New formulation of Viread (Gilead Sciences) makes gel safer for rectal use against HIV

New results show that a change in the formulation of Viread (tenofovir gel), from Gilead Sciences, developed for vaginal use to protect against HIV may make it safer to use in the rectum. The rectal epithelium is much thinner than the vaginal lining, so the gel may not be safe or effective to use rectally. To make Viread safe and more amenable to rectal use, researchers from CONRAD, a research organization which holds the rights to develop the gel, reformulated it with a reduced amount of glycerin. suggested it was safe and acceptable in 65 HIV-negative men and women who used it rectally once a day for one week. Results from this study were presented at the 19th Conference on Retroviruses and Opportunistic Infections. Researchers are also planning a Phase II, multi-site trial called MTN-017 that will involve 186 men who have sex with men, and transgender women at clinical sites in Peru, South Africa, Thailand, and the US Participants will cycle through three study regimens: reduced glycerin tenofovir gel used daily, reduced glycerin tenofovir gel used before and after anal sex, and daily use of the antiretroviral tablet Truvada. In addition, a Phase III trial called FACTS 001 is currently evaluating the vaginal formulation of tenofovir gel using the same regimen as CAPRISA 004, with results expected in 2014.