Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Late-Presenting People With HIV-1 Infection.

Background: The efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) have been demonstrated in treatment-naive clinical trials. However, real-world evidence for this regimen in late-presenting patients with HIV-1 (PWH) is lacking. We investigated the virologic and safety outcomes of BIC/FTC/TAF in late-presenting PWH.

Methods: This retrospective cohort analysis consisted of late-presenting PWH who initiated an antiretroviral regimen of BIC/FTC/TAF between June 2021 and June 2023. Treatment effectiveness, defined as HIV-1 RNA <50 copies/mL, was analyzed. Changes in immunologic, metabolic, liver, and renal parameters were evaluated. Late-presenting PWH were defined as surviving PWH with CD4 <200 cells/μL or surviving patients who met the criteria for AIDS-defining conditions with a CD4 ranging from 200 to 499 cells/μL.

Results: A total of 130 participants were included in the study. At week 48, 93.8% (122/130) of the patients achieved HIV-1 RNA levels <50 copies/mL. CD4 increased by 150.0 cells/μL, and CD4/CD8 increased by 0.16 (P < .001). Sixteen (12.3%) participants experienced adverse events, and 6 (4.6%) experienced drug-related adverse events. None of the participants discontinued treatment due to either a lack of effectiveness or adverse events.

Conclusions: BIC/FTC/TAF demonstrated robust virologic suppression and tolerability in patients presenting late in the course of HIV infection.