The
recent approval of the first-ever daily pill to help prevent against
HIV was by US regulators has raised concerns of encouraging risky sex
behaviour.
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 sex and regular testing. It was
approved by the United States yesterday for use in uninfected adults who
are at risk for getting the virus that causes AIDS.
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
sex behavior.
Now, let’s try to understand this drug better.
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 on Truvada, called the iPrEx trial, published in 2010 in
the New England Journal of Medicine included 2,499 men who were sexually
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 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.
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.
Side Effects
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.
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.”
So, what do you think about Truvada? Would you rather abstain or use
the drug? Do you think it would encourage risky sexual behavior among
adults?
Please share your thoughts.
News Source: Vanguard
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