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首页> 外文期刊>The Lancet >Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: The COSMOS randomised study
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Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: The COSMOS randomised study

机译：Simeprevir加sofosbuvir联合利巴韦林或不联合利巴韦林，用于治疗对聚乙二醇化干扰素和利巴韦林无反应的初治患者和初治患者的丙型肝炎病毒基因型1慢性感染：COSMOS随机研究

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Background Interferon-free regimens are needed to treat hepatitis C virus (HCV) infections. We investigated the efficacy of combined simeprevir and sofosbuvir.Methods We enrolled patients with chronic HCV genotype 1 infections who had previously not responded to pegylated interferon (peginterferon) and ribavirin or were treatment naive. Patients were randomly assigned in a 2:1:2:1 ratio to receive 150 mg simeprevir and 400 mg sofosbuvir daily for 24 weeks with (group 1) or without (group 2) ribavirin or for 12 weeks with (group 3) or without (group 4) ribavirin, in two cohorts: previous non-responders with METAVIR scores F0-F2 (cohort 1) and previous non-responders and treatment-naive patients with METAVIR scores F3-F4 (cohort 2). The primary endpoint was sustained virological response 12 weeks after stopping treatment (SVR12). Analysis was done by intention to treat. Safety data from cohorts 1 and 2 were pooled for analysis. This study is registered with ClinicalTrials.gov, number NCT01466790.
机译：背景技术需要无干扰素的方案来治疗丙型肝炎病毒（HCV）感染。方法我们招募了慢性HCV基因型1型感染的患者，这些患者以前对聚乙二醇化干扰素（peginterferon）和利巴韦林没有反应，或未接受过治疗。患者按2：1：2：1的比例随机分配，在（第1组）或不使用（第2组）利巴韦林的情况下每天接受150 mg simeprevir和400 mg索非布韦治疗24周，或在（第3组）或不接受利巴韦林的情况下接受12周（第4组）利巴韦林，分为两个队列：先前的METAVIR评分为F0-F2的无反应者（队列1）和先前的METAVIR评分为F3-F4的无反应者和未接受治疗的患者（队列2）。主要终点是停止治疗后12周的持续病毒学应答（SVR12）。分析是按意向进行的。收集来自队列1和2的安全性数据进行分析。该研究已在ClinicalTrials.gov上注册，编号为NCT01466790。

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