Switch to ATV/r monotherapy  ATARITMO  Swedish Study  ACTG A5201  OREY  MODAt Study

Switch to ATV/r monotherapy - ATARITMO - Swedish Study - ACTG A OREY

 Design  Primary endpoint –Proportion of patients with virologic rebound (HIV-1 RNA ≥ 400 c/mL) or treatment discontinuation by W48 Pulido F, EACS 2009;Abs. PS4/6 OREY Open-label Single-arm Pilot trial HIV+ No history of prior virologic failure On ATV/r + 2 NRTIs ≥ 8 weeks HIV-1 RNA < 50 c/mL ≥ 24 weeks N = 61 OREY Study: Switch to ATV/r monotherapy Switch to ATV/r 300/100 mg qd monotherapy W48

 Mean duration of prior ATV/r therapy: 84 weeks  Use of PI prior to ATV/r: 59%  Median CD4 cell count/mm 3 at inclusion: 514  Outcome at Week 48 –Treatment failure, N = 13: 21% (95% CI: %) –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  Conclusion –Pilot study of ATV/r monotherapy showing maintenance of virologic suppression in 79% of patients Pulido F, EACS 2009;Abs. PS4/6 OREY OREY Study: Switch to ATV/r monotherapy