AIDS Prevention: Pill Helps Gay Men Avoid HIV Infection,
Study Finds

Marilynn Marchione | 
11/23/10 09:31 PM |
Associated Press
http://www.huffingtonpost.com/2010/11/23/aids-prevention-new-pill-_n_787327.html

In the nearly 30 years the AIDS epidemic has raged,
there has never been a more hopeful day than this. Three
striking developments took place Tuesday: U.N. officials
said new HIV cases are dropping dramatically worldwide.
A study showed that a daily pill already on pharmacy
shelves could help prevent new infections in gay men.
And the pope opened the way for the use of condoms to
prevent AIDS.

"I don't know of a day where so many pieces are
beginning to align for HIV prevention and treatment, and
frankly with a view to ending the epidemic," said
Mitchell Warren, head of the AIDS Vaccine Advocacy
Coalition, a nonprofit group that works on HIV
prevention research. "This is an incredibly opportune
moment and we have to be sure we seize it."

President Barack Obama said the groundbreaking research
on the AIDS drug "could mark the beginning of a new era
in HIV prevention."

The U.N. report said that new cases dropped nearly 20
percent over the last decade and that 33.3 million
people are living with HIV now.

"We can say with confidence and conviction that we have
broken the trajectory of the AIDS pandemic," said UNAIDS
Executive Director Michel Sidibe in Geneva.

Health officials credit part of the decline to wider
condom use, and on Tuesday, in a historic shift in
church teachings, the Vatican said that using a condom
is a lesser evil than infecting a sexual partner with
HIV.

Condoms remain the best weapon against AIDS, and the new
prevention pill is not the chemical equivalent. But
scientists called it a true breakthrough. The pill,
Gilead Science's Truvada, is already used to treat
people with HIV. A three-year global study found that
daily doses cut the risk of infection in healthy gay and
bisexual men when given with condoms, counseling and
other prevention services.

The drug lowered the chances of infection by 44 percent,
and by 73 percent or more among men who took their pills
most faithfully. Researchers had feared the pills might
give a false sense of security and make men less likely
to use condoms or to limit their partners, but the
opposite happened – risky sex declined.

The results are "a major advance" that can help curb the
epidemic in gay men, said Dr. Kevin Fenton, AIDS
prevention chief at the U.S. Centers for Disease Control
and Prevention. But he warned they may not apply to
people exposed to HIV through male-female sex, drug use
or other ways. Studies in those groups are under way.
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Because Truvada is already on the market, the CDC is
rushing to develop guidelines for doctors who want to
use it to prevent HIV, and urged people to wait until
those are ready.

As a practical matter, price could limit use. The pills
cost $5,000 to $14,000 a year in the United States, but
roughly $140 a year in some poor countries where they
are sold in generic form.

Whether insurers or government health programs should
pay for them is one of the tough issues to be sorted
out, said Dr. Anthony Fauci, director of the National
Institute of Allergy and Infectious Diseases.

"This is an exciting finding," but it "is only one study
in one specific study population," so its impact on
others is unknown, Fauci said.

His institute sponsored the study with the Bill &
Melinda Gates Foundation. The findings were published
online by the New England Journal of Medicine.

It is the third AIDS prevention victory in about a year.
In September 2009, scientists announced that a vaccine
they are now trying to improve protected 1 in 3 people
from getting HIV in a study in Thailand. In July,
research in South Africa showed that a vaginal gel
spiked with an AIDS drug could cut nearly in half a
woman's chances of getting HIV from an infected partner.

Gay and bisexual men account for nearly half of the more
than 1 million Americans living with HIV. Worldwide,
more than 7,000 new infections occur each day. Only 5 to
10 percent of global cases involve sex between men.

"The condom is still the first line of defense," because
it also prevents other sexually spread diseases and
unwanted pregnancies, said the study leader, Dr. Robert
M. Grant of the Gladstone Institutes, a private
foundation affiliated with the University of California,
San Francisco. But many men don't or won't use condoms
all the time, so researchers have been testing other
prevention tools.

AIDS drugs already are used to prevent infection in
health care workers accidentally exposed to HIV, and in
babies born to infected mothers. Taking these drugs
before exposure to the virus may keep it from taking
hold, just as taking malaria pills in advance can
prevent that disease when someone is bitten by an
infected mosquito.

The strategy showed great promise in monkey studies
using tenofovir (brand name Viread) and emtricitabine,
or FTC (Emtriva), sold in combination as Truvada by
California-based Gilead Sciences Inc.

The company donated Truvada for the study, which
involved about 2,500 men at high risk of HIV infection
in Peru, Ecuador, Brazil, South Africa, Thailand and the
United States (San Francisco and Boston). The foreign
sites were chosen because of high rates of HIV infection
and diverse populations.

More than 40 percent of participants had taken money for
sex at least once. At the start of the study, they had
18 partners on average; that dropped to around six by
the end.

The men were given either Truvada or dummy pills. All
had monthly visits to get HIV testing, more pills and
counseling. Every six months, they were tested for other
sexually spread diseases and treated as needed.

After a median follow-up of just over a year, there were
64 HIV infections among the 1,248 men on dummy pills,
and only 36 among the 1,251 on Truvada.

Among men who took their pills at least half the time,
the risk of infection fell by 50 percent. For those who
took pills on 90 percent or more days, risk fell 73
percent. Tests of drug levels in the blood confirmed
that more consistent pill-taking gave better protection,
and in one subgroup, the reduction in risk was 92
percent.

The treatment was safe. Side effects were similar in
both groups except for nausea in the Truvada patients.
Weight loss also was more common in the drug group, but
it occurred in very few. Further study is needed on
possible long-term risks.

All participants will get a chance to take Truvada in an
18-month extension of the study to see if men will take
the pill more consistently if they know it helps, and
whether that provides better protection. About 20,000
people are enrolled in other studies testing Truvada or
its component drugs around the world.

The government will review all ongoing prevention
studies, such as those of vaccines or anti-AIDS gels,
and consider whether people getting dummy medicines
should now get Truvada since it has been shown effective
in gay men.

Gilead may seek approval to market Truvada for
prevention, said Dr. Howard Jaffe, president of the
company's philanthropic arm. Doctors can prescribe it
for this purpose now if patients are willing to pay for
it, and some already do.

Some people have speculated that could expose Gilead to
new liability concerns, if someone took the pill and
then sued if it did not prevent infection.

"The potential for having an intervention like this that
has never been broadly available before raises new
questions. It is something we would have to discuss
internally and externally," Jaffe said.

Until the CDC's detailed advice on Truvada is available,
the agency said gay and bisexual men should use condoms
consistently and correctly, get tested and treated for
HIV and other sexually transmitted diseases, get
counseling and reduce their number of sexual partners.

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