Switch to LPV/r monotherapy

Cahn P. EACS 2009; Abs. PS4/3

Type of ARV Trial
Switch studies in virologically suppressed patients
» Switch to PI/r monotherapy
Drugs
LPV/r, SQV/r, 2 NRTI

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  • LPV/r monotherapy is a potential strategy in virologically suppressed patients on a PI/r-containing regimen

Design (multicenter study in South and North America) :

Primary endpoint :

  • Proportion of patients with HIV-1 RNA < 200 c/mL at Day 360 (ITT analysis)
  • PI/r used at screening: LPV/r = 56% ; SQV/r = 21% ; IDV/r = 21%
  • Outcome at Day 360
    • HIV-1 RNA < 200 c/mL
      • Triple therapy: 96.9% vs LPV/r monotherapy: 97.4%
    • HIV-1 RNA < 50 c/mL
      • Triple therapy: 93.8% vs LPV/r monotherapy: 94.9%
  • Discontinuation: 7 in the triple therapy group vs 2 in the LPV/r group
  • 4 patients on LPV/r monotherapy required reinitiation of 2 NRTIs, all achieving HIV-1 RNA < 50 c/mL
  • Diarrhoea was more frequent in the LPV/r group (3.5% vs 1.1 %)
  • Patients on LPV/r monotherapy had higher LDL cholesterol levels