Contra Costa Times (12.15.11) - Friday, December 16, 2011
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."