SILVER SPRING, Md. — The first drug shown
to prevent HIV infection won the
endorsement of a panel of federal advisers
Thursday, clearing the way for a landmark
approval in the 30-year fight against the
virus that causes AIDS.
In a move that could lead to a new
milestone for treatment in the evolution of
the worldwide AIDS epidemic, the Food and
Drug Administration advisory committee
voted 19-3 to endorse the drug's use for
controlling HIV infection among the highest
risk group - men who have sex with men.
The panel also approved Truvada's use for
the domestic partners of HIV-infected
people and others at risk for sexual
transmission, but several members said
there should be more data on the drug's
efficacy to justify its use in the wider
population.
Dr. Lauren Wood of the National Cancer
Institute said she voted against all
preventive applications because clinical
studies did not measure the dangers of
drug-related renal problems among black
people, who are among the hardest
impacted by HIV infection and the most
susceptible to kidney problems linked to
AIDS drugs.
"I don't think that is adequate when you're
talking about the population that is most at
risk," she said.
Studies showed Truvada to be more than 90
percent effective at preventing HIV infection
among test subjects who took the drug as
prescribed, but only 44 percent effective
among test populations that included
intermittent use.
Some witnesses expressed concern that
Truvada's $14,000 a year price tag could
encourage the healthy to treat it as "a party
drug" for weekend use, raising the danger
of increasing HIV drug resistance and
making the treatment harder to obtain for
people who are infected with HIV.
FDA officials also said restrictions could be
easily circumvented because the drug is also
sold to HIV infected patients.
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