Sixth International Congress Drug Therapy in HIV Infection 17-21 November, 2002 Glasgow, UK

Atazanavir (ATV) is a potent, safe, and effective once-daily PI in phase III development. In BMS trial AI424-008, ATV demonstrated a lipid profile superior to nelfinavir (NFV) in treatment-naïve subjects. The objectives of BMS AI424-044 were to evaluate lipid profiles of subjects switched from NFV to ATV as well as ATV safety and tolerability. AI424-008 completers (n=346) were treated with ATV/d4T/3TC in AI424-044: subjects on NFV switched to ATV 400 mg; subjects on ATV continued with ATV 400 or 600 mg. Total cholesterol and fasting LDL, HDL, and triglycerides were assessed on entry into AI424-044 and at 12 weeks. Subjects treated with ATV in both AI424-008 and AI424-044 maintained cholesterol and triglycerides at levels comparable to AI424-044 entry at week 12. From entry to week 12, subjects who switched from NFV to ATV showed a significant mean % increase in HDL (5%, P<0.05) and significant mean % decreases in total cholesterol (16%), LDL (21%), and triglycerides (28%) (P<0.0001). The % of subjects switched from NFV to ATV with total cholesterol ³240 mg/dL and LDL ³130 mg/dL decreased from 32% to 10% and 55% to 22%, respectively, from entry to week 12. ATV was safe and well tolerated. These results demonstrate that substituting ATV for NFV as part of a 3-drug treatment regimen with d4T and 3TC correlates with significant improvement in lipid levels at week 12. Lipid improvements of this degree may reduce cardiovascular risk and the need for dietary and pharmacologic interventions.

Presenting author: Robert Murphy

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1 Northwestern University, Chicago.

2 Bristol-Myers Squibb, USA.

3 Federal AIDS Center, Russian Federation.

4 Hospital Tennon, Paris, France.

2002-11-17
PL3-2

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