FDA Delays Gilead's New HIV Prevention Drug

The FDA says it will take at least three months to debate approval of the Foster City-based company's daily drug Truvada, which allegedly prevents HIV infection.

Despite the fact that the Food and Drug Administration (FDA) approve it, the FDA has delayed a vote on whether or not to greenlight Gilead Science's new HIV drug, Truvada.

Truvada, developed by the Foster City-based biotech company Gilead Sciences, can allegedly reduce the risk of spreading and contracting HIV. The drug was designed to be taken daily by those at the highest risk for contracting HIV, such as homosexual and bisexual men.

However, Truvada was dealt a blow Friday when the FDA said it will take at least three months to vote on whether or not to approve the drug.

In May of this year, a panel of experts announced they had found Truvada to be "safe and effective" in reducing risks associated with HIV.

After meeting with the panel of experts last month, Gilead representatives said the company was re-working the safety materials that would be distributed to patients prescribed Truvada. Reportedly, it is common practice for the FDA to extend its review period after receiving such additional information.

Results of a three-year study of the drug were made public back in 2010. The study showed that, when used as a precautionary measure along with condoms and counseling, Truvada helped reduce the risk in gay and bisexual men of contracting HIV by 42 percent. In heterosexual couples in which one is infected with HIV but the other is not, the study showed Truvada helped reduce the risk to the uninfected partner by as much as 75 percent.

However, groups such as the AIDS Healthcare Foundation have expressed concern over the FDA's approval of Truvada, suggesting that the availability of the drug could give some a false sense of security and encourage risky behavior. Such groups assert that condoms are "the most consistently reliable prevention against HIV and AIDS."

The FDA is now expected to rule on Truvada by Sept. 14.


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