单位:[1]Beijing Key Lab for Hepatitis C and Immunologic LiverDisease, Peking University Hepatology Institute, PekingUniversity People’s Hospital, 11 Xizhimen S St, XichengDistrict, Beijing 100044, China[2]Ruijin Hospital, Shanghai Jiaotong University, Shanghai,China[3]Nanfang Hospital of Southern Medical University,Guangzhou, China[4]West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[5]Tongji Hospital of Tongji Medical College, HuanzhongUniversity of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[6]Beijing Ditan Hospital Affiliated to Capital MedicalUniversity, Beijing, China[7]The Third Hospital of Hebei Medical University, Hebei,China[8]The First Affiliated Hospital of Nanchang University,Nanchang, China[9]The First Affiliated Hospital with Nanjing MedicalUniversity, Nanjing, China[10]The First Affiliated Hospital of Guangxi Medical University,Guangxi, China[11]Gilead Sciences, Inc., Foster City, USA[12]The Second Xiangya Hospital of Central South University,Changsha, China[13]Jinan Infectious Disease Hospital, Jinan, China[14]Clinical Center of Shanghai Public Health, Shanghai, China[15]Peking University First Hospital, Beijing, China[16]The Second Affiliated Hospital of Chongqing MedicalUniversity, Chongqing, China[17]The First Hospital of Jilin University, Changchun, China[18]Beijing Friendship Hospital, Capital Medical University,Beijing, China首都医科大学附属北京友谊医院[19]Beijing You-An Hospital, Capital Medical University,Beijing, China
Background Chronic hepatitis C virus (HCV) infection is a significant medical burden in China, affecting more than 10 million persons. In clinical trials and real-world settings, treatment with ledipasvir/sofosbuvir in patients with genotype 1 HCV infection resulted in high sustained virologic response rates. Ledipasvir/sofosbuvir may provide a highly effective, short-duration, single-tablet regimen for Chinese patients with HCV infection. Methods Chinese patients with genotype 1 HCV infection who were HCV treatment naive or treatment experienced, without cirrhosis or with compensated cirrhosis, were treated with open-label ledipasvir/sofosbuvir for 12 weeks. The primary efficacy endpoint was sustained virologic response 12 weeks after completing treatment (SVR12). For treatment-naive patients, SVR12 was compared to a historical rate of 57%. The primary safety endpoint was adverse events leading to permanent discontinuation of study drug; serious adverse events were also evaluated. The presence of resistance-associated substitutions (RASs) was evaluated by viral sequencing. Results All 206 enrolled patients achieved SVR12 (100%; 95% CI 98-100%), including 106 treatment-naive patients (100%; 95% CI 97-100%), which was superior to a historical SVR rate of 57%(p < 0.001). All patients with baseline NS5A and NS5B RASs (14 and 1% of patients, respectively) achieved SVR12. The most common adverse events were viral upper respiratory tract infection (17%), upper respiratory tract infection (14%), and cough (6%). There were no discontinuations due to adverse events; and no treatment-related serious adverse events were reported. Conclusion Ledipasvir/sofosbuvir is a well tolerated and highly effective treatment for Chinese patients with genotype 1 HCV, regardless of prior treatment experience, cirrhosis status, or the presence of pretreatment RASs.
基金:
Gilead Sciences Inc., Foster City, CA, USAGilead Sciences
第一作者单位:[1]Beijing Key Lab for Hepatitis C and Immunologic LiverDisease, Peking University Hepatology Institute, PekingUniversity People’s Hospital, 11 Xizhimen S St, XichengDistrict, Beijing 100044, China
通讯作者:
推荐引用方式(GB/T 7714):
Lai Wei,Qing Xie,Jin Lin Hou,et al.Ledipasvir/sofosbuvir for treatment-naive and treatment-experienced Chinese patients with genotype 1 HCV: an open-label, phase 3b study[J].HEPATOLOGY INTERNATIONAL.2018,12(2):126-132.doi:10.1007/s12072-018-9856-z.
APA:
Lai Wei,Qing Xie,Jin Lin Hou,Hong Tang,Qin Ning...&Zhongping Duan.(2018).Ledipasvir/sofosbuvir for treatment-naive and treatment-experienced Chinese patients with genotype 1 HCV: an open-label, phase 3b study.HEPATOLOGY INTERNATIONAL,12,(2)
MLA:
Lai Wei,et al."Ledipasvir/sofosbuvir for treatment-naive and treatment-experienced Chinese patients with genotype 1 HCV: an open-label, phase 3b study".HEPATOLOGY INTERNATIONAL 12..2(2018):126-132