Solid, tablet-like dosage form for dual-compartment (vaginal or rectal) on-demand use. Studies in non-human primates demonstrate proof-of-concept that the TAF/EVG insert dosed either vaginally (single dose) or rectally (double dose) provides strong protection against vaginal or rectal SHIV exposure. A Phase I study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a single TAF/EVG insert administered vaginally (CONRAD A18-146) was completed in 2019, and a Phase 1 study to assess PK and safety after rectal administration of the TAF/EVG insert (MTN-039) was completed in April 2021; both studies demonstrated the TAF/EVG insert was well tolerated and provided promising PK and modeled PD results for event-driven HIV (and possibly HSV-2) prophylaxis. A placebo form of this insert was also evaluated in two international, multi-site acceptability studies, including the Quatro study, comparing four vaginal dosage forms in African women, and the MTN-035 (DESIRE) study, comparing three different rectal dosage forms. An expanded Phase 1 safety and PK study of multiple dosings of TAF/EVG insert used vaginally was completed in December 2024 in US, Kenya, and South Africa, with data analysis on-going. Also, the RITE-PrEP study to evaluate multiple dosings of the insert used rectally in both men and women at one site in the US was completed in March 2025, with data analysis planned. A new insert generation with additional antibacterial properties is also under preclinical characterization.

For more information, contact: Meredith Clark at clarkmr@odu.edu /  conradinnovations@odu.edu