FDA recommends approval of AIDS drug Truvada for HIV preventionBreaking News, Top Highlights Saturday, May 12th, 2012
On Thursday, an FDA advisory committee voted 19-3 that the agency approve Truvada for pre-exposure prophylaxis, or PrEP, for men who have sex with men and are not infected with HIV. They also voted 19-2 with one abstention to approve the drug for uninfected individuals whose partners are infected with the virus, and 12-8 with two abstentions to extend the approval to anyone who takes part in risky sexual practices.
Truvada is a daily drug that prevents the HIV virus from replicating, as opposed to eliminating it completely. Produced by Gilead Sciences, Inc., the drug is currently used in conjunction with other HIV medication.
Despite the committee’s votes in favor of preventative Truvada approval, over 40 health care professionals and advocates spoke out in resistance to such use, citing the likely decrease in other safe-sex practices and HIV-prevention tactics that might follow Truvada’s broadened availability, as well as the side effects that may harm patients using the drug.
“Approving PrEP would be a reckless act,” said Michael Weinstein, president and founder of the AIDS Healthcare Foundation.
In making their recommendation decision this week, the FDA looked at data from clinical trials that showed 43.8% fewer infections in men who have sex with men who used Truvada, and 63% infection rate reduction in healthy men and women deemed at risk for contracting HIV, as well as a 73% reduction in those who took both Truvada and another HIV drug, tenofovir. They also considered known side effects of Truvada, ranging from loss of appetite, diarrhea, nausea and vomiting to liver and kidney toxicity and bone density loss.
Supporters of the measure argued that health care professionals need more tools to fight AIDS and HIV infection. As American Foundation for AIDS Research vice president Chris Collins stated, “PrEP is certainly not for everyone, but it may have a role in HIV-infection rates down. It’s time to learn how PrEP may be useful in the real world.”
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