1. 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
- Author
-
Wang, Ran, Sun, Lijun, Wang, Xi, Zhai, Yuanyi, Wang, Lijing, Ma, Ping, Wu, Cuisong, Zhou, Yingquan, Chen, Renfang, Wang, Rugang, Zhang, Fengchi, Hua, Wei, Li, Aixin, Xia, Wei, Gao, Yue, Li, Rui, Lv, Shiyun, Shao, Ying, Cao, Yu, and Zhang, Tong
- Subjects
- *
COMBINATION drug therapy , *MEN , *PATIENT compliance , *ANTIRETROVIRAL agents , *HIV seroconversion , *VIRAL load , *DRUG side effects , *PATIENT safety , *BODY mass index , *RESEARCH funding , *TENOFOVIR , *STATISTICAL sampling , *CD4 lymphocyte count , *FISHER exact test , *TREATMENT effectiveness , *DESCRIPTIVE statistics , *MANN Whitney U Test , *CHI-squared test , *HIGHLY active antiretroviral therapy , *EMTRICITABINE , *ANTIVIRAL agents , *RNA , *HOMOSEXUALITY , *DRUG efficacy , *RESEARCH , *DRUGS , *CONFIDENCE intervals , *DATA analysis software , *TIME , *EVALUATION - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF