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Comparison of PI vs PI
Study BMS 089: ATV vs ATV/r QD, in combination with 3TC + d4T XR QD
Original article : J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):161-7 - DR Malan
Last update : 28/03/2009

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • For first-line antiretroviral therapy, ATV/r 300/100 mg QD was virologically non inferior to ATV 400 mg QD, when combined with 3TC and d4T XR QD
  • Response rate at an HIV RNA < 50 c/mL at W48 was 25% less in patients with baseline HIV RNA > 100,000 c/mL as compared with baseline HIV RNA < 100,000 c/mL
  • Virologic failure occurred more frequently in the ATV group (9.5% vs 3.2%) with emergence of major atazanavir-associated mutations in 3/8 tested patients in the ATV group
  • Results (HIV RNA < 50 c/mL at W48, virologic failure rate, resistance data) suggest ATV/r is more potent than ATV
  • Discontinuation due to treatment-related adverse event occurred more frequently in the ATV/r group
  • Increases in total cholesterol and triglycerides were greater in the ATV/r group
  • Possible impact of stavudine on lipid increases
  • Limitation: small size of the study

Design :

Objective :

  • Non inferiority of ATV/r 300/100 vs ATV 400 at W48: % HIV RNA < 400 c/mL, ITT, TLOVR algorithm (lower margin of the 95% CI for the difference = -10%, 80% power)

Baseline characteristics and patient disposition :

Response to treatment at week 48 (ITT, TLOVR) :

Treatment-emergent resistance :

Safety :

  • Upward shift of > 1 NCEP category at W48 for ATV/r vs ATV:
    • total cholesterol: 16% vs 11%
    • LDL-cholesterol: 46% vs 48%
    • triglycerides: 30% vs 18%


   

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