Switch studies in virologically suppressed patients

Switch to ATV/r monotherapy
ACTG A5201
Original article : J Infect Dis. 2009 Mar 15;199(6):866-71 – TJ Wilkin

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Limited pilot study, no control arm

Design :


Primary endpoint :

  • Time to virologic failure (2 consecutive HIV-1 RNA ≥ 200 c/mL)
    • 85% power to detect a difference between W24 success rate of 75% with ATV/r alone vs a nominal rate of 90%

 

  • Prior PI therapy
  • Median CD4 cell count/mm3: at inclusion = 616 ; nadir = 253
  • Kaplan-Meier estimate of the probability of virologic success at W48 = 0.88 (lower limit of the 90% 1-sided CI: 0.81)
  • In the 4 subjects with confirmed virologic failure there were no major PI-resistance mutations detected
  • Grade 3 or 4 elevation of total biliribun: 17/34 subjects

 

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