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Efficacy and safety of elbasvir/grazoprevir intreatment-naiveChinese adults with hepatitis C virus infection: A randomized trial

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单位: [1]Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease, Peking University People’s Hospital, Peking University Hepatology Institute, [2]Beijing Key Laboratory of Translational Medicine on Cirrhosis, National Clinical Research Center for Digestive Diseases, Liver Research Center, Beijing Friendship Hospital, Capital Medical University, [3]Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University, [4]Treatment and Research Center for Infectious Diseases, Beijing 302 Hospital, [5]Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, [6]Department of Hepatology, First Hospital, Jilin University, Changchun, [7]Division of Microbiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, [8]Department of Integrated Traditional and Western Medicine on Liver Diseases, The Sixth People’s Hospital of Shenyang, Shenyang, [9]Department of Infectious Diseases, Hunan Key Laboratory of Viral Hepatitis, Xiangya Hospital, Central South University, Changsha, [10]Center of Liver Disease, The 81st Hospital of PLA, Nanjing, [11]Department of Infectious Diseases, Shanghai Public Health Center, Shanghai, [12]Department of Infectious Disease, First Affiliated Hospital of Medicine College, Xi’an Jiaotong University, [13]Center of Infectious Diseases, Tangdu Hospital, Fourth Military Medical University, Xi’an, China, [14]Department of Infectious Diseases, MSD, China, Beijing [15]Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, New Jersey, USA
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关键词: hepatitis C virus clinical trials hepatitis C clinical viral hepatitis virology hepatitis C virus treatment

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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.

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大类 | 4 区 医学
小类 | 4 区 胃肠肝病学
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Q4 GASTROENTEROLOGY & HEPATOLOGY

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第一作者单位: [1]Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease, Peking University People’s Hospital, Peking University Hepatology Institute,
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通讯机构: [15]Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, New Jersey, USA [*1]Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
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