FDA approves first pill to help prevent HIV - NBC News

WASHINGTON — The Food and
Drug Administration on Monday
approved the first drug shown to
reduce the risk of HIV infection, a
milestone in the 30-year battle
against the virus that causes AIDS.
The agency approved Gilead
Sciences' pill Truvada as a
preventive measure for people who
are at high risk of acquiring HIV
through sexual activity, such as
those who have HIV-infected
partners.
Public health advocates say the
approval could help slow the
spread of HIV, which has held
steady at about 50,000 new
infections per year for the last 15
years. An estimated 1.2 million
Americans have HIV, which
develops into AIDS unless treated
with antiviral drugs. With an
estimated 240,000 HIV carriers
unaware of their status, doctors
and patients say new methods are
needed to fight the spread of the
virus.
Gilead Sciences Inc. has marketed
Truvada since 2004 as a treatment
for people who are already infected
with the virus.
But starting in 2010, studies
showed that the drug could
actually prevent people from
contracting HIV when used as a
precautionary measure. A three-
year study found that daily doses
cut the risk of infection in healthy
gay and bisexual men by 42
percent, when accompanied by
condoms and counseling.
Last year another study found that
Truvada reduced infection by 75
percent in heterosexual couples in
which one partner was infected
with HIV and the other was not.
Because Truvada is on the market
to manage HIV, some doctors
already prescribe it as a preventive
measure. FDA approval will allow
Gilead Sciences to formally market
the drug for that use, which could
dramatically increase prescribing.
Truvada's groundbreaking
preventive ability has exposed
disagreements about managing
the disease among those in the
HIV community. Groups including
the AIDS Healthcare Foundation
asked the FDA to reject the new
indication, saying it could give
patients a false sense of security
and reduce the use of condoms,
the most reliable preventive
measure against HIV.
But FDA scientists said Monday
said there was no indication from
clinical trials that Truvada users
were more likely to engage in risky
sexual behavior.
"What we found was that condom
use increased over time and
sexually transmitted infections
either remained at baseline levels
or decreased," said Dr. Debra
Birnkrant, FDA's director of
antiviral products. "So in essence,
we don't have any strong evidence
that condoms were not used or
there was a decrease in condom
use."

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