carbamates has been researched along with Hepatitis C, Chronic in 835 studies
Hepatitis C, Chronic: INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS.
| Excerpt | Relevance | Reference |
|---|---|---|
| "gov: NCT02786537) was the first comparative effectiveness study to directly compare ledipasvir/sofosbuvir (LDV/SOF) and elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic hepatitis C virus (HCV)." | 9.51 | Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial. ( Dong, M; Evon, DM; Lok, AS; Michael, L; Nelson, DR; Peter, J; Reeve, BB; Stewart, PW, 2022) |
| "Sofosbuvir-velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection." | 9.30 | Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. ( Asselah, T; Bourgeois, S; Brainard, DM; Davis, MN; Huang, KC; Lai, CL; Mathurin, P; McNally, J; Nguyen, MH; Osinusi, A; Shafran, SD; Shaikh, OS; Svarovskaia, E; Tran, TT; Willems, B, 2019) |
| "Recently, sofosbuvir and the fixed-dose combination of sofosbuvir/ledipasvir were approved for the treatment of chronic hepatitis C virus infection in adolescents, criteria being 12 years old and above or weighing at least 35 kg." | 9.27 | Shortened 8 Weeks Course of Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients, With Chronic Hepatitis C Infection. ( Abdo, AM; El-Khayat, HR; El-Shabrawi, MH; Yakoot, M, 2018) |
| "The combination of sofosbuvir (SOF) plus an NS5A inhibitor for 12 weeks is highly efficacious in patients with chronic hepatitis C." | 9.27 | Viral kinetics analysis and virological characterization of treatment failures in patients with chronic hepatitis C treated with sofosbuvir and an NS5A inhibitor. ( Chevaliez, S; Fourati, S; Francois, M; Guedj, J; Hézode, C; Mallat, A; Nguyen, THT; Pawlotsky, JM; Poiteau, L; Roudot-Thoraval, F; Ruiz, I; Scoazec, G; Soulier, A; Varaut, A, 2018) |
| "This study aims to systematically review recent economic evaluations of elbasvir/grazoprevir (EBR/GZR) for chronic hepatitis C (CHC), to critically appraise the reporting quality and to summarize the results." | 9.22 | Cost-Effectiveness of Elbasvir/Grazoprevir for the Treatment of Chronic Hepatitis C: A Systematic Review. ( Guo, M; Ke, L; Liu, J; You, R, 2022) |
| "Systematic search of Pubmed, Embase, Scopus, and Google Scholar was conducted using the search term (end-stage renal disease OR renal replacement therapy OR chronic kidney failure OR severe renal impairment OR chronic kidney disease OR haemodialysis OR dialysis OR peritoneal dialysis) AND (sofosbuvir OR velpatasvir OR NS5A inhibitors OR directly acting antivirals)." | 9.22 | Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta-analysis. ( De, A; Duseja, A; Mishra, S; Premkumar, M; Roy, A; Singh, V; Taneja, S; Verma, N, 2022) |
| "2% sustained virologic response at 12 weeks (SVR12) rate using the NS3/4A protease inhibitor grazoprevir and the NS5A inhibitor elbasvir together with ribavirin in treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1 infection." | 9.22 | Grazoprevir, Elbasvir, and Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection After Failure of Pegylated Interferon and Ribavirin With an Earlier-Generation Protease Inhibitor: Final 24-Week Results From C-SALVAGE. ( Barr, E; Buti, M; Calleja, JL; DiNubile, MJ; Forns, X; Gilbert, C; Gordon, SC; Hofer, H; Howe, AY; Lawitz, E; Palcza, J; Robertson, MN; Wahl, J; Zuckerman, E, 2016) |
| " In a phase 2 study we aimed to assess the efficacy and safety of grazoprevir (MK-5172; HCV NS3/4A protease inhibitor) and two doses of elbasvir (MK-8742; HCV NS5A inhibitor) in patients with HCV mono-infection and HIV/HCV co-infection." | 9.20 | Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando ( Barr, E; Bourliere, M; DeJesus, E; Dutko, F; Gerstoft, J; Haber, B; Hezode, C; Howe, AY; Hwang, P; Kugelmas, M; Mallolas, J; Murillo, A; Nahass, R; Pol, S; Robertson, M; Serfaty, L; Shaughnessy, M; Shibolet, O; Sulkowski, M; Vierling, JM; Wahl, J; Weis, N; Zuckerman, E, 2015) |
| " 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) |
| "Merimepodib (MMPD) is an orally administered, inosine monophosphate dehydrogenase inhibitor that has shown antiviral activity in nonresponders with chronic hepatitis C (CHC) when combined with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV)." | 9.14 | Merimepodib, pegylated interferon, and ribavirin in genotype 1 chronic hepatitis C pegylated interferon and ribavirin nonresponders. ( Aalyson, M; Afdhal, N; Alam, J; Bengtsson, L; Bonkovsky, HL; Chandorkar, G; Gharakhanian, S; Gordon, SC; Harding, M; Kauffman, R; Lawitz, E; Lee, WM; McHutchison, JG; McNair, L; Poordad, F; Rustgi, VK, 2009) |
| "While combination of peginterferon-alpha (PEG-IFN) and ribavirin (RBV) therapy is the current standard of care for chronic hepatitis C (CHC), only 44-51% of genotype-1 patients achieve a sustained virological response (SVR), and both agents produce treatment-limiting toxicities." | 9.12 | Phase 2 study of the combination of merimepodib with peginterferon-alpha2b, and ribavirin in nonresponders to previous therapy for chronic hepatitis C. ( Alam, J; Bengtsson, L; Bronowicki, JP; Garg, V; Grange, JD; Horsmans, Y; Marcellin, P; McNair, L; Nevens, F; Purdy, S; Vetter, D, 2007) |
| "The fixed-dose combination of sofosbuvir, a nucleotide analogue NS5B polymerase inhibitor, and velpatasvir, a second-generation NS5A inhibitor, has been approved by the United States Food and Drug Administration and the European Medicines Agency for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection." | 8.95 | Sofosbuvir/velpatasvir fixed-dose combination for the treatment of chronic hepatitis C virus infection. ( Nehra, V; Rizza, SA; Temesgen, Z, 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) |
| "A systematic literature review of Phase III clinical trials identified 2 trials of SOF+R-PHOTON-1 (A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus [HCV] and Human Immunodeficiency Virus [HIV] Co-Infected Subjects) and PHOTON-2 (A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus [HCV] and Human Immunodeficiency Virus [HIV] Co-Infected Subjects) suitable for comparison with the trial of DCV+SOF in patients coinfected with HIV and HCV-ALLY-2 (A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C [Genotype 1, 2, 3, 4, 5, or 6] Subjects Coinfected With Human Immunodeficiency Virus [HIV])." | 8.93 | Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison. ( Ackerman, P; Kalsekar, A; Kelley, C; Mu, F; Peeples, M; Signorovitch, J; Song, J; Swallow, E; Yuan, Y, 2016) |
| "The objective of this study was to compare the efficacy of sofosbuvir-based treatments in patients with chronic hepatitis C virus (HCV) infection using a model-based meta-analysis (MBMA)." | 8.93 | A model-based meta-analysis of sofosbuvir-based treatments in chronic hepatitis C patients. ( Ferriols-Lisart, R; Guglieri-López, B; Merino-Sanjuán, M; Pérez-Pitarch, A, 2016) |
| "Ombitasvir (ABT-267) is a potent inhibitor of the hepatitis C virus protein NS5A, has favorable pharmacokinetic characteristics and is active in the picomolar range against genotype 1 - 6." | 8.90 | Ombitasvir (ABT-267), a novel NS5A inhibitor for the treatment of hepatitis C. ( Stirnimann, G, 2014) |
| "The objective of this study was to determine the clinical relationship between proton pump inhibitor (PPI) use and sustained virologic response (SVR) in patients treated with sofosbuvir/velpatasvir (SOF/VEL) for chronic hepatitis C virus (HCV) infection." | 8.12 | Impact of proton pump inhibitors on sustained virologic response in veterans treated with sofosbuvir/velpatasvir for chronic hepatitis C virus: A retrospective cohort study. ( Jacob, DA; Kolberg, JL; Rumph, DM; Straley, CM, 2022) |
| "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) |
| "Grazoprevir/elbasvir and glecaprevir/pibrentasvir (G/P) are the two preferred treatment options for patients with chronic hepatitis C virus (HCV) infection and a glomerular filtration rate (GFR) <30 mL/min." | 8.12 | Hepatitis C therapy with grazoprevir/elbasvir and glecaprevir/pibrentasvir in patients with advanced chronic kidney disease: data from the German Hepatitis C-Registry (DHC-R). ( Berg, T; Heyne, R; John, C; Klinker, H; Naumann, U; Niederau, C; Serfert, Y; Stein, K; Stoehr, A; Teuber, G; Wiegand, J; Zeuzem, S, 2022) |
| "Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) with or without low-dose ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI) are limited." | 8.12 | Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment. ( Chang, CC; Chang, CH; Chang, CY; Chen, CY; Chen, JJ; Chen, PY; Fang, YJ; Hsieh, TY; Huang, CS; Huang, JJ; Huang, KJ; Huang, YJ; 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; Yang, SS, 2022) |
| "Report the real-world experience of the efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in chronic hepatitis C virus (HCV) infected patients who have previously experienced a direct-acting antiviral (DAA) containing regimen." | 8.02 | Efficacy of sofosbuvir/velpatasvir/voxilaprevir in direct-acting antiviral experienced patients with hepatitis C virus. ( Da, BL; Dieterich, D; Kushner, T; Lourdusamy, V; Saberi, B, 2021) |
| "To evaluate the effect of generic sofosbuvir and daclatasvir (SOF/DCV) treatment on the glycemic state and insulin resistance as well as lipid profiles of those who achieved sustained virological response (SVR) in diabetic chronic hepatitis C virus (CHC) patients." | 8.02 | Impact of sustained virological response on metabolic disorders in diabetic chronic hepatitis C virus patients after treatment with generic sofosbuvir and daclatasvir. ( Abdel Alem, S; Abdellatif, Z; Abdo, M; Moustafa, A; Rabiee, A, 2021) |
| "In clinical trials, hepatitis C virus (HCV) salvage treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) achieved an SVR12 rate of >95% in NS5A-experienced participants." | 8.02 | Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics. ( Ahlenstiel, G; Bowden, S; Dore, GJ; Douglas, M; Doyle, J; Farrell, G; Fisher, L; George, J; Haque, M; Hazeldine, S; Hellard, M; Levy, M; MacQuillan, G; McGarity, B; New, K; O'Beirne, J; O'Keefe, J; Papaluca, T; Prewett, E; Roberts, SK; Sawhney, R; Sievert, W; Sinclair, M; Sood, S; Stoove, M; Strasser, SI; Stuart, KA; Thomas, J; Thompson, AJ; Tse, E; Valaydon, Z; Valiozis, I; Wade, AJ; Weltman, M; Wigg, A; Wilson, M; Woodward, A, 2021) |
| "There is emerging data on the use of Sofosbuvir-based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end-stage renal disease (ESRD) on maintenance haemodialysis (MHD)." | 8.02 | Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end-stage renal disease on maintenance haemodialysis. ( De, A; Dhiman, RK; Duseja, A; Kohli, HS; Kumar, V; Mehta, M; Premkumar, M; Ramachandran, R; Ratho, RK; Singh, MP; Singh, V; Taneja, S; Verma, N, 2021) |
| "Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited." | 8.02 | Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan. ( Chang, CC; Chang, CH; Chang, CY; Chen, CY; Chen, JJ; Chen, PY; Fang, YJ; Hsieh, TY; Huang, CS; Huang, JJ; Huang, KJ; Huang, YJ; Hung, CC; 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; Yang, SS, 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." | 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) |
| "Sofosbuvir plus daclatasvir with or without ribavirin has demonstrated a high efficacy and an acceptable safety profile in clinical trials of patients infected with genotype 2 hepatitis Cvirus (HCV); however, there are currently no real-world data available for this regimen." | 7.96 | Sofosbuvir-Daclatasvir is suboptimal in patients with genotype 2 chronic hepatitis C infection: real-life experience from the HEPATHER ANRS CO22 cohort. ( Bronowicki, JP; Carrat, F; Chazouillères, O; Chevaliez, S; de Lédinghen, V; Dorival, C; Fontaine, H; Larrey, D; Lusivika-Nzinga, C; Marcellin, P; Metivier, S; Pawlotsky, JM; Pol, S; Samuel, D; Tran, A; Zoulim, F, 2020) |
| "This prospective study was conducted on a real word cohort of 1562 treatment naïve chronic hepatitis C (CHC) Egyptian patients, who received 12-weeks therapy with sofosbuvir (SOF) plus daclatasvir (DCV) ± ribavirin (RBV)." | 7.96 | Morbidity and mortality during hepatitis C treatment using sofosbuvir and daclatasvir with or without ribavirin, in a cohort of Egyptian patients. ( Abdelbaser, ES; Elsadek, HM; Emara, MH; Farag, AA; Soliman, HH, 2020) |
| "We report a case of hepatitis B virus reactivation in a Caucasian patient infected with hepatitis C virus during treatment with sofosbuvir and velpatasvir." | 7.91 | Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case r ( Andreoni, M; Aragri, M; Cerva, C; Ferrari, L; Foroghi Biland, L; Gentile, A; Malagnino, V; Salpini, R; Sarmati, L; Svicher, V; Teti, E, 2019) |
| "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) |
| "To assess the efficacy and the risk of sofosbuvir-daclatasvir treatment among kidney transplant recipients (KTRs) with chronic hepatitis C virus (HCV) infection." | 7.91 | Treatment of chronic hepatitis C viral infection with sofosbuvir and daclatasvir in kidney transplant recipients. ( Chen, J; Deng, H; Huang, H; Shen, J; Tang, H; Wu, J; Xie, W; Zhou, Q, 2019) |
| "Sofosbuvir plus daclatasvir is effective in the eradication of HCV and improvement of symptoms in patients with psoriasis having CHC infection." | 7.91 | Effect of sofosbuvir plus daclatasvir for treatment of chronic hepatitis C on patients with psoriasis. ( Ismail, WA; Yousef, AE, 2019) |
| "In the current study, we aimed to assess the efficacy of different Sofosbuvir (SOF)-based antiviral regimens available in Egypt in the treatment of Pegylated interferon/Ribavirin (PEG-INF/RBV)-experienced chronic hepatitis C virus (HCV) patients." | 7.91 | Retreatment of Egyptian Chronic Hepatitis C Patients Not Responding to Pegylated Interferon and Ribavirin Dual Therapy. ( Abdelrazik, M; Aboushady, M; Alwassief, A; Elbahrawy, A; Elmestikawy, A; Shahba, H; Ziada, D, 2019) |
| " Forty chronic hepatitis C virus-infected adolescents, 12-17 years of age, were treated with sofosbuvir/daclatasvir therapy for 12 weeks." | 7.91 | Effects of Dual Sofosbuvir/Daclatasvir Therapy on Weight and Linear Growth in Adolescent Patients with Chronic Hepatitis C Virus Infection. ( AbdElgawad, MM; Abdo, AM; El-Khayat, HR; El-Shabrawi, MH; Helmy, S; Kamal, EM; Kamal, NM; Khalil, AF; Mahfouz, AA; Yakoot, M, 2019) |
| "We assessed the effectiveness and safety of sofosbuvir (SOF) combined with ledipasvir (LDV) or daclatasvir (DCV) in 12 heart transplant recipients with chronic hepatitis C virus (HCV)." | 7.88 | Sofosbuvir-based Interferon-Free Direct Acting Antiviral Regimens for Heart Transplant Recipients With Chronic Hepatitis C Virus Infection. ( Chen, DS; Chen, PJ; Chen, YS; Hong, CM; Kao, JH; Liu, CH; Liu, CJ; Su, TH; Wang, SS; Yang, HC, 2018) |
| " Food and Drug Administration (FDA) approved sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (Vosevi) fixed-dose combination (FDC), an interferon-free, complete regimen for adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing a nonstructural protein 5A (NS5A) inhibitor; and • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor." | 7.88 | Benefit-risk assessment for sofosbuvir/velpatasvir/voxilaprevir based on patient population and hepatitis C virus genotype: U. S. Food and Drug Administration's evaluation. ( Birnkrant, D; Chan-Tack, K; Naeger, LK; Qi, K; Struble, K, 2018) |
| "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) |
| "We report the first real-world prospective multicenter cohort study that evaluated the effectiveness and safety of original or generic sofosbuvir-based regimens in patients with chronic hepatitis C in Latin America." | 7.88 | Effectiveness and safety of original and generic sofosbuvir for the treatment of chronic hepatitis C: A real world study. ( Bessone, F; Borzi, SM; Cartier, M; D'Amico, C; Descalzi, VI; Fainboim, HA; Figueroa Escuti, S; Frías, S; Gadano, AC; Gaite, LA; Galdame, OA; Haddad, L; Longo, C; Marciano, S; Marino, M; Peralta, M; Perez Ravier, R; Reggiardo, MV; Vistarini, C, 2018) |
| "There is sparse data on the use of Sofosbuvir based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1." | 7.88 | Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease. ( Chawla, Y; De, A; Dhiman, RK; Duseja, A; Gupta, KL; Kohli, HS; Kumar, V; Mehta, M; Ramachandran, R; Taneja, S, 2018) |
| "Dual sofosbuvir/daclatasvir (SOF/DCV) therapy is currently recommended by the European Association for Study of Liver (EASL) as an option for the treatment of chronic hepatitis C virus (HCV) infection in adults for all genotypes; however, it is still not considered for patients younger than 18 years old." | 7.88 | Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients With Chronic Hepatitis C Infection. ( AbdElgawad, MM; Abdo, AM; El-Khayat, HR; El-Shabrawi, MH; Helmy, S; Mahfouz, AA; Yakoot, M, 2018) |
| "A 74-year-old Japanese man with a history of chronic hepatitis C and kidney transplant (KT) was administered pegylated-interferon plus ribavirin therapy." | 7.88 | Ombitasvir-Paritaprevir-Ritonavir Therapy in a Kidney Transplant Recipient With Chronic Hepatitis C Virus Genotype 1 Infection: A Case Report on the Importance of Considering Drug-Drug Interactions and Monitoring Cyclosporine Levels. ( Hashimoto, S; Hayashi, K; Nakagawa, Y; Saito, K; Takahashi, K; Takamura, M; Takeuchi, S; Tanabe, Y; Tasaki, M; Terai, S; Tomita, Y; Yamagiwa, S; Yoshida, T, 2018) |
| " 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) |
| "Treatment of Hepatitis C virus (HCV) in patients with severe renal insufficiency is cumbersome as sofosbuvir is mainly excreted by the kidneys." | 7.88 | Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency. ( De, A; Kumar, P; Kumari, S; Singh, A; Singh, V, 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) |
| "From March 2016 to October 2016, 374 chronic hepatitis C patients were enrolled for this prospective, observational study and received SOF, DCV with ribavirin, to evaluate the changes in liver function parameters, international normalized ratio, complete blood count, model for end-stage liver disease, and Child-Turcotte-Pugh scores after achieving a sustained virological response 12 weeks after treatment." | 7.85 | Sofosbuvir and daclatasvir plus ribavirin treatment improve liver function parameters and clinical outcomes in Egyptian chronic hepatitis C patients. ( Bassiony, MAA; Hanafy, AS; Hussein, S; Mohamed, MS, 2017) |
| "Pruritus observed during OBV/PTV/r ± DSV treatment of chronic hepatitis C is associated with increased on-treatment serum bile acid levels, possibly due to ritonavir-induced alterations of bile acid transport." | 7.85 | Anti-HCV treatment with ombitasvir/paritaprevir/ritonavir ± dasabuvir is associated with increased bile acid levels and pruritus. ( Fauler, G; Kessler, HH; Leber, B; Mangge, H; Posch, A; Rainer, F; Spindelboeck, W; Stadlbauer, V; Stauber, RE; Streit, A, 2017) |
| "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) |
| "This study compared the cost-effectiveness of chronic hepatitis C virus (HCV) genotype 1b (GT1b) therapy ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) vs daclatasvir + asunaprevir (DCV/ASV) and no treatment in patients without cirrhosis." | 7.83 | Cost-effectiveness of direct-acting antiviral regimen ombitasvir/paritaprevir/ritonavir in treatment-naïve and treatment-experienced patients infected with chronic hepatitis C virus genotype 1b in Japan. ( Igarashi, A; Johnson, S; Mitchell, D; Samp, JC; Virabhak, S; Yamazaki, K; Yasui, K; Yuen, C, 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 efficacy of the all-oral administration of daclatasvir and asunaprevir for 24 weeks was compared with that of telaprevir for 12 weeks plus pegylated interferon and ribavirin (PEG-IFN/RBV) for 24 weeks, and that of simeprevir for 12 weeks plus PEG-IFN/RBV for 24 weeks, with a focus on the prevention of occurrence and recurrence of hepatocellular carcinoma (HCC)." | 7.81 | Comparison of Daclatasvir and Asunaprevir for Chronic HCV 1b Infection with Telaprevir and Simeprevir plus Peginterferon and Ribavirin, with a Focus on the Prevention of Occurrence and Recurrence of Hepatocellular Carcinoma. ( Hatae, T; Hayashi, Y; Imoto, S; Kim, KI; Kim, SK; Kim, SR; Kudo, M; Ohtani, A; Sugimoto, K; Tohyama, M; Yano, Y, 2015) |
| "A 12 week course of sofosbuvir-velpatasvir-voxilaprevir is safe and efficacious for the re-treatment of individuals infected with HCV genotype 4 non-a/d subtypes with frequent baseline NS5A resistance-associated substitutions, following failure of previous direct-acting antiviral treatment." | 7.11 | Safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trial. ( Camus, G; Grant, PM; Gupta, N; Kabihizi, J; Kateera, F; Makuza, JD; Manirambona, L; Mukabatsinda, C; Murangwa, A; Musabeyezu, E; Muvunyi, CM; Nsanzimana, S; Serumondo, J; Shumbusho, F, 2022) |
| "A 12-week regimen of sofosbuvir-velpatasvir is safe and efficacious in treating chronic HCV genotype 4 infection in patients in Rwanda." | 7.11 | Safety and efficacy of sofosbuvir-velpatasvir to treat chronic hepatitis C virus infection in treatment-naive patients in Rwanda (SHARED-3): a single-arm trial. ( Camus, G; Grant, PM; Gupta, N; Kabakambira, JD; Kabihizi, J; Kateera, F; Makuza, JD; Manirambona, L; Murangwa, A; Muvunyi, CM; Nsanzimana, S; Serumondo, J; Shumbusho, F; Sylvain, H, 2022) |
| " Adverse events (AEs) were found in less than one half of patients (45 patients, or 42." | 6.90 | [Efficacy and safety of narlaprevir/ritonavir and daclatasvir non interferon combination in population of Russian patients with chronic hepatitis C]. ( Batskikh, SN; Burnevich, EZ; Chulanov, VP; Gusev, DA; Kizlo, SN; Klimova, EA; Krasavina, EN; Mamonova, NA; Samsonov, MY; Tarkhova, EP; Yushchuk, ND; Znoyko, OO, 2019) |
| "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) |
| " However, ribavirin is associated with adverse events that can limit its use." | 6.90 | Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis. ( Bank, L; Bernstein, D; Epstein, M; Krishnan, P; Lucey, MR; Martinez, M; Nelson, DR; Pockros, PJ; Polepally, AR; Poordad, F; Ravendhran, N; Reindollar, R; Sedghi, S; Trinh, R; Unnebrink, K, 2019) |
| " 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) |
| " However, evening atazanavir plus ritonavir and lopinavir/ritonavir regimens are not recommended in combination with the 3D regimen." | 6.82 | Evaluation of Drug-Drug Interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HIV-1 Protease Inhibitors. ( Awni, W; Dutta, S; Khatri, A; Menon, R; Podsadecki, T; Trinh, R; Wang, H, 2016) |
| " We examined the efficacy and safety of an all-oral interferon-free regimen of ombitasvir, an NS5A inhibitor, and paritaprevir (ABT-450), an NS3/4A protease inhibitor dosed with ritonavir (ombitasvir plus paritaprevir plus ritonavir), given with or without ribavirin." | 6.80 | Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. ( Asselah, T; Berenguer, M; Fleischer-Stepniewska, K; Hall, C; Hassanein, T; Hézode, C; Marcellin, P; Mobashery, N; Pilot-Matias, T; Pol, S; Reddy, KR; Redman, R; Schnell, G; Vilchez, RA, 2015) |
| " 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) |
| "3%) reported ≥1 adverse event (AE) and 491 had AEs (28." | 6.66 | Safety and tolerability of elbasvir/grazoprevir in chronic hepatitis C virus therapy: Integrated analysis from clinical trials. ( Brown, DD; Haber, BA; Klopfer, SO; Kwo, P; Nangia, G; Reddy, KR; Robertson, MN; Vierling, JM, 2020) |
| " Expert opinion: This combination, taken orally with or without food, has an excellent pharmacokinetic and pharmacodynamic profile." | 6.58 | Pharmacodynamic and pharmacokinetic evaluation of the combination of daclatasvir/sofosbuvir/ribavirin in the treatment of chronic hepatitis C. ( Brieva, T; Frias, M; Rivero, A; Rivero-Juarez, A, 2018) |
| "Treatments for hepatitis C virus (HCV) have advanced greatly, becoming more efficacious with fewer adverse events, due to the availability of direct-acting antiviral agents, which target specific steps in the HCV life cycle." | 6.58 | Safety and efficacy of elbasvir/grazoprevir for the treatment of chronic hepatitis C: current evidence. ( Morikawa, K; Nakamura, A; Sakamoto, N; Shimazaki, T, 2018) |
| " Demographic information, HCV viral load (VL), profiles of lipid and sugar, and adverse events were recorded and reviewed." | 5.72 | Real-world effectiveness and safety of sofosbuvir/velpatasvir and glecaprevir/pibrentasvir for genotype 6 chronic hepatitis C. ( Chen, JJ; Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC; Lee, PL; Tung, HD, 2022) |
| " Retrospective analysis of the fractions of patients that achieved sustained virological response (SVR) was performed, and the incidence of adverse events was noted." | 5.62 | Effectiveness and safety of elbasvir/grazoprevir in Korean patients with hepatitis C virus infection: a nationwide real-world study. ( Chung, WJ; Jang, ES; Jeong, SH; Kim, IH; Kim, KA; Kim, YS; Lee, BS; Lee, YJ, 2021) |
| " The secondary outcome measures were SVR12 stratified by the presence of decompensated cirrhosis, prior treatment, HCC, and HIV/hepatitis C virus coinfection and the occurrence rate of serious adverse events requiring treatment cessation or hospitalization." | 5.62 | Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort. ( Ang, TL; Fock, KM; Koh, J; Kumar, LS; Kumar, R; Kwek, A; Law, NM; Lee, ZC; Li, W; Tan, J; Tan, YB; Teo, EK; Thurairajah, PH; Wong, YJ, 2021) |
| "The assessment of drug-drug interaction (DDI) is important not only for safety but also for maintaining the efficacy of direct acting antivirals in chronic hepatitis C (CHC)." | 5.56 | Limited drug-drug interaction of elbasvir/grazoprevir for chronic hepatitis C. ( Cheng, PN; Liu, CJ; Lo, CC; Tseng, IH; Tseng, KC, 2020) |
| " Only four patients discontinued treatment before week 4 due to non-hepatic adverse events." | 5.56 | Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study. ( Bunchorntavakul, C; Charatcharoenwitthaya, P; Chonprasertsuk, S; Komolmit, P; Piratvisuth, T; Sanpajit, T; Sethasine, S; Siripipattanamongkol, C; Sobhonslidsuk, A; Sukeepaisarnjaroen, W; Sutthivana, C; Tangkijvanich, P; Tanwandee, T; Wongpaitoon, V, 2020) |
| " It was associated with high risk IFN-related adverse reactions due to reduced renal clearance of IFN." | 5.56 | Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease: A real-life experience. ( Abd-Elsalam, S; Abo-Amer, YE; Ahmed, R; Badawi, R; El-Abgeegy, M; Elguindy, AMA; Elkadeem, M; Elsergany, HF; Elshweikh, SA; Hawash, N; Mansour, L; Mohmed, AA; Soliman, MY; Soliman, S, 2020) |
| "SOF-based pangenotypic DAAs including SOF plus DCV and SOF plus VEL, were effective and safe for CHC patients without GT determination in this study." | 5.56 | Efficacy and safety of sofosbuvir-based pangenotypic direct-acting antiviral agents for chronic hepatitis C patients without genotype determination: Real-world experience of a retrospective study. ( Chen, EQ; Chen, XB; Jiang, W; Li, J; Tao, YC; Wang, ML; Wang, YH; Wu, DB; Xiao, GB, 2020) |
| "gov: NCT02786537) was the first comparative effectiveness study to directly compare ledipasvir/sofosbuvir (LDV/SOF) and elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic hepatitis C virus (HCV)." | 5.51 | Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial. ( Dong, M; Evon, DM; Lok, AS; Michael, L; Nelson, DR; Peter, J; Reeve, BB; Stewart, PW, 2022) |
| " As advanced age is associated with increasing risk of development of cirrhosis and hepatocellular carcinoma, elderly patients are in special need of safe and effective antiviral therapies." | 5.51 | Efficacy and safety of sofosbuvir and daclatasvir with or without ribavirin in elderly patients with chronic hepatitis C virus infection. ( Abdel-Samiee, M; Abdo, M; Elbaz, T; Esmat, G; Gamil, M; Hassan, EA; Moustafa, A; Omar, H; Qawzae, A; Zaghloul, AM, 2019) |
| " Combined SOF/DCV was found to be effective and safe for treating HCV Genotype 4-infected children, 8 years of age and above." | 5.51 | Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4. ( Abdel Gawad, M; Abdel Ghaffar, A; Abdel Ghaffar, TY; El Naghi, S; Helmy, S; Moafy, M; Yousef, M, 2019) |
| " Data were analyzed to assess the on-treatment and off-therapy HCV viral load and on-treatment adverse events." | 5.48 | Real-world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without ribavirin for patients with chronic hepatitis C virus genotype 1b infection in Taiwan. ( Chen, DS; Chen, PJ; Hong, CM; Kao, JH; Liu, CH; Liu, CJ; Su, TH; Tseng, TC; Yang, HC, 2018) |
| "5%) patients (calcium channel blockers, ACE inhibitors, statins, diuretics, tacrolimus); four patients required further adjustment of antihypertensive drugs or tacrolimus dosage on-treatment." | 5.48 | Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir Regimen in the Treatment of Genotype 1 Chronic Hepatitis C Infection in Patients with Severe Renal Impairment and End-Stage Renal Disease: a Real-Life Cohort. ( Chmelova, K; Frankova, S; Kreidlova, M; Merta, D; Senkerikova, R; Sperl, J, 2018) |
| " There were no severe adverse events associated with the treatment." | 5.48 | Real-world virological efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis C virus genotype 1 infection in Japan. ( Abe, H; Asano, T; Atsukawa, M; Deguchi, A; Fujioka, S; Hiraoka, A; Iio, E; Ishikawa, T; Itobayashi, E; Iwakiri, K; Kato, K; Kondo, C; Kumada, T; Masaki, T; Michitaka, K; Mikami, S; Moriya, A; Ogawa, C; Okubo, H; Okubo, T; Senoh, T; Shimada, N; Tada, T; Takaguchi, K; Tamai, H; Tanaka, Y; Tani, J; Toyoda, H; Tsubota, A; Tsuji, K; Uojima, H; Watanabe, T; Yoneyama, H, 2018) |
| " The most common adverse events recorded were fatigue, headache, nausea, asthenia, and gastrointestinal troubles." | 5.48 | Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. ( Abdel-Gabaar, M; Abdel-Moneim, A; Aboud, A; Ramadan, M; Zanaty, MI, 2018) |
| " Treatment in the post-transplantation setting may be complicated by significant drug-drug interactions between antiviral agents and standard immune suppressive treatment regimens." | 5.48 | Ombitasvir/paritaprevir/ritonavir plus dasabuvir regimen may be used safely in combination with sirolimus for the treatment of chronic hepatitis C. ( Dolman, GE; Gelson, WT; Selby, P, 2018) |
| " Other correlates with adverse events of clinical importance included concomitant ribavirin treatment, sex, race, and presence of cirrhosis, consistent with previous observations." | 5.46 | Exposure-Safety Response Relationship for Ombitasvir, Paritaprevir/Ritonavir, Dasabuvir, and Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: Analysis of Data from Five Phase II and Six Phase III Studies. ( Awni, W; DaSilva-Tillmann, B; Dutta, S; Lin, CW; Liu, W; Menon, R; Podsadecki, T; Shulman, N, 2017) |
| "The risk of hepatocellular carcinoma (HCC) development is reduced following viral elimination by interferon therapy in chronic hepatitis C patients." | 5.46 | The risks of hepatocellular carcinoma development after HCV eradication are similar between patients treated with peg-interferon plus ribavirin and direct-acting antiviral therapy. ( Aikata, H; Chayama, K; Daijo, K; Fujino, H; Hatooka, M; Hayes, CN; Hiramatsu, A; Honda, F; Imamura, M; Kan, H; Kawakami, Y; Kawaoka, T; Kobayashi, T; Masaki, K; Miki, D; Morio, K; Morio, R; Nagaoki, Y; Nakahara, T; Nakamura, Y; Ochi, H; Ono, A; Teraoka, Y; Tsuge, M, 2017) |
| "The patient early terminated treatment due to dengue fever but eventually achieved SVR12." | 5.43 | Four weeks of paritaprevir/ritonavir/ombitasvir plus dasabuvir encountering dengue fever resulted in sustained virological response in an HCV patient: A case report. ( Huang, CF; Jang, TY; Lu, PL; Yu, ML, 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) |
| "This study evaluated 12-week retreatment with sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C virus (HCV) infection who did not achieve sustained virologic response after previous treatment with a sofosbuvir- and velpatasvir-containing regimen." | 5.30 | Sofosbuvir/Velpatasvir/Voxilaprevir for patients with HCV who previously received a Sofosbuvir/Velpatasvir-containing regimen: Results from a retreatment study. ( Brainard, DM; Dvory-Sobol, H; Gane, EJ; Hyland, RH; Nyberg, L; Ruane, P; Shafran, S; Shao, J; Stamm, LM; Strasser, SI; Tran, T, 2019) |
| "In clinical studies, sofosbuvir-velpatasvir has demonstrated high cure rates and favorable tolerability in patients chronically infected with chronic hepatitis C virus (HCV) of any genotype." | 5.30 | Sofosbuvir-velpatasvir single-tablet regimen administered for 12 weeks in a phase 3 study with minimal monitoring in India. ( Amrose, P; Bhatia, S; Brainard, DM; Camus, G; Chowdhury, A; Duseja, A; Goswami, B; Hyland, RH; Kabrawala, M; Kapoor, D; Koshy, A; Lu, S; Prasad, M; Saraswat, V; Sarin, SK; Shah, SR; Sood, A; Stamm, LM; Subramanian, GM, 2019) |
| "Sofosbuvir-velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection." | 5.30 | Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. ( Asselah, T; Bourgeois, S; Brainard, DM; Davis, MN; Huang, KC; Lai, CL; Mathurin, P; McNally, J; Nguyen, MH; Osinusi, A; Shafran, SD; Shaikh, OS; Svarovskaia, E; Tran, TT; Willems, B, 2019) |
| "Recently, sofosbuvir and the fixed-dose combination of sofosbuvir/ledipasvir were approved for the treatment of chronic hepatitis C virus infection in adolescents, criteria being 12 years old and above or weighing at least 35 kg." | 5.27 | Shortened 8 Weeks Course of Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients, With Chronic Hepatitis C Infection. ( Abdo, AM; El-Khayat, HR; El-Shabrawi, MH; Yakoot, M, 2018) |
| "The combination of sofosbuvir (SOF) plus an NS5A inhibitor for 12 weeks is highly efficacious in patients with chronic hepatitis C." | 5.27 | Viral kinetics analysis and virological characterization of treatment failures in patients with chronic hepatitis C treated with sofosbuvir and an NS5A inhibitor. ( Chevaliez, S; Fourati, S; Francois, M; Guedj, J; Hézode, C; Mallat, A; Nguyen, THT; Pawlotsky, JM; Poiteau, L; Roudot-Thoraval, F; Ruiz, I; Scoazec, G; Soulier, A; Varaut, A, 2018) |
| "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) |
| "Sofosbuvir/velpatasvir is a combination of two drugs in one tablet that is approved for the treatment of patients with chronic hepatitis C virus (HCV) infection." | 5.27 | Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients. ( Agarwal, K; Arterburn, S; Brainard, DM; Camus, G; Castells, L; Dufour, JF; Forns, X; Mani Subramanian, G; Mariño, Z; McNabb, B; McNally, J; Müllhaupt, B; Rosenberg, WMC; Stamm, LM, 2018) |
| "Patients with chronic hepatitis C virus (HCV) infection have high rates of sustained virologic response (SVR) after 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir." | 5.24 | Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. ( Agarwal, K; Asselah, T; Berg, T; Bhandari, BR; Borgia, SM; Brainard, DM; Bräu, N; Davis, M; Dore, GJ; Dvory-Sobol, H; Feld, JJ; Foster, GR; Gane, EJ; Hyland, RH; Jacobson, IM; Lawitz, E; McHutchison, JG; Nahass, RG; Pearlman, B; Roberts, SK; Ruane, PJ; Shafran, SD; Stamm, LM; Stedman, CAM; Subramanian, GM; Svarovskaia, E; Thompson, AJ; Willems, BE; Workowski, KA; Zhu, Y, 2017) |
| "In the C-SURFER study, therapy with the all-oral elbasvir plus grazoprevir regimen for 12 weeks in patients with chronic hepatitis C virus (HCV) infection and stage 4-5 chronic kidney disease resulted in a high rate of virological cure compared with placebo." | 5.24 | Elbasvir plus grazoprevir in patients with hepatitis C virus infection and stage 4-5 chronic kidney disease: clinical, virological, and health-related quality-of-life outcomes from a phase 3, multicentre, randomised, double-blind, placebo-controlled trial ( Arduino, JM; Barr, E; Bruchfeld, A; Greaves, W; Hwang, P; Londoño, MC; Martin, P; Monsour, H; Nelson, DR; Nguyen, BY; Pol, S; Robertson, M; Roth, D; Silva, M; Wahl, J, 2017) |
| "The direct-acting antiviral agent (DAA) combination of ombitasvir and paritaprevir (administered with ritonavir) with (3D regimen) or without (2D regimen) dasabuvir has shown very high efficacy rates in the treatment of chronic hepatitis C virus (HCV) infection." | 5.24 | Pharmacokinetics and Tolerability of Anti-Hepatitis C Virus Treatment with Ombitasvir, Paritaprevir, Ritonavir, with or Without Dasabuvir, in Subjects with Renal Impairment. ( Awni, WM; Dutta, S; Khatri, A; Marbury, TC; Menon, RM; Preston, RA; Rodrigues, L; Wang, H, 2017) |
| "A Phase 2a, open-label study (NCT01724086) was conducted to assess the efficacy and safety of a once-daily, 2-direct-acting-antiviral-agent (2-DAA) combination of simeprevir + TMC647055/ritonavir ± ribavirin and of the 3-DAA combination of simeprevir + TMC647055/ritonavir + JNJ-56914845 in chronic hepatitis C virus genotype (GT)1-infected treatment-naïve and prior-relapse patients." | 5.24 | Efficacy, safety and pharmacokinetics of simeprevir and TMC647055/ritonavir with or without ribavirin and JNJ-56914845 in HCV genotype 1 infection. ( Arastéh, K; Bourgeois, S; Buggisch, P; Francque, S; Hoeben, E; Horsmans, Y; Jacquemyn, B; Kakuda, TN; Luo, D; Moreno, C; Nevens, F; Orlent, H; Schattenberg, JM; Van Remoortere, P; Van Vlierberghe, H; Vandebosch, A; Verloes, R; Vijgen, L, 2017) |
| "This study aims to systematically review recent economic evaluations of elbasvir/grazoprevir (EBR/GZR) for chronic hepatitis C (CHC), to critically appraise the reporting quality and to summarize the results." | 5.22 | Cost-Effectiveness of Elbasvir/Grazoprevir for the Treatment of Chronic Hepatitis C: A Systematic Review. ( Guo, M; Ke, L; Liu, J; You, R, 2022) |
| "Systematic search of Pubmed, Embase, Scopus, and Google Scholar was conducted using the search term (end-stage renal disease OR renal replacement therapy OR chronic kidney failure OR severe renal impairment OR chronic kidney disease OR haemodialysis OR dialysis OR peritoneal dialysis) AND (sofosbuvir OR velpatasvir OR NS5A inhibitors OR directly acting antivirals)." | 5.22 | Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta-analysis. ( De, A; Duseja, A; Mishra, S; Premkumar, M; Roy, A; Singh, V; Taneja, S; Verma, N, 2022) |
| "2% sustained virologic response at 12 weeks (SVR12) rate using the NS3/4A protease inhibitor grazoprevir and the NS5A inhibitor elbasvir together with ribavirin in treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1 infection." | 5.22 | Grazoprevir, Elbasvir, and Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection After Failure of Pegylated Interferon and Ribavirin With an Earlier-Generation Protease Inhibitor: Final 24-Week Results From C-SALVAGE. ( Barr, E; Buti, M; Calleja, JL; DiNubile, MJ; Forns, X; Gilbert, C; Gordon, SC; Hofer, H; Howe, AY; Lawitz, E; Palcza, J; Robertson, MN; Wahl, J; Zuckerman, E, 2016) |
| "Twenty-four weeks of treatment with peginterferon and ribavirin for chronic hepatitis C virus (HCV) genotype 2 or 3 infection produces a sustained virologic response (SVR) in 70%-80% of patients." | 5.20 | Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. ( Brunetto, MR; Cohen, D; Cooney, E; de Lédinghen, V; Dore, GJ; Fung, SK; George, J; Ghesquiere, W; Hagens, P; Harley, H; Hernandez, D; Hézode, C; Hughes, EA; Larrey, D; Lawitz, E; Lee, SS; McPhee, F; Noviello, S; Pol, S; Ramji, A; Shafran, SD; Strasser, SI; Taliani, G; Tatum, HA; Tran, A; Weis, N; Zaltron, S, 2015) |
| " In a phase 2 study we aimed to assess the efficacy and safety of grazoprevir (MK-5172; HCV NS3/4A protease inhibitor) and two doses of elbasvir (MK-8742; HCV NS5A inhibitor) in patients with HCV mono-infection and HIV/HCV co-infection." | 5.20 | Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando ( Barr, E; Bourliere, M; DeJesus, E; Dutko, F; Gerstoft, J; Haber, B; Hezode, C; Howe, AY; Hwang, P; Kugelmas, M; Mallolas, J; Murillo, A; Nahass, R; Pol, S; Robertson, M; Serfaty, L; Shaughnessy, M; Shibolet, O; Sulkowski, M; Vierling, JM; Wahl, J; Weis, N; Zuckerman, E, 2015) |
| "Paritaprevir (administered with ritonavir, PTV/r), ombitasvir (OBV), and dasabuvir (DSV) are direct-acting antiviral agents (DAAs) for the treatment of chronic hepatitis C virus (HCV) infection." | 5.20 | Drug-drug interaction profile of the all-oral anti-hepatitis C virus regimen of paritaprevir/ritonavir, ombitasvir, and dasabuvir. ( Awni, WM; Badri, PS; Coakley, EP; Dutta, S; Hu, B; Khatri, A; Menon, RM; Podsadecki, TJ; Polepally, AR; Wang, H; Wang, T; Zha, J, 2015) |
| "This open-label, phase 3 study (HALLMARK-QUAD; NCT01573351) treated patients with chronic hepatitis C virus (HCV) genotype 1 (n=354) or 4 (n=44) infection who had a prior null or partial response to peginterferon/ribavirin." | 5.20 | Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. ( Bernstein, D; Brunetto, M; de Ledinghen, V; Elkhashab, M; Everson, G; Hennicken, D; Heo, J; Hézode, C; Hughes, E; Jensen, D; Kugelmas, M; Luketic, V; Mauss, S; McPhee, F; Mendez, P; Noviello, S; Pol, S; Serfaty, L; Sherman, KE; Tran, A; Vierling, J; Younes, ZH; Zeuzem, S, 2015) |
| " 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) |
| "GSK2336805 is a HCV NS5A inhibitor for chronic hepatitis C (CHC)." | 5.19 | A double-blind, randomized, placebo-controlled study to assess the safety, antiviral activity and pharmacokinetics of GSK2336805 when given as monotherapy and in combination with peginterferon alfa-2a and ribavirin in hepatitis C virus genotype 1-infected ( Adkison, K; Cutrell, A; Elko-Simms, C; Gardner, S; Hamatake, R; Hong, Z; Rodriguez-Torres, M; Walker, J, 2014) |
| "GSK2336805 is a hepatitis C virus NS5A inhibitor in clinical development for the treatment of chronic hepatitis C virus infection." | 5.17 | Echocardiogram study to evaluate the effect of the novel hepatitis C virus NS5A inhibitor GSK2336805 on cardiac contractility in healthy subjects. ( Adkison, KK; Gan, J; Jones, LA; Lou, Y; Spreen, W; Wilfret, DA, 2013) |
| "Patients with chronic hepatitis C virus (HCV) infection who have not had a response to therapy with peginterferon and ribavirin may benefit from the addition of multiple direct-acting antiviral agents to their treatment regimen." | 5.16 | Preliminary study of two antiviral agents for hepatitis C genotype 1. ( Dimitrova, DI; Eley, T; Everson, GT; Gardiner, DF; Ghalib, R; Grasela, DM; Guo, T; Lawitz, E; Lok, AS; Martorell, C; McPhee, F; Pasquinelli, C; Persson, A; Reindollar, R; Rustgi, V; Wind-Rotolo, M; Zhu, K, 2012) |
| "Merimepodib (MMPD) is an orally administered, inosine monophosphate dehydrogenase inhibitor that has shown antiviral activity in nonresponders with chronic hepatitis C (CHC) when combined with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV)." | 5.14 | Merimepodib, pegylated interferon, and ribavirin in genotype 1 chronic hepatitis C pegylated interferon and ribavirin nonresponders. ( Aalyson, M; Afdhal, N; Alam, J; Bengtsson, L; Bonkovsky, HL; Chandorkar, G; Gharakhanian, S; Gordon, SC; Harding, M; Kauffman, R; Lawitz, E; Lee, WM; McHutchison, JG; McNair, L; Poordad, F; Rustgi, VK, 2009) |
| "While combination of peginterferon-alpha (PEG-IFN) and ribavirin (RBV) therapy is the current standard of care for chronic hepatitis C (CHC), only 44-51% of genotype-1 patients achieve a sustained virological response (SVR), and both agents produce treatment-limiting toxicities." | 5.12 | Phase 2 study of the combination of merimepodib with peginterferon-alpha2b, and ribavirin in nonresponders to previous therapy for chronic hepatitis C. ( Alam, J; Bengtsson, L; Bronowicki, JP; Garg, V; Grange, JD; Horsmans, Y; Marcellin, P; McNair, L; Nevens, F; Purdy, S; Vetter, D, 2007) |
| "The fixed-dose combination of sofosbuvir, a nucleotide analogue NS5B polymerase inhibitor, and velpatasvir, a second-generation NS5A inhibitor, has been approved by the United States Food and Drug Administration and the European Medicines Agency for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection." | 4.95 | Sofosbuvir/velpatasvir fixed-dose combination for the treatment of chronic hepatitis C virus infection. ( Nehra, V; Rizza, SA; Temesgen, Z, 2017) |
| "Ombitasvir, paritaprevir (given with low-dose ritonavir), and dasabuvir are direct-acting antivirals (DAAs) used with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) infection." | 4.95 | Effects of Mild and Moderate Renal Impairment on Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, and Ribavirin Pharmacokinetics in Patients with Chronic HCV Infection. ( Badri, PS; Eckert, D; Menon, RM; Mensing, S; Polepally, AR, 2017) |
| " 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) |
| "A systematic literature review of Phase III clinical trials identified 2 trials of SOF+R-PHOTON-1 (A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus [HCV] and Human Immunodeficiency Virus [HIV] Co-Infected Subjects) and PHOTON-2 (A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus [HCV] and Human Immunodeficiency Virus [HIV] Co-Infected Subjects) suitable for comparison with the trial of DCV+SOF in patients coinfected with HIV and HCV-ALLY-2 (A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C [Genotype 1, 2, 3, 4, 5, or 6] Subjects Coinfected With Human Immunodeficiency Virus [HIV])." | 4.93 | Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison. ( Ackerman, P; Kalsekar, A; Kelley, C; Mu, F; Peeples, M; Signorovitch, J; Song, J; Swallow, E; Yuan, Y, 2016) |
| "The objective of this study was to compare the efficacy of sofosbuvir-based treatments in patients with chronic hepatitis C virus (HCV) infection using a model-based meta-analysis (MBMA)." | 4.93 | A model-based meta-analysis of sofosbuvir-based treatments in chronic hepatitis C patients. ( Ferriols-Lisart, R; Guglieri-López, B; Merino-Sanjuán, M; Pérez-Pitarch, A, 2016) |
| "A fixed-dose tablet comprising the NS5A inhibitor ombitasvir, the NS3/4A inhibitor paritaprevir and ritonavir (ombitasvir/paritaprevir/ritonavir) (Technivie(®), Viekirax(®)) is available for use, in combination with ribavirin, for the treatment of chronic hepatitis C virus (HCV) genotype 4 infection." | 4.93 | Ombitasvir/Paritaprevir/Ritonavir: A Review in Chronic HCV Genotype 4 Infection. ( Keating, GM, 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 (ABT-267) is a potent inhibitor of the hepatitis C virus protein NS5A, has favorable pharmacokinetic characteristics and is active in the picomolar range against genotype 1 - 6." | 4.90 | Ombitasvir (ABT-267), a novel NS5A inhibitor for the treatment of hepatitis C. ( Stirnimann, G, 2014) |
| "The objective of this study was to determine the clinical relationship between proton pump inhibitor (PPI) use and sustained virologic response (SVR) in patients treated with sofosbuvir/velpatasvir (SOF/VEL) for chronic hepatitis C virus (HCV) infection." | 4.12 | Impact of proton pump inhibitors on sustained virologic response in veterans treated with sofosbuvir/velpatasvir for chronic hepatitis C virus: A retrospective cohort study. ( Jacob, DA; Kolberg, JL; Rumph, DM; Straley, CM, 2022) |
| "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) |
| "Owing to the advent of pangenotypic direct-acting antiviral agents (DAAs) for hepatitis C virus (HCV) treatment, utilization of HCV-infected deceased donor kidneys with simplified genotyping/subtyping-free sofosbuvir/velpatasvir (SOF/VEL) treatment strategy is now becoming a promising strategy for expanding the organ donor pool." | 4.12 | Utilization of HCV Viremic Kidneys with Genotyping/Subtyping-Free Sofosbuvir/Velpatasvir Treatment Strategy: Experience from China. ( Dai, H; Fang, C; Guo, Y; Hu, S; Lan, G; Liu, Q; Nie, M; Peng, F; Peng, L; Tan, L; Xie, X; Zhang, H; Zhong, M, 2022) |
| "Grazoprevir/elbasvir and glecaprevir/pibrentasvir (G/P) are the two preferred treatment options for patients with chronic hepatitis C virus (HCV) infection and a glomerular filtration rate (GFR) <30 mL/min." | 4.12 | Hepatitis C therapy with grazoprevir/elbasvir and glecaprevir/pibrentasvir in patients with advanced chronic kidney disease: data from the German Hepatitis C-Registry (DHC-R). ( Berg, T; Heyne, R; John, C; Klinker, H; Naumann, U; Niederau, C; Serfert, Y; Stein, K; Stoehr, A; Teuber, G; Wiegand, J; Zeuzem, S, 2022) |
| "Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) with or without low-dose ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI) are limited." | 4.12 | Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment. ( Chang, CC; Chang, CH; Chang, CY; Chen, CY; Chen, JJ; Chen, PY; Fang, YJ; Hsieh, TY; Huang, CS; Huang, JJ; Huang, KJ; Huang, YJ; 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; Yang, SS, 2022) |
| "Report the real-world experience of the efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in chronic hepatitis C virus (HCV) infected patients who have previously experienced a direct-acting antiviral (DAA) containing regimen." | 4.02 | Efficacy of sofosbuvir/velpatasvir/voxilaprevir in direct-acting antiviral experienced patients with hepatitis C virus. ( Da, BL; Dieterich, D; Kushner, T; Lourdusamy, V; Saberi, B, 2021) |
| "To evaluate the effect of generic sofosbuvir and daclatasvir (SOF/DCV) treatment on the glycemic state and insulin resistance as well as lipid profiles of those who achieved sustained virological response (SVR) in diabetic chronic hepatitis C virus (CHC) patients." | 4.02 | Impact of sustained virological response on metabolic disorders in diabetic chronic hepatitis C virus patients after treatment with generic sofosbuvir and daclatasvir. ( Abdel Alem, S; Abdellatif, Z; Abdo, M; Moustafa, A; Rabiee, A, 2021) |
| "In clinical trials, hepatitis C virus (HCV) salvage treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) achieved an SVR12 rate of >95% in NS5A-experienced participants." | 4.02 | Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics. ( Ahlenstiel, G; Bowden, S; Dore, GJ; Douglas, M; Doyle, J; Farrell, G; Fisher, L; George, J; Haque, M; Hazeldine, S; Hellard, M; Levy, M; MacQuillan, G; McGarity, B; New, K; O'Beirne, J; O'Keefe, J; Papaluca, T; Prewett, E; Roberts, SK; Sawhney, R; Sievert, W; Sinclair, M; Sood, S; Stoove, M; Strasser, SI; Stuart, KA; Thomas, J; Thompson, AJ; Tse, E; Valaydon, Z; Valiozis, I; Wade, AJ; Weltman, M; Wigg, A; Wilson, M; Woodward, A, 2021) |
| "There is emerging data on the use of Sofosbuvir-based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with end-stage renal disease (ESRD) on maintenance haemodialysis (MHD)." | 4.02 | Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end-stage renal disease on maintenance haemodialysis. ( De, A; Dhiman, RK; Duseja, A; Kohli, HS; Kumar, V; Mehta, M; Premkumar, M; Ramachandran, R; Ratho, RK; Singh, MP; Singh, V; Taneja, S; Verma, N, 2021) |
| "This case describes suspected P-glycoprotein (P-gp) deinduction by carbamazepine resulting in a slow viral response during treatment of chronic hepatitis C virus (HCV) infection." | 4.02 | Deinduction of P-glycoprotein resulting in delayed viral response during hepatitis C treatment. ( Cole, JL; Stark, JE, 2021) |
| "Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited." | 4.02 | Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan. ( Chang, CC; Chang, CH; Chang, CY; Chen, CY; Chen, JJ; Chen, PY; Fang, YJ; Hsieh, TY; Huang, CS; Huang, JJ; Huang, KJ; Huang, YJ; Hung, CC; 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; Yang, SS, 2021) |
| "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) |
| "The current recommendation for treating hepatitis C virus (HCV) in HIV patients includes the combination of sofosbuvir (SOF) and daclatasvir (DCV)." | 4.02 | Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus. ( Dehghan Manshadi, SA; Kalantari, S; Karimi, J; Malekzadeh, R; Malekzadeh, Z; Mardani, M; Merat, D; Merat, S; Mirminachi, B; Mohraz, M; Nikbin, M; Norouzi, A; Poustchi, H; Rasoolinejad, M; Sali, S; Sedghi, R; Sharifi, AH; Somi, MH; Tabarsi, P; Tayeri, K, 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) |
| "Sofosbuvir (SOF)/daclatasvir (DCV) is the direct-acting antiviral regimen of choice in many low- and middle-income countries for curative treatment of chronic hepatitis C virus (HCV) infection in adults, but data on the use of DCV in children are lacking." | 4.02 | Effective and Safe Daclatasvir Drug Exposures Predicted in Children Using Adult Formulations. ( Abbassi, M; Al-Nahari, M; Cressey, TR; Easterbrook, P; El-Sayed, MH; Farid, S; Indolfi, G; Lallemant, M; Penazzato, M, 2021) |
| " In 2015, three direct-acting antivirals (DAAs), simeprevir (SMV), sofosbuvir (SOF) and daclatasvir (DCV) were included in the Brazilian protocol for the treatment of chronic hepatitis C." | 3.96 | Baseline resistance associated substitutions in HCV genotype 1 infected cohort treated with Simeprevir, Daclatasvir and Sofosbuvir in Brazil. ( Aguiar, BF; Bittar, C; Campos, GRF; Marques, NN; Martinelli, ALC; Molina, BF; Pereira, LRL; Rahal, P; Rodrigues, JPV; Souza, FF, 2020) |
| "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) |
| "We conducted an observational prospective study, on 232 patients with chronic kidney disease, undergoing treatment with paritaprevir/ombitasvir/ritonavir and dasabuvir, for chronic hepatitis C infection - genotype 1b." | 3.96 | Safety and efficacy of direct-acting antivirals for chronic hepatitis C in patients with chronic kidney disease. ( Iliescu, EL; Mercan-Stanciu, A; Toma, L, 2020) |
| "Sofosbuvir plus daclatasvir with or without ribavirin has demonstrated a high efficacy and an acceptable safety profile in clinical trials of patients infected with genotype 2 hepatitis Cvirus (HCV); however, there are currently no real-world data available for this regimen." | 3.96 | Sofosbuvir-Daclatasvir is suboptimal in patients with genotype 2 chronic hepatitis C infection: real-life experience from the HEPATHER ANRS CO22 cohort. ( Bronowicki, JP; Carrat, F; Chazouillères, O; Chevaliez, S; de Lédinghen, V; Dorival, C; Fontaine, H; Larrey, D; Lusivika-Nzinga, C; Marcellin, P; Metivier, S; Pawlotsky, JM; Pol, S; Samuel, D; Tran, A; Zoulim, F, 2020) |
| "To assess the safety, efficacy, and pharmacokinetics of mini-tablet formulations of ombitasvir (OBV), paritaprevir (PTV), ritonavir, and dasabuvir (DSV) with or without ribavirin for 12 weeks in children infected with chronic hepatitis C virus (HCV) genotype (GT) 1." | 3.96 | Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Mini-Tabs Plus Ribavirin for Children Aged 3-11 Years with Hepatitis C Genotype 1a. ( Hsu, EK; Jolley, CD; Jonas, MM; Leung, DH; Liu, L; Lobritto, SJ; Molleston, JP; Narkewicz, MR; Rosenthal, P; Wen, J; Yao, BB; Zha, J, 2020) |
| "This prospective study was conducted on a real word cohort of 1562 treatment naïve chronic hepatitis C (CHC) Egyptian patients, who received 12-weeks therapy with sofosbuvir (SOF) plus daclatasvir (DCV) ± ribavirin (RBV)." | 3.96 | Morbidity and mortality during hepatitis C treatment using sofosbuvir and daclatasvir with or without ribavirin, in a cohort of Egyptian patients. ( Abdelbaser, ES; Elsadek, HM; Emara, MH; Farag, AA; Soliman, HH, 2020) |
| "In Brazil, the sofosbuvir-based therapy was introduced in the public health system (SUS) in 2015 to treat Chronic Hepatitis C (CHC)." | 3.96 | The benefits of a public pharmacist service in chronic hepattis C treatment: The real-life results of sofosbuvir-based therapy. ( Farias, MR; Foppa, AA; Gomes, LO; Rosa, JAD; Rover, MRM; Teixeira, MR, 2020) |
| " Twelve weeks long treatment with sofsobuvir, daclatasvir, ribavirin, and tenofovir resulted in sustained virological response (SVR) and cleared HBV, HCV, and HEV in diabetic and asthmatic patient." | 3.96 | Successful treatment of HBV, HCV, & HEV, with 12-week long use of tenofovir, sofosbuvir, daclatasvir, and ribavirin: A case report. ( Wahid, B, 2020) |
| "We report a case of hepatitis B virus reactivation in a Caucasian patient infected with hepatitis C virus during treatment with sofosbuvir and velpatasvir." | 3.91 | Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case r ( Andreoni, M; Aragri, M; Cerva, C; Ferrari, L; Foroghi Biland, L; Gentile, A; Malagnino, V; Salpini, R; Sarmati, L; Svicher, V; Teti, E, 2019) |
| "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) |
| "To assess the efficacy and the risk of sofosbuvir-daclatasvir treatment among kidney transplant recipients (KTRs) with chronic hepatitis C virus (HCV) infection." | 3.91 | Treatment of chronic hepatitis C viral infection with sofosbuvir and daclatasvir in kidney transplant recipients. ( Chen, J; Deng, H; Huang, H; Shen, J; Tang, H; Wu, J; Xie, W; Zhou, Q, 2019) |
| "Sofosbuvir plus daclatasvir is effective in the eradication of HCV and improvement of symptoms in patients with psoriasis having CHC infection." | 3.91 | Effect of sofosbuvir plus daclatasvir for treatment of chronic hepatitis C on patients with psoriasis. ( Ismail, WA; Yousef, AE, 2019) |
| "Ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) regimens show high efficacy and good tolerability in clinical trials for chronic hepatitis C virus (HCV) genotypes (GT) 1 or 4." | 3.91 | Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi ( Back, D; Bondin, M; Bourgeois, S; Buggisch, P; Charafeddine, M; Crown, E; Curescu, M; Dorr, P; Ferenci, P; Flisiak, R; Kleine, H; Larrey, D; Marra, F; Norris, S, 2019) |
| "The present study aimed at evaluation of changes in estimated glomerular filtration rate (eGFR) among chronic Hepatitis C virus (HCV) patients with chronic kidney disease (CKD) Stages 3-5 who were treated with 12 weeks of ritonavir-boosted paritaprevir, ombitasvir plus ribavirin." | 3.91 | Ritonavir-boosted paritaprevir, ombitasvir plus ribavirin could improve eGFR in patients with renal impairment and HCV: an Egyptian cohort. ( Dabes, H; ElSaeed, K; ElSerafy, M; ElShazly, Y; Hamed, S; Omar, H; Saad, Y; Said, M; Soliman, Z, 2019) |
| "In the current study, we aimed to assess the efficacy of different Sofosbuvir (SOF)-based antiviral regimens available in Egypt in the treatment of Pegylated interferon/Ribavirin (PEG-INF/RBV)-experienced chronic hepatitis C virus (HCV) patients." | 3.91 | Retreatment of Egyptian Chronic Hepatitis C Patients Not Responding to Pegylated Interferon and Ribavirin Dual Therapy. ( Abdelrazik, M; Aboushady, M; Alwassief, A; Elbahrawy, A; Elmestikawy, A; Shahba, H; Ziada, D, 2019) |
| " Forty chronic hepatitis C virus-infected adolescents, 12-17 years of age, were treated with sofosbuvir/daclatasvir therapy for 12 weeks." | 3.91 | Effects of Dual Sofosbuvir/Daclatasvir Therapy on Weight and Linear Growth in Adolescent Patients with Chronic Hepatitis C Virus Infection. ( AbdElgawad, MM; Abdo, AM; El-Khayat, HR; El-Shabrawi, MH; Helmy, S; Kamal, EM; Kamal, NM; Khalil, AF; Mahfouz, AA; Yakoot, M, 2019) |
| "To determine real-world effect of adding daclatasvir (DCV) to chronic hepatitis C treatment by comparing sustained viral response of sofosbuvir (SOF)/DCV±ribavirin (RBV) and SOF+RBV combination in patients with genotype 3 hepatitis C." | 3.91 | Effect of adding daclatasvir in sofosbuvir-based therapy in genotype 3 hepatitis C: real-world experience in Pakistan. ( Aleem, A; Khan, AA; Sarwar, S; Tarique, S, 2019) |
| "Based on the previously published results, 12 weeks of sofosbuvir (SOF) 400 mg/day plus ribavirin (RBV), the current direct antiviral agent regimen reimbursed by Bureau-of National-Health-Insurance (BNHI) of Taiwan for genotype-2 chronic hepatitis C (CHC), is suboptimal in efficacy, especially for difficult-to-treat subpopulations such as liver cirrhosis, previous interferon (IFN) treatment failure, and high viral-load." | 3.91 | Daclatasvir plus sofosbuvir, with or without ribavirin, is highly effective for all kinds of genotype-2 chronic hepatitis-C infection in Taiwan. ( Chu, CJ; Hou, MC; Huang, YH; Lee, FY; Lee, SD; Lin, CC; Su, CW; Wang, YJ; Wu, SH, 2019) |
| "We assessed the effectiveness and safety of sofosbuvir (SOF) combined with ledipasvir (LDV) or daclatasvir (DCV) in 12 heart transplant recipients with chronic hepatitis C virus (HCV)." | 3.88 | Sofosbuvir-based Interferon-Free Direct Acting Antiviral Regimens for Heart Transplant Recipients With Chronic Hepatitis C Virus Infection. ( Chen, DS; Chen, PJ; Chen, YS; Hong, CM; Kao, JH; Liu, CH; Liu, CJ; Su, TH; Wang, SS; Yang, HC, 2018) |
| " Food and Drug Administration (FDA) approved sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (Vosevi) fixed-dose combination (FDC), an interferon-free, complete regimen for adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing a nonstructural protein 5A (NS5A) inhibitor; and • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor." | 3.88 | Benefit-risk assessment for sofosbuvir/velpatasvir/voxilaprevir based on patient population and hepatitis C virus genotype: U. S. Food and Drug Administration's evaluation. ( Birnkrant, D; Chan-Tack, K; Naeger, LK; Qi, K; Struble, K, 2018) |
| "Subgenomic hepatitis C virus (HCV) replicons for genotype (GT) 1b, 2b, 3a, and 4a were treated with the mammalian target of rapamycin (mTOR) inhibitors everolimus and sirolimus or with the calcineurin inhibitors (CNIs) cyclosporine or tacrolimus, either alone or in combination with selected DAAs." | 3.88 | The influence of immunosuppressants on direct-acting antiviral therapy is dependent on the hepatitis C virus genotype. ( Frey, A; Gerken, G; Herzer, K; Piras-Straub, K; Timm, J; Walker, A, 2018) |
| "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) |
| "We report the first real-world prospective multicenter cohort study that evaluated the effectiveness and safety of original or generic sofosbuvir-based regimens in patients with chronic hepatitis C in Latin America." | 3.88 | Effectiveness and safety of original and generic sofosbuvir for the treatment of chronic hepatitis C: A real world study. ( Bessone, F; Borzi, SM; Cartier, M; D'Amico, C; Descalzi, VI; Fainboim, HA; Figueroa Escuti, S; Frías, S; Gadano, AC; Gaite, LA; Galdame, OA; Haddad, L; Longo, C; Marciano, S; Marino, M; Peralta, M; Perez Ravier, R; Reggiardo, MV; Vistarini, C, 2018) |
| "There is sparse data on the use of Sofosbuvir based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1." | 3.88 | Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease. ( Chawla, Y; De, A; Dhiman, RK; Duseja, A; Gupta, KL; Kohli, HS; Kumar, V; Mehta, M; Ramachandran, R; Taneja, S, 2018) |
| "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) |
| "Dual sofosbuvir/daclatasvir (SOF/DCV) therapy is currently recommended by the European Association for Study of Liver (EASL) as an option for the treatment of chronic hepatitis C virus (HCV) infection in adults for all genotypes; however, it is still not considered for patients younger than 18 years old." | 3.88 | Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients With Chronic Hepatitis C Infection. ( AbdElgawad, MM; Abdo, AM; El-Khayat, HR; El-Shabrawi, MH; Helmy, S; Mahfouz, AA; Yakoot, M, 2018) |
| " The standard-of-care for chronic hepatitis C in China is Pegylated interferon plus ribavirin (PR), which is associated with tolerability and efficacy issues." | 3.88 | Cost-effectiveness of daclatasvir plus asunaprevir for chronic hepatitis C genotype 1b treatment-naïve patients in China. ( Chang, F; Duan, CA; Jin, X; Lu, Y, 2018) |
| "A 74-year-old Japanese man with a history of chronic hepatitis C and kidney transplant (KT) was administered pegylated-interferon plus ribavirin therapy." | 3.88 | Ombitasvir-Paritaprevir-Ritonavir Therapy in a Kidney Transplant Recipient With Chronic Hepatitis C Virus Genotype 1 Infection: A Case Report on the Importance of Considering Drug-Drug Interactions and Monitoring Cyclosporine Levels. ( Hashimoto, S; Hayashi, K; Nakagawa, Y; Saito, K; Takahashi, K; Takamura, M; Takeuchi, S; Tanabe, Y; Tasaki, M; Terai, S; Tomita, Y; Yamagiwa, S; Yoshida, T, 2018) |
| " Our aim was to assess the efficacy and safety of 12 or 24 weeks of Sofosbuvir 400 mg plus Daclatasvir 60 mg, with or without ribavirin (800-1000 mg) in treating chronic hepatitis C genotype 4 patients." | 3.88 | Sofosbuvir plus Daclatasvir with or without ribavirin for treatment of chronic HCV genotype 4 patients: real-life experience. ( ElBasiony, M; Hassan, AA; Mikhail, NNH; Shiha, G; Soliman, R, 2018) |
| " We report the case of a psoriatic patient, in treatment with Etanercept, who needed to undergo HCV eradication with Daclastavir and Sofosbuvir because of worsening liver fibrosis due to chronic hepatitis C." | 3.88 | Safety and efficacy of HCV eradication during etanercept treatment for severe psoriasis. ( Di Cesare, A; Lazzeri, L; Pescitelli, L; Prignano, F; Ricceri, F; Tripo, L, 2018) |
| " 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) |
| "In this issue, Alric and colleagues demonstrate through real-world experience that grazoprevir-elbasvir is safe and effective for treating hepatitis C in advanced kidney disease patients with higher comorbidity burdens." | 3.88 | Treating hepatitis C infection in patients with advanced CKD in the real world: time to refocus on what our real treatment goals should be. ( Bloom, RD; Potluri, VS, 2018) |
| " The patients were taking sorafenib for advanced hepatocellular carcinoma and received OBV/PTV/r+DSV for 12 weeks." | 3.88 | Concomitant use of sorafenib with ombitasvir/paritaprevir/ritonavir and dasabuvir: Effectiveness and safety in clinical practice. ( Giménez-Manzorro, A; Herranz-Alonso, A; Matilla-Peña, A; Revuelta-Herrero, JL; Sanjurjo-Sáez, M, 2018) |
| "Treatment of Hepatitis C virus (HCV) in patients with severe renal insufficiency is cumbersome as sofosbuvir is mainly excreted by the kidneys." | 3.88 | Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency. ( De, A; Kumar, P; Kumari, S; Singh, A; Singh, V, 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) |
| "There is scarcity of data in literature regarding the treatment response to sofosbuvir- (SOF-) based therapies in Chinese patients with chronic Hepatitis C Virus (HCV) infection." | 3.88 | Sofosbuvir-Based Therapies for Patients with Hepatitis C Virus Infection: Real-World Experience in China. ( Chen, X; Deng, H; Hu, C; Huang, H; Li, W; Li, Y; Liu, J; Peng, Y; Ren, Y; Wu, T; Yuan, G; Zhang, YY; Zhou, Y, 2018) |
| "In study TMC647055HPC2001, a 3-direct-acting-antiviral (DAA) regimen combining NS3/4A protease inhibitor simeprevir (SMV), non-nucleoside NS5B inhibitor TMC647055/ritonavir (RTV) and NS5A inhibitor JNJ-56914845 resulted in high sustained virologic response 12 weeks after actual end of treatment (SVR12) in chronic hepatitis C virus (HCV) genotype 1-infected patients." | 3.85 | Virology analysis in HCV genotype 1-infected patients treated with the combination of simeprevir and TMC647055/ritonavir, with and without ribavirin, and JNJ-56914845. ( De Meyer, S; Thys, K; Van Remoortere, P; Vandebosch, A; Verloes, R; Vijgen, L, 2017) |
| "From March 2016 to October 2016, 374 chronic hepatitis C patients were enrolled for this prospective, observational study and received SOF, DCV with ribavirin, to evaluate the changes in liver function parameters, international normalized ratio, complete blood count, model for end-stage liver disease, and Child-Turcotte-Pugh scores after achieving a sustained virological response 12 weeks after treatment." | 3.85 | Sofosbuvir and daclatasvir plus ribavirin treatment improve liver function parameters and clinical outcomes in Egyptian chronic hepatitis C patients. ( Bassiony, MAA; Hanafy, AS; Hussein, S; Mohamed, MS, 2017) |
| "Pruritus observed during OBV/PTV/r ± DSV treatment of chronic hepatitis C is associated with increased on-treatment serum bile acid levels, possibly due to ritonavir-induced alterations of bile acid transport." | 3.85 | Anti-HCV treatment with ombitasvir/paritaprevir/ritonavir ± dasabuvir is associated with increased bile acid levels and pruritus. ( Fauler, G; Kessler, HH; Leber, B; Mangge, H; Posch, A; Rainer, F; Spindelboeck, W; Stadlbauer, V; Stauber, RE; Streit, A, 2017) |
| "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) |
| "Paritaprevir/ritonavir/ombitasvir+dasabuvir (PrOD) is a direct-acting antiviral (DAA) approved for the treatment of chronic hepatitis C virus." | 3.85 | Paritaprevir/ritonavir/ombitasvir+dasabuvir plus ribavirin therapy and inhibition of the anticoagulant effect of warfarin: a case report. ( Ashby, CR; Jankovich, RD; Jodlowski, TZ; Puglisi, GM; Smith, SM, 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) |
| "This study compared the cost-effectiveness of chronic hepatitis C virus (HCV) genotype 1b (GT1b) therapy ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) vs daclatasvir + asunaprevir (DCV/ASV) and no treatment in patients without cirrhosis." | 3.83 | Cost-effectiveness of direct-acting antiviral regimen ombitasvir/paritaprevir/ritonavir in treatment-naïve and treatment-experienced patients infected with chronic hepatitis C virus genotype 1b in Japan. ( Igarashi, A; Johnson, S; Mitchell, D; Samp, JC; Virabhak, S; Yamazaki, K; Yasui, K; Yuen, C, 2016) |
| "To evaluate the effectiveness and safety in real clinical practice of the combination of OBV/PTV/r+DSV with or without ribavirin for 12 weeks in treatment-naïve and previously treated adult patients with chronic hepatitis C virus (HCV) genotype 1 infection." | 3.83 | Effectiveness and Safety of Ombitasvir-Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin for HCV Genotype 1 Infection for 12 Weeks Under Routine Clinical Practice. ( Chamorro-de-Vega, E; Collado Borrell, R; Escudero-Vilaplana, V; Fernandez-Llamazares, CM; Gimenez-Manzorro, A; Herranz, A; Ibañez-Garcia, S; Lallana Sainz, E; Lobato Matilla, E; Lorenzo-Pinto, A; Manrique-Rodriguez, S; Marzal-Alfaro, M; Ribed, A; Rodriguez-Gonzalez, CG; Romero Jimenez, RM; Sanjurjo, M; Sarobe Gonzalez, C, 2016) |
| "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) |
| "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) |
| "Direct-acting antiviral has replaced pegylated interferon-α and ribavirin-based treatment in the treatment of chronic hepatitis C virus (HCV) infection." | 3.81 | T-cell homeostasis in chronic HCV-infected patients treated with interferon and ribavirin or an interferon-free regimen. ( Birch, C; Clausen, MR; Gaardbo, JC; Gerstoft, J; Hartling, HJ; Hove, M; Nielsen, SD; Trøseid, M; Ullum, H, 2015) |
| "The 2 direct-acting antiviral combination (2D) of ombitasvir and paritaprevir (coadministered with ritonavir) is being evaluated for the treatment of chronic hepatitis C virus infection in Japan." | 3.81 | Drug Interactions Between Hepatoprotective Agents Ursodeoxycholic Acid or Glycyrrhizin and Ombitasvir/Paritaprevir/Ritonavir in Healthy Japanese Subjects. ( Alves, K; Badri, PS; Ding, B; Dutta, S; Menon, RM; Redman, R; Rodrigues, L; Uchiyama, N; Zha, J, 2015) |
| "The efficacy of the all-oral administration of daclatasvir and asunaprevir for 24 weeks was compared with that of telaprevir for 12 weeks plus pegylated interferon and ribavirin (PEG-IFN/RBV) for 24 weeks, and that of simeprevir for 12 weeks plus PEG-IFN/RBV for 24 weeks, with a focus on the prevention of occurrence and recurrence of hepatocellular carcinoma (HCC)." | 3.81 | Comparison of Daclatasvir and Asunaprevir for Chronic HCV 1b Infection with Telaprevir and Simeprevir plus Peginterferon and Ribavirin, with a Focus on the Prevention of Occurrence and Recurrence of Hepatocellular Carcinoma. ( Hatae, T; Hayashi, Y; Imoto, S; Kim, KI; Kim, SK; Kim, SR; Kudo, M; Ohtani, A; Sugimoto, K; Tohyama, M; Yano, Y, 2015) |
| " The most common adverse events were hepatic steatosis, upper respiratory tract infection, hypercholesterolaemia, hypertriglyceridaemia, blood bilirubin increased, and total bile acids increased." | 3.11 | Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open-label, phase 2 study. ( Chen, J; Gao, H; Guan, Y; Hua, R; Huang, Y; Jiang, Y; Kong, F; Li, C; Li, G; Ma, H; Mao, X; Meng, C; Niu, J; Tan, Y; Wang, J; Wang, Z; Wen, X; Wu, Q; Xin, Y; Xiong, Q; Xu, B; Zhang, X; Zhang, Y; Zhao, L, 2022) |
| "A 12 week course of sofosbuvir-velpatasvir-voxilaprevir is safe and efficacious for the re-treatment of individuals infected with HCV genotype 4 non-a/d subtypes with frequent baseline NS5A resistance-associated substitutions, following failure of previous direct-acting antiviral treatment." | 3.11 | Safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trial. ( Camus, G; Grant, PM; Gupta, N; Kabihizi, J; Kateera, F; Makuza, JD; Manirambona, L; Mukabatsinda, C; Murangwa, A; Musabeyezu, E; Muvunyi, CM; Nsanzimana, S; Serumondo, J; Shumbusho, F, 2022) |
| "A 12-week regimen of sofosbuvir-velpatasvir is safe and efficacious in treating chronic HCV genotype 4 infection in patients in Rwanda." | 3.11 | Safety and efficacy of sofosbuvir-velpatasvir to treat chronic hepatitis C virus infection in treatment-naive patients in Rwanda (SHARED-3): a single-arm trial. ( Camus, G; Grant, PM; Gupta, N; Kabakambira, JD; Kabihizi, J; Kateera, F; Makuza, JD; Manirambona, L; Murangwa, A; Muvunyi, CM; Nsanzimana, S; Serumondo, J; Shumbusho, F; Sylvain, H, 2022) |
| " Patients from 46 centers were dosed for 12 or 24 weeks with or without ribavirin, in line with existing guidelines." | 2.94 | SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial. ( Merat, S, 2020) |
| " Drug-related adverse events occurred in 42% (n = 22) and 50% (n = 32) of participants receiving 8 and 12 weeks of treatment, respectively." | 2.94 | Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study. ( Ahmed, SNS; Alric, L; Asante-Appiah, E; Asselah, T; Bronowicki, JP; Brown, D; Guidoum, A; Haber, BA; Hagen, K; Hall, JD; Hanna, GJ; Hezode, C; Hwang, P; Larrey, D; Leroy, V; Loustaud-Ratti, V; Nguyen-Khac, E; Ozenne, V; Pol, S; Robertson, MN; Serfaty, L; Su, FH; Talwani, R; Tran, A, 2020) |
| " Pharmacokinetic similarity criteria (90% CIs lie within 70%-143% acceptance range) were used for AUC0-∞ and AUC0-72." | 2.94 | Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection. ( Abbink, EJ; Burger, DM; Colbers, A; Drenth, JPH; Pijnenburg, DWM; van Seyen, M, 2020) |
| " Adverse events (AEs) were found in less than one half of patients (45 patients, or 42." | 2.90 | [Efficacy and safety of narlaprevir/ritonavir and daclatasvir non interferon combination in population of Russian patients with chronic hepatitis C]. ( Batskikh, SN; Burnevich, EZ; Chulanov, VP; Gusev, DA; Kizlo, SN; Klimova, EA; Krasavina, EN; Mamonova, NA; Samsonov, MY; Tarkhova, EP; Yushchuk, ND; Znoyko, OO, 2019) |
| " Intensive or sparse pharmacokinetic sampling was performed for assessments of plasma drug concentrations." | 2.90 | Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients. ( Alves, K; Ding, B; Luo, Y; Menon, RM; Mobashery, N; Wang, H; Yu, C; Zha, J; Zhao, W, 2019) |
| " Three patients discontinued treatment due to adverse events (AEs) including dizziness, dyspnea, and neutropenia." | 2.90 | Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C Virus Genotype 1b Infection on Hemodialysis. ( Jang, JW; Kim, HS; Kim, JH; Kim, SB; Kim, SH; Ko, SY; Kwon, JH; Lee, BS; Lee, SH; Lee, TH; Song, DS; Song, MJ, 2019) |
| " A total of 4 serious adverse events were reported and considered treatment-unrelated." | 2.90 | Efficacy and safety of 12 weeks of daclatasvir, asunaprevir plus ribavirin for HCV genotype-1b infection without NS5A resistance-associated substitutions. ( Chen, DS; Chen, PJ; Cheng, PN; Chien, RN; Chuang, WL; Hsu, SJ; Huang, CF; Huang, JF; Huang, YH; Hung, CH; Kao, JH; Lin, CY; Liu, CH; Liu, CJ; Peng, CY; Su, CW; Yu, ML, 2019) |
| "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) |
| "To describe the phase 1 and population pharmacokinetic investigations that support dosing recommendations for elbasvir/grazoprevir (EBR/GZR) in hepatitis C virus-infected people with advanced chronic kidney disease." | 2.90 | Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment. ( Bhagunde, P; Butterton, JR; Caro, L; Du, L; Fandozzi, C; Feng, HP; Guo, Z; Iwamoto, M; Marshall, WL; Panebianco, D; Wenning, L; Yeh, WW, 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) |
| " However, ribavirin is associated with adverse events that can limit its use." | 2.90 | Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis. ( Bank, L; Bernstein, D; Epstein, M; Krishnan, P; Lucey, MR; Martinez, M; Nelson, DR; Pockros, PJ; Polepally, AR; Poordad, F; Ravendhran, N; Reindollar, R; Sedghi, S; Trinh, R; Unnebrink, K, 2019) |
| " Efficacy was defined as HCV RNA below the lower limit of detection 12 weeks after the end of treatment (SVR12), while safety endpoints included the incidence of grade 3 and 4 adverse events (AEs) following treatment, and the proportion of patients who stopped treatment prematurely due to AEs." | 2.90 | A pilot study of safety and efficacy of HCV retreatment with sofosbuvir/velpatasvir/voxilaprevir in patients with or without HIV (RESOLVE STUDY). ( Chua, J; Comstock, E; Covert, E; Emmanuel, B; Hoffmann, J; Husson, J; Kattakuzhy, S; Kottilil, S; Masur, H; Mathur, P; Price, A; Rosenthal, E; Tang, L; Wilson, E, 2019) |
| "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) |
| " The safety profile was similar across treatment arms, with adverse events tending to occur more frequently among participants receiving RBV." | 2.87 | Efficacy and safety of 12 weeks of elbasvir ± grazoprevir ± ribavirin in participants with hepatitis C virus genotype 2, 4, 5 or 6 infection: The C-SCAPE study. ( Badshah, C; Barr, E; Brown, A; Durkan, C; Foster, GR; Haber, B; Hézode, C; Lahser, F; Roberts, SK; Robertson, M; Wahl, J; Zekry, A; Zhang, B; Zuckerman, E, 2018) |
| " During the study, we did not record any serious adverse drug reaction or drug interaction and no patients discontinued the treatment." | 2.87 | Efficacy and Safety of Elbasvir-Grazoprevir Fixed Dose in the Management of Polytreated HCV Patients: Evidence From Real-Life Clinical Practice. ( Caroleo, B; Colangelo, L; De Sarro, G; Gallelli, L; Perticone, M, 2018) |
| " However, information about the rate of adverse events (AEs) across different DAA regimens is limited." | 2.87 | Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals: a clinical randomized study. ( Andersen, ES; Bukh, J; Christensen, PB; Fahnøe, U; Gerstoft, J; Kjær, MS; Laursen, AL; Mössner, B; Pedersen, MS; Røge, BT; Schønning, K; Sølund, C; Weis, N, 2018) |
| " We evaluated non-adherence (<90% adherent) as measured by electronic blister-pack assessed using logistic regression and generalised estimating equations (continuous) with detailed analyses of dosing dynamics." | 2.87 | Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use: The SIMPLIFY study. ( Amin, J; Applegate, TL; Bruggmann, P; Bruneau, J; Conway, B; Cooper, C; Cunningham, EB; Dalgard, O; Dillon, JF; Dore, GJ; Dunlop, AJ; Feld, JJ; Fraser, C; Gane, E; Grebely, J; Hajarizadeh, B; Hellard, M; Litwin, AH; Marks, P; Matthews, GV; Norton, B; Powis, J; Quiene, S; Read, P; Shaw, D; Siriragavan, S; Thurnheer, MC; Weltman, M, 2018) |
| " 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) |
| " Pharmacokinetic curves were recorded at steady-state." | 2.84 | Metformin and daclatasvir: absence of a pharmacokinetic-pharmacodynamic drug interaction in healthy volunteers. ( Aarnoutse, RE; Burger, DM; Colbers, A; de Kanter, CTMM; Drenth, JPH; Smolders, EJ; Tack, CJ; van Ewijk-Beneken Kolmer, N; Velthoven-Graafland, K; Wolberink, LT, 2017) |
| " 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) |
| " Overall, the most common adverse events were headache (55 [23%] of 240), fatigue (47 [20%] of 240), and nausea (32 [13%] of 240)." | 2.84 | Safety and efficacy of an 8-week regimen of grazoprevir plus ruzasvir plus uprifosbuvir compared with grazoprevir plus elbasvir plus uprifosbuvir in participants without cirrhosis infected with hepatitis C virus genotypes 1, 2, or 3 (C-CREST-1 and C-CREST ( Agarwal, K; Barr, E; Ben-Ari, Z; Butterton, JR; Chen, HL; Dutko, FJ; Esteban, R; Fernsler, D; Fitzgerald, B; Foster, GR; Gane, EJ; Gao, W; Gerstoft, J; Grandhi, A; Huang, HC; Laursen, AL; Li, JJ; Liu, H; Nguyen, BT; Pianko, S; Plank, RM; Roberts, SK; Robertson, MN; Su, FH; Thompson, AJ; Wahl, J; Wan, S; Yeh, WW; Zeng, Z; Zeuzem, S; Zuckerman, E, 2017) |
| " Participants with mild, moderate, or severe HI and controls (aged 18 to 65 years) matched for race, age, sex, and body mass index were enrolled in a 3-part, open-label, sequential-panel pharmacokinetic study." | 2.84 | Effect of Hepatic Impairment on the Pharmacokinetics of Grazoprevir, a Hepatitis C Virus Protease Inhibitor. ( Angus, P; Butterton, JR; Caro, L; Fandozzi, C; Fraser, IP; Gane, E; Guo, Z; Ho, M; Iwamoto, M; Marbury, T; Panebianco, D; Reitmann, C; Smith, WB; Talaty, J; Uemura, N; Wenning, L; Yeh, WW, 2017) |
| "Using data from a phase III clinical trial (GIFT-I) that enrolled Japanese patients with HCV genotype 1b infection, population pharmacokinetic models were developed for the drugs that comprise the 2D regimen: paritaprevir, ombitasvir, and ritonavir." | 2.84 | Population Pharmacokinetics of Paritaprevir, Ombitasvir, and Ritonavir in Japanese Patients with Hepatitis C Virus Genotype 1b Infection. ( Gopalakrishnan, SM; Khatri, A; Menon, RM; Mensing, S; Polepally, AR, 2017) |
| " Virological response and adverse events according to age were analyzed." | 2.84 | Safety and efficacy of dual therapy with daclatasvir and asunaprevir for older patients with chronic hepatitis C. ( Aikata, H; Chayama, K; Hiramatsu, A; Imamura, M; Kawakami, Y; Kawaoka, T; Kimura, Y; Kobayashi, T; Miki, D; Mori, N; Morio, K; Morio, R; Nagaoki, Y; Nelson Hayes, C; Ochi, H; Takahashi, S; Takaki, S; Tsuge, M; Tsuji, K; Yokoyama, S, 2017) |
| " The sustained virological response (SVR) rate after treatment and the adverse events during therapy were compared between CTR-met (patients who met the inclusion criteria) and CTR-unmet (patients who did not meet the inclusion criteria) groups." | 2.84 | The efficacy and safety of dual oral therapy with daclatasvir and asunaprevir for genotype 1b in Japanese real-life settings. ( Akuta, N; Arase, Y; Fujiyama, S; Hosaka, T; Ikeda, K; Kawamura, Y; Kobayashi, M; Kumada, H; Saitoh, S; Sezaki, H; Suzuki, F; Suzuki, Y, 2017) |
| " Most common adverse events (AEs) were fatigue, neutropenia, anemia, asthenia and headache." | 2.84 | Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. ( Ackerman, P; Berenguer, J; Cheinquer, H; Côté, P; Dieterich, D; Eley, T; Fessel, WJ; Gadano, A; Hernandez, D; Hughes, E; Lazzarin, A; Liu, Z; Matthews, G; McPhee, F; Mendez, P; Molina, JM; Moreno, C; Noviello, S; Pineda, JA; Pulido, F; Rivero, A; Rockstroh, J; Sulkowski, MS; Zakharova, N, 2017) |
| " The combination was generally well tolerated, with an adverse event profile consistent with that observed in previous clinical trials of SMV or DCV separately." | 2.84 | Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation: The Phase II SATURN study. ( Andreone, P; Berenguer, M; Calleja, JL; Cieciura, T; Donato, MF; Durlik, M; Fagiuoli, S; Forns, X; Herzer, K; Janssen, K; Jessner, W; Kalmeijer, R; Lenz, O; Mariño, Z; Ouwerkerk-Mahadevan, S; Peeters, M; Shukla, U; Sterneck, M; Verbinnen, T, 2017) |
| " Patients were randomly assigned (1:1) to receive 25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir once daily, with weight-based ribavirin dosed twice daily for either 12 weeks or 16 weeks." | 2.82 | Ombitasvir, paritaprevir, and ritonavir plus ribavirin in adults with hepatitis C virus genotype 4 infection and cirrhosis (AGATE-I): a multicentre, phase 3, randomised open-label trial. ( Asselah, T; ElKhashab, M; Feld, JJ; Ferenci, P; Hassanein, T; Hézode, C; Mobashery, N; Moreno, C; Papatheodoridis, G; Pilot-Matias, T; Qaqish, RB; Redman, R; Yu, Y; Zeuzem, S, 2016) |
| " 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) |
| " Rates of discontinuation due to adverse events (0-1% and 8-11%, respectively, p<0." | 2.82 | Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials. ( Arama, V; Campbell, A; Caruntu, FA; Conway, B; Curescu, M; Dalgard, O; Dore, GJ; Fuster, F; Ghesquiere, W; Greenbloom, S; Janczewska, E; Kapoor, M; Knysz, B; Liu, X; Liu, Y; Luo, Y; Mazur, W; Motoc, A; Podsadecki, T; Sasadeusz, J; Shaw, D; Skoien, R; Soza, A; Streinu-Cercel, A; Sullivan, D; Tornai, I, 2016) |
| " This phase 1, drug-drug interaction, open-label, multiple-dose study enrolled 32 healthy subjects to receive the 3D or 2D regimen in combination with sofosbuvir." | 2.82 | Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir. ( Awni, WM; Cohen, D; Ding, B; Dutta, S; King, JR; Menon, RM; Podsadecki, TJ, 2016) |
| " However, evening atazanavir plus ritonavir and lopinavir/ritonavir regimens are not recommended in combination with the 3D regimen." | 2.82 | Evaluation of Drug-Drug Interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HIV-1 Protease Inhibitors. ( Awni, W; Dutta, S; Khatri, A; Menon, R; Podsadecki, T; Trinh, R; Wang, H, 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) |
| " No adverse constitutional events were observed in either of the groups." | 2.82 | Safety and efficacy of dual direct-acting antiviral therapy (daclatasvir and asunaprevir) for chronic hepatitis C virus genotype 1 infection in patients on hemodialysis. ( Iio, E; Ishikawa, T; Kumada, T; Tada, T; Takaguchi, K; Tanaka, Y; Toyoda, H; Tsuji, K; Zeniya, M, 2016) |
| " Drug-drug interaction (DDI) studies of the 3D regimen and commonly used medications were conducted in healthy volunteers to provide information on coadministering these medications with or without dose adjustments." | 2.82 | Drug-Drug Interactions Between the Anti-Hepatitis C Virus 3D Regimen of Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and Eight Commonly Used Medications in Healthy Volunteers. ( Chiu, YL; Ding, B; Dumas, EO; Khatri, A; King, JR; Menon, RM; Podsadecki, TJ; Polepally, AR; Shuster, DL, 2016) |
| "Telaprevir-treated patients received 12 wk of telaprevir plus pegIFN/RBV followed by 12 (with eRVR) or 36 (no eRVR) wk of pegIFN/RBV." | 2.82 | Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1. ( Abdurakhmanov, D; Baruch, Y; Bruck, R; Diago, M; Ferenci, P; Flisiak, R; Gadano, A; Hughes, EA; Jacobson, I; Janczewska, E; Knysz, B; Kopit, J; Lueth, S; McPhee, F; Michener, T; Noviello, S; Safadi, R; Shafran, S; Thabut, D; Thompson, AJ; Yin, PD; Zarebska-Michaluk, D; Zeuzem, S; Zignego, AL, 2016) |
| "Grazoprevir (GZR) is a second-generation hepatitis C virus NS3/4A protease inhibitor." | 2.82 | Efficacy and safety of grazoprevir + ribavirin for 12 or 24 weeks in treatment-naïve patients with hepatitis C virus genotype 1 infection. ( Baruch, Y; Ben Ari, Z; Bhanja, S; Bruck, R; Gane, E; Howe, AY; Hwang, P; Mollison, L; Robertson, MN; Wahl, J; Zhao, Y; Zuckerman, E, 2016) |
| " A single 100-mg dose of EDP-239 resulted in reductions in HCV genotype 1a viral RNA of >3 log10 IU/ml within the first 48 h after dosing and reductions in genotype 1b viral RNA of >4-log10 IU/ml within 96 h." | 2.82 | Preclinical Profile and Clinical Efficacy of a Novel Hepatitis C Virus NS5A Inhibitor, EDP-239. ( Box, TD; Brasher, BB; Buggisch, P; Cao, H; Colvin, R; Jiang, L; Lawitz, E; Lin, K; McAllister, N; Or, YS; Owens, CM; Peng, X; Polemeropoulos, A; Poordad, F; Qiu, YL; Rhodin, MH; Rondon, J; Wang, C; Ying, L; Zeuzem, S, 2016) |
| " These data indicate that the 3-direct-acting-antiviral regimen can be administered with dolutegravir or abacavir plus lamivudine without dose adjustment." | 2.82 | Drug-Drug Interaction between the Direct-Acting Antiviral Regimen of Ombitasvir-Paritaprevir-Ritonavir plus Dasabuvir and the HIV Antiretroviral Agent Dolutegravir or Abacavir plus Lamivudine. ( Khatri, A; Menon, R; Podsadecki, T; Trinh, R; Zhao, W, 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) |
| " The most common adverse events were fatigue (one [17%] of six patients receiving sofosbuvir, ledipasvir, and asunaprevir; one [17%] of six patients receiving sofosbuvir, daclatasvir, and simeprevir; and two [33%] of six patients receiving sofosbuvir, daclatasvir, and asunaprevir) and headache (one [17%] patient in each group)." | 2.82 | Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study. ( Bassit, L; Benhamou, Y; Chen, G; Chen, J; Hou, J; Hsiao, HM; Ji, D; Jiang, Y; Ke, R; Lau, G; Li, B; Li, F; Li, J; Liu, J; Perelson, AS; Schinazi, RF; Shao, Q; Sun, J; Tao, S; Tsang, ST; Wang, C; Wang, Y; Wong, A; Wong, CL; Wu, V, 2016) |
| "Miravirsen is a β-D-oxy-locked nucleic acid-modified phosphorothioate antisense oligonucleotide targeting the liver-specific microRNA-122 (miR-122)." | 2.80 | In vitro antiviral activity and preclinical and clinical resistance profile of miravirsen, a novel anti-hepatitis C virus therapeutic targeting the human factor miR-122. ( Hodges, MR; Ottosen, S; Parsley, TB; Patick, AK; Raney, AK; van der Veer, E; van Doorn, LJ; Yang, L; Zeh, K, 2015) |
| "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) |
| "Observed DCV exposure increases were within the normal range of variability and were not associated with an elevated risk of adverse events." | 2.80 | Single-dose pharmacokinetics and safety of daclatasvir in subjects with renal function impairment. ( Alcorn, H; Bertz, R; Bifano, M; Garimella, T; Hwang, C; Kandoussi, H; Luo, WL; Marbury, TC; Sherman, D; Wang, R, 2015) |
| " We examined the efficacy and safety of an all-oral interferon-free regimen of ombitasvir, an NS5A inhibitor, and paritaprevir (ABT-450), an NS3/4A protease inhibitor dosed with ritonavir (ombitasvir plus paritaprevir plus ritonavir), given with or without ribavirin." | 2.80 | Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. ( Asselah, T; Berenguer, M; Fleischer-Stepniewska, K; Hall, C; Hassanein, T; Hézode, C; Marcellin, P; Mobashery, N; Pilot-Matias, T; Pol, S; Reddy, KR; Redman, R; Schnell, G; Vilchez, RA, 2015) |
| " Adverse events included eye stye, insomnia, and pain from an infiltrated intravenous line." | 2.80 | Pharmacokinetics and safety of co-administered paritaprevir plus ritonavir, ombitasvir, and dasabuvir in hepatic impairment. ( Awni, WM; Bernstein, BM; Ding, B; Dutta, S; Khatri, A; Lawitz, EJ; Marbury, TC; Menon, RM; Mullally, VM; Podsadecki, TJ, 2015) |
| " 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) |
| " GS-5816 5-150 mg for 3 days was well tolerated and resulted in rapid declines in HCV RNA that were sustained over the dosing period." | 2.80 | A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. ( Brainard, DM; Freilich, B; German, P; Han, L; Lawitz, E; Link, J; Marbury, T; McNally, J; Mo, H; Rodriguez-Torres, M, 2015) |
| " The efficacy and safety of daclatasvir combined with peginterferon alfa-2a (alfa-2a) and ribavirin were assessed in a randomized, double-blind Phase IIa study of Japanese patients with chronic HCV genotype-1 infection." | 2.79 | Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese patients infected with hepatitis C genotype 1. ( Hu, W; Hughes, EA; Ishikawa, H; Izumi, N; Kawada, N; Kumada, H; McPhee, F; Osaki, Y; Sata, M; Ueki, T; Yamamoto, K; Yokosuka, O, 2014) |
| " Daclatasvir 60 mg once daily and asunaprevir 600 mg twice daily were dosed for 7 days alone followed by combination dosing for 14 days at 30 mg once daily and 200 mg twice daily, respectively." | 2.79 | The pharmacokinetics of daclatasvir and asunaprevir administered in combination in studies in healthy subjects and patients infected with hepatitis C virus. ( Bertz, R; Bifano, M; Eley, T; Gardiner, D; Grasela, DM; He, B; Huang, SP; Kandoussi, H; Sevinsky, H; Zhu, K, 2014) |
| "Several direct-acting antivirals for chronic hepatitis C virus (HCV) infection are available, but they are limited by tolerability and dosing schedules." | 2.77 | Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. ( Abrams, GA; Bräu, N; Bronowicki, JP; Diva, U; Everson, GT; Ghalib, RH; Hernandez, D; Hézode, C; Hindes, R; Hughes, EA; Lim, JK; Martorell, C; McPhee, F; Morris, DW; Pol, S; Reindollar, RW; Rustgi, VK; Schnittman, S; Tatum, HA; Thuluvath, PJ; Wind-Rotolo, M; Yin, PD, 2012) |
| " The PK profile was supportive of once-daily dosing with median peak plasma concentrations at 1-2 hours postdose and mean terminal half-life of 12-15 hours." | 2.76 | Multiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. ( Bifano, M; Chung, E; DeMicco, MP; Fuentes, E; Gao, M; Goldwater, R; Grasela, DM; Lawitz, E; Lopez-Talavera, JC; Marbury, TC; Nettles, RE; Persson, A; Rodriguez-Torres, M; Vutikullird, A, 2011) |
| "BILN 2061 is a potent and specific inhibitor of HCV serine protease in vitro." | 2.71 | Short-term antiviral efficacy of BILN 2061, a hepatitis C virus serine protease inhibitor, in hepatitis C genotype 1 patients. ( Benhamou, Y; Calleja, JL; Chaves, RL; Crönlein, J; Erhardt, A; Forns, X; Hinrichsen, H; Nehmiz, G; Reiser, M; Sentjens, RE; Steinmann, GG; Wedemeyer, H; Yong, CL, 2004) |
| " All the studies that reported the sustained virologic response (SVR) and adverse events of DAAs in HIV/HCV co-infected patients were included." | 2.66 | Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis. ( Fan, XG; Ma, SJ; Xiong, YH; Zheng, YX, 2020) |
| "3%) reported ≥1 adverse event (AE) and 491 had AEs (28." | 2.66 | Safety and tolerability of elbasvir/grazoprevir in chronic hepatitis C virus therapy: Integrated analysis from clinical trials. ( Brown, DD; Haber, BA; Klopfer, SO; Kwo, P; Nangia, G; Reddy, KR; Robertson, MN; Vierling, JM, 2020) |
| " Daclatasvir undergoes rapid absorption, with a time to reach maximum plasma concentration of 1-2 h and an elimination half-life of ~ 10 to 14 h observed in single-ascending dose studies." | 2.58 | Daclatasvir: A Review of Preclinical and Clinical Pharmacokinetics. ( Bertz, RJ; Eley, T; Fura, A; Gandhi, Y; Garimella, T; Li, W, 2018) |
| " Expert opinion: This combination, taken orally with or without food, has an excellent pharmacokinetic and pharmacodynamic profile." | 2.58 | Pharmacodynamic and pharmacokinetic evaluation of the combination of daclatasvir/sofosbuvir/ribavirin in the treatment of chronic hepatitis C. ( Brieva, T; Frias, M; Rivero, A; Rivero-Juarez, A, 2018) |
| "Treatments for hepatitis C virus (HCV) have advanced greatly, becoming more efficacious with fewer adverse events, due to the availability of direct-acting antiviral agents, which target specific steps in the HCV life cycle." | 2.58 | Safety and efficacy of elbasvir/grazoprevir for the treatment of chronic hepatitis C: current evidence. ( Morikawa, K; Nakamura, A; Sakamoto, N; Shimazaki, T, 2018) |
| " 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) |
| " While many of the second-generation DAAs are principally metabolized by the hepatic system, dosing in severe renal impairment (creatinine clearance [CrCl] <30 mL/min) or dialysis has remained questionable due to limited experience." | 2.55 | New and Emerging Evidence on the Use of Second-Generation Direct Acting Antivirals for the Treatment of Hepatitis C Virus in Renal Impairment. ( Cope, R; Friedman, ML; Sorbera, MA, 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 pharmacokinetic characteristics of ombitasvir are similar in healthy subjects and HCV-infected patients, and are not appreciably altered by hepatic or renal impairment." | 2.55 | Clinical Pharmacokinetics of Ombitasvir. ( Badri, PS; Dutta, S; Menon, RM; Shuster, DL, 2017) |
| "The treatment of chronic hepatitis C is revolutionizing rapidly." | 2.53 | Daclatasvir-containing all-oral regimens for the treatment of hepatitis C virus infection. ( Kao, JH; Yang, SS, 2016) |
| "There has been a revolution in the treatment of chronic hepatitis C." | 2.53 | Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives. ( Asselah, T; Boyer, N; Marcellin, P; Martinot-Peignoux, M; Saadoun, D, 2016) |
| "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) |
| " While direct-acting antiviral-based regimens have been shown to be greatly superior to pegIFN/RBV-based regimens in terms of efficacy and safety, they have a greater susceptibility to drug-drug interactions (DDIs)." | 2.53 | A Review of Daclatasvir Drug-Drug Interactions. ( Bertz, R; Bifano, M; Eley, T; Garimella, T; Huang, SP; Kandoussi, H; Wang, R; You, X, 2016) |
| "Most HCV(+) patients with ESRD are genotype 1: in that setting, a recent study reported that the association of grazoprevir/elbasvir 100/50 mg/day led to a SVR of nearly 95% with very few side effects." | 2.53 | Use of direct-acting agents for hepatitis C virus-positive kidney transplant candidates and kidney transplant recipients. ( Alric, L; Kamar, N; Rostaing, L, 2016) |
| "Over the past year, interferon (IFN) free dosing regimens have become available to treat chronic hepatitis C." | 2.52 | Optimal interferon-free therapy in treatment-experienced chronic hepatitis C patients. ( Nelson, DR; Peter, J, 2015) |
| "Viral recurrence occurs in all patients with detectable serum HCV RNA at the time of transplantation leading to cirrhosis in 20-30% of patients within 5 years." | 2.52 | Management of post transplant hepatitis C in the direct antiviral agents era. ( Coilly, A; Duclos-Vallée, JC; Roche, B; Samuel, D, 2015) |
| " Daclastavir is generally safe and well tolerated, with a low barrier to resistance and low potential for drug-drug interaction." | 2.52 | Review article: the efficacy and safety of daclatasvir in the treatment of chronic hepatitis C virus infection. ( Bunchorntavakul, C; Reddy, KR, 2015) |
| " DCV + ASV had lower adverse events rates than comparators." | 2.52 | Comparative efficacy and safety of daclatasvir/asunaprevir versus IFN-based regimens in genotype 1b hepatitis C virus infection. ( Behl, AS; Betts, KA; Kalsekar, A; Li, J; Signorovitch, JE; Song, Y; Sorg, RA, 2015) |
| "With recent advances in the treatment of chronic hepatitis C, patients with elevated aminotransferase levels, detectable HCV RNA in the serum, and chronic inflammation are candidates for therapy." | 2.41 | Current and future therapies of hepatitis C. ( McHutchison, JG; Shad, JA, 2001) |
| " The most common adverse event was anemia, which was more common in group 2." | 1.91 | Efficacy and safety of ombitasvir/paritaprevir/ritonavir-based therapy in HCV patients with chronic kidney disease. ( Ammar, I; Doss, W; El Raziky, M; El-Sayed, M; Elakel, W; Elsaeed, K; Elserafy, M; Elshazly, Y; Fayad, T; Hassany, M; Korany, M; Mahrous, M; Mehrez, M; Saad, Y; Salama, R; Zaki, A, 2023) |
| " Demographic information, HCV viral load (VL), profiles of lipid and sugar, and adverse events were recorded and reviewed." | 1.72 | Real-world effectiveness and safety of sofosbuvir/velpatasvir and glecaprevir/pibrentasvir for genotype 6 chronic hepatitis C. ( Chen, JJ; Cheng, PN; Chien, SC; Chiu, HC; Chiu, YC; Lee, PL; Tung, HD, 2022) |
| " In the present study, a sensitive bioanalytical method for velpatasvir was developed using high-performance liquid chromatography coupled with a fluorescence detector system, which was applied to elucidate the factors determining the oral bioavailability and disposition of velpatasvir." | 1.72 | A simple and sensitive HPLC-FL method for bioanalysis of velpatasvir, a novel hepatitis C virus NS5A inhibitor, in rat plasma: Investigation of factors determining its oral bioavailability. ( Choi, E; Han, DG; Jung, Y; Lee, HY; Park, JE; Song, IS; Yoo, JW; Yoon, IS, 2022) |
| "HCV-infected patients can be treated well with an interferon-free SOF/DAC regimen, tolerated with generally mild adverse effects with a higher SVR." | 1.62 | Diagnostic approach to elucidate the efficacy and side effects of direct-acting antivirals in HCV infected patients. ( Alsrhani, A; Alzahrani, B; Ejaz, H; Gohar, UF; Junaid, K; Mukhtar, H; Qamar, MU; Younas, S, 2021) |
| " Retrospective analysis of the fractions of patients that achieved sustained virological response (SVR) was performed, and the incidence of adverse events was noted." | 1.62 | Effectiveness and safety of elbasvir/grazoprevir in Korean patients with hepatitis C virus infection: a nationwide real-world study. ( Chung, WJ; Jang, ES; Jeong, SH; Kim, IH; Kim, KA; Kim, YS; Lee, BS; Lee, YJ, 2021) |
| " The secondary outcome measures were SVR12 stratified by the presence of decompensated cirrhosis, prior treatment, HCC, and HIV/hepatitis C virus coinfection and the occurrence rate of serious adverse events requiring treatment cessation or hospitalization." | 1.62 | Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort. ( Ang, TL; Fock, KM; Koh, J; Kumar, LS; Kumar, R; Kwek, A; Law, NM; Lee, ZC; Li, W; Tan, J; Tan, YB; Teo, EK; Thurairajah, PH; Wong, YJ, 2021) |
| " 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) |
| "The assessment of drug-drug interaction (DDI) is important not only for safety but also for maintaining the efficacy of direct acting antivirals in chronic hepatitis C (CHC)." | 1.56 | Limited drug-drug interaction of elbasvir/grazoprevir for chronic hepatitis C. ( Cheng, PN; Liu, CJ; Lo, CC; Tseng, IH; Tseng, KC, 2020) |
| " Incidence rates of liver adverse events (LAE) were calculated; Poisson regression model was used to identify factors associated with LAE." | 1.56 | Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts. ( Bonora, S; Cingolani, A; d'Arminio Monforte, A; Lo Caputo, S; Marinaro, L; Mussini, C; Puoti, M; Rossotti, R; Saracino, A; Soria, A; Tavelli, A; Uberti-Foppa, C, 2020) |
| "This work aims to evaluate the therapeutic survey of adverse events during antiviral treatment of hepatitis in the three major University Hospitals in Abidjan." | 1.56 | Pharmacological management of adverse events during treatment of chronic viral hepatitis in three Ivorian university hospitals . ( Allah-Kouadio, E; Allouka, KCE; Gnépéhi, OB; Kohi, DS; N'guessan-Irié, AG; Siransy-Kouakou, NG, 2020) |
| " Only four patients discontinued treatment before week 4 due to non-hepatic adverse events." | 1.56 | Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study. ( Bunchorntavakul, C; Charatcharoenwitthaya, P; Chonprasertsuk, S; Komolmit, P; Piratvisuth, T; Sanpajit, T; Sethasine, S; Siripipattanamongkol, C; Sobhonslidsuk, A; Sukeepaisarnjaroen, W; Sutthivana, C; Tangkijvanich, P; Tanwandee, T; Wongpaitoon, V, 2020) |
| " This study was to evaluate the pharmacokinetic characteristics and effectiveness of daclatasvir/sofosbuvir (DAC/SOF) and ledipasvir/SOF (LDV/SOF) in HD patients." | 1.56 | Effect of Hemodialysis on Efficacy and Pharmacokinetics of Sofosbuvir Coformulated with Either Daclatasvir or Ledipasvir in Patients with End-Stage Renal Disease. ( Feng, Z; Gao, H; Huang, R; Li, Z; Liang, X; Lin, T; Liu, S; Ma, J; Wang, X; Xu, L; Zhang, L, 2020) |
| " 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) |
| " It was associated with high risk IFN-related adverse reactions due to reduced renal clearance of IFN." | 1.56 | Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease: A real-life experience. ( Abd-Elsalam, S; Abo-Amer, YE; Ahmed, R; Badawi, R; El-Abgeegy, M; Elguindy, AMA; Elkadeem, M; Elsergany, HF; Elshweikh, SA; Hawash, N; Mansour, L; Mohmed, AA; Soliman, MY; Soliman, S, 2020) |
| "SOF-based pangenotypic DAAs including SOF plus DCV and SOF plus VEL, were effective and safe for CHC patients without GT determination in this study." | 1.56 | Efficacy and safety of sofosbuvir-based pangenotypic direct-acting antiviral agents for chronic hepatitis C patients without genotype determination: Real-world experience of a retrospective study. ( Chen, EQ; Chen, XB; Jiang, W; Li, J; Tao, YC; Wang, ML; Wang, YH; Wu, DB; Xiao, GB, 2020) |
| " 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) |
| " Adverse events were reported in 185 (35." | 1.51 | Real-life effectiveness and safety of the daclatasvir/asunaprevir combination therapy for genotype 1b chronic hepatitis C patients: An emphasis on the pretreatment NS5A resistance-associated substitution test. ( Chung, WJ; Jang, ES; Jeong, SH; Kim, IH; Kim, KA; Kim, YS; Lee, BS; Lee, YJ, 2019) |
| " The last wave of DAAs is also characterized by a lesser tendency to generate or being victim of drug-drug interactions." | 1.51 | Drug-drug interactions in anti-HCV therapy: a comparison among options available in Italy. ( Cariti, G; Di Perri, G, 2019) |
| "7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision." | 1.51 | Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice - Vie-KinD study. ( Ahumada, A; Aldamiz-Echevarría, T; Baliellas, C; Barril, G; Benlloch, S; Bonet, L; Carmona, I; Castaño, MA; Castro, Á; de Álvaro, C; de Los Santos, I; Delgado, M; Devesa-Medina, MJ; García-Buey, L; García-Samaniego, J; Gea-Rodríguez, F; González-Parra, E; Gutiérrez, ML; Jiménez-Pérez, M; Laguno, M; Londoño, MC; Losa, JE; Mallolas, J; Manzanares, A; Martín-Granizo, I; Montero-Alonso, M; Montes, ML; Morán-Sánchez, S; Morano, L; Muñoz-Gómez, R; Navascués, CA; Polo-Lorduy, B; Riveiro-Barciela, M; Rivero, A; Roget, M; Serra, MÁ, 2019) |
| " As advanced age is associated with increasing risk of development of cirrhosis and hepatocellular carcinoma, elderly patients are in special need of safe and effective antiviral therapies." | 1.51 | Efficacy and safety of sofosbuvir and daclatasvir with or without ribavirin in elderly patients with chronic hepatitis C virus infection. ( Abdel-Samiee, M; Abdo, M; Elbaz, T; Esmat, G; Gamil, M; Hassan, EA; Moustafa, A; Omar, H; Qawzae, A; Zaghloul, AM, 2019) |
| " No serious adverse effects like anemia and decompensation were reported." | 1.51 | Direct-acting antiviral Therapy Is Safe and Effective in Pediatric Chronic Hepatitis C: The Public Health Perspective. ( Dhiman, RK; Duseja, A; Grover, GS; Premkumar, M; Rathi, S; Satsangi, S; Taneja, S, 2019) |
| " Combined SOF/DCV was found to be effective and safe for treating HCV Genotype 4-infected children, 8 years of age and above." | 1.51 | Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4. ( Abdel Gawad, M; Abdel Ghaffar, A; Abdel Ghaffar, TY; El Naghi, S; Helmy, S; Moafy, M; Yousef, M, 2019) |
| " SOF-based therapy was well-tolerated, and no serious adverse events were reported." | 1.51 | Safety and efficacy of sofosbuvir-based direct-acting antiviral regimens for hepatitis C virus genotype 6 in Southwest China: Real-world experience of a retrospective study. ( Chen, B; Chen, EQ; Jiang, W; Tang, H; Tao, YC; Wang, ML; Wang, YH; Wu, DB, 2019) |
| "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) |
| "Data are sparse on treatment of chronic hepatitis C virus (HCV) in cancer patients." | 1.51 | Sofosbuvir-Based Therapy in Hepatitis C Virus-Infected Cancer Patients: A Prospective Observational Study. ( Angelidakis, G; Blechacz, B; Economides, MP; Granwehr, BP; Hosry, J; Jiang, Y; Kaseb, A; Kyvernitakis, A; Mahale, P; Miller, E; Naing, A; Raad, II; Samaniego, F; Torres, HA, 2019) |
| "Limited data exist on the pharmacokinetic profile of novel direct-acting antivirals in kidney transplant recipients." | 1.51 | Pharmacokinetics of Daclatasvir, Sofosbuvir, and GS-331007 in a Prospective Cohort of Hepatitis C Virus-Positive Kidney Transplant Recipients. ( Algharably, E; Budde, K; Duerr, M; Glander, P; Halleck, F; Hoffmann, F; Jaeger, C; Kreutz, R; Lisec, J; Schrezenmeier, E; Schrezenmeier, J, 2019) |
| " The rate of discontinuation due to an adverse event was 4." | 1.51 | Real-world virological efficacy and safety of daclatasvir/asunaprevir/beclabuvir in patients with chronic hepatitis C virus genotype 1 infection in Japan. ( Chayama, K; Hiraoka, A; Imamura, M; Joko, K; Kudo, M; Kumada, H; Kumada, T; Michitaka, K; Nagano, T; Nakamuta, M; Ogawa, C; Okubo, H; Senoh, T; Shibata, H; Suzuki, Y; Tachi, Y; Tada, T; Takaguchi, K; Takaki, S; Toyoda, H; Tsuji, K; Tsutsui, A; Watanabe, T, 2019) |
| " Data on treatment outcomes and adverse events (AE) were analysed in patients with available sustained virologic response 12 weeks after cessation of treatment (SVR12) information overall and by subgroups." | 1.51 | Real-world effectiveness and safety of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir hepatitis C treatment in a single centre in Germany. ( Atanasov, PK; Buggisch, P; Lee, J; Petersen, J; Stoehr, A; Supiot, R; Ting, J; Wursthorn, K, 2019) |
| " In addition, the study was extended to evaluate the pharmacokinetic interaction between DCV and a co-prescribed antidepressant drug, fluoxetine (FLX) in real blood samples, collected from volunteering patients who were diagnosed with HCV and treated with DCV alone or combined with FLX." | 1.51 | A clinical study for the evaluation of pharmacokinetic interaction between daclatasvir and fluoxetine. ( Abdul-Rahman, E; Ali, R; Elsutohy, MM; Khorshed, A; Oraby, M, 2019) |
| " The patients were evaluated in respect of demographic, clinical and virological data, sustained virologic response (SVR) and adverse events." | 1.51 | [EFFICACY AND SAFETY OF OMBITASVIR/PARITAPREVIR/RITONAVIR AND DASABUVIR IN PATIENTS WITH HCV 1B GENOTYPE INFECTION: REAL WORLD DATA]. ( Skorokhodova, N; Tsarova, O; Zhyvytsia, D, 2019) |
| " Data were analyzed to assess the on-treatment and off-therapy HCV viral load and on-treatment adverse events." | 1.48 | Real-world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without ribavirin for patients with chronic hepatitis C virus genotype 1b infection in Taiwan. ( Chen, DS; Chen, PJ; Hong, CM; Kao, JH; Liu, CH; Liu, CJ; Su, TH; Tseng, TC; Yang, HC, 2018) |
| " The treatment of two patients (2%) was discontinued because of adverse events." | 1.48 | The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients. ( Ida, Y; Iguchi, M; Kato, J; Kawashima, A; Kitano, M; Maekita, T; Moribata, K; Nakao, T; Shimizu, R; Shingaki, N; Taki, S; Tamai, H, 2018) |
| "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) |
| "Objective Since the majority of direct-acting antivirals (DAAs) that are used in the treatment of hepatitis C virus (HCV) infection are mainly metabolized by CYP3A4, it is hypothesized that inter-individual differences in CYP3A4 activity may be associated with the bioavailability of these agents." | 1.48 | Differences in the Serum 4β-hydroxycholesterol Levels of Patients with Chronic Hepatitis C Virus (HCV) Infection: A Possible Impact on the Efficacy and Safety of Interferon (IFN)-free Treatment. ( Hirayama, T; Honda, A; Ikegami, T; Kohjima, M; Matsuzaki, Y; Miyazaki, T; Nakamuta, M; Yara, SI, 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) |
| "5%) patients (calcium channel blockers, ACE inhibitors, statins, diuretics, tacrolimus); four patients required further adjustment of antihypertensive drugs or tacrolimus dosage on-treatment." | 1.48 | Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir Regimen in the Treatment of Genotype 1 Chronic Hepatitis C Infection in Patients with Severe Renal Impairment and End-Stage Renal Disease: a Real-Life Cohort. ( Chmelova, K; Frankova, S; Kreidlova, M; Merta, D; Senkerikova, R; Sperl, J, 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) |
| " There were no severe adverse events associated with the treatment." | 1.48 | Real-world virological efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis C virus genotype 1 infection in Japan. ( Abe, H; Asano, T; Atsukawa, M; Deguchi, A; Fujioka, S; Hiraoka, A; Iio, E; Ishikawa, T; Itobayashi, E; Iwakiri, K; Kato, K; Kondo, C; Kumada, T; Masaki, T; Michitaka, K; Mikami, S; Moriya, A; Ogawa, C; Okubo, H; Okubo, T; Senoh, T; Shimada, N; Tada, T; Takaguchi, K; Tamai, H; Tanaka, Y; Tani, J; Toyoda, H; Tsubota, A; Tsuji, K; Uojima, H; Watanabe, T; Yoneyama, H, 2018) |
| " The most common adverse events recorded were fatigue, headache, nausea, asthenia, and gastrointestinal troubles." | 1.48 | Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. ( Abdel-Gabaar, M; Abdel-Moneim, A; Aboud, A; Ramadan, M; Zanaty, MI, 2018) |
| "DAA in adult dosage are safe and effective for treatment of chronic hepatitis C (genotype 3) in pediatric β-thalassemic major population." | 1.48 | Efficacy and Safety of Direct Acting Antiviral Therapy for Chronic Hepatitis C in Thalassemic Children. ( Garg, K; Gupta, GK; Maharshi, S; Nijhawan, S; Padhi, S, 2018) |
| " 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) |
| " Treatment in the post-transplantation setting may be complicated by significant drug-drug interactions between antiviral agents and standard immune suppressive treatment regimens." | 1.48 | Ombitasvir/paritaprevir/ritonavir plus dasabuvir regimen may be used safely in combination with sirolimus for the treatment of chronic hepatitis C. ( Dolman, GE; Gelson, WT; Selby, P, 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) |
| " Other correlates with adverse events of clinical importance included concomitant ribavirin treatment, sex, race, and presence of cirrhosis, consistent with previous observations." | 1.46 | Exposure-Safety Response Relationship for Ombitasvir, Paritaprevir/Ritonavir, Dasabuvir, and Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: Analysis of Data from Five Phase II and Six Phase III Studies. ( Awni, W; DaSilva-Tillmann, B; Dutta, S; Lin, CW; Liu, W; Menon, R; Podsadecki, T; Shulman, N, 2017) |
| "The risk of hepatocellular carcinoma (HCC) development is reduced following viral elimination by interferon therapy in chronic hepatitis C patients." | 1.46 | The risks of hepatocellular carcinoma development after HCV eradication are similar between patients treated with peg-interferon plus ribavirin and direct-acting antiviral therapy. ( Aikata, H; Chayama, K; Daijo, K; Fujino, H; Hatooka, M; Hayes, CN; Hiramatsu, A; Honda, F; Imamura, M; Kan, H; Kawakami, Y; Kawaoka, T; Kobayashi, T; Masaki, K; Miki, D; Morio, K; Morio, R; Nagaoki, Y; Nakahara, T; Nakamura, Y; Ochi, H; Ono, A; Teraoka, Y; Tsuge, M, 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) |
| "Our data shows that successful treatment of CHC patients with and without prior RG-101 dosing results in reduction of broad immune activation, and normalisation of miR-122 levels (EudraCT: 2014-002808-25)." | 1.46 | Immune responses in DAA treated chronic hepatitis C patients with and without prior RG-101 dosing. ( Barnes, E; Brown, A; de Vree, JML; Klenerman, P; Kootstra, NA; Reesink, HW; Sinnige, MJ; Stelma, F; Swadling, L; van der Ree, MH; van der Valk, M; van Nuenen, AC; Willemse, SB, 2017) |
| " One of the ZBDHW components, Penta-O-Galloyl-Glucose (PGG), was further analyzed for its mode of action in vitro, its antiviral activity in primary human hepatocytes as well as for its bioavailability and hepatotoxicity in mice." | 1.46 | Pentagalloylglucose, a highly bioavailable polyphenolic compound present in Cortex moutan, efficiently blocks hepatitis C virus entry. ( Alves, MP; Banda, D; Behrendt, P; Colpitts, CC; Manns, MP; Menzel, N; Meuleman, P; Perin, P; Pfaender, S; Pietschmann, T; Schang, LM; Steinmann, E; Thiel, V; Vondran, FWR, 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) |
| "New highly effective treatments for chronic hepatitis C virus (HCV) infection are now available, but safety and efficacy data on the use of anti-HCV therapies in patients with renal failure, particularly those requiring PD, remain limited." | 1.46 | Successful treatment of chronic hepatitis C virus infection in a patient receiving daily peritoneal dialysis. ( Cole, J; Stark, JE, 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) |
| " Details of serious adverse events (SAEs) were recorded." | 1.46 | Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort. ( Albillos, A; Ampuero, J; Arenas, J; Bañares, R; Calleja, JL; Crespo, J; Diago, M; Fernandez, I; García-Eliz, M; García-Samaniego, J; Gea, F; Jorquera, F; Lens, S; Llaneras, J; Llerena, S; Mariño, Z; Morillas, RM; Muñoz, R; Navascues, CA; Pascasio, JM; Perelló, C; Rincón, D; Rodriguez, CF; Ruiz-Antorán, B; Sacristán, B; Serra, MA; Simon, MA; Torras, X; Turnes, J, 2017) |
| " 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) |
| "New regimens for the treatment of chronic hepatitis C virus (HCV) genotype 3 have demonstrated substantial improvement in sustained virologic response (SVR) compared with existing therapies, but are considerably more expensive." | 1.43 | Cost-effectiveness of daclatasvir plus sofosbuvir-based regimen for treatment of hepatitis C virus genotype 3 infection in Canada. ( Goeree, R; Martel, MJ; Moshyk, A; Tahami Monfared, AA, 2016) |
| " We evaluated the 12-week sustained virologic response (SVR12) and adverse events during treatment." | 1.43 | Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C. ( Furuya, K; Horimoto, H; Izumi, T; Kimura, M; Kobayashi, T; Konno, J; Kudo, M; Morikawa, K; Nagasaka, A; Nakai, M; Natsuizaka, M; Ogawa, K; Sakamoto, N; Sato, F; Shinada, K; Sho, T; Suda, G; Tateyama, M; Terashita, K; Tsukuda, Y; Tsunematsu, S; Umemura, M; Yamamoto, Y; Yamasaki, K, 2016) |
| " Regarding safety, adverse events and serious adverse events were more frequently reported in patients taking concomitant ARAs, though baseline population differences may have played a role." | 1.43 | Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With or Without Ribavirin in HCV-Infected Patients Taking Concomitant Acid-Reducing Agents. ( Asselah, T; Bennett, M; Forns, X; Liu, L; Moller, J; Pedrosa, M; Planas Vila, R; Reau, N; Rustgi, V; Shiffman, ML, 2016) |
| " Recently, interferon-ribavirin free direct acting antivirals (DAAs) treatment has shown strong efficacy and fewer adverse events for chronic HCV infection patients without using dialysis, but there are few reports about DAAs for such patients." | 1.43 | Effect and Safety of Daclatasvir-Asunaprevir Combination Therapy for Chronic Hepatitis C Virus Genotype 1b -Infected Patients on Hemodialysis. ( Miyagi, K; Miyazaki, R, 2016) |
| " 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) |
| "HRQoL/fatigue was evaluated at baseline (BL), midway, and 12 weeks after the end of treatment (FU)." | 1.43 | Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease: A retrospective study. ( Aichelburg, MC; Bucsics, T; Chromy, D; Grabmeier-Pfistershammer, K; Mandorfer, M; Peck-Radosavljevic, M; Reiberger, T; Scheiner, B; Schwabl, P; Steiner, S; Trauner, M, 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) |
| "The patient early terminated treatment due to dengue fever but eventually achieved SVR12." | 1.43 | Four weeks of paritaprevir/ritonavir/ombitasvir plus dasabuvir encountering dengue fever resulted in sustained virological response in an HCV patient: A case report. ( Huang, CF; Jang, TY; Lu, PL; Yu, ML, 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) |
| "The future treatment of hepatitis C virus (HCV) infection will be combinations of direct-acting antivirals (DAAs) that not only target multiple viral targets, but are also effective against different HCV genotypes." | 1.42 | Prevalence of polymorphisms with significant resistance to NS5A inhibitors in treatment-naive patients with hepatitis C virus genotypes 1a and 3a in Sweden. ( Bondeson, K; Kjellin, M; Lannergard, A; Lennerstrand, J; Lindström, I; Palanisamy, N; Wesslén, L, 2015) |
| " Importantly, adjustments to the immunosuppressant dosage were not required." | 1.42 | Daclatasvir, Simeprevir and Ribavirin as a Promising Interferon-Free Triple Regimen for HCV Recurrence after Liver Transplant. ( Achterfeld, A; Canbay, A; Gerken, G; Herzer, K; Papadopoulos-Köhn, A; Paul, A; Timm, J; Walker, A, 2015) |
| " 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) |
| " Among HCV protease inhibitors, the safety, potency, and convenient dosing of simeprevir, asunaprevir, faldaprevir, and ABT-450/r were particularly highlighted." | 1.39 | Hepatitis C therapy: highlights from the 2012 annual meeting of the European Association for the Study of the Liver. ( Barreiro, P; Fernández-Montero, JV; Poveda, E; Soriano, V; Vispo, E, 2013) |
| " Overcoming antiviral resistance, broad genotype coverage, and a convenient dosing regimen are important attributes for future agents to be used in combinations without interferon." | 1.38 | MK-5172, a selective inhibitor of hepatitis C virus NS3/4a protease with broad activity across genotypes and resistant variants. ( Burlein, C; Carroll, SS; Claudio, G; Coleman, PJ; Di Filippo, M; Dimuzio, JM; Fandozzi, C; Ferrara, M; Gates, AT; Graham, DJ; Harper, S; Hazuda, DJ; Huang, Q; Liverton, NJ; Ludmerer, SW; McCauley, JA; McHale, C; Monteagudo, E; Olsen, DB; Pucci, V; Rowley, M; Rudd, MT; Soriano, A; Stahlhut, MW; Summa, V; Vacca, JP, 2012) |
| " Future investigation should address the possible hepatocarcinogenicity of pesticides using biomarkers of exposure and other techniques to better estimate dose-response relationships." | 1.33 | Associations of pesticides, HCV, HBV, and hepatocellular carcinoma in Egypt. ( Abdel-Hamid, A; Abdel-Hamid, M; Eissa, SA; El-Ghorory, L; Ezzat, S; Hifnawy, T; Labib, NA; Loffredo, CA; Mikhail, NN; Mokhtar, N; Strickland, GT, 2005) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 14 (1.68) | 29.6817 |
| 2010's | 681 (81.56) | 24.3611 |
| 2020's | 140 (16.77) | 2.80 |
| Authors | Studies |
|---|---|
| Turgeon, MK | 1 |
| Shah, SA | 1 |
| Delman, AM | 1 |
| Tran, BV | 1 |
| Agopian, VG | 1 |
| Wedd, JP | 1 |
| Magliocca, JF | 1 |
| Kim, A | 1 |
| Cameron, A | 1 |
| Olyaei, A | 1 |
| Orloff, SL | 1 |
| Anderson, MP | 1 |
| Kubal, CA | 1 |
| Cannon, RM | 1 |
| Locke, JE | 1 |
| Simpson, MA | 1 |
| Akoad, ME | 1 |
| Wongjirad, CP | 1 |
| Emamaullee, J | 1 |
| Moro, A | 1 |
| Aucejo, F | 1 |
| Feizpour, CA | 1 |
| Vagefi, PA | 1 |
| Nguyen, MH | 4 |
| Esquivel, CO | 1 |
| Dhanireddy, K | 1 |
| Subramanian, V | 1 |
| Chavarriaga, A | 1 |
| Kazimi, MM | 1 |
| Anderson, MS | 1 |
| Sonnenday, CJ | 1 |
| Kim, SC | 1 |
| Foley, DP | 1 |
| Abdouljoud, M | 1 |
| Salgia, RJ | 1 |
| Moris, D | 1 |
| Sudan, DL | 1 |
| Ganesh, SR | 1 |
| Humar, A | 1 |
| Doyle, M | 1 |
| Chapman, WC | 1 |
| Maithel, SK | 1 |
| El-Nabarawi, M | 1 |
| Nafady, M | 1 |
| Elmenshawe, S | 1 |
| Elkarmalawy, M | 1 |
| Teaima, M | 1 |
| Chang, WC | 1 |
| Chen, HW | 1 |
| Hsieh, TY | 4 |
| Lin, JC | 1 |
| El Kassas, M | 5 |
| Abdeen, N | 1 |
| Omran, D | 2 |
| Alboraie, M | 2 |
| Salaheldin, M | 1 |
| Eltabbakh, M | 1 |
| Farghaly, R | 1 |
| Emadeldeen, M | 2 |
| Afify, S | 1 |
| Sweedy, A | 1 |
| Ghalwash, A | 1 |
| Abbass, A | 1 |
| Ezzat, S | 3 |
| Tahoon, M | 1 |
| ELshazly, HM | 1 |
| Hamdy, H | 1 |
| Omar, H | 4 |
| Patel, S | 1 |
| Martin, MT | 1 |
| Flamm, SL | 5 |
| Calvaruso, V | 3 |
| Petta, S | 3 |
| Ferraro, D | 1 |
| La Mantia, C | 1 |
| Gibilaro, G | 1 |
| Reina, G | 1 |
| Di Maio, VC | 3 |
| Licata, A | 1 |
| Ceccherini-Silberstein, F | 3 |
| Di Marco, V | 2 |
| Craxì, A | 5 |
| Mastrorosa, I | 2 |
| Tempestilli, M | 2 |
| Notari, S | 2 |
| Lorenzini, P | 1 |
| Fabbri, G | 2 |
| Grilli, E | 1 |
| Bellagamba, R | 2 |
| Vergori, A | 1 |
| Cicalini, S | 1 |
| Ammassari, A | 2 |
| Agrati, C | 2 |
| Antinori, A | 3 |
| Tergast, TL | 1 |
| Kordecki, N | 1 |
| Ohlendorf, V | 1 |
| Beier, C | 1 |
| Sandmann, L | 1 |
| Wedemeyer, H | 15 |
| Cornberg, M | 7 |
| Maasoumy, B | 1 |
| Ghanm, SE | 1 |
| Shebl, NA | 1 |
| El Sayed, IET | 1 |
| Abdel-Bary, HM | 1 |
| Saad, BF | 1 |
| Othman Saad, W | 1 |
| Younas, S | 1 |
| Mukhtar, H | 1 |
| Gohar, UF | 1 |
| Alsrhani, A | 1 |
| Alzahrani, B | 1 |
| Junaid, K | 1 |
| Qamar, MU | 1 |
| Ejaz, H | 1 |
| Townshend-Bulson, L | 1 |
| Roik, E | 1 |
| Barbour, Y | 1 |
| Bruden, DJT | 1 |
| Homan, CE | 1 |
| Espera, HGF | 1 |
| Stevenson, TJ | 1 |
| Hewitt, AM | 1 |
| Rhodes, W | 1 |
| Gove, JE | 1 |
| Plotnik, JN | 1 |
| Snowball, MM | 1 |
| McGilvray, J | 1 |
| Simons, BC | 1 |
| Johnston, JM | 1 |
| McMahon, BJ | 1 |
| Lai, PC | 1 |
| Chen, CH | 4 |
| Jeng, LB | 1 |
| Yu, TM | 1 |
| Tsai, SF | 1 |
| Wu, MJ | 1 |
| Cheng, SB | 1 |
| Yang, SS | 7 |
| Lee, TY | 3 |
| Yoo, HW | 1 |
| Park, JY | 3 |
| Kim, SG | 1 |
| Jung, YK | 1 |
| Lee, SH | 4 |
| Kim, MY | 1 |
| Jun, DW | 1 |
| Jang, JY | 1 |
| Lee, JW | 1 |
| Kwon, OS | 1 |
| Hua, R | 1 |
| Kong, F | 1 |
| Wen, X | 1 |
| Xiong, Q | 1 |
| Chen, J | 4 |
| Meng, C | 1 |
| Ma, H | 1 |
| Tan, Y | 1 |
| Huang, Y | 3 |
| Jiang, Y | 3 |
| Guan, Y | 1 |
| Mao, X | 1 |
| Wang, J | 3 |
| Xin, Y | 1 |
| Gao, H | 2 |
| Xu, B | 1 |
| Li, C | 3 |
| Wu, Q | 1 |
| Zhang, X | 2 |
| Wang, Z | 2 |
| Zhao, L | 1 |
| Zhang, Y | 4 |
| Li, G | 1 |
| Niu, J | 2 |
| Indolfi, G | 2 |
| Kelly, D | 1 |
| Nebbia, G | 1 |
| Iorio, R | 1 |
| Mania, A | 1 |
| Giacomet, V | 1 |
| Szenborn, L | 1 |
| Shao, J | 2 |
| Sang Yue, M | 1 |
| Hsueh, CH | 1 |
| Parhy, B | 2 |
| Kersey, K | 2 |
| Mangia, A | 12 |
| Pawlowska, M | 1 |
| Bansal, S | 1 |
| Gupta, N | 2 |
| Manirambona, L | 2 |
| Shumbusho, F | 2 |
| Kabihizi, J | 2 |
| Murangwa, A | 2 |
| Serumondo, J | 2 |
| Makuza, JD | 2 |
| Nsanzimana, S | 2 |
| Muvunyi, CM | 2 |
| Mukabatsinda, C | 1 |
| Musabeyezu, E | 1 |
| Camus, G | 7 |
| Grant, PM | 2 |
| Kateera, F | 2 |
| Kabakambira, JD | 1 |
| Sylvain, H | 1 |
| Rumph, DM | 1 |
| Straley, CM | 1 |
| Kolberg, JL | 1 |
| Jacob, DA | 1 |
| Chen, JJ | 5 |
| Chiu, YC | 3 |
| Lee, PL | 4 |
| Tung, HD | 1 |
| Chiu, HC | 2 |
| Chien, SC | 2 |
| Cheng, PN | 5 |
| Liu, J | 3 |
| Guo, M | 1 |
| Ke, L | 1 |
| You, R | 1 |
| Evon, DM | 3 |
| Dong, M | 1 |
| Reeve, BB | 2 |
| Peter, J | 3 |
| Michael, L | 1 |
| Lok, AS | 6 |
| Nelson, DR | 13 |
| Stewart, PW | 2 |
| Sonsuz, A | 1 |
| Bozcan, S | 1 |
| Hatemi, İ | 1 |
| Özdemir, S | 1 |
| Canbakan, B | 1 |
| Yıldırım, S | 1 |
| Gültürk, İ | 1 |
| Ar, C | 1 |
| Wong, YJ | 2 |
| Kumar, R | 3 |
| Tan, J | 2 |
| Liu, CH | 9 |
| Hui, VK | 1 |
| Tan, SS | 1 |
| Kao, JH | 16 |
| Wong, GH | 1 |
| Thurairajah, PH | 2 |
| 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 | 2 |
| Iliescu, L | 1 |
| Karimi-Sari, H | 1 |
| Rezaee-Zavareh, MS | 1 |
| Falade-Nwulia, O | 1 |
| Lim, JK | 4 |
| Choi, E | 1 |
| Han, DG | 1 |
| Park, JE | 1 |
| Lee, HY | 1 |
| Yoo, JW | 1 |
| Jung, Y | 1 |
| Song, IS | 1 |
| Yoon, IS | 1 |
| Zhang, H | 1 |
| Liu, Q | 3 |
| Hu, S | 1 |
| Zhong, M | 1 |
| Peng, F | 1 |
| Guo, Y | 1 |
| Fang, C | 1 |
| Nie, M | 1 |
| Tan, L | 1 |
| Dai, H | 1 |
| Xie, X | 1 |
| Peng, L | 1 |
| Lan, G | 1 |
| Mashaal, AR | 1 |
| Abd El-Hameed, M | 1 |
| El Ray, AA | 1 |
| Mahmoud Diab, T | 1 |
| Dawood, RM | 1 |
| Shemis, MA | 1 |
| Seyam, M | 1 |
| El-Sayed, M | 1 |
| Elserafy, M | 2 |
| El Raziky, M | 1 |
| Elakel, W | 2 |
| Saad, Y | 2 |
| Fayad, T | 1 |
| Korany, M | 3 |
| Mehrez, M | 1 |
| Salama, R | 1 |
| Mahrous, M | 1 |
| Zaki, A | 1 |
| Hassany, M | 5 |
| Ammar, I | 2 |
| Elsaeed, K | 4 |
| Elshazly, Y | 3 |
| Doss, W | 7 |
| Degasperi, E | 5 |
| 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 | 7 |
| Vinci, M | 1 |
| Gatti, F | 1 |
| Carolo, G | 1 |
| Zoncada, A | 1 |
| Bonfanti, P | 1 |
| Russo, FP | 1 |
| Aghemo, A | 9 |
| Soria, A | 2 |
| Centenaro, R | 1 |
| Maggiolo, F | 1 |
| Rovere, P | 1 |
| Pasin, F | 1 |
| Paon, V | 1 |
| Faggiano, G | 1 |
| Vario, A | 1 |
| Grossi, G | 1 |
| Soffredini, R | 1 |
| Carriero, C | 1 |
| Paolucci, S | 4 |
| Noventa, F | 1 |
| Alberti, A | 4 |
| Lampertico, P | 6 |
| Fagiuoli, S | 4 |
| Jang, ES | 2 |
| Kim, KA | 2 |
| Kim, YS | 2 |
| Kim, IH | 2 |
| Lee, BS | 3 |
| Lee, YJ | 6 |
| Chung, WJ | 3 |
| Jeong, SH | 2 |
| Pérez, AB | 1 |
| Chueca, N | 1 |
| Macías, J | 1 |
| Pineda, JA | 2 |
| Salmerón, J | 3 |
| Rivero-Juárez, A | 2 |
| Hidalgo-Tenorio, C | 1 |
| Espinosa, MD | 1 |
| Téllez, F | 2 |
| Von-Wichmann, MÁ | 2 |
| Omar, M | 1 |
| Santos, J | 2 |
| Hernández-Quero, J | 1 |
| Antón, JJ | 1 |
| Collado, A | 1 |
| Lozano, AB | 1 |
| García-Deltoro, M | 1 |
| Casado, M | 1 |
| Pascasio, JM | 5 |
| Selfa, A | 1 |
| Rosales, JM | 2 |
| De la Iglesia, A | 1 |
| Arenas, JI | 1 |
| García-Bujalance, S | 1 |
| Ríos, MJ | 1 |
| Bernal, E | 1 |
| Martínez, O | 1 |
| García-Herola, A | 1 |
| Vélez, M | 1 |
| Rincón, P | 1 |
| García, F | 2 |
| Merli, M | 2 |
| Rossotti, R | 2 |
| Travi, G | 1 |
| Ferla, F | 1 |
| Lauterio, A | 1 |
| Angelini Zucchetti, T | 1 |
| Alcantarini, C | 1 |
| Bargiacchi, O | 1 |
| De Carlis, L | 1 |
| Merat, S | 2 |
| Aguiar, BF | 1 |
| Campos, GRF | 1 |
| Rodrigues, JPV | 1 |
| Marques, NN | 1 |
| Molina, BF | 1 |
| Bittar, C | 1 |
| Souza, FF | 1 |
| Martinelli, ALC | 1 |
| Rahal, P | 1 |
| Pereira, LRL | 1 |
| Foroghi Biland, L | 1 |
| Ferrari, L | 1 |
| Malagnino, V | 1 |
| Teti, E | 1 |
| Cerva, C | 1 |
| Gentile, A | 1 |
| Aragri, M | 1 |
| Salpini, R | 1 |
| Svicher, V | 1 |
| Andreoni, M | 1 |
| Sarmati, L | 1 |
| Di Perri, G | 8 |
| Cariti, G | 7 |
| Londoño, MC | 6 |
| Riveiro-Barciela, M | 4 |
| Ahumada, A | 1 |
| Muñoz-Gómez, R | 1 |
| Roget, M | 1 |
| Devesa-Medina, MJ | 1 |
| Serra, MÁ | 2 |
| Navascués, CA | 2 |
| Baliellas, C | 1 |
| Aldamiz-Echevarría, T | 2 |
| Gutiérrez, ML | 1 |
| Polo-Lorduy, B | 2 |
| Carmona, I | 2 |
| Benlloch, S | 1 |
| Bonet, L | 1 |
| García-Samaniego, J | 3 |
| Jiménez-Pérez, M | 1 |
| Morán-Sánchez, S | 2 |
| Castro, Á | 1 |
| Delgado, M | 4 |
| Gea-Rodríguez, F | 1 |
| Martín-Granizo, I | 2 |
| Montes, ML | 1 |
| Morano, L | 2 |
| Castaño, MA | 1 |
| de Los Santos, I | 1 |
| Laguno, M | 1 |
| Losa, JE | 1 |
| Montero-Alonso, M | 1 |
| Rivero, A | 3 |
| de Álvaro, C | 1 |
| Manzanares, A | 2 |
| Mallolas, J | 3 |
| Barril, G | 1 |
| González-Parra, E | 1 |
| García-Buey, L | 2 |
| Abdelaty, LN | 1 |
| Elnaggar, AA | 1 |
| Said, AA | 1 |
| Hussein, RRS | 1 |
| Saito, Y | 2 |
| Imamura, M | 16 |
| Uchida, T | 2 |
| Osawa, M | 4 |
| Teraoka, Y | 3 |
| Fujino, H | 2 |
| Nakahara, T | 5 |
| Ono, A | 3 |
| Murakami, E | 5 |
| Kawaoka, T | 8 |
| Miki, D | 9 |
| Tsuge, M | 11 |
| Serikawa, M | 1 |
| Aikata, H | 11 |
| Abe-Chayama, H | 1 |
| Hayes, CN | 11 |
| Chayama, K | 34 |
| Wiegand, J | 2 |
| Buggisch, P | 8 |
| Mauss, S | 3 |
| Boeker, KHW | 1 |
| Klinker, H | 5 |
| Müller, T | 1 |
| Günther, R | 1 |
| Serfert, Y | 3 |
| Manns, MP | 11 |
| Zeuzem, S | 36 |
| Berg, T | 8 |
| Hinrichsen, H | 7 |
| C-Registry, GH | 1 |
| Liu, CJ | 10 |
| Tseng, KC | 4 |
| Lo, CC | 4 |
| Tseng, IH | 1 |
| Kim, JW | 1 |
| Costa, VD | 1 |
| Pellegrini, P | 1 |
| Rotman, V | 1 |
| Pittella, AM | 1 |
| Nunes, EP | 2 |
| Lago, BV | 1 |
| Lampe, E | 1 |
| Mello, FCA | 1 |
| Cursino, CN | 1 |
| Monteiro, PGO | 1 |
| Duarte, GDS | 1 |
| Vieira, TBQ | 1 |
| Crisante, VC | 1 |
| Giordani, F | 1 |
| Xavier, AR | 1 |
| de Almeida, RMVR | 1 |
| Calil-Elias, S | 1 |
| Manuel Sousa, J | 1 |
| Vergara, M | 1 |
| Pulido, F | 2 |
| Sánchez Antolín, G | 1 |
| Hijona, L | 1 |
| Carnicer, F | 1 |
| Rincón, D | 2 |
| Mateos-Muñoz, B | 1 |
| Jou, A | 1 |
| Rubín, Á | 1 |
| Escarda, A | 1 |
| Aguilar, P | 1 |
| Carrión, JA | 4 |
| Hernández-Guerra, M | 2 |
| Chimeno-Hernández, S | 1 |
| Espinosa, N | 1 |
| Morillas, RM | 5 |
| Andrade, RJ | 1 |
| Gallego, A | 2 |
| Magaz, M | 1 |
| Moreno-Planas, JM | 1 |
| Estébanez, Á | 1 |
| Rico, M | 1 |
| Menéndez, F | 1 |
| Sampedro, B | 1 |
| Izquierdo, S | 1 |
| Zozaya, JM | 1 |
| Rodríguez, M | 1 |
| Lorente, S | 1 |
| Nagaty, A | 1 |
| Helmy, SH | 1 |
| Abd El-Wahab, EW | 1 |
| Zarębska-Michaluk, D | 5 |
| Jaroszewicz, J | 3 |
| Buczyńska, I | 2 |
| Simon, K | 4 |
| Lorenc, B | 2 |
| Tudrujek-Zdunek, M | 2 |
| Tomasiewicz, K | 4 |
| Sitko, M | 2 |
| Garlicki, A | 4 |
| Janczewska, E | 8 |
| Dybowska, D | 2 |
| Halota, W | 3 |
| Pawłowska, M | 1 |
| Pabjan, P | 1 |
| Mazur, W | 3 |
| Czauż-Andrzejuk, A | 2 |
| Berak, H | 4 |
| Horban, A | 3 |
| Socha, Ł | 2 |
| Klapaczyński, J | 1 |
| Piekarska, A | 4 |
| Blaszkowska, M | 1 |
| Belica-Wdowik, T | 2 |
| Dobracka, B | 1 |
| Tronina, O | 4 |
| Deroń, Z | 2 |
| Białkowska-Warzecha, J | 2 |
| Laurans, Ł | 2 |
| Flisiak, R | 11 |
| Asselah, T | 19 |
| Pol, S | 22 |
| Hezode, C | 29 |
| Loustaud-Ratti, V | 5 |
| Leroy, V | 8 |
| Ahmed, SNS | 1 |
| Ozenne, V | 1 |
| Bronowicki, JP | 14 |
| Larrey, D | 8 |
| Tran, A | 7 |
| Alric, L | 6 |
| Nguyen-Khac, E | 2 |
| Robertson, MN | 11 |
| Hanna, GJ | 1 |
| Brown, D | 1 |
| Asante-Appiah, E | 3 |
| Su, FH | 3 |
| Hwang, P | 13 |
| Hall, JD | 1 |
| Guidoum, A | 1 |
| Hagen, K | 1 |
| Haber, BA | 3 |
| Talwani, R | 4 |
| Serfaty, L | 12 |
| Cheema, SUR | 1 |
| Rehman, MS | 1 |
| Hussain, G | 1 |
| Cheema, SS | 1 |
| Gilani, N | 1 |
| Abdelkawy, KS | 1 |
| El-Haggar, SM | 1 |
| Ziada, DH | 1 |
| Ebaid, NF | 1 |
| El-Magd, MA | 1 |
| Elbarbry, FA | 1 |
| Ohya, K | 2 |
| Morio, K | 5 |
| Yamauchi, M | 1 |
| Hiramatsu, A | 4 |
| Ramirez, S | 3 |
| Fernandez-Antunez, C | 1 |
| Mikkelsen, LS | 1 |
| Pedersen, J | 2 |
| Li, YP | 2 |
| Bukh, J | 4 |
| Choi, DT | 1 |
| Puenpatom, A | 1 |
| Yu, X | 1 |
| Erickson, KF | 1 |
| Kanwal, F | 1 |
| El-Serag, HB | 1 |
| Kramer, JR | 1 |
| Rabaan, AA | 1 |
| Al-Ahmed, SH | 1 |
| Bazzi, AM | 1 |
| Alfouzan, WA | 1 |
| Alsuliman, SA | 1 |
| Aldrazi, FA | 1 |
| Haque, S | 1 |
| Zappulo, E | 2 |
| Scotto, R | 3 |
| Buonomo, AR | 3 |
| Maraolo, AE | 1 |
| Pinchera, B | 2 |
| Gentile, I | 3 |
| Holmes, JA | 1 |
| Chung, RT | 4 |
| Cordie, A | 2 |
| Elsharkawy, A | 3 |
| Abdel Alem, S | 2 |
| Meshaal, S | 1 |
| El Akel, W | 4 |
| Abdellatif, Z | 3 |
| Kamal, W | 1 |
| Al Askalany, M | 1 |
| Kamel, S | 1 |
| Abdel Aziz, H | 1 |
| Kandeel, A | 1 |
| Esmat, G | 11 |
| Mogul, A | 1 |
| Teixeira, E | 1 |
| McAuliffe, L | 1 |
| Promrat, K | 1 |
| Zullo, AR | 1 |
| Iliescu, EL | 1 |
| Mercan-Stanciu, A | 1 |
| Tavelli, A | 1 |
| Bonora, S | 1 |
| Cingolani, A | 1 |
| Lo Caputo, S | 2 |
| Saracino, A | 2 |
| Marinaro, L | 1 |
| Uberti-Foppa, C | 2 |
| Mussini, C | 1 |
| d'Arminio Monforte, A | 1 |
| Tatar, B | 1 |
| Köse, Ş | 1 |
| Ergun, NC | 1 |
| Turken, M | 1 |
| Onlen, Y | 1 |
| Yılmaz, Y | 1 |
| Akhan, S | 1 |
| Patel, SV | 1 |
| Jayaweera, DT | 1 |
| Althoff, KN | 1 |
| Eron, JJ | 1 |
| Radtchenko, J | 1 |
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| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| 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) | ||
| 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 | |||
| A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C[NCT04070235] | Phase 2/Phase 3 | 440 participants (Anticipated) | Interventional | 2019-03-29 | Active, not recruiting | ||
| Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)[NCT03888729] | Phase 4 | 100 participants (Anticipated) | Interventional | 2019-08-26 | Recruiting | ||
| THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders[NCT02786537] | Phase 4 | 1,275 participants (Actual) | Interventional | 2016-06-30 | Completed | ||
| [NCT03200184] | Phase 4 | 1,448 participants (Actual) | Interventional | 2016-09-01 | Completed | ||
| The Real World Analysis of Drug-Drug Interactions of Grazoprevir/Elbasvir in Treatment of Chronic Hepatitis C Patients in Taiwan[NCT03706222] | 400 participants (Actual) | Observational | 2018-10-22 | Completed | |||
| A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects With Chronic Hepatitis C Virus (HCV) Genotype 4 Infection[NCT03111108] | Phase 4 | 117 participants (Actual) | Interventional | 2017-06-20 | Completed | ||
| Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet[NCT03389061] | Phase 4 | 0 participants (Actual) | Interventional | 2018-04-01 | Withdrawn (stopped due to Lack of patients who are eligible for inclusion: less patients on treatment and not using epclusa.) | ||
| Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis[NCT02992457] | Phase 4 | 10,000 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| 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.) | ||
| An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4[NCT02486406] | Phase 2/Phase 3 | 64 participants (Actual) | Interventional | 2015-10-28 | Completed | ||
| Bioequivalence Study of CRUshed ElbaSvir/GrAzoprevir compareD to the wholE Tablet (CRUSADE-2)/Hep-NED005[NCT03817619] | Phase 1 | 11 participants (Actual) | Interventional | 2019-03-28 | Completed | ||
| Efficacy of a Fixed-Dose Combination Pill of Sofosbuvir and Daclatasvir in Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus[NCT03369327] | Phase 3 | 232 participants (Actual) | Interventional | 2017-01-01 | Completed | ||
| Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study[NCT03949764] | Phase 4 | 374 participants (Actual) | Interventional | 2019-09-23 | Active, not recruiting | ||
| Use of a Patient-Centered Electronic App to Increase Emergency Department Patient's Knowledge on HCV Infection, Disease Progression, and Care to Improve the HCV Care Continuum[NCT04162938] | 308 participants (Anticipated) | Interventional | 2022-03-24 | Recruiting | |||
| The Patient-Reported Outcomes Project of HCV-TARGET (PROP UP)[NCT02601820] | 1,601 participants (Actual) | Observational | 2015-11-30 | 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 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subje[NCT02607800] | Phase 3 | 943 participants (Actual) | Interventional | 2015-11-16 | 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 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infect[NCT02639338] | Phase 3 | 220 participants (Actual) | Interventional | 2015-12-23 | Completed | ||
| 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 | ||
| A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)[NCT02265237] | Phase 3 | 184 participants (Actual) | Interventional | 2014-10-28 | 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 | ||
| An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)[NCT02582632] | Phase 3 | 166 participants (Actual) | Interventional | 2015-11-24 | Completed | ||
| A Drug-drug Interaction Study Between the Novel Anti-hepatitis c Virus (HCV) Agent Daclatasvir and The Antidiabetic Agent Metformin in Healthy Volunteers[NCT02565862] | Phase 1 | 20 participants (Actual) | Interventional | 2016-01-31 | Completed | ||
| A Phase IIa, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of a 12 Weeks Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Chronic Genotype 1 Hepatit[NCT01724086] | Phase 2 | 90 participants (Actual) | Interventional | 2012-10-31 | 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 | ||
| 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 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 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 | |||
| An Open-label, 3-Part, Multiple Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172)[NCT01390428] | Phase 1 | 50 participants (Actual) | Interventional | 2011-07-28 | 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 | ||
| Expression of Inflammasomes in HCV Patients Before and After Treatment[NCT04244383] | Phase 4 | 50 participants (Anticipated) | Interventional | 2020-01-31 | Not yet recruiting | ||
| Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir[NCT02647632] | Phase 2 | 26 participants (Actual) | Interventional | 2016-01-31 | 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 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 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 | ||
| A Phase II, Open-label, Single Arm, Multicentre, International Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use[NCT02336139] | Phase 2 | 103 participants (Actual) | Interventional | 2016-03-16 | 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 | ||
| Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs[NCT04943588] | 25,000 participants (Anticipated) | Observational [Patient Registry] | 2021-11-01 | 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 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)[NCT02604017] | Phase 3 | 703 participants (Actual) | Interventional | 2015-10-31 | Completed | ||
| A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in Adults With Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)[NCT02640157] | Phase 3 | 506 participants (Actual) | Interventional | 2015-12-31 | 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 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 | |||
| Efficacy of Ombitasvir With Paritaprevir/Ritonavir Plus Ribavirin on the Treatment naïve Patients With Chronic Hepatitis C Virus Genotype 4[NCT04378608] | Phase 1/Phase 2 | 100 participants (Actual) | Interventional | 2017-01-05 | Completed | ||
| Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients[NCT04391985] | Phase 1/Phase 2 | 113 participants (Actual) | Interventional | 2017-03-01 | Completed | ||
| A Sofosbuvir-based Quadruple Regimen is Highly Effective in HCV Type 4-infected Egyptian Patients With DAA Treatment Failure[NCT04387539] | Phase 1/Phase 2 | 94 participants (Actual) | Interventional | 2017-03-01 | Completed | ||
| Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4[NCT04387526] | Phase 2/Phase 3 | 946 participants (Actual) | Interventional | 2016-04-01 | Completed | ||
| A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant[NCT02781571] | Phase 2 | 79 participants (Actual) | Interventional | 2016-07-27 | 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 | ||
| Randomized Clinical Trial to Assess the Effectiveness of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1 (TNT-1 Study)[NCT02624063] | Phase 4 | 121 participants (Actual) | Interventional | 2015-12-31 | Completed | ||
| An Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Treatment-Naïve and Treatment-Experienced Asian Adults With GT1b Chronic Hepatitis C Virus (HCV) In[NCT02517528] | Phase 3 | 104 participants (Actual) | Interventional | 2015-07-20 | Completed | ||
| Multiple-Dose Pharmacokinetics, Safety and Tolerability of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects[NCT02534870] | Phase 1 | 18 participants (Actual) | Interventional | 2015-09-30 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepa[NCT02517515] | Phase 3 | 650 participants (Actual) | Interventional | 2015-07-31 | Completed | ||
| The Puglia HCV Micro-elimination in People With Substance Use Disorders[NCT03923595] | 231 participants (Actual) | Observational | 2019-07-30 | Completed | |||
| A Phase III, Multi-center, Open-label Trial to Investigate the Impact of a Treat, Counsel and Cure Strategy in Men Who Have Sex With Men With Hepatitis C Infection in the Swiss HIV Cohort Study[NCT02785666] | Phase 3 | 150 participants (Actual) | Interventional | 2016-06-30 | 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 | |||
| Evaluation of the Clinical Effects of Ombitasvir/Paritaprevir/Ritonavir Regimen in the Treatment of Chronic HCV Patients in CKD Versus ESRD Patients in Assiut University Hospital[NCT03341988] | Phase 1 | 100 participants (Actual) | Interventional | 2017-11-22 | Completed | ||
| Direct Acting Antiviral Agent (DAA) Therapy Is Safe and Efficacious in Pediatric Patients With Chronic Hepatitis C: Real World Data From the Public Health Perspective[NCT03481036] | 100 participants (Anticipated) | Interventional | 2016-06-18 | Recruiting | |||
| 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 | ||
| The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure[NCT02580474] | Phase 4 | 21 participants (Actual) | Interventional | 2016-02-29 | 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 | ||
| An Open-Label Study to Investigate the Pharmacokinetics of MK-5172 and MK-8742 in Subjects With Renal Insufficiency[NCT01937975] | Phase 1 | 24 participants (Actual) | Interventional | 2013-09-06 | Completed | ||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Kuwait[NCT02798315] | 40 participants (Actual) | Observational | 2016-05-25 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in France[NCT02618928] | 735 participants (Actual) | Observational | 2015-12-15 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Austria (REAL)[NCT02582658] | 173 participants (Actual) | Observational | 2015-10-06 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Colombia (outCome)[NCT02851069] | 66 participants (Actual) | Observational | 2017-02-23 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C - An Observational Study in Israel (CITRINE STUDY)[NCT02803138] | 256 participants (Actual) | Observational | 2016-07-07 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Romania[NCT02807402] | 522 participants (Actual) | Observational | 2016-07-14 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)[NCT02615145] | 472 participants (Actual) | Observational | 2015-12-03 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary - VERITAS[NCT02636608] | 244 participants (Actual) | Observational | 2015-11-27 | Completed | |||
| Real World Evidence (RWE) of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Poland (HCV RWE PMOS)[NCT02640547] | 394 participants (Actual) | Observational | 2015-11-26 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium[NCT02581163] | 314 participants (Actual) | Observational | 2015-10-07 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland[NCT02582671] | 101 participants (Actual) | Observational | 2015-11-05 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Canada (AMBER)[NCT02581189] | 565 participants (Actual) | Observational | 2015-10-13 | Completed | |||
| Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C - An Observational Study in Greece[NCT02725866] | 216 participants (Actual) | Observational | 2016-04-05 | 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 | ||
| An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)[NCT02609659] | Phase 3 | 105 participants (Actual) | Interventional | 2015-10-28 | 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 | ||
| An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection[NCT02346721] | Phase 3 | 111 participants (Actual) | Interventional | 2015-02-23 | 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 Randomized, Double Blind, Single Dose, Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805 in Healthy Adult Volunteers[NCT01424540] | Phase 1 | 20 participants (Actual) | Interventional | 2011-09-01 | Completed | ||
| Double-Blind, Randomized, Placebo-Controlled Study to Assess Safety, Efficacy, and Pharmacokinetics (PK) of GSK2336805 in Combination With Peginterferon and Ribavirin in Treatment-naive Chronic Hepatitis C Subjects With Hepatitis C Virus Genotypes 1 or 4[NCT01439373] | Phase 2 | 16 participants (Actual) | Interventional | 2011-07-07 | Completed | ||
| Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With He[NCT01455090] | Phase 2 | 320 participants (Actual) | Interventional | 2011-11-30 | Completed | ||
| Neuropsychiatric Adverse Effects in Patients With Chronic Hepatitis C Treated by Direct Acting Antiviral Drugs[NCT03268317] | 100 participants (Anticipated) | Observational | 2018-01-31 | Not yet recruiting | |||
| Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1,[NCT01359644] | Phase 2 | 350 participants (Actual) | Interventional | 2011-06-30 | Completed | ||
| Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT)[NCT02478229] | Phase 3 | 1 participants (Actual) | Interventional | 2015-06-30 | Terminated (stopped due to difficulty recruiting patients) | ||
| 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 | ||
| Association of Serum Interleukin -6 and Transforming Growth Factor Beta Levels With Response to Antiviral Therapy for Chronic Hepatitis c Patients[NCT03882307] | Early Phase 1 | 40 participants (Anticipated) | Interventional | 2022-10-31 | Recruiting | ||
| Evaluation of Quality of Life, Neurocognitive Performance, Fatigue, and Emotional State in HCV Patients Before, During, and in the (Long-term) Follow-up of an IFN-free Antiviral Therapy[NCT02469012] | 30 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting | |||
| A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatm[NCT01464827] | Phase 2 | 580 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
| A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects[NCT01508156] | Phase 1/Phase 2 | 130 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection[NCT01016912] | Phase 2 | 51 participants (Actual) | Interventional | 2009-12-31 | 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 Daclatasvir Plus Asunaprevir Treatment in Patients With Chronic Hepatitis C : Prospective Cohort Study[NCT02639585] | Phase 4 | 32 participants (Anticipated) | Interventional | 2015-12-31 | Recruiting | ||
| A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C V[NCT01715415] | Phase 3 | 395 participants (Actual) | Interventional | 2012-11-30 | Completed | ||
| A Multicenter, Open-label Study of Harvoni ® (Sofosbuvir Ledipasvir Fixed Dose Combination) in Subjects Infected With Chronic Hepatitis C and Advanced Heart Failure or Lung Disease[NCT02858180] | Phase 4 | 15 participants (Actual) | Interventional | 2016-12-31 | Completed | ||
| A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus [NCT01716585] | Phase 3 | 636 participants (Actual) | Interventional | 2012-11-30 | 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 | ||
| A Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naive Adults With Genotype 1b Chronic Hepatitis [NCT01767116] | Phase 3 | 419 participants (Actual) | Interventional | 2012-12-31 | Completed | ||
| A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1a Chronic Hepatitis [NCT01833533] | Phase 3 | 305 participants (Actual) | Interventional | 2013-03-31 | 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 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 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection[NCT01125189] | Phase 2 | 558 participants (Actual) | Interventional | 2010-07-31 | Completed | ||
| A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection[NCT01257204] | Phase 2 | 196 participants (Actual) | Interventional | 2010-12-31 | Completed | ||
| A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (Miravirsen) Administered to Treatment-Naïve Subjects With Chronic Hepatitis C (CHC)[NCT01200420] | Phase 2 | 38 participants (Actual) | Interventional | 2010-09-30 | Completed | ||
| Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 With ABT-333 and With or Without RBV in HCV Genotype 1 and ABT-450/r/ABT-267 With RBV in HCV GT4-Infected Adult Liver or Renal Transplant Recipie[NCT01782495] | Phase 2 | 129 participants (Actual) | Interventional | 2013-02-25 | 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 | ||
| The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4[NCT03080415] | Phase 3 | 40 participants (Actual) | Interventional | 2017-03-18 | Completed | ||
| Single Dose Pharmacokinetics and Safety of Daclatasvir in Subjects With Renal Function Impairment[NCT01830205] | Phase 1 | 58 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4[NCT02772744] | 250 participants (Anticipated) | Observational | 2017-11-01 | Not yet recruiting | |||
| A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C G[NCT01573351] | Phase 3 | 398 participants (Actual) | Interventional | 2012-05-31 | 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 | ||
| An Open-label, Single-Arm, Phase 2 Study to Evaluate the Combination of ABT-450/r/ABT-267 and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Hepatitis C Virus (HCV) Infection Taking Methadone or Buprenorphine[NCT01911845] | Phase 2 | 38 participants (Actual) | Interventional | 2013-04-30 | 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.) | ||
| 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 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C[NCT01979939] | Phase 3 | 416 participants (Actual) | Interventional | 2013-12-31 | Completed | ||
| 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 | ||
| Pilot Study to Assess the Efficacy and Tolerance to a QUadruple Therapy With Asunaprevir , Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a, in HIV-HCV Genotype 1 or 4 Coinfected Patients Previously Null Responders to a Standard Pegylated Interfer[NCT01725542] | Phase 2 | 75 participants (Actual) | Interventional | 2012-12-31 | Completed | ||
| 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, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection[NCT01995071] | Phase 2 | 89 participants (Actual) | Interventional | 2013-11-30 | Completed | ||
| Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic Hepatitis C Virus Infection[NCT01740791] | Phase 1 | 103 participants (Actual) | Interventional | 2012-11-06 | 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 | ||
| A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)[NCT02032888] | Phase 3 | 238 participants (Actual) | Interventional | 2014-02-28 | Completed | ||
| Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients[NCT02282709] | Phase 3 | 12 participants (Actual) | Interventional | 2014-02-28 | Completed | ||
| A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon a-2a and Ribavirin in Treatment-Experienced Adult[NCT01854528] | Phase 3 | 148 participants (Actual) | Interventional | 2013-06-30 | Completed | ||
| A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With and Without Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve A[NCT01854697] | Phase 3 | 311 participants (Actual) | Interventional | 2013-03-31 | Completed | ||
| A Phase II Randomized, Dose Ranging, Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Different Doses of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment Naïve Subjects With Chronic Hepatiti[NCT01710501] | Phase 2 | 87 participants (Actual) | Interventional | 2012-12-07 | 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 | ||
| A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C[NCT01628692] | Phase 2 | 230 participants (Actual) | Interventional | 2012-07-31 | Completed | ||
| "Real World Administration of Zepatier (Grazoprevir Plus Elvasvir) in Chronic Hemodialysis Patients With Hepatitis C Infection. Strategies for Identification of Patients, Insurance Approval, Treatment , and Laboratory Monitoring"[NCT03365635] | Phase 4 | 6 participants (Actual) | Interventional | 2019-09-22 | 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 | ||
| A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection[NCT01858766] | Phase 2 | 379 participants (Actual) | Interventional | 2013-04-30 | 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 | |||
| 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 | ||
| An Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With or Without Sofosbuvir (SOF) and Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Tre[NCT02356562] | Phase 2 | 29 participants (Actual) | Interventional | 2015-02-03 | 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 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 | ||
| Dynamics of Viral Reservoir in HIV-positive Patients With or Without HCV Coinfection in the Era of Direct-acting Antiviral and Antiretroviral Drugs[NCT02836782] | 600 participants (Anticipated) | Observational [Patient Registry] | 2016-04-30 | Recruiting | |||
| Nationwide Hepatitis C NAT+ Cardiac Transplant Experience[NCT04493385] | 500 participants (Anticipated) | Observational | 2019-09-16 | Recruiting | |||
| Viral Kinetics and Liver Gene Expression in Response to Ribavirin and Peginterferon Therapy of Chronic Hepatitis C[NCT00718172] | Phase 1 | 81 participants (Actual) | Interventional | 2008-07-11 | Completed | ||
| Unraveling the Mechanisms of Non-Response in Patients With and Without Cirrhosis Due to Chronic Hepatitis C[NCT01888900] | Phase 2 | 35 participants (Actual) | Interventional | 2013-05-31 | Completed | ||
| A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection[NCT02021656] | Phase 3 | 384 participants (Actual) | Interventional | 2013-12-10 | Completed | ||
| A Phase 3 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 II Randomized Clinical Trial to Study the Efficacy and Safety of MK-5172 in Combination With Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection[NCT01716156] | Phase 2 | 26 participants (Actual) | Interventional | 2013-01-18 | Completed | ||
| A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers[NCT01718158] | Phase 3 | 444 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection[NCT02378935] | Phase 2 | 205 participants (Actual) | Interventional | 2015-02-17 | Completed | ||
| A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Non-Genotype 1 HCV Infection[NCT02378961] | Phase 2 | 128 participants (Actual) | Interventional | 2015-02-16 | Completed | ||
| Double-Blind, Randomized, Placebo-controlled, Multi-center Trial to Determine the Safety and Antiviral Effect of Single Doses of EDP239 in Hepatitis C Virus (HCV) Infected Subjects[NCT01856426] | Phase 1 | 28 participants (Actual) | Interventional | 2013-06-30 | Completed | ||
| A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C[NCT02097966] | 0 participants | Expanded Access | No longer available | ||||
| Therapeutic Option for Hepatitis B and C: a French Cohort[NCT01953458] | 20,902 participants (Actual) | Observational | 2012-08-06 | Active, not recruiting | |||
| 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 | ||
| A Phase II Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172, MK-8742, and Sofosbuvir in Treatment-Naïve Subjects With Chronic HCV GT1 or GT3 Infection[NCT02133131] | Phase 2 | 143 participants (Actual) | Interventional | 2014-06-13 | 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, Safety and Pharmacokinetics of 12 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir, Followed by a 5-Year Post-treatment Long-term Follow-up, in Treatment-naïve and Treatment-experienced[NCT02262728] | Phase 2 | 40 participants (Actual) | Interventional | 2014-09-30 | Completed | ||
| Effect of Triple Direct Acting Antiviral Agents (DAAs) for Non-cirrhotic Subjects With Chronic HCV G1b Infection[NCT02470858] | Phase 2 | 18 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis C (FOURward Study)[NCT02175966] | Phase 2 | 35 participants (Actual) | Interventional | 2014-07-28 | 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 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)[NCT01471574] | Phase 3 | 549 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
| A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen[NCT02536313] | Phase 2 | 49 participants (Actual) | Interventional | 2015-07-29 | Completed | ||
| Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Subjects With Recurrent Chronic Hepatitis C Genotype 1b Infection [NCT01938625] | Phase 2 | 35 participants (Actual) | Interventional | 2013-12-12 | Completed | ||
| A Phase 2b Study of Merimepodib in Combination With Pegylated Interferon Alfa-2a (Pegasys®) and Ribavirin in Subjects With Chronic Hepatitis C Non-Responsive to Prior Therapy With Pegylated Interferon Alfa and Ribavirin[NCT00088504] | Phase 2 | 315 participants | Interventional | 2004-07-31 | Completed | ||
| Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of Daclatasvir in Subjects Infected With Hepatitis C Virus Genotype 1[NCT00663208] | Phase 2 | 167 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| Safety, Tolerability, and Efficacy of Daclatasvir and Asunaprevir, With or Without BMS-791325, in Subjects Coinfected With HIV-HCV[NCT02124044] | Phase 2 | 30 participants (Actual) | Interventional | 2014-02-28 | Completed | ||
| A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1[NCT00874770] | Phase 2 | 74 participants (Actual) | Interventional | 2009-06-30 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"Efficacy of Hepatitis C Virus (HCV) Treatment with Zepatier (Elbasvir/Grazobevir) with Ribavirin (RBV) for 16 weeks when used in Genotype 1a patients with Baseline RASs (NS5a Resistance Associated Substitutions or RAPs -Resistance Associated Polymorphisms).~Efficacy defined as HCV RNA undetectable 12 weeks post treatment. Table excludes Genotype 1b patients." (NCT02786537)
Timeframe: 12 weeks post treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| EBR/GZR With RBV-16 Weeks | 34 |
Number/Percentage of patients with persistence of viral cure, SVR (SVR = Sustained Virologic Response)- defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. (NCT02786537)
Timeframe: 24 weeks post-end of treatment up to 153 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| EBR/GZR | 255 |
| EBR/GZR With Ribavirin | 17 |
| SOF/LDV | 146 |
| SOF/LDV With RBV | 2 |
| PrOD | 14 |
| PrOD With RBV | 36 |
Percentage of Cirrhotic patients with persistence of viral cure, SVR, (SVR= Sustained Virologic Response) defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. (NCT02786537)
Timeframe: Up to 132 weeks post HCV treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| EBR/GZR | 43 |
| EBR/GZR With RBV | 7 |
| SOF/LDV | 35 |
| SOF/LDV With RBV | 7 |
| PrOD | 6 |
| PrOD With RBV | 7 |
Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline and Average On-Treatment Score
| Intervention | score on a scale (Mean) |
|---|---|
| EBR/GZR With RBV | -1.0 |
| EBR/GZR | -2.1 |
| SOF/LDV With RBV | -3.7 |
| SOF/LDV | -2.2 |
Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline to On-treatment
| Intervention | units on a scale (Mean) |
|---|---|
| EBR/GZR With RBV | 1.5 |
| EBR/GZR | -1.2 |
| SOF/LDV With RBV | -7.2 |
| SOF/LDV | -2.0 |
| PrOD With RBV | -1.9 |
| PrOD | -3.0 |
"HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'overall functioning and well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Baseline to End of Treatment
| Intervention | units on a scale (Mean) |
|---|---|
| EBR/GZR With RBV | -0.9 |
| EBR/GZR | 5.6 |
| SOF/LDV With RBV | 2.5 |
| SOF/LDV | 6.9 |
| PrOD With RBV | 3.2 |
| PrOD | 9.9 |
"HCV-PRO, a survey designed to assess functional status of patients with HCV and measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered. End of Treatment -Baseline were used to calculate CHANGE in outcome. Number of subjects reflects participants from both Phase 1 and 2." (NCT02786537)
Timeframe: End of Treatment - Baseline
| Intervention | score on a scale (Mean) |
|---|---|
| EBR/GZR With RBV | 3.2 |
| EBR/GZR | 6.1 |
| SOF/LDV With RBV | 6.3 |
| SOF/LDV | 6.8 |
Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: Baseline to On-Treatment
| Intervention | units on a scale (Mean) |
|---|---|
| EBR/GZR With RBV | -0.8 |
| EBR/GZR | -0.7 |
| SOF/LDV With RBV | 0.4 |
| SOF/LDV | -0.8 |
Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement in symptom. (NCT02786537)
Timeframe: Baseline to On-Treatment
| Intervention | units on a scale (Mean) |
|---|---|
| EBR/GZR With Ribavirin (RBV) | 0.0 |
| EBR/GZR Regimen | -0.8 |
| SOF/LDV With RBV | -0.7 |
| SOF/LDV | -0.5 |
| PrOD With RBV Regimen | -0.2 |
| PrOD | -2.2 |
"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.~The estimates of mean change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes. The model expressed mean score as a function of DAA regimen, cirrhosis status, HCV genotype, sex, age, race, and previous treatment status." (NCT02786537)
Timeframe: Baseline to On-Treatment
| Intervention | units on a scale (Mean) |
|---|---|
| EBR/GZR With RBV | 1.3 |
| EBR/GZR | -1.4 |
| SOF/LDV With RBV | -3.9 |
| SOF/LDV | -0.7 |
| PrOD With RBV | 2.5 |
| PrOD | 0.7 |
"Participants completed the Patient Reported Outcomes surveys (PROs) 'PROMIS Nausea/Vomiting -4 Short Form' at baseline and during treatment. Raw scores are converted to standardized T-scores with a range of 45.0-80.1. Higher scores indicate worse nausea/vomiting.~Results presented as mean difference from baseline to average of on Treatment Scores (highest/worst) score during treatment.~A negative (-) PROMIS change score is suggestive of symptom improvement or lack of drug side effect. Estimates of mean change were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline and Average On-Treatment Score
| Intervention | units on a scale (Mean) |
|---|---|
| EBR/GZR With RBV | -0.3 |
| EBR/GZR | -0.6 |
| SOF/LDV With RBV | -1.6 |
| SOF/LDV | -0.4 |
Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline to End of Treatment
| Intervention | units on a scale (Median) |
|---|---|
| EBR/GZR With RBV | 2.2 |
| EBR/GZR Regimen | -0.9 |
| SOF/LDV With RBV | -10.2 |
| SOF/LDV | -3.4 |
| PrOD Regimen With RBV | -0.2 |
| PrOD | -4.1 |
Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35. (NCT02786537)
Timeframe: Baseline-On Treatment (up to 16 weeks)
| Intervention | units on a scale (Median) |
|---|---|
| EBR/GZR With RBV | -1.3 |
| EBR/GZR | -1.2 |
| SOF/LDV With RBV | -2.4 |
| SOF/LDV | -1.4 |
"HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'Overall Functioning and Well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Baseline to End of Treatment
| Intervention | score on a scale (Median) |
|---|---|
| EBR/GZR With RBV | 0.0 |
| EBR/GZR | 4.3 |
| SOF/LDV With RBV | 4.7 |
| SOF/LDV | 4.7 |
| PrOD With RBV | 3.1 |
| PrOD | 8.6 |
Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: 12 weeks (Baseline and Average On-treatment Score)
| Intervention | units on a scale (Median) |
|---|---|
| EBR/GZR (Elbasvir/Grazoprevir) With RBV | 0.0 |
| EBR/GZR (Elbasvir/Grazoprevir) | 0.0 |
| SOF/LDV (Sofosbuvir/Ledipasvir) With RBV | -2.0 |
| SOF/LDV (Sofosbuvir/Ledipasvir) | -1.0 |
| PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) With RBV (Phase 1 Only) | 0.0 |
| PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) | -1.0 |
Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of median change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD (NCT02786537)
Timeframe: Baseline -on Treatment (12-16 weeks)
| Intervention | units on a scale (Median) |
|---|---|
| EBR/GZR With RBV | -1.0 |
| EBR/GZR | 0.0 |
| SOF/LDV With RBV | 0.5 |
| SOF/LDV | -0.5 |
"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.~The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline to end of treatment
| Intervention | units on a scale (Median) |
|---|---|
| EBR/GZR With RBV | 0.4 |
| EBR/GZR | 0.0 |
| SOF/LDV With RBV | -6.1 |
| SOF/LDV | 0.0 |
| PrOD With RBV | 0.0 |
| PrOD | 0.0 |
"Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for change represent improvement.~The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes." (NCT02786537)
Timeframe: Baseline- On Treatment (up to 16 weeks)
| Intervention | score on a scale (Median) |
|---|---|
| EBR/GZR With RBV | 0.0 |
| EBR/GZR | 0.0 |
| SOF/LDV With RBV | 0.0 |
| SOF/LDV | 0.0 |
The number of participants with adverse events that led to early treatment discontinuation (defined as duration less than originally prescribed treatment regimen) (NCT02786537)
Timeframe: Treatment start date through treatment completion (up to 24 weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| EBR/GZR Regimen | 12 |
| SOF/LDV Regimen | 4 |
"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~Number of subjects reflects participants randomized during Phase 1 only." (NCT02786537)
Timeframe: 12 -24 weeks post-treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| EBR/GZR With RBV | 9 |
| EBR/GZR | 108 |
| SOF/LDV With RBV | 6 |
| SOF/LDV | 88 |
| PrOD With RBV | 77 |
| PrOD (Phase 1 Only) | 42 |
"SVR (Sustained Virologic Response) 12 will be defined as patients who have undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~mITT with imputation (missing=failure). Total number of subjects reflects participants from Phase 1 only." (NCT02786537)
Timeframe: 12 weeks post-treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| EBR/GZR With RBV | 9 |
| EBR/GZR | 108 |
| SOF/LDV With RBV | 6 |
| SOF/LDV | 88 |
| PrOD With RBV | 77 |
| PrOD | 42 |
"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site).~Number of subjects reflects participants who started EBR/GZR or SOF/LDV- based treatment (with or without RBV) during Phase 1 and 2." (NCT02786537)
Timeframe: 12-24 weeks post HCV treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| EBR/GZR With RBV | 40 |
| EBR/GZR | 516 |
| SOF/LDV With RBV | 14 |
| SOF/LDV | 335 |
Mean change (delta) in FIB-4, an indirect non-invasive measure of liver fibrosis, calculated as baseline median -long term follow up median, following SVR after any of the study treatment regimens. Change in FIB-4 where negative values indicate improvement in liver fibrosis score and positive values indicate worsening of fibrosis score. There is no upper or lower limit for change. FIB-4 = age (years) * AST(IU/L)/Platelets (10^3/L) * ALT^.5(IU/L). In general, Score of 0-1.29 is low risk for advanced fibrosis, 1.30-1.67: intermediate risk for advanced liver fibrosis, >2.67: high risk for advanced fibrosis. (NCT02786537)
Timeframe: Baseline to up to 3 years post treatment discontinuation
| Intervention | score on a scale (Median) |
|---|---|
| EBR/GZR, SOF/LDV or PrOD Based HCV Treatment | -1.36 |
"SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation at discretion of provider).~mITT with imputation (missing=failure). Total number of subjects reflects participants from EBR/GZR with or without RBV and SOF/LDV with or without RBV randomized during Phase 1 and Phase 2." (NCT02786537)
Timeframe: 12 weeks post-treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| EBR/GZR With RBV | 40 |
| EBR/GZR | 516 |
| SOF/LDV With RBV | 14 |
| SOF/LDV | 335 |
"The Voils Medication Adherence Survey (VMAS) was used to evaluate medication adherence during HCV treatment. Participants responded to three questions about the extent of adherence during the past seven days of treatment (during early and late on-treatment occasions). Participants responded using a five-point ordinal scale of missed dosing from 1 (none of the time) to 5 (all of the time). On each occasion participants were coded as being Non-adherent if any response was > 1, otherwise they were coded as Adherent. Probability estimates of percentage of patients reporting non-adherence were calculated per HCV treatment (Direct Acting Antiviral-DAA) regimen: 1)EBR/GZV (elbasvir/grazoprevir, 2)SOF/LDV (sofosbuvir/ledipasvir), 3)PrOD" (NCT02786537)
Timeframe: 12-16 weeks of HCV treatment
| Intervention | percentage of patients (Number) |
|---|---|
| EBR/GZR | 23 |
| SOF/LDV | 19 |
| PrOD | 26 |
"HCV-PRO score, a validated PROMIS survey used to evaluate overall functioning and well-being in HCV patients, was utilized to compare long-term 'within treatment' changes of functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive estimate (Post treatment to baseline) suggests baseline functional well-being improvement.~Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered." (NCT02786537)
Timeframe: Treatment start date up to 2 years post-treatment
| Intervention | score on a scale (Mean) | |
|---|---|---|
| 9 months post treatment | 20 months post treatment | |
| EBR/GZR Regimen | 8.02 | 9.87 |
| SOF/LDV Regimen | 9.90 | 11.54 |
Change in HCV-associated symptoms was calculated as the mean differences of mean scores from multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)-- Fatigue, nausea, belly pain, sleep disturbance, and diarrhea) and functional status (well-being) when comparing baseline to early post-treatment and late post treatment surveys. Mean change scores were calculated by comparing baseline to early post-treatment (1 yr) and late post-treatment (approximately 3 years) surveys. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.Negative numbers suggest better symptoms (improvement in HCV-associated symptoms). PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.HCV-PRO positive estimates suggest baseline functional well-being improvement. (NCT02786537)
Timeframe: 1 year post treatment discontinuation (Early post-tx)
| Intervention | units on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Nausea | Belly Pain | Diarrhea | Fatigue | Sleep Disturbance | Cognitive Impairment | HCV-PRO | |
| EBR/GZR Regimen | 0.00 | -0.82 | -1.12 | -2.08 | 0.65 | -0.54 | 8.02 |
| SOF/LDV Regimen | -4.99 | -6.47 | -5.77 | -7.59 | -1.72 | -4.48 | 9.90 |
Number of participants who achieved SVR (sustained virologic response), defined as undetectable HCV RNA 12 weeks post-treatment with RASs (Resistant Associated Substitutions) after treatment with EBR/GZR or SOF/LDV regimen (NCT02786537)
Timeframe: 12 weeks post HCV treatment
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| With NS5a RAS | Without NS5a RAS | |
| EBR/GZR Regimen | 47 | 485 |
| SOF/LDV Regimen | 42 | 286 |
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. (NCT03111108)
Timeframe: Up to Study Week 12
| Intervention | Participants (Number) |
|---|---|
| Arm 1: EBR/GZR for 8 Weeks | 0 |
| Arm 2: EBR/GZR for 12 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. (NCT03111108)
Timeframe: Up to 14 weeks
| Intervention | Participants (Number) |
|---|---|
| Arm 1: EBR/GZR for 8 Weeks | 33 |
| Arm 2: EBR/GZR for 12 Weeks | 46 |
The percentage of participants to achieve SVR12 was determined for each arm (SVR12 was defined as HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] at 12 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL. (NCT03111108)
Timeframe: 12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Arm 1: EBR/GZR for 8 Weeks | 94.3 |
| Arm 2: EBR/GZR for 12 Weeks | 95.3 |
The percentage of participants to achieve SVR24 was determined for each arm (SVR24 was defined as HCV RNA < LLOQ at 24 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL. (NCT03111108)
Timeframe: 24 weeks after completing study treatment (Arm 1: Week 32 / Arm 2: Week 36)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Arm 1: EBR/GZR for 8 Weeks | 94.3 |
| Arm 2: EBR/GZR for 12 Weeks | 93.8 |
Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS3 gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a direct-acting antiviral (DAA) and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS3. (NCT03111108)
Timeframe: Day 1
| Intervention | Participants (Number) | ||
|---|---|---|---|
| GT4 | GT4D | GT4-Other | |
| Arm 1: EBR/GZR for 8 Weeks | 5 | 3 | 6 |
| Arm 2: EBR/GZR for 12 Weeks | 6 | 3 | 9 |
Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS5A gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a DAA and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS5A. (NCT03111108)
Timeframe: Day 1
| Intervention | Participants (Number) | ||
|---|---|---|---|
| GT4 | GT4D | GT4-Other | |
| Arm 1: EBR/GZR for 8 Weeks | 3 | 10 | 13 |
| Arm 2: EBR/GZR for 12 Weeks | 2 | 16 | 21 |
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 |
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of dasabuvir present was measured up to 12 hours after dosing. For two subjects in the 15-29 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. For one subject in the 30-44 kg group, the 24 h concentration was used as the 12 h concentration due to the significant sampling time deviation. (NCT02486406)
Timeframe: At Week 2
| Intervention | ng•h/mL (Geometric Mean) |
|---|---|
| 15 - 29 kg Body Weight | 3960 |
| 30 - 44 kg Body Weight | 5960 |
| ≥ 45 kg Body Weight | 4630 |
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ombitasvir present was measured up to 24 hours after dosing. (NCT02486406)
Timeframe: At Week 2
| Intervention | ng•h/mL (Geometric Mean) |
|---|---|
| 15 - 29 kg Body Weight | 1270 |
| 30 - 44 kg Body Weight | 1490 |
| ≥ 45 kg Body Weight | 1060 |
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of paritaprevir present was measured up to 24 hours after dosing. (NCT02486406)
Timeframe: At Week 2
| Intervention | ng•h/mL (Geometric Mean) |
|---|---|
| 15 - 29 kg Body Weight | 2180 |
| 30 - 44 kg Body Weight | 8640 |
| ≥ 45 kg Body Weight | 5770 |
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of ritonavir present was measured up to 24 hours after dosing. (NCT02486406)
Timeframe: At Week 2
| Intervention | ng•h/mL (Geometric Mean) |
|---|---|
| 15 - 29 kg Body Weight | 6570 |
| 30 - 44 kg Body Weight | 14100 |
| ≥ 45 kg Body Weight | 8900 |
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| 15 - 29 kg Body Weight | 579 |
| 30 - 44 kg Body Weight | 830 |
| ≥ 45 kg Body Weight | 671 |
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| 15 - 29 kg Body Weight | 99.6 |
| 30 - 44 kg Body Weight | 116 |
| ≥ 45 kg Body Weight | 83.7 |
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| 15 - 29 kg Body Weight | 294 |
| 30 - 44 kg Body Weight | 1540 |
| ≥ 45 kg Body Weight | 870 |
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose. (NCT02486406)
Timeframe: At Week 2
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| 15 - 29 kg Body Weight | 1090 |
| 30 - 44 kg Body Weight | 1830 |
| ≥ 45 kg Body Weight | 1180 |
SVR24 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 24 weeks after the last actual dose of study drug. (NCT02486406)
Timeframe: 24 weeks after last dose of study drug (Week 36 or 48 depending on treatment duration)
| Intervention | percentage of participants (Number) |
|---|---|
| Participants in Parts 1 and 2 of the Study | 96.9 |
| Adult Tablet, 12-17 YR, ≥ 45 kg | 100 |
| Mini-tablet, 9-11 YR, 15 to 29 kg | 100.0 |
| Mini-tablet, 9-11 YR, 30 to 44 kg | 88.9 |
| Mini-tablet, 9-11 YR, ≥ 45 kg | 100.0 |
| Mini-tablet, 3-8 YR, 15 to 29 kg | 92.9 |
| Mini-tablet Total | 92.3 |
Alanine aminotransferase (ALT) normalization during treatment is defined as ALT ≤ the upper limit of normal (ULN) at the final treatment visit for participants with ALT > ULN at baseline. (NCT02486406)
Timeframe: 12 or 24 weeks after starting study drug, depending on treatment duration
| Intervention | percentage of participants (Number) |
|---|---|
| Adult Tablet,12-17 YR, ≥ 45 kg, ALT Normalization | 87.5 |
| Mini-tablet, 9-11 YR, 15 to 29 kg, ALT Normalization | 100 |
| Mini-tablet, 9-11 YR, 30 to 44 kg, ALT Normalization | 100 |
| Mini-tablet, 3-8 YR, 15 to 29 kg, ALT Normalization | 80.0 |
| Mini-tablet Total, ALT Normalization | 87.5 |
| Participants in Parts 1 and 2 of the Study, ALT Normalization | 87.5 |
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. (NCT02486406)
Timeframe: 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
| Intervention | percentage of participants (Number) |
|---|---|
| All Participants, Total | 98.4 |
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. (NCT02486406)
Timeframe: 12 weeks after last dose of study drug (Week 24 or 36 depending on treatment duration)
| Intervention | percentage of participants (Number) |
|---|---|
| Adult Tablet, 12-17 YR, ≥ 45 kg | 100 |
| Mini-tablet, 9-11 YR, 15 to 29 kg | 100 |
| Mini-tablet, 9-11 YR, 30 to 44 kg | 100 |
| Mini-tablet, 9-11 YR, ≥ 45 kg | 100 |
| Mini-tablet, 3-8 YR, 15 to 29 kg | 92.9 |
| Mini-tablet Total | 96.2 |
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8
| Intervention | ng/mL (Geometric Mean) | |
|---|---|---|
| Week 2 | Week 8 | |
| ≥ 45 kg Body Weight | 165 | 191 |
| 15 - 29 kg Body Weight | 110 | 168 |
| 30 - 44 kg Body Weight | 215 | 264 |
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8
| Intervention | ng/mL (Geometric Mean) | |
|---|---|---|
| Week 2 | Week 8 | |
| ≥ 45 kg Body Weight | 21.8 | 20.9 |
| 15 - 29 kg Body Weight | 24.7 | 29.6 |
| 30 - 44 kg Body Weight | 28.2 | 30.4 |
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8
| Intervention | ng/mL (Geometric Mean) | |
|---|---|---|
| Week 2 | Week 8 | |
| ≥ 45 kg Body Weight | 18.0 | 23.5 |
| 15 - 29 kg Body Weight | 9.86 | 17.3 |
| 30 - 44 kg Body Weight | 16.1 | 18.4 |
Minimum plasma concentration (Ctrough; measured in ng/mL) was directly determined from the concentration-time data. (NCT02486406)
Timeframe: At Weeks 2 and 8
| Intervention | ng/mL (Geometric Mean) | |
|---|---|---|
| Week 2 | Week 8 | |
| ≥ 45 kg Body Weight | 29.8 | 58.2 |
| 15 - 29 kg Body Weight | 16.1 | 91.8 |
| 30 - 44 kg Body Weight | 32.1 | 38.1 |
"HCV-specific Functional Well-Being was measured using the disease-specific HCV-PRO. The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.~The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T5 HCV-PRO mean score.~Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~HCV-PRO mean change scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to 1 year post-treatment
| Intervention | units on a scale (Mean) |
|---|---|
| Chronic HCV Patients Who Achieved SVR | 7.0 |
| Chronic HCV Patients Who Did Not Achieve SVR | 0.6 |
"HCV-specific Functional Well-Being was measured using the disease-specific HCV-PRO.~The means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T4 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~HCV-PRO Mean Change Scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to 3-months post-treatment
| Intervention | units on a scale (Mean) |
|---|---|
| Chronic HCV Patients Who Achieved SVR | 6.5 |
| Chronic HCV Patients Who Did Not Achieve SVR | 2.0 |
"Change in Overall Symptom Burden from Baseline to 1 year post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T5 TMSAS mean score.~Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful" (NCT02601820)
Timeframe: Baseline to 1 year post-treatment
| Intervention | units on a scale (Mean) |
|---|---|
| Chronic HCV Patients Who Achieved SVR | -0.2 |
| Chronic HCV Patients Who Did Not Achieve SVR | 0 |
"Change in Overall Symptom Burden from Baseline to 3-months post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS).~The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T4 TMSAS mean score.~Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~TMSAS Mean Change Scores could range from +/- 4.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to 3-months post-treatment
| Intervention | units on a scale (Mean) |
|---|---|
| Chronic HCV Patients Who Achieved SVR | -0.2 |
| Chronic HCV Patients Who Did Not Achieve SVR | -0.1 |
"Cumulative out of pocket (OOP) costs incurred by patients during HCV treatment was measured by a survey recording 5 direct and 5 indirect costs of treatment. OOP costs were collected early on-treatment (T2), late on-treatment (T3), and early post-treatment (T4) in case patients paid bills after treatment ended.~The Mean is the average dollar ($$) amount for Total OOP Cost of HCV Treatment for the cohort, calculated by summing the OOP costs for each patient reported at T2+T3+T4." (NCT02601820)
Timeframe: Up to 24 weeks of HCV Treatment
| Intervention | units on a scale (Mean) |
|---|---|
| Chronic HCV Patients During and After HCV Treatment | 582.50 |
"Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T4 mean. Lower change scores (-) indicate symptom improved~PROMIS Fatigue mean change score range = +/- 53.9~PROMIS Sleep Disturbance mean change score range = +/- 47.1~PROMIS Nausea mean change score range = +/- 44.0~PROMIS Diarrhea mean change score range = +/- 42.8~PROMIS Anger mean change score range = +/- 50.5.~PROMIS Anxiety mean change score range = +/- 41.4~PROMIS Depression mean change score range = +/- 43.1~PROMIS Cognitive Concern mean change score range = +/- 39.5~PROMIS Pain mean change score range = +/- 36.4~PROMIS Belly Pain mean change score range = +/- 50.2~Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically minimally important change (MIC). The 5% MIC = +/- 2.5 points.~Change scores were calculated for two subgroups: Patients who did and did not achieve SVR" (NCT02601820)
Timeframe: Baseline to 3-months post-treatment
| Intervention | units on a scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Depression change score | Anger change score | Anxiety change score | Cognitive Concerns change score | Pain Interference change score | Fatigue change score | Sleep change score | Belly Pain change score | Diarrhea change score | Nausea change score | Headache change score | |
| Chronic HCV Patients Who Achieved SVR | -2.3 | -2.1 | -1.7 | -1.4 | -2.3 | -4.1 | -3.1 | -2.3 | -0.1 | -1.5 | -1.5 |
| Chronic HCV Patients Who Did Not Achieve SVR | 0.2 | 0.7 | -0.7 | 0 | -1.7 | -2.9 | -0.9 | 0.9 | 0.7 | -0.3 | -1.1 |
"HCV-specific Functional Well-Being was measured using the disease-specific HCV-PRO. The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.~The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T2 HCV-PRO mean score or Baseline HCV-PRO mean score minus T3 HCV-PRO mean score.~HCV-PRO mean change scores range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to up to 24 weeks of HCV Treatment
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change in HCV-PRO mean score from T1 to T2 | Change in HCV-PRO mean score from T1 to T3 | |
| Chronic HCV Patients on Therapy | 3.2 | 3.8 |
"Change in Overall Symptom Burden was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score.~Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful." (NCT02601820)
Timeframe: Baseline to up to 24 weeks of HCV Treatment
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change in TMSAS score from T1 to T2 | Change in TMSAS score from T1 to T3 | |
| Chronic HCV Patients on Therapy | -0.10 | -0.1 |
"Change in Treatment-Related Symptoms was measured using multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and the Headache Impact Test (HIT-6). Mean CHANGE Scores were calculated as baseline mean score minus T2 mean score or baseline mean score minus T3 mean score. Lower change scores (-) indicate symptoms improved.~PROMIS Fatigue-7 mean change score range = +/- 53.9~PROMIS Sleep Disturbance-8a mean change score range = +/- 47.1~PROMIS Nausea/Vomiting-4 mean change score range = +/- 44.0~PROMIS Diarrhea-6 mean change score range = +/- 42.8~PROMIS Anger-5 mean change score range = +/- 50.5.~PROMIS Anxiety-4 mean change score range = +/- 41.4~HIT-6 mean change score range = +/- 42~To aid in interpretation of clinical significance, a 5% change from baseline is considered a minimally important change (MIC). The 5% MIC change in a PROMIS or HIT-6 score is +/- 2.5 points." (NCT02601820)
Timeframe: Baseline to up to 24 weeks of HCV Treatment
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change in Fatigue Mean Score from T1 to T2 | Change in Sleep disturbance score from T1 to T2 | Change in Nausea/Vomiting mean score from T1 to T2 | Change in Diarrhea mean score from T1 to T2 | Change in Irritability mean score from T1 to T2 | Change in Anxiety mean score from T1 to T2 | Change in headache HIT-6 mean score from T1 to T2 | Change in Fatigue mean score from T1 to T3 | Change in sleep disturbance score from T1 to T3 | Change in nausea/vomiting mean score from T1 to T3 | Change in Diarrhea mean score from T1 to T3 | Change in anger mean score from T1 to T3 | Change in anxiety mean score from T1 to T3 | Change in headache HIT-6 mean score from T1 to T3 | |
| Chronic HCV Patients on Therapy | -1.1 | -1.6 | 0.8 | 0.8 | -1.2 | -1.5 | 0.2 | -1.1 | -1.8 | -0.2 | 0.6 | -0.8 | -1.4 | -0.1 |
"Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T5 mean. Lower change scores (-) indicate symptom improved~PROMIS Fatigue mean change score range = +/- 53.9~PROMIS Sleep Disturbance mean change score range = +/- 47.1~PROMIS Nausea mean change score range = +/- 44.0~PROMIS Diarrhea mean change score range = +/- 42.8~PROMIS Anger mean change score range = +/- 50.5.~PROMIS Anxiety mean change score range = +/- 41.4~PROMIS Depression mean change score range = +/- 43.1~PROMIS Cognitive Concern mean change score range = +/- 39.5~PROMIS Pain mean change score range = +/- 36.4~PROMIS Belly Pain mean change score range = +/- 50.2~Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically minimally important change (MIC). The 5% MIC = +/- 2.5 points.~Change scores were calculated for two subgroups: Patients who did and did not achieve SVR" (NCT02601820)
Timeframe: Baseline to 1 year post-treatment
| Intervention | units on a scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Depression change score | Anger change score | Anxiety change score | Cognitive Concern change score | Pain Interference change score | Fatigue change score | Sleep Disturbance change score | Belly Pain change score | Diarrhea change score | Nausea change score | Headache HIT-6 Change score | |
| Chronic HCV Patients Who Achieved SVR | -2.2 | -2.2 | -2.0 | -1.7 | -1.9 | -3.6 | -3.1 | -2.6 | -0.3 | -1.4 | -1.5 |
| Chronic HCV Patients Who Did Not Achieve SVR | -0.9 | -0.3 | -0.4 | 0.3 | -0.8 | -0.6 | -1.3 | -3.7 | -0.1 | -0.1 | -0.7 |
Medication adherence was measured using the Voils' Medication Adherence Survey (VMAS). The VMAS consists of 3 items that evaluated the extent of adherence using a 5-point Likert scale from 1=None of the time to 5=All of the time. The 3 items assess how often participants missed doses, skip doses, or do not take doses over the past 7 days and are averaged into a single score. A dichotomous variable was created to categorize patients as 100% (adherent) or <100% (nonadherent) during HCV treatment at early treatment (T2) and late treatment (T3). (NCT02601820)
Timeframe: Up to 24 weeks of HCV Treatment
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Nonadherence rate (%) early on-treatment (T2) | Nonadherence rate (%) late on-treatment (T3) | |
| Patients With Baseline Alcohol Abuse | 5.9 | 13.7 |
| Patients With Baseline Mental Health Disturbance | 4.5 | 9 |
| Patients With Baseline Substance Use | 5.5 | 9 |
| Patients Without Baseline Alcohol Abuse | 4 | 7.2 |
| Patients Without Baseline Mental Health Disturbance | 4.2 | 7.6 |
| Patients Without Baseline Substance Use | 4.3 | 7.8 |
(NCT02607800)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX 8 Weeks | 0 |
| SOF/VEL 12 Weeks | 0.5 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02607800)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX 8 Weeks | 95.2 |
| SOF/VEL 12 Weeks | 98.2 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02607800)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX 8 Weeks | 4.2 |
| SOF/VEL 12 Weeks | 0.7 |
(NCT02607800)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12
| Intervention | log10 IU/mL (Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | |
| SOF/VEL/VOX 8 Weeks | -4.23 | -4.75 | -4.95 | -4.99 |
(NCT02607800)
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12
| Intervention | log10 IU/mL (Mean) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | |
| SOF/VEL 12 Weeks | -4.24 | -4.77 | -4.99 | -5.03 | -5.03 |
(NCT02607800)
Timeframe: Weeks 1, 2, 4, 8, and 12
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | |
| SOF/VEL/VOX 8 Weeks | 24.8 | 65.9 | 92.4 | 99.2 |
(NCT02607800)
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 | 22.7 | 61.3 | 92.0 | 99.8 | 99.8 |
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02607800)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR 24 | |
| SOF/VEL 12 Weeks | 98.9 | 98.0 |
| SOF/VEL/VOX 8 Weeks | 96.4 | 95.0 |
(NCT02639338)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX 8 Weeks | 0 |
| SOF/VEL 12 Weeks | 0.9 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02639338)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX 8 Weeks | 96.4 |
| SOF/VEL 12 Weeks | 96.3 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit" (NCT02639338)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX 8 Weeks | 1.8 |
| SOF/VEL 12 Weeks | 1.8 |
(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12
| Intervention | log10 IU/mL (Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | |
| SOF/VEL/VOX 8 Weeks | -4.06 | -4.60 | -4.84 | -4.90 |
(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12
| Intervention | log10 IU/mL (Mean) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | |
| SOF/VEL 12 Weeks | -4.09 | -4.73 | -5.00 | -5.09 | -5.14 |
(NCT02639338)
Timeframe: Weeks 1, 2, 4, 8 and 12
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 8 | |
| SOF/VEL/VOX 8 Weeks | 17.3 | 56.4 | 87.3 | 97.3 |
(NCT02639338)
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 | 10.1 | 50.9 | 85.2 | 99.1 | 100.0 |
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02639338)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| SOF/VEL 12 Weeks | 97.2 | 96.3 |
| SOF/VEL/VOX 8 Weeks | 97.3 | 96.4 |
(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 |
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA >= LLOQ with at least 6 weeks of treatment. (NCT02265237)
Timeframe: Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 1.7 |
| Arm B | 0 |
| Arm C | 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. (NCT02265237)
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 | 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 | 96.6 |
| Arm B | 100.0 |
| Arm C | 93.4 |
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 | 96.6 |
| Arm B | 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 B | 100 |
| Arm C | 93.4 |
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 |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 97.9 |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 97.8 |
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 97.6 |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 98.2 |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Baseline and 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 98.1 |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Baseline and 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 98.7 |
On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Up to 8 weeks while on treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 0.6 |
On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method. (NCT02582632)
Timeframe: Up to 8 weeks while on treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 0 |
Relapse12 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 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Up to 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 1.2 |
Relapse12 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 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. (NCT02582632)
Timeframe: Up to 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir | 1.2 |
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. 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 |
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 |
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 |
Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. (NCT01390428)
Timeframe: Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
| Intervention | hr. (Geometric Mean) |
|---|---|
| Part 1-Mild HI | 54.24 |
| Part 1-Healthy Matched to Mild HI | 35.85 |
| Part 2-Moderate HI | 39.59 |
| Part 2-Healthy Matched to Moderate HI | 39.80 |
| Part 3-Severe HI | 42.00 |
| Part 3-Healthy Matched to Severe HI | 31.02 |
Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. (NCT01390428)
Timeframe: Day 1 at 24 hours postdose
| Intervention | nM (Geometric Mean) |
|---|---|
| Part 1-Mild HI | 21.4 |
| Part 1-Healthy Matched to Mild HI | 11.5 |
| Part 2-Moderate HI | 17.7 |
| Part 2-Healthy Matched to Moderate HI | 5.90 |
Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. (NCT01390428)
Timeframe: Day 1 at 24 hours postdose
| Intervention | nM (Median) |
|---|---|
| Part 3-Severe HI | 15.6 |
| Part 3-Healthy Matched to Severe HI | 1.86 |
Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. (NCT01390428)
Timeframe: Days 10 at 24 hours postdose
| Intervention | nM (Geometric Mean) |
|---|---|
| Part 1-Mild HI | 32.6 |
| Part 1-Healthy Matched to Mild HI | 17.0 |
| Part 2-Moderate HI | 48.9 |
| Part 2-Healthy Matched to Moderate HI | 13.6 |
| Part 3-Severe HI | 55.0 |
| Part 3-Healthy Matched to Severe HI | 5.89 |
Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma AUC0-24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. (NCT01390428)
Timeframe: Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
| Intervention | uM*hr (Geometric Mean) | |
|---|---|---|
| Day 1 | Day 10 | |
| Part 1-Healthy Matched to Mild HI | 1.42 | 3.74 |
| Part 1-Mild HI | 1.71 | 6.20 |
| Part 2-Healthy Matched to Moderate HI | 0.321 | 0.874 |
| Part 2-Moderate HI | 1.61 | 4.21 |
| Part 3-Healthy Matched to Severe HI | 0.0592 | 0.257 |
| Part 3-Severe HI | 1.17 | 3.00 |
Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. (NCT01390428)
Timeframe: Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
| Intervention | uM (Geometric Mean) | |
|---|---|---|
| Day 1 | Day 10 | |
| Part 1-Healthy Matched to Mild HI | 0.305 | 1.02 |
| Part 1-Mild HI | 0.257 | 1.40 |
| Part 2-Healthy Matched to Moderate HI | 0.0580 | 0.106 |
| Part 2-Moderate HI | 0.433 | 0.631 |
| Part 3-Healthy Matched to Severe HI | 0.0157 | 0.0304 |
| Part 3-Severe HI | 0.238 | 0.396 |
Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. (NCT01390428)
Timeframe: Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
| Intervention | hr. (Median) | |
|---|---|---|
| Day 1 | Day 10 | |
| Part 1-Healthy Matched to Mild HI | 2.50 | 3.01 |
| Part 1-Mild HI | 3.50 | 3.00 |
| Part 2-Healthy Matched to Moderate HI | 1.75 | 2.00 |
| Part 2-Moderate HI | 2.00 | 3.00 |
| Part 3-Healthy Matched to Severe HI | 1.50 | 1.00 |
| Part 3-Severe HI | 1.75 | 1.75 |
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 |
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 |
(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 |
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 |
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
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 particpants (Number) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 0.0 |
| ABT-493/ABT-530 for 8 Weeks | 0.3 |
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
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) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 0.0 |
| ABT-493/ABT-530 for 8 Weeks | 0.3 |
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
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 0.0 |
| ABT-493/ABT-530 for 8 Weeks | 0.0 |
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
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 0.0 |
| ABT-493/ABT-530 for 8 Weeks | 0.0 |
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) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 99.7 |
SVR12 was defined as plasma HCV RNA level
Timeframe: 12 weeks after last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 99.7 |
| ABT-493/ABT-530 for 8 Weeks | 99.1 |
SVR12 was defined as plasma HCV RNA level
Timeframe: 12 weeks after last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 100.0 |
| ABT-493/ABT-530 for 8 Weeks | 100.0 |
SVR12 was defined as plasma HCV RNA level
Timeframe: 12 weeks after last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 100.0 |
| ABT-493/ABT-530 for 8 Weeks | 100.0 |
SVR12 was defined as plasma HCV RNA level
Timeframe: 12 weeks after last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 99.7 |
| ABT-493/ABT-530 for 8 Weeks | 99.1 |
SVR12 was defined as plasma HCV RNA level
Timeframe: 12 weeks after last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 100.0 |
| ABT-493/ABT-530 for 8 Weeks | 100 |
SVR12 was defined as plasma HCV RNA level
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-493/ABT-530 for 12 Weeks | 99.7 |
| ABT-493/ABT-530 for 8 Weeks | 99.1 |
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. (NCT02640157)
Timeframe: Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 0.4 |
| Arm B | 0 |
| Arm C | 0.6 |
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. (NCT02640157)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 1.4 |
| Arm B | 0.9 |
| Arm C | 3.3 |
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 | 95.3 |
| Arm B | 96.5 |
SVR12 was defined as plasma HCV RNA level
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 95.3 |
| Arm C | 94.9 |
SVR12 was defined as plasma HCV RNA level
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 95.3 |
| Arm B | 96.5 |
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 |
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 |
(NCT02781571)
Timeframe: Baseline; Week 12
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | -5.22 |
(NCT02781571)
Timeframe: Baseline; Week 2
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | -4.75 |
(NCT02781571)
Timeframe: Baseline; Week 4
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | -5.13 |
(NCT02781571)
Timeframe: Baseline; Week 8
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | -5.20 |
(NCT02781571)
Timeframe: Week 12
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | 1.15 |
(NCT02781571)
Timeframe: Week 2
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | 1.59 |
(NCT02781571)
Timeframe: Week 4
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | 1.23 |
(NCT02781571)
Timeframe: Week 8
| Intervention | log10 IU/mL (Mean) |
|---|---|
| SOF/VEL | 1.15 |
(NCT02781571)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 1.3 |
(NCT02781571)
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 100.0 |
(NCT02781571)
Timeframe: Week 2
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 40.5 |
(NCT02781571)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 85.9 |
(NCT02781571)
Timeframe: Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 98.7 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. (NCT02781571)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 96.2 |
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02781571)
Timeframe: Posttreatment Week 4
| Intervention | Percentage of participants (Number) |
|---|---|
| SOF/VEL | 97.5 |
"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 12 weeks of treatment)~Virologic relapse:~HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement" (NCT02781571)
Timeframe: Up to Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL | 2.5 |
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 |
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. (NCT02517528)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 + ABT-333 + Ribavirin | 100 |
SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China. (NCT02517528)
Timeframe: 24 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 + ABT-333 + Ribavirin | 100 |
On treatment virologic failure is defined as confirmed HCV RNA greater than or equal to the LLOQ at any point during treatment after HCV RNA less than LLOQ, confirmed increase from the lowest value post-baseline in HCV RNA (two consecutive HCV RNA measurements greater than 1 log10 IU/mL above the lowest value post-baseline) at any time point during treatment, or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks (greater than or equal to 36 days) of treatment. 95% CI is calculated using Wilson's score method. (NCT02517528)
Timeframe: Within 12 weeks after first dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 + ABT-333 + Ribavirin | 0 |
Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. (NCT02517528)
Timeframe: Within 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 + ABT-333 + Ribavirin | 0 |
Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 24 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method. (NCT02517528)
Timeframe: Within 24 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 + ABT-333 + Ribavirin | 0 |
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of active treatment. (NCT02517515)
Timeframe: up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Double-blind 3-DAA (Treatment-Naïve) | 1.1 |
| Double-blind 3-DAA (Treatment-Experienced) | 0 |
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02517515)
Timeframe: From the end of treatment through 12 weeks after the last dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Double-blind 3-DAA (Treatment-Naïve) | 0 |
| Double-blind 3-DAA (Treatment-Experienced) | 0 |
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02517515)
Timeframe: From the end of treatment through 24 weeks after the last dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Double-blind 3-DAA (Treatment-Naïve) | 0 |
| Double-blind 3-DAA (Treatment-Experienced) | 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 active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Double-blind 3-DAA (Treatment-Naïve) | 99.5 |
| Double-blind 3-DAA (Treatment-Experienced) | 100 |
SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Timeframe: 24 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Double-blind 3-DAA (Treatment-Naïve) | 99.5 |
| Double-blind 3-DAA (Treatment-Experienced) | 100 |
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 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | Hours (Geometric Mean) |
|---|---|
| Participants With End Stage Renal Disease: HD Day 10 | 23.04 |
| Participants With Severe Renal Impairment: Day 10 | 28.97 |
| Healthy Participants: Day 10 | 25.02 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | Hours (Geometric Mean) |
|---|---|
| Participants With End Stage Renal Disease: HD Day 10 | 28.38 |
| Participants With Severe Renal Impairment: Day 10 | 36.30 |
| Healthy Participants: Day 10 | 35.18 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10 (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | Liters (Geometric Mean) |
|---|---|
| Participants With End Stage Renal Disease: HD Day 10 | 857 |
| Participants With Severe Renal Impairment: Day 10 | 569 |
| Healthy Participants: Day 10 | 901 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10 (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | Liters (Geometric Mean) |
|---|---|
| Participants With End Stage Renal Disease: HD Day 10 | 5430 |
| Participants With Severe Renal Impairment: Day 10 | 3490 |
| Healthy Participants: Day 10 | 5760 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | Liters/hr (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 25.9 |
| Participants With End Stage Renal Disease | 29.9 | 26.2 |
| Participants With Severe Renal Impairment: Day 10 | NA | 13.9 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | Liters/hr (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 114 |
| Participants With End Stage Renal Disease | 135 | 138 |
| Participants With Severe Renal Impairment: Day 10 | NA | 69.4 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | uM*hr (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 2.19 |
| Participants With End Stage Renal Disease | 1.89 | 2.16 |
| Participants With Severe Renal Impairment: Day 10 | NA | 4.07 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: Up to 24 hours postdose
| Intervention | uM*hr (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 1.14 |
| Participants With End Stage Renal Disease | 0.969 | 0.944 |
| Participants With Severe Renal Impairment: Day 10 | NA | 1.88 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | uM (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 0.163 |
| Participants With End Stage Renal Disease | 0.137 | 0.154 |
| Participants With Severe Renal Impairment: Day 10 | NA | 0.271 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | uM (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 0.154 |
| Participants With End Stage Renal Disease | 0.141 | 0.135 |
| Participants With Severe Renal Impairment: Day 10 | NA | 0.255 |
Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: 24 hours postdose
| Intervention | nM (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 60.9 |
| Participants With End Stage Renal Disease | 46.9 | 58.2 |
| Participants With Severe Renal Impairment: Day 10 | NA | 126 |
Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) (NCT01937975)
Timeframe: 24 hours postdose
| Intervention | nM (Geometric Mean) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 14.5 |
| Participants With End Stage Renal Disease | 11.4 | 11.3 |
| Participants With Severe Renal Impairment: Day 10 | NA | 23.3 |
Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | Hours (Median) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 4.00 |
| Participants With End Stage Renal Disease | 4.00 | 5.00 |
| Participants With Severe Renal Impairment: Day 10 | NA | 4.00 |
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 (NCT01937975)
Timeframe: Up to 120 hours postdose
| Intervention | Hours (Median) | |
|---|---|---|
| Day 9 | Day 10 | |
| Healthy Participants: Day 10 | NA | 2.50 |
| Participants With End Stage Renal Disease | 2.00 | 2.50 |
| Participants With Severe Renal Impairment: Day 10 | NA | 3.00 |
(NCT02798315)
Timeframe: Up to 48 weeks
| Intervention | percentage of planned duration of RBV (Mean) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 101.0 |
"The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Based on responses to the 13-item measure, the score is calculated by adding up the raw scores (range of the sum: 13 - 52) and mapping up the value onto a scale of 0-100 indicating strength of agreement with the 13 items. A higher score indicates that the patient is likely to participate more actively in health care processes and takes more responsibility for his or her health." (NCT02798315)
Timeframe: Up to 48 weeks
| Intervention | units on a scale (Median) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 7.60 |
SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug (NCT02798315)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 100 |
Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment. (NCT02798315)
Timeframe: Up to EoT, maximum of 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0 |
Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL. (NCT02798315)
Timeframe: Up to EoT, maximum of 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0 |
Virological response defined as HCV RNA level less than 50 IU/mL. (NCT02798315)
Timeframe: Up to EoT, maximum of 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 100 |
Percentage of the DAA dose taken in relation to the target dose of DAA (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose. (NCT02798315)
Timeframe: Up to 48 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| > 95% to ≤ 105% of target dose | > 80% to ≤ 95% of target dose | |
| Participants With HCV Genotype 1 or 4 | 38 | 1 |
Percentage of the RBV dose taken in relation to the target dose of RBV (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose. (NCT02798315)
Timeframe: Up to 48 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| > 95% to ≤ 105% of target dose | > 80% to ≤ 95% of target dose | |
| Participants With HCV Genotype 1 or 4 | 32 | 1 |
Percentage of participants using each component of the PSP, including personal support, educational and information material (printed, online) and additional digital and mobile resources (web-portal, app, and reminders). (NCT02798315)
Timeframe: Up to EoT, maximum of 24 weeks
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Personal support | Educational/information material - printed | Educational/information material - online | Additional resources - web portal | Additional resources - app | Additional resources - reminders | |
| Participants With HCV Genotype 1 or 4 | 28 | 24 | 6 | 3 | 6 | 2 |
On-treatment virologic failure defined as breakthrough (at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). Relapse (defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment). (NCT02798315)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug
| Intervention | percentage of participants (Number) | |
|---|---|---|
| On-treatment virologic failure | Relapse | |
| Participants With HCV Genotype 1 or 4 | 0 | 0 |
Premature study drug discontinuation category is defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure. The final SVR non-response category was defined as missing SVR12 data and/or none of the above criteria. (NCT02798315)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Premature study drug discontinuation | Missing SVR12 data / other | |
| Participants With HCV Genotype 1 or 4 | 0 | 0 |
"PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation." (NCT02618928)
Timeframe: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)
| Intervention | units on a scale (Mean) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 0.44 |
(NCT02618928)
Timeframe: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)
| Intervention | percent glycosylated hemoglobin (Mean) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | -7.07 |
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure. (NCT02618928)
Timeframe: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 90.7 |
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. (NCT02618928)
Timeframe: End of treatment (week 8, 12, or 24 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 94.4 |
Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. (NCT02618928)
Timeframe: 8, 12, or 24 weeks (depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 0.5 |
RVR 4 was defined as participants with HCV RNA < 50 IU/mL at week 4. (NCT02618928)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 49.0 |
Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. (NCT02618928)
Timeframe: End of treatment (week 8, 12, or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 1.2 |
"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The Core Population with sufficient follow-up data regarding SVR12 included all core population participants who~had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure." (NCT02618928)
Timeframe: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 95.5 |
"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.~The Core population with sufficient follow-up data regarding SVR24 included all core population participants who~had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure." (NCT02618928)
Timeframe: 24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 94.8 |
(NCT02618928)
Timeframe: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.
| Intervention | percentage of days (Mean) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 98.5 |
The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication. (NCT02618928)
Timeframe: Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Specific Concerns | Specific Necessity | General Overuse | General Harm | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | -0.100 | -0.099 | 0.119 | 0.135 |
"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 0.044 | 0.088 | 0.087 |
"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 6.8 | 10.6 | 10.4 |
"The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients.~The FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impact" (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | -6.78 | -18.27 | -16.75 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 5.2 | 0.4 | -1.5 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | -1.2 | -5.5 | -7.4 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 1.6 | -7.2 | -9.5 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems." (NCT02618928)
Timeframe: Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 1.3 | -4.9 | -8.7 |
"SVR12 non-response was categorized according to the following:~On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death~Premature treatment discontinuation with no on-treatment virologic failure;~Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria~Missing SVR12 data and/or none of the above criteria." (NCT02618928)
Timeframe: 12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| On-treatment virological failure | Relapse | Death | Premature treatment discontinuation | Insufficient virological response reported | Missing/none of the above | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 11 | 7 | 2 | 14 | 3 | 30 |
Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose. (NCT02618928)
Timeframe: From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| Any co-medication | Beta blocking agents | Analgesics | Thyroid therapy | Peptic ulcer / gastro-oesophageal reflux disease | Benzodiazepine derivatives | ACE inhibitors | Diuretics | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 351 | 60 | 58 | 46 | 45 | 40 | 39 | 37 |
(NCT02618928)
Timeframe: From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any adverse event | Serious adverse event | Pregnancy | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 163 | 20 | 1 |
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of study drug. (NCT02582658)
Timeframe: 12 Weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 84.8 |
SVR12 is defined as HCV RNA levels < 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU). (NCT02582658)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 95.9 |
The percentage of participants with on-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment]). (NCT02582658)
Timeframe: Up to approximately 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 1.2 |
The percentage of participants with relapse (defined as HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL) (NCT02582658)
Timeframe: Up to 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 0.0 |
The percentage of participants with virological response (HCV RNA <50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin [RBV]). (NCT02582658)
Timeframe: Up to 24 weeks of treatment
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 94.5 |
Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ [initially prescribed dose x planned duration]). (NCT02582658)
Timeframe: Up to 24 weeks of treatment
| Intervention | percentage of planned RBV dose taken (Mean) |
|---|---|
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 95.7 |
The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem (NCT02582658)
Timeframe: Day 0 to post treatment week 12
| Intervention | percentage (Mean) | |||
|---|---|---|---|---|
| Change from baseline in absenteeism | Change from baseline in presenteeism | Change from baseline in total work impairment | Change from baseline in total activity impairment | |
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 0.1 | -10.6 | -10.5 | -8.3 |
The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP. (NCT02582658)
Timeframe: Up to 24 weeks of treatment
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Participants Using at least 1 PSP since last visit | Personal support - satisfaction Very Good | Personal support satisfaction - Good | Personal support satisfaction - Satisfactory | |
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 65.4 | 34.6 | 7.7 | 3.8 |
Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days. (NCT02582658)
Timeframe: Up to 24 weeks of treatment
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Early discontinuation | Exeedance | Not deviated | |
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 7.9 | 1.8 | 90.3 |
Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% to <=105%, >80% to <=95%, >50% to <=80%, <=50%. (NCT02582658)
Timeframe: Up to 24 weeks of treatment
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| > 105% Adherence | >95% - <=105% Adherence | >80% - <=95% Adherence | >50% - <=80% Adherence | <=50% Adherence | |
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 1.8 | 88.5 | 3.0 | 3.6 | 3.0 |
Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% - <=105%, >80% - <=95%, >50% - <=80%, <=50%. (NCT02582658)
Timeframe: Up to 24 weeks of treatment
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| > 105% Adherence | >95% - <=105% Adherence | >80% - <=95% Adherence | >50% - <=80% Adherence | <=50% Adherence | |
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 3.3 | 85.0 | 1.7 | 5.0 | 5.0 |
Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0). (NCT02582658)
Timeframe: Day 0
| Intervention | percentage of participants (Number) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All co-morbidities and co-infections | HCV co-infections | Liver and/or CHC related co-morbidities | Chronic kidney disease | Psychiatric disorders | Diabetes mellitus | Lipid disorder | Hyperthyroidism | Hypothyroidism | Cardiovascular disease | Immunologically medicated disease | Psychoactive substance dependency | Other | |
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 57.6 | 1.8 | 5.5 | 3.0 | 15.2 | 9.7 | 5.5 | 0.6 | 8.5 | 23.0 | 1.2 | 10.9 | 20.6 |
Percentage of participants taking at least 1 concomitant medication (NCT02582658)
Timeframe: Day 0 to end of treatment (up to 24 weeks)
| Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients Taking at least 1 co-medication | Analgesics | Antidepressants | Beta blocking agents | Calcium channel blockers | Thyroid therapy | Vitamins | Blood glucose lowering drugs | Drugs used in addictive disorders | ACE inhibitors | Angriotensin II antagonists | Anti-asthmatics | Benzodiazepine derivatives | Antithrombotic | Drugs for peptic ulcer/gastroesophageal reflux dis | Angiotensin II Antagonists | Antipsychotics | Diuretics | ACE inhibitors, combinations | Insulin and analogues | Mineral supplements | Antieplieptics | Anti-inflammatory and antirheumatic products | Drugs used in benign prostatic hypertrophy | Herbal medicine | Vasodilators for cardiac diseases | Anti-dementia drugs | Antibacterials | Anti-gout preparations | Drugs for functional gastrointestinal disorders | HMG COA reductase inhibitors | Hypnotics and sedatives | Immunosuppressive agents | Lipotropics | Vasoprotectives | Anti-adrenergic antihypertensives | Antibiotics for dermatological use | Antiemetics and anti nauseants | Antigloucoma | Antihistamines | Antineoplastic/immunomodulating agents, cytostatic | |
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 49.1 | 12.3 | 11.7 | 9.9 | 8.8 | 7.6 | 5.8 | 4.7 | 4.7 | 4.1 | 4.1 | 4.1 | 4.1 | 3.5 | 3.5 | 2.9 | 2.9 | 2.9 | 2.3 | 2.3 | 2.3 | 1.8 | 1.8 | 1.8 | 1.8 | 1.8 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 |
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement. (NCT02582658)
Timeframe: Day 0 and post treatment week 12
| Intervention | score on a scale (Mean) | |||
|---|---|---|---|---|
| EQ-5D-5L: Index Score Basline | EQ-5D-5L: Index Score 12 Weeks EOT | EQ-5D-5L: VAS Score Basline | EQ-5D-5L: VAS Score 12 Weeks EOT | |
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 0.83 | 0.88 | 70.4 | 79.4 |
"The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management." (NCT02582658)
Timeframe: Day 0 and End of Treatment (EoT)
| Intervention | score on a scale (Mean) | |
|---|---|---|
| PAM-13 Day 0 | PAM-13 EOT | |
| ABBVIE REGIMEN +/- Ribavirin (RBV) | 63.3 | 62.6 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health). (NCT02851069)
Timeframe: 12 weeks post EoT (up to 24 weeks)
| Intervention | units on a scale (Mean) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 0.039 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health). (NCT02851069)
Timeframe: 24 weeks post EoT (up to 24 weeks)
| Intervention | units on a scale (Mean) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 0.046 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. (NCT02851069)
Timeframe: 12 weeks post EoT (up to 24 weeks)
| Intervention | units on a scale (Mean) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 7.5 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. (NCT02851069)
Timeframe: 24 weeks post EoT (up to 24 weeks)
| Intervention | units on a scale (Mean) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 4.0 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life. (NCT02851069)
Timeframe: End of Treatment (up to 24 weeks)
| Intervention | units on a scale (Mean) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 5.7 |
The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health). (NCT02851069)
Timeframe: EoT (up to 24 weeks)
| Intervention | units on a scale (Mean) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 0.005 |
SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]). (NCT02851069)
Timeframe: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 87.7 |
On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL). (NCT02851069)
Timeframe: Up to EoT, maximum of 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 1.5 |
RVR4 was defined as HCV RNA < 50 IU/mL at Week 4. (NCT02851069)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 66.2 |
Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated. (NCT02851069)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 1.5 |
Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window. (NCT02851069)
Timeframe: 12 weeks (i.e. at least 70 days) after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 1.8 |
SVR24 was defined as HCV RNA < 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24. (NCT02851069)
Timeframe: 24 weeks after EoT (up to 24 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 44.4 |
Viral breakthrough was defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. (NCT02851069)
Timeframe: Up to EoT, maximum of 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 0.0 |
Virologic response is defined as HCV RNA level <50 IU/mL. (NCT02851069)
Timeframe: Up to EoT, maximum of 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| ABBVIE REGIMEN ± Ribavirin (RBV) | 95.4 |
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough [at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]). (NCT02851069)
Timeframe: Up to EoT, maximum of 24 weeks
| Intervention | participants (Number) | |
|---|---|---|
| Premature Termination ABBVIE REGIMEN | No Premature Termination ABBVIE REGIMEN | |
| ABBVIE REGIMEN ± Ribavirin (RBV) | 4 | 61 |
Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus [HIV] or hepatitis B virus [HBV], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other). (NCT02851069)
Timeframe: Baseline (Day 0)
| Intervention | participants (Number) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All co-morbidities and co-infections | HCV Co-infections | Liver and/or CHC related co-morbidities | Other Co-morbidities | Kidney Transplantation | Chronic Kidney Disease | Psychiatric Disorders | Diabetes Mellitus | Lipid Disorder | Hypothyroidism | Cardiovascular disease | Hemophilia | Other | |
| ABBVIE REGIMEN ± Ribavirin (RBV) | 58 | 2 | 5 | 57 | 3 | 7 | 3 | 14 | 4 | 17 | 28 | 2 | 40 |
"This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.~Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux." (NCT02851069)
Timeframe: Day 0 to EoT, maximum 24 weeks
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number taking at least 1 co-medication | Beta Blocking Agents | Thyroid Therapy | Vitamins | Angiotensin II Antagonists | Drugs for Peptic Ulcer and GERD | Blood glucose lowering | Diuretics | Analgesics | Calcium Channel Blockers | ACE Inhibitors | Mineral Supplements | Antidepressants | Corticosteroids | Drugs for treatment of bone disease | HMG COA Reductase Inhibitors | Anti-anemic | Antibacterials | Antithrombotic | Dermatologicals | Drugs for Constipation | Immunosuppressive agents | Anti-asthmatics | Insulin and Analogues | Anti-andrenergic Antihypertensives | Anti-arrhythmics | Antidiarrheals | Anti-inflammatory/antirheumatic products | Antineoplastic,immunomodulating agents, cytostatic | Antipsychotics | Antivirals for HIV, combinations | Antivirals, reverse transcriptase inhibitors HIV | Benzodiazepine derivatives | Bile therapy | Blood substitutes/perfusion solutions | Hemostatics/vitamin K | Lipotropics | Other antivirals, HIV treatment | Other Sex hormones | Vasoprotectives | |
| ABBVIE REGIMEN ± Ribavirin (RBV) | 55 | 18 | 17 | 16 | 15 | 13 | 11 | 11 | 9 | 8 | 5 | 5 | 4 | 4 | 4 | 4 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
"For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:~On-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]);~Relapse (defined as HCV RNA <50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment [not more than 7 days shortened]);~Premature study drug discontinuation with no on-treatment virologic failure;~Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data).~Abbreviations: EoT=end of treatment." (NCT02851069)
Timeframe: During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Non-response 12 weeks after EoT | On-treatment virologic failure | Relapse | Premature treatment discontinuation | Missing SVR12 data/None of the above criteria | |
| ABBVIE REGIMEN ± Ribavirin (RBV) | 12.3 | 1.5 | 1.5 | 4.6 | 4.6 |
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 70.6 |
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 1.8 |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0 |
The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 25.9 |
On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02803138)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 1.3 |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02803138)
Timeframe: Up to 48 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0.0 |
"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02803138)
Timeframe: 12 weeks (at least 70 days) after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 95.8 |
Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02803138)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0.0 |
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02803138)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 82.0 |
"PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation" (NCT02807402)
Timeframe: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | -3.94 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | -4.00 |
Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose. (NCT02807402)
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
| Intervention | Participants (Count of Participants) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 263 |
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. (NCT02807402)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin | 98.1 |
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. (NCT02807402)
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin | 99.6 |
"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The core population with sufficient follow-up data regarding SVR12 included all core population participants who~had evaluable HCV RNA data ≥ 70 days after the last actual dose of paritaprevir/ritonavir, ombitasvir and dasabuvir~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of paritaprevir/ritonavir, ombitasvir with dasabuvir due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure." (NCT02807402)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin | 98.5 |
Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. (NCT02807402)
Timeframe: 12 or 24 weeks (depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin | 0.00 |
Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. (NCT02807402)
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin | 0.8 |
(NCT02807402)
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
| Intervention | percentage of days (Mean) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin | 94.5 |
The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication. (NCT02807402)
Timeframe: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Specific Concerns | Specific Necessity | General Overuse | General Harm | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | 0.06 | -0.21 | 0.01 | 0.10 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | -0.26 | -0.07 | 0.01 | -0.02 |
"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| End of Treatment | 12 weeks post treatment | 24 weeks post treatment | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | 0.04 | 0.08 | 0.10 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | 0.07 | 0.09 | 0.09 |
"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. with a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| End of Treatment | 12 weeks post treatment | 24 weeks post treatment | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | 8.36 | 12.7 | 15.2 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | 10.9 | 13.9 | 18.8 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of Treatment | 12 weeks post treatment | 24 weeks post treatment | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | -1.4 | -3.8 | -8.7 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | -1.3 | -15.4 | -7.5 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of Treatment | 12 weeks post treatment | 24 weeks post treatment | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | -8.5 | -10.4 | -9.3 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | -23.3 | -16.7 | -70.0 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of Treatment | 12 weeks post treatment | 24 weeks post treatment | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | -10.4 | -10.5 | -11.5 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | -2.9 | -9.5 | -8.9 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems." (NCT02807402)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of Treatment | 12 weeks post treatment | 24 weeks post treatment | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | -8.7 | -11.5 | -20.7 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | -18.5 | -17.0 | -72.3 |
(NCT02807402)
Timeframe: From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The over all median (minimum, maximum) duration of treatment was 84 (28, 175) days.
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any adverse event | Serious adverse events | Pregnancies | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | 82 | 17 | 0 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | 6 | 3 | 0 |
| Paritaprevir/Ritonavir + Ombitasvir With RBV | 0 | 0 | 0 |
(NCT02807402)
Timeframe: Baseline
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Any comorbidity or coinfection | Any coinfection | Coinfection with human immunodeficiency virus (HIV | Coinfection with hepatitis B virus | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 335 | 9 | 4 | 6 |
"SVR12 non-response was categorized according to the following:~On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death;~Premature treatment discontinuation with no on-treatment virological failure;~Missing SVR12 data and/or none of the above criteria." (NCT02807402)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| On-treatment virologic failure | Relapse | Death | Premature treatment discontinuation | None of the above criteria | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin | 0.2 | 0.8 | 0.6 | 0.2 | 0.2 |
The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Scores range from 0 to 100. Higher scores indicate a higher level of knowledge, skill and confidence. (NCT02615145)
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks)
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| 2 DAA+RBV | 1.91 |
| 3DAA | 0.01 |
| 3DAA+RBV | -0.74 |
(NCT02615145)
Timeframe: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Total | 59.1 |
| 2 DAA+RBV | 64.4 |
| 3DAA | 54.1 |
| 3DAA+RBV | 66.0 |
(NCT02615145)
Timeframe: up to post-treatment Week 48 (treatment period was 12 or 24 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| All Participants | 70.0 |
| Genotype 1 Participants | 69.3 |
| Genotype 1a Participants | 71.0 |
| Genotype 1b Participants | 68.3 |
| Genotype 4 Participants | 76.6 |
RVR4 is defined as participants with HCV RNA < 50 IU/mL at Week 4. (NCT02615145)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| All Participants | 57.0 |
| All Genotype 1 Participants | 57.2 |
| Genotype 1a Participants | 62.1 |
| Genotype 1b Participants | 54.7 |
| Genotype 4 Participants | 55.3 |
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN. (NCT02615145)
Timeframe: 12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| All Participants | 88.1 |
| All Genotype 1 Participants | 88.4 |
| Genotype 1a Participants | 77.9 |
| Genotype 1b Participants | 93.9 |
| Genotype 4 Participants | 85.1 |
SVR24 is defined as HCV RNA < 50 IU/mL 24 Weeks After EoT. (NCT02615145)
Timeframe: 24 Weeks After EoT (treatment period was 12 or 24 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| All Participants | 95.0 |
| All Genotype 1 Participants | 95.4 |
| Genotype 1a Participants | 92.8 |
| Genotype 1b Participants | 96.5 |
| Genotype 4 Participants | 91.9 |
SVR48 is defined as participants with HCV RNA < 50 IU/mL 48 weeks after EoT. (NCT02615145)
Timeframe: 48 Weeks After EoT (treatment period was 12 or 24 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| All Participants | 92.7 |
| Genotype 1 Participants | 93.2 |
| Genotype 1a Participants | 89.0 |
| Genotype 1b Participants | 95.1 |
| Genotype 4 Participants | 88.0 |
Virological response is defined as HCV RNA < 50 IU/mL. End of Treatment (EoT) is defined as the last intake of ABBVIE REGIMEN or RBV. (NCT02615145)
Timeframe: EoT, (treatment period was 12 weeks or 24 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| All Participants | 93.4 |
| All Genotype 1 Participants | 94.8 |
| Genotype 1a Participants | 89.0 |
| Genotype 1b Participants | 97.8 |
| Genotype 4 Participants | 80.9 |
The FACIT-F Scale is a 13-item questionnaire that assesses self-reported fatigue during the past 7 days and its impact upon daily activities and function. Scores range from 0 - 100, with higher scores indicating a lesser degree of fatigue. (NCT02615145)
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT
| Intervention | score on a scale (Least Squares Mean) | ||
|---|---|---|---|
| EoT | 12 Weeks EoT | 48 Weeks EoT | |
| 2 DAA+RBV | 4.17 | 12.5 | 13.3 |
| 3DAA | 6.45 | 9.92 | 9.68 |
| 3DAA+RBV | 4.49 | 10.2 | 10.3 |
"PRISM is a visual quantitative method to assess the perceived burden of suffering due to illness. The distance between the center of the self (yellow disk) and the illness disk (red disk) is called self-illness separation (SIS) and is measured in cm (range is 0 - 27). The smaller the distance, the higher the burden of suffering." (NCT02615145)
Timeframe: Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)
| Intervention | cm (Least Squares Mean) | |
|---|---|---|
| 12 Weeks EoT | 48 Weeks EoT | |
| 2 DAA+RBV | 5.41 | 10.2 |
| 3DAA | 7.05 | 10.1 |
| 3DAA+RBV | 5.31 | 10.3 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment indicates the percentage of general (non-work) activity impairment due to health problems." (NCT02615145)
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
| Intervention | percentage impairment of activity (Mean) | ||
|---|---|---|---|
| EoT | 12 Weeks EoT | 24 Weeks EoT | |
| 2 DAA+RBV | 7.0 | -7.7 | -11.3 |
| 3DAA | -3.0 | -13.3 | -12.3 |
| 3DAA+RBV | -2.8 | -10.5 | -16.3 |
| Total | -2.1 | -11.9 | -13.4 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment indicates the percentage of overall work impairment due to health problems." (NCT02615145)
Timeframe: Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT
| Intervention | percentage of overall work impairment (Mean) | ||
|---|---|---|---|
| EoT | 12 Weeks EoT | 24 Weeks EoT | |
| 2 DAA+RBV | 5.0 | -4.2 | -3.2 |
| 3DAA | 4.4 | -3.8 | -7.2 |
| 3DAA+RBV | 7.5 | -5.4 | -9.7 |
| Total | 5.5 | -4.3 | -7.4 |
Documented by participant interview and/or participant diary. (NCT02615145)
Timeframe: Up to Week 12 or Week 24
| Intervention | days (Mean) |
|---|---|
| ABBVIE REGIMEN | |
| 3DAA | 83 |
Documented by participant interview and/or participant diary. (NCT02615145)
Timeframe: Up to Week 12 or Week 24
| Intervention | days (Mean) | |
|---|---|---|
| ABBVIE REGIMEN | RBV | |
| 2 DAA+RBV | 84 | 84 |
| 3DAA+RBV | 84 | 81 |
| Total | 83 | 81 |
"The number of participants meeting the following SVR12 non-response categories:~On-treatment virological failure (breakthrough) defined >= 1 documented HCV RNA < 50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value >= 50 IU/mL)~Relapse defined as HCV RNA < 50 IU/mL at EoT followed by HCV RNA >= 50 IU/mL post-treatment in participants who completed treatment (<= 7 days shortened)." (NCT02615145)
Timeframe: Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| On-Treatment Virological Failure | Relapse | |
| All Genotype 1 Participants | 3 | 5 |
| All Participants | 6 | 5 |
| Genotype 1a Participants | 3 | 1 |
| Genotype 1b Participants | 0 | 4 |
| Genotype 4 Participants | 3 | 0 |
An adverse event (AE) is defined as any untoward medical occurrence. If an AE meets any of the following criteria, it is considered serious: results in death, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in significant disability/incapacity, or is an important medical event. TEAEs are defined as any reported event that begins or worsens in severity after initiation of study drug through 30 days post-study drug dosing. (NCT02615145)
Timeframe: up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| ≥ 1 TEAE | ≥ 1 Serious TEAE | Pregnancy | |
| 2 DAA+RBV | 16 | 1 | 0 |
| 3DAA | 65 | 7 | 0 |
| 3DAA+RBV | 43 | 5 | 0 |
| Total | 124 | 13 | 0 |
Planned duration of treatment was 12 or 24 weeks. (NCT02615145)
Timeframe: Up to Week 12 or Week 24
| Intervention | percentage of planned treatment duration (Mean) | |
|---|---|---|
| ABBVIE REGIMEN | RBV | |
| All Genotype 1 Participants | 98.6 | 94.1 |
| All Participants | 98.7 | 95.4 |
| Genotype 1a Participants | 97.7 | 95.3 |
| Genotype 1b Participants | 99.1 | 83.5 |
| Genotype 4 Participants | 99.8 | 99.8 |
"PAM-13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating that the participant is likely to participate more actively in health care processes and takes more responsibility for his or her health." (NCT02636608)
Timeframe: Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | 0.85 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | 0.22 |
(NCT02636608)
Timeframe: Up to post treatment week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 179 |
Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. (NCT02636608)
Timeframe: 12 or 24 weeks (depending on the treatment regimen)
| Intervention | Participants (Count of Participants) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 0 |
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure. (NCT02636608)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 94.5 |
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. (NCT02636608)
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 97.1 |
Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. (NCT02636608)
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 1.3 |
"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.~The Core population with sufficient follow-up data regarding SVR24 included all core population participants who~had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure." (NCT02636608)
Timeframe: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 96.6 |
(NCT02636608)
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
| Intervention | percentage of days (Mean) |
|---|---|
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 93.1 |
"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status." (NCT02636608)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | 0.02 | 0.04 | 0.04 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | 0.02 | 0.03 | 0.04 |
"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status." (NCT02636608)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir With RBV | 2.77 | 5.98 | 6.07 |
| Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir Without RBV | 5.70 | 9.18 | 10.5 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems." (NCT02636608)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | -2.1 | -1.7 | 1.0 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems." (NCT02636608)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 0.6 | -5.7 | -7.3 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems." (NCT02636608)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | -0.5 | -6.7 | -8.5 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems." (NCT02636608)
Timeframe: Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks after end of treatment | 24 weeks after end of treatment | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | -2.3 | -8.1 | -7.3 |
Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose. (NCT02636608)
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| Any concomitant medication | Beta blocking agents | ACE inhibitors | Diuretics | Peptic ulcer / gastro-oesophageal reflux disease | Calcium channel blockers | Blood glucose-lowering drugs | Mineral supplements | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 169 | 78 | 53 | 42 | 42 | 34 | 27 | 25 |
(NCT02636608)
Timeframe: From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen)
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Adverse events | Serious adverse events | Pregnancies | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 29 | 6 | 0 |
"SVR12 non-response was categorized according to the following:~On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death;~Premature treatment discontinuation with no on-treatment virologic failure;~None of the above criteria or missing SVR12 data" (NCT02636608)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| On-treatment virologic failure | Relapse | Death | Premature treatment discontinuation | None of the above criteria | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 2 | 3 | 3 | 2 | 3 |
"Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration) * 100" (NCT02636608)
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| > 105% | > 95% to ≤ 105% | > 80% to ≤ 95% | > 50% to ≤ 80% | ≤ 50% | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 1.0 | 78.1 | 5.7 | 6.7 | 8.6 |
"Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration) * 100~The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir." (NCT02636608)
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| > 105% | > 95% to ≤ 105% | > 80% to ≤ 95% | > 50% to ≤ 80% | ≤ 50% | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 3.4 | 93.7 | 0.8 | 0.8 | 1.3 |
"At the end of treatment visit participants were asked to indicate which of the following PSP services they had used:~Personal support (e.g., Care Coach)~Printed educational material~Online educational materials~Web-portal~App" (NCT02636608)
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen)
| Intervention | Participants (Count of Participants) | ||||||
|---|---|---|---|---|---|---|---|
| Any | Personal support | Printed educational material | Online educational material | Web-portal | App | None/missing | |
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 141 | 134 | 128 | 58 | 65 | 54 | 38 |
At the end of treatment visit participants were asked to indicate their level of satisfaction with each of the PSP services they had used. (NCT02636608)
Timeframe: End of treatment (weeks 12 or 24 depending on treatment regimen)
| Intervention | Participants (Count of Participants) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Personal support72564016 | Printed educational material72564016 | Online educational material72564016 | Web-portal72564016 | App72564016 | ||||||||||||||||
| Good | Satisfactory | Poor | Very good | |||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 95 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 33 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 6 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 50 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 42 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 11 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 21 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 27 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 24 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 23 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 8 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 1 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 14 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 31 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 2 | |||||||||||||||||||
| Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin | 0 | |||||||||||||||||||
Concomitant medication other than for chromic hepatitis C used from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose. (NCT02640547)
Timeframe: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen
| Intervention | Participants (Count of Participants) |
|---|---|
| 2 DAA + RBV | 10 |
| 3 DAA Without RBV | 103 |
| 3 DAA + RBV | 64 |
Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. (NCT02640547)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Genotype 1 (Total) | 96.8 |
| Genotype 1a | 100.0 |
| Genotype 1b | 96.6 |
| Genotype 4 | 95.0 |
Sustained virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. (NCT02640547)
Timeframe: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Genotype 1 (Total) | 96.3 |
| Genotype 1a | 100.0 |
| Genotype 1b | 96.0 |
| Genotype 4 | 95.0 |
Virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL. (NCT02640547)
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Genotype 1 (Total) | 95.5 |
| Genotype 1a | 100.0 |
| Genotype 1b | 95.1 |
| Genotype 4 | 100.0 |
"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The core population with sufficient follow-up data regarding SVR12 included all core population participants who~had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE regimen,~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE regimen due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure." (NCT02640547)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Genotype 1 (Total) | 97.6 |
| Genotype 1a | 100.0 |
| Genotype 1b | 97.4 |
| Genotype 4 | 95.0 |
"Rapid virological response at week 4 (RVR4) was defined as participants with HCV RNA < 50 IU/mL at week 4.~Due to the non-interventional character of the study, many participants did not have an HCV RNA assessed at treatment week 4 since this is not generally recommended in the label. Participants with missing data at the RVR4 time point were considered as virological failures." (NCT02640547)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Genotype 1 (Total) | 3.7 |
| Genotype 1a | 0.0 |
| Genotype 1b | 4.0 |
| Genotype 4 | 5.0 |
Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment. (NCT02640547)
Timeframe: 12 or 24 weeks (depending on the treatment regimen)
| Intervention | percentage of participants (Number) |
|---|---|
| Genotype 1 (Total) | 0.0 |
| Genotype 1a | 0.0 |
| Genotype 1b | 0.0 |
| Genotype 4 | 0.0 |
Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment. (NCT02640547)
Timeframe: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.
| Intervention | percentage of participants (Number) |
|---|---|
| Genotype 1 (Total) | 0.6 |
| Genotype 1a | 0.0 |
| Genotype 1b | 0.6 |
| Genotype 4 | 0.0 |
"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status." (NCT02640547)
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks post treatment | 24 weeks post treatment | |
| 2 DAA + RBV | 0.06 | 0.07 | 0.05 |
| 3 DAA + RBV | 0.04 | 0.04 | 0.04 |
| 3 DAA Without RBV | 0.04 | 0.05 | 0.07 |
"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. with a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)." (NCT02640547)
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| End of treatment | 12 weeks post treatment | 24 weeks post treatment | |
| 2 DAA + RBV | 4.10 | 7.93 | 6.54 |
| 3 DAA + RBV | 5.13 | 7.01 | 9.20 |
| 3 DAA Without RBV | 7.41 | 9.11 | 11.8 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems." (NCT02640547)
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks post treatment
| Intervention | percent impairment (Median) | ||
|---|---|---|---|
| End of treatment | 12 weeks post treatment | 24 weeks post treatment | |
| 2 DAA + RBV | 0.0 | 0.0 | 0.0 |
| 3 DAA + RBV | 0.0 | 0.0 | 0.0 |
| 3 DAA Without RBV | 0.0 | 0.0 | 0.0 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems." (NCT02640547)
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Median) | ||
|---|---|---|---|
| End of treatment | 12 weeks post treatment | 24 weeks post treatment | |
| 2 DAA + RBV | -5.0 | -5.0 | -10.0 |
| 3 DAA + RBV | 0.0 | 0.0 | 0.0 |
| 3 DAA Without RBV | 0.0 | 0.0 | -10.0 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems." (NCT02640547)
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Median) | ||
|---|---|---|---|
| End of treatment | 12 weeks post treatment | 24 weeks post treatment | |
| 2 DAA + RBV | 0.0 | 0.0 | -5.0 |
| 3 DAA + RBV | 0.0 | 0.0 | 0.0 |
| 3 DAA Without RBV | 0.0 | 0.0 | -10.0 |
"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems." (NCT02640547)
Timeframe: Baseline, end of treatment, and at 12 and 24 weeks after end of treatment
| Intervention | percent impairment (Median) | ||
|---|---|---|---|
| End of treatment | 12 weeks post treatment | 24 weeks post treatment | |
| 2 DAA + RBV | -5.0 | -5.0 | -10.0 |
| 3 DAA + RBV | 0.0 | 0.0 | 0.0 |
| 3 DAA Without RBV | 0.0 | 0.0 | -10.0 |
(NCT02640547)
Timeframe: From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any adverse event | Serious adverse events | Pregnancies | |
| 2 DAA + RBV | 8 | 3 | 0 |
| 3 DAA + RBV | 42 | 8 | 0 |
| 3 DAA Without RBV | 19 | 3 | 0 |
(NCT02640547)
Timeframe: Baseline
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Any comorbidity or coinfection | Any coinfection | Coinfection with human immunodeficiency virus (HIV | Coinfection with hepatitis B virus | |
| Genotype 1 (Total) | 224 | 15 | 8 | 8 |
| Genotype 1a | 10 | 2 | 2 | 0 |
| Genotype 1b | 214 | 13 | 6 | 8 |
| Genotype 4 | 16 | 4 | 4 | 0 |
"SVR12 non-response was categorized according to the following:~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death;~Premature treatment discontinuation with no on-treatment virological failure;~Missing SVR12 data and/or none of the above criteria." (NCT02640547)
Timeframe: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Relapse | Death | Premature treatment discontinuation | Missing SVR12 data/None of the above | |
| Genotype 1 (Total) | 0.5 | 1.6 | 0.3 | 0.8 |
| Genotype 1a | 0.0 | 0.0 | 0.0 | 0.0 |
| Genotype 1b | 0.6 | 1.7 | 0.3 | 0.9 |
| Genotype 4 | 0.0 | 0.0 | 5.0 | 0.0 |
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 1.6 |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 1.9 |
The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 5.8 |
On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 1.6 |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02581163)
Timeframe: Up to 48 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 2.3 |
Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02581163)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0.3 |
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02581163)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 92.9 |
"SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02581163)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Core population (CP) | CPSFU12 | |
| Participants With HCV Genotype 1 or 4 | 87.7 | 93.8 |
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02582671)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 | 2.0 |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02582671)
Timeframe: Up to 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 | 0 |
The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. (NCT02582671)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 | 1.0 |
On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02582671)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 | 0 |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02582671)
Timeframe: From the end of treatment through the end of study (maximum of 48 weeks post-treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 | 0 |
Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02582671)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 | 0 |
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02582671)
Timeframe: Up to 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 | 97.0 |
"SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02582671)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Core population (CP) | CPSFU12 | |
| Participants With HCV Genotype 1 | 97.0 | 98.0 |
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 2.1 |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 2.1 |
The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented. (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 6.6 |
On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 1.3 |
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02581189)
Timeframe: Up to 48 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 2.6 |
Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02581189)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0.9 |
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02581189)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 93.8 |
"SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02581189)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Core population (CP) | CPSFU12 | |
| Participants With HCV Genotype 1 or 4 | 86.6 | 94.1 |
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure. (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 2.3 |
Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment. (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0.9 |
The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response was documented. (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 3.8 |
On-treatment virologic failure was defined as breakthrough (at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0.5 |
Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL. (NCT02725866)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0.9 |
Viral breakthrough was defined as at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment. (NCT02725866)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 0.0 |
Virologic response was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment. (NCT02725866)
Timeframe: Up to 24 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Participants With HCV Genotype 1 or 4 | 93.9 |
"SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure" (NCT02725866)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Core population (CP) | CPSFU12 | |
| Participants With HCV Genotype 1 or 4 | 91.1 | 95.6 |
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 |
The percentage of participants with hemoglobin <10 g/dL during treatment is provided. (NCT02609659)
Timeframe: up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA + RBV 600 mg | 0 |
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment. (NCT02609659)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA + RBV 600 mg | 1.0 |
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, excluding reinfection, among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02609659)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA + RBV 600 mg | 4.1 |
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) |
|---|---|
| 3-DAA + RBV 600 mg | 89.5 |
The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided. (NCT02609659)
Timeframe: Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)
| Intervention | g/L (Mean) | ||||
|---|---|---|---|---|---|
| Week 2 | Week 4 | Week 8 | Week 12 | Final Treatment Visit | |
| 3-DAA + RBV 600 mg | -6.4 | -8.9 | -11.2 | -12.4 | -12.1 |
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 |
(NCT02346721)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL 12 Weeks | 0.9 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02346721)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL 12 Weeks | 97.3 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02346721)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL 12 Weeks | 0.9 |
(NCT02346721)
Timeframe: Baseline 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 12 Weeks | -4.23 | -4.79 | -5.10 | -5.11 | -5.11 | -5.11 | -5.11 |
(NCT02346721)
Timeframe: Baseline to Week 12
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | |
| SOF/VEL 12 Weeks | 18.0 | 55.0 | 94.6 | 99.1 | 100.0 | 100.0 | 100.0 |
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02346721)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| SOF/VEL 12 Weeks | 98.2 | 97.3 |
The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters (NCT01439373)
Timeframe: 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1)
| Intervention | L/h (Geometric Mean) |
|---|---|
| GSK2336805 60 mg | 18.27 |
The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported. (NCT01439373)
Timeframe: Up to 42 days
| Intervention | Participants (Count of Participants) |
|---|---|
| GSK2336805 60 mg + PEG + RIBA | 0 |
| Placebo + PEG + RIBA | 0 |
The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed by nominal analysis was reported. (NCT01439373)
Timeframe: Day 28
| Intervention | Posterior probability (Mean) |
|---|---|
| GSK2336805 60 mg + PEG + RIBA | 0.67 |
| Placebo + PEG + RIBA | 0.21 |
The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed was reported. (NCT01439373)
Timeframe: Day 28
| Intervention | Posterior probability (Mean) |
|---|---|
| GSK2336805 60 mg + PEG + RIBA | 0.62 |
| Placebo + PEG + RIBA | 0.21 |
Blood samples for determination of HCV RNA levels were collected at immediately prior to and 1, 2, 4, 6, and 8 and 24 h after the first dose in Part 1 (Day 1). Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value. Virus RNA levels reported as <43 are undetectable levels. If the result for HCV RNA (IU/ML) was <43, then change from Baseline was calculated using 42, and the change from Baseline on the log scale was calculated using log (42). (NCT01439373)
Timeframe: Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h)
| Intervention | Log IU/mL (Mean) | |||||
|---|---|---|---|---|---|---|
| 1 h post-dose | 2 h post-dose | 4 h post-dose | 6 h post-dose | 8 h post-dose | 24 h post-dose | |
| GSK2336805 60 mg (Part A) | 0.02 | -0.03 | -0.70 | -1.37 | -1.83 | -2.38 |
| Placebo (Part A) | -0.01 | -0.00 | -0.07 | 0.08 | 0.07 | -0.11 |
Single 12-lead electrocardiogram (ECG) was obtained. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. QTc Interval was calculated using Frederica correction formula: QTcF = QT / (RR)^1/3. Change from Baseline was calculated by subtracting the Baseline assessment value from post Baseline visit value. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. The change from Baseline in QTc Interval at Day 2 and 28 were reported. (NCT01439373)
Timeframe: Baseline (Day 1, Pre-dose ), Day 2 and Day 28
| Intervention | msec (Mean) | |
|---|---|---|
| DAY 2 | DAY 28 | |
| GSK2336805 60 mg + PEG + RIBA | 0.01 | -5.15 |
| Placebo + PEG + RIBA | 0.82 | 9.13 |
Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value. (NCT01439373)
Timeframe: Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42
| Intervention | Units per litre (U/L) (Mean) | ||||
|---|---|---|---|---|---|
| Day 7 | Day 14 | Day 21 | Day 28 | Follow-up (Day 42) | |
| GSK2336805 60 mg + PEG + RIBA | -15.3 | -25.7 | -25.9 | -24.4 | -19.5 |
| Placebo + PEG + RIBA | -15.0 | -0.5 | -10.0 | 7.0 | -19.5 |
AUC values were determined using the linear-up, log-down trapezoidal rule. The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were below quantification limit (BLQ) before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters. (NCT01439373)
Timeframe: 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2)
| Intervention | Nanogram (ng)*h/mL (Geometric Mean) | |
|---|---|---|
| AUC (0-24) | AUC(0-inf) | |
| GSK2336805 60 mg (Part A) | 2977.79 | 3284.90 |
Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. (NCT01439373)
Timeframe: Baseline (Day 1, Pre -dose ) and Day 2 (24 h, post-dose), Day 28
| Intervention | Log IU/mL (Mean) | |
|---|---|---|
| Day 2, 24 h post-dose | Day 28, Pre or Post AM dose | |
| GSK2336805 60 mg + PEG + RIBA | -2.38 | -4.78 |
| Placebo + PEG + RIBA | -0.11 | -1.99 |
The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by non-compartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters. (NCT01439373)
Timeframe: 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1)
| Intervention | ng/mL (Geometric Mean) | |
|---|---|---|
| Cmax | C24 | |
| GSK2336805 60 mg (Part A) | 404.84 | 26.98 |
The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters. (NCT01439373)
Timeframe: 0 (pre-dose), 0 to 2 h, > 2 h up to 4 h, > 4 h up to 6 h, or > 6 h up to 10 h on Days 7, 14, 21 and 28
| Intervention | ng/ml (Geometric Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 7, Predose | Day 7, >2 to 4 h | Day 7, >4 to 6 h | Day 14, Predose | Day 14, >0 to 2 h | Day 14, >2 to 4 h | Day 14, >4 to 6 h | Day 21, Predose | Day 21, >2 to 4 h | Day 21, >4 to 6 h | Day 21, >6 to 10 h | Day 28, Predose | Day 28, >0 to 2 h | Day 28, >2 to 4 h | |
| GSK2336805 60 mg (Part A) | 37.80 | 621.40 | 314.19 | 121.57 | 518.82 | 364.75 | 304.03 | 484.18 | 346.00 | 546.72 | 317.49 | 16.95 | 607.02 | 402.05 |
Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. (NCT01439373)
Timeframe: Baseline (Day 1, pre-dose), Day 2 (24 h, Post-dose) and Day 28
| Intervention | Log IU/mL (Mean) | ||
|---|---|---|---|
| Day 1, Pre-dose, | Day 2, 24 h post-dose | Day 28, Pre or Post ante meridian (AM) dose | |
| GSK2336805 60 mg + PEG + RIBA | 6.61 | 4.23 | 1.80 |
| Placebo + PEG + RIBA | 5.43 | 5.33 | 3.44 |
Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels. (NCT01439373)
Timeframe: Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42
| Intervention | U/L (Median) | |||||
|---|---|---|---|---|---|---|
| Baseline | Day 7 | Day 14 | Day 21 | Day 28 | Follow-up (Day 42) | |
| GSK2336805 60 mg + PEG + RIBA | 56.0 | 41.5 | 28.0 | 27.0 | 28.0 | 29.0 |
| Placebo + PEG + RIBA | 43.5 | 37.0 | 48.5 | 39.0 | 48.0 | 27.0 |
The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters (NCT01439373)
Timeframe: 0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2)
| Intervention | h (Median) | |
|---|---|---|
| Tmax | Tlag | |
| GSK2336805 60 mg (Part A) | 2.00 | 0.00 |
RVR was defined as the proportion of participants below the assay lower limit of detection (LOD) <18 International units per milliliter (IU/mL) for Hepatitis C virus (HCV) ribonucleic acid (RNA) after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure . Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants. (NCT01439373)
Timeframe: Day 28
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| HCV RNA >= Low Limit of Quantification (LLOQ) | Undetectable HCV RNA | |
| GSK2336805 60 mg + PEG + RIBA | 3 | 8 |
| Placebo + PEG + RIBA | 3 | 1 |
RVR was defined as the proportion of participants LOD <18 IU/mL for HCV RNA after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure. Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants. The primary and supportive analysis differs from the nominal analysis as supportive analysis is assessed at Day 28 ± 2 (2 days visit window) whereas, the nominal analysis was assessed at Day 28. (NCT01439373)
Timeframe: Day 28
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Undetectable HCV RNA | HCV RNA >= LLOQ | |
| GSK2336805 60 mg + PEG + RIBA | 7 | 4 |
| Placebo + PEG + RIBA | 1 | 3 |
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (NCT01439373)
Timeframe: Up to Day 28
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any AE | Any SAE | |
| GSK2336805 60 mg + PEG + RIBA | 11 | 0 |
| Placebo + PEG + RIBA | 4 | 0 |
Serum for determination of HCV genotype was collected at the screening visit. Genotype was determined by the VERSANT HCV genotype 2.0 Assay (LiPA). Number of participants with HCV genotype 1 were reported. (NCT01439373)
Timeframe: Day 7, 14 and 21
| Intervention | Participants (Count of Participants) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Day 7, Undetectable HCV RNA | Day 7, Detectable HCV RNA but < LLOQ | Day 7, HCV RNA >= LLOQ | Day 14, Undetectable HCV RNA | Day 14, Detectable HCV RNA but < LLOQ | Day 14, HCV RNA >= LLOQ | Day 21, Undetectable HCV RNA | Day 21, Detectable HCV RNA but < LLOQ | Day 21, HCV RNA >= LLOQ | |
| GSK2336805 60 mg + PEG + RIBA | 1 | 1 | 9 | 4 | 2 | 5 | 7 | 1 | 3 |
| Placebo + PEG + RIBA | 0 | 0 | 4 | 0 | 0 | 4 | 0 | 0 | 4 |
Abnormalities were graded according to the modified DAIDS version 1.0. Shift from Baseline to worst post Baseline toxicity grade were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Clinical chemistry parameters were alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, creatine phosphokinase, total CO2, chloride, creatinine, glucose, sodium, phosphate, potassium, total albumin, total bilirubin, and direct bilirubin. Only participants with change in toxicity grades are reported. (NCT01439373)
Timeframe: Baseline (Day 1) and 28
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alanine aminotransferase, No toxicity | Alanine aminotransferase, Grade 1 | Albumin, No toxicity | Albumin, Grade 1 | Aspartate aminotransferase, No toxicity | Aspartate aminotransferase, Grade 1 | Aspartate aminotransferase, Grade 2 | Total Bilirubin, No toxicity | Total Bilirubin, Grade 1 | Total Bilirubin, Grade 2 | Carbon dioxide, No toxicity | Carbon dioxide, Grade 1 | Creatine phosphokinase, No toxicity | Creatine phosphokinase, Grade 1 | Glucose, No toxicity | Glucose, Grade 1 | Glucose, Grade 2 | Phosphorus, inorganic, No toxicity | Phosphorus, inorganic, Grade 1 | Phosphorus, inorganic, Grade 2 | Potassium, No toxicity | Potassium, Grade 1 | Sodium, No toxicity | Sodium, Grade 2 | |
| GSK2336805 60 mg + PEG + RIBA | 11 | 0 | 11 | 0 | 8 | 1 | 0 | 9 | 2 | 0 | 8 | 1 | 10 | 1 | 5 | 4 | 1 | 8 | 2 | 1 | 10 | 1 | 9 | 2 |
| Placebo + PEG + RIBA | 2 | 1 | 3 | 1 | 1 | 1 | 1 | 3 | 0 | 1 | 1 | 1 | 4 | 0 | 4 | 0 | 0 | 4 | 0 | 0 | 3 | 0 | 4 | 0 |
Laboratory abnormalities were graded according to the modified division of AIDS ( DAIDS）version 1.0. Shift from Baseline to worst post baseline toxicity grade (where applicable) were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Hematology parameters were red blood cell, hemoglobin, hematocrit, platelet white blood cell count with differential leukocyte count, mean corpuscular volume, prothrombin time and international normalized ratio. (NCT01439373)
Timeframe: Baseline (Day 1) to Day 28
| Intervention | Participants (Count of Participants) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin, No toxicity | Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | International normalized ratio, No toxicity | International normalized ratio, Grade 1 | Lymphocytes absolute, No toxicity | Lymphocytes absolute, Grade 4 | Platelet count, No toxicity | Platelet count, Grade 1 | Platelet count, Grade 2 | Prothrombin time, No toxicity | Prothrombin time, Grade 1 | Total neutrophils, absolute, No toxicity | Total neutrophils, absolute, Grade 1 | Total neutrophils, absolute, Grade 2 | Total neutrophils, absolute, Grade 3 | White cell count, No toxicity | White cell count, Grade 1 | White cell count, Grade 2 | |
| GSK2336805 60 mg + PEG + RIBA | 7 | 3 | 1 | 10 | 1 | 10 | 1 | 10 | 1 | 0 | 10 | 1 | 7 | 1 | 2 | 1 | 8 | 2 | 1 |
| Placebo + PEG + RIBA | 3 | 1 | 0 | 3 | 1 | 4 | 0 | 3 | 0 | 1 | 3 | 1 | 2 | 2 | 0 | 0 | 3 | 1 | 0 |
The urinalysis parameters analyzed were Leukocyte esterase, bilirubin, occult blood, glucose, ketones, nitrite, pH, specific gravity and dipstick assessments. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important urinalysis findings at specified visit were reported. Visits where no abnormal values were observed not reported. (NCT01439373)
Timeframe: Day 14, 28, Follow-up (Day 42)
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Occult blood, Day 14 | Occult blood, Follow-up | Ketone, Day 14 | Nitrate, Day 14 | Leukocytes, Day 14 | |
| GSK2336805 60 mg + PEG + RIBA | 0 | 0 | 1 | 1 | 1 |
| Placebo + PEG + RIBA | 1 | 1 | 2 | 1 | 1 |
Change from baseline in log10 HCV RNA at scheduled sampling time. (NCT01359644)
Timeframe: Baseline, Follow-up week 24
| Intervention | IU/mL (Mean) | |
|---|---|---|
| Baseline | Change at Follow-up week 24 | |
| Treatment A: Sofosbuvir + Daclatasvir | 1.28 | -5.19 |
| Treatment B: Sofosbuvir + Daclatasvir | 0.95 | -5.23 |
| Treatment C: Sofosbuvir + Daclatasvir | 0.95 | -5.67 |
| Treatment D: Sofosbuvir + Daclatasvir | 0.98 | -5.83 |
| Treatment E: Sofosbuvir + Daclatasvir + Ribavirin | 0.95 | -5.77 |
| Treatment F: Sofosbuvir + Daclatasvir + Ribavirin | 0.95 | -5.61 |
| Treatment G: Sofosbuvir + Daclatasvir | 0.95 | -5.19 |
| Treatment H: Sofosbuvir + Daclatasvir + Ribavirin | 0.95 | -5.48 |
| Treatment I: Sofosbuvir + Daclatasvir | 0.95 | -5.39 |
| Treatment J: Sofosbuvir + Daclatasvir + Ribavirin | 0.95 | -5.36 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe. (NCT01359644)
Timeframe: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Deaths | SAEs | AEs leading to discontinuation | Gr 3 Phosporus | Gr 3 Fasting serum glucose | Gr 3 Serum glucose | Gr 3 Total cholesterol | Gr 3 Uric acid | |
| Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks) | 0 | 1 | 0 | 3 | 0 | 0 | 1 | 1 |
| Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks) | 0 | 6 | 1 | 1 | 1 | 2 | 0 | 0 |
| Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks) | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks) | 0 | 7 | 1 | 1 | 2 | 1 | 1 | 0 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe (NCT01359644)
Timeframe: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Deaths | SAEs | Grade 3-4 Lab Abnormalities: Serum glucose | |
| Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks) | 0 | 2 | 1 |
| Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks) | 0 | 4 | 0 |
| Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks) | 0 | 2 | 0 |
| Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks) | 0 | 4 | 0 |
Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment. (NCT01359644)
Timeframe: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| DCV/SOF with ribavirin (n=56, 14, 20) | DCV/SOF without ribavirin (n=70, 30, 21) | |
| Telaprevir or Boceprevir Failures With Genotype 1 | 0 | 0 |
| Treatment-naive Participants With Genotype 1 | 0 | 1.4 |
| Treatment-naive Participants With Genotype 2 or 3 | 0 | 3.3 |
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir. (NCT01359644)
Timeframe: Follow-up Week 12
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| DCV/SOF with ribavirin (n=56, 14, 20) | DCV/SOF without ribavirin (n=70, 30, 21) | DCF/SOF All | |
| Telaprevir or Boceprevir Failures With Genotype 1 | 95.0 | 100.0 | 97.6 |
| Treatment-naive Participants With Genotype 1 | 96.4 | 100.0 | 98.4 |
| Treatment-naive Participants With Genotype 2 or 3 | 85.7 | 93.3 | 90.9 |
SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir. (NCT01359644)
Timeframe: Follow-up Week 24
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| DCV/SOF with ribavirin (n=56, 14, 20) | DCV/SOF without ribavirin (n=70, 30, 21) | DCV/SOF All | |
| Telaprevir/Boceprevir Failures With Genotype 1 | 100.0 | 100.0 | 100.0 |
| Treatment-naive Participants With Genotype 1 | 94.6 | 95.7 | 95.2 |
| Treatment-naive Participants With Genotype 2 or 3 | 92.9 | 93.3 | 93.2 |
Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8. (NCT01359644)
Timeframe: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| DCV/SOF with ribavirin (n=56, 14, 20) | DCV/SOF without ribavirin (n=70, 30, 21) | |
| Telaprevir or Boceprevir Failures With Genotype 1 | 0 | 0 |
| Treatment-naive Participants With Genotype 1 | 0 | 0 |
| Treatment-naive Participants With Genotype 2 or 3 | 0 | 3.3 |
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 [Group B] or ABT-450/ritonavir plus ABT-267 [Groups C + D + J]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L). (NCT01464827)
Timeframe: Post-Treatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Group B | 82.9 |
| Groups C + D + J | 88.7 |
| Groups F + G + K + L | 95.2 |
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with or without ribavirin (Group E versus Groups F + G + K + L). (NCT01464827)
Timeframe: Post-Treatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Group E | 88.6 |
| Groups F + G + K + L | 95.2 |
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N). (NCT01464827)
Timeframe: Post-Treatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Group A | 87.5 |
| Groups F + G + K + L | 95.2 |
| Groups H + I + M + N | 92.7 |
"The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G)." (NCT01464827)
Timeframe: Post Treatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Group A | 87.5 |
| Group B | 82.9 |
| Group C | 84.6 |
| Group D | 92.5 |
| Group E | 88.6 |
| Group F | 97.4 |
| Group G | 95.0 |
| Group H | 92.5 |
| Group I | 90.0 |
| Group J | 88.9 |
| Group K | 91.3 |
| Group L | 95.5 |
| Group M | 91.3 |
| Group N | 100.0 |
This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N). (NCT01464827)
Timeframe: Post-Treatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Groups F + G + H + I | 93.7 |
| Groups K + L + M + N | 94.3 |
"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either:~Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention." (NCT01464827)
Timeframe: From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Any adverse event | Any adverse event at least possibly DAA-related | Any severe adverse event | Any serious adverse event | Any AE leading to discontinuation of study drug | Any AE leading to interruption of study drug | Any AE leading to ribavirin dose modification | Any fatal adverse events | |
| Group A | 67 | 58 | 3 | 0 | 1 | 0 | 2 | 0 |
| Group B | 36 | 29 | 0 | 0 | 0 | 1 | 2 | 0 |
| Group C + D | 71 | 53 | 3 | 2 | 0 | 2 | 4 | 0 |
| Group E | 68 | 51 | 5 | 2 | 0 | 1 | 0 | 0 |
| Group F + G | 71 | 57 | 3 | 1 | 3 | 0 | 9 | 0 |
| Group H + I | 77 | 68 | 3 | 1 | 3 | 1 | 10 | 0 |
| Group J | 42 | 35 | 1 | 0 | 1 | 0 | 3 | 0 |
| Group K + L | 39 | 30 | 1 | 0 | 0 | 0 | 1 | 0 |
| Group M + N | 37 | 28 | 1 | 2 | 1 | 0 | 3 | 0 |
cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory (NCT01016912)
Timeframe: At Week 12 on treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | 62.5 |
| Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive) | 77.8 |
| Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive) | 100.0 |
| Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders) | 55.6 |
| Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders) | 55.6 |
eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory. (NCT01016912)
Timeframe: At Weeks 4 and 12 on treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | 0 |
| Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive) | 66.7 |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment Naive) | 80.0 |
| Daclatasvir 10- mg + pegINFα + Ribavirin (Nonresponders) | 55.6 |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders) | 22.2 |
RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory . (NCT01016912)
Timeframe: At Week 4 on treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | 0 |
| Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive) | 77.8 |
| Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive) | 80.0 |
| Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders) | 55.6 |
| Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders) | 33.3 |
Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN. (NCT01016912)
Timeframe: From baseline to 30 days after last dose of study drug
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Hemoglobin | Lymphocytes | Neutrophils | WBC | ALT | AST | Total bilirubin | |
| Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders) | 3 | 3 | 2 | 2 | 0 | 0 | 0 |
| Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive) | 0 | 2 | 4 | 1 | 1 | 1 | 1 |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | 0 | 2 | 0 | 0 | 1 | 1 | 0 |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Treatment-naive) | 1 | 3 | 2 | 0 | 0 | 0 | 0 |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | 1 | 2 | 2 | 1 | 0 | 0 | 0 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. (NCT01016912)
Timeframe: From baseline to 30 days after last dose of study drug
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| SAEs | Discontinuation due to AEs | Treatment-related AEs | Death | |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | 0 | 1 | 9 | 0 |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | 1 | 0 | 9 | 0 |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | 0 | 1 | 10 | 0 |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | 0 | 0 | 9 | 0 |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | 0 | 0 | 8 | 0 |
SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory . (NCT01016912)
Timeframe: Follow-up Weeks 4, 12, and 24
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| SVR4: Follow-up Week 4 | SVR12: Follow-up Week 12 | SVR24: Follow-up Week 24 | |
| Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders) | 22.2 | 22.2 | 22.2 |
| Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive) | 66.7 | 66.7 | 66.7 |
| Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders) | 33.3 | 33.3 | 33.3 |
| Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive) | 90.0 | 90.0 | 90.0 |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | 75.0 | 62.5 | 62.5 |
Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment. (NCT01016912)
Timeframe: From on-treatment Week 1 to Follow-up Week 24
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Virologic failure | Virologic breakthrough | Relapse | |
| Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders) | 77.8 | 44.4 | 33.3 |
| Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive) | 33.3 | 11.1 | 11.1 |
| Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive) | 10.0 | 0.0 | 10.0 |
| Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders) | 66.7 | 44.4 | 22.2 |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | 37.5 | 12.5 | 25.0 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01715415)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 96.0 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01715415)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 96.7 |
Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline. (NCT01715415)
Timeframe: At 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 96.9 |
| Placebo | 12.8 |
Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment. (NCT01715415)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 0 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01715415)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 96.3 |
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. (NCT01715415)
Timeframe: Within 12 weeks post-treatment
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 2.4 |
Assessment for discontinuation due to adverse events and serious adverse events, as addressed by adverse events and laboratory tests. Final study visit is 12 weeks after treatment. (NCT02858180)
Timeframe: 12 weeks after completing treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Heart Failure Cohort | 0 |
| Lung Disease Cohort | 0 |
The primary safety endpoint is the number of subjects who complete a full course of therapy. (NCT02858180)
Timeframe: 24 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Heart Failure Cohort | 0 |
| Lung Disease Cohort | 1 |
The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 12 weeks after completing therapy. (NCT02858180)
Timeframe: 12 weeks after completing treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Heart Failure Cohort | 10 |
| Lung Disease Cohort | 3 |
The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 4 weeks after completing treatment. (NCT02858180)
Timeframe: 4 weeks after completing treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Heart Failure Cohort | 8 |
| Lung Disease Cohort | 3 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01716585)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 95.7 |
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. (NCT01716585)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 98.0 |
Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline. (NCT01716585)
Timeframe: At 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 97.0 |
| Placebo | 15.8 |
Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment. (NCT01716585)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 0.2 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01716585)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 96.4 |
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. (NCT01716585)
Timeframe: Within 12 weeks post-treatment
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 1.5 |
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 |
The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment. (NCT01767116)
Timeframe: Baseline (Day 1) and Week 12 (End of Treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 51.2 |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 3.4 |
"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN)." (NCT01767116)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 99.5 |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 100.0 |
"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV." (NCT01767116)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 99.5 |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 100 |
"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV." (NCT01767116)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of particpants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 99.5 |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 100 |
Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (
Timeframe: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 0 |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 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 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). (NCT01767116)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Rebound | Failure to suppress | |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 0 | 0 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 0.5 | 0 |
The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment. (NCT01833533)
Timeframe: Baseline (Day 1) and Week 12 (End of Treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 42.0 |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 3.9 |
"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV." (NCT01833533)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 97.0 |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 90.2 |
"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV." (NCT01833533)
Timeframe: 12 weeks after last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 97.0 |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 90.2 |
Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (
Timeframe: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 1.0 |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 5.2 |
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment). (NCT01833533)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Rebound | Failure to suppress | |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | 2.9 | 0 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 1.0 | 0 |
SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and
Timeframe: Follow-up Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin | 64.6 |
| Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | 60.3 |
| Placebo + Peg-interferon Alfa-2a + Ribavirin | 36.1 |
cEVR was defined as undetectable RNA (HCV RNA
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin | 77.6 |
| Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | 75.3 |
| Placebo + Peg-interferon Alfa-2a + Ribavirin | 43.1 |
eRVR was defined as HCV RNA
Timeframe: Weeks 4 and 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin | 54.4 |
| Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | 54.1 |
| Placebo + Peg-interferon Alfa-2a + Ribavirin | 13.9 |
RVR was defined as undetectable RNA (HCV RNA
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin | 59.9 |
| Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | 56.8 |
| Placebo + Peg-interferon Alfa-2a + Ribavirin | 15.3 |
SVR24 was defined as HCV
Timeframe: Follow-up Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin | 59.2 |
| Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | 59.6 |
| Placebo + Peg-interferon Alfa-2a + Ribavirin | 37.5 |
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT01125189)
Timeframe: From start of study treatment (day 1) up to follow-up Week 48
| Intervention | participants (Number) | ||
|---|---|---|---|
| SAEs | Discontinuations Due to AEs | Death | |
| Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin | 12 | 7 | 2 |
| Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | 13 | 7 | 0 |
| Placebo + Peg-interferon Alfa-2a + Ribavirin | 6 | 8 | 0 |
"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA
Timeframe: Follow-up Week 48
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Virologic Breakthrough | Week 4 Futility Rule | Detectable HCV RNA at EOT | Other Criteria | Relapse | |
| Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin | 8.2 | 2.0 | 7.5 | 1.4 | 18.5 |
| Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin | 10.3 | 2.1 | 6.8 | 0.1 | 19.0 |
| Placebo + Peg-interferon Alfa-2a + Ribavirin | 2.8 | 25.0 | 5.6 | 6.9 | 22.0 |
cEVR was defined as undetectable HCV RNA (HCV RNA
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir, 60 mg, 12-Week Cohort | 91.7 |
| Daclatasvir, 60 mg, 16-Week Cohort | 82.6 |
| Placebo | 75.0 |
cEVR was defined as undetectable HCV RNA (HCV RNA
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir, 60 mg, 12-Week Cohort | 80.8 |
| Dacalatasvir, 60 mg, 16-Week Cohort | 88.9 |
| Placebo | 59.3 |
RVR was defined as undetectable HCV RNA (HCV RNA
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir, 60 mg, 12-Week Cohort | 87.5 |
| Daclatasvir, 60 mg, 16-Week Cohort | 73.9 |
| Placebo | 41.7 |
RVR was defined as undetectable HCV RNA (HCV RNA
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir, 60 mg, 12-Week Cohort | 84.6 |
| Daclatasvir, 60 mg, 16-Week Cohort | 74.1 |
| Placebo | 37.0 |
SVR12 was defined as undetectable HCV RNA (HCV RNA
Timeframe: Follow-up Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir, 60 mg, 12-Week Cohort | 87.5 |
| Daclatasvir, 60 mg, 16-Week Cohort | 82.6 |
| Placebo | 70.8 |
SVR12 was defined as undetectable HCV RNA (HCV RNA
Timeframe: Follow-up Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir, 60 mg, 12-Week Cohort | 69.2 |
| Daclatasvir, 60 mg, 16-Week Cohort | 77.8 |
| Placebo | 51.9 |
SVR24 was defined as undetectable HCV RNA (HCV RNA
Timeframe: Follow-up Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir, 60 mg, 12-Week Cohort | 83.3 |
| Daclatasvir, 60 mg, 16-Week Cohort | 82.6 |
| Placebo | 62.5 |
SVR24 was defined as undetectable HCV RNA (HCV RNA
Timeframe: Follow-up Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir, 60 mg, 12-Week Cohort | 69.2 |
| Daclatasvir, 60 mg, 16-Week Cohort | 66.7 |
| Placebo | 59.3 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. (NCT01257204)
Timeframe: From end of treatment period up to Week 48 (follow-up period)
| Intervention | participants (Number) | ||
|---|---|---|---|
| AEs | SAEs | Deaths | |
| Daclatasvir, 60 mg, 12-Week Cohort: Follow-up | 16 | 2 | 0 |
| Daclatasvir, 60 mg, 16-Week Cohort: Follow-up | 12 | 0 | 0 |
| Placebo: Follow-up | 11 | 0 | 0 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported. (NCT01257204)
Timeframe: Baseline (Day 1) up to 24 weeks (treatment period)
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| AEs | SAEs | Discontinuations due to AEs | Grade 2-4 Treatment-related AEs | Deaths | |
| Daclatasvir, 60 mg, 12-Week Cohort | 49 | 4 | 4 | 27 | 0 |
| Daclatasvir, 60 mg, 16-Week Cohort | 49 | 0 | 3 | 22 | 0 |
| Placebo | 50 | 3 | 2 | 30 | 0 |
"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA
Timeframe: Baseline up to Week 48
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Virologic breakthrough (n=24,23,24) | <1 log10 decrease in HCV RNA at Week4 (n=24,23,24) | HCV RNA ≥LLOQ or | Relapse (n=23,21,22) | | |
| Daclatasvir, 60 mg, 12-Week Cohort | 0 | 0 | 1 | 1 |
| Daclatasvir, 60 mg, 16-Week Cohort | 1 | 1 | 2 | 0 |
| Placebo | 1 | 0 | 1 | 2 |
"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA
Timeframe: Baseline up to Week 48
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Virologic breakthrough (n=26,27,27) | <1 log10 decrease in HCV RNA at Week4 (n=26,27,27) | HCV RNA ≥LLOQ or | Relapse (n=25,24,21) | | |
| Daclatasvir, 60 mg, 12-Week Cohort | 0 | 0 | 1 | 6 |
| Daclatasvir, 60 mg, 16-Week Cohort | 0 | 1 | 2 | 6 |
| Placebo | 1 | 3 | 3 | 3 |
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or confirmed HCV RNA ≥ LLOQ at any point during treatment after HCV RNA < LLOQ, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. (NCT01782495)
Timeframe: Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 0 |
| Arm B | 3.7 |
| Arm C | 0 |
| Arm D | 0 |
| Arm E | 0 |
| Arm F | 0 |
| Arm G | 0 |
| Arm H | 0 |
| Arm I | 0 |
| Arm J | 0 |
| Arm K | 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. (NCT01782495)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 3.0 |
| Arm B | 0 |
| Arm C | 0 |
| Arm D | 0 |
| Arm E | 0 |
| Arm F | 4.8 |
| Arm G | 0 |
| Arm H | 0 |
| Arm I | 0 |
| Arm J | 0 |
| Arm K | 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 | 97.1 |
| Arm B | 96.3 |
| Arm C | 100 |
| Arm D | 100 |
| Arm E | 100 |
| Arm F | 95.5 |
| Arm G | 100 |
| Arm H | 66.7 |
| Arm I | 100 |
| Arm J | 100 |
| Arm K | 100 |
SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Timeframe: 24 weeks after the last actual dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A | 97.1 |
| Arm B | 96.3 |
| Arm C | 100 |
| Arm D | 100 |
| Arm E | 100 |
| Arm F | 95.5 |
| Arm G | 100 |
| Arm H | 66.7 |
| Arm I | 100 |
| Arm J | 100 |
| Arm K | 100 |
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 |
Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | milliliter/minute (mL/min) (Geometric Mean) |
|---|---|
| Normal Renal Function | 89.164 |
| Mild Renal Impairment | 47.034 |
| Moderate Renal Impairment | 40.339 |
| Severe Renal Impairment | 45.565 |
| End Stage Renal Disease | 70.139 |
The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | Liters (Geometric Mean) |
|---|---|
| Normal Renal Function | 105.157 |
| Mild Renal Impairment | 63.761 |
| Moderate Renal Impairment | 59.054 |
| Severe Renal Impairment | 79.769 |
| End Stage Renal Disease | 95.186 |
AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | nanograms*hours/milliliter (ng*h/mL) (Geometric Mean) |
|---|---|
| Normal Renal Function | 11215.264 |
| Mild Renal Impairment | 21261.199 |
| Moderate Renal Impairment | 24789.951 |
| Severe Renal Impairment | 21946.450 |
| End Stage Renal Disease | 14257.489 |
AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | ng*hour (h)/mL (Geometric Mean) |
|---|---|
| Normal Renal Function | 11092.967 |
| Mild Renal Impairment | 20852.129 |
| Moderate Renal Impairment | 24343.711 |
| Severe Renal Impairment | 21238.909 |
| End Stage Renal Disease | 13934.562 |
Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| Normal Renal Function | 1111.497 |
| Mild Renal Impairment | 1619.572 |
| Moderate Renal Impairment | 1745.845 |
| Severe Renal Impairment | 1207.137 |
| End Stage Renal Disease | 1085.344 |
The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined. (NCT01830205)
Timeframe: Baseline up to Day 5 post dose
| Intervention | Participants (Number) |
|---|---|
| Normal Renal Function/Mild Renal Impairment | 0 |
| Mild/Moderate Renal Impairment | 0 |
| Mild/Severe Renal Impairment | 0 |
| End Stage Renal Disease | 0 |
Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator. (NCT01830205)
Timeframe: Baseline up to Day 5 post dose
| Intervention | Participants (Number) |
|---|---|
| Normal Renal Function/Mild Renal Impairment | 0 |
| Mild/Moderate Renal Impairment | 0 |
| Mild/Severe Renal Impairment | 0 |
| End Stage Renal Disease | 0 |
The total number of participants with abnormal range vital signs which were considered as adverse events was determined. (NCT01830205)
Timeframe: Baseline up to Day 5 post dose
| Intervention | Participants (Number) |
|---|---|
| Normal Renal Function/Mild Renal Impairment | 0 |
| Mild/Moderate Renal Impairment | 0 |
| Mild/Severe Renal Impairment | 0 |
| End Stage Renal Disease | 1 |
The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods. The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | Percentage of daclatasvir recovered (Geometric Mean) |
|---|---|
| Normal Renal Function | 5.007 |
| Mild Renal Impairment | 5.820 |
| Moderate Renal Impairment | 3.530 |
| Severe Renal Impairment | 2.658 |
| End Stage Renal Disease | 0.199 |
Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | hours (Geometric Mean) |
|---|---|
| Normal Renal Function | 13.625 |
| Mild Renal Impairment | 15.661 |
| Moderate Renal Impairment | 16.912 |
| Severe Renal Impairment | 20.224 |
| End Stage Renal Disease | 15.678 |
The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Normal Renal Function | 4.465 |
| Mild Renal Impairment | 2.737 |
| Moderate Renal Impairment | 1.424 |
| Severe Renal Impairment | 1.165 |
| End Stage Renal Disease | 0.147 |
Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | hours (Median) |
|---|---|
| Normal Renal Function | 1.000 |
| Mild Renal Impairment | 1.250 |
| Moderate Renal Impairment | 1.000 |
| Severe Renal Impairment | 1.500 |
| End Stage Renal Disease | 1.250 |
The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Normal Renal Function | 11926.796 |
| Mild Renal Impairment | 7802.955 |
| Moderate Renal Impairment | 6900.602 |
| Severe Renal Impairment | 7164.575 |
| End Stage Renal Disease | 9926.962 |
AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | ng*h/mL (Geometric Mean) |
|---|---|
| Normal Renal Function | 83.845 |
| Mild Renal Impairment | 128.157 |
| Moderate Renal Impairment | 144.915 |
| Severe Renal Impairment | 139.576 |
| End Stage Renal Disease | 100.736 |
Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point. (NCT01830205)
Timeframe: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| Normal Renal Function | 8.309 |
| Mild Renal Impairment | 9.762 |
| Moderate Renal Impairment | 10.206 |
| Severe Renal Impairment | 7.677 |
| End Stage Renal Disease | 7.668 |
Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation. (NCT01830205)
Timeframe: First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs
| Intervention | Participants (Number) | ||
|---|---|---|---|
| SAEs | Death | Discontinuations due to AEs | |
| End Stage Renal Disease | 0 | 0 | 0 |
| Mild/Moderate Renal Impairment | 0 | 0 | 0 |
| Mild/Severe Renal Impairment | 0 | 0 | 0 |
| Normal Renal Function/Mild Renal Impairment | 0 | 0 | 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). (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 |
The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01911845)
Timeframe: 12 weeks after the last actual dose of study drug
| Intervention | Percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 97.4 |
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks [≥ 36 days] of treatment. (NCT01911845)
Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12
| Intervention | Percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 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. Completion of treatment was defined as a study drug duration ≥ 77 days. (NCT01911845)
Timeframe: From the end of treatment through 12 weeks after the last actual dose of study drug
| Intervention | Percentage of participants (Number) |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | 0 |
Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng*hr/mL)] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose
| Intervention | ng*hr/mL (Mean) | |||||
|---|---|---|---|---|---|---|
| ABT-450 | Ritonavir | ABT-267 | ABT-333 | ABT-333 M1 metabolite | Ribavirin | |
| Buprenorphine ± Naloxone | 27438.94 | 14303.27 | 1523.48 | 5666.15 | 3086.73 | 33362.24 |
| Methadone | 37174.89 | 11375.38 | 1486.72 | 5021.41 | 2950.36 | 33499.39 |
Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose
| Intervention | ng/mL (Mean) | |||||
|---|---|---|---|---|---|---|
| ABT-450 | Ritonavir | ABT-267 | ABT-333 | ABT-333 M1 metabolite | Ribavirin | |
| Buprenorphine ± Naloxone | 3269.50 | 1261.92 | 102.00 | 805.08 | 469.92 | 3389.17 |
| Methadone | 2973.30 | 888.70 | 95.98 | 671.90 | 439.64 | 3232.00 |
Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose
| Intervention | ng/mL (Mean) | |||||
|---|---|---|---|---|---|---|
| ABT-450 | Ritonavir | ABT-267 | ABT-333 | ABT-333 M1 metabolite | Ribavirin | |
| Buprenorphine ± Naloxone | 170.01 | 167.35 | 33.75 | 223.76 | 86.98 | 2555.83 |
| Methadone | 458.53 | 136.87 | 32.78 | 147.95 | 71.10 | 2632.00 |
Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data. (NCT01911845)
Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose
| Intervention | hours (Mean) | |||||
|---|---|---|---|---|---|---|
| ABT-450 | Ritonavir | ABT-267 | ABT-333 | ABT-333 M1 metabolite | Ribavirin | |
| Buprenorphine ± Naloxone | 4.38 | 4.18 | 4.69 | 4.25 | 4.40 | 3.72 |
| Methadone | 6.81 | 7.01 | 5.26 | 4.05 | 4.65 | 5.83 |
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 |
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 |
Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1. (NCT01995071)
Timeframe: Day 1 through prior to first dose of the combination regimen on Study Day 4
| Intervention | Log10 IU/mL (Mean) |
|---|---|
| Arm 1 Non-cirrhotic | -4.11 |
| Arm 2 Non-cirrhotic | -4.02 |
| Arm 3 Non-cirrhotic | -4.31 |
| Arm 4 Non-cirrhotic + Arm 5 Compensated Cirrhotic | -4.06 |
| Arm 6 Non-cirrhotic | -3.38 |
| Arm 7 Non-cirrhotic + Arm 10 Compensated Cirrhotic | -4.21 |
| Arm 8 Non-cirrhotic | -4.25 |
| Arm 9 Non-cirrhotic | -4.08 |
| Arm 11 Non-cirrhotic | -3.79 |
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment. (NCT01995071)
Timeframe: Up to 87 days
| Intervention | participants (Number) |
|---|---|
| Arm 1 Non-cirrhotic | 0 |
| Arm 2 Non-cirrhotic | 0 |
| Arm 3 Non-cirrhotic | 0 |
| Arm 4 Non-cirrhotic | 0 |
| Arm 5 Compensated Cirrhotic | 0 |
| Arm 6 Non-cirrhotic | 0 |
| Arm 7 Non-cirrhotic | 12.5 |
| Arm 8 Non-cirrhotic | 0 |
| Arm 9 Non-cirrhotic | 0 |
| Arm 10 Compensated Cirrhotic | 0 |
| Arm 11 Non-cirrhotic | 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 completing combination treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT01995071)
Timeframe: From the end of treatment through 12 weeks after the last dose of combination study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1 Non-cirrhotic | 0 |
| Arm 2 Non-cirrhotic | 0 |
| Arm 3 Non-cirrhotic | 0 |
| Arm 4 Non-cirrhotic | 0 |
| Arm 5 Compensated Cirrhotic | 0 |
| Arm 6 Non-cirrhotic | 0 |
| Arm 7 Non-cirrhotic | 0 |
| Arm 8 Non-cirrhotic | 0 |
| Arm 9 Non-cirrhotic | 0 |
| Arm 10 Compensated Cirrhotic | 0 |
| Arm 11 Non-cirrhotic | 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 last actual dose of combination study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1 Non-cirrhotic | 87.5 |
| Arm 2 Non-cirrhotic | 100 |
| Arm 3 Non-cirrhotic | 87.5 |
| Arm 4 Non-cirrhotic | 100 |
| Arm 5 Compensated Cirrhotic | 100 |
| Arm 6 Non-cirrhotic | 100 |
| Arm 7 Non-cirrhotic | 87.5 |
| Arm 8 Non-cirrhotic | 87.5 |
| Arm 9 Non-cirrhotic | 100 |
| Arm 10 Compensated Cirrhotic | 100 |
| Arm 11 Non-cirrhotic | 100 |
Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing). (NCT01740791)
Timeframe: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 17.6 |
| Velpatasvir 5 mg | 25.0 |
| Velpatasvir 25 mg | 26.7 |
| Velpatasvir 50 mg | 8.3 |
| Velpatasvir 100 mg | 37.5 |
| Velpatasvir 150 mg | 29.0 |
AUCinf is defined as the concentration of drug extrapolated to infinite time. (NCT01740791)
Timeframe: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1
| Intervention | h*ng/mL (Mean) |
|---|---|
| Velpatasvir 5 mg | 113.8 |
| Velpatasvir 25 mg | 857.9 |
| Velpatasvir 50 mg | 2054.3 |
| Velpatasvir 100 mg | 2727.3 |
| Velpatasvir 150 mg | 4546.6 |
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01740791)
Timeframe: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3
| Intervention | h*ng/mL (Mean) |
|---|---|
| Velpatasvir 5 mg | 86.4 |
| Velpatasvir 25 mg | 857.5 |
| Velpatasvir 50 mg | 1950.5 |
| Velpatasvir 100 mg | 2745.3 |
| Velpatasvir 150 mg | 5003.0 |
Ctau is defined as the observed drug concentration at the end of the dosing interval. (NCT01740791)
Timeframe: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3
| Intervention | ng/mL (Mean) |
|---|---|
| Velpatasvir 5 mg | 0.6 |
| Velpatasvir 25 mg | 10.8 |
| Velpatasvir 50 mg | 22.4 |
| Velpatasvir 100 mg | 30.8 |
| Velpatasvir 150 mg | 60.6 |
(NCT01740791)
Timeframe: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
| Intervention | log10 IU/mL (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 10 | Day 17 | |
| Placebo | 6.523 | 6.518 | 6.512 | 6.493 | 6.527 | 6.555 | 6.659 | 6.503 |
| Velpatasvir 100 mg (GT 1a) | 6.458 | 3.304 | 3.398 | 3.745 | 4.185 | 4.678 | 5.315 | 5.657 |
| Velpatasvir 150 mg (GT 1a) | 6.335 | 2.687 | 2.699 | 3.104 | 3.862 | 3.791 | 4.319 | 5.455 |
| Velpatasvir 150 mg (GT 1b) | 6.379 | 2.574 | 2.466 | 2.400 | 2.217 | 2.396 | 3.074 | 4.890 |
| Velpatasvir 150 mg (GT 2) | 6.753 | 2.708 | 2.681 | 2.644 | 2.903 | 3.194 | 3.834 | 5.867 |
| Velpatasvir 150 mg (GT 3) | 6.318 | 3.484 | 4.059 | 4.450 | 4.938 | 5.256 | 5.120 | 6.093 |
| Velpatasvir 150 mg (GT 4) | 5.734 | 2.465 | 2.907 | 3.491 | 3.842 | 4.256 | 5.240 | 5.383 |
| Velpatasvir 25 mg (GT 1a) | 6.461 | 2.823 | 2.922 | 3.321 | 4.036 | 4.387 | 5.156 | 6.237 |
| Velpatasvir 25 mg (GT 3) | 6.150 | 3.151 | 3.329 | 3.753 | 4.361 | 4.922 | 5.103 | 5.275 |
| Velpatasvir 5 mg (GT 1a) | 6.639 | 3.535 | 4.642 | 5.395 | 5.608 | 5.699 | 5.960 | 6.505 |
| Velpatasvir 50 mg (GT 1a) | 6.459 | 3.121 | 3.336 | 3.755 | 4.275 | 4.756 | 4.986 | 5.468 |
| Velpatasvir 50 mg (GT 3) | 6.240 | 3.858 | 4.110 | 4.503 | 4.498 | 4.698 | 5.190 | 6.007 |
Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo. (NCT01740791)
Timeframe: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
| Intervention | log10 IU/mL (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Change at Day 4 | Change at Day 5 | Change at Day 6 | Change at Day 7 | Change at Day 8 | Change at Day 10 | Change at Day 17 | |
| Placebo | -0.005 | -0.018 | -0.037 | -0.003 | 0.027 | 0.142 | -0.025 |
| Velpatasvir 100 mg (GT 1a) | -3.154 | -3.060 | -2.713 | -2.273 | -1.780 | -1.143 | -0.801 |
| Velpatasvir 150 mg (GT 1a) | -3.648 | -3.636 | -3.221 | -2.481 | -2.544 | -2.032 | -0.879 |
| Velpatasvir 150 mg (GT 1b) | -3.848 | -3.955 | -4.021 | -4.205 | -4.026 | -3.348 | -1.532 |
| Velpatasvir 150 mg (GT 2) | -4.044 | -4.148 | -4.109 | -3.850 | -3.559 | -2.918 | -0.886 |
| Velpatasvir 150 mg (GT 3) | -2.834 | -2.259 | -1.869 | -1.380 | -1.062 | -1.198 | -0.225 |
| Velpatasvir 150 mg (GT 4) | -3.269 | -2.827 | -2.243 | -1.892 | -1.478 | -0.494 | -0.351 |
| Velpatasvir 25 mg (GT 1a) | -3.638 | -3.538 | -3.140 | -2.424 | -2.074 | -1.304 | -0.223 |
| Velpatasvir 25 mg (GT 3) | -2.796 | -2.617 | -2.193 | -1.586 | -1.025 | -0.844 | -0.672 |
| Velpatasvir 5 mg (GT 1a) | -3.104 | -1.998 | -1.244 | -1.031 | -0.941 | -0.679 | -0.135 |
| Velpatasvir 50 mg (GT 1a) | -3.338 | -3.123 | -2.704 | -2.184 | -1.702 | -1.472 | -1.110 |
| Velpatasvir 50 mg (GT 3) | -2.382 | -2.130 | -1.737 | -1.742 | -1.542 | -1.051 | -0.085 |
The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. (NCT01740791)
Timeframe: Days 4, 5, 6, 7, and 8
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Day 4 < LLOQ detected | Day 5 < LLOQ detected | Day 6 < LLOQ detected | Day 7 < LLOQ detected | Day 8 < LLOQ detected | |
| Placebo | 0 | 0 | 0 | 0 | 0 |
| Velpatasvir 100 mg (GT 1a) | 0 | 0 | 0 | 0 | 0 |
| Velpatasvir 150 mg (GT 1a) | 1 | 1 | 1 | 0 | 1 |
| Velpatasvir 150 mg (GT 1b) | 0 | 0 | 0 | 0 | 0 |
| Velpatasvir 150 mg (GT 2) | 1 | 0 | 0 | 0 | 0 |
| Velpatasvir 150 mg (GT 3) | 0 | 0 | 0 | 0 | 0 |
| Velpatasvir 150 mg (GT 4) | 0 | 0 | 0 | 0 | 0 |
| Velpatasvir 25 mg (GT 1a) | 0 | 1 | 1 | 0 | 0 |
| Velpatasvir 25 mg (GT 3) | 1 | 1 | 0 | 0 | 0 |
| Velpatasvir 5 mg (GT 1a) | 0 | 0 | 0 | 0 | 0 |
| Velpatasvir 50 mg (GT 1a) | 2 | 1 | 0 | 1 | 0 |
| Velpatasvir 50 mg (GT 3) | 0 | 0 | 0 | 0 | 0 |
The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs. (NCT01740791)
Timeframe: First dose date up to Day 17
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Number of participants sequenced pretreatment | Number of participants with RAVs at pretreatment | Number of participants sequenced at postbaseline | Number of participants with RAVs at postbaseline | |
| Placebo | 8 | 2 | 2 | 0 |
| Velpatasvir 100 mg (GT 1a) | 8 | 3 | 8 | 8 |
| Velpatasvir 150 mg (GT 1a) | 7 | 2 | 6 | 6 |
| Velpatasvir 150 mg (GT 1b) | 8 | 1 | 6 | 6 |
| Velpatasvir 150 mg (GT 2) | 8 | 4 | 8 | 7 |
| Velpatasvir 150 mg (GT 3) | 6 | 2 | 6 | 6 |
| Velpatasvir 150 mg (GT 4) | 2 | 2 | 2 | 2 |
| Velpatasvir 25 mg (GT 1a) | 8 | 2 | 8 | 7 |
| Velpatasvir 25 mg (GT 3) | 7 | 2 | 6 | 6 |
| Velpatasvir 5 mg (GT 1a) | 4 | 0 | 4 | 4 |
| Velpatasvir 50 mg (GT 1a) | 8 | 3 | 7 | 6 |
| Velpatasvir 50 mg (GT 3) | 4 | 1 | 4 | 4 |
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose. (NCT01740791)
Timeframe: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | |
| Placebo | 41.2 | 17.6 | 11.8 |
| Velpatasvir 100 mg | 62.5 | 25.0 | 0 |
| Velpatasvir 150 mg | 33.3 | 33.3 | 6.7 |
| Velpatasvir 25 mg | 40.0 | 33.3 | 13.3 |
| Velpatasvir 5 mg | 25.0 | 0 | 0 |
| Velpatasvir 50 mg | 58.3 | 8.3 | 16.7 |
CL/F is defined as the apparent oral clearance following administration of the drug. (NCT01740791)
Timeframe: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose
| Intervention | mL/hr (Mean) | |
|---|---|---|
| Day 1 | Day 3 | |
| Velpatasvir 100 mg | 49237.5 | 53,194.3 |
| Velpatasvir 150 mg | 38011.7 | 37,362.8 |
| Velpatasvir 25 mg | 37170.7 | 34,820.1 |
| Velpatasvir 5 mg | 61312.2 | 59173.6 |
| Velpatasvir 50 mg | 27930.6 | 27,263.0 |
Cmax is defined as the maximum observed plasma concentration of drug. (NCT01740791)
Timeframe: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose.
| Intervention | ng/mL (Mean) | |
|---|---|---|
| Day 1 (Single-Dose) | Day 3 (Multiple-Dose) | |
| Velpatasvir 100 mg | 372.8 | 413.9 |
| Velpatasvir 150 mg | 583.3 | 690.1 |
| Velpatasvir 25 mg | 110.8 | 122.9 |
| Velpatasvir 5 mg | 20.1 | 16.2 |
| Velpatasvir 50 mg | 272.3 | 292.4 |
(NCT01740791)
Timeframe: Days 4, 5, 6, 7, 8, 10, and 17
| Intervention | log10 IU/mL (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 10 | Day 17 | |
| Placebo (IL28B Genotype CC) | 6.473 | 6.604 | 6.595 | 6.563 | 6.643 | 6.817 | 6.601 |
| Placebo (IL28B Genotype Non-CC) | 6.549 | 6.450 | 6.426 | 6.504 | 6.503 | 6.580 | 6.444 |
| Velpatasvir 100 mg (GT 1a) (IL28B Genotype CC) | 2.891 | 2.996 | 3.138 | 3.390 | 3.867 | 4.059 | 4.572 |
| Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC) | 3.442 | 3.532 | 3.947 | 4.449 | 4.949 | 5.733 | 6.019 |
| Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC) | 2.687 | 2.699 | 3.104 | 3.862 | 3.791 | 4.319 | 5.455 |
| Velpatasvir 150 mg (GT 1b) (IL28B Genotype CC) | 2.539 | 2.605 | 2.801 | 3.312 | 3.441 | 3.948 | 6.953 |
| Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC) | 2.579 | 2.443 | 2.334 | 2.034 | 2.222 | 2.928 | 4.546 |
| Velpatasvir 150 mg (GT 2) (IL28B Genotype CC) | 2.758 | 2.689 | 2.668 | 2.684 | 2.913 | 3.438 | 5.127 |
| Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC) | 2.678 | 2.673 | 2.629 | 3.034 | 3.362 | 4.073 | 6.311 |
| Velpatasvir 150 mg (GT 3) (IL28B Genotype CC) | 3.590 | 3.742 | 3.653 | 3.713 | 4.114 | 4.754 | 6.621 |
| Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC) | 3.463 | 4.123 | 4.609 | 5.183 | 5.485 | 5.193 | 5.987 |
| Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC) | 2.465 | 2.907 | 3.491 | 3.842 | 4.256 | 5.240 | 5.383 |
| Velpatasvir 25 mg (GT 1a) (IL28B Genotype CC) | 2.603 | 2.581 | 2.740 | 3.637 | 3.875 | 4.369 | 6.147 |
| Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC) | 2.955 | 3.127 | 3.669 | 4.276 | 4.694 | 5.629 | 6.292 |
| Velpatasvir 25 mg (GT 3) (IL28B Genotype CC) | 2.976 | 3.117 | 3.813 | 4.196 | 4.553 | 5.061 | 6.744 |
| Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC) | 3.186 | 3.372 | 3.741 | 4.394 | 4.996 | 5.111 | 4.981 |
| Velpatasvir 5 mg (GT 1a) (IL28B Genotype CC) | 3.410 | 4.578 | 5.388 | 5.612 | 5.744 | 6.171 | 6.713 |
| Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC) | 3.660 | 4.705 | 5.403 | 5.604 | 5.653 | 5.750 | 6.297 |
| Velpatasvir 50 mg (GT 1a) (IL28B Genotype CC) | 1.762 | 1.748 | 2.134 | 2.988 | 3.053 | 3.488 | 2.949 |
| Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC) | 3.574 | 3.865 | 4.295 | 4.704 | 5.324 | 5.485 | 5.888 |
| Velpatasvir 50 mg (GT 3) (IL28B Genotype CC) | 4.304 | 4.620 | 5.035 | 5.038 | 5.123 | 5.724 | 5.881 |
| Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC) | 2.521 | 2.577 | 2.907 | 2.877 | 3.423 | 3.585 | 6.260 |
Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to < 2, ≥ 2 to < 3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17. (NCT01740791)
Timeframe: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| ≥1 and <2 log10 IU/mL decrease in HCV RNA | ≥2 and <3 log10 IU/mL decrease in HCV RNA | Missing HCV RNA | < 1 log10 IU/mL decrease in HCV RNA | ≥3 log10 IU/mL decrease in HCV RNA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 100 mg (GT 1a) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1a) | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1b) | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 2) | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 3) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 1a) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 5 mg (GT 1a) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 1a) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 3) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 3) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 1a) | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1a) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 2) | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 3) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 1a) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 1a) | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 2) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 1a) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1a) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 2) | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 3) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 5 mg (GT 1a) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 1a) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 100 mg (GT 1a) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1b) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 2) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 3) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 5 mg (GT 1a) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 1a) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 1a) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 100 mg (GT 1a) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1b) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 3) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 3) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 4) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 5 mg (GT 1a) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 1a) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 1a) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1a) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 2) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 3) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 3) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 100 mg (GT 1a) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1b) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 3) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 3) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1a) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1b) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 2) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 3) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 4) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 5 mg (GT 1a) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 1a) | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 1a) | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 100 mg (GT 1a) | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1a) | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 2) | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 25 mg (GT 3) | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 3) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 3) | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 4) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1b) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 50 mg (GT 1a) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 100 mg (GT 1a) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 1a) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Velpatasvir 150 mg (GT 2) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SVR12 was defined as HCV RNA
Timeframe: At follow-up Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 96.4 |
SVR12 was defined as HCV RNA
Timeframe: At follow-up Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 97.7 |
SVR12 was defined as HCV RNA
Timeframe: At follow-up Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 75.6 |
SVR12 was defined as HCV RNA levels
Timeframe: At follow-up Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 97.0 |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 76.0 |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 98.1 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT02032888)
Timeframe: AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| AEs | SAEs | AEs requiring dose interruption or discontinuation | Treatment-related AEs | Treatment-related Grade 3 to 4 AEs | Grade 3 to 4 AEs | Death | |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 37 | 3 | 0 | 17 | 0 | 4 | 0 |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 75 | 1 | 0 | 39 | 0 | 3 | 0 |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 29 | 0 | 0 | 13 | 1 | 2 | 0 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT02032888)
Timeframe: AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| AEs | SAEs | AEs Grade 3 to 4 | SAEs Grade 3 to 4 | Death | |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 5 | 0 | 0 | 0 | 0 |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 11 | 3 | 3 | 2 | 1 |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 5 | 1 | 1 | 1 | 1 |
Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. (NCT02032888)
Timeframe: From screening up to week 24 of post treatment follow--up
| Intervention | Participants (Number) | |||||
|---|---|---|---|---|---|---|
| International normalized ratio | Leukocytes | Aspartate aminotransferase | Bilirubin (total) | Lipase (total) | Alanine aminotransferase | |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 1 | 1 | 1 | 2 | 1 | 1 |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 1 | 0 | 0 | 5 | 5 | 0 |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 0 | 0 | 1 | 1 | 1 | 1 |
Participants with HCV RNA levels
Timeframe: At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
| Intervention | Percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | End of treatment | |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 5.8 | 23.1 | 63.5 | 94.2 | 100.0 | 98.1 | 100.0 |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 9.9 | 33.7 | 70.3 | 89.1 | 98.0 | 96.0 | 99.0 |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 6.0 | 34.0 | 78.0 | 90.0 | 96.0 | NA | 100.0 |
Participants with hepatitis C virus CV) levels to be
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24
| 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 | |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 34.6 | 71.2 | 92.3 | 98.1 | 100.0 | 98.1 | 100.0 | 96.2 | 92.3 |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 34.7 | 77.2 | 93.1 | 99.0 | 98.0 | 96.0 | 99.0 | 98.0 | 92.1 |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 44.0 | 78.0 | 98.0 | 98.0 | 96.0 | NA | 100.0 | 82.0 | 72.0 |
SVR is defined as hepatitis C virus RNA
Timeframe: At Follow-up Week 12
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| CC Genotype (n=28,13,13) | Non-CC Genotype (n=73,37, 39) | |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | 100.0 | 97.4 |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | 100.0 | 95.9 |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | 69.2 | 78.4 |
The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being). (NCT01854528)
Timeframe: Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)
| Intervention | units on a scale (Mean) |
|---|---|
| 3-DAA/RBV | -1.3 |
| TPV/RBV | -9.8 |
The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being). (NCT01854528)
Timeframe: Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)
| Intervention | units on a scale (Mean) |
|---|---|
| 3-DAA/RBV | 0.4 |
| TPV/RBV | -7.7 |
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. The LLOQ for the assay was 25 IU/mL. (NCT01854528)
Timeframe: 12 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA/RBV | 100.0 |
| TPV/RBV | 66.0 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. (NCT01854528)
Timeframe: 24 weeks after the last dose of study drug
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA/RBV | 99.0 |
| TPV/RBV | 66.0 |
Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment. (NCT01854528)
Timeframe: Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV)
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA/RBV | 0 |
| TPV/RBV | 19.1 |
Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (
Timeframe: Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| 3-DAA/RBV | 0 |
| TPV/RBV | 6.3 |
SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL). (NCT01854697)
Timeframe: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E
| Intervention | units on a scale (Mean) |
|---|---|
| Arm A: 3-DAA + RBV in GT1a | 0.5 |
| Arm B: TPV/PR in GT1a | -5.5 |
| Arm C: 3-DAA + RBV in GT1b | 0.4 |
| Arm D: 3-DAA in GT1b | 2.2 |
| Arm E: TPV/PR in GT1b | -5.5 |
SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL). (NCT01854697)
Timeframe: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E
| Intervention | units on a scale (Mean) |
|---|---|
| Arm A: 3-DAA + RBV in GT1a | -4.2 |
| Arm B: TPV/PR in GT1a | -5.8 |
| Arm C: 3-DAA + RBV in GT1b | -0.3 |
| Arm D: 3-DAA in GT1b | -0.1 |
| Arm E: TPV/PR in GT1b | -6.4 |
Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment. (NCT01854697)
Timeframe: Within 24 weeks post treatment
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A: 3-DAA + RBV in GT1a | 0 |
| Arm B: TPV/PR in GT1a | 0 |
| Arm C: 3-DAA + RBV in GT1b | 1.2 |
| Arm D: 3-DAA in GT1b | 0 |
| Arm E: TPV/PR in GT1b | 6.3 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. (NCT01854697)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A: 3-DAA + RBV in GT1a | 97.1 |
| Arm B: TPV/PR in GT1a | 82.4 |
| Arm C: 3-DAA + RBV in GT1b | 98.8 |
| Arm D: 3-DAA in GT1b | 97.6 |
| Arm E: TPV/PR in GT1b | 78.0 |
The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug. (NCT01854697)
Timeframe: 24 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A: 3-DAA + RBV in GT1a | 95.7 |
| Arm B: TPV/PR in GT1a | 82.4 |
| Arm C: 3-DAA + RBV in GT1b | 97.6 |
| Arm D: 3-DAA in GT1b | 97.6 |
| Arm E: TPV/PR in GT1b | 78.0 |
The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug. (NCT01854697)
Timeframe: 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A: 3-DAA + RBV in GT1a | 97.1 |
| Arm B: TPV/PR in GT1a | 82.4 |
| Arm C: 3-DAA + RBV in GT1b | 98.8 |
| Arm D: 3-DAA in GT1b | 97.6 |
| Arm E: TPV/PR in GT1b | 78.0 |
"Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy:~Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment~Failure to achieve HCV RNA < LLOQ by Week 6 or~Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ.~Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows:~HCV RNA > 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV~HCV RNA > 1000 IU/mL at Week 12, discontinue pegIFN and RBV~Confirmed HCV RNA > lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV~Confirmed HCV RNA > LLOD at Week 36, discontinue pegIFN and RBV." (NCT01854697)
Timeframe: 12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E
| Intervention | percentage of participants (Number) |
|---|---|
| Arm A: 3-DAA + RBV in GT1a | 2.9 |
| Arm B: TPV/PR in GT1a | 5.9 |
| Arm C: 3-DAA + RBV in GT1b | 0 |
| Arm D: 3-DAA in GT1b | 1.2 |
| Arm E: TPV/PR in GT1b | 12.2 |
Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available. (NCT01710501)
Timeframe: From Day 1 up to Follow-up Week 24 (up to 48 weeks total)
| Intervention | participants (Number) |
|---|---|
| Grazoprevir 25 mg + PEG-IFN + RBV | 9 |
| Grazoprevir 50 mg + PEG-IFN + RBV | 5 |
| Grazoprevir 100 mg + PEG-IFN + RBV | 3 |
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. (NCT01710501)
Timeframe: Up to 24 weeks
| Intervention | participants (Number) |
|---|---|
| Grazoprevir 25 mg + PEG-IFN + RBV | 1 |
| Grazoprevir 50 mg + PEG-IFN + RBV | 1 |
| Grazoprevir 100 mg + PEG-IFN + RBV | 1 |
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. (NCT01710501)
Timeframe: 14 days following last dose of study drug (up to 26 weeks)
| Intervention | participants (Number) |
|---|---|
| Grazoprevir 25 mg + PEG-IFN + RBV | 28 |
| Grazoprevir 50 mg + PEG-IFN + RBV | 28 |
| Grazoprevir 100 mg + PEG-IFN + RBV | 28 |
Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy. (NCT01710501)
Timeframe: 12 weeks after end of treatment (up to 36 weeks total)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir 25 mg + PEG-IFN + RBV | 54.2 |
| Grazoprevir 50 mg + PEG-IFN + RBV | 84.0 |
| Grazoprevir 100 mg + PEG-IFN + RBV | 88.5 |
HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy. (NCT01710501)
Timeframe: 4 weeks after end of treatment (up to 28 weeks total)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir 25 mg + PEG-IFN + RBV | 76.9 |
| Grazoprevir 50 mg + PEG-IFN + RBV | 88.0 |
| Grazoprevir 100 mg + PEG-IFN + RBV | 92.3 |
HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy. (NCT01710501)
Timeframe: 24 weeks after end of treatment (up to 48 weeks total)
| Intervention | percentage of participants (Number) |
|---|---|
| Grazoprevir 25 mg + PEG-IFN + RBV | 54.2 |
| Grazoprevir 50 mg + PEG-IFN + RBV | 84.0 |
| Grazoprevir 100 mg + PEG-IFN + RBV | 84.6 |
HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. (NCT01710501)
Timeframe: From TW 2 through end of treatment (up to 24 weeks)
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 2 (n=29, 25, 29) | Week 4 (n=28, 26, 29) | Week 12 (n=28, 26, 28) | End of all Therapy (n=26, 25, 26) | |
| Grazoprevir 100 mg + PEG-IFN + RBV | 96.6 | 100.0 | 100.0 | 100.0 |
| Grazoprevir 25 mg + PEG-IFN + RBV | 86.2 | 96.4 | 96.4 | 92.3 |
| Grazoprevir 50 mg + PEG-IFN + RBV | 88.0 | 100.0 | 100.0 | 100.0 |
HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA < 9.3 IU/mL. (NCT01710501)
Timeframe: From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 2 (n=29, 25, 29) | Week 4 (n=28, 26, 29) | Week 12 (n=28, 26, 28) | End of All Therapy (n=26, 25, 26) | |
| Grazoprevir 100 mg + PEG-IFN + RBV | 55.2 | 89.7 | 100.0 | 100.0 |
| Grazoprevir 25 mg + PEG-IFN + RBV | 34.5 | 82.1 | 96.4 | 92.3 |
| Grazoprevir 50 mg + PEG-IFN + RBV | 32.0 | 76.9 | 92.3 | 92.0 |
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 |
cEVR was defined as hepatitis C virus (HCV) RNA levels to be
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Genotype 1b: Daclatasvir + Simeprevir (Naive) | 84.9 |
| Genotype 1b: Daclatasvir + Simeprevir (Null) | 73.9 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | 82.4 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | 90 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | 66.7 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | 11.1 |
EOTR were defined as hepatitis C virus (HCV) RNA levels
Timeframe: End of treatment (Week 24)
| Intervention | Percentage of participants (Number) |
|---|---|
| Genotype 1b: Daclatasvir + Simeprevir (Naive) | 88.7 |
| Genotype 1b: Daclatasvir + Simeprevir (Null) | 78.3 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | 78.4 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | 95 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | 66.7 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | 0 |
eRVR were defined as hepatitis C virus (HCV) RNA levels to be
Timeframe: Week 4 and Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Genotype 1b: Daclatasvir + Simeprevir (Naive) | 71.7 |
| Genotype 1b: Daclatasvir + Simeprevir (Null) | 60.9 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | 62.7 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | 75 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | 58.3 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | 11.1 |
RVR was defined as hepatitis C virus (HCV) RNA levels to be
Timeframe: Week 4
| Intervention | Percentage of participants (Number) |
|---|---|
| Genotype 1b: Daclatasvir + Simeprevir (Naive) | 79.2 |
| Genotype 1b: Daclatasvir + Simeprevir (Null) | 69.6 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | 68.6 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | 85 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | 75 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | 33.3 |
SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be
Timeframe: Post Treatment Week 12 (Follow-up period)
| Intervention | Percentage of participants (Number) |
|---|---|
| Genotype 1b: Daclatasvir + Simeprevir (Naive) | 84.9 |
| Genotype 1b: Daclatasvir + Simeprevir (Null) | 69.6 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | 74.5 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | 95 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | 66.7 |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | 0 |
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT01628692)
Timeframe: From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
| Intervention | Participants (Number) | ||
|---|---|---|---|
| SAEs | AEs Leading to Discontinuation | Death | |
| Genotype 1b: Daclatasvir + Simeprevir (Naive + Null) | 7 | 2 | 1 |
| Genotype1a: Daclatasvir +Simeprevir + Ribavirin(Naive + Null) | 1 | 0 | 0 |
| Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null) | 3 | 2 | 0 |
Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. (NCT01628692)
Timeframe: Baseline, post-treatment Week 12 (Follow-up period)
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| IL28B Genotype CC type (n= 16,1,13,1,3,0) | IL28B Genotype CT type (n= 22,15, 28,10,9,8) | IL28B Genotype TT type (n= 12,6,10,7,0,1) | |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive) | 66.7 | 66.7 | NA |
| Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null) | NA | 0 | 0 |
| Genotype 1b: Daclatasvir + Simeprevir (Naive) | 87.5 | 95.5 | 66.7 |
| Genotype 1b: Daclatasvir + Simeprevir (Null) | 100 | 60 | 83.3 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive) | 84.6 | 82.1 | 40 |
| Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null) | 100 | 90 | 100 |
The number of participants for whom their third party insurance approved payment of the DAA (study drug) (NCT03365635)
Timeframe: Within one month of last patient enrolled
| Intervention | Participants (Count of Participants) |
|---|---|
| Genotype 1a -Rx Naive -no NS5A Polymorph | 0 |
| Genotype 1b - Rx Naive | 0 |
Absence of HCV by viral RNA quantitation at 12 weeks post treatment (NCT03365635)
Timeframe: 12 weeks after completion of Elbasivir/Grazoprevir treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Genotype 1a -Rx Naive -no NS5A Polymorph | 3 |
| Genotype 1a, Rx Naive + NS5A Polymorph | 0 |
| Genotype 1b - Rx Naive | 1 |
| Genotype 1a/1b -Prior INF or NS3/4A | 0 |
| Genotype4 - Treatment Naive | 0 |
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 |
(NCT01858766)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF+VEL 25 mg 12 Weeks | 0 |
| SOF+VEL 100 mg 12 Weeks | 0 |
| SOF+VEL 25 mg 8 Weeks | 1.8 |
| SOF+VEL 25 mg + RBV 8 Weeks | 0 |
| SOF+VEL 100 mg 8 Weeks | 0 |
| SOF+VEL 100 mg + RBV 8 Weeks | 0 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT01858766)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| SOF+VEL 25 mg 12 Weeks (GT1) | 96.3 |
| SOF+VEL 100 mg 12 Weeks (GT1) | 100.0 |
| SOF+VEL 25 mg 12 Weeks (GT2) | 90.9 |
| SOF+VEL 100 mg 12 Weeks (GT2) | 100.0 |
| SOF+VEL 25 mg 12 Weeks (GT3) | 92.6 |
| SOF+VEL 100 mg 12 Weeks (GT3) | 92.6 |
| SOF+VEL 25 mg 12 Weeks (GT4) | 100.0 |
| SOF+VEL 100 mg 12 Weeks (GT4) | 85.7 |
| SOF+VEL 25 mg 12 Weeks (GT5) | 100.0 |
| SOF+VEL 25 mg 12 Weeks (GT6) | 100.0 |
| SOF+VEL 100 mg 12 Weeks (GT6) | 100.0 |
| SOF+VEL 25 mg 8 Weeks (GT1) | 86.7 |
| SOF+VEL 25 mg + RBV 8 Weeks (GT1) | 83.3 |
| SOF+VEL 100 mg 8 Weeks (GT1) | 89.7 |
| SOF+VEL 100 mg + RBV 8 Weeks (GT1) | 80.6 |
| SOF+VEL 25 mg 8 Weeks (GT2) | 76.9 |
| SOF+VEL 25 mg + RBV 8 Weeks (GT2) | 88.0 |
| SOF+VEL 100 mg 8 Weeks (GT2) | 88.5 |
| SOF+VEL 100 mg + RBV 8 Weeks (GT2) | 88.5 |
"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT01858766)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF+VEL 25 mg 12 Weeks (GT1) | 3.7 |
| SOF+VEL 100 mg 12 Weeks (GT1) | 0 |
| SOF+VEL 25 mg 12 Weeks (GT2) | 0 |
| SOF+VEL 100 mg 12 Weeks (GT2) | 0 |
| SOF+VEL 25 mg 12 Weeks (GT3) | 7.4 |
| SOF+VEL 100 mg 12 Weeks (GT3) | 7.4 |
| SOF+VEL 25 mg 12 Weeks (GT4) | 0 |
| SOF+VEL 100 mg 12 Weeks (GT4) | 0 |
| SOF+VEL 25 mg 12 Weeks (GT5) | 0 |
| SOF+VEL 25 mg 12 Weeks (GT6) | 0 |
| SOF+VEL 100 mg 12 Weeks (GT6) | 0 |
| SOF+VEL 25 mg 8 Weeks (GT1) | 10.0 |
| SOF+VEL 25 mg + RBV 8 Weeks (GT1) | 16.7 |
| SOF+VEL 100 mg 8 Weeks (GT1) | 10.3 |
| SOF+VEL 100 mg + RBV 8 Weeks (GT1) | 16.1 |
| SOF+VEL 25 mg 8 Weeks (GT2) | 23.1 |
| SOF+VEL 25 mg + RBV 8 Weeks (GT2) | 8.0 |
| SOF+VEL 100 mg 8 Weeks (GT2) | 11.5 |
| SOF+VEL 100 mg + RBV 8 Weeks (GT2) | 11.5 |
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT01858766)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| SOF+VEL 100 mg + RBV 8 Weeks (GT1) | 87.1 | 80.6 |
| SOF+VEL 100 mg + RBV 8 Weeks (GT2) | 88.5 | 88.5 |
| SOF+VEL 100 mg 12 Weeks (GT1) | 100.0 | 100.0 |
| SOF+VEL 100 mg 12 Weeks (GT2) | 100.0 | 100.0 |
| SOF+VEL 100 mg 12 Weeks (GT3) | 100.0 | 92.6 |
| SOF+VEL 100 mg 12 Weeks (GT4) | 85.7 | 85.7 |
| SOF+VEL 100 mg 12 Weeks (GT6) | 100.0 | 100.0 |
| SOF+VEL 100 mg 8 Weeks (GT1) | 93.1 | 89.7 |
| SOF+VEL 100 mg 8 Weeks (GT2) | 92.3 | 88.5 |
| SOF+VEL 25 mg + RBV 8 Weeks (GT1) | 83.3 | 83.3 |
| SOF+VEL 25 mg + RBV 8 Weeks (GT2) | 88.0 | 88.0 |
| SOF+VEL 25 mg 12 Weeks (GT1) | 96.3 | 92.6 |
| SOF+VEL 25 mg 12 Weeks (GT2) | 90.9 | 90.9 |
| SOF+VEL 25 mg 12 Weeks (GT3) | 92.6 | 92.6 |
| SOF+VEL 25 mg 12 Weeks (GT4) | 100.0 | 100.0 |
| SOF+VEL 25 mg 12 Weeks (GT5) | 100.0 | 100.0 |
| SOF+VEL 25 mg 12 Weeks (GT6) | 100.0 | 100.0 |
| SOF+VEL 25 mg 8 Weeks (GT1) | 86.7 | 86.7 |
| SOF+VEL 25 mg 8 Weeks (GT2) | 88.5 | 76.9 |
(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 |
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 dose of active drug
| Intervention | percentage of participants (Number) |
|---|---|
| Part 1, 3-DAA With SOF With or Without RBV | 95.5 |
SVR12 was defined as plasma HCV RNA level
Timeframe: 12 weeks after the last dose of active drug
| Intervention | percentage of participants (Number) |
|---|---|
| Part 2, 3-DAA With RBV | 85.7 |
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. (NCT02356562)
Timeframe: Up to week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Part 1, 3-DAA With SOF With or Without RBV | 0.0 |
| Part 2, 3-DAA With RBV | 14.3 |
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. (NCT02356562)
Timeframe: Within 12 weeks after the last actual dose of active study drug
| Intervention | percentage of participants (Number) |
|---|---|
| Part 1, 3-DAA With SOF With or Without RBV | 4.8 |
| Part 2, 3-DAA With RBV | 0.0 |
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 |
end of treatment response (HCV RNA
Timeframe: Week 24 post treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Hepatitis C Virus Genotype 1A | 20 |
| Hepatitis C Virus Genotype 1B | 8 |
extended rapid virological response (HCV RNA
Timeframe: Both weeks 4 and 12 post treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Hepatitis C Virus Genotype 1A | 21 |
| Hepatitis C Virus Genotype 1B | 9 |
(NCT01888900)
Timeframe: post treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Hepatitis C Virus Genotype 1A | 1 |
| Hepatitis C Virus Genotype 1B | 4 |
rapid virological response (HCV RNA
Timeframe: Week 4 post treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Hepatitis C Virus Genotype 1A | 22 |
| Hepatitis C Virus Genotype 1B | 11 |
whether raw ALT value is in normal range which is less than 41 U/L. (NCT01888900)
Timeframe: Week 12 post treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Hepatitis C Virus Genotype 1A | 15 |
| Hepatitis C Virus Genotype 1B | 6 |
sustained virological response at follow-up week 12 (NCT01888900)
Timeframe: Week 12 post treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Hepatitis C Virus Genotype 1A | 19 |
| Hepatitis C Virus Genotype 1B | 8 |
HCV RNA >= LLOQ level after therapy is stopped in a patient who previously achieved an end-of-treatment virological response (NCT01888900)
Timeframe: beyond Week 24 post treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Hepatitis C Virus Genotype 1A | 1 |
| Hepatitis C Virus Genotype 1B | 0 |
"Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression.~The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray." (NCT01888900)
Timeframe: baseline and either 2 or 4 weeks
| Intervention | relative expression (Median) | ||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACADSB | ACSM3 | ADH6 | ANXA9 | APOA5 | APOF | BDH1 | CCL19 | CCL2 | CCL20 | CCL4 | CXCL10 | CXCL11 | CXCL9 | CYP1A1 | CYP4A11 | DDX58 | DDX60 | EIF2AK2 | FDPS | HMGCS2 | IFI27 | IFI44L | IFI6 | IFIH1 | IFIT1 | IFIT2 | IFIT3 | IFITM1 | IRF9 | ISG15 | ISG20 | LCAT | LIPC | LSS | MX1 | NPC1L1 | OAS1 | OAS2 | OAS3 | OASL | PLSCR1 | PPARA | PRKAB2 | RSAD2 | STAT1 | TAP1 | |
| Hepatitis C Virus Genotype 1A | -0.04915 | -0.49980 | -0.11373 | -0.07636 | -0.12453 | -0.26305 | -0.08100 | 0.61221 | 0.15200 | 0.41719 | 0.68293 | 2.08246 | 1.34781 | 1.46361 | 0.31399 | -0.09207 | -0.11579 | 0.15820 | -0.30273 | 0.13720 | -0.12509 | -0.02793 | -0.74607 | 0.35068 | -0.04591 | -0.07569 | 0.36377 | -0.00220 | 0.00657 | -0.07023 | 0.25402 | 0.55260 | -0.23342 | -0.16928 | 0.04955 | -0.20869 | 0.22706 | -0.16315 | -0.07088 | 0.05866 | 1.03897 | -0.29797 | -0.51770 | 0.01071 | -0.14051 | 0.15195 | 0.14096 |
| Hepatitis C Virus Genotype 1B | -0.35948 | -0.79328 | -0.36659 | -0.50104 | -0.48167 | -0.39732 | -0.27664 | 1.08586 | 0.66422 | 0.91927 | 0.89852 | 2.34623 | 1.62034 | 1.16119 | -0.71461 | -0.21412 | 0.71105 | 1.75573 | 0.79761 | -0.62267 | -0.24445 | 0.95729 | 2.33014 | 0.44506 | 1.11512 | 1.49718 | 1.09749 | 1.45782 | 0.87242 | 0.07203 | 2.25228 | 0.79333 | -0.28993 | -0.77129 | -0.87048 | 2.03597 | -0.14370 | 1.38768 | 2.08119 | 1.76892 | 2.27481 | 0.63596 | -0.50756 | -0.30954 | 1.60724 | 1.44922 | 0.68816 |
Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). (NCT02021656)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| LDV/SOF: China | 0 |
| LDF/SOF: Overall | 0 |
Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR. (NCT02021656)
Timeframe: Week 12 to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| LDV/SOF: China | 0 |
| LDF/SOF: Overall | 0.5 |
(NCT02021656)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| LDV/SOF: China | 0 |
| LDV/SOF: Overall | 0.5 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL in Korea and Taiwan and < 15 IU/mL in China) 12 weeks following the last dose of study drug. (NCT02021656)
Timeframe: Posttreatment Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| LDV/SOF: China | 100.0 |
| LDV/SOF: Overall | 99.2 |
(NCT02021656)
Timeframe: Baseline; Week 12
| Intervention | log10 IU/mL (Mean) | |
|---|---|---|
| Baseline | Change at Week 12 | |
| LDV/SOF: China | 6.31 | -5.16 |
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02021656)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| LDF/SOF: Overall | 99.2 | 99.0 |
| LDV/SOF: China | 100.0 | 100.0 |
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 |
SVR12 was defined as HCV RNA <25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: Up to Week 36
| Intervention | Percentage of participants (Number) |
|---|---|
| Grazoprevir 100 mg + RBV 12 Weeks | 58.3 |
| Grazoprevir 100 mg + RBV 24 Weeks | 90.0 |
HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL 24 weeks after the end of all study therapy. (NCT01716156)
Timeframe: Up to Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Grazoprevir 100 mg + RBV 12 Weeks | 62.5 |
| Grazoprevir 100 mg + RBV 12 Weeks Extended | 50.0 |
| Grazoprevir 100 mg + RBV 24 Weeks | 80.0 |
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment. (NCT01716156)
Timeframe: Up to 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Grazoprevir 100 mg + RBV: up to 12 Weeks | 0 |
| Grazoprevir 100 mg + RBV: Beyond 12 Weeks | 0 |
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment. (NCT01716156)
Timeframe: Fourteen days following last dose of study drug (up to 26 weeks)
| Intervention | Percentage of participants (Number) |
|---|---|
| Grazoprevir 100 mg + RBV: up to 12 Weeks | 72.7 |
| Grazoprevir 100 mg + RBV: Beyond 12 Weeks | 86.7 |
HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL 4 weeks after the end of all study therapy. (NCT01716156)
Timeframe: Up to Week 28
| Intervention | Percentage of participants (Number) |
|---|---|
| Grazoprevir 100 mg + RBV 12 Weeks | 87.5 |
| Grazoprevir 100 mg + RBV 12 Weeks Extended | 75.0 |
| Grazoprevir 100 mg + RBV 24 Weeks | 90.9 |
The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: Up to Week 24
| Intervention | Days (Mean) |
|---|---|
| Grazoprevir 100 mg + RBV HCV GT1a | 27.1 |
| Grazoprevir 100 mg + RBV HCV GT1non-a | 19.7 |
HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: From Week 2 through end of treatment (up to 24 weeks)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 2 | Week 4; Grazoprevir 100 mg + RBV 24 Weeks, n=11 | Week 12; Grazoprevir 100 mg + RBV 24 Weeks, n=11 | End of all therapy | |
| Grazoprevir 100 mg + RBV 12 Weeks | 100.0 | 100.0 | 100.0 | 100.0 |
| Grazoprevir 100 mg + RBV 12 Weeks Extended | 75.0 | 100.0 | 75.0 | 75.0 |
| Grazoprevir 100 mg + RBV 24 Weeks | 100.0 | 100.0 | 90.9 | 91.7 |
HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: From Week 2 through end of treatment (up to 24 weeks)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 2 | Week 4; Grazoprevir 100 mg + RBV 24 Weeks, n=11 | Week 12; Grazoprevir 100 mg + RBV 24 Weeks, n=11 | End of all therapy | |
| Grazoprevir 100 mg + RBV 12 Weeks | 50.0 | 100.0 | 100.0 | 100.0 |
| Grazoprevir 100 mg + RBV 12 Weeks Extended | 0.0 | 0.0 | 75.0 | 75.0 |
| Grazoprevir 100 mg + RBV 24 Weeks | 41.7 | 81.8 | 81.8 | 91.7 |
(NCT02378935)
Timeframe: Up to 12 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 0 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 0 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 0 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 6.5 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 0 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 0 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 0 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. (NCT02378935)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 70.6 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 100.0 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 93.9 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 80.6 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 100 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 100.0 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 100.0 |
"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02378935)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 29.4 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 0 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 6.1 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 19.4 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 0 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 0 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 0 |
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| Intervention | log10 IU/mL (Mean) | |||
|---|---|---|---|---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | -4.64 | -5.00 | -5.07 | -5.07 |
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| 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 | |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | -4.15 | -4.57 | -4.81 | -4.84 | -4.85 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | -4.60 | -4.98 | -5.06 | -5.08 | -5.08 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | -4.31 | -4.85 | -5.17 | -5.16 | -5.16 |
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| 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 | |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | -4.19 | -4.66 | -4.84 | -4.84 | -4.84 | -4.84 | -4.84 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | -4.40 | -4.97 | -5.22 | -5.24 | -5.24 | -5.24 | -5.24 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | -4.71 | -5.27 | -5.35 | -5.35 | -5.35 | -5.35 | -5.35 |
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 23.5 | 79.4 | 100.0 | 100.0 |
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 33.3 | 63.6 | 90.9 | 97.0 | 100.0 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 38.9 | 75.0 | 94.4 | 100.0 | 100.0 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 16.1 | 54.8 | 96.8 | 100.0 | 100.0 |
(NCT02378935)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 12.5 | 75.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 28.1 | 62.5 | 96.9 | 100.0 | 100.0 | 100.0 | 100.0 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 22.6 | 58.1 | 93.5 | 100.0 | 100.0 | 100.0 | 100.0 |
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02378935)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | 100.0 | 100.0 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | 100.0 | 100.0 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | 100.0 | 100.0 |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 88.2 | 70.6 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 93.9 | 93.9 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | 100.0 | 100.0 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | 87.1 | 80.6 |
(NCT02378961)
Timeframe: Up to 12 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 0 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 6.7 |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 0 |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 3.4 |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. (NCT02378961)
Timeframe: Posttreatment Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 87.9 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 93.3 |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 100.0 |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 96.6 |
"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02378961)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 12.1 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 6.7 |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 0 |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 3.4 |
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| Intervention | log10 IU/mL (Mean) | |||
|---|---|---|---|---|
| Change at Week 1 | Change at Week 2 | Change at Week 4 | Change at Week 6 | |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | -4.51 | -4.91 | -5.01 | -5.01 |
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| 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 | |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | -4.28 | -4.84 | -4.99 | -4.99 | -4.98 |
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| 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 | |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | -4.24 | -4.96 | -5.25 | -5.29 | -5.30 | -5.30 | -5.32 |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | -4.51 | -4.95 | -5.14 | -5.19 | -5.19 | -5.19 | -5.19 |
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 33.3 | 81.8 | 100.0 | 100.0 |
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 20.0 | 73.3 | 100.0 | 100.0 | 100.0 |
(NCT02378961)
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 10. | 58.6 | 89.7 | 96.6 | 100.0 | 100.0 | 100.0 |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 33.3 | 72.2 | 88.9 | 97.2 | 100.0 | 100.0 | 100.0 |
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively. (NCT02378961)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 100.0 | 96.6 |
| VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | 100.0 | 100.0 |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | 90.9 | 87.9 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | 96.7 | 93.3 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02133131)
Timeframe: Up to Week 12
| Intervention | Number of participants (Number) |
|---|---|
| GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks | 0 |
| GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks | 0 |
| GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks | 0 |
| GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks | 1 |
| GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks | 0 |
| GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks | 0 |
| GT3: C Grazoprevir/Elbasvir + SOF 12 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. (NCT02133131)
Timeframe: Up to Week 14
| Intervention | Number of participants (Number) |
|---|---|
| GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks | 5 |
| GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks | 7 |
| GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks | 7 |
| GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks | 4 |
| GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks | 4 |
| GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks | 3 |
| GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks | 3 |
The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0. (NCT02133131)
Timeframe: Up to 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks | 33.3 |
| GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks | 89.3 |
| GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks | 80.0 |
| GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks | 89.5 |
| GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks | 93.3 |
| GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks | 100.0 |
| GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks | 90.9 |
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 |
On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. (NCT02262728)
Timeframe: Week 12
| Intervention | Percentage of Participants (Number) |
|---|---|
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 0 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 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. (NCT02262728)
Timeframe: Week 24
| Intervention | Percentage of Participants (Number) |
|---|---|
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 100 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 100 |
Percentage of participants with SVR12 who maintained to have HCV RNA
Timeframe: Week 24 post treatment until the end of 3-year follow-up
| Intervention | Percentage of participants (Number) |
|---|---|
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 78.9 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 85.7 |
(NCT02262728)
Timeframe: Follow-up Week 24 (Week 36)
| Intervention | Units per Liter (U/L) (Mean) | |||
|---|---|---|---|---|
| Baseline : ALT | Baseline : AST | Follow-Up Week 24 : ALT | Follow-Up Week 24 : AST | |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 137.8 | 119.1 | 34.8 | 39.2 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 60.9 | 83.5 | 32.3 | 35.0 |
The AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after dosing. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8
| Intervention | ng.h/mL (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Simeprevir : Week 2 | Simeprevir : Week 8 | Daclatasvir : Week 2 | Daclatasvir : Week 8 | Sofosbuvir : Week 2 | Sofosbuvir : Week 8 | GS-331007 : Week 2 | GS-331007 : Week 8 | |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 113835 | 98568 | 16487 | 15574 | 2870 | 2746 | 17900 | 18132 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 142162 | 207221 | 17858 | 20787 | 3915 | 3933 | 21118 | 22829 |
The Cmax is the maximum observed plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8
| Intervention | nanogram per milliliter (ng/mL) (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Simeprevir : Week 2 (reference) | Simeprevir : Week 8 (test) | Daclatasvir : Week 2 | Daclatasvir : Week 8 | Sofosbuvir : Week 2 | Sofosbuvir : Week 8 | GS-331007 : Week 2 | GS-331007 : Week 8 | |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 6976 | 6029 | 1187 | 1072 | 1571 | 1276 | 1403 | 1404 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 7726 | 10498 | 1145 | 1210 | 1615 | 1527 | 1561 | 1594 |
The Cmin is the minimum observed plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8
| Intervention | ng/mL (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Simeprevir : Week 2 | Simeprevir : Week 8 | Daclatasvir : Week 2 | Daclatasvir : Week 8 | Sofosbuvir : Week 2 | Sofosbuvir : Week 8 | GS-331007 : Week 2 | GS-331007 : Week 8 | |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 3133 | 2639 | 414 | 442 | NA | NA | 419 | 443 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 4363 | 6955 | 519 | 660 | NA | NA | 441 | 523 |
On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point:
Timeframe: Week 1, 2, 4, 6, 8, 10, 12
| Intervention | Percentage of Participants (Number) | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 : >= 15 IU/mL | Week 1 : < 100 IU/mL | Week 1: < 15 IU/mL undetect/detectable | Week 1 : < 15 IU/mL detectable | Week 1 : < 15 IU/mL Undetectable | Week 2 : >= 15 IU/mL | Week 2 : < 100 IU/mL | Week 2: < 15 IU/mL undetect/detectable | Week 2 : < 15 IU/mL detectable | Week 2: < 15 IU/mL undetectable (vRVR) | Week 4 : >= 15 IU/mL | Week 4 : < 100 IU/mL | Week 4: < 15 IU/mL undetect/detectable | Week 4 : < 15 IU/mL detectable | Week 4 : < 15 IU/mL undetectable (RVR) | Week 6 : >= 15 IU/mL | Week 6 : < 100 IU/mL | Week 6: < 15 IU/mL undetect/detectable | Week 6 : < 15 IU/mL detectable | Week 6 : < 15 IU/mL undetectable | Week 8 : >= 15 IU/mL | Week 8 : < 100 IU/mL | Week 8: < 15 IU/mL undetect/detectable | Week 8 : < 15 IU/mL detectable | Week 8 : < 15 IU/mL undetectable | Week 10 : >= 15 IU/mL | Week 10 : < 100 IU/mL | Week 10: < 15 IU/mL undetect/detectable | Week 10 : < 15 IU/mL detectable | Week 10 : < 15 IU/mL undetectable | Week 12 : >= 15 IU/mL | Week 12 :< 100 IU/mL | Week 12: < 15 IU/mL undetect/detectable | Week 12 : < 15 IU/mL detectable | Week 12 : < 15 IU/mL undetectable | |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 72.2 | 61.1 | 27.8 | 11.1 | 16.7 | 10.5 | 94.7 | 89.5 | 36.8 | 52.6 | 0 | 100.0 | 100.0 | 5.6 | 94.4 | 0 | 100.0 | 100.0 | 5.3 | 94.7 | 0 | 100.0 | 100.0 | 0 | 100.0 | 0 | 100.0 | 100.0 | 0 | 100.0 | 0 | 100.0 | 100.0 | 0 | 100.0 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 76.2 | 38.1 | 23.8 | 19.0 | 4.8 | 47.6 | 71.4 | 52.4 | 19.0 | 33.3 | 9.5 | 100.0 | 90.5 | 28.6 | 61.9 | 0 | 100.0 | 100.0 | 20.0 | 80.0 | 0 | 100.0 | 100.0 | 4.8 | 95.2 | 0 | 100.0 | 100.0 | 0 | 100.0 | 0 | 100.0 | 100.0 | 0 | 100.0 |
Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was
Timeframe: Week 16 and Week 36
| Intervention | Percentage of Participants (Number) | |
|---|---|---|
| SVR 4 | SVR 24 | |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 100 | 100 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 100 | 100 |
The C0h is the pre-dose plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8
| Intervention | nanogram/milliliter (ng/mL) (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Simeprevir : Week 2 | Simeprevir : Week 8 | Daclatasvir : Week 2 | Daclatasvir : Week 8 | Sofosbuvir : Week 2 | Sofosbuvir : Week 8 | GS-331007 : Week 2 | GS-331007 : Week 8 | |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 3577 | 3160 | 494 | 492 | NA | NA | 484 | 478 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 5218 | 8577 | 646 | 824 | NA | NA | 490 | 572 |
Tmax is the time to reach maximum observed plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8
| Intervention | Hours (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| Simeprevir: Week 2 | Simeprevir: Week 8 | Daclatasvir: Week 2 | Daclatasvir: Week 8 | Sofosbuvir: Week 2 | Sofosbuvir: Week 8 | GS-331007: Week 2 | GS-331007: Week 8 | |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | 6.00 | 6.00 | 3.00 | 2.50 | 1.00 | 1.75 | 4.00 | 4.00 |
| SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | 8.00 | 8.00 | 4.00 | 4.00 | 2.00 | 2.00 | 4.00 | 4.00 |
Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. (NCT02175966)
Timeframe: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
| Intervention | Participants (Count of Participants) |
|---|---|
| 4 Weeks DCV 3DAA + SOF | 0 |
| 6 Weeks DCV 3DAA + SOF | 0 |
EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment. (NCT02175966)
Timeframe: End of the treatment
| Intervention | Percentage of participants (Number) |
|---|---|
| 4 Weeks DCV 3DAA + SOF | 92.9 |
| 6 Weeks DCV 3DAA + SOF | 100.0 |
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach. (NCT02175966)
Timeframe: 12 Weeks after treatment discontinuation (Follow-up Week 12)
| Intervention | Percentage of participants (Number) |
|---|---|
| 4 Weeks DCV 3DAA + SOF | 28.6 |
| 6 Weeks DCV 3DAA + SOF | 57.1 |
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect. (NCT02175966)
Timeframe: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Death | Serious Adverse Events | AEs Leading to Discontinuation | |
| 4 Weeks DCV 3DAA + SOF | 0 | 1 | 0 |
| 6 Weeks DCV 3DAA + SOF | 0 | 0 | 0 |
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24). (NCT02175966)
Timeframe: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24
| Intervention | Percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Follow-Up Week 2 | Follow-Up Week 4 | Follow-Up Week 12 | Follow-Up Week 24 | |
| 4 Weeks DCV 3DAA + SOF | 21.4 | 42.9 | 92.9 | NA | 71.4 | 42.9 | 28.6 | 28.6 |
| 6 Weeks DCV 3DAA + SOF | 7.1 | 64.3 | 100.0 | 100.0 | 92.9 | 71.4 | 57.1 | 57.1 |
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24). (NCT02175966)
Timeframe: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)
| Intervention | Percentage of Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Follow-Up Week 2 | Follow-Up Week 4 | Follow-Up Week 12 | Follow-Up Week 24 | |
| 4 Weeks DCV 3DAA + SOF | 35.7 | 78.6 | 100.0 | NA | 78.6 | 42.9 | 28.6 | 28.6 |
| 6 Weeks DCV 3DAA + SOF | 71.4 | 100.0 | 100.0 | 100.0 | 100.0 | 78.6 | 57.1 | 57.1 |
Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b (NCT02175966)
Timeframe: Post-treatment Week 12
| Intervention | Percentage of Participants (Number) | |
|---|---|---|
| Genotype 1a | Genotype 1b | |
| 4 Weeks DCV 3DAA + SOF | 27.3 | 33.3 |
| 6 Weeks DCV 3DAA + SOF | 54.5 | 66.7 |
Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported. (NCT02175966)
Timeframe: Post-treatment Week 12
| Intervention | Percentage of Participants (Number) | |
|---|---|---|
| CC genotype | Non-CC Genotype | |
| 4 Weeks DCV 3DAA + SOF | 40.0 | 22.2 |
| 6 Weeks DCV 3DAA + SOF | 66.7 | 50.0 |
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 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Follow-up Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | 75 |
| HAART Therapy: Daclatasvir, 60 mg | 71.8 |
| HAART: Daclatasvir, 30 mg + 60 mg | 71.7 |
| HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 73.3 |
| Non-HAART Therapy: Daclatasvir, 60 mg | 87.5 |
Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: From Day 1 to 7 days post last dose of study treatment (up to Week 48)
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Deaths | SAEs | Grade 3 to 4 AEs | AEs leading to discontinuation | |
| HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 2 | 24 | 93 | 17 |
| HAART Therapy: Daclatasvir, 30 mg + 60 mg | 0 | 6 | 35 | 6 |
| HAART Therapy: Daclatasvir, 60 mg | 1 | 6 | 12 | 4 |
| Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | 0 | 12 | 46 | 7 |
| Non-HAART Therapy: Daclatasvir, 60 mg | 0 | 0 | 4 | 1 |
Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
| Intervention | Percentage of participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | Weeks 4 and 12 | End of treatment | Follow-up Week 12 | Follow-up Week 24 | |
| HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 39.7 | 71.5 | 82.7 | 84.1 | 84.1 | 85.2 | 78.7 | 84.8 | 73.3 | 70.4 |
| Non-HAART Therapy: Daclatasvir, 60 mg | 41.7 | 91.7 | 95.8 | 87.5 | 95.8 | 91.7 | 91.7 | 95.8 | 87.5 | 83.3 |
Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. (NCT01471574)
Timeframe: Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
| Intervention | Percentage of participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 | Weeks 4 and 12 | End of treatment | Follow-up Week 12 | Follow-up Week 24 | |
| HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 9 | 33.9 | 64.3 | 74.4 | 78 | 81.2 | 61.4 | 84.8 | 73.3 | 70.4 |
| Non-HAART Therapy: Daclatasvir, 60 mg | 16.7 | 50 | 91.7 | 87.5 | 95.8 | 91.7 | 87.5 | 95.8 | 87.5 | 83.3 |
Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined. (NCT01471574)
Timeframe: End of treatment (up to Week 48)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| HIV RNA <40 copies/mL | HIV RNA ≥400 copies/mL | |
| HAART Therapy: Daclatasvir 30 or 60 or 90 mg | 90.6 | 0.4 |
| HAART Therapy: Daclatasvir, 30mg + 60 mg | 93.4 | 0.0 |
| HAART Therapy: Daclatasvir, 60 mg | 89.7 | 2.6 |
| Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | 88.6 | 0.0 |
Percentages calculated as number of responders/number who received treatment. (NCT01471574)
Timeframe: Follow-up Week 12
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| CC Genotype (n=36, 14, 39, 89, 6) | CT Genotype (n=72, 22, 50,144, 15) | TT Genotype (n=22, 3, 12, 37, 2) | Not reported (n=2, 0, 5, 7, 1) | |
| HAART Therapy: Daclatasvir 30, 60 or 90 mg | 87.6 | 67.4 | 62.2 | 71.4 |
| HAART Therapy: Daclatasvir, 30 mg + 60 mg | 79.5 | 70.0 | 58.3 | 60.0 |
| HAART Therapy: Daclatasvir, 60 mg | 92.9 | 63.6 | 33.3 | 0.0 |
| Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg | 94.4 | 66.7 | 68.2 | 100.0 |
| Non-HAART Therapy: Daclatasvir, 60 mg | 100.0 | 93.3 | 50.0 | 0.0 |
(NCT02536313)
Timeframe: Up to 12 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX | 0 |
| SOF/VEL/VOX + RBV | 0 |
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02536313)
Timeframe: Posttreatment Week 12
| Intervention | percentage of particpants (Number) |
|---|---|
| SOF/VEL/VOX | 100.0 |
| SOF/VEL/VOX + RBV | 96.0 |
"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." (NCT02536313)
Timeframe: Up to Posttreatment Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| SOF/VEL/VOX | 0 |
| SOF/VEL/VOX + RBV | 4.0 |
(NCT02536313)
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/VOX | -4.63 | -4.97 | -5.10 | -5.10 | -5.10 |
| SOF/VEL/VOX + RBV | -4.53 | -4.95 | -5.14 | -5.18 | -5.18 |
(NCT02536313)
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/VOX | 54.2 | 79.2 | 100 | 100.0 | 100.0 |
| SOF/VEL/VOX + RBV | 40 | 60.0 | 92.0 | 100.0 | 100.0 |
SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. (NCT02536313)
Timeframe: Posttreatment Weeks 4 and 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| SVR4 | SVR24 | |
| SOF/VEL/VOX | 100.0 | 100.0 |
| SOF/VEL/VOX + RBV | 96.0 | 96.0 |
On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been
Timeframe: Up to Week 24 after actual EOT (week 24)
| Intervention | participants (Number) |
|---|---|
| Cyclosporine | 0 |
| Tacrolimus | 3 |
Viral breakthrough is defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in participants whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment. (NCT01938625)
Timeframe: Up to week 24
| Intervention | participants (Number) |
|---|---|
| Cyclosporine | 0 |
| Tacrolimus | 3 |
Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up. (NCT01938625)
Timeframe: Up to Week 24 after actual EOT (week 24)
| Intervention | participants (Number) |
|---|---|
| Cyclosporine | 0 |
| Tacrolimus | 0 |
Percentage of participants with HCV RNA (<) 100 IU/mL at week 4 were reported. (NCT01938625)
Timeframe: Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Cyclosporine | 100 |
| Tacrolimus | 100 |
Participants were considered to have achieved SVR12 if hepatitis C virus ribonucleic acid (HCV RNA) levels were less than (<) 25 international unit per milliliter (IU/mL) detectable or undetectable at 12 weeks after the end of treatment. (NCT01938625)
Timeframe: Week 36
| Intervention | percentage of participants (Number) |
|---|---|
| Cyclosporine | 100 |
| Tacrolimus | 88 |
Participants were considered to have achieved SVR 24 if hepatitis C virus ribonucleic acid (HCV RNA) levels were (<) 25 IU/mL detectable or undetectable at 24 weeks after the end of treatment. (NCT01938625)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cyclosporine | 100 |
| Tacrolimus | 88 |
Participants were considered to have achieved SVR4 if HCV RNA levels were (<) 25 IU/mL detectable or undetectable at 4 weeks after the end of treatment. (NCT01938625)
Timeframe: Week 28
| Intervention | percentage of participants (Number) |
|---|---|
| Cyclosporine | 100 |
| Tacrolimus | 88 |
Percentage of participants with detectable and undetectable HCV RNA (<) 25 IU/mL during treatment at Weeks 2,4, 12, and 24 were reported. (NCT01938625)
Timeframe: Weeks 2, 4, 12, and 24
| Intervention | percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 2: <25 IU/mL detectable | Week 2: <25 IU/mL undetectable | Week 4: <25 IU/mL detectable | Week 4: <25 IU/mL undetectable | Week 12: <25 IU/mL detectable | Week 12: <25 IU/mL undetectable | Week 24: <25 IU/mL detectable | Week 24: <25 IU/mL undetectable | |
| Cyclosporine | 30 | 10 | 30 | 70 | 0 | 100 | 0 | 100 |
| Tacrolimus | 36 | 12 | 24 | 68 | 0 | 96 | 0 | 100 |
The apparent total body clearance at steady state (CLT/F) was defined as the apparent body clearance of canakinumab from the serum when the systemic availability was unknown. CLT/F was derived from plasma concentration-time data analyzed by non-compartmental methods. CLT/F of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. (NCT00663208)
Timeframe: 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Daclatasvir (1 mg) QD | 181.118 |
| Daclatasvir (10 mg) QD | 125.119 |
| Daclatasvir (30 mg) QD | 113.861 |
| Daclatasvir (60 mg) QD | 66.133 |
| Daclatasvir (30 mg) BID | 92.054 |
| Daclatasvir (100 mg) QD | 94.736 |
The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 international units/ millilitre (IU/mL). Baseline was Day -1 (NCT00663208)
Timeframe: Baseline, Day 7
| Intervention | log10 IU/mL (Mean) |
|---|---|
| Daclatasvir (1 mg) QD | -2.13 |
| Daclatasvir (10 mg) QD | -3.31 |
| Daclatasvir (30 mg) QD | -2.91 |
| Daclatasvir (60 mg) QD | -2.58 |
| Daclatasvir (30 mg) BID | -3.03 |
| Daclatasvir (100 mg) QD | -3.56 |
| Placebo | 0.00 |
The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. (NCT00663208)
Timeframe: Baseline, Day 7
| Intervention | log10 IU/mL (Mean) |
|---|---|
| Daclatasvir (1 mg) QD | -2.13 |
| Daclatasvir (10 mg) QD | -3.31 |
| Daclatasvir (30 mg) QD | -2.91 |
| Daclatasvir (60 mg) QD | -2.58 |
| Daclatasvir (30 mg) BID | -3.03 |
| Daclatasvir (100 mg) QD | -3.56 |
| Placebo | 0.00 |
The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. (NCT00663208)
Timeframe: Baseline to Day 14
| Intervention | log10 IU/mL (Mean) |
|---|---|
| Daclatasvir (1 mg) QD | -1.89 |
| Daclatasvir (10 mg) QD | -2.32 |
| Daclatasvir (30 mg) QD | -1.68 |
| Daclatasvir (60 mg) QD | -1.34 |
| Daclatasvir (30 mg) BID | -3.55 |
| Daclatasvir (100 mg) QD | -1.35 |
| Placebo | -0.59 |
The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. (NCT00663208)
Timeframe: Baseline to Day 4
| Intervention | log10 IU/mL (Mean) |
|---|---|
| Daclatasvir (1 mg) QD | -2.16 |
| Daclatasvir (10 mg) QD | -3.29 |
| Daclatasvir (30 mg) QD | -3.04 |
| Daclatasvir (60 mg) QD | -3.85 |
| Daclatasvir (30 mg) BID | -3.82 |
| Daclatasvir (100 mg) QD | -3.14 |
| Placebo | -0.07 |
The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. (NCT00663208)
Timeframe: Day 1 up to Day 14
| Intervention | log10 IU/mL (Mean) |
|---|---|
| Daclatasvir (1 mg) QD | -2.81 |
| Daclatasvir (10 mg) QD | -3.63 |
| Daclatasvir (30 mg) QD | -3.31 |
| Daclatasvir (60 mg) QD | -4.03 |
| Daclatasvir (30 mg) BID | -4.88 |
| Daclatasvir (100 mg) QD | -3.62 |
| Placebo | -1.32 |
Vital signs included: body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. Blood pressure and heart rate were measured after the participant had been supine, semi-supine, or seated quietly for at least 5 minutes. Baseline was defined as the last observation prior to dosing on Day 1. (NCT00663208)
Timeframe: Screening, Day -1 and prior to morning dose on Day 1, 2, 14, and 28
| Intervention | participants (Number) |
|---|---|
| Daclatasvir (1 mg) QD | 0 |
| Daclatasvir (10 mg) QD | 0 |
| Daclatasvir (30 mg) QD | 0 |
| Daclatasvir (60 mg) QD | 0 |
| Daclatasvir (30 mg) BID | 0 |
| Daclatasvir (100 mg) QD | 0 |
| Placebo | 0 |
The absolute values of lamda (λ) were used to evaluate apparent terminal half-life (T-half) was defined as T-half= ln 2/λ. T-half was derived from plasma concentration-time data analyzed by non-compartmental methods. T-half of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. (NCT00663208)
Timeframe: 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
| Intervention | h (Mean) |
|---|---|
| Daclatasvir (1 mg) QD | 11.68 |
| Daclatasvir (10 mg) QD | 14.31 |
| Daclatasvir (30 mg) QD | 12.99 |
| Daclatasvir (60 mg) QD | 12.81 |
| Daclatasvir (30 mg) BID | 13.04 |
| Daclatasvir (100 mg) QD | 15.19 |
Participants without baseline drug resistance were assessed for time to reach maximum decrease in log10 HCV RNA level. (NCT00663208)
Timeframe: Day 1 up to Day 14
| Intervention | Days (Mean) |
|---|---|
| Daclatasvir (1 mg) QD | 4.50 |
| Daclatasvir (10 mg) QD | 5.25 |
| Daclatasvir (30 mg) QD | 3.50 |
| Daclatasvir (60 mg) QD | 3.33 |
| Daclatasvir (30 mg) BID | 10.33 |
| Daclatasvir (100 mg) QD | 7.67 |
| Placebo | 10.17 |
Accumulation index area under the concentration-time curve of daclatasvir to the end of the dosing period [AI AUC(TAU)] was defined as the ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose.Accumulation index maximum observed concentration of daclatasvir in plasma (AI Cmax) was defined as the ratio of Cmax at steady-state to Cmax after the first dose. Degree of Fluctuation (DF) was defined as the ratio of difference between Cmax and Cmin at steady state by Css-av. The parameters were analyzed using non-compartmental methods, assayed by validated liquid chromatography tandem mass spectrometry (LC-MS/MS). (NCT00663208)
Timeframe: 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
| Intervention | ratio (Geometric Mean) | ||
|---|---|---|---|
| AI AUC(TAU) | AI Cmax | Degree of Fluctuation | |
| Daclatasvir (1 mg) QD | 0.823 | 0.663 | 2.389 |
| Daclatasvir (10 mg) QD | 1.196 | 0.966 | 2.335 |
| Daclatasvir (100 mg) QD | 1.162 | 0.946 | 2.133 |
| Daclatasvir (30 mg) BID | 1.642 | 1.476 | 1.251 |
| Daclatasvir (30 mg) QD | 1.245 | 1.150 | 2.659 |
| Daclatasvir (60 mg) QD | 1.414 | 1.225 | 2.321 |
The area under the concentration-time curve in 1 Dosing Interval AUC(TAU) was used to measure the drug exposure over 1 dosing interval., derived from plasma concentration-time data analyzed by non-compartmental methods. AUC(TAU) of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. (NCT00663208)
Timeframe: 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
| Intervention | ng*h/mL (Geometric Mean) | |
|---|---|---|
| Day 1 | Day 14 | |
| Daclatasvir (1 mg) QD | 111.8 | 92.0 |
| Daclatasvir (10 mg) QD | 1113.6 | 1332.1 |
| Daclatasvir (100 mg) QD | 15136.1 | 17592.8 |
| Daclatasvir (30 mg) BID | 3307.2 | 5431.6 |
| Daclatasvir (30 mg) QD | 3528.6 | 4391.3 |
| Daclatasvir (60 mg) QD | 10691.5 | 15120.9 |
The average observed plasma concentration at steady state (Css-av) was calculated as ratio of AUC(TAU) by TAU, where TAU = 24 h for QD dosing and 12 h for BID dosing. Css-av was derived from plasma concentration-time data analyzed by non-compartmental methods. Css-av of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. (NCT00663208)
Timeframe: 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11,13, and 24, 48 and 72 hours (post morning dose) at Day 14
| Intervention | ng/mL (Geometric Mean) | |
|---|---|---|
| Day 1 | Day 14 | |
| Daclatasvir (1 mg) QD | 4.659 | 3.834 |
| Daclatasvir (10 mg) QD | 46.401 | 55.503 |
| Daclatasvir (100 mg) QD | 630.673 | 733.035 |
| Daclatasvir (30 mg) BID | 275.596 | 452.634 |
| Daclatasvir (30 mg) QD | 147.024 | 182.972 |
| Daclatasvir (60 mg) QD | 445.478 | 630.039 |
The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1. (NCT00663208)
Timeframe: Baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours post dose on Day 1
| Intervention | log10 IU/mL (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Change at Hour 2 | Change at Hour 4 | Change at Hour 6 | Change at Hour 8 | Change at Hour 12 | Change at Hour 16 | Change at Hour 20 | Change at Hour 24 | |
| Daclatasvir (1 mg) QD | 0.02 | -0.78 | -1.47 | -1.92 | -2.18 | -2.09 | -1.92 | -1.82 |
| Daclatasvir (10 mg) QD | -0.00 | -0.91 | -1.73 | -2.12 | -2.44 | -2.76 | -2.80 | -2.97 |
| Daclatasvir (100 mg) QD | 0.04 | -1.01 | -1.36 | -1.74 | -2.00 | -2.03 | -2.29 | -2.58 |
| Daclatasvir (30 mg) BID | -0.35 | -1.24 | -1.99 | -2.59 | -2.92 | -3.04 | -3.38 | -3.53 |
| Daclatasvir (30 mg) QD | -0.21 | -1.22 | -2.05 | -2.62 | -2.91 | -2.95 | -3.02 | -3.24 |
| Daclatasvir (60 mg) QD | -0.43 | -1.24 | -1.96 | -2.47 | -3.08 | -3.38 | -3.50 | -3.60 |
| Placebo | -0.00 | 0.07 | 0.00 | -0.01 | -0.01 | -0.00 | 0.01 | 0.02 |
Correlation between decline of log10 hepatitis C virus (HCV) RNA and exposure to study drug was measured by Pearson Correlation Coefficients. The change from baseline at Day 4 in log10 HCV RNA and the maximum decline in log10 HCV RNA were evaluated against the PK parameters Cmax, Cmin and AUC(TAU). (NCT00663208)
Timeframe: Day 4, Day 14
| Intervention | Correlation Coefficient (Number) | |||||
|---|---|---|---|---|---|---|
| Cmax and Delta log10 HCV RNA at Day 4 | AUC(Tau) and Delta log10 HCV RNA at Day 4 | Cmin and Delta log10 HCV RNA at Day 4 | Cmax and Maximum Decline in log10 HCV RNA | AUC(Tau) and Maximum Decline in log10 HCV RNA | Cmin and Maximum Decline in log10 HCV RNA | |
| All Daclatasvir Treated Participants | -0.61 | -0.61 | -0.63 | -0.51 | -0.50 | -0.59 |
The peak concentrations in plasma (Cmax) and minimum observed plasma concentration (Cmin) were defined as the peak maximum and minimum plasma level of daclatasvir, derived from plasma concentration-time data analyzed by non-compartmental methods. Cmax and Cmin of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. (NCT00663208)
Timeframe: 0 hour (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13 and 24, 48 and 72 hours (post morning dose) at Day 14
| Intervention | nanograms/milliliters(ng/mL) (Geometric Mean) | |||
|---|---|---|---|---|
| Cmax at Day 1 | Cmax at Day 14 | Cmin at Day 1 | Cmin at Day 14 | |
| Daclatasvir (1 mg) QD | 15.731 | 10.430 | 1.212 | 1.234 |
| Daclatasvir (10 mg) QD | 159.665 | 154.196 | 15.141 | 23.674 |
| Daclatasvir (100 mg) QD | 1960.732 | 1853.925 | 174.642 | 287.852 |
| Daclatasvir (30 mg) BID | 563.569 | 831.792 | 171.330 | 206.941 |
| Daclatasvir (30 mg) QD | 483.365 | 555.878 | 41.114 | 61.635 |
| Daclatasvir (60 mg) QD | 1409.202 | 1726.383 | 129.822 | 254.602 |
Pre-specified criteria were defined as, Heart rate (HR) minimum as <=50 bpm/change from baseline <-20 bpm/maximum HR >100 bpm, QT interval corrected using Fridericia's formula (QTcF) maximum as QTcF<=450 msec/450 msec
Timeframe: Screening, Day 2, 3, 5, 7, 9, 11, 13, 15, 21 and 28
| Intervention | participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Heart Rate <=50 bpm | Heart Rate > 100 bpm | HR Change from baseline <-20bpm | Maximum QTcF <= 450 msec | Maximum QTcF >450 msec | Maximum Delta QTcF<=30 | Maximum Delta QTcF >30 msec | Maximum QRS <=120 msec | Maximum QRS > 120 msec | Maximum PR <=200 msec | Maximum PR > 200 msec | |
| Daclatasvir (1 mg) QD | 0 | 0 | 0 | 4 | 0 | 4 | 0 | 4 | 0 | 4 | 0 |
| Daclatasvir (10 mg) QD | 0 | 0 | 0 | 4 | 0 | 4 | 0 | 4 | 0 | 4 | 0 |
| Daclatasvir (100 mg) QD | 0 | 0 | 0 | 4 | 0 | 4 | 0 | 4 | 0 | 4 | 1 |
| Daclatasvir (30 mg) BID | 0 | 0 | 4 | 4 | 0 | 4 | 0 | 4 | 0 | 4 | 0 |
| Daclatasvir (30 mg) QD | 0 | 0 | 0 | 4 | 0 | 4 | 0 | 4 | 0 | 4 | 0 |
| Daclatasvir (60 mg) QD | 0 | 0 | 0 | 4 | 0 | 4 | 0 | 4 | 0 | 4 | 0 |
| Placebo | 0 | 0 | 0 | 6 | 0 | 6 | 0 | 6 | 0 | 6 | 0 |
Liver and kidney function marked laboratory abnormalities were defined as Alanine Aminotransferase (ALT) units per liter (U/L) High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Aspartate Aminotransferase (AST) U/L High as > 1.25* PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Alkaline Phosphatase(ALP)U/L High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, G-Glutamyl Transferase (GGT) in U/L High as >1.15*ULN if PreRx<=ULN/>1.15* if PreRx missing/>1.2* PreRx if PreRx>ULN, Phosphorus Inorganic (mg/dL) Low as < 0.85*LLN if LLN <= PreRx <= ULN/< 0.85*LLN if PreRx = Missing/< 0.85*PreRx if PreRx < LLN/< LLN if PreRx > ULN, and Potassium serum milliequivalents per liter (mEq/L) High as > 1.1*PreRx if PreRx > ULN/> 1.1*ULN if LLN <= PreRx <= ULN/> 1.1*ULN if PreRx = Missing/> ULN if PreRx < LLN. (NCT00663208)
Timeframe: Screening, Day 3, Day 7, Day 11, Day 14, and Day 28
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| ALT High | AST High | ALP High | GGT | Phosporus Low | Potassium High | |
| Daclatasvir (1 mg) QD | 0 | 0 | 0 | 0 | 1 | 0 |
| Daclatasvir (10 mg) QD | 1 | 1 | 0 | 0 | 0 | 0 |
| Daclatasvir (100 mg) QD | 2 | 2 | 1 | 1 | 0 | 0 |
| Daclatasvir (30 mg) BID | 2 | 2 | 0 | 2 | 0 | 0 |
| Daclatasvir (30 mg) QD | 0 | 0 | 0 | 2 | 0 | 1 |
| Daclatasvir (60 mg) QD | 1 | 0 | 0 | 0 | 0 | 0 |
| Placebo | 0 | 1 | 0 | 2 | 0 | 1 |
Hematology marked laboratory abnormalities were defined as Hemoglobin (g/dL) Low as < 0.85*Pre-therapy (PreRx), Hematocrit (%) Low as < 0.85*PreRx, Platelet Count *10^9 c/L Low as < 0.85*Lower Limits of Normal (LLN) if PreRx = Missing/< 0.85*LLN if PreRx >= LLN/< 0.85*PreRx if PreRx < LLN, Eosinophils (absolute) *10^3 c/µL High as > 0.75*count, Leukocytes White Blood Cell (WBC) *10^3 c/µL High as > 1.2*ULN if LLN <= PreRx <= Upper Limits of Normal (ULN) > 1.2*ULN if PreRx = Missing/> 1.5*PreRx if PreRx > ULN/> ULN if PreRx < LLN. (NCT00663208)
Timeframe: Screening, Day 3, Day 7, Day 11, Day 14, and Day 28
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Low Hematocrit | Low Hemoglobin | Low Platelet | High Eosinophils | High Leukocytes | |
| Daclatasvir (1 mg) QD | 0 | 1 | 0 | 0 | 0 |
| Daclatasvir (10 mg) QD | 0 | 0 | 0 | 0 | 0 |
| Daclatasvir (100 mg) QD | 0 | 0 | 1 | 1 | 1 |
| Daclatasvir (30 mg) BID | 0 | 0 | 0 | 0 | 0 |
| Daclatasvir (30 mg) QD | 0 | 0 | 0 | 0 | 0 |
| Daclatasvir (60 mg) QD | 1 | 1 | 0 | 0 | 0 |
| Placebo | 0 | 1 | 0 | 0 | 0 |
Marked abnormalities were defined as Lipase (U/L) High as >1.5*ULN, Glucose fasting serum (mg/dL) High as > 1.3*ULN if LLN <= PreRx <= ULN/> 1.3*ULN if PreRx = Missing/>2*PreRx; if PreRx > ULN/> ULN if PreRx < LLN. (NCT00663208)
Timeframe: Screening, Day 3, Day 7, Day 11, Day 14, and Day 28
| Intervention | participants (Number) | |
|---|---|---|
| Lipase High | Glucose Fasting High | |
| Daclatasvir (1 mg) QD | 0 | 0 |
| Daclatasvir (10 mg) QD | 1 | 0 |
| Daclatasvir (100 mg) QD | 0 | 1 |
| Daclatasvir (30 mg) BID | 1 | 0 |
| Daclatasvir (30 mg) QD | 0 | 0 |
| Daclatasvir (60 mg) QD | 0 | 0 |
| Placebo | 0 | 1 |
Marked laboratory abnormalities in urinalysis were defined as, Blood Urine High as >= 2*PreRx if PreRx >= 1/>= 2 if PreRx < 1/>= 2 if PreRx = Missing. Glucose Urine High as >= 1 if PreRx < 1/>= 1 if PreRx = Missing/>= 2*PreRx if PreRx >= 1. (NCT00663208)
Timeframe: Screening, Day 3, Day 7, Day 11, Day 14, and Day 28
| Intervention | participants (Number) | |
|---|---|---|
| Urine Blood High | Urine Glucose High | |
| Daclatasvir (1 mg) QD | 1 | 1 |
| Daclatasvir (10 mg) QD | 1 | 0 |
| Daclatasvir (100 mg) QD | 0 | 0 |
| Daclatasvir (30 mg) BID | 0 | 0 |
| Daclatasvir (30 mg) QD | 0 | 0 |
| Daclatasvir (60 mg) QD | 1 | 0 |
| Placebo | 1 | 2 |
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT00663208)
Timeframe: Day 1 to Day 182 or Day of Discharge
| Intervention | participants (Number) | ||
|---|---|---|---|
| SAEs | Discontinuation Due to AEs | Death | |
| Daclatasvir (1 mg) QD | 0 | 0 | 0 |
| Daclatasvir (10 mg) QD | 0 | 0 | 0 |
| Daclatasvir (100 mg) QD | 0 | 0 | 0 |
| Daclatasvir (30 mg) BID | 0 | 0 | 0 |
| Daclatasvir (30 mg) QD | 0 | 0 | 0 |
| Daclatasvir (60 mg) QD | 0 | 0 | 0 |
| Placebo | 0 | 0 | 0 |
Tmax was defined as the time to reach maximum observed plasma concentration of daclatasvir in plasma. Tmax was derived from plasma concentration-time data analyzed by non-compartmental methods. Tmax of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method. (NCT00663208)
Timeframe: 0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14
| Intervention | h (Median) | |
|---|---|---|
| Day 1 | Day 14 | |
| Daclatasvir (1 mg) QD | 2.000 | 1.250 |
| Daclatasvir (10 mg) QD | 1.000 | 1.250 |
| Daclatasvir (100 mg) QD | 1.500 | 1.750 |
| Daclatasvir (30 mg) BID | 2.500 | 1.750 |
| Daclatasvir (30 mg) QD | 1.000 | 1.000 |
| Daclatasvir (60 mg) QD | 1.500 | 1.000 |
The primary outcome was the percentage of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification. (NCT02124044)
Timeframe: 12 weeks after stop of treatment
| Intervention | Percentage of subjects (Number) |
|---|---|
| HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325 | 90 |
| HIV/HCV GT-1b, 24 Wks ASV/DCV | 80 |
cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12 (NCT00874770)
Timeframe: At Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Riibavirin | 58.3 |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | 83.3 |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | 83.3 |
| Placebo + pegIFNα-2a + Ribavirin | 41.7 |
EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL. (NCT00874770)
Timeframe: At Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | 75 |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | 100 |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | 83.3 |
| Placebo + pegIFNα-2a + Ribavirin | 66.7 |
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12. (NCT00874770)
Timeframe: A Weeks 4 and 12
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | 41.7 |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | 83.3 |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | 75 |
| Placebo + pegIFNα-2a + Ribavirin | 8.3 |
RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4. (NCT00874770)
Timeframe: At Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | 41.7 |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | 91.7 |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | 83.3 |
| Placebo + pegIFNα-2a + Ribavirin | 8.3 |
Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L. (NCT00874770)
Timeframe: From screening up to Week 12 (treatment period)
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Hemoglobin (n= 11,12,12,11) | Lymphocytes (n= 11,12,12,12) | Neutrophils (n= 11,12,12,12) | Platelets (n= 11,12,12,12) | ALT (n= 11,12,12,12) | AST (n= 11,12,12,12) | Total bilirubin (n= 11,12,12,12) | WBC (n= 11, 12, 12, 12) | |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | 0 | 3 | 4 | 0 | 1 | 0 | 0 | 2 |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | 1 | 3 | 3 | 0 | 0 | 0 | 1 | 1 |
| Placebo + pegIFNα-2a + Ribavirin | 0 | 3 | 4 | 1 | 3 | 3 | 0 | 2 |
An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. (NCT00874770)
Timeframe: From Day 31 up to Week 24 of post treatment follow-up
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| SAEs (n=10,12,12,10) | Discontinuation due to AEs | Grade 2 to 4 Related AEs | Deaths | |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | 0 | 0 | 0 | 0 |
| Daclatasvir 3 mg + pegIFNα-2a + Rribavirin | 0 | 0 | 0 | 0 |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | 3 | 0 | 0 | 0 |
| Placebo + pegIFNα-2a + Ribavirin | 0 | 0 | 0 | 0 |
An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. (NCT00874770)
Timeframe: SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| SAEs | Discontinuation due to AEs | Grade 2 to 4 Related AEs | Deaths | |
| Daclatasvir 10 mg + pegIFNα-2a + Ribavirin | 1 | 1 | 6 | 0 |
| Daclatasvir 3 mg + pegIFNα-2a + Ribavirin | 1 | 1 | 6 | 0 |
| Daclatasvir 60 mg + pegIFNα-2a + Ribavirin | 1 | 4 | 9 | 0 |
| Placebo + pegIFNα-2a + Ribavirin | 0 | 2 | 7 | 0 |
98 reviews available for carbamates and Hepatitis C, Chronic
| Article | Year |
|---|---|
Cost-Effectiveness of Elbasvir/Grazoprevir for the Treatment of Chronic Hepatitis C: A Systematic Review.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cost-Benefit Analysis; Cyclopropanes; Hepacivirus | 2022 |
Overview of hepatitis C infection, molecular biology, and new treatment.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Drug Combinations; Drug Resistance, Viral; Genotype; H | 2020 |
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 |
New approaches in viraemic organ transplantation and antiviral therapies.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Cyclopropanes; Guani | 2020 |
Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysis.
Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; C | 2020 |
Progress Toward Hepatitis C Virus Elimination: Therapy and Implementation.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Benzofurans; Carbamates; Drug Therapy, Combination; Glo | 2020 |
Safety and tolerability of elbasvir/grazoprevir in chronic hepatitis C virus therapy: Integrated analysis from clinical trials.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Genotype; Hepacivirus; Hepa | 2020 |
Hepatitis C-Associated Osteosclerosis: Improvement After Treatment with Sofosbuvir, Daclatasvir, and Ibandronate: Case Report and Literature Review.
Topics: Carbamates; Hepacivirus; Hepatitis C; Hepatitis C, Chronic; Humans; Ibandronic Acid; Imidazoles; Mal | 2021 |
Treatment failure with DAA therapy: Importance of resistance.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Drug Combinations; Drug Resistance, Viral; Genotype; H | 2021 |
Elbasvir/grazoprevir administered for 12 weeks via percutaneous endoscopic gastrostomy tube achieves sustained virologic response: A case report and a review of the literature.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Gastros | 2021 |
Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta-analysis.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or | 2022 |
Ombitasvir and paritaprevir boosted with ritonavir and combined with dasabuvir for chronic hepatitis C.
Topics: 2-Naphthylamine; Administration, Oral; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug C | 2017 |
Sofosbuvir/velpatasvir fixed-dose combination for the treatment of chronic hepatitis C virus infection.
Topics: Animals; Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Combinations; Drug Interaction | 2017 |
Sofosbuvir and velpatasvir for the treatment of hepatitis C.
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Combinations; Drug Interactions; Drug R | 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 |
Sofosbuvir, velpatasvir and voxilaprevir combination for the treatment of hepatitis C.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Hepat | 2017 |
Sofosbuvir-velpatasvir: A single-tablet treatment for hepatitis C infection of all genotypes.
Topics: Animals; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Drug Combinations; Genot | 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 |
Beclabuvir in combination with asunaprevir and daclatasvir for hepatitis C virus genotype 1 infection: A systematic review and meta-analysis.
Topics: Antiviral Agents; Benzazepines; Carbamates; Drug Therapy, Combination; Drug-Related Side Effects and | 2018 |
Citius, Altius, Fortius: The New Paradigm in the Treatment of Chronic Hepatitis C Disease.
Topics: Anilides; Antiviral Agents; Carbamates; Clinical Trials as Topic; Cyclopropanes; Drug Therapy, Combi | 2018 |
Effectiveness of current and future regimens for treating genotype 3 hepatitis C virus infection: a large-scale systematic review.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C, Chronic | 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 |
Daclatasvir: A Review of Preclinical and Clinical Pharmacokinetics.
Topics: Absorption, Physiological; Animals; Antiviral Agents; Biological Availability; Carbamates; Clinical | 2018 |
Sustained Virological Response in Special Populations with Chronic Hepatitis C Using Interferon-Free Treatments: A Systematic Review and Meta-analysis of Observational Cohort Studies.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; Cyclopropan | 2018 |
Sofosbuvir/Velpatasvir/Voxilaprevir: A Review in Chronic Hepatitis C.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Approval; Drug Combinations | 2018 |
Daclatasvir, asunaprevir and beclabuvir fixed-dose combination for patients with genotype 1 chronic hepatitis C.
Topics: Antiviral Agents; Benzazepines; Carbamates; Drug Combinations; Drug Resistance, Viral; Genotype; Hep | 2018 |
Pharmacodynamic and pharmacokinetic evaluation of the combination of daclatasvir/sofosbuvir/ribavirin in the treatment of chronic hepatitis C.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans | 2018 |
2017 KASL clinical practice guidelines management of hepatitis C: Treatment of chronic hepatitis C.
Topics: Benzimidazoles; Carbamates; Dose-Response Relationship, Drug; Drug Interactions; Fluorenes; Hepatiti | 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 |
Safety and efficacy of elbasvir/grazoprevir for the treatment of chronic hepatitis C: current evidence.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Hepacivirus; Hepatitis C, Chronic; | 2018 |
Review article: novel antivirals for hepatitis C-sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.
Topics: Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; Clinical Trials, Phase III as T | 2018 |
Sofosbuvir/Velpatasvir for the treatment of Hepatitis C Virus infection.
Topics: Adult; Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Therapy, Combination; Fatigue; F | 2018 |
Expert opinion on the management of renal manifestations of chronic HCV infection.
Topics: 2-Naphthylamine; Amides; Aminoisobutyric Acids; Anilides; Antiviral Agents; Benzimidazoles; Benzofur | 2018 |
Treatment of hepatitis C virus genotype 4 in the DAA era.
Topics: Aminoisobutyric Acids; Anilides; Antiviral Agents; Carbamates; Clinical Trials as Topic; Cyclopropan | 2018 |
[Advances in combination therapy of ombitasvir and dasabuvir for chronic hepatitis C virus genotype 1 infection].
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepaci | 2018 |
Evolutionary Pathways to Persistence of Highly Fit and Resistant Hepatitis C Virus Protease Inhibitor Escape Variants.
Topics: 2-Naphthylamine; Aminoisobutyric Acids; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cycl | 2019 |
Retreatment of Hepatitis C Virus-Infected Patients with Direct-Acting Antiviral Failures.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Drug Combinations; Drug Resistance, Viral; Drug Therap | 2019 |
NS5A inhibitors in the treatment of hepatitis C.
Topics: Administration, Oral; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Clinical Trials as Top | 2013 |
NS5A inhibitor, daclatasvir, for the treatment of chronic hepatitis C virus infection.
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Evaluation, Preclinical; Drug Resistanc | 2013 |
Daclatasvir: potential role in hepatitis C.
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Resistance, Viral; Hepacivirus; Hepatit | 2013 |
Ombitasvir (ABT-267), a novel NS5A inhibitor for the treatment of hepatitis C.
Topics: Anilides; Animals; Antiviral Agents; Carbamates; Clinical Trials, Phase II as Topic; Clinical Trials | 2014 |
[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 |
Optimal therapy in genotype 4 chronic hepatitis C: finally cured?
Topics: Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Com | 2015 |
Optimal interferon-free therapy in treatment-experienced chronic hepatitis C patients.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Fluorenes; Genotype; Hepaci | 2015 |
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 |
Daclatasvir: a review of its use in adult patients with chronic hepatitis C virus infection.
Topics: Antiviral Agents; Carbamates; Drug Interactions; Drug Resistance, Viral; Drug Therapy, Combination; | 2015 |
ABT-450/ ritonavir and ABT-267 in combination with ABT-333 for the treatment of hepatitis C virus.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; H | 2015 |
Management of post transplant hepatitis C in the direct antiviral agents era.
Topics: Antiviral Agents; Carbamates; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Interferons; Li | 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 |
Therapy for hepatitis C genotype 3: moving forward.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Health Care Costs; Health Service | 2015 |
Review article: the efficacy and safety of daclatasvir in the treatment of chronic hepatitis C virus infection.
Topics: Antiviral Agents; Carbamates; Drug Interactions; Drug Therapy, Combination; Genotype; Hepacivirus; H | 2015 |
[New era in the treatment of chronic hepatitis C - novel direct acting antivirals].
Topics: 2-Naphthylamine; Administration, Oral; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Clini | 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 for the treatment of chronic hepatitis C virus infection.
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Discovery; Drug Interactions; Drug Resi | 2015 |
Comparative efficacy and safety of daclatasvir/asunaprevir versus IFN-based regimens in genotype 1b hepatitis C virus infection.
Topics: Antiviral Agents; Carbamates; Comparative Effectiveness Research; Drug Therapy, Combination; Female; | 2015 |
Advances in hepatitis C therapies.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit | 2015 |
Management of direct-acting antiviral agent failures.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Clinical Trials as Topic; C | 2015 |
Asunaprevir for hepatitis C: a safety evaluation.
Topics: Animals; Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C | 2015 |
Ideal oral combinations to eradicate HCV: The role of ribavirin.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Drug Therapy, Combination; Fluorenes; G | 2016 |
Asunaprevir (BMS-650032) for the treatment of hepatitis C virus.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Genotype; Hepacivir | 2015 |
Next-Generation Regimens: The Future of Hepatitis C Virus Therapy.
Topics: Amides; Antiviral Agents; Benzazepines; Benzofurans; Carbamates; Clinical Trials, Phase I as Topic; | 2015 |
Daclatasvir: A NS5A Replication Complex Inhibitor for Hepatitis C Infection.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Headache; Hepacivirus; Hepatitis | 2016 |
Daclatasvir-containing all-oral regimens for the treatment of hepatitis C virus infection.
Topics: Administration, Oral; Antiviral Agents; Benzazepines; Carbamates; Clinical Trials as Topic; Drug Int | 2016 |
Daclatasvir for the treatment of chronic hepatitis C.
Topics: Antiviral Agents; Carbamates; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topi | 2015 |
Dual daclatasvir and sofosbuvir for treatment of genotype 3 chronic hepatitis C virus infection.
Topics: Antiviral Agents; Carbamates; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; | 2016 |
Profile of paritaprevir/ritonavir/ombitasvir plus dasabuvir in the treatment of chronic hepatitis C virus genotype 1 infection.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Carrier Proteins; Cyclopropanes; Drug Inter | 2015 |
[Possibilities of IFN-free therapy of hepatitis C].
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Drug Ther | 2015 |
Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives.
Topics: 2-Naphthylamine; Amides; Anilides; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Cyclop | 2016 |
Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives.
Topics: 2-Naphthylamine; Amides; Anilides; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Cyclop | 2016 |
Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives.
Topics: 2-Naphthylamine; Amides; Anilides; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Cyclop | 2016 |
Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives.
Topics: 2-Naphthylamine; Amides; Anilides; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Cyclop | 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 |
Asunaprevir plus daclatasvir for the treatment of chronic hepatitis C virus infection.
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Interactions; Drug Resistance, Viral; D | 2015 |
Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison.
Topics: Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic; Coinfection; Drug Therapy, Combin | 2016 |
Pharmacodynamics and pharmacokinetics of elbasvir and grazoprevir in the treatment of hepatitis C.
Topics: Administration, Oral; Amides; Animals; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Dru | 2016 |
Virological and Clinical Response to Interferon-Free Regimens in Patients with HCV-Related Mixed Cryoglobulinemia: Preliminary Results of a Prospective Pilot Study.
Topics: Aged; Anilides; Antiviral Agents; Carbamates; Cryoglobulinemia; Cyclopropanes; Female; Hepacivirus; | 2017 |
New and Emerging Evidence on the Use of Second-Generation Direct Acting Antivirals for the Treatment of Hepatitis C Virus in Renal Impairment.
Topics: Amides; Animals; Antiviral Agents; Carbamates; Cyclopropanes; Hepacivirus; Hepatitis C; Hepatitis C, | 2017 |
A model-based meta-analysis of sofosbuvir-based treatments in chronic hepatitis C patients.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Female; Fluorenes; Hepacivi | 2016 |
Grazoprevir + elbasvir for the treatment of hepatitis C virus infection.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug Combinations; Dr | 2016 |
Elbasvir/Grazoprevir: First Global Approval.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Hepaciv | 2016 |
Effects of Mild and Moderate Renal Impairment on Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir, and Ribavirin Pharmacokinetics in Patients with Chronic HCV Infection.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Area Under Curve; Carbamates; | 2017 |
Daclatasvir for the Treatment of Chronic Hepatitis C: A Critique of the Clinical and Economic Evidence.
Topics: Antiviral Agents; Carbamates; Cost-Benefit Analysis; Drug Therapy, Combination; Genotype; Hepaciviru | 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 |
Ombitasvir/Paritaprevir/Ritonavir: A Review in Chronic HCV Genotype 4 Infection.
Topics: Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Genotype; Hepacivirus; Hepatitis C, Chronic; | 2016 |
Daclatasvir: A Review in Chronic Hepatitis C.
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Therapy, Combination; Hepatitis C, Chro | 2016 |
Elbasvir/grazoprevir for treatment of chronic hepatitis C virus infection.
Topics: Amides; Animals; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Combinations; Hepaci | 2017 |
HCV NS5A replication complex inhibitors.
Topics: Administration, Oral; Antiviral Agents; Carbamates; Drug Design; Hepacivirus; Hepatitis C, Chronic; | 2016 |
A Review of Daclatasvir Drug-Drug Interactions.
Topics: Antiviral Agents; Carbamates; Drug Interactions; Drug Therapy, Combination; Hepacivirus; Hepatitis C | 2016 |
Use of direct-acting agents for hepatitis C virus-positive kidney transplant candidates and kidney transplant recipients.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Genotype; Hepacivirus; Hepatitis C | 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 |
Sofosbuvir/velpatasvir: a pangenotypic drug to simplify HCV therapy.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Com | 2017 |
The practical management of chronic hepatitis C infection in Japan - dual therapy of daclatasvir + asunaprevir.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Hepatitis C, Chroni | 2017 |
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 |
Clinical Pharmacokinetics of Ombitasvir.
Topics: Anilides; Animals; Antiviral Agents; Carbamates; Drug Interactions; Drug Therapy, Combination; Food- | 2017 |
Sofosbuvir/velpatasvir regimen promises an effective pan-genotypic hepatitis C virus cure.
Topics: Antiviral Agents; Carbamates; Genotype; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More Ring | 2017 |
Treatment of chronic hepatitis C--are interferons really necessary?
Topics: Antiviral Agents; Carbamates; Cyclophilins; Cyclosporine; Drug Substitution; Hepatitis C, Chronic; H | 2012 |
Anti-HCV drugs in the pipeline.
Topics: Animals; Antiviral Agents; Carbamates; Cyclosporine; Deoxycytidine; Hepacivirus; Hepatitis C, Chroni | 2011 |
Current and future therapies of hepatitis C.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Enzyme Inhibitors; Glycoside Hydrolase Inhi | 2001 |
209 trials available for carbamates and Hepatitis C, Chronic
| Article | Year |
|---|---|
Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open-label, phase 2 study.
Topics: Antiviral Agents; Carbamates; China; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C, | 2022 |
Safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trial.
Topics: Adolescent; Adult; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Death, Sudden | 2022 |
Safety and efficacy of sofosbuvir-velpatasvir to treat chronic hepatitis C virus infection in treatment-naive patients in Rwanda (SHARED-3): a single-arm trial.
Topics: Adolescent; Adult; Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocy | 2022 |
Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial.
Topics: Amides; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Comb | 2022 |
SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C, | 2020 |
Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Egypt; | 2020 |
Efficacy and tolerability of sofosbuvir and daclatasvir for treatment of hepatitis C genotype 1 & 3 in patients undergoing hemodialysis- a prospective interventional clinical trial.
Topics: Antiviral Agents; Carbamates; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug M | 2019 |
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 |
Intrahepatic Viral Kinetics During Direct-Acting Antivirals for Hepatitis C in Human Immunodeficiency Virus Coinfection: The AIDS Clinical Trials Group A5335S Substudy.
Topics: 2-Naphthylamine; Acquired Immunodeficiency Syndrome; Adult; Anilides; Antiviral Agents; Carbamates; | 2020 |
Grazoprevir/elbasvir for the immediate treatment of recently acquired HCV genotype 1 or 4 infection in MSM.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Europe; | 2020 |
High success rates for the use of sofosbuvir/ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir/simeprevir/daclatasvir + ribavirin in retreatment of chronic hepatitis C infection after unsuccessful sofosbuvir/daclatasvir therapy: a real-life exp
Topics: Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hep | 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 |
Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Combinations; Hepacivi | 2020 |
[Efficacy and safety of narlaprevir/ritonavir and daclatasvir non interferon combination in population of Russian patients with chronic hepatitis C].
Topics: Adult; Antiviral Agents; Carbamates; Cyclopropanes; Dipeptides; Drug Therapy, Combination; Female; G | 2019 |
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 |
Short-duration treatment with the novel non-nucleoside inhibitor CDI-31244 plus sofosbuvir/velpatasvir for chronic hepatitis C: An open-label study.
Topics: Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepat | 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 |
Eliminating hepatitis C in a rural Appalachian county: protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C; | 2021 |
Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyc | 2017 |
Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyc | 2017 |
Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyc | 2017 |
Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyc | 2017 |
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 in adults with hepatitis C virus genotype 4 infection and cirrhosis (AGATE-I): a multicentre, phase 3, randomised open-label trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; D | 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 |
Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial.
Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropan | 2017 |
Metformin and daclatasvir: absence of a pharmacokinetic-pharmacodynamic drug interaction in healthy volunteers.
Topics: Administration, Oral; Adult; Area Under Curve; Blood Glucose; Carbamates; Cross-Over Studies; Diabet | 2017 |
Sofosbuvir-velpatasvir with ribavirin for 24 weeks in hepatitis C virus patients previously treated with a direct-acting antiviral regimen.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Combinations; Drug Resistance, Viral; Drug Therapy, | 2017 |
Elbasvir plus grazoprevir in patients with hepatitis C virus infection and stage 4-5 chronic kidney disease: clinical, virological, and health-related quality-of-life outcomes from a phase 3, multicentre, randomised, double-blind, placebo-controlled trial
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Double-Blind Method; Drug A | 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 |
Safety and efficacy of an 8-week regimen of grazoprevir plus ruzasvir plus uprifosbuvir compared with grazoprevir plus elbasvir plus uprifosbuvir in participants without cirrhosis infected with hepatitis C virus genotypes 1, 2, or 3 (C-CREST-1 and C-CREST
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Administration S | 2017 |
Safety and efficacy of an 8-week regimen of grazoprevir plus ruzasvir plus uprifosbuvir compared with grazoprevir plus elbasvir plus uprifosbuvir in participants without cirrhosis infected with hepatitis C virus genotypes 1, 2, or 3 (C-CREST-1 and C-CREST
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Administration S | 2017 |
Safety and efficacy of an 8-week regimen of grazoprevir plus ruzasvir plus uprifosbuvir compared with grazoprevir plus elbasvir plus uprifosbuvir in participants without cirrhosis infected with hepatitis C virus genotypes 1, 2, or 3 (C-CREST-1 and C-CREST
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Administration S | 2017 |
Safety and efficacy of an 8-week regimen of grazoprevir plus ruzasvir plus uprifosbuvir compared with grazoprevir plus elbasvir plus uprifosbuvir in participants without cirrhosis infected with hepatitis C virus genotypes 1, 2, or 3 (C-CREST-1 and C-CREST
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Administration S | 2017 |
Resistance characterization of hepatitis C virus genotype 2 from Japanese patients treated with ombitasvir and paritaprevir/ritonavir.
Topics: Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug Therapy, Combina | 2018 |
Effect of Hepatic Impairment on the Pharmacokinetics of Grazoprevir, a Hepatitis C Virus Protease Inhibitor.
Topics: Adolescent; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Ther | 2017 |
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 |
Retreatment With Sofosbuvir Plus Grazoprevir/Elbasvir Plus Ribavirin of Patients With Hepatitis C Virus Genotype 1 or 4 Who Previously Failed an NS5A- or NS3-Containing Regimen: The ANRS HC34 REVENGE Study.
Topics: Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; F | 2018 |
IFNL4 Genotype Is Associated With Virologic Relapse After 8-Week Treatment With Sofosbuvir, Velpatasvir, and Voxilaprevir.
Topics: Aminoisobutyric Acids; Carbamates; Cyclopropanes; Drug Combinations; Genotype; Hepacivirus; Hepatiti | 2017 |
Intrapatient viral diversity and treatment outcome in patients with genotype 3a hepatitis C virus infection on sofosbuvir-containing regimens.
Topics: Antiviral Agents; Carbamates; Genetic Variation; Genotype; Hepacivirus; Hepatitis C, Chronic; Hetero | 2018 |
Shortened 8 Weeks Course of Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients, With Chronic Hepatitis C Infection.
Topics: Adolescent; Antiviral Agents; Carbamates; Child; Drug Administration Schedule; Drug Therapy, Combina | 2018 |
Efficacy and safety of 12 weeks of elbasvir ± grazoprevir ± ribavirin in participants with hepatitis C virus genotype 2, 4, 5 or 6 infection: The C-SCAPE study.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo | 2018 |
Resistance analysis in patients with genotype 1-6 HCV infection treated with sofosbuvir/velpatasvir in the phase III studies.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Genetic Variation; | 2018 |
Viral kinetics analysis and virological characterization of treatment failures in patients with chronic hepatitis C treated with sofosbuvir and an NS5A inhibitor.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; Drug T | 2018 |
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 and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial.
Topics: Administration, Oral; Adult; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Packag | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 2018 |
Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; | 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 |
Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; D | 2018 |
Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; D | 2018 |
Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; D | 2018 |
Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; D | 2018 |
Characterization of demographics and NS5A genetic diversity for hepatitis C virus genotype 4-infected patients with or without cirrhosis treated with ombitasvir/paritaprevir/ritonavir.
Topics: Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Clinical Trials, Phase II as | 2018 |
A sofosbuvir-based quadruple regimen is highly effective in HCV type 4-infected Egyptian patients with DAA treatment failure.
Topics: Adult; Antiviral Agents; Carbamates; Cohort Studies; Drug Resistance, Multiple, Viral; Drug Therapy, | 2018 |
Efficacy and Safety of Elbasvir-Grazoprevir Fixed Dose in the Management of Polytreated HCV Patients: Evidence From Real-Life Clinical Practice.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Dr | 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 |
Deferred treatment with sofosbuvir-velpatasvir-voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Combinations; Female; Genot | 2018 |
Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Female; Genotype; Hepacivirus; Hepatitis C, Chronic | 2018 |
Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Female; Genotype; Hepacivirus; Hepatitis C, Chronic | 2018 |
Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Female; Genotype; Hepacivirus; Hepatitis C, Chronic | 2018 |
Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Female; Genotype; Hepacivirus; Hepatitis C, Chronic | 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 |
Sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks in noncirrhotic subjects chronically infected with hepatitis C virus genotype 1: a randomized clinical trial.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Gen | 2019 |
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Asian People; Carbamates; China; Cyclopropanes; | 2019 |
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Asian People; Carbamates; China; Cyclopropanes; | 2019 |
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Asian People; Carbamates; China; Cyclopropanes; | 2019 |
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Asian People; Carbamates; China; Cyclopropanes; | 2019 |
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Asian People; Carbamates; China; Cyclopropanes; | 2019 |
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Asian People; Carbamates; China; Cyclopropanes; | 2019 |
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Asian People; Carbamates; China; Cyclopropanes; | 2019 |
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Asian People; Carbamates; China; Cyclopropanes; | 2019 |
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Asian People; Carbamates; China; Cyclopropanes; | 2019 |
Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals: a clinical randomized study.
Topics: 2-Naphthylamine; Adult; Anemia; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropane | 2018 |
Sofosbuvir-velpatasvir plus ribavirin in Japanese patients with genotype 1 or 2 hepatitis C who failed direct-acting antivirals.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Administrat | 2018 |
Exposure-Response (Efficacy) Analysis of Daclatasvir and Asunaprevir in Japanese Patients With Hepatitis C Virus Infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Female; Genotype; Hepatitis C, Ch | 2018 |
No impact of resistance-associated substitutions on the efficacy of sofosbuvir, velpatasvir, and voxilaprevir for 12 weeks in HCV DAA-experienced patients.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2018 |
Daclatasvir Plasma Levels in a Cohort of Patients with Hepatitis C Virus Infection Taking Methadone: A Prospective Analysis.
Topics: Adult; Analgesics, Opioid; Antiviral Agents; Carbamates; Cohort Studies; Drug Interactions; Female; | 2018 |
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 |
Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use: The SIMPLIFY study.
Topics: Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C, Chronic; Hetero | 2018 |
Population Pharmacokinetics of AL-335 and Its Two Main Metabolites (ALS-022399, ALS-022227) in Monotherapy and in Combination with Odalasvir and/or Simeprevir.
Topics: Administration, Oral; Alanine; Antiviral Agents; Benzimidazoles; Biological Variation, Population; C | 2018 |
Sofosbuvir/velpatasvir for chronic hepatitis C infection in patients with transfusion-dependent thalassemia.
Topics: Antiviral Agents; Blood Transfusion; Carbamates; Female; Hepatitis C, Chronic; Heterocyclic Compound | 2019 |
Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C Virus Genotype 1b Infection on Hemodialysis.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Gen | 2019 |
The accuracy of baseline viral load for predicting the efficacy of elbasvir/grazoprevir in participants with hepatitis C virus genotype 1a infection: An integrated analysis.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Data Interpretation, Statistical; | 2019 |
Efficacy and safety of 12 weeks of daclatasvir, asunaprevir plus ribavirin for HCV genotype-1b infection without NS5A resistance-associated substitutions.
Topics: Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Hepac | 2019 |
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 |
Sofosbuvir/Velpatasvir/Voxilaprevir for patients with HCV who previously received a Sofosbuvir/Velpatasvir-containing regimen: Results from a retreatment study.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Hepac | 2019 |
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 2019 |
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 2019 |
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 2019 |
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
Topics: Adult; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 2019 |
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 |
A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients.
Topics: Adult; Aged; Aminoisobutyric Acids; Antiviral Agents; Biopsy, Needle; Calcineurin Inhibitors; Carbam | 2019 |
Sofosbuvir-velpatasvir single-tablet regimen administered for 12 weeks in a phase 3 study with minimal monitoring in India.
Topics: Adult; Aged; Carbamates; Drug Combinations; Drug Monitoring; Female; Genotype; Hepacivirus; Hepatiti | 2019 |
Ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir for patients with hepatitis C virus genotype 1 infection who failed a prior course of direct-acting antiviral therapy.
Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropan | 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 |
Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administration Schedule | 2019 |
A pilot study of safety and efficacy of HCV retreatment with sofosbuvir/velpatasvir/voxilaprevir in patients with or without HIV (RESOLVE STUDY).
Topics: Aged; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; | 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 |
Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Drug-Related Side Effects and Adverse Reactions; Fe | 2019 |
Persistence of resistant variants in hepatitis C virus-infected patients treated with the NS5A replication complex inhibitor daclatasvir.
Topics: Amino Acid Substitution; Antiviral Agents; Carbamates; Dose-Response Relationship, Drug; Double-Blin | 2013 |
Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir.
Topics: Adult; Antiviral Agents; Carbamates; Dose-Response Relationship, Drug; Drug Resistance, Viral; Drug | 2013 |
Echocardiogram study to evaluate the effect of the novel hepatitis C virus NS5A inhibitor GSK2336805 on cardiac contractility in healthy subjects.
Topics: Adult; Antiviral Agents; Carbamates; Echocardiography; Female; Hepatitis C, Chronic; Humans; Male; M | 2013 |
A double-blind, randomized, placebo-controlled study to assess the safety, antiviral activity and pharmacokinetics of GSK2336805 when given as monotherapy and in combination with peginterferon alfa-2a and ribavirin in hepatitis C virus genotype 1-infected
Topics: Adult; Aged; Antiviral Agents; Biomarkers; Carbamates; Double-Blind Method; Drug Administration Sche | 2014 |
Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection.
Topics: Administration, Oral; Adolescent; Adult; Aged; Antiviral Agents; Benzazepines; Carbamates; Drug Admi | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1.
Topics: Administration, Oral; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Thera | 2014 |
A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus genotype 1, 2, 3 or 4.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Dose-Response Relationship, Drug; Double-Blind | 2014 |
Randomized trial of daclatasvir and asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Genotype; H | 2014 |
A randomized trial of daclatasvir with peginterferon alfa-2b and ribavirin for HCV genotype 1 infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese patients infected with hepatitis C genotype 1.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2014 |
Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection.
Topics: Adult; Aged; Carbamates; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis C, Chronic; Human | 2014 |
Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dou | 2014 |
Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dou | 2014 |
Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dou | 2014 |
Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dou | 2014 |
Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dou | 2014 |
Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dou | 2014 |
Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dou | 2014 |
Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dou | 2014 |
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 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug The | 2014 |
Emergence of resistant variants detected by ultra-deep sequencing after asunaprevir and daclatasvir combination therapy in patients infected with hepatitis C virus genotype 1.
Topics: Administration, Oral; Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Comb | 2015 |
Sofosbuvir plus daclatasvir for post-transplant recurrent hepatitis C: potent antiviral activity but no clinical benefit if treatment is given late.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Compassionate Use Trials; Drug Administration Schedule; D | 2014 |
All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Co | 2014 |
All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Co | 2014 |
All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Co | 2014 |
All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Co | 2014 |
Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study.
Topics: Adolescent; Adult; Aged; Carbamates; Double-Blind Method; Drug Administration Schedule; Drug Therapy | 2015 |
The pharmacokinetics of daclatasvir and asunaprevir administered in combination in studies in healthy subjects and patients infected with hepatitis C virus.
Topics: Adult; Antiviral Agents; Area Under Curve; Carbamates; Drug Interactions; Drug Therapy, Combination; | 2014 |
Exploratory trial of ombitasvir and ABT-450/r with or without ribavirin for HCV genotype 1, 2, and 3 infection.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Femal | 2015 |
Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Double-Blind Method; Drug Therapy, Combinatio | 2015 |
In vitro antiviral activity and preclinical and clinical resistance profile of miravirsen, a novel anti-hepatitis C virus therapeutic targeting the human factor miR-122.
Topics: 5' Untranslated Regions; Antiviral Agents; Carbamates; Cyclohexanols; Drug Resistance, Viral; Drug T | 2015 |
An interferon-free antiviral regimen for HCV after liver transplantation.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Calcineurin Inhibitors; Carbamates; Cyclop | 2014 |
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The | 2015 |
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The | 2015 |
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The | 2015 |
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The | 2015 |
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The | 2015 |
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The | 2015 |
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The | 2015 |
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The | 2015 |
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a rando
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Coinfection; Cyclopropanes; Drug The | 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 |
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 |
A randomized trial of daclatasvir in combination with asunaprevir and beclabuvir in patients with chronic hepatitis C virus genotype 4 infection.
Topics: Adult; Antiviral Agents; Benzazepines; Carbamates; Drug Monitoring; Drug Resistance, Viral; Enzyme I | 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 |
Drug-drug interaction profile of the all-oral anti-hepatitis C virus regimen of paritaprevir/ritonavir, ombitasvir, and dasabuvir.
Topics: 2-Naphthylamine; Administration, Oral; Adolescent; Adult; Anilides; Antiviral Agents; Carbamates; Cy | 2015 |
Single-dose pharmacokinetics and safety of daclatasvir in subjects with renal function impairment.
Topics: Antiviral Agents; Carbamates; Female; Glomerular Filtration Rate; Hepatitis C, Chronic; Humans; Imid | 2015 |
Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders.
Topics: Adult; Aged; Antiviral Agents; Carbamates; DNA, Viral; Drug Administration Schedule; Drug Carriers; | 2015 |
Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders.
Topics: Adult; Aged; Antiviral Agents; Carbamates; DNA, Viral; Drug Administration Schedule; Drug Carriers; | 2015 |
Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders.
Topics: Adult; Aged; Antiviral Agents; Carbamates; DNA, Viral; Drug Administration Schedule; Drug Carriers; | 2015 |
Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders.
Topics: Adult; Aged; Antiviral Agents; Carbamates; DNA, Viral; Drug Administration Schedule; Drug Carriers; | 2015 |
Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial.
Topics: Adolescent; Adult; Aged; Alanine Transaminase; Anilides; Antiviral Agents; Aspartate Aminotransferas | 2015 |
Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial.
Topics: Adolescent; Adult; Aged; Alanine Transaminase; Anilides; Antiviral Agents; Aspartate Aminotransferas | 2015 |
Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial.
Topics: Adolescent; Adult; Aged; Alanine Transaminase; Anilides; Antiviral Agents; Aspartate Aminotransferas | 2015 |
Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial.
Topics: Adolescent; Adult; Aged; Alanine Transaminase; Anilides; Antiviral Agents; Aspartate Aminotransferas | 2015 |
Ombitasvir/paritaprevir/r and dasabuvir plus ribavirin in HCV genotype 1-infected patients on methadone or buprenorphine.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Analgesics, Opioid; Anilides; Antiviral Agents; Buprenorph | 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 |
Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection.
Topics: Adult; Aged; Alanine Transaminase; Antiviral Agents; Benzazepines; Carbamates; Drug Therapy, Combina | 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 |
Long term persistence of NS5A inhibitor-resistant hepatitis C virus in patients who failed daclatasvir and asunaprevir therapy.
Topics: Aged; Amino Acid Substitution; Antiviral Agents; Carbamates; Drug Resistance, Viral; Female; Genotyp | 2015 |
High Cure Rate With 24 Weeks of Daclatasvir-Based Quadruple Therapy in Treatment-Experienced, Null-Responder Patients With HIV/Hepatitis C Virus Genotype 1/4 Coinfection: The ANRS HC30 QUADRIH Study.
Topics: Antiviral Agents; Carbamates; Coinfection; Female; Hepacivirus; Hepatitis C, Chronic; HIV Infections | 2015 |
[Healing rate after 12 weeks over 90% for the first time].
Topics: Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazol | 2015 |
[In Process Citation].
Topics: Anti-HIV Agents; Antiviral Agents; Carbamates; Cost Savings; Dose-Response Relationship, Drug; Drug | 2015 |
Pharmacokinetics and safety of co-administered paritaprevir plus ritonavir, ombitasvir, and dasabuvir in hepatic impairment.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Cytochrome P-450 CYP3A Inhib | 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 |
A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocyclic C | 2015 |
A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocyclic C | 2015 |
A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocyclic C | 2015 |
A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocyclic C | 2015 |
Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Topics: Adult; Aged; Anti-Retroviral Agents; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Ther | 2015 |
Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Topics: Adult; Aged; Anti-Retroviral Agents; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Ther | 2015 |
Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Topics: Adult; Aged; Anti-Retroviral Agents; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Ther | 2015 |
Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Topics: Adult; Aged; Anti-Retroviral Agents; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Ther | 2015 |
Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Topics: Adult; Aged; Anti-Retroviral Agents; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Ther | 2015 |
Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Topics: Adult; Aged; Anti-Retroviral Agents; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Ther | 2015 |
Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Topics: Adult; Aged; Anti-Retroviral Agents; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Ther | 2015 |
Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Topics: Adult; Aged; Anti-Retroviral Agents; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Ther | 2015 |
Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1.
Topics: Adult; Aged; Anti-Retroviral Agents; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Ther | 2015 |
Immunological Analysis During Interferon-Free Therapy for Chronic Hepatitis C Virus Infection Reveals Modulation of the Natural Killer Cell Compartment.
Topics: Antiviral Agents; Carbamates; Case-Control Studies; Cytokines; Gene Expression Regulation; Hepatitis | 2016 |
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 |
Hepatitis C virus genotype 4 resistance and subtype demographic characterization of patients treated with ombitasvir plus paritaprevir/ritonavir.
Topics: Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Drug Therapy, | 2015 |
Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, C | 2016 |
Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, C | 2016 |
Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, C | 2016 |
Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, C | 2016 |
Grazoprevir plus peginterferon and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection: a randomized trial.
Topics: Adult; Aged; Amides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; | 2016 |
Grazoprevir, Elbasvir, and Ribavirin for Chronic Hepatitis C Virus Genotype 1 Infection After Failure of Pegylated Interferon and Ribavirin With an Earlier-Generation Protease Inhibitor: Final 24-Week Results From C-SALVAGE.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Viral; Hepaciviru | 2016 |
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 |
Serum miR-122 may serve as a biomarker for response to direct acting antivirals: effect of paritaprevir/R with dasabuvir or ombitasvir on miR-122 in HCV-infected subjects.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Biomarkers; Carbamates; Cyclopropanes; Drug Therapy, Co | 2016 |
Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; DNA, Viral; Dose-Response Relationship, Drug; Drug Admini | 2016 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study.
Topics: Aged; Amides; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Daclatasvir + asunaprevir + beclabuvir ± ribavirin for chronic HCV genotype 1-infected treatment-naive patients.
Topics: Adult; Aged; Antiviral Agents; Benzazepines; Carbamates; Drug Administration Schedule; Drug Monitori | 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 |
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 With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Resistance, Viral; Dru | 2015 |
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 |
Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Dr | 2016 |
Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Dr | 2016 |
Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Dr | 2016 |
Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Dr | 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 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 |
Evaluation of Drug-Drug Interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HIV-1 Protease Inhibitors.
Topics: 2-Naphthylamine; Adolescent; Adult; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropan | 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 |
Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus.
Topics: Adult; Aged; Benzimidazoles; Carbamates; Drug Combinations; Female; Fluorenes; Genotype; Hepacivirus | 2016 |
Retreatment with sofosbuvir and simeprevir of patients with hepatitis C virus genotype 1 or 4 who previously failed a daclatasvir-containing regimen.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C, Chronic; Humans; Imida | 2016 |
Safety and efficacy of dual direct-acting antiviral therapy (daclatasvir and asunaprevir) for chronic hepatitis C virus genotype 1 infection in patients on hemodialysis.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis C, Chr | 2016 |
Drug-Drug Interactions Between the Anti-Hepatitis C Virus 3D Regimen of Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and Eight Commonly Used Medications in Healthy Volunteers.
Topics: 2-Naphthylamine; Adolescent; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Inte | 2016 |
[Complication sequelae prevented, morbidity decreased].
Topics: Carbamates; Drug Therapy, Combination; Hepatitis C, Chronic; Humans; Imidazoles; Liver Cirrhosis; Py | 2015 |
A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2016 |
All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study.
Topics: Administration, Oral; Adult; Aged; Alanine Transaminase; Antiviral Agents; Asian People; Carbamates; | 2016 |
Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combina | 2016 |
[Daclatasvir/sofosbuvir is effective also in advanced liver disease].
Topics: Carbamates; Drug Administration Schedule; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatiti | 2016 |
Exposure-Response Relationship for Ombitasvir and Paritaprevir/Ritonavir in Hepatitis C Virus Subgenotype 1b-Infected Japanese Patients in the Phase 3 Randomized GIFT-I Study.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Double-Blind Method; Drug Monito | 2016 |
[High chance of healing for opiate dependent patients].
Topics: Amides; Benzofurans; Carbamates; Cyclopropanes; Double-Blind Method; Drug Combinations; Hepatitis C, | 2016 |
Exposure-Efficacy Analyses of Ombitasvir, Paritaprevir/Ritonavir with Dasabuvir ± Ribavirin in HCV Genotype 1-Infected Patients.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dou | 2016 |
[New therapy option in the pipeline].
Topics: Administration, Oral; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Approva | 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 daclatasvir/asunaprevir according to resistance-associated variants in chronic hepatitis C with genotype 1.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, | 2017 |
[In HIV-HCV co-infection check for drug interactions].
Topics: AIDS-Related Opportunistic Infections; Anti-HIV Agents; Antiviral Agents; Carbamates; Compassionate | 2016 |
Efficacy and safety of grazoprevir + ribavirin for 12 or 24 weeks in treatment-naïve patients with hepatitis C virus genotype 1 infection.
Topics: Adult; Amides; Antiviral Agents; Carbamates; Cyclopropanes; Drug-Related Side Effects and Adverse Re | 2016 |
Population Pharmacokinetics of Paritaprevir, Ombitasvir, and Ritonavir in Japanese Patients with Hepatitis C Virus Genotype 1b Infection.
Topics: Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Double-Blind Method; | 2017 |
Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Dose-Response Relationship, Drug; Drug Therapy, Combinati | 2016 |
Daclatasvir/peginterferon lambda-1a/ribavirin in patients with chronic HCV infection and haemophilia who are treatment naïve or prior relapsers to peginterferon alfa-2a/ribavirin.
Topics: Adult; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Combination; Genoty | 2016 |
Clinical Resistance to Velpatasvir (GS-5816), a Novel Pan-Genotypic Inhibitor of the Hepatitis C Virus NS5A Protein.
Topics: Amino Acid Substitution; Antiviral Agents; Carbamates; Double-Blind Method; Drug Administration Sche | 2016 |
Pharmacokinetics and Tolerability of Anti-Hepatitis C Virus Treatment with Ombitasvir, Paritaprevir, Ritonavir, with or Without Dasabuvir, in Subjects with Renal Impairment.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combinat | 2017 |
Ribavirin-Free Regimen With Sofosbuvir and Velpatasvir Is Associated With High Efficacy and Improvement of Patient-Reported Outcomes in Patients With Genotypes 2 and 3 Chronic Hepatitis C: Results From Astral-2 and -3 Clinical Trials.
Topics: Adult; Carbamates; Comorbidity; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis | 2016 |
Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyc | 2016 |
Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyc | 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 |
Preclinical Profile and Clinical Efficacy of a Novel Hepatitis C Virus NS5A Inhibitor, EDP-239.
Topics: Animals; Antiviral Agents; Benzimidazoles; Carbamates; Cell Line; Drug Evaluation, Preclinical; Drug | 2016 |
Drug-Drug Interaction between the Direct-Acting Antiviral Regimen of Ombitasvir-Paritaprevir-Ritonavir plus Dasabuvir and the HIV Antiretroviral Agent Dolutegravir or Abacavir plus Lamivudine.
Topics: 2-Naphthylamine; Adult; Anilides; Anti-HIV Agents; Anti-Retroviral Agents; Carbamates; Cyclopropanes | 2016 |
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 |
Safety and efficacy of dual therapy with daclatasvir and asunaprevir for older patients with chronic hepatitis C.
Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Administ | 2017 |
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 |
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Combinations; Dr | 2017 |
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Combinations; Dr | 2017 |
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Combinations; Dr | 2017 |
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Combinations; Dr | 2017 |
Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial.
Topics: Adult; Aged; Amides; Benzofurans; Carbamates; Confidence Intervals; Cyclopropanes; Dose-Response Rel | 2017 |
Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial.
Topics: Adult; Aged; Amides; Benzofurans; Carbamates; Confidence Intervals; Cyclopropanes; Dose-Response Rel | 2017 |
Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial.
Topics: Adult; Aged; Amides; Benzofurans; Carbamates; Confidence Intervals; Cyclopropanes; Dose-Response Rel | 2017 |
Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial.
Topics: Adult; Aged; Amides; Benzofurans; Carbamates; Confidence Intervals; Cyclopropanes; Dose-Response Rel | 2017 |
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 |
Simeprevir, daclatasvir and sofosbuvir for hepatitis C virus-infected patients with decompensated liver disease.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug-Related Side Effects and Adverse Reactions; Female; | 2017 |
Efficacy and tolerability of an IFN-free regimen with DCV/ASV for elderly patients infected with HCV genotype 1B.
Topics: Adult; Age Factors; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination | 2017 |
Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study.
Topics: Administration, Oral; Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Drug Administration | 2016 |
Short-duration treatment for chronic hepatitis C virus with daclatasvir, asunaprevir, beclabuvir and sofosbuvir (FOURward study).
Topics: Adult; Antiviral Agents; Benzazepines; Carbamates; Drug Therapy, Combination; Female; Hepacivirus; H | 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 |
The efficacy and safety of dual oral therapy with daclatasvir and asunaprevir for genotype 1b in Japanese real-life settings.
Topics: Administration, Oral; Aged; Alanine Transaminase; Antiviral Agents; Carbamates; Drug Resistance, Vir | 2017 |
Efficacy, safety and pharmacokinetics of simeprevir and TMC647055/ritonavir with or without ribavirin and JNJ-56914845 in HCV genotype 1 infection.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepatitis C, | 2017 |
Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepacivir | 2017 |
Sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin in direct-acting antiviral-experienced patients with genotype 1 hepatitis C virus.
Topics: Adult; Aged; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Confidence Intervals; Cyclopropane | 2017 |
Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study.
Topics: Administration, Oral; Adult; Amides; Benzofurans; Biopsy, Needle; Blood Coagulation Disorders, Inher | 2017 |
Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation: The Phase II SATURN study.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cyclosporine; Drug Therapy, Combination; Female; Genotype | 2017 |
Merimepodib, pegylated interferon, and ribavirin in genotype 1 chronic hepatitis C pegylated interferon and ribavirin nonresponders.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Double-Blind Method; Drug Therapy, Combinatio | 2009 |
Multiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1.
Topics: Adolescent; Adult; Antiviral Agents; Carbamates; Double-Blind Method; Female; Half-Life; Hepacivirus | 2011 |
Preliminary study of two antiviral agents for hepatitis C genotype 1.
Topics: Adult; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Geno | 2012 |
Preliminary study of two antiviral agents for hepatitis C genotype 1.
Topics: Adult; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Geno | 2012 |
Preliminary study of two antiviral agents for hepatitis C genotype 1.
Topics: Adult; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Geno | 2012 |
Preliminary study of two antiviral agents for hepatitis C genotype 1.
Topics: Adult; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Geno | 2012 |
Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Double-Blind Method; Drug Therapy, Combination; Female; F | 2012 |
Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female | 2013 |
Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options.
Topics: Administration, Oral; Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; | 2013 |
Short-term antiviral efficacy of BILN 2061, a hepatitis C virus serine protease inhibitor, in hepatitis C genotype 1 patients.
Topics: Antiviral Agents; Carbamates; Dose-Response Relationship, Drug; Double-Blind Method; Female; Hepatit | 2004 |
"Strong reasons make strong actions"--The antiviral efficacy of NS3/4A protease inhibitors.
Topics: Antiviral Agents; Carbamates; Double-Blind Method; Drug Resistance, Viral; Hepatitis C, Chronic; Hum | 2005 |
Antiviral efficacy of NS3-serine protease inhibitor BILN-2061 in patients with chronic genotype 2 and 3 hepatitis C.
Topics: Administration, Oral; Adult; Carbamates; Double-Blind Method; Drug Administration Schedule; Female; | 2005 |
A randomized, double-blind, placebo-controlled dose-escalation trial of merimepodib (VX-497) and interferon-alpha in previously untreated patients with chronic hepatitis C.
Topics: Administration, Oral; Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Double-Blind Method; Dr | 2005 |
Viral kinetics in patients with chronic hepatitis C treated with the serine protease inhibitor BILN 2061.
Topics: Adult; Antiviral Agents; Area Under Curve; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Hu | 2006 |
Phase 2 study of the combination of merimepodib with peginterferon-alpha2b, and ribavirin in nonresponders to previous therapy for chronic hepatitis C.
Topics: Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis C, Ch | 2007 |
528 other studies available for carbamates and Hepatitis C, Chronic
| Article | Year |
|---|---|
Optimal Timing of Administration of Direct-acting Antivirals for Patients With Hepatitis C-associated Hepatocellular Carcinoma Undergoing Liver Transplantation.
Topics: Aged; Antiviral Agents; Benzimidazoles; Carbamates; Carcinoma, Hepatocellular; Drug Administration S | 2021 |
Liver Targeting of Daclatasvir via Tailoring Sterically Stabilized Bilosomes: Fabrication, Comparative In Vitro/In Vivo Appraisal and Biodistribution Studies.
Topics: Antiviral Agents; Carbamates; Drug Carriers; Drug Delivery Systems; Hepatitis C, Chronic; Humans; Im | 2021 |
Successful treatment of chronic hepatitis C virus infection with crushed elbasvir/grazoprevir administered through a nasogastric tube in a patient with hypoxic encephalopathy.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Female; Genotype; Hepacivirus; Hep | 2022 |
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 |
Efficacy of 8 weeks elbasvir/grazoprevir regimen for naïve-genotype 1b, HCV infected patients with or without glucose abnormalities: Results of the EGG18 study.
Topics: Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; F | 2022 |
Association of Sofosbuvir and Daclatasvir Plasma Trough Concentrations with Patient-, Treatment-, and Disease-Related Factors Among HIV/HCV-Coinfected Persons.
Topics: Antiviral Agents; Area Under Curve; Carbamates; Cohort Studies; Drug Therapy, Combination; Female; H | 2022 |
[Glecaprevir/Pibrentasvir + Sofosbuvir + Ribavirin as a salvage regimen after Sofosbuvir + Velpatasvir + Voxilaprevir re-treatment failure].
Topics: Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; Child; Cyclopropanes; Drug Ther | 2022 |
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 |
Diagnostic approach to elucidate the efficacy and side effects of direct-acting antivirals in HCV infected patients.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2021 |
The Alaska Native/American Indian experience of hepatitis C treatment with sofosbuvir-based direct-acting antivirals.
Topics: Adult; Aged; Alaska; American Indian or Alaska Native; Antiviral Agents; Benzimidazoles; Carbamates; | 2021 |
Grazoprevir/Elbasvir Treatment in Liver or Kidney Transplant Recipients with Genotype 1b Hepatitis C Virus Infection.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; | 2022 |
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 |
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 |
Impact of proton pump inhibitors on sustained virologic response in veterans treated with sofosbuvir/velpatasvir for chronic hepatitis C virus: A retrospective cohort study.
Topics: Antiviral Agents; Carbamates; Genotype; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, 4 | 2022 |
Real-world effectiveness and safety of sofosbuvir/velpatasvir and glecaprevir/pibrentasvir for genotype 6 chronic hepatitis C.
Topics: Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Benzopyrans; Carbamates; Cyclopropanes; Dru | 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 |
Treatment outcomes of sofosbuvir/velpatasvir/voxilaprevir among NS5A inhibitor-experienced patients with hepatitis C: Real-world data from a multicenter Asian registry.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Genotype; Hepacivirus; Hepatitis | 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 |
Non-responders to sofosbuvir/velpatasvir/voxilaprevir in the treatment of chronic hepatitis C infection.
Topics: Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Benzopyrans; Carbamates; Cyclopropanes; Gen | 2022 |
A simple and sensitive HPLC-FL method for bioanalysis of velpatasvir, a novel hepatitis C virus NS5A inhibitor, in rat plasma: Investigation of factors determining its oral bioavailability.
Topics: Administration, Oral; Animals; Antiviral Agents; Biological Availability; Carbamates; Chromatography | 2022 |
Utilization of HCV Viremic Kidneys with Genotyping/Subtyping-Free Sofosbuvir/Velpatasvir Treatment Strategy: Experience from China.
Topics: Adult; Antiviral Agents; Carbamates; Female; Genotype; Hepacivirus; Hepatitis C; Hepatitis C, Chroni | 2022 |
Detection of Occult Hepatitis C Virus Infection in Egyptian Patients Who Achieved a Sustained Virologic Response to Direct-Acting Antiviral Agents.
Topics: Aged; alpha-Fetoproteins; Antiviral Agents; Carbamates; Cross-Sectional Studies; Drug Therapy, Combi | 2022 |
Efficacy and safety of ombitasvir/paritaprevir/ritonavir-based therapy in HCV patients with chronic kidney disease.
Topics: Anilides; Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis | 2023 |
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 |
Real-life effectiveness and safety of the daclatasvir/asunaprevir combination therapy for genotype 1b chronic hepatitis C patients: An emphasis on the pretreatment NS5A resistance-associated substitution test.
Topics: Aged; Amino Acid Substitution; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, C | 2019 |
Prevalence of resistance associated substitutions and efficacy of baseline resistance-guided chronic hepatitis C treatment in Spain from the GEHEP-004 cohort.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Viral; Female; Ge | 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 |
Baseline resistance associated substitutions in HCV genotype 1 infected cohort treated with Simeprevir, Daclatasvir and Sofosbuvir in Brazil.
Topics: Antiviral Agents; Brazil; Carbamates; Cohort Studies; Drug Resistance, Viral; Female; Genotype; Hepa | 2020 |
Hepatitis B virus reactivation sustained by a hepatitis B virus surface antigen immune-escape mutant isolate in a patient who was hepatitis B core antibody positive during treatment with sofosbuvir and velpatasvir for hepatitis C virus infection: a case r
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepatitis B; Hepatit | 2019 |
Drug-drug interactions in anti-HCV therapy: a comparison among options available in Italy.
Topics: Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Drug Combinations; Drug Interactions; Hep | 2019 |
Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice - Vie-KinD study.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Ther | 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 |
Ribavirin induces hepatitis C virus genome mutations in chronic hepatitis patients who failed to respond to prior daclatasvir plus asunaprevir therapy.
Topics: Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Carbamates; Cell Line; Drug Resistance, V | 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 |
Limited drug-drug interaction of elbasvir/grazoprevir for chronic hepatitis C.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Interactions; Hepacivirus; He | 2020 |
What is the Long-term Benefit of Direct-acting Antiviral Therapy in Chronic Hepatitis C?
Topics: Antiviral Agents; Carbamates; Fibrosis; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazo | 2019 |
Resistance Mutations A30K and Y93N Associated with Treatment Failure with Sofosbuvir and Daclatasvir for Hepatitis C Virus Infection Non-Responder Patients: Case Reports.
Topics: Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Female; Hepacivirus; Hepatitis C, Chroni | 2019 |
Predictors of adverse drug reactions associated with ribavirin in direct-acting antiviral therapies for chronic hepatitis C.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Antiviral Agents; Brazil; Carbamates; Drug Therapy, Combinat | 2019 |
Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; F | 2019 |
Sofosbuvir-/Daclatasvir-based therapy for chronic HCV and HCV/hepatitis B virus coinfected patients in Egypt.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Egypt; Genotype; Hepacivirus; Hepatitis B; | 2020 |
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 |
The effect of genetic variations on ribavirin pharmacokinetics and treatment response in HCV-4 Egyptian patients receiving sofosbuvir/daclatasvir and ribavirin.
Topics: Carbamates; Drug Therapy, Combination; Egypt; Endpoint Determination; Gene Frequency; Genetic Variat | 2020 |
Three Children Treated with Direct-acting Antivirals for Chronic Hepatitis C Virus Genotype 1b Infection.
Topics: Adolescent; Aminoisobutyric Acids; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Child; Cy | 2020 |
Cell Culture Studies of the Efficacy and Barrier to Resistance of Sofosbuvir-Velpatasvir and Glecaprevir-Pibrentasvir against Hepatitis C Virus Genotypes 2a, 2b, and 2c.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Cell Line, Tumor; Culture Media; Drug Combinations; Dr | 2020 |
Effectiveness of Elbasvir/Grazoprevir in patients with hepatitis C virus genotype 1 infection and chronic kidney disease in the United States veterans population.
Topics: Adolescent; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Ther | 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 |
Effectiveness of crushed sofosbuvir-velpatasvir in a patient with dysphagia.
Topics: Administration, Oral; Antiviral Agents; Carbamates; Deglutition Disorders; Drug Combinations; Female | 2020 |
Safety and efficacy of direct-acting antivirals for chronic hepatitis C in patients with chronic kidney disease.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cryoglobulinemia; Cyclopropanes; Drug Thera | 2020 |
Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2020 |
Response to direct-acting antiviral agents in chronic hepatitis C patients with end-stage renal disease: a clinical experience.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, C | 2019 |
Real-world efficacy of direct acting antiviral therapies in patients with HIV/HCV.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Coinfection; Drug Therapy, Combination; F | 2020 |
Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL) in HCV-Positive Egyptian Patients Treated with Sofosbuvir.
Topics: Acute Kidney Injury; Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Egypt; Female; | 2020 |
Daclatasvir plus asunaprevir in the treatment of uremic patients with chronic hepatitis C genotype 1b infection.
Topics: Carbamates; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquinolines; Pyrrolid | 2020 |
Pharmacological management of adverse events during treatment of chronic viral hepatitis in three Ivorian university hospitals
.
Topics: Antiviral Agents; Carbamates; Cote d'Ivoire; Cross-Sectional Studies; Drug Therapy, Combination; Gen | 2020 |
Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study.
Topics: Adiponectin; Aged; Alanine Transaminase; Benzimidazoles; Blood Glucose; Carbamates; Cholesterol; Dru | 2020 |
Crushed application of sofosbuvir and velpatasvir in a patient with swallowing disorder.
Topics: Antiviral Agents; Carbamates; Deglutition Disorders; Drug Combinations; Hepatitis C, Chronic; Hetero | 2020 |
Screening and Treatment Program to Eliminate Hepatitis C in Egypt.
Topics: Adolescent; Adult; Antiviral Agents; Carbamates; Egypt; Female; Health Care Costs; Hepatitis C, Chro | 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 |
Effect of Hemodialysis on Efficacy and Pharmacokinetics of Sofosbuvir Coformulated with Either Daclatasvir or Ledipasvir in Patients with End-Stage Renal Disease.
Topics: Adult; Aged; Benzimidazoles; Carbamates; Clinical Trials as Topic; Drug Monitoring; Drug Therapy, Co | 2020 |
Evolution of Hepatitis C Virus Treatment During the Era of Sofosbuvir-Based Therapies: A Real-World Experience in France.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Fra | 2021 |
Utilization and effectiveness of elbasvir/grazoprevir and adoption of resistance-associated substitutions testing in real-world treatment of hepatitis C virus genotype 1A infection: results from the German Hepatitis C-Registry.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Genotyp | 2021 |
Modeling-Based Response-Guided Glecaprevir-Pibrentasvir Therapy for Chronic Hepatitis C to Identify Patients for Ultrashort Treatment Duration.
Topics: Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Drug A | 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 |
Sofosbuvir-Daclatasvir is suboptimal in patients with genotype 2 chronic hepatitis C infection: real-life experience from the HEPATHER ANRS CO22 cohort.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C; Hepatit | 2020 |
Global real-world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts.
Topics: Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C; | 2020 |
Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Mini-Tabs Plus Ribavirin for Children Aged 3-11 Years with Hepatitis C Genotype 1a.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Child; Child, Preschool; Cyclopropanes; Cyt | 2020 |
Efficacy of NS5A inhibitors against unusual and potentially difficult-to-treat HCV subtypes commonly found in sub-Saharan Africa and South East Asia.
Topics: Africa South of the Sahara; Antiviral Agents; Asia, Eastern; Benzimidazoles; Benzofurans; Carbamates | 2020 |
Sustained virological response following an 11-day course of direct acting antiviral therapy for hepatitis C infection.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Cytochrome P-450 CYP3A Inhib | 2020 |
Anti-rod and ring antibodies in patients with chronic hepatitis C using direct-acting antivirals.
Topics: Aged; Antibodies, Antinuclear; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Fluo | 2020 |
Effectiveness and safety of elbasvir/grazoprevir in Korean patients with hepatitis C virus infection: a nationwide real-world study.
Topics: Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; G | 2021 |
Efficacy of sofosbuvir/velpatasvir/voxilaprevir in direct-acting antiviral experienced patients with hepatitis C virus.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Genotype; Hepacivirus; Hepatitis | 2021 |
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 |
Sofosbuvir/velpatasvir/voxilaprevir plus ribavirin for chronic hepatitis C patients with direct acting antiviral failures: Implications for viral elimination in Taiwan.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Combinations; Genotype; Hep | 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 |
Chronic Hepatitis C Virus Infection After Kidney Transplantation With or Without Direct-Acting Antivirals in a Real-Life Setting: A French Multicenter Experience.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Female; Fluorenes; France; Hepatitis C, Chronic | 2020 |
Cure or curd: Modification of lipid profiles and cardio-cerebrovascular events after hepatitis C virus eradication.
Topics: Aged; Antiviral Agents; Carbamates; Cholesterol, HDL; Cholesterol, LDL; Coronary Artery Disease; Dys | 2020 |
Real-word efficacy of sofosbuvir, velpatasvir plus ribavirin therapy for chronic hepatitis patients who failed to prior DAA therapy with NS5A-P32 deletion mutated HCV infection.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C; Hepatit | 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 |
Impact of sustained virological response on metabolic disorders in diabetic chronic hepatitis C virus patients after treatment with generic sofosbuvir and daclatasvir.
Topics: Antiviral Agents; Carbamates; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Genotype; Hepaci | 2021 |
Effectiveness of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C virus infection and virologic failure to direct-acting antivirals.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Combinations; Drug Therapy, | 2021 |
Cost-utility of sofosbuvir/velpatasvir versus other direct-acting antivirals for chronic hepatitis C genotype 1b infection in China.
Topics: Antiviral Agents; Carbamates; China; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C, | 2020 |
Identification of microRNA associated with the elimination of hepatitis C virus genotype 1b by direct-acting antiviral therapies.
Topics: Amides; Antiviral Agents; Benzofurans; Biomarkers; Carbamates; Cyclopropanes; Disease Eradication; D | 2021 |
Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Genotype; Hepacivirus; Hepatitis | 2021 |
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 |
The interrelation between lipid profile in chronic HCV patients and their response to antiviral agents.
Topics: Adult; Antiviral Agents; Carbamates; Female; Hepatitis C, Chronic; Humans; Imidazoles; Interferons; | 2021 |
Sofosbuvir, velpatasvir, and voxilaprevir for patients with failure of previous direct-acting antiviral therapy for chronic hepatitis C: Results from the German Hepatitis C-Registry (DHC-R).
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Genot | 2020 |
Hepatitis C therapy with grazoprevir/elbasvir and glecaprevir/pibrentasvir in patients with advanced chronic kidney disease: data from the German Hepatitis C-Registry (DHC-R).
Topics: Amides; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Cyclopropa | 2022 |
Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end-stage renal disease on maintenance haemodialysis.
Topics: Adult; Antiviral Agents; Carbamates; Drug Combinations; Drug Therapy, Combination; Genotype; Hepaciv | 2021 |
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 |
Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease: A real-life experience.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Egypt | 2020 |
Efficacy and safety of sofosbuvir-based pangenotypic direct-acting antiviral agents for chronic hepatitis C patients without genotype determination: Real-world experience of a retrospective study.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cohort Studies; Female; Genotype; Hepacivirus; Hepatitis | 2020 |
Direct-acting antiviral treatment failure in genotype 2 hepatitis C chronic infection.
Topics: Antiviral Agents; Carbamates; Genotype; Hepatitis C; Hepatitis C, Chronic; Humans; Imidazoles; Pyrro | 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 |
Morbidity and mortality during hepatitis C treatment using sofosbuvir and daclatasvir with or without ribavirin, in a cohort of Egyptian patients.
Topics: Antiviral Agents; Carbamates; Child; Drug Therapy, Combination; Egypt; Female; Genotype; Hepacivirus | 2020 |
Efficacy and safety of sofosbuvir/velpatasvir in a real-world chronic hepatitis C genotype 3 cohort.
Topics: Adult; Carbamates; Coinfection; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis | 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 |
Effectiveness of direct-acting antivirals in maintenance hemodialysis patients complicated with chronic hepatitis C.
Topics: Alanine Transaminase; Amides; Antiviral Agents; Aspartate Aminotransferases; Benzofurans; Carbamates | 2020 |
Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Combinations; Drug Therapy, Combi | 2022 |
Deinduction of P-glycoprotein resulting in delayed viral response during hepatitis C treatment.
Topics: Anti-Retroviral Agents; ATP Binding Cassette Transporter, Subfamily B, Member 1; Carbamates; Carbama | 2021 |
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 |
Retreatment of Chronic Hepatitis C Failed to Daclatasvir Plus Asunaprevir by Other Direct-acting Antivirals.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C, Chronic | 2021 |
Salvage Therapy with Sofosbuvir/Velpatasvir/Voxilaprevir in DAA-experienced Patients: Results from a Prospective Canadian Registry.
Topics: Aminoisobutyric Acids; Antiviral Agents; Canada; Carbamates; Cyclopropanes; Drug Therapy, Combinatio | 2021 |
Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan.
Topics: Antiviral Agents; Carbamates; Genotype; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, 4 | 2021 |
Resistance-associated substitutions after sofosbuvir/velpatasvir/voxilaprevir triple therapy failure.
Topics: Aged; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Viral; Dr | 2021 |
Association between interleukin 28B polymorphism and sustained virological response to sofosbuvir plus daclatasvir in chronic hepatitis C genotype 4 Egyptian patients.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Black People; Carbamates; Drug Therapy, Combination; Egyp | 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 |
Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepatitis C, Chronic | 2021 |
Sofosbuvir/Velpatasvir Plus Ribavirin Combination Therapy for Patients with Hepatitis C Virus Genotype 1a, 2a, or 3b after Glecaprevir/Pibrentasvir Therapy Failed.
Topics: Aged; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Drug Thera | 2021 |
Impact of sofosbuvir and daclastavir on health-related quality of life in patients co-infected with hepatitis C and human immunodeficiency virus.
Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepatitis C, Ch | 2021 |
Real-world experience of serial serum levels of GS-331007 in chronic hepatitis C hemodialysis patients during and after sofosbuvir/velpatasvir therapy.
Topics: Carbamates; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More Rings; Humans; Renal Dialysis; S | 2021 |
Prevalence of resistance-associated substitutions to NS3, NS5A and NS5B inhibitors at DAA-failure in hepatitis C virus in Italy from 2015 to 2019.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Drug Combinations; Fluorenes; Genotype; Hepacivirus; H | 2021 |
Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.
Topics: Adult; Analgesics, Opioid; Antiviral Agents; Carbamates; Directly Observed Therapy; Drug Therapy, Co | 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 |
Reply to: "Real-world experience of serial serum levels of GS-331007 in chronic hepatitis C hemodialysis patients during and after sofosbuvir/velpatasvir therapy".
Topics: Carbamates; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More Rings; Humans; Renal Dialysis; S | 2021 |
Effective and Safe Daclatasvir Drug Exposures Predicted in Children Using Adult Formulations.
Topics: Adolescent; Adult; Antiviral Agents; Carbamates; Child; Dose-Response Relationship, Drug; Egypt; Fem | 2021 |
Retreatment with sofosbuvir, ledipasvir, and add-on ribavirin for patients who failed daclatasvir and asunaprevir combination therapy.
Topics: Aged; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Female; Fluorenes; Ge | 2017 |
Transplantation of kidneys from hepatitis C-positive donors into hepatitis C virus-infected recipients followed by early initiation of direct acting antiviral therapy: a single-center retrospective study.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Donor Selection; Drug Therapy, Combinatio | 2017 |
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 |
Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment.
Topics: Adult; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Drug Combinations; Female; Fluoren | 2017 |
Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment.
Topics: Adult; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Drug Combinations; Female; Fluoren | 2017 |
Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment.
Topics: Adult; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Drug Combinations; Female; Fluoren | 2017 |
Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment.
Topics: Adult; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; Drug Combinations; Female; Fluoren | 2017 |
Evolution of multi-drug resistant HCV clones from pre-existing resistant-associated variants during direct-acting antiviral therapy determined by third-generation sequencing.
Topics: Aged; Antiviral Agents; Carbamates; Drug Resistance, Multiple; Drug Resistance, Viral; Drug Therapy, | 2017 |
Daclatasvir plasma concentration assessment in HIV-HCV-coinfected real-life patients.
Topics: Antiviral Agents; Carbamates; Coinfection; Genotype; Hepacivirus; Hepatitis C; Hepatitis C, Chronic; | 2017 |
Sofosbuvir-Daclatasvir-Simeprevir Plus Ribavirin in Direct-Acting Antiviral-Experienced Patients With Hepatitis C.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Genotype; H | 2017 |
Daclatasvir/asunaprevir/beclabuvir, all-oral, fixed-dose combination for patients with chronic hepatitis C virus genotype 1.
Topics: Adult; Aged; Aged, 80 and over; Benzazepines; Carbamates; Cohort Studies; Drug Combinations; Female; | 2017 |
The Role of e-Health in Optimizing Task-Shifting in the Delivery of Antiviral Therapy for Chronic Hepatitis C.
Topics: Antiviral Agents; California; Carbamates; Communication; Computer Security; Confidentiality; Drug Co | 2017 |
Exposure-Safety Response Relationship for Ombitasvir, Paritaprevir/Ritonavir, Dasabuvir, and Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: Analysis of Data from Five Phase II and Six Phase III Studies.
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Clinical Trials, P | 2017 |
Impact of interferon-free antivirus therapy on lipid profiles in patients with chronic hepatitis C genotype 1b.
Topics: Aged; Aged, 80 and over; Carbamates; Cohort Studies; Drug Therapy, Combination; Female; Hepacivirus; | 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 |
Long-Term Follow-Up of Resistance-Associated Substitutions in Hepatitis C Virus in Patients in Which Direct Acting Antiviral-Based Therapy Failed.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female | 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 |
Relationship of hepatitis B virus infection to the recurrence of hepatocellular carcinoma after direct acting antivirals.
Topics: Aged; Aged, 80 and over; Antibodies, Viral; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; | 2017 |
Daclatasvir and asunaprevir in hemodialysis patients with hepatitis C virus infection: a nationwide retrospective study in Japan.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Gen | 2018 |
Virology analysis in HCV genotype 1-infected patients treated with the combination of simeprevir and TMC647055/ritonavir, with and without ribavirin, and JNJ-56914845.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Genotype; Genotyping Techniques; Hepacivirus; | 2017 |
The Influence of Hepatitis C Virus Therapy on the DNA Base Excision Repair System of Peripheral Blood Mononuclear Cells.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cell Nucleus; Cyclopropanes; Deoxyuridine; | 2017 |
Effective Treatment With Daclatasvir and Asunaprevir in Kidney Transplant Patients Infected With Hepatitis C Virus: A Report of Two Cases.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis C, Chr | 2017 |
Favouring modulation of circulating lipoproteins and lipid loading capacity by direct antiviral agents grazoprevir/elbasvir or ledipasvir/sofosbuvir treatment against chronic HCV infection.
Topics: Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzimidazoles; Benzofurans; Carbamates; C | 2018 |
Oral Direct Acting Antivirals treatment failed to cure a patient with chronic hepatitis C due to shifts of viral genotype.
Topics: Administration, Oral; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Substitution; Drug | 2017 |
Assessing the Budget Impact and Economic Outcomes of the Introduction of Daclatasvir + Asunaprevir and Sofosbuvir/Ledipasvir for the Treatment of Chronic Hepatitis C Virus Infection in Japan.
Topics: Aged; Antiviral Agents; Benzimidazoles; Carbamates; Cost-Benefit Analysis; Drug Therapy, Combination | 2017 |
The elderly and direct antiviral agents: Constraint or challenge?
Topics: Aged; Antiviral Agents; Benzimidazoles; Carbamates; Drug Interactions; Drug Therapy, Combination; Fe | 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 |
Emergence of drug resistance-associated variants and changes in serum lipid profiles in sofosbuvir plus ledipasvir-treated chronic hepatitis C patients.
Topics: Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropane | 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 based treatment of chronic hepatitis C genotype 3 infections-A Scandinavian real-life study.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2017 |
Hepatitis B reactivation in a patient with chronic hepatitis C treated with direct-acting antivirals.
Topics: Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Therapy, Combination; Guani | 2018 |
Re: Saint-Laurent Thibault C, Moorjaney D, Ganz ML, et al. Cost-effectiveness of combination daclatasvir-sofosbuvir for treatment of genotype 3 chronic hepatitis C infection in the United States. J Med Econ 2017;20:692-702.
Topics: Carbamates; Cost-Benefit Analysis; Genotype; Hepatitis C, Chronic; Humans; Imidazoles; Pyrrolidines; | 2017 |
Reply: Cost-effectiveness of combination daclatasvir-sofosbuvir for treatment of genotype 3 chronic hepatitis C infection in the United States.
Topics: Carbamates; Cost-Benefit Analysis; Genotype; Hepatitis C, Chronic; Humans; Imidazoles; Pyrrolidines; | 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-world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without ribavirin for patients with chronic hepatitis C virus genotype 1b infection in Taiwan.
Topics: 2-Naphthylamine; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dru | 2018 |
Intra-Hepatic Depletion of Mucosal-Associated Invariant T Cells in Hepatitis C Virus-Induced Liver Inflammation.
Topics: Antiviral Agents; Biopsy; Carbamates; Case-Control Studies; Cytokines; Drug Combinations; Hepatitis | 2017 |
The risks of hepatocellular carcinoma development after HCV eradication are similar between patients treated with peg-interferon plus ribavirin and direct-acting antiviral therapy.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Carcinoma, Hepatocellular; Drug Therap | 2017 |
The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients.
Topics: Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combina | 2018 |
Rational Heart Transplant From a Hepatitis C Donor: New Antiviral Weapons Conquer the Trojan Horse.
Topics: Adult; Antiviral Agents; Carbamates; Drug Combinations; Female; Heart Failure; Heart Transplantation | 2017 |
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 |
Reduction in warfarin effect associated with sofosbuvir-velpatasvir.
Topics: Anticoagulants; Antiviral Agents; Carbamates; Drug Combinations; Drug Interactions; Hepatitis C, Chr | 2017 |
Immune responses in DAA treated chronic hepatitis C patients with and without prior RG-101 dosing.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Chemokine CXCL10; Drug Therapy, Combination; Female; Geno | 2017 |
Direct Acting Antiviral Agents in Korean Patients with Chronic Hepatitis C and Hemophilia Who Are Treatment-Naïve or Treatment-Experienced.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Drug Resistance, Viral; Female; Fluorenes | 2017 |
Effect of Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir and Ledipasvir/Sofosbuvir Regimens on Survival Compared With Untreated Hepatitis C Virus-Infected Persons: Results From ERCHIVES.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Drug T | 2017 |
Serial changes in liver stiffness and controlled attenuation parameter following direct-acting antiviral therapy against hepatitis C virus genotype 1b.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Elasticity Imaging Techniques; Female; | 2018 |
Pentagalloylglucose, a highly bioavailable polyphenolic compound present in Cortex moutan, efficiently blocks hepatitis C virus entry.
Topics: Animals; Antiviral Agents; Biological Availability; Carbamates; Cell Line, Tumor; Cells, Cultured; D | 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 |
Successful treatment of chronic hepatitis C virus infection in a patient receiving daily peritoneal dialysis.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administration Sc | 2017 |
Sofosbuvir and daclatasvir plus ribavirin treatment improve liver function parameters and clinical outcomes in Egyptian chronic hepatitis C patients.
Topics: Adult; Alanine Transaminase; Antiviral Agents; Aspartate Aminotransferases; Bilirubin; Carbamates; D | 2017 |
Mavyret and Vosevi--two new combinations for chronic HCV infection.
Topics: Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Drug Combination | 2017 |
Anti-HCV treatment with ombitasvir/paritaprevir/ritonavir ± dasabuvir is associated with increased bile acid levels and pruritus.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Bile Acids and Salts; Carbamates; Cyclopropanes; Drug Therap | 2017 |
Resistance characterization of ledipasvir and velpatasvir in hepatitis C virus genotype 4.
Topics: Amino Acid Substitution; Antiviral Agents; Benzimidazoles; Carbamates; Drug Resistance, Multiple, Vi | 2018 |
Potential drug-drug interactions of OMBITASVIR, PARITAPREVIR/ritonavir ± DASABUVIR ± ribavirin in clinical practice.
Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Anilides; Carbamates; Cyclopropanes; Drug Interacti | 2018 |
Sofosbuvir-based Interferon-Free Direct Acting Antiviral Regimens for Heart Transplant Recipients With Chronic Hepatitis C Virus Infection.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Drug-Related Side Ef | 2018 |
Rapid reversal of innate immune dysregulation in blood of patients and livers of humanized mice with HCV following DAA therapy.
Topics: Aged; Animals; Antiviral Agents; Benzazepines; Carbamates; Disease Models, Animal; Female; Gene Expr | 2017 |
Hepatocellular Carcinoma after Achievement of Sustained Viral Response with Daclatasvir and Asunaprevir in Patients with Chronic Hepatitis C Virus Infection.
Topics: Adult; Aged; Aged, 80 and over; alpha-Fetoproteins; Antiviral Agents; Carbamates; Carcinoma, Hepatoc | 2017 |
The outcomes of glucose abnormalities in chronic hepatitis C patients receiving interferon-free direct antiviral agents.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combinat | 2017 |
Benefit-risk assessment for sofosbuvir/velpatasvir/voxilaprevir based on patient population and hepatitis C virus genotype: U. S. Food and Drug Administration's evaluation.
Topics: Adult; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination | 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 |
MSF pushes down price of generic hepatitis C drugs to new low level.
Topics: Antiviral Agents; Carbamates; Developing Countries; Drug Costs; Drug Industry; Drugs, Generic; Hepat | 2017 |
Association between alanine aminotransferase elevation and UGT1A1*6 polymorphisms in daclatasvir and asunaprevir combination therapy for chronic hepatitis C.
Topics: Adult; Aged; Aged, 80 and over; Alanine Transaminase; Antiviral Agents; Biomarkers; Carbamates; Chem | 2018 |
Plasma trough concentrations of antiretrovirals in HIV-infected persons treated with direct-acting antiviral agents for hepatitis C in the real world.
Topics: 2-Naphthylamine; Anilides; Anti-Retroviral Agents; Carbamates; Coinfection; Cyclopropanes; Drug Inte | 2018 |
The influence of immunosuppressants on direct-acting antiviral therapy is dependent on the hepatitis C virus genotype.
Topics: Antiviral Agents; Benzimidazoles; Calcineurin Inhibitors; Carbamates; Cell Line; Cyclosporine; Evero | 2018 |
Daclatasvir and asunaprevir treatment in patients infected by genotype 1b of hepatitis C virus with no or subtle resistant associated substitutions (RAS) in NS5A-Y93.
Topics: Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Female; Genotype; Hepacivirus; Hepatitis | 2018 |
Patient-Reported Outcomes Following Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir and Velpatasvir, With or Without Voxilaprevir.
Topics: Adult; Aged; Aged, 80 and over; Aminoisobutyric Acids; Antiviral Agents; Carbamates; Clinical Trials | 2018 |
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 |
Long-term follow-up of ribavirin-free DAA-based treatment in HCV recurrence after orthotopic liver transplantation.
Topics: Aged; Antiviral Agents; Austria; Benzimidazoles; Carbamates; Carcinoma, Hepatocellular; Drug Therapy | 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 |
Remarkable plasma HIV RNA decrease by ombitasvir/paritaprevir/ritonavir in an HIV-HCV coinfection case.
Topics: Adult; Anilides; Antiviral Agents; Carbamates; Coinfection; Cyclopropanes; Hepacivirus; Hepatitis C, | 2018 |
Rapid Changes in Serum Lipid Profiles during Combination Therapy with Daclatasvir and Asunaprevir in Patients Infected with Hepatitis C Virus Genotype 1b.
Topics: Aged; Antiviral Agents; Carbamates; Cohort Studies; Drug Monitoring; Drug Therapy, Combination; Fema | 2018 |
HCV kinetic and modeling analyses project shorter durations to cure under combined therapy with daclatasvir and asunaprevir in chronic HCV-infected patients.
Topics: Antiviral Agents; Carbamates; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquinolines; | 2017 |
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 |
Estudio de impacto presupuestal de Daclatasvir asociado a Asunaprevir desde la perspectiva del sistema de salud público chileno.
Topics: Antiviral Agents; Carbamates; Chile; Cohort Studies; Cost-Benefit Analysis; Drug Therapy, Combinatio | 2017 |
Uptake of direct-acting antiviral treatment for chronic hepatitis C in Australia.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Australia; Benzimidazoles; Carbamates; Drug Utiliz | 2018 |
Differences in the Serum 4β-hydroxycholesterol Levels of Patients with Chronic Hepatitis C Virus (HCV) Infection: A Possible Impact on the Efficacy and Safety of Interferon (IFN)-free Treatment.
Topics: Aged; Anilides; Antiviral Agents; Carbamates; Case-Control Studies; Cyclopropanes; Cytochrome P-450 | 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 |
Future Considerations for the Evaluation of Hepatitis C Virus Treatments in Pan-Genotypic Therapy for Noncirrhotic Treatment-Naive Patients.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Genetic Testing; Genotype; Hepacivirus; Hepatitis C | 2018 |
Role of ribavirin in the treatment of hepatitis C virus-associated mixed cryoglobulinemia with interferon-free regimens.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cryoglobulinemia; Cyclopropanes; Dru | 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 |
Editorial: direct-acting antivirals significantly improve quality of life in patients with hepatitis C virus infection-Author's reply.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Hepacivirus; Hepatitis C, Chroni | 2018 |
Editorial: direct-acting antivirals significantly improve quality of life in patients with hepatitis C virus infection.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Hepacivirus; Hepatitis C, Chroni | 2018 |
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 |
Effectiveness and safety of original and generic sofosbuvir for the treatment of chronic hepatitis C: A real world study.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Argentina; Carbamates; Drug-Related Si | 2018 |
Spur-of-the-Moment Modification in National Treatment Policies Leads to a Surprising HCV Viral Suppression in All Treated Patients: Real-Life Egyptian Experience.
Topics: Antiviral Agents; Carbamates; Egypt; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; | 2018 |
Case of psoriatic patient who maintains long-term remission after anti-hepatitis C virus agents and ustekinumab treatment.
Topics: Aged; Antiviral Agents; Carbamates; Dermatologic Agents; Hepacivirus; Hepatitis C, Chronic; Humans; | 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 |
Cost Effectiveness of Daclatasvir Plus Asunaprevir Therapy for Chinese Patients with Chronic Hepatitis C Virus Genotype 1b.
Topics: Adult; Antiviral Agents; Carbamates; China; Cost-Benefit Analysis; Drug Therapy, Combination; Female | 2018 |
Complete Response of Diffuse Large B Cell Lymphoma After Direct-Acting Antiviral Therapy for Hepatitis C Virus.
Topics: Aged; Antiviral Agents; Carbamates; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More Rings; H | 2019 |
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 |
HCV Genotype 6a Escape From and Resistance to Velpatasvir, Pibrentasvir, and Sofosbuvir in Robust Infectious Cell Culture Models.
Topics: Amino Acid Substitution; Antiviral Agents; Benzimidazoles; Carbamates; Cell Culture Techniques; Cell | 2018 |
Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease.
Topics: Adult; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therapy, Combination; Female | 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 |
HCV genotype-3h, a difficult-to-diagnose sub-genotype in the DAA era.
Topics: 2-Naphthylamine; Aged; Amino Acid Substitution; Anilides; Antiviral Agents; Carbamates; Cyclopropane | 2018 |
Successful treatment of HCV-related glomerulonephritis with sofosbuvir and daclatasvir.
Topics: Antiviral Agents; Carbamates; Glomerulonephritis; Hepacivirus; Hepatitis C, Chronic; Host-Pathogen I | 2018 |
Chronic Hepatitis C Treatment with Daclatasvir Plus Asunaprevir Does Not Lead to a Decreased Quality of Life.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Chronic Disease; Drug Therapy, Combina | 2018 |
Improvement of Proteinuria due to Combination Therapy with Daclatasvir and Asunaprevir in Hepatitis C Virus-associated Renal Disease without Cryoglobulinemia.
Topics: Aged, 80 and over; Antiviral Agents; Ascites; Carbamates; Drug Therapy, Combination; Female; Glomeru | 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 |
Anti-E1E2 antibodies status prior therapy favors direct-acting antiviral treatment efficacy.
Topics: Aged; Antibodies; Antiviral Agents; Biomarkers; Carbamates; Drug Therapy, Combination; Enzyme-Linked | 2018 |
Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients With Chronic Hepatitis C Infection.
Topics: Adolescent; Antiviral Agents; Carbamates; Child; Drug Therapy, Combination; Female; Hepatitis C, Chr | 2018 |
Real-life 3D therapy failure: Analysis of NS5A 93H RAS plus 108 K polymorphism in complex with ombitasvir by molecular modeling.
Topics: Aged; Anilides; Antiviral Agents; Carbamates; Hepatitis C, Chronic; Humans; Male; Models, Molecular; | 2018 |
'Real-life' experience with direct-acting antiviral agents for hepatitis C virus in end-stage renal disease.
Topics: Aged; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; Drug Therapy, Combination; Femal | 2018 |
A Patient with HCV Infection and a Sustained Virological Response to Direct-acting Antiviral Treatment Who Developed Inclusion Body Myositis.
Topics: Aged; Anilides; Antiviral Agents; Carbamates; Cryoglobulinemia; Cyclopropanes; Female; Hepatitis C, | 2018 |
Sofosbuvir + velpatasvir + voxilaprevir for the treatment of hepatitis C infection.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Hepat | 2018 |
Cost-effectiveness of daclatasvir plus asunaprevir for chronic hepatitis C genotype 1b treatment-naïve patients in China.
Topics: Adult; Antiviral Agents; Carbamates; China; Cohort Studies; Cost-Benefit Analysis; Disease Progressi | 2018 |
Ombitasvir-Paritaprevir-Ritonavir Therapy in a Kidney Transplant Recipient With Chronic Hepatitis C Virus Genotype 1 Infection: A Case Report on the Importance of Considering Drug-Drug Interactions and Monitoring Cyclosporine Levels.
Topics: Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Cyclosporine; Drug Interactions; Drug T | 2018 |
Sofosbuvir plus Daclatasvir with or without ribavirin for treatment of chronic HCV genotype 4 patients: real-life experience.
Topics: Administration, Oral; Adult; Antiviral Agents; Carbamates; Drug Administration Schedule; Drug Therap | 2018 |
Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir Regimen in the Treatment of Genotype 1 Chronic Hepatitis C Infection in Patients with Severe Renal Impairment and End-Stage Renal Disease: a Real-Life Cohort.
Topics: 2-Naphthylamine; Anilides; Antihypertensive Agents; Antiviral Agents; Carbamates; Cyclopropanes; Dru | 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 |
Pre-emptive Treatment of HCV after Living Donor Liver Transplantation with Direct-Acting Antiviral Agents.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Female; Fluore | 2018 |
Sofosbuvir Causing Diabetes Mellitus: Is there a Link?
Topics: Antiviral Agents; Benzimidazoles; Blood Glucose; Carbamates; Diabetes Mellitus; Drug Therapy, Combin | 2018 |
Safety and efficacy of HCV eradication during etanercept treatment for severe psoriasis.
Topics: Aged; Antiviral Agents; Carbamates; Etanercept; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazole | 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 |
Real-world virological efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis C virus genotype 1 infection in Japan.
Topics: Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resi | 2018 |
Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4.
Topics: Adult; Antiviral Agents; Carbamates; Cohort Studies; Dose-Response Relationship, Drug; Drug Monitori | 2018 |
Evolution and persistence of resistance-associated substitutions of hepatitis C virus after direct-acting antiviral treatment failures.
Topics: Aged; Antiviral Agents; Carbamates; Cell Line, Tumor; Drug Resistance, Viral; Drug Therapy, Combinat | 2018 |
Efficacy and Safety of Direct Acting Antiviral Therapy for Chronic Hepatitis C in Thalassemic Children.
Topics: Adolescent; Antiviral Agents; beta-Thalassemia; Carbamates; Child; Child, Preschool; Drug Therapy, C | 2018 |
Successful Ombitasvir/Paritaprevir/Ritonavir Plus Ribavirin Retreatment for a Chronic Hepatitis C Genotype 2a Patient Who Relapsed after Sofosbuvir Plus Ribavirin Treatment.
Topics: Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Female; Geno | 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 |
Vitamin D pathway gene polymorphisms affecting daclatasvir plasma concentration at 2 weeks and 1 month of therapy.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Female; Genotype; Hepatitis C, Chronic; Humans; Imidazole | 2018 |
Daclatasvir and asunaprevir combination therapy for patients with chronic hepatitis C virus genotype 1b infection in real world.
Topics: Aged; Antiviral Agents; Carbamates; Drug Combinations; Female; Genotype; Hepacivirus; Hepatitis C, C | 2019 |
[Daclatasvir-sofosbuvir combination therapy for chronic hepatitis C virus infection: progress in clinical studies].
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Hepatitis C, Chronic; Humans; Imidazoles; P | 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 |
Comment on 'Efficacy of daclatasvir-based quadruple therapy in nonresponder patients infected by hepatitis C virus genotype 4: the ANRS HC32 QUATTRO study'.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C, Chronic | 2018 |
Retreatment of hepatitis C virus: can it get any better?
Topics: Aminoisobutyric Acids; Carbamates; Cyclopropanes; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Co | 2018 |
Daclatasvir combined with asunaprevir is a cost-effective and cost-saving treatment for hepatitis C infection in China.
Topics: Antiviral Agents; Carbamates; China; Cost-Benefit Analysis; Drug Therapy, Combination; Genotype; Hea | 2018 |
Letter: concordance of SVR4 and SVR12 following direct-acting anti-viral treatment in Egypt.
Topics: Antiviral Agents; Carbamates; Egypt; Hepatitis C, Chronic; Humans; Imidazoles; Pyrrolidines; Ribavir | 2018 |
Ombitasvir/paritaprevir/ritonavir plus dasabuvir regimen may be used safely in combination with sirolimus for the treatment of chronic hepatitis C.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Dru | 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 |
Successful treatment of chronic hepatitis C infection with crushed elbasvir/grazoprevir administered via a percutaneous endoscopic gastrostomy tube.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Gastros | 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 |
Treating hepatitis C infection in patients with advanced CKD in the real world: time to refocus on what our real treatment goals should be.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Genotyp | 2018 |
Editorial: real-life data confirm efficacy of elbasvir/grazoprevir in HCV patients with severe kidney disease-Author's reply.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Hepatitis C, Chronic; Humans; Imid | 2018 |
Editorial: real-life data confirm efficacy of elbasvir/grazoprevir in HCV patients with severe kidney disease.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Hepatitis C, Chronic; Humans; Imid | 2018 |
Concomitant use of sorafenib with ombitasvir/paritaprevir/ritonavir and dasabuvir: Effectiveness and safety in clinical practice.
Topics: 2-Naphthylamine; Aged; Anilides; Antineoplastic Agents; Antiviral Agents; Carbamates; Carcinoma, Hep | 2018 |
Direct-acting antiviral drugs are triggers for psoriasis: report of three cases.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2018 |
Late relapse of hepatitis C virus in patients with sustained virological response after daclatasvir and asunaprevir therapy.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Female; Follow-Up Studies; Genotype; H | 2018 |
Three renal failure cases successfully treated with ombitasvir/paritaprevir/ritonavir for genotype 1b hepatitis C virus reinfection after liver transplantation.
Topics: Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Drug Monitoring; Fem | 2019 |
Study of Adverse Drug Effects of Direct-Acting Antivirals for Chronic HCV Infection at Fayoum Governorate, Egypt - A Pharmacovigilance Study.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Egypt; Female; Genotype; Hepac | 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 |
Cost-Effectiveness Analysis of Early Treatment of Chronic HCV with Sofosbuvir/Velpatasvir in Italy.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Cost-Benefit Analysis; Dru | 2018 |
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 |
High sustained virologic response rate using generic directly acting antivirals in the treatment of chronic hepatitis C virus Egyptian patients: single-center experience.
Topics: Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Drugs, Generic; Egypt; Female; Hepat | 2018 |
Sofosbuvir based regimens in the treatment of chronic hepatitis C genotype 1 infection in African-American patients: a community-based retrospective cohort study.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Black or African American; Carbama | 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 |
High Cure Rates With Grazoprevir-Elbasvir With or Without Ribavirin Guided by Genotypic Resistance Testing Among Human Immunodeficiency Virus/Hepatitis C Virus-coinfected Men Who Have Sex With Men.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2019 |
Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Carbamates; Female; Fl | 2018 |
HA1077 displays synergistic activity with daclatasvir against hepatitis C virus and suppresses the emergence of NS5A resistance-associated substitutions in mice.
Topics: 1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine; Animals; Antiviral Agents; Carbamates; Cell Line, Tum | 2018 |
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 |
Efficacy and safety of sofosbuvir and daclatasvir with or without ribavirin in elderly patients with chronic hepatitis C virus infection.
Topics: Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Drug-Related Side | 2019 |
Resolution of Atypical Lichen Myxedematosus Following Successful Treatment of Chronic Hepatitis C Virus Infection With Sofosbuvir-Velpatasvir Combination Therapy.
Topics: Aged; Antiviral Agents; Carbamates; Drug Combinations; Hepatitis C, Chronic; Heterocyclic Compounds, | 2018 |
Topics: Amides; Antiviral Agents; Carbamates; Cell Line, Tumor; Cyclopropanes; Drug Resistance, Viral; Drug | 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 |
Efficacy of ombitasvir/paritaprevir/ritonavir/ribavirin in management of HCV genotype 4 and end-stage kidney disease.
Topics: Adult; Aged, 80 and over; Algorithms; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Co | 2019 |
Cost-Effectiveness of Elbasvir/Grazoprevir Versus Daclatasvir Plus Asunaprevir in Patients with Chronic Hepatitis C Virus Genotype 1b Infection in China.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzofurans; Carbamates; China; Cohort Studies; Co | 2018 |
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 |
Direct-acting antiviral Therapy Is Safe and Effective in Pediatric Chronic Hepatitis C: The Public Health Perspective.
Topics: Adolescent; Antiviral Agents; Carbamates; Child; Drug Administration Schedule; Drug Therapy, Combina | 2019 |
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 |
Real-world effectiveness of daclatasvir plus sofosbuvir and velpatasvir/sofosbuvir in hepatitis C genotype 2 and 3.
Topics: Antiviral Agents; Carbamates; DNA, Viral; Drug Therapy, Combination; Female; Follow-Up Studies; Geno | 2019 |
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 |
The choice of antiviral therapy for hepatitis C recurrence after liver transplantation in the real world.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Genotype; Hepatitis C; Hepat | 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 |
Oral direct-acting antiviral therapy for hepatitis C virus infection in X-linked agammaglobulinemia.
Topics: 2-Naphthylamine; Administration, Oral; Adult; Agammaglobulinemia; Anilides; Antiviral Agents; Carbam | 2019 |
A Patient of Chronic Hepatitis C Complicated by Thalassemia Major and Chronic Osteomyelitis: A Therapeutic Challenge for a Clinician.
Topics: Adolescent; Antiviral Agents; beta-Thalassemia; Blood Transfusion; Carbamates; Chronic Disease; Fema | 2018 |
Cost-effectiveness analysis of Daclatasvir/Sofosbuvir for the treatment of the HCV patients failed after the first line with second generation of DAAs in Italy.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; Cost-Benefit Analysis; Drug Therapy, C | 2019 |
Treatment of chronic hepatitis C viral infection with sofosbuvir and daclatasvir in kidney transplant recipients.
Topics: Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis C, Ch | 2019 |
Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4.
Topics: Adolescent; Antiviral Agents; Carbamates; Child; Combined Modality Therapy; Drug Therapy, Combinatio | 2019 |
Safety and efficacy of sofosbuvir-based direct-acting antiviral regimens for hepatitis C virus genotype 6 in Southwest China: Real-world experience of a retrospective study.
Topics: Adult; Aged; Antiviral Agents; Carbamates; China; Drug Therapy, Combination; Female; Genotype; Hepac | 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 |
Paritaprevir, ritonavir, ombitasvir, and dasabuvir with and without ribavirin in people with HCV genotype 1 and recent injecting drug use or receiving opioid substitution therapy.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administration S | 2018 |
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 |
Sofosbuvir-Based Therapy in Hepatitis C Virus-Infected Cancer Patients: A Prospective Observational Study.
Topics: Aged; Antiviral Agents; Benzimidazoles; Breast Neoplasms; Carbamates; Carcinoma, Hepatocellular; Dru | 2019 |
Pharmacokinetics of Daclatasvir, Sofosbuvir, and GS-331007 in a Prospective Cohort of Hepatitis C Virus-Positive Kidney Transplant Recipients.
Topics: Antiviral Agents; Carbamates; Cohort Studies; Drug Therapy, Combination; Female; Glomerular Filtrati | 2019 |
Polymorphism in interferon λ3/interleukin-28B gene and risk to noncirrhotic chronic hepatitis C genotype 3 virus infection and its effect on the response to combined daclatasvir and sofosbuvir therapy.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Case-Control Studies; Female; Genetic Predisposition to D | 2019 |
The efficacy of paritaprevir/ritonavir/ombitasvir+dasabuvir and ledipasvir/sofosbuvir is comparable in patients who failed interferon-based treatment with first generation protease inhibitors - a multicenter cohort study.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies | 2018 |
Quality of life of Brazilian chronic hepatitis C patients treated with interferon-free therapies.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepatitis C, Chronic; Hum | 2018 |
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 |
Drug pricing: still a barrier to elimination of HCV.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Disease Eradication; Drug Combinations; Drug Costs; Fl | 2018 |
Sofosbuvir-Based Therapies for Patients with Hepatitis C Virus Infection: Real-World Experience in China.
Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; China; Drug Therapy, Combination; Female; Fluor | 2018 |
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 |
Effective drugs on the road to HCV elimination and a therapeutic gap to close.
Topics: Asia; Carbamates; Hepatitis C; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More Rings; Humans | 2019 |
Safety Exposure-Response Analysis for Daclatasvir, Asunaprevir, and Beclabuvir Combinations in HCV-Infected Subjects.
Topics: Antiviral Agents; Asian People; Benzazepines; Carbamates; Clinical Trials, Phase II as Topic; Clinic | 2019 |
The Successful Retreatment with Glecaprevir and Pibrentasvir of Genotype 1 or 2 HCV-infected Hemodialysis Patients who Failed to Respond to NS5A and Protease Inhibitor Treatment.
Topics: Aged; Aminoisobutyric Acids; Anti-Retroviral Agents; Antiviral Agents; Benzimidazoles; Carbamates; C | 2019 |
Successful treatment of genotype 3 hepatitis C infection in a noncirrhotic HIV infected patient on chronic dialysis with the combination of sofosbuvir and velpatasvir: A case report.
Topics: Antiviral Agents; Carbamates; Coinfection; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More R | 2018 |
Comparative efficacy of sofosbuvir-ribavirin versus sofosbuvir-daclatasvir for treatment of chronic hepatitis C in an area with limited NS5A inhibitor availability.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hea | 2018 |
Effectiveness of ombitasvir/paritaprevir/ritonavir, dasabuvir for HCV in HIV/HCV coinfected subjects: a comprehensive analysis.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Clinical Trials as Topic; Coinfectio | 2019 |
Management of acute HCV in the era of direct-acting antivirals: implications for elimination.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Genotype; Hepatitis C, Chronic; Hu | 2019 |
Real-life results of treatment with ombitasvir, paritaprevir, dasabuvir, and ritonavir combination in patients with chronic renal failure infected with HCV in Turkey.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, C | 2019 |
Effectiveness of fixed-dose combination of paritaprevir, ritonavir, ombitasvir, and dasabuvir in patients with chronic hepatitis C virus infection and chronic kidney diseases: real-life experiences.
Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropan | 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 |
Sofosbuvir-based direct acting antiviral therapies for patients with hepatitis C virus genotype 2 infection.
Topics: Aged; Antiviral Agents; Benzimidazoles; Carbamates; Comparative Effectiveness Research; Female; Fluo | 2019 |
Effect of sofosbuvir plus daclatasvir for treatment of chronic hepatitis C on patients with psoriasis.
Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Cross-Sectional Studies; Dose-Response Relati | 2019 |
Effect of sofosbuvir and daclatasvir on lipid profile, glycemic control and quality of life index in chronic hepatitis C, genotype 3 patients.
Topics: Administration, Oral; Adolescent; Adult; Antiviral Agents; Carbamates; Cholesterol; Dexamethasone; D | 2019 |
Successful Treatment With Direct-Acting Antiviral Agents of Hepatitis C in Patients With End-Stage Renal Disease and Kidney Transplant Recipients.
Topics: 2-Naphthylamine; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactio | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 2019 |
Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studi
Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; | 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 |
Ritonavir-boosted paritaprevir, ombitasvir plus ribavirin could improve eGFR in patients with renal impairment and HCV: an Egyptian cohort.
Topics: Adult; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; Egypt | 2019 |
Real-world virological efficacy and safety of daclatasvir/asunaprevir/beclabuvir in patients with chronic hepatitis C virus genotype 1 infection in Japan.
Topics: Aged; Aged, 80 and over; Antiviral Agents; Benzazepines; Carbamates; Drug Therapy, Combination; Fema | 2019 |
The benefits of a public pharmacist service in chronic hepattis C treatment: The real-life results of sofosbuvir-based therapy.
Topics: Antiviral Agents; Carbamates; Community Pharmacy Services; Drug Therapy, Combination; Female; Hepati | 2020 |
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 |
Real-world effectiveness and safety of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir hepatitis C treatment in a single centre in Germany.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; Drug Administration Sched | 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 |
A clinical study for the evaluation of pharmacokinetic interaction between daclatasvir and fluoxetine.
Topics: Area Under Curve; Carbamates; Chromatography, High Pressure Liquid; Drug Interactions; Drug Stabilit | 2019 |
Real-world effectiveness of sofosbuvir/velpatasvir/voxilaprevir in 573 direct-acting antiviral experienced hepatitis C patients.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Cohort Studies; Drug Combinations; Dru | 2019 |
Validated RP-HPLC Method for Simultaneous Determination of Ribavirin, Sofosbuvir and Daclatasvir in Human Plasma: A Treatment Protocol Administered to HCV Patients in Egypt.
Topics: Carbamates; Chromatography, High Pressure Liquid; Egypt; Hepatitis C, Chronic; Humans; Imidazoles; L | 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 |
Sofosbuvir/Velpatasvir/Voxilaprevir for Previous Treatment Failures With Glecaprevir/Pibrentasvir in Chronic Hepatitis C Infection.
Topics: Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Drug Resistance, | 2019 |
Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study.
Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Amides; Anilides; Antiviral Agents; Benzimidazoles; | 2019 |
[EFFICACY AND SAFETY OF OMBITASVIR/PARITAPREVIR/RITONAVIR AND DASABUVIR IN PATIENTS WITH HCV 1B GENOTYPE INFECTION: REAL WORLD DATA].
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2019 |
A proof-of-concept study in HCV-infected Huh7.5 cells for shortening the duration of DAA-based triple treatment regimens.
Topics: Antiviral Agents; Carbamates; Cell Death; Cell Line, Tumor; Drug Synergism; Drug Therapy, Combinatio | 2019 |
High sustained virologic response in genotypes 3 and 6 with generic NS5A inhibitor and sofosbuvir regimens in chronic HCV in myanmar.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2019 |
B.A.R.C.O.S. (Brazilian Argentine Hepatitis C Collaborative Observational Study): Effectiveness and clinical outcomes of HCV treatment with daclatasvir and sofosbuvir with or without ribavirin.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Argentina; Brazil; Carbamates; Female; | 2019 |
Evaluation of Glycated Haemoglobin (HbA1c) Level in Type 2 Diabetic Chronic HCV Non-cirrhotic Treatment-Naïve Egyptian Patients Eradicated with Sofosbuvir Plus Daclatasvir.
Topics: Antiviral Agents; Blood Glucose; Carbamates; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Dru | 2020 |
Retreatment of Egyptian Chronic Hepatitis C Patients Not Responding to Pegylated Interferon and Ribavirin Dual Therapy.
Topics: Antiviral Agents; Carbamates; Egypt; Female; Hepatitis C, Chronic; Humans; Imidazoles; Interferon-al | 2019 |
Effects of Dual Sofosbuvir/Daclatasvir Therapy on Weight and Linear Growth in Adolescent Patients with Chronic Hepatitis C Virus Infection.
Topics: Adolescent; Antiviral Agents; Body Height; Body Weight; Carbamates; Child; Child Development; Female | 2019 |
A Cost-Effectiveness Analysis of Shortened Direct-Acting Antiviral Treatment in Genotype 1 Noncirrhotic Treatment-Naive Patients With Chronic Hepatitis C Virus.
Topics: Aminoisobutyric Acids; Antiviral Agents; Carbamates; Cost-Benefit Analysis; Cyclopropanes; Decision | 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 |
Successful treatment of HBV, HCV, & HEV, with 12-week long use of tenofovir, sofosbuvir, daclatasvir, and ribavirin: A case report.
Topics: Aged; Antiviral Agents; Asthma; Carbamates; Coinfection; Diabetes Complications; Drug Administration | 2020 |
Effect of adding daclatasvir in sofosbuvir-based therapy in genotype 3 hepatitis C: real-world experience in Pakistan.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Follow-Up Studies; Genotype; Hepaci | 2019 |
Single nucleotide polymorphisms associated with elevated alanine aminotransferase in patients receiving asunaprevir plus daclatasvir combination therapy for chronic hepatitis C.
Topics: Adult; Aged; Aged, 80 and over; Alanine Transaminase; Carbamates; Chemical and Drug Induced Liver In | 2019 |
Daclatasvir plus sofosbuvir, with or without ribavirin, is highly effective for all kinds of genotype-2 chronic hepatitis-C infection in Taiwan.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; | 2019 |
[Effectiveness and safety of sofosbuvir+daclatasvir in the treatment of chronic hepatitis C virus infection in Yan'an, Shaanxi].
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Hepacivirus; Hepatitis C, Chronic; Humans; | 2019 |
Treatment of hepatitis C infection among Egyptian hemodialysis patients: the dream becomes a reality.
Topics: Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Cytochrome P-450 CYP3A Inhibitors; Dru | 2019 |
Relation between microRNA-21, transforming growth factor β and response to treatment among chronic hepatitis C patients.
Topics: Adult; Antiviral Agents; Biomarkers; Carbamates; Drug Therapy, Combination; Female; Hepacivirus; Hep | 2019 |
Ribavirin facilitates early viral kinetics in chronic hepatitis C patients receiving daclatasvir/asunaprevir.
Topics: Aged; Carbamates; Female; Hepatitis C, Chronic; Humans; Imidazoles; Isoquinolines; Male; Middle Aged | 2020 |
Modeling shows that the NS5A inhibitor daclatasvir has two modes of action and yields a shorter estimate of the hepatitis C virus half-life.
Topics: Adult; Antiviral Agents; Bayes Theorem; Carbamates; Cell Line; Deoxycytidine; Female; Half-Life; Hep | 2013 |
Sofosbuvir and daclatasvir combination therapy in a liver transplant recipient with severe recurrent cholestatic hepatitis C.
Topics: Carbamates; Cholestasis; Dose-Response Relationship, Drug; Drug Therapy, Combination; Follow-Up Stud | 2013 |
Selection of resistant-associated variants to the NS5A inhibitor daclatasvir: revenge of the hepatitis C virus.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquin | 2013 |
The hepatitis C virus NS5A inhibitor daclatasvir has a dual mode of action and leads to a new virus half-life estimate.
Topics: Antiviral Agents; Carbamates; Enzyme Inhibitors; Half-Life; Hepacivirus; Hepatitis C, Chronic; Human | 2013 |
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 |
"There are decades where nothing happens; and there are weeks where decades happen"--Vladimir Ilyich Lenin.
Topics: Antiviral Agents; Carbamates; Female; Hepatitis C, Chronic; Humans; Imidazoles; Isoquinolines; Male; | 2014 |
Virological escape in HCV genotype-1-infected patients receiving daclatasvir plus ribavirin and peginterferon alfa-2a or alfa-2b.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female | 2014 |
Prevalence of baseline polymorphisms for potential resistance to NS5A inhibitors in drug-naive individuals infected with hepatitis C genotypes 1-4.
Topics: Antiviral Agents; Carbamates; Codon; Drug Resistance, Viral; Genotype; Hepacivirus; Hepatitis C, Chr | 2015 |
HCV therapy with daclatasvir, PEG-IFN, and RBV after boceprevir-based therapy failure post-liver transplantation in hyper-IgM syndrome.
Topics: Adult; Antiviral Agents; Carbamates; Drug Therapy, Combination; Hepatitis C, Chronic; Humans; Hyper- | 2014 |
Viral hepatitis: new hepatitis C therapies-a medical pick and mix.
Topics: Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Female; Fluorenes; Hepacivirus; Hepatitis C, | 2014 |
Therapy of hepatitis C--back to the future.
Topics: Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Female; Hepacivirus; Hepatitis C, Chronic; Hu | 2014 |
[The beginning of the end for interferon therapy? - novel interferon-free treatment options for hepatitis C].
Topics: Anilides; Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazole | 2014 |
Hepatitis C beware--the end is nigh.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquin | 2014 |
Daclatasvir + asunaprevir: first global approval.
Topics: Antiviral Agents; Carbamates; Drug Approval; Drug Combinations; Drug Design; Genotype; Hepacivirus; | 2014 |
HCV cirrhosis at the edge of decompensation: will paritaprevir with ritonavir, ombitasvir, dasabuvir, and ribavirin solve the need for treatment?
Topics: Anilides; Antiviral Agents; Carbamates; Female; Hepatitis C, Chronic; Humans; Macrocyclic Compounds; | 2014 |
Daclatasvir: a team player rather than a prima donna in the treatment of hepatitis C.
Topics: Antiviral Agents; Benzazepines; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Genot | 2015 |
ABT-450/r-ombitasvir and dasabuvir with ribavirin eliminates viraemia in most patients with HCV infection with cirrhosis.
Topics: Anilides; Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Macrocycl | 2015 |
[New hepatitis C treatments: pharmacological considerations and potential for drug interactions].
Topics: Antiviral Agents; Carbamates; Drug Interactions; Hepatitis C, Chronic; Heterocyclic Compounds, 3-Rin | 2014 |
Drug-induced immunoallergic hepatitis during combination therapy with daclatasvir and asunaprevir.
Topics: Carbamates; Chemical and Drug Induced Liver Injury; Drug Therapy, Combination; Hepatitis C, Chronic; | 2015 |
Low relapse rate leads to high concordance of sustained virologic response (SVR) at 12 weeks with SVR at 24 weeks after treatment with ABT-450/ritonavir, ombitasvir, and dasabuvir plus ribavirin in subjects with chronic hepatitis C virus genotype 1 infect
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Resistance, Vira | 2015 |
Hepatitis: treating HCV after liver transplant.
Topics: Anilides; Antiviral Agents; Carbamates; Female; Hepatitis C, Chronic; Humans; Liver Transplantation; | 2015 |
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 |
[Interferon-free treatment for patients with chronic hepatitis C].
Topics: Aged; Antiviral Agents; Carbamates; Hepatitis C, Chronic; Humans; Imidazoles; Isoquinolines; Proteas | 2015 |
[Direct-acting antiviral-resistant variant].
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Hepacivirus; Hepatitis C, Chronic; Humans; Imi | 2015 |
[Pharmacological properties and clinical efficacy of daclatasvir (Daklinza®) and asunaprevir (Sunvepra®)].
Topics: Administration, Oral; Carbamates; Drug Resistance, Viral; Hepacivirus; Hepatitis C, Chronic; Humans; | 2015 |
Cost-effectiveness of novel regimens for the treatment of hepatitis C virus.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Cost-Benefit Analysis; Disease Progression; Drug Costs | 2015 |
HCV NS5A resistance-associated variants in a group of real-world Japanese patients chronically infected with HCV genotype 1b.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Hepacivirus; Hepatitis C, Chronic; Humans; Imi | 2015 |
Towards interferon-free treatment for all HCV genotypes.
Topics: Anilides; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Macrocyclic Compounds; Male | 2015 |
Prevalence of polymorphisms with significant resistance to NS5A inhibitors in treatment-naive patients with hepatitis C virus genotypes 1a and 3a in Sweden.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Genotype; Hepacivirus; Hepatitis C; Hepatitis | 2015 |
Dynamics of HCV genotype 4 resistance-associated variants during virologic escape with pIFN/RBV+daclatasvir: a case study using ultra deep pyrosequencing.
Topics: Adolescent; Adult; Antiviral Agents; Carbamates; Drug Resistance, Viral; Genetic Variation; Genotype | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combina | 2015 |
Continued progress against hepatitis C infection.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquin | 2015 |
Daclatasvir, Simeprevir and Ribavirin as a Promising Interferon-Free Triple Regimen for HCV Recurrence after Liver Transplant.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Hepacivirus | 2015 |
Thousands of patients in England to get new hepatitis C drugs.
Topics: Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; England; Fluorenes; Hepatitis | 2015 |
Low frequency of drug-resistant virus did not affect the therapeutic efficacy in daclatasvir plus asunaprevir therapy in patients with chronic HCV genotype-1 infection.
Topics: Adult; Aged; Amino Acid Substitution; Antiviral Agents; Biomarkers; Carbamates; Drug Resistance, Vir | 2016 |
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 |
[High chance for cure].
Topics: 2-Naphthylamine; Anilides; Carbamates; Cyclopropanes; Drug Combinations; Drug Therapy, Combination; | 2015 |
Emergence of hepatitis C virus NS5A L31V plus Y93H variant upon treatment failure of daclatasvir and asunaprevir is relatively resistant to ledipasvir and NS5B polymerase nucleotide inhibitor GS-558093 in human hepatocyte chimeric mice.
Topics: Animals; Antiviral Agents; Benzimidazoles; Carbamates; Drug Combinations; Drug Resistance, Multiple, | 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 |
Prednisolone does not affect direct-acting antivirals against hepatitis C, but inhibits interferon-alpha production by plasmacytoid dendritic cells.
Topics: Antiviral Agents; Biomarkers; Carbamates; Cell Line, Tumor; Dendritic Cells; Drug Interactions; Drug | 2015 |
Decreased tacrolimus concentration following a temporal increase during interferon-free therapy with asunaprevir and daclatasvir in patients with recurrent hepatitis C after liver transplantation.
Topics: Adult; Aged; Carbamates; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Intera | 2016 |
T-cell homeostasis in chronic HCV-infected patients treated with interferon and ribavirin or an interferon-free regimen.
Topics: Adult; Aged; Amides; Antiviral Agents; Apoptosis; Benzofurans; Carbamates; CD4-Positive T-Lymphocyte | 2015 |
Relationships between serum asunaprevir concentration and alanine aminotransferase elevation during daclatasvir plus asunaprevir for chronic HCV genotype 1b infection.
Topics: Aged; Aged, 80 and over; Alanine Transaminase; Carbamates; Drug Therapy, Combination; Female; Genoty | 2016 |
Cost-effectiveness analysis of simeprevir with daclatasvir for non-cirrhotic genotype-1b-naïve patients plus chronic hepatitis C.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cost-Benefit Analysis; Disease Progression; Drug Therapy, | 2016 |
Interferon-free treatments against HCV are far from free.
Topics: Anilides; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Macrocyclic Compounds; Male | 2015 |
Pharmacokinetics in hepatic impairment: Mind the protein binding.
Topics: Anilides; Carbamates; Female; Hepatic Insufficiency; Hepatitis C, Chronic; Humans; Macrocyclic Compo | 2015 |
Reply to "Pharmacokinetics in hepatic impairment: Mind the protein binding".
Topics: Anilides; Carbamates; Female; Hepatic Insufficiency; Hepatitis C, Chronic; Humans; Macrocyclic Compo | 2015 |
Suspected pharmacokinetic interaction between raltegravir and the 3D regimen of ombitasvir, dasabuvir and paritaprevir/ritonavir in an HIV-HCV liver transplant recipient.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Drug Ther | 2016 |
Successful treatment of post-transplant hepatitis C virus cirrhosis with daclatasvir and asunaprevir.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C, | 2015 |
Multi-scale model for hepatitis C viral load kinetics under treatment with direct acting antivirals.
Topics: Antiviral Agents; Carbamates; Drug Synergism; Drug Therapy, Combination; Gene Expression Regulation, | 2016 |
Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir.
Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepacivirus; He | 2015 |
Cost-effectiveness of daclatasvir plus sofosbuvir-based regimen for treatment of hepatitis C virus genotype 3 infection in Canada.
Topics: Adult; Aged; Antiviral Agents; Canada; Carbamates; Cost-Benefit Analysis; Drug Therapy, Combination; | 2016 |
Memory re-differentiation and reduced lymphocyte activation in chronic HCV-infected patients receiving direct-acting antivirals.
Topics: Antiviral Agents; Benzazepines; Carbamates; CD3 Complex; CD4-Positive T-Lymphocytes; CD8-Positive T- | 2015 |
Drug Interactions Between Hepatoprotective Agents Ursodeoxycholic Acid or Glycyrrhizin and Ombitasvir/Paritaprevir/Ritonavir in Healthy Japanese Subjects.
Topics: Adult; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interactions; Drug Therapy, Combi | 2015 |
Cost Effectiveness of Daclatasvir/Asunaprevir Versus Peginterferon/Ribavirin and Protease Inhibitors for the Treatment of Hepatitis c Genotype 1b Naïve Patients in Chile.
Topics: Antiviral Agents; Carbamates; Chile; Cost-Benefit Analysis; Drug Therapy, Combination; Genotype; Hep | 2015 |
The cost-effectiveness of daclatasvir-based regimens for the treatment of hepatitis C virus genotypes 1 and 4 in the UK.
Topics: Antiviral Agents; Carbamates; Computer Simulation; Cost-Benefit Analysis; Drug Costs; Genotype; Hepa | 2016 |
Simple, Effective, but Out of Reach? Public Health Implications of HCV Drugs.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, 4 o | 2015 |
Comparison of Daclatasvir and Asunaprevir for Chronic HCV 1b Infection with Telaprevir and Simeprevir plus Peginterferon and Ribavirin, with a Focus on the Prevention of Occurrence and Recurrence of Hepatocellular Carcinoma.
Topics: Adult; Aged; Aged, 80 and over; alpha-Fetoproteins; Antiviral Agents; Carbamates; Carcinoma, Hepatoc | 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 |
Rapid decrease in hepatitis C viremia by direct acting antivirals improves the natural killer cell response to IFNα.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cell Degranulation; Cells, Cultured; Drug Therapy, Combin | 2017 |
Rapid decrease in hepatitis C viremia by direct acting antivirals improves the natural killer cell response to IFNα.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cell Degranulation; Cells, Cultured; Drug Therapy, Combin | 2017 |
Rapid decrease in hepatitis C viremia by direct acting antivirals improves the natural killer cell response to IFNα.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cell Degranulation; Cells, Cultured; Drug Therapy, Combin | 2017 |
Rapid decrease in hepatitis C viremia by direct acting antivirals improves the natural killer cell response to IFNα.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cell Degranulation; Cells, Cultured; Drug Therapy, Combin | 2017 |
Interferon-free treatment with sofosbuvir/daclatasvir achieves sustained virologic response in 100% of HIV/hepatitis C virus-coinfected patients with advanced liver disease.
Topics: Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2016 |
Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Hepatitis C, Chronic; Humans; | 2016 |
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 + asunaprevir versus sofosbuvir/ledipasvir for hepatitis C genotype 1 in Japanese patients: an indirect comparison.
Topics: Antiviral Agents; Benzimidazoles; Carbamates; Clinical Trials, Phase III as Topic; Drug Therapy, Com | 2016 |
Amplification and pyrosequencing of near-full-length hepatitis C virus for typing and monitoring antiviral resistant strains.
Topics: Antiviral Agents; Carbamates; Drug Resistance, Viral; Genotype; Genotyping Techniques; Hepacivirus; | 2016 |
[Daclatasvir plus asunaprevir combination therapy for patients with chronic hepatitis C].
Topics: Carbamates; Clinical Trials as Topic; Combined Modality Therapy; Drug Combinations; Hepatitis C, Chr | 2015 |
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 |
Sustained virological response after a 17-day treatment with daclatasvir plus asunaprevir in a cirrhotic patient with hepatitis C virus genotype 1b and null response for peginterferon ribavirin therapy.
Topics: Administration, Oral; Antiviral Agents; Carbamates; Drug Administration Schedule; Female; Genotype; | 2016 |
HCV kinetic and modeling analyses indicate similar time to cure among sofosbuvir combination regimens with daclatasvir, simeprevir or ledipasvir.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Female; Fluore | 2016 |
Severe Pulmonary Arterial Hypertension in Patients Treated for Hepatitis C With Sofosbuvir.
Topics: Antiviral Agents; Carbamates; Comorbidity; Drug Therapy, Combination; Female; Hepatitis C, Chronic; | 2016 |
Treatment of chronic hepatitis C with direct acting antiviral agents in patients with haemophilia, end-stage liver disease and coinfected with HIV.
Topics: Adult; Antiviral Agents; Carbamates; CD4 Lymphocyte Count; Coinfection; Drug Interactions; Hemophili | 2016 |
Hemoglobin Decrease with Iron Deficiency Induced by Daclatasvir plus Asunaprevir Combination Therapy for Chronic Hepatitis C Virus Genotype 1b.
Topics: Adult; Aged; Aged, 80 and over; Carbamates; Female; Genotype; Hemoglobins; Hepacivirus; Hepatitis C, | 2016 |
Sofosbuvir and Velpatasvir: A complete pan-genotypic treatment for HCV patients.
Topics: Antiviral Agents; Carbamates; Genotype; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, 4 | 2016 |
Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With or Without Ribavirin in HCV-Infected Patients Taking Concomitant Acid-Reducing Agents.
Topics: 2-Naphthylamine; Anilides; Antacids; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Comb | 2016 |
Cost-effectiveness of currently recommended direct-acting antiviral treatments in patients infected with genotypes 1 or 4 hepatitis C virus in the US.
Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Benzimidazoles; Carbama | 2016 |
Ombitasvir/paritaprevir/ritonavir plus dasabuvir combination in the treatment of chronic HCV infection.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; H | 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 |
Effect and Safety of Daclatasvir-Asunaprevir Combination Therapy for Chronic Hepatitis C Virus Genotype 1b -Infected Patients on Hemodialysis.
Topics: Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Genot | 2016 |
What does it mean to put new hepatitis C drugs on a list of essential medicines?
Topics: Antiviral Agents; Carbamates; Drug Costs; Drugs, Essential; Health Priorities; Hepatitis C, Chronic; | 2016 |
Drug-induced lung injury associated with combination therapy of daclatasvir and asunaprevir: The first case report.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Hepatitis C, Chronic; Humans; Imidazoles; I | 2016 |
Sofosbuvir and Velpatasvir for Patients with HCV Infection.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, 4 o | 2016 |
Sofosbuvir and Velpatasvir for Patients with HCV Infection.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, 4 o | 2016 |
[New combination heals still more patients in an even shorter period of time].
Topics: Carbamates; Drug Combinations; Genotype; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, | 2016 |
Sofosbuvir and Velpatasvir for Patients with HCV Infection.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, 4 o | 2016 |
Sofosbuvir and Velpatasvir for Patients with HCV Infection.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Heterocyclic Compounds, 4 o | 2016 |
Interferon/Ribavirin-Free Antiviral Treatment in Septuagenarians and Octogenarians With Chronic Hepatitis C.
Topics: Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Fa | 2016 |
Sixty milligram daclatasvir is the right dose for hepatitis C virus treatment in combination with etravirine and darunavir/ritonavir.
Topics: Anti-HIV Agents; Antiviral Agents; Area Under Curve; Carbamates; Coinfection; Darunavir; Diuretics; | 2016 |
Economic evaluation of ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic genotype 1 hepatitis c virus infection.
Topics: 2-Naphthylamine; Adult; Anilides; Antiviral Agents; Carbamates; Cost-Benefit Analysis; Cyclopropanes | 2016 |
Sofosbuvir and daclatasvir.
Topics: Antiviral Agents; Carbamates; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Pyrrolidines; S | 2016 |
DAA-based antiviral treatment of patients with chronic hepatitis C in the pre- and postkidney transplantation setting.
Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; Drug Therapy, Combination | 2016 |
Application of Static Models to Predict Midazolam Clinical Interactions in the Presence of Single or Multiple Hepatitis C Virus Drugs.
Topics: Algorithms; Antiviral Agents; Benzazepines; Biotransformation; Carbamates; Cells, Cultured; Cytochro | 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 |
Favorable efficacy of daclatasvir plus asunaprevir in treatment of elderly Japanese patients infected with HCV genotype 1b aged 70 and older.
Topics: Adult; Aged; Aged, 80 and over; alpha-Fetoproteins; Antiviral Agents; Asian People; Carbamates; Drug | 2017 |
Daclatasvir plus Asunaprevir Treatment for Real-World HCV Genotype 1-Infected Patients in Japan.
Topics: Aged; Antiviral Agents; Carbamates; Drug Resistance, Viral; Drug Therapy, Combination; Female; Genot | 2016 |
Impact of Pre-existing NS5A-L31 or -Y93H Minor Variants on Response Rates in Patients Infected with HCV Genotype-1b Treated with Daclatasvir/Asunaprevir.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatit | 2016 |
Comparative effectiveness of ledipasvir/sofosbuvir ± ribavirin vs. ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin in 6961 genotype 1 patients treated in routine medical practice.
Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Benzimidazoles; Black o | 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 |
A case of acute hepatitis B in a chronic hepatitis C patient after daclatasvir and asunaprevir combination therapy: hepatitis B virus reactivation or acute self-limited hepatitis?
Topics: Acute Disease; Aged, 80 and over; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combinati | 2016 |
Impact of resistance-associated variant dominancy on treatment in patients with HCV genotype 1b receiving daclatasvir/asunaprevir.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Resistance, Viral; Female; Genoty | 2017 |
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 |
Cost-effectiveness of direct-acting antiviral regimen ombitasvir/paritaprevir/ritonavir in treatment-naïve and treatment-experienced patients infected with chronic hepatitis C virus genotype 1b in Japan.
Topics: Anilides; Antiviral Agents; Carbamates; Cost-Benefit Analysis; Cyclopropanes; Drug Therapy, Combinat | 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 |
Severe Elevation of Liver Enzymes Does Not Necessarily Require Treatment Interruption in Patients Treated With a Combination of Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir for HCV Infection.
Topics: 2-Naphthylamine; Alanine Transaminase; Anilides; Antiviral Agents; Aspartate Aminotransferases; Carb | 2016 |
Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease: A retrospective study.
Topics: Antiviral Agents; Austria; Benzimidazoles; Carbamates; Coinfection; Fatigue; Female; Fluorenes; Hepa | 2016 |
Effectiveness and Safety of Ombitasvir-Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin for HCV Genotype 1 Infection for 12 Weeks Under Routine Clinical Practice.
Topics: 2-Naphthylamine; Aged; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combinat | 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 |
Oral therapy approved for chronic HCV infection of all genotypes.
Topics: Administration, Oral; Antiviral Agents; Carbamates; Drug Approval; Drug Combinations; Genotype; Hepa | 2016 |
Reply to: "Therapeutic drug monitoring for sofosbuvir and daclatasvir in transplant recipients with chronic hepatitis C and advanced renal disease".
Topics: Antiviral Agents; Carbamates; Drug Monitoring; Drug Therapy, Combination; Hepacivirus; Hepatitis C, | 2016 |
Therapeutic drug monitoring for sofosbuvir and daclatasvir in transplant recipients with chronic hepatitis C and advanced renal disease.
Topics: Antiviral Agents; Carbamates; Drug Monitoring; Drug Therapy, Combination; Hepacivirus; Hepatitis C, | 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 |
Effective treatment of hepatitis C virus infection with sofosbuvir and daclatasvir 90 mg in a patient with severe epilepsy on oxcarbazepine.
Topics: Anticonvulsants; Antiviral Agents; Carbamates; Carbamazepine; Drug Interactions; Drug Therapy, Combi | 2016 |
Treatment of HCV patients on hemodialysis with daclatasvir and asunaprevir.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Hepatitis C, Chronic; Humans; Imidazoles; I | 2017 |
Successful Anti-HCV Therapy of a Former Intravenous Drug User with Sofosbuvir and Daclatasvir in a Peritranspant Setting: A Case Report.
Topics: Adult; Antiviral Agents; Carbamates; Hepatitis C, Chronic; Humans; Imidazoles; Liver Transplantation | 2016 |
[Combined therapy with daclatasvir plus asunaprevir for chronic hepatitis C genotype 1b: a case report].
Topics: Adult; Antiviral Agents; Carbamates; Female; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Im | 2016 |
Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cohort Studies; Compassionate Use Trials; Drug Monitoring | 2016 |
Characterization of NS5A polymorphisms and their impact on response rates in patients with HCV genotype 2 treated with daclatasvir-based regimens.
Topics: Amino Acid Substitution; Antiviral Agents; Carbamates; Clinical Trials as Topic; Drug Resistance, Vi | 2016 |
Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; France; Hepacivirus; Hepatiti | 2017 |
Protease Inhibitor Resistance Remains Even After Mutant Strains Become Undetectable by Deep Sequencing.
Topics: Animals; Antiviral Agents; Carbamates; Drug Resistance, Viral; Hepacivirus; Hepatitis C, Chronic; Hi | 2016 |
Ombitasvir-Paritaprevir-Ritonavir-Dasabuvir (Viekira Pak)-Induced Lactic Acidosis.
Topics: 2-Naphthylamine; Acidosis, Lactic; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Combi | 2017 |
HCV Resistance Profile Evolution in a GT1b, DAA-Naive Patient Before, On, and After Failing Triple DAA Therapy.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Disease Progression; Drug Co | 2017 |
Predictable threats to public health through delaying universal access to innovative medicines for hepatitis C: a pharmaceutical standpoint.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Benzimidazoles; Carbamates; Cyclopropanes; Drug Industr | 2016 |
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 |
Drug-Induced Lung Injury in a Liver Transplant Patient Treated With Sofosbuvir.
Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Drug-Related Side Effects and Adverse React | 2016 |
Sofosbuvir-Containing Regimens for Chronic Hepatitis C Are Successful in the Safety-Net Population: A Real-World Experience.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Carbamates; Cohort Studies; Drug T | 2016 |
Successful treatment of three patients with human immunodeficiency virus and hepatitis C virus genotype 1b co-infection by daclatasvir plus asunaprevir.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Genotype; Hepaciv | 2017 |
Usefulness of combination therapy with Daclatasvir plus Asunaprevir in chronic hepatitis C patients with chronic kidney disease.
Topics: Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Female; Genotype; | 2017 |
Complex Pattern of Resistance-Associated Substitutions of Hepatitis C Virus after Daclatasvir/Asunaprevir Treatment Failure.
Topics: Aged; Carbamates; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imid | 2016 |
Pre-Existing HCV Variants Resistant to DAAs and Their Sensitivity to PegIFN/RBV in Chinese HCV Genotype 1b Patients.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Asian People; Base Sequence; Carbamates; China; Dr | 2016 |
Paritaprevir/ritonavir/ombitasvir+dasabuvir plus ribavirin therapy and inhibition of the anticoagulant effect of warfarin: a case report.
Topics: 2-Naphthylamine; Anilides; Anticoagulants; Antiviral Agents; Carbamates; Cyclopropanes; Drug Interac | 2017 |
Detection of Occult Hepatitis C Virus Infection in Patients Who Achieved a Sustained Virologic Response to Direct-Acting Antiviral Agents for Recurrent Infection After Liver Transplantation.
Topics: Alanine Transaminase; Antiviral Agents; Aspartate Aminotransferases; Benzimidazoles; Carbamates; Dru | 2017 |
Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug Therapy, Combination; Female; Genotype; | 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 |
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 |
Four weeks of paritaprevir/ritonavir/ombitasvir plus dasabuvir encountering dengue fever resulted in sustained virological response in an HCV patient: A case report.
Topics: 2-Naphthylamine; Aged, 80 and over; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Dengue; D | 2016 |
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 |
Time to viral suppression is not related to achievement of SVR12 in HCV GT1-infected patients treated with ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin.
Topics: Adolescent; Adult; Aged; Anilides; Antiviral Agents; Carbamates; Clinical Trials, Phase III as Topic | 2017 |
Cost-effectiveness of elbasvir/grazoprevir use in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and chronic kidney disease in the United States.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Computer Simulation; Cost-Benefit Analysis; Cyclo | 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 |
Real-world experience with daclatasvir plus sofosbuvir ± ribavirin for post-liver transplant HCV recurrence and severe liver disease.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cohort Studies; Drug Therapy, Combination; End Stage Live | 2017 |
Real World Data of Daclatasvir and Asunaprevir Combination Therapy for HCV Genotype 1b Infection in Patients With Renal Dysfunction.
Topics: Antiviral Agents; Carbamates; Chemical and Drug Induced Liver Injury; Drug Therapy, Combination; Dru | 2017 |
A profiling study of a newly developed HCVcc strain PR63cc's sensitivity to direct-acting antivirals.
Topics: Adenosine; Antiviral Agents; Carbamates; Drug Discovery; Drug Resistance, Viral; Enzyme Inhibitors; | 2017 |
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 |
Combination Therapy with Ombitasvir/Paritaprevir/Ritonavir for Dialysis Patients Infected with Hepatitis C Virus: A Prospective Multi-Institutional Study.
Topics: Aged; Anilides; Carbamates; Cyclopropanes; Demography; Disease Progression; Drug Resistance, Viral; | 2017 |
Successful retreatment of a patient with chronic hepatitis C genotype 2k/1b virus with ombitasvir/paritaprevir/ritonavir plus dasabuvir.
Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Therapy, Combination; G | 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 |
Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis.
Topics: Amides; Antiviral Agents; Asthenia; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combinatio | 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 |
Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort.
Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; Benzimidazoles; Carbama | 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 |
INF-free sofosbuvir-based treatment of post-transplant hepatitis C relapse - a Swedish real life experience.
Topics: Adult; Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; End Stage L | 2017 |
Real-World Efficacy of Daclatasvir and Sofosbuvir, With and Without Ribavirin, in HIV/HCV Coinfected Patients With Advanced Liver Disease in a French Early Access Cohort.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug-Related Side Effects and Adverse Reacti | 2017 |
Cost-effectiveness of combination daclatasvir-sofosbuvir for treatment of genotype 3 chronic hepatitis C infection in the United States.
Topics: Adult; Aged; Antiviral Agents; Carbamates; Cost-Benefit Analysis; Drug Therapy, Combination; Female; | 2017 |
Improvement of liver stiffness in patients with hepatitis C virus infection who received direct-acting antiviral therapy and achieved sustained virological response.
Topics: Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Elasticity; Elasticity Imaging Techni | 2017 |
[Individualized therapy with fosamprenavir/r. A PI suitable in liver problems].
Topics: Anti-HIV Agents; Carbamates; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Admini | 2008 |
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 |
Fosamprenavir treatment in a highly active antiretroviral therapy schedule induces a HCV-RNA decrease and a Th1 network boost in HIV/HCV-coinfected patients.
Topics: Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Carbamates; CD4 Lymphocyte Count; Female; Fu | 2010 |
A watershed moment in the treatment of hepatitis C.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Male; P | 2012 |
Prevalence of natural polymorphisms at the HCV NS5A gene associated with resistance to daclatasvir, an NS5A inhibitor.
Topics: Adult; Antiviral Agents; Carbamates; Coinfection; Drug Resistance, Viral; Female; Genotype; Hepacivi | 2012 |
MK-5172, a selective inhibitor of hepatitis C virus NS3/4a protease with broad activity across genotypes and resistant variants.
Topics: Amides; Animals; Antiviral Agents; Carbamates; Cyclopropanes; Dogs; Drug Resistance, Viral; Genotype | 2012 |
NS5A inhibitors to treat hepatitis C virus infection.
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Male; P | 2012 |
Hepatitis C therapy: highlights from the 2012 annual meeting of the European Association for the Study of the Liver.
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Congresses as Topic; Drug Therapy, Combinati | 2013 |
Daclatasvir: a promising triple therapy for children with chronic hepatitis C.
Topics: Adolescent; Carbamates; Child; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic | 2013 |
Interferon free regimens for the "difficult-to-treat": are we there?
Topics: Antiviral Agents; Carbamates; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Isoquin | 2013 |
Natural prevalence of NS5A polymorphisms in subjects infected with hepatitis C virus genotype 3 and their effects on the antiviral activity of NS5A inhibitors.
Topics: Amino Acid Sequence; Antiviral Agents; Carbamates; Drug Resistance, Viral; Hepacivirus; Hepatitis C, | 2013 |
Use of placebo: is it a boon or bane?
Topics: Antiviral Agents; Carbamates; Clinical Trials as Topic; Ethics, Clinical; Hepacivirus; Hepatitis C, | 2005 |
Associations of pesticides, HCV, HBV, and hepatocellular carcinoma in Egypt.
Topics: Adult; Carbamates; Carcinoma, Hepatocellular; Case-Control Studies; Egypt; Environmental Exposure; F | 2005 |
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 |
Naturally occurring NS3-protease-inhibitor resistant mutant A156T in the liver of an untreated chronic hepatitis C patient.
Topics: Adult; Amino Acid Sequence; Base Sequence; Carbamates; DNA, Viral; Drug Resistance, Viral; Genes, Vi | 2008 |