Switch to LPV/r monotherapy  Pilot LPV/r  M  LPV/r Mono  KalMo  OK  OK04  KALESOLO  MOST  HIV-NAT 077

 Design Continuation of current regimen with 2 NRTIs + (NNRTI or PI) Randomisation 1 : 1 Open-label 60 HIV+ ≥ 18 years On 2 NRTIs + (NNRTI or PI) > 6 months HIV-1 RNA 6 months CD4 cell count > 200/mm 3 N = 30 KalMo Study: Switch to LPV/r monotherapy Nunes EP, HIV Clin Trials 2009;10: KalMo W96 * 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 = 30 Age, median years4039 Female31%45% Hepatitis C co-infection3%10% CD4 cell count, median/mm Duration of ARV treatment, median months PI treatment at screening37%33% NNRTI treatment at screening70%63% Discontinuation by W48, n36 Discontinuation for adverse event01 (diarrhoea) Confirmed HIV RNA elevation11 Baseline characteristics and patient disposition Nunes EP, HIV Clin Trials 2009;10: KalMo

* Includes only patients who completed 96 weeks of follow-up without discontinuation for other reasons than virologic failure Virologic outcome Nunes EP, HIV Clin Trials 2009;10: KalMo 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 analysis HIV-1 RNA < 80 c/mL On-treatment analysis* Triple therapyLPV/r mono %