Hepatology:Glecaprevir/Pibrentasvir治疗先前直接抗病毒治疗失败的HCV基因1型或4型患者

2017-11-25 MedSci MedSci原创

先前使用NS5A抑制剂或NS3蛋白酶抑制剂治疗失败的HCV基因1型患者,16周的G/P治疗可获得较高的可持续病毒学应答。

研究背景:丙型肝炎病毒(HCV)患者接受含有NS5A抑制剂治疗,治疗失败后,再治疗选择有限。

研究方法:MAGELLAN-1 Part 2是一项随机、开放的3期研究,本研究的目的是评价glecaprevir和pibrentasvir(无利巴韦林治疗)治疗的有效性和安全性。纳入研究的患者是先前至少使用一种NS3/4A蛋白酶或NS5A抑制剂治疗失败的HCV患者。HCV患者肝脏功能处于代偿状态,存在或者不存在肝硬化。HCV基因1,4,5,6型患者随机以1:1的比例接受12周或者16周的glecaprevir和pibrentasvir(G/P)治疗。主要终点是治疗后12周的可持续病毒学反应(SVR12)。

研究结果:在91例患者中,87例为HCV基因1型患者,4例为HCV基因4型患者。接受12周G/P治疗的患者,SVR12为89% (39/44);接受16周G/P治疗的患者,SVR12为91% (43/47)。接受12周G/P治疗的患者中,9% (4/44)的患者发生病毒学复发;然而,接受12周G/P治疗的患者中,没有患者发生病毒学突破。之前采用一类抑制剂(蛋白酶或NS5A)治疗对SVR12没有影响,然而之前采用两类抑制剂治疗与低SVR12速率有关。最常见的不良事件是头痛(≥10%的患者),并没有严重的不良事件(AEs)。

研究结论:先前使用NS5A抑制剂或NS3蛋白酶抑制剂治疗失败的HCV基因1型患者,16周的G/P治疗可获得较高的可持续病毒学应答。

原始出处:

Poordad F, Pol S, Asatryan A, et al. Glecaprevir/Pibrentasvir in Patients with HCV Genotype 1 or 4 and Prior Direct-acting Antiviral Treatment Failure. Hepatology, 2017, Nov 20. doi: 10.1002/hep.29671.

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    2018-07-05 smlt2008
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    2017-11-27 ymljack
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    2017-11-27 yahu
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    2017-11-27 gwc384

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