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Switch to ATV-containing regimen - ARIES - INDUMA - ASSURE

Switch to ATV-containing regimen - ARIES - INDUMA - ASSURE. ARIES Study: Switch ATV/r to ATV. Design. Randomisation* 1 : 1 Open-label. W84. Induction phase 36 weeks. Maintenance phase 48 weeks. HIV+≥ 18 years ARV-naïve HLA-B*5701-negative HIV-1 RNA ≥ 1000 c/mL Any CD4

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Switch to ATV-containing regimen - ARIES - INDUMA - ASSURE

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  1. Switch to ATV-containing regimen • - ARIES • - INDUMA • - ASSURE

  2. ARIES Study: Switch ATV/r to ATV • Design Randomisation* 1 : 1 Open-label W84 Induction phase 36 weeks Maintenance phase 48 weeks HIV+≥ 18 years ARV-naïve HLA-B*5701-negative HIV-1 RNA ≥ 1000 c/mL Any CD4 HBs Ag-negative N = 515 N = 209 N = 210 * Randomisation if 2 consecutive HIV-1 RNA < 50 c/mL prior to W36 ; randomisation stratified on baseline viral load (< 100.000 or ≥ 100.000 c/mL) • Endpoints • Primary: non inferiority in the proportion of patients with HIV-1 RNA < 50 c/mL at W48 of the maintenance phase (intent-to-treat, exposed analysis), lower limit of the 95% CI for the difference = -12%, 90% power • Secondary: treatment failure, CD4, fasting lipids, adverse events Squires K, AIDS 2010;24:2019-27 ARIES

  3. ARIES Study: Switch ATV/r to ATV Baseline characteristics and patient disposition Squires K, AIDS 2010;24:2019-27 ARIES

  4. % 100 86 81 80 60 40 20 0 ITT-e (TLOVR) ARIES Study: Switch ATV/r to ATV Outcome at week 48 of the maintenance phase HIV RNA < 50 c/mL Other endpoints ATV/r ATV • HIV-1 RNA < 50 c/mL at W48 of the maintenance phase according to baseline plasma viral load • Per-protocol virologic failure(confirmed HIV-1 RNA > 400 c/mL after achieving < 400 c/mL) • ATV/r, N = 7 • ATV, N = 1 • No major PI-resistance mutations at failure 95% CI for the difference= -1.75 ; 12.48 Squires K, AIDS 2010;24:2019-27 ARIES

  5. ARIES Study: Switch ATV/r to ATV Grades 2 to 4 drug-related adverse events (frequency ≥ 3%) and serious adverse events (intent-to-treat exposed) Squires K, AIDS 2010;24:2019-27 ARIES

  6. ARIES Study: Switch ATV/r to ATV Fasting lipids (mg/dL), observed analysis (intent-to-treat exposed) Squires K, AIDS 2010;24:2019-27 ARIES

  7. ARIES Study: Switch ATV/r to ATV • Conclusions • ATV + ABC/3TC • Is potent and well tolerated in patients who have achieved initial virologic suppression on a 36 weeks induction regimen of ATV/r + ABC/3TC • Represents a viable treatment simplification strategy • Limitations • Such a strategy is restricted to NRTI backbone such as ABC/3TC(TDF may lead to decrease in ATV levels and is therefore not recommended) • Unboosted ATV may offer less forgiveness than ritonavir-boosted ATV Squires K, AIDS 2010;24:2019-27 ARIES

  8. ARIES Study: Switch ATV/r to ATV HIV RNA < 50 c/mL at W144, ITT Drug-related AE between W36-W144 % ATV/r ATV 100 94 92 80 80 77 78 73 60 Emergence of resistance mutations 40 • ATV, N = 2 • ATV/r, N = 1 20 0 TLOVR M/D = F Observed Squires K, IAS 2011, Abs. MOPE215 ARIES

  9. ARIES Study: Switch ATV/r to ATV Median values of fasting lipids, mg/dL NCEP thresholds ATV/r ATV (from W36) Total cholesterol 200 mg/dL Triglycerides 200 150 mg/dL 186 183 181 182 160 LDL-C 163 153 152 160 130 mg/dL 151 120 127 123 121 104 HDL-C 98 98 99 80 88 85 40 mg/dL 40 51 49 46 45 39 37 0 0 36 144 0 36 144 0 36 144 0 36 144 Weeks W0-W36: all patients received induction therapy with ABC/3TC + ATV/r Squires K, IAS 2011, Abs. MOPE215 ARIES

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