On November 10, the US Food and Drug AdministrationThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA). approved Egrifta (tesamorelin) to treat HIV people with visceral body fat caused through lipodystrophy.
Egrifta is a synthetic growth hormone releasing factor drug that is administered in a once-daily injection.
The drug was evaluated in two clinical trials involving 816 HIV positive adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week, placebo-controlledA method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. period. In both studies, patients treated with the drug experienced greater reductions in abdominal fat (15 - 17%) as measured by CT scan.
Some patients reported improvements in their self image. Whether or not it decreases the risk of cardiovascular disease has yet to be studied.
NAPWHA has commenced assessments to progress the availability of this drug in Australia.