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.
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).
Plasma lipid levels were compared with baseline values at weeks 12, 24, and 48. Safety, viral load, and CD4 profiles were also evaluated.
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.
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: firstname.lastname@example.org).