Glecaprevir-pibrentasvir to treat chronic hepatitis C virus infection in Asia: two multicentre, phase 3 studies- a randomised, double-blind study (VOYAGE-1) and an open-label, single-arm study (VOYAGE-2).

The Lancet. Gastroenterology & Hepatology
Lai WeiJin Lin Hou

Abstract

Glecaprevir-pibrentasvir results in high rates of sustained virological response in patients with chronic hepatitis C virus (HCV) genotype 1-6 infection. Data for glecaprevir-pibrentasvir in non-Japanese Asian patients have been minimal. The aim of these studies was to assess the efficacy and safety of glecaprevir-pibrentasvir in treatment-naive and treatment-experienced Asian patients with chronic HCV genotype 1-6 infection without cirrhosis (VOYAGE-1) and with compensated cirrhosis (VOYAGE-2). We did two phase 3 studies in treatment-naive and treatment-experienced patients with chronic HCV genotype 1-6 infection. VOYAGE-1 was a randomised, double-blind, placebo-controlled study that recruited patients without cirrhosis at 47 sites across China, South Korea, and Singapore. Randomisation was 2:1 with a fixed block size of three and stratified by geographical region and HCV genotype. Investigators, study site personnel, the study sponsor, and patients were masked to treatment allocation. VOYAGE-2 was a single-arm, open-label study that recruited patients with compensated cirrhosis at 34 sites across China and South Korea. Glecaprevir (300 mg) and pibrentasvir (120 mg) or placebo (VOYAGE-1, 2:1 ratio), administered as three table...Continue Reading

Citations

Feb 5, 2021·Journal of Chemical Information and Modeling·Anjela ManandharKhaled M Elokely
Sep 22, 2020·Journal of Hepatology·UNKNOWN European Association for the Study of the Liver. Electronic address: easloffice@easloffice.euUNKNOWN Panel members:
Jul 6, 2021·Journal of Clinical and Translational Hepatology·Xiaozhong Wang, Lai Wei
Jul 31, 2021·World Journal of Gastroenterology : WJG·Fátima Higuera-de la TijeraLuis Servín-Abad

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