FDA Advisers Back Pill to Help Prevent HIV Infection

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 approval of 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.

But there are potential drawbacks to using the medication as a way to
combat 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
.

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