Switch to LPV/r monotherapy - Pilot LPV/r - M03-613 - American Study - KalMo - OK - OK04 - KALESOLO - MOST - HIV-NAT 077

American Study: Switch to LPV/r monotherapy ARV-trial.com American Study: Switch to LPV/r monotherapy Design (multicenter study in South and North America) Randomisation 1 : 1 Open-label W48 N = 39 Continuation of current regimen with 2 NRTIs + PI/r 80 HIV+ First ARV regimen with 2 NRTIs + PI/r HIV-1 RNA < 50 c/mL ≥ 6 months CD4 cell count ≥ 100/mm3 N = 41 LPV/r 400/100 mg bid Primary endpoint Proportion of patients with HIV-1 RNA < 200 c/mL at Day 360 (ITT analysis) LPV/r mono Cahn P, EACS 2009;Abs. PS4/3

American Study: Switch to LPV/r monotherapy 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 Conclusion LPV/r monotherapy is a potential strategy in virologically suppressed patients on a PI/r-containing regimen LPV/r mono Cahn P, EACS 2009;Abs. PS4/3