ledipasvir profile

ledipasvir : A benzimidazole derivative that is used in combination with sofosbuvir (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]

ID Source	ID
PubMed CID	67505836
CHEMBL ID	2374220
CHEBI ID	85089
SCHEMBL ID	2706494
SCHEMBL ID	15116943
MeSH ID	M0591686

Synonym
gs5885
013te6e4wv ,
ledipasvir [usan:inn]
carbamic acid, n-((1s)-1-(((6s)-6-(5-(9,9-difluoro-7-(2-((1r,3s,4s)-2-((2s)-2-((methoxycarbonyl)amino)-3-methyl-1-oxobutyl)-2-azabicyclo(2.2.1)hept-3-yl)-1h-benzimidazol-6-yl)-9h-fluoren-2-yl)-1h-imidazol-2-yl)-5-azaspiro(2.4)hept-5-yl)carbonyl)-2-methylp
1256388-51-8
ledipasvir
methyl ((1s)-1-((1r,3s,4s)-3-(5-(9,9-difluoro-7-(2-((6s)-5-(n-(methoxycarbonyl)- l-valyl)-5-azaspiro(2.4)hept-6-yl)-1h-imidazol-4-yl)-9h-fluoren-2-yl)-1h-benzimidazol-2-yl)-2-azabicyclo(2.2.1)heptane-2-carbonyl)-2-methylpropyl)carbamate
gs-5885 ,
gs 5885
who 9796
unii-013te6e4wv
ledipasvir (usan)
D10442
ledipasvir [orange book]
ledipasvir [usan]
ledipasvir [vandf]
ledipasvir component of harvoni
ledipasvir [who-dd]
ledipasvir acetonate [jan]
ledipasvir [inn]
ledipasvir [mi]
harvoni component ledipasvir
CHEMBL2374220
ledipasvir acetonate
chebi:85089 ,
HY-15602
CS-1653
methyl n-[(1s)-1-[(5s)-5-[5-[9,9-difluoro-7-[2-[(1s,2s,4r)-3-[(2s)-2-(methoxycarbonylamino)-3-methyl-butanoyl]-3-azabicyclo[2.2.1]heptan-2-yl]-3h-benzimidazol-5-yl]fluoren-2-yl]-1h-imidazol-2-yl]-6-azaspiro[2.4]heptane-6-carbonyl]-2-methyl-propyl]carbamat
SCHEMBL2706494
SCHEMBL15116943
methyl [(2s)-1-{(6s)-6-[4-(9,9-difluoro-7-{2-[(1r,3s,4s)-2-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2-azabicyclo[2.2.1]hept-3-yl]-1h-benzimidazol-5-yl}-9h-fluoren-2-yl)-1h-imidazol-2-yl]-5-azaspiro[2.4]hept-5-yl}-3-methyl-1-oxobutan-2-yl]carbama
AC-28378
DTXSID90154829
DB09027
mfcd25976756
EX-A411
AKOS027323908
methyl ((s)-1-((s)-6-(5-(9,9-difluoro-7-(2-((1r,3s,4s)-2-((methoxycarbonyl)-l-valyl)-2-azabicyclo[2.2.1]heptan-3-yl)-1h-benzo[d]imidazol-6-yl)-9h-fluoren-2-yl)-1h-imidazol-2-yl)-5-azaspiro[2, aldrichcpr
bdbm50505966
methyl n-[(2s)-1-[(6s)-6-[5-[9,9-difluoro-7-[2-[(1s,2s,4r)-3-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl]-3-azabicyclo[2.2.1]heptan-2-yl]-3h-benzimidazol-5-yl]fluoren-2-yl]-1h-imidazol-2-yl]-5-azaspiro[2.4]heptan-5-yl]-3-methyl-1-oxobutan-2-yl]carbama
methyl ((s)-1-((s)-6-(5-(9,9-difluoro-7-(2-((1r,3s,4s)-2-((methoxycarbonyl)-l-valyl)-2-azabicyclo[2.2.1]heptan-3-yl)-1h-benzo[d]imidazol-6-yl)-9h-fluoren-2-yl)-1h-imidazol-2-yl)-5-azaspiro[2.4]heptan-5-yl)-3-methyl-1-oxobutan-2-yl)carbamate
Q15409409
methyl n-[(2s)-1-[(6s)-6-[5-[9,9-difluoro-7-[2-[(1r,3s,4s)-2-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl]-2-azabicyclo[2.2.1]heptan-3-yl]-3h-benzimidazol-5-yl]fluoren-2-yl]-1h-imidazol-2-yl]-5-azaspiro[2.4]heptan-5-yl]-3-methyl-1-oxobutan-2-yl]carbama
NCGC00378990-02
gtpl11271
harvoni (ledipasvir + sofosbuvir)
AS-56214
NCGC00378990-05
EN300-37158594
methyl n-[(2s)-1-[(6s)-6-[4-(9,9-difluoro-7-{2-[(1r,3s,4s)-2-[(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]-2-azabicyclo[2.2.1]heptan-3-yl]-1h-1,3-benzodiazol-5-yl}-9h-fluoren-2-yl)-1h-imidazol-2-yl]-5-azaspiro[2.4]heptan-5-yl]-3-methyl-1-oxobutan-2-y
vrtwbaajjohbqu-kmwazvgdsa-n

Excerpt	Reference	Relevance
"Ledipasvir/sofosbuvir is an oral combination therapy containing fixed doses of direct-acting antiviral agents indicated for the treatment of hepatitis C virus (HCV) infection. "	( Treatment of chronic hepatitis C virus infection with crushed ledipasvir/sofosbuvir administered through a percutaneous endoscopic gastrostomy tube in a patient with HIV coinfection. Andrade, DC; Eckardt, PA; Huffman, V; Niu, J; Sherman, E, 2021)	2.3
"Ledipasvir is an effective direct acting antiviral agent used in the treatment of hepatitis C virus. "	( Liver targeting of ledipasvir via galactosylated chitosan-coated spanlastics: chemical synthesis, statistical optimization, in vitro, and pharmacokinetic evaluation. Abdelbary, A; Elshafeey, AH; Fatouh, AM, 2022)	2.49
"Ledipasvir is a NS5A inhibitor with multi genotypic activity but modest barrier to resistance."	( Sofosbuvir plus ledipasvir in combination for the treatment of hepatitis C infection. Adhoute, X; Ansaldi, C; Benali, S; Bourlière, M; Castellani, P; Halfon, P; Oules, V; Portal, I, 2015)	1.48
"Ledipasvir-sofosbuvir is an oral fixed-dose (ledipasvir 90 mg-sofosbuvir 400 mg) combination of two direct-acting antiviral drugs."	( Ledipasvir-Sofosbuvir: A Once-Daily Oral Treatment Option for Chronic Hepatitis C Virus Genotype 1 Infection. Holle, LM; Jensen, CM, 2016)	2.6

Excerpt	Reference	Relevance
"Ledipasvir/sofosbuvir treatment was discontinued."	( Sustained Virologic Suppression After 4 Weeks of Ledipasvir/Sofosbuvir in Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) Co-Infection. Bares, SH; Havens, JP; Regan, NN, 2020)	1.53
"Treatment with ledipasvir/sofosbuvir was safe and effective in patients with end-stage renal disease undergoing dialysis."	( Ledipasvir/Sofosbuvir for 8, 12, or 24 Weeks in Hepatitis C Patients Undergoing Dialysis for End-Stage Renal Disease. Biancone, L; Buggisch, P; Camargo, M; Chuang, WL; Dvory-Sobol, H; Gaggar, A; Hu, TH; Hyland, R; Kirby, BJ; Liu, CH; Lu, S; Mangia, A; Moreno, C; Osinusi, A; Peng, CY; Sise, ME; Su, WW, 2021)	2.42
"Treatment with ledipasvir-sofosbuvir for 12 or 24 weeks was well-tolerated and seemed to have an acceptable safety profile among kidney transplant recipients with HCV genotype 1 or 4 infection, all of whom achieved SVR12."	( Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Aghemo, A; Bourlière, M; Brainard, DM; Colombo, M; Dvory-Sobol, H; Hyland, R; Liu, H; Manns, M; Massetto, B; McHutchison, JG; Peck-Radosavljevic, M; Pol, S; Yun, C; Zhang, J, 2017)	1.16
"Pretreatment ledipasvir-specific RASs that were present in 8-16% of patients have an impact on treatment outcome in some patient groups, particularly treatment-experienced patients with genotype 1a HCV."	( NS5A resistance-associated substitutions in patients with genotype 1 hepatitis C virus: Prevalence and effect on treatment outcome. Brainard, DM; Chuang, WL; Doehle, B; Dore, GJ; Dvory-Sobol, H; Han, KH; Hedskog, C; Jacobson, I; Knox, S; Mangia, A; Martin, R; McHutchison, JG; Miller, MD; Mizokami, M; Mo, H; Pianko, S; Sulkowski, M; Svarovskaia, E; Yun, C; Zeuzem, S, 2017)	0.82
"Treatment with ledipasvir-sofosbuvir for patients with HCV genotype 1 or 4 infection or sofosbuvir plus ribavirin for patients with genotype 2 or 3 infection was highly effective and well tolerated among those with inherited bleeding disorders."	( Ledipasvir-sofosbuvir and sofosbuvir plus ribavirin in patients with chronic hepatitis C and bleeding disorders. Balba, G; Bowlus, CL; Brainard, DM; Cohen, A; Fried, MW; Han, B; Hyland, RH; Kim, AY; Kouides, P; McHutchison, JG; Reddy, KR; Rhame, F; Sax, PE; Stamm, LM; Terrault, NA; von Drygalski, A; Walsh, CE; Wang, J; Workowski, K, 2017)	2.25

Excerpt	Reference	Relevance
" 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)	0.74
"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)	0.69
" 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)	0.71
" 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)	0.9
" 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)	0.74
"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)	0.74
" 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)	0.68
"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
" 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)	0.65
" 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
" 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)	0.74
" 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)	0.77
"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)	0.77
" 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)	0.69
" 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)	0.75
"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)	0.75
" 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)	0.73
" 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)	0.77
" 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)	0.67
" 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)	0.76
" 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)	0.76
"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)	0.76
" 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
" 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)	0.83
" 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)	0.82
" 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)	1
"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)	0.89
" 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)	0.92
" 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)	0.92
"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)	0.92
" 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)	0.93
" 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)	1.11
" 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)	1.11
"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)	2.47
"Hepatitis C virus (HCV) infection is an independent risk factor associated with adverse outcomes in patients with end-stage renal disease (ESRD)."	( The efficacy and safety of direct-acting antiviral regimens for end-stage renal disease patients with HCV infection: a systematic review and network meta-analysis. Chen, R; Wang, X; Xiao, Y; Xiong, Y; Zeng, Y; Zheng, Y, 2023)	0.91
" Study data that contained patient characteristics, study design, treatment regimens, intention-to-treat sustained virologic response (SVR), and adverse event (AE) data per regimen were extracted into a structured electronic database and analyzed."	( The efficacy and safety of direct-acting antiviral regimens for end-stage renal disease patients with HCV infection: a systematic review and network meta-analysis. Chen, R; Wang, X; Xiao, Y; Xiong, Y; Zeng, Y; Zheng, Y, 2023)	0.91

Excerpt	Reference	Relevance
" 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)	0.81
" 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)	0.96
" 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)	0.82
" 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)	0.82
" 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)	1.05
"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)	1.23
" 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)	0.98
" 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)	0.78
" 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)	2.2
" 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)	2.23
" A pharmacokinetic study was carried out to evaluate the ability of the prepared galactosylated chitosan-coated spanlastics formulation to enhance ledipasvir liver bioavailability when it was administrated via the oral route."	( Liver targeting of ledipasvir via galactosylated chitosan-coated spanlastics: chemical synthesis, statistical optimization, in vitro, and pharmacokinetic evaluation. Abdelbary, A; Elshafeey, AH; Fatouh, AM, 2022)	1.25
"The pharmacokinetic study revealed that the optimized galactosylated chitosan-coated spanlastics exhibited significantly higher liver peak concentration (Cmax) and area under liver concentration versus time curve (AUC0-72 h) and significant prolongation in the liver terminal half life (t½) and mean residence time (MRT) compared to the free ledipasvir dispersion with values of 6270 ng/g, 61,706."	( Liver targeting of ledipasvir via galactosylated chitosan-coated spanlastics: chemical synthesis, statistical optimization, in vitro, and pharmacokinetic evaluation. Abdelbary, A; Elshafeey, AH; Fatouh, AM, 2022)	1.22
" 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)	0.93

Excerpt	Reference	Relevance
" 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)	2.09

Excerpt	Reference	Relevance
" GS-9451 showed good oral bioavailability in all three species tested."	( Preclinical characterization of the novel hepatitis C virus NS3 protease inhibitor GS-9451. Cheng, G; Corsa, AC; Delaney, WE; Kim, CU; Krawczyk, S; Mo, H; Pakdaman, R; Peng, B; Qi, X; Robinson, M; Shen, M; Sheng, XC; Tay, C; Tian, Y; Wang, Y; Yang, C; Yang, H, 2014)	0.4
" We administered five bRo5 substrates (asunaprevir, cyclosporine, danoprevir, ledipasvir, and simeprevir) intravenously or orally to wild-type and Mdr1a, Bcrp, and Mdr1a/Bcrp knockout rats, calculated the clearance, oral bioavailability, and absorption rate profile of each substrate, and compared the results."	( Estimating Efflux Transporter-Mediated Disposition of Molecules beyond the Rule of Five (bRo5) Using Transporter Gene Knockout Rats. Miyake, T, 2020)	0.79
" A pharmacokinetic study was carried out to evaluate the ability of the prepared galactosylated chitosan-coated spanlastics formulation to enhance ledipasvir liver bioavailability when it was administrated via the oral route."	( Liver targeting of ledipasvir via galactosylated chitosan-coated spanlastics: chemical synthesis, statistical optimization, in vitro, and pharmacokinetic evaluation. Abdelbary, A; Elshafeey, AH; Fatouh, AM, 2022)	1.25
"Enhanced liver bioavailability of ledipasvir has been accomplished using the developed galactosylated chitosan-coated spanlastics which can be a base for probable reduction in the required dose of ledipasvir in HCV treatment."	( Liver targeting of ledipasvir via galactosylated chitosan-coated spanlastics: chemical synthesis, statistical optimization, in vitro, and pharmacokinetic evaluation. Abdelbary, A; Elshafeey, AH; Fatouh, AM, 2022)	1.33
" 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)	0.95

Excerpt	Relevance	Reference
"Genotype 1 HCV-infected patients were randomized to 3 days of once-daily (QD) dosing with placebo (n=12) or GS-5885 1 mg (n=10), 3 mg (n=10), 10 mg (n=20), 30 mg (n=10), or 90 mg (n=10)."	( A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C. Brainard, DM; Cheng, G; Gruener, D; Hill, JM; Lawitz, EJ; Link, JO; Marbury, T; Mathias, A; McHutchison, JG; Mo, H; Moorehead, L; Wong, KA, 2012)	0.38
"3 log10 HCV RNA IU/ml across dosing cohorts (1, 3, 10, 30, or 90 mg once daily)."	( Characterization of Hepatitis C virus resistance from a multiple-dose clinical trial of the novel NS5A inhibitor GS-5885. Brainard, DM; Lawitz, E; Martin, R; Miller, MD; Mo, H; Svarovskaia, E; Wong, KA; Worth, A, 2013)	0.39
" Compound 39 (GT1a replicon EC50 = 31 pM) has an extended plasma half-life of 37-45 h in healthy volunteers and produces a rapid >3 log viral load reduction in monotherapy at oral doses of 3 mg or greater with once-daily dosing in genotype 1a HCV-infected patients."	( Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection. Cheng, G; Cornpropst, M; Desai, MC; Guo, H; Kato, D; Kellar, T; Kirschberg, T; Link, JO; Liu, H; Matles, M; Mitchell, M; Mogalian, E; Mondou, E; Parrish, J; Perry, J; Squires, N; Sun, J; Taylor, JG; Tian, Y; Wang, K; Wang, Y; Xu, L; Yang, C; Yang, ZY, 2014)	0.77
"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
" 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)	0.9
" 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)	0.96
" 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)	0.73
" 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)	0.76

Role	Description
antiviral drug	A substance used in the prophylaxis or therapy of virus diseases.
hepatitis C protease inhibitor	An inhibitor of hepatitis C protease, an enzyme required for production of proteins needed for viral assembly.
[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]

Class	Description
carbamate ester	Any ester of carbamic acid or its N-substituted derivatives.
L-valine derivative	A proteinogenic amino acid derivative resulting from reaction of L-valine at the amino group or the carboxy group, or from the replacement of any hydrogen of L-valine by a heteroatom.
bridged compound	A polycyclic compound in which two rings have two or more atoms in common.
carboxamide	An amide of a carboxylic acid, having the structure RC(=O)NR2. The term is used as a suffix in systematic name formation to denote the -C(=O)NH2 group including its carbon atom.
benzimidazole	A mancude organic heterobicyclic parent that is a heterocyclic organic compound comprising fused benzene and imidazole rings.
fluorenes	An ortho-fused polycyclic arene in which the skeleton is composed of two benzene rings ortho-fused to cyclopentane.
organofluorine compound	An organofluorine compound is a compound containing at least one carbon-fluorine bond.
imidazoles	A five-membered organic heterocycle containing two nitrogen atoms at positions 1 and 3, or any of its derivatives; compounds containing an imidazole skeleton.
N-acylpyrrolidine
azaspiro compound	An azaspiro compound is a spiro compound in which at least one of the cyclic components is a nitrogen heterocyle.
[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]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Nonstructural protein 5A		IC50 (µMol)	0.0310	0.0000	0.0155	0.0410	AID1527678; AID1527679
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Nonstructural protein 5A		EC50 (µMol)	0.1551	0.0000	0.1375	8.1000	AID1588160; AID1588161; AID1588164; AID1588165; AID1588166; AID1588167; AID1588168; AID1588169; AID1588170; AID1588171; AID1588172; AID1588179; AID1588180; AID1588181; AID1588182; AID1588183; AID1588184; AID1588185; AID1588186; AID1588187; AID1588204; AID1588205; AID1588206; AID1588207; AID1588208; AID1588209; AID1588210; AID1588211; AID1588212; AID1588213; AID1588214
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Assay ID	Title	Year	Journal	Article
AID1588209	Inhibition of NS5A in wild type HCV genotype 2b AY232738 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1588179	Inhibition of NS5A M28T mutant in HCV genotype 1a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1588167	Inhibition of NS5A in HCV genotype 2a J6 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1588180	Inhibition of NS5A Q30H mutant in HCV genotype 1a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1649892	Inhibition of HCV NS3/4a protease	2019	European journal of medicinal chemistry, Mar-01, Volume: 165	Hepatitis C - New drugs and treatment prospects.
AID1588206	Inhibition of NS5A N62V mutant in HCV genotype 2a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071167	Ratio of EC50 for HCV genotype 1a H77 infected in human HuH7 cells in presence of 10% BSA to EC50 for HCV genotype 1a H77 infected in human HuH7 cells	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071163	Toxicity in Sprague-Dawley rat assessed as adverse effects by 14 day toxicology study	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071139	Plasma concentration in fasted healthy human at 60 mg/kg, po at 24 hrs	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588170	Inhibition of NS5A in HCV genotype 4a ED43 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1649893	Half life in human	2019	European journal of medicinal chemistry, Mar-01, Volume: 165	Hepatitis C - New drugs and treatment prospects.
AID1527678	Inhibition of NS5A in HCV genotype 2a JFH-1 by cell based luciferase reporter gene assay	2019	Journal of medicinal chemistry, 12-12, Volume: 62, Issue:23	Discovery and Characterization of Potent Pan-Genotypic HCV NS5A Inhibitors Containing Novel Tricyclic Central Core Leading to Clinical Candidate.
AID1071169	Antiviral activity against HCV genotype 1b Con1 infected in human HuH7 cells assessed as inhibition of viral RNA replication after 3 days by renilla luciferase reporter gene assay in presence of human serum	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588160	Inhibition of NS5A in wild type HCV genotype 1a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071183	Oral bioavailability in Sprague-Dawley rat at 2 mg/kg	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071151	Cmax in fasted healthy human at 30 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588214	Inhibition of NS5A in wild type HCV genotype 3a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071164	Toxicity in beagle dog assessed as adverse effects by 14 day toxicology study	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071134	Plasma concentration in fasted healthy human at 100 mg/kg, po at 24 hrs	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588187	Inhibition of NS5A Y93H mutant in HCV genotype 1b infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071180	Half life in beagle dog at 0.2 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071188	Antiviral activity against HCV genotype 1b Con1 infected in human HuH7 cells assessed as inhibition of viral RNA replication after 3 days by renilla luciferase reporter gene assay	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588164	Inhibition of NS5A in HCV genotype 1a H77 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1588185	Inhibition of NS5A Y93H mutant in HCV genotype 1a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1649895	Drug excretion in human feces	2019	European journal of medicinal chemistry, Mar-01, Volume: 165	Hepatitis C - New drugs and treatment prospects.
AID1071145	Plasma concentration in fasted healthy human at 30 mg/kg, po at 24 hrs	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071144	Cmax in fasted healthy human at 60 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071156	Cmax in fasted healthy human at 10 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588168	Inhibition of NS5A in HCV genotype 2b MD2b-1 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1588186	Inhibition of NS5A in wild type HCV genotype 1b infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071135	AUC (infinity) in fasted healthy human at 100 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1649894	Oral bioavailability in human	2019	European journal of medicinal chemistry, Mar-01, Volume: 165	Hepatitis C - New drugs and treatment prospects.
AID1071149	Tmax in fasted healthy human at 30 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588213	Inhibition of NS5A P58S mutant in HCV genotype 2b infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071165	Ratio of EC50 for HCV genotype 1b Con1 infected in human HuH7 cells in presence of 10% BSA to EC50 for HCV genotype 1b Con1 infected in human HuH7 cells	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588210	Inhibition of NS5A A30K mutant in HCV genotype 3a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1588207	Inhibition of NS5A N62S mutant in HCV genotype 2a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071160	AUClast in fasted healthy human at 3 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071157	Plasma concentration in fasted healthy human at 3 mg/kg, po at 24 hrs	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071148	AUC (infinity) in fasted healthy human at 30 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071170	Antiviral activity against HCV genotype 1a H77 infected in human HuH7 cells assessed as inhibition of viral RNA replication after 3 days by renilla luciferase reporter gene assay in presence of 10% BSA	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588166	Inhibition of NS5A in HCV genotype 2a JFH1 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1588172	Inhibition of NS5A in HCV genotype 6e D88 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071155	AUClast in fasted healthy human at 10 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071166	Ratio of EC50 for HCV genotype 1b Con1 infected in human HuH7 cells in presence of human serum to EC50 for HCV genotype 1b Con1 infected in human HuH7 cells	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588183	Inhibition of NS5A Y93C mutant in HCV genotype 1a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071174	Oral bioavailability in cynomolgus monkey at 1 mg/kg	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071181	Volume of distribution at steady state in beagle dog at 0.2 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071141	Half life in fasted healthy human at 60 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071161	Tmax in fasted healthy human at 3 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071142	AUClast in fasted healthy human at 60 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071126	Metabolic stability in cynomolgus monkey liver microsomes assessed as hepatic extraction at 3 uM after 60 mins by LC/MS/MS analysis	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071162	Cmax in fasted healthy human at 3 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588205	Inhibition of NS5A K44R mutant in HCV genotype 2a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071143	Tmax in fasted healthy human at 60 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071125	Metabolic stability in human liver microsomes assessed as hepatic extraction at 3 uM after 60 mins by LC/MS/MS analysis	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071131	Ratio of EC50 for HCV genotype 1a H77 infected in human HuH7 cells in presence of 10% BSA to plasma concentration in fasted healthy human at 3 mg/kg, po at 24 hrs	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588208	Inhibition of NS5A in wild type HCV genotype 2b MD2b-1 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071150	Plasma concentration in fasted healthy human at 10 mg/kg, po at 24 hrs	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071128	Metabolic stability in Sprague-Dawley rat liver microsomes assessed as hepatic extraction at 3 uM after 60 mins by LC/MS/MS analysis	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071172	Antiviral activity against HCV genotype 1b Con1 infected in human HuH7 cells assessed as inhibition of viral RNA replication after 3 days by renilla luciferase reporter gene assay in presence of 10% BSA	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071129	Ratio of EC50 for HCV genotype 1a H77 infected in human HuH7 cells in presence of 10% BSA to plasma concentration in fasted healthy human at 100 mg/kg, po at 24 hrs	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071159	AUC (infinity) in fasted healthy human at 3 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588165	Inhibition of NS5A in HCV genotype 1b Con1 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071127	Metabolic stability in beagle dog liver microsomes assessed as hepatic extraction at 3 uM after 60 mins by LC/MS/MS analysis	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071153	AUC (infinity) in fasted healthy human at 10 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588182	Inhibition of NS5A L31M mutant in HCV genotype 1a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1588212	Inhibition of NS5A R44K mutant in HCV genotype 2b infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071133	Half life in fasted healthy human at 100 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071175	Mean residence time in cynomolgus monkey at 0.5 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588171	Inhibition of NS5A in HCV genotype 5a SA13 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071177	Volume of distribution at steady state in cynomolgus monkey at 0.5 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071136	Tmax in fasted healthy human at 100 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071176	Half life in cynomolgus monkey at 0.5 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588161	Inhibition of NS5A in HCV genotype 6a HK6 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071158	Half life in fasted healthy human at 3 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071146	Half life in fasted healthy human at 30 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071178	Clearance in cynomolgus monkey at 0.5 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1527679	Inhibition of NS5A in HCV genotype 3a by cell based luciferase reporter gene assay	2019	Journal of medicinal chemistry, 12-12, Volume: 62, Issue:23	Discovery and Characterization of Potent Pan-Genotypic HCV NS5A Inhibitors Containing Novel Tricyclic Central Core Leading to Clinical Candidate.
AID1588169	Inhibition of NS5A in HCV genotype 3a S52 infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071152	Half life in fasted healthy human at 10 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071140	AUC (infinity) in fasted healthy human at 60 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071138	Cmax in fasted healthy human at 100 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071137	AUClast in fasted healthy human at 100 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071182	Clearance in beagle dog at 0.2 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071147	AUClast in fasted healthy human at 30 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071186	Volume of distribution at steady state in Sprague-Dawley rat at 1 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071171	Antiviral activity against HCV genotype 1a H77 infected in human HuH7 cells assessed as inhibition of viral RNA replication after 3 days by renilla luciferase reporter gene assay in presence of human serum	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071132	Ratio of EC50 for HCV genotype 1a H77 infected in human HuH7 cells in presence of human serum to plasma concentration in fasted healthy human at 3 mg/kg, po at 24 hrs	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588211	Inhibition of NS5A Y93H mutant in HCV genotype 3a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071179	Mean residence time in beagle dog at 0.2 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071185	Half life in Sprague-Dawley rat at 1 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071130	Ratio of EC50 for HCV genotype 1a H77 infected in human HuH7 cells in presence of human serum to plasma concentration in fasted healthy human at 100 mg/kg, po at 24 hrs	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071173	Oral bioavailability in beagle dog at 0.5 mg/kg	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588181	Inhibition of NS5A Q30R mutant in HCV genotype 1a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071184	Mean residence time in Sprague-Dawley rat at 1 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588204	Inhibition of NS5A in HCV wild type genotype 2a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071168	Ratio of EC50 for HCV genotype 1a H77 infected in human HuH7 cells in presence of human serum to EC50 for HCV genotype 1a H77 infected in human HuH7 cells	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1588184	Inhibition of NS5A Q30E mutant in HCV genotype 1a infected in human HuH7 replicon cells assessed as reduction in viral replication after 3 days by luciferase reporter gene assay
AID1071187	Clearance in Sprague-Dawley rat at 1 mg/kg, iv	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071189	Antiviral activity against HCV genotype 1a H77 infected in human HuH7 cells assessed as inhibition of viral RNA replication after 3 days by renilla luciferase reporter gene assay	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1071154	Tmax in fasted healthy human at 10 mg/kg, po	2014	Journal of medicinal chemistry, 03-13, Volume: 57, Issue:5	Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection.
AID1745855	NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay	2023	Disease models & mechanisms, 03-01, Volume: 16, Issue:3	In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745854	NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS	2023	Disease models & mechanisms, 03-01, Volume: 16, Issue:3	In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	276 (77.09)	24.3611
2020's	82 (22.91)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	66 (17.65%)	5.53%
Reviews	42 (11.23%)	6.00%
Case Studies	39 (10.43%)	4.05%
Observational	20 (5.35%)	0.25%
Other	207 (55.35%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (99)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Escalating, Multiple, Oral Doses of GS 5885 in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Vir [NCT01193478]	Phase 1	71 participants (Actual)	Interventional	2010-08-31	Completed
The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia [NCT03169348]		50 participants (Anticipated)	Interventional	2017-11-01	Recruiting
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 4	15 participants (Actual)	Interventional	2016-12-31	Completed
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 4	25 participants (Anticipated)	Interventional	2018-08-01	Recruiting
Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital [NCT03965286]		80 participants (Anticipated)	Observational	2019-06-01	Not yet recruiting
A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 With Peginterferon Alfa 2a and Ribavirin (RBV) in Treatment-Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype [NCT01384383]	Phase 2	248 participants (Actual)	Interventional	2011-08-31	Terminated
The Relationship Between Direct Acting Antiviral Treatment Effect and Myeloid-Derived Suppressor Cells and NK Cells Activity in Chronic Hepatitis C [NCT03188276]	Early Phase 1	52 participants (Actual)	Interventional	2016-02-01	Completed
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 2	95 participants (Actual)	Interventional	2017-06-27	Completed
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared With GS-5885, GS-9451 With Tegobuvir or RBV in Treatment-Experienced Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) I [NCT01435226]	Phase 2	170 participants (Actual)	Interventional	2011-09-30	Completed
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy Using Combinations of Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Ch [NCT01371578]	Phase 2	163 participants (Actual)	Interventional	2011-07-31	Completed
A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection [NCT01353248]	Phase 2	141 participants (Actual)	Interventional	2011-05-31	Completed
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 2	68 participants (Actual)	Interventional	2014-08-31	Completed
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV In [NCT01434498]	Phase 2	163 participants (Actual)	Interventional	2011-09-30	Completed
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Vi [NCT01356160]	Phase 2	351 participants (Actual)	Interventional	2011-07-31	Completed
Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs. [NCT04457050]	Phase 4	160 participants (Actual)	Interventional	2017-10-30	Completed
Efficacy of Adding Sofosbuvir/Ledipasvir Combination, or Nitazoxanide to the Standard of Care in Treatment of COVID-19: A Randomized Controlled Trial [NCT04498936]	Phase 4	240 participants (Actual)	Interventional	2020-07-15	Completed
Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents [NCT03343444]	Phase 3	80 participants (Anticipated)	Interventional	2017-04-15	Enrolling 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 4	10 participants (Anticipated)	Interventional	2018-04-03	Recruiting
Phase I Pharmacokinetic and Safety Trial of Ledipasvir/Sofosbuvir Fixed Dose Combination in Pregnant Women With Chronic Hepatitis C Virus Infection [NCT02683005]	Phase 1	9 participants (Actual)	Interventional	2016-09-30	Completed
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 4	40 participants (Anticipated)	Interventional	2015-09-30	Recruiting
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 2	120 participants (Actual)	Interventional	2015-10-31	Completed
The Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Naïve Children [NCT05091008]	Phase 2	50 participants (Actual)	Interventional	2018-03-01	Completed
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection [NCT02472886]	Phase 3	153 participants (Actual)	Interventional	2015-06-17	Completed
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)	Observational	2012-01-31	Recruiting
Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy [NCT03903185]	Phase 1/Phase 2	24 participants (Actual)	Interventional	2019-03-01	Completed
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 3	50 participants (Actual)	Interventional	2016-09-30	Completed
Metabolic Changes in Chronic Hepatitis C Virus Patients Receiving Direct Acting Antivirals [NCT04211844]		100 participants (Anticipated)	Observational [Patient Registry]	2019-10-01	Recruiting
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods [NCT02657694]		10,000 participants (Anticipated)	Observational [Patient Registry]	2015-07-01	Enrolling by invitation
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC [NCT02771405]	Phase 3	150 participants (Anticipated)	Interventional	2016-03-31	Recruiting
Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection [NCT02576314]	Phase 3	48 participants (Actual)	Interventional	2015-05-31	Completed
Pharmacokinetics of Sofosbuvir and Ledipasvir in Hepatitis C Virus - Infected Adolescent Patients With Haematological Disorders [NCT04353986]	Phase 3	24 participants (Anticipated)	Interventional	2018-06-11	Recruiting
Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients [NCT02555943]	Phase 2/Phase 3	23 participants (Actual)	Interventional	2015-02-28	Completed
Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine [NCT04038320]		868 participants (Actual)	Observational	2018-03-26	Completed
Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria. JAILFREE-C [NCT02768961]	Phase 4	64 participants (Actual)	Interventional	2016-05-10	Completed
Evolution of Estimated Glomerular Filtration Rate in Chronic Hepatitis C Patients Receiving Sofosbuvir-based or Sofosbuvir-free Direct Acting Antivirals [NCT04047680]		441 participants (Actual)	Observational	2015-02-28	Completed
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 4	50 participants (Actual)	Interventional	2017-10-01	Completed
Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects With Chronic Hepatitis C [NCT03118674]	Phase 2	23 participants (Actual)	Interventional	2017-09-06	Completed
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 4	16 participants (Actual)	Interventional	2016-08-01	Completed
Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment [NCT04530422]	Phase 3	250 participants (Actual)	Interventional	2020-04-15	Completed
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 3	14 participants (Actual)	Interventional	2016-01-31	Completed
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)	Observational	2015-01-31	Recruiting
Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication [NCT03823911]	Phase 4	87 participants (Actual)	Interventional	2018-11-18	Completed
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)	Interventional	2016-03-31	Completed
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)	Observational	2010-01-01	Completed
Impact of Serum Alpha-fetoprotein Levels on the Response to Direct Antiviral Therapy in Egyptian Patients With Chronic Hepatitis C [NCT03402165]	Phase 4	1,200 participants (Anticipated)	Interventional	2017-01-01	Recruiting
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)	Observational	2016-12-05	Completed
A Pilot/Feasibility Study of Ledipasvir/Sofosbuvir as Treatment for Hepatitis C in Hematopoietic Cell Transplantation (HCT) Recipients. [NCT03279133]	Phase 4	0 participants (Actual)	Interventional	2017-09-01	Withdrawn(stopped due to Unable to find eligible patients with untreated hepatitis C virus.)
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 3	111 participants (Actual)	Interventional	2015-12-22	Completed
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 2	111 participants (Actual)	Interventional	2015-04-30	Completed
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 2	17 participants (Actual)	Interventional	2015-05-22	Completed
A Pilot Study to Evaluate the Safety and Efficacy of Multiple Anti-HCV Combination Therapy in Chronically Infected Hepatitis C Patients [NCT01805882]	Phase 2	229 participants (Actual)	Interventional	2013-01-31	Completed
Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World [NCT02964091]	Phase 4	300 participants (Actual)	Interventional	2016-10-31	Completed
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]	2015-10-21	Terminated(stopped due to The study stopped early because the study objectives were met.)
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients [NCT02631772]	Phase 4	32 participants (Actual)	Interventional	2016-06-01	Completed
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)	Observational	2014-12-31	Completed
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 4	10,000 participants (Actual)	Interventional	2015-01-31	Completed
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection [NCT01768286]	Phase 3	441 participants (Actual)	Interventional	2013-01-31	Completed
An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection [NCT01924949]	Phase 2	5 participants (Actual)	Interventional	2013-07-31	Completed
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 2	10 participants (Actual)	Interventional	2015-03-02	Completed
Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study [NCT02717949]	Phase 4	1 participants (Actual)	Interventional	2016-02-25	Terminated(stopped due to failure to recruit)
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 2	40 participants (Actual)	Interventional	2016-03-31	Completed
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 3	25 participants (Actual)	Interventional	2016-04-30	Completed
Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection [NCT03061032]	Phase 3	200 participants (Anticipated)	Interventional	2017-03-31	Not yet recruiting
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 3	870 participants (Actual)	Interventional	2012-09-30	Completed
Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia [NCT02825212]	Phase 2/Phase 3	10 participants (Actual)	Interventional	2016-02-29	Completed
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 4	0 participants (Actual)	Interventional	2016-11-30	Withdrawn(stopped due to The supplies of study drug were halted by Gilead Sciences Ltd.)
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 2	40 participants (Actual)	Interventional	2014-08-31	Completed
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 2	26 participants (Actual)	Interventional	2015-06-30	Completed
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 2	50 participants (Actual)	Interventional	2013-06-30	Completed
A Phase II Open-Label Study of Ledipasvir/Sofosbuvir for 12 Weeks in Subjects With Hepatitis B Virus Infection [NCT03312023]	Phase 2	21 participants (Actual)	Interventional	2018-02-01	Completed
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 4	34 participants (Actual)	Interventional	2016-11-15	Completed
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 2	41 participants (Actual)	Interventional	2015-05-19	Completed
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 2	7 participants (Actual)	Interventional	2016-02-17	Terminated(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)	Interventional	2015-07-15	Terminated(stopped due to Unable to meet enrollment goal)
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 2	19 participants (Actual)	Interventional	2016-08-28	Completed
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 2	20 participants (Actual)	Interventional	2015-05-31	Completed
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)	Observational	2016-01-01	Completed
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 3	150 participants (Actual)	Interventional	2016-04-01	Completed
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 3	384 participants (Actual)	Interventional	2013-12-10	Completed
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 3	255 participants (Actual)	Interventional	2015-09-07	Completed
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 4	600 participants (Actual)	Interventional	2015-01-07	Completed
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 2	339 participants (Actual)	Interventional	2013-09-30	Completed
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]	2019-03-06	Recruiting
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 3	87 participants (Actual)	Interventional	2015-11-11	Terminated(stopped due to Due to lack of feasibility of enrolling participants, the study was terminated early.)
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 3	647 participants (Actual)	Interventional	2013-05-31	Completed
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)	Interventional	2014-10-31	Recruiting
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)	Interventional	2016-06-18	Recruiting
THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders [NCT02786537]	Phase 4	1,275 participants (Actual)	Interventional	2016-06-30	Completed
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 2	226 participants (Actual)	Interventional	2014-11-05	Completed
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 3	335 participants (Actual)	Interventional	2014-02-28	Completed
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute HCV in HIV-1 Infected Individuals (SWIFT-C) [NCT02128217]	Phase 1	44 participants (Actual)	Interventional	2014-05-30	Completed
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 2	155 participants (Actual)	Interventional	2013-10-31	Completed
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 2	100 participants (Actual)	Interventional	2014-07-31	Completed
Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT) [NCT02478229]	Phase 3	1 participants (Actual)	Interventional	2015-06-30	Terminated(stopped due to difficulty recruiting patients)
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 2	21 participants (Anticipated)	Interventional	2017-09-01	Not 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 2	334 participants (Actual)	Interventional	2014-01-31	Completed
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 2	114 participants (Actual)	Interventional	2014-10-14	Completed
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 2	47 participants (Actual)	Interventional	2014-07-31	Completed
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 2	85 participants (Actual)	Interventional	2014-03-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT01701401 (10) [back to overview]	Percentage of Participants With Virologic Failure
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)
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]	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]	Change From Baseline in HCV RNA at Week 8
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 2
NCT01768286 (14) [back to overview]	Percentage of Participants With Virologic Failure
NCT01768286 (14) [back to overview]	Change From Baseline in HCV RNA at Week 1
NCT01768286 (14) [back to overview]	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT01768286 (14) [back to overview]	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT01768286 (14) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 8
NCT01768286 (14) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 4
NCT01768286 (14) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 24
NCT01768286 (14) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 2
NCT01768286 (14) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 12
NCT01768286 (14) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 1
NCT01768286 (14) [back to overview]	Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
NCT01768286 (14) [back to overview]	Change From Baseline in HCV RNA at Week 8
NCT01768286 (14) [back to overview]	Change From Baseline in HCV RNA at Week 4
NCT01768286 (14) [back to overview]	Change From Baseline in HCV RNA at Week 2
NCT01805882 (1) [back to overview]	The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
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]	Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
NCT01851330 (10) [back to overview]	Change From Baseline in HCV RNA at Week 8
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 4
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 With HCV RNA < LLOQ at Week 8
NCT01851330 (10) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 2
NCT01878799 (1) [back to overview]	Percentage of Participants With Achieved SVR12 (HCV RNA
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]	HCV RNA Change From Baseline
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]	Percentage of Participants Experiencing Virologic Failure
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 HCV RNA < LLOQ on Treatment
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 Who Discontinued Study Drug Due to an Adverse Event
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]	HCV RNA and Change From Baseline at Week 4
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]	HCV RNA and Change From Baseline at Week 1
NCT01938430 (25) [back to overview]	Percentage of Participants With Virologic Failure
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 Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
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 4
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 12
NCT01938430 (25) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 16
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 HCV RNA < LLOQ at Week 6
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 20
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 a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
NCT01965535 (5) [back to overview]	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
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 HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
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 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 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
NCT01987453 (6) [back to overview]	Percentage of Participants With Virologic Failure
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)
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 SVR 24 Weeks After Discontinuation of Therapy (SVR24)
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 SVR 8 Weeks After Discontinuation of Therapy (SVR8)
NCT02010255 (25) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 16
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 a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
NCT02010255 (25) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 4
NCT02010255 (25) [back to overview]	HCV RNA Levels and Change From Baseline at Week 8
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 4
NCT02010255 (25) [back to overview]	HCV RNA Levels and Change From Baseline at Week 2
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 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 HCV RNA < LLOQ at Week 6
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 HCV RNA < LLOQ at Week 24
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 12
NCT02010255 (25) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 1
NCT02010255 (25) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Week 20
NCT02010255 (25) [back to overview]	Percentage of Participants With Virologic Failure
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 With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
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 Experiencing Viral Relapse
NCT02021656 (6) [back to overview]	HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only
NCT02021656 (6) [back to overview]	Percentage of Participants Experiencing Viral Breakthrough
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
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
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
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 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 SOF
NCT02128217 (19) [back to overview]	Percentage of Participants With HCV RNA Undetectable After End of Study Treatment
NCT02128217 (19) [back to overview]	Self-reported Adherence to RBV
NCT02128217 (19) [back to overview]	Count of Participants With HIV-1 RNA <50 Copies/mL
NCT02128217 (19) [back to overview]	Percentage of HCV Virologic Failure Participants That Developed SOF- or LDV-Associated Resistance Mutations
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]	Adherence as Measured by SOF Pill Count
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]	Cellular Concentration of Tenofovir Diphosphate (TFV-DP)
NCT02128217 (19) [back to overview]	Concentration of Tenofovir (TFV) in Plasma
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 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 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]	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 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)
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 MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol
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 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: Executive 2 Conceptual Shift and Initiation
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]	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 4 Weeks After Discontinuation of Therapy: Attention Scaled Score
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: Executive 2 Conceptual Shift and Initiation
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 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 WPAI: Hepatitis C - Activity Impairment
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)
NCT02226549 (3) [back to overview]	Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
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 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, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02249182 (26) [back to overview]	For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
NCT02249182 (26) [back to overview]	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]	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]	Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
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]	For Participants in the PK Lead-in 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 the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
NCT02249182 (26) [back to overview]	For the Treatment Phase, Change From Baseline in HCV RNA
NCT02249182 (26) [back to overview]	For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
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 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 With HCV RNA < LLOQ While On Treatment
NCT02249182 (26) [back to overview]	For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
NCT02249182 (26) [back to overview]	For the Treatment Phase, 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 Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
NCT02249182 (26) [back to overview]	For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
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
NCT02251717 (4) [back to overview]	Percentage of Participants With Virologic Failure
NCT02251717 (4) [back to overview]	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02301936 (14) [back to overview]	Percentage of Participants With HCV RNA < LLOQ on Treatment
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]	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]	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]	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 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]	Percentage of Participants With Virologic Failure
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 Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02301936 (14) [back to overview]	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
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]	Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT02339038 (1) [back to overview]	Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
NCT02347345 (5) [back to overview]	Virologic Response to Therapy as Measured by HCV RNA
NCT02347345 (5) [back to overview]	sCD14 (ng/mL)
NCT02347345 (5) [back to overview]	sCD14 (ng/mL)
NCT02347345 (5) [back to overview]	Gene Expression Profiles
NCT02347345 (5) [back to overview]	Gene Expression Profiles
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 Who Prematurely Discontinued Study Drug Due to an Adverse Event
NCT02350569 (5) [back to overview]	Percentage of Participants With Virologic Failure
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)
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 Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02413593 (6) [back to overview]	Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12
NCT02413593 (6) [back to overview]	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
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
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]	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]	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]	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Ledipasvir
NCT02421211 (19) [back to overview]	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT02421211 (19) [back to overview]	Minimum Plasma Concentration (Cmin) of Ledipasvir (LDV)
NCT02421211 (19) [back to overview]	Trough Plasma Concentration (Ctrough) of Simeprevir
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]	Percentage of Participants With On-treatment Virologic Response
NCT02421211 (19) [back to overview]	Trough Plasma Concentration (Ctrough) of Ledipasvir
NCT02457611 (9) [back to overview]	Percent Change From Baseline in CD4 T-cell Count at the End of 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 Virologic Failure
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 Who Permanently Discontinued Any Study Drug Due to an Adverse Event
NCT02457611 (9) [back to overview]	Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)
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]	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
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 HCV RNA < LLOQ on Treatment
NCT02472886 (8) [back to overview]	HCV RNA Change From Day 1
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]	Percentage of Participants With Virologic Failure
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 Who Discontinued Study Drug Due to Any Adverse Event (AE)
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
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 With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
NCT02487030 (4) [back to overview]	Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)
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
NCT02503735 (6) [back to overview]	Change in Urinary β-2microglobulin Levels After Therapy
NCT02503735 (6) [back to overview]	The Percent Change in Proteinuria
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
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 Breakthrough
NCT02600351 (6) [back to overview]	Number of Participants With Emerging Resistance
NCT02600351 (6) [back to overview]	Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event
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 Relapse
NCT02605304 (11) [back to overview]	Percentage of Participants With Protocol-specified Renal Events
NCT02605304 (11) [back to overview]	Number of Participants With Unquantifiable HCV RNA
NCT02605304 (11) [back to overview]	Number of Participants With HIV-1 RNA >50 Copies/mL
NCT02605304 (11) [back to overview]	Number of Participants With HIV-1 RNA >50 Copies/mL
NCT02605304 (11) [back to overview]	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]	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 24 Weeks After Treatment Discontinuation (SVR24)
NCT02605304 (11) [back to overview]	Percentage of Participants With Grade 3 or Higher Adverse Event (AE), Serious AE (SAE), or AE Reported as the Reason for Permanent Discontinuation of Study Treatment
NCT02605304 (11) [back to overview]	Number of Participants With Unquantifiable HCV RNA
NCT02613871 (16) [back to overview]	HCV RNA Change From Baseline While on Treatment
NCT02613871 (16) [back to overview]	Serum LOXL-2 Level Change From Baseline While on Treatment
NCT02613871 (16) [back to overview]	Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
NCT02613871 (16) [back to overview]	Plasma HBV DNA Change From Baseline While on Treatment
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 With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
NCT02613871 (16) [back to overview]	Percentage of Participants With HCV RNA < LLOQ While on Treatment
NCT02613871 (16) [back to overview]	Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
NCT02613871 (16) [back to overview]	Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study
NCT02613871 (16) [back to overview]	Percentage of Participants With Virologic Failure
NCT02613871 (16) [back to overview]	Percentage of Participants That Required HBV Therapy During the Study
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]	Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
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 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
NCT02631772 (3) [back to overview]	Number of Participants With Virologic Failure
NCT02631772 (3) [back to overview]	Hemoglobin Levels
NCT02631772 (3) [back to overview]	Treatment Efficacy
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 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 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)
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
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
NCT02786537 (28) [back to overview]	Mean Change in HCV- PRO- Phase 1
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]	HCV SVR Durability-Patients With Cirrhosis
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]	16 Wk EBR/GZR With RBV Efficacy on Patients With HCV RASs
NCT02786537 (28) [back to overview]	Median Change in Headache -Phase 1
NCT02786537 (28) [back to overview]	HCV SVR Durability -No Cirrhosis
NCT02786537 (28) [back to overview]	Treatment Non-Adherence Probability Estimates
NCT02786537 (28) [back to overview]	Change in Functional Status (HCV-PRO) Within Treatment
NCT02786537 (28) [back to overview]	Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation
NCT02786537 (28) [back to overview]	Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2
NCT02786537 (28) [back to overview]	Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF
NCT02786537 (28) [back to overview]	Mean Change in Headache-EBR/GZR and SOF/LDV
NCT02786537 (28) [back to overview]	Mean Change in Headache-PRO Scores -Phase 1
NCT02786537 (28) [back to overview]	Mean Change in Nausea/Vomiting PRO Score -Phase 1
NCT02786537 (28) [back to overview]	Median Change in Fatigue -Phase 1
NCT02786537 (28) [back to overview]	Median Change in Fatigue-Phase 2
NCT02786537 (28) [back to overview]	Median Change in HCV-PRO (Overall Well Being) -Phase 1
NCT02786537 (28) [back to overview]	Median Change in Headache-Phase 2
NCT02786537 (28) [back to overview]	Median Change in Nausea PRO Score -Phase 1
NCT02786537 (28) [back to overview]	Median Change in Nausea PROMIS Score-EBR/GZR SOF/LDV
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]	Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)
NCT02786537 (28) [back to overview]	Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation
NCT02786537 (28) [back to overview]	Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)
NCT02786537 (28) [back to overview]	Post-treatment Progression/Regression of Liver Disease-Fib-4
NCT02786537 (28) [back to overview]	Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV
NCT02825212 (2) [back to overview]	Sustained Virologic Response (SVR)
NCT02825212 (2) [back to overview]	Response in Patients With Mixed Cryoglobulinemia (MC)
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 With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
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 Who Permanently Discontinued Study Drug Due to an Adverse Event
NCT02868242 (7) [back to overview]	Percentage of Participants With HCV RNA < LLOQ While on Treatment
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]	Percentage of Participants With Virologic Failure
NCT02868242 (7) [back to overview]	HCV RNA Change From Baseline/Day 1
NCT03036839 (20) [back to overview]	PK Parameter: Cmax of SOF
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]	Change From Baseline in HCV RNA
NCT03036839 (20) [back to overview]	HCV RNA
NCT03036839 (20) [back to overview]	HCV RNA
NCT03036839 (20) [back to overview]	HCV RNA
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 SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
NCT03036839 (20) [back to overview]	Pharmacokinetics (PK) Parameter: AUCtau of LDV
NCT03036839 (20) [back to overview]	Percentage of Participants With Virologic Failure
NCT03036839 (20) [back to overview]	Percentage of Participants With HCV RNA < LLOQ on Treatment
NCT03036839 (20) [back to overview]	Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
NCT03036839 (20) [back to overview]	PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
NCT03036839 (20) [back to overview]	PK Parameter: AUCtau of SOF
NCT03036839 (20) [back to overview]	PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
NCT03036839 (20) [back to overview]	PK Parameter: Cmax of LDV
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
NCT03118674 (4) [back to overview]	Time to Resolution of Active PCT
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 Cure of CHC
NCT03118674 (4) [back to overview]	Number of Participants With Complete Biochemical Remission of PCT
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.
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.
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

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

,,,

Intervention	percentage of participants (Number)
	On-treatment virologic failure	Virologic relapse
LDV/SOF 12 Weeks	0	0.5
LDV/SOF 24 Weeks	0.5	0.5
LDV/SOF+RBV 12 Weeks	0	0
LDV/SOF+RBV 24 Weeks	0	0

Intervention	percentage of participants (Number)
LDV/SOF 12 Weeks	100
LDV/SOF+RBV 12 Weeks	99.1
LDV/SOF 24 Weeks	100
LDV/SOF+RBV 24 Weeks	100

Intervention	percentage of participants (Number)
LDV/SOF 12 Weeks	99.5
LDV/SOF+RBV 12 Weeks	100
LDV/SOF 24 Weeks	99.5
LDV/SOF+RBV 24 Weeks	100

Intervention	percentage of participants (Number)
LDV/SOF 12 Weeks	98.6
LDV/SOF+RBV 12 Weeks	97.2
LDV/SOF 24 Weeks	98.2
LDV/SOF+RBV 24 Weeks	99.1

Intervention	percentage of participants (Number)
	SVR4	SVR24
LDV/SOF 12 Weeks	98.6	98.6
LDV/SOF 24 Weeks	99.1	98.2
LDV/SOF+RBV 12 Weeks	98.2	97.2
LDV/SOF+RBV 24 Weeks	99.1	99.1

Intervention	percentage of participants (Number)
LDV/SOF 12 Weeks	82.2
LDV/SOF+RBV 12 Weeks	83.4
LDV/SOF 24 Weeks	82.9
LDV/SOF+RBV 24 Weeks	82.9

Intervention	log10 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

Intervention	log10 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

Intervention	log10 IU/mL (Mean)
LDV/SOF 12 Weeks	-4.57
LDV/SOF+RBV 12 Weeks	-4.50
LDV/SOF 24 Weeks	-4.47
LDV/SOF+RBV 24 Weeks	-4.50

Intervention	percentage of participants (Number)
LDV/SOF 12 Weeks	93.6
LDV/SOF+RBV 12 Weeks	96.4
LDV/SOF 24 Weeks	99.1
LDV/SOF+RBV 24 Weeks	99.1

Intervention	percentage of participants (Number)
LDV/SOF 12 Weeks	100.0
LDV/SOF+RBV 12 Weeks	100.0
LDV/SOF 24 Weeks	100.0
LDV/SOF+RBV 24 Weeks	100.0

Intervention	percentage of participants (Number)
LDV/SOF 12 Weeks	81.7
LDV/SOF+RBV 12 Weeks	82.9
LDV/SOF 24 Weeks	81.7
LDV/SOF+RBV 24 Weeks	83.8

Intervention	percentage of participants (Number)
LDV/SOF 12 Weeks	26.6
LDV/SOF+RBV 12 Weeks	33.3
LDV/SOF 24 Weeks	20.2
LDV/SOF+RBV 24 Weeks	29.7

Intervention	log10 IU/mL (Mean)
LDV/SOF 12 Weeks	-5.16
LDV/SOF+RBV 12 Weeks	-5.02
LDV/SOF 24 Weeks	-5.06
LDV/SOF+RBV 24 Weeks	-5.08

Intervention	percentage of subjects (Number)
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir	100
B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669	95
C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451	95
D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir	91.2
D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir	100
E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir	95
F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451	76
G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451	40
H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669	20

Intervention	percentage of participants (Number)
	On-treatment virologic failure	Virologic relapse
LDV/SOF 12 Week	0	1.4
LDV/SOF 8 Week	0	5.1
LDV/SOF+RBV 8 Week	0	4.2

Intervention	log10 IU/mL (Mean)
LDV/SOF 8 Week	-5.12
LDV/SOF+RBV 8 Week	-5.05
LDV/SOF 12 Week	-5.04

Intervention	percentage of participants (Number)
Subjects With HIV and HCV on Antiretroviral Agents	97
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents	100

Intervention	log10 IU/mL (Mean)
	Change at Week 1	Change at Week 4	Change at Week 8
LDV/SOF 12 Weeks	-4.36	-4.56	-4.56

Intervention	percentage of participants (Number)
	Week 1	Week 4	Week 8	Week 12
LDV/SOF 12 Weeks	60.0	100.0	100.0	100.0

Intervention	percentage of participants (Number)
	Decrease	No Change	Increase
Cohort A: Baseline CPT Class A (24 wk)	0.0	0.0	100.0
Cohort A: Baseline CPT Class B (12 wk)	63.3	23.3	13.3
Cohort A: Baseline CPT Class B (24 wk)	50.0	38.5	11.5
Cohort A: Baseline CPT Class C (12 wk)	89.5	10.5	0.0
Cohort A: Baseline CPT Class C (24 wk)	72.2	27.8	0.0
Cohort B: Baseline CPT Class A (12 wk)	18.2	68.2	13.6
Cohort B: Baseline CPT Class A (24 wk)	47.8	52.2	0.0
Cohort B: Baseline CPT Class B (12 wk)	56.5	34.8	8.7
Cohort B: Baseline CPT Class B (24 wk)	59.1	31.8	9.1
Cohort B: Baseline CPT Class C (12 wk)	50.0	50.0	0.0
Cohort B: Baseline CPT Class C (24 wk)	100.0	0.0	0.0

ledipasvir

Description

Cross-References

Synonyms (51)

Research Excerpts

Overview

Treatment

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Roles (2)

Drug Classes (10)

Protein Targets (1)

Inhibition Measurements

Activation Measurements

Bioassays (104)

Research

Studies (358)

Market Indicators

Research Demand Index: 54.31

Study Types

Clinical Trials (99)

Trial Overview

Trial Outcomes

Percentage of Participants With Virologic Failure

Percentage of Participants With HCV RNA < LLOQ at Week 4

Percentage of Participants With HCV RNA < LLOQ at Week 8

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

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

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

Percentage of Participants With HCV RNA < LLOQ at Week 2

Change From Baseline in HCV RNA at Week 8

Change From Baseline in HCV RNA at Week 4

Change From Baseline in HCV RNA at Week 2

Percentage of Participants With Virologic Failure

Change From Baseline in HCV RNA at Week 1

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

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

Percentage of Participants With HCV RNA < LLOQ at Week 8

Percentage of Participants With HCV RNA < LLOQ at Week 4

Percentage of Participants With HCV RNA < LLOQ at Week 24

Percentage of Participants With HCV RNA < LLOQ at Week 2

Percentage of Participants With HCV RNA < LLOQ at Week 12

Percentage of Participants With HCV RNA < LLOQ at Week 1

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

Change From Baseline in HCV RNA at Week 8

Change From Baseline in HCV RNA at Week 4

Change From Baseline in HCV RNA at Week 2

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

Percentage of Participants Experiencing Virologic Failure

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

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

Change From Baseline in HCV RNA at Week 8

Change From Baseline in HCV RNA at Week 4

Change From Baseline in HCV RNA at Week 2

Percentage of Participants With HCV RNA < LLOQ at Week 4

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

Percentage of Participants With HCV RNA < LLOQ at Week 8

Percentage of Participants With HCV RNA < LLOQ at Week 2

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

HCV RNA Change From Baseline

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

Percentage of Participants Experiencing Virologic Failure

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

Percentage of Participants With HCV RNA < LLOQ on Treatment

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

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

HCV RNA and Change From Baseline at Week 8

HCV RNA and Change From Baseline at Week 6

HCV RNA and Change From Baseline at Week 4

HCV RNA and Change From Baseline at Week 2

HCV RNA and Change From Baseline at Week 12

HCV RNA and Change From Baseline at Week 1

Percentage of Participants With Virologic Failure

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

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

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

Percentage of Participants With HCV RNA < LLOQ at Week 1

Intervention	percentage of participants (Number)
	Discontinued LDV/SOF	Discontinued Any Study Drug
Cohort A, Group 1 (12 wk): CPT Class B (7-9)	0.0	0.0
Cohort A, Group 1 (24 wk): CPT Class B (7-9)	6.9	13.8
Cohort A, Group 2 (12 wk): CPT Class C (10-12)	4.3	13.0
Cohort A, Group 2 (24 wk): CPT Class C (10-12)	7.7	34.6
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis	0.0	10.9
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	3.6	17.9
Cohort B, Group 4 (12 wk): CPT Class A (5-6)	3.8	15.4
Cohort B, Group 4 (24 wk): CPT Class A (5-6)	0.0	8.0
Cohort B, Group 5 (12 wk): CPT Class B (7-9)	7.7	23.1
Cohort B, Group 5 (24 wk): CPT Class B (7-9)	11.5	34.6
Cohort B, Group 6 (12 wk): CPT Class C (10-12)	0.0	40.0
Cohort B, Group 6 (24 wk): CPT Class C (10-12)	0.0	25.0
Cohort B, Group 7 (12 wk): FCH	0.0	25.0
Cohort B, Group 7 (24 wk): FCH	0.0	0.0

Intervention	log10 IU/mL (Mean)
	Week 6	Change 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 Fibrosis	1.15	-5.32
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	1.15	-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): FCH	1.15	-5.36
Cohort B, Group 7 (24 wk): FCH	1.15	-5.28

Intervention	log10 IU/mL (Mean)
	Week 2	Change 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 Fibrosis	1.64	-4.83
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	1.59	-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): FCH	1.66	-4.85
Cohort B, Group 7 (24 wk): FCH	1.61	-4.81

Intervention	log10 IU/mL (Mean)
	Week 12	Change 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 Fibrosis	1.15	-5.33
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	1.15	-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): FCH	1.15	-5.36
Cohort B, Group 7 (24 wk): FCH	1.15	-5.91

Intervention	percentage 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 Fibrosis	3.6
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	0.0
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): FCH	3.6
Cohort B, Group 7 (24 wk): FCH	0.0

Intervention	percentage 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 Fibrosis	96.4
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	98.2
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): FCH	100.0
Cohort B, Group 7 (24 wk): FCH	100.0

Intervention	percentage 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 Fibrosis	96.4
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	98.2
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): FCH	100.0
Cohort B, Group 7 (24 wk): FCH	100.0

Intervention	percentage 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 Fibrosis	87.3
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	90.9
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): FCH	100.0
Cohort B, Group 7 (24 wk): FCH	50.0

Intervention	percentage 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 Fibrosis	100.0
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	98.2
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): FCH	100.0
Cohort B, Group 7 (24 wk): FCH	100.0

Intervention	percentage 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 Fibrosis	49.1
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	41.8
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): FCH	50.0
Cohort B, Group 7 (24 wk): FCH	0.0