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Switch studies in virologically suppressed patients

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

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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. ATAZIP Study: Switch LPV/r to ATV/r • Design Randomisation 1 : 1 Open-label M24 N = 121 265 patients HIV+ ≥ 18 years On LPV/r + 2 NRTIs ≥ 6 months HIV RNA < 200 c/mL > 6 months* N = 127 * Not more than 2 previous virologic failure on PI and if genotype performed < 5 mutations ** Switch in NRTI not counted as failure • Endpoints • Primary: non inferiority in the proportion of patients with treatment failure at W48 (intent-to-treat analysis), lower limit of the 95% CI for the difference =-12.5%, 80% power • Treatment failure = virologic rebound (2 consecutive HIV-1 RNA ≥ 200 c/mL), lost to follow-up, withdrawn consent, discontinuation for any reason, progression to a new CDC event or death Mallolas J, JAIDS 2009;51:29-36 ATAZIP

  3. ATAZIP Study: Switch LPV/r to ATV/r Baseline characteristics and patient disposition Mallolas J, JAIDS 2009;51:29-36 ATAZIP

  4. Time to treatment failure and time to virological failure did not differ between groups The median changes in CD4 count at 48 weeks were +27 cells/mm3 (IQR: -42 to 119) with ATV/r and +48 cells/mm3 (IQR: -5 to 112) with LPV/r (p = 0.315) ATAZIP Study: Switch LPV/r to ATV/r % 30 30 p = 0.0018 25 25 20 20 20 15 15 17 p < 0.0001 10 10 5 5 7 5 0 0 6/121 9/127 21/121 25/127 -2.3% (-12.0%, 8.0%) -2.1% (-8.7%, 4.2%) Results: W48 outcome Virologic rebound Treatment failure % Switch to ATV/r Continue on LPV/r Difference estimate (95% CI) Mallolas J, JAIDS 2009;51:29-36 ATAZIP

  5. ATAZIP Study: Switch LPV/r to ATV/r 3 p = 0.043 Median change from baseline (mg/dL) 200 p < 0.001 2 TC/HDL-C ratio p < 0.001 p = 0.149 p = 0.185 100 1 0 0 -1 -100 -2 Total cholesterol/HDL cholesterol -200 -3 -300 Triglycerides Total cholesterol LDLcholesterol HDLcholesterol Fasting plasma lipids changes from baseline to week 48 Switch to ATV/r 300/100 qd(N = 121) Continue on LPV/r 400/100 bid(N = 127) Mallolas J, JAIDS 2009;51:29-36 ATAZIP

  6. ATAZIP Study: Switch LPV/r to ATV/r Adverse events by W48 Mallolas J, JAIDS 2009;51:29-36 ATAZIP

  7. ATAZIP Study: Switch LPV/r to ATV/r • Conclusions • Switching to a simplified PI-based regimen containing ATV/r provides virological suppression and treatment failure similar to those observed with continued unmodified therapy with LPV/r • Safety and tolerability profile were similar in both groups • Improved lipid parameters were observed in the ATV/r arm • High incidence of hyperbilirubinemia occurred in the ATV/r arm • Switching patients with virologic suppression on LPV/r to once-daily ATV/r can provide an effective and well-tolerated treatment option Mallolas J, JAIDS 2009;51:29-36 ATAZIP

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