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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0b013e3181a5701c
Clinical Science

Improvement in Lipid Profiles in Antiretroviral-Experienced HIV-Positive Patients With Hyperlipidemia After a Switch to Unboosted Atazanavir

Sension, Michael MD*; Andrade Neto, Jose Luiz de MD, PhD†; Grinsztejn, Beatriz MD, PhD‡; Molina, Jean Michel MD§; Zavala, Isidro MD‖; González-García, Juan MD¶; Donnelly, Alice BS#; Phiri, Phillip PhD#; Ledesma, Emilio MD#; McGrath, Donnie MD, MPH#; for the 067 Study Group

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Abstract

Objective: The primary objective was to compare the change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 12 between patients receiving an atazanavir-containing regimen and those receiving comparator protease inhibitor (PI) regimens.

Design: AI424-067 was a 48-week, open-label, randomized, prospective study of 246 patients on PI-based regimens with hyperlipidemia [fasting LDL cholesterol >130 mg/dL (>3.4 mmol/L)] and with HIV RNA <50 copies per milliliter. Patients were randomized to switch to atazanavir (400 mg once daily) on day 1 (immediate switch) or maintain current PI regimen for the first 24 weeks, then switch to atazanavir (delayed switch).

Methods: Plasma lipid levels were compared with baseline values at weeks 12, 24, and 48. Safety, viral load, and CD4 profiles were also evaluated.

Results: At week 12, the mean percent changes in LDL cholesterol from baseline for the immediate-switch and delayed-switch groups were −15% and +1%, respectively (P < 0.0001). Favorable LDL cholesterol levels in the immediate-switch group were sustained through week 48. Both groups maintained comparable virologic control. Switching to atazanavir did not produce a significant change in safety or tolerability.

Conclusions: A switch-either immediate or delayed-from a boosted or unboosted PI to unboosted atazanavir in patients with hyperlipidemia was associated with improvements in plasma lipid parameters without loss of virological suppression.

© 2009 Lippincott Williams & Wilkins, Inc.

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