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Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single-arm, open-label, phase 3 trial

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单位: [1]First Hosp Jilin Univ, Dept Hepatol, 1 Xinmin St, Changchun 130021, Jilin, Peoples R China [2]Zhengzhou Sixth Municipal Peoples Hosp, Cirrhosis Dept, Zhengzhou, Henan, Peoples R China [3]Capital Med Univ, Beijing You An Hosp, Difficult & Complicated Liver Dis & Artificial Li, Beijing, Peoples R China [4]Sichuan Prov Peoples Hosp, Dept Infect Dis, Chengdu, Sichuan, Peoples R China [5]Liuzhou Peoples Hosp, Dept Hepatol, Liuzhou, Peoples R China [6]Peoples Liberat Army Gen Hosp, Med Ctr 5, Liver Failure Treatment & Res Ctr, Beijing, Peoples R China [7]Xinjiang Uygur Autonomous Reg Tradit Chinese Med, Dept Hepatol, Urumqi, Xinjiang, Peoples R China [8]Shenyang Sixth Peoples Hosp Shenyang, Dept Hepatol, Shenyang, Liaoning, Peoples R China [9]Capital Med Univ, Beijing Ditan Hosp, Dept Hepatol, Div 3, Beijing, Peoples R China [10]Capital Med Univ, Beijing Youyi Hosp, Liver Res Ctr, Beijing, Peoples R China [11]Peoples Liberat Army Air Force Med Univ, Affiliated Hosp 2, Dept Infect Dis, Xian, Shaanxi, Peoples R China [12]Guangzhou Eighth Peoples Hosp, Dept Hepatol, Guangzhou, Peoples R China [13]Yanbian Univ, Affiliated Hosp, Dept Gastroenterol, Yanji, Jilin, Peoples R China [14]Chongqing Univ, Chongqing Gorges Cent Hosp 3, Gorges Hosp 3, Dept Hepatol, Chongqing, Peoples R China [15]Dr Sun Yat Sen Univ, Affiliated Hosp 3, Dept Infect Dis, Guangzhou, Guangdong, Peoples R China [16]Jinan Municipal Hosp Infect Dis, Dept Hepatol, Jinan, Shandong, Peoples R China [17]Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Infect Dis, Wuhan, Hubei, Peoples R China [18]Peoples Liberat Army Med Univ, Affiliated Hosp 1, Inst Infect Dis, Chongqing, Peoples R China [19]Nanjing Second Municipal Hosp, Dept Hepatol, Nanjing, Peoples R China [20]Beijing Kawin Technol Share Holding Co Ltd, Res & Dev Ctr, Beijing, Peoples R China [21]First Hosp Jilin Univ, Dept Phase Clin Trial, Changchun, Jilin, Peoples R China [22]Hangzhou Sciwind Biosci Co Ltd, Clin Dev, Hangzhou, Peoples R China
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关键词: coblopasvir pangenotypic regimen safety sofosbuvir sustained virological response

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Background & Aim An affordable, pangenotypic regimen remains as an unmet medical need for chronic hepatitis C patients in China. This single-arm, open-label, multicenter, phase 3 trial evaluated the efficacy and safety of coblopasvir, a pangenotypic non-structural protein 5A (NS5A) inhibitor, combined with sofosbuvir for treating Chinese patients with chronic hepatitis C virus (HCV) infection. Methods Treatment-naive and interferon-experienced adult patients, including those with advanced fibrosis (F3) or compensated cirrhosis (F4), were treated with a universal, combinational regimen of coblopasvir 60 mg and sofosbuvir 400 mg, once daily, for 12 weeks. The primary efficacy endpoint was sustained virological response at post-treatment week 12 (SVR12). Results Overall, 371 patients (men, 51%; age, 47 +/- 11 years; genotype 1a < 1%, 1b 48%, 2a 26%, 3a 6%, 3b 7% and 6 12%) were enrolled from 19 sites. Fifty-one patients (14%) had F3, 39 patients (11%) had F4 and 39 patients (11%) were interferon experienced. The overall SVR12 was 97% (95% CI, [94%, 98%]) for the full analysis set and was equal to or above 90% for all predefined subsets. Ten patients (3%) experienced virological relapse and two patients did not complete follow-up. No adverse events (AEs) occurred at a frequency >= 5%, and the most often reported AEs (>= 1%) were neutropenia and fatigue. The majority of AEs were mild to moderate and transient without specific medical intervention. Conclusions The universal, pangenotypic combo of coblopasvir plus sofosbuvir is an efficacious and safe treatment for Chinese patients monoinfected with HCV of genotype 1, 2, 3 and 6, including those with compensated cirrhosis. Lay summary The regimen of coblopasvir and sofosbuvir is a safe and effective treatment for Chinese patients with genotype 1, 2, 3 and 6 HCV infection, including those with compensated cirrhosis. Therefore, this regimen would be a novel choice of treatment for this patient population.

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出版当年[2019]版:
大类 | 2 区 医学
小类 | 3 区 胃肠肝病学
最新[2025]版:
大类 | 2 区 医学
小类 | 3 区 胃肠肝病学
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出版当年[2018]版:
Q1 GASTROENTEROLOGY & HEPATOLOGY
最新[2023]版:
Q1 GASTROENTEROLOGY & HEPATOLOGY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2018版] 出版当年五年平均[2014-2018] 出版前一年[2017版] 出版后一年[2019版]

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第一作者单位: [1]First Hosp Jilin Univ, Dept Hepatol, 1 Xinmin St, Changchun 130021, Jilin, Peoples R China
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