在感染 HIV 的男男性行为者中，与依非韦伦、拉米夫定和富马酸替诺福韦二吡呋酯相比，联合使用比克替拉韦、恩曲他滨和替诺福韦艾拉酚胺快速启动抗逆转录病毒治疗：在中国多中心、随机临床试验的第 48 周结果。
Rapid Initiation of Antiretroviral Therapy With Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide Versus Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate in HIV-Positive Men Who Have Sex With Men in China: Week 48 Results of the Multicenter, Randomized Clinical Trial.
机构信息
Beijing Youan Hospital, Capital Medical University, Beijing, People's Republic of China.
Shijiazhuang Fifth Hospital, Shijiazhuang, People's Republic of China.
出版信息
Clin Infect Dis. 2024 Jul 19;79(1):169-176. doi: 10.1093/cid/ciae012.
BACKGROUND
Most international treatment guidelines recommend rapid initiation of antiretroviral therapy (ART) for people newly diagnosed with human immunodeficiency virus (HIV)-1 infection, but experiences with rapid ART initiation remain limited in China. We aimed to evaluate the efficacy and safety of efavirenz (400 mg) plus lamivudine and tenofovir disoproxil fumarate (EFV + 3TC + TDF) versus coformulated bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) in rapid ART initiation among men who have sex with men (MSM) who have been diagnosed with HIV.
METHODS
This multicenter, open-label, randomized clinical trial enrolled MSM aged ≥18 years to start ART within 14 days of confirmed HIV diagnosis. The participants were randomly assigned in a 1:1 ratio to receive EFV (400 mg) + 3TC + TDF or BIC/FTC/TAF. The primary end point was viral suppression (<50 copies/mL) at 48 weeks per US Food and Drug Administration Snapshot analysis.
RESULTS
Between March 2021 and July 2022, 300 participants were enrolled; 154 were assigned to receive EFV + 3TC + TDF (EFV group) and 146 BIC/FTC/TAF (BIC group). At week 48, 118 (79.2%) and 140 (95.9%) participants in the EFV and BIC group, respectively, were retained in care with viral suppression, and 24 (16.1%) and 1 (0.7%) participant in the EFV and BIC group (P < .001), respectively, discontinued treatment because of adverse effects, death, or lost to follow-up. The median increase of CD4 count was 181 and 223 cells/μL (P = .020), respectively, for the EFV and BIC group, at week 48. The overall incidence of adverse effects was significantly higher for the EFV group (65.8% vs 37.7%, P < .001).
CONCLUSIONS
BIC/FTC/TAF was more efficacious and safer than EFV (400 mg) + 3TC + TDF for rapid ART initiation among HIV-positive MSM in China.
背景
大多数国际治疗指南建议对新诊断出人类免疫缺陷病毒（HIV）-1 感染的人立即开始抗逆转录病毒治疗（ART），但中国在快速启动 ART 方面的经验仍然有限。我们旨在评估依非韦伦（400 mg）加拉米夫定和替诺福韦富马酸酯（EFV+3TC+TDF）与富马酸丙酚替诺福韦艾拉酚胺、恩曲他滨和替诺福韦二吡呋酯（BIC/FTC/TAF）在已确诊 HIV 的男男性行为者（MSM）中快速启动 ART 的疗效和安全性。
方法
这项多中心、开放性、随机临床试验招募了年龄≥18 岁的 MSM，他们在确诊 HIV 后 14 天内开始接受 ART。参与者以 1:1 的比例随机分配接受 EFV（400 mg）+3TC+TDF 或 BIC/FTC/TAF。主要终点是根据美国食品和药物管理局快照分析，在 48 周时病毒抑制（<50 拷贝/mL）。
结果
2021 年 3 月至 2022 年 7 月，共纳入 300 名参与者；其中 154 名被分配接受 EFV+3TC+TDF（EFV 组），146 名接受 BIC/FTC/TAF（BIC 组）。在第 48 周时，EFV 组和 BIC 组分别有 118（79.2%）和 140（95.9%）名参与者保留在治疗中并病毒得到抑制，EFV 组和 BIC 组分别有 24（16.1%）和 1（0.7%）名参与者因不良反应、死亡或失访而停止治疗（P<.001）。EFV 组和 BIC 组在第 48 周时的 CD4 计数中位数分别增加了 181 和 223 个细胞/μL（P=.020）。EFV 组的总体不良反应发生率明显高于 BIC 组（65.8%比 37.7%，P<.001）。
结论
在中国，对于 HIV 阳性的 MSM，BIC/FTC/TAF 比 EFV（400 mg）+3TC+TDF 更有效、更安全，适用于快速启动 ART。
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