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Concerns regarding negative drug\u2013drug interactions (DDIs) between ART drugs and gender\u2010affirming hormone therapy (GAHT), specifically feminizing hormone therapy (FHT), may contribute to the lower ART uptake by trans women with HIV compared with their cis counterparts. The aim of this study is to investigate the bidirectional pharmacokinetic effects of components of FHT regimens (oral oestradiol and androgen\u2010suppressing medications) with the ART regimen (bictegravir\/emtricitabine\/tenofovir alafenamide [B\/F\/TAF)].<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We present a protocol for a three\u2010armed, parallel\u2010group, longitudinal (6\u2010month), DDI study. Group 1 includes 15 3trans women with HIV taking FHT and ART; group 2 includes 15 premenopausal cis women with HIV taking ART; group 3 includes 15 trans women without HIV taking FHT. Women with HIV must be on or switch to B\/F\/TAF at baseline and be virally suppressed for \u22653\u00a0months. Trans women must be taking a stable regimen of \u22652\u00a0mg daily oral oestradiol and an anti\u2010androgen (pharmaceutical, and\/or surgical, and\/or medical) for \u22653\u00a0months. Plasma ART drug concentrations will be sampled at Month 2 and compared between groups 1 and 2. Serum oestradiol concentrations will be sampled at baseline and Month 2 visits and compared between groups 1 and 3. The primary outcomes are B\/F\/TAF pharmacokinetic parameters (<jats:italic>C<\/jats:italic><jats:sub>min<\/jats:sub>, <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> and AUC) and oestradiol concentrations (<jats:italic>C<\/jats:italic><jats:sub>min<\/jats:sub>, <jats:italic>C<\/jats:italic><jats:sub>4h,<\/jats:sub> <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> and AUC) at month 2.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>This study is of global importance as it provides critical information regarding safe coadministration of B\/F\/TAF and FHT, both of which are life\u2010saving therapies for trans women with HIV.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.16162","type":"journal-article","created":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T04:18:38Z","timestamp":1720757918000},"page":"2349-2359","source":"Crossref","is-referenced-by-count":1,"title":["Protocol of a drug\u2013drug interaction study between bictegravir\/emtricitabine\/tenofovir alafenamide and feminizing hormones in trans women living with HIV"],"prefix":"10.1111","volume":"90","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9023-8877","authenticated-orcid":false,"given":"Ashley","family":"Lacombe\u2010Duncan","sequence":"first","affiliation":[{"name":"Women's College Hospital  Toronto Ontario Canada"},{"name":"School of Social Work University of Michigan  Ann Arbor Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6480-6690","authenticated-orcid":false,"given":"Alice","family":"Tseng","sequence":"additional","affiliation":[{"name":"Toronto General Hospital Unity Health Network  Toronto Ontario Canada"},{"name":"Leslie Dan Faculty of Pharmacy University of Toronto  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9406-693X","authenticated-orcid":false,"given":"Kimberly K.","family":"Scarsi","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center  Omaha Nebraska USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-6275-5988","authenticated-orcid":false,"given":"Tessa","family":"Senneker","sequence":"additional","affiliation":[{"name":"Kingston Health Sciences Centre  Kingston Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hadas","family":"Kluger","sequence":"additional","affiliation":[{"name":"College of Literature, Science, and the Arts University of Michigan  Ann Arbor Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasmeen","family":"Persad","sequence":"additional","affiliation":[{"name":"Women's College Hospital  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5427-4862","authenticated-orcid":false,"given":"Angela","family":"Underhill","sequence":"additional","affiliation":[{"name":"Women's College Hospital  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"V. 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