Switch studies in virologically suppressed patients

Switch to RAL-containing regimen
CHEER Study: Switch ENF to RAL
Original article : J Acquir Immune Defic Syndr. 2009 Aug 1;51(4):367-73 – W Towner
Last update : 28/03/2014

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Replacing ENF with RAL in treatment-experienced HIV-infected patients with sustained viral suppression is safe and efficacious

 

  • Pilot, open-label study
  • 52 adults on salvage therapy with enfuvirtide-based regimen and HIV-1 RNA < 75 c/mL (bDNA) or < 50 c/mL (PCR) for at least 6 months
  • Switch of enfuvirtide to RAL 400 mg bid, the remainder of the salvage regimen being unchanged. At the time of the switch:
    • Mean length of time on prior ARV therapy: 15 years
    • ENF had been administered for a median of 2.7 years
    • Salvage regimen containing a PI/r in 47 patients (90%)
    • Baseline CD4 cell count: 377/mm3

  • Virologic and immunologic outcomes at week 24 (intent-to-treat analysis)
    • HIV-1 RNA below the limit of quantification, N = 49 (94%)
    • Treatment failures, N = 3
      • Withdrew consent N = 1
      • Virologic failure N = 1
      • Death N = 1
    • Average CD4 cell count change: + 32/mm3
  • No grade 3 or 4 laboratory abnormalities
  • No adverse event leading to discontinuation of RAL
  • Patient treatment satisfaction significantly improved on RAL

 

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