HIV prevention by enhancing compliance of Tenofovir microbicide. Using a Novel delivery system

Abstract

CAPRISA 004 (Centre for the AIDS Programme of Research in South Africa) ( 1 ) revealed that women who had high self-reported adherence with Tenofovir microbicide application achieved a 54% reduction in HIV seroconversion in comparison to placebo. Conversely, there was only a 28% reduction in the poor compliance group. To enhance the adherence of Tenofovir application, we investigated an alternative to the vaginal applicator ( Figure 1 ), which was used before and after intercourse in CAPRISA study. The FemCap contraceptive device ( Figure 2 ) has a unique delivery system for microbicides on its cervical and vaginal sides to ensure better coverage, and retention of gel on the cervix and vagina. To evaluate this delivery system, 20 women compared the use of the vaginal applicator to deliver a vaginal lubricant before and after intercourse versus the FemCap to deliver the same lubricant once before intercourse. Forty percent ( 8 ) women missed the application of the lubricant with the vaginal applicator before intercourse and 10% missed it after intercourse. The FemCap, users (10%) ( 2 ) women missed application of the vaginal lubricant before intercourse and both inserted it after intercourse. The gel was better retained over the cervix by single application with the FemCap versus two applications with the applicator. Participants preferred the FemCap, due to elimination of leakage and the single application, versus two applications with the vaginal applicator. The increased adherence and retention of gel over the cervix by using the FemCap may potentially increase the efficacy of Tenofovir.