E-DRUG: FDA Approves First Medication to Reduce HIV Risk
People diagnosed with HIV - the human immunodeficiency virus that without
treatment develops into AIDS - take antiviral medications to control the
infection that attacks their immune system.
Now, for the first time, adults who do not have HIV but are at risk of becoming
infected can take a medication to reduce the risk of sexual transmission of the
The Food and Drug Administration (FDA) has approved the new use of Truvada -
to be taken once daily and used in combination with safer sex practices - to
reduce the risk of sexually acquired HIV-1 infection in adults who do not have
HIV but are at high risk of becoming infected. (HIV-1 is the most common form
In two large clinical trials, daily use of Truvada was shown to significantly
reduce the risk of HIV infection
*by 42 percent in a study sponsored by the National Institutes of Health (NIH)
of about 2,500 HIV-negative gay and bisexual men and transgender women, and
*by 75 percent in a study sponsored by the University of Washington of about
4,800 heterosexual couples in which one partner was HIV positive and the other
Debra Birnkrant, M.D., director of the Division of Antiviral Products at FDA,
explains that Truvada works to prevent HIV from establishing itself and
multiplying in the body. She notes that while this is a new approved use,
Truvada is not a new product. It was approved by FDA in 2004 for use in
combination with other medications to treat HIV-infected adults and children
over 12 years old.
?In the 80s and early 90s, HIV was viewed as a life-threatening disease; in
some parts of the world it still is. Medical advances, along with the
availability of close to 30 approved individual HIV drugs, have enabled us to
treat it as a chronic disease most of the time,? Birnkrant says.
"But it is still better to prevent HIV than to treat a life-long infection of
HIV," she says.
Birnkrant stresses that Truvada is meant to be used as part of a comprehensive
HIV prevention plan that includes consistent and correct condom use, risk
reduction counseling, regular HIV testing, and treatment of any other
sexually-transmitted infections. Truvada is not a substitute for safer sex
practices, she says.
Person Must Be HIV Negative
Truvada, produced by Gilead Sciences Inc., is a combination of two
antiretroviral medications used to treat HIV - tenofovir disoproxil fumarate
and emtricitabine. When Truvada is used as a treatment for HIV rather than a
preventive, the patient also takes a third drug, Birnkrant says. Which of the
other approved HIV drugs is added depends on the needs of the patient.
Before this medicine is prescribed, Birnkrant says there are several factors
that a person and his or her health care professional must consider in weighing
the risk versus the benefit:
*The person must be tested to ensure that he or she is HIV negative.
*Flu-like symptoms such as fever or muscle aches are a red flag because they
could indicate the presence of early, acute HIV infection, even if test results
are negative. There is a window of four to five weeks with some tests, and up
to three months with others, in which the antibodies that indicate HIV
infection do not appear in the blood.
*Safety concerns tied to Truvada have to do with its effect on the bones and
kidneys. While effects observed in clinical trials were mild and reversible
with discontinuation of the medication, people with a history of bone or kidney
ailments should be regularly monitored to ensure their continued health.
*It is recommended that the person also be tested for hepatitis B because
worsening of hepatitis B infections has been reported in those who have both
HIV-1 and hepatitis B when treatment with Truvada was stopped.
Infection Rates Unchanged
To help prescribers and other health care professionals advise uninfected
people considering taking Truvada, the medicine is being approved with a Risk
Evaluation and Mitigation Strategy (REMS). The goals of the REMS are to inform
prescribers and potential users of Truvada of the importance of taking the
medication every day, the importance of regular HIV testing and the importance
of using Truvada in combination with other measures known to reduce the risk of
HIV infection. As part of the REMS, a voluntary training and education plan
will be made available to potential prescribers. This program includes a
medication guide and safety brochure for the prospective Truvada users that
would detail the risks, recommended screening tests and key information to
share with a health care professional.
About 1.2 million Americans have HIV. The body?s immune system is devastated by
AIDS, leaving those who have it vulnerable to deadly infections. Each year,
about 50,000 adults and adolescents in the U.S. are newly diagnosed with HIV.
The overall rate of HIV infection has remained stable at least since 2004. "The
rates of new HIV infections have not significantly changed for a long time,"
says Birnkrant. "From FDA?s standpoint, this is not acceptable for a serious
This article appears on FDA's Consumer Updates page, which features the latest
on all FDA-regulated products.
July 16, 2012
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