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The Food and Drug Administration is
delaying by three months a decision on whether to approve the HIV treatment
Truvada to prevent HIV infection. According to a spokesperson with Gilead
Sciences, its manufacturer, FDA needs time to review a new plan to limit the
drug’s risks to healthy people.
If approved, Truvada would become
the first drug marketed for the prevention of HIV. FDA now is expected to make
a decision by September 14.
In May, an FDA advisory committee
recommended approval of Truvada for HIV prevention in specific high-risk groups,
including men who have sex with men, and partners of those infected. FDA
advisors’ concerns included that men taking the drug would stop using condoms
and that healthy people would not take the drug daily as prescribed.
An HIV testing plan to ensure that
those who are getting Truvada for prevention are HIV-negative also is
“pivotal,” said Mitchell Warren, of the AIDS advocacy group AVAC. He added:
“Gilead has said they will provide free HIV testing” to potential users of
Truvada. Interim CDC guidelines state that anyone who might use Truvada for
prevention must first be tested.
Michael Weinstein, president of the
AIDS Healthcare Foundation, applauded the delay. “From the beginning, we
believe there was a rush to judgment by government officials and others in
favor of ... approval, despite decidedly mixed studies” regarding the drug's
effectiveness, he said.
Studies have shown that taken daily,
Truvada reduces the risk of infection by more than 90 percent. One study was
stopped early because women were not taking Truvada as prescribed and so were
not protected. Side-effects can include intestinal discomfort and diarrhea and,
in rare cases, liver damage.
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.
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