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10th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV6-8 November 2008, London, UK |
EFFECTS OF TESAMORELIN (TH9507), A GROWTH HORMONE-RELEASING FACTOR (GRF) ANALOGUE, ON VISCERAL ADIPOSE TISSUE (VAT) IN HIV-INFECTED PATIENTS WITH EXCESS ABDOMINAL FAT: IMPACT OF ANTIRETROVIRAL THERAPY REGIMEN
Antiviral Therapy 2008; 13(Suppl. 4):A36 (abstract no. P-19)
J Falutz1, J-C Mamputu2, C Marsolais2, D Potvin2, M Zoltowska2, D Aeschliman2, D Kotler3 and S Grinspoon4
1Montreal General Hospital, McGill University Health Centre, Montreal, Canada; 2Theratechnologies Inc., Montreal, Quebec, Canada; 3St. Luke’s Roosevelt Hospital Centre, Columbia University College of Physicians and Surgeons, New York, NY, USA; 4Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
BACKGROUND: HIV-infected patients on antiretroviral therapy (ART) often show increased visceral adipose tissue (VAT), a known cardiovascular risk factor. Previous data showed that administration of daily 2 mg tesamorelin, a growth hormone-releasing factor analogue, to HIV-infected patients with excess abdominal fat for 26 weeks resulted in a significant decrease in visceral adipose tissue (VAT) over placebo and improvements in lipids as well as patient-reported outcomes related to body image. Here we report the percent change from baseline to week 26 in VAT per type of ART regimen for the combined Phase III studies of tesamorelin in HIV-infected patients with lipohypertrophy.
METHODS: A total of 816 HIV-infected patients with abdominal fat accumulation in the context of HIV treatment were randomized in two independent Phase III studies to receive daily subcutaneous injection of either tesamorelin 2 mg (n=550) or placebo (n=266) for 26 weeks. The primary endpoint of these studies was the percent change from baseline to week 26 in VAT, as assessed by computerized tomography (CT) scan, using the intent-totreat population with the last observation carried forward for patients not completing the study.
RESULTS: Mean (±sd) age was 48 ±7 years, waist circumference 105 ±9 cm, body mass index 29 ±4 kg/m2, CD4 cell count 599 ±290 cells/mm3 and 76% of patients had undetectable HIV viral load at baseline. Mean time since initial diagnosis of HIV infection was 13.2 years. Mean duration on ART was 4.5 years, whereas mean time since initial diagnosis of lipodystrophy syndrome was 3.9 years. Patients received the following types of ART regimen during the studies: nucleoside reverse transcriptase inhibitors/non-nucleoside reverse transcriptase inhibitors (‘NRTI/NNRTI’; 33%), ‘NRTI/protease inhibitors (PI)’ (45%), ‘NRTI/NNRTI/PI’ (10%), ‘NRTIs alone’ (5%) and ‘Other’ (7%). At baseline, VAT values were 190, 175, 189, 199 and 171 cm2 for the ‘NRTI/NNRTI’, ‘NRTI/PI’, ‘NRTI/NNRTI/PI’, ‘NRTIs alone’ and ‘Other’ groups, respectively. Overall, VAT decreased from baseline by 13% in tesamorelin-treated patients after 26 weeks of treatment (P<0.001 versus placebo). The mean percent changes from baseline to Week 26 in VAT were -12.3, -14.5, -10.9, -16.0 and -8.2% for tesamorelin-treated patients in the groups ‘NRTI/NNRTI’, ‘NRTI/PI’, ‘NRTI/ NNRTI/PI’, ‘NRTIs alone’ and ‘Other’, respectively, whereas the mean percent changes from baseline in VAT were 0.6, 2.9, 1.4, 1.6, and 6.6% for placebo-treated patients in the same groups (P<0.05 for tesamorelin versus placebo for each type of ART regimen).
CONCLUSIONS: The results of this study indicate that daily administration of 2 mg tesamorelin is useful for reducing VAT in HIV-infected patients with excess abdominal fat on ART, regardless of type of ART regimen.
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2008-11-06
P-19
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