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| |  Tesamorelin Helps Improve Body Composition in HIV Patients at Increased Cardiovascular Risk: Presented at CROI By Maria Bishop BOSTON, MA -- February 6, 2008 -- Patients infected with HIV and experiencing lipodystrophy may derive benefit from treatment with the novel agent tesamorelin, investigators reported here at the 15th Conference on Retroviruses and Opportunistic Infections (CROI). The study was presented by lead author Julian Falutz, MD, Assistant Professor of Medicine, McGill University; Associate Physician, Montreal General Hospital, McGill University Health Center; and Director, HIV Metabolic Clinic, Immune Deficiency Treatment Center, Montreal General Hospital, Montreal, Quebec, Canada. Patients on antiretroviral therapy (ART) are at increased risk for cardiovascular diseases due to lipodystrophy, which is characterized by body changes and metabolic abnormalities, including dyslipidemia and insulin resistance, Dr. Falutz noted in his presentation on February 4. In their phase 3 trial, Dr. Falutz and colleagues randomized 410 patients on ART with central fat accumulation to subcutaneous administration of 2 mg tesamorelin (n = 273) or placebo (n = 137) for 26 weeks. At 26 weeks, all patients were re-randomized through week 52: 154 tesamorelin patients were continued on tesamorelin (T-T), while 50 tesamorelin patients were switched to placebo (T-P), and 111 placebo patients were switched to tesamorelin (P-T). No clinical differences were demonstrated in shifts from normal to high fasting glucose levels between patients treated with tesamorelin for all 52 weeks (12.2%) and those who received tesamorelin for the first 26 weeks only (11.1%). The percentage in the placebo group was 10% at week 26. The percentage of patients who went from a normal to an abnormal 2-hour glucose level on an oral glucose tolerance test was 11.6% among patients treated with tesamorelin for 52 weeks versus 12.1% among patients who stopped treatment at week 26. At week 52, changes from baseline in visceral adipose tissue were significant in both males and females in the T-T group (-17.4% and -23.4%, respectively). The decrease in trunk fat from baseline at week 26 was sustained at week 52, and the increase from baseline in lean body mass at week 26 was also sustained at week 52 of treatment. The investigators concluded that tesamorelin, a stabilized analogue of growth hormone-releasing factor/ growth hormone-releasing hormone, resulted in improved body composition, including maintenance of visceral adipose tissue loss, with preservation of subcutaneous adipose tissue and limb fat.
[Presentation title: Data on 52-Week Safety and Efficacy of Tesamorelin, a Growth Hormone-Releasing Factor Analogue, in HIV-Infected Patients With Abdominal Fat Accumulation. Abstract 943]
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