Switch studies in virologically suppressed patients

Switch to EVG/c/FTC/TDF
STRATEGY-PI Study: Switch PI/r to EVG/c
Original article : Lancet Infect Dis. 2014 Jul;14(7):581-9 - JR Arribas
Last update : 26/11/2014

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Coformulated EVG/c/FTC/TDF is an effective, safe, and tolerable simplification from a PI/r plus FTC and TDF regimen in virologically suppressed, HIV-infected adults with no history of virological failure or resistance to FTC or TDF
  • Low frequency of virologic failure and absence of emergent resistance in the group switched to EVG/c/FTC/TDF
  • Rare discontinuations because of adverse events
  • Nausea more frequent in the switch group ; diarrhea and bloating improved
  • Small increase in creatinine, moderate improvement in lipids
  • EVG/c/FTC/TDF is a switch option in virologically suppressed patients with no history of virological failure who want to simplify their existing PI/r regimen, or who have concerns about the long-term safety and side-effects of their existing regimen

Design :


Endpoints :

  • Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 (mITT, snapshot) ; non-inferiority if lower margin of a two-sided 95% CI for the difference = -12%, 85% power. If non-inferiority and lower margin > 0, assessment for superiority
  • Secondary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 (TLOVR algorithm), CD4, safety, tolerability to W96

Baseline characteristics and patient disposition :

Virologic outcome at W48 (mITT, snapshot)

HIV RNA < 50 c/mL - Sensitivity and secondary analysis :

  • No participants met the criteria for resistance testing (HIV RNA > 400 c/mL at virologic failure or early discontinuation)

Virologic sucess overall and by subgroup at W48 (mITT) :

Adverse events and grade3-4 laboratory abnormalities :

  • Improvement in lipids in the switch group
  • HIV Symptom Index : rates of diarrhea and bloating decreased in the switch group
  • Higher tretament satisfaction scores in the switch group

 

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