Lancet:度鲁特韦联合拉米夫定可作为HIV感染者的首先治疗方案

2018-11-10 MedSci MedSci原创

有效的两药方案可减少HIV-1抗逆转录病毒疗法(ART)的长期药物暴露和毒性。现研究人员对两药方案和三药方案治疗HIV-1感染的安全性和疗效进行对比研究。研究人员在21个国家的192个中心进行了两项相同设计的、多中心的、双盲随机非劣效性的3期试验:GEMINI-1和GEMINI-2。招募年满18岁的未进行过ART治疗的HIV-1感染者(HIV-1 RNA≤500 000拷贝/ml)。将受试者按1:

有效的两药方案可减少HIV-1抗逆转录病毒疗法(ART)的长期药物暴露和毒性。现研究人员对两药方案和三药方案治疗HIV-1感染的安全性和疗效进行对比研究。

研究人员在21个国家的192个中心进行了两项相同设计的、多中心的、双盲随机非劣效性的3期试验:GEMINI-1和GEMINI-2。招募年满18岁的未进行过ART治疗的HIV-1感染者(HIV-1 RNA≤500 000拷贝/ml)。将受试者按1:1随机分至两药组(度鲁特韦50mg+拉米夫定300mg,1/日)或三药组(度鲁特韦50mg+延胡索酸300mg+恩曲他滨200mg,1/日),均口服。主要结点是48周时,HIV-1 RNA少于50拷贝/ml的受试者比例。

2016年7月18日-2017年3月31日,两个研究共1441位受试者被随机分至两药组(719位)或三药组(722位)。GEMINI-1试验48周时,接受两药治疗的356位受试者中有320位(90%)、接受三药治疗的358位受试者中有332位(93%)的血浆HIV-1 RNA<50拷贝/ml(校正治疗差异 -2.6%,95% CI -6.7~1.5);在GEMINI-2试验中,两药组360位受试者中有335位(93%)、三药组359位中有337位(94%)的血浆HIV-1 RNA<50拷贝/ml(校正治疗差异 -0.7%,95% CI -4.3~2.9),在两个研究中显示为非劣效性(混总分析:两药组 vs 三药组=655[91%]vs 669[93%];校正治疗差 -1.7%,95% CI -4.4~1.1)。三药组药物相关副反应事件要多于两药组(169[24%] vs 126[18%]);部分受试者因副反应而终止治疗(三药组16例[2%]、两药组15例[2%])。GEMINI-2试验的两药组出现2例死亡,但均与研究用药无关。

相比指南推荐的三药方案,度鲁特韦联合拉米夫定治疗未进行过ART治疗的成人HIV感染者48周时的非劣效性和相似的耐受性,支持其作为HIV-1感染者的初始治疗方案。


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    2019-12-21 794264462

    评论好几次了

    0

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    2019-12-21 794264462

    写的非常细心,学到很多东西

    0

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    2019-12-21 794264462

    讲的特别好,很认真

    0

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    2019-12-21 794264462

    善于总结知识点

    0

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    2019-12-21 794264462

    学习的时候注意做笔记

    0

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    2019-12-21 794264462

    学习了,收货非常大,认真学习

    0

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    2019-05-29 howi
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