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Switch studies in virologically suppressed patients

Switch studies in virologically suppressed patients

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Switch studies in virologically suppressed patients

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  1. 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

  2. EASIER Study: Switch ENF to RAL • Design Randomisation 1 : 1 Open-label W24 193 HIV+ adults History of triple class (NRTI, NNRTI, PI) failure or intolerance HIV-1 RNA < 400 c/mL > 3 monthson an ENF-based regimen Integrase inhibitor-naïve N = 85 N = 85 • Objective • Non inferiority in the proportion of patients with virologic failure at W24(Intent-to-treat analysis) ; upper limit of the 95% CI for the difference =10%, 80% power • Virologic failure : confirmed HIV-1 RNA ≥ 400 c/mL, or a singleHIV-1 RNA ≥ 400 c/mL followed by treatment modification or last HIV-1 RNA ≥ 400 c/mL without confirmation De Castro N, CID 2009;49:1259-67 EASIER

  3. EASIER Study: Switch ENF to RAL Baseline characteristics and patient disposition * TPV/r in 34% vs 44% and DRV/r in 40% vs 36%, in ENF vs RAL groups, respectively De Castro N, CID 2009;49:1259-67 EASIER

  4. EASIER Study: Switch ENF to RAL HIV-1 RNA < 50 c/mL % ENF RAL 100 89 88 80 60 40 20 1.2 1.2 1.2 0 0 On-treatment analysis ITT analysis ITT analysis 95% CI for the difference= -6.7 ; 6.8 95% CI for the difference= -5.6 ; 8.1 Outcome at week 24 Virologic failure Other endpoints • Median CD4 increase • ENF: +15/mm3 • RAL: +11/mm3 • No AIDS events • No difference in the overall incidence of adverse reactions between both groups • Higher incidence of grade 1 to 4 laboratory abnormalities in the RAL arm (p = 0.001) • Median increases in triglycerides and total cholesterol were significantly higher in the RAL group De Castro N, CID 2009;49:1259-67 EASIER

  5. EASIER Study: Switch ENF to RAL Grade 3 or 4 emerging adverse events or laboratory abnormalities De Castro N, CID 2009;49:1259-67 EASIER

  6. EASIER Study: Switch ENF to RAL • Conclusions from W24 data • In patients infected with multidrug-resistant HIV-1 receiving suppressive enfuvirtide-containing antiretroviral therapy, aswitch from enfuvirtide to RAL is: • Safe • Well-tolerated • And virologically non-inferior to the maintenance of ENF De Castro N, CID 2009;49:1259-67 EASIER