一项随机、双盲比较 coformulated elvitegravir/cobicistat/恩曲他滨/替诺福韦酯 DF 与ritonavir-boosted 阿扎那韦加 coformulated 恩曲他滨和替诺福韦酯 DF 用于初始治疗 HIV-1 感染的疗效：第 96 周结果分析。
A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results.
机构信息
Department of Medicine I, University of Bonn, Bonn, Germany.
出版信息
J Acquir Immune Defic Syndr. 2013 Apr 15;62(5):483-6. doi: 10.1097/QAI.0b013e318286415c.
This ongoing, randomized, double-blind, active-controlled phase 3 international trial demonstrated the noninferior efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF) compared with atazanavir boosted by ritonavir (ATV/RTV) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) at 48 weeks. Here, we report the week 96 results. Of 708 treated subjects, virological success (Food and Drug Administration snapshot) was maintained at week 96 with EVG/COBI/FTC/TDF and ATV/RTV + FTC/TDF (83% vs 82%, difference 1.1%, 95% confidence interval -4.5% to 6.7%). Study drug discontinuations due to adverse events were low (4% vs 6%). Median increases from baseline in serum Cr (mg/dL) in EVG/COBI/FTC/TDF vs ATV/RTV + FTC/TDF at week 96 (0.12 vs 0.08) were similar to those at week 48 (0.12 vs 0.08). EVG/COBI/FTC/TDF showed similar mean decreases (%) in bone mineral density from baseline vs ATV/RTV + FTC/TDF (hip: -3.16 vs -4.19, P = 0.069; spine: -1.96 vs -3.54, P = 0.049). Overall, week 96 results support durable efficacy and safety of EVG/COBI/FTC/TDF in HIV-1-infected patients.
这项正在进行的、随机的、双盲、阳性对照的 3 期国际试验表明，与阿扎那韦（ATV）联合利托那韦（RTV）增效后加恩曲他滨（FTC）/替诺福韦二吡呋酯（TDF）相比，艾维雷格（elvitegravir）/考比司他（cobicistat）/恩曲他滨（FTC）/替诺福韦艾拉酚胺（TDF）在第 48 周时具有非劣效性。在此，我们报告第 96 周的结果。在 708 例接受治疗的受试者中，第 96 周时，EVG/COBI/FTC/TDF 和 ATV/RTV + FTC/TDF 均维持病毒学成功（FDA 快照）（83%比 82%，差异 1.1%，95%置信区间-4.5%至 6.7%）。因不良事件而停止研究药物的比例较低（4%比 6%）。第 96 周时，与 ATV/RTV + FTC/TDF 相比，EVG/COBI/FTC/TDF 导致血清肌酐（Cr）（mg/dL）从基线的中位数升高（0.12 比 0.08），与第 48 周相似（0.12 比 0.08）。EVG/COBI/FTC/TDF 与 ATV/RTV + FTC/TDF 相比，骨矿物质密度（BMD）从基线的平均降低（%）相似（髋部：-3.16 比-4.19，P=0.069；脊柱：-1.96 比-3.54，P=0.049）。总体而言，第 96 周的结果支持 HIV-1 感染患者中 EVG/COBI/FTC/TDF 的持久疗效和安全性。
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