PrEP douche achieves more protective drug levels than 2:1:1 oral dosing

This study looked at three prototype tenofovir products designed to be used as an on-demand anal douche for PrEP.

After a single use, protective tenofovir levels in rectal tissue were higher and more durable than those seen following standard 2:1:1 oral dosing with TDF/FTC. The tenofovir dose in the douche was lower than used when taken as oral tablets.

The study involved 21 HIV negative men who used each formulation, separated by at least one month washout each time. The douche needed to be held for five minutes before being expelled.

Drug levels were measured in plasma, peripheral blood mononuclear cells (PBMCs), rectal fluid and colorectal tissue (biopsies) at baseline and over 7 days.

Before the study, 88% of men were interesting in using an on-demand PrEP douche and this increased to 95% after experience in the study.

Weld ED et al. Tenofovir Douche as HIV Preexposure Prophylaxis for Receptive Anal Intercourse: Safety Acceptability Pharmacokinetics and Pharmacodynamics (DREAM 01) The Journal of Infectious Diseases 2023 jiad535
https://doi.org/10.1093/infdis/jiad535