Background There is an urgent need for safe and effective antiretroviral therapy (ART) for human immunodeficiency virus type 2 (HIV-2) infection. We undertook the first clinical trial of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) to assess its effectiveness in HIV-2-infected individuals in Senegal, West Africa. Methods HIV-2-infected, ART-naive adults with World Health Organization stage 3-4 disease or CD4 count <750 cells/μL were eligible for this 48-week, open-label trial. We analyzed HIV-2 viral loads (VL), CD4 counts, clinical and adverse events, mortality, and loss to follow-up. Results We enrolled 30 subjects who initiated E/C/F/TDF. Twenty-nine subjects completed 48 weeks of follow-up. The majority were female (80%). There were no deaths, no new AIDS-associated clinical events, and 1 loss to follow-up. The median baseline CD4 count was 408 (range, 34-747) cells/μL, which increased by a median 161 (range, 27-547) cells/μL at week 48. Twenty-five subjects had baseline HIV-2 VL of <50 copies/mL of plasma. In those with detectable HIV-2 VL, the median was 41 (range, 10-6135) copies/mL. Using a modified intent-to-treat analysis (US Food and Drug Administration Snapshot method), 28 of 30 (93.3%; 95% confidence interval, 77.9%-99.2%) had viral suppression at 48 weeks. The 1 subject with virologic failure had multidrug-resistant HIV-2 (reverse transcriptase mutation: K65R; integrase mutations: G140S and Q148R) detected at week 48. There were 8 grade 3-4 adverse events; none were deemed study related. Adherence and acceptability were good. Conclusions Our data suggest that E/C/F/TDF, a once-daily, single-tablet-regimen, is safe, effective, and well tolerated. Our findings support the use of integrase inhibitor-based regimens for HIV-2 treatment. Clinical Trials Registration NCT02180438.

中文翻译：

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Elvitegravir，Cobicistat，Emtricitabine和Tenofovir Disoproxil Fumarate的单片治疗方案在资源有限的环境中用于人类免疫缺陷病毒2型感染的初始治疗的试验：西非塞内加尔48周结果。

背景技术迫切需要安全有效的2型人类免疫缺陷病毒（HIV-2）感染的抗逆转录病毒疗法（ART）。我们进行了包含艾格列韦，考比司他，恩曲他滨和替诺福韦富马酸替诺福韦酯（E / C / F / TDF）的单片治疗方案的首次临床试验，以评估其在西非塞内加尔的HIV-2感染者中的有效性。方法该为期48周的开放标签试验符合世界卫生组织3-4期或CD4计数<750细胞/μL的HIV-2感染，未接受ART的成人的条件。我们分析了HIV-2病毒载量（VL），CD4计数，临床和不良事件，死亡率以及失访情况。结果我们招募了发起E / C / F / TDF的30名受试者。29名受试者完成了48周的随访。多数是女性（80％）。没有死亡，没有新的与艾滋病相关的临床事件，且有1例随访失败。中位数基线CD4计数为408（范围为34-747）细胞/μL，在第48周时中位数为161（范围为27-547）细胞/μL。25名受试者的基线HIV-2 VL < 50拷贝/ mL血浆。在可检测到HIV-2 VL的患者中，中位数为41（范围为10-6135）拷贝/ mL。使用改良的意向性治疗分析（美国食品药品监督管理局快照方法），在30周内有30个患者中有28个（93.3％； 95％置信区间为77.9％-99.2％）具有病毒抑制作用。1名病毒学衰竭的受试者在第48周时检测到多药耐药HIV-2（逆转录酶突变：K65R；整合酶突变：G140S和Q148R）。共发生8例3-4级不良事件； 3例不良反应为3级。没有人被认为与研究有关。坚持性和可接受性都很好。结论我们的数据表明，E / C / F / TDF，每天一次，单片的方案安全，有效且耐受性良好。我们的研究结果支持使用基于整合酶抑制剂的方案治疗HIV-2。临床试验注册NCT02180438。