The Global Campaign for Microbicides (GCM) welcomes today's news from the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Disease (NIAID) of the US National Institutes of Health (NIH) and the Gladstone Institutes of the University of California, San Francisco that daily use of oral emtricitabine (FTC) with tenofovir (TDF) in one tablet shows promise to safely and effectively help to prevent HIV infection among men who have sex with men (MSM).
The iPrEx Study, conducted in six countries spanning four continents, found an average of 43.8 percent fewer HIV infections among individuals at high risk for infection who took a FTC/TDF tablet compared to those given a placebo tablet. FTC/TDF is already being used to treat people living with HIV infection.
"This has been a landmark year for HIV prevention research," said Yasmin Halima, director of the Global Campaign for Microbicides. "We now have proof of concept that both topical gels and oral pills have potential to work in preventing HIV among those at highest risk."
The Phase III study, which was conducted among 2,499 HIV-negative gay men, male to female transgendered women and other MSM at 11 sites in Brazil, Ecuador, Peru, South Africa, Thailand, and the United States, demonstrates that Pre Exposure Prophylaxis (PrEP), such as FTC/TDF, is likely to be a useful addition to combination approaches, including safer sex counseling and condom use, to prevent HIV in MSM. The study also offers significant insights into human behaviour, risk perceptions and the importance of adherence, all of which will be valuable for existing and future trials.
While the trial did not study the effectiveness of FTC/TDF in women, it gives the Global Campaign and scientific community reason to be optimistic about its potential. Women around the world continue to bear the greatest burden of HIV and findings from other PrEP trials that are currently underway, such as VOICE, will be an important milestone in demonstrating success and the move toward licensure of both the gel and oral pills for women who are most at risk.
Given the Global Campaign's mission to ensure access to new and existing HIV prevention options, especially for women, 2013 the year that results of the VOICE trial are due may prove to be an even more exciting year. The Global Campaign has been advocating for and supporting the critical need for more HIV prevention methods for nearly 12 years.
"There is light at the end of the long HIV prevention research tunnel," continued Halima. "With good news on the product front, efforts must be stepped up to ensure that the drug is approved and political and community will is established for such products to get in the hands of people who need them as quickly as possible."
About the Trial
Global iPrEx, or the Pre-Exposure Prophylaxis Initiative study, is a clinical trial exploring whether two antiretroviral (ARV) medications that are used to treat HIV/AIDS can also help prevent HIV acquisition by HIV-uninfected people at high risk of HIV infection.
The trial, which enrolled its first participant on 19 July 2007, was conducted at 11 sites in Brazil, Ecuador, Peru, South Africa, Thailand, and the United States. A total of 2,499 gay men, male-to-female transgendered women, and other men who have sex with men (MSM) participated.
Global iPrEx is the first large efficacy study to evaluate the use of PrEP in MSM in Africa, Asia, and North and South America. MSM are one of the groups most affected by the HIV/AIDS pandemic. In low- and middle-income countries in these regions, they have a markedly greater risk of being infected with HIV than the general population.
These six countries were chosen because MSM there are highly affected by HIV and because there is good clinical trial infrastructure and experience.
The study was designed to determine whether the daily use of one tablet combining tenofovir (TDF) and emtricitabine (FTC) is safe and effective in preventing HIV transmission among MSM who are at high risk of infection.
Source: Global Campaign for Microbicides