Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1:48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial
Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1:48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial
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DOI：
10.1016/s2352-3018(18)30091-2
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发表时间：
2018-07-01
期刊：
影响因子：
16.1
通讯作者：
Quirk, Erin
中科院分区：
文献类型：
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作者：
Daar, Eric S.;Dejesus, Edwin;Quirk, Erin
从基于增强蛋白酶抑制剂的治疗转换为bictegravir，恩曲他滨和替诺福韦艾拉酚胺可以避免病毒学抑制的HIV-1感染成人的药物相互作用和不必要的副作用，同时保持耐药性的高屏障，并提供简化的每日一次，单片剂方案。在这里，我们报告48周的3期研究调查此switch.Methods的结果，在这个多中心，随机，开放标签，活性对照，非劣效性，3期试验，成人HIV-1感染者在121个门诊中心在10个国家。符合条件的参与者年龄为18岁或以上，估计肾小球滤过率为50 mL/min或更高，病毒学抑制（血浆HIV-1 RNA
Background Switching from therapy based on a boosted protease inhibitor to bictegravir, emtricitabine, and tenofovir alafenamide could avoid drug interactions and unwanted side-effects in virologically suppressed adults with HIV-1 infection, while maintaining a high barrier to resistance and providing a simplified once-daily, single-tablet regimen. Here, we report 48 week results of a phase 3 study investigating this switch.Methods In this multicentre, randomised, open-label, active-controlled, non-inferiority, phase 3 trial, adults with HIV-1 infection were enrolled at 121 outpatient centres in ten countries. Eligible participants were aged 18 years or older, had an estimated glomerular filtration rate of 50 mL per min or higher, had been virologically suppressed (plasma HIV-1 RNA