Comparative safety of B/F/TAF versus other antiretroviral therapy regimens for treatment-naïve people with HIV-1: a systematic literature review and network meta-analysis
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: Bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) is a single-tablet regimen approved for the treatment of HIV-1 in treatment-naive (TN) and virologically suppressed people with HIV-1 (PWH). While the efficacy of antiretroviral therapy (ART) regimens in TN PWH is well established, regimen selection is often influenced by safety and tolerability concerns. This systematic literature review and network meta-analysis compares the safety outcomes of B/F/TAF with other ART regimens in TN PWH, addressing a key aspect of therapeutic decision-making. Materials & methods: A systematic literature review was performed to identify phase III and IV RCTs assessing B/F/TAF and comparator regimens in TN adults (≥18 years) with HIV-1. MEDLINE, Embase, Cochrane Database of Systematic Reviews and CENTRAL databases were last searched on 14 June 2023. Study design, population and outcome definitions were evaluated to ensure consistency across studies. Bayesian network meta-analyses were conducted where feasible, following key methodological guidelines. Results: Nineteen studies were included in indirect comparisons following assessments of heterogeneity and network connectivity. B/F/TAF performed better than the majority of interventions in safety and tolerability outcomes, notably discontinuation due to adverse events (AEs), treatment-related AEs and nausea. Additionally, with comparable risk of experiencing grade 3/4 treatment-emergent AEs, diarrhea and all-cause discontinuation rates to other interventions, B/F/TAF was non-inferior to any other regimen for all outcomes. B/F/TAF typically outperformed interventions containing non-nucleoside reverse transcriptase inhibitor third agents in terms of treatment-related AEs, nausea, and discontinuation due to AEs, although treatment class effects were not estimated separately. Conclusion: This analysis highlights the favorable safety profile of B/F/TAF compared with other ART regimens in TN PWH, demonstrating that B/F/TAF remains a safe and well-tolerated ART option for most TN PWH.
Plain language summary: comparative safety of B/F/TAF in people with HIV-1 who have not yet received any treatment
What is this article about?
B/F/TAF is a single-tablet treatment for HIV-1 which combines three medications – bictegravir (B), emtricitabine (F) and tenofovir alafenamide (TAF). B/F/TAF is recommended by US and international guidelines for the treatment of HIV-1 in people who may or may not have received any treatment before starting B/F/TAF.
This article compares B/F/TAF with other available HIV-1 treatments to see how they differ in terms of safety for people newly diagnosed with HIV-1.
Why is this important?
HIV-1 is a serious global health issue, and a major cause of death and illness worldwide. Finding safe and effective treatments is crucial for people with HIV-1.
What methods were used in the research?
The researchers reviewed a large number of studies that looked at B/F/TAF and other treatments. The data were then analyzed to compare how safe these treatments are for people who are starting HIV-1 therapy for the first time.
What were the results?
The analysis found that B/F/TAF has a favorable safety profile compared with many other HIV-1 treatments, particularly in terms of treatment-related adverse events, nausea and treatment discontinuation due to adverse events.
What do the results mean?
These findings suggest that B/F/TAF is a safe and tolerable option for most people newly diagnosed with HIV-1. It may be preferable for many patients, as it has fewer side effects compared with other available HIV-1 treatments.
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References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
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Received: 13 December 2024
Accepted: 9 May 2025
Published online: 30 May 2025
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Comparative safety of B/F/TAF versus other antiretroviral therapy regimens for treatment-naïve people with HIV-1: a systematic literature review and network meta-analysis. (2025) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2024-0231
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