3rd International AIDS Society Conference on HIV Pathogenesis and Treatment


Rio de Janeiro - July 24 - 27, 2005


SHIFT FROM PROTEASE INHIBITOR- TOWARDS NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR-BASED HAART VERSUS LIPID-LOWERING TREATMENT, FOR THE MANAGEMENT OF HAART-RELATED DYSLIPIDEMIA

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuFo0105

Calza L., Manfredi R., Colangeli V., Tampellini L., Sebastiani T., Pocaterra D., Chiodo F.
University of Bologna, Bologna, Italy


INTRODUCTION: Hypertriglyceridemia and/or hypercholesterolemia are the main tolerability concerns of protease inhibitor-based HAART, since they are associated with the development of serious cardiovascular events in proportionally young HIV-infected patients. Aim of our study is to evaluate simplified protease inhibitor-sparing antiretroviral treatment versus added lipid-lowering therapy for the management of HAART-induced hyperlipidemia.

METHODS: A randomized, open-label clinical trial assessing the efficacy on hyperlipidemia of a switching therapy from protease inhibitors to non-nucleoside reverse transcriptase inhibitors (nevirapine or efavirenz) versus a hypolipidemic treatment (containing either pravastatin or bezafibrate) added to current, unchanged protease inhibitor-based antiretroviral combination, was carried out at our centre. All HIV-infected patients on their first HAART regimen, with stable immunological-virological features, naïve to all non-nucleoside reverse transcriptase inhibitors, and with mixed hyperlipidemia, were randomized to replace protease inhibitors with nevirapine (arm 1) or efavirenz (arm 2), or to receive pravastatin (arm 3) or bezafibrate (arm 4) with unchanged HAART regimen, and were followed-up for 12 consecutive months.

RESULTS: One hundred and thirty patients were evaluable at this time: 29 patients were randomized to arm 1, 34 to arm 2, 36 to arm 3, and 31 to arm 4. At the end of the established 12-month follow-up, a reduction of 25.2%, 9.4%, 41.2% and 46.6% in mean triglyceridemia versus respective baseline values was reported in groups 1, 2, 3, and 4, respectively, with statistically significant difference between arms A-B and C-D (p<.01). Comparable results (p<.01) were reported when analyzing the trend of both total and LDL-cholesterol levels. Both virological-immunological efficacy and the comprehensive tolerability profile were comparable in all considered study arms.

CONCLUSIONS: Pravastatin and bezafibrate proved significantly more effective in the management of HAART-related hyperlipidemia, than the switching therapy from a protease inhibitor-based regimen, toward a nevirapine- or efavirenz-based one. Further studies are needed to elaborate guidelines for pharmacological management of HAART-associated hyperlipidemia.

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TuFo0105
Complications of HIV therapy


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