1. Switch to LPV/r monotherapy
ARV-trial.com
Switch to LPV/r monotherapy
Pilot LPV/r
M03-613
LPV/r Mono
KalMo OK
OK04
KALESOLO
MOST
HIV-NAT 077 1

2. OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy
Design
Randomisation
1 : 1
Open-label
W48
N = 21
LPV/r 400/100 mg bid
+ continuation of the 2 NRTIs
42 HIV+ ≥ 18 years
On 2 NRTIs + LPV/r > 4 weeks
No history of prior virologic failure on PI
HIV-1 RNA < 50 c/mL > 6 months
N = 21
LPV/r 400/100 mg bid
Endpoints: pilot study
Primary outcome: proportion of patients with HIV-1 RNA < 500 c/mL at W48 (ITT analysis)
Secondary outcomes: proportion of patients with HIV-1 RNA < 50 c/mL at W48, time to loss of virologic suppression, development of HIV resistance, CD4 changes, safety, treatment-related adverse events OK
Arribas J, JAIDS 2005;40:280-7

3. OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy
ARV-trial.com
OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy
Baseline characteristics and patient disposition
LPV/r + 2 NRTIs
N = 21
LPV/r monotherapy
Median age, years 42
Female
14%
19%
IV drug user
29%
38%
HCV co-infection
48%
Prior AIDS
67%
71%
CD4 cell count, median/mm3
585
662
HIV-RNA pre-HAART, median log10 c/mL
4.93
5.11
Time with HIV-1 RNA < 50 c/mL, median months
15.7
28.6
Months on LPV/r, median 13
N of PIs prior to LPV/r: 0 / 1 / 2
29% / 47% / 24%
33% / 67% / 0
NRTIs prior to randomisation
ZDV + 3TC
d4T + 3TC
Other
43% 29%
33%
Discontinuation by W48, n
1 (hyperlipidemia)
1 (lost to follow-up) OK
Arribas J, JAIDS 2005;40:280-7

4. OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy
Virologic outcome
HIV-1 RNA < 500 c/mL
at W48 (ITT)*
HIV-1 RNA < 50 c/mL
at W72 (ITT) 25 50
100 75 95 81
123 %
90.5
129
127 N=
95% CI for the difference = ; 4.9
95% CI for the difference = ; 11.4
Time to loss of virologic suppression
Percent with suppression 20 40 60
100
Weeks 80 12 24 36 48
* All patients with HIV RNA < 500 c/mL were < 50 c/mL
LPV/r + 2 NRTIs
LPV/r mono OK
Arribas J, JAIDS 2005;40:280-7

5. OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy
Other outcomes
4 blips in the monotherapy group vs 1 in the triple therapy group
No significant changes in CD4 cell count in any group at W48
Median adherence was 96% in the triple therapy group and 86% in the monotherapy group (p = 0.09)
Loss of virologic suppression was associated with shorter time of HIV-1 RNA < 50 c/mL prior to monotherapy (median of 40 weeks vs 132 weeks in patients with maintenance of virologic suppression ; p = 0.02)
Patients with loss of virologic suppression on LPV/r monotherapy were safely reinduced with prior NRTIs and achieved HIV-1 RNA < 50 c/mL
Grade 3 hypertriglyceridemia occurred in 3 patients in the triple therapy arm vs none in the monotherapy arm. One patient in each arm had grade 3 hypercholesterolemia
Conclusion: this pilot study provides preliminary evidence suggesting that in patients suppressed on a triple therapy with LPV/r, continuation with LPV/r monotherapy can maintain HIV suppression in a large proportion of patients OK
Arribas J, JAIDS 2005;40:280-7