Beijing Youan Hospital, Capital Medical University, Beijing, People's Republic of China.
Shijiazhuang Fifth Hospital, Shijiazhuang, People's Republic of China.
Clin Infect Dis. 2024 Jul 19;79(1):169-176. doi: 10.1093/cid/ciae012.
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.
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.
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).
BIC/FTC/TAF was more efficacious and safer than EFV (400 mg) + 3TC + TDF for rapid ART initiation among HIV-positive MSM in China.
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。
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）。
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）。
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。
