No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 study
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...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-05-01
|
| Series: | Journal of the International AIDS Society |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/jia2.26502 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849736253523623936 |
|---|---|
| author | Akarin Hiransuthikul Narukjaporn Thammajaruk Stephen Kerr Rena Janamnuaysook Siriporn Nonenoy Piranun Hongchookiat Rapee Trichavaroj Yardpiroon Tawon Jakkrapatara Boonruang Nipat Teeratakulpisarn Tim R. Cressey Peter L. Anderson Nittaya Phanuphak the iFACT3 study team |
| author_facet | Akarin Hiransuthikul Narukjaporn Thammajaruk Stephen Kerr Rena Janamnuaysook Siriporn Nonenoy Piranun Hongchookiat Rapee Trichavaroj Yardpiroon Tawon Jakkrapatara Boonruang Nipat Teeratakulpisarn Tim R. Cressey Peter L. Anderson Nittaya Phanuphak the iFACT3 study team |
| author_sort | Akarin Hiransuthikul |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-a52a0e6b5b7a4bb7a1e2e5ff9fdbf7dc |
| institution | DOAJ |
| issn | 1758-2652 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the International AIDS Society |
| spelling | doaj-art-a52a0e6b5b7a4bb7a1e2e5ff9fdbf7dc2025-08-20T03:07:20ZengWileyJournal of the International AIDS Society1758-26522025-05-01285n/an/a10.1002/jia2.26502No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 studyAkarin Hiransuthikul0Narukjaporn Thammajaruk1Stephen Kerr2Rena Janamnuaysook3Siriporn Nonenoy4Piranun Hongchookiat5Rapee Trichavaroj6Yardpiroon Tawon7Jakkrapatara Boonruang8Nipat Teeratakulpisarn9Tim R. Cressey10Peter L. Anderson11Nittaya Phanuphak12the iFACT3 study teamInstitute of HIV Research and Innovation (IHRI) Bangkok ThailandInstitute of HIV Research and Innovation (IHRI) Bangkok ThailandBiostatistics Excellence Centre, Faculty of Medicine Chulalongkorn University Bangkok ThailandInstitute of HIV Research and Innovation (IHRI) Bangkok ThailandInstitute of HIV Research and Innovation (IHRI) Bangkok ThailandInstitute of HIV Research and Innovation (IHRI) Bangkok ThailandInstitute of HIV Research and Innovation (IHRI) Bangkok ThailandAMS/PHPT Research Collaboration Faculty of Associated Medical Sciences Chiang Mai University Chiang Mai ThailandInstitute of HIV Research and Innovation (IHRI) Bangkok ThailandInstitute of HIV Research and Innovation (IHRI) Bangkok ThailandAMS/PHPT Research Collaboration Faculty of Associated Medical Sciences Chiang Mai University Chiang Mai ThailandDepartment of Pharmaceutical Sciences University of Colorado, Anschutz Medical Campus Aurora Colorado USAInstitute of HIV Research and Innovation (IHRI) Bangkok ThailandAbstract 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 NCT04590417https://doi.org/10.1002/jia2.26502drug−drug interactionsfeminizing hormone therapyHIV preventionpre‐exposure prophylaxisThailandtransgender women |
| spellingShingle | Akarin Hiransuthikul Narukjaporn Thammajaruk Stephen Kerr Rena Janamnuaysook Siriporn Nonenoy Piranun Hongchookiat Rapee Trichavaroj Yardpiroon Tawon Jakkrapatara Boonruang Nipat Teeratakulpisarn Tim R. Cressey Peter L. Anderson Nittaya Phanuphak the iFACT3 study team No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 study Journal of the International AIDS Society drug−drug interactions feminizing hormone therapy HIV prevention pre‐exposure prophylaxis Thailand transgender women |
| title | No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 study |
| title_full | No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 study |
| title_fullStr | No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 study |
| title_full_unstemmed | No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 study |
| title_short | No significant drug−drug interaction between oral TAF‐based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT‐3 study |
| title_sort | no significant drug drug interaction between oral taf based prep and feminizing hormone therapy among transgender women in thailand the ifact 3 study |
| topic | drug−drug interactions feminizing hormone therapy HIV prevention pre‐exposure prophylaxis Thailand transgender women |
| url | https://doi.org/10.1002/jia2.26502 |
| work_keys_str_mv | AT akarinhiransuthikul nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT narukjapornthammajaruk nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT stephenkerr nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT renajanamnuaysook nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT siripornnonenoy nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT piranunhongchookiat nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT rapeetrichavaroj nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT yardpiroontawon nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT jakkrapataraboonruang nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT nipatteeratakulpisarn nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT timrcressey nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT peterlanderson nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT nittayaphanuphak nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study AT theifact3studyteam nosignificantdrugdruginteractionbetweenoraltafbasedprepandfeminizinghormonetherapyamongtransgenderwomeninthailandtheifact3study |