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Switch to ATV + r-containing regimen - SWAN - SLOAT. SLOAT Study: switch LPV/r to ATV + r. Design. Randomisation Open-label. W48. N = 87. 224 HIV+ patients On LPV/r + 2 NRTIs ≥ 3 months HIV RNA < 50 c/mL ≥ 24 weeks. N = 102.
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Switch to ATV + r-containing regimen • - SWAN • - SLOAT
SLOAT Study: switch LPV/r to ATV+r • Design Randomisation Open-label W48 N = 87 224 HIV+ patients On LPV/r + 2 NRTIs ≥ 3 months HIV RNA < 50 c/mL ≥ 24 weeks N = 102 * ATV 400 mg (N = 49), or ATV/r 300/100 mg if TDF part of NRTI backbone (N = 53) • Objective • Non inferiority in the proportion of patients with virologic rebound at W48(upper limit of the 95% CI for the difference = 90%, 90% power) • Virologic rebound: HIV-1 RNA > 50 c/mL Soriano V, JAC 2008;61:200-5 SLOAT
SLOAT Study: switch LPV/r to ATV+r Baseline characteristics and patient disposition * Nearly half of the patients had been exposed to other PIs, before LPV/r, and failure on prior PIs had occurred in two-thirds of these PI-experienced patients Soriano V, JAC 2008;61:200-5 SLOAT
SLOAT Study: switch LPV/r to ATV+r % 30 25 20 15 11.7 10 10.3 5 0 9/87 12/102 Results: W48 outcome • Resistance mutations at virologic failure • LPV/r: 1/9 • ATV: 2/5 • ATV/r: 3/7 • Median ATV Ctrough * • ATV/r: 0.822 mg/L • ATV: 0.234 mg/L • Median CD4 increase between baseline and W48 • LPV/r: 46/mm3 • ATV+r: 42/mm3 Virologic failure Continue on LPV/r Switch to ATV±r * Effective minimal Ctrough = 0.15 mg/L Soriano V, JAC 2008;61:200-5 SLOAT
SLOAT Study: switch LPV/r to ATV+r Metabolic parameters Use of lipid-lowering agents was more frequent in the LPV/r group: 17% vs 5% (p = 0.006) Soriano V, JAC 2008;61:200-5 SLOAT
SLOAT Study: switch LPV/r to ATV+r • Conclusion • For patients with undetectable viraemia on a stableLPV/r-based regimen, replacement of LPV/r by ATV+r may provide: • An overall reduction in fasting cholesterol and triglycerides • No increased risk of virologic failure Soriano V, JAC 2008;61:200-5 SLOAT