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Ledipasvir/sofosbuvir for treatment-naive and treatment-experienced Chinese patients with genotype 1 HCV: an open-label, phase 3b study

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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 [5]Tongji Hospital of Tongji Medical College, HuanzhongUniversity of Science and Technology, Wuhan, China [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 [19]Beijing You-An Hospital, Capital Medical University,Beijing, China
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关键词: China Genotype 1 Hepatitis C virus Ledipasvir Sofosbuvir Single-tablet regimen

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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.

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出版当年[2017]版:
大类 | 4 区 医学
小类 | 4 区 胃肠肝病学
最新[2025]版:
大类 | 1 区 医学
小类 | 2 区 胃肠肝病学
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出版当年[2016]版:
Q3 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[2016版] 出版当年五年平均[2012-2016] 出版前一年[2015版] 出版后一年[2017版]

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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
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