Improvement in lipid profiles in antiretroviral-experienced HIV-positive patients with hyperlipidemia after a switch to unboosted atazanavir.
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.


METHODS
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.
Sension
Michael
M
HIV Clinical Research, North Broward Hospital District, Ft Lauderdale, FL 33311, USA. msension@nbhd.org
Andrade Neto
Jose Luiz de
JL
Grinsztejn
Beatriz
B
Molina
Jean Michel
JM
Zavala
Isidro
I
González-García
Juan
J
Donnelly
Alice
A
Phiri
Phillip
P
Ledesma
Emilio
E
McGrath
Donnie
D
D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069446:Atazanavir Sulfate; D008078:Cholesterol, LDL / Q000097:blood*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000150:complications*; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D008078:Cholesterol, LDL; D009842:Oligopeptides; D011725:Pyridines; D000069446:Atazanavir Sulfate