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

2. 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

3. 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: %)
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