US approves first-ever pill for
HIV prevention, but at 14,000 dollars a yr Truvada shows encouraging signs
WASHINGTON, Jul 17: The first-ever daily pill to
help prevent HIV infection was approved Monday by US regulators for use by
healthy 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 combination
with safe sex and regular testing.
The pill as pre-exposure prophylaxis (PrEP) has
been hailed by some AIDS experts as a potent new tool against human
immunodeficiency virus, while other health care providers are concerned it
could encourage risky sex 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 sex 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
drugs.
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 heterosexual couples.
One study of men who were sexually active with
other men but were not infected with the virus that causes AIDS found 44
percent fewer infections in those taking Truvada versus a placebo.
Those in the study who took the drug regularly had
almost 73 percent fewer infections.
A second study on heterosexual 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.
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, the adherence rate -- meaning how often
people in the study actually took the drug daily -- was low in the study of men
who have sex with men, at just 30 percent, Birnkrant said.
In the study of heterosexual partners, adherence
was much higher, at between 80 and 90 percent.
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."
As to concerns about whether the pill might boost
risky sex 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 said.
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 United States," Birnkrant
said.
The FDA approval drew the support of amfaR, The
Foundation for AIDS Research.
"We know that Truvada, when taken as directed,
works. Now we need to figure out how to properly use it to change the course of
the epidemic," said a statement by amfaR chief executive Kevin Robert
Frost.
However, the AIDS Healthcare Foundation described
the move as "reckless," largely because the FDA recommends but does
not explicitly require a negative HIV test prior to use.
"The FDA's move today is negligence bordering
the equivalence of malpractice which will sadly result in new infections, drug
resistance and serious side effects among many, many people," said AHF
president Michael Weinstein.