Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Sep 30;77(10):2729-2736.
doi: 10.1093/jac/dkac229.

Impact of feminizing hormone therapy on tenofovir and emtricitabine plasma pharmacokinetics: a nested drug-drug interaction study in a cohort of Brazilian transgender women using HIV pre-exposure prophylaxis

Vitória Berg Cattani  1 , Emilia Moreira Jalil  1 , Leonardo Eksterman  1 , Thiago Torres  1 , Sandra Wagner Cardoso  1 , Cristiane R V Castro  1 , Laylla Monteiro  1 , Erin Wilson  2 , Lane Bushman  3 , Peter Anderson  3 , Valdilea Gonçalves Veloso  1 , Beatriz Grinsztejn  1 , Rita Estrela  1   4 ; PrEParadas study team
Collaborators, Affiliations

Impact of feminizing hormone therapy on tenofovir and emtricitabine plasma pharmacokinetics: a nested drug-drug interaction study in a cohort of Brazilian transgender women using HIV pre-exposure prophylaxis

Vitória Berg Cattani et al. J Antimicrob Chemother. .

Abstract

Objectives: Potential interactions between feminizing hormone therapy (FHT) and pre-exposure prophylaxis (PrEP) may be a barrier to PrEP use among transgender women (TGW). We aimed to assess the impact of FHT on PrEP plasma pharmacokinetics (PK) among TGW.

Methods: This was a PK substudy of the effects of FHT on tenofovir disoproxil fumarate/emtricitabine nested to a trans-specific PrEP demonstration study (NCT03220152). Participants were assigned to receive PrEP only (noFHT) or standardized FHT (sFHT; oestradiol valerate 2-6 mg plus spironolactone 100-300 mg) plus PrEP for 12 weeks, after which they could start any FHT (aFHT). Short- and long-term PK assessment occurred at Weeks 12 and 30-48, respectively (plasma samples prior and 0.5, 1, 2, 4, 6, 8 and 24 h after dose). Non-compartmental PK parameters of tenofovir and emtricitabine were compared as geometric mean ratios (GMRs) between noFHT and PrEP and FHT (sFHT at short-term PK; aFHT at long-term PK) participants.

Results: No differences in tenofovir and emtricitabine plasma PK parameters were observed between the short-term PK of noFHT (n = 12) and sFHT participants (n = 18), except for emtricitabine Cmax [GMR: 1.15 (95% CI: 1.01-1.32)], or between noFHT short-term PK and aFHT long-term PK (n = 13). Most participants were on oestradiol valerate 2 mg at the short-term PK (56%) and 4 mg at the long-term PK (54%). Median (IQR) oestradiol levels were 56.8 (43.2-65.4) pg/mL at short-term PK (sFHT) and 44.8 (24.70-57.30) pg/mL at long-term PK (aFHT). No participants in this analysis seroconverted during the study.

Conclusions: Our results indicate no interaction of FHT on tenofovir levels, further supporting PrEP use among TGW using FHT.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Study flow chart of participants of the PrEParadas DDI substudy. * excluded during data analysis.
Figure 2.
Figure 2.
Concentration versus time at short-term PK assessment of noFHT and sFHT participants. Plasma tenofovir (TFV) and emtricitabine (FTC) at pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 h in TGW are shown in (a) and (b), respectively, for noFHT participants (no FHT, PrEP only; circles, n = 12) and sFHT participants (PrEP plus standardized FHT; squares, n = 18). Data are means with error bars indicating SDs.
See this image and copyright information in PMC

References

    1. Baral SD, Poteat T, Stromdahl Set al. . Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis 2013; 13: 214–22. - PubMed
    1. Grinsztejn B, Jalil EM, Monteiro Let al. . Unveiling of HIV dynamics among transgender women: a respondent-driven sampling study in Rio de Janeiro, Brazil. Lancet HIV 2017; 4: e169–76. - PMC - PubMed
    1. Teixeira SLM, Jalil CM, Jalil EMet al. . Evidence of an untamed HIV epidemic among MSM and TGW in Rio de Janeiro, Brazil: a 2018 to 2020 cross-sectional study using recent infection testing. J Int AIDS Soc 2021; 24: e25743. - PMC - PubMed
    1. Grinsztejn B, Hoagland B, Moreira RIet al. . 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. Lancet HIV 2018; 5: e136–45. - PubMed
    1. Fonner VA, Dalglish SL, Kennedy CEet al. . Effectiveness and safety of oral HIV preexposure prophylaxis for all populations. AIDS 2016; 30: 1973–83. - PMC - PubMed

Publication types