Switch studies in virologically suppressed patients

Switch to DRV/r 600/100 mg
DRV600 Study
Original article : Molto J. J AntimicrobChemother 2015;70:1139-45
Last update : 02/06/2015

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • The efficacy of a DRV daily dose of 600 mg seemed to be similar to the efficacy of the standard 800 mg dose, in combination with ritonavir 100 mg and 2 NRTI, in virologically suppressed HIV-infected patients switching from therapy with DRV/r 800/100 mg + 2 NRTI
  • This strategy can potentially translate to substantial savings in the cost of care of HIV-infected patients
    • Average reduction in annual cost per successfully treated DRV 600-arm patient of 7273 $US
  • Limitation : trial not powered to detect differences in efficacy below 15%, which might be clinically relevant

Design


* Randomisation was stratified on HIV RNA (≤ or > 100,000 c/ mL ) prior to ART start

Objective

  • Primary Endpoint : proportion with treatment success at W48 (ITT analysis)
    • Assuming 90% efficacy at W48, sample size of 100 provide 80% power to detect a minimum difference of 15% in efficacy
  • Other endpoints : observed analysis of virologic efficacy, PK substudy , cost-efficacy analysis

Baseline characteristics and disposition

Results


Genotype done in 3/5 VF : no emergence of resistance

Safety


No discontinuation for AE

Phamacokinetics

  • Mean DRV Ctrough
    • 2.21 ± 1.44 mg/ dL for DRV/r 800/100 vs
    • 2.19 ± 1.50 mg/ dL for DRV/r 600/100 (p = 0.94)
  • No significant difference in AUC nor other PK parameters between the 2 groups

Full PK analysis

 

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