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1. Retention, engagement, and adherence to pre-exposure prophylaxis for men who have sex with men and transgender women in PrEP Brasil: 48 week results of a demonstration study

Author

Adão, Valvina Madeira, Alencastro, Paulo R, Amaral, Ana Paula, Araújo, Toni, Araújo, Denivalda, Bertevello, Daniel Artur, Bressani, Cristiane, Cardoso, Sandra Wagner, Carneiro, Robério Alves, Jr., Carvalho, Renan, Cerqueira, Natália Barros, Cocolato, Leandro, da Costa, Marcus Vinícius M., da Silva, Rosângela Vitória Soares, Dantas, Maria Cândida de Souza, de Castro, Cristiane Regina V, Dias, Karine Milani da Silva, Donini, Camila Sunaitis, dos Anjos, Aline Tatiane Lumertz, dos Santos, Arlene Augusta, Estrela, Rita de Cássia Elias, Fernandes, Nilo Martinez, Ferrari, Lilian, Freitas, Josias, Gomes, Tatiane da Silva, Gonzalez, Maura L, Goulart, Raphaela, Granjeiro, José Roberto, Lacerda, Marcus Vinicius G, Menezes, Priscilla de Lima e, Mizuno, Gustavo, Monteiro, Laylla, Moraes, Issler, Moreira, Carlos, Mourão, Denise Sales, Nakagawa, Zelinda Bartolomei, Nazer, Sandro, Neves, Maria Angelica Alcalá, Nogueira, Roberta Schiavon, Odongo, Fatuma, Porto, Tiago, Prado, Gladys, Puerro, Marcia, Reis, Gisele N., Ribeiro, Valéria, Rocha, Charlene, Rodrigues, Camila, Salles, Rafael, Sauer, Mariana, Sousa, Taís, Tavares, Celso Oliveira, Tomiyama, Claudia Satiko, Tomiyama, Helena, Vieira, Desirée, Vieira, Vinicius, Villela, Larissa, Waite, Daniel M. McMahon, Zuccaro, Nélio, Grinsztejn, Beatriz, Hoagland, Brenda, Moreira, Ronaldo I, Kallas, Esper G, Madruga, Jose V, Goulart, Silvia, Leite, Iuri C, Freitas, Lucilene, Martins, Luana M S, Torres, Thiago S, Vasconcelos, Ricardo, De Boni, Raquel B, Anderson, Peter L, Liu, Albert, Luz, Paula M, and Veloso, Valdiléa G

Published
2018
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2. Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre-Exposure Prophylaxis: Analysis of Potential Interactions.

Author

Cattani, Vitória Berg, Jalil, Emilia Moreira, Eksterman, Leonardo, Torres, Thiago, Wagner Cardoso, Sandra, Castro, Cristiane R. V., Monteiro, Laylla, Wilson, Erin, Bushman, Lane, Anderson, Peter, Veloso, Valdilea Gonçalves, Grinsztejn, Beatriz, Estrela, Rita, the PrEParadas study team, Hoagland, Brenda, Moura, Isabele, Waite, Daniel M. McMahon, Vieira, Desirée, Granjeiro, José Roberto, and Freitas, Josias

Subjects
TENOFOVIR, TRANS women, PRE-exposure prophylaxis, HIV, ESTRADIOL, SPIRONOLACTONE, PHARMACOKINETICS
Abstract

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. Trial Registration: This trial (NCT03220152) was registered on July 18, 2017. [ABSTRACT FROM AUTHOR]

Published
2023
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3. Retention, engagement, and adherence to pre-exposure prophylaxis for men who have sex with men and transgender women in PrEP Brasil: 48 week results of a demonstration study

Author

Grinsztejn, Beatriz, primary, Hoagland, Brenda, additional, Moreira, Ronaldo I, additional, Kallas, Esper G, additional, Madruga, Jose V, additional, Goulart, Silvia, additional, Leite, Iuri C, additional, Freitas, Lucilene, additional, Martins, Luana M S, additional, Torres, Thiago S, additional, Vasconcelos, Ricardo, additional, De Boni, Raquel B, additional, Anderson, Peter L, additional, Liu, Albert, additional, Luz, Paula M, additional, Veloso, Valdiléa G, additional, Adão, Valvina Madeira, additional, Alencastro, Paulo R, additional, Amaral, Ana Paula, additional, Araújo, Toni, additional, Araújo, Denivalda, additional, Bertevello, Daniel Artur, additional, Bressani, Cristiane, additional, Cardoso, Sandra Wagner, additional, Carneiro, Robério Alves, additional, Carvalho, Renan, additional, Cerqueira, Natália Barros, additional, Cocolato, Leandro, additional, da Costa, Marcus Vinícius M., additional, da Silva, Rosângela Vitória Soares, additional, Dantas, Maria Cândida de Souza, additional, de Castro, Cristiane Regina V, additional, Dias, Karine Milani da Silva, additional, Donini, Camila Sunaitis, additional, dos Anjos, Aline Tatiane Lumertz, additional, dos Santos, Arlene Augusta, additional, Estrela, Rita de Cássia Elias, additional, Fernandes, Nilo Martinez, additional, Ferrari, Lilian, additional, Freitas, Josias, additional, Gomes, Tatiane da Silva, additional, Gonzalez, Maura L, additional, Goulart, Raphaela, additional, Granjeiro, José Roberto, additional, Lacerda, Marcus Vinicius G, additional, Menezes, Priscilla de Lima e, additional, Mizuno, Gustavo, additional, Monteiro, Laylla, additional, Moraes, Issler, additional, Moreira, Carlos, additional, Mourão, Denise Sales, additional, Nakagawa, Zelinda Bartolomei, additional, Nazer, Sandro, additional, Neves, Maria Angelica Alcalá, additional, Nogueira, Roberta Schiavon, additional, Odongo, Fatuma, additional, Porto, Tiago, additional, Prado, Gladys, additional, Puerro, Marcia, additional, Reis, Gisele N., additional, Ribeiro, Valéria, additional, Rocha, Charlene, additional, Rodrigues, Camila, additional, Salles, Rafael, additional, Sauer, Mariana, additional, Sousa, Taís, additional, Tavares, Celso Oliveira, additional, Tomiyama, Claudia Satiko, additional, Tomiyama, Helena, additional, Vieira, Desirée, additional, Vieira, Vinicius, additional, Villela, Larissa, additional, Waite, Daniel M. McMahon, additional, and Zuccaro, Nélio, additional

Published
2018
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