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使用完全活性依曲韦林的病毒学应答:DUET - 1和DUET - 2试验的汇总结果。

Virological response with fully active etravirine: pooled results from the DUET-1 and DUET-2 trials.

作者信息

Clumeck N, Cahn P, Molina J-M, Mills A, Nijs S, Vingerhoets J, Witek J

机构信息

Division of Infectious Diseases, Saint-Pierre University Hospital, Brussels, Belgium.

出版信息

Int J STD AIDS. 2010 Nov;21(11):738-40. doi: 10.1258/ijsa.2010.010139.

Abstract

The objective of this subanalysis of the Phase III DUET trials was to examine virological response to an etravirine-containing regimen in patients harbouring virus fully sensitive to etravirine. Full etravirine sensitivity was defined as fold change in 50% effective concentration (FC) ≤3 or weighted genotypic score ≤2. At Week 48 in the etravirine group, 74% of patients with etravirine FC ≤3 and 77% with etravirine genotypic score ≤2 had viral load <50 HIV-1 RNA copies/mL, versus 48% and 46%, respectively, in the placebo group (P < 0.0001). Response rates increased with baseline phenotypic sensitivity score, but were consistently higher with etravirine (56-82%) than placebo (2-72%). Similar observations were made in patients harbouring virus with full etravirine and darunavir sensitivity. Our findings support current recommendations to include three active agents in treatment-experienced patients' regimens.

摘要

这项III期DUET试验的亚分析目的是,在对依曲韦林完全敏感的病毒携带者患者中,检测含依曲韦林方案的病毒学反应。依曲韦林完全敏感性定义为50%有效浓度(FC)的变化倍数≤3或加权基因型评分≤2。在依曲韦林组第48周时,依曲韦林FC≤3的患者中有74%、依曲韦林基因型评分≤2的患者中有77%的病毒载量<50 HIV-1 RNA拷贝/mL,而安慰剂组分别为48%和46%(P<0.0001)。反应率随基线表型敏感性评分增加,且依曲韦林组(56-82%)始终高于安慰剂组(2-72%)。在对依曲韦林和达芦那韦均完全敏感的病毒携带者患者中也有类似观察结果。我们的研究结果支持目前关于在有治疗经验患者的治疗方案中纳入三种活性药物的建议。

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