The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients
with lipodystrophy, a condition in which excess fat develops in different areas of the body, most
notably around the liver, stomach, and other abdominal organs. The condition is associated with
many antiretroviral drugs used to treat HIV.
Egrifta, the first FDA-approved
treatment for lipodystrophy, is a growth hormone releasing factor (GRF) drug that is administered
in a once-daily injection.
Whether Egrifta decreases the risk of cardiovascular
disease or improves compliance with antiretroviral drugs has not been studied.
Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with
lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week,
placebo-controlled period. In both studies, patients treated with Egrifta experienced greater
reductions in abdominal fat as measured by CT scan, compared with patients receiving another
injectable solution (placebo). Some patients reported improvements in their self image.
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