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Maraviroc, sold
under the trade name Selzentry, got sanction
from The U.S. Food and Drug Administration (FDA)
on August 6, 2007. Maraviroc, an antiretroviral drug for use
in adult HIV patients, is the first
in a new class of drugs designed to slow the advancement of
HIV and received priority analysis by the FDA.
Maraviroc is approved for the treatment of adults with CCR5-tropic
HIV-1 and it can be used in combination with other
antiretroviral drugs to treat adults, who have been treated
with other HIV medications and who have evidence of elevated
levels of HIV in their blood (viral load). Maraviroc prevents
the virus from entering uninfected cells by blocking the predominant
route of entry, the CCR5 co-receptor rather than fighting
HIV inside white blood cells. CCR5 is a protein on the surface
of some types of immune cells. Among patients who have previously
received HIV medications, approximately 50 percent to 60 percent
have circulating CCR5-tropic HIV-1. "This is an important new product for many HIV-infected patients who have not responded to other treatments and have few options,"
said Steven Galson, M.D., M.P.H., director of FDA's Center
for Drug Evaluation and Research.
The FDA's approval of maraviroc is based on safety and effectiveness data from two double-blind, placebo-controlled studies. The 1,076 clinical trial participants were selected because they still showed evidence of HIV-1 in their blood, despite treatment with other HIV medications. A blood test for CCR5 tropic HIV-1 was used during clinical trials to identify patients appropriate for treatment with maraviroc.
The product label includes a boxed warning about liver toxicity
(hepatoxicity) and also about the possibility
of heart attacks. The safety and effectiveness
of maraviroc have not been established in adult and pediatric
patients who have never been treated with any other HIV drug.
The most common adverse events reported with maraviroc were
cough, fever, upper respiratory tract infections, rash, musculoskeletal
symptoms, abdominal pain, and dizziness.
Additionally, the drug has not been tested or studied in pregnant women. The FDA recommends that HIV positive women should not breast feed, whether or not they are on antiretroviral medications.
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