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Switch studies in virologically suppressed patients. Switch to TDF/FTC/EFV AI266-073 Switch to FTC + ddI + EFV ALIZE Switch to ATV/r-containing regimen ATAZIP Switch to ATV ± r-containing regimen SWAN SLOAT Switch to ATV-containing regimen ARIES INDUMA Switch to ATV/r monotherapy
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Switch studies in virologically suppressed patients Switch to TDF/FTC/EFV AI266-073 Switch to FTC + ddI + EFV ALIZE Switch to ATV/r-containing regimen ATAZIP Switch to ATV±r-containing regimen SWAN SLOAT Switch to ATV-containing regimen ARIES INDUMA Switch to ATV/r monotherapy ATARITMO Swedish Study ACTG A5201 OREY Synopsis • Switch to LPV/r monotherapy • Pilot LPV/r • M03-613 • American Study • KalMo • OK • OK04 • KALESOLO • MOST • HIV-NAT 077 • Switch to DRV/r monotherapy • MONOI • MONET • Switch to RAL-containing regimen • Canadian Study • CHEER • Montreal Study • EASIER • SWITCHMRK • SPIRAL
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 • 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
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 Pulido F, EACS 2009;Abs. PS4/6 OREY