Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial

Hepatology : Official Journal of the American Association for the Study of Liver Diseases
Graham R FosterBarbara A Haber

Abstract

Many direct-acting antiviral regimens have reduced activity in people with hepatitis C virus (HCV) genotype (GT) 3 infection and cirrhosis. The C-ISLE study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) plus sofosbuvir (SOF) with and without ribavirin (RBV) in compensated cirrhotic participants with GT3 infection. This was a phase 2, randomized, open-label study. Treatment-naive participants received EBR/GZR + SOF + RBV for 8 weeks or EBR/GZR + SOF for 12 weeks, and peginterferon/RBV treatment-experienced participants received EBR/GZR + SOF ± RBV for 12 weeks or EBR/GZR + SOF for 16 weeks. The primary endpoint was HCV RNA <15 IU/mL 12 weeks after the end of treatment (sustained virologic response at 12 weeks [SVR12]). Among treatment-naive participants, SVR12 was 91% (21/23) in those treated with RBV for 8 weeks and 96% (23/24) in those treated for 12 weeks. Among treatment-experienced participants, SVR12 was 94% (17/18) and 100% (17/17) in the 12-week arm, with and without RBV, respectively, and 94% (17/18) in the 16-week arm. Five participants failed to achieve SVR: 2 relapsed (both in the 8-week arm), 1 discontinued due to vomiting/cellulitis (16-week arm), and 2 discontinued (consent withdrawn/lost to f...Continue Reading

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Citations

Oct 20, 2018·Expert Review of Anti-infective Therapy·Elisabetta LoggiPietro Andreone
May 23, 2019·Clinical Pharmacokinetics·Elise J SmoldersDavid M Burger
Jul 30, 2019·Liver International : Official Journal of the International Association for the Study of the Liver·Timothy PapalucaAlexander Thompson
Apr 17, 2020·European Journal of Hospital Pharmacy. Science and Practice·Luis Margusino-FramiñánÁngeles Castro-Iglesias
Nov 6, 2018·World Journal of Hepatology·Monjur Ahmed
Jan 12, 2021·Expert Review of Anti-infective Therapy·Szu-Jen WangMing-Lung Yu
May 4, 2020·Journal of the Formosan Medical Association = Taiwan Yi Zhi·Ming-Lung YuWan-Long Chuang
Mar 30, 2021·World Journal of Gastroenterology : WJG·Dorota Zarębska-Michaluk
Jul 6, 2021·Journal of Clinical and Translational Hepatology·Xiaozhong Wang, Lai Wei

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