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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]Peking Univ, Beijing Key Lab Hepatitis C & Immunol Liver Dis, Inst Hepatol, Peoples Hosp, 11 Xizhimen S St, Beijing 100044, Peoples R China [2]Shanghai Jiao Tong Univ, Ruijin Hosp, Shanghai, Peoples R China [3]Southern Med Univ, Nanfang Hosp, Guangzhou, Guangdong, Peoples R China [4]Sichuan Univ, West China Hosp, Chengdu, Sichuan, Peoples R China [5]Huanzhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Wuhan, Hubei, Peoples R China [6]Capital Med Univ, Beijing Ditan Hosp, Beijing, Peoples R China [7]Hebei Med Univ, Hosp 3, Shijiazhuang, Hebei, Peoples R China [8]Nanchang Univ, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China [9]Nanjing Med Univ, Affiliated Hosp 1, Nanjing, Jiangsu, Peoples R China [10]Guangxi Med Univ, Affiliated Hosp 1, Nanning, Guangxi, Peoples R China [11]Gilead Sci Inc, 353 Lakeside Dr, Foster City, CA 94404 USA [12]Cent S Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China [13]Jinan Infect Dis Hosp, Jinan, Shandong, Peoples R China [14]Clin Ctr Shanghai Publ Hlth, Shanghai, Peoples R China [15]Peking Univ, Hosp 1, Beijing, Peoples R China [16]Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China [17]Jilin Univ, Hosp 1, Changchun, Jilin, Peoples R China [18]Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China [19]Capital Med Univ, Beijing You An Hosp, Beijing, Peoples R 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 出版当年[2016版] 出版当年五年平均 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]Peking Univ, Beijing Key Lab Hepatitis C & Immunol Liver Dis, Inst Hepatol, Peoples Hosp, 11 Xizhimen S St, Beijing 100044, Peoples R China
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