here - CD8 T cells - The Body

PHOTO: JOSHuA THORnE
BRIEFLY
EnID VázqUEz
FDA approves Truvada for PrEP
The Food and Drug Administration (FDA)
in July approved truvada as the first
medication to help prevent Hiv infection.
As expected, the approval came
with restrictions.
Truvada, a combination of tenofovir
(Viread) and emtricitabine (Emtriva), is
one of the most prescribed medications
for HIV in this country. For HIV prevention,
the use of Truvada is called “PrEP,”
for “pre-exposure prophylaxis.”
“[We] commend the FDA’s approval of
[Truvada] for the use of [PrEP] to prevent
HIV transmission. This approach can
prevent many new infections and could
dramatically impact HIV transmission
worldwide,” said Kenneth H. Mayer, MD,
Medical Research Director and Co-chair
of The Fenway Institute at Fenway Health.
“My colleagues and I are delighted to have
helped to demonstrate the utility of this
promising approach for HIV prevention.”
David Ernesto Munar, President/CEO
of the AIDS Foundation of Chicago, said,
“Our challenge now is to implement PrEP
as strategically as possible, and to ensure
the people who need it most, those who
are most at risk for HIV, have access.”
“This is an enormous turning point, a
real game changer, in the fight against
HIV,” said Jim Pickett, AFC’s Director
of Prevention Advocacy and Gay Men’s
Health. “The toolbox we have now has
Truvada as PrEP. We can look forward to
more sex acts being protected, especially
among individuals who have already
chosen, for whatever reason, to not use
condoms consistently.”
According to a press release from the
FDA, “Truvada is to be used for [PrEP] in
combination with safer sex practices to
prevent sexually-acquired HIV infection in
adults at high risk.”
The FDA said Truvada for PrEP should
be used as part of a comprehensive
HIV prevention plan that includes risk
reduction counseling, consistent and
correct condom use, regular HIV testing,
and screening for and treatment of other
sexually-transmitted infections, stating
that “Truvada is not a substitute for safer
sex practices.”
Truvada now carries a Boxed Warning
on its drug label alerting health care
professionals and uninfected individuals
that Truvada for PrEP must only be used
by people confirmed to be HIV-negative
before being prescribed the drug and
tested at least every three months during
use to reduce the risk of developing
drug resistance. Both the antiviral and the
PrEP dose is one pill taken once daily.
Truvada maker Gilead Sciences worked
with the FDA to create a Risk Evaluation
and Mitigation Strategy (REMS) for
Truvada PrEP. The REMS focuses on a prescriber
training and education program
in counseling and managing individuals
who are taking or considering Truvada for
PrEP. The REMS looks at the elements of
a comprehensive HIV prevention strategy,
the importance of adhering to the recommended
daily dosing regimen, and the
serious risks of taking Truvada for PrEP if
already infected with HIV or of becoming
infected while taking it.
According to the press release,
“Truvada’s safety and efficacy for PrEP
were demonstrated in two large, randomized,
double-blind, placebo-controlled
clinical trials. The iPrEx trial evaluated
Truvada in 2,499 HIV-negative men
or transgender women who have sex
with men and with evidence of high
risk behavior for HIV infection... Results
showed Truvada was effective in reducing
the risk of HIV infection by 42% compared
with placebo in this population.
Efficacy was strongly correlated with
drug adherence in this trial.”
It was also shown in iPrEX that there
was a 92% reduction of risk for HIV in
participants who
took Truvada in the
prescribed oncedaily
dose.
“The Partners
PrEP trial was conducted
in 4,758 heterosexual couples,
where one partner was HIV-infected and
the other was not (serodiscordant couples),”
the press release continued. “The
trial evaluated the efficacy and safety of
[both] Truvada and [Viread] tenofovir
versus placebo in preventing HIV infection
in the uninfected male or female partner.
Results showed Truvada reduced the risk
of becoming infected by 75% compared
with placebo.
“No new side effects were identified
in the clinical trials evaluating Truvada
for the PrEP indication. The most common
side effects reported with Truvada
include diarrhea, nausea, abdominal
pain, headache, and weight loss. Serious
adverse events in general, as well as
those specifically related to kidney or
bone toxicity, were uncommon.”
As a condition of approval, Gilead
Sciences is required to collect and
analyze samples from individuals who
become infected with HIV while taking
Truvada to see if they’ve developed drug
resistance. The company is also required
to collect data on women who become
pregnant while taking Truvada for PrEP
and to conduct other research.
“Today’s decision is the culmination
of almost 20 years of research involving
investigators, academic and medical
institutions, funding agencies, and nearly
20,000 trial participants around the
world, and Gilead is proud to have been
a partner in this effort,” said Norbert
Bischofberger, PhD, Executive Vice
President, Research and Development
and Chief Scientific Officer, Gilead
Sciences. >>
POSiTivElyAwARE.COM SEPTEMBER+OCTOBER 2012 13