The Safety and Effectiveness of B/F/TAF for HIV-1 in a Prospective Multicenter Observational Study in the Republic of Korea.

INTRODUCTION: This study aimed to evaluate the safety and the effectiveness of B/F/TAF in patients living with HIV-1 treated in real-world settings in the Republic of Korea (ROK). METHODS: This prospective, multicenter, observational study aimed to enroll all patients initiating B/F/TAF at 45 sites between July 2019 and November 2023. Safety was assessed up to 48 weeks post-treatment initiation. HIV-1 RNA and CD4 + T-cell were recorded at baseline, and then at approximately 48 weeks (i.e., between 36 and 64 weeks) post-treatment initiation. RESULTS: Of the 2844 patients enrolled, 2761 were analyzed (mean age 44 ± 14 years; 93.48% male; 81.53% treatment-experienced). Adverse events were reported in 37.16% of patients, adverse drug reactions (ADRs) in 5.40%, serious adverse events in 3.48%, and serious adverse drug reactions in 0.04%. No fatal ADRs were reported. Viral suppression rates (HIV-1 RNA < 50 copies/mL) were 97.83% for treatment-experienced patients, 93.84% for treatment-naïve, and 97.19% overall. CD4⁺ T-cell counts increased in both groups. CONCLUSION: In this large real-world cohort, B/F/TAF demonstrated a favorable safety profile and high effectiveness, consistent with prior studies. No new safety concerns were identified.