FDA Panel Recommends Truvada for HIV Prevention
U.S Food and Drug Administration panel on Thursday recommended approval for Truvada - a daily pill aimed at reducing risk of HIV infection in healthy people.
A final decision by FDA is expected by June 15.
Truvada, if approved by FDA will be the first of its kind in preventing the deadly disease. Earlier reports had suggested that preventive medication costs for HIV would cost billions of dollars. The recommendation for approval has come amid concerns that people might not take the pill every day as required. Also, experts feel that the use of pill might lead to reduced use of condoms.
"The trouble is adherence, but I don't think it's our charge to judge whether people will take the medicine. I think our charge is to judge whether it works when it's taken and whether the risks outweigh the benefits,” said Dr. Tom Giordano of Baylor College of Medicine to FoxNews.
"Truvada needs to be taken every day, 100 percent of the time, and my experience as a registered nurse tells me that won't happen .In my eight years, not one patient that I've cared for has been 100 percent adherent." said Karen Haughey, a nurse.
There were people who were optimistic that the drug will work despite all the hurdles.
“I really think this provides for an amazing opportunity to turn the tide of the epidemic. For somebody living with HIV for 23 years, I’m tired of seeing the ongoing infection rate.” said Matthew V. Sharp, a patient advocate on the committee, to Washington Post.
And those who were strongly critical like Lauren V. Wood of the National Cancer Institute who voted against the drug.
“I have significant safety concerns. I want to make the committee aware that there is not a single African American female in any one of the studies put forward for approval. I think that’s unacceptable,” Wood said.
Reports say that the drug is already approved by FDA for treatment of HIV. But, if FDA approves Truvada for PrEP, it will mean that Gilead Sciences, the drug maker, will be able to market it as a drug to prevent HIV as well.
The panel has approved the drug in a series of votes; 19 to 3 in favor of its use in MSM (men who have sex with men.)
Pre-exposure prophylaxis or PrEP is a part of comprehensive HIV prevention services in which HIV negative people who are at high risk, take antiretroviral medication to prevent an HIV infection.
An estimated 1.2 million Americans have HIV, according to CDC.