Efficacy of same-day initiation of antiretroviral therapy with coformulated bictegravir, emtricitabine, and tenofovir alafenamide: Week 48 results of a single-arm, open-label, multicenter clinical trial.
Journal
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
Journal Volume
163
Start Page
Article number 108284
ISSN
1878-3511
Date Issued
2026-02
Author(s)
Ko, Wen-Chien
Cheng, Shu-Hsing
Huang, Sung-Hsi
Yang, Chia-Jui
Tang, Hung-Jen
Lin, Shih-Ping
Liou, Bo-Huang
Lee, Yuan-Ti
Lu, Po-Liang
Abstract
Objectives In a national program of integration of rapid HIV diagnosis with linkage to antiretroviral therapy (ART), this multicenter, single-arm trial evaluated the efficacy and feasibility of same-day initiation of coformulated bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) in a high-income setting. Methods Adults aged ≥20 years and without prior ART exposure were enrolled and started BIC/FTC/TAF within 24 hours of confirmed HIV diagnosis. Primary endpoints included engagement in care and plasma HIV RNA load (PVL) <50 copies/mL at Week 48. Secondary endpoints included PVL <200 copies/mL at Weeks 1, 4, and 48, and drug-related adverse events. Results Among 225 enrolled participants (94.2% being gay, bisexual, and other men who have sex with men), 34.9% had CD4 <200 cells/μL and 63.2% PVL >100,000 copies/mL. At Week 48, 96.0% of the participants retained in care, and 76.0% and 81.0% achieved PVL <50 copies/mL in intention-to-treat and per-protocol analysis, respectively; and 96.5% achieved PVL <200 copies/mL in per-protocol analysis. A high baseline PVL and low CD4 count were associated with lower odds of achieving PVL <50 copies/mL. No serious adverse events were attributable to BIC/FTC/TAF. Conclusion Initiation of BIC/FTC/TAF on the same day of HIV diagnosis is feasible, safe, and efficacious in achieving virologic suppression and engagement in care.
Subjects
Care continuum
Integrase strand transfer inhibitor
Retention in care
Treat-all
Treatment as prevention
Undetectable-equals-untransmittable (U=U)
Type
journal article