Due to the low number of individuals with HIV-2, no randomised trials of HIV-2 treatment have ever been done. We hypothesised that a non-comparative study describing the outcomes of several antiretroviral therapy (ART) regimens in parallel groups would improve understanding of how differences between HIV-1 and HIV-2 might lead to different therapeutic approaches. This pilot, phase 2, non-comparative, open-label, randomised controlled trial was done in Burkina Faso, Côte d'Ivoire, Senegal, and Togo. Adults with HIV-2 who were ART naive with CD4 counts of 200 cells per μL or greater were randomly assigned 1:1:1 to one of three treatment groups. A computer-generated sequentially numbered block randomisation list stratified by country was used for online allocation to the next available treatment group. In all groups, tenofovir disoproxil fumarate (henceforth tenofovir) was dosed at 245 mg once daily with either emtricitabine at 200 mg once daily or lamivudine at 300 mg once daily. The triple nucleoside reverse transcriptase inhibitor (NRTI) group received zidovudine at 250 mg twice daily. The ritonavir-boosted lopinavir group received lopinavir at 400 mg twice daily boosted with ritonavir at 100 mg twice daily. The raltegravir group received raltegravir at 400 mg twice daily. The primary outcome was the rate of treatment success at week 96, defined as an absence of serious morbidity event during follow-up, plasma HIV-2 RNA less than 50 copies per mL at week 96, and a substantial increase in CD4 cells between baseline and week 96. This trial is registered at , , and is closed to new participants. Between Jan 26, 2016, and June 29, 2017, 210 participants were randomly assigned to treatment groups. Five participants died during the 96 weeks of follow-up (triple NRTI group, n=2; ritonavir-boosted lopinavir group, n=2; and raltegravir group, n=1), eight had a serious morbidity event (triple NRTI group, n=4; ritonavir-boosted lopinavir group, n=3; and raltegravir group, n=1), 17 had plasma HIV-2 RNA of 50 copies per mL or greater at least once (triple NRTI group, n=11; ritonavir-boosted lopinavir group, n=4; and raltegravir group, n=2), 32 (all in the triple NRTI group) switched to another ART regimen, and 18 permanently discontinued ART (triple NRTI group, n=5; ritonavir-boosted lopinavir group, n=7; and raltegravir group, n=6). The Data Safety Monitoring Board recommended premature termination of the triple NRTI regimen for safety reasons. The overall treatment success rate was 57% (95% CI 47–66) in the ritonavir-boosted lopinavir group and 59% (49–68) in the raltegravir group. The raltegravir and ritonavir-boosted lopinavir regimens were efficient and safe in adults with HIV-2. Both regimens could be compared in future phase 3 trials. The results of this pilot study suggest a trend towards better virological and immunological efficacy in the raltegravir-based regimen. ANRS MIE.

中文翻译：

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三种抗逆转录病毒治疗方案对未经治疗的非洲 HIV-2 成年人 (FIT-2) 的疗效和安全性：一项试点、2 期、非比较、开放标签、随机对照试验


由于感染 HIV-2 的人数较少，因此尚未进行过 HIV-2 治疗的随机试验。我们假设，一项描述平行组中几种抗逆转录病毒治疗 (ART) 方案结果的非比较研究将增进对 HIV-1 和 HIV-2 之间的差异如何导致不同治疗方法的理解。这项试点、2 期、非比较、开放标签、随机对照试验在布基纳法索、科特迪瓦、塞内加尔和多哥进行。未接受 ART 且 CD4 计数为 200 个细胞/μL 或更高的 HIV-2 成人按 1:1:1 随机分配到三个治疗组之一。计算机生成的按国家分层的连续编号的区块随机化列表用于在线分配到下一个可用的治疗组。在所有组中，富马酸替诺福韦二吡呋酯（以下称为替诺福韦）每日一次 245 毫克，联合恩曲他滨 200 毫克每日一次或拉米夫定 300 毫克每日一次。三核苷逆转录酶抑制剂 (NRTI) 组接受齐多夫定 250 mg，每日两次。利托那韦强化洛匹那韦组接受洛匹那韦 400 mg 每日两次，并加用利托那韦 100 mg 每日两次强化治疗。拉替拉韦组接受拉替拉韦 400 mg，每日两次。主要结局是第 96 周时的治疗成功率，定义为在随访期间没有出现严重发病事件、第 96 周时血浆 HIV-2 RNA 低于 50 拷贝/mL、以及 CD4 细胞与基线相比大幅增加和第 96 周。该试验在 、 、 注册，并且不对新参与者开放。 2016年1月26日至2017年6月29日期间，210名参与者被随机分配到治疗组。 5 名参与者在 96 周的随访期间死亡（三重 NRTI 组，n=2；利托那韦增强洛匹那韦组，n=2；拉替拉韦组，n=1），八名参与者出现严重发病事件（三重 NRTI 组，n=1）。 n = 4；利托那韦增强洛匹那韦组，n = 3；拉替拉韦组，n = 1），17 名血浆 HIV-2 RNA 至少一次达到 50 拷贝/mL（三重 NRTI 组，n = 11；利托那韦） -洛匹那韦加强组，n=4；拉替拉韦组，n=2），32 名（全部在三联 NRTI 组）转为另一种 ART 方案，18 名永久停止 ART（三联 NRTI 组，n=5；利托那韦加强组）洛匹那韦组，n=7；拉替拉韦组，n=6)。出于安全原因，数据安全监测委员会建议提前终止三重 NRTI 治疗方案。利托那韦强化洛匹那韦组的总体治疗成功率为 57% (95% CI 47-66)，拉替拉韦组为 59% (49-68)。拉替拉韦和利托那韦强化洛匹那韦治疗方案对于 HIV-2 成人患者有效且安全。两种方案都可以在未来的 3 期试验中进行比较。这项初步研究的结果表明，以拉替拉韦为基础的治疗方案有更好的病毒学和免疫学疗效的趋势。安尔斯米。