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Comprehensive Lipid Evaluation in Patients Switching from PI/r-based cART to a RAL-based cART: The SPIRAL Substudy
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Reported by Jules Levin
CROI 2011 March 2 Boston
Maria Saumoy*1, J Ordo–ez2, E Martinez1, J Llibre3, E Ribera4, H Knobel5, and D Podzamczer1
1Hosp Univ de Bellvitge, Hosp de Llobregat, Spain; 2Hosp de Sant Pau, Barcelona, Spain; 3Hosp Germans Trias i Pujol, Badalona, Spain; 4Hosp Vall d'Hebron, Barcelona, Spain; and 5Hosp del Mar, Barcelona, Spain
Background: The SPIRAL study showed that switching from a ritonavir-boosted protease inhibitor (PI/r) -based to a raltegravir (RAL) -based combination ART (cART) in otherwise stable, healthy HIV+ patients decreases plasma lipids and Framingham cardiovascular risk score. We designed a prospective substudy of the SPIRAL study to investigate in more detail the lipid changes in patients switching from PI/r-based to a RAL-based cART.
Methods: Fasting total cholesterol (TC), VLDL, HDL, and LDL cholesterol, apoA1, apoB, triglycerides (TG), and LDL were measured at baseline and at week 48 in patients participating in this substudy. Unpaired t- or Mann-Whitney U (between groups) and paired t- or Wilcoxon's signed rank (within group) tests were used for comparisons.
Results: We evaluated 81 patients (PI/r n = 41 and RAL n = 40). Baseline demographic and lipid characteristics of substudy participants did not differ from those of SPIRAL study patients. Baseline demographic and metabolic variables in both substudy groups were not different except for apo B (PI/r 1.07 vs 0.97 g/L, p = 0.042). At week 48, TC (p <0.001), LDL (p = 0.023), non-HDL (p <0.001), TG (p <0.001), apoB (p = 0.001), and apoA1 (p = 0.004) decreased in the RAL group compared to the PI/r group. HDL decreased within RAL group (p = 0.005), but there were no differences between groups (p = 0.108). TC/HDL (p = 0.026) and apoB/apoA1 (p = 0.073) ratios improved in the RAL group relative to the PI/r group. A significant shift from the LDL atherogenic phenotype B to the less atherogenic phenotype A was only observed in the RAL group (phenotype A 38% at baseline and 75% at week 48; p <0.001). In both groups, LDL size increased (PI/r 2.1 nm, p = 0.019 vs RAL 3.8 nm, p = 0.001) and cholesterol content in small and dense LDL subfractions decreased (PI/r to 0.37 mmol/L, p = 0.007 vs RAL to 0.23 mmol/L, p = 0.006) at week 48, but changes were larger in the RAL group.
Conclusions: Switching a PI/r-based to a RAL-based cART in otherwise stable, healthy HIV+ patients was associated with a shift to a less atherogenic LDL phenotype and an overall improvement in lipid profile.
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