699-T. A Randomized Trial of Metabolic and Body Composition Changes in Patients Switching from PI-Containing Regimens to Abacavir (ABC), Efavirenz (EFV) or Nevirapine (NVP)

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Session 92 Poster Session
Switch Studies/Treatment of Lipodystrophy Syndromes
Session Time: 4:30-6:30 pm
Room 4E-F

699-T.

A Randomized Trial of Metabolic and Body Composition Changes in Patients Switching from PI-Containing Regimens to Abacavir (ABC), Efavirenz (EFV) or Nevirapine (NVP)
C. Fisac*, E. Fumero, M. Crespo, B. Rosón, N. Virgili, E. Ribera, E. Ferrer, J. M. Gatell, and D. Podzamczer
Hosp. Bellvitge, Hosp. Vall d`Hebron, Hosp. Clin., Barcelona, Spain

Background: PI metabolic and body composition changes have been evaluated after switching to a PI-sparing regimen, but there is no report comparing 3 different PI-sparing treatments concerning these metabolic problems.
Methods: NEFA is an ongoing, open-label, randomized study comparing 3 different PI-sparing regimens (ABC, EFV, and NVP) in individuals who have been previously exposed to a HAART PI-containing regimen. A sub-study in 93 patients is being conducted to evaluate the switching effect on metabolic and body composition parameters. 6-month metabolic outcomes are presented. Fasting total cholesterol (TC), low density lipoprotein cholesterol (LDLc), high density lipoprotein cholesterol (HDLc), triglycerides (TG), glucose, insulin, and C-peptide levels were determined to evaluate possible metabolic changes. Insulin resistance (IR) by the homeostasis model assessment and TC:HDLc ratio were also calculated.
Results: A total of 93 patients randomized to ABC (n=29), EFV (n=32), and NVP (n=32) were evaluated at baseline and after 6 months. During the study period 12 patients did not continue with the assigned regimen due to toxicity (11 patients, including 2 EFV patients with risky hypertriglyceridemia) and were lost to follow-up (1 patient). Hence, results of 81 patients are presented (ABC n=27, EFV n=26, NVP n=28). Duration NUCs and HAART-PI regimens mean time (32.3 and 29.5 months, respectively) did not differ among treatment groups. Total group insulin and insulin sensitivity (p<0.001), HDLc (p<0.01), LDLc (p=0.001), and TC:HDLc ratio (p<0.001) improved significantly. Insulin serum levels and insulin resistance diminished with significance in all 3 groups (p<0.001). Both NVP and EFV groups increased significantly HDLc and TC:HDLc ratio (NVP: p<0.001, EFV: p<0.05 and NVP: p<0.001, EFV: p<0.01, respectively). Contrarily, a significant reduction of HDLc (p<0.05) occurred in ABC-group. Only in the NVP-group a significant reduction in mean serum triglycerides was observed (from 3.25 to 2.32 mmol/L; p<0.01).
Conclusions: A marked metabolic benefit was observed at 6 months of switching from a PI to either randomized treatment arm. An especially metabolic trend to a cardioprotective lipid profile was observed in the NVP group.