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

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.

Keywords: Care continuum; Integrase strand transfer inhibitor; Retention in care; Treat-all; Treatment as prevention; Undetectable-equals-untransmittable (U=U).