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A Food and Drug Administration
advisory panel will consider whether to recommend that FDA approve the first
drug for high-risk but healthy people to take to prevent HIV infection.
Truvada, made by Gilead Sciences Inc., is already one of the most widely used
drugs to treat HIV infection. Gilead has submitted data from two large clinical
trials to support marketing Truvada as pre-exposure prophylaxis (PrEP).
Gilead submitted one study involving
about 2,500 at-risk gay and bisexual men that found the drug, in addition to
other prevention measures like condom use, reduced their HIV infection risk by
44 percent. In another involving about 4,800 serodiscordant heterosexual
couples, HIV infection risk was cut 73 percent among HIV-negative partners
taking Truvada, interim data showed. But a study among some 2,000 women was
stopped last year after it was determined it was unlikely to show whether
Truvada helped prevent infection among them.
The AIDS Healthcare Foundation filed
a petition in March urging FDA to reject the application, saying PrEP data are
not strong enough. AHF also cited worries over side-effects, the drug’s
$14,000-a-year cost, and adherence problems. However, the prevention advocacy
group AVAC is among 14 organizations calling for FDA’s approval.
Dr. Rodney Wright, AHF’s board
chair, said he is concerned about “a blanket approval” of Truvada for PrEP and
the lack of data for it among women. Wright and other physicians already
prescribe Truvada as PrEP on a limited basis, including for serodiscordant
couples wishing to have children. CDC last year released interim PrEP
guidelines for certain men who have sex with men, and it is weighing similar
guidance for heterosexuals.
“PrEP will be the most beneficial
for people at very high risk of HIV infection,” but strict adherence to the
daily regimen is essential, said Jonathan Mermin, director of CDC’s Division of
HIV/AIDS Prevention.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
TOGETHER WE REMAIN STRONG!
