The Food and Drug Administration on Wednesday approved for the first time a drug to treat lipodystrophy in patients undergoing antiretroviral (ARV) therapy for HIV infection. Lipodystrophy, a condition in which excess fat develops in different areas of the body, is associated with many of the ARVs used to treat HIV.
The drug, Egrifta (tesamorelin), was developed by Montreal-based Theratechnologies Inc. and is marketed in the United States by EMD Serono of Rockland, Mass. Egrifta is a growth hormone-releasing factor drug that is injected once daily.
Two clinical trials of Egrifta enrolled 816 HIV-positive adult men and women with lipodystrophy and excess abdominal fat. During a 26-week period, 543 patients received Egrifta and the rest received placebos. In both studies, the Egrifta patients experienced greater reductions in abdominal fat as measured by CT scan compared with patients in the control group. Some patients also reported improvements in their self-image.
"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," said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in FDA's Center for Drug Evaluation and Research.
Whether Egrifta improves compliance with ARV regimens or decreases the risk of cardiovascular disease has not been studied.
The most commonly noted side effects included joint pain, redness and rash at injection site, stomach pain, swelling, and muscle pain. Compared with placebo patients, worsening blood sugar control occurred more often in Egrifta patients.
For more information, visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm233516.htm.
11/11/10
UNITED STATES: FDA Approves Egrifta, the First Drug to Treat HIV Patients with Lipodystrophy
Source: Los Angeles Times (11.10.10):: Thomas H. Maugh II; Courtesy of the CDC National Center for HIV, STD, and TB Prevention