{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T17:56:20Z","timestamp":1793382980992,"version":"4.5.0"},"reference-count":61,"publisher":"Becaris Publishing Limited","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"abstract":"<jats:p>\n            <jats:bold>Aim:<\/jats:bold>\n            Bictegravir, emtricitabine\u00a0and 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\u00a0and network meta-analysis\u00a0compares the safety outcomes of B\/F\/TAF with other ART regimens in TN PWH, addressing a key aspect of therapeutic decision-making.\n            <jats:bold>Materials &amp; methods:<\/jats:bold>\n            A systematic literature review\u00a0was performed to identify phase III\u00a0and IV\u00a0RCTs assessing B\/F\/TAF and comparator regimens in TN adults (\u226518\u00a0years) with HIV-1. MEDLINE, Embase, Cochrane Database of Systematic Reviews and CENTRAL databases were last searched on 14\u00a0June 2023. Study design, population\u00a0and outcome definitions were evaluated to ensure consistency across studies. Bayesian network meta-analyses\u00a0were conducted where feasible, following key methodological guidelines.\n            <jats:bold>Results:<\/jats:bold>\n            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\u00a0and 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.\n            <jats:bold>Conclusion:<\/jats:bold>\n            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.\n          <\/jats:p>","DOI":"10.57264\/cer-2024-0231","type":"journal-article","created":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T04:17:57Z","timestamp":1748578677000},"source":"Crossref","is-referenced-by-count":2,"title":["Comparative safety of B\/F\/TAF versus other antiretroviral therapy regimens for treatment-na\u00efve people with HIV-1: a systematic literature review and network meta-analysis"],"prefix":"10.57264","author":[{"given":"Tristan","family":"Curteis","sequence":"first","affiliation":[{"name":"Costello Medical, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy A","family":"Eddowes","sequence":"additional","affiliation":[{"name":"Costello Medical, Bristol, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Chen","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc, Foster City, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bhumi","family":"Gandhi-Patel","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc, Foster City, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrei","family":"Karlsson","sequence":"additional","affiliation":[{"name":"Costello Medical, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Luedke","sequence":"additional","affiliation":[{"name":"Costello Medical, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manon","family":"Rubinstein","sequence":"additional","affiliation":[{"name":"Costello Medical, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathias","family":"Hempfling","sequence":"additional","affiliation":[{"name":"Costello Medical, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernesto G","family":"Scerpella","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc, Foster City, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paresh","family":"Chaudhari","sequence":"additional","affiliation":[{"name":"HEOR Consultant, SimulStat Incorporated, Solana Beach, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Jarrett","sequence":"additional","affiliation":[{"name":"Gilead Sciences Inc, Foster City, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"36897","published-online":{"date-parts":[[2025,5,30]]},"reference":[{"key":"e_1_3_9_3_2","unstructured":"World Health Organization (WHO). 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Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/210251s000lbl.pdf"},{"issue":"6","key":"e_1_3_9_9_2","doi-asserted-by":"crossref","first-page":"e355","DOI":"10.1016\/S2352-3018(19)30077-3","article-title":"Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase III, non-inferiority trial","volume":"6","author":"Wohl DA","year":"2019","unstructured":"Wohl DA, Yazdanpanah Y, Baumgarten A Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase III, non-inferiority trial. Lancet HIV 6(6), e355\u2013e363 (2019).","journal-title":"Lancet HIV"},{"issue":"10107","key":"e_1_3_9_10_2","doi-asserted-by":"crossref","first-page":"2063","DOI":"10.1016\/S0140-6736(17)32299-7","article-title":"Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase III, randomised controlled non-inferiority trial","volume":"390","author":"Gallant J","year":"2017","unstructured":"Gallant J, Lazzarin A, Mills A Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase III, randomised controlled non-inferiority trial. 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Lancet HIV 7(6), e389\u2013e400 (2020).","journal-title":"Lancet HIV"},{"issue":"10107","key":"e_1_3_9_12_2","doi-asserted-by":"crossref","first-page":"2073","DOI":"10.1016\/S0140-6736(17)32340-1","article-title":"Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380\u20131490): a randomised, double-blind, multicentre, phase III, non-inferiority trial","volume":"390","author":"Sax PE","year":"2017","unstructured":"Sax PE, Pozniak A, Montes ML Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380\u20131490): a randomised, double-blind, multicentre, phase III, non-inferiority trial. Lancet 390(10107), 2073\u20132082 (2017).","journal-title":"Lancet"},{"issue":"6","key":"e_1_3_9_13_2","doi-asserted-by":"crossref","first-page":"e364","DOI":"10.1016\/S2352-3018(19)30080-3","article-title":"Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase III, non-inferiority trial","volume":"6","author":"Stellbrink HJ","year":"2019","unstructured":"Stellbrink HJ, Arribas JR, Stephens JL Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase III, non-inferiority trial. 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