ASST Fatebenefratelli-Sacco, Milan, Italy.
School of Clinical Medicine, Faculty of Health Science University of the Witwatersrand, Johannesburg, South Africa.
AIDS. 2019 Aug 1;33(10):1583-1593. doi: 10.1097/QAD.0000000000002244.
To evaluate the efficacy and safety of switching from an abacavir/lamivudine (ABC/3TC)-based regimen to an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen in virologically suppressed, HIV-1-infected adults.
Randomized, open-label, noninferiority study.
Participants with HIV-1 RNA levels less than 50 copies/ml receiving ABC/3TC plus a third agent for at least 6 months were randomized 2 : 1 to switch immediately to E/C/F/TAF (immediate-switch group) for 48 weeks or to continue receiving ABC/3TC plus a third agent for 24 weeks followed by E/C/F/TAF for 24 weeks (delayed-switch group). The primary endpoint was HIV-1 RNA less than 50 copies/ml at Week 24 by Food and Drug Administration Snapshot algorithm (-12% noninferiority margin).
Baseline characteristics of 274 participants (183 in immediate-switch group and 91 in delayed-switch group) were similar. Virologic response was maintained at Week 24 by 93.4 and 97.8% of participants in the immediate-switch and delayed-switch groups, respectively, with a treatment difference of -4.4% (95% confidence interval: -9.4 to 1.9%), confirming noninferiority. Adverse events of any grade were similar between groups through Week 24 (66% E/C/F/TAF, 64% ABC/3TC); adverse event-related drug discontinuations occurred in 4% of participants switching to E/C/F/TAF (no discontinuations because of renal events) and no participants continuing ABC/3TC. Renal biomarkers of urine albumin:creatinine and beta-2-microglobulin:creatinine ratios significantly improved on E/C/F/TAF. Self-reported treatment satisfaction was significantly higher with E/C/F/TAF.
Switching to E/C/F/TAF was noninferior to continuing ABC/3TC plus a third agent for maintenance of HIV RNA suppression at Week 24. This study supports E/C/F/TAF as an efficacious and well tolerated option for participants switching from ABC/3TC-based regimens.
评估在病毒学抑制的 HIV-1 感染成年人中，从阿巴卡韦/拉米夫定（ABC/3TC）为基础的方案转换为艾维雷格韦/考比司他/恩曲他滨/替诺福韦艾拉酚胺（E/C/F/TAF）单片复方制剂的疗效和安全性。
随机、开放标签、非劣效性研究。
接受 ABC/3TC 加第三种药物至少 6 个月且 HIV-1 RNA 水平低于 50 拷贝/ml 的参与者，以 2：1 的比例随机分为立即转换为 E/C/F/TAF（立即转换组），共 48 周，或继续接受 ABC/3TC 加第三种药物 24 周，然后转换为 E/C/F/TAF 24 周（延迟转换组）。主要终点是根据食品和药物管理局（FDA）Snapshot 算法，在第 24 周 HIV-1 RNA 低于 50 拷贝/ml（-12%非劣效性边界）。
274 名参与者（立即转换组 183 名，延迟转换组 91 名）的基线特征相似。在第 24 周，立即转换组和延迟转换组分别有 93.4%和 97.8%的参与者保持病毒学应答，治疗差异为-4.4%（95%置信区间：-9.4 至 1.9%），证实了非劣效性。在第 24 周时，两组之间任何级别的不良事件相似（E/C/F/TAF 组为 66%，ABC/3TC 组为 64%）；转换为 E/C/F/TAF 的参与者中有 4%因不良事件停药（没有因肾脏事件停药），而继续使用 ABC/3TC 的参与者没有。尿液白蛋白：肌酐和β-2-微球蛋白：肌酐比值的肾脏生物标志物在服用 E/C/F/TAF 后显著改善。E/C/F/TAF 的自我报告治疗满意度显著高于 ABC/3TC。
在第 24 周时，转换为 E/C/F/TAF 与继续使用 ABC/3TC 加第三种药物维持 HIV RNA 抑制相比非劣效。这项研究支持 E/C/F/TAF 作为一种有效的、耐受性良好的方案，用于从 ABC/3TC 为基础的方案转换的参与者。
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