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

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Design 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 LPV/r 400/100 mg bid + continuation of the 2 NRTIs LPV/r 400/100 mg bid Randomisation 1 : 1 Open-label 42 HIV+ 18 years On 2 NRTIs + LPV/r > 4 weeks No history of prior virologic failure on PI HIV-1 RNA 6 months N = 21 W48 OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy Arribas J, JAIDS 2005;40:280-7 OK

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LPV/r + 2 NRTIs N = 21 LPV/r monotherapy N = 21 Median age, years42 Female14%19% IV drug user29%38% HCV co-infection48% Prior AIDS67%71% CD4 cell count, median/mm 3 585662 HIV-RNA pre-HAART, median log 10 c/mL4.935.11 Time with HIV-1 RNA < 50 c/mL, median months15.728.6 Months on LPV/r, median13 N of PIs prior to LPV/r: 0 / 1 / 229% / 47% / 24%33% / 67% / 0 NRTIs prior to randomisation ZDV + 3TC d4T + 3TC Other 43% 29% 29% 33% 38% 29% Discontinuation by W48, n1 (hyperlipidemia)1 (lost to follow-up) Baseline characteristics and patient disposition OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy Arribas J, JAIDS 2005;40:280-7 OK

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* All patients with HIV RNA < 500 c/mL were < 50 c/mL OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy Arribas J, JAIDS 2005;40:280-7 OK Virologic outcome LPV/r + 2 NRTIsLPV/r mono Percent with suppression 0 20 40 60 100 0 Weeks 80 12243648 HIV-1 RNA < 500 c/mL at W48 (ITT)* HIV-1 RNA < 50 c/mL at W72 (ITT) 0 25 50 100 75 95 81 123 % 90.5 123129127 81 N= 95% CI for the difference = - 33.4 ; 4.9 95% CI for the difference = - 30.5 ; 11.4 Time to loss of virologic suppression

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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 Other outcomes OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy Arribas J, JAIDS 2005;40:280-7 OK

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