The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy

D. A. Cooper, D. V. Cordery, P. Reiss, K. Henry, M. Nelson, Mary O'Hearn, J. Reynes, K. Arastéh, J. Chung, L. Rowell, D. Guimaraes, A. Bertasso

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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 (n=155) 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 +0.99 kg; 95% confidence interval (CI) +0.54, +1.44] and, in those who had body scans, there was a significant increase in truncal fat (by DEXA: median change +419.4 g; 95% CI+71.3, +767.5) and total fat [visceral adipose tissue (VAT)+subcutaneous adipose tissue (SAT) by single-slice abdominal CT scan: median change +25.5 cm2; 95% CI+8.9, +42.0] 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.

Original languageEnglish (US)
Pages (from-to)31-39
Number of pages9
JournalHIV Medicine
Volume12
Issue number1
DOIs
StatePublished - Jan 2011

Fingerprint

Body Composition
Fats
Photon Absorptiometry
Confidence Intervals
Control Groups
VLDL Cholesterol
Body Weight Changes
X Ray Computed Tomography
Intra-Abdominal Fat
C-Peptide
Subcutaneous Fat
Therapeutics
LDL Cholesterol
HDL Cholesterol
Fasting
Cholesterol
Tomography
Body Weight
Insulin
Glucose

Keywords

  • Antiretroviral therapy
  • Enfuvirtide
  • HIV fusion inhibitor
  • Lipodystrophy

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)
  • Health Policy

Cite this

The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy. / Cooper, D. A.; Cordery, D. V.; Reiss, P.; Henry, K.; Nelson, M.; O'Hearn, Mary; Reynes, J.; Arastéh, K.; Chung, J.; Rowell, L.; Guimaraes, D.; Bertasso, A.

In: HIV Medicine, Vol. 12, No. 1, 01.2011, p. 31-39.

Research output: Contribution to journalArticle

Cooper, DA, Cordery, DV, Reiss, P, Henry, K, Nelson, M, O'Hearn, M, Reynes, J, Arastéh, K, Chung, J, Rowell, L, Guimaraes, D & Bertasso, A 2011, 'The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy', HIV Medicine, vol. 12, no. 1, pp. 31-39. https://doi.org/10.1111/j.1468-1293.2010.00845.x
Cooper, D. A. ; Cordery, D. V. ; Reiss, P. ; Henry, K. ; Nelson, M. ; O'Hearn, Mary ; Reynes, J. ; Arastéh, K. ; Chung, J. ; Rowell, L. ; Guimaraes, D. ; Bertasso, A. / The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy. In: HIV Medicine. 2011 ; Vol. 12, No. 1. pp. 31-39.
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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 (n=155) 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 +0.99 kg; 95{\%} confidence interval (CI) +0.54, +1.44] and, in those who had body scans, there was a significant increase in truncal fat (by DEXA: median change +419.4 g; 95{\%} CI+71.3, +767.5) and total fat [visceral adipose tissue (VAT)+subcutaneous adipose tissue (SAT) by single-slice abdominal CT scan: median change +25.5 cm2; 95{\%} CI+8.9, +42.0] 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.",
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AU - Henry, K.

AU - Nelson, M.

AU - O'Hearn, Mary

AU - Reynes, J.

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AB - 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 (n=155) 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 +0.99 kg; 95% confidence interval (CI) +0.54, +1.44] and, in those who had body scans, there was a significant increase in truncal fat (by DEXA: median change +419.4 g; 95% CI+71.3, +767.5) and total fat [visceral adipose tissue (VAT)+subcutaneous adipose tissue (SAT) by single-slice abdominal CT scan: median change +25.5 cm2; 95% CI+8.9, +42.0] 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.

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