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
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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