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

2. 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

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