Bictegravir/emtricitabine/tenofovir alafenamide fixed-dose combination in advanced HIV disease.

INTRODUCTION: Real-world data on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) showed high virologic suppression (VS) in treatment-naive (TN) and experienced (TE) people living with HIV (PLWH). The BIC-CD4 study aims to describe safety, persistence, and VS in PLWH who started B/F/TAF with CD4 <200/mm3, representing advanced HIV disease (AHD). MATERIALS AND METHODS: This retrospective, multisite, observational, open cohort study, included TN and TE PLWH who started B/F/TAF from October 2019 to January 2024 in three HIV clinics in Argentina. RESULTS: Of 3527 patients starting B/F/TAF, 250 (7%) had CD4 <200/mm3: 132 TN and 117 TE. The cohort was predominantly male (74%) with a median age of 43 years. For TN patients, 48-week persistence was 99%, VS was 83%, and median CD4 increased from 94 to 284/mm3. TE patients were divided into those with and without VS at baseline (TEU: treatment-experienced undetectable; TENU: treatment-experienced not-undetectable). Half of the TE patients corresponded to TENU subgroup which had lower CD4 counts and higher frequencies of exposure to efavirenz and atazanavir/ritonavir, ongoing toxicity, and virologic failure compared to TEU. At 48 weeks, VS rates for TEU and TENU were 98% and 89%, respectively. Overall persistence was >99% for both groups. Median CD4 counts increased in both TEU and TENU groups. No adverse events were reported. DISCUSSION: B/F/TAF demonstrated excellent persistence, safety, and adequate VS rates in PLWH with AHD, including both TN and TE patients, supporting its use in this population.