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Tuesday, November 23, 2010

New drug approved for treatment of Lipodystropy in HIV patients caused by antiretroviral drugs.

New drug approved for treatment of Lipodystropy in HIV patients caused by antiretroviral drugs.

US FDA has approved drug Egrifta (Tesamorelin) for treating  antiretroviral drugs associated lipodystrophy in HIV positive patients, lipodystrophy a condition of abnormal lipid metabolism that result in loss subcutaneous of fat on face , legs and buttocks, and accumulation of fat on abdomen , liver, stomach, and other abdominal organs resulting in abdominal obesity and fat deposition in their upper backs and chest. Lipodystrophy in HIV patients affects the health and quality of life.

Lipodystrophy in HIV positive patients is attributed to use of antiretroviral drugs belonging to class protease inhibitors and nucleoside reverse transcriptase inhibitors.Drug Egrifta (Tesamorelin) is now a first US FDA approved drug available for treatment of lipodystrophy in HIV positive patients associated with antiretroviral drugs.

Drug Egrifta (Tesamorelin) is a growth hormone releasing factor (GRF) drug which is required to be administered as injection once in a day.Drug Egrifta’s (Tesamorelin) safety and efficacy was evaluated in two clinical trials which included 816 HIV positive adult men and women with lipodystrophy and excess abdominal fat.

Out of 543 patients who received Egrifta for 26 weeks , placebo controlled period in bot studies it was observed that patients taking drug Egrifta (Tesamorelin) show reduction in abdominal fat measured by CT scan , compared to patients on placebo. Cardiovascular benefits of Egrifta if it reduces the risk of cardiovascular disease or it improves compliance with antiretroviral drugs are yet to be studied.

Side effects of Drug Egrifta (Tesamorelin) reported in clinical trial are muscle pain (myalgia), stomach pain, swelling, joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), blood sugar control worsening was observed in patients taking Egrifta and not in patients taking placebo.

Drug Egrifta’s (Tesamorelin) is developed by a Montreal-based pharmaceutical company Theratechnologies Inc. and it is marketed in the U.S. by Rockland, Mass.-based EMD Serono


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