@article{251f90c8608a455ca152fcf9aee9fc66,
title = "Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial",
abstract = "This study assessed the efficacy and safety of ribavirin-free coformulated glecaprevir/pibrentasvir (G/P) in patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis, a patient population with limited treatment options. SURVEYOR-II, Part 3 was a partially randomized, open-label, multicenter, phase 3 study. Treatment-experienced (prior interferon or pegylated interferon ± ribavirin or sofosbuvir plus ribavirin ± pegylated interferon therapy) patients without cirrhosis were randomized 1:1 to receive 12 or 16 weeks of G/P (300 mg/120 mg) once daily. Treatment-naive or treatment-experienced patients with compensated cirrhosis were treated with G/P for 12 or 16 weeks, respectively. The primary efficacy endpoint was the percentage of patients with sustained virologic response at posttreatment week 12 (SVR12). Safety was evaluated throughout the study. There were 131 patients enrolled and treated. Among treatment-experienced patients without cirrhosis, SVR12 was achieved by 91% (20/22; 95% confidence interval [CI], 72-97) and 95% (21/22; 95% CI, 78-99) of patients treated with G/P for 12 or 16 weeks, respectively. Among those with cirrhosis, SVR12 was achieved by 98% (39/40; 95% CI, 87-99) of treatment-naive patients treated for 12 weeks and 96% (45/47; 95% CI, 86-99) of patients with prior treatment experience treated for 16 weeks. No adverse events led to discontinuation of study drug, and no serious adverse events were related to study drug. Conclusion: Patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis achieved high SVR12 rates following 12 or 16 weeks of treatment with G/P. The regimen was well tolerated. (Hepatology 2018;67:514-523).",
author = "David Wyles and Fred Poordad and Stanley Wang and Laurent Alric and Franco Felizarta and Kwo, {Paul Y.} and Benedict Maliakkal and Kosh Agarwal and Tarek Hassanein and Frank Weilert and Lee, {Samuel S.} and Jens Kort and Lovell, {Sandra S.} and Ran Liu and Lin, {Chih Wei} and Tami Pilot-Matias and Preethi Krishnan and Mensa, {Federico J.}",
note = "Funding Information: Copyright VC 2017 The Authors and AbbVie. HEPATOLOGY published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. View this article online at wileyonlinelibrary.com. DOI 10.1002/hep.29541 Potential conflict of interest: Dr. Wyles consults for and received grants from AbbVie, Gilead, and Merck. Dr. Felizarta is on the speakers{\textquoteright} bureau of and received grants from AbbVie, Gilead, Janssen, and Merck. Dr. Agarwal consults for, advises, is on the speakers{\textquoteright} bureau of, and received grants from AbbVie. He consults for, advises, and is on the speakers{\textquoteright} bureau of Merck. He consults for, is on the speakers{\textquoteright} bureau of, and received grants from Gilead. Dr. Kwo advises and received grants from AbbVie, Bristol-Myers Squibb, Gilead, and Merck. He advises Abbott, CVS, and Quest. Dr. Alric consults for, is on the speakers{\textquoteright} bureau of, and received grants from MSD, Gilead, AbbVie, and Bristol-Myers Squibb. He received grants from Roche and Janssen. Dr. Lee consults for, advises, is on the speakers{\textquoteright} bureau of, and received grants from AbbVie, Bristol-Myers Squibb, Gilead, and Merck. He consults for, is on the speakers{\textquoteright} bureau of, and received grants from Janssen. He consults for and received grants from Roche. He is on the speakers{\textquoteright} bureau of Pendopharm. Dr. Hassanein is on the speakers{\textquoteright} bureau of and received grants from AbbVie. Dr. Lin is employed by and owns stock in AbbVie. Dr. Lovell is employed by and owns stock in AbbVie. Dr. Liu is employed by and owns stock in AbbVie. Dr. Pilot-Matias is employed by and owns stock in AbbVie. Dr. Kort is employed by and owns stock in AbbVie. Dr. Mensa is employed by and owns stock in AbbVie. Dr. Krishnan is employed by AbbVie.",
year = "2018",
month = feb,
day = "1",
doi = "10.1002/hep.29541",
language = "English (US)",
volume = "67",
pages = "514--523",
journal = "Hepatology",
issn = "0270-9139",
publisher = "John Wiley and Sons Ltd",
number = "2",
}