EASL 2014：SOF/LDV固定剂量组合对难治性丙肝患者安全有效

2014-04-16 佚名 DXY

丙肝患者现有的治疗方案主要为口服直接抗病毒药（DAA）组合，但仍有部分患者由于肝病晚期、感染HCV基因3型或之前DAA方案治疗失败等原因而成为难治性肝病患者。新西兰奥克兰临床研究中心Gane等对上述人群进行了一项临床研究，旨在探讨 sofosbuvir/ledipasvir（SOF/LDV）固定剂量组合方案对这部分难治性人群的疗效和安全性。该研究将50例HCV基因3型的初治患者随机、均等地分配

丙肝患者现有的治疗方案主要为口服直接抗病毒药（DAA）组合，但仍有部分患者由于肝病晚期、感染HCV基因3型或之前DAA方案治疗失败等原因而成为难治性肝病患者。

新西兰奥克兰临床研究中心Gane等对上述人群进行了一项临床研究，旨在探讨

sofosbuvir/ledipasvir（SOF/LDV）固定剂量组合方案对这部分难治性人群的疗效和安全性。
该研究将50例HCV基因3型的初治患者随机、均等地分配到两个治疗组，分别接受SOF/LDV+RBV和SOF/LDV治疗，疗程为12周；20例HCV基因1型且Child-Turcotte-Pugh（CPT）分级B级的患者接受SOF/LDV治疗12周；19例HCV基因1型患者接受SOF/LDV+RBV治疗12周。

研究共纳入90例患者进行SOF/LDV±RBV方案治疗，患者耐受良好，除了2例患者中断治疗外（1名因治疗不相关的不良反应退出、另一名因依从性差退出），其余患者均按计划完成治疗。

CPT B级肝硬化患者与代偿性肝硬化患者具有相似的不良反应谱；SOF/LDV+RBV治疗与RBV治疗安全性相一致，但前者不良事件和实验室检查异常更多见些。

该研究表明，SOF/LDV±RBV方案治疗对晚期肝病和那些既往SOF治疗失败的患者安全有效，在HCV基因3型患者中，SOF/LDV方案中添加RBV可增加获得SVR率，获得SVR12的最终数据随后公布。

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2014-07-04 医者仁心

#患者安全#

71 0
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2014-04-18 kord1983

#EASL#

66 0
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2014-04-18 lq1771

#ASL#

57 0
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2014-04-18 一叶知秋

#难治性#

58 0

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