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Session 100 Poster Abstracts
Dyslipidemias and Body Fat Abnormalities: Incidence, Risk Factors, Response to Therapy
Monday, 1:30 - 3:30 pm
Poster Hall


715    
The Effects of Enfuvirtide Therapy on Body Composition and Serum Lipids through 48 Weeks in the TORO Trials
D A Cooper*1, P Reiss2, K Henry3, M Nelson4, M O'Hearn5, P Piliero6, J Reynes7, K Arasteh8, J Chung9, D Guimaraes9, T Kinchelow9, A Bertasso9, and the TORO 1 and TORO 2 study groups
1Natl. Ctr. in HIV Epidemiology and Clin. Res., Univ. of New South Wales, Sydney, Australia; 2Academic Med. Ctr., Amsterdam, The Netherlands; 3Hennepin County Med. Ctr., Minneapolis, MN, USA; 4Chelsea and Westminster Hosp., London, UK; 5Oregon Hlth. and Sci. Univ., Portland, USA; 6Albany Med. Coll., NY, USA; 7Hosp. Gui de Chauliac, Montpellier, France; 8EPIMED c/o Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany; and 9Roche, Nutley, NJ, USA

Background:  Antiretrovirals have been implicated in the development of metabolic and morphologic adverse effects in HIV infected patients, but the effect of enfuvirtide (ENF) on body composition and lipid parameters has not been determined.

Methods:  TORO 1 and 2 are ongoing randomized phase 3 studies of ENF plus optimized background vs optimized background alone. To determine the effect of ENF on body composition, whole body DEXA and single slice at L4 vertebrae CT scans were preformed in a substudy of TORO 1 and 2 patients who volunteered for these assessments at sites capable of performing the scans. Scans were taken at baseline and weeks 24 and 48. Anthropometric measurements of the waist and hips were determined in all patients enrolled in TORO 1 and 2 at these visits. For all patients, fasting chemistry (glucose, insulin, total cholesterol, HDL, triglycerides, C-peptide, and calculated LDL and VLDL) was assessed at aseline and weeks 8, 16, 24, 32, and 48.

Results: Body composition changes from baseline to week 48 are noted in the table below:

Method

Parameter

Median Change from BL

ENF+ Optimized Background (n)

Optimized Background Alone (n)

DEXA

Left* leg fat tissue (%)

0.06 (65)

-0.62 (12)

Truncal fat:peripheral fat* ratio

0.00 (65)

0.36 (12)

CT

VAT (cm2)

14.9 (67)

-9.3 (12)

SAT (cm2)

7.8 (67)

-5.8 (12)

VAT/SAT (%)

-1.2 (67)

-2.0 (12)

Anthropometrics

Waist:hip ratio

0.01 (440)

0.00 (70)

Body Weight

Substudy patients (kg)

1.70 (81)

1.00 (15)

All patients (kg)

0.90 (492)

1.00 (77)

*Some DEXA scanners only collected data from the left extremity, so the left extremity data were used in calculations

These results should be interpreted with caution due to the small number of patients in each group at 48 weeks. Changes from baseline in lab parameters were of similar magnitude in the ENF+ optimized background and optimized background groups for glucose, total cholesterol, LDL, and triglycerides. There was no change from baseline in either treatment group for HDL and C-peptide. The only differences observed were for insulin (mean change 0.44 μU/mL for ENF + optimized background, -0.81 μU/mL for optimized background alone) and VLDL (mean change -0.15 mmol/L for ENF + optimized background, 0.20 mmol/L for optimized background alone). The composition of the optimized background regimen was similar between the treatment groups.

Conclusions:  Based on body composition scans (DEXA and CT) and anthropometric measurements, ENF does not appear to have any adverse effect on fat redistribution compared with patients on optimized background treatment alone. ENF was not associated with any adverse lipid or glycemic lab parameters.

 

Keywords: enfuvirtide; metabolic effects; fusion inhibitors