单位：[1]Peking University People’s Hospital[2]Beijing Friendship Hospital Affiliated with Capital Medical University首都医科大学附属北京友谊医院[3]Beijing Ditan Hospital Affiliated with Capital Medical University[4]Peking University First Hospital[5]Beijing You’an Hospital Affiliated with CapitalMedical University, Beijing[6]Shanghai Jiaotong University Ruijin Hospital[7]Clinical Center of Shanghai Public Health, Shanghai[8]Nanfang Hospital of Southern Medical University[9]Guangzhou Eighth People’s Hospital[10]The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou中山大学附属第三医院[11]The First Affiliated Hospital of Kunming Medical University, Kunming昆明医科大学附属第一医院[12]First Affiliated Hospital, Nanjiang Medical University[13]The Second Hospital of Nanjing, Nanjing[14]Jinan Infectious Disease Hospital, Jinan[15]The Second Xiangya Hospital of Central South University, Changsha[16]The First Hospital of Jilin University, Changchun[17]The Second Affiliated Hospital of Chongqing Medical University, Chongqing[18]West China Hospital, Sichuan University, Chengdu四川大学华西医院[19]Shengjing Hospital of China Medical University, Shenyang中国医科大学附属盛京医院[20]The First Affiliated Hospital Zhejiang University Medical College, Hangzhou浙江大学医学院附属第一医院[21]The First Affiliated Hospital of Nanchang University, Nanchang[22]Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan华中科技大学同济医学院附属同济医院[23]The First Affiliated Hospital of GuangxiMedical University, Guangxi[24]Hainan General Hospital, Hainan[25]The Third Hospital of HebeiMedical University,Hebei[26]First Affiliated Hospital of Fujian Medical University, Fujian, China[27]Gilead Sciences, Inc., Foster City, CA, USA
Background and AimSofosbuvir is a nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B RNA polymerase with pangenotypic potency. This phase 3b study evaluated the safety and efficacy of sofosbuvir+ribavirinpeginterferon in Chinese patients infected with HCV genotype 1, 2, 3, or 6. MethodsPatients with genotype 1 or 6 received sofosbuvir+peginterferon/ribavirin for 12weeks or sofosbuvir+ribavirin for 24weeks, depending on prior treatment and interferon eligibility. Patients with genotype 2 or 3 received sofosbuvir+ribavirin for 12 or 24weeks, respectively. The primary endpoint was sustained virologic response at 12weeks after the end of treatment (SVR12). ResultsOf 389 patients, 42% had genotype 1, 16% genotype 2, 32% genotype 3, and 9% genotype 6. Half were male, 58% were treatment-naive, and 15% had cirrhosis. SVR12 rates for patients receiving 12 weeks of sofosbuvir+peginterferon/ribavirin were 94% (95% confidence interval [CI], 87-98%) for HCV genotype 1 and 97% (95% CI, 84-100%) for genotype 6. SVR12 rates for those receiving sofosbuvir+ribavirin for 24weeks were 95% (95% CI, 87-99%) for genotype 1, 100% (95% CI, 40-100%) for genotype 6, and 95% (95% CI, 90-98%) for genotype 3. For genotype 2 patients receiving sofosbuvir+ribavirin for 12weeks, the SVR12 rate was 92% (95% CI, 83-97%). Twenty patients (5%) relapsed. Ten (3%) experienced serious adverse events. Three (<1%) discontinued treatment because of adverse events, of whom one died because of treatment-unrelated adverse events. ConclusionsSofosbuvir-based regimens were highly effective and safe in Chinese patients with HCV genotype 1, 2, 3, or 6, suggesting sofosbuvir could serve as the backbone for HCV treatment in China irrespective of genotype.
基金：
Gilead Sciences Inc., Foster City, CA, USAGilead Sciences
第一作者单位：[1]Peking University People’s Hospital[*1]Peking University People’s Hospital, 11 Xizhimen S St, Xicheng District, Beijing 100044, China.
通讯作者：
通讯机构：[1]Peking University People’s Hospital[*1]Peking University People’s Hospital, 11 Xizhimen S St, Xicheng District, Beijing 100044, China.
推荐引用方式(GB/T 7714)：
Lai Wei,Qing Xie,Jin Lin Hou,et al.Sofosbuvir plus ribavirin with or without peginterferon for the treatment of hepatitis C virus: Results from a phase 3b study in China[J].JOURNAL of GASTROENTEROLOGY and HEPATOLOGY.2018,33(6):1168-1176.doi:10.1111/jgh.14102.
APA：
Lai Wei,Qing Xie,Jin Lin Hou,Jidong Jia,Wu Li...&Zhongping Duan.(2018).Sofosbuvir plus ribavirin with or without peginterferon for the treatment of hepatitis C virus: Results from a phase 3b study in China.JOURNAL of GASTROENTEROLOGY and HEPATOLOGY,33,(6)
MLA：
Lai Wei,et al."Sofosbuvir plus ribavirin with or without peginterferon for the treatment of hepatitis C virus: Results from a phase 3b study in China".JOURNAL of GASTROENTEROLOGY and HEPATOLOGY 33..6(2018):1168-1176
