Elbasvir/grazoprevir in Asia-Pacific/Russian participants with chronic hepatitis C virus genotype 1, 4, or 6 infection

Hepatology Communications
Jacob GeorgeC‐CORAL Study Investigators

Abstract

The prevalence of hepatitis C virus (HCV) infection in Asian countries is high. This study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in participants with HCV infection from Asia-Pacific countries and Russia. In this phase 3, randomized, placebo-controlled, double-blind study, treatment-naive participants with HCV genotype (GT) 1, 4, or 6 infection were randomized to EBR 50 mg/GZR 100 mg (immediate-treatment group [ITG]) or placebo (deferred-treatment group [DTG]) once daily for 12 weeks (Protocol PN-5172-067, NCT02251990). The primary efficacy variable was a nonrandomized comparison of sustained virologic response at 12 weeks after the end of therapy (SVR12) for the ITG with a historical control. The primary safety outcome was a randomized comparison between the ITG and DTG. Three hundred thirty-seven participants were randomized to the ITG (n = 251) or DTG (n = 86); 199 (59.2%) participants were Asian, and 250 (74.4%) had HCV GT1b infection. Overall, 232/250 (92.8%) participants in the ITG achieved SVR12 (97.5% confidence interval, 89.1, 96.5). Of the 18 participants who failed to attain SVR12, 1 was lost to follow-up and 17 had virologic failure, 13 of whom had HCV GT6 infection. The incidence of adve...Continue Reading

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Citations

Feb 20, 2019·Journal of Gastroenterology and Hepatology·Lai WeiRohit Talwani
May 23, 2019·Clinical Pharmacokinetics·Elise J SmoldersDavid M Burger
Jul 6, 2019·Journal of Viral Hepatitis·Charlotte PronierUNKNOWN AFEF/ANRS Hepather study group
Oct 11, 2019·Journal of Medical Virology·Tzu-Cheng TsaiChao-Wei Hsu
May 24, 2020·Liver International : Official Journal of the International Association for the Study of the Liver·Betty B YaoTarik Asselah
May 6, 2020·Hepatic Medicine : Evidence and Research·Konstantin ZhdanovMichael N Robertson
Jan 12, 2021·Expert Review of Anti-infective Therapy·Szu-Jen WangMing-Lung Yu
Dec 16, 2020·JGH Open : an Open Access Journal of Gastroenterology and Hepatology·Lai WeiRohit Talwani

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Methods Mentioned

BETA
biopsy

Clinical Trials Mentioned

NCT02251990

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