Evaluating B/F/TAF at the first HIV-specialist appointment in antiretroviral naive persons living with HIV: the bifast study

Initiating antiretroviral therapy (ART) immediately after HIV diagnosis is strongly recommended. We evaluated the efficacy, safety, and patient-reported outcomes (PROs) of starting bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) at the first specialist appointment in treatment-naïve patients without prior laboratory results. A phase IV, open-label, non-randomized clinical trial was conducted at a tertiary hospital in Madrid between November 2020 and March 2022. -1 ART-naïve adults were assigned to one of two groups according to the availability of baseline laboratory results at their first HIV-specialist visit. Participants in Group 1 (FAST-ART) initiated ART immediately, without baseline data, whereas those in Group 2 (C-ART) started ART once baseline assessments—including plasma HIV-1 RNA, CD4⁺ T-cell count, and genotypic resistance testing— were available. The primary endpoint was the proportion of participants achieving plasma HIV-1 RNA < 50 copies/mL at week 48 in both intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary endpoints included time to viral suppression after ART initiation, time from HIV diagnosis to ART initiation, changes in CD4⁺ T-cell count, safety outcomes, and PROs measured with validated questionnaires (EQ-5D-5 L and Hospital Anxiety and Depression Scale [HADS]). Ninety-nine participants were enrolled (40 in Group 1; 59 in Group 2). At week 48, overall efficacy was 84.8% (ITT) and 95.5% (PP), with no significant differences between groups. Median time to viral suppression was 5.1 weeks in both groups. The median time from diagnosis to ART initiation was 2.4 weeks (IQR 1.9–3.3) in Group 1 versus 3.9 weeks (IQR 2.0–7.4) in Group 2 (p = 0.015). Only one Grade 1 adverse event led to discontinuation. Both groups showed significant improvements in health-related quality of life (HQoL) and reductions in anxiety and depression by week 48. Higher anxiety and depression scores at week 4 were associated with lower treatment efficacy at week 48. Initiating B/F/TAF at the first specialist visit without baseline laboratory data was feasible and associated with high rates of virologic suppression and a favorable safety profile in this cohort. This approach may improve HQoL, although timely psychological support remains important. Early anxiety and depression were associated to lower treatment efficacy. Overall, these findings support the potential of early ART initiation strategies with comprehensive care, but further studies in larger and more diverse populations are needed.