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Sofosbuvir plus ribavirin with or without peginterferon for the treatment of hepatitis C virus: Results from a phase 3b study in China

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机构: [1]Peking Univ, Peoples Hosp, 11 Xizhimen S St, Beijing 100044, Peoples R China [2]Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China [3]Capital Med Univ, Beijing Ditan Hosp, Beijing, Peoples R China [4]Peking Univ, Hosp 1, Beijing, Peoples R China [5]Capital Med Univ, Beijing Youan Hosp, Beijing, Peoples R China [6]Shanghai Jiao Tong Univ, Ruijin Hosp, Shanghai, Peoples R China [7]Clin Ctr Shanghai Publ Hlth, Shanghai, Peoples R China [8]Southern Med Univ, Nanfang Hosp, Guangzhou, Guangdong, Peoples R China [9]Guangzhou Eighth Peoples Hosp, Guangzhou, Guangdong, Peoples R China [10]Sun Yat Sen Univ, Affiliated Hosp 3, Guangzhou, Guangdong, Peoples R China [11]Kunming Med Univ, Affiliated Hosp 1, Kunming, Yunnan, Peoples R China [12]Nanjiang Med Univ, Affiliated Hosp 1, Nanjing, Jiangsu, Peoples R China [13]Second Hosp Nanjing, Nanjing, Jiangsu, Peoples R China [14]Jinan Infect Dis Hosp, Jinan, Shandong, Peoples R China [15]Cent S Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China [16]Jilin Univ, Hosp 1, Changchun, Jilin, Peoples R China [17]Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China [18]Sichuan Univ, West China Hosp, Chengdu, Sichuan, Peoples R China [19]China Med Univ, Shengjing Hosp, Shenyang, Liaoning, Peoples R China [20]Zhejiang Univ, Coll Med, Affiliated Hosp 1, Hangzhou, Zhejiang, Peoples R China [21]Nanchang Univ, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China [22]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Wuhan, Hubei, Peoples R China [23]Guangxi Med Univ, Affiliated Hosp 1, Nanning, Guangxi, Peoples R China [24]Hainan Gen Hosp, Haikou, Hainan, Peoples R China [25]Hebei Med Univ, Hosp 3, Shijiazhuang, Hebei, Peoples R China [26]Fujian Med Univ, Affiliated Hosp 1, Fuzhou, Fujian, Peoples R China [27]Gilead Sci Inc, 353 Lakeside Dr, Foster City, CA 94404 USA
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关键词: direct-acting antiviral agents NS5B polymerase inhibitor pangenotypic SVR12

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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.

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出版当年[2019]版:
大类 | 2 区 医学
小类 | 3 区 胃肠肝病学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 胃肠肝病学
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出版当年[2018]版:
Q2 GASTROENTEROLOGY & HEPATOLOGY
最新[2023]版:
Q2 GASTROENTEROLOGY & HEPATOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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第一作者机构: [1]Peking Univ, Peoples Hosp, 11 Xizhimen S St, Beijing 100044, Peoples R China
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通讯机构: [1]Peking Univ, Peoples Hosp, 11 Xizhimen S St, Beijing 100044, Peoples R China
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