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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, MPHfor the 067 Study Group

JAIDS Journal of Acquired Immune Deficiency Syndromes: June 2009 - Volume 51 - Issue 2 - p 153-162
doi: 10.1097/QAI.0b013e3181a5701c
Clinical Science

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.

From the *HIV Clinical Research, North Broward Hospital District, Ft Lauderdale, FL; †Pontifícia Universidade Católica do Paraná, Curitiba, Brazil; ‡Hospital Evandro Chagas, Rio de Janeiro, Brazil; §Hospital Saint-Louis, Paris, France; ∥Hospital Dr Angel Leano Consultorio de Infectiologica, Jalisco, Mexico; ¶Hospital La Paz, Madrid, Spain; and #Pharmaceutical Research Institute, Bristol-Myers Squibb, Wallingford, CT.

Received for publication June 23, 2008; accepted February 17, 2009.

Supported by funding from Bristol-Myers Squibb.

Presented at the 12th Conference on Retroviruses and Opportunistic Infections, February 22-25, 2005, Boston, MA.

Correspondence to: Michael Sension, MD, HIV Clinical Research, North Broward Hospital District, 1101 NW 1st Street, Ft Lauderdale, FL 33311 (e-mail: msension@nbhd.org).

Copyright © 2009 Wolters Kluwer Health, Inc. All rights reserved.