Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI

<b>Background:</b> HIV-1-infected, virologically suppressed adults wanting to simplify or change their non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens may benefit from switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF). <b>Objective:</b> We examined differences in the proportion of participants with HIV-1 RNA <b>Methods:</b> STRATEGY-NNRTI was a 96-week, phase 3b, randomized, open-label, study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF in virologically suppressed individuals (HIV-1 RNA <b>Results:</b> At Week 96, 87% (251/290) of switch and 80% (115/143) of no-switch participants maintained HIV-1 RNA p = 0.12) according to the FDA-defined snapshot algorithm. Both groups had similar proportions of subjects with virologic failure (2.8% switch, 1.4% no-switch). Discontinuations resulting from adverse events were infrequent (3% [9/291] switch, 2% [3/143] no-switch). Three switch participants (1%) discontinued due to renal adverse events (2 of the 3 before Week 48). Switch participants reported significant improvements in neuropsychiatric symptoms by as early as Week 4, and which were maintained through Week 96. <b>Conclusions:</b> E/C/F/TDF is safe and effective and reduces NNRTI-associated neuropsychiatric symptoms for virologically suppressed HIV-positive adults switching from an NNRTI plus FTC/TDF-based regimen.

<b>背景：</b> 感染人类免疫缺陷病毒1型（HIV-1）且已实现病毒学抑制的成人患者，若希望简化或调整基于非核苷类逆转录酶抑制剂（non-nucleoside reverse transcriptase inhibitor, NNRTI）的治疗方案，可考虑切换至单片复方制剂埃替格韦（elvitegravir）、考比司他（cobicistat）、恩曲他滨（emtricitabine）与富马酸替诺福韦二吡呋酯（tenofovir disoproxil fumarate，简称E/C/F/TDF）。<b>研究目的：</b> 本研究旨在探讨两组受试者中HIV-1 RNA维持抑制状态的比例差异。<b>研究方法：</b> STRATEGY-NNRTI是一项为期96周的3b期随机开放标签临床试验，旨在评估病毒学抑制的HIV-1感染者（HIV-1 RNA低于检测下限）切换至E/C/F/TDF方案的有效性、安全性与耐受性。<b>研究结果：</b> 第96周时，切换治疗组与未切换治疗组分别有87%（251/290）与80%（115/143）的受试者维持HIV-1 RNA水平符合美国食品药品监督管理局（FDA）定义的快照算法标准，组间差异无统计学意义（p=0.12）。两组的病毒学失败受试者比例相近（切换组2.8%，未切换组1.4%）。因不良事件终止治疗的情况较为少见（切换组3%[9/291]，未切换组2%[3/143]）。共有3名切换组受试者（1%）因肾脏不良事件终止治疗，其中2例发生于第48周前。切换组受试者早在第4周即报告神经精神症状出现显著改善，且该改善持续至第96周。<b>研究结论：</b> 对于从基于非核苷类逆转录酶抑制剂联合恩曲他滨/富马酸替诺福韦二吡呋酯方案切换治疗的病毒学抑制HIV-1阳性成人患者而言，E/C/F/TDF方案安全有效，且可减轻与非核苷类逆转录酶抑制剂相关的神经精神症状。