Researchers in Montreal and Boston have identified a potential new treatment for the HIV/HAART*-associated Lipodystrophy Syndrome. This syndrome is a common side-effect of anti-retroviral medications to treat HIV infection. Dr. Julian Falutz, Director of the HIV Metabolic Clinic at the McGill University Health Centre (MUHC), and Dr. Steven Grinspoon, Director at the Massachusetts General Hospital Program in Nutritional Metabolism are publishing the results of their recent clinical trial in the December 6, 2007 issue of the New England Journal of Medicine.
The Lipodystrophy Syndrome consists of several metabolic disruptions that lead to abnormal lipid and glucose levels, as well as a generalized decrease in superficial fat tissues and an increase in deep abdominal fat. The observed body shape changes may cause significant impairment of patients' quality-of-life leading many patients to stop taking their anti-retroviral medications. But the major health-threat related to the development of the Lipodystrophy Syndrome is an increased long-term cardiovascular risk.
Early in this decade, Dr. Falutz and Dr. Grinspoon began collaborating with Theratechnologies Inc., a Montreal-based biotechnology company that had developed a synthetic analogue of the naturally occurring growth hormone-releasing factor (GRF-tesamorelin). Its action is to regulate growth hormone levels that are important in controlling various metabolic processes. The effectiveness of this drug in reducing increased deep abdominal fat, and secondarily decreasing blood lipid levels, was initially confirmed in a small phase II study published in 2005. The current published results are from a large phase III Study conducted at 43 centers in the USA and Canada, which followed 412 patients for 6 months.
Its conclusions are decisive: "Patients treated with tesamorelin saw their abdominal fat decrease by 15% on average, compared to a 5% average increase for the placebo group", explained Dr. Falutz. "Also, the side-effects are minimal".
"This is a novel strategy to improve cardiovascular risk indices in HIV-infected patients and could represent a therapeutic breakthrough for many patients", stated Dr. Grinspoon.
A second confirmatory trial is ongoing in order to comply with US FDA (US Food and Drug Administration) regulations. "If this second clinical study is as conclusive as the first, there is hope that patients will have tesamorelin available as a treatment option for HIV-associated lipodystrophy within the next couple of years.", said Dr. Falutz.
*HAART: Highly Active Anti-Retroviral Therapies
The Research Institute of the McGill University Health Centre (RI MUHC) is a world-renowned biomedical and health-care hospital research centre. Located in Montreal, Quebec, the institute is the research arm of the MUHC, a university health center affiliated with the Faculty of Medicine at McGill University. The institute supports over 500 researchers, nearly 1000 graduate and post-doctoral students and operates more than 300 laboratories devoted to a broad spectrum of fundamental and clinical research. The Research Institute operates at the forefront of knowledge, innovation and technology and is inextricably linked to the clinical programs of the MUHC, ensuring that patients benefit directly from the latest research-based knowledge. For further details visit: www.muhc.ca/research.