Comparison of the Pharmacokinetics and Pharmacodynamics of Single-Dose Tenofovir Vaginal Film and Gel Formulation (FAME 05).

ABSTRACT: OBJECTIVE:Although preexposure prophylaxis with oral tenofovir (TFV) disoproxil fumarate/emtricitabine reduces HIV acquisition rates, poor adherence to and acceptability of daily vaginal gels have led to development of vaginal film formulations to improve adherence and, potentially, to enable episodic use. STUDY DESIGN:In this 2-arm, cross-over study of a fast-dissolving tenofovir film (40 mg) compared with a previously studied semisolid tenofovir 1% gel (40 mg), 10 healthy women received a single vaginal dose of each study product. Clinical, pharmacokinetic, and antiviral assessments were performed over 1 week after dose. RESULTS:Nine of 10 participants experienced mild to moderate adverse effects, similar between products, with no severe adverse events or events attributed to study produ

SUBMITTER: Robinson JA 

PROVIDER: S-EPMC5821271 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature