YI-CHIA HUANGKo, Wen-ChienWen-ChienKoHSIN-YUN SUNCheng, Shu-HsingShu-HsingChengHuang, Sung-HsiSung-HsiHuangYang, Chia-JuiChia-JuiYangTang, Hung-JenHung-JenTangLin, Shih-PingShih-PingLinLiou, Bo-HuangBo-HuangLiouLee, Yuan-TiYuan-TiLeeLu, Po-LiangPo-LiangLuCHIEN-CHING HUNG2026-02-262026-02-262026-02https://scholars.lib.ntu.edu.tw/handle/123456789/736007Objectives 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.enCare continuumIntegrase strand transfer inhibitorRetention in careTreat-allTreatment as preventionUndetectable-equals-untransmittable (U=U)journal article10.1016/j.ijid.2025.10828441354205