Switch studies in virologically suppressed patients

Switch to DRV/r + RAL
SPARE Study
Original article : PLoS One. 2013 Aug 8;8(8) - T Nishijima
Dernière mise à jour : 18/07/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Switching LPV/r + TDF/FTC to RAL+ DRV/r did not significantly increase the proportion of patients who showed >10% improvement in renal function among those with relatively preserved eGFR . However, the switch improved urinary β2 microglobulin , suggesting that discontinuation of TDF might be beneficial in the long-term
  • RAL +DRV/r showed favorable viral efficacy in patients with suppressed viral load
  • Limitations
    • Small sample size
    • Adverse events self-reported, open-label unblinded design

Design


* Randomisation was stratified based on baseline body weight of 60 kg

Objective

  • Primary endpoint: proportion of patients with > 10% improvement in eGFR at 48 weeks from the baseline calculated with the CG equation
  • Secondary endpoints: changes in per protocol renal tubular markers from baseline to week 48, proportions of patients with HIV-1 RNA < 50 c/mL at W24 and W48 (per protocol and ITT)

Baseline characteristics (mean), and disposition

Endpoints by W48

 

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