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- Title
The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy.
- Authors
Cooper, D. A.; Cordery, D. V.; Reiss, P.; Henry, K.; Nelson, M.; O'Hearn, M.; Reynes, J.; Arastéh, K.; Chung, J.; Rowell, L.; Guimaraes, D.; Bertasso, A
- Abstract
Objective, The aim of the study was to compare the metabolic and morphological effects of enfuvirtide plus an optimized background (OB) regimen vs. OB alone (control group) in treatment-experienced patients in the T-20 vs. Optimized Regimen Only (TORO) studies. Methods, Body composition and metabolic changes were investigated in patients over 48 weeks, based on fasting chemistries, body weight, and other anthropometric measurements. Dual-energy X-ray absorptiometry (DEXA) and computed tomography (CT) scans were performed in a patient subgroup (n5155) at baseline and at weeks 24 and 48. Results, At week 48, mean changes from baseline were similar between treatment groups for glucose, insulin, C-peptide, total cholesterol, low-density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglyceride levels. The enfuvirtide group experienced a significant increase in body weight [mean change from baseline 10.99 kg; 95% confidence interval (CI) 10.54, 11.44] and, in those who had body scans, there was a significant increase in truncal fat (by DEXA: median change 1419.4 g; 95% CI171.3, 1767.5) and total fat [visceral adipose tissue (VAT)1subcutaneous adipose tissue (SAT) by singleslice abdominal CT scan: median change 125.5 cm2; 95% CI18.9, 142.0] over 48 weeks; significant increases in these parameters were not seen in the control group. There was no significant change in truncal:peripheral fat ratio in either the enfuvirtide or the control group. Conclusion, The addition of enfuvirtide to an OB regimen does not appear to have unfavourable effects on fat distribution or metabolic parameters.
- Subjects
ADIPOSE tissues; ANALYSIS of variance; BLOOD sugar; BODY composition; BODY weight; HUMAN body composition; C-peptide; CHOLESTEROL; CONFIDENCE intervals; HIV infections; INSULIN; METABOLISM; HEALTH outcome assessment; STATISTICAL sampling; STATISTICS; TOMOGRAPHY; TRIGLYCERIDES; X-ray densitometry in medicine; DATA analysis; RANDOMIZED controlled trials; BLIND experiment; ENFUVIRTIDE (Drug); PHARMACODYNAMICS; THERAPEUTICS
- Publication
HIV Medicine, 2011, Vol 12, Issue 1, p31
- ISSN
1464-2662
- Publication type
Article
- DOI
10.1111/j.1468-1293.2010.00845.x