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Thursday, November 11, 2010

FDA Approves Egrifta, First Treatment for HIV-Related Abdominal Fat

On Wednesday, Food and Drug Administration (FDA) health regulators announced the approval of Egrifta (tesamorelin), a first-of-its-kind treatment for HIV-associated lipodystrophy, a common side effect of antiretroviral medications characterized by abnormal fat distribution within the body.
Egrifta is a growth hormone-releasing factor, given as a once-daily injection, that works to reduce abdominal fat in patients who experience lipodystrophy while undergoing treatment with certain antiretroviral medications to treat HIV, the virus that causes AIDS.
Patients taking HIV-1 protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir) and saquinavir (Invirase), commonly experience an increase in fat deposits that can accumulate around the liver, the stomach and abdominal organs. Fat deposits can also form at the base of the neck, resulting in a bulge known as a "buffalo hump."
"The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," said Dr. Curtis Rosebraugh, director of the FDA's Office of Drug Evaluation II. "The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important."
In clinical trials involving more than 800 HIV-positive patients who took Egrifta daily for 26 weeks, patients reported improvements in self-image, as well as a reduction in abdominal fat deposits as shown by a CT scan.
It is not yet known if Egrifta additionally helps to lower the risk of heart disease in patients with excess abdominal fat.
Common side effects reported with Egrifta treatment include joint and muscle pain, injection site rash and redness, stomach pain and changes in blood sugar levels.
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