carbamates has been researched along with Cirrhosis, Liver in 238 studies
| Excerpt | Relevance | Reference |
|---|---|---|
| "The Daclatasvir and Sofosbuvir combination therapy (SOF/DCV) has shown efficacy in patients with chronic hepatitis C in clinical trials." | 9.27 | Sofosbuvir plus daclatasvir with or without ribavirin in 551 patients with hepatitis C-related cirrhosis, genotype 4. ( El-Amin, H; El-Khayat, H; Fouad, Y; Kamal, EM; Maher, M; Mohamed, HI; Risk, A, 2018) |
| "In phase 3 trials and real-world settings, smaller proportions of patients with genotype 3 hepatitis C virus (HCV) infection and cirrhosis have a sustained virologic response 12 weeks after treatment (SVR12) with the combination of sofosbuvir and velpatasvir than in patients without cirrhosis." | 9.27 | Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. ( Andrade, RJ; Brainard, DM; Buti, M; Calleja, JL; Camus, G; Carrión, JA; Casado, M; Esteban, R; Forns, X; Lens, S; McNabb, B; Morano Amado, LE; Morillas, RM; Pascasio Acevedo, JM; Pineda, JA; Riveiro-Barciela, M; Rivero, A; Rodríguez, M; Stamm, LM; Subramanian, GM; Turnes, J; Zhang, G, 2018) |
| "We performed a phase 2 trial of the efficacy and safety of 4, 6, and 8 weeks of sofosbuvir, given in combination with the NS5A inhibitor velpatasvir and the NS3/4A protease inhibitor GS-9857, in patients with hepatitis C virus (HCV) infection." | 9.22 | Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. ( Brainard, DM; Gane, EJ; Hyland, RH; McHutchison, JG; Schwabe, C; Stamm, LM; Stedman, CA; Svarovskaia, E; Yang, Y, 2016) |
| " The C-EDGE CO-INFECTION study assessed the efficacy, safety, and tolerability of grazoprevir (MK-5172) plus elbasvir (MK-8742) in patients with HCV and HIV co-infection." | 9.20 | Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. ( Barr, E; Bloch, M; Gress, J; Katlama, C; Klopfer, S; Lalezari, J; Mallolas, J; Matthews, GV; Nelson, M; Nguyen, BY; Orkin, C; Platt, HL; Robertson, MN; Rockstroh, JK; Saag, MS; Shaughnessy, M; Sulkowski, M; Wahl, J; Zamor, PJ, 2015) |
| "Abstract Our objective was to evaluate the liver toxicity of antiretroviral regimens including fosamprenavir plus ritonavir (FPV/r) 1400/100 mg once daily (QD) in HIV/hepatitis C virus (HCV)-coinfected patients." | 9.15 | Liver toxicity of antiretroviral combinations including fosamprenavir plus ritonavir 1400/100 mg once daily in HIV/hepatitis C virus-coinfected patients. ( Delgado-Fernández, M; García-Figueras, C; López-Cortés, LF; Macías, J; Márquez-Solero, M; Martínez-Pérez, MA; Mata, R; Merchante, N; Merino, D; Omar, M; Pasquau, J; Pineda, JA; Ríos-Villegas, MJ; Rivero, A, 2011) |
| "The direct-acting antiviral regimen of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r)±dasabuvir (DSV)±ribavirin (RBV) demonstrated high rates of sustained viral response at post-treatment week 12 (SVR12) in clinical trials for treatment of hepatitis C virus (HCV) genotypes (GT) 1 and 4." | 8.95 | Real-world effectiveness of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in patients with hepatitis C virus genotype 1 or 4 infection: A meta-analysis. ( Bao, Y; Calleja, JL; Craxí, A; Dieterich, D; Flisiak, R; Martinez, M; Pangerl, A; Roberts, SK; Wedemeyer, H; Zhang, Z; Zuckerman, E, 2017) |
| " Areas covered: This review covers the preclinical and clinical development of sofosbuvir/velpatasvir (SOF/VEL), an interferon-free, once daily, pangenotypic treatment for the treatment of chronic hepatitis C virus (HCV) infection." | 8.95 | A pangenotypic, single tablet regimen of sofosbuvir/velpatasvir for the treatment of chronic hepatitis C infection. ( Jacobson, IM; Weisberg, IS, 2017) |
| "Ombitasvir + paritaprevir combined with ritonavir and dasabuvir ± ribavirin is an effective treatment for patients infected with genotype 1 hepatitis C who have coagulation disorders." | 8.12 | Efficacy and Safety of Ombitasvir/Paritaprevir/ Ritonavir + Dasabuvir ± Ribavirin Combinations in Patients with Genotype 1 Hepatitis C and Inherited Bleeding Disorders. ( Ar, C; Bozcan, S; Canbakan, B; Gültürk, İ; Hatemi, İ; Özdemir, S; Sonsuz, A; Yıldırım, S, 2022) |
| "BACKGROUND In the European Union, a tablet with fixed doses of ombitasvir, paritaprevir, and ritonavir combined with dasabuvir is an authorized treatment for patients with chronic hepatitis C virus (HCV) infection." | 8.12 | A Real-World Study to Compare the Safety and Efficacy of Paritaprevir/Ombitasvir/Ritonavir and Dasabuvir, with or without Ribavirin, in 587 Patients with Chronic Hepatitis C at the Fundeni Clinical Institute, Bucharest, Romania. ( Bacinschi, X; Gales, L; Haineala, B; Iliescu, L; Mercan, A; Popescu, GC; Rodica, A; Serban, D; Toma, L; Zgura, A, 2022) |
| "Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited." | 8.02 | Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis. ( Chang, CC; Chang, CH; Chang, CY; Chen, CY; Chen, JJ; Chen, PY; Fang, YJ; Hsieh, TY; Huang, CS; Huang, KJ; Huang, YJ; Hwang, JJ; Kao, JH; Kao, WY; Lai, HC; Lee, FJ; Lee, PL; Liu, CH; Liu, CJ; Lo, CC; Peng, CY; Shih, YL; Su, PY; Su, WW; Tsai, MC; Tseng, CW; Tseng, KC; Wu, JH; Yang, SS, 2021) |
| "The aim of this study was to compare and evaluate the safety and efficacy of sofosbuvir/ daclatasvir versus sofosbuvir/ledipasvir for the treatment of non-cirrhotic naïve patients with chronic Hepatitis C Virus (HCV) genotype 4 infection for 12 weeks." | 7.96 | Ledipasvir/Sofosbuvir versus Daclatasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype 4 Patients. ( Abdelaty, LN; Elnaggar, AA; Hussein, RRS; Said, AA, 2020) |
| "Twelve weeks sofosbuvir/velpatasvir (SOF/VEL) is a highly effective pan-genotypic regimen for hepatitis C." | 7.96 | Eight weeks of sofosbuvir/velpatasvir for genotype 3 hepatitis C in previously untreated patients with significant (F2/3) fibrosis. ( Barclay, ST; Boyle, A; Datta, S; Heydtmann, M; Marra, F; Peters, E; Priest, M; Ritchie, T, 2020) |
| "Many of the treatment regimens available for hepatitis C include sofosbuvir." | 7.96 | The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. ( Afshar, B; Agah, S; Amiriani, T; Fattahi Abdizadeh, M; Fattahi, MR; Hormati, A; Khoshnia, M; Latifnia, M; Majd Jabbari, S; Maleki, I; Malekzadeh, R; Malekzadeh, Z; Mansour-Ghanaei, F; Merat, D; Merat, S; Minakari, M; Moini, M; Mokhtare, M; Poustchi, H; Roozbeh, F; Sharifi, AH; Shayesteh, AA; Shayesteh, E; Sofian, M; Sohrabi, M; Somi, MH, 2020) |
| "Sofosbuvir/velpatasvir (SOF/VEL) is expected to be highly effective, even in patients with decompensated liver cirrhosis." | 7.96 | Hepatitis C virus-associated decompensated liver cirrhosis with refractory hepatic encephalopathy successfully treated by balloon-occluded retrograde transvenous obliteration after sofosbuvir/velpatasvir. ( Kakizaki, S; Kizawa, K; Kosone, T; Marubashi, K; Sato, K; Shimizu, M; Takagi, H; Takakusagi, S; Uraoka, T; Yokoyama, Y, 2020) |
| "Sofosbuvir (SOF) and daclatasvir (DCV) treatment achieves excellent efficacy and safety in treating chronic hepatitis C (CHC) with various genotypes." | 7.91 | Real-world effectiveness and safety of sofosbuvir plus daclatasvir with or without ribavirin for genotype 2 chronic hepatitis C in Taiwan. ( Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC, 2019) |
| "Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3." | 7.88 | Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt. ( AbdAllah, M; Doss, W; El Akel, W; El Kassas, M; El Shazly, H; El Shazly, Y; Elbaz, T; Elsaeed, K; Esmat, G; Gomaa, AA; Ismail, SA; Korany, M; Nasr, A; Omar, H; Said, M; Shaker, MK; Waked, I; Yousif, M, 2018) |
| "Twelve weeks of the pangenotypic direct-acting antiviral (DAA) combination sofosbuvir/velpatasvir (SOF/VEL) was highly efficient in patients with hepatitis C virus (HCV) genotype 3 (GT3) infection in the ASTRAL-3 approval study." | 7.88 | High efficacy of sofosbuvir/velpatasvir and impact of baseline resistance-associated substitutions in hepatitis C genotype 3 infection. ( Baumgarten, A; Boesecke, C; Busch, HW; Christensen, S; Daeumer, M; Hueppe, D; Ingiliz, P; Luebke, N; Lutz, T; Mauss, S; Rockstroh, JK; Sarrazin, C; Schewe, K; Schulze Zur Wiesch, J; Simon, KG; Timm, J; Vermehren, J; von Felden, J, 2018) |
| " The study included patients from 16 hepatologic centres involved in the AMBER, investigator-initiated study on treatment of chronic hepatitis C patients within a programme preceding EU registration of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin." | 7.88 | Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in the AMBER, real-world experience study. ( Berak, H; Białkowska, J; Bolewska, B; Fleischer-Stępniewska, K; Flisiak, R; Garlicki, A; Janczewska, E; Karpińska, E; Karwowska, K; Nazzal, K; Piekarska, A; Simon, K; Tomasiewicz, K; Tronina, O; Tuchendler, E; Zarębska-Michaluk, D; Łucejko, M, 2018) |
| "Hepatic decompensation is a severe on-treatment adverse event for chronic hepatitis C treated with paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD)." | 7.88 | Hepatic decompensation during paritaprevir/ritonavir/ombitasvir/dasabuvir treatment for genotype 1b chronic hepatitis C patients with advanced fibrosis and compensated cirrhosis. ( Chen, WT; Chen, YC; Hsieh, YC; Huang, CH; Jeng, WJ; Lin, CY; Lin, SM; Sheen, IS; Tai, DI; Teng, W, 2018) |
| "Sofosbuvir (SOF) and daclatasvir combination with or without ribavirin proved to be effective and safe in the treatment of hepatitis C virus infection." | 7.88 | Association of IL-1β, IL-1RN, and ESR1 genes polymorphism with risk of infection and response to sofosbuvir plus daclatasvir combination therapy in hepatitis C virus genotype-4 patients. ( Abd Elfatah, AS; Abdalla, NH; Abdel-Raheim, S; Abdulghany, HM; Khairy, RM; Zenhom, NM, 2018) |
| "To report a case series of three patients with hepatitis C virus infection who all presented with severe type B lactic acidosis shortly after starting treatment with ombitasvir-paritaprevir-ritonavir-dasabuvir." | 7.85 | Ombitasvir-Paritaprevir-Ritonavir-Dasabuvir (Viekira Pak)-Induced Lactic Acidosis. ( Hiensch, RJ; Oberg, CL; Poor, HD, 2017) |
| "Among 41 patients treated, 35 (85%) patients had genotype 1b HCV infection, 6 (15%) had co-infection with human immunodeficiency virus, 35 (85%) failed previous peginterferon and ribavirin therapy, 25 (61%) had compensated liver cirrhosis, and 3 (7%) had liver transplantation." | 7.85 | Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong. ( But, DY; Chan, CK; Chan, HL; Chan, KH; Fung, J; Hui, YT; Lai, CL; Lai, MS; Lam, YS; Lao, WC; Li, C; Lui, GC; Seto, WK; Tsang, OT; Wong, GL; Wong, VW; Yuen, MF, 2017) |
| "For six adult chronic hepatitis C 1b patients with a pre-existing NS5A-Y93H (>20%) polymorphism, we added ribavirin (800 mg/d) to daclatasvir/asunaprevir for 24 weeks and followed through 12-weeks post-treatment." | 7.85 | Addition of ribavirin to daclatasvir plus asunaprevir for chronic hepatitis C 1b patients with baseline NS5A resistance-associated variants improved response. ( Chen, PJ; Hong, CM; Liu, CJ; Yeh, SH, 2017) |
| "We observed a sustained viral response (SVR) of ombitasvir/paritaprevir/ritonavir, dasabuvir and ribavirin therapy, for 12 wk, in two cases with compensated liver cirrhosis and fully destroyed early hepatocellular carcinoma (HCC)." | 7.83 | Ombitasvir, paritaprevir, ritonavir, dasabuvir and ribavirin in cirrhosis after complete destruction of hepatocellular carcinoma. ( Antonov, K; Atanasova, E; Boyanova, Y; Jelev, D; Krastev, Z; Mateva, L; Petkova, T; Tomov, B; Zheleva, N, 2016) |
| "We investigated the real-world effectiveness of sofosbuvir, ledipasvir/sofosbuvir, and paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD) in treatment of different subgroups of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, or 4." | 7.83 | Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care System. ( Berry, K; Beste, LA; Chang, MF; Green, PK; Ioannou, GN; Lowy, E; Su, F; Tsui, JI, 2016) |
| "Sofosbuvir (SOF) plus daclatasvir (DCV) with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C." | 7.83 | Sofosbuvir plus daclatasvir with or without ribavirin for chronic hepatitis C infection: Impact of drug concentration on viral load decay. ( Bailly, F; Choupeaux, L; Gagnieu, MC; Maynard, M; Pradat, P; Scholtès, C; Virlogeux, V; Zoulim, F, 2016) |
| "The aim of this study was to compare amprenavir pharmacokinetics in HIV/hepatitis C virus (HCV)-co-infected cirrhotic patients receiving non-boosted fosamprenavir 700 mg twice daily with HCV/HIV-co-infected non-cirrhotic subjects and HIV-mono-infected subjects receiving fosamprenavir/ritonavir 700/100 mg twice daily." | 7.75 | Unboosted fosamprenavir is associated with low drug exposure in HIV-infected patients with mild-moderate liver impairment resulting from HCV-related cirrhosis. ( Bonora, S; Carosi, G; de Requena, DG; Gatti, F; Loregian, A; Matti, A; Nasta, P; Pagni, S; Palù, G; Parisi, SG; Prestini, K; Puoti, M, 2009) |
| "The most common adverse events were upper respiratory tract infection (36 [10%] patients) and headache (18 [5%] patients)." | 6.90 | Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. ( Brainard, DM; Cheng, J; Dao, L; Dou, X; Duan, Z; Dvory-Sobol, H; Gao, Y; Gao, ZL; Gong, G; Hou, JL; Hu, P; Huang, Y; Jia, J; Le Manh, H; Le, TTP; Li, J; Lim, SG; Lin, F; Lu, S; Mao, Y; Mo, H; Mohamed, R; Mou, Z; Nan, Y; Ning, Q; Piratvisuth, T; Shang, J; Sobhonslidsuk, A; Stamm, LM; Su, M; Tan, CK; Tang, H; Tangkijvanich, P; Tanwandee, T; Tee, HP; Thongsawat, S; Văn, KN; Wang, GQ; Wei, L; Wu, S; Xie, Q; Xu, M; Yang, YF; Zhang, L, 2019) |
| " Adverse effects were mild and non-specific." | 6.90 | Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs. ( Antonio Carrión, J; Arenas, J; Arencibia, A; Badia, E; Bernal, V; Buti, M; Cachero, A; Carmona, I; Conde, I; Delgado, M; Diago, M; Esteban, R; Fernández, I; Fernández-Bermejo, M; Fernández-Rodríguez, C; Figueruela, B; García-Samaniego, J; Gea, F; González-Santiago, JM; Hernández-Guerra, M; Iñarrairaegui, M; Lens, S; Llaneras, J; Llerena, S; Luis Calleja, J; María Morillas, R; Mariño, Z; Montoliu, S; Pascasio, JM; Riveiro-Barciela, M; Rosales, JM; Torras, X; Turnes, J, 2019) |
| " The most common adverse events were headache (143 [22%] of 664), fatigue (129 [19%] of 664), and nausea (83 [13%] of 664)." | 6.84 | Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2, ( Almasio, PL; Barr, E; Bruno, S; Buti, M; Butterton, JR; Dutko, FJ; Fernsler, D; Gao, W; Grandhi, A; Hassanein, TI; Huang, HC; Jancoriene, L; Lawitz, E; Li, JJ; Liu, H; Muellhaupt, B; Nguyen, BT; Pearlman, B; Plank, RM; Robertson, MN; Ruane, PJ; Shepherd, A; Su, FH; Tannenbaum, B; Vierling, JM; Wahl, J; Wan, S; Yeh, WW; Yoshida, EM, 2017) |
| " We assessed the efficacy and safety of the two direct-acting antiviral drugs ombitasvir, an NS5A inhibitor, and paritaprevir, an NS3/4A protease inhibitor dosed with ritonavir, plus ribavirin in treatment of chronic HCV infection in Egypt." | 6.82 | Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. ( Allam, N; Asselah, T; Doss, W; Esmat, G; Hall, C; Hassany, M; Mobashery, N; Mohey, MA; Qaqish, RB; Redman, R; Shiha, G; Soliman, R; Waked, I; Yosry, A; Zayed, N, 2016) |
| " Common adverse events included headache, asthenia, pruritus, and diarrhea." | 6.80 | Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis. ( Akarca, US; Hall, C; Hézode, C; Lawitz, E; Makara, M; Mobashery, N; Morillas, RM; Pilot-Matias, T; Preotescu, LL; Redman, R; Thuluvath, PJ; Varunok, P; Vilchez, RA, 2015) |
| "Although the combination with PrOD significantly affects the pharmacokinetics of CsA, it is effective and safe with regular monitoring of the CsA blood concentrations and appropriate CsA dose adjustment." | 5.72 | Drug-Drug Interactions With Cyclosporine in the Anti-Hepatitis C Viral PrOD Combination Regimen of Paritaprevir/Ritonavir-Ombitasvir and Dasabuvir in Organ Transplant Recipients With Severe Hepatic Fibrosis or Cirrhosis. ( Chang, YL; Chou, YC; Hsu, CC; Huang, YH; Huang, YY; Loong, CC; Wu, TH, 2022) |
| " The primary safety endpoint was treatment withdrawal rates secondary to severe adverse events." | 5.51 | Effectiveness and safety of daclatasvir/sofosbuvir with or without ribavirin in genotype 3 hepatitis C virus infected patients. Results in real clinical practice. ( Castro-Iglesias, A; Cid-Silva, P; Delgado-Blanco, M; Margusino-Framiñán, L; Martín-Herranz, I; Mena-de-Cea, A; Pernas-Souto, B; Pertega-Díaz, S; Rodríguez-Osorio, I, 2019) |
| " The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pre-treatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment." | 5.46 | Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 - final results of the REV1TAL study. ( Bollipo, S; Cheng, W; Chivers, S; Dore, G; Fragomeli, V; Galhenage, S; Gazzola, A; George, J; Gow, P; Iser, D; Jones, T; Levy, M; Lubel, J; MacQuillan, G; Mitchell, JL; Nazareth, S; Pianko, S; Roberts, SK; Sasadeusz, J; Strasser, S; Stuart, KA; Thompson, A; Tse, E; Wade, A; Weltman, M; Wigg, A; Zekry, A, 2017) |
| "DCV was dosed at week 4 and at week 8 of treatment, and RBV at week 8." | 5.43 | Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin. ( Andreis, S; Basso, M; Cattelan, AM; Cavinato, S; Dal Bello, F; Loregian, A; Messa, L; Nannetti, G; Palù, G; Parisi, SG; Scaggiante, R, 2016) |
| "We conducted a nonrandomized clinical trial of 12 or 24 weeks of paritaprevir-ritonavir-ombitasvir plus dasabuvir (PrOD) with or without ribavirin in persons with HCV-1/HIV coinfection suppressed with antiretroviral therapy." | 5.34 | Hepatitis C Virus (HCV) Direct-Acting Antiviral Therapy in Persons With Human Immunodeficiency Virus-HCV Genotype 1 Coinfection Resulting in High Rate of Sustained Virologic Response and Variable in Normalization of Soluble Markers of Immune Activation. ( Alston-Smith, BL; Anthony, DD; Balagopal, A; Bhattacharya, D; Cohen, DE; Damjanovska, S; Kowal, CM; Shive, CL; Smeaton, LM; Sulkowski, MS; Wyles, DL, 2020) |
| "gov: NCT02349048) study investigated the efficacy, safety and pharmacokinetics of a 6- or 8-week regimen of simeprevir, daclatasvir and sofosbuvir in treatment-naïve patients with chronic hepatitis C virus (HCV) genotype (GT) 1 infection and either early-stage fibrosis or compensated cirrhosis." | 5.27 | Efficacy and safety of 6 or 8 weeks of simeprevir, daclatasvir, sofosbuvir for HCV genotype 1 infection. ( Beumont, M; Corregidor, AM; Feld, JJ; Felizarta, F; Gamil, M; Ghalib, R; Kakuda, TN; Khalid, O; Lawitz, E; Luo, D; Ouwerkerk-Mahadevan, S; Smith, WB; Sulkowski, MS; Van Eygen, V; Van Remoortere, P; Vijgen, L, 2018) |
| "The Daclatasvir and Sofosbuvir combination therapy (SOF/DCV) has shown efficacy in patients with chronic hepatitis C in clinical trials." | 5.27 | Sofosbuvir plus daclatasvir with or without ribavirin in 551 patients with hepatitis C-related cirrhosis, genotype 4. ( El-Amin, H; El-Khayat, H; Fouad, Y; Kamal, EM; Maher, M; Mohamed, HI; Risk, A, 2018) |
| "In phase 3 trials and real-world settings, smaller proportions of patients with genotype 3 hepatitis C virus (HCV) infection and cirrhosis have a sustained virologic response 12 weeks after treatment (SVR12) with the combination of sofosbuvir and velpatasvir than in patients without cirrhosis." | 5.27 | Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. ( Andrade, RJ; Brainard, DM; Buti, M; Calleja, JL; Camus, G; Carrión, JA; Casado, M; Esteban, R; Forns, X; Lens, S; McNabb, B; Morano Amado, LE; Morillas, RM; Pascasio Acevedo, JM; Pineda, JA; Riveiro-Barciela, M; Rivero, A; Rodríguez, M; Stamm, LM; Subramanian, GM; Turnes, J; Zhang, G, 2018) |
| "We performed a phase 2 trial of the efficacy and safety of 4, 6, and 8 weeks of sofosbuvir, given in combination with the NS5A inhibitor velpatasvir and the NS3/4A protease inhibitor GS-9857, in patients with hepatitis C virus (HCV) infection." | 5.22 | Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. ( Brainard, DM; Gane, EJ; Hyland, RH; McHutchison, JG; Schwabe, C; Stamm, LM; Stedman, CA; Svarovskaia, E; Yang, Y, 2016) |
| " The C-EDGE CO-INFECTION study assessed the efficacy, safety, and tolerability of grazoprevir (MK-5172) plus elbasvir (MK-8742) in patients with HCV and HIV co-infection." | 5.20 | Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. ( Barr, E; Bloch, M; Gress, J; Katlama, C; Klopfer, S; Lalezari, J; Mallolas, J; Matthews, GV; Nelson, M; Nguyen, BY; Orkin, C; Platt, HL; Robertson, MN; Rockstroh, JK; Saag, MS; Shaughnessy, M; Sulkowski, M; Wahl, J; Zamor, PJ, 2015) |
| "Abstract Our objective was to evaluate the liver toxicity of antiretroviral regimens including fosamprenavir plus ritonavir (FPV/r) 1400/100 mg once daily (QD) in HIV/hepatitis C virus (HCV)-coinfected patients." | 5.15 | Liver toxicity of antiretroviral combinations including fosamprenavir plus ritonavir 1400/100 mg once daily in HIV/hepatitis C virus-coinfected patients. ( Delgado-Fernández, M; García-Figueras, C; López-Cortés, LF; Macías, J; Márquez-Solero, M; Martínez-Pérez, MA; Mata, R; Merchante, N; Merino, D; Omar, M; Pasquau, J; Pineda, JA; Ríos-Villegas, MJ; Rivero, A, 2011) |
| "The direct-acting antiviral regimen of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r)±dasabuvir (DSV)±ribavirin (RBV) demonstrated high rates of sustained viral response at post-treatment week 12 (SVR12) in clinical trials for treatment of hepatitis C virus (HCV) genotypes (GT) 1 and 4." | 4.95 | Real-world effectiveness of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in patients with hepatitis C virus genotype 1 or 4 infection: A meta-analysis. ( Bao, Y; Calleja, JL; Craxí, A; Dieterich, D; Flisiak, R; Martinez, M; Pangerl, A; Roberts, SK; Wedemeyer, H; Zhang, Z; Zuckerman, E, 2017) |
| " Areas covered: This review covers the preclinical and clinical development of sofosbuvir/velpatasvir (SOF/VEL), an interferon-free, once daily, pangenotypic treatment for the treatment of chronic hepatitis C virus (HCV) infection." | 4.95 | A pangenotypic, single tablet regimen of sofosbuvir/velpatasvir for the treatment of chronic hepatitis C infection. ( Jacobson, IM; Weisberg, IS, 2017) |
| "A literature search through EMBASE and PubMed was conducted (January 1966 to August 2015) using the terms BMS-790052, daclatasvir, and hepatitis C." | 4.93 | Daclatasvir: A NS5A Replication Complex Inhibitor for Hepatitis C Infection. ( Mohammad, RA; Regal, RE; Smith, MA, 2016) |
| "To review the data with ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection." | 4.91 | Ombitasvir/paritaprevir/ritonavir and dasabuvir tablets for hepatitis C virus genotype 1 infection. ( Gale, SE; Klibanov, OM; Santevecchi, B, 2015) |
| "A fixed-dose tablet comprising ombitasvir (an NS5A replication complex inhibitor), paritaprevir (an NS3/4A protease inhibitor) and ritonavir (a cytochrome P450 inhibitor) taken in combination with dasabuvir (an NS5B polymerase inhibitor) is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in several countries, including the USA (copackaged as Viekira Pak(™)) and those of the EU (Viekirax(®) and Exviera(®))." | 4.91 | Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir: A Review in Chronic HCV Genotype 1 Infection. ( Deeks, ED, 2015) |
| "Ombitasvir + paritaprevir combined with ritonavir and dasabuvir ± ribavirin is an effective treatment for patients infected with genotype 1 hepatitis C who have coagulation disorders." | 4.12 | Efficacy and Safety of Ombitasvir/Paritaprevir/ Ritonavir + Dasabuvir ± Ribavirin Combinations in Patients with Genotype 1 Hepatitis C and Inherited Bleeding Disorders. ( Ar, C; Bozcan, S; Canbakan, B; Gültürk, İ; Hatemi, İ; Özdemir, S; Sonsuz, A; Yıldırım, S, 2022) |
| "BACKGROUND In the European Union, a tablet with fixed doses of ombitasvir, paritaprevir, and ritonavir combined with dasabuvir is an authorized treatment for patients with chronic hepatitis C virus (HCV) infection." | 4.12 | A Real-World Study to Compare the Safety and Efficacy of Paritaprevir/Ombitasvir/Ritonavir and Dasabuvir, with or without Ribavirin, in 587 Patients with Chronic Hepatitis C at the Fundeni Clinical Institute, Bucharest, Romania. ( Bacinschi, X; Gales, L; Haineala, B; Iliescu, L; Mercan, A; Popescu, GC; Rodica, A; Serban, D; Toma, L; Zgura, A, 2022) |
| "To evaluate the cost-effectiveness of therapeutic strategies initiated at different stages of liver fibrosis using three direct-acting antivirals (DAAs), sofosbuvir-ledipasvir (SL), glecaprevir-pibrentasvir (GP), and elbasvir plus grazoprevir (E/G), for Japanese patients with chronic hepatitis C (CHC) genotype 1." | 4.02 | Cost-effectiveness of a "treat-all" strategy using Direct-Acting Antivirals (DAAs) for Japanese patients with chronic hepatitis C genotype 1 at different fibrosis stages. ( Hidaka, I; Hirao, T; Ishida, H; Sakaida, I; Suenaga, R; Suka, M, 2021) |
| "Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited." | 4.02 | Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis. ( Chang, CC; Chang, CH; Chang, CY; Chen, CY; Chen, JJ; Chen, PY; Fang, YJ; Hsieh, TY; Huang, CS; Huang, KJ; Huang, YJ; Hwang, JJ; Kao, JH; Kao, WY; Lai, HC; Lee, FJ; Lee, PL; Liu, CH; Liu, CJ; Lo, CC; Peng, CY; Shih, YL; Su, PY; Su, WW; Tsai, MC; Tseng, CW; Tseng, KC; Wu, JH; Yang, SS, 2021) |
| "The aim of this study was to compare and evaluate the safety and efficacy of sofosbuvir/ daclatasvir versus sofosbuvir/ledipasvir for the treatment of non-cirrhotic naïve patients with chronic Hepatitis C Virus (HCV) genotype 4 infection for 12 weeks." | 3.96 | Ledipasvir/Sofosbuvir versus Daclatasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype 4 Patients. ( Abdelaty, LN; Elnaggar, AA; Hussein, RRS; Said, AA, 2020) |
| "Grazoprevir/elbasvir (GZR/EBR) was approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 and 4 infected patients with or without compensated liver cirrhosis." | 3.96 | Real-world experience with Grazoprevir/Elbasvir in the treatment of previously "difficult to treat" patients infected with hepatitis C virus genotype 1 and 4. ( Belica-Wdowik, T; Berak, H; Białkowska-Warzecha, J; Blaszkowska, M; Buczyńska, I; Czauż-Andrzejuk, A; Deroń, Z; Dobracka, B; Dybowska, D; Flisiak, R; Garlicki, A; Halota, W; Horban, A; Janczewska, E; Jaroszewicz, J; Klapaczyński, J; Laurans, Ł; Lorenc, B; Mazur, W; Pabjan, P; Pawłowska, M; Piekarska, A; Simon, K; Sitko, M; Socha, Ł; Tomasiewicz, K; Tronina, O; Tudrujek-Zdunek, M; Zarębska-Michaluk, D, 2020) |
| "Twelve weeks sofosbuvir/velpatasvir (SOF/VEL) is a highly effective pan-genotypic regimen for hepatitis C." | 3.96 | Eight weeks of sofosbuvir/velpatasvir for genotype 3 hepatitis C in previously untreated patients with significant (F2/3) fibrosis. ( Barclay, ST; Boyle, A; Datta, S; Heydtmann, M; Marra, F; Peters, E; Priest, M; Ritchie, T, 2020) |
| "Since 2017 treatment-naïve patients infected with genotype 1b of hepatitis C virus and minimal or moderate fibrosis can be treated with Ombitasvir/Paritaprevir/ritonavir + Dasabuvir (OPrD) for 8 weeks according to updated Summary of Product Characteristics." | 3.96 | Comparative effectiveness of 8 versus 12 weeks of Ombitasvir/Paritaprevir/ritonavir and Dasabuvir in treatment-naïve patients infected with HCV genotype 1b with non-advanced hepatic fibrosis. ( Baka-Ćwierz, B; Belica-Wdowik, T; Białkowska, J; Buczyńska, I; Citko, J; Czauż-Andrzejuk, A; Deroń, Z; Dobracka, B; Dybowska, D; Flisiak, R; Garlicki, A; Halota, W; Janczewska, E; Jaroszewicz, J; Klapaczyński, J; Krygier, R; Laurans, Ł; Lorenc, B; Mazur, W; Pabjan, P; Pawłowska, M; Piekarska, A; Simon, K; Sitko, M; Tomasiewicz, K; Tronina, O; Tudrujek-Zdunek, M; Zarębska-Michaluk, D, 2020) |
| "Many of the treatment regimens available for hepatitis C include sofosbuvir." | 3.96 | The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. ( Afshar, B; Agah, S; Amiriani, T; Fattahi Abdizadeh, M; Fattahi, MR; Hormati, A; Khoshnia, M; Latifnia, M; Majd Jabbari, S; Maleki, I; Malekzadeh, R; Malekzadeh, Z; Mansour-Ghanaei, F; Merat, D; Merat, S; Minakari, M; Moini, M; Mokhtare, M; Poustchi, H; Roozbeh, F; Sharifi, AH; Shayesteh, AA; Shayesteh, E; Sofian, M; Sohrabi, M; Somi, MH, 2020) |
| "Sofosbuvir/velpatasvir (SOF/VEL) is expected to be highly effective, even in patients with decompensated liver cirrhosis." | 3.96 | Hepatitis C virus-associated decompensated liver cirrhosis with refractory hepatic encephalopathy successfully treated by balloon-occluded retrograde transvenous obliteration after sofosbuvir/velpatasvir. ( Kakizaki, S; Kizawa, K; Kosone, T; Marubashi, K; Sato, K; Shimizu, M; Takagi, H; Takakusagi, S; Uraoka, T; Yokoyama, Y, 2020) |
| "In this prospective single-arm study, 18 TM adolescents with Chronic Hepatitis C received sofosbuvir based generic DAAs." | 3.91 | Treatment of Chronic Hepatitis C Infection with Direct Acting Antivirals in Adolescents with Thalassemia Major. ( Gandhi, M; Jhaveri, A; Merchant, R; Nagral, A; Nagral, N; Parikh, NS; Sawant, S, 2019) |
| "Sofosbuvir (SOF) and daclatasvir (DCV) treatment achieves excellent efficacy and safety in treating chronic hepatitis C (CHC) with various genotypes." | 3.91 | Real-world effectiveness and safety of sofosbuvir plus daclatasvir with or without ribavirin for genotype 2 chronic hepatitis C in Taiwan. ( Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC, 2019) |
| "Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3." | 3.88 | Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt. ( AbdAllah, M; Doss, W; El Akel, W; El Kassas, M; El Shazly, H; El Shazly, Y; Elbaz, T; Elsaeed, K; Esmat, G; Gomaa, AA; Ismail, SA; Korany, M; Nasr, A; Omar, H; Said, M; Shaker, MK; Waked, I; Yousif, M, 2018) |
| "Twelve weeks of the pangenotypic direct-acting antiviral (DAA) combination sofosbuvir/velpatasvir (SOF/VEL) was highly efficient in patients with hepatitis C virus (HCV) genotype 3 (GT3) infection in the ASTRAL-3 approval study." | 3.88 | High efficacy of sofosbuvir/velpatasvir and impact of baseline resistance-associated substitutions in hepatitis C genotype 3 infection. ( Baumgarten, A; Boesecke, C; Busch, HW; Christensen, S; Daeumer, M; Hueppe, D; Ingiliz, P; Luebke, N; Lutz, T; Mauss, S; Rockstroh, JK; Sarrazin, C; Schewe, K; Schulze Zur Wiesch, J; Simon, KG; Timm, J; Vermehren, J; von Felden, J, 2018) |
| "To assess the cost-effectiveness of the elbasvir/grazoprevir (EBR/GZR) regimen in patients with genotype 1 chronic hepatitis C virus (HCV) infection with severe and end-stage renal disease compared to no treatment." | 3.88 | Cost-effectiveness analysis of elbasvir-grazoprevir regimen for treating hepatitis C virus genotype 1 infection in stage 4-5 chronic kidney disease patients in France. ( Abergel, A; Clément, A; Di Martino, V; Durand-Zaleski, I; Levy-Bachelot, L; Maunoury, F; Nwankwo, C; Thervet, E, 2018) |
| " The study included patients from 16 hepatologic centres involved in the AMBER, investigator-initiated study on treatment of chronic hepatitis C patients within a programme preceding EU registration of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin." | 3.88 | Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in the AMBER, real-world experience study. ( Berak, H; Białkowska, J; Bolewska, B; Fleischer-Stępniewska, K; Flisiak, R; Garlicki, A; Janczewska, E; Karpińska, E; Karwowska, K; Nazzal, K; Piekarska, A; Simon, K; Tomasiewicz, K; Tronina, O; Tuchendler, E; Zarębska-Michaluk, D; Łucejko, M, 2018) |
| "Hepatic decompensation is a severe on-treatment adverse event for chronic hepatitis C treated with paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD)." | 3.88 | Hepatic decompensation during paritaprevir/ritonavir/ombitasvir/dasabuvir treatment for genotype 1b chronic hepatitis C patients with advanced fibrosis and compensated cirrhosis. ( Chen, WT; Chen, YC; Hsieh, YC; Huang, CH; Jeng, WJ; Lin, CY; Lin, SM; Sheen, IS; Tai, DI; Teng, W, 2018) |
| "Sofosbuvir (SOF) and daclatasvir combination with or without ribavirin proved to be effective and safe in the treatment of hepatitis C virus infection." | 3.88 | Association of IL-1β, IL-1RN, and ESR1 genes polymorphism with risk of infection and response to sofosbuvir plus daclatasvir combination therapy in hepatitis C virus genotype-4 patients. ( Abd Elfatah, AS; Abdalla, NH; Abdel-Raheim, S; Abdulghany, HM; Khairy, RM; Zenhom, NM, 2018) |
| "To report a case series of three patients with hepatitis C virus infection who all presented with severe type B lactic acidosis shortly after starting treatment with ombitasvir-paritaprevir-ritonavir-dasabuvir." | 3.85 | Ombitasvir-Paritaprevir-Ritonavir-Dasabuvir (Viekira Pak)-Induced Lactic Acidosis. ( Hiensch, RJ; Oberg, CL; Poor, HD, 2017) |
| "Among 41 patients treated, 35 (85%) patients had genotype 1b HCV infection, 6 (15%) had co-infection with human immunodeficiency virus, 35 (85%) failed previous peginterferon and ribavirin therapy, 25 (61%) had compensated liver cirrhosis, and 3 (7%) had liver transplantation." | 3.85 | Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong. ( But, DY; Chan, CK; Chan, HL; Chan, KH; Fung, J; Hui, YT; Lai, CL; Lai, MS; Lam, YS; Lao, WC; Li, C; Lui, GC; Seto, WK; Tsang, OT; Wong, GL; Wong, VW; Yuen, MF, 2017) |
| "For six adult chronic hepatitis C 1b patients with a pre-existing NS5A-Y93H (>20%) polymorphism, we added ribavirin (800 mg/d) to daclatasvir/asunaprevir for 24 weeks and followed through 12-weeks post-treatment." | 3.85 | Addition of ribavirin to daclatasvir plus asunaprevir for chronic hepatitis C 1b patients with baseline NS5A resistance-associated variants improved response. ( Chen, PJ; Hong, CM; Liu, CJ; Yeh, SH, 2017) |
| "Daclatasvir (DCV) is a potent, pangenotypic nonstructural protein 5A inhibitor with demonstrated antiviral efficacy when combined with sofosbuvir (SOF) or simeprevir (SMV) with or without ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection." | 3.83 | Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection. ( Bahirwani, R; Berg, C; Brown, RS; Castells, L; Chacko, KR; Durand, CM; ElSharkawy, AM; Emond, B; Ferenci, P; Fontana, RJ; Herzer, K; Ionescu-Ittu, R; Jafri, SM; Joshi, S; Knop, V; Lionetti, R; Loiacono, L; Londoño, MC; Montalbano, M; Moreno-Zamora, A; Mubarak, A; Pellicelli, AM; Prieto, M; Reddy, KR; Stadler, B; Stauber, RE; Stenmark, S; Torti, C; Vekeman, F; Weiland, O, 2016) |
| "We observed a sustained viral response (SVR) of ombitasvir/paritaprevir/ritonavir, dasabuvir and ribavirin therapy, for 12 wk, in two cases with compensated liver cirrhosis and fully destroyed early hepatocellular carcinoma (HCC)." | 3.83 | Ombitasvir, paritaprevir, ritonavir, dasabuvir and ribavirin in cirrhosis after complete destruction of hepatocellular carcinoma. ( Antonov, K; Atanasova, E; Boyanova, Y; Jelev, D; Krastev, Z; Mateva, L; Petkova, T; Tomov, B; Zheleva, N, 2016) |
| "We investigated the real-world effectiveness of sofosbuvir, ledipasvir/sofosbuvir, and paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD) in treatment of different subgroups of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, or 4." | 3.83 | Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care System. ( Berry, K; Beste, LA; Chang, MF; Green, PK; Ioannou, GN; Lowy, E; Su, F; Tsui, JI, 2016) |
| "Sofosbuvir (SOF) plus daclatasvir (DCV) with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C." | 3.83 | Sofosbuvir plus daclatasvir with or without ribavirin for chronic hepatitis C infection: Impact of drug concentration on viral load decay. ( Bailly, F; Choupeaux, L; Gagnieu, MC; Maynard, M; Pradat, P; Scholtès, C; Virlogeux, V; Zoulim, F, 2016) |
| "A 40-year-old man, diagnosed with decompensated liver cirrhosis because of hepatitis C virus, was on the wait list for a liver transplant when he began treatment with the direct-acting antivirals simeprevir 150 mg and sofosbuvir 400 mg." | 3.83 | First Case in Kazakhstan of Successful Therapy With 2 Consecutive Direct-Acting Antiviral Regimens in a Patient with Hepatitis C Virus-Induced Decompensated Liver Cirrhosis on a Liver Transplant Wait List. ( Ashimkhanova, A; Kaliaskarova, K; Yesmembetov, K, 2016) |
| "Portal hypertension is the strongest predictor of virological response to pegylated interferon (IFN)/ribavirin in patients with chronic hepatitis C (CHC)-related cirrhosis." | 3.81 | Interferon-free regimens for chronic hepatitis C overcome the effects of portal hypertension on virological responses. ( Beinhardt, S; Ferenci, P; Ferlitsch, A; Freissmuth, C; Hofer, H; Kozbial, K; Mandorfer, M; Peck-Radosavljevic, M; Reiberger, T; Schwabl, P; Schwarzer, R; Stättermayer, AF; Trauner, M, 2015) |
| "The aim of this study was to compare amprenavir pharmacokinetics in HIV/hepatitis C virus (HCV)-co-infected cirrhotic patients receiving non-boosted fosamprenavir 700 mg twice daily with HCV/HIV-co-infected non-cirrhotic subjects and HIV-mono-infected subjects receiving fosamprenavir/ritonavir 700/100 mg twice daily." | 3.75 | Unboosted fosamprenavir is associated with low drug exposure in HIV-infected patients with mild-moderate liver impairment resulting from HCV-related cirrhosis. ( Bonora, S; Carosi, G; de Requena, DG; Gatti, F; Loregian, A; Matti, A; Nasta, P; Pagni, S; Palù, G; Parisi, SG; Prestini, K; Puoti, M, 2009) |
| " The patient received since four years pyridinolcarbamate (Prodectin) because of obliterating peripheral arteriosclerosis." | 3.67 | [Pyridimocarbamate (prodectin)-induced acute liver damage, cirrhosis and primary liver cancer--accidental finding?]. ( Kendrey, G; Kiss, F; László, B, 1989) |
| " Most adverse events (AEs) were consistent with clinical sequelae of advanced liver disease or known toxicities of ribavirin." | 2.90 | Efficacy and safety of sofosbuvir-velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial. ( Brainard, DM; Chayama, K; De-Oertel, S; Dvory-Sobol, H; Ikeda, F; Kanda, T; Kurosaki, M; Matsuda, T; Mita, E; Nishiguchi, S; Sakamoto, M; Sakamoto, N; Stamm, LM; Takehara, T; Takikawa, Y; Tamori, A; Tanaka, Y; Tatsumi, T; Ueno, Y; Yatsuhashi, H; Zhang, G, 2019) |
| "The most common adverse events were upper respiratory tract infection (36 [10%] patients) and headache (18 [5%] patients)." | 2.90 | Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. ( Brainard, DM; Cheng, J; Dao, L; Dou, X; Duan, Z; Dvory-Sobol, H; Gao, Y; Gao, ZL; Gong, G; Hou, JL; Hu, P; Huang, Y; Jia, J; Le Manh, H; Le, TTP; Li, J; Lim, SG; Lin, F; Lu, S; Mao, Y; Mo, H; Mohamed, R; Mou, Z; Nan, Y; Ning, Q; Piratvisuth, T; Shang, J; Sobhonslidsuk, A; Stamm, LM; Su, M; Tan, CK; Tang, H; Tangkijvanich, P; Tanwandee, T; Tee, HP; Thongsawat, S; Văn, KN; Wang, GQ; Wei, L; Wu, S; Xie, Q; Xu, M; Yang, YF; Zhang, L, 2019) |
| "Patients with HCV GT3 infection and/or liver cirrhosis were excluded." | 2.90 | JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1. ( Ackaert, O; Aghemo, A; Beumont, M; Biermer, M; Bourgeois, S; Buggisch, P; Buti, M; Corbett, C; Fevery, B; Greenbloom, S; Janczewska, E; Kalmeijer, R; Lampertico, P; Lim, SG; Moreno, C; Ouwerkerk-Mahadevan, S; Sinha, R; Tam, E; Vijgen, L; Willems, W; Zeuzem, S, 2019) |
| "Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population." | 2.90 | Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. ( Agarwal, K; Ampuero, J; Ben-Ari, Z; Borgia, SM; Brown, A; Bruck, R; Calleja, JL; Cooper, C; Cramp, ME; Dearden, J; Dvory-Sobol, H; Esteban, R; Fox, R; Foxton, M; Gane, EJ; Haider, S; Hyland, R; Kirby, BJ; Lu, S; Lurie, Y; Markova, S; Meng, A; Osinusi, AO; Rodriguez, CF; Ryder, SD; Shafran, SD; Shaw, D; Willems, B; Yoshida, EM, 2019) |
| " Adverse effects were mild and non-specific." | 2.90 | Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs. ( Antonio Carrión, J; Arenas, J; Arencibia, A; Badia, E; Bernal, V; Buti, M; Cachero, A; Carmona, I; Conde, I; Delgado, M; Diago, M; Esteban, R; Fernández, I; Fernández-Bermejo, M; Fernández-Rodríguez, C; Figueruela, B; García-Samaniego, J; Gea, F; González-Santiago, JM; Hernández-Guerra, M; Iñarrairaegui, M; Lens, S; Llaneras, J; Llerena, S; Luis Calleja, J; María Morillas, R; Mariño, Z; Montoliu, S; Pascasio, JM; Riveiro-Barciela, M; Rosales, JM; Torras, X; Turnes, J, 2019) |
| " No patients from the G/P Arm prematurely discontinued the study drug or experienced a treatment-emergent serious adverse event (TESAE)." | 2.87 | Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 1 hepatitis C virus infection with and without cirrhosis. ( Alves, K; Atarashi, T; Burroughs, M; Chayama, K; Eguchi, Y; Karino, Y; Kato, K; Kawakami, Y; Krishnan, P; Kumada, H; Naganuma, A; Oberoi, RK; Pilot-Matias, TJ; Pugatch, DL; Redman, R; Sato, K; Seike, M; Suzuki, F; Takei, Y; Watanabe, T; Xie, W; Yoshiji, H, 2018) |
| " Pharmacokinetics and safety assessments were performed, and pharmacokinetic parameters were calculated using non-compartmental methods and summarized using descriptive statistics and compared statistically by geometric least-squares mean ratios and 90% confidence intervals." | 2.87 | Pharmacokinetics and Safety of Velpatasvir and Sofosbuvir/Velpatasvir in Subjects with Hepatic Impairment. ( Brainard, DM; Curtis, C; Lasseter, K; Lawitz, E; Ling, KHJ; Marbury, T; Mathias, A; Mogalian, E; Moorehead, L; Murray, B; Osinusi, A; Perry, R, 2018) |
| " Overall there was a low rate of serious adverse events (n = 6, 2." | 2.87 | Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced Fibrosis. ( Affonso-de-Araújo, ES; Álvares-da-Silva, MR; Alves, K; Brandão-Mello, CE; Cheinquer, H; Coelho, HS; Cohen, DE; Ferraz, ML; Ferreira, PRA; Furtado, J; Lari, SA; Liu, L; Martinelli, A; Mendes-Correa, MC; Nunes, EP; Parana, R; Pessoa, MG; Pilot-Matias, T; Ramalho-Madruga, JV; Shulman, NS; Silva, G; Tripathi, R, 2018) |
| " The most common adverse events were headache (143 [22%] of 664), fatigue (129 [19%] of 664), and nausea (83 [13%] of 664)." | 2.84 | Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2, ( Almasio, PL; Barr, E; Bruno, S; Buti, M; Butterton, JR; Dutko, FJ; Fernsler, D; Gao, W; Grandhi, A; Hassanein, TI; Huang, HC; Jancoriene, L; Lawitz, E; Li, JJ; Liu, H; Muellhaupt, B; Nguyen, BT; Pearlman, B; Plank, RM; Robertson, MN; Ruane, PJ; Shepherd, A; Su, FH; Tannenbaum, B; Vierling, JM; Wahl, J; Wan, S; Yeh, WW; Yoshida, EM, 2017) |
| " We assessed the efficacy and safety of the two direct-acting antiviral drugs ombitasvir, an NS5A inhibitor, and paritaprevir, an NS3/4A protease inhibitor dosed with ritonavir, plus ribavirin in treatment of chronic HCV infection in Egypt." | 2.82 | Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. ( Allam, N; Asselah, T; Doss, W; Esmat, G; Hall, C; Hassany, M; Mobashery, N; Mohey, MA; Qaqish, RB; Redman, R; Shiha, G; Soliman, R; Waked, I; Yosry, A; Zayed, N, 2016) |
| " The open-label ALLY-1 study assessed the safety and efficacy of a 60-mg once-daily dosage of daclatasvir (pan-genotypic NS5A inhibitor) in combination with sofosbuvir at 400 mg once daily (NS5B inhibitor) and ribavirin at 600 mg/day for 12 weeks with a 24-week follow-up in two cohorts of patients with chronic HCV infection of any genotype and either compensated/decompensated cirrhosis or posttransplantation recurrence." | 2.82 | Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence. ( Fontana, RJ; Hughes, EA; Landis, C; McPhee, F; Noviello, S; Poordad, F; Schiff, ER; Swenson, ES; Vierling, JM; Yang, R, 2016) |
| " Adverse events occurred in 151 (72." | 2.82 | Real-world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study. ( Berak, H; Bialkowska, J; Bolewska, B; Fleischer-Stępniewska, K; Flisiak, R; Garlicki, A; Halota, W; Horban, A; Jabłkowski, M; Janczewska, E; Jaroszewicz, J; Karpińska, E; Karwowska, K; Knysz, B; Kryczka, W; Lucejko, M; Madej, G; Mozer-Lisewska, I; Nazzal, K; Piekarska, A; Pisula, A; Rostkowska, K; Simon, K; Tomasiewicz, K; Tronina, O; Tudrujek, M; Wawrzynowicz-Syczewska, M; Wiercińska-Drapało, A; Zarębska-Michaluk, D, 2016) |
| "Treatment with grazoprevir plus elbasvir, both with and without ribavirin and for both 12 and 18 weeks' treatment duration, showed high rates of efficacy in previously untreated patients with cirrhosis and previous PR-null responders with and without cirrhosis." | 2.80 | Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous ( Alric, L; Balart, L; Barr, E; Bronowicki, JP; Dutko, F; Gane, E; Ghalib, R; Ghesquiere, W; Guyader, D; Haber, B; Howe, AY; Hwang, P; Lagging, M; Lawitz, E; Lester, L; Pearlman, B; Robertson, M; Shaughnessy, M; Sievert, W; Sund, F; Tam, E; Wahl, J, 2015) |
| " This phase 2, randomized, open-label study evaluated an IFN- and RBV-free regimen of once-daily ombitasvir (ABT-267), an NS5A inhibitor, plus paritaprevir (ABT-450), an NS3/4A protease inhibitor dosed with ritonavir (paritaprevir/ritonavir), in pegylated IFN/RBV treatment-experienced Japanese patients with hepatitis C virus subtype 1b or genotype 2 infection." | 2.80 | Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients. ( Badri, P; Chayama, K; Kumada, H; Kurosaki, M; Notsumata, K; Pilot-Matias, T; Rodrigues, L; Sato, K; Setze, C; Vilchez, RA, 2015) |
| " A total of 321 patients without cirrhosis were randomized and dosed with double-blind study drug (106 received double-blind placebo and later received open-label OBV/PTV/r), and 42 patients with cirrhosis were enrolled and dosed with open-label OBV/PTV/r." | 2.80 | Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis. ( Burroughs, M; Chayama, K; Ikeda, K; Karino, Y; Kioka, K; Kumada, H; Matsuzaki, Y; Patwardhan, M; Pilot-Matias, T; Redman, R; Rodrigues, L; Sato, K; Setze, C; Suzuki, F; Toyoda, H; Vilchez, RA, 2015) |
| " Common adverse events included headache, asthenia, pruritus, and diarrhea." | 2.80 | Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis. ( Akarca, US; Hall, C; Hézode, C; Lawitz, E; Makara, M; Mobashery, N; Morillas, RM; Pilot-Matias, T; Preotescu, LL; Redman, R; Thuluvath, PJ; Varunok, P; Vilchez, RA, 2015) |
| " Mean half-life (t(1/2)) values were prolonged in the moderate impairment group (21 hours) relative to the normal group (11 hours)." | 2.77 | Effect of mild and moderate hepatic impairment on the pharmacokinetics and safety of carisbamate. ( Brashear, HR; Greenspan, A; Moore, K; Solanki, B; Verhaeghe, T; Zannikos, P, 2012) |
| " Following administration of a single, oral dose of 600 mg of amprenavir, pharmacokinetic parameters were determined for 10 subjects with severe cirrhosis, 10 subjects with moderate cirrhosis, and 10 healthy volunteers." | 2.69 | Single-dose pharmacokinetics of amprenavir, a human immunodeficiency virus type 1 protease inhibitor, in subjects with normal or impaired hepatic function. ( Delvaux, M; Fosse, S; Gillotin, C; Lou, Y; Masliah, C; Petite, JP; Pillegand, B; Rautaureau, J; Sadler, BM; Stein, DS; Veronese, L, 2000) |
| " The number and percentage of patients with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs consistent with hepatic decompensation were reported." | 2.55 | Safety of the 2D/3D direct-acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis - A pooled analysis. ( Cohen, DE; Cohen, E; Feld, JJ; Foster, GR; Fried, MW; Larsen, L; Mobashery, N; Nelson, DR; Poordad, F; Tatsch, F; Wedemeyer, H, 2017) |
| "02), while it increased the risk of serious adverse events (p = 0." | 2.55 | Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysis. ( Abdel-Daim, MM; Abushouk, AI; Ahmed, H; Loutfy, SA; Menshawy, A; Mohamed, A; Negida, A, 2017) |
| " The safety data available for LDV/SOF±RBV and OBV/PTV/r±DSV±RBV show that discontinuation due to adverse events was necessary in no more than 3% of patients and the frequency of serious adverse events was between 0 and 11%, in particular in real-world studies." | 2.55 | Hepatitis C: efficacy and safety in real life. ( Flisiak, R; Flisiak-Jackiewicz, M; Pogorzelska, J, 2017) |
| "The therapeutic landscape for the treatment of chronic hepatitis C virus infection has been rapidly evolving, and by 2016 there will be six approved, all-oral regimens for use in patients in the USA and most of Western Europe." | 2.53 | Hepatitis C virus: how to provide the best treatment with what I have. ( Nelson, DR; Peter, J, 2016) |
| "Patients suffering recurrence are known to have faster times to fibrosis and consequently higher rates of graft failure." | 2.52 | Hepatitis C management in post-transplant patients. ( Firpi, RJ; Hilgenfeldt, E, 2015) |
| "Although the combination with PrOD significantly affects the pharmacokinetics of CsA, it is effective and safe with regular monitoring of the CsA blood concentrations and appropriate CsA dose adjustment." | 1.72 | Drug-Drug Interactions With Cyclosporine in the Anti-Hepatitis C Viral PrOD Combination Regimen of Paritaprevir/Ritonavir-Ombitasvir and Dasabuvir in Organ Transplant Recipients With Severe Hepatic Fibrosis or Cirrhosis. ( Chang, YL; Chou, YC; Hsu, CC; Huang, YH; Huang, YY; Loong, CC; Wu, TH, 2022) |
| " In the 194 subjects treated with sofosbuvir/ribavirin, median initial ribavirin dosage was 13." | 1.62 | Sofosbuvir-based therapies in genotype 2 hepatitis C virus cirrhosis: A real-life experience with focus on ribavirin dose. ( Bellan, M; Crobu, MG; D'Avolio, A; Gualerzi, A; Pirisi, M; Smirne, C, 2021) |
| " We developed a long-acting DAA system (LA-DAAS) capable of prolonged dosing and explored its cost-effectiveness." | 1.56 | 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) |
| "Assessing liver fibrosis is important for predicting the efficacy of direct-acting antivirals (DAAs) and patient prognosis." | 1.56 | M2BPGi for assessing liver fibrosis in patients with hepatitis C treated with direct-acting antivirals. ( Alhusseini, MM; Mohamed, GA; Salama, MM; Saleh, SA, 2020) |
| "Furthermore, hepatocellular carcinoma (HCC) is known to dedifferentiate from hypovascular tumors, such as dysplastic nodules or well-differentiated HCC, to hypervascular tumors." | 1.56 | Hypovascular tumors developed into hepatocellular carcinoma at a high rate despite the elimination of hepatitis C virus by direct-acting antivirals. ( Fujisaki, K; Hashiguchi, M; Hiramine, Y; Hori, T; Ido, A; Ijuin, S; Imanaka, D; Inada, Y; Kanmura, S; Kumagai, K; Kure, T; Mawatari, S; Moriuchi, A; Oda, K; Saisyoji, A; Sakae, H; Sakurai, K; Tabu, K; Tamai, T; Taniyama, O; Toyodome, A; Uto, H, 2020) |
| " Most frequent adverse events included fatigue (6%), hyperbilirubinemia (6%) and anemia (4%)." | 1.51 | Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure. ( Aghemo, A; Alberti, A; Bonfanti, P; Carolo, G; Carriero, C; Centenaro, R; Degasperi, E; Fabris, P; Faggiano, G; Fagiuoli, S; Gatti, F; Giorgini, A; Grossi, G; Lampertico, P; Landonio, S; Lombardi, A; Lomonaco, L; Maggiolo, F; Noventa, F; Paolucci, S; Paon, V; Pasin, F; Pasulo, L; Pozzoni, P; Puoti, M; Romano, A; Rossi, MC; Rovere, P; Russo, FP; Soffredini, R; Soria, A; Spinetti, A; Vario, A; Vinci, M; Zoncada, A, 2019) |
| "After the treatment, liver fibrosis scores of apartate aminotransferase to platelet ratio index (2." | 1.51 | A retrospective study of the efficacy of sofosbuvir plus NS5A inhibitors for patients with hepatitis C virus genotype-2 chronic infection. ( Chen, EQ; Lv, DD; Tang, H; Tao, YC; Wang, ML; Wu, DB; Zhang, DM, 2019) |
| " The primary safety endpoint was treatment withdrawal rates secondary to severe adverse events." | 1.51 | Effectiveness and safety of daclatasvir/sofosbuvir with or without ribavirin in genotype 3 hepatitis C virus infected patients. Results in real clinical practice. ( Castro-Iglesias, A; Cid-Silva, P; Delgado-Blanco, M; Margusino-Framiñán, L; Martín-Herranz, I; Mena-de-Cea, A; Pernas-Souto, B; Pertega-Díaz, S; Rodríguez-Osorio, I, 2019) |
| "Hepatic disease progression and new hepatocellular carcinoma were diagnosed in 15 and 23 patients, respectively." | 1.48 | Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens. ( Brunetto, MR; Chayama, K; Gadano, A; Gerken, G; Ghesquiere, W; Heo, J; Kumada, H; Lawitz, EJ; Levin, J; Linaberry, M; Liu, Z; McPhee, F; Noviello, S; Peng, CY; Pol, S; Reddy, KR; Silva, M; Strasser, SI; Thuluvath, PJ; Toyota, J; Yang, R, 2018) |
| " RBV was dosed by physician discretion between 200 mg weekly and 200 mg daily." | 1.48 | High Efficacy of ombitasvir/paritaprevir/ritonavir plus dasabuvir in hepatitis C genotypes 4 and 1-infected patients with severe chronic kidney disease. ( Afghani, AA; Alghamdi, AS; Alghamdi, MN; AlMousa, A; Alswat, K; AlZanbagi, A; Aseeri, M; Assiri, AM; Babatin, MA; Sanai, FM, 2018) |
| " Safety outcomes were based on the incidence of adverse events." | 1.48 | Twelve weeks of ombitasvir/paritaprevir/r and dasabuvir without ribavirin is effective and safe in the treatment of patients with HCV genotype 1b infection and compensated cirrhosis: results from a real-world cohort study. ( Chamorro-de-Vega, E; De Lorenzo-Pinto, A; Escudero-Vilaplana, V; Gimenez-Manzorro, A; Herranz-Alonso, A; Iglesias-Peinado, I; Rodriguez-Gonzalez, CG; Sanjurjo Saez, M, 2018) |
| " Serious adverse events occurred in 3." | 1.48 | The safety and efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 1b infection. ( Barr, E; Cheng, W; George, J; Hwang, P; Kumada, H; Platt, H; Robertson, M; Serfaty, L; Sperl, J; Strasser, S; Talwani, R; Vierling, J; Wahl, J; Zeuzem, S, 2018) |
| "Liver fibrosis was graded with the use of biopsies taken <12 months before treatment and stratified as early (0-1) or moderate to advanced (2-4) according to the Metavir score." | 1.48 | Daclatasvir and Sofosbuvir With or Without Ribavirin in Liver Transplant Recipients: A Single-Center Real-World Study. ( Bandeira de Mello Brandao, A; Costabeber, AM; Cracco Cantisani, GP; Kiss, G; Leipnitz, I; Marroni, CA; Martini, J; Medeiros Fleck, A; Meine, MH; Mucenic, M; Sacco, FKF; Soares Schlindwein, E; Zanotelli, ML, 2018) |
| "Ascites and hepatic encephalopathy occurred in 10." | 1.48 | High efficacy of direct-acting anti-viral agents in hepatitis C virus-infected cirrhotic patients with successfully treated hepatocellular carcinoma. ( Aghemo, A; Aglitti, A; Andreone, P; Boccaccio, V; Bollani, S; Brunetto, MR; Bruno, S; Calvaruso, V; Ciancio, A; Coco, B; Conti, F; Degasperi, E; Di Leo, A; Di Marco, V; Giorgini, A; Lampertico, P; Lleo, A; Maisonneuve, P; Marzi, L; Persico, M; Rendina, M; Troshina, G; Villa, E; Zuin, M, 2018) |
| " Adverse events occurred in 15 patients (26%), 26% of which were grade 1 or 2." | 1.48 | The Real-world Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir for Hepatitis C Genotype 1. ( Abe, K; Hoshino, T; Kawakami, T; Miyasaka, A; Murakami, A; Ohuchi, K; Sawara, K; Takikawa, Y; Watanabe, D; Yoshida, T; Yoshida, Y, 2018) |
| "Patients who suffered any adverse event (AE) were 74/240 (30." | 1.48 | Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis. ( Aghemo, A; Ascione, A; Bruno, S; Craxì, A; De Luca, M; Fontanella, L; Gasbarrini, A; Giannini, EG; Izzi, A; Marzioni, M; Melazzini, M; Messina, V; Montilla, S; Orlandini, A; Petta, S; Puoti, M; Sangiovanni, V; Trotta, MP; Villa, E; Zignego, AL, 2018) |
| " Safety and effectiveness assessments included incidence of adverse drug reactions (ADRs) and sustained viral response (SVR) rates at 24 weeks (SVR24)." | 1.48 | Safety and effectiveness of daclatasvir and asunaprevir dual therapy in patients with genotype 1 chronic hepatitis C: results from postmarketing surveillance in Japan. ( Bando, E; Hatanaka, N; Komoto, A; Nakamura, K; Suzuki, F, 2018) |
| " The plasma pharmacokinetic profiles of daclatasvir and asunaprevir were described by a 1-compartment model." | 1.48 | Population Pharmacokinetic Analysis for Daclatasvir and Asunaprevir in Japanese Subjects With Chronic Hepatitis C Virus Infection. ( Garimella, T; Imai, Y; Ishikawa, H; Osawa, M; Ueno, T, 2018) |
| " The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pre-treatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment." | 1.46 | Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 - final results of the REV1TAL study. ( Bollipo, S; Cheng, W; Chivers, S; Dore, G; Fragomeli, V; Galhenage, S; Gazzola, A; George, J; Gow, P; Iser, D; Jones, T; Levy, M; Lubel, J; MacQuillan, G; Mitchell, JL; Nazareth, S; Pianko, S; Roberts, SK; Sasadeusz, J; Strasser, S; Stuart, KA; Thompson, A; Tse, E; Wade, A; Weltman, M; Wigg, A; Zekry, A, 2017) |
| "Liver cirrhosis was found in 34." | 1.46 | Real-life prevalence of resistance-associated variants against non-structural protein 5A inhibitors and efficiency of Daclatasvir + Asunaprevir therapy in Korean patients with genotype 1b hepatitis C. ( Kim, JK; Lee, JI; Lee, KS; Yu, JH, 2017) |
| "At the age of 46, he was diagnosed with hepatocellular carcinoma with subsequent resection of the tumour in May 2015." | 1.46 | Successful twice interrupted therapy of HCV infection in patients with cirrhosis with hepatocellular carcinoma before and after liver transplantation. ( Rostkowska, K; Simon, K; Szymanek-Pasternak, A, 2017) |
| " No serious adverse events (AEs) were observed." | 1.46 | Efficacy and safety of sofosbuvir and daclatasvir in treatment of kidney transplantation recipients with hepatitis C virus infection. ( Li, T; Liu, F; Qu, YD; Wang, L; Xue, Y; Zhang, LX, 2017) |
| " Direct-acting antiviral (DAA) drug regimens are safe and highly effective, allowing administration of treatment also in elderly." | 1.46 | Efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for the treatment of HCV genotype 1b compensated cirrhosis in patients aged 70 years or older. ( Bataga, S; Brisc, C; Caruntu, FA; Chiriac, S; Cijevschi Prelipcean, C; Curescu, M; Gheorghe, L; Girleanu, I; Goldis, A; Iacob, S; Miftode, E; Mihai, C; Preda, C; Rogoveanu, I; Singeap, AM; Sporea, I; Stanciu, C; Stefanescu, G; Trifan, A, 2017) |
| " Plasma concentrations of daclatasvir and asunaprevir at day 5 of treatment, end-of-treatment response, sustained virological response (SVR), and the frequencies of adverse events were analyzed." | 1.46 | Real-world efficacy and safety of daclatasvir and asunaprevir therapy for hepatitis C virus-infected cirrhosis patients. ( Aikata, H; Chayama, K; Hayes, CN; Hiramatsu, A; Honda, Y; Imamura, M; Kawakami, Y; Kawaoka, T; Kobayashi, T; Makokha, GN; Miki, D; Mori, N; Morio, K; Morio, R; Nagaoki, Y; Ochi, H; Takaki, S; Tsuge, M; Tsuji, K; Yokoyama, S, 2017) |
| " Serious adverse events were reported in 3% (8 of 264) patients and no patient had a decompensation-related event." | 1.46 | Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. ( Barr, E; Haber, BA; Hézode, C; Howe, AYM; Hwang, P; Jacobson, IM; Kwo, PY; Lawitz, E; Peng, CY; Robertson, M; Wahl, J, 2017) |
| " DCV and ASV were well tolerated in most of the patients, with treatment discontinuation due to adverse events (elevated liver enzyme and decompensation) occurring in two patients." | 1.43 | Efficacy and safety of daclatasvir and asunaprevir for hepatitis C virus genotype 1b infection. ( Lee, HL; Nam, HC; Song, MJ; Yang, H, 2016) |
| "DCV was dosed at week 4 and at week 8 of treatment, and RBV at week 8." | 1.43 | Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin. ( Andreis, S; Basso, M; Cattelan, AM; Cavinato, S; Dal Bello, F; Loregian, A; Messa, L; Nannetti, G; Palù, G; Parisi, SG; Scaggiante, R, 2016) |
| "Excellent SVR12 rates and the favorable side-effect profile of DAA-combination therapy can be well translated into "real-world"." | 1.43 | 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) |
| "None of the patients had hepatocellular carcinoma before and during antiviral therapy." | 1.43 | Liver Fibrosis and Body Mass Index Predict Hepatocarcinogenesis following Eradication of Hepatitis C Virus RNA by Direct-Acting Antivirals. ( Akuta, N; Arase, Y; Fujiyama, S; Hosaka, T; Ikeda, K; Kawamura, Y; Kobayashi, M; Kumada, H; Saitoh, S; Sezaki, H; Suzuki, F; Suzuki, Y, 2016) |
| "Hepatic decompensation and acute liver failure are rare but severe complications of Ritonavir-boosted Paritaprevir, Ombitasvir and Dasabuvir plus Ribavirin therapy in patients with compensated cirrhosis." | 1.43 | A Case of Acute Liver Failure during Ritonavir-Boosted Paritaprevir, Ombitasvir and Dasabuvir Therapy in a Patient with HCV Genotype 1b Cirrhosis. ( Andreone, P; Magalotti, D; Martino, E; Masetti, M; Scuteri, A; Zoli, M, 2016) |
| " Raltegravir pharmacokinetic parameters remained unchanged whether administered on or off anti-HCV therapy." | 1.42 | Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir. ( Barrail-Tran, A; Cheret, A; Furlan, V; Molina, JM; Piroth, L; Rosa, I; Rosenthal, E; Taburet, AM; Vincent, C, 2015) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 2 (0.84) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 4 (1.68) | 29.6817 |
| 2010's | 190 (79.83) | 24.3611 |
| 2020's | 42 (17.65) | 2.80 |
| Authors | Studies |
|---|---|
| El Kassas, M | 2 |
| Abdeen, N | 1 |
| Omran, D | 1 |
| Alboraie, M | 1 |
| Salaheldin, M | 1 |
| Eltabbakh, M | 1 |
| Farghaly, R | 1 |
| Emadeldeen, M | 1 |
| Afify, S | 1 |
| Sweedy, A | 1 |
| Ghalwash, A | 1 |
| Abbass, A | 1 |
| Ezzat, S | 1 |
| Tahoon, M | 1 |
| ELshazly, HM | 1 |
| Hamdy, H | 1 |
| Omar, H | 2 |
| Patel, S | 1 |
| Martin, MT | 1 |
| Flamm, SL | 4 |
| Ghanm, SE | 1 |
| Shebl, NA | 1 |
| El Sayed, IET | 1 |
| Abdel-Bary, HM | 1 |
| Saad, BF | 1 |
| Othman Saad, W | 1 |
| Yoo, HW | 1 |
| Park, JY | 2 |
| Kim, SG | 1 |
| Jung, YK | 1 |
| Lee, SH | 1 |
| Kim, MY | 1 |
| Jun, DW | 1 |
| Jang, JY | 1 |
| Lee, JW | 1 |
| Kwon, OS | 1 |
| Huang, YY | 1 |
| Huang, YH | 1 |
| Wu, TH | 1 |
| Loong, CC | 1 |
| Hsu, CC | 1 |
| Chou, YC | 1 |
| Chang, YL | 1 |
| Indolfi, G | 1 |
| Kelly, D | 1 |
| Nebbia, G | 1 |
| Iorio, R | 1 |
| Mania, A | 1 |
| Giacomet, V | 1 |
| Szenborn, L | 1 |
| Shao, J | 1 |
| Sang Yue, M | 1 |
| Hsueh, CH | 1 |
| Parhy, B | 1 |
| Kersey, K | 1 |
| Mangia, A | 10 |
| Pawlowska, M | 1 |
| Bansal, S | 1 |
| Sonsuz, A | 1 |
| Bozcan, S | 1 |
| Hatemi, İ | 1 |
| Özdemir, S | 1 |
| Canbakan, B | 1 |
| Yıldırım, S | 1 |
| Gültürk, İ | 1 |
| Ar, C | 1 |
| Bacinschi, X | 1 |
| Popescu, GC | 1 |
| Zgura, A | 1 |
| Gales, L | 1 |
| Rodica, A | 1 |
| Mercan, A | 1 |
| Serban, D | 1 |
| Haineala, B | 1 |
| Toma, L | 1 |
| Iliescu, L | 1 |
| Degasperi, E | 4 |
| Spinetti, A | 1 |
| Lombardi, A | 1 |
| Landonio, S | 1 |
| Rossi, MC | 1 |
| Pasulo, L | 2 |
| Pozzoni, P | 1 |
| Giorgini, A | 2 |
| Fabris, P | 1 |
| Romano, A | 1 |
| Lomonaco, L | 1 |
| Puoti, M | 6 |
| Vinci, M | 1 |
| Gatti, F | 2 |
| Carolo, G | 1 |
| Zoncada, A | 1 |
| Bonfanti, P | 1 |
| Russo, FP | 1 |
| Aghemo, A | 7 |
| Soria, A | 1 |
| Centenaro, R | 1 |
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| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Regression of Liver Fibrosis Assessed by Transient Elastography After Daclatasvir and Asunaprevir Combined Treatment in Advanced Fibrotic/Cirrhotic Patients With Chronic Hepatitis C Genotype 1b Infection[NCT02865369] | 103 participants (Anticipated) | Observational [Patient Registry] | 2016-09-30 | Not yet recruiting | |||
| Does Hepatitis C Management Protect Egyptian Population Against Severe Corona Virus Disease-2019 (COVID-19)?[NCT04757272] | 2,106 participants (Actual) | Observational | 2020-05-01 | Completed | |||
| Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.[NCT03063879] | Phase 4 | 95 participants (Actual) | Interventional | 2017-04-01 | Completed | ||
| Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Participants With HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy (C_ASCENT)[NCT02194998] | Phase 2 | 46 participants (Actual) | Interventional | 2015-09-16 | Terminated (stopped due to The study closed to accrual before the planned accrual goal was attained due to the availability of newer directly-acting antiviral (DAA) treatments for HCV.) | ||
| A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis[NCT02201901] | Phase 3 | 268 participants (Actual) | Interventional | 2014-07-31 | Completed | ||
| An Open-Label Study to Evaluate the Safety and Efficacy of the Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Chronic Hepatitis C Virus Genotype 4 Infection in Egypt[NCT02247401] | Phase 3 | 160 participants (Actual) | Interventional | 2014-11-04 | Completed | ||
| A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjec[NCT02639247] | Phase 3 | 333 participants (Actual) | Interventional | 2015-12-23 | Completed | ||
| A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HC[NCT02607735] | Phase 3 | 416 participants (Actual) | Interventional | 2015-11-11 | Completed | ||
| A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT3, GT4, GT5, and GT6 Infection[NCT02332720] | Phase 2 | 413 participants (Actual) | Interventional | 2015-01-28 | Completed | ||
| A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT1 and GT2 Infection[NCT02332707] | Phase 2 | 443 participants (Actual) | Interventional | 2015-01-22 | Completed | ||
| A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus [NCT02292719] | Phase 2 | 70 participants (Actual) | Interventional | 2014-12-19 | Completed | ||
| A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis C[NCT01492504] | 1,850 participants (Anticipated) | Observational | 2012-02-07 | Completed | |||
| A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)[NCT02707952] | Phase 3 | 295 participants (Actual) | Interventional | 2016-02-22 | Completed | ||
| A Phase 2, Randomized, Open-label Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 6 or 8 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Subjects With Chronic Hepatitis C Virus Genotype 1 I[NCT02349048] | Phase 2 | 68 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| Pharmacokinetics of Low-dose Sofosbuvir in Dialysis-dependent Patients With Hepatitis C Virus Infection[NCT03883698] | Phase 3 | 30 participants (Actual) | Interventional | 2019-03-15 | Completed | ||
| A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 Versus Sofosbuvir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects With Chronic HCV GT1, 4 [NCT02358044] | Phase 3 | 257 participants (Actual) | Interventional | 2015-02-27 | Completed | ||
| A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic HCV GT1, GT4 and GT6 Infection With Inherited Blood Disorders With and Without HIV Co-Infection[NCT02252016] | Phase 3 | 159 participants (Actual) | Interventional | 2014-10-22 | Completed | ||
| A Phase III Randomized Multinational Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects With Chronic HCV GT 1, GT 4 and GT 6 Infection[NCT02251990] | Phase 3 | 489 participants (Actual) | Interventional | 2015-01-28 | Completed | ||
| A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are on Opiate Substitution Therapy[NCT02105688] | Phase 3 | 301 participants (Actual) | Interventional | 2014-09-02 | Completed | ||
| A Phase II Clinical Trial to Evaluate the Efficacy and Safety of a Combination Regimen of MK-5172 With/Without MK-8742 and/or Ribavirin (RBV) in Treatment-naive Subjects With Chronic Hepatitis C Genotype 2, 4, 5 and 6 Infection[NCT01932762] | Phase 2 | 98 participants (Actual) | Interventional | 2013-10-01 | Completed | ||
| A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV[NCT02105662] | Phase 3 | 218 participants (Actual) | Interventional | 2014-06-03 | Completed | ||
| A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects Who Have Failed Prior Treatment With Pegylated Interferon and Ribavirin (P/R) With Chronic HCV GT1, GT4, and GT6 Infection[NCT02105701] | Phase 3 | 420 participants (Actual) | Interventional | 2014-06-05 | Completed | ||
| A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection.[NCT02105467] | Phase 3 | 421 participants (Actual) | Interventional | 2014-06-05 | 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 | |||
| Therapy for Hepatitis C Virus (HCV) in Primary Treatment Failure in Pakistan[NCT05248919] | 318 participants (Anticipated) | Interventional | 2023-06-01 | Enrolling by invitation | |||
| A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis[NCT02781558] | Phase 2 | 204 participants (Actual) | Interventional | 2016-07-29 | Completed | ||
| The Puglia HCV Micro-elimination in People With Substance Use Disorders[NCT03923595] | 231 participants (Actual) | Observational | 2019-07-30 | Completed | |||
| Efficacy and Safety in Clinical Practice of Ombitasvir/Paritaprevir/ Ritonavir and Dasabuvir Administered for 8 Weeks (3D8) in Treatment-naïve Genotype 1b Hepatitis C Virus Infected Patients: Analysis of Data From Hepa-C Registry.[NCT03122132] | 200 participants (Actual) | Observational | 2017-02-20 | Completed | |||
| A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection[NCT02673489] | Phase 3 | 106 participants (Actual) | Interventional | 2016-03-15 | Completed | ||
| A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV[NCT02671500] | Phase 3 | 375 participants (Actual) | Interventional | 2016-04-19 | Completed | ||
| Real Life Experience in the Management of HCV Related Decompensated Cirrhosis With Direct Antiviral Agents[NCT03547895] | 80 participants (Actual) | Interventional | 2015-06-01 | Completed | |||
| A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection With Advanced Cirrhosis and Child-Pugh (CP)-B Hepatic Insufficiency[NCT02115321] | Phase 2/Phase 3 | 40 participants (Actual) | Interventional | 2014-05-09 | Completed | ||
| A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease[NCT03036852] | Phase 2 | 59 participants (Actual) | Interventional | 2017-03-22 | Completed | ||
| A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOIS[NCT01704755] | Phase 3 | 381 participants (Actual) | Interventional | 2012-10-31 | Completed | ||
| Open-Labeled Trial Of Direct-Acting Antiviral Treatment Of Hepatitis C-Negative Patients Who Receive Kidney Transplants From Hepatitis C-Positive Donors[NCT02743897] | Phase 1/Phase 2 | 62 participants (Actual) | Interventional | 2016-05-01 | Completed | ||
| A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection[NCT01717326] | Phase 2 | 573 participants (Actual) | Interventional | 2013-02-07 | Completed | ||
| Open-Labeled Trial Of Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors[NCT03146741] | Phase 1/Phase 2 | 20 participants (Actual) | Interventional | 2017-05-16 | Completed | ||
| A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection[NCT01672983] | Phase 2 | 110 participants (Actual) | Interventional | 2012-07-31 | Completed | ||
| A Prospective Cohort Study to Improve HCV Care Using Multidisciplinary Approach to the Treatment of Chronic Hepatitis C in Dialysis Patients: The MATCH-D Study[NCT03791814] | Phase 4 | 0 participants (Actual) | Interventional | 2019-01-01 | Withdrawn (stopped due to The study was stopped due to difficulty in identifying potential patients.) | ||
| An Open-label, Cohort Study of Grazoprevir/Elbasvir Combination Therapy for Patients With Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation[NCT03723824] | Phase 4 | 14 participants (Actual) | Interventional | 2019-02-14 | Terminated (stopped due to COV-19 pandemic) | ||
| Effect Of Interferon-Free Direct Acting Antiviral Agents For Treatment Of Hepatitis C Virus Patients On The Normal Kidney[NCT03296930] | Phase 4 | 100 participants (Anticipated) | Interventional | 2017-10-01 | Not yet recruiting | ||
| A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects With Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis[NCT01973049] | Phase 3 | 202 participants (Actual) | Interventional | 2013-12-31 | Completed | ||
| Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents[NCT01944527] | 699 participants (Actual) | Observational | 2013-10-31 | Active, not recruiting | |||
| A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Treatment-Naïve and Treatment-Experienced Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infe[NCT02023099] | Phase 3 | 363 participants (Actual) | Interventional | 2013-12-31 | Completed | ||
| A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)[NCT01685203] | Phase 2 | 316 participants (Actual) | Interventional | 2012-08-31 | Completed | ||
| Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4: Efficacy and Tolerability of Grazoprevir 100mg/Elbasvir 50mg During 8 Weeks[NCT02886624] | Phase 2 | 30 participants (Actual) | Interventional | 2017-05-31 | Completed | ||
| Efficacy and Tolerability of Grazoprevir and Elbasvir in Peginterferon Alfa Plus Ribavirin Experienced Patients With Chronic Genotype 1 HCV and HIV Co-infection: a Non-randomised, Open-label Clinical Trial[NCT03098121] | Phase 4 | 40 participants (Actual) | Interventional | 2017-10-20 | Completed | ||
| An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)[NCT02219503] | Phase 3 | 60 participants (Actual) | Interventional | 2014-09-30 | Completed | ||
| An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient[NCT03801707] | Phase 2/Phase 3 | 54 participants (Actual) | Interventional | 2019-03-22 | Completed | ||
| A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection[NCT01909804] | Phase 2 | 323 participants (Actual) | Interventional | 2013-06-30 | Completed | ||
| Phase 1 Pharmacokinetic Trial of Sofosbuvir/Velpatasvir in Pregnant Women With Chronic Hepatitis C Virus Infection[NCT04382404] | Phase 1 | 11 participants (Actual) | Interventional | 2020-10-22 | Completed | ||
| A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV[NCT02201940] | Phase 3 | 741 participants (Actual) | Interventional | 2014-07-31 | Completed | ||
| Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine[NCT04038320] | 868 participants (Actual) | Observational | 2018-03-26 | Completed | |||
| Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs[NCT04943588] | 25,000 participants (Anticipated) | Observational [Patient Registry] | 2021-11-01 | Recruiting | |||
| A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection[NCT02201953] | Phase 3 | 558 participants (Actual) | Interventional | 2014-07-31 | Completed | ||
| A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection[NCT02220998] | Phase 3 | 269 participants (Actual) | Interventional | 2014-09-30 | Completed | ||
| A Phase 2a Study of BMS-790052 and BMS-650032 in Combination Therapy With Japanese Subjects With Genotype 1 Chronic Hepatitis C (HCV) Virus Infection[NCT01051414] | Phase 2 | 43 participants (Actual) | Interventional | 2010-04-30 | Completed | ||
| Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1[NCT01012895] | Phase 2 | 215 participants (Actual) | Interventional | 2009-12-31 | Completed | ||
| A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection[NCT01581203] | Phase 3 | 748 participants (Actual) | Interventional | 2012-05-31 | Completed | ||
| A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant[NCT01497834] | Phase 3 | 224 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| Efficacy and Safety of Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly Cirrhotic Patients: a Real Life Study[NCT02702739] | Phase 4 | 270 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection[NCT02032901] | Phase 3 | 173 participants (Actual) | Interventional | 2014-01-31 | Completed | ||
| A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection[NCT02202980] | Phase 2 | 273 participants (Actual) | Interventional | 2014-08-04 | Completed | ||
| A Phase II, Randomized Clinical Trial to Study the Safety, Tolerability, and Efficacy of the Combination Regimen of MK-5172 and MK-8742 in Japanese Subjects With Chronic Hepatitis C and a Phase III, Randomized Placebo-Controlled Clinical Trial to Study th[NCT02203149] | Phase 2/Phase 3 | 399 participants (Actual) | Interventional | 2014-08-01 | Completed | ||
| A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects[NCT02268864] | Phase 2 | 106 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| A Phase II Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 + MK-8742 + Ribavirin (R) in Subjects With Chronic Hepatitis C Virus Infection Who Failed Prior Direct Acting Antiviral Therapy[NCT02105454] | Phase 2 | 79 participants (Actual) | Interventional | 2014-05-23 | Completed | ||
| A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease[NCT02092350] | Phase 2/Phase 3 | 237 participants (Actual) | Interventional | 2014-03-17 | Completed | ||
| The Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, Non-Cirrhotic, HCV GT4-Infected Patients: A Single-Center, Single-Arm, Open-Label, Phase III Trial[NCT03578640] | Phase 3 | 30 participants (Actual) | Interventional | 2018-07-01 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL. (NCT02194998)
Timeframe: From treatment initiation to 4 weeks after last dose of HCV study treatment. HIV-1 RNA was measured at weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. The durations for HCV study treatment for Cohorts A/C and Cohorts B/D were 24 and 12 weeks, respectively.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 1 |
HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA
Timeframe: From treatment initiation to either 24 weeks (for Cohort A and C) or 12 weeks (for Cohort B and D). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 1 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 1 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation. (NCT02194998)
Timeframe: From treatment initiation to end of study follow-up at 48 weeks.The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively. The duration for ARV treatment for all cohorts was 48 weeks.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 1 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
"Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation.~If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0." (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 5 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 3 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 3 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment. (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 1 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 1 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 2 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
"Participants with signs/symptoms of grade 3 or higher post treatment initiation.~Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0." (NCT02194998)
Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 2 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 3 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome. (NCT02194998)
Timeframe: At confirmation of HIV-1 virologic failure.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 0 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 0 |
"SVR12 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 12 weeks post HCV treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method.~For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome." (NCT02194998)
Timeframe: At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 95.2 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 60 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 100 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 100 |
"SVR24 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 24 weeks post treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson.~For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome." (NCT02194998)
Timeframe: At 24 weeks after the date of last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 90.5 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 60 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 93.3 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 100 |
Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | pg/mL (Median) | |
|---|---|---|
| Change from baseline to EOT | Change from baseline to 12 weeks post EOT | |
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | -244.4 | -127 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | -22.2 | -29.1 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | -116 | -83.1 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | -61.1 | -114.9 |
Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | ng/mL (Median) | |
|---|---|---|
| Change from baseline to EOT | Change from baseline to 12 weeks post EOT | |
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 307.6 | 145.2 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | -1,063.2 | -894.2 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | -380.3 | -22.6 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 318.2 | -987.0 |
Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | pg/mL (Median) | ||
|---|---|---|---|
| IP-10 at baseline | IP-10 at EOT | IP-10 at 12 weeks post EOT | |
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 379 | 100.9 | 94.6 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 120.2 | 60.4 | 85.5 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 225.5 | 76.6 | 82.5 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 196.4 | 182.6 | 159.5 |
Levels of sCD14. Baseline was defined as the date of first treatment dose. (NCT02194998)
Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
| Intervention | ng/mL (Median) | ||
|---|---|---|---|
| sCD14 at Baseline | sCD14 at EOT | sCD14 at 12 weeks post EOT | |
| Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 1,832.0 | 2,126.5 | 1,977.3 |
| Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 2,226.8 | 1,132.8 | 1,367.4 |
| Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] | 3,157.0 | 2,421.1 | 3,424.5 |
| Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] | 3,092.0 | 2,801.3 | 2,608.3 |
(NCT02201901)
Timeframe: Up to 24 weeks plus 30 days
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL 12 Weeks (Group 1) | 1.1 |
| SOF/VEL+RBV 12 Weeks (Group 2) | 16.1 |
| SOF/VEL 24 Weeks (Group 3) | 4.4 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02201901)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL 12 Weeks (Group 1) | 83.3 |
| SOF/VEL+RBV 12 Weeks (Group 2) | 94.3 |
| SOF/VEL 24 Weeks (Group 3) | 87.8 |
"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement" (NCT02201901)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL 12 Weeks (Group 1) | 12.2 |
| SOF/VEL+RBV 12 Weeks (Group 2) | 3.4 |
| SOF/VEL 24 Weeks (Group 3) | 8.9 |
(NCT02201901)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
| Intervention | log10 IU/mL (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Wk 1(Group 1: N=89; Group 2: N=83; Group 3: N=88) | Wk 2(Group 1: N=89; Group 2: N=87; Group 3: N=88) | Wk 4(Group 1: N=88; Group 2: N=86; Group 3: N=88) | Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88) | Wk 8(Group 1: N=89; Group 2: N=83; Group 3: N=87) | Wk 10(Group 1: N=89; Group 2: N=84; Group 3, N=87) | Wk 12(Group 1: N=89; Group 2: N=82; Group 3: N=86) | Wk 16 (Group 1: N=0; Group 2: N=0; Group 3: N=85) | Wk 20 (Group 1: N=0; Group 2: N=0; Group 3: N =84) | Wk 24 (Group 1: N=0; Group 2: N=0; Group 3: N =84) | |
| SOF/VEL 12 Weeks (Group 1) | -3.51 | -4.24 | -4.78 | -4.87 | -4.87 | -4.87 | -4.87 | NA | NA | NA |
| SOF/VEL 24 Weeks (Group 3) | -3.72 | -4.38 | -4.70 | -4.74 | -4.76 | -4.76 | -4.75 | -4.76 | -4.77 | -4.77 |
| SOF/VEL+RBV 12 Weeks (Group 2) | -3.63 | -4.17 | -4.58 | -4.68 | -4.68 | -4.67 | -4.68 | NA | NA | NA |
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease. (NCT02201901)
Timeframe: Baseline to Posttreatment Week 24
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Decrease (Improvement) | No Change | Increase (Worsening) | |
| SOF/VEL 12 Weeks (Group 1) | 44.9 | 43.5 | 11.6 |
| SOF/VEL 24 Weeks (Group 3) | 63.8 | 27.5 | 8.7 |
| SOF/VEL+RBV 12 Weeks (Group 2) | 53.3 | 37.3 | 9.3 |
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. (NCT02201901)
Timeframe: Baseline to Posttreatment Week 24
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Decrease (Improvement) | No Change | Increase (Worsening) | |
| SOF/VEL 12 Weeks (Group 1) | 55.1 | 20.3 | 24.6 |
| SOF/VEL 24 Weeks (Group 3) | 50.7 | 21.7 | 27.5 |
| SOF/VEL+RBV 12 Weeks (Group 2) | 49.3 | 25.3 | 25.3 |
(NCT02201901)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
| Intervention | percentage of participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Wk 1(Group 1: N=90; Group 2: N=87; Group 3: N=90) | Wk 2 (Group 1: N=90; Group 2: N=87;Group 3: N=89) | Wk 4 (Group 1: N=90; Group 2: N=87; Group 3: N=89) | Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88) | Wk 8(Group 1: N=89; Group 2: N=84; Group 3: N=87) | Wk 10(Group 1: N=89; Group 2: N=84; Group 3: N=87) | Wk 12(Group 1: N=89; Group 2: N=83; Group 3: N=87) | Wk 16(Group 1: N=0; Group 2: N=0; Group 3: N=86) | Wk 20(Group 1: N=0; Group 2: N=0;Group 3: N=84) | Wk 24(Group 1: N=0; Group 2: N=0; Group 3: N=84) | |
| SOF/VEL 12 Weeks (Group 1) | 2.2 | 34.4 | 81.1 | 98.9 | 98.9 | 100.0 | 100.0 | NA | NA | NA |
| SOF/VEL 24 Weeks (Group 3) | 11.1 | 39.3 | 91.0 | 98.9 | 100.0 | 100.0 | 97.7 | 97.7 | 100.0 | 100.0 |
| SOF/VEL+RBV 12 Weeks (Group 2) | 14.9 | 49.4 | 80.5 | 97.6 | 98.8 | 98.8 | 98.8 | NA | NA | NA |
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02201901)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| SOF/VEL 12 Weeks (Group 1) | 92.2 | 83.3 |
| SOF/VEL 24 Weeks (Group 3) | 90.0 | 87.8 |
| SOF/VEL+RBV 12 Weeks (Group 2) | 95.4 | 94.3 |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section. (NCT02247401)
Timeframe: Screening until 30 days after last dose
| Intervention | Participants (Count of Participants) |
|---|---|
| Arm A | 80 |
| Arm B | 26 |
| Arm C | 25 |
On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment. (NCT02247401)
Timeframe: Up to 12 or 24 weeks after first dose
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 1.0 |
| Arm B | 3.2 |
| Arm C | 3.4 |
Post-treatment relapse was defined as defined as confirmed HCV RNA > LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. (NCT02247401)
Timeframe: Up to 12 weeks after first dose
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 3.1 |
| Arm B | 0.0 |
| Arm C | 0.0 |
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug. (NCT02247401)
Timeframe: 12 weeks after last dose
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 94.0 |
| Arm B | 96.8 |
| Arm C | 93.1 |
(NCT02639247)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX 12 Weeks | 0 |
| SOF/VEL 12 Weeks | 0.7 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02639247)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX 12 Weeks | 97.8 |
| SOF/VEL 12 Weeks | 90.1 |
"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02639247)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX 12 Weeks | 0.5 |
| SOF/VEL 12 Weeks | 9.9 |
(NCT02639247)
Timeframe: Weeks 1, 2, 4, 8, and 12
| Intervention | log10 IU/mL (Mean) | ||||
|---|---|---|---|---|---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | |
| SOF/VEL 12 Weeks | -4.17 | -4.78 | -5.06 | -5.08 | -5.09 |
| SOF/VEL/VOX 12 Weeks | -4.29 | -4.93 | -5.13 | -5.17 | -5.17 |
(NCT02639247)
Timeframe: Weeks 1, 2, 4, 8 and 12
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | |
| SOF/VEL 12 Weeks | 17.2 | 56.3 | 90.7 | 98.7 | 99.3 |
| SOF/VEL/VOX 12 Weeks | 15.9 | 62.6 | 88.5 | 100.0 | 98.9 |
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02639247)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participcants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| SOF/VEL 12 Weeks | 91.4 | 90.1 |
| SOF/VEL/VOX 12 Weeks | 98.4 | 97.8 |
(NCT02607735)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX (Primary Study) | 0.4 |
| Placebo (Primary Study) | 2.0 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02607735)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX (Primary Study) | 96.2 |
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02607735)
Timeframe: Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX (Primary Study) | 96.2 |
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment, respectively. (NCT02607735)
Timeframe: Posttreatment Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX (Primary Study) | 97.7 |
| Placebo (Primary Study) | 0 |
"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or~Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit." (NCT02607735)
Timeframe: Up to Posttreatment Week 24 (Deferred Treatment Substudy)
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX (Deferred Treatment Substudy) | 2.7 |
"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or~Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit." (NCT02607735)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX (Primary Study) | 2.7 |
(NCT02607735)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)
| Intervention | log10 IU/mL (Mean) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | |
| SOF/VEL/VOX (Deferred Treatment Substudy) | -4.30 | -4.93 | -5.16 | -5.20 | -5.20 |
(NCT02607735)
Timeframe: Baseline; Weeks 1, 2, 4, 8 and 12
| Intervention | log10 IU/mL (Mean) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | |
| Placebo (Primary Study) | 0.02 | 0.02 | -0.01 | 0.05 | 0.03 |
| SOF/VEL/VOX (Primary Study) | -4.20 | -4.81 | -5.07 | -5.11 | -5.10 |
(NCT02607735)
Timeframe: Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | |
| SOF/VEL/VOX (Deferred Treatment Substudy) | 14.3 | 62.6 | 93.2 | 100.0 | 100.0 |
(NCT02607735)
Timeframe: Weeks 1, 2, 4, 8 and 12
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | |
| Placebo (Primary Study) | 0 | 0 | 0 | 0 | 0 |
| SOF/VEL/VOX (Primary Study) | 15.6 | 56.7 | 92.7 | 100.0 | 99.6 |
SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively. (NCT02607735)
Timeframe: Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| SVR4 | SVR12 | SVR24 | |
| SOF/VEL/VOX (Deferred Treatment Substudy) | 98.6 | 97.3 | 97.3 |
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks. (NCT02332720)
Timeframe: Up to 40 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks) | 18 |
| A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks) | 14 |
| A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks) | 16 |
| A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks) | 17 |
| A4+ B4: GT3 NC TN MK-3682B (8 Weeks) | 26 |
| B4: GT3 NC TN MK-3682B (8 Weeks) | 9 |
| B5: GT3 NC TN MK-3682B + RBV (8 Weeks) | 30 |
| B6: GT3 NC TN MK-3682B (12 Weeks) | 25 |
| B7: GT3 NC TN MK-3682B + RBV (12 Weeks) | 33 |
| B8: GT3 NC TE MK-3682B (8 Weeks) | 12 |
| B9: GT3 NC TE MK-3682B + RBV (8 Weeks) | 12 |
| B10: GT3 NC TE MK-3682B (12 Weeks) | 9 |
| B11: GT3 NC TE MK-3682B + RBV (12 Weeks) | 13 |
| B12: GT3 NC TE MK-3682B (16 Weeks) | 13 |
| B13: GT3 C TN MK-3682B (12 Weeks) | 9 |
| B14: GT3 C TN MK-3682B + RBV (12 Weeks) | 14 |
| B15: GT3 C TN MK-3682B (16 Weeks) | 12 |
| B16: GT3 C TE MK-3682B (12 Weeks) | 12 |
| B17: GT3 C TE MK-3682B + RBV (12 Weeks) | 12 |
| B18: GT3 C TE MK-3682B (16 Weeks) | 16 |
| B19: GT3 C TE MK-3682B + RBV (16 Weeks) | 21 |
| B20: GT4 NC TN MK-3682B (8 Weeks) | 3 |
| B22: GT6 NC TN MK-3682B (12 Weeks) | 3 |
| Part C: GT3 NC TN: MK-3682B + RBV (16 Weeks) | 7 |
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks. (NCT02332720)
Timeframe: Up to 16 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks) | 0 |
| A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks) | 0 |
| A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks) | 0 |
| A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks) | 0 |
| A4+ B4: GT3 NC TN MK-3682B (8 Weeks) | 0 |
| B4: GT3 NC TN MK-3682B (8 Weeks) | 0 |
| B5: GT3 NC TN MK-3682B + RBV (8 Weeks) | 0 |
| B6: GT3 NC TN MK-3682B (12 Weeks) | 0 |
| B7: GT3 NC TN MK-3682B + RBV (12 Weeks) | 1 |
| B8: GT3 NC TE MK-3682B (8 Weeks) | 0 |
| B9: GT3 NC TE MK-3682B + RBV (8 Weeks) | 0 |
| B10: GT3 NC TE MK-3682B (12 Weeks) | 0 |
| B11: GT3 NC TE MK-3682B + RBV (12 Weeks) | 0 |
| B12: GT3 NC TE MK-3682B (16 Weeks) | 0 |
| B13: GT3 C TN MK-3682B (12 Weeks) | 0 |
| B14: GT3 C TN MK-3682B + RBV (12 Weeks) | 1 |
| B15: GT3 C TN MK-3682B (16 Weeks) | 1 |
| B16: GT3 C TE MK-3682B (12 Weeks) | 0 |
| B17: GT3 C TE MK-3682B + RBV (12 Weeks) | 0 |
| B18: GT3 C TE MK-3682B (16 Weeks) | 1 |
| B19: GT3 C TE MK-3682B + RBV (16 Weeks) | 0 |
| B20: GT4 NC TN MK-3682B (8 Weeks) | 0 |
| B22: GT6 NC TN MK-3682B (12 Weeks) | 0 |
| Part C: GT3 NC TN: MK-3682B + RBV (16 Weeks) | 0 |
SVR24 is defined as HCV RNA
Timeframe: Up to 40 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks) | 90.0 |
| A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks) | 95.2 |
| A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks) | 86.4 |
| A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks) | 90.9 |
| A4+B4: GT3 NC TN MK-3682B (8 Weeks) | 92.1 |
| B4: GT3 NC TN MK-3682B (8 Weeks) | 93.8 |
| B5: GT3 NC TN MK-3682B + RBV (8 Weeks) | 100.0 |
| B6: GT3 NC TN MK-3682B (12 Weeks) | 97.2 |
| B7: GT3 NC TN MK-3682B + RBV (12 Weeks) | 100.0 |
| B8: GT3 NC TE MK-3682B (8 Weeks) | 100.0 |
| B9: GT3 NC TE MK-3682B + RBV (8 Weeks) | 92.9 |
| B10: GT3 NC TE MK-3682B (12 Weeks) | 100.0 |
| B11: GT3 NC TE MK-3682B + RBV (12 Weeks) | 93.3 |
| B12: GT3 NC TE MK-3682B (16 Weeks) | 93.8 |
| B13: GT3 C TN MK-3682B (12 Weeks) | 92.3 |
| B14: GT3 C TN MK-3682B + RBV (12 Weeks) | 100.0 |
| B15: GT3 C TN MK-3682B (16 Weeks) | 100.0 |
| B16: GT3 C TE MK-3682B (12 Weeks) | 100.0 |
| B17: GT3 C TE MK-3682B + RBV (12 Weeks) | 100.0 |
| B18: GT3 C TE MK-3682B (16 Weeks) | 100.0 |
| B19: GT3 C TE MK-3682B + RBV (16 Weeks) | 96.0 |
SVR12 is defined as HCV ribonucleic acid (RNA) less than the lower limit of quantification (
Timeframe: Up to 20 weeks (Part A), up to 28 weeks (Part B)
| Intervention | Percentage of participants (Number) |
|---|---|
| A1: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks) | 90.5 |
| A2: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks) | 95.2 |
| A3: GT3 NC TN Grazoprevir+Uprifosbuvir+Elbasvir (8 Weeks) | 86.4 |
| A4: GT3 NC TN Grazoprevir+Uprifosbuvir+Ruzasvir (8 Weeks) | 90.9 |
| A4+B4: GT3 NC TN MK-3682B (8 Weeks) | 92.1 |
| B4: GT3 NC TN MK-3682B (8 Weeks) | 93.8 |
| B5: GT3 NC TN MK-3682B + RBV (8 Weeks) | 100.0 |
| B6: GT3 NC TN MK-3682B (12 Weeks) | 97.2 |
| B7: GT3 NC TN MK-3682B + RBV (12 Weeks) | 100.0 |
| B8: GT3 NC TE MK-3682B (8 Weeks) | 100.0 |
| B9: GT3 NC TE MK-3682B + RBV (8 Weeks) | 92.9 |
| B10: GT3 NC TE MK-3682B (12 Weeks) | 100.0 |
| B11: GT3 NC TE MK-3682B + RBV (12 Weeks) | 93.3 |
| B12: GT3 NC TE MK-3682B (16 Weeks) | 93.8 |
| B13: GT3 C TN MK-3682B (12 Weeks) | 92.3 |
| B14: GT3 C TN MK-3682B + RBV (12 Weeks) | 100.0 |
| B15: GT3 C TN MK-3682B (16 Weeks) | 100.0 |
| B16: GT3 C TE MK-3682B (12 Weeks) | 100.0 |
| B17: GT3 C TE MK-3682B + RBV (12 Weeks) | 100.0 |
| B18: GT3 C TE MK-3682B (16 Weeks) | 100.0 |
| B19: GT3 C TE MK-3682B + RBV (16 Weeks) | 96.0 |
The percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) < Lower Limit of Quantification (LLoQ) 12 weeks after completing treatment (i.e., SVR12) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL. (NCT02332707)
Timeframe: Up to 28 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| A1: GT1 NC GZR+UPR+EBR (8 Weeks) | 100.0 |
| A2: GT1 NC GZR+UPR+RZR (8 Weeks) | 100.0 |
| A3: GT2 NC GZR+UPR+EBR (8 Weeks) | 68.8 |
| A4: GT2 NC GZR+UPR+RZR (8 Weeks) | 71.4 |
| A5: GT1 NC GZR+UPR+EBR (8 Weeks) | 100.0 |
| A6: GT1 NC GZR+UPR+RZR (8 Weeks) | 91.3 |
| B6: GT1 NC GZR+UPR+RVR (8 Weeks) | 100.0 |
| A7: GT2 NC GZR+UPR+EBR (8 Weeks) | 60.0 |
| A8: GT2 NC GZR+UPR+RZR (8 Weeks) | 93.8 |
| B8: GT2 NC GZR+UPR+RZR (8 Weeks) | 87.5 |
| B9: GT1 NC GZR+UPR+RZR (12 Weeks) | 100.0 |
| B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV | 83.3 |
| B11: GT2 NC GZR+UPR+RZR (12 Weeks) | 100.0 |
| B12: GT1 C GZR+UPR+RZR (8 Weeks) | 97.1 |
| B13: GT1 C GZR+UPR+RZR (12 Weeks) | 100.0 |
| B14: GT2 C GZR+UPR+RZR (12 Weeks) | 100.0 |
| B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV | 100.0 |
| 16: GT2 C GZR+UPR+RZR (16 Weeks) | 100.0 |
The percentage of participants with HCV RNA < LLoQ 24 weeks after completing treatment (i.e., SVR24) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL. (NCT02332707)
Timeframe: Up to 40 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| A1: GT1 NC GZR+UPR+EBR (8 Weeks) | 100.0 |
| A2: GT1 NC GZR+UPR+RZR (8 Weeks) | 100.0 |
| A3: GT2 NC GZR+UPR+EBR (8 Weeks) | 68.8 |
| A4: GT2 NC GZR+UPR+RZR (8 Weeks) | 71.4 |
| A5: GT1 NC GZR+UPR+EBR (8 Weeks) | 100.0 |
| A6: GT1 NC GZR+UPR+RZR (8 Weeks) | 90.9 |
| B6: GT1 NC GZR+UPR+RVR (8 Weeks) | 100.0 |
| A7: GT2 NC GZR+UPR+EBR (8 Weeks) | 60.0 |
| A8: GT2 NC GZR+UPR+RZR (8 Weeks) | 93.8 |
| B8: GT2 NC GZR+UPR+RZR (8 Weeks) | 87.5 |
| B9: GT1 NC GZR+UPR+RZR (12 Weeks) | 100.0 |
| B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV | 83.3 |
| B11: GT2 NC GZR+UPR+RZR (12 Weeks) | 100.0 |
| B12: GT1 C GZR+UPR+RZR (8 Weeks) | 97.1 |
| B13: GT1 C GZR+UPR+RZR (12 Weeks) | 100.0 |
| B14: GT2 C GZR+UPR+RZR (12 Weeks) | 100.0 |
| B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV | 100.0 |
| 16: GT2 C GZR+UPR+RZR (16 Weeks) | 100.0 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02332707)
Timeframe: Up to 16 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| A1: GT1 NC GZR+UPR+EBR (8 Weeks) | 0 |
| A2: GT1 NC GZR+UPR+RZR (8 Weeks) | 0 |
| A3: GT2 NC GZR+UPR+EBR (8 Weeks) | 0 |
| A4: GT2 NC GZR+UPR+RZR (8 Weeks) | 0 |
| A5: GT1 NC GZR+UPR+EBR (8 Weeks) | 0 |
| A6: GT1 NC GZR+UPR+RZR (8 Weeks) | 0 |
| B6: GT1 NC GZR+UPR+RVR (8 Weeks) | 0 |
| A7: GT2 NC GZR+UPR+EBR (8 Weeks) | 0 |
| A8: GT2 NC GZR+UPR+RZR (8 Weeks) | 0 |
| B8: GT2 NC GZR+UPR+RZR (8 Weeks) | 0 |
| B9: GT1 NC GZR+UPR+RZR (12 Weeks) | 0 |
| B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV | 6.5 |
| B11: GT2 NC GZR+UPR+RZR (12 Weeks) | 0 |
| B12: GT1 C GZR+UPR+RZR (8 Weeks) | 0 |
| B13: GT1 C GZR+UPR+RZR (12 Weeks) | 2.5 |
| B14: GT2 C GZR+UPR+RZR (12 Weeks) | 0 |
| B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV | 12.5 |
| 16: GT2 C GZR+UPR+RZR (16 Weeks) | 0 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02332707)
Timeframe: Up to 18 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| A1: GT1 NC GZR+UPR+EBR (8 Weeks) | 60.9 |
| A2: GT1 NC GZR+UPR+RZR (8 Weeks) | 83.3 |
| A3: GT2 NC GZR+UPR+EBR (8 Weeks) | 56.3 |
| A4: GT2 NC GZR+UPR+RZR (8 Weeks) | 71.4 |
| A5: GT1 NC GZR+UPR+EBR (8 Weeks) | 73.9 |
| A6: GT1 NC GZR+UPR+RZR (8 Weeks) | 60.9 |
| B6: GT1 NC GZR+UPR+RVR (8 Weeks) | 62.3 |
| A7: GT2 NC GZR+UPR+EBR (8 Weeks) | 86.7 |
| A8: GT2 NC GZR+UPR+RZR (8 Weeks) | 75.0 |
| B8: GT2 NC GZR+UPR+RZR (8 Weeks) | 68.8 |
| B9: GT1 NC GZR+UPR+RZR (12 Weeks) | 72.9 |
| B10: GT2 NC GZR+UPR+RZR (8 Weeks) + RBV | 80.6 |
| B11: GT2 NC GZR+UPR+RZR (12 Weeks) | 71.0 |
| B12: GT1 C GZR+UPR+RZR (8 Weeks) | 57.1 |
| B13: GT1 C GZR+UPR+RZR (12 Weeks) | 72.5 |
| B14: GT2 C GZR+UPR+RZR (12 Weeks) | 53.3 |
| B15: GT2 C GZR+UPR+RZR (12 Weeks) + RBV | 81.3 |
| 16: GT2 C GZR+UPR+RZR (16 Weeks) | 69.2 |
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment. (NCT02292719)
Timeframe: Up to Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A (Genotype [GT]3, Noncirrhotic) | 0 |
| Arm B (GT3, Noncirrhotic) | 0 |
| Arm C (GT2, Noncirrhotic) | 0 |
| Arm D (GT2, Noncirrhotic) | 0 |
| Arm E (GT3, Cirrhotic) | 0 |
| Arm F (GT3, Noncirrhotic) | 0 |
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02292719)
Timeframe: Up to 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A (Genotype [GT]3, Noncirrhotic) | 0 |
| Arm B (GT3, Noncirrhotic) | 0 |
| Arm C (GT2, Noncirrhotic) | 10.0 |
| Arm D (GT2, Noncirrhotic) | 55.6 |
| Arm E (GT3, Cirrhotic) | 0 |
| Arm F (GT3, Noncirrhotic) | 0 |
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A (Genotype [GT]3, Noncirrhotic) | 100 |
| Arm B (GT3, Noncirrhotic) | 90.9 |
| Arm C (GT2, Noncirrhotic) | 90.0 |
| Arm D (GT2, Noncirrhotic) | 44.4 |
| Arm E (GT3, Cirrhotic) | 100 |
| Arm F (GT3, Noncirrhotic) | 100 |
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 99.2 |
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 99.1 |
| Arm B | 100 |
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method. (NCT02707952)
Timeframe: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 0 |
| Arm B | 0 |
| Arm C | 1.0 |
| Arm D | 0 |
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. The confidence interval was calculated using the Wilson score method. (NCT02707952)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 0 |
| Arm B | 0 |
| Arm C | 3.0 |
| Arm D | 0 |
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With Severe RI and without Cirrhosis | |
| Arm D | 100 |
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| HCV GT1 Participants with Compensated Cirrhosis | HCV GT2 Participants with Compensated Cirrhosis | DAA Experienced Participants | HCV GT3,4,5 and 6 Participants | Participants With Severe RI and with Cirrhosis | |
| Arm C | 100 | 100 | 93.9 | 83.3 | 100.0 |
Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify preexisting sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. (NCT02349048)
Timeframe: Up to Week 30 for Arm A and up to Week 32 for Arm B
| Intervention | Participants (Number) |
|---|---|
| Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 8 |
| Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 0 |
Late Viral Relapse: Participant who achieved SVR12 and the post treatment HCV RNA measurement fulfilled 1 the following conditions: a) at least 2 consecutive measurements not lesser than (<)15 IU/mL undetectable, of which at least the second measurement was >=15 IU/mL quantifiable or b) the last available measurement was >=15 IU/mL quantifiable. (NCT02349048)
Timeframe: From Week 18 to Week 30 (for Arm A), From Week 20 to Week 32 (for Arm B)
| Intervention | Participants (Number) |
|---|---|
| Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 1 |
| Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 0 |
Viral Relapse: Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during followup. (NCT02349048)
Timeframe: From Week 6 to Week 18 (for Arm A) and From Week 8 to Week 20 (for Arm B)
| Intervention | Participants (Number) |
|---|---|
| Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 7 |
| Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 0 |
Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. Includes participants with: 1) viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA 2) confirmed detectable HCV RNA at the actual end of treatment (example, completed treatment, discontinued due to adverse events, withdrawal of consent) of >100 IU/mL in participants whose HCV RNA had previously been
Timeframe: Baseline up to End of Treatment (Week 6 for Arm A and Week 8 for Arm B)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 1.7 |
| Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 0 |
Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment. (NCT02349048)
Timeframe: 12 weeks after end of study drug treatment (week 18 for Arm A and week 20 for Arm B)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 86.4 |
| Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 100 |
"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point:
Timeframe: Day 2, Day 3, Week 1, 2, 3, 4, 6 (for Arm A) and 8 (for Arm B only)
| Intervention | Percentage of Participants (Number) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 2 : >= 15 IU/mL (n = 56, 9) | Day 2 : < 100 IU/mL (n = 56, 9) | Day 2 : < 15 IU/mL undetect/detectable (n = 56, 9) | Day 2 : < 15 IU/mL detectable (n = 56, 9) | Day 2: < 15 IU/mL undetectable (n = 56, 9) | Day 3 : >= 15 IU/mL (n = 58, 9) | Day 3 : < 100 IU/mL (n = 58, 9) | Day 3 : < 15 IU/mL undetect/detectable (n = 58, 9) | Day 3 : < 15 IU/mL detectable (n = 58, 9) | Day 3 : < 15 IU/mL undetectable (n = 58, 9) | Week 1: >= 15 IU/mL (n = 58, 9) | Week 1: < 100 IU/mL (n = 58, 9) | Week 1: < 15 IU/mL undetect/detectable (n = 58, 9) | Week 1 : < 15 IU/mL detectable (n = 58, 9) | Week 1 : < 15 IU/mL undetectable (n = 58, 9) | Week 2 : >= 15 IU/mL (n = 56, 9) | Week 2: < 100 IU/mL (n = 56, 9) | Week 2: < 15 IU/mL undetect/detectable (n = 56, 9) | Week 2 : < 15 IU/mL detectable (n = 56, 9) | Week 2: < 15 IU/mL undetectable (vRVR) (n = 56, 9) | Week 3: >= 15 IU/mL (n = 56, 9) | Week 3: < 100 IU/mL (n = 56, 9) | Week 3: < 15 IU/mL undetect/detectable (n = 56, 9) | Week 3 : < 15 IU/mL detectable (n = 56, 9) | Week 3 : < 15 IU/mL undetectable (n = 56, 9) | Week 4 : >= 15 IU/mL (n = 58, 9) | Week 4: < 100 IU/mL (n = 58, 9) | Week 4: < 15 IU/mL undetect/detectable (n = 58, 9) | Week 4 : < 15 IU/mL detectable ( n = 58, 9) | Week 4 : < 15 IU/mL undetectable (RVR) (n = 58, 9) | Week 6 : >= 15 IU/mL (n = 58, 9) | Week 6: < 100 IU/mL ( n = 58, 9) | Week 6: < 15 IU/mL undetect/detectable (n = 58, 9) | Week 6 : < 15 IU/mL detectable (n = 58, 9) | Week 6 : < 15 IU/mL undetectable (n= 58, 9) | Week 8 : >= 15 IU/ml (n = 0, 9) | Week 8: < 100 IU/mL (n = 0, 9) | Week 8: < 15 IU/mL undetect/detectable (n = 0, 9) | Week 8: < 15 IU/mL detectable (n = 0, 9) | Week 8: < 15 IU/mL undetectable (n = 0, 9) | |
| Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 96.4 | 7.1 | 3.6 | 3.6 | 0 | 94.8 | 19.0 | 5.2 | 5.2 | 0 | 58.6 | 75.9 | 41.4 | 36.2 | 5.2 | 19.6 | 94.6 | 80.4 | 41.1 | 39.3 | 7.1 | 100 | 92.9 | 21.4 | 71.4 | 3.4 | 98.3 | 96.6 | 8.6 | 87.9 | 0 | 100 | 100 | 6.9 | 93.1 | NA | NA | NA | NA | NA |
| Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 100 | 0 | 0 | 0 | 0 | 100 | 11.1 | 0 | 0 | 0 | 66.7 | 33.3 | 33.3 | 33.3 | 0 | 66.7 | 77.8 | 33.3 | 0 | 33.3 | 33.3 | 100 | 66.7 | 22.2 | 44.4 | 11.1 | 100 | 88.9 | 33.3 | 55.6 | 0 | 100 | 100 | 0 | 100 | 0 | 100 | 100 | 0 | 100 |
The Q80K polymorphism, associated with low level SMV in vitro resistance. Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported. (NCT02349048)
Timeframe: up to Week 30 for Arm A and Week 32 for Arm B
| Intervention | Percentage of Participants (Number) | |
|---|---|---|
| With NS3 Q80K polymorphism at baseline (n=25,9) | Without NS3 Q80K polymorphism at baseline (n=23,9) | |
| Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 88.0 | 78.3 |
| Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 100 | 100 |
Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was
Timeframe: 4 weeks after end of study drug treatment (week 10 for Arm A and 12 for Arm B); 24 weeks after end of study drug treatment (week 30 for Arm A and 32 for Arm B)
| Intervention | Percentage of Participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks | 93.2 | 84.7 |
| Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks | 100 | 100 |
HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR24 was defined as HCV RNA
Timeframe: 24 weeks after end of all therapy (Study Week 36)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir + Elbasvir | 98.4 |
| SOF + PR | 89.7 |
HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR4 was defined as HCV RNA
Timeframe: 4 weeks after end of all therapy (Study Week 16)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir + Elbasvir | 99.2 |
| SOF + PR | 92.1 |
"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.~The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial." (NCT02358044)
Timeframe: Up to Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir + Elbasvir | 0.8 |
| SOF + PR | 0.8 |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm. (NCT02358044)
Timeframe: Treatment + First 14 days of follow-up (Up to Week 14)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir + Elbasvir | 51.9 |
| SOF + PR | 93.7 |
Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (
Timeframe: 12 weeks after end of all therapy (Study Week 24)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir + Elbasvir | 99.2 |
| SOF + PR | 90.5 |
Tier 1 safety events were pre-specified by the protocol to evaluate safety and test the safety superiority hypothesis. Tier 1 safety events were chosen to assess broad tolerability, hematological side effects and liver-related laboratory abnormalities. For this study, Tier 1 safety events included: any serious drug-related AE, any drug-related AE leading to permanent discontinuation (DC) of all study drugs, neutrophil count <0.75 x 10^9/L, hemoglobin <10 g/dL, severe depression, hepatic events of clinical interest (defined by abnormal increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]), or events meeting stopping rule criteria for DC from trial (due to abnormal increases of ALT, AST, or ALP with/without pre-specified related AEs). The percentage of participants who experienced each individual event that was defined as a Tier 1 safety event during the study treatment period was reported for each treatment arm. (NCT02358044)
Timeframe: Treatment + First 14 days of follow-up (Up to Week 14)
| Intervention | percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Total Tier 1 AEs | Tier 1 AE: Serious drug-related AE | Tier 1 AE: DC due to drug-related AE | Tier 1 AE: Neutrophil count <0.75 x 10^9/L | Tier 1 AE: Hemoglobin <10 g/dL | Tier 1 AE: Severe depression | Tier 1 AE: Hepatic event of clinical interest | Tier 1 AE: Trial DC due to stopping rule | |
| Grazoprevir + Elbasvir | 0.8 | 0.0 | 0.0 | 0.0 | 0.8 | 0.0 | 0.0 | 0.0 |
| SOF + PR | 27.8 | 2.4 | 0.8 | 12.7 | 14.3 | 0.0 | 0.0 | 0.0 |
The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL. (NCT02252016)
Timeframe: 12 weeks after completing study therapy (Week 24)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment | 93.5 |
| Deferred Treatment | 91.8 |
The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL. (NCT02252016)
Timeframe: 24 weeks after completing study therapy (Week 36)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment | 90.7 |
| Deferred Treatment | 91.8 |
An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. (NCT02252016)
Timeframe: Up to Week 12
| Intervention | Percentage of Participants (Number) |
|---|---|
| Immediate Treatment | 0.0 |
| Deferred Treatment | 1.9 |
An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. (NCT02252016)
Timeframe: Up to Week 14
| Intervention | Percentage of Participants (Number) |
|---|---|
| Immediate Treatment | 72.9 |
| Deferred Treatment | 65.4 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification (LLOQ) of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (
Timeframe: 12 weeks after end of all therapy (Study Week 24)
| Intervention | percentage of participants (Number) |
|---|---|
| Immediate Treatment Group (ITG): Grazoprevir/Elbasvir | 94.2 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA
Timeframe: 24 weeks after end of all therapy (Study Week 36)
| Intervention | percentage of participants (Number) |
|---|---|
| Immediate Treatment Group (ITG): Grazoprevir/Elbasvir | 94.0 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a LLOQ of 15 IU/mL. SVR4 was defined as HCV RNA
Timeframe: 4 weeks after end of all therapy (Study Week 16)
| Intervention | percentage of participants (Number) |
|---|---|
| Immediate Treatment Group (ITG): Grazoprevir/Elbasvir | 96.2 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period. (NCT02251990)
Timeframe: DB Treatment period plus first 14 follow-up days (up to 14 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Immediate Treatment Group (ITG): Grazoprevir/Elbasvir | 50.7 |
| Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir | 51.2 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. A participant could discontinue from treatment but continue to participate in the study as long as consent was not withdrawn. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period. (NCT02251990)
Timeframe: DB Treatment period (up to 12 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Immediate Treatment Group (ITG): Grazoprevir/Elbasvir | 0.3 |
| Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir | 0.8 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (
Timeframe: 12 weeks after end of all therapy (Study Week 24 for Immediate Treatment Arm and Study Week 40 for Deferred Treatment Arm)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Immediate Treatment Arm: Grazoprevir/Elbasvir | 95.5 |
| Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir | 96.6 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA
Timeframe: 24 weeks after end of all therapy (Study Week 36 for Immediate Treatment Arm and Study Week 52 for Deferred Treatment Arm)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Immediate Treatment Arm: Grazoprevir/Elbasvir | 94.1 |
| Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir | 96.5 |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants discontinuing study therapy due to an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period. (NCT02105688)
Timeframe: DB Treatment period (up to Study Week 12)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Immediate Treatment Arm: Grazoprevir/Elbasvir | 0.5 |
| Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir | 1.0 |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants experiencing an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period. (NCT02105688)
Timeframe: DB Treatment period plus first 14 follow-up days (up to Study Week 14)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Immediate Treatment Arm: Grazoprevir/Elbasvir | 83.1 |
| Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir | 83.0 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS). (NCT01932762)
Timeframe: From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)
| Intervention | days (Mean) |
|---|---|
| GT2: Grazoprevir + Elbasvir + RBV (Arm A1) | 25.2 |
| GT2: Grazoprevir + RBV (Arm B1) | 26.9 |
| GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) | 27.4 |
| GT 4,5,6: Grazoprevir + Elbasvir (Arm B3) | 21.3 |
SVR24 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population. (NCT01932762)
Timeframe: 24 weeks after end of all therapy (Study Week 36)
| Intervention | percentage of participants (Number) |
|---|---|
| GT2: Grazoprevir + Elbasvir + RBV (Arm A1) | 84.6 |
| GT2: Grazoprevir + RBV (Arm B1) | 75.0 |
| GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) | 94.1 |
| GT 4,5,6: Grazoprevir + Elbasvir (Arm B3) | 76.9 |
SVR4 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population. (NCT01932762)
Timeframe: 4 weeks after end of all therapy (Study Week 16)
| Intervention | percentage of participants (Number) |
|---|---|
| GT2: Grazoprevir + Elbasvir + RBV (Arm A1) | 88.9 |
| GT2: Grazoprevir + RBV (Arm B1) | 83.3 |
| GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) | 94.1 |
| GT 4,5,6: Grazoprevir + Elbasvir (Arm B3) | 78.6 |
SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) <25 IU/mL, either target detected but unquantifiable (TD[u]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population. (NCT01932762)
Timeframe: 12 weeks after end of all therapy (Study Week 24)
| Intervention | percentage of participants (Number) |
|---|---|
| GT2: Grazoprevir + Elbasvir + RBV (Arm A1) | 85.2 |
| GT2: Grazoprevir + RBV (Arm B1) | 75.0 |
| GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) | 94.1 |
| GT 4,5,6: Grazoprevir + Elbasvir (Arm B3) | 76.9 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels <25 IU/ml (either TD[u] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population. (NCT01932762)
Timeframe: From TW 2 through TW 12 (up to 12 weeks)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Week 2 (n=28, 24, 16, 15) | Week 4 (n=28, 24, 17, 15) | Week 12 (n=28, 24, 17, 14) | |
| GT 4,5,6: Grazoprevir + Elbasvir (Arm B3) | 93.3 | 93.3 | 85.7 |
| GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) | 87.5 | 100.0 | 100.0 |
| GT2: Grazoprevir + Elbasvir + RBV (Arm A1) | 96.4 | 100.0 | 96.4 |
| GT2: Grazoprevir + RBV (Arm B1) | 79.2 | 91.7 | 87.5 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population. (NCT01932762)
Timeframe: From TW 2 through TW 12 (up to 12 weeks)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Week 2 (n=28, 24, 16, 15) | Week 4 (n=28, 24, 17, 15) | Week 12 (n=28, 24, 17, 14) | |
| GT 4,5,6: Grazoprevir + Elbasvir (Arm B3) | 53.3 | 80.0 | 78.6 |
| GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) | 50.0 | 88.2 | 100.0 |
| GT2: Grazoprevir + Elbasvir + RBV (Arm A1) | 42.9 | 85.7 | 96.4 |
| GT2: Grazoprevir + RBV (Arm B1) | 50.0 | 79.2 | 83.3 |
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The investigator determined the relationship of the AE to the treatment as unrelated or possibly, probably, or definitely related. (NCT01932762)
Timeframe: Treatment period plus the first 14 days of follow-up (up to 14 weeks)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| AEs | SAEs | Drug-related AE | Drug-related SAE | Discontinuation due to AE | |
| GT 4,5,6: Grazoprevir + Elbasvir (Arm B3) | 78.9 | 0.0 | 36.8 | 0.0 | 5.3 |
| GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2) | 94.7 | 0.0 | 57.9 | 0.0 | 0.0 |
| GT2: Grazoprevir + Elbasvir + RBV (Arm A1) | 86.7 | 3.3 | 63.3 | 0.0 | 0.0 |
| GT2: Grazoprevir + RBV (Arm B1) | 86.7 | 3.3 | 63.3 | 3.3 | 0.0 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy. (NCT02105662)
Timeframe: 12 weeks after end of all therapy (Study Week 24)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir+Elbasvir | 96.3 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy. (NCT02105662)
Timeframe: 24 weeks after end of all therapy (Study Week 36)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir+Elbasvir | 93.1 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02105662)
Timeframe: Treatment Period (up to 12 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir+Elbasvir | 0.0 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02105662)
Timeframe: Treatment Period plus first 14 follow-up days (up to 14 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir+Elbasvir | 73.9 |
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02105701)
Timeframe: Up to 16 weeks
| Intervention | Number of participants (Number) |
|---|---|
| Grazoprevir + Elbasvir 12 Weeks | 1 |
| Grazoprevir + Elbasvir + RBV 12 Weeks | 1 |
| Grazoprevir + Elbasvir 16 Weeks | 0 |
| Grazoprevir + Elbasvir + RBV 16 Weeks | 5 |
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02105701)
Timeframe: Up to 18 weeks
| Intervention | Number of participants (Number) |
|---|---|
| Grazoprevir + Elbasvir 12 Weeks | 74 |
| Grazoprevir + Elbasvir + RBV 12 Weeks | 85 |
| Grazoprevir + Elbasvir 16 Weeks | 77 |
| Grazoprevir + Elbasvir + RBV 16 Weeks | 95 |
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. (NCT02105701)
Timeframe: 12 weeks after the end of all study treatment (up to 28 weeks)
| Intervention | Percentage of participants (Number) |
|---|---|
| Grazoprevir + Elbasvir 12 Weeks | 92.4 |
| Grazoprevir + Elbasvir + RBV 12 Weeks | 94.2 |
| Grazoprevir + Elbasvir 16 Weeks | 92.4 |
| Grazoprevir + Elbasvir + RBV 16 Weeks | 98.1 |
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. (NCT02105701)
Timeframe: 24 weeks after the end of all study treatment (up to 40 weeks)
| Intervention | Percentage of participants (Number) |
|---|---|
| Grazoprevir + Elbasvir 12 Weeks | 91.4 |
| Grazoprevir + Elbasvir + RBV 12 Weeks | 94.2 |
| Grazoprevir + Elbasvir 16 Weeks | 89.5 |
| Grazoprevir + Elbasvir + RBV 16 Weeks | 95.3 |
Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR12 was defined as HCV RNA
Timeframe: Week 24 (12 weeks after the end of treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment Group | 94.6 |
Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR24 was defined as HCV RNA
Timeframe: Week 36 (24 weeks after the end of treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment Group | 94.3 |
Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR4 was defined as HCV RNA
Timeframe: Week 16 (4 weeks after the end of treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment Group | 97.2 |
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. (NCT02105467)
Timeframe: Up to Week 12 (end of Blinded Treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment Group | 0.9 |
| Deferred Treatment Group | 1.0 |
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. (NCT02105467)
Timeframe: Up to Week 14 (14 days after the Blinded Treatment was completed)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment Group | 67.4 |
| Deferred Treatment Group | 68.6 |
(NCT02781558)
Timeframe: Baseline; Week 12
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | -5.04 |
| SOF/VEL + RBV | -5.13 |
(NCT02781558)
Timeframe: Baseline; Week 2
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | -4.67 |
| SOF/VEL + RBV | -4.80 |
(NCT02781558)
Timeframe: Baseline; Week 4
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | -4.96 |
| SOF/VEL + RBV | -5.09 |
(NCT02781558)
Timeframe: Baseline; Week 8
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | -5.04 |
| SOF/VEL + RBV | -5.13 |
(NCT02781558)
Timeframe: Week 12
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | 1.15 |
| SOF/VEL + RBV | 1.15 |
(NCT02781558)
Timeframe: Week 2
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | 1.52 |
| SOF/VEL + RBV | 1.47 |
(NCT02781558)
Timeframe: Week 4
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | 1.22 |
| SOF/VEL + RBV | 1.19 |
(NCT02781558)
Timeframe: Week 8
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | 1.15 |
| SOF/VEL + RBV | 1.15 |
SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. (NCT02781558)
Timeframe: Posttreatment Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 93.1 |
| SOF/VEL + RBV | 97.1 |
(NCT02781558)
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 99.0 |
| SOF/VEL + RBV | 100.0 |
(NCT02781558)
Timeframe: Week 2
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 51.0 |
| SOF/VEL + RBV | 44.7 |
(NCT02781558)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 85.0 |
| SOF/VEL + RBV | 90.3 |
(NCT02781558)
Timeframe: Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 99.0 |
| SOF/VEL + RBV | 100.0 |
(NCT02781558)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 1.0 |
| SOF/VEL + RBV | 1.9 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02781558)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 91.1 |
| SOF/VEL + RBV | 96.1 |
"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement" (NCT02781558)
Timeframe: Up to Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 5.9 |
| SOF/VEL + RBV | 1.9 |
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach. (NCT02673489)
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| HCV Treatment Naive | 92.6 |
| HCV Treatment Experienced | 75.0 |
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach. (NCT02673489)
Timeframe: Week 12 (Follow-up period)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| NS5A-Y93 Polymorphism: YES | NS5A-Y93 Polymorphism: NO | |
| HCV Treatment Experienced | 0.0 | 78.3 |
| HCV Treatment Naive | 85.7 | 93.6 |
HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach. (NCT02673489)
Timeframe: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks)
| Intervention | Percentage (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | End of Treatment | Follow Up Week 4 | Follow Up Week 12 (Imputed) | Follow Up Week 24 | |
| HCV Treatment Experienced | 12.5 | 54.2 | 75.0 | 91.7 | 87.5 | 83.3 | 83.3 | 87.5 | 91.7 | 79.2 | 75.0 | 66.7 |
| HCV Treatment Naive | 14.8 | 50.0 | 92.6 | 98.1 | 92.6 | 90.7 | 94.4 | 88.9 | 100.0 | 88.9 | 92.6 | 92.6 |
"HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up.~Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria." (NCT02673489)
Timeframe: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24
| Intervention | Percentage (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | End of Treatment | Follow Up Week 4 | Follow Up Week 12 | Follow Up Week 24 | |
| HCV Treatment Experienced | 0.0 | 12.5 | 62.5 | 83.3 | 83.3 | 79.2 | 83.3 | 83.3 | 87.5 | 79.2 | 75.0 | 66.7 |
| HCV Treatment Naive | 1.9 | 11.1 | 64.8 | 94.4 | 90.7 | 90.7 | 94.4 | 88.9 | 100.0 | 88.9 | 90.7 | 90.7 |
(NCT02671500)
Timeframe: Up to 12 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| SOF/VEL | 0 |
Virologic failure was defined as: (1) On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT02671500)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 3.2 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| SOF/VEL (Overall) | 96.5 |
| SOF/VEL (China - Region 1) | 96.2 |
| SOF/VEL (Southeast Asia - Region 2) | 97.3 |
SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 96.5 |
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 4
| Intervention | Percentage of participants (Number) |
|---|---|
| SOF/VEL | 97.1 |
(NCT02671500)
Timeframe: Baseline and up to Week 12
| Intervention | log10 IU/mL (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 10 | Change at Week 12 | |
| SOF/VEL | -4.38 | -4.89 | -5.02 | -5.03 | -5.03 | -5.03 | -5.03 |
(NCT02671500)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12
| Intervention | Percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | |
| SOF/VEL | 27.7 | 73.8 | 95.5 | 99.7 | 100.0 | 100.0 | 100.0 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02115321)
Timeframe: Up to 12 weeks
| Intervention | Number of participants (Number) |
|---|---|
| Part A: CP-B GZR 50 mg + EBR 50 mg | 0 |
| Part A: NC GZR 100 mg + ER 50 mg | 0 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02115321)
Timeframe: Up to 14 weeks
| Intervention | Number of participants (Number) |
|---|---|
| Part A: CP-B GZR 50 mg + EBR 50 mg | 25 |
| Part A: NC GZR 100 mg + ER 50 mg | 8 |
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels below the lower limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL. (NCT02115321)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Part A: CP-B GZR 50 mg + EBR 50 mg | 90.0 |
| Part A: NC GZR 100 mg + ER 50 mg | 100.0 |
SVR24 was defined as HCV RNA levels
Timeframe: Week 36
| Intervention | Percentage of participants (Number) |
|---|---|
| Part A: CP-B GZR 50 mg + EBR 50 mg | 90.0 |
| Part A: NC GZR 100 mg + ER 50 mg | 100.0 |
SVR4 was defined as HCV RNA levels
Timeframe: Week 16
| Intervention | Percentage of participants (Number) |
|---|---|
| Part A: CP-B GZR 50 mg + EBR 50 mg | 93.3 |
| Part A: NC GZR 100 mg + ER 50 mg | 100.0 |
The MELD score provides an objective and granular assessment of liver improvement as a continuous variable. The calculation of MELD score is based on three biochemical variables (serum bilirubin, creatinine and international normalized ratio [INR] of prothrombin time). The MELD equation is as follows: 9.57 x ln(creatinine mg/dL) +3.78 x ln(bilirubin mg/dL) +11.2 x ln (INR) + 6.43. Scores are multiplied by 10 and rounded to the nearest whole number and range from 6 (less ill) to 40 (gravely ill). MELD scores were determined at Baseline (Day 1) and again at Week 12, Follow-up (FU) Week 12 (Week 24), and FU Week 24 (Week 36). Change from baseline in MELD score = Post-baseline MELD score - baseline MELD score. (NCT02115321)
Timeframe: Baseline and Weeks 12, 24, and 36
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| Week 12 (n=30) | FU Week 12 (Week 24) [n=29] | FU Week 24 (Week 36) [n=29] | |
| Part A: CP-B GZR 50 mg + EBR 50 mg | -0.67 | -0.38 | -0.34 |
Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL. (NCT03036852)
Timeframe: First dose date up to Posttreatment Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| SOF/VEL | 0 |
(NCT03036852)
Timeframe: First dose date up to Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 0 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment. (NCT03036852)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL (Total) | 94.9 |
| SOF/VEL (GT-1) | 92.0 |
| SOF/VEL (GT-2) | 100.0 |
| SOF/VEL (GT-3) | 93.8 |
| SOF/VEL (GT-4) | 100.0 |
| SOF/VEL (GT-6) | 100.0 |
| SOF/VEL (Indeterminate) | 100.0 |
SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment. (NCT03036852)
Timeframe: Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL (Total) | 94.9 |
| SOF/VEL (GT-1) | 92.0 |
| SOF/VEL (GT-2) | 100.0 |
| SOF/VEL (GT-3) | 93.8 |
| SOF/VEL (GT-4) | 100.0 |
| SOF/VEL (GT-6) | 100.0 |
| SOF/VEL (Indeterminate) | 100.0 |
SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment. (NCT03036852)
Timeframe: Posttreatment Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL (Total) | 96.6 |
| SOF/VEL (GT-1) | 96.0 |
| SOF/VEL (GT-2) | 100.0 |
| SOF/VEL (GT-3) | 93.8 |
| SOF/VEL (GT-4) | 100.0 |
| SOF/VEL (GT-6) | 100.0 |
| SOF/VEL (Indeterminate) | 100.0 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT03036852)
Timeframe: Baseline to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL (Total) | 3.4 |
| SOF/VEL (GT-1) | 4.0 |
| SOF/VEL (GT-2) | 0 |
| SOF/VEL (GT-3) | 6.3 |
| SOF/VEL (GT-4) | 0 |
| SOF/VEL (GT-6) | 0 |
| SOF/VEL (Indeterminate) | 0 |
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | h*ng/mL (Mean) |
|---|---|
| SOF/VEL | 2381.9 |
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | h*ng/mL (Mean) |
|---|---|
| SOF/VEL | 230989.2 |
AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | h*ng/mL (Mean) |
|---|---|
| SOF/VEL | 4279.4 |
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | ng/mL (Mean) |
|---|---|
| SOF/VEL | 9776.2 |
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | ng/mL (Mean) |
|---|---|
| SOF/VEL | 1041.0 |
Cmax is defined as the population PK derived maximum concentration of the drug. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | ng/mL (Mean) |
|---|---|
| SOF/VEL | 226.9 |
Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose. (NCT03036852)
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
| Intervention | ng/mL (Mean) |
|---|---|
| SOF/VEL | 137.2 |
(NCT03036852)
Timeframe: Baseline; Weeks 2, 4, 6, 8, and 12
| Intervention | log10 IU/mL (Mean) | ||||
|---|---|---|---|---|---|
| Change at Week 2 | Change at Week 4 | Change at Week 6 | Change at Week 8 | Change at Week 12 | |
| SOF/VEL (GT-1) | -4.69 | -4.81 | -4.81 | -4.81 | -4.81 |
| SOF/VEL (GT-2) | -3.78 | -4.05 | -4.05 | -4.05 | -4.05 |
| SOF/VEL (GT-3) | -5.07 | -5.20 | -5.20 | -5.20 | -5.20 |
| SOF/VEL (GT-4) | -4.23 | -4.48 | -4.48 | -4.48 | -4.48 |
| SOF/VEL (GT-6) | -5.29 | -5.29 | -5.29 | -5.29 | -5.29 |
| SOF/VEL (Indeterminate) | -3.24 | -3.26 | -3.26 | -3.26 | -3.26 |
| SOF/VEL (Total) | -4.54 | -4.69 | -4.69 | -4.69 | -4.69 |
(NCT03036852)
Timeframe: Weeks 2, 4, 6, 8, and 12
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | |
| SOF/VEL (GT-1) | 76.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (GT-2) | 85.7 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (GT-3) | 43.8 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (GT-4) | 50.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (GT-6) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (Indeterminate) | 80.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| SOF/VEL (Total) | 67.8 | 100.0 | 100.0 | 100.0 | 100.0 |
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). (NCT01704755)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
| Intervention | Percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 0.5 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 1.7 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01704755)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | Percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 91.8 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 96.5 |
A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug. (NCT01704755)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | Percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 91.8 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 96.5 |
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. (NCT01704755)
Timeframe: within 12 weeks after the last dose of study drug
| Intervention | Percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 5.9 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 0.6 |
Subjects with post-treatment sustained virologic response (SVR) = Number of subjects with negative HCV RNA 12 weeks after completing therapy / number of subjects treated post-kidney transplantation (NCT02743897)
Timeframe: Baseline to 24 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Direct-acting Antiviral Treatment for HCV | 62 |
Number of subjects with major adverse events attributable to HCV therapy in post-kidney transplant (NCT02743897)
Timeframe: Baseline to 52 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Direct-acting Antiviral Treatment for HCV | 1 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA. (NCT01717326)
Timeframe: From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)
| Intervention | days (Mean) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 21.7 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 19.2 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 23.4 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 27.9 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 30.7 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 32.0 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 37.0 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 33.2 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 33.1 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 33.7 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 31.9 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 37.4 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 37.4 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 42.7 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 27.6 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 29.0 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 23.7 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 34.5 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 30.1 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 19.8 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 93.3 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 100.0 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 100.0 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 92.9 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 47.4 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 75.0 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 2
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 91.3 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 92.0 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 91.7 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 86.2 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 73.3 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 77.4 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 60.0 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 79.3 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 78.1 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 67.7 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 77.4 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 66.7 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 57.6 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 62.5 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 89.7 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 76.7 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 76.7 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 61.3 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 70.0 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 85.0 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 90.0 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 100.0 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 90.3 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 96.9 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 97.0 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 93.8 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 96.8 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 65.0 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 83.3 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 12 weeks after end of therapy (up to 30 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 95.8 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 82.8 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 96.8 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 90.0 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 96.6 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 93.5 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 90.9 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 96.6 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 92.9 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 93.1 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 93.5 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 47.4 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 61.1 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 24 weeks after end of therapy (up to 42 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 95.8 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 78.6 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 96.8 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 90.0 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 96.6 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 93.1 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 90.9 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 96.6 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 88.9 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 93.1 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 93.5 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 47.4 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 58.8 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: 4 weeks after end of therapy (up to 22 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 95.8 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 93.3 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 96.8 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 96.7 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 96.6 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.8 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 93.9 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 96.6 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 93.1 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 93.1 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 96.8 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 50.0 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 61.1 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 100.0 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 100.0 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 100.0 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 93.3 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 96.6 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 100.0 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 100.0 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 100.0 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 93.8 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 100.0 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 96.9 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 93.1 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 92.9 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 47.7 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 65.0 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 2
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 52.2 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 44.0 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 41.7 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 44.8 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 20.0 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 16.1 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 6.7 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 10.3 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 25.0 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 16.1 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 12.9 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 6.1 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 6.1 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 6.3 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 37.9 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 40.0 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 46.7 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 12.9 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 40.0 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 70.0 |
HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method. (NCT01717326)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 73.9 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 91.7 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 75.0 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 73.3 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 83.3 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 77.4 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 60.0 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 79.3 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 71.9 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 71.0 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 83.3 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 68.8 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 69.7 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 53.1 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 75.9 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 78.6 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 86.7 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 74.2 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 50.0 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 77.8 |
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01717326)
Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 0.0 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 0.0 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 0.0 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 0.0 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 0.0 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 6.3 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 0.0 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 3.1 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 0.0 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 0.0 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 0.0 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 0.0 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 0.0 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 0.0 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 0.0 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 4.8 |
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. (NCT01717326)
Timeframe: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk | 88.0 |
| A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 85.7 |
| A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 91.7 |
| B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 90.0 |
| B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 72.7 |
| B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 87.1 |
| B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 77.4 |
| B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk | 65.5 |
| B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 87.5 |
| B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 83.9 |
| B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk | 81.3 |
| B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 78.8 |
| B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 97.0 |
| B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk | 81.3 |
| B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 65.5 |
| B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk | 53.3 |
| C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk | 73.3 |
| C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk | 54.8 |
| D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | 85.0 |
| D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | 90.5 |
The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR; negative HCV RNA after completing Zepatier therapy) / (number of subjects treated with Zepatier post-heart transplantation) (NCT03146741)
Timeframe: Baseline to 24 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) | 9 |
(NCT03146741)
Timeframe: Baseline to 52 weeks
| Intervention | Severe adverse event (Number) |
|---|---|
| Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) | 0 |
The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL. (NCT01672983)
Timeframe: 12 or 24 weeks after first dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1 | 100 |
| Arm 2 | 100 |
| Arm 3 | 100 |
| Arm 4 | 100 |
| Arm 5 | 63.2 |
| Arm 6 | 83.3 |
The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL. (NCT01672983)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1 | 100 |
| Arm 2 | 88.9 |
| Arm 3 | 100 |
| Arm 4 | 100 |
| Arm 5 | 57.9 |
| Arm 6 | 72.2 |
The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL. (NCT01672983)
Timeframe: 24 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1 | 100 |
| Arm 2 | 88.9 |
| Arm 3 | 100 |
| Arm 4 | 100 |
| Arm 5 | 57.9 |
| Arm 6 | 72.2 |
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose. (NCT01672983)
Timeframe: TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.
| Intervention | participants (Number) | |
|---|---|---|
| Adverse Events | Serious Adverse Events | |
| Arm 1 + Arm 5 | 28 | 1 |
| Arm 2 + Arm 6 | 31 | 2 |
| Arm 3 | 16 | 2 |
| Arm 4 | 15 | 0 |
The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution. (NCT02023099)
Timeframe: 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Substudy 1, Arm A: DB 2-DAA | 94.6 |
"On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267. On-treatment virologic failure is defined as the occurrence of at least one of the following:~confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point during treatment after HCV RNA < LLOQ (rebound), or~confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during treatment (rebound), or~HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment (failure to suppress).~The 95% confidence interval was calculated using the Wilson's score method." (NCT02023099)
Timeframe: up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Substudy 1, Arm A: DB 2-DAA | 0.5 |
| Substudy 2, Arm C: OL 2-DAA | 2.4 |
Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267 and completed treatment. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method. (NCT02023099)
Timeframe: within 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Substudy 1, Arm A: DB 2-DAA | 2.4 |
| Substudy 2, Arm C: OL 2-DAA | 5.0 |
Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and for all enrolled participants with compensated cirrhosis who received at least one dose of open-label ABT-450/r/ABT-267. The 95% confidence interval was calculated using the Wilson's score method. (NCT02023099)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Substudy 1, Arm A: DB 2-DAA | 94.9 |
| Substudy 2, Arm C: OL 2-DAA | 90.5 |
"Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low BL viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT.~Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method." (NCT02023099)
Timeframe: within 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| T-naïve: high BL viral load, IFN-eligible; n=109 | T-naïve: low BL viral load; n=6 | T-naïve: IFN-ineligible; n=22 | T-exp. w/prior IFN-BT: relapser; n=21 | T-exp. w/prior IFN-BT: nonresponder; n=28 | T-exp. w/prior IFN-BT: IFN-intolerant; n=25 | |
| Substudy 1, Arm A: DB 2-DAA | 2.8 | 0 | 4.5 | 0 | 0 | 4.0 |
Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic T-naïve participants with a high BL viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-BT; noncirrhotic T-naïve participants with low BL viral load (HCV RNA < 100,000 IU/mL); noncirrhotic T-naïve participants who are ineligible for IFN-BT; noncirrhotic T-exp participants who relapsed after prior IFN-BT; noncirrhotic T-exp participants who were nonresponders to prior IFN-BT; noncirrhotic T-exp participants who were intolerant to IFN-BT. The 95% confidence interval was calculated using the Wilson's score method. (NCT02023099)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| T-naïve: all; n=139 | T-naïve: high BL viral load, IFN-eligible; n=112 | T-naïve: low BL viral load; n=6 | T-naïve: IFN-ineligible; n=23 | T-exp. w/prior IFN-BT: all; n=76 | T-exp. w/prior IFN-BT: relapser; n=22 | T-exp. w/prior IFN-BT: nonresponder; n=28 | T-exp. w/prior IFN-BT: IFN-intolerant; n=26 | |
| Substudy 1, Arm A: DB 2-DAA | 94.2 | 94.6 | 100 | 91.3 | 96.1 | 95.5 | 100 | 92.3 |
On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. On-treatment virologic failure is defined in Outcome measure 2. The 95% confidence interval was calculated using the Wilson's score method. (NCT02023099)
Timeframe: up to 12 weeks
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| T-naïve: high BL viral load, IFN-eligible; n=112 | T-naïve: low BL viral load; n=6 | T-naïve: IFN-ineligible; n=23 | T-exp. w/prior IFN-BT: relapser; n=22 | T-exp. w/prior IFN-BT: nonresponder; n=28 | T-exp. w/prior IFN-BT: IFN-intolerant; n=26 | |
| Substudy 1, Arm A: DB 2-DAA | 0 | 0 | 0 | 0 | 0 | 3.8 |
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). (NCT01685203)
Timeframe: Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8
| Intervention | Percentage of participants (Number) |
|---|---|
| Group 1 | 2.3 |
| Group 2 | 0 |
| Group 3 | 2.5 |
| Group 4 | 0 |
| Group 6 | 0 |
| Group 7 | 0 |
| Group 8 | 0 |
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. (NCT01685203)
Timeframe: Within 12 weeks after the last dose of study drug
| Intervention | Percentage of participants (Number) |
|---|---|
| Group 1 | 4.8 |
| Group 2 | 0 |
| Group 3 | 7.7 |
| Group 4 | 0 |
| Group 6 | 0 |
| Group 7 | 0 |
| Group 8 | 1.9 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | Percentage of participants (Number) |
|---|---|
| Group 1 | 90.9 |
| Group 2 | 95.2 |
| Group 3 | 90.0 |
| Group 4 | 100 |
| Group 6 | 100 |
| Group 7 | 97.9 |
| Group 8 | 98.1 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [
Timeframe: 24 weeks after the last actual dose of study drug
| Intervention | Percentage of participants (Number) |
|---|---|
| Group 1 | 86.4 |
| Group 2 | 92.9 |
| Group 3 | 90.0 |
| Group 4 | 100.0 |
| Group 6 | 100.0 |
| Group 7 | 97.9 |
| Group 8 | 98.1 |
Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug. (NCT01685203)
Timeframe: From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.
| Intervention | Percentage of participants (Number) |
|---|---|
| Group 1 | 77.3 |
| Group 2 | 73.8 |
| Group 3 | 80.0 |
| Group 4 | 88.1 |
| Group 6 | 85.7 |
| Group 7 | 85.1 |
| Group 8 | 71.2 |
CD4+ T cell count at 12 weeks post treatment (in HIV-positive co-infected patients) (NCT02886624)
Timeframe: 12 weeks
| Intervention | cells/mm^3 (Median) |
|---|---|
| Grazoprevir/Elbasvir | 655 |
Number of participants with undetectable HIV RNA at 12 weeks post treatment (in HIV-positive co-infected patients) (NCT02886624)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Grazoprevir/Elbasvir | 27 |
Undetectable plasma HCV RNA (<12 IU/mL) 12 weeks post-treatment. (NCT02886624)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Grazoprevir/Elbasvir | 28 |
Number of patients missing study drug within the last four days during treatment (NCT02886624)
Timeframe: 8 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Grazoprevir/Elbasvir | 2 |
Number of patients harboring HCV (NS5A and NS3/4) resistance mutations 12 weeks post treatment (NCT02886624)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Grazoprevir/Elbasvir | 1 |
Number of patients with positive HCV RNA 48-weeks post treatment. (NCT02886624)
Timeframe: 48 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| With phylogentically different strain | With phylogentically similar strain | |
| Grazoprevir/Elbasvir | 2 | 1 |
On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment. (NCT02219503)
Timeframe: Day 1 through Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir | 0 |
Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment. (NCT02219503)
Timeframe: Post-treatment Day 1 to Post-treatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir | 0 |
"Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.~The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis." (NCT02219503)
Timeframe: Post-treatment Day 1 to Post-treatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir | 100 |
Proportion of patients with undetectable hepatitis C virus (HCV) polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment was to test the efficacy of the treatment. (NCT03801707)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Intervention Group | 28 |
Estimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant was to test the safety of utilizing of HepC positive kidneys. (NCT03801707)
Timeframe: 6 and 12 months
| Intervention | ml/min/1.73m^2 (Median) | |
|---|---|---|
| eGFR at 6 months | eGFR at 12 months | |
| Intervention Group | 54 | 46 |
Graft survival at 6 and 12 months measuring safety of utilizing HepC positive kidneys. (NCT03801707)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| 6 months graft survival | 12 months graft survival | |
| Intervention Group | 30 | 30 |
Patient's survival at 6 and 12 months measuring safety of utilizing of HepC positive kidneys. (NCT03801707)
Timeframe: 6 and 12 months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| 6 months patient survival | 12 months patient survival | |
| Intervention Group | 30 | 30 |
(NCT01909804)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF+VEL 25 mg | 0 |
| SOF+VEL 25 mg + RBV | 1.2 |
| SOF+VEL 100 mg | 0 |
| SOF+VEL 100 mg + RBV | 0 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT01909804)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF+VEL 25 mg (GT3 Non-Cirrhotic) | 84.6 |
| SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) | 96.4 |
| SOF+VEL 100 mg (GT3 Non-Cirrhotic) | 100.0 |
| SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) | 100.0 |
| SOF+VEL 25 mg (GT3 Cirrhotic) | 57.7 |
| SOF+VEL 25 mg + RBV (GT3 Cirrhotic) | 84.0 |
| SOF+VEL 100 mg (GT3 Cirrhotic) | 88.5 |
| SOF+VEL 100 mg + RBV (GT3 Cirrhotic) | 96.2 |
| SOF+VEL 25 mg (GT1) | 100.0 |
| SOF+VEL 25 mg + RBV (GT1) | 96.6 |
| SOF+VEL 100 mg (GT1) | 100.0 |
| SOF+VEL 100 mg + RBV (GT1) | 96.4 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01909804)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF+VEL 25 mg (GT3 Non-Cirrhotic) | 15.4 |
| SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) | 3.6 |
| SOF+VEL 100 mg (GT3 Non-Cirrhotic) | 0 |
| SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) | 0 |
| SOF+VEL 25 mg (GT3 Cirrhotic) | 42.3 |
| SOF+VEL 25 mg + RBV (GT3 Cirrhotic) | 12.0 |
| SOF+VEL 100 mg (GT3 Cirrhotic) | 11.5 |
| SOF+VEL 100 mg + RBV (GT3 Cirrhotic) | 3.8 |
| SOF+VEL 25 mg (GT1) | 0 |
| SOF+VEL 25 mg + RBV (GT1) | 3.4 |
| SOF+VEL 100 mg (GT1) | 0 |
| SOF+VEL 100 mg + RBV (GT1) | 3.6 |
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT01909804)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| SOF+VEL 100 mg (GT1) | 100.0 | 100.0 |
| SOF+VEL 100 mg (GT3 Cirrhotic) | 88.5 | 92.3 |
| SOF+VEL 100 mg (GT3 Non-Cirrhotic) | 100.0 | 100.0 |
| SOF+VEL 100 mg + RBV (GT1) | 96.4 | 96.4 |
| SOF+VEL 100 mg + RBV (GT3 Cirrhotic) | 96.2 | 96.2 |
| SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) | 100.0 | 100.0 |
| SOF+VEL 25 mg (GT1) | 100.0 | 100.0 |
| SOF+VEL 25 mg (GT3 Cirrhotic) | 61.5 | 57.7 |
| SOF+VEL 25 mg (GT3 Non-Cirrhotic) | 88.5 | 84.6 |
| SOF+VEL 25 mg + RBV (GT1) | 96.6 | 96.6 |
| SOF+VEL 25 mg + RBV (GT3 Cirrhotic) | 84.0 | 84.0 |
| SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) | 96.4 | 96.4 |
(NCT02201940)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 0.2 |
| Placebo | 1.7 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02201940)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 99.0 |
| Placebo | 0 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02201940)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 0.3 |
| Placebo | 100 |
(NCT02201940)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12
| Intervention | log10 IU/mL (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Change at Wk 1 (SOF/VEL: N= 617; Placebo: N= 114) | Change at Wk 2 (SOF/VEL: N= 622; Placebo: N= 116) | Change at Wk 4 (SOF/VEL: N= 617; Placebo: N= 114) | Change at Wk 6 (SOF/VEL: N= 623; Placebo: N= 115) | Change at Wk 8 (SOF/VEL: N= 622; Placebo: N= 113) | Change at Wk 10 (SOF/VEL: N= 622; Placebo: N= 112) | Change at Wk 12 (SOF/VEL: N= 622; Placebo: N= 111) | |
| Placebo | -0.05 | 0.01 | -0.01 | 0.07 | 0.05 | 0.05 | -0.06 |
| SOF/VEL | -4.29 | -4.82 | -5.08 | -5.11 | -5.11 | -5.12 | -5.12 |
(NCT02201940)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (SOF/VEL: N = 624; Placebo: N = 116) | Week 2 (SOF/VEL: N = 624; Placebo: N = 116) | Week 4 (SOF/VEL: N = 623; Placebo: N = 116) | Week 6 (SOF/VEL: N = 623; Placebo: N = 115) | Week 8 (SOF/VEL: N = 622; Placebo: N = 114) | Week 10 (SOF/VEL: N = 622; Placebo: N = 114) | Week 12 (SOF/VEL: N = 622; Placebo: N = 113) | |
| Placebo | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SOF/VEL | 18.8 | 56.9 | 90.5 | 98.9 | 99.7 | 100.0 | 100.0 |
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02201940)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| Placebo | 0 | 0 |
| SOF/VEL | 99.2 | 99.0 |
(NCT02201953)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL 12 Weeks | 0 |
| SOF+RBV 24 Weeks | 3.3 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02201953)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL 12 Weeks | 95.3 |
| SOF+RBV 24 Weeks | 80.7 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02201953)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL 12 Weeks | 4.0 |
| SOF+RBV 24 Weeks | 14.2 |
(NCT02201953)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
| Intervention | log10 IU/mL (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Change at Wk 1 (SOF/VEL: N =272; SOF+RBV: N =268) | Change at Wk 2 (SOF/VEL: N =274; SOF+RBV: N =272) | Change at Wk 4 (SOF/VEL: N =276; SOF+RBV: N =270) | Change at Wk 6 (SOF/VEL: N =275; SOF+RBV: N =269) | Change at Wk 8 (SOF/VEL: N =276; SOF+RBV: N =269) | Change at Wk 10 (SOF/VEL: N =276; SOF+RBV: N =267) | Change at Wk 12 (SOF/VEL: N =275; SOF+RBV: N =264) | Change at Wk 16 (SOF/VEL: N = 0; SOF+RBV: N = 262) | Change at Wk 20 (SOF/VEL: N = 0; SOF+RBV: N = 259) | Change at Wk 24 (SOF/VEL: N = 0; SOF+RBV: N = 255) | |
| SOF/VEL 12 Weeks | -4.26 | -4.82 | -5.02 | -5.06 | -5.07 | -5.07 | -5.08 | NA | NA | NA |
| SOF+RBV 24 Weeks | -4.16 | -4.79 | -5.09 | -5.13 | -5.13 | -5.14 | -5.14 | -5.11 | -5.14 | -5.14 |
(NCT02201953)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
| Intervention | percentage of participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (SOF/VEL: N = 277; SOF+RBV: N = 275) | Week 2 (SOF/VEL: N = 276; SOF+RBV: N = 274) | Week 4 (SOF/VEL: N = 276; SOF+RBV: N = 272) | Week 6 (SOF/VEL: N = 276; SOF+RBV: N = 269) | Week 8 (SOF/VEL: N = 276; SOF+RBV: N = 269) | Week 10 (SOF/VEL: N = 276; SOF+RBV: N = 268) | Week 12 (SOF/VEL: N = 275; SOF+RBV: N = 265) | Week 16 (SOF/VEL: N = 0; SOF+RBV: N = 262) | Week 20 (SOF/VEL: N = 0; SOF+RBV: N = 260) | Week 24 (SOF/VEL: N = 0; SOF+RBV: N = 255) | |
| SOF/VEL 12 Weeks | 18.4 | 62.0 | 91.7 | 96.7 | 99.6 | 100.0 | 100.0 | NA | NA | NA |
| SOF+RBV 24 Weeks | 17.5 | 50.0 | 88.2 | 98.9 | 99.3 | 99.3 | 99.6 | 98.9 | 99.6 | 100.0 |
SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug. (NCT02201953)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| SOF/VEL 12 Weeks | 96.8 | 95.3 |
| SOF+RBV 24 Weeks | 82.2 | 80.7 |
(NCT02220998)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 0.7 |
| SOF+RBV | 0 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02220998)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 99.3 |
| SOF+RBV | 93.9 |
"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02220998)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 0 |
| SOF+RBV | 4.5 |
(NCT02220998)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12
| Intervention | log10 IU/mL (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Change at Wk 1 (SOF/VEL: N= 132; SOF+RBV: N= 131) | Change at Wk 2 (SOF/VEL: N= 132; SOF+RBV: N= 131) | Change at Wk 4 (SOF/VEL: N= 132; SOF+RBV: N= 131) | Change at Wk 6 (SOF/VEL: N= 133; SOF+RBV: N= 131) | Change at Wk 8 (SOF/VEL: N= 133; SOF+RBV: N= 132) | Change at Wk 10 (SOF/VEL: N= 133; SOF+RBV: N= 132) | Change at Wk 12 (SOF/VEL: N= 133; SOF+RBV: N= 131) | |
| SOF/VEL | -4.51 | -5.08 | -5.29 | -5.31 | -5.32 | -5.32 | -5.32 |
| SOF+RBV | -4.51 | -5.04 | -5.24 | -5.27 | -5.27 | -5.27 | -5.26 |
(NCT02220998)
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 2 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 4 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 6 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 8 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 10 (SOF/VEL: N = 133; SOF+RBV: N = 132) | Week 12 (SOF/VEL: N = 133; SOF+RBV: N = 131) | |
| SOF/VEL | 12.8 | 57.1 | 90.2 | 97.7 | 100.0 | 100.0 | 100.0 |
| SOF+RBV | 22.7 | 59.8 | 90.2 | 99.2 | 100.0 | 100.0 | 100.0 |
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02220998)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| SOF/VEL | 99.3 | 99.3 |
| SOF+RBV | 96.2 | 93.9 |
cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 98.0 |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 100.0 |
EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Up to the end of treatment (up to 24 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 99.0 |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 100.0 |
RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 4
| Intervention | Percentage of participants (Number) |
|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 63.4 |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 72.5 |
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12 (Follow-up period)
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 86.3 |
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12 (Follow-up period)
| Intervention | Percentage of participants (Number) |
|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 90.1 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT02032901)
Timeframe: From Day 1 first dose to last dose plus 7 days
| Intervention | Participants (Number) | |
|---|---|---|
| SAEs | Discontinuations Due to AEs | |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 0 | 0 |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 1 | 0 |
Percentage of participants who achieved HCV RNA
Timeframe: Week 1, 2, 6, 8 (treatment period)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 6 | Week 8 | |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 2.0 | 29.4 | 90.2 | 98.0 |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 11.9 | 34.7 | 86.1 | 95.0 |
Percentage of participants who achieved HCV RNA
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
| Intervention | Percentage of participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | End of treatment | Follow-up Week 4 | Follow-up Week 24 | |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 23.5 | 68.6 | 98.0 | 98.0 | 100.0 | 100.0 | 100.0 | 86.3 | 82.4 |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 39.6 | 77.2 | 94.1 | 100.0 | 100.0 | 98.0 | 99.0 | 91.1 | 89.1 |
Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT02032901)
Timeframe: Week 12 (Follow-up period)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Genotype: CC (n=40, 20) | Genotype: Non-CC (n=61, 31) | |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 95.0 | 80.6 |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 90.0 | 90.2 |
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse. (NCT02032901)
Timeframe: Baseline, Week 12 (Follow-up period)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| With cirrhosis (n= 19, 13) | Without cirrhosis (n= 75, 34) | |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 69.2 | 94.1 |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 57.9 | 97.3 |
(NCT02202980)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 7.1 |
| LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 0 |
| LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 0 |
| LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 0 |
| LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 0 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 0 |
| SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 0 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 0 |
| SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 0 |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 0 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 0 |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 0 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 0 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 0 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02202980)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 92.9 |
| LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 96.2 |
| LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 74.1 |
| LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 100.0 |
| LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 76.9 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 93.3 |
| SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 26.7 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 86.7 |
| SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 83.3 |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 100.0 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 100.0 |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 89.3 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 66.7 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 100.0 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02202980)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 7.1 |
| LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 0 |
| LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 22.2 |
| LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 0 |
| LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 23.1 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 6.7 |
| SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 73.3 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 13.3 |
| SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 11.1 |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 0 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 0 |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 10.7 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 30.0 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 0 |
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Week 1 | Week 2 | Week 4 | |
| SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 26.7 | 53.3 | 100.0 |
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 26.7 | 66.7 | 100.0 | 100.0 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 26.7 | 66.7 | 100.0 | 100.0 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 13.3 | 43.3 | 93.3 | 96.7 |
| SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 16.7 | 88.9 | 100.0 | 100.0 |
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | |
| LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 7.4 | 40.7 | 92.6 | 96.3 |
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 5.9 | 41.2 | 76.5 | 100.0 | 100.0 |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 7.1 | 60.7 | 85.7 | 96.4 | 100.0 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 5.3 | 42.1 | 84.2 | 94.7 | 100.0 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 0 | 25.0 | 100.0 | 100.0 | 100.0 |
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | |
| LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 9.4 | 53.1 | 87.5 | 100.0 | 100.0 |
| LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 28.0 | 60.0 | 92.0 | 100.0 | 100.0 |
| LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 7.7 | 7.7 | 84.6 | 100.0 | 100.0 |
(NCT02202980)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
| Intervention | percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | |
| LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 7.1 | 64.3 | 100.0 | 100.0 | 100.0 | 92.9 | 92.9 | 100.0 |
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02202980)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) | 100.0 | 100.0 |
| LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) | 96.2 | 96.2 |
| LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) | 76.9 | 76.9 |
| LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) | 81.5 | 74.1 |
| LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) | 92.9 | 92.9 |
| SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) | 73.3 | 20.0 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) | 100.0 | 93.3 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) | 86.7 | 86.7 |
| SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) | 86.7 | 66.7 |
| SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) | 88.9 | 83.3 |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) | 100.0 | 100.0 |
| SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) | 92.9 | 89.3 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) | 100.0 | 100.0 |
| SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) | 100.0 | 100.0 |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4). (NCT02203149)
Timeframe: Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Part 1 Grazoprevir 50 mg + Elbasvir | 67.7 |
| Part 1 Grazoprevir 100 mg + Elbasvir | 74.2 |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4. (NCT02203149)
Timeframe: Up to Study Week 12 in Part 1
| Intervention | percentage of participants (Number) |
|---|---|
| Part 1 Grazoprevir 50 mg + Elbasvir | 0.0 |
| Part 1 Grazoprevir 100 mg + Elbasvir | 0.0 |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo. (NCT02203149)
Timeframe: Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | 64.8 |
| Part 2 Non-cirrhotic Deferred: Placebo | 67.6 |
| Part 2 Cirrhotic: Grazoprevir + Elbasvir | 80.0 |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo. (NCT02203149)
Timeframe: Up to Study Week 12 in Part 2
| Intervention | percentage of participants (Number) |
|---|---|
| Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | 1.3 |
| Part 2 Non-cirrhotic Deferred: Placebo | 1.4 |
| Part 2 Cirrhotic: Grazoprevir + Elbasvir | 0.0 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis. (NCT02203149)
Timeframe: 12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)
| Intervention | percentage of participants (Number) |
|---|---|
| Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | 96.6 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA
Timeframe: Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| TW2 | TW4 | TW12 | EOT | FUWK4 | FUWK12 | FUWK24 | |
| Part 1 Grazoprevir 100 mg + Elbasvir | 71.0 | 100.0 | 100.0 | 100.0 | 100.0 | 96.8 | 96.8 |
| Part 1 Grazoprevir 50 mg + Elbasvir | 61.3 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates. (NCT02203149)
Timeframe: Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| TW2 | TW4 | TW12 | EOT | FUWK4 | FUWK12 | FUWK24 | |
| Part 1 Grazoprevir 100 mg + Elbasvir | 35.5 | 83.9 | 100.0 | 100.0 | 100.0 | 96.8 | 96.8 |
| Part 1 Grazoprevir 50 mg + Elbasvir | 22.6 | 77.4 | 100.0 | 100.0 | 100.0 | 100.0 | 96.8 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA
Timeframe: Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| TW2 | TW4 | TW12 | EOT | FUWK4 | FUWK12 | FUWK24 | |
| Part 2 Cirrhotic: Grazoprevir + Elbasvir | 60.0 | 94.3 | 100.0 | 100.0 | 97.1 | 97.1 | 97.1 |
| Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir | 69.9 | 98.6 | 100.0 | 100.0 | 100.0 | 97.3 | 95.9 |
| Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | 60.8 | 96.0 | 98.7 | 99.6 | 98.2 | 96.5 | 96.5 |
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates. (NCT02203149)
Timeframe: Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| TW2 | TW4 | TW12 | EOT | FUWK4 | FUWK12 | FUWK24 | |
| Part 2 Cirrhotic: Grazoprevir + Elbasvir | 11.4 | 65.7 | 100.0 | 100.0 | 97.1 | 97.1 | 94.3 |
| Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir | 39.7 | 86.3 | 100.0 | 100.0 | 100.0 | 95.9 | 95.9 |
| Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir | 25.1 | 70.5 | 97.8 | 98.7 | 98.2 | 96.5 | 96.5 |
Participants were considered to have had viral breakthrough if they had a confirmed greater than (>) 1.0 log10 international units/milliliter (IU/mL) increase in HCV RNA from nadir OR confirmed HCV RNA >100 IU/mL while previously having achieved HCV RNA
Timeframe: Up to Week 24
| Intervention | participants (Number) |
|---|---|
| 12 Weeks Prior Amendment | 4 |
| 12 Weeks Post Amendment | 0 |
| 24 Weeks Extension | 3 |
Participants were considered to have had viral relapse if they did not achieve SVR12 and met the following conditions: had HCV RNA
Timeframe: Up to Week 24 after actual EOT
| Intervention | participants (Number) |
|---|---|
| 12 Weeks Prior Amendment | 0 |
| 12 Weeks Post Amendment | 0 |
| 24 Weeks Extension | 1 |
Participants were considered on-treatment failures if they did not achieve SVR12 and had (confirmed) detectable HCV RNA, ie,
Timeframe: Up to Week 24 after actual EOT
| Intervention | percentage of participants (Number) |
|---|---|
| 12 Weeks Prior Amendment | 29.4 |
| 12 Weeks Post Amendment | 0.0 |
| 24 Weeks Extension | 4.7 |
Participants were considered to have reached SVR12, if 12 weeks after the actual end of treatment (EOT), hepatitis C virus (HCV) ribonucleic acid (RNA) was less than lower limit of quantification (
Timeframe: At 12 weeks after end of treatment
| Intervention | percentage of participants (Number) |
|---|---|
| 12 Weeks Prior Amendment | 70.6 |
| 12 Weeks Post Amendment | 100 |
| 24 Weeks Extension | 93.8 |
Participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was
Timeframe: At 4 weeks after actual EOT
| Intervention | percentage of participants (Number) |
|---|---|
| 12 Weeks Prior Amendment | 70.6 |
| 12 Weeks Post Amendment | 100 |
| 24 Weeks Extension | 93.8 |
Participants were considered to have reached SVR24, if 24 weeks after the actual EOT, HCV RNA was
Timeframe: At 24 weeks after actual EOT
| Intervention | percentage of participants (Number) |
|---|---|
| 12 Weeks Prior Amendment | 70.6 |
| 12 Weeks Post Amendment | 100 |
| 24 Weeks Extension | 93.8 |
SVR12 is defined as participants having hepatitis C virus ribonucleic acid (HCV RNA) level lower than the limit of quantification (LLoQ, <15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. (NCT02105454)
Timeframe: Up to 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| GZR 100 mg + EBR 50 mg + RBV for 12 Weeks | 97.1 |
Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. (NCT02105454)
Timeframe: Up to 12 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| GZR 100 mg + EBR 50 mg + RBV for 12 Weeks | 1.3 |
Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. (NCT02105454)
Timeframe: Up to 40 weeks (from Day 1 [post-dose] through 24 [-12/+4] weeks following last dose of study drug)
| Intervention | Percentage of participants (Number) |
|---|---|
| GZR 100 mg + EBR 50 mg + RBV for 12 Weeks | 79.7 |
SVR12 is defined as participants having HCV RNA level lower than the LLoQ (<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. Prior DAA therapy regimen included boceprevir, telaprevir, simeprevir, or sofosbuvir taken concomitantly with peginterferon and ribavirin. Below categories specify with our without resistance-associated variants (RAVs) of the hepatitis C virus. (NCT02105454)
Timeframe: Up to 24 weeks
| Intervention | Percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Boceprevir with signature baseline RAVs, n=9 | Boceprevir without signature baseline RAVs, n=16 | Telaprevir with signature baseline RAVs, n=18 | Telaprevir without signature baseline RAVs, n=22 | Simeprevir with signature baseline RAVs, n=4 | Simeprevir without signature baseline RAVs, n=1 | |
| GZR 100 mg + EBR 50 mg + RBV for 12 Weeks | 88.9 | 100.0 | 94.4 | 100.0 | 100.0 | 100.0 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group. (NCT02092350)
Timeframe: Up to Week 12
| Intervention | Participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 0 |
| Deferred Treatment | 5 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group. (NCT02092350)
Timeframe: Up to Week 14
| Intervention | Participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 93 |
| Deferred Treatment | 96 |
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL. (NCT02092350)
Timeframe: Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 99.1 |
| Deferred Treatment | 98.0 |
SVR24 was defined as HCV RNA
Timeframe: Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 97.4 |
| Deferred Treatment Group | 98.0 |
SVR4 was defined as HCV RNA
Timeframe: Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Treatment + Intensive PK | 100.00 |
| Deferred Treatment Group | 99.0 |
24 reviews available for carbamates and Cirrhosis, Liver
| Article | Year |
|---|---|
Efficacy and safety of a fixed dose combination tablet of asunaprevir + beclabuvir + daclatasvir for the treatment of Hepatitis C.
Topics: Antiviral Agents; Benzazepines; Carbamates; Drug Combinations; Genotype; Hepacivirus; Hepatitis C, C | 2020 |
Real-world effectiveness of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in patients with hepatitis C virus genotype 1 or 4 infection: A meta-analysis.
Topics: Anilides; Antiviral Agents; Carbamates; Comorbidity; Cyclopropanes; Drug Therapy, Combination; Genot | 2017 |
Safety of the 2D/3D direct-acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis - A pooled analysis.
Topics: 2-Naphthylamine; Administration, Oral; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; C | 2017 |
Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysis.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; G | 2017 |
Micro-costing analysis of guideline-based treatment by direct-acting agents: the real-life case of hepatitis C management in Brazil.
Topics: Antiviral Agents; Brazil; Carbamates; Costs and Cost Analysis; Drug Costs; Genotype; Hepatitis C, Ch | 2017 |
Sofosbuvir/Velpatasvir/Voxilaprevir: A Review in Chronic Hepatitis C.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Approval; Drug Combinations | 2018 |
Are there any challenges left in hepatitis C virus therapy of HIV-infected patients?
Topics: Antiretroviral Therapy, Highly Active; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Dr | 2020 |
Upcoming direct acting antivirals for hepatitis C patients with a prior treatment failure.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Hepatitis C; Heterocyclic Compou | 2019 |
Efficacy of 12-weeks velpatasvir plus sofosbuvir-based regimen in HCV-naive subjects with mild fibrosis: a meta-analysis.
Topics: Antiviral Agents; Carbamates; Controlled Clinical Trials as Topic; Drug Administration Schedule; Dru | 2019 |
Hepatitis C management in post-transplant patients.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Fluorenes; Hepatitis C; Het | 2015 |
[All-oral, interferon-free therapies for patients with chronic genotype 1 hepatitis C virus infection].
Topics: 2-Naphthylamine; Administration, Oral; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Clini | 2014 |
ABT-450: a novel agent for the treatment of CHC genotype 1: focus on treatment-experienced patients.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Clinical Trials, | 2015 |
Ombitasvir/paritaprevir/ritonavir and dasabuvir tablets for hepatitis C virus genotype 1 infection.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Clinical Trials, Phase I as Topic; Clinical | 2015 |
Interferon-free antiviral treatment of chronic hepatitis C in the transplant setting.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cholestasis, Intrahepatic; Clinical Trials | 2015 |
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir: A Review in Chronic HCV Genotype 1 Infection.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance; Drug Resist | 2015 |
Daclatasvir: A NS5A Replication Complex Inhibitor for Hepatitis C Infection.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Headache; Hepacivirus; Hepatitis | 2016 |
Hepatitis C virus: how to provide the best treatment with what I have.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2016 |
Interferon-free treatment for HCV-infected patients with decompensated cirrhosis.
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Combinations; Hepacivirus; Hepatitis C, | 2017 |
Daclatasvir: A Review in Chronic Hepatitis C.
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Therapy, Combination; Hepatitis C, Chro | 2016 |
Sofosbuvir/Velpatasvir: A Review in Chronic Hepatitis C.
Topics: Adult; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Resistance, Viral; Drug Ther | 2016 |
Treatment of hepatitis C virus genotype 3 infection with direct-acting antiviral agents.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepatitis C; Hepatitis C, Chronic | 2016 |
Hepatitis C: efficacy and safety in real life.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit | 2017 |
A pangenotypic, single tablet regimen of sofosbuvir/velpatasvir for the treatment of chronic hepatitis C infection.
Topics: Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Drug Combinations; Genotype; Hepacivirus; H | 2017 |
HCV management in resource-constrained countries.
Topics: Aminoisobutyric Acids; Antiviral Agents; Australia; Benzimidazoles; Carbamates; Continuity of Patien | 2017 |
62 trials available for carbamates and Cirrhosis, Liver
| Article | Year |
|---|---|
JNJ-4178 (adafosbuvir, odalasvir, and simeprevir) in Japanese patients with chronic hepatitis C virus genotype 1 or 2 infection with or without compensated cirrhosis: the Phase IIa OMEGA-3 study.
Topics: Adult; Aged; Alanine; Antiviral Agents; Benzimidazoles; Carbamates; Drug Combinations; Female; Follo | 2020 |
Hepatitis C Virus (HCV) Direct-Acting Antiviral Therapy in Persons With Human Immunodeficiency Virus-HCV Genotype 1 Coinfection Resulting in High Rate of Sustained Virologic Response and Variable in Normalization of Soluble Markers of Immune Activation.
Topics: 2-Naphthylamine; Adult; Anilides; Anti-HIV Agents; Antiviral Agents; Biomarkers; Carbamates; Coinfec | 2020 |
Sofosbuvir plus velpatasvir treatment for hepatitis C virus in patients with decompensated cirrhosis: a Japanese real-world multicenter study.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Com | 2021 |
Real-world clinical outcomes of sofosbuvir and velpatasvir treatment in HCV genotype 1- and 2-infected patients with decompensated cirrhosis: A nationwide multicenter study by the Japanese Red Cross Liver Study Group.
Topics: Aged; Antiviral Agents; Carbamates; Drug Combinations; Female; Genotype; Hepacivirus; Hepatitis C, C | 2021 |
Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial.
Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug | 2016 |
Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial.
Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbam | 2016 |
Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; | 2017 |
Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; | 2017 |
Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; | 2017 |
Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; | 2017 |
Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2,
Topics: Adult; Amides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administration Schedule; Female; Ge | 2017 |
Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2,
Topics: Adult; Amides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administration Schedule; Female; Ge | 2017 |
Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2,
Topics: Adult; Amides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administration Schedule; Female; Ge | 2017 |
Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2,
Topics: Adult; Amides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administration Schedule; Female; Ge | 2017 |
Efficacy and safety results of patients with HCV genotype 2 or 3 infection treated with ombitasvir/paritaprevir/ritonavir and sofosbuvir with or without ribavirin (QUARTZ II-III).
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Femal | 2018 |
Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 1 hepatitis C virus infection with and without cirrhosis.
Topics: Adult; Age Distribution; Aged; Aged, 80 and over; Aminoisobutyric Acids; Anilides; Antiviral Agents; | 2018 |
Interferon-free therapy with direct acting antivirals for HCV/HIV-1 co-infected Japanese patients with inherited bleeding disorders.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Drug Therapy, Combination; Female; | 2017 |
Efficacy of daclatasvir-based quadruple therapy in nonresponder patients infected by hepatitis C virus genotype 4: the ANRS HC32 QUATTRO study.
Topics: Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepat | 2018 |
Efficacy and safety of 6 or 8 weeks of simeprevir, daclatasvir, sofosbuvir for HCV genotype 1 infection.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Drug-Related Side Effects and Adverse Reactio | 2018 |
Sofosbuvir plus daclatasvir with or without ribavirin in 551 patients with hepatitis C-related cirrhosis, genotype 4.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2018 |
Pharmacokinetics and Safety of Velpatasvir and Sofosbuvir/Velpatasvir in Subjects with Hepatic Impairment.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Drug Combinations; Drug Therapy, Combination; | 2018 |
Ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin for chronic hepatitis C virus genotype 1b-infected cirrhotics (TURQUOISE-IV).
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Combinatio | 2018 |
Viral eradication is required for sustained improvement of patient-reported outcomes in patients with hepatitis C.
Topics: Aged; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 2019 |
Change in the hepatic profile of hepatitis C virus genotype 4-infected patients with compensated cirrhosis receiving ombitasvir, paritaprevir, and ritonavir plus ribavirin: A subanalysis of the AGATE-II study.
Topics: Adult; Aged; Alanine Transaminase; Anilides; Antiviral Agents; Aspartate Aminotransferases; Carbamat | 2018 |
Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Bacterial; Female; Genotype; Hepac | 2018 |
Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Bacterial; Female; Genotype; Hepac | 2018 |
Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Bacterial; Female; Genotype; Hepac | 2018 |
Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Bacterial; Female; Genotype; Hepac | 2018 |
Efficacy and safety of sofosbuvir-velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Female; Genotype; H | 2019 |
Serum asunaprevir concentrations showing correlation with the extent of liver fibrosis as a factor inducing liver injuries in patients with genotype-1b hepatitis C virus receiving daclatasvir plus asunaprevir therapy.
Topics: Adult; Aged; Antigens, Neoplasm; Antiviral Agents; Biomarkers; Carbamates; Drug Therapy, Combination | 2018 |
Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial.
Topics: Adult; Antiviral Agents; Carbamates; China; Drug Combinations; Female; Genotype; Headache; Hepacivir | 2019 |
Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ± Ribavirin for HCV in Brazilian Adults with Advanced Fibrosis.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Brazil; Carbamates; Cyclopropanes; Drug Co | 2018 |
JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1.
Topics: Adult; Aged; Alanine; Antiviral Agents; Benzimidazoles; Carbamates; Dose-Response Relationship, Drug | 2019 |
Elbasvir/Grazoprevir in People With Hepatitis C Genotype 1 Infection and Child-Pugh Class B Cirrhosis: The C-SALT Study.
Topics: Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Dose-Response Relationship, | 2019 |
SVR12 Higher than 97% in GT3 Cirrhotic Patients with Evidence of Portal Hypertension Treated with SOF/VEL without Ribavirin: A Nation-Wide Cohort Study.
Topics: Adult; Aged; Carbamates; Cohort Studies; Comorbidity; Female; Hepacivirus; Heterocyclic Compounds, 4 | 2019 |
Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Drug Monitoring; Female; Hepacivirus; Hepatitis C, | 2019 |
Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs.
Topics: Adult; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Combinations; Drug M | 2019 |
ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2015 |
Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2015 |
Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2015 |
Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2015 |
Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2015 |
Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2015 |
Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2015 |
Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2015 |
Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2015 |
Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Femal | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; | 2015 |
Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Benzazepines; Carbamates; Drug Therapy, Combination; Female; Genotype | 2015 |
Efficacy of Sofosbuvir and Daclatasvir in Patients With Fibrosing Cholestatic Hepatitis C After Liver Transplantation.
Topics: Antiviral Agents; Belgium; Carbamates; Cholestasis; Drug Therapy, Combination; Drug-Related Side Eff | 2015 |
Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis.
Topics: Aged; Anilides; Antiviral Agents; Asian People; Carbamates; Cyclopropanes; Double-Blind Method; Drug | 2015 |
Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis.
Topics: Administration, Oral; Aged; Anilides; Antiviral Agents; Carbamates; Carrier Proteins; Cyclopropanes; | 2015 |
Ombitasvir/paritaprevir/r, dasabuvir and ribavirin for cirrhotic HCV patients with thrombocytopaenia and hypoalbuminaemia.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dru | 2015 |
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru | 2015 |
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru | 2015 |
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru | 2015 |
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru | 2015 |
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru | 2015 |
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru | 2015 |
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru | 2015 |
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru | 2015 |
Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial.
Topics: Adult; Amides; Antiviral Agents; Australia; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Dru | 2015 |
Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administra | 2016 |
Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administra | 2016 |
Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administra | 2016 |
Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administra | 2016 |
Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Combination; | 2015 |
Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Com | 2015 |
Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Com | 2015 |
Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Com | 2015 |
Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Com | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Double-Blind Method; Drug Combinations | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Vi | 2015 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.
Topics: Alanine Transaminase; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Comb | 2016 |
Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hep | 2016 |
Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+).
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female | 2016 |
[Complication sequelae prevented, morbidity decreased].
Topics: Carbamates; Drug Therapy, Combination; Hepatitis C, Chronic; Humans; Imidazoles; Liver Cirrhosis; Py | 2015 |
[Daclatasvir/sofosbuvir is effective also in advanced liver disease].
Topics: Carbamates; Drug Administration Schedule; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatiti | 2016 |
On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3-infected patients treated with daclatasvir and sofosbuvir.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2016 |
Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections.
Topics: Adult; Aged; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combi | 2016 |
Sofosbuvir-based treatment of hepatitis C with severe fibrosis (METAVIR F3/F4) after liver transplantation.
Topics: Aged; Antiviral Agents; Belgium; Carbamates; Compassionate Use Trials; Female; France; Genotype; Hep | 2016 |
Daclatasvir/asunaprevir/beclabuvir fixed-dose combination in Japanese patients with HCV genotype 1 infection.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzazepines; Carbamates; Double-Blind Method; Dru | 2017 |
Efficacy and Safety of Sofosbuvir/Velpatasvir in Patients With Chronic Hepatitis C Virus Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ASTRAL Trials.
Topics: Adult; Antiviral Agents; Carbamates; Data Interpretation, Statistical; Drug Administration Schedule; | 2016 |
Real-world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Diarrhea; Drug Therap | 2016 |
The impact of directly acting antivirals on the enzymatic liver function of liver transplant recipients with recurrent hepatitis C.
Topics: Administration, Oral; Aged; Antiviral Agents; Biopsy; Carbamates; Cohort Studies; Drug Therapy, Comb | 2016 |
The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbama | 2017 |
The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease.
Topics: Antiviral Agents; Bayes Theorem; Carbamates; Cohort Studies; Drug Therapy, Combination; Europe; Fema | 2017 |
Simeprevir and daclatasvir for 12 or 24 weeks in treatment-naïve patients with hepatitis C virus genotype 1b and advanced liver disease.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Gen | 2017 |
Effect of mild and moderate hepatic impairment on the pharmacokinetics and safety of carisbamate.
Topics: Administration, Oral; Adult; Aged; Analgesics; Anticonvulsants; Area Under Curve; Biotransformation; | 2012 |
Liver toxicity of antiretroviral combinations including fosamprenavir plus ritonavir 1400/100 mg once daily in HIV/hepatitis C virus-coinfected patients.
Topics: Adult; Anti-HIV Agents; Carbamates; CD4 Lymphocyte Count; Chemical and Drug Induced Liver Injury; Co | 2011 |
Single-dose pharmacokinetics of amprenavir, a human immunodeficiency virus type 1 protease inhibitor, in subjects with normal or impaired hepatic function.
Topics: Adult; Area Under Curve; Carbamates; Female; Furans; HIV Protease Inhibitors; HIV-1; Humans; Liver C | 2000 |
152 other studies available for carbamates and Cirrhosis, Liver
| Article | Year |
|---|---|
Safety and efficacy of sofosbuvir/ledipasvir and sofosbuvir/daclatasvir in the treatment of hepatitis C in patients with decompensated cirrhosis.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; End Stage Liver Disease; Fl | 2021 |
Sofosbuvir/velpatasvir/voxilaprevir for hepatitis C virus retreatment in decompensated cirrhosis.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Genot | 2021 |
Direct Relationship between Interleukin-10 Gene Polymorphism and Hepatocellular Carcinoma Complicated by Direct Acting Antiviral Treatment of Hepatitis C Virus.
Topics: Adult; Aged; Antiviral Agents; Ascites; Carbamates; Carcinoma, Hepatocellular; Drug Therapy, Combina | 2021 |
Regression of liver fibrosis and hepatocellular carcinoma development after HCV eradication with oral antiviral agents.
Topics: Administration, Oral; Aged; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Drug Therapy, C | 2022 |
Drug-Drug Interactions With Cyclosporine in the Anti-Hepatitis C Viral PrOD Combination Regimen of Paritaprevir/Ritonavir-Ombitasvir and Dasabuvir in Organ Transplant Recipients With Severe Hepatic Fibrosis or Cirrhosis.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Cyclosporine; Drug Interacti | 2022 |
Sofosbuvir-velpatasvir-voxilaprevir in adolescents 12 to 17 years old with HCV infection.
Topics: Adolescent; Adult; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Child; Cyclopropanes; Genoty | 2022 |
Efficacy and Safety of Ombitasvir/Paritaprevir/ Ritonavir + Dasabuvir ± Ribavirin Combinations in Patients with Genotype 1 Hepatitis C and Inherited Bleeding Disorders.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Child; Cyclopropanes; Drug Therapy, | 2022 |
A Real-World Study to Compare the Safety and Efficacy of Paritaprevir/Ombitasvir/Ritonavir and Dasabuvir, with or without Ribavirin, in 587 Patients with Chronic Hepatitis C at the Fundeni Clinical Institute, Bucharest, Romania.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; H | 2022 |
Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure.
Topics: Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Drug Combinations; Drug Resistance, Viral; | 2019 |
Sustained virological response with 16-week glecaprevir/pibrentasvir after failure to sofosbuvir/velpatasvir in post-transplant severe HCV recurrence in HIV.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Carcinoma, Hepatocellular; Drug Combinations; Drug Res | 2019 |
Ledipasvir/Sofosbuvir versus Daclatasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype 4 Patients.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Drug-Related S | 2020 |
Hepatitis C therapy with direct antiviral agents in patients with advanced chronic kidney disease: real-world experience of the German Hepatitis C-Registry (Deutsches Hepatitis C-Register).
Topics: 2-Naphthylamine; Acute Disease; Adult; Aged; Anemia; Anilides; Antiviral Agents; Benzimidazoles; Car | 2019 |
Real-world experience with Grazoprevir/Elbasvir in the treatment of previously "difficult to treat" patients infected with hepatitis C virus genotype 1 and 4.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Comor | 2020 |
Eight weeks of sofosbuvir/velpatasvir for genotype 3 hepatitis C in previously untreated patients with significant (F2/3) fibrosis.
Topics: Adult; Antiviral Agents; Carbamates; Female; Genotype; Hepacivirus; Hepatitis C; Heterocyclic Compou | 2020 |
Comparative effectiveness of 8 versus 12 weeks of Ombitasvir/Paritaprevir/ritonavir and Dasabuvir in treatment-naïve patients infected with HCV genotype 1b with non-advanced hepatic fibrosis.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2020 |
Sustained virologic response and changes in liver fibrosis parameters following 12-wk administration of generic sofosbuvir and daclatasvir in HIV/HCV-coinfected patients with HCV genotype 4 infection.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit | 2020 |
Daclatasvir and Sofosbuvir Mitigate Hepatic Fibrosis Through Downregulation of TNF-α / NF-κB Signaling Pathway.
Topics: Animals; Carbamates; Carbon Tetrachloride; Disease Progression; Down-Regulation; Hepatic Stellate Ce | 2020 |
The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C; Humans; Imidazoles; Li | 2020 |
Hepatocellular carcinoma occurs frequently and early after treatment in HCV genotype 3 infected persons treated with DAA regimens.
Topics: Adult; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Drug Therapy, Combination; Female; G | 2020 |
Development of a long-acting direct-acting antiviral system for hepatitis C virus treatment in swine.
Topics: Animals; Antiviral Agents; Benzimidazoles; Carbamates; Cost-Benefit Analysis; Disease Models, Animal | 2020 |
M2BPGi for assessing liver fibrosis in patients with hepatitis C treated with direct-acting antivirals.
Topics: Adult; Antigens, Neoplasm; Antiviral Agents; Biomarkers; Biomarkers, Tumor; Carbamates; Drug Combina | 2020 |
Virological patterns of hepatitis C virus patients with failure to the current-generation direct-acting antivirals.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Drug Comb | 2020 |
Hypovascular tumors developed into hepatocellular carcinoma at a high rate despite the elimination of hepatitis C virus by direct-acting antivirals.
Topics: Aged; alpha-Fetoproteins; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Female; Genotype; | 2020 |
Hepatitis C virus-associated decompensated liver cirrhosis with refractory hepatic encephalopathy successfully treated by balloon-occluded retrograde transvenous obliteration after sofosbuvir/velpatasvir.
Topics: Balloon Occlusion; Carbamates; Female; Hepacivirus; Hepatic Encephalopathy; Hepatitis C; Heterocycli | 2020 |
Incidence and predictors for abnormal liver function during direct-acting antiviral agents in chronic hepatitis C patients.
Topics: Adult; Alanine Transaminase; Amides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Dr | 2020 |
Cost-effectiveness analysis of sofosbuvir and velpatasvir in chronic hepatitis C patients with decompensated cirrhosis.
Topics: Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Cost-Benefit Analysis; Genotype; Hepaciviru | 2021 |
Real-world effectiveness of direct-acting antiviral agents for chronic hepatitis C patients with genotype-2 infection after completed treatment.
Topics: Age Factors; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Carcinoma, Hepatocellular; Drug Com | 2021 |
Failure on voxilaprevir, velpatasvir, sofosbuvir and efficacy of rescue therapy.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Multiple, Viral; Drug Therapy, Com | 2021 |
Successful use of generic direct acting antiviral medications to treat hepatitis C-a New Zealand-wide study.
Topics: Aged; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Drugs, Generic; Femal | 2020 |
Changing epidemiology of patients treated with direct acting antivirals for HCV and persistently high SVR12 in an endemic area for HCV infection in Italy: real-life 'LIver Network Activity' (LINA) cohort update results.
Topics: Adult; Age Distribution; Aged; Amides; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Benz | 2021 |
Histone deacetylase inhibitor givinostat alleviates liver fibrosis by regulating hepatic stellate cell activation.
Topics: Animals; Carbamates; Carbon Tetrachloride; Cell Line; Female; Gene Expression Profiling; Gene Expres | 2021 |
Cost-effectiveness of a "treat-all" strategy using Direct-Acting Antivirals (DAAs) for Japanese patients with chronic hepatitis C genotype 1 at different fibrosis stages.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzimidazoles; Carbamates; Cost-Benefit A | 2021 |
Sofosbuvir/velpatasvir is an effective treatment for patients with hepatitis C and advanced fibrosis or cirrhosis in a real-world setting in Taiwan.
Topics: Antiviral Agents; Carbamates; Hepacivirus; Hepatitis C; Hepatitis C, Chronic; Heterocyclic Compounds | 2021 |
Sofosbuvir-based therapies in genotype 2 hepatitis C virus cirrhosis: A real-life experience with focus on ribavirin dose.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Gen | 2021 |
Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis.
Topics: Antiviral Agents; Carbamates; Genotype; Hepacivirus; Hepatitis C; Hepatitis C, Chronic; Heterocyclic | 2021 |
Estimating the net value of treating hepatitis C virus using sofosbuvir-velpatasvir in India.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Cost of Illness; Disability Evaluation; Drugs | 2021 |
Histone deacetylase inhibitor givinostat attenuates nonalcoholic steatohepatitis and liver fibrosis.
Topics: Animals; Carbamates; Histone Deacetylase Inhibitors; Liver; Liver Cirrhosis; Methionine; Mice; Mice, | 2022 |
Real-world experience with the all-oral, interferon-free regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic hepatitis C virus infection in the German Hepatitis C Registry.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Carbamates; Cohort Studies; Cyclopropanes; Drug Therapy, Com | 2017 |
Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 - final results of the REV1TAL study.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Bilirubin; Biomarkers; Carbamates; Cyclopr | 2017 |
Treatment of chronic hepatitis C with direct-acting antivirals in patients with β-thalassaemia major and advanced liver disease.
Topics: Adult; Antiviral Agents; beta-Thalassemia; Carbamates; Drug Therapy, Combination; Female; Genotype; | 2017 |
Ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin for patients with hepatitis C virus genotype 1 or 4 infection with cirrhosis (ABACUS): a prospective observational study.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Compassionate Use Trials; Cycl | 2017 |
Effectiveness of a fixed combination formula of ombitasvir/paritaprevir/ritonavir for hepatitis C virus infection in patients on maintenance haemodialysis.
Topics: Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Disease Progression; | 2017 |
Treatment of chronic genotype-3 hepatitis C virus infection using direct-acting antiviral agents: An Indian experience.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Cohort Studies; Drug Therapy, Combination; Fe | 2017 |
Paritaprevir/ritonavir/ombitasvir plus dasabuvir with ribavirin for treatment of recurrent chronic hepatitis C genotype 1 infection after liver transplantation: Real-world experience.
Topics: 2-Naphthylamine; Aged; Alanine Transaminase; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; | 2018 |
Effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir for hepatitis C virus in clinical practice: A population-based observational study.
Topics: 2-Naphthylamine; Aged; Anilides; Carbamates; Cyclopropanes; Drug Combinations; Female; Genotype; Hep | 2017 |
Sofosbuvir/velpatasvir in patients with hepatitis C virus genotypes 1-6 and compensated cirrhosis or advanced fibrosis.
Topics: Aged; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Combination; Female; | 2018 |
Real-life prevalence of resistance-associated variants against non-structural protein 5A inhibitors and efficiency of Daclatasvir + Asunaprevir therapy in Korean patients with genotype 1b hepatitis C.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Base Sequence; Carbamates; Drug Combinations; Drug | 2017 |
Successful twice interrupted therapy of HCV infection in patients with cirrhosis with hepatocellular carcinoma before and after liver transplantation.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Cyclopropanes; D | 2017 |
Real-Life Use of 3 Direct-Acting Antiviral Regimen in a Large Cohort of Patients with Genotype-1b HCV Compensated Cirrhosis.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combinat | 2017 |
Efficacy and safety of sofosbuvir and daclatasvir in treatment of kidney transplantation recipients with hepatitis C virus infection.
Topics: Adult; Antiviral Agents; Carbamates; China; Drug Therapy, Combination; Graft Rejection; Hepacivirus; | 2017 |
Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Disease Progression; Drug Resistance, Viral; Drug Therapy | 2018 |
Cost-Effectiveness Analysis of New HCV Treatments in Egyptian Cirrhotic and Non-Cirrhotic Patients: A Societal Perspective.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Cost-Benefit Analysis; Drug Therapy, Combination; Egyp | 2017 |
Sofosbuvir and velpatasvir with or without voxilaprevir in direct-acting antiviral-naïve chronic hepatitis C: patient-reported outcomes from POLARIS 2 and 3.
Topics: Adult; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Cyc | 2018 |
Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt.
Topics: Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Drugs, Generic; Egypt; Female; Hepat | 2018 |
Sofosbuvir plus daclatasvir with or without ribavirin is safe and effective for post-transplant hepatitis C recurrence and severe fibrosis and cirrhosis: A prospective study.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Follow-Up Studies; Hepacivirus; Hep | 2018 |
Sofosbuvir and daclatasvir therapy in patients with hepatitis C-related advanced decompensated liver disease (MELD ≥ 15).
Topics: Antiviral Agents; Australia; Carbamates; Compassionate Use Trials; Disease Progression; Drug Therapy | 2018 |
Late Relapse after a Sustained Virologic Response at 24 Weeks after Treatment with Daclatasvir and Asunaprevir Combination Therapy for Chronic Hepatitis C Virus Genotype 1b Infection with Liver Cirrhosis.
Topics: Aged; Amino Acid Sequence; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype | 2018 |
High Efficacy of ombitasvir/paritaprevir/ritonavir plus dasabuvir in hepatitis C genotypes 4 and 1-infected patients with severe chronic kidney disease.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cohort Studies; Cyclopropanes; Drug | 2018 |
Twelve weeks of ombitasvir/paritaprevir/r and dasabuvir without ribavirin is effective and safe in the treatment of patients with HCV genotype 1b infection and compensated cirrhosis: results from a real-world cohort study.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cohort Studies; Cyclopropanes; Drug I | 2018 |
Daclatasvir and reduced-dose sofosbuvir: An effective and pangenotypic treatment for hepatitis C in patients with estimated glomerular filtration rate <30 mL/min.
Topics: Adult; Antiviral Agents; Carbamates; Comorbidity; Dose-Response Relationship, Drug; Drug Monitoring; | 2019 |
The safety and efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 1b infection.
Topics: Adolescent; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, Phase I | 2018 |
Efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for the treatment of HCV genotype 1b compensated cirrhosis in patients aged 70 years or older.
Topics: 2-Naphthylamine; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dru | 2017 |
Daclatasvir Plus Asunaprevir for the Treatment of Patients with Hepatitis C Virus Genotype 1b Infection: Real-World Efficacy, Changes in Liver Stiffness and Fibrosis Markers, and Safety.
Topics: Adult; Aged; Antiviral Agents; Biomarkers; Carbamates; Drug Therapy, Combination; Female; Genotype; | 2018 |
Retreatment with sofosbuvir/velpatasvir in cirrhotic patients with genotype-4 who failed a previous interferon-free regimen: a case series.
Topics: Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Resistance, Viral; Female; Gene Exp | 2018 |
Editorial: sofosbuvir plus daclatasvir for the treatment of hepatitis C-can one size fit all?
Topics: Carbamates; Genotype; Hepacivirus; Hepatitis C; Humans; Imidazoles; Liver Cirrhosis; Pyrrolidines; R | 2018 |
12 weeks ombitasvir/paritaprevir-ritonavir + ribavirin achieve high SVR rates in HCV-4 patients with advanced fibrosis.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Femal | 2018 |
Potent viral suppression and improvements in alpha-fetoprotein and measures of fibrosis in Japanese patients receiving a daclatasvir/asunaprevir/beclabuvir fixed-dose combination for the treatment of HCV genotype-1 infection.
Topics: Adult; Aged; Aged, 80 and over; alpha-Fetoproteins; Antiviral Agents; Benzazepines; Biopsy; Carbamat | 2018 |
High efficacy of sofosbuvir/velpatasvir and impact of baseline resistance-associated substitutions in hepatitis C genotype 3 infection.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Cohort Studies; Drug Resistance, Viral; Drug | 2018 |
Cost-effectiveness analysis of elbasvir-grazoprevir regimen for treating hepatitis C virus genotype 1 infection in stage 4-5 chronic kidney disease patients in France.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cost-Benefit Analysis; Cyclopropanes; Drug Therap | 2018 |
Daclatasvir and Sofosbuvir With or Without Ribavirin in Liver Transplant Recipients: A Single-Center Real-World Study.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepati | 2018 |
Generic sofosbuvir-based direct-acting antivirals in hepatitis C virus-infected patients with chronic kidney disease.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combinat | 2018 |
High efficacy of direct-acting anti-viral agents in hepatitis C virus-infected cirrhotic patients with successfully treated hepatocellular carcinoma.
Topics: Aged; Antiviral Agents; Benzimidazoles; Carbamates; Carcinoma, Hepatocellular; Cohort Studies; Drug | 2018 |
The Real-world Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir for Hepatitis C Genotype 1.
Topics: Adult; Aged; Alanine Transaminase; Anilides; Antiviral Agents; Carbamates; Cohort Studies; Cycloprop | 2018 |
Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis.
Topics: 2-Naphthylamine; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Biomarkers; Carbamates; Cyclop | 2018 |
Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in the AMBER, real-world experience study.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Cyc | 2018 |
Safety and effectiveness of daclatasvir and asunaprevir dual therapy in patients with genotype 1 chronic hepatitis C: results from postmarketing surveillance in Japan.
Topics: Adult; Age Factors; Aged; Aged, 80 and over; Antiviral Agents; Body Mass Index; Carbamates; Drug The | 2018 |
100% sustained virological response and fibrosis improvement in real-life use of direct acting antivirals in genotype-1b recurrent hepatitis C following liver transplantation.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; | 2018 |
Real Life Egyptian Experience of Daclatasvir Plus Sofosbuvir with Ribavirin in Naïve Difficult to Treat HCV Patients.
Topics: Administration, Oral; Adult; Carbamates; Case-Control Studies; Drug Combinations; Egypt; Female; Hep | 2020 |
Population Pharmacokinetic Analysis for Daclatasvir and Asunaprevir in Japanese Subjects With Chronic Hepatitis C Virus Infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2018 |
Real life rates of sustained virological response (SVR) and predictors of relapse following DAA treatment in genotype 3 (GT3) patients with advanced fibrosis/cirrhosis.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C, Chronic | 2018 |
Treatment of Chronic Hepatitis C Infection with Direct Acting Antivirals in Adolescents with Thalassemia Major.
Topics: Adolescent; Antiviral Agents; Benzimidazoles; beta-Thalassemia; Carbamates; Child; Drug Therapy, Com | 2019 |
Hepatic decompensation during paritaprevir/ritonavir/ombitasvir/dasabuvir treatment for genotype 1b chronic hepatitis C patients with advanced fibrosis and compensated cirrhosis.
Topics: 2-Naphthylamine; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cohort Studies; Cy | 2018 |
Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild-moderate fibrosis: Results from a real-world cohort.
Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropan | 2019 |
Does Ribavirin Still Have a Role in Sofosbuvir and Velpatasvir Therapy for Patients With HCV Genotype 3 Infection and Cirrhosis?
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C; Hepatit | 2018 |
Impact of new direct-acting antiviral drugs on hepatitis C virus-related decompensated liver cirrhosis.
Topics: Antiviral Agents; Benzimidazoles; Biomarkers; Carbamates; Case-Control Studies; Drug Therapy, Combin | 2019 |
Association of IL-1β, IL-1RN, and ESR1 genes polymorphism with risk of infection and response to sofosbuvir plus daclatasvir combination therapy in hepatitis C virus genotype-4 patients.
Topics: Antiviral Agents; Carbamates; Case-Control Studies; Drug Therapy, Combination; Egypt; Estrogen Recep | 2018 |
Satisfactory virological response and fibrosis improvement of sofosbuvir-based regimens for Chinese patients with hepatitis C virus genotype 3 infection: results of a real-world cohort study.
Topics: Adult; Antiviral Agents; Asian People; Carbamates; Female; Follow-Up Studies; Genotype; Hepacivirus; | 2018 |
Elbasvir plus grazoprevir for patients with chronic hepatitis C genotype 1: A multicenter, real-world cohort study focusing on chronic kidney disease.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cohort Studies; C | 2018 |
Real-world effectiveness and safety of sofosbuvir plus daclatasvir with or without ribavirin for genotype 2 chronic hepatitis C in Taiwan.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepati | 2019 |
Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C).
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2019 |
A retrospective study of the efficacy of sofosbuvir plus NS5A inhibitors for patients with hepatitis C virus genotype-2 chronic infection.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Drug Combinations; Drug Therapy, Combination; F | 2019 |
Successful DAA Treatment and Global Improvement in a Cirrhotic Patient with Concomitant HCV Infection and Autoimmune Hepatitis.
Topics: Alanine Transaminase; Antiviral Agents; Aspartate Aminotransferases; Bilirubin; Carbamates; Female; | 2019 |
Reply to: "Sofosbuvir/velpatasvir for patients with chronic genotype 3 HCV infection with compensated cirrhosis: Response to EASL recommendations on treatment of Hepatitis C 2018": EASL Recommendations on Treatment of Hepatitis C 2018: Precision on the tr
Topics: Carbamates; Genotype; Hepacivirus; Hepatitis C; Heterocyclic Compounds, 4 or More Rings; Humans; Liv | 2019 |
Sofosbuvir/velpatasvir for patients with chronic genotype 3 HCV infection with compensated cirrhosis: Response to EASL Recommendations on Treatment of Hepatitis C 2018.
Topics: Carbamates; Genotype; Hepacivirus; Hepatitis C; Heterocyclic Compounds, 4 or More Rings; Humans; Liv | 2019 |
Sustained virologic response rates in patients with chronic hepatitis C genotype 6 treated with ledipasvir+sofosbuvir or sofosbuvir+velpatasvir.
Topics: Aged; Antiviral Agents; Asia; Benzimidazoles; Carbamates; Cohort Studies; Drug Combinations; Female; | 2019 |
Tolerability and effectiveness of generic direct-acting antiviral drugs in eradication of hepatitis C genotype 4 among Egyptian patients.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Drugs, Generic; Egyp | 2019 |
Long-awaited treatment for hepatitis C virus decompensated cirrhosis.
Topics: Carbamates; Hepacivirus; Hepatitis C; Heterocyclic Compounds, 4 or More Rings; Humans; Japan; Liver | 2019 |
Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Drug-Related Side Effects and | 2019 |
Management of HCV-related decompensated cirrhosis with direct-acting antiviral agents: who should be treated?
Topics: Adult; Antiviral Agents; Ascites; Carbamates; Drug Therapy, Combination; Esophageal and Gastric Vari | 2019 |
Effectiveness and safety of daclatasvir/sofosbuvir with or without ribavirin in genotype 3 hepatitis C virus infected patients. Results in real clinical practice.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cohort Studies; Drug Therapy, Combination; Female; Genoty | 2019 |
The change in liver stiffness, controlled attenuation parameter and fibrosis-4 index for chronic hepatitis C patients with direct-acting antivirals.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Female; Genotype; Hep | 2019 |
High Efficacy and Safety of Flat-Dose Ribavirin Plus Sofosbuvir/Daclatasvir in Genotype 3 Cirrhotic Patients.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C, | 2020 |
Contemporary HCV pangenotypic DAA treatment protocols are exclusionary to real world HIV-HCV co-infected patients.
Topics: Adult; Aged; Aminoisobutyric Acids; Anti-Retroviral Agents; Antiviral Agents; Benzimidazoles; Carbam | 2019 |
Real-world safety and efficacy of paritaprevir/ritonavir/ombitasvir plus dasabuvir ± ribavirin in patients with hepatitis C virus genotype 1 and advanced hepatic fibrosis or compensated cirrhosis: a multicenter pooled analysis.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combinat | 2019 |
SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Carbamates; Drug Interactions; Female; Hepatitis C; Hete | 2019 |
Recurrence rate of hepatocellular carcinoma in patients with treated hepatocellular carcinoma and hepatitis C virus-associated cirrhosis after ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin therapy.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Chemoembol | 2019 |
A reduced grade of liver fibro-steatosis after raltegravir, maraviroc and fosamprenavir in an HIV/HCV co-infected patient with chronic hepatitis, cardiomyopathy, intolerance to nelfinavir and a marked increase of serum creatine phosphokinase levels probab
Topics: Adult; Carbamates; Cardiomyopathies; Chemical and Drug Induced Liver Injury; Creatine Kinase; Cycloh | 2012 |
New kids on the block--step by step to an ideal HCV therapy.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Female; Hepatitis C, Chronic; HIV | 2015 |
Continued progress against hepatitis C infection.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquin | 2015 |
High Sustained Virologic Response to Daclatasvir Plus Asunaprevir in Elderly and Cirrhotic Patients with Hepatitis C Virus Genotype 1b Without Baseline NS5A Polymorphisms.
Topics: Adult; Aged; Antiviral Agents; Asian People; Carbamates; Drug Resistance, Viral; Drug Therapy, Combi | 2015 |
Antiviral Therapy in Patients with Hepatitis C Virus-Induced Cirrhosis.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Drug Therapy | 2015 |
Interferon-free regimens for chronic hepatitis C overcome the effects of portal hypertension on virological responses.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2015 |
Improvement of liver function parameters in advanced HCV-associated liver cirrhosis by IFN-free antiviral therapies.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cohort Studies; Drug Therapy, Combination; Female; Hepati | 2015 |
Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir.
Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepacivirus; He | 2015 |
Paritaprevir/ritonavir/ombitasvir and dasabuvir for the treatment of chronic hepatitis C virus infection.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Clinical Trials, Phase II as Topic; Clinica | 2015 |
The combination of daclatasvir and sofosbuvir for curing genotype 2 patients who cannot tolerate ribavirin.
Topics: Aged; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Combination; Fatigue | 2016 |
Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection.
Topics: Aged; Antiviral Agents; Carbamates; Compassionate Use Trials; Drug Therapy, Combination; Female; Gen | 2016 |
Ombitasvir, paritaprevir, ritonavir, dasabuvir and ribavirin in cirrhosis after complete destruction of hepatocellular carcinoma.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Cyclopropa | 2016 |
Treatment of severe recurrent hepatitis C after liver transplantation in HIV infected patients using sofosbuvir-based therapy.
Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; End Stage Liver Disease | 2016 |
Direct Observed Therapy of Chronic Hepatitis C With Interferon-Free All-Oral Regimens at a Low-Threshold Drug Treatment Facility-a New Concept for Treatment of Patients With Borderline Compliance Receiving Opioid Substitution Therapy.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Directly Observed Therapy; Drug Th | 2016 |
Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care System.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Female | 2016 |
Successful treatment of hepatitis C virus infection combining daclatasvir and simeprevir in a heart transplant recipient with decompensated cirrhosis.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Heart Transplantation; Hepatitis C; Humans; | 2016 |
Full-dose sofosbuvir and daclatasvir for chronic hepatitis C infection in haemodialysis patients.
Topics: Antiviral Agents; Carbamates; Female; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazole | 2016 |
Cost-Effectiveness of Genotype 1 Chronic Hepatitis C Virus Treatments in Patients Coinfected with Human Immunodeficiency Virus in the United States.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Carcinoma, Hepatocel | 2016 |
Efficacy and safety of daclatasvir and asunaprevir for hepatitis C virus genotype 1b infection.
Topics: Aged; Alanine Transaminase; Antiviral Agents; Aspartate Aminotransferases; Carbamates; Drug Administ | 2016 |
Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Resistance, Viral; Drug Therapy, Combination; Female | 2016 |
Serial measurement of Wisteria floribunda agglutinin positive Mac-2-binding protein is useful for predicting liver fibrosis and the development of hepatocellular carcinoma in chronic hepatitis C patients treated with IFN-based and IFN-free therapy.
Topics: Antigens, Neoplasm; Antiviral Agents; Biomarkers, Tumor; Carbamates; Carcinoma, Hepatocellular; Carr | 2016 |
Sofosbuvir plus daclatasvir with or without ribavirin for chronic hepatitis C infection: Impact of drug concentration on viral load decay.
Topics: Aged; Antiviral Agents; Carbamates; Drug Monitoring; Drug Therapy, Combination; Female; France; Glom | 2016 |
Real-world efficacy and safety of daclatasvir and asunaprevir therapy for hepatitis C virus-infected cirrhosis patients.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug The | 2017 |
Ombitasvir-Paritaprevir-Ritonavir-Dasabuvir (Viekira Pak)-Induced Lactic Acidosis.
Topics: 2-Naphthylamine; Acidosis, Lactic; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Combi | 2017 |
Second-generation direct-acting-antiviral hepatitis C virus treatment: Efficacy, safety, and predictors of SVR12.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Female; Fluorenes; H | 2016 |
Liver Fibrosis and Body Mass Index Predict Hepatocarcinogenesis following Eradication of Hepatitis C Virus RNA by Direct-Acting Antivirals.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Body Mass Index; Carbamates; Carcinoma, Hepatocell | 2016 |
First Case in Kazakhstan of Successful Therapy With 2 Consecutive Direct-Acting Antiviral Regimens in a Patient with Hepatitis C Virus-Induced Decompensated Liver Cirrhosis on a Liver Transplant Wait List.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2016 |
[Sofosbuvir and daclatasvir combination therapy in hemodialysis patient with liver transplantation].
Topics: Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Drug Therapy, Combination; Hepatitis C; Hum | 2016 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Combin | 2017 |
Treatment with daclatasvir and sofosbuvir for 24 weeks without ribavirin in cirrhotic patients who failed first-generation protease inhibitors.
Topics: Antiviral Agents; Carbamates; Female; Hepatitis C, Chronic; Humans; Imidazoles; Liver Cirrhosis; Mal | 2017 |
Real-life efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir in chronic hepatitis C patients in Hong Kong.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Administra | 2017 |
The cost-effectiveness of testing for NS5a resistance-associated polymorphisms at baseline in genotype 1a-infected (treatment-naïve and treatment-experienced) subjects treated with all-oral elbasvir/grazoprevir regimens in the United States.
Topics: Administration, Oral; Amides; Antiviral Agents; Benzofurans; Carbamates; Cost-Benefit Analysis; Cycl | 2017 |
A Case of Acute Liver Failure during Ritonavir-Boosted Paritaprevir, Ombitasvir and Dasabuvir Therapy in a Patient with HCV Genotype 1b Cirrhosis.
Topics: 2-Naphthylamine; Aged, 80 and over; Anilides; Antiviral Agents; Ascites; Carbamates; Chemical and Dr | 2016 |
Cost-effectiveness analysis of the use of daclatasvir + sofosbuvir + ribavirin (16 weeks and 12 weeks) vs sofosbuvir + ribavirin (16 weeks and 24 weeks) for the treatment of cirrhotic patients affected with hepatitis C virus genotype 3 in Italy.
Topics: Antiviral Agents; Carbamates; Cost-Benefit Analysis; Drug Therapy, Combination; Genotype; Hepaciviru | 2018 |
Addition of ribavirin to daclatasvir plus asunaprevir for chronic hepatitis C 1b patients with baseline NS5A resistance-associated variants improved response.
Topics: Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Genot | 2017 |
New resistance-associated substitutions and failure of dual oral therapy with daclatasvir and asunaprevir.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, | 2017 |
Progress in eradication of HCV in HIV positive patients with significant liver fibrosis in Vienna.
Topics: 2-Naphthylamine; Adult; AIDS-Related Opportunistic Infections; Anilides; Anti-HIV Agents; Antiviral | 2017 |
Daclatasvir plus sofosbuvir, with or without ribavirin, for hepatitis C virus genotype 3 in a French early access programme.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cohort Studies; Drug Therapy, Combination; Female; France | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Clinical Trials, | 2017 |
Daclatasvir and asunaprevir treatment in patients with severe liver fibrosis by hepatitis C virus genotype 1b infection: Real-world data.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepati | 2017 |
Effectiveness of Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir in Hemodialysis Patients With Hepatitis C Virus Infection and Advanced Liver Fibrosis: Case Reports.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; H | 2017 |
Unboosted fosamprenavir is associated with low drug exposure in HIV-infected patients with mild-moderate liver impairment resulting from HCV-related cirrhosis.
Topics: Adult; Alanine Transaminase; Anti-HIV Agents; Carbamates; Chromatography, High Pressure Liquid; Elas | 2009 |
Comment on: Unboosted fosamprenavir is associated with low drug exposure in HIV-infected patients with mild-moderate liver impairment resulting from HCV-related cirrhosis.
Topics: Anti-HIV Agents; Carbamates; Furans; Hepatitis C, Chronic; HIV Infections; Humans; Liver Cirrhosis; | 2009 |
[CLINICAL STUDY OF A NEW COMPLEX HYPOTENSIVE DRUG COMBINATION].
Topics: Antihypertensive Agents; Arteriosclerosis; Carbamates; Cerebrovascular Disorders; Coronary Disease; | 1963 |
Liver function parameters in HIV/HCV co-infected patients treated with amprenavir and ritonavir and correlation with plasma levels.
Topics: Adult; Antiviral Agents; Carbamates; Chromatography, High Pressure Liquid; Furans; Hepacivirus; Hepa | 2007 |
[Pyridimocarbamate (prodectin)-induced acute liver damage, cirrhosis and primary liver cancer--accidental finding?].
Topics: Acute Disease; Arteriosclerosis; Carbamates; Chemical and Drug Induced Liver Injury; Female; Humans; | 1989 |