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Efficacy and safety of elbasvir/grazoprevir in participants with hepatitis C virus genotype 1, 4, or 6 infection from the Asia-Pacific region and Russia: Final results from the randomized C-CORAL study

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单位: [1]Peking University Hepatology Institute, Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease, Peking University People’s Hospital, [2]Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Cirrhosis, National Clinical Research Center for Digestive Diseases, [3]Treatment and Research Center for Infectious Diseases, Beijing 302 Hospital, [4]Merck Sharp & Dohme, and [5]Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University, Beijing, [6]Department of Hepatology, First Hospital, Jilin University, Changchun, Jilin, China [7]Merck & Co., Inc., Kenilworth, New Jersey, USA [8]Military Medical Academy n.a. S.M. Kirov, St. Petersburg and [9]Department of Gastroenterology and Hepatology, Federal Research Center of Nutrition and Biotechnology,Moscow, Russia [10]National Cheng Kung University, Tainan, Taiwan [11]Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand [12]National Hospital of Tropical Diseases, Hanoi, Vietnam [13]College of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, Republic of Korea [14]Storr Liver Centre, Westmead Institute for Medical Research, Westmead Hospital and University of Sydney, Westmead, New South Wales, Australia
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关键词: HCV clinical trials HCV treatment hepatitis C clinical

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Background and Aim Although treatment with direct-acting antivirals has dramatically improved morbidity and mortality attributable to chronic hepatitis C virus infection, universal access to these medicines has been slow in the Asia-Pacific region and Russia. This study evaluated efficacy and safety of elbasvir/grazoprevir in participants with hepatitis C virus infection from Asia-Pacific countries and Russia (C-CORAL). Methods C-CORAL was a phase 3, randomized, placebo-controlled study (NCT02251990). Treatment-naive, HIV-negative, cirrhotic and non-cirrhotic participants with chronic hepatitis C genotype 1, 4, or 6 infection were randomized to elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks (immediate-treatment group) or placebo followed by deferred treatment with elbasvir/grazoprevir (deferred-treatment group). The primary efficacy outcome was sustained virologic response at 12 weeks, and the primary safety outcome was a comparison between the immediate-treatment group and placebo phase of the deferred-treatment group. Results A total of 489 participants were randomized (immediate-treatment group, n = 366; deferred-treatment group, n = 123). Sustained virologic response at 12 weeks in the combined immediate/deferred-treatment groups was 94.4% (459/486; 95% confidence interval = 92.4-96.5%). Sustained virologic response at 12 weeks was 98.2% in participants with genotype 1b, 91.9% with genotype 1a, and 66.7% with genotype 6 infection. Similar rates of adverse events and drug-related adverse events were seen in the immediate-treatment group versus placebo phase of the deferred-treatment group (51.0% vs 50.4% and 21.4% vs 21.1%). Conclusions Elbasvir/grazoprevir for 12 weeks represents an effective and well-tolerated treatment option for treatment-naive people with genotype 1 infection from Asia-Pacific countries and Russia.

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出版当年[2018]版:
大类 | 2 区 医学
小类 | 3 区 胃肠肝病学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 胃肠肝病学
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出版当年[2017]版:
Q2 GASTROENTEROLOGY & HEPATOLOGY
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Q2 GASTROENTEROLOGY & HEPATOLOGY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2017版] 出版当年五年平均[2013-2017] 出版前一年[2016版] 出版后一年[2018版]

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第一作者单位: [1]Peking University Hepatology Institute, Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease, Peking University People’s Hospital, [*1]Peking University Hepatology Institute, Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease, Peking University People’s Hospital, 11 Xizhimen South Street, Beijing 100044, China.
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通讯机构: [1]Peking University Hepatology Institute, Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease, Peking University People’s Hospital, [*1]Peking University Hepatology Institute, Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease, Peking University People’s Hospital, 11 Xizhimen South Street, Beijing 100044, China.
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