Rapporteur report
Track C report by Gaston Djomand
A review of the most suitable in vitro models for candidate microbicides was presented. Despite the primary focus of showing antiviral activity on pathogens and safety profile, there was the recognition that these models needed to include elements reflecting aspects of sexual transmission such as dendritic cells , epithelial cells , seminal and vaginal fluid factors. Other issues to improve model fitness account included documentation of antiviral activity against cell-free and cell associated HIV and monitoring for emergence of possible resistance.
There are currently 3 (NRTI) microbicides (Tenofovir, Dapavirine and UC-781) undergoing clinical development. Most of them have evaluated safety in men and women. One efficacy trial with Tenofovir in gel formulation is underway and will be completed in 201-0. Two large efficacy trials with tenofovir along or in combination with other antivirals (VOICE and IPM-009) are planned to start within the next 2 years. There are 5 ongoing and 2 planned PrEP trials. Of particular interest are the “partners PrEP trial” in Uganda and Kenya enrolling discordant couples and the VOICE trial planning to compare efficacy of vaginal versus oral formulations of PreP. Mathematical modeling of the impact of PrEP on the emergence of drug resistance indicated that improper use of PrEP may increase the population prevalence of drug resistance. However, even with low levels of resistance, the effectiveness of PREP may still be preserved. Lastly, it was recommended that any PrEP rollout be coupled with VCT.
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