Rapid Initiation of Antiretroviral Therapy with Coformulated Bictegravir, Emtricitabine, 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

Ran Wang; Lijun Sun; Xi Wang; Yuanyi Zhai; Lijing Wang; Ping Ma; Cuisong Wu; Yingquan Zhou; Renfang Chen; Rugang Wang; Fengchi Zhang; Wei Hua; Aixin Li; Wei Xia; Yue Gao; Rui Li; Shiyun Lv; Ying Shao; Yu Cao; Tong Zhang; Hao Wu; Chao Cai; Lili Dai

doi:10.1093/cid/ciae012

Rapid Initiation of Antiretroviral Therapy with Coformulated Bictegravir, Emtricitabine, 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

Clin Infect Dis. 2024 Jan 17:ciae012. doi: 10.1093/cid/ciae012. Online ahead of print.

Authors

Ran Wang¹, Lijun Sun¹, Xi Wang¹, Yuanyi Zhai¹, Lijing Wang², Ping Ma³, Cuisong Wu⁴, Yingquan Zhou⁵, Renfang Chen⁶, Rugang Wang⁷, Fengchi Zhang⁸, Wei Hua¹, Aixin Li¹, Wei Xia¹, Yue Gao¹, Rui Li¹, Shiyun Lv¹, Ying Shao¹, Yu Cao¹, Tong Zhang¹, Hao Wu¹, Chao Cai¹, Lili Dai¹

Affiliations

¹ Beijing Youan Hospital, Capital Medical University, Beijing, People's Republic of China.
² Shijiazhuang Fifth Hospital, Shijiazhuang, People's Republic of China.
³ Tianjin Second People's Hospital, Tianjin, People's Republic of China.
⁴ Zhenjiang Third People's Hospital, Zhenjiang, People's Republic of China.
⁵ Lanzhou Pulmonary Hospital, Lanzhou, People's Republic of China.
⁶ Wuxi Fifth People's Hospital, Wuxi, People's Republic of China.
⁷ Dalian Public Health Clinical Center, Dalian, People's Republic of China.
⁸ Xuzhou Infectious Disease Hospital, Xuzhou, People's Republic of China.

PMID: 38236137
DOI: 10.1093/cid/ciae012

Abstract

Background: Most international treatment guidelines recommend rapid initiation of antiretroviral therapy (ART) for people newly diagnosed with 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, tenofovir alafenamide (BIC/FTC/TAF) in rapid ART initiation among HIV-positive men who have sex with men (MSM).

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 FDA 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 < 0.001), respectively, discontinued treatment due to adverse effects, death, or loss to follow-up. The median increase of CD4 count was 181 and 223 cells/μL (p = 0.020), 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 < 0.001).

Conclusion: BIC/FTC/TAF was more efficacious and safer than EFV(400-mg) + 3TC + TDF for rapid ART initiation among HIV-positive MSM in China.

Keywords: care cascade; integrase strand-transfer inhibitor; non-nucleoside reverse-transcriptase inhibitor; treatment retention; treatment-as-prevention.