By Ed Susman
MEXICO CITY -- August 5, 2008 -- Patients with human immunodeficiency virus (HIV) achieved more than a 10% reduction in visceral adipose tissue without adverse glucose tolerance after receiving daily injections of the investigational growth hormone analogue tesamorelin, researchers stated here at the 17th International AIDS Conference (AIDS 2008).
"Daily subcutaneous administration of 2 mg tesamorelin for 26 weeks to HIV patients with excess abdominal fat significantly decreases visceral adipose tissue; improves belly image, improves triglyceride levels, and is overall well tolerated," said Julian Falutz, MD, HIV Metabolic Clinic, Montreal General Hospital, and McGill University Medical School, Montreal, Quebec.
Adverse results to glucose-tolerance tests -- a problem previously experienced in other studies involving similar products used to treat lipodystrophy in HIV -- were not demonstrated, said Dr. Falutz, presenting his late-breaker poster here on August 4.
In this phase 3, placebo-controlled study, visceral adipose tissue decreased by 10.9% in patients taking tesamorelin compared with a 0.6% decrease in patients receiving placebo injections (P > .001). The primary endpoint of the study was to achieve an 8% decrease in visceral adipose tissue.
Dr. Falutz and colleagues recruited 404 patients into the study; eventually 270 individuals were assigned to receive tesamorelin while 126 individuals were randomly assigned to placebo. More than 90% of the subjects in both treatment arms had undetectable viral loads, based on the 400 copies/mL assay.
Fasting glucose increased by 0.09 mmol/L among patients on tesamorelin compared with 0.06 mmol/L among subjects on placebo (P = .16). In the 2-hour oral fasting glucose test, patients on tesamorelin registered a 0.35 mmol/L increase after 26 weeks of therapy compared with a 0.15 mmol/L decrease among placebo subjects (P = .18). Fasting insulin at the end of the study was decreased 14.30 pmol/L among the tesamorelin patients and was increased by 2.32 pmol/L in placebo subjects (P = .47).
Treatment with tesamorelin increased lean body mass and decreased truncal fat without affecting subcutaneous fat or limb fat.
"Excess abdominal fat has been shown to have a negative impact on body image, which often results in nonadherence [to] antiretroviral therapy," Dr. Falutz noted.
About 84% of the participants in this study were men. The average age of subjects was 48 years.
Funding for this study was provided by Theratechnologies Inc., Montreal, Quebec.
[Presentation title: Results From the 26-Week Confirmatory, Phase 3 Trial of Tesamorelin (TH9507), a Growth Hormone-Releasing Factor Analogue, in HIV Patients With Excess Abdominal Fat: A Multicenter, Double-Blind, Placebo-Controlled Study With 404 Randomized Patients. Abstract LBPE1156]
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