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FDA Approves First Drug for
Reducing the Risk of Sexually Acquired HIV
Infection
By Erica Jefferson, US Food
and Drug Administration
July 16, 2012
Today, the U.S.
Food and Drug Administration approved Truvada
(emtricitabine/tenofovir disoproxil fumarate), the first
drug approved to reduce the risk of HIV infection in
uninfected individuals who are at high risk of HIV
infection and who may engage in sexual activity with
HIV-infected partners. Truvada, taken daily, is to be
used for pre-exposure prophylaxis (PrEP) in combination
with safer sex practices to reduce the risk of
sexually-acquired HIV infection in adults at high risk.
The FDA previously approved Truvada to be used in
combination with other antiretroviral agents for the
treatment of HIV-infected adults and children 12 years
or older.
As part of PrEP, HIV-uninfected individuals who are at
high risk will take Truvada daily to lower their chances
of becoming infected with HIV should they be exposed to
the virus. A PrEP indication means Truvada is approved
for use 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.
"Today’s approval marks an important milestone in our
fight against HIV," said FDA Commissioner Margaret A.
Hamburg, M.D. "Every year, about 50,000 U.S. adults and
adolescents are diagnosed with HIV infection, despite
the availability of prevention methods and strategies to
educate, test, and care for people living with the
disease. New treatments as well as prevention methods
are needed to fight the HIV epidemic in this country."
As a part of this action, the FDA is strengthening
Truvada’s Boxed Warning to alert health care
professionals and uninfected individuals 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. The
drug is contraindicated for PrEP in individuals with
unknown or positive HIV status. The FDA strongly
recommends against such use.
Truvada for PrEP is being approved with a Risk
Evaluation and Mitigation Strategy (REMS) to minimize
the risk to uninfected individuals of acquiring HIV
infection and to reduce the risk of development of
resistant HIV-1 variants. The central component of this
REMS is a training and education program to assist
prescribers in counseling individuals who are taking or
considering Truvada for PrEP. The training and education
program will not restrict distribution of Truvada but
will provide information about the importance of
adhering to the recommended dosing regimen and
understanding the serious risks of becoming infected
with HIV while taking Truvada for the PrEP indication.
"The REMS for Truvada for the PrEP indication is aimed
at educating health care professionals and uninfected
individuals to help ensure its safe use for this
indication without placing an unnecessary burden on
health care professionals and patients," said Janet
Woodcock, M.D., director of the FDA’s Center for Drug
Evaluation and Research.
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, such
as inconsistent or no condom use during sex with a
partner of positive or unknown HIV status, a high number
of sex partners, and exchange of sex for commodities.
Results showed Truvada was effective in reducing the
risk of HIV infection by 42 percent compared with
placebo in this population. Efficacy was strongly
correlated with drug adherence in this trial.
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
trial evaluated the efficacy and safety of Truvada and
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
percent 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 included
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, Truvada’s manufacturer,
Gilead Sciences, Inc., is required to collect viral
isolates from individuals who acquire HIV while taking
Truvada and to evaluate these isolates for the presence
of resistance. Additionally, the company is required to
collect data on pregnancy outcomes for women who become
pregnant while taking Truvada for PrEP and to conduct a
trial to evaluate drug adherence and its relationship to
adverse events, risk of seroconversion, and resistance
development in seroconverters. Gilead has committed to
provide national drug utilization data in order to
better characterize individuals who utilize Truvada for
a PrEP indication and to develop an adherence
questionnaire that will assist prescribers in
identifying individuals at risk for low compliance.
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