Population pharmacokinetics of tenofovir, emtricitabine and intracellular metabolites in transgender women.

ABSTRACT:

Aims

Transgender women (TGW) have been underrepresented in trials and use gender-affirming hormonal therapies (GAHT) that may alter renal function by significantly increasing creatinine clearance. Population pharmacokinetic (popPK) models and simulations would aid in understanding potential differences in emtricitabine/tenofovir disproxil fumarate (F/TDF) parent-metabolite concentrations in TGW on GAHT when compared to cisgender men (CGM) not exposed to GAHT.

Methods

Pharmacokinetic (PK) data from a Phase 1, open-label clinical trial with directly observed therapy of daily F/TDF consisting of 8 TGW and 8 CGM was utilized for model building. PopPK analysis was performed using nonlinear mixed effects modelling (NONMEM 7.5.0). Covariates of body weight, creatinine clearance, an

SUBMITTER: Tanaudommongkon A 

PROVIDER: S-EPMC9296590 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature