On 11th November 2010, US FDA approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy. It is the first FDA-approved treatment for lipodystrophy .
Lipodystrophy , also called fat redistribution , is a disturbance in the way the body produces, uses, and stores fat. There are two different kinds of lipodystrophy-lipoatrophy, and hyperadiposity. 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.
Presently it is not known 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.
The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.
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