Bictegravir/emtricitabine/tenofovir alafenamide: A review of the real-world experience in Spain within the last five years

Integrase strand inhibitor (INSTI)-based antiretroviral regimens are the preferred choices for treating people with human immunodeficiency virus (PWH). The once-daily single-tablet combination of INSTI bictegravir, co-formulated with emtricitabine and tenofovir alafenamide (BIC/FTC/TAF), has shown effectiveness and good tolerability in randomized clinical trials, both in treatment-naïve (TN) and virologically suppressed patients switched to this regimen. Real-world evidence represents clinical practice and may fill data gaps left by pivotal studies. Based on literature search for real-world studies in Spain within five years, and using clinical trial data as a contextual framework, this narrative review synthesizes observational experience with BIC/FTC/TAF, focusing on the interplay between comorbidities, advanced age, and treatment outcomes from underrepresented subgroups in clinical trials. This fixed-dose combination proved effective and well-tolerated for TN and treatment-experienced PWH, with low virological failure even in difficult-to-treat patients. Low rates of treatment discontinuations due to adverse events or drug-drug interactions aligned with clinical trial findings.