A 96-week efficacy and safety of BIC/FTC/TAF in ART-naïve HIV-1 infected patients in China

To evaluate 96-week virologic, immunologic, resistance and metabolic outcomes of bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) in antiretroviral therapy (ART)-naïve people living with HIV (PLWH). Retrospective cohort of ART-naïve PLWH initiating BIC/FTC/TAF between January 2020 and December 2022. Primary outcome was HIV-1 RNA <50 copies/mL at week 96. Secondary outcomes included drug resistance and changes in CD4⁺ T cell count, CD4⁺/CD8⁺, body weight, lipid profile, liver and renal function by week 96. We enrolled 228 patients; median age 32 years, 92.1% male, homosexual intercourse 57.0%. Virologic suppression did not differ by baseline HIV-1 RNA levels, CD4⁺ T cell counts, or opportunistic infection (OI), and immune reconstitution was similarly consistent across subgroups. One patient developed V179E mutation. Median body mass index increased from 21.7 (20.0-23.7) to 23.1 (21.2-25.1) by week 48 and then stabilized. Lipid levels increased early and remained stable, liver function remained stable after week 48, and renal function showed a slight decline before stabilizing by week 48. BIC/FTC/TAF demonstrated strong efficacy in patients with high baseline HIV-1 RNA and OIs, with no patient developing drug-related resistance mutations and minimal impact on metabolism, liver and renal function, supporting its use in broader populations as a first-line regimen.