{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T03:39:44Z","timestamp":1787974784805,"version":"build-2784847793"},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T00:00:00Z","timestamp":1743984000000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","award":["IN\u2010US\u2010412\u20105796"],"award-info":[{"award-number":["IN\u2010US\u2010412\u20105796"]}],"id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Int AIDS Soc."],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Concerns regarding potential drug\u2212drug interactions (DDIs) between hormone therapy and pre\u2010exposure prophylaxis (PrEP) may hinder PrEP use among transgender persons. Transgender men have often been overlooked in biomedical HIV research, and potential DDIs between masculinizing hormone therapy (MHT) and PrEP have not been addressed. We aimed to assess the potential DDIs between MHT and daily oral PrEP among transgender men.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Transgender men without HIV who never underwent oophorectomy were enrolled between May and October 2022. Participants were randomly assigned to receive emtricitabine\u2010tenofovir disoproxil fumarate (F\/TDF) or emtricitabine\u2010tenofovir alafenamide (F\/TAF) for daily oral PrEP. Intramuscular testosterone enanthate 200 mg was administered every 2 weeks from baseline to week 12, while oral PrEP was initiated at week 6 and continued until week 16. Pharmacokinetic (PK) sampling was conducted at weeks 4 and 12 to assess the impact of PrEP on MHT and at weeks 12 and 16 to evaluate the impact of MHT on PrEP. Plasma total testosterone, TAF, tenofovir (TFV) and FTC; tenofovir\u2010diphosphate (TFV\u2010DP) and emtricitabine\u2010triphosphate (FTC\u2010TP) concentrations in peripheral blood mononuclear cells (PBMCs) were measured in all participants. Cervical and rectal tissues were obtained in a subset of 20 participants (10 per group) to measure TDF\u2010DP and FTC\u2010TP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty\u2010nine participants (19 F\/TDF and 20 F\/TAF) completed the PK visits. No significant changes in the PK parameters of plasma total testosterone, TFV, FTC and TAF (for F\/TAF group); urine TFV and FTC; and PBMC and rectal tissue TFV\u2010DP and FTC\u2010TP were observed when MHT and PrEP were administered together. Both TFV\u2010DP and FTC\u2010TP concentrations in cervical tissue were significantly lower when MHT was co\u2010administered with F\/TAF (TFV\u2010DP: median [IQR] of 12.9 [6.78\u201314.56] fmol\/mg at weeks 12 vs. 20.63 [7.47\u201353.43] fmol\/mg at week 16, <jats:italic>p<\/jats:italic> = 0.04; and FTC\u2010TP: 67.05 [27.24\u201377.24] fmol\/mg vs. 120.43 [65.98\u2013245.76] fmol\/mg, <jats:italic>p<\/jats:italic> = 0.02).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our findings across multiple anatomical compartments suggest that oral PrEP should not affect the effectiveness of MHT and that F\/TDF\u2010based PrEP should be effective when taken with MHT. However, further research is needed to assess the effectiveness of TAF\u2010based PrEP in transgender men.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Number<\/jats:title><jats:p>NCT04593680.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.26445","type":"journal-article","created":{"date-parts":[[2025,4,8]],"date-time":"2025-04-08T07:28:37Z","timestamp":1744097317000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Exploring potential drug\u2212drug interactions between masculinizing hormone therapy and oral pre\u2010exposure prophylaxis (F\/TDF and F\/TAF) among transgender men (iMACT study): a randomized, open\u2010label pharmacokinetic study in Thailand"],"prefix":"10.1002","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1906-8171","authenticated-orcid":false,"given":"Akarin","family":"Hiransuthikul","sequence":"first","affiliation":[{"name":"Institute of HIV Research and Innovation (IHRI)  Bangkok Thailand"},{"name":"Department of Preventive and Social Medicine Faculty of Medicine Chulalongkorn University  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Narukjaporn","family":"Thammajaruk","sequence":"additional","affiliation":[{"name":"Institute of HIV Research and Innovation (IHRI)  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Kerr","sequence":"additional","affiliation":[{"name":"Biostatistics Excellence Centre Faculty of Medicine Chulalongkorn University  Bangkok Thailand"},{"name":"HIV\u2010NAT, Thai Red Cross AIDS Research Centre  Bangkok Thailand"},{"name":"The Kirby Institute University of New South Wales  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8054-482X","authenticated-orcid":false,"given":"Rena","family":"Janamnuaysook","sequence":"additional","affiliation":[{"name":"Institute of HIV Research and Innovation (IHRI)  Bangkok Thailand"},{"name":"Center of Excellence in Transgender Health (CETH) Faculty of Medicine Chulalongkorn University  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siriporn","family":"Nonenoy","sequence":"additional","affiliation":[{"name":"Institute of HIV Research and Innovation (IHRI)  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piranun","family":"Hongchookiat","sequence":"additional","affiliation":[{"name":"Institute of HIV Research and Innovation (IHRI)  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rapee","family":"Trichavaroj","sequence":"additional","affiliation":[{"name":"Institute of HIV Research and Innovation (IHRI)  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yardpiroon","family":"Tawon","sequence":"additional","affiliation":[{"name":"AMS\/PHPT Research Collaboration Faculty of Associated Medical Sciences Chiang Mai University  Chiang Mai Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-1097-8157","authenticated-orcid":false,"given":"Jakkrapatara","family":"Boonruang","sequence":"additional","affiliation":[{"name":"Institute of HIV Research and Innovation (IHRI)  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nipat","family":"Teeratakulpisarn","sequence":"additional","affiliation":[{"name":"Institute of HIV Research and Innovation (IHRI)  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim R.","family":"Cressey","sequence":"additional","affiliation":[{"name":"AMS\/PHPT Research Collaboration Faculty of Associated Medical Sciences Chiang Mai University  Chiang Mai Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1200-8494","authenticated-orcid":false,"given":"Peter L.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences University of Colorado, Anschutz Medical Campus  Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0036-3165","authenticated-orcid":false,"given":"Nittaya","family":"Phanuphak","sequence":"additional","affiliation":[{"name":"Institute of HIV Research and Innovation (IHRI)  Bangkok Thailand"},{"name":"Center of Excellence in Transgender Health (CETH) Faculty of Medicine Chulalongkorn University  Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the iMACT study team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,4,7]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.7326\/M23-2073"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/17441692.2016.1154085"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1089\/lgbt.2017.0057"},{"key":"e_1_2_11_5_1","volume-title":"Standards of care (SOC) for the health of transsexual, transgender, and gender nonconforming people","author":"Coleman E","year":"2011"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.19.3.20810"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.25338"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz290"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.25405"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkaa016"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa1160"},{"issue":"1","key":"e_1_2_11_12_1","first-page":"46","article-title":"Gender affirming hormones do not affect the exposure and efficacy of F\/TDF or F\/TAF for HIV preexposure prophylaxis: a subgroup analysis from the DISCOVER Trial","volume":"9","author":"Cespedes MS","year":"2024","journal-title":"Transgender Health"},{"key":"e_1_2_11_13_1","unstructured":"BlumenthalJ GoyalR BurkeL Dub\u00e9M HoeniglM MooreDJ et\u00a0al.The bi\u2010directional effects of hormone therapy and PrEP in transgender individuals (Abstract #84).Conference on Retroviruses and Opportunistic Infections (CROI).2022."},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1089\/aid.2022.0044"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-023-01248-0"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001744"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)31065-5"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2021.100893"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2017-01658"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.3004006"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkx064"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiw077"}],"container-title":["Journal of the International AIDS Society"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jia2.26445","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,20]],"date-time":"2025-05-20T10:24:38Z","timestamp":1747736678000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jia2.26445"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4]]},"references-count":21,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1002\/jia2.26445"],"URL":"https:\/\/doi.org\/10.1002\/jia2.26445","archive":["Portico"],"relation":{},"ISSN":["1758-2652","1758-2652"],"issn-type":[{"value":"1758-2652","type":"print"},{"value":"1758-2652","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4]]},"assertion":[{"value":"2024-06-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-07","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e26445"}}