Rapid start with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment in people with human immunodeficiency virus-1 (HIV-1): A systematic literature review of clinical and patient-reported outcomes.

Background: Treatment guidelines recommend rapid antiretroviral therapy (ART) initiation among eligible people with HIV to improve treatment outcomes and reduce HIV transmission. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), an integrase strand transfer inhibitor-based single-tablet regimen, is recommended for rapid start in US and European guidelines. This systematic literature review synthesized evidence on the efficacy, safety and effect on patient-reported outcomes (PROs) of B/F/TAF rapid start among newly diagnosed people with HIV.

Methods: MEDLINE, Embase, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials databases were searched in January 2024, supplemented by searches of conference proceedings and clinical trial records. English-language interventional studies of B/F/TAF rapid start among ART-naïve people with HIV reporting efficacy, safety or PROs were eligible. Study quality was assessed using York Centre for Reviews and Dissemination or Risk Of Bias In Non-randomized Studies of Interventions checklists. Results were synthesized narratively.

Results: Across eight included studies, 745 people with HIV received B/F/TAF rapid start, 171 received rapid start comparators and 255 received non-rapid start comparators. At Weeks 24 and 48, 80%-94% and 74%-96% of people with HIV treated with B/F/TAF rapid start achieved viral load <50 copies/mL, respectively. Treatment discontinuation due to adverse events was 0%-3%, and grade 3/4 adverse events occurred in 0%-3% of people with HIV receiving B/F/TAF rapid start. Rapid start improved engagement in care over traditional non-rapid start approaches, and B/F/TAF rapid start reduced anxiety and improved quality of life among people with HIV. Limitations of the review included heterogeneous study definitions of "rapid start" and limited data availability.

Conclusions: B/F/TAF rapid start was efficacious, safe and associated with high engagement in care and improved PROs.