Gilead Seeks First-Ever Approval for Drug to Prevent HIV

On Thursday, Gilead Sciences Inc. announced it has asked US regulators to approve its once-daily pill Truvada (emtricitabine/tenofovir) as the world's first drug to prevent HIV infection. Gilead has sold Truvada for years as an HIV treatment; the new application seeks to extend Food and Drug Administration (FDA) approval to cover pre-exposure prophylaxis (PrEP) against sexually acquired HIV.

"This is a really exciting moment," said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, adding "the implications are huge." Though health authorities continue to stress the importance of using condoms and avoiding risky behaviors like needle-sharing, "there are many people who can benefit from an additional prevention option," Warren said, urging FDA to expedite the application.

It is not known how FDA will respond to the request, called a supplemental new drug application, and the process could take years. However, several published international studies conducted with federal support have shown Truvada to be effective in blocking sexual HIV transmission.

"The data from these large-scale clinical trials suggest that Truvada may have a role to play in meeting the urgent public health need to reduce new HIV infections," John Martin, Gilead's CEO, said in a statement. "We commend the many institutions, investigators and study volunteers for their commitment to advancing this important area of research."

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