{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T23:22:54Z","timestamp":1792106574063,"version":"4.4.0"},"reference-count":42,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,12,26]],"date-time":"2023-12-26T00:00:00Z","timestamp":1703548800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Real\u2010world evidence is an essential component of evidence\u2010based medicine. The aim of the BICSTaR (BICtegravir Single Tablet Regimen) study is to assess effectiveness and safety of bictegravir\/emtricitabine\/tenofovir alafenamide (B\/F\/TAF) in antiretroviral treatment\u2010na\u00efve (TN) and treatment\u2010experienced (TE) people with HIV.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>BICSTaR is a prospective, observational cohort study. Participants (\u226518\u2009years) are being followed for 24\u2009months. A pooled analysis is presented at 12\u2009months, with the primary endpoint of effectiveness (HIV\u20101 RNA &lt;50 copies\/mL) and secondary endpoints of safety and tolerability (as per protocol). An exploration of patient\u2010reported outcome measures using standardized questionnaires is included.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between June 2018 and May 2021, 1552 people with HIV were enrolled across 12 countries. The analysed population comprised 1509 individuals (279 TN, 1230 TE); most were white (76%), male (84%) and had one or more comorbid conditions (68%). Median age was 47\u2009years. After 12\u2009months of B\/F\/TAF treatment, HIV\u20101 RNA was &lt;50 copies\/mL in 94% (221\/236) of TN participants and 97% (977\/1008) of TE participants. Median CD4 cell count increased by 214 cells\/\u03bcL (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) in TN participants and 13 cells\/\u03bcL (<jats:italic>p<\/jats:italic>\u2009=\u20090.014) in TE participants; median CD4\/CD8 ratios increased by 0.30 and 0.03, respectively (both <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Persistence was high at 12\u2009months (TN, 97%; TE, 95%). No resistance to B\/F\/TAF emerged. Study drug\u2010related adverse events occurred in 13% of participants through 12\u2009months, leading to B\/F\/TAF discontinuation in 6%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The findings of this study provide robust real\u2010world evidence to support the broad use of B\/F\/TAF in both TN and TE people with HIV.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.13593","type":"journal-article","created":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T05:44:11Z","timestamp":1703655851000},"page":"440-453","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":53,"title":["Twelve\u2010month effectiveness and safety of bictegravir\/emtricitabine\/tenofovir alafenamide in people with <scp>HIV<\/scp>: Real\u2010world insights from <scp>BICSTaR<\/scp> cohorts"],"prefix":"10.1111","volume":"25","author":[{"given":"Stefan","family":"Esser","sequence":"first","affiliation":[{"name":"Clinic of Dermatology, Department of Venerology University Hospital Essen  Essen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Brunetta","sequence":"additional","affiliation":[{"name":"Maple Leaf Medical Clinic  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexy","family":"Inciarte","sequence":"additional","affiliation":[{"name":"HIV Unit Hospital Clinic of Barcelona  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itzchak","family":"Levy","sequence":"additional","affiliation":[{"name":"Infectious Disease Unit, Sheba Medical Center, Israel and the Sackler Faculty of Medicine Tel Aviv University  Tel Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0073-1789","authenticated-orcid":false,"given":"Antonella","family":"D'Arminio Monforte","sequence":"additional","affiliation":[{"name":"Clinic of Infectious Diseases, Department of Health Sciences University of Milan, \u201cASST Santi Paolo e Carlo\u201d  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John S.","family":"Lambert","sequence":"additional","affiliation":[{"name":"Mater Misericordiae University Hospital University College Dublin  Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5601-4207","authenticated-orcid":false,"given":"Berend","family":"van Welzen","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases University Medical Centre Utrecht  Utrecht Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuji","family":"Teruya","sequence":"additional","affiliation":[{"name":"National Center for Global Health and Medicine: NCGM AIDS Clinical Center (ACC)  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Boffito","sequence":"additional","affiliation":[{"name":"Chelsea and Westminster Hospital  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chun\u2010Eng","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Changhua Christian Hospital  Changhua Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ozlem","family":"Altuntas Ayd\u0131n","sequence":"additional","affiliation":[{"name":"University of Health Sciences Ba\u015fak\u015fehir \u00c7am and Sakura City Hospital  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Thorpe","sequence":"additional","affiliation":[{"name":"Gilead Sciences Ltd  Stockley Park UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marion","family":"Heinzkill","sequence":"additional","affiliation":[{"name":"Gilead Sciences GmbH  Martinsried Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Marongiu","sequence":"additional","affiliation":[{"name":"Gilead Sciences Ltd  Stockley Park UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tali","family":"Cassidy","sequence":"additional","affiliation":[{"name":"Gilead Sciences Ltd  Stockley Park UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Haubrich","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  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