9th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 19-21 July 2007, Sydney, Australia

FURTHER DATA ON THE EFFECTS OF TESAMORELIN (TH9507), A GROWTH HORMONE-RELEASING FACTOR ANALOGUE, ON BODY COMPOSITION AND METABOLIC PARAMETERS IN HIV-INFECTED PATIENTS WITH ABDOMINAL FAT ACCUMULATION

Antiviral Therapy 2007; 12(Suppl. 2):L9 (abstract no. O-08)

J Falutz¹, S Allas², J-C Mamputu², D Potvin², D Kotler³ and S Grinspoon^4
1Montreal General Hospital, McGill University Health Center, Montreal, Canada; ²Theratechnologies, Inc. Montreal, Canada; ³St. Lukes Hospital Roosevelt Hospital Center, Columbia University College of Physicians and Surgeons, Canada; ⁴Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA

BACKGROUND: We previously reported that 26-week treatment with tesamorelin resulted in significant decreases in visceral adipose tissue (VAT) and improvements in lipids. Here we report further data, which have not previously been presented, on the time course for changes in VAT and metabolic parameters, and the relationship of baseline VAT and change in IGF-I to change in VAT with tesamorelin.

METHODS: Patients on ART with abdominal fat accumulation were randomized to tesamorelin 2 mg (n=273) or placebo (n=137) subcutaneously daily for 26 weeks. The percent change from baseline in VAT was the primary end-point. Secondary endpoints included changes in triglycerides, TC/HDL-C ratio and IGF-1.

RESULTS: Baseline age was 48±7 (SD) years, WC 104 ±10 cm, WHR 1.1 ±0.1 with no differences between treatment groups. Most of the VAT loss occurred within the first 13 weeks: -12.1% (P<0.001 versus placebo), with further loss by Week 26 (-5.2%, P<0.001 versus placebo, P<0.001 for time effect within the tesamorelin group). IGF-1 increased from baseline at Week 13 (82%, P<0.001 versus placebo), with no further changes at Week 26 (81%, P<0.001 versus placebo). Adiponectin increased significantly at Week 26 (0.5 ±2.7 versus -0.1 ±1.3 µg/ml P=0.03 versus placebo). In addition, there were significant but small correlations between changes from baseline in IGF-1 and VAT at Weeks 13 (r=-0.29, P<0.001) and 26 (r=-0.23, P<0.001) in tesamorelin-treated patients. Finally, the change in VAT was greater among patients with larger VAT at baseline (Week 26: -35 cm² for 75th, -25.8 cm² for 50th and -17.6 cm² for 25th percentile, P<0.001 versus placebo at all points).

CONCLUSION: These data provide more information as to the effects of tesamorelin on VAT and related metabolic parameters in HIV-infected patients with central fat accumulation. Significant changes in VAT were mainly achieved within the first 13 weeks of treatment, with further benefits over the following 13 weeks. These changes were observed in association with changes in IGF-I. The absolute reduction in VAT was related to the magnitude of VAT accumulation at baseline. Increased adiponectin may help improve metabolic parameters with use of tesamorelin.

Download PDF of this abstract.

2007-07-24
O-08

Copyright © 2007 - International Medical Press Ltd. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Medical Editor, International Medical Press, 36 St Mary-at-Hill, London EC3R 8DU, United Kingdom.