FDA Panel Clears Way For HIV Prevention Pill

UPDATE: The FDA's advisory panel on Thursday signed off on using a popular HIV-fighting pill as a preemptive measure to prevent healthy people from contracting the virus in the first place, a landmark decision that could play a major role in the worldwide fight against AIDS.

The move was the latest in a series that most likely puts Gilead Science's Truvada on track for final federal approval next month. While the FDA isn't bound to follow the independent panel's advice, it traditionally does, and federal drug regulators have already affirmed existing research showing the pill is effective at preemptive protection.

While there was overwhelming support for approving the medication for the highest-risk group (men who have sex with men), there was more substantial dissent among the panel when it came to approving Truvada for use in the wider population, Reuters reports. The biggest fear: that people who become infected while on the drug could develop drug-resistant trains of the virus.

Tuesday, May 8: Federal drug regulators on Tuesday set the stage for FDA approval of a popular pill designed to help combat HIV to be used as a preemptive prescription to prevent healthy people from contracting the virus in the first place.

The Associated Press explains that Tuesday's decision by FDA reviewers to affirm existing research showing the pill is effective for such use may make the final bureaucratic steps toward official approval mostly a formality.

A panel of FDA advisers will meet Thursday to vote on whether to approve the drug, Gilead Science's Truvada, for people who have HIV-positive partners, gay and bisexual men, and others at high risk. While the agency isn't bound by the panel's decision, it traditionally follows its recommendation and would be all the more likely to do so given Tuesday's finding, according to the AP.

Still, Tuesday's affirmation of the pill as a preventative measure came with a word of caution: the drug must be taken on a daily basis to prove effective.

Meanwhile, Reuters flags another potential problem: Truvada's price. Stanford University researchers have estimated that giving a daily preventive dose to all U.S men at risk from having gay sex would cost nearly $500 billion over 20 years, when the cost of the drug and health-care visits are taken into account.

You can read more on Truvada and its trial successes (and failures) over at the Associated Press.