Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in People with HIV: A Real-World Data from the Spanish BICSTaR Cohort.

Background: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended as first-line HIV treatment in international guidelines. This analysis aimed to assess the effectiveness and safety of B/F/TAF in real-world Spanish clinical practice. Methods: This was an analysis of the Spanish subset from the BICSTaR study in treatment-naïve (TN) and treatment-experienced (TE) people with HIV who started treatment between November 2019 and July 2021 (European study registration: EUPAS22185). The primary endpoint was virologic suppression (HIV-1 RNA <50 copies/mL); additional endpoints included CD4 cell count changes, treatment persistence, adverse events, weight changes, and the 36-Item Short Form Survey mental and physical component summary (MCS/PCS) scores at 12 months. Results: In total, 249 people with HIV initiated B/F/TAF treatment (62 TN, 187 TE). At 12 months, virologic suppression was achieved by 86% of TN and 98% of TE participants, with 91% of those TE participants with baseline HIV-1 RNA ≥50 copies/µL achieving suppression. Median CD4 count increased by 296 cells/µL in TN (p<0.001) and 12 cells/µL in TE (p=0.302) participants. Persistence at 12 months was high in all participants, with 95% still on treatment. Overall, none of TN and less than 3% of TE participants discontinued B/F/TAF due to drug-related adverse events, all of which were mild or moderate. Median weight increase was 2.9 kg in TN (p<0.001) and 1.0 kg in TE (p<0.001) participants. Median MCS scores improved in the TN group (8.4-point increase, p<0.001) but not in the TE group (0.4-point increase, p=0.767), while PCS scores remained stable both among TN and TE. Conclusion: These real-world findings strongly support B/F/TAF use in TN and TE people with HIV in Spain, demonstrating high 12-month persistence and effectiveness, and mental health benefits in TN participants, with minimal adverse events.