May 11, 2012

Panel Recommends HIV Prevention Drug Get FDA Approval

A panel of health experts have backed a drug to prevent HIV infection in healthy people for the first time.

The U.S. panel recommended that regulators approve Truvada for use by people considered at high risk of contracting the AIDS virus.

The U.S. Food and Drug Administration (FDA) is not required to follow the panel's advice, but typically is found to do so.

Advocates who approve of the panel's advice say that it could be a big milestone in the fight against HIV/AIDS.

The FDA has already approved Truvada for people who are HIV-positive, and the drug is taken along with existing anti-retroviral drugs.

According to past studies, Truvada reduced the risk of HIV in healthy gay men and healthy heterosexual men who had HIV-positive partners by between 44 percent and 73 percent.

The Antiviral Drugs Advisory Committee voted 19 to 3 in favor of prescribing the drug to the higher risk group, which include non-infected men who have sex with multiple male partners.

The committee also approved it for uninfected people with HIV-positive partners, and other groups considered at risk of acquiring HIV through sexual activity.

"This brings us closer to a watershed for global HIV prevention efforts," Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, told BBC.

Some who oppose the recommendation are concerned that users could gain a false sense of security.  They also fear that it could lead to a drug-resistant strain of HIV.

"Truvada needs to be taken every day, 100% of the time, and my experience as a registered nurse tells me that won't happen," Nurse Karen Haughey told the panel. "In my eight years, not one patient that I've cared for has been 100% adherent."

The panel debated for 12-hours on whether the drug might lead to the reduced use of condoms, which is considered the most reliable defense against HIV.

The experts also questioned the drug's effectiveness in women, based on what studies have shown.

The panelists recommend that people who are candidates to take Truvada be tested for HIV, because patients who have the virus and begin taking the drug could develop a resistance to it.

Truvada costs $900 a month, which is a little less than $11,000 per year.  The AIDS Healthcare Foundation, which is against the approval of the drug, says that 20 HIV-positive patients could be treated for the cost of treating one patient with the preventive.

"Truvada for prevention will squeeze already-constrained health care resources that can be better spent on cheaper and more effective prevention therapies," the group wrote in a petition to the FDA.

About 1.2 million Americans have HIV, and gay and bisexual men account for nearly two-thirds of the cases.

The FDA is expected to make a decision on whether it will approve the drug for broader use by June 15.


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