Chicago, November 23, 2010 Results of the world's first efficacy trial of an HIV-prevention approach called oral pre-exposure prophylaxis, or PrEP, were released online in the New England Journal of Medicine today. Data from this trial, called iPrEx, indicated an estimated 43.8% reduction of new HIV infections among men who took an antiretroviral tablet daily to prevent HIV, compared to those who took a placebo pill.
"This discovery alters the HIV prevention landscape forever. While this level of efficacy is relatively strong, PrEP is not quite ready for prime time and work remains before this strategy is rolled out. However, we are thrilled to have a new prevention option beyond male and female condoms visible on the horizon," said Jim Pickett, Director of Advocacy at AIDS Foundation of Chicago and Chair of IRMA International Rectal Microbicide Advocates.
The iPrEx trial evaluated the safety and efficacy of the antiretroviral (ARV) drug TDF/FTC (brand name Truvada) taken once daily for HIV prevention among HIV-negative gay men, transgender women, and other men who have sex with men (MSM).
The participants, 2,499 in all, included individuals from Peru, Ecuador, Brazil, South Africa, Thailand and the United States. Half the men were randomized into the active arm that received Truvada, and the other half were randomized into the placebo arm and received a look-alike pill with no active ingredient. The participants and the researchers did not know who was in either arm. Enrollment for the trial began in June 2007 and was completed in December 2009. The primary analysis of the results released today includes participants who were followed until May 1, 2010, or for an average of 14 months.
Each participant was tested for HIV at monthly trial visits and given intensive pre-and-post test counseling. Additionally, they were regularly screened for sexually transmitted infections and received condoms, making up a very robus
|Contact: Jim Pickett|
International Rectal Microbicide Advocates