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PK substudy of the effects of feminizing hormone therapy (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 26&8197;mg plus spironolactone 100300&8197;mg) plus PrEP for 12&8197;weeks, after which they could start any FHT (aFHT). 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.
When comparing PK parameters between the short-term PK of noFHT (n12) and sFHT participants (n18), the only observably different PK parameter was emtricitabine Cmax (1656 ng/mL in the noFHT group vs 1911 ng/mL in the sFHT group; GMR: 1.15 95 CI: 1.011.32). No differences in PK parameters were detected between the noFHT short-term PK group compared to the aFHT long-term PK group.
Results of this study indicate no interaction of feminizing hormone therapy (FHT) on tenofovir levels, further supporting PrEP use among transgender women using FHT.
Cattani, V, Jalil, E, Eksterman, L, Torres, T, Cardoso, S, Castro, C, Monteiro, L, Wilson, E, Bushman, L, Anderson, P, Veloso, V, Grinsztejn, B, Estrela, R. 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 prop. Journal Of Antimicrobial Chemotherapy. 2022; 10: 2729-2736.