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

Switch to ATV-containing regimen - ARIES - INDUMA - ASSURE. INDUMA Study: Switch ATV/r to ATV. Design. Randomisation* 1 : 1 Open-label. W48. Induction phase 26 to 30 weeks. Maintenance phase. N = 252. HIV+ ARV-naïve HIV-1 RNA ≥ 5000 c/mL CD4 ≥ 50/mm 3. N = 85. N = 87.

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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. INDUMA Study: Switch ATV/r to ATV • Design Randomisation* 1 : 1 Open-label W48 Induction phase 26 to 30 weeks Maintenance phase N = 252 HIV+ ARV-naïve HIV-1 RNA ≥ 5000 c/mL CD4 ≥ 50/mm3 N = 85 N = 87 * Randomisation if 2 consecutives HIV-1 RNA < 50 c/mL between W16 and W28 ** TDF not allowed • Endpoints • Primary: non inferiority in the proportion of patients with HIV-1 RNA < 50 c/mL at W48 of the maintenance phase (non completer = failure, intent-to-treat analysis), lower limit of the 95% CI for the difference = - 15%, 80% power) • Secondary: treatment failure, CD4, fasting lipids, adverse events Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA

  3. INDUMA Study: Switch ATV/r to ATV Baseline characteristics and patient disposition Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA

  4. % ATV/r ATV 100 88 89 78 75 80 60 40 20 0 ITT, NC = F Observed data 95% CI for the difference= - 9.8 ; 15.5 95% CI for the difference= -11.8 ; 8.7 INDUMA Study: Switch ATV/r to ATV Outcome at week 48 of the maintenance phase HIV RNA < 50 c/mL Other endpoints • Virological rebound(HIV-1 RNA ≥ 50 c/mL) • ATV/r: 7% • ATV: 13% • Time to treatment failure or to virological rebound not significantly different between the 2 groups • Serious adverse events • ATV/r: 3 (4%) • ATV: 4 (5%) NC=F: Non completer equals Failure Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA

  5. INDUMA Study: Switch ATV/r to ATV Lipid changes and adverse events during maintenance phase * mg/dL, last observation carried forward ; ** p < 0.0001 Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA

  6. INDUMA Study: Switch ATV/r to ATV • Conclusions • After induction with ritonavir-boosted ATV, switching to unboosted ATV shows non-inferior efficacy and a more favourable safety profile than a triple combination regimen based on boosted ATV for up to 48 weeks • Switching to ATV might represent a feasible treatment optionin patients with virologic suppression on ATV/r Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA

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