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

THE IMPACT OF TESAMORELIN (TH9507), A GROWTH HORMONE RELEASING FACTOR ANALOGUE, ON BODY IMAGE AND HEALTH-RELATED QUALITY OF LIFE IN HIV-INFECTED PATIENTS WITH ABDOMINAL FAT ACCUMULATION

Antiviral Therapy 2007; 12(Suppl. 2):L33 (abstract no. P-22)

RR Turner¹, J Falutz², MA Testa¹, S Allas³, D Potvin³, J-C Mamputu³, M Su¹ and S Grinspoon^4
1Phase V Technologies, Wellesley, MA, USA; ²Montreal General Hospital and McGill University Health Centre, Montreal, Canada; ³Theratechnologies Inc., Montreal, Canada; ⁴Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA

BACKGROUND: HIV lipodystrophy is characterized by excess visceral adipose tissue (VAT), and/or loss of subcutaneous fat (SAT) in association with dyslipidaemia and insulin resistance, resulting in significant body dysmorphia with impaired body image and health-related quality of life (HRQOL). Treatment with tesamorelin for 26 weeks has been previously shown to significantly reduce VAT while preserving SAT. Data on body image and HRQOL are reported here.

METHODS: Patients on ART with abdominal fat accumulation were randomized to tesamorelin 2 mg daily (n=273) or placebo (n=137) for 26 weeks. Standardized patient- reported outcomes were measured at baseline and week 26. Body image included belly appearance distress, belly size and belly profile silhouette assessments; HRQOL included global HRQOL, mental health, general perceived health, and symptom impact.

RESULTS: Patients (86% male, 48 ±7 years) treated with tesamorelin reported significantly less body image distress for face, belly and composite body assessment (P<0.05 for all comparisons versus placebo). No significant changes were noted in body size parameters, but more tesamorelin- treated patients than placebo patients improved their current belly profile (P<0.05) and weight evaluation (P=0.05). Changes in belly appearance distress, composite body distress and belly profile were significantly correlated with changes in VAT (P<0.01) for tesamorelin treated- patients. Summary analogue HRQOL also improved (P=0.05), with no significant changes in symptom incidence or distress.

CONCLUSION: ART-related changes in body conformation are potential barriers to treatment adherence. Tesamorelin 2 mg daily treatment significantly improved body dysmorphia through improvement in body appearance distress and belly profile, resulting in improved overall HRQOL with no significant increase in symptom incidence or distress. Successful reduction of body image distress and improved HRQOL may have important implications for HIV treatment outcomes.

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2007-07-24
P-22

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