Truvada: FDA Delays Decision
On First HIV Prevention Drug
By Matthew Perone, Huffington
June 8, 2012
Associated Press photo in Huffington Post
-- Federal health regulators have delayed a decision
on whether to approve the first pill shown to prevent
HIV infection, the drug's manufacturer says.
Gilead Sciences disclosed Friday that the Food and
Drug Administration will take three more months to
review its application for Truvada, after the company
submitted additional materials to the agency earlier
In May, a panel of experts recommended approval of the
daily pill for healthy people who are at high risk of
contracting HIV, including gay and bisexual men. The
vote was nonbinding, though the FDA often follows the
Gilead said it submitted updated information on its
planned safety materials for patients and doctors
using the drug. The FDA typically extends its reviews
after receiving such information.
The FDA is now expected to rule by Sept. 14, the
company said in a statement.
Gilead Sciences Inc., based in Foster City, Calif.,
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
Truvada made headlines in 2010, when government
researchers showed it 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.
An estimated 1.2 million Americans have HIV, which
develops into AIDS unless treated with antiviral
drugs. AIDS causes the body's immune system to break
down, leading to infections which are eventually
fatal. Gay and bisexual men account for the majority
of cases – nearly two-thirds.
Because Truvada is on the market to manage HIV, some
doctors already prescribe it as a preventive measure.
FDA approval would allow Gilead Sciences to formally
market its drug for that use.
But Truvada's groundbreaking preventive ability has
exposed stark disagreements on prevention among those
in the HIV community. While Truvada's supporters say
the drug is an important new option to stop the spread
of AIDS, critics worry that the drug could give users
a false sense of security and encourage risky
Groups including the AIDS Healthcare Foundation have
asked the FDA to reject the new indication, saying it
could reduce use of condoms, the most consistently
reliable prevention against HIV.
The number of new HIV infections in the U.S. has held
steady for 15 years at about 50,000 per year. With no
vaccine in sight and an estimated 240,000 HIV carriers
unaware of their status, most doctors and patients say
new methods are needed to fight the spread of the
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