EASL 2014:FDV+DBV+ PPI-668的三联疗法可获得较高SVR率

2014-05-13 佚名 dxy

Faldaprevir(FDV)为NS3/4A抑制剂,deleobuvir(DBV)为NS5B抑制剂,PPI-668为NS5A抑制剂。来自美国加州的研究人员使用上述药物对HCV1a型初治患者进行了为期12周的临床2期试验。该研究结果公布于2014年4月11日在伦敦举行的EASL2014会上。 该研究共纳入了36例患者。其中24例被随机分配到队列1或2中(FDV120mg QD,PPI-668 20

Faldaprevir(FDV)为NS3/4A抑制剂,deleobuvir(DBV)为NS5B抑制剂,PPI-668为NS5A抑制剂。来自美国加州的研究人员使用上述药物对HCV1a型初治患者进行了为期12周的临床2期试验。该研究结果公布于2014年4月11日在伦敦举行的EASL2014会上。

该研究共纳入了36例患者。其中24例被随机分配到队列1或2中(FDV120mg QD,PPI-668 200 mg QD,DBV 600mg或400mg BD ,加利巴韦林)。另外12名患者进入无利巴韦林队列。

基线时,患者的HCVRNA > 5 log10,64%患者为IL28B CT/TT。目前为止,28/36例患者完成了12周的治疗。27/28 (96%)例患者在治疗结束时的HCV RNA水平低于检测下限(< LLOD )。19/20(95%)例患者治疗结束已经随访4周的患者实现了SVR4(1例复发),其中12/12 (100%)例已经实现SVR 8。

3例患者出现病毒学突破。1例患者检测到了NS5A上的耐药相关性突变(Q30L+ Y93H)和NS5B上的耐药相关性突变A421V。1例患者体内的血药浓度较低(原因不明)。

已经有2例患者停药:1例在第9周出现持续性的不良事件(治疗7周后,已经检测不到HCV RNA),1例肝硬化患者出现失代偿。与以前的FDV/DBV试验一样,患者发生皮疹和胃肠道事件。无RBV的队列不良事件较少。

研究结果表明,FDV+DBV+ PPI-668的三重口服药物组合(加或不加利巴韦林)均可获得较高病毒学应答率。

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    2014-06-14 仁医06
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    2014-05-15 kord1983
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    2014-05-15 w363522450
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    2014-05-15 lq1771
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