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Silver Spring
(Maryland):
The first drug shown to prevent HIV infection won the
endorsement of a panel of US federal advisers, clearing
the way for a landmark approval in the 30-year fight
against the virus that causes AIDS.
In a series of votes on Thursday, a Food and Drug
Administration advisory panel recommended approval of
the daily pill Truvada for healthy people who are at
high risk of contracting HIV, including gay and bisexual
men and heterosexual couples with one HIV-positive
partner.
The FDA is not required to follow the panel’s
advice, though it usually does. A final decision is
expected by June 15. Gilead Sciences Inc., based in
Foster City, California, has marketed Truvada since 2004
as a treatment for people who are infected with the
virus.
The medication is a combination of two older HIV
drugs, Emtriva and Viread. Doctors usually prescribe it
as part of a drug cocktail to repress the virus. While
panelists ultimately backed Truvada for prevention, the
12-hour meeting highlighted a number of concerns created
by the first drug to prevent HIV.
In particular, the panel debated whether Truvada
might lead to reduced use of condoms, the most reliable
defence against HIV. The experts also questioned the
drug’s effectiveness in women, who have shown much lower
rates of protection in studies. Panelists struggled to
outline steps that would ensure patients take the pill
every day. In clinical trials, patients who didn’t take
their medication diligently were not protected, and
patients in the real world are even more likely to
forget than those in studies.
“The trouble is adherence, but I don’t think it’s
our charge to judge whether people will take the
medicine,” said Dr Tom Giordano of Baylor College of
Medicine, who voted in favour of the drug. “I think our
charge is to judge whether it works when it’s taken and
whether the risks outweigh the benefits.” |
