May 12, 2012
A U.S. Food and Drug Administration (FDA) advisory committee recommended that the agency approve the use of the drug Truvada, manufactured by Gilead Sciences Inc., as a means to help prevent HIV infections. In a series of votes, the FDA panel approved the use of the drug for pre-exposure prophylaxis (PrEP) among HIV-negative people in three categories, including 19-3 in favor for men who have sex with men, 19-2 (with one abstention) for heterosexual serodiscordant couples, and 12-8 (with two people not voting) for other individuals who are at risk of acquiring HIV through sexual activity.
The issue of PrEP leaves the HIV/AIDS community divided.
Of the 40 advocates, people living with HIV/AIDS, and doctors who testified at the 12-hour meeting on Thursday, many were against the use of Truvada for HIV prevention.
Some were concerned that PrEP would usher in a decline in condom use, that the likelihood of adherence would be low, and that giving the drug to people who are unaware that they are positive could lead to drug resistance down the road. There were also questions about side effects of Truvada, the high cost of these drugs, and the lack of equal access that people living with HIV/AIDS have to these drugs.
According to CNN.com, some of those opposed to PrEP included:
Robert Elliott, a registered nurse: "There is no question that, if efforts on using PrEP is widespread, condom use and other means of preventing HIV infection will decrease. At this point we simply don't know enough about how to increase adherence rates to work with the PrEP or how to counteract the risk compensation and the use of PrEP. Until then, PrEP is not and cannot be considered safe and effective for preventing HIV infections."
AIDS Activist Miki Jackson: "A recommendation for the use of Truvada as PrEP is akin to issuing an engraved invitation for lawsuits. To knowingly recommend a drug as powerful as Truvada with such serious side effects and given to people who are perfectly healthy is frightening."
Michael Weinstein, president and founder of the AIDS Healthcare Foundation: "Approving PrEP would be a reckless act."
Supporters had different takes:
Richard Elion, the director of clinical research at the Whitman Walker Clinic in Washington: "We are not winning the battle. Please, we're asking today to allow a modality that's still being developed to be added to our toolbox."
Kirk Myers, the founder and CEO of Abounding Prosperity Inc. who is HIV positive: "This drug is wanted. Another tool we can use. The right thing to do. Without this option, desperation will continue to drive up statistics of new incidents."
Chris Collins, vice president and director of public policy for the American Foundation for AIDS Research: "We need new tools to fight this epidemic that include treatment, condoms and education. PrEP is certainly not for everyone, but it may have a role in bringing HIV-infection rates down. It's time to learn how PrEP may be useful in the real world."
Other media outlets collected similar responses and reactions.
Dr. Robert Grant, who led the panel's research and is the associate director of the Center for AIDS Research at the University of California, San Francisco: "I think this is a huge milestone. I think we are in an era for the first time when we can see the end of the AIDS epidemic."
Dr. Tom Giordano of Baylor College of Medicine: "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."
Jim Pickett, director of prevention advocacy and gay men's health at the AIDS Foundation of Chicago: "10 years down the line [the risk of kidney issues] may be less than the risk for acquiring HIV, which is significantly more problematic and can be fatal. We need options for people. This is one option. It wouldn't be an option for everybody. It's not meant for everybody."
Justin B. Terry-Smith (TheBody.com blogger): "There has to [be] much more production of this drug for this to actually go forward."
A final decision will be made by June 15.
How do you feel about PrEP? Sound off in the comments section!
Kellee Terrell is the former news editor for TheBody.com and TheBodyPRO.com.
Follow Kellee on Twitter: @kelleent.
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