeks after completion of therapy. (NCT02745535)
Timeframe: Post-treatment week 12

InterventionParticipants (Count of Participants)
SOF/VEL/VOX70

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Number of Participants Who Achieve Sustained Virologic Response (SVR) 24 Weeks After Completion of Therapy.

Per protocol analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 24 weeks after completion of therapy. (NCT02745535)
Timeframe: Post-treatment week 24

InterventionParticipants (Count of Participants)
SOF/VEL/VOX70

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Number of Participants Who Achieve Sustained Virologic Response (SVR) 4 Weeks After Completion of Therapy.

Per protocol analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 4 weeks after completion of therapy. (NCT02745535)
Timeframe: Post-treatment week 4

InterventionParticipants (Count of Participants)
SOF/VEL/VOX70

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Number of Participants With Grade 3 and 4 Adverse Events

Number of participants with grade 3 and 4 adverse events during treatment with and/or within 30 of completion of SOF/VEL/VOX in HCV infected (NCT02745535)
Timeframe: up to 16 weeks

InterventionParticipants (Count of Participants)
SOF/VEL/VOX12

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Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR

Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR (NCT02759861)
Timeframe: 12 weeks after the end of Harvoni therapy

InterventionParticipants (Count of Participants)
F3/F48

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The Number of Subjects Who Achieve Negative RNA in Alcoholics

Sustained viral response in treatment -naive heavy alcohol drinking patients. (NCT02759861)
Timeframe: 12 weeks after the end of Harvoni therapy

InterventionParticipants (Count of Participants)
Harvoni x 8 or 12 Weeks14

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HCV RNA at Week 2

(NCT02781558)
Timeframe: Week 2

Interventionlog10 IU/mL (Mean)
SOF/VEL1.52
SOF/VEL + RBV1.47

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HCV RNA at Week 12

(NCT02781558)
Timeframe: Week 12

Interventionlog10 IU/mL (Mean)
SOF/VEL1.15
SOF/VEL + RBV1.15

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Change From Baseline in HCV RNA at Week 8

(NCT02781558)
Timeframe: Baseline; Week 8

Interventionlog10 IU/mL (Mean)
SOF/VEL-5.04
SOF/VEL + RBV-5.13

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Change From Baseline in HCV RNA at Week 4

(NCT02781558)
Timeframe: Baseline; Week 4

Interventionlog10 IU/mL (Mean)
SOF/VEL-4.96
SOF/VEL + RBV-5.09

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Change From Baseline in HCV RNA at Week 2

(NCT02781558)
Timeframe: Baseline; Week 2

Interventionlog10 IU/mL (Mean)
SOF/VEL-4.67
SOF/VEL + RBV-4.80

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Change From Baseline in HCV RNA at Week 12

(NCT02781558)
Timeframe: Baseline; Week 12

Interventionlog10 IU/mL (Mean)
SOF/VEL-5.04
SOF/VEL + RBV-5.13

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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 on 2 consecutive measurements 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:~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" (NCT02781558)
Timeframe: Up to Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL5.9
SOF/VEL + RBV1.9

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation 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. (NCT02781558)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL91.1
SOF/VEL + RBV96.1

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HCV RNA at Week 4

(NCT02781558)
Timeframe: Week 4

Interventionlog10 IU/mL (Mean)
SOF/VEL1.22
SOF/VEL + RBV1.19

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Percentage of Participants Who Have HCV RNA < LLOQ at Week 8

(NCT02781558)
Timeframe: Week 8

Interventionpercentage of participants (Number)
SOF/VEL99.0
SOF/VEL + RBV100.0

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Percentage of Participants Who Have HCV RNA < LLOQ at Week 4

(NCT02781558)
Timeframe: Week 4

Interventionpercentage of participants (Number)
SOF/VEL85.0
SOF/VEL + RBV90.3

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Percentage of Participants Who Have HCV RNA < LLOQ at Week 2

(NCT02781558)
Timeframe: Week 2

Interventionpercentage of participants (Number)
SOF/VEL51.0
SOF/VEL + RBV44.7

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Percentage of Participants Who Have HCV RNA < LLOQ at Week 12

(NCT02781558)
Timeframe: Week 12

Interventionpercentage of participants (Number)
SOF/VEL99.0
SOF/VEL + RBV100.0

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Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)

SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. (NCT02781558)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF/VEL93.1
SOF/VEL + RBV97.1

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HCV RNA at Week 8

(NCT02781558)
Timeframe: Week 8

Interventionlog10 IU/mL (Mean)
SOF/VEL1.15
SOF/VEL + RBV1.15

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Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event

(NCT02781558)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL1.0
SOF/VEL + RBV1.9

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Change From Baseline in HCV RNA at Week 4

(NCT02781571)
Timeframe: Baseline; Week 4

Interventionlog10 IU/mL (Mean)
SOF/VEL-5.13

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Change From Baseline in HCV RNA at Week 2

(NCT02781571)
Timeframe: Baseline; Week 2

Interventionlog10 IU/mL (Mean)
SOF/VEL-4.75

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Change From Baseline in HCV RNA at Week 12

(NCT02781571)
Timeframe: Baseline; Week 12

Interventionlog10 IU/mL (Mean)
SOF/VEL-5.22

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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 on 2 consecutive measurements 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 12 weeks of treatment)~Virologic 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" (NCT02781571)
Timeframe: Up to Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL2.5

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Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02781571)
Timeframe: Posttreatment Week 4

InterventionPercentage of participants (Number)
SOF/VEL97.5

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02781571)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL96.2

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Percentage of Participants With HCV RNA < LLOQ at Week 8

(NCT02781571)
Timeframe: Week 8

Interventionpercentage of participants (Number)
SOF/VEL98.7

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Percentage of Participants With HCV RNA < LLOQ at Week 4

(NCT02781571)
Timeframe: Week 4

Interventionpercentage of participants (Number)
SOF/VEL85.9

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Percentage of Participants With HCV RNA < LLOQ at Week 2

(NCT02781571)
Timeframe: Week 2

Interventionpercentage of participants (Number)
SOF/VEL40.5

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Percentage of Participants With HCV RNA < LLOQ at Week 12

(NCT02781571)
Timeframe: Week 12

Interventionpercentage of participants (Number)
SOF/VEL100.0

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Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event

(NCT02781571)
Timeframe: Up to 12 weeks

Interventionpercentage of participants (Number)
SOF/VEL1.3

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HCV RNA at Week 8

(NCT02781571)
Timeframe: Week 8

Interventionlog10 IU/mL (Mean)
SOF/VEL1.15

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HCV RNA at Week 4

(NCT02781571)
Timeframe: Week 4

Interventionlog10 IU/mL (Mean)
SOF/VEL1.23

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HCV RNA at Week 2

(NCT02781571)
Timeframe: Week 2

Interventionlog10 IU/mL (Mean)
SOF/VEL1.59

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HCV RNA at Week 12

(NCT02781571)
Timeframe: Week 12

Interventionlog10 IU/mL (Mean)
SOF/VEL1.15

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Change From Baseline in HCV RNA at Week 8

(NCT02781571)
Timeframe: Baseline; Week 8

Interventionlog10 IU/mL (Mean)
SOF/VEL-5.20

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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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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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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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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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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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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 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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 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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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 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 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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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 16

(NCT02822794)
Timeframe: Week 16

Interventionpercentage of participants (Number)
SOF/VEL+RBV 24 Weeks100.0

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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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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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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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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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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 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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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 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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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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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 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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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 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 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 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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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 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 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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Response in Patients With Mixed Cryoglobulinemia (MC)

Response to medication in patients with MC categorized as either complete response (100% response) vs partial response (50% response). (NCT02825212)
Timeframe: up to 24 weeks after treatment

InterventionParticipants (Count of Participants)
Partial ResponseComplete ResponseNo Response
Pts With Hep C Virus Infection-Related Cryoglobulinemia901

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Sustained Virologic Response (SVR)

Number of participants who attain SVR, ie, cleared HCV (NCT02825212)
Timeframe: 2-4 weeks and 24 weeks after treatment

InterventionParticipants (Count of Participants)
2-4 weeks after treatment24 weeks after treatment
Pts With Hep C Virus Infection-Related Cryoglobulinemia1010

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Number of Subjects With Sustained Virologic Response (SVR) 4

The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 4 weeks after completing treatment. (NCT02858180)
Timeframe: 4 weeks after completing treatment

InterventionParticipants (Count of Participants)
Heart Failure Cohort8
Lung Disease Cohort3

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Number of Subjects With Sustained Virologic Response (SVR) 12

The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 12 weeks after completing therapy. (NCT02858180)
Timeframe: 12 weeks after completing treatment

InterventionParticipants (Count of Participants)
Heart Failure Cohort10
Lung Disease Cohort3

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Number of Subjects Who Completed 24 Weeks of Therapy

The primary safety endpoint is the number of subjects who complete a full course of therapy. (NCT02858180)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Heart Failure Cohort0
Lung Disease Cohort1

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Discontinuation for Adverse Events and Serious Adverse Events

Assessment for discontinuation due to adverse events and serious adverse events, as addressed by adverse events and laboratory tests. Final study visit is 12 weeks after treatment. (NCT02858180)
Timeframe: 12 weeks after completing treatment

InterventionParticipants (Count of Participants)
Heart Failure Cohort0
Lung Disease Cohort0

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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

(NCT02868242)
Timeframe: First dose date up to Week 12

Interventionpercentage of participants (Number)
LDV/SOF0

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Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02868242)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF100.0

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Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02868242)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
LDV/SOF100.0

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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" (NCT02868242)
Timeframe: Baseline to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF0

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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, 50 IU/mL) at 12 weeks after stopping study treatment. (NCT02868242)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF100.0

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HCV RNA Change From Baseline/Day 1

(NCT02868242)
Timeframe: Baseline; Weeks 1, 4, 8, and 12

Interventionlog10 IU/mL (Mean)
Change at Week 1Change at Week 4Change at Week 8Change at Week 12
LDV/SOF-3.34-3.62-3.36-3.62

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Percentage of Participants With HCV RNA < LLOQ While on Treatment

(NCT02868242)
Timeframe: Weeks 1, 4, 8, and 12

Interventionpercentage of participants (Number)
Week 1Week 4Week 8Week 12
LDV/SOF89.5100.094.7100.0

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Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.

"The HCV RNA levels (viral burden) from each infected hepatocytes were measured using Quantitative Real-Time Polymerase Chain Reaction (PCR) from each participants at pre-treatment and post-treatment.~The level of HCV RNA (viral burden) decline were reported from intracellular hepatocytes and compared to those treated with Sofosbuvir/Velpatasvir (SOF/VEL) vs Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) and between HCV mono infection and HIV/HCV co infection groups." (NCT02938013)
Timeframe: Pre-treatment, after first week

,,
InterventionInternational unit (IU) per hepatocyte (Median)
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Pre treatParticipant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Post treatParticipant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)Pre treatParticipant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)Post treatParticipant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)Pre treatParticipant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)Post treatParticipant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)Pre treatParticipant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)Post treatParticipant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)Pre treatParticipant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)Post treat
Group A8.6120.9119.74010.3514.7629.259.1515.314.55
Group B7.572.8311.0412.9327.189.253.4502.362.27
Group C32.737.818.368.163015.7214.2505.494.09

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Reduction Over the First Week in Plasma HCV RNA

"During one week after treatment with direct-acting antivirals, the decline from the baseline plasma HCV RNA levels observed for each individual participant using HCV Quantitative real time PCR.~The level of HCV RNA decline compared to those treated with Sofosbuvir/Velpatasvir (SOF/VEL) vs Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) and between HCV mono infection and HIV/HCV co infection groups." (NCT02938013)
Timeframe: Pre-treatment, up to 1 week

,,
InterventionIU/ml (Median)
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C)Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)
Group A631217.751029.756617.52506.5
Group B2240884.751348500551.5627.5
Group C14817.5635.55327.56507512992.5

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Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy

"Estimate the total number of HCV-infected Hepatocytes (virus burden) for each participant between pre-treatment liver biopsy and post treatment liver biopsy samples using HCV Quantitative real time PCR.~Comparison of total number of HCV-infected Hepatocytes (virus burden) were reported between HCV mono infection and co infection groups." (NCT02938013)
Timeframe: Pre-treatment, Day 7

,,
InterventionHepatocytes (Number)
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C)pre treaParticipant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C)pos treaParticipant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)pre treaParticipant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)pos treaParticipant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)pretreatParticipant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)postreatParticipant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)pre treaParticipant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)pos treaParticipant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)pretreParticipant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)postre
Group A452530182109312618
Group B165111212924141
Group C2907333216241307412

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Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).

"Total number of hepatocytes that express interferon-stimulated genes (ISGs) were estimated using Quantitative real time PCR for each participant on pre-treatment and post treatment liver biopsy samples.~Comparison of total number of hepatocytes that express interferon-stimulated genes (ISGs) were reported between HCV mono infection and co infection groups." (NCT02938013)
Timeframe: Pre-treatment, up to 1 week

,,
InterventionISG positive hepatocytes (Number)
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Pre TreatmentParticipant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Post TreatmentParticipant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C) Pre TreatmentParticipant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C) Post TreatmentParticipant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C) Pre TreatmentParticipant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C) Post TreatmentParticipant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C) Pre TreatmentParticipant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C) Post TreatmentParticipant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C) Pre TreatmentParticipant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C) Post Treatment
Group A1485762788371717972
Group B71683624664649276766
Group C41683940555736633442

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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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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 HCV RNA < LLOQ While on Study Treatment

(NCT02994056)
Timeframe: Weeks 2, 4, 8, and 12

,,,
InterventionPercentage of participants (Number)
Week 2Week 4Week 8Week 12
SOF/VEL+ RBV (GT-1)38.9100.0100.0100.0
SOF/VEL+ RBV (GT-2)075.0100.0100.0
SOF/VEL+ RBV (GT-3)71.4100.0100.0100.0
SOF/VEL+ RBV (Total)43.896.6100.0100.0

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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." (NCT02994056)
Timeframe: Baseline to Posttreatment Week 24

Interventionpercentage of participants (Number)
Decrease (Improvement)No ChangeIncrease (Worsening)
SOF/VEL+ RBV52.621.126.3

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Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event

(NCT02994056)
Timeframe: First dose date up to Week 12

Interventionpercentage of participants (Number)
Discontinuation of SOF/VELDiscontinuation of RBV
SOF/VEL+ RBV6.321.9

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Absolute HCV RNA Level Through Week 12

(NCT02994056)
Timeframe: Baseline; Weeks 2, 4, 8, and 12

,,,
Interventionlog10 IU/mL (Mean)
BaselineWeek 2Week 4Week 8Week 12
SOF/VEL+ RBV (GT-1)5.461.471.151.151.15
SOF/VEL+ RBV (GT-2)6.011.631.151.151.15
SOF/VEL+ RBV (GT-3)4.841.431.151.151.15
SOF/VEL+ RBV (Total)5.171.461.151.151.15

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Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment. (NCT02994056)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF/VEL+ RBV (Total)87.5
SOF/VEL+ RBV (GT-1)88.9
SOF/VEL+ RBV (GT-2)80.0
SOF/VEL+ RBV (GT-3)85.7

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Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02994056)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL+ RBV (Total)75.0
SOF/VEL+ RBV (GT-1)72.2
SOF/VEL+ RBV (GT-2)80.0
SOF/VEL+ RBV (GT-3)71.4

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Number 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" (NCT02994056)
Timeframe: Baseline up to Posttreatment Week 24

InterventionParticipants (Count of Participants)
SOF/VEL+ RBV (GT-1)0
SOF/VEL+ RBV (GT-2)0
SOF/VEL+ RBV (GT-3)1
SOF/VEL+ RBV (Total)1

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Change From Baseline in HCV RNA

(NCT02994056)
Timeframe: Baseline; Weeks 2, 4, 8, and 12

,,,
Interventionlog10 IU/mL (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12
SOF/VEL+ RBV (GT-1)-4.06-4.39-4.39-4.39
SOF/VEL+ RBV (GT-2)-4.50-4.88-4.72-4.72
SOF/VEL+ RBV (GT-3)-3.41-3.70-3.70-3.70
SOF/VEL+ RBV (Total)-3.72-3.99-4.00-4.00

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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. (NCT02994056)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL+ RBV (Total)78.1
SOF/VEL+ RBV (GT-1)72.2
SOF/VEL+ RBV (GT-2)80.0
SOF/VEL+ RBV (GT-3)85.7

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Percentage of Participants With No Change, 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. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24. (NCT02994056)
Timeframe: Baseline to Posttreatment Week 24

InterventionPercentage of participants (Number)
Improved CPT ClassWorsened CPT ClassNo Change CPT Class
SOF/VEL+ RBV42.1057.9

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Treatment Phase: 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. (NCT03022981)
Timeframe: Up to Posttreatment Week 24

Interventionpercentage of participants (Number)
12 to < 18 Years Old1.0
6 to < 12 Years Old1.4
3 to < 6 Years Old0.0

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Treatment Phase: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. (NCT03022981)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
12 to < 18 Years Old96.1
6 to < 12 Years Old94.5
3 to < 6 Years Old82.9

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Treatment Phase: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR 24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. (NCT03022981)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
12 to < 18 Years Old95.1
6 to < 12 Years Old93.2
3 to < 6 Years Old82.9

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Treatment Phase: 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, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT03022981)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
12 to < 18 Years Old95.1
6 to < 12 Years Old93.2
3 to < 6 Years Old82.9

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Treatment Phase: Percentage of Participants Who Discontinued Study Drug Due to Any Treatment-Emergent Adverse Event (TEAE)

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug. (NCT03022981)
Timeframe: From first dose through last dose of the study drug (Up to 12 weeks) plus 30 days

Interventionpercentage of participants (Number)
12 to < 18 Years Old0.0
6 to < 12 Years Old2.7
3 to < 6 Years Old2.4

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Treatment Phase: Growth and Development as Measured by Parental Height

Mid-parental height was calculated as the average of the biological father's and mother's heights. For boys, the sex-adjusted mid-parental height was calculated by adding 2.5 inches or 6.5 cm to the mean of the parents' heights. For girls, 2.5 inches or 6.5 cm was subtracted from the mean of the parents' heights. (NCT03022981)
Timeframe: Day 1

Interventioncm (Median)
12 to < 18 Years Old170.5
6 to < 12 Years Old170.0
3 to < 6 Years Old168.7

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PK Lead-in Phase: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT03022981)
Timeframe: First dose date up to Day 7

Interventionpercentage of participants (Number)
12 to < 18 Years Old0.0
6 to < 12 Years Old0.0
3 to < 6 Years Old0.0

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PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Velpatasvir (VEL)

AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). (NCT03022981)
Timeframe: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose

Interventionhours*nanograms per milliliter (h*ng/mL) (Mean)
12 to < 18 Years Old4479.3
6 to < 12 Years Old3697.5
3 to < 6 Years Old4450.3

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PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Sofosbuvir (SOF)

AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval). (NCT03022981)
Timeframe: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose

Interventionh*ng/mL (Mean)
12 to < 18 Years Old3020.1
6 to < 12 Years Old1764.5
Cohort 3 (3 to < 6 Years Old)3306.2

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PK Lead-in Phase: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval 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). (NCT03022981)
Timeframe: Day 7: 0 (predose), 0.5, 1, 2, 3, 4, 6 (Cohorts 1 and 2 only), 8, and 12 hours postdose

Interventionh*ng/mL (Mean)
12 to < 18 Years Old13852.9
6 to < 12 Years Old9913.8
3 to < 6 Years Old11604.0

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Treatment Phase: Percentage of Participants With HCV RNA < LLOQ On Treatment

Percentage of participants with HCV RNA < LLOQ while on treatment by analysis visit. (NCT03022981)
Timeframe: Weeks 1, 4, 8, and 12

,,
Interventionpercentage of participants (Number)
Week 1Week 4Week 8Week 12
12 to < 18 Years Old44.196.1100.0100.0
3 to < 6 Years Old36.891.4100.0100.0
6 to < 12 Years Old39.794.498.698.6

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Treatment Phase: Swallowability of SOF/VEL as Assessed by the Participant's Ability to Swallow SOF/VEL Placebo Tablets at Baseline

A SOF/VEL FDC swallowability assessment was performed using placebo tablets at baseline. (NCT03022981)
Timeframe: Baseline

,
InterventionParticipants (Count of Participants)
SOF/VEL 400/100mg Placebo Tablet, Able to SwallowSOF/VEL 400/100mg Placebo, Not Able to SwallowSOF/VEL 200/50mg Placebo, Able to SwallowSOF/VEL 200/50mg Placebo, Not Able to Swallow
12 to < 18 Years Old9210100
6 to < 12 Years Old10721

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Treatment Phase: Quality of Life (QoL) and Neuropsychiatric Assessments as Measured by PedsQL™ Pediatric QoL Survey

To evaluate the effect of treatment with SOF/VEL on general and disease-specific health-related QoL, the PedsQL™ Pediatric QoL Inventory V4.0 Short Form (SF15) was completed at Day 1, end of treatment, early termination (if applicable), and posttreatment Weeks 12 and 24. The SF15 questionnaire represented 4 domains: physical, emotional, social, and school functioning, with the emotional, social, and school functioning domains representing the psychosocial health summary. Neuropsychiatric assessment was conducted using the PedsQL™ Pediatric QoL Inventory V4.0 SF15 psychosocial domain-related scores. Items were calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better QoL. (NCT03022981)
Timeframe: Baseline; Week 12, End of Treatment (EOT), Posttreatment/Follow-up (FU) Week-12 (FU-12), and FU Week-24 (FU-24)

,,
Interventionscore on a scale (Mean)
Parents Reports, Total Score at BaselineParents Reports, Total Score at Week 12Parents Reports, Total Score at EOTParents Reports, Total Score at Follow Up-12Parents Reports, Total Score at Follow Up-24Participants Reports, Total Score at BaselineParticipants Reports, Total Score at Week 12Participants Reports, Total Score at EOTParticipants Reports, Total Score at Follow Up-12Participants Reports, Total Score at Follow Up-24
12 to < 18 Years Old80.082.482.481.780.879.980.980.982.581.4
3 to < 6 Years Old86.587.387.087.788.382.283.383.380.582.1
6 to < 12 Years Old79.782.882.281.579.777.980.079.781.181.7

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Treatment Phase: Percentage of Participants Who Develop Viral Resistance to SOF and/or VEL During Treatment and After Discontinuation of Treatment

Drug-resistant substitutions were analyzed as part of the Virology Study. Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline deep sequencing of the HCV nonstructural protein (NS)5A and NS5B genes was performed for all participants at the first time point after virologic failure if the plasma or serum sample was available. Pretreatment full-length NS5A deep sequencing data were obtained at a 15% assay cutoff for the Resistance Analysis Population which covered all NS5A and NS5B nucleoside inhibitor (NI) resistance-associated variants (RAVs). (NCT03022981)
Timeframe: First dose date up to Posttreatment Week 24

,,
Interventionpercentage of participants (Number)
Pretreatment NS5A NI RAVsPretreatment NS5B NI RAVs
12 to < 18 Years Old16.35.1
3 to < 6 Years Old18.13.0
6 to < 12 Years Old10.20.0

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Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Week 12

Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability. (NCT03022981)
Timeframe: Week 12

,,,,,
InterventionParticipants (Count of Participants)
Taste, Participants Who Did Not Taste Study DrugTaste, Participants Who Marked > 60 to 100Taste, Participants Who Marked 40 to 60Taste, Participants Who Marked 0 to < 40Easy to Take, Participants Who Marked > 60 to 100Easy to Take, Participants Who Marked 40 to 60Easy to Take, Participants Who Marked 0 to < 40Feel About Taking Pills, Who Marked > 60 to 100Feel About Taking Pills, Who Marked 40 to 60Feel About Taking Pills, Who Marked 0 to < 40
12 to < 18 Years Old492410783338233
12 to <18 Years Old2513902812
3 to < 6 Years Old84472012NANANA
3 to <6 Years Old2132611NANANA
6 to < 12 Years Old3314121165506073
6 to <12 Years Old0010100NANANA

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Treatment Phase: Number of Participants With Acceptability of SOF/VEL as Measured by a Questionnaire to Assess Acceptability, Including Palatability at Day 1

Acceptability was assessed by numeric response marked on line between numbers 0 - 100. Higher scores indicate better acceptability and/or palatability. (NCT03022981)
Timeframe: Day 1

,,,,,
InterventionParticipants (Count of Participants)
Taste, Participants Who Did Not Taste Study DrugTaste, Participants Who Marked > 60 to 100Taste, Participants Who Marked 40 to 60Taste, Participants Who Marked 0 to < 40Easy to Take, Participants Who Marked > 60 to 100Easy to Take, Participants Who Marked 40 to 60Easy to Take, Participants Who Marked 0 to < 40
12 to < 18 Years Old61161138252
12 to <18 Years Old5312911
3 to < 6 Years Old864913410
3 to <6 Years Old5313426
6 to < 12 Years Old42116126038
6 to <12 Years Old0001001

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Treatment Phase: Changes in Growth and Development as Measured by Tanner Stage Assessment From Baseline

Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages were used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes and penis, 3: Enlargement of penis, 4: Penis size enlargement, 5: Genitalia adult in size and shape). (NCT03022981)
Timeframe: Baseline; EOT, FU-12 and FU-24

,,
InterventionParticipants (Count of Participants)
Pubic Hair (Male): Baseline, Stage 1Pubic Hair (Male): Baseline, Stage 2Pubic Hair (Male): Baseline, Stage 3Pubic Hair (Male): Baseline, Stage 4Pubic Hair (Male): Baseline, Stage 5Pubic Hair (Male): EOT, Stage 1Pubic Hair (Male): EOT, Stage 2Pubic Hair (Male): EOT, Stage 3Pubic Hair (Male): EOT, Stage 4Pubic Hair (Male): EOT, Stage 5Pubic Hair (Male): FU-12, Stage 1Pubic Hair (Male): FU-12, Stage 2Pubic Hair (Male): FU-12, Stage 3Pubic Hair (Male): FU-12, Stage 4Pubic Hair (Male): FU-12, Stage 5Pubic Hair (Male): FU-24, Stage 1Pubic Hair (Male): FU-24, Stage 2Pubic Hair (Male): FU-24, Stage 3Pubic Hair (Male): FU-24, Stage 4Pubic Hair (Male): FU-24, Stage 5Genitalia (Male): Baseline, Stage 1Genitalia (Male): Baseline, Stage 2Genitalia (Male): Baseline, Stage 3Genitalia (Male): Baseline, Stage 4Genitalia (Male): Baseline, Stage 5Genitalia (Male): EOT, Stage 1Genitalia (Male): EOT, Stage 2Genitalia (Male): EOT, Stage 3Genitalia (Male): EOT, Stage 4Genitalia (Male): EOT, Stage 5Genitalia (Male): FU-12, Stage 1Genitalia (Male): FU-12, Stage 2Genitalia (Male): FU-12, Stage 3Genitalia (Male): FU-12, Stage 4Genitalia (Male): FU-12, Stage 5Genitalia (Male): FU-24, Stage 1Genitalia (Male): FU-24, Stage 2Genitalia (Male): FU-24, Stage 3Genitalia (Male): FU-24, Stage 4Genitalia (Male): FU-24, Stage 5Pubic Hair (Female): Baseline, Stage 1Pubic Hair (Female): Baseline, Stage 2Pubic Hair (Female): Baseline, Stage 3Pubic Hair (Female): Baseline, Stage 4Pubic Hair (Female): Baseline, Stage 5Pubic Hair (Female): EOT, Stage 1Pubic Hair (Female): EOT, Stage 2Pubic Hair (Female): EOT, Stage 3Pubic Hair (Female): EOT, Stage 4Pubic Hair (Female): EOT, Stage 5Pubic Hair (Female): FU-12, Stage 1Pubic Hair (Female): FU-12, Stage 2Pubic Hair (Female): FU-12, Stage 3Pubic Hair (Female): FU-12, Stage 4Pubic Hair (Female): FU-12, Stage 5Pubic Hair (Female): FU-24, Stage 1Pubic Hair (Female): FU-24, Stage 2Pubic Hair (Female): FU-24, Stage 3Pubic Hair (Female): FU-24, Stage 4Pubic Hair (Female): FU-24, Stage 5Breasts (Female): Baseline, Stage 1Breasts (Female): Baseline, Stage 2Breasts (Female): Baseline, Stage 3Breasts (Female): Baseline, Stage 4Breasts (Female): Baseline, Stage 5Breasts (Female): EOT, Stage 1Breasts (Female): EOT, Stage 2Breasts (Female): EOT, Stage 3Breasts (Female): EOT, Stage 4Breasts (Female): EOT, Stage 5Breasts (Female): FU-12, Stage 1Breasts (Female): FU-12, Stage 2Breasts (Female): FU-12, Stage 3Breasts (Female): FU-12, Stage 4Breasts (Female): FU-12, Stage 5Breasts (Female): FU-24, Stage 1Breasts (Female): FU-24, Stage 2Breasts (Female): FU-24, Stage 3Breasts (Female): FU-24, Stage 4Breasts (Female): FU-24, Stage 5
12 to < 18 Years Old431014192471324156102514213254381619237152314711241241325239162222610302188322089311561723126142712515281061330
3 to < 6 Years Old170000130000140000140000170000130000140000140000240000210000210000201000240000210000210000201000
6 to < 12 Years Old31210028310026310029210031210028310026310027410031520029521024731024614029630025921020112202010320

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Treatment Phase: Change From Baseline in HCV RNA at Weeks 1, 4, 8, and 12

(NCT03022981)
Timeframe: Baseline; Weeks 1, 4, 8, and 12

,,
Interventionlog10 IU/mL (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 12
12 to < 18 Years Old6.06-4.46-4.89-4.91-4.91
3 to < 6 Years Old5.86-4.06-4.49-4.56-4.56
6 to < 12 Years Old5.87-4.28-4.64-4.69-4.70

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Treatment Phase: Change From Baseline in Growth and Development as Measured by Weight Percentiles

An age- and sex-specific percentile was derived for each weight, height, and BMI measurement according to the SAS program available on the CDC website using the year 2000 growth charts. (NCT03022981)
Timeframe: Baseline; Weeks 1, 4, 8, 12, FU-4, FU-12, and FU-24

,,
Interventionpercentile (Median)
BaselineChange From Baseline at Week 1Change From Baseline at Week 4Change From Baseline at Week 8Change From Baseline at Week 12Change From Baseline at FU-4Change From Baseline at FU-12Change From Baseline at FU-24
12 to < 18 Years Old67.20.00.00.00.20.10.00.1
3 to < 6 Years Old64.6-0.50.30.2-1.7-0.8-0.8-1.3
6 to < 12 Years Old45.90.10.20.10.50.00.51.4

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Treatment Phase: Change From Baseline in Growth and Development as Measured by Height Percentiles

An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts. (NCT03022981)
Timeframe: Baseline; Weeks 1, 4, 8, 12, Follow-up (FU) Week 4 (FU-4), FU-12, and FU-24

,,
Interventionpercentile (Median)
BaselineChange From Baseline at Week 1Change From Baseline at Week 4Change From Baseline at Week 8Change From Baseline at Week 12Change From Baseline at FU-4Change From Baseline at FU-12Change From Baseline at FU-24
12 to < 18 Years Old44.50.00.00.0-0.10.0-0.2-0.6
3 to < 6 Years Old39.30.51.40.30.21.20.60.3
6 to < 12 Years Old41.90.10.2-0.10.20.20.1-0.2

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Treatment Phase: Change From Baseline in Growth and Development as Measured by Bone Age

Bone age was determined based on x-ray of the left wrist, hand, and fingers. Baseline value is the last available value on or prior to first dose date of study drug. (NCT03022981)
Timeframe: Baseline; FU-24

,,
Interventionyears (Median)
BaselineChange From Baseline at FU-24
12 to < 18 Years Old15.50.6
3 to < 6 Years Old4.80.5
6 to < 12 Years Old7.81.0

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PK Lead-in Phase: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 7

(NCT03022981)
Timeframe: Baseline; Day 7

,,
Interventionlog10 international units per mL (IU/mL) (Mean)
BaselineChange from Baseline at Day 7
12 to < 18 Years Old6.09-4.48
3 to < 6 Years Old5.77-3.94
6 to < 12 Years Old5.84-4.20

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PK Parameter: AUCtau of SOF

AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

Interventionh*ng/mL (Mean)
LDV/SOF for 8 Weeks2435.4
LDV/SOF for 12 Weeks2296.6
LDV/SOF for 24 Weeks2838.2

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PK Parameter: Cmax of SOF

Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

Interventionng/mL (Mean)
LDV/SOF for 8 Weeks1059.8
LDV/SOF for 12 Weeks1005.8
LDV/SOF for 24 Weeks1052.5

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HCV RNA

(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24

Interventionlog10 IU/mL (Mean)
Week 2Week 4Week 6Week 8Week 12
LDV/SOF for 12 Weeks1.221.151.151.151.15

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HCV RNA

(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24

Interventionlog10 IU/mL (Mean)
Week 2Week 4Week 6Week 8Week 12Week 16Week 20Week 24
LDV/SOF for 24 Weeks1.181.151.151.151.151.151.151.15

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Percentage of Participants With HCV RNA < LLOQ on Treatment

"The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA < LLOQ detected plus the number of participants with HCV RNA < LLOQ target not detected (TND). LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method." (NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24

Interventionpercentage of participants (Number)
Week 2Week 4Week 6Week 8
LDV/SOF for 8 Weeks84.4100.0100.0100.0

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Percentage of Participants With HCV RNA < LLOQ on Treatment

"The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA < LLOQ detected plus the number of participants with HCV RNA < LLOQ target not detected (TND). LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method." (NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24

Interventionpercentage of participants (Number)
Week 2Week 4Week 6Week 8Week 12
LDV/SOF for 12 Weeks90.3100.0100.0100.0100.0

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Percentage of Participants With HCV RNA < LLOQ on Treatment

"The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA < LLOQ detected plus the number of participants with HCV RNA < LLOQ target not detected (TND). LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method." (NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24

Interventionpercentage of participants (Number)
Week 2Week 4Week 6Week 8Week 12Week 16Week 20Week 24
LDV/SOF for 24 Weeks84.2100.094.7100.0100.0100.0100.0100.0

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Change From Baseline in HCV RNA

(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24

Interventionlog10 IU/mL (Mean)
Change at Week 2Change at Week 4Change at Week 6Change at Week 8
LDV/SOF for 8 Weeks-4.63-4.61-4.61-4.61

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Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

(NCT03036839)
Timeframe: First dose date up to Week 24

Interventionpercentage of participants (Number)
LDV/SOF for 8 Weeks0
LDV/SOF for 12 Weeks0
LDV/SOF for 24 Weeks0

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Change From Baseline in HCV RNA

(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24

Interventionlog10 IU/mL (Mean)
Change at Week 2Change at Week 4Change at Week 6Change at Week 8Change at Week 12
LDV/SOF for 12 Weeks-4.71-4.79-4.79-4.79-4.79

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Change From Baseline in HCV RNA

(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24

Interventionlog10 IU/mL (Mean)
Change at Week 2Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
LDV/SOF for 24 Weeks-4.67-4.71-4.81-4.81-4.79-4.79-4.79-4.75

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Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. (NCT03036839)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
LDV/SOF for 8 Weeks97.8
LDV/SOF for 12 Weeks100.0
LDV/SOF for 24 Weeks84.2

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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method. (NCT03036839)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
LDV/SOF for 8 Weeks93.3
LDV/SOF for 12 Weeks100.0
LDV/SOF for 24 Weeks84.2

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Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. (NCT03036839)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF for 8 Weeks93.3
LDV/SOF for 12 Weeks100.0
LDV/SOF for 24 Weeks84.2

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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." (NCT03036839)
Timeframe: Baseline up to Posttreatment Week 24

Interventionpercentage of participants (Number)
LDV/SOF for 8 Weeks0
LDV/SOF for 12 Weeks0
LDV/SOF for 24 Weeks0

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Pharmacokinetics (PK) Parameter: AUCtau of LDV

AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

Interventionh*ng/mL (Mean)
LDV/SOF for 8 Weeks11923.9
LDV/SOF for 12 Weeks13632.7
LDV/SOF for 24 Weeks13542.5

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PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)

AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

Interventionh*ng/mL (Mean)
LDV/SOF for 8 Weeks234980.1
LDV/SOF for 12 Weeks269050.3
LDV/SOF for 24 Weeks280829.5

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HCV RNA

(NCT03036839)
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24

Interventionlog10 IU/mL (Mean)
Week 2Week 4Week 6Week 8
LDV/SOF for 8 Weeks1.171.151.151.15

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PK Parameter: Cmax of GS-331007 (Metabolite of SOF)

Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

Interventionng/mL (Mean)
LDV/SOF for 8 Weeks9956.3
LDV/SOF for 12 Weeks11392.7
LDV/SOF for 24 Weeks11882.4

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PK Parameter: Cmax of LDV

Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036839)
Timeframe: Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

Interventionng/mL (Mean)
LDV/SOF for 8 Weeks544.2
LDV/SOF for 12 Weeks618.4
LDV/SOF for 24 Weeks607.0

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Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment

Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL. (NCT03036852)
Timeframe: First dose date up to Posttreatment Week 24

InterventionParticipants (Count of Participants)
SOF/VEL0

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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" (NCT03036852)
Timeframe: Baseline to Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL (Total)3.4
SOF/VEL (GT-1)4.0
SOF/VEL (GT-2)0
SOF/VEL (GT-3)6.3
SOF/VEL (GT-4)0
SOF/VEL (GT-6)0
SOF/VEL (Indeterminate)0

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Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment. (NCT03036852)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF/VEL (Total)96.6
SOF/VEL (GT-1)96.0
SOF/VEL (GT-2)100.0
SOF/VEL (GT-3)93.8
SOF/VEL (GT-4)100.0
SOF/VEL (GT-6)100.0
SOF/VEL (Indeterminate)100.0

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Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment. (NCT03036852)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL (Total)94.9
SOF/VEL (GT-1)92.0
SOF/VEL (GT-2)100.0
SOF/VEL (GT-3)93.8
SOF/VEL (GT-4)100.0
SOF/VEL (GT-6)100.0
SOF/VEL (Indeterminate)100.0

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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, 15 IU/mL) 12 weeks after stopping the study treatment. (NCT03036852)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL (Total)94.9
SOF/VEL (GT-1)92.0
SOF/VEL (GT-2)100.0
SOF/VEL (GT-3)93.8
SOF/VEL (GT-4)100.0
SOF/VEL (GT-6)100.0
SOF/VEL (Indeterminate)100.0

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PK Parameter: Cmax of SOF

Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))

Interventionng/mL (Mean)
SOF/VEL1041.0

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PK Parameter: Cmax of VEL

Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))

Interventionng/mL (Mean)
SOF/VEL226.9

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PK Parameter: Ctau of VEL

Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))

Interventionng/mL (Mean)
SOF/VEL137.2

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Change From Baseline in HCV RNA

(NCT03036852)
Timeframe: Baseline; Weeks 2, 4, 6, 8, and 12

,,,,,,
Interventionlog10 IU/mL (Mean)
Change at Week 2Change at Week 4Change at Week 6Change at Week 8Change at Week 12
SOF/VEL (GT-1)-4.69-4.81-4.81-4.81-4.81
SOF/VEL (GT-2)-3.78-4.05-4.05-4.05-4.05
SOF/VEL (GT-3)-5.07-5.20-5.20-5.20-5.20
SOF/VEL (GT-4)-4.23-4.48-4.48-4.48-4.48
SOF/VEL (GT-6)-5.29-5.29-5.29-5.29-5.29
SOF/VEL (Indeterminate)-3.24-3.26-3.26-3.26-3.26
SOF/VEL (Total)-4.54-4.69-4.69-4.69-4.69

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Percentage of Participants With HCV RNA < LLOQ on Treatment

(NCT03036852)
Timeframe: Weeks 2, 4, 6, 8, and 12

,,,,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 6Week 8Week 12
SOF/VEL (GT-1)76.0100.0100.0100.0100.0
SOF/VEL (GT-2)85.7100.0100.0100.0100.0
SOF/VEL (GT-3)43.8100.0100.0100.0100.0
SOF/VEL (GT-4)50.0100.0100.0100.0100.0
SOF/VEL (GT-6)100.0100.0100.0100.0100.0
SOF/VEL (Indeterminate)80.0100.0100.0100.0100.0
SOF/VEL (Total)67.8100.0100.0100.0100.0

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Pharmacokinetic (PK) Parameter: AUCtau of SOF

AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))

Interventionh*ng/mL (Mean)
SOF/VEL2381.9

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PK Parameter: AUCtau of VEL

AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))

Interventionh*ng/mL (Mean)
SOF/VEL4279.4

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PK Parameter: Cmax of GS-331007 (Metabolite of SOF)

Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))

Interventionng/mL (Mean)
SOF/VEL9776.2

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Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event

(NCT03036852)
Timeframe: First dose date up to Week 12

Interventionpercentage of participants (Number)
SOF/VEL0

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PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)

AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))

Interventionh*ng/mL (Mean)
SOF/VEL230989.2

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Number of Participants Achieving Sustained Virologic Response (SVR)

Number of participants with non-detectable Hepatitis C Virus (HCV) Ribonucleic acid (RNA) post-treatment as measured by SVR testing (NCT03057847)
Timeframe: End of treatment (12 weeks postpartum) up to 18 months

InterventionParticipants (Count of Participants)
SOF/VEL13

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Number of Missed Treatment Doses

Treatment adherence assessed by missed treatment doses (NCT03057847)
Timeframe: End of treatment (12 weeks postpartum)

Interventiondoses (Median)
SOF/VEL2

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Number of Participants Reporting Treatment Side Effects

Number of participants reporting treatment side effects using standardized list (NCT03057847)
Timeframe: End of treatment (12 weeks postpartum)

InterventionParticipants (Count of Participants)
SOF/VEL12

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Intravenous Drug Use Recidivism

Rate of intravenous drug use recidivism by participant self-report and Urine Drug Screening (NCT03057847)
Timeframe: 15 months post-treatment, up to 18 months

InterventionParticipants (Count of Participants)
SOF/VEL3

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Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment

Number of participants initiating HCV treatment (NCT03057847)
Timeframe: Delivery to 10 months postpartum

InterventionParticipants (Count of Participants)
SOF/VEL21

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HCV Reinfection

Count of participants 15 months post-treatment with Hepatitis C Virus reinfection as measured by related lab tests (NCT03057847)
Timeframe: 15 months post-treatment

InterventionParticipants (Count of Participants)
SOF/VEL0

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Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

(NCT03074331)
Timeframe: Up to Week 12

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks0

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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. (NCT03074331)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks93.0

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as the following:~On Treatment Virologic Failure: HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (nonresponse), or~Relapse: HCV RNA ≥ LLOQ at Posttreatment Week 12 having achieved HCV RNA < LLOQ at end of treatment." (NCT03074331)
Timeframe: Up to Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL 12 Weeks2.3

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Number of Participants With Resolution of Active PCT by 7 Months After Start of Therapy

Resolution of active PCT, defined as normalization of plasma porphyrins (less than 0.9 mcg/dL) by 7 months after start of therapy (NCT03118674)
Timeframe: 7 months

InterventionParticipants (Count of Participants)
Harvoni9

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Number of Participants With Complete Biochemical Remission of PCT

Defined as a decrease of the sum of urinary uro- and hepta-carboxyl porphyrins to less than 100 mcg/g creatinine and a normal urine porphyrin HPLC pattern defined as the total of highly carboxylated porphyrins (uro- and heptacarboxyl-porphyrins) being less than that of coproporphyrins, and the absence of a plasma fluorescence peak by fluorescence scanning (NCT03118674)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Harvoni5

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Number of Participants With Cure of CHC

Defined as no detectable HCV RNA at end of treatment and persisting for at least 12 weeks after end of treatment. (NCT03118674)
Timeframe: Up to 15 months

InterventionParticipants (Count of Participants)
Harvoni11

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Time to Resolution of Active PCT

Time to resolution of active PCT, defined as cessation of any new blisters or bullae and normalization of plasma porphyrins (NCT03118674)
Timeframe: through study completion, an average of 1 year

Interventiondays (Mean)
Harvoni240

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Adherence to Study Treatment

To assess adherence to velpatasvir/sofosbuvir therapy among participants administered treatment in the context of visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental health care. (NCT03235154)
Timeframe: This outcome measure will be assessed for each participant during a 12 week course of study treatment.

Intervention% of prescribed doses taken (Mean)
Single Arm Intervention94

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Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment (SVR-12)

To assess the effectiveness of HCV treatment with velpatasvir/sofosbuvir administered by psychiatrist/licensed buprenorphine/naloxone providers during regularly scheduled visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental healthcare, as measured by percentage of patients achieving SVR-12 (defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of study treatment), (NCT03235154)
Timeframe: This outcome measure will be assessed for each participant 12 weeks after completion of a 12 week course of treatment

InterventionParticipants (Count of Participants)
Treatment Arm7

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Adherence as Assessed by the Total Percentage of Tablets Taken (Out of Those Dispensed) During the Treatment Period

Adherence of daily directly observed therapy group from daily logs Adherence measured by counting tablets returned after each 2 week treatment period (fortnightly pickup groups) Adherence of participants infected with genotype 3 and treated with Sovaldi measured using medication event monitoring system (MEMS®) cap. (NCT03236506)
Timeframe: 12 weeks for genotype 1 HCV, 8 weeks for genotype 3 HCV infection

Interventionpercentage of medication taken (Mean)
Daily Observed Therapy69
Fortnightly Pick-up96
Fortnightly Pick-up +Psych Intervention98

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Change of Serum Hepatitis B Surface Antigen (HBsAg as Measured in log10 IU/mL) Level as an Indicator of Antiviral Activity of Ledipasvir and/or Sofosbuvir in Subjects With Chronic Hepatitis B From Baseline to End of 12 Weeks Treatment.

Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir and/or sofosbuvir and their HBsAg will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change (decline) in HBsAg from baseline to end of the 12 week treatment will be compared. (NCT03312023)
Timeframe: 12 weeks

InterventionLog10 IU/mL (Mean)
Group A (LDV/SOF for Low Replicative HBV)0.39
Group B (LDV/SOF for Viral Suppressed HBV)0.40
Group C (SOF for Low Replicative HBV)0.19
Group D (LDV for Low Replicative HBV)-0.05

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Changes in Serum Hepatitis B Virus DNA Levels (HBV DNA as Measured in IU/mL) With Treatment of Ledipasvir and/or Sofosbuvir From Baseline to End of 12 Weeks of Treatment in Subjects With Chronic Hepatitis B Infection.

"Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir and/or sofosbuvir and their serum hepatitis B DNA levels (HBV DNA) will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change in HBV DNA levels from baseline to end of the 12 week treatment will be compared.~Note: Group B (virally suppressed HBV subjects) - all had HBV DNA below the limit of detection; Hence, mean change was 0." (NCT03312023)
Timeframe: 12 weeks

InterventionLog10 IU/mL (Mean)
Group A (LDV/SOF for Low Replicative HBV)0.51
Group B (LDV/SOF for Virally Suppressed HBV)0
Group C (SOF for Low Replicative HBV)0.68
Group D (LDV for Low Replicative HBV)0.21

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Incidence of Adverse Events Leading to Permanent Discontinuation of Ledipasvir and/or Sofosbuvir Treatment in Subjects With Chronic Hepatitis B Infection.

Number of subjects who discontinued study drug due to adverse event (NCT03312023)
Timeframe: 12 Weeks

InterventionParticipants (Count of Participants)
Group A (LDV/SOF for Low Replicative HBV)0
Group B (LDV/SOF for Viral Suppressed HBV)0
Group C (SOF for Low Replicative HBV)0
Group D (LDV for Low Replicative HBV)0

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Medication Adherence

Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence (NCT03480932)
Timeframe: 4 weeks for SOF+DAC+PEG and 12 weeks for SOF+DAC

InterventionParticipants (Count of Participants)
SOF+DAC+PEG35
SOF+DAC, DOT31
SOF+DAC, Standard10

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Serious Adverse Events

Number of participants with treatment-related serious adverse events by laboratory tests and physician examination (NCT03480932)
Timeframe: 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC

InterventionParticipants (Count of Participants)
SOF+DAC+PEG0
SOF+DAC, DOT0
SOF+DAC, Standard0

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SVR12

Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion (NCT03480932)
Timeframe: 12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC

InterventionParticipants (Count of Participants)
SOF+DAC+PEG26
SOF+DAC, DOT30
SOF+DAC, Standard17

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Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Below the Lower Limit of Quantitation (LLOQ) at Post-Treatment Follow-Up Week 12

"HCV RNA levels were measured by using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test v2.0. This assay has a lower limit of quantitation (LLOQ) = 15 IU/mL.~The outcome includes both results where Target was Detected (TD) but below LLOQ and results were Target was Not Detected (TND)" (NCT03487848)
Timeframe: 12 weeks after last dose

InterventionPercent of Participants (Number)
Daclatasvir (DCV) + Sofosbuvir (SOF)100

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Apparent Total Body Clearance (CLT/F) for Daclatasvir

(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

InterventionmL/min (Geometric Mean)
Daclatasvir (DCV) + Sofosbuvir (SOF)86.69

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Area Under the Concentration-Time Curve (AUC(TAU)) for Daclatasvir

(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

Interventionh*ng/mL (Geometric Mean)
Daclatasvir (DCV) + Sofosbuvir (SOF)11535.45

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Maximum Observed Plasma Concentration (Cmax) for Daclatasvir

(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

Interventionng/mL (Geometric Mean)
Daclatasvir (DCV) + Sofosbuvir (SOF)1215.32

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Number of Participants Experiencing Laboratory Abnormalities - Follow-up Analysis

"Laboratory tests abnormalities were analyzed in the following categories:~Hematology (hemoglobin, platelets, international normalized ratio (INR), white blood cell count (WBC), lymphocytes (absolute), neutrophils + bands (absolute; ANC)).~Hepatobiliary enzymes (ALT, AST, alkaline phosphatase, total bilirubin, albumin).~Pancreatic enzymes (lipase, creatinine). Tests results were reported by worst toxicity grade (0 to 4) based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (2017).~Only laboratory abnormalities with a worst toxicity grade 3 or higher in any of the above-mentioned tests, experienced during the follow-up period, are reported here." (NCT03487848)
Timeframe: From day after last dose to end of follow-up period (up to approximately 96 weeks)

InterventionParticipants (Count of Participants)
Daclatasvir (DCV) + Sofosbuvir (SOF)2

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Time of Maximum Observed Plasma Concentration (Tmax) for Daclatasvir

(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

InterventionHours (Median)
Daclatasvir (DCV) + Sofosbuvir (SOF)2.00

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Number of Participants Experiencing Laboratory Abnormalities - On-treatment Analysis

"Laboratory tests abnormalities were analyzed in the following categories:~Hematology (hemoglobin, platelets, international normalized ratio (INR), white blood cell count (WBC), lymphocytes (absolute), neutrophils + bands (absolute; ANC)).~Hepatobiliary enzymes (ALT, AST, alkaline phosphatase, total bilirubin, albumin).~Pancreatic enzymes (lipase, creatinine). Tests results were reported by worst toxicity grade (0 to 4) based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (2017).~Only laboratory abnormalities with a worst toxicity grade 3 or higher in any of the above-mentioned tests, experienced during the on-treatment period, are reported here." (NCT03487848)
Timeframe: From the day after first dose to last dose (approximately 12 weeks)

InterventionParticipants (Count of Participants)
Daclatasvir (DCV) + Sofosbuvir (SOF)1

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Number of Participants Experiencing Adverse Events

This outcome describes the number of participants experiencing different types of any grade adverse events. (NCT03487848)
Timeframe: From first dose to last dose (12 weeks)

InterventionParticipants (Count of Participants)
Adverse Events (AEs)Serious Adverse Events (SAEs)AEs leading to discontinuation
Daclatasvir (DCV) + Sofosbuvir (SOF)400

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Minimum (Trough) Observed Plasma Concentration (Cmin) for Daclatasvir

(NCT03487848)
Timeframe: Day 10 after first dose, collection timepoints at pre-dose, 30 min, 1 hour, 2 hours, 4 hours, and 8 hours post-dose

Interventionng/mL (Geometric Mean)
Daclatasvir (DCV) + Sofosbuvir (SOF)152.94

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Percentage of Participants Who Prematurely Discontinued HCV Study Medications

"Since there were no planned clinic visits during the 12 week study medication period, the last dose of study treatment was self-reported by participants, and recorded at the SVR evaluation visit at 24 weeks. Premature treatment discontinuation was defined when the self-reported final dose date was <11 weeks (<77 days) after the date of initial dose (accounting for any reported treatment holds). Participants discontinuing study follow up without information about completion of HCV study medications were counted as having prematurely discontinued medications.~A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From at least 22 weeks and up to 76 weeks from treatment initiation

Interventionpercentage of participants (Number)
MINMON 24 Weeks With SOF/VEL 12 Weeks1.0

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Percentage of Participants With Sustained Virologic Response 12 (SVR12)

"SVR12 was defined as plasma HCV RNA less than the lower limit of quantification (LLOQ) from the earliest sample drawn at least 22 weeks following study treatment initiation (i.e. at a visit scheduled at least 10 weeks after scheduled end of study treatment). Participants without any HCV RNA result at least 22 weeks after treatment initiation will be considered as having HCV RNA greater than the LLOQ.~LLOQ was defined as <15 IU/mL for results tested at USA centralized testing laboratory Quest using the Roche COBAS® HCV Quantitative nucleic acid test for use on the COBAS® 6800/8800 assays for quantitation (and detection) of HCV, and <12 IU/mL for results tested at regional international labs using Abbott RealTime HCV assay for quantitation (and detection) of HCV.~A two-sided 95%, confidence interval was calculated for this percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From at least 22 weeks and up to 76 weeks from treatment initiation

Interventionpercentage of participants (Number)
MINMON 24 Weeks With SOF/VEL 12 Weeks95.0

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Percentage of Participants With at Least One Unplanned Clinic Visit Prior to SVR12 Evaluation

"According to the study minimal monitoring intervention, there were no planned clinic visits prior to study week 24, when SVR12 was scheduled to be evaluated. An unplanned clinic visit was defined as an in-clinic visit occurring from treatment initiation to up to week 22.~A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From treatment initiation to 22 weeks

Interventionpercentage of participants (Number)
MINMON 24 Weeks With SOF/VEL 12 Weeks3.8

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Percentage of Participants With an Occurrence of Serious Adverse Events According to International Council for Harmonization (ICH) Criteria

"Serious adverse events (SAEs) as defined by ICH guidelines.~A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From treatment initiation to 28 weeks

Interventionpercentage of participants (Number)
MINMON 24 Weeks With SOF/VEL 12 Weeks3.5

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Percentage of Participants With an Occurrence of One or More Non-serious, Grade >= 3 Adverse Event (AE), or Treatment Limiting AE.

"AEs included all primary diagnoses, primary signs/symptoms, and primary laboratory abnormalities that either had severity grade ≥ 3 or led to a change in study medication. Serious Adverse Events (SAE) by International Council for Harmonization (ICH) criteria were excluded as they contributed to the primary safety outcome measure.~Severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1.~A two-sided, 95% confidence interval was calculated for the percentage using the Wilson (score) method." (NCT03512210)
Timeframe: From treatment initiation to 28 weeks

Interventionpercentage of participants (Number)
MINMON 24 Weeks With SOF/VEL 12 Weeks5.8

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Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)

"The primary outcome was sustained virologic response, defined as HCV RNA below the lower limit of quantification 12 weeks after treatment completion (SVR12). Secondary outcomes included the proportion of patients with SVR24 defined as HCV RNA < lower limit of quantification 24 weeks after the end of treatment; with viral relapse defined as HCV RNA 1 log increase in viral RNA after treatment week 1.~Safety was measured as the adverse events and serious adverse events attributed by the investigator to HCV infection or antiviral therapy; the proportion of recipients who prematurely discontinued antiviral therapy before the planned end of treatment; and patient and graft survival at 6 months post-transplant." (NCT03619837)
Timeframe: 12 weeks after end of treatment

InterventionParticipants (Count of Participants)
Treatment Arm23

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Survival Rate of Patients and Their Allografts 6 Months Post Transplant

Graft and patient survival at 24 weeks after transplant (NCT03619837)
Timeframe: 6 months from time of liver transplant

InterventionParticipants (Count of Participants)
Treatment Arm23

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Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment

1 of 23 patients prematurely discontinued antiviral therapy due to intercurrent graft-versus-host disease that progressed to multiorgan failure. (NCT03619837)
Timeframe: 12 weeks after start of treatment

InterventionParticipants (Count of Participants)
Treatment Arm1

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Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant

Estimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant was to test the safety of utilizing of HepC positive kidneys. (NCT03801707)
Timeframe: 6 and 12 months

Interventionml/min/1.73m^2 (Median)
eGFR at 6 monthseGFR at 12 months
Intervention Group5446

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Graft Survival at 6 and 12 Months

Graft survival at 6 and 12 months measuring safety of utilizing HepC positive kidneys. (NCT03801707)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
6 months graft survival12 months graft survival
Intervention Group3030

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Patient's Survival at 6 and 12 Months

Patient's survival at 6 and 12 months measuring safety of utilizing of HepC positive kidneys. (NCT03801707)
Timeframe: 6 and 12 months

InterventionParticipants (Count of Participants)
6 months patient survival12 months patient survival
Intervention Group3030

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Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment

Proportion of patients with undetectable hepatitis C virus (HCV) polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment was to test the efficacy of the treatment. (NCT03801707)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Intervention Group28

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Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein

Change in high-sensitivity C-reactive protein (NCT03823911)
Timeframe: Baseline to 72 weeks after functional cure of HCV

Interventionmg/L (Mean)
Hepatitis C Mono-Infected0.6
HIV and Hepatitis C Co-Infected0

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Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug

TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug. (NCT04112303)
Timeframe: First dose date up to Week 12.1

Interventionpercentage of participants (Number)
SOF/VEL0

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Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)

SVR24 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 24 weeks after stopping study treatment. (NCT04112303)
Timeframe: Posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL100.0

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Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)

SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) at 4 weeks after stopping study treatment. (NCT04112303)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF/VEL100.0

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Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment. (NCT04112303)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL100.0

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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 IL/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 end of treatment." (NCT04112303)
Timeframe: First dose date up to posttreatment Week 24

Interventionpercentage of participants (Number)
SOF/VEL0

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Number of Participants With Alanine Aminotransferase (ALT) Normalization

Number of participants with ALT normalization, defined as ALT > upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT ≤ ULN, at each visit was presented. (NCT04211909)
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12

,
Interventionparticipants (Number)
Baseline (ALT>ULN)Week 2 (ALT≤ ULN)Week 4 (ALT≤ ULN)Week 8 (ALT≤ ULN)Week 12 (ALT≤ ULN)
SOF/VEL2121211917
SOF/VEL/VOX1613131313

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Change From Baseline in HCV RNA

(NCT04211909)
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12

,
Interventionlog10 IU/mL (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12
SOF/VEL5.95-4.78-4.81-4.79-4.79
SOF/VEL/VOX6.48-5.19-5.33-5.33-5.33

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Percentage of Participants With Virologic Failure

"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values), 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" (NCT04211909)
Timeframe: Baseline up to Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL1.9
SOF/VEL/VOX0

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Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment

SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) 4 weeks after stopping study treatment. (NCT04211909)
Timeframe: Posttreatment Week 4

Interventionpercentage of participants (Number)
SOF/VEL98.1
SOF/VEL/VOX100

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Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment

SVR12 was defined as HCV RNA < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment. (NCT04211909)
Timeframe: Posttreatment Week 12

Interventionpercentage of participants (Number)
SOF/VEL98.1
SOF/VEL/VOX100

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Percentage of Participants With HCV RNA < LLOQ on Treatment

LLOQ was 15 IU/mL. (NCT04211909)
Timeframe: Week 2, Week 4, Week 8, Week 12

,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12
SOF/VEL90.6100.0100.0100.0
SOF/VEL/VOX69.7100.0100.0100.0

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Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event

(NCT04211909)
Timeframe: First dose date up to 12 weeks plus 30 days

Interventionpercentage of participants (Number)
SOF/VEL1.9
SOF/VEL/VOX0

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