DOI: 10.6084/m9.figshare.29192603.v1
title: Supplementary materials: Comparative safety of B/F/TAF versus other antiretroviral therapy regimens for treatment-na¨ıve people with HIV-1: a systematic literature review and network meta-analysis

description: <b>These are peer-reviewed supplementary materials for the article</b><b> </b><b>'</b><b>Comparative safety of B/F/TAF versus </b><b>other antiretroviral therapy regimens for </b><b>treatment-na¨ıve people with HIV-1: a </b><b>systematic literature review and network </b><b>meta-analysis</b><b>'</b><b> </b><b>published in the</b><b> </b><b><i>Journal of Comparative Effectiveness Research</i></b><b>.</b><b>SLR Methodology</b><b>NMA Methodology</b><b>Model Specification</b><b>Table S1: </b>Search terms for MEDLINE<b>Table S2:</b> Eligibility Criteria, Using PICO Framework<b>Table S3: </b>Treatment regimens of interest for ITCs<b>Table S4: </b>Outcome Definitions (Week 48)<b>Table S5: </b>List of studies in the TN population excluded from the feasibility assessment<b>Table S6: </b>PRISMA-NMA Checklist<b>Table S7: </b>Summary of Week 48 NMA inputs for the studies included in the NMA<b>Table S8: </b>Study characteristics of included studies<b>Table S9:</b> Quality assessments of studies included in the NMA<b>Table S10: </b>Quality assessment of all studies included in the NMA<b>Table S11: </b>Summary of baseline demographic and clinical characteristics in included studies<b>Table S12: </b>NMA Results Summary Table at Week 48: Absolute Risk (95% CrI)<b>Table S13:</b> NMA Results Summary Table at Week 48: Mean SUCRA<b>Table S14: </b>NMA Results Summary Table at Week 48: Probability Best<b>Table S15: </b>Model Fit Statistics: TRAE at Week 48<b>Table S16: </b>Model Fit Statistics: Grade 3/4 TEAE at Week 48<b>Table S17:</b> Model Fit Statistics: Diarrhoea at Week 48<b>Table S18: </b>Model Fit Statistics: Nausea at Week 48<b>Table S19: </b>Model Fit Statistics: All-Cause Discontinuation at Week 48<b>Table S20: </b>Model Fit Statistics: Discontinuation due to AE at Week 48<b>Table S21: </b>Treatment-Emergent Resistance Mutations Reported at Week 48<b>Table S22: </b>NMA Results Summary Table at Week 96<b>References</b><b>Aim: </b>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. <b>Materials & methods: </b>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. <b>Results:</b> 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. <b>Conclusion: </b>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 welltolerated ART option for most TN PWH.