PMID- 33319038 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220419 IS - 2397-9070 (Electronic) IS - 2397-9070 (Linking) VI - 4 IP - 6 DP - 2020 Dec TI - Efficacy and safety of elbasvir/grazoprevir in treatment-naive Chinese adults with hepatitis C virus infection: A randomized trial. PG - 1065-1073 LID - 10.1002/jgh3.12387 [doi] AB - 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. CI - (c) 2020 The Authors. JGH Open: An open access journal of gastroenterology and hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd. FAU - Wei, Lai AU - Wei L AD - Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease Peking University People's Hospital, Peking University Hepatology Institute Beijing China. FAU - Jia, Ji Dong AU - Jia JD AD - Beijing Key Laboratory of Translational Medicine on Cirrhosis, National Clinical Research Center for Digestive Diseases Liver Research Center, Beijing Friendship Hospital, Capital Medical University Beijing China. FAU - Duan, Zhong Ping AU - Duan ZP AD - Artificial Liver Center Beijing YouAn Hospital, Capital Medical University Beijing China. FAU - Wang, Fu Sheng AU - Wang FS AD - Treatment and Research Center for Infectious Diseases Beijing 302 Hospital Beijing China. FAU - Niu, Jun Qi AU - Niu JQ AD - Department of Hepatology First Hospital, Jilin University Changchun China. FAU - Xie, Wen AU - Xie W AD - Center of Liver Diseases Beijing Ditan Hospital, Capital Medical University Beijing China. FAU - Huang, Wen Xiang AU - Huang WX AD - Division of Microbiology The First Affiliated Hospital of Chongqing Medical University Chongqing China. FAU - Zhang, Ming Xiang AU - Zhang MX AD - Department of Integrated Traditional and Western Medicine on Liver Diseases The Sixth People's Hospital of Shenyang Shenyang China. FAU - Huang, Yan AU - Huang Y AD - Department of Infectious Diseases Hunan Key Laboratory of Viral Hepatitis, Xiangya Hospital, Central South University Changsha China. FAU - Wang, Mao Rong AU - Wang MR AD - Center of Liver Disease The 81st Hospital of PLA Nanjing China. FAU - Wu, Shan Ming AU - Wu SM AD - Department of Infectious Diseases Shanghai Public Health Center Shanghai China. FAU - Zhao, Ying Ren AU - Zhao YR AD - Department of Infectious Disease First Affiliated Hospital of Medicine College, Xi'an Jiaotong University Xi'an China. FAU - Jia, Zhan Sheng AU - Jia ZS AD - Center of Infectious Diseases Tangdu Hospital, Fourth Military Medical University Xi'an China. FAU - Zhao, Xu Min AU - Zhao XM AD - Department of Infectious Diseases MSD China Beijing. FAU - Mu, Sheng Mei AU - Mu SM AD - Department of Infectious Diseases MSD China Beijing. FAU - Liang, Li Wen AU - Liang LW AD - Department of Infectious Diseases MSD China Beijing. FAU - Wang, Zaiqi AU - Wang Z AD - Department of Infectious Diseases MSD China Beijing. FAU - Puenpatom, Amy AU - Puenpatom A AD - Department of Infectious Diseases Merck & Co., Inc. Kenilworth New Jersey USA. FAU - Hwang, Peggy AU - Hwang P AD - Department of Infectious Diseases Merck & Co., Inc. Kenilworth New Jersey USA. FAU - Robertson, Michael N AU - Robertson MN AUID- ORCID: 0000-0001-8247-1057 AD - Department of Infectious Diseases Merck & Co., Inc. Kenilworth New Jersey USA. FAU - Ingravallo, Paul AU - Ingravallo P AD - Department of Infectious Diseases Merck & Co., Inc. Kenilworth New Jersey USA. FAU - Asante-Appiah, Ernest AU - Asante-Appiah E AD - Department of Infectious Diseases Merck & Co., Inc. Kenilworth New Jersey USA. FAU - Wei, Bo AU - Wei B AD - Department of Infectious Diseases Merck & Co., Inc. Kenilworth New Jersey USA. FAU - Evans, Barbara AU - Evans B AD - Department of Infectious Diseases Merck & Co., Inc. Kenilworth New Jersey USA. FAU - Hanna, George J AU - Hanna GJ AUID- ORCID: 0000-0001-6687-7081 AD - Department of Infectious Diseases Merck & Co., Inc. Kenilworth New Jersey USA. FAU - Talwani, Rohit AU - Talwani R AD - Department of Infectious Diseases Merck & Co., Inc. Kenilworth New Jersey USA. LA - eng SI - ClinicalTrials.gov/NCT02251990 PT - Journal Article DEP - 20200715 PL - Australia TA - JGH Open JT - JGH open : an open access journal of gastroenterology and hepatology JID - 101730833 PMC - PMC7731814 OTO - NOTNLM OT - hepatitis C clinical OT - hepatitis C virus clinical trials OT - viral hepatitis OT - virology, hepatitis C virus treatment EDAT- 2020/12/16 06:00 MHDA- 2020/12/16 06:01 PMCR- 2020/07/15 CRDT- 2020/12/15 06:05 PHST- 2020/04/22 00:00 [received] PHST- 2020/06/18 00:00 [accepted] PHST- 2020/12/15 06:05 [entrez] PHST- 2020/12/16 06:00 [pubmed] PHST- 2020/12/16 06:01 [medline] PHST- 2020/07/15 00:00 [pmc-release] AID - JGH312387 [pii] AID - 10.1002/jgh3.12387 [doi] PST - epublish SO - JGH Open. 2020 Jul 15;4(6):1065-1073. doi: 10.1002/jgh3.12387. eCollection 2020 Dec.