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NEJM:Sofosbuvir和Velpatasvir治疗HCV感染有较高的病毒学应答率

2015-11-17 崔倩 译 MedSci原创

在有效的范围内广泛使用一个简单的治疗方案治疗慢性感染丙型肝炎病毒的患者(HCV)仍然是一个未满足的医疗需求。

在有效的范围内广泛使用一个简单的治疗方案治疗慢性感染丙型肝炎病毒的患者(HCV)仍然是一个未满足的医疗需求。

研究人员进行了一项3期,双盲,安慰剂对照研究,涉及未经治疗的和以前治疗过的慢性HCV基因型1、2、4、5或6型感染,包括那些代偿性肝硬化患者。HCV基因型1、2、4或6患者被随机分配以5:1的比例接受核苷酸聚合酶抑制剂索非布韦和NS5A抑制剂velpatasvir,每日一次,固定剂量组合的片剂的或匹配的安慰剂服用12周。因为在研究范围内基因型5的患病率较低,所以基因型5的a患者没有进行随机化,但被分配到索非布韦-velpatasvir组。主要终点是在12周的治疗结束后的持续病毒学应答。

在接受索非布韦-velpatasvir治疗的624名患者中,34%的患者为HCV基因型1a,19%为基因型1b,17%为基因型2,19%为基因型4,6%为基因型5,7%为基因型6。8%的患者是黑人,19%有肝硬化,32%以前接受过HCV的治疗。在接受索非布韦-velpatasvir的患者中持续病毒学应答率为99%(95%置信区间,98〜>99)。接受索非布韦-velpatasvir的两名都为HCV基因型1的患者,有病毒学复发。接受安慰剂治疗的116例患者都没有持续病毒学应答。严重不良事件的报告,在索非布韦-velpatasvir组中有15例(2%),安慰剂组没有。

感染HCV基因型1、2、4、5或6的患者无论在感染之前是否经过治疗,包括那些代偿性肝硬化的患者,每日接受一次索非布韦-velpatasvir治疗,都有较高的持续的病毒学应答率。

原始出处:

Jordan J. Feld,Ira M. Jacobson,Christophe Hézode,et al.Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection,NEJM,2015.11.16

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    2015-11-18 ymljack
  5. 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    2015-11-18 bbjsj_1981
  6. 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  7. 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    2015-11-18 周虎
  9. 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