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

KalMo Study: Switch to LPV/r monotherapy Design Randomisation 1 : 1 Open-label W96 N = 30 60 HIV+ ≥ 18 years On 2 NRTIs + (NNRTI or PI) > 6 months HIV-1 RNA < 80 c/mL > 6 months CD4 cell count > 200/mm3 Continuation of current regimen with 2 NRTIs + (NNRTI or PI) N = 30 LPV/r 400/100 mg bid* * 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 KalMo Nunes EP, HIV Clin Trials 2009;10:368-74

KalMo Study: Switch to LPV/r monotherapy ARV-trial.com KalMo Study: Switch to LPV/r monotherapy Baseline characteristics and patient disposition Triple therapy N = 29 LPV/r bid monotherapy N = 30 Age, 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 1 (diarrhoea) Confirmed HIV RNA elevation 1 KalMo Nunes EP, HIV Clin Trials 2009;10:368-74

KalMo Study: Switch to LPV/r monotherapy Virologic outcome Other outcomes 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* 86.7 96 80 25 50 75 100 Triple therapy LPV/r mono % * Includes only patients who completed 96 weeks of follow-up without discontinuation for other reasons than virologic failure KalMo Nunes EP, HIV Clin Trials 2009;10:368-74