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AOP Orphan, a pioneering pharmaceutical company in the field of rare diseases, is launching in Europe the world’s first drug approved by the FDA that can be used effectively against lipodystrophy (excess abdominal fat), which is widespread among HIV patients: EGRIFTA®.
It has been possible to bring HIV under control in recent years with the use of antiretroviral drugs, and many HIV-positive people live much longer than they used to. However, many patients develop complex metabolic changes in the course of essential treatment with HIV drugs, which can lead to a marked increase in visceral abdominal fat (lipohyertrophy) and cardiovascular diseases, as well as favouring myocardial ischaemia. The quality of life among HIV patients is also often negatively impacted by these physical changes. With EGRIFTA®, physicians now have a way of treating suitable patients (on a case-by-case basis) that demonstrably reduces this excess abdominal fat.
Tesamorelin, which is already available on the Canadian and US markets under the trademark EGRIFTA® as a subcutaneous injection, is a synthetic form of growth-hormone-releasing hormone (GHRH). It stimulates the release of the body’s own growth hormone and helps to reduce the amount of fat around the liver, stomach and other abdominal organs. Furthermore, it can have a positive effect on lipid levels and lower cardiovascular disease risks.
The effectiveness of EGRIFTA® was evaluated in two separate, randomised and placebo-controlled Phase III studies with 806 HIV-infected men and women afflicted by lipodystrophy. (1) The patients were either given EGRIFTA® or a placebo over the course of 26 weeks. After this phase of the treatment, patients who had been given EGRIFTA® saw an 18% (first study) and 14% (second study) reduction in visceral fat, whereas only a 2% increase or decrease in fat levels was observed in the control group. Tesamorelin (EGRIFTA®) is injected daily and to be used permanently.
Reference:
Falutz J et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab 2010; 95:4291–4304.
