Switch studies in virologically suppressed patients
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Switch to ATV-containing regimen
INDUMA
Original article : Antivir Ther. 2010;15(7):993-1002 – J Ghosn
Last update : Epub 2007 Nov 13

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • 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 option in patients with virologic suppression on ATV/r

Design :


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

Baseline characteristics and patient disposition :

Outcome at week 48 of the maintenance phase

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%)

Lipid changes and adverse events during maintenance phase :

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