Gender-Affirming Hormone Pharmacokinetics Among Adolescent and Young Adult Transgender Persons Receiving Daily Emtricitabine/Tenofovir Disoproxil Fumarate
Transgender persons have an increased vulnerability to HIV infection yet have not been well-represented in past clinical trials for pre-exposure prophylaxis (PrEP). Because of this, there are few data available to understand whether gender-affirming hormone concentrations are influenced by PrEP agen...
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| Veröffentlicht in: | AIDS research and human retroviruses 2022-12, Vol.38 (12), p.939-943 |
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| creator | Yager, Jenna Brooks, Kristina M Brothers, Jennifer Mulligan, Kathleen Landovitz, Raphael J Reirden, Daniel Malhotra, Meenakshi Glenny, Carrie Harding, Paul Powell, Tina Anderson, Peter L Hosek, Sybil |
| description | Transgender persons have an increased vulnerability to HIV infection yet have not been well-represented in past clinical trials for pre-exposure prophylaxis (PrEP). Because of this, there are few data available to understand whether gender-affirming hormone concentrations are influenced by PrEP agents in transgender men (TM) and transgender women (TW). The objective of this study was to compare gender-affirming hormone concentrations with versus without emtricitabine (F, FTC)-tenofovir disoproxil fumarate (TDF). TM and TW without HIV, aged 15-24 years, were enrolled for 1 month of directly observed daily F/TDF. Participants were required to be receiving a stable hormone dose (estradiol or testosterone) for at least 1 month or three consecutive doses, whichever was longer, before enrollment and willing to continue the same dose. Intensive pharmacokinetic (PK) sampling for gender-affirming hormones was collected before and 2-3 weeks after daily F/TDF. Serum estradiol and total testosterone were determined by liquid chromatography-tandem mass spectrometry; free testosterone by equilibrium dialysis. Maximum concentrations (C
) and area under the curve (AUC
) were log-transformed and compared between baseline and on F/TDF using geometric mean ratios (GMRs) with 95% confidence intervals (CIs). Twenty-five TW and 24 TM were enrolled (median age: 20 and 21 years, respectively). In TW, estradiol C
(GMR [95% CI]: 0.85 [0.65-1.11]) and AUC
(GMR [95% CI]: 0.87 [0.73-1.03]) were comparable on F/TDF versus baseline. In TM, similar comparability was observed for PrEP versus baseline including total testosterone C
(GMR [95% CI]: 0.91 [0.80-1.03]) and AUC
(GMR [95% CI]: 0.91 [0.81-1.04]) and free testosterone C
(GMR [95% CI]: 0.89 [0.74-1.07]) and AUC
(GMR [95% CI]: 0.88 [0.74-1.03]). Estradiol and testosterone exposures in young TW and TM did not significantly differ on F/TDF versus baseline. These findings should reassure patients and providers that F/TDF can be used as PrEP without concern for altering gender-affirming hormone PK. ClinicalTrials.gov (NCT03652623). |
| doi_str_mv | 10.1089/AID.2022.0044 |
| format | Article |
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) and area under the curve (AUC
) were log-transformed and compared between baseline and on F/TDF using geometric mean ratios (GMRs) with 95% confidence intervals (CIs). Twenty-five TW and 24 TM were enrolled (median age: 20 and 21 years, respectively). In TW, estradiol C
(GMR [95% CI]: 0.85 [0.65-1.11]) and AUC
(GMR [95% CI]: 0.87 [0.73-1.03]) were comparable on F/TDF versus baseline. In TM, similar comparability was observed for PrEP versus baseline including total testosterone C
(GMR [95% CI]: 0.91 [0.80-1.03]) and AUC
(GMR [95% CI]: 0.91 [0.81-1.04]) and free testosterone C
(GMR [95% CI]: 0.89 [0.74-1.07]) and AUC
(GMR [95% CI]: 0.88 [0.74-1.03]). Estradiol and testosterone exposures in young TW and TM did not significantly differ on F/TDF versus baseline. These findings should reassure patients and providers that F/TDF can be used as PrEP without concern for altering gender-affirming hormone PK. ClinicalTrials.gov (NCT03652623).</description><identifier>ISSN: 0889-2229</identifier><identifier>ISSN: 1931-8405</identifier><identifier>EISSN: 1931-8405</identifier><identifier>DOI: 10.1089/AID.2022.0044</identifier><identifier>PMID: 35815468</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>17β-Estradiol ; Adolescent ; Adolescents ; Adult ; Anti-HIV Agents - therapeutic use ; Clinical Trial/Clinical Study ; Clinical trials ; Dialysis ; Emtricitabine ; Emtricitabine - therapeutic use ; Equilibrium dialysis ; Estradiol ; Female ; Gender ; HIV ; HIV Infections - drug therapy ; HIV Infections - prevention & control ; Hormones ; Human immunodeficiency virus ; Humans ; Liquid chromatography ; Male ; Mass spectrometry ; Mass spectroscopy ; Pharmacokinetics ; Pharmacology ; Pre-Exposure Prophylaxis - methods ; Prophylaxis ; Reverse Transcriptase Inhibitors - therapeutic use ; Sex hormones ; Tenofovir ; Tenofovir - therapeutic use ; Testosterone ; Transgender Persons ; Young Adult ; Young adults</subject><ispartof>AIDS research and human retroviruses, 2022-12, Vol.38 (12), p.939-943</ispartof><rights>Copyright Mary Ann Liebert, Inc. Dec 2022</rights><rights>Copyright 2022, Mary Ann Liebert, Inc., publishers 2022 Mary Ann Liebert, Inc., publishers</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-59bcd78e7f592d0857316c558cbf97ac4a24f62220f773a1b122d4498d9fc0b93</citedby><cites>FETCH-LOGICAL-c415t-59bcd78e7f592d0857316c558cbf97ac4a24f62220f773a1b122d4498d9fc0b93</cites><orcidid>0000-0001-7841-1465</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35815468$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yager, Jenna</creatorcontrib><creatorcontrib>Brooks, Kristina M</creatorcontrib><creatorcontrib>Brothers, Jennifer</creatorcontrib><creatorcontrib>Mulligan, Kathleen</creatorcontrib><creatorcontrib>Landovitz, Raphael J</creatorcontrib><creatorcontrib>Reirden, Daniel</creatorcontrib><creatorcontrib>Malhotra, Meenakshi</creatorcontrib><creatorcontrib>Glenny, Carrie</creatorcontrib><creatorcontrib>Harding, Paul</creatorcontrib><creatorcontrib>Powell, Tina</creatorcontrib><creatorcontrib>Anderson, Peter L</creatorcontrib><creatorcontrib>Hosek, Sybil</creatorcontrib><title>Gender-Affirming Hormone Pharmacokinetics Among Adolescent and Young Adult Transgender Persons Receiving Daily Emtricitabine/Tenofovir Disoproxil Fumarate</title><title>AIDS research and human retroviruses</title><addtitle>AIDS Res Hum Retroviruses</addtitle><description>Transgender persons have an increased vulnerability to HIV infection yet have not been well-represented in past clinical trials for pre-exposure prophylaxis (PrEP). Because of this, there are few data available to understand whether gender-affirming hormone concentrations are influenced by PrEP agents in transgender men (TM) and transgender women (TW). The objective of this study was to compare gender-affirming hormone concentrations with versus without emtricitabine (F, FTC)-tenofovir disoproxil fumarate (TDF). TM and TW without HIV, aged 15-24 years, were enrolled for 1 month of directly observed daily F/TDF. Participants were required to be receiving a stable hormone dose (estradiol or testosterone) for at least 1 month or three consecutive doses, whichever was longer, before enrollment and willing to continue the same dose. Intensive pharmacokinetic (PK) sampling for gender-affirming hormones was collected before and 2-3 weeks after daily F/TDF. Serum estradiol and total testosterone were determined by liquid chromatography-tandem mass spectrometry; free testosterone by equilibrium dialysis. Maximum concentrations (C
) and area under the curve (AUC
) were log-transformed and compared between baseline and on F/TDF using geometric mean ratios (GMRs) with 95% confidence intervals (CIs). Twenty-five TW and 24 TM were enrolled (median age: 20 and 21 years, respectively). In TW, estradiol C
(GMR [95% CI]: 0.85 [0.65-1.11]) and AUC
(GMR [95% CI]: 0.87 [0.73-1.03]) were comparable on F/TDF versus baseline. In TM, similar comparability was observed for PrEP versus baseline including total testosterone C
(GMR [95% CI]: 0.91 [0.80-1.03]) and AUC
(GMR [95% CI]: 0.91 [0.81-1.04]) and free testosterone C
(GMR [95% CI]: 0.89 [0.74-1.07]) and AUC
(GMR [95% CI]: 0.88 [0.74-1.03]). Estradiol and testosterone exposures in young TW and TM did not significantly differ on F/TDF versus baseline. These findings should reassure patients and providers that F/TDF can be used as PrEP without concern for altering gender-affirming hormone PK. ClinicalTrials.gov (NCT03652623).</description><subject>17β-Estradiol</subject><subject>Adolescent</subject><subject>Adolescents</subject><subject>Adult</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Clinical Trial/Clinical Study</subject><subject>Clinical trials</subject><subject>Dialysis</subject><subject>Emtricitabine</subject><subject>Emtricitabine - therapeutic use</subject><subject>Equilibrium dialysis</subject><subject>Estradiol</subject><subject>Female</subject><subject>Gender</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - prevention & control</subject><subject>Hormones</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Liquid chromatography</subject><subject>Male</subject><subject>Mass spectrometry</subject><subject>Mass spectroscopy</subject><subject>Pharmacokinetics</subject><subject>Pharmacology</subject><subject>Pre-Exposure Prophylaxis - methods</subject><subject>Prophylaxis</subject><subject>Reverse Transcriptase Inhibitors - therapeutic use</subject><subject>Sex hormones</subject><subject>Tenofovir</subject><subject>Tenofovir - therapeutic use</subject><subject>Testosterone</subject><subject>Transgender Persons</subject><subject>Young Adult</subject><subject>Young adults</subject><issn>0889-2229</issn><issn>1931-8405</issn><issn>1931-8405</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkU9rFDEYxoModls9epWAl15mm2SSneQiDN3-g4JF1oOnkMmfbepMsiYzi_0qftpm2lrUU-DNjx_P-z4AfMBoiREXJ-3VekkQIUuEKH0FFljUuOIUsddggTgXFSFEHIDDnO8QQoIQ9hYc1IxjRld8AX5f2GBsqlrnfBp82MLLmIYYLLy5VWlQOv7wwY5eZ9iW8Ra2JvY2axtGqIKB3-P0OJz6EW6SCnn76IM3NuUYMvxqtfX72btWvr-HZ8OYvPaj6or2ZGNDdHHvE1z7HHcp_vI9PJ8GldRo34E3TvXZvn9-j8C387PN6WV1_eXi6rS9rjTFbKyY6LRpuG0cE8QgzpoarzRjXHdONEpTRahblSsg1zS1wh0mxFAquBFOo07UR-Dzk3c3dYM182pJ9XKXfMlxL6Py8t-f4G_lNu6lEBhhxIrg-FmQ4s_J5lEOvlyo71WwccqSrDifc4kZ_fQfehenFMp6kjSs5gTRBheqeqJ0ijkn617CYCTn1qXyRs6ty7n1wn_8e4MX-k_N9QPsFauz</recordid><startdate>202212</startdate><enddate>202212</enddate><creator>Yager, Jenna</creator><creator>Brooks, Kristina M</creator><creator>Brothers, Jennifer</creator><creator>Mulligan, Kathleen</creator><creator>Landovitz, Raphael J</creator><creator>Reirden, Daniel</creator><creator>Malhotra, Meenakshi</creator><creator>Glenny, Carrie</creator><creator>Harding, Paul</creator><creator>Powell, Tina</creator><creator>Anderson, Peter L</creator><creator>Hosek, Sybil</creator><general>Mary Ann Liebert, Inc</general><general>Mary Ann Liebert, Inc., publishers</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T5</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>M7N</scope><scope>P64</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7841-1465</orcidid></search><sort><creationdate>202212</creationdate><title>Gender-Affirming Hormone Pharmacokinetics Among Adolescent and Young Adult Transgender Persons Receiving Daily Emtricitabine/Tenofovir Disoproxil Fumarate</title><author>Yager, Jenna ; Brooks, Kristina M ; Brothers, Jennifer ; Mulligan, Kathleen ; Landovitz, Raphael J ; Reirden, Daniel ; Malhotra, Meenakshi ; Glenny, Carrie ; Harding, Paul ; Powell, Tina ; Anderson, Peter L ; Hosek, Sybil</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-59bcd78e7f592d0857316c558cbf97ac4a24f62220f773a1b122d4498d9fc0b93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>17β-Estradiol</topic><topic>Adolescent</topic><topic>Adolescents</topic><topic>Adult</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Clinical Trial/Clinical Study</topic><topic>Clinical trials</topic><topic>Dialysis</topic><topic>Emtricitabine</topic><topic>Emtricitabine - therapeutic use</topic><topic>Equilibrium dialysis</topic><topic>Estradiol</topic><topic>Female</topic><topic>Gender</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - prevention & control</topic><topic>Hormones</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Liquid chromatography</topic><topic>Male</topic><topic>Mass spectrometry</topic><topic>Mass spectroscopy</topic><topic>Pharmacokinetics</topic><topic>Pharmacology</topic><topic>Pre-Exposure Prophylaxis - methods</topic><topic>Prophylaxis</topic><topic>Reverse Transcriptase Inhibitors - therapeutic use</topic><topic>Sex hormones</topic><topic>Tenofovir</topic><topic>Tenofovir - therapeutic use</topic><topic>Testosterone</topic><topic>Transgender Persons</topic><topic>Young Adult</topic><topic>Young adults</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yager, Jenna</creatorcontrib><creatorcontrib>Brooks, Kristina M</creatorcontrib><creatorcontrib>Brothers, Jennifer</creatorcontrib><creatorcontrib>Mulligan, Kathleen</creatorcontrib><creatorcontrib>Landovitz, Raphael J</creatorcontrib><creatorcontrib>Reirden, Daniel</creatorcontrib><creatorcontrib>Malhotra, Meenakshi</creatorcontrib><creatorcontrib>Glenny, Carrie</creatorcontrib><creatorcontrib>Harding, Paul</creatorcontrib><creatorcontrib>Powell, Tina</creatorcontrib><creatorcontrib>Anderson, Peter L</creatorcontrib><creatorcontrib>Hosek, Sybil</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>AIDS research and human retroviruses</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yager, Jenna</au><au>Brooks, Kristina M</au><au>Brothers, Jennifer</au><au>Mulligan, Kathleen</au><au>Landovitz, Raphael J</au><au>Reirden, Daniel</au><au>Malhotra, Meenakshi</au><au>Glenny, Carrie</au><au>Harding, Paul</au><au>Powell, Tina</au><au>Anderson, Peter L</au><au>Hosek, Sybil</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Gender-Affirming Hormone Pharmacokinetics Among Adolescent and Young Adult Transgender Persons Receiving Daily Emtricitabine/Tenofovir Disoproxil Fumarate</atitle><jtitle>AIDS research and human retroviruses</jtitle><addtitle>AIDS Res Hum Retroviruses</addtitle><date>2022-12</date><risdate>2022</risdate><volume>38</volume><issue>12</issue><spage>939</spage><epage>943</epage><pages>939-943</pages><issn>0889-2229</issn><issn>1931-8405</issn><eissn>1931-8405</eissn><abstract>Transgender persons have an increased vulnerability to HIV infection yet have not been well-represented in past clinical trials for pre-exposure prophylaxis (PrEP). Because of this, there are few data available to understand whether gender-affirming hormone concentrations are influenced by PrEP agents in transgender men (TM) and transgender women (TW). The objective of this study was to compare gender-affirming hormone concentrations with versus without emtricitabine (F, FTC)-tenofovir disoproxil fumarate (TDF). TM and TW without HIV, aged 15-24 years, were enrolled for 1 month of directly observed daily F/TDF. Participants were required to be receiving a stable hormone dose (estradiol or testosterone) for at least 1 month or three consecutive doses, whichever was longer, before enrollment and willing to continue the same dose. Intensive pharmacokinetic (PK) sampling for gender-affirming hormones was collected before and 2-3 weeks after daily F/TDF. Serum estradiol and total testosterone were determined by liquid chromatography-tandem mass spectrometry; free testosterone by equilibrium dialysis. Maximum concentrations (C
) and area under the curve (AUC
) were log-transformed and compared between baseline and on F/TDF using geometric mean ratios (GMRs) with 95% confidence intervals (CIs). Twenty-five TW and 24 TM were enrolled (median age: 20 and 21 years, respectively). In TW, estradiol C
(GMR [95% CI]: 0.85 [0.65-1.11]) and AUC
(GMR [95% CI]: 0.87 [0.73-1.03]) were comparable on F/TDF versus baseline. In TM, similar comparability was observed for PrEP versus baseline including total testosterone C
(GMR [95% CI]: 0.91 [0.80-1.03]) and AUC
(GMR [95% CI]: 0.91 [0.81-1.04]) and free testosterone C
(GMR [95% CI]: 0.89 [0.74-1.07]) and AUC
(GMR [95% CI]: 0.88 [0.74-1.03]). Estradiol and testosterone exposures in young TW and TM did not significantly differ on F/TDF versus baseline. These findings should reassure patients and providers that F/TDF can be used as PrEP without concern for altering gender-affirming hormone PK. ClinicalTrials.gov (NCT03652623).</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>35815468</pmid><doi>10.1089/AID.2022.0044</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0001-7841-1465</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0889-2229 |
| ispartof | AIDS research and human retroviruses, 2022-12, Vol.38 (12), p.939-943 |
| issn | 0889-2229 1931-8405 1931-8405 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9910105 |
| source | MEDLINE; Alma/SFX Local Collection |
| subjects | 17β-Estradiol Adolescent Adolescents Adult Anti-HIV Agents - therapeutic use Clinical Trial/Clinical Study Clinical trials Dialysis Emtricitabine Emtricitabine - therapeutic use Equilibrium dialysis Estradiol Female Gender HIV HIV Infections - drug therapy HIV Infections - prevention & control Hormones Human immunodeficiency virus Humans Liquid chromatography Male Mass spectrometry Mass spectroscopy Pharmacokinetics Pharmacology Pre-Exposure Prophylaxis - methods Prophylaxis Reverse Transcriptase Inhibitors - therapeutic use Sex hormones Tenofovir Tenofovir - therapeutic use Testosterone Transgender Persons Young Adult Young adults |
| title | Gender-Affirming Hormone Pharmacokinetics Among Adolescent and Young Adult Transgender Persons Receiving Daily Emtricitabine/Tenofovir Disoproxil Fumarate |
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