Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactions

Detalhes bibliográficos
Autor(a) principal: Cattani, Vitória Berg
Data de Publicação: 2023
Outros Autores: Jalil, Emilia Moreira, Eksterman, Leonardo, Torres, Thiago, Cardoso, Sandra Wagner, Castro, Cristiane R. V., Monteiro, Laylla, Wilson, Erin, Bushman, Lane, Anderson, Peter, Veloso, Valdiléa G., Grinsztejn, Beatriz, Estrela, Rita
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/60705
Resumo: PrEParadas study team: Brenda Hoagland, Isabele Moura, Daniel M McMahon Waite, Desirée Vieira, José Roberto Granjeiro, Josias Freitas, Toni Santos, Nilo Fernandes, Sandro Nazer, Luana M S Marins, Valéria R T Ribeiro, Robson P N Silva, Giovanna G Costa, Ana Carolina Vieira, Renata A Bastos, Aline Alves, Tania Krstic, Ana Cristina G Ferreira, Monica Derrico, Luciana Kamel, Cristina M Jalil, Eduardo Carvalheira Netto, Marcos Davi G de Sousa, Pedro Leite, Kim Geraldo Mattos, Jessica Bezerra Felix, Tamires Vilela Baião, Gisele Hottz, Natália Gomes Maia, Tamiris Paixão da Silva, Michelle Ramos, Tiago Porto.
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spelling Cattani, Vitória BergJalil, Emilia MoreiraEksterman, LeonardoTorres, ThiagoCardoso, Sandra WagnerCastro, Cristiane R. V.Monteiro, LayllaWilson, ErinBushman, LaneAnderson, PeterVeloso, Valdiléa G.Grinsztejn, BeatrizEstrela, Rita2023-10-04T23:45:23Z2023-10-04T23:45:23Z2023CATTANI, Vitória Berg et al. Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre-Exposure Prophylaxis: Analysis of Potential Interactions. Clinical Pharmacokinetics, v. 62, n. 7, p. 1031-1041, Jul. 2023.0312-5963https://www.arca.fiocruz.br/handle/icict/6070510.1007/s40262-023-01248-01179-1926PrEParadas study team: Brenda Hoagland, Isabele Moura, Daniel M McMahon Waite, Desirée Vieira, José Roberto Granjeiro, Josias Freitas, Toni Santos, Nilo Fernandes, Sandro Nazer, Luana M S Marins, Valéria R T Ribeiro, Robson P N Silva, Giovanna G Costa, Ana Carolina Vieira, Renata A Bastos, Aline Alves, Tania Krstic, Ana Cristina G Ferreira, Monica Derrico, Luciana Kamel, Cristina M Jalil, Eduardo Carvalheira Netto, Marcos Davi G de Sousa, Pedro Leite, Kim Geraldo Mattos, Jessica Bezerra Felix, Tamires Vilela Baião, Gisele Hottz, Natália Gomes Maia, Tamiris Paixão da Silva, Michelle Ramos, Tiago Porto.This work was supported by the Brazilian Ministry of Health (Brasília, Brazil; #01/2013 BRA/K57), Secretaria de Vigilância em Saúde (SVS; #281/2013), and partially supported by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior—CAPES—Finance Code 001. Gilead Sciences donated the study drug and covered costs related to drug concentration assessment, but had no role in study design, collection, analysis, and interpretation of data, writing of the manuscript, or the decision to submit the manuscript for publication.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.University of California. San Francisco, USA.University of Colorado. Aurora, USA.University of Colorado. Aurora, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil / Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Rio de Janeiro, RJ, Brazil.Background and objective: An important barrier to HIV prevention among transgender women (TGW) is the concern that oral pre-exposure prophylaxis (PrEP) negatively affects the efficacy of feminizing hormone therapy (FHT). We aimed to assess the impact of PrEP on FHT pharmacokinetics (PK) among TGW from Brazil. Methods: We performed a drug-drug interaction sub-study among TGW enrolled in a daily oral PrEP demonstration study (PrEParadas, NCT03220152). Participants had a first PK assessment (PK1) 15 days after FHT (estradiol valerate 2-6 mg plus spironolactone 100-200 mg) initiation and then started PrEP (tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg). A second PK evaluation was performed 12 weeks later (PK2). Blood samples were collected prior and after the directly observed dosing (0, 0.5, 1, 2, 4, 6, 8, and 24 hours). Pharmacokinetic parameters of estradiol, spironolactone, and metabolites were estimated by non-compartmental analysis (Monolix 2021R2, Lixoft®) and compared as geometric mean ratios (GMRs, 90% confidence interval [CI]). Results: Among 19 TGW who completed the substudy, median age was 26 years (interquartile range: 23-27.5). Estradiol area under the plasma concentration-time curve (AUCτ) and trough concentrations did not differ between PK1 and PK2 evaluations (GMR [90% CI]: 0.89 [0.76-1.04] and 1.06 [0.94-1.20], respectively). Spironolactone and canrenone AUCτ were statistically lower at PK2 than PK1 (0.76 [0.65-0.89] and 0.85 [0.78-0.94], respectively). Canrenone maximum concentration was also lower at PK2 than PK1 (0.82 [0.74-0.91]). Conclusion: Estradiol PK was not influenced by PrEP concomitant use. The small differences observed in some spironolactone and canrenone PK parameters should not prevent the concomitant use of estradiol-based FHT and PrEP.engSpringerEstradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactionsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleHIVHIV preventionPre-exposure prophylaxis (PrEP)info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/60705/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALve_Vitória_Cattani_etal_INI_2023.pdfve_Vitória_Cattani_etal_INI_2023.pdfapplication/pdf918539https://www.arca.fiocruz.br/bitstream/icict/60705/2/ve_Vit%c3%b3ria_Cattani_etal_INI_2023.pdfa1f94764069095ed56817e9ea6bb30a7MD52icict/607052023-10-04 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dc.title.en_US.fl_str_mv Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactions
title Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactions
spellingShingle Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactions
Cattani, Vitória Berg
HIV
HIV prevention
Pre-exposure prophylaxis (PrEP)
title_short Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactions
title_full Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactions
title_fullStr Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactions
title_full_unstemmed Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactions
title_sort Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre‑Exposure Prophylaxis: Analysis of Potential Interactions
author Cattani, Vitória Berg
author_facet Cattani, Vitória Berg
Jalil, Emilia Moreira
Eksterman, Leonardo
Torres, Thiago
Cardoso, Sandra Wagner
Castro, Cristiane R. V.
Monteiro, Laylla
Wilson, Erin
Bushman, Lane
Anderson, Peter
Veloso, Valdiléa G.
Grinsztejn, Beatriz
Estrela, Rita
author_role author
author2 Jalil, Emilia Moreira
Eksterman, Leonardo
Torres, Thiago
Cardoso, Sandra Wagner
Castro, Cristiane R. V.
Monteiro, Laylla
Wilson, Erin
Bushman, Lane
Anderson, Peter
Veloso, Valdiléa G.
Grinsztejn, Beatriz
Estrela, Rita
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Cattani, Vitória Berg
Jalil, Emilia Moreira
Eksterman, Leonardo
Torres, Thiago
Cardoso, Sandra Wagner
Castro, Cristiane R. V.
Monteiro, Laylla
Wilson, Erin
Bushman, Lane
Anderson, Peter
Veloso, Valdiléa G.
Grinsztejn, Beatriz
Estrela, Rita
dc.subject.en.en_US.fl_str_mv HIV
HIV prevention
Pre-exposure prophylaxis (PrEP)
topic HIV
HIV prevention
Pre-exposure prophylaxis (PrEP)
description PrEParadas study team: Brenda Hoagland, Isabele Moura, Daniel M McMahon Waite, Desirée Vieira, José Roberto Granjeiro, Josias Freitas, Toni Santos, Nilo Fernandes, Sandro Nazer, Luana M S Marins, Valéria R T Ribeiro, Robson P N Silva, Giovanna G Costa, Ana Carolina Vieira, Renata A Bastos, Aline Alves, Tania Krstic, Ana Cristina G Ferreira, Monica Derrico, Luciana Kamel, Cristina M Jalil, Eduardo Carvalheira Netto, Marcos Davi G de Sousa, Pedro Leite, Kim Geraldo Mattos, Jessica Bezerra Felix, Tamires Vilela Baião, Gisele Hottz, Natália Gomes Maia, Tamiris Paixão da Silva, Michelle Ramos, Tiago Porto.
publishDate 2023
dc.date.accessioned.fl_str_mv 2023-10-04T23:45:23Z
dc.date.available.fl_str_mv 2023-10-04T23:45:23Z
dc.date.issued.fl_str_mv 2023
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv CATTANI, Vitória Berg et al. Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre-Exposure Prophylaxis: Analysis of Potential Interactions. Clinical Pharmacokinetics, v. 62, n. 7, p. 1031-1041, Jul. 2023.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/60705
dc.identifier.issn.en_US.fl_str_mv 0312-5963
dc.identifier.doi.none.fl_str_mv 10.1007/s40262-023-01248-0
dc.identifier.eissn.none.fl_str_mv 1179-1926
identifier_str_mv CATTANI, Vitória Berg et al. Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre-Exposure Prophylaxis: Analysis of Potential Interactions. Clinical Pharmacokinetics, v. 62, n. 7, p. 1031-1041, Jul. 2023.
0312-5963
10.1007/s40262-023-01248-0
1179-1926
url https://www.arca.fiocruz.br/handle/icict/60705
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Springer
publisher.none.fl_str_mv Springer
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/60705/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/60705/2/ve_Vit%c3%b3ria_Cattani_etal_INI_2023.pdf
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repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
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