Substitution of nevirapine or efavirenz for protease inhibitor versus lipid-lowering therapy for the management of dyslipidaemia

Objectives: To evaluate simplified protease inhibitor (Pl)-sparing antiretroviral treatment versus lipid-lowering therapy for the management of highly active antiretroviral therapy(HAART)-induced hyperlipidaemia. Design: Randomized, open-label clinical trial assessing the efficacy on hyperlipidaemia of a switching therapy from PI to non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine or efavirenz versus a hypolipiclaernic treatment (with pravastatin or bezafibrate) added to current, unchanged antiretroviral combination. Methods: All HIV-infected patients on their first HAART regimen, with stable immuno-virological features, naive to all NNRTIs, and with mixed hyperlipidaemia, were randomized to replace PI with nevirapine (arm A) or efavirenz (arm B), or to receive pravastatin (arm Q or bezafibrate (arm D) with unchanged HAART regimen, and were followed-up for 12 months. Results: One hundred and thirty patients were evaluated: 29 patients were randomized to arm A,34 to arm B,36 to arm C,and 31 to arm D. At the end of the 12-month follow-up, a reduction of 25.2, 9.4, 41.2 and 46.6% in mean triglyceridaemia versus respective baseline values was reported in groups A, B, C and D, respectively, with statistically significant difference between arms A-B and C-D (P < 0.01). Similar results were reported for total and low-density lipoprotein cholesterol levels. Viro-immunological efficacy and tolerability profile were comparable in all considered arms. Conclusion: Pravastatin and bezafibrate proved significantly more effective in the management of HAART-related hyperlipidaemia than the switching therapy from PI to nevirapine or efavirenz. (c) 2005 Lippincott Williams & Wilkins.