Fibrates or statins and lipid plasma levels in 245 patients treated with highly active antiretroviral therapy. Aquitaine Cohort, France, 1999-2001.

OBJECTIVES: To describe the effect and tolerance of lipid-lowering drugs (LLD; fibrates and statins) in patients treated with highly active antiretroviral therapy (HAART).
METHODS: A prospective study was performed in a large cohort of HAART-treated HIV-infected patients using guidelines for case management of dyslipidaemia. Inclusion criteria were: age over 18 years; HIV infection treated with HAART including at least one protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI); total cholesterol (TC)>5.5 mmol/L and/or triglycerides (TG)>2.2 mmol/L; and initiation of fibrates or statins. Viral load, CD4 cell count, plasma lipid levels and liver enzymes were measured at baseline (M0) and 3(M3) and 12(M12) months thereafter. Muscular enzymes were not assessed.
RESULTS: Fibrates were prescribed to 179 patients and statins to 66 patients. There was a significant mean decrease of TG in the fibrates group between M0 and M3 [-2.29 mmol/L; 95% confidence interval (CI)=-3.53, -1.05; P<10(-4)] and between M0 and M12 (-2.25 mmol/L; 95% CI:-4.23, -0.29; P<10(-4)); a significant decrease of TC was also noticed between M0 and M3 (-0.55 mmol/L; 95% CI:-0.95, -0.15; P=0.008) but not at M12 (-0.33 mmol/L; 95% CI:-0.94, 0.26; P=0.27). In the statins group, TC significantly decreased between M0 and M3 (-0.78 mmol/L; 95% CI:-1.3, -0.27; P=0.004) and between M0 and M12 (-0.70 mmol/L; 95% CI:-1.31, -0.09; P=0.03). There was no significant difference between the decreases of TG or TC observed in patients treated with PI or NNRTI. There were no significant modifications of viral load, CD4 cell count or liver enzymes during the 12 months of followup.
CONCLUSIONS: In this HAART-treated cohort, fibrates and statins were safe and associated with a favourable but moderate effect on lipid plasma levels.