Switch to ATV/r monotherapy ARV-trial.com Switch to ATV/r monotherapy ATARITMO Swedish Study ACTG A5201 OREY MODAt Study 1

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

OREY Study: Switch to ATV/r monotherapy 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 Conclusion Pilot study of ATV/r monotherapy showing maintenance of virologic suppression in 79% of patients OREY Pulido F, EACS 2009;Abs. PS4/6