Open AccessEfficacy and safety of elbasvir/grazoprevir in treatment‐naive Chinese adults with hepatitis C virus infection: A randomized trial
Author(s) -
Wei Lai,
Jia Ji Dong,
Duan Zhong Ping,
Wang Fu Sheng,
Niu Jun Qi,
Xie Wen,
Huang Wen Xiang,
Zhang Ming Xiang,
Huang Yan,
Wang Mao Rong,
Wu Shan Ming,
Zhao Ying Ren,
Jia Zhan Sheng,
Zhao Xu Min,
Mu Sheng Mei,
Liang Li Wen,
Wang Zaiqi,
Puenpatom Amy,
Hwang Peggy,
Robertson Michael N.,
Ingravallo Paul,
AsanteAppiah Ernest,
Wei Bo,
Evans Barbara,
Hanna George J.,
Talwani Rohit
Publication year - 2020
Publication title -
jgh open
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.546
H-Index - 8
ISSN - 2397-9070
DOI - 10.1002/jgh3.12387
Subject(s) - medicine , placebo , adverse effect , clinical endpoint , randomized controlled trial , gastroenterology , alternative medicine , pathology
Background and Aim In China, clinical experience with direct‐acting antiviral treatments for hepatitis C virus (HCV) infection is still emerging. C‐CORAL is a phase 3, multinational, placebo‐controlled, double‐blind trial of elbasvir/grazoprevir (EBR/GZR) in participants with HCV infection from the Asia‐Pacific region and Russia. Here, we report the data from participants enrolled in China. Methods Treatment‐naive participants with chronic HCV genotype (GT) 1, GT4, or GT6 infection were randomly assigned to receive 50 mg EBR/100 mg GZR for 12 weeks (immediate‐treatment group, ITG) or placebo followed by deferred treatment with EBR/GZR (deferred‐treatment group, DTG). The primary efficacy end‐point was sustained virologic response at 12 weeks after completing treatment (SVR12), and the primary safety end‐point was a comparison of safety between participants receiving EBR/GZR and placebo (NCT02251990; Protocol PN‐5172‐067). Results A total of 152 participants in China were randomly assigned (ITG, n = 115; DTG, n = 37). SVR12 was achieved in 96.7% (146/151) participants overall and in 97.3% (142/146) of those with GT1b infection. Four participants relapsed (GT1b, n = 3; GT6a, n = 1). Drug‐related AEs were reported in 25 (21.7%) and 9 (24.3%) participants receiving EBR/GZR and placebo, respectively; no drug‐related serious adverse events (AEs) occurred. Two (1.7%) participants receiving EBR/GZR had late hepatic transaminase elevations. Patient‐reported outcomes indicate improved quality of life at follow‐up week 4 in participants receiving EBR/GZR compared to placebo. Conclusion EBR/GZR administered for 12 weeks represents a highly effective and safe treatment option for Chinese individuals with HCV GT1 infection.