Efficacy and safety of elbasvir/grazoprevir in treatment‐naive Chinese adults with hepatitis C virus infection: A randomized trial. Issue 6 (15th July 2020)

• Record Type: Journal Article
• Authors: 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; Asante‐Appiah, Ernest; Wei, Bo; Evans, Barbara; Hanna, George J.; Talwani, Rohit
• Is Part Of: JGH open. Volume 4:Issue 6(2020)
• Page Start: 1065
• Page End: 1073
• Publication Date: 2020-07-15
• Subjects: hepatitis C virus clinical trials -- hepatitis C clinical -- viral hepatitis -- virology, hepatitis C virus treatment
• DOI: 10.1002/jgh3.12387
• Languages: English
• ISSNs: 2397-9070

Abstract

Abstract: 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. Abstract : A sustained virologic response was achieved by 96.7% (146/151) of treatment‐naive participants with hepatitis c virus infection receiving elbasvir/grazoprevir (50 mg/100 mg) for 12 weeks. Patient‐reported outcomes indicate improved quality of life following clearance of HCV.