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We evaluated the outcomes of switching virologically suppressed (HIV-1 RNA\u2009&lt;\u200950 copies\/mL) individuals harbouring major RAMs from boosted protease inhibitor (bPI)-based therapy to B\/F\/TAF.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>Participants had various historical genotypic patterns including M184V\/I, \u22642 thymidine analogue mutations (TAMs), and other NRTI RAMs (NAMs), and no integrase resistance. Baseline RAMs were explored by retrospective sequencing of cellular HIV-1 DNA. Participants were randomised (1:1) to switching to B\/F\/TAF either immediately or after 24 weeks. The primary outcome was the proportion of participants maintaining virological suppression (pure virologic response) at week-24; secondary outcomes were proportion of participants with virological suppression at week-48, pre-specified safety measures, and treatment-emergent resistance.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Historically, 21\/72 (29.2%) participants had M184V\/I, 5 (6.9%) M184V\/I\u2009+\u20091 NAM, 31 (43.1%) 1 TAM\u2009\u00b1\u2009M184V\/I\u2009\u00b1\u20091 NAM, and 15 (20.8%) 2 TAMs\u2009\u00b1\u2009M184V\/I\u2009\u00b1\u20091 NAM. At week-24, proportions maintaining virological suppression were 33\/33 (100%) on B\/F\/TAF vs. 38\/39 (97.4%) on bPI (difference 2.6%; 95% CI -2.4%, 7.5%). Drug-related adverse events (AEs) were reported in 10\/33 (30.3%) vs. 1\/39 (2.6%), respectively. The immediate switch arm had improved lipid parameters but increased HbA1c and weight. Virological suppression was maintained at week-48. There were six discontinuations; four on B\/F\/TAF were drug-related and the two on bPI were not drug-related.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Historical NRTI resistance did not compromise the effectiveness of B\/F\/TAF in virologically suppressed adults. 12% experienced treatment-limiting AEs after switching.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Registration<\/jats:title>\n            <jats:p>EudraCT no: 2018-004732-30<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/s12985-025-02648-3","type":"journal-article","created":{"date-parts":[[2025,2,10]],"date-time":"2025-02-10T08:09:28Z","timestamp":1739174968000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Outcomes of switching from protease inhibitor-based antiretroviral therapy to bictegravir\/emtricitabine\/tenofovir alafenamide (B\/F\/TAF) in virologically suppressed adults with nucleos(t)ide analogue resistance\u2013 a phase IV randomised, open-label study (PIBIK study)"],"prefix":"10.1186","volume":"22","author":[{"given":"Collins","family":"Iwuji","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Waters","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Milinkovic","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chloe","family":"Orkin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie","family":"Fox","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Post","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicky","family":"Perry","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chloe","family":"Bruce","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalie","family":"Dailey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ye","family":"To","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Bremner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Duncan","family":"Churchill","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna Maria","family":"Geretti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,2,10]]},"reference":[{"issue":"11","key":"2648_CR1","doi-asserted-by":"publisher","first-page":"1739","DOI":"10.1093\/infdis\/jis261","volume":"205","author":"KC Sigaloff","year":"2012","unstructured":"Sigaloff KC, Hamers RL, Wallis CL, Kityo C, Siwale M, Ive P, et al. 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Clinical Trial Authorisation was granted by the Medicine and Healthcare Products Regulatory Agency. All participants provided written informed consent prior to enrolment in the trial.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"C.I has received honoraria, support to attend conferences and research funding (paid to university of Sussex) from Gilead Sciences. AMG: reports personal fees from Abbott, Gilead, GSK, MSD, Roche, ViiV and research funding (to institution) from Gilead, Roche, ViiV. FP reports personal fees from Gilead Sciences, ViiV Healthcare\/GlaxoSmithKline and MSD, and grants from Gilead Sciences, ViiV Healthcare\/GlaxoSmithKline and MSD. LW has received speaker or advisory fees from ViiV, Janssen & Merck. She is an investigator on trials sponsored by Gilead, ViiV and Merck. C.O has received grants to her institution from Gilead, MSD ViiV, Janssen, Astra Zeneca. Travel Grants, honoraria and lecture fees from Gilead, MSD ViiV, Janssen, Bavarian nordic. J.F has received research grant from GSK paid to her institution and honorarium paid to her by ABBVIE.D.C; S.B; Y.T; N.D; C.B; Y.T; N.P: No conflict of interest to declare.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"33"}}