WASHINGTON (AFP) – The first-ever daily pill
to help prevent against HIV was approved
Monday by US regulators for use in
uninfected adults who are at risk for getting
the virus that causes AIDS.
Truvada, made by Gilead Sciences in
California, has been on the market
since 2004 and was approved by the
Food and Drug Administration for a new
use as a tool to help ward off HIV in
otherwise healthy people, in
combination with safe s*x and regular
The pill as pre-exposure prophylaxis (PrEP)
has been hailed by some AIDS experts as a
potent new tool against human
immunodeficiency virus, but some health
care providers are concerned it could
encourage risky s*x behavior.
In addition, the regimen is estimated to cost
around $14,000 per year, making it out of
reach of many.
“Truvada alone should not be used to
prevent HIV infection,” said Debra Birnkrant,
director of the division of antiviral products
at the FDA.
“Truvada as PrEP represents another effective,
evidence-based approach that can be added
to other prevention methods to help reduce
the spread of HIV.”
The FDA said Truvada should be used as
“part of a comprehensive HIV
prevention strategy that includes other
prevention methods, such as safe s*x
practices, risk reduction counseling,
and regular HIV testing.”
Truvada was previously approved as a
treatment for people infected with HIV to be
used in combination with other antiretroviral
The decision by the FDA followed the
advice of an independent panel in May
that supported Truvada for prevention
in uninfected people, after clinical
trials showed it could lower the risk of
HIV in gay men and heteros*xual
One study on Truvada, called the iPrEx trial,
published in 2010 in the New England Journal
of Medicine included 2,499 men who were
s*xually active with other men but were not
infected with the virus that causes AIDS.
Participants were selected at random to take
a daily dose of Truvada — a combination of
200 milligrams of emtricitabine and 300
milligrams of tenofovir disoproxil fumarate
— or a placebo.
Those in the study who took the drug
regularly had almost 73 percent fewer
infections. Across the entire study, including
those who had not been as diligent in taking
Truvada, there were 44 percent fewer
infections than in those who took a placebo.
A second study on 4,758 heteros*xual
couples in which one partner was infected
with HIV and the other was not, showed that
Truvada reduced the risk of becoming infected
by 75 percent compared with a placebo.
Experts have described the results as game-
changing and the first demonstration that an
already-approved oral drug could decrease
the likelihood of HIV infections.
Common side effects were the same as
experienced by people with HIV who
were taking Truvada, and included
diarrhea, nausea, abdominal pain,
headache, and weight loss.
However, adherence rates — meaning how
often people in the study actually took the
drug daily — were low in the study of men
who Be Intimate with men, just 30 percent,
In the study of heteros*xual partners,
adherence was much higher, between 80 and
Therefore, the drug label must include special
instructions for health care providers on how
to counsel potential users of the drug.
The drugmaker must also include a
warning that Truvada for PrEP “must
only be used by individuals who are
confirmed to be HIV-negative prior to
prescribing the drug and at least every
three months during use.”
Gilead Sciences is also required to collect
samples from people who test positive for
HIV while taking the drug and analyze them
for signs of drug resistance.
As to concerns about whether the pill might
boost risky s*x practices and lead people to
abandon condoms as a first line of
protection, Birnkrant said the studies have
not shown that so far.
“We don’t really have any strong evidence to
show that condoms were not used or that
there was a decrease in condom use when
Truvada was used,” she told reporters.
The goal of the approval is to eventually cut
back on the rate of new infections in the
United States, which have stayed steady in
recent years at about 50,000 annually, she
A key goal of the US strategy against HIV/AIDS,
set forth in 2010, is to decrease the number
of new infections by 25 percent by 2015.
“The hope is that over time it will decrease
the rate of new infections or incidence in the