Efficacy and safety of bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) versus efavirenz, lamivudine, and tenofovir disoproxil fumarate (EFV+3TC + TDF) in late-presenting people with HIV rapid initial antiretroviral therapy

To compare the efficacy and safety of BIC/FTC/TAF versus EFV+3TC + TDF for rapid ART initiation in late-presenting (CD4 < 200 cells/µL) people with HIV in the real world. This retrospective cohort included 366 ART-naïve adults at Beijing Ditan Hospital (2021–2024). Patients were stratified by opportunistic infection (OI) status and initiated on either BIC/FTC/TAF or EFV+3TC + TDF. The primary endpoint was virological suppression (HIV-1 RNA < 50 copies/mL) at Week 48. At Week 48, virological suppression rates were significantly higher with BIC/FTC/TAF versus EFV+3TC + TDF in both patients without OIs (92.4% vs. 62.5%) and with OIs (92.3% vs. 55.9%). Treatment retention was also superior with BIC/FTC/TAF (94.1% vs. 62.3%). Kaplan-Meier analysis confirmed a higher cumulative probability of maintaining suppression with BIC/FTC/TAF (96.7% vs. 80.4%, log-rank p < 0.001). Pre-treatment drug resistance in NNRTIs was present in 11.6% of the EFV group and 1.4% of the BIC group. Acquired resistance emerged only in the EFV group (10.8% by Week 24). CD4 + T-cell counts in both groups increased. BIC/FTC/TAF was associated with early, stable increases in creatinine and lipids, while EFV+3TC + TDF showed a marked triglyceride rise. In this real-world cohort of late-presenting people with HIV, BIC/FTC/TAF demonstrated superior virological efficacy, treatment retention, and resistance profile over EFV+3TC + TDF, supporting its use in rapid ART initiation.