Efficacy and safety of elbasvir/grazoprevir in treatment‐naive Chinese adults with hepatitis C virus infection: A randomized trial
Year: 2020
Type: article
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: = 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.
Source: JGH Open
DOI: 10.1002/jgh3.12387
Authors: Lai Wei, Ji Dong Jia, Zhong Ping Duan, Fu Sheng Wang, Jun Qi Niu, Wen Xie, Wen Xiang Huang, Ming Xiang Zhang, Yan Huang, Mao Rong Wang, Shan Ming Wu, Ying Ren Zhao, Zhan Sheng Jia, Xu Min Zhao, Sheng Mei Mu, Li Wen Liang, Zaiqi Wang, Amy Puenpatom, Peggy Hwang, Michael N. Robertson, Paul Ingravallo, Ernest Asante‐Appiah, Bo Wei, Barbara Evans, George J. Hanna, Rohit Talwani
Institutions: Peking University People's Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing Friendship Hospital, Beijing YouAn Hospital, 302 Military Hospital of China, Jilin University, First Hospital of Jilin University, Beijing Ditan Hospital, The Affiliated Yongchuan Hospital of Chongqing Medical University, The Sixth People's Hospital of Shenyang, Central South University, Xiangya Hospital Central South University, 81th Hospital of PLA, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an Jiaotong University, Tang Du Hospital, Air Force Medical University, MSD (China) Investment Co., Ltd. (China), Merck & Co., Inc., Rahway, NJ, USA (United States)
Language: English
Topic: Hepatitis C virus research
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,000
Funder: Merck Sharp and Dohme
OpenAlex ID: W3042716820