Ashley Lacombe-Duncan, Alice Tseng, Kimberly K. Scarsi, Tessa Senneker, Hadas Kluger, Yasmeen Persad, Angela Underhill, V. Logan Kennedy, Ian Armstrong, Raymond Fung, Amy Bourns, Quang Nguyen, Susan Hranilovic, Thea Weisdorf, Louie Chan, Hannah Kia, Roberta Halpenny, Harshita Iyer, Nirubini Jeyarajah, George Kovchazov, Wangari Tharao, Mona Loutfy
{"title":"在感染艾滋病毒的变性妇女中开展比特拉韦/恩曲他滨/替诺福韦-阿拉非那酰胺与女性化激素之间的药物相互作用研究。","authors":"Ashley Lacombe-Duncan, Alice Tseng, Kimberly K. Scarsi, Tessa Senneker, Hadas Kluger, Yasmeen Persad, Angela Underhill, V. Logan Kennedy, Ian Armstrong, Raymond Fung, Amy Bourns, Quang Nguyen, Susan Hranilovic, Thea Weisdorf, Louie Chan, Hannah Kia, Roberta Halpenny, Harshita Iyer, Nirubini Jeyarajah, George Kovchazov, Wangari Tharao, Mona Loutfy","doi":"10.1111/bcp.16162","DOIUrl":null,"url":null,"abstract":"<div>\n \n <section>\n \n <h3> Aims</h3>\n \n <p>Trans/transfeminine women are disproportionally affected by HIV. Concerns regarding negative drug–drug interactions (DDIs) between ART drugs and gender-affirming 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-suppressing medications) with the ART regimen (bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF)].</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>We present a protocol for a three-armed, parallel-group, longitudinal (6-month), 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 ≥3 months. Trans women must be taking a stable regimen of ≥2 mg daily oral oestradiol and an anti-androgen (pharmaceutical, and/or surgical, and/or medical) for ≥3 months. 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 (<i>C</i><sub>min</sub>, <i>C</i><sub>max</sub> and AUC) and oestradiol concentrations (<i>C</i><sub>min</sub>, <i>C</i><sub>4h,</sub> <i>C</i><sub>max</sub> and AUC) at month 2.</p>\n </section>\n \n <section>\n \n <h3> Discussion</h3>\n \n <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-saving therapies for trans women with HIV.</p>\n </section>\n </div>","PeriodicalId":9251,"journal":{"name":"British journal of clinical pharmacology","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/bcp.16162","citationCount":"0","resultStr":"{\"title\":\"Protocol of a drug–drug interaction study between bictegravir/emtricitabine/tenofovir alafenamide and feminizing hormones in trans women living with HIV\",\"authors\":\"Ashley Lacombe-Duncan, Alice Tseng, Kimberly K. Scarsi, Tessa Senneker, Hadas Kluger, Yasmeen Persad, Angela Underhill, V. Logan Kennedy, Ian Armstrong, Raymond Fung, Amy Bourns, Quang Nguyen, Susan Hranilovic, Thea Weisdorf, Louie Chan, Hannah Kia, Roberta Halpenny, Harshita Iyer, Nirubini Jeyarajah, George Kovchazov, Wangari Tharao, Mona Loutfy\",\"doi\":\"10.1111/bcp.16162\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n <section>\\n \\n <h3> Aims</h3>\\n \\n <p>Trans/transfeminine women are disproportionally affected by HIV. Concerns regarding negative drug–drug interactions (DDIs) between ART drugs and gender-affirming 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-suppressing medications) with the ART regimen (bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF)].</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>We present a protocol for a three-armed, parallel-group, longitudinal (6-month), 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 ≥3 months. Trans women must be taking a stable regimen of ≥2 mg daily oral oestradiol and an anti-androgen (pharmaceutical, and/or surgical, and/or medical) for ≥3 months. Plasma ART drug concentrations will be sampled at Month 2 and compared between groups 1 and 2. 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Protocol of a drug–drug interaction study between bictegravir/emtricitabine/tenofovir alafenamide and feminizing hormones in trans women living with HIV
Aims
Trans/transfeminine women are disproportionally affected by HIV. Concerns regarding negative drug–drug interactions (DDIs) between ART drugs and gender-affirming 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-suppressing medications) with the ART regimen (bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF)].
Methods
We present a protocol for a three-armed, parallel-group, longitudinal (6-month), 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 ≥3 months. Trans women must be taking a stable regimen of ≥2 mg daily oral oestradiol and an anti-androgen (pharmaceutical, and/or surgical, and/or medical) for ≥3 months. 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 (Cmin, Cmax and AUC) and oestradiol concentrations (Cmin, C4h,Cmax and AUC) at month 2.
Discussion
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-saving therapies for trans women with HIV.
期刊介绍:
Published on behalf of the British Pharmacological Society, the British Journal of Clinical Pharmacology features papers and reports on all aspects of drug action in humans: review articles, mini review articles, original papers, commentaries, editorials and letters. The Journal enjoys a wide readership, bridging the gap between the medical profession, clinical research and the pharmaceutical industry. It also publishes research on new methods, new drugs and new approaches to treatment. The Journal is recognised as one of the leading publications in its field. It is online only, publishes open access research through its OnlineOpen programme and is published monthly.