将低HIV-1 RNA转换为固定剂量组合：在一线受抑制的HIV感染者中，TDF/FTC/RPV不劣于TDF/FTC/EFV。

Southern African journal of HIV medicine Pub Date : 2019-07-23 eCollection Date: 2019-01-01 DOI:10.4102/sajhivmed.v20i1.949

Paula Munderi, Edwin Were, Anchalee Avihingsanon, Pascale A M Mbida, Lerato Mohapi, Samba B Moussa, Marjolein Jansen, Ceyhun Bicer, Perry Mohammed, Yvon van Delft

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引用次数: 3

摘要

背景：在低收入和中等收入国家（LMIC），对负担得起的单片方案（STR）的需求仍未得到满足。利匹韦林（RPV，TMC278）与富马酸替诺福韦二普罗西（TDF）和恩曲他滨（FTC）在低成本STR中配制。目的：将低HIV-1 RNA转换为固定剂量组合（SALIF），将RPV与依非韦伦（EFV）作为与TDF和FTC的STR，以维持病毒学抑制。方法：SALIF是一项3b期、随机、开放标签、非劣效性研究，在喀麦隆、肯尼亚、塞内加尔、南非、乌干达和泰国对受病毒抑制的成年人（HIV-1 RNA<50拷贝/mL）进行基于非核苷逆转录酶抑制剂（NNRTI）的一线抗逆转录病毒疗法（ART）。根据NNRTI的使用对患者（N=426）进行分层，以1:1的比例随机接受TDF/FTC/RPV（300/200/25 mg qd）或TDF/FTC/CFV（300/200/600 mg qd。主要终点是病毒抑制患者的比例（HIV-1 RNA结果：患者接受TDF/FTC/RPV（n=213）或TDF/FTC/EFV（n=211）。在第48周，RPV组的200/213名（93.9%）患者和EFV组的203/211名（96.2%）患者的病毒学抑制得以维持（差异-2.3%；95%置信区间：-6.4，+1.8），表明TDF/FTC/RPV的非劣效性。每只手臂中有一名患者出现病毒学失败，没有出现治疗突发耐药性。27名患者过早停药（8.0%RPV vs.4.7%EFV），最常见的原因是不良事件（分别为3.3%vs.0.5%）、部位闭合（1.9%vs.0.5%），失访（0.9%vs.1.4%）和同意退出（0.9%vs.1.4%），在保持具有可比耐受性的高病毒抑制率方面，转换为TDF/FTC/RPV的STR并不劣于TDF/FTC/CFV。

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Switching at Low HIV-1 RNA into Fixed Dose Combinations: TDF/FTC/RPV is non-inferior to TDF/FTC/EFV in first-line suppressed patients living with HIV.

Background: In low- and middle-income countries (LMICs), a substantial unmet need for affordable single-tablet regimen (STR) options remains. Rilpivirine (RPV, TMC278) is formulated in a low-cost STR with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC).

Objectives: Switching at Low HIV-1 RNA into Fixed Dose Combinations (SALIF) compared RPV with efavirenz (EFV), both as STRs with TDF and FTC, in maintaining virologic suppression.

Methods: SALIF was a phase 3b, randomised, open-label, non-inferiority study in virologically suppressed adults (HIV-1 RNA < 50 copies/mL) on non-nucleoside reverse transcriptase inhibitor (NNRTI)-based first-line antiretroviral therapy (ART) in Cameroon, Kenya, Senegal, South Africa, Uganda and Thailand. Patients (N = 426), stratified by NNRTI use, were randomised 1:1 to receive TDF/FTC/RPV (300/200/25 mg qd) or TDF/FTC/EFV (300/200/600 mg qd). Primary endpoint was proportion of patients with virologic suppression (HIV-1 RNA < 400 copies/mL) at week 48 (intent-to-treat, modified Food and Drug Administration Snapshot, 10% non-inferiority margin).

Results: Patients received TDF/FTC/RPV (n = 213) or TDF/FTC/EFV (n = 211). At week 48, virologic suppression was maintained in 200/213 (93.9%) patients in the RPV arm and 203/211 (96.2%) in the EFV arm (difference -2.3%; 95% confidence interval: -6.4, +1.8), demonstrating non-inferiority of TDF/FTC/RPV. One patient in each arm experienced virologic failure without treatment-emergent resistance. Twenty-seven patients discontinued prematurely (8.0% RPV vs. 4.7% EFV), the most frequent reasons being adverse events (3.3% vs. 0.5%, respectively), site closure (1.9% vs. 0.5%), loss to follow-up (0.9% vs. 1.4%) and consent withdrawal (0.9% vs. 1.4%).

Conclusion: In adults with suppressed viral load on first-line NNRTI-based ART in LMICs, switching to an STR of TDF/FTC/RPV was non-inferior to TDF/FTC/EFV in maintaining high rates of viral suppression with a comparable tolerability profile.

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