Introduction
PD
VIRUS, SECONDARY
Over 37 million people worldwide are infected with human immunodeficiency virus type 1 (HIV-1) (Development of safe, effective, and acceptable microbicides and pre-exposure prophylaxis (PrEP) products can successfully reduce HIV-1 sexual transmission in young women (Topical tenofovir (TFV), as a 1% vaginal gel, was effective in reducing the incidence of HIV-1 (However, vaginal or rectal administration of pharmaceuticals and PrEP products provides local absorption of drug, resulting in enhanced bioavailability and high concentrations at the portal of virus entry, with limited systemic exposure, decreasing systemic side effects, which may increase adherence (We previously treated cervico-vaginal (CV) explant tissues at varying times pre, during and post exposure to HIV-1The co-primary objectives of the current study as stated in the protocol were to evaluate genital and systemic safety, and describe multi-compartmental pharmacokinetics (PK) after a single vaginal dose of the TAF/EVG vaginal insert in healthy, HIV-1 uninfected women. The secondary objectives of this study were to model pharmacodynamics (PD) 