THURSDAY, May 10 (HealthDay News) -- U.S. Food and Drug
Administration advisers on Thursday endorsed the use of the drug
Truvada as a means to help prevent HIV infection in healthy people
at high risk of contracting the AIDS-causing virus.
In a series of votes that could lead to a major new weapon in
the fight against AIDS, the FDA advisers recommended approval of
the daily pill for healthy, at-risk individuals, including gay and
bisexual men and heterosexual couples with one HIV-infected person,
the
Associated Press reported.
The FDA is not bound to follow the recommendations of its
advisory panels, but it typically does so. A final decision is
expected by mid-June.
A report released earlier this week by the FDA suggested that
scientists believe the drug is safe and effective. It has been
available since 2004 to treat people already infected with HIV.
But there are potential drawbacks to using the medication as a
way to try to prevent HIV infection. Truvada -- which combines two
HIV-fighting drugs, tenofovir (Viread) and emtricitabine (Emtriva)
-- is very expensive and may cause side effects. And although
doctors can already prescribe it to people trying to avoid HIV
infection, critics contend it's too early to officially allow it to
be promoted for that use.
On the other hand, those who support marketing the drug as a
preventive agent say it can help high-risk people avoid the
disease, especially if they don't use condoms or if they want an
added layer of protection.
"I don't see it as a panacea, but it's an option, and that's important," said Dr. Kenneth Mayer, an AIDS specialist and medical research director of The Fenway Institute at Fenway Health in Boston. "Some people won't use a condom, but will say, 'if you give me another option, I'll use that.'"
Truvada works to combat HIV from replicating in the body's
cells. Mayer explained that in someone who is not yet infected but
is exposed to HIV, the drug may prevent the virus from reproducing
even if it has already invaded cells. As a result, he said, "the
virus cannot start turning the newly exposed person's body into a
'factory' to produce more HIV particles."
A study published in 2010 in the
New England Journal of Medicine found that Truvada cut the
risk of HIV infection by almost 44 percent in those at highest risk
for contracting the virus, namely sexually active gay and bisexual
men. The risk reduction climbed to nearly 73 percent among study
participants who took the pill 90 percent of the time, the
researchers added.
Research suggests that people who use Truvada daily along with
condoms would gain an added layer of protection, because condoms
aren't 100 percent effective. But one organization, the AIDS
Healthcare Foundation, worries that wider use of the drug could
lead to more infections by discouraging people from bothering to
use condoms.
"Why would you take this medication if you intended to use condoms?" asked the group's president, Michael Weinstein, in an interview with Bloomberg News. He used a sartorial metaphor to elaborate how unlikely that might be: "You've got to be really paranoid about your pants falling down to wear a belt and suspenders."
A. David Paltiel, a professor at Yale University School of
Medicine, said his research has shown that the use of preventive
drug treatments should reduce the risk of infection overall. Still,
he said, it's unknown if "people (would) take more chances because
they feel protected by a 'chemical condom.'"
Potential markets for Truvada as a preventive drug, Mayer said,
include gay men who have sex with more than one man and any
committed couple in which one person is HIV-positive, including
some heterosexual couples who want to have children.
Mayer, who has conducted research into the drug, said that
allowing the marketing will probably lead to an increase in its
usage for prevention. But, "this is not a one-time,
end-of-the-problem approach like a shot of penicillin to treat an
infection like syphilis," he said. "Also, it involves someone
perceiving that he or she is at risk, or a provider being
comfortable enough to ask about a person's risk. We know that a lot
of health providers don't like to talk to their patients about
sex."
Truvada, which is manufactured by Gilead Sciences, can also
cause a long list of side effects, including gastrointestinal
problems. And it's costly, with prices in the United States tagged
at about $26 a day or $10,000 a year. Still, a study released this
year found the drug would be cost-effective if used extensively by
gay and bisexual men at high risk of becoming infected.
For his part, Paltiel said his research came to the same
conclusion: That widespread use of the drug in high-risk people
would be "as cost-effective as other widely accepted public health
and medical interventions."
More information
Find out more about HIV/AIDS at the
U.S. National Library of Medicine.