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• 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