The U.S. Food and Drug Administration decided today, July 16, to approve the use of an HIV treatment drug for reducing the risk of acquiring HIV.
Following the recommendation of the Antiviral Drugs Advisory Committee made on May 10, the FDA approved the medication generically known as combination emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, branded as Truvada), for HIV prophylaxis for people who test HIV negative. Truvada is manufactured by Gilead Sciences Inc. in Foster City, Calif., and is currently prescribed with other HIV drugs for treatment of those infected with the virus.
In evaluating whether to allow Truvada to be prescribed for HIV prevention purposes for those who are not HIV infected, the FDA reviewed the evidence from two studies the largest of which was conducted by the University of Washington's International Clinical Research Center (ICRC).
The study, known as the Partners PrEP Study (PrEP is short for pre-exposure prophylaxis), is led by the UW's International Clinical Research Center. Nine research sites in Kenya and Uganda enrolled 4,758 serodiscordant heterosexual couples, in which one partner has HIV and the other does not, and followed them monthly for up to three years.
The Partners PrEP Study is the largest study of its kind to date and found that FTC/TDF reduced the chances of HIV transmission by 75 percent. Not surprisingly, the protective effect was higher when the drug was taken regularly, without missing doses when analyses considered whether participants had detectable levels of the medication in their blood, the protective effect was approximately 9) percent. Results of the study were published July 11 in The New England Journal of Medicine.
"HIV serodiscordant couples recognized their risk, were highly motivated to take PrEP, and the medication offered high levels of protection for both women and men," said Dr. Connie Celum, director of the ICRC and a UW professor of gl
|Contact: Bobbi Nodell|
University of Washington