Switch to LPV/r monotherapy

Pilot LPV/r M03-613 LPV/r Mono KalMo OK OK04 KALESOLO MOST HIV-NAT 077

Design

Continuation of current regimen with 2 NRTIs + (NNRTI or PI)

Randomisation1 : 1

Open-label

Randomisation1 : 1

Open-label

60 HIV+ ≥ 18 yearsOn 2 NRTIs + (NNRTI or PI)

> 6 monthsHIV-1 RNA < 80 c/mL > 6 months

CD4 cell count > 200/mm3

60 HIV+ ≥ 18 yearsOn 2 NRTIs + (NNRTI or PI)

> 6 monthsHIV-1 RNA < 80 c/mL > 6 months

CD4 cell count > 200/mm3N = 30

N = 30

KalMo Study: Switch to LPV/r monotherapy

Nunes EP, HIV Clin Trials 2009;10:368-74 KalMoKalMo

W96W96

* 533/133 mg bid for the first 2 weeks if on NNRTI at screening

Endpoints– Primary endpoint: proportion of patients with HIV-1 RNA < 80 c/mL

at W96 (ITT, missing equals failure analysis)– Secondary endpoints: virologic failure (2 consecutive HIV-1 RNA

> 500 c/mL), AIDS-defining illnesses, CD4, safety, adverse events

LPV/r 400/100 mg bid*

KalMo Study: Switch to LPV/r monotherapy

Triple therapy

N = 29

LPV/r bid monotherapy

N = 30Age, median years 40 39

Female 31% 45%

Hepatitis C co-infection 3% 10%

CD4 cell count, median/mm3 510 538

Duration of ARV treatment, median months 43.4 40.5

PI treatment at screening 37% 33%

NNRTI treatment at screening 70% 63%

Discontinuation by W48, n 3 6

Discontinuation for adverse event 0 1 (diarrhoea)

Confirmed HIV RNA elevation 1 1

Baseline characteristics and patient disposition

Nunes EP, HIV Clin Trials 2009;10:368-74 KalMoKalMo

* Includes only patients who completed96 weeks of follow-up without discontinuation

for other reasons than virologic failure

Virologic outcome

Nunes EP, HIV Clin Trials 2009;10:368-74 KalMoKalMo

Other outcomes

KalMo Study: Switch to LPV/r monotherapy

1 virologic failure (confirmed HIV-1 RNA > 500 c/mL) in each group. No resistance mutation on genotype

No difference in CD4 changes between groups

GI adverse events more frequent in the monotherapy group: 24 vs 10(p = 0.001)

5 patients in the triple therapy group underwent regimen changes due to drug-related toxicities

Conclusion: switching to LPV/r monotherapy is effective, safe and well tolerated through 96 weeks

ITT analysisHIV-1 RNA < 80 c/mL

On-treatmentanalysis*

86.79696

80

0

25

50

75

100

Triple therapy LPV/r mono

%