he Food and Drug Administration on Monday approved the first drug
shown to reduce the risk of HIV infection, the latest milestone in the
30-year battle against the virus that causes AIDS.
The agency approved Gilead Sciences' pill Truvada as a preventive
measure for healthy people who are at high risk of acquiring HIV
through sexual activity, such as those who have HIV-infected partners.
The decision comes less than two weeks after the agency approved another
landmark product: the first over-the-counter HIV test that Americans
can use in the privacy of their homes.
The two developments are seen as the biggest steps in years
toward curbing the spread of HIV in the US, 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. And it's estimated that one-fifth, or about
240,000 people, are unaware that they are infected.
Associated Press
"I think the combination of self-testing and a medicine that you can
take at home to prevent infection could mean a whole new approach to HIV
prevention that is a bit more realistic," said Dr. Demetre Daskalakis
of New York University's Langone Medical Center, who served on the FDA
panel that recommended approving Truvada. While a positive step forward,
Daskalakis added that Truvada would likely be unavailable for many
people without health insurance, who often face the greatest risk of
acquiring HIV.
Researchers had long sought to create a pill that could help stem
the epidemic. Public health advocates said Monday that Truvada
represents a major breakthrough, both as a medical therapy and as a
means of expanding other preventive measures. Patients who get a
prescription for Truvada will be expected to take part in a
comprehensive HIV prevention plan, which experts say will enhance the
drug's impact.
"It really marks a new era in HIV prevention because in adding
Truvada as a prevention strategy, what comes with it is expanded access
to HIV testing, condoms and preventive counseling and support," said
James Loduca, vice president of the San Francisco AIDS Foundation.
But HIV experts have raised concerns that patients might not use
the drug correctly. Dr. Tom Giordano of Baylor College of Medicine said
Monday the drug must be taken every day to be effective, and would be
most effective for a relatively small group of people.
"It's been most effective in people who are at very high risk and
are able to take the drug on a regular basis," said Giordano, who
served on the FDA panel that recommended approving the drug. "When you
really boil it down that's going to be a relatively focused population,
but it's an important population to treat."
The drug's label carries a warning that people should be tested
to make sure they don't have HIV before starting Truvada. Patients who
already have the virus could develop resistance to the drug, making
their disease more difficult to treat. The label also warns of side
effects, including kidney and liver problems.
Gilead Sciences Inc. has marketed Truvada since 2004 as a
treatment for people who are already infected with the virus. The
once-a-day pill is a combination of two older HIV drugs, Emtriva and
Viread.
Starting in 2010, studies showed that the drug could 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 prescriptions.
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."
Gilead Sciences said Monday that it would keep the pill at its
current price, nearly $14,000 per year. Even at that price, HIV
physicians said the drug could be cost effective if it prevents people
from contracting the virus.
"It is expensive, but on the other hand it's far cheaper than a
lifetime of HIV treatment," said Dr. Joel Gallant of Johns Hopkins
University School of Medicine. "So if there are people who will not use
condoms but are willing to use this, then for those people it's cost
effective."
The lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.
The decision by the FDA on Truvada follows its approval of the
OraQuick test earlier this month. The test, which detects the presence
of HIV in saliva collected using a mouth swab and returns a result
within 40 minutes, is aimed at people who might not otherwise be tested.
The FDA has said the test is not 100 percent accurate.
