No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 study
Introduction Concerns regarding potential drug−drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre‐exposure prophylaxis (PrEP) may hinder PrEP use among transgender women. We assessed the potential DDI between FHT and emtricitabine‐tenofovir alafenamide (F/TAF)‐based PrEP amo...
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| Published in | Journal of the International AIDS Society Vol. 28; no. 5; pp. e26502 - n/a |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Switzerland
John Wiley & Sons, Inc
01.05.2025
John Wiley and Sons Inc Wiley |
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| Online Access | Get full text |
| ISSN | 1758-2652 1758-2652 |
| DOI | 10.1002/jia2.26502 |
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| Abstract | Introduction
Concerns regarding potential drug−drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre‐exposure prophylaxis (PrEP) may hinder PrEP use among transgender women. We assessed the potential DDI between FHT and emtricitabine‐tenofovir alafenamide (F/TAF)‐based PrEP among transgender women.
Methods
Transgender women without HIV who never underwent orchiectomy were enrolled between January and February 2022. Oral FHT (oestradiol valerate 2 mg and cyproterone acetate 25 mg) was initiated at baseline and continued until week 9, while oral PrEP (F/TAF 200/25 mg) was initiated at week 3 and continued until week 12. Intensive blood sampling was performed at weeks 3 and 9 to assess the impact of PrEP on FHT; and weeks 9 and 12 to assess the impact of FHT on PrEP. Pharmacokinetics (PKs) of plasma oestradiol (E2), TAF, tenofovir (TFV) and emtricitabine (FTC); urine TFV and FTC; and tenofovir‐diphosphate (TFV‐DP) and emtricitabine‐triphosphate (FTC‐TP) in peripheral blood mononuclear cells (PBMCs) and rectal tissues were assessed.
Results
Eighteen participants completed all PK visits. No significant differences in PK parameters for plasma E2, TAF and TFV were observed with FHT and F/TAF administration. The geometric mean of FTC AUC0−24 at week 9 was 9% lower than at week 12, but the 90% CI (0.88−0.95) remained within the 80–125% range. There were no significant differences in PBMCs and rectal tissues TFV‐DP and FTC‐TP concentrations when F/TAF was administered with FHT.
Conclusions
No bidirectional clinically significant DDI between FHT and F/TAF‐based PrEP was observed across systemic and local tissue anatomical compartments, supporting the use of oral F/TAF‐based PrEP among transgender women.
Clinical Trial Number
NCT04590417 |
|---|---|
| AbstractList | Abstract Introduction Concerns regarding potential drug−drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre‐exposure prophylaxis (PrEP) may hinder PrEP use among transgender women. We assessed the potential DDI between FHT and emtricitabine‐tenofovir alafenamide (F/TAF)‐based PrEP among transgender women. Methods Transgender women without HIV who never underwent orchiectomy were enrolled between January and February 2022. Oral FHT (oestradiol valerate 2 mg and cyproterone acetate 25 mg) was initiated at baseline and continued until week 9, while oral PrEP (F/TAF 200/25 mg) was initiated at week 3 and continued until week 12. Intensive blood sampling was performed at weeks 3 and 9 to assess the impact of PrEP on FHT; and weeks 9 and 12 to assess the impact of FHT on PrEP. Pharmacokinetics (PKs) of plasma oestradiol (E2), TAF, tenofovir (TFV) and emtricitabine (FTC); urine TFV and FTC; and tenofovir‐diphosphate (TFV‐DP) and emtricitabine‐triphosphate (FTC‐TP) in peripheral blood mononuclear cells (PBMCs) and rectal tissues were assessed. Results Eighteen participants completed all PK visits. No significant differences in PK parameters for plasma E2, TAF and TFV were observed with FHT and F/TAF administration. The geometric mean of FTC AUC0−24 at week 9 was 9% lower than at week 12, but the 90% CI (0.88−0.95) remained within the 80–125% range. There were no significant differences in PBMCs and rectal tissues TFV‐DP and FTC‐TP concentrations when F/TAF was administered with FHT. Conclusions No bidirectional clinically significant DDI between FHT and F/TAF‐based PrEP was observed across systemic and local tissue anatomical compartments, supporting the use of oral F/TAF‐based PrEP among transgender women. Clinical Trial Number NCT04590417 Concerns regarding potential drug-drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre-exposure prophylaxis (PrEP) may hinder PrEP use among transgender women. We assessed the potential DDI between FHT and emtricitabine-tenofovir alafenamide (F/TAF)-based PrEP among transgender women.INTRODUCTIONConcerns regarding potential drug-drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre-exposure prophylaxis (PrEP) may hinder PrEP use among transgender women. We assessed the potential DDI between FHT and emtricitabine-tenofovir alafenamide (F/TAF)-based PrEP among transgender women.Transgender women without HIV who never underwent orchiectomy were enrolled between January and February 2022. Oral FHT (oestradiol valerate 2 mg and cyproterone acetate 25 mg) was initiated at baseline and continued until week 9, while oral PrEP (F/TAF 200/25 mg) was initiated at week 3 and continued until week 12. Intensive blood sampling was performed at weeks 3 and 9 to assess the impact of PrEP on FHT; and weeks 9 and 12 to assess the impact of FHT on PrEP. Pharmacokinetics (PKs) of plasma oestradiol (E2), TAF, tenofovir (TFV) and emtricitabine (FTC); urine TFV and FTC; and tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in peripheral blood mononuclear cells (PBMCs) and rectal tissues were assessed.METHODSTransgender women without HIV who never underwent orchiectomy were enrolled between January and February 2022. Oral FHT (oestradiol valerate 2 mg and cyproterone acetate 25 mg) was initiated at baseline and continued until week 9, while oral PrEP (F/TAF 200/25 mg) was initiated at week 3 and continued until week 12. Intensive blood sampling was performed at weeks 3 and 9 to assess the impact of PrEP on FHT; and weeks 9 and 12 to assess the impact of FHT on PrEP. Pharmacokinetics (PKs) of plasma oestradiol (E2), TAF, tenofovir (TFV) and emtricitabine (FTC); urine TFV and FTC; and tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in peripheral blood mononuclear cells (PBMCs) and rectal tissues were assessed.Eighteen participants completed all PK visits. No significant differences in PK parameters for plasma E2, TAF and TFV were observed with FHT and F/TAF administration. The geometric mean of FTC AUC0-24 at week 9 was 9% lower than at week 12, but the 90% CI (0.88-0.95) remained within the 80-125% range. There were no significant differences in PBMCs and rectal tissues TFV-DP and FTC-TP concentrations when F/TAF was administered with FHT.RESULTSEighteen participants completed all PK visits. No significant differences in PK parameters for plasma E2, TAF and TFV were observed with FHT and F/TAF administration. The geometric mean of FTC AUC0-24 at week 9 was 9% lower than at week 12, but the 90% CI (0.88-0.95) remained within the 80-125% range. There were no significant differences in PBMCs and rectal tissues TFV-DP and FTC-TP concentrations when F/TAF was administered with FHT.No bidirectional clinically significant DDI between FHT and F/TAF-based PrEP was observed across systemic and local tissue anatomical compartments, supporting the use of oral F/TAF-based PrEP among transgender women.CONCLUSIONSNo bidirectional clinically significant DDI between FHT and F/TAF-based PrEP was observed across systemic and local tissue anatomical compartments, supporting the use of oral F/TAF-based PrEP among transgender women.NCT04590417.CLINICAL TRIAL NUMBERNCT04590417. Concerns regarding potential drug-drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre-exposure prophylaxis (PrEP) may hinder PrEP use among transgender women. We assessed the potential DDI between FHT and emtricitabine-tenofovir alafenamide (F/TAF)-based PrEP among transgender women. Transgender women without HIV who never underwent orchiectomy were enrolled between January and February 2022. Oral FHT (oestradiol valerate 2 mg and cyproterone acetate 25 mg) was initiated at baseline and continued until week 9, while oral PrEP (F/TAF 200/25 mg) was initiated at week 3 and continued until week 12. Intensive blood sampling was performed at weeks 3 and 9 to assess the impact of PrEP on FHT; and weeks 9 and 12 to assess the impact of FHT on PrEP. Pharmacokinetics (PKs) of plasma oestradiol (E2), TAF, tenofovir (TFV) and emtricitabine (FTC); urine TFV and FTC; and tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in peripheral blood mononuclear cells (PBMCs) and rectal tissues were assessed. Eighteen participants completed all PK visits. No significant differences in PK parameters for plasma E2, TAF and TFV were observed with FHT and F/TAF administration. The geometric mean of FTC AUC at week 9 was 9% lower than at week 12, but the 90% CI (0.88-0.95) remained within the 80-125% range. There were no significant differences in PBMCs and rectal tissues TFV-DP and FTC-TP concentrations when F/TAF was administered with FHT. No bidirectional clinically significant DDI between FHT and F/TAF-based PrEP was observed across systemic and local tissue anatomical compartments, supporting the use of oral F/TAF-based PrEP among transgender women. NCT04590417. Introduction Concerns regarding potential drug−drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre‐exposure prophylaxis (PrEP) may hinder PrEP use among transgender women. We assessed the potential DDI between FHT and emtricitabine‐tenofovir alafenamide (F/TAF)‐based PrEP among transgender women. Methods Transgender women without HIV who never underwent orchiectomy were enrolled between January and February 2022. Oral FHT (oestradiol valerate 2 mg and cyproterone acetate 25 mg) was initiated at baseline and continued until week 9, while oral PrEP (F/TAF 200/25 mg) was initiated at week 3 and continued until week 12. Intensive blood sampling was performed at weeks 3 and 9 to assess the impact of PrEP on FHT; and weeks 9 and 12 to assess the impact of FHT on PrEP. Pharmacokinetics (PKs) of plasma oestradiol (E2), TAF, tenofovir (TFV) and emtricitabine (FTC); urine TFV and FTC; and tenofovir‐diphosphate (TFV‐DP) and emtricitabine‐triphosphate (FTC‐TP) in peripheral blood mononuclear cells (PBMCs) and rectal tissues were assessed. Results Eighteen participants completed all PK visits. No significant differences in PK parameters for plasma E2, TAF and TFV were observed with FHT and F/TAF administration. The geometric mean of FTC AUC0−24 at week 9 was 9% lower than at week 12, but the 90% CI (0.88−0.95) remained within the 80–125% range. There were no significant differences in PBMCs and rectal tissues TFV‐DP and FTC‐TP concentrations when F/TAF was administered with FHT. Conclusions No bidirectional clinically significant DDI between FHT and F/TAF‐based PrEP was observed across systemic and local tissue anatomical compartments, supporting the use of oral F/TAF‐based PrEP among transgender women. Clinical Trial Number NCT04590417 Introduction Concerns regarding potential drug−drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre‐exposure prophylaxis (PrEP) may hinder PrEP use among transgender women. We assessed the potential DDI between FHT and emtricitabine‐tenofovir alafenamide (F/TAF)‐based PrEP among transgender women. Methods Transgender women without HIV who never underwent orchiectomy were enrolled between January and February 2022. Oral FHT (oestradiol valerate 2 mg and cyproterone acetate 25 mg) was initiated at baseline and continued until week 9, while oral PrEP (F/TAF 200/25 mg) was initiated at week 3 and continued until week 12. Intensive blood sampling was performed at weeks 3 and 9 to assess the impact of PrEP on FHT; and weeks 9 and 12 to assess the impact of FHT on PrEP. Pharmacokinetics (PKs) of plasma oestradiol (E2), TAF, tenofovir (TFV) and emtricitabine (FTC); urine TFV and FTC; and tenofovir‐diphosphate (TFV‐DP) and emtricitabine‐triphosphate (FTC‐TP) in peripheral blood mononuclear cells (PBMCs) and rectal tissues were assessed. Results Eighteen participants completed all PK visits. No significant differences in PK parameters for plasma E2, TAF and TFV were observed with FHT and F/TAF administration. The geometric mean of FTC AUC0−24 at week 9 was 9% lower than at week 12, but the 90% CI (0.88−0.95) remained within the 80–125% range. There were no significant differences in PBMCs and rectal tissues TFV‐DP and FTC‐TP concentrations when F/TAF was administered with FHT. Conclusions No bidirectional clinically significant DDI between FHT and F/TAF‐based PrEP was observed across systemic and local tissue anatomical compartments, supporting the use of oral F/TAF‐based PrEP among transgender women. Clinical Trial Number NCT04590417 |
| Author | Janamnuaysook, Rena Phanuphak, Nittaya Nonenoy, Siriporn Trichavaroj, Rapee Cressey, Tim R. Hiransuthikul, Akarin Anderson, Peter L. Boonruang, Jakkrapatara Hongchookiat, Piranun Tawon, Yardpiroon Teeratakulpisarn, Nipat Thammajaruk, Narukjaporn Kerr, Stephen |
| AuthorAffiliation | 4 HIV‐NAT, Thai Red Cross AIDS Research Centre Bangkok Thailand 8 Department of Pharmaceutical Sciences University of Colorado, Anschutz Medical Campus Aurora Colorado USA 1 Institute of HIV Research and Innovation (IHRI) Bangkok Thailand 3 Biostatistics Excellence Centre, Faculty of Medicine Chulalongkorn University Bangkok Thailand 2 Department of Preventive and Social Medicine Faculty of Medicine Chulalongkorn University Bangkok Thailand 7 AMS/PHPT Research Collaboration Faculty of Associated Medical Sciences Chiang Mai University Chiang Mai Thailand 5 The Kirby Institute University of New South Wales Sydney New South Wales Australia 6 Center of Excellence in Transgender Health (CETH) Faculty of Medicine Chulalongkorn University Bangkok Thailand |
| AuthorAffiliation_xml | – name: 5 The Kirby Institute University of New South Wales Sydney New South Wales Australia – name: 2 Department of Preventive and Social Medicine Faculty of Medicine Chulalongkorn University Bangkok Thailand – name: 7 AMS/PHPT Research Collaboration Faculty of Associated Medical Sciences Chiang Mai University Chiang Mai Thailand – name: 3 Biostatistics Excellence Centre, Faculty of Medicine Chulalongkorn University Bangkok Thailand – name: 1 Institute of HIV Research and Innovation (IHRI) Bangkok Thailand – name: 8 Department of Pharmaceutical Sciences University of Colorado, Anschutz Medical Campus Aurora Colorado USA – name: 6 Center of Excellence in Transgender Health (CETH) Faculty of Medicine Chulalongkorn University Bangkok Thailand – name: 4 HIV‐NAT, Thai Red Cross AIDS Research Centre Bangkok Thailand |
| Author_xml | – sequence: 1 givenname: Akarin orcidid: 0000-0003-1906-8171 surname: Hiransuthikul fullname: Hiransuthikul, Akarin email: akarin.h@chula.ac.th organization: Chulalongkorn University – sequence: 2 givenname: Narukjaporn surname: Thammajaruk fullname: Thammajaruk, Narukjaporn organization: Institute of HIV Research and Innovation (IHRI) – sequence: 3 givenname: Stephen surname: Kerr fullname: Kerr, Stephen organization: University of New South Wales – sequence: 4 givenname: Rena orcidid: 0000-0002-8054-482X surname: Janamnuaysook fullname: Janamnuaysook, Rena organization: Chulalongkorn University – sequence: 5 givenname: Siriporn surname: Nonenoy fullname: Nonenoy, Siriporn organization: Institute of HIV Research and Innovation (IHRI) – sequence: 6 givenname: Piranun surname: Hongchookiat fullname: Hongchookiat, Piranun organization: Institute of HIV Research and Innovation (IHRI) – sequence: 7 givenname: Rapee surname: Trichavaroj fullname: Trichavaroj, Rapee organization: Institute of HIV Research and Innovation (IHRI) – sequence: 8 givenname: Yardpiroon surname: Tawon fullname: Tawon, Yardpiroon organization: Chiang Mai University – sequence: 9 givenname: Jakkrapatara orcidid: 0009-0004-1097-8157 surname: Boonruang fullname: Boonruang, Jakkrapatara organization: Institute of HIV Research and Innovation (IHRI) – sequence: 10 givenname: Nipat surname: Teeratakulpisarn fullname: Teeratakulpisarn, Nipat organization: Institute of HIV Research and Innovation (IHRI) – sequence: 11 givenname: Tim R. surname: Cressey fullname: Cressey, Tim R. organization: Chiang Mai University – sequence: 12 givenname: Peter L. orcidid: 0000-0002-1200-8494 surname: Anderson fullname: Anderson, Peter L. organization: University of Colorado, Anschutz Medical Campus – sequence: 13 givenname: Nittaya orcidid: 0000-0002-0036-3165 surname: Phanuphak fullname: Phanuphak, Nittaya organization: University of New South Wales |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40390323$$D View this record in MEDLINE/PubMed |
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| Copyright | 2025 The Author(s). published by John Wiley & Sons Ltd on behalf of the International AIDS Society. 2025 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society. 2025. This work is published under http://creativecommons.org/licenses/by/4.0/ (the "License"). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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Transgender Health |
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Concerns regarding potential drug−drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre‐exposure prophylaxis (PrEP) may... Concerns regarding potential drug-drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre-exposure prophylaxis (PrEP) may hinder PrEP use... Introduction Concerns regarding potential drug−drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre‐exposure prophylaxis (PrEP) may... Abstract Introduction Concerns regarding potential drug−drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre‐exposure prophylaxis (PrEP)... |
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| SubjectTerms | Adenine - administration & dosage Adenine - analogs & derivatives Adenine - pharmacokinetics Administration, Oral Adult Alanine Anti-HIV Agents - administration & dosage Anti-HIV Agents - pharmacokinetics Antiretroviral drugs Cyproterone Acetate - administration & dosage Cyproterone Acetate - pharmacokinetics Drug dosages Drug Interactions drug−drug interactions Emtricitabine - administration & dosage Emtricitabine - pharmacokinetics Endocrine therapy Estradiol - administration & dosage Estradiol - pharmacokinetics Female feminizing hormone therapy HIV HIV Infections - prevention & control HIV prevention Human immunodeficiency virus Humans Male Middle Aged Pharmacokinetics Plasma Pre-Exposure Prophylaxis - methods pre‐exposure prophylaxis Prophylaxis Sample size Tenofovir - administration & dosage Tenofovir - analogs & derivatives Tenofovir - pharmacokinetics Testosterone Thailand Transgender Persons transgender women Women Young Adult |
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| Title | No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 study |
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