Switch studies in virologically suppressed patients

Switch to ATV/r monotherapy
OREY
Original article : Pulido F, EACS 2009;Abs. PS4/6

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Pilot study of ATV/r monotherapy showing maintenance of virologic suppression in 79% of patients

Design :


Primary endpoint :

  • Proportion of patients with virologic rebound (HIV-1 RNA ≥ 400 c/mL) or treatment discontinuation by W48

 

  • Mean duration of prior ATV/r therapy: 84 weeks
  • Use of PI prior to ATV/r: 59%
  • Median CD4 cell count/mm3 at inclusion: 514

Outcome at Week 48

    • Treatment failure, N = 13: 21% (95% CI: 11.9 -33.7%)
    • Virologic rebound ≥ 400 c/mL, N = 7: 12%
    • Virologic rebound ≥ 50 c/ml, N = 16: 27%
    • Maintenance of HIV-1 RNA suppression < 50 c/mL: 67%
    • Genotype at virologic rebound > 400 c/ml, N = 7 ; Major PI resistance in 1/7 + 1 post W48
    • Grade 3 or 4 total bilirubin: 64%
    • AE leading to discontinuation, N = 1

 

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