CONRAD congratulates Global iPrEx study team for HIV prevention trial

Successful trial provides proof of concept for oral use of antiretrovirals in preventing HIV infections in men who have sex with men

CONRAD is pleased to join in congratulating the Global iPrEx study team for their successful trial of oral tenofovir (TDF) with emtricitabine (FTC) for HIV prevention. Results of the National Institutes of Health (NIH) sponsored study were announced today in the New England Journal of Medicine. Daily use of the widely used antiretroviral combination pill was found to be an average of 44% effective in reducing risk of HIV infection in men who have sex with men (MSM), a historically high risk population. Among participants who took the pill at least 50% of the days, risk of HIV infection fell by 50.2%, and among those who used the pill on 90% or more of days, the antiretroviral reduced infection risk by 72.8% .

"This has been an incredible year for those of us working in the field of HIV prevention," said Dr. Henry Gabelnick, Executive Director of CONRAD. "The CAPRISA 004 trial of tenofovir gel broke new ground and now with the successful iPrEx trial, we have some great momentum here in terms of new options for HIV prevention."

The Phase III study of 2499 healthy, sexually active HIV-negative men was conducted at eleven locations in Peru, Ecuador, Boston, San Francisco, South Africa, Brazil and Thailand. The University of California, San Francisco conducted the study which was co-funded by NIH and the Bill and Melinda Gates Foundation, with study medication donated by Gilead Sciences. Pre-exposure prophylaxis (PrEP) is a strategy being studied in several trials as part of an effort to develop new HIV prevention tools. It is a therapy that has been used successfully by HIV-infected mothers during childbirth to reduce an infant's chance of contracting the virus by about 75 percent. Treatment with anti-HIV drugs can also significantly reduce the risk of infection when taken immediately after exposure to the virus.

CONRAD was one of the partners in the CAPRISA 004 study which evaluated 1% tenofovir gel in prevention of male-to-female HIV transmission and was the first study to show that a vaginal gel can reduce the risk of HIV and herpes infection in women. CONRAD manufactured and provided the tenofovir gel for the study. The FDA recently granted Fast Track approval designation for 1% tenofovir gel, and confirmed that the current NIH funded VOICE trial, conducted by the Microbicide Trials Network, can serve as a confirmatory study for the gel.

In 2006, CONRAD and IPM obtained a co-exclusive, royalty-free license from Gilead Sciences to develop 1% tenofovir gel as a topical microbicide for use by women in developing countries to prevent HIV.