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Growth Hormone Prodrug Reduces Visceral Fat by 15% in HIV Patients With Fat Accumulation Syndrome: Presented at CROI

By Ed Susman

LOS ANGELES, CA -- February 28, 2007 -- The investigative growth hormone-releasing factor analog TH9507 appears to help patients infected with HIV to decrease their visceral fat levels by 15%, researchers reported here at the 14^th annual Conference on Retroviruses and Opportunistic Infections (CROI).

"We had agreed in discussion with the Food and Drug Administration that an 8% reduction in visceral fat accumulation would be significant," said Steven Grinspoon, MD, associate professor of medicine, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts, United States.

"We were pleased to get this 15.2% reduction among patients with visceral fat accumulation in HIV-infected patients," Dr. Grinspoon said in a press briefing on February 26th. In contrast, placebo patients increased their visceral fat accumulation by 5%, he said. This difference reached statistical significance at the P <.0001 level.

In the trial, 275 patients with HIV were assigned to receive TH9507 and 137 patients were treated with placebo. Both groups received daily subcutaneous injections for 26 weeks. Patients were mainly men with an average age of 48 years. All the patients had stable HIV viral loads.

Dr. Grinspoon said the primary endpoint of the trial was the percentage of change in visceral abdominal fat as assessed by computer-assisted tomography. In all, 80% of subjects completed 26 weeks.

Although the visceral fat level was decreased by TH9507, he said patients' overall weight remained unchanged. Basically, he said, the fat migrated from the visceral abdomen to other parts of the body, he said.

Dr. Grinspoon said the patients treated with TH9507 also achieved a significant reduction in triglycerides -- a decrease of 0.6 mmol compared with a 0.1-mmol increase among patients on placebo (P <.0010). The favourable total cholesterol to high density lipoprotein cholesterol ratio also improved, decreasing by 0.3 in patients on TH9507 and increasing by 0.2 in placebo patients (P <.001). There was no difference in adverse events between the 2 groups.

"TH9507 may represent a novel treatment strategy for HIV patients with central fat accumulation, including those with impaired glucose homeostasis," Dr. Grinspoon said.

The study was supported by Theratechnologies, Inc, Montreal, Canada.


[Presentation title: Effects of TH9507, a Growth Hormone Releasing Factor Analog, on HIV-associated Abdominal Fat Accumulation: A Multicenter, Double-Blind Placebo-Controlled Trial With 412 Randomized Patients. Abstract 45]

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