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Hepatology:DCV-SOF-RBV治疗HCV基因型3感染的晚期肝脏疾病患者(ALLY-3+)

2016-03-07 Mechront 译 MedSci原创

基因型3的(丙型肝炎病毒)HCV感染常常会导致进展期肝病,当前迫切需要有效的治疗。先前有研究表明,达卡他韦(DCV:泛基因型NS5A抑制剂)和索非布韦(SOF:核苷酸NS5B抑制剂)联合治疗非肝硬化HCV基因型3的感染长达12周,有效性达96%。ALLY-3+ Ⅲ期研究评估了DCV-SOF和利巴韦林(RBV)对晚期纤维化(n = 14)或代偿期肝硬化(n = 36)的HCV基因型3感染患者的疗效,

基因型3的(丙型肝炎病毒)HCV感染常常会导致进展期肝病,当前迫切需要有效的治疗。先前有研究表明,达卡他韦(DCV:泛基因型NS5A抑制剂)和索非布韦(SOF:核苷酸NS5B抑制剂)联合治疗非肝硬化HCV基因型3的感染长达12周,有效性达96%。

ALLY-3+ Ⅲ期研究评估了DCV-SOF和利巴韦林(RBV)对晚期纤维化(n = 14)或代偿期肝硬化(n = 36)的HCV基因型3感染患者的疗效,其中有13名患者为首次治疗。患者按1:1随机分为DCV-SOF (60 + 400 mg/d)+基于体重的RBV,治疗时间为12周或16周。在治疗后12周时患者持续病毒学应答(SVR12)作为主要终点指标。

研究数据显示,总体SVR12(ITT)为90%(45/50):12周治疗组为88% (21/24;观察率91%),16周治疗组为92% (24/26)。所有晚期纤维化患者均达到SVR12。肝硬化患者中总体SVR12为86%(31/36):12周治疗组为83% (15/18;观察率88%),16周治疗组为89% (16/18);先前治疗过的肝硬化患者,总体SVR12、12周治疗组SVR12和16周治疗组SVR12分别为87% (26/30)、88% (14/16; 观察率93%)和86% (12/14)。

12周治疗组中有一名患者因为与治疗无关的死亡,而没能进行治疗后随访。无论是12周还是16周治疗组,分别有2名患者病情复发,无病毒学突破。研究期间最常见的不良事件(AEs)为失眠、疲劳、头痛。但是没有因为AEs而停药、也没有发生与治疗相关的严重AEs。

研究结果表明,HCV基因型3感染的晚期肝脏疾病,无论先前有没有接受到HCV的治疗,使用DCV-SOF-RBV治疗12周或16周后,有相似的高SVR12。

原始出处:

Leroy V, Angus P,et al.Daclatasvir, Sofosbuvir, and Ribavirin for Hepatitis C Virus Genotype 3 and Advanced Liver Disease: A Randomized Phase III Study (ALLY-3+).Hepatology. 2016 Jan 28. doi: 10.1002/hep.28473. [Epub ahead of print]

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    2016-03-09 ymljack
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    2016-03-09 膀胱癌
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    2016-03-09 gwc384

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