单位：[1]Department of Hepatology,The First Hospital of Jilin University[2]Department of Emerging Infectious Diseases, Institute of Translational Medicine, The First Hospital of Jilin University[3]Institute of Virology and AIDS Research, The First Hospital of Jilin University[4]Department of Epidemiology and Biostatistics, School of Public Health, Jilin University, Changchun[5]Department of Hepatology, Liuzhou People’s Hospital, Liuzhou[6]Department of Hepatology, Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital[7]Department of Infectious Diseases, First Affiliated Hospital of Xinjiang Medical University, Urumqi[8]Department of Hepatology, Chongqing University Three Gorges Hosipital, Chongqing Three Gorges Central Hospital[9]Department of Hepatology, Chongqing Public Health Medical Center, Chongqing[10]Department of Infectious Diseases, Affiliated Hospital of ZunyiMedical University, Zunyi[11]Department of Hepatology, Public Health Clinical Center of Chengdu[12]Department of Infectious Diseases, Sichuan Provincial People’s Hospital, Chengdu四川省人民医院[13]Department of Hepatology Division 3, Beijing Ditan Hospital, Capital Medical University[14]Difficult and Complicated Liver Diseases and Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University[15]Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing临床科室国家中心肝病分中心首都医科大学附属北京友谊医院[16]Department of Infectious Disease, The Affiliated Hospital of Xuzhou Medical University, Xuzhou[17]Department of Infectious Diseases, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology华中科技大学同济医学院附属同济医院[18]Department of Hepatology, Wuhan Public Health Medical Center, Wuhan[19]Department of Infectious Diseases,Wuxi No. 5 People’s Hospital,Wuxi[20]Department of Infectious Diseases, The First Affiliated Hospital of Shanxi Medical University, Taiyuan[21]Department of Infectious Diseases, Huzhou Central Hospital, Huzhou[22]Department of Infectious Disease, The First Affiliated Hospital of GuangxiMedical University, Nanning[23]Center of Liver Diseases, The First Affiliated Hospital of HebeiMedical University, Shijiazhuang[24]Department of Infectious Disease, QingdaoMunicipal Hospital, Qingdao[25]Department of Hepatology, The Affiliated TCMHospital of SouthwestMedical University, Luzhou[26]General Manager Office, Shanghai Viromedicine Co., Ltd., Shanghai[27]Department of Clinical Research, Shanghai Viromedicine Co., Ltd., Shanghai[28]Cirrhosis Department, Zhengzhou Sixth Municipal People’s Hospital, Zhengzhou, China
Background and Aim This single-arm, open-label, multicenter, phase 3 trial evaluated the efficacy and safety of seraprevir, an hepatitis C virus (HCV) nonstructural protein 3/4A (NS3/4A) inhibitor, combined with sofosbuvir for treating Chinese patients with chronic HCV infection without cirrhosis. Methods Treatment-naive or interferon-experienced adult patients without cirrhosis were treated with a universal, combinational regimen of seraprevir 100 mg, twice daily and sofosbuvir 400 mg, once daily, for 12 or 24 weeks. The primary efficacy endpoint was sustained virologic response at week 12 after treatment (SVR12). Results Overall, 205 patients with genotype 1 HCV infection without cirrhosis were enrolled from 23 sites, 202 of whom completed the full treatment and post-treatment course and 3 discontinued follow-up. In total, 27 patients (13.2%) were interferon experienced. SVR12 was achieved by 201 out of 205 (98.0% [95% CI, 95.1%, 99.5%]) patients, 100.0% of patients with genotype 1a, and 98.0% of genotype 1b. In the other exploratory study, SVR 12 was achieved by 100% patients with genotype 2 (n = 21), genotype 3 (n = 7), and genotype 6 (n = 8). The majority of adverse events were mild to moderate and transient and did not require a specific medical intervention. Conclusions The all-oral, ribavirin-free regimen of seraprevir and sofosbuvir is an effective and well-tolerated treatment option for Chinese patients mono-infected with HCV, including those with a history of interferon treatment.
第一作者单位：[1]Department of Hepatology,The First Hospital of Jilin University[4]Department of Epidemiology and Biostatistics, School of Public Health, Jilin University, Changchun
共同第一作者：
通讯作者：
通讯机构：[1]Department of Hepatology,The First Hospital of Jilin University[7]Department of Infectious Diseases, First Affiliated Hospital of Xinjiang Medical University, Urumqi[28]Cirrhosis Department, Zhengzhou Sixth Municipal People’s Hospital, Zhengzhou, China[*1]Department of Hepatology, The First Hospital of Jilin University, No. 1 Xinmin Street, Changchun 130021, Jilin, China[*2]Cirrhosis Department, Zhengzhou Sixth Municipal People’s Hospital, No. 29 Jingguang South Road, Zhengzhou 45000, Henan, China[*3]Department of Infectious Diseases, First Affiliated Hospital of Xinjiang Medical University, No. 137 Liyushan South Road, Urumqi, Xinjiang, China
推荐引用方式(GB/T 7714)：
Fei Kong,Xiaoyu Wen,Xiaofeng Wen,et al.Seraprevir and sofosbuvir for treatment of chronic hepatitis C virus infection: A single-arm, open-label, phase 3 trial[J].JOURNAL of GASTROENTEROLOGY and HEPATOLOGY.2021,36(9):2375-2382.doi:10.1111/jgh.15412.
APA：
Fei Kong,Xiaoyu Wen,Xiaofeng Wen,Xiaozhong Wang,Guicheng Wu...&Junqi Niu.(2021).Seraprevir and sofosbuvir for treatment of chronic hepatitis C virus infection: A single-arm, open-label, phase 3 trial.JOURNAL of GASTROENTEROLOGY and HEPATOLOGY,36,(9)
MLA：
Fei Kong,et al."Seraprevir and sofosbuvir for treatment of chronic hepatitis C virus infection: A single-arm, open-label, phase 3 trial".JOURNAL of GASTROENTEROLOGY and HEPATOLOGY 36..9(2021):2375-2382
