A real-world pharmacovigilance study of FDA adverse event reporting system events for bictegravir/emtricitabine/tenofovir alafenamide

Abstract

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a widely used antiretroviral regimen, but its real-world long-term safety profile in diverse populations remains incompletely characterized. We analyzed adverse drug signals from the FAERS database (2018–2025) with B/F/TAF as the primary suspected drug. Disproportionality analyses using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) algorithms were performed to detect safety signals. A total of 6,816 case reports and 13,853 adverse events were included. The highest numbers of reports were related to “Injury, poisoning and procedural complications” (n = 1,792), followed by “General disorders and administration site conditions” (n = 1,726) and “Investigations” (n = 1,499). The System Organ Classes (SOCs) meeting all four disproportionality criteria were “Congenital, familial and genetic disorders” and “Pregnancy, puerperium and perinatal conditions.” The most frequently reported preferred terms were weight increase (408 cases), product dose omission (242 cases), and maternal exposure during pregnancy (202 cases), while the strongest signals by ROR were viral load increased (ROR 160.14), CD4 lymphocytes decreased (ROR 124.60), and immune reconstitution inflammatory syndrome (ROR 88.12). Overall, 37.94% of events occurred within the first month of treatment, and 17.49% occurred after one year. These pharmacovigilance signals merit clinical awareness, particularly regarding metabolic monitoring, virologic/immunologic parameters (which likely reflect treatment response rather than drug toxicity), and pregnancy exposure reporting. Events occurred both early and late, reinforcing the necessity of longitudinal pharmacovigilance for this widely used antiretroviral regimen. However, these findings are exploratory and should not be interpreted as confirmed causal associations.