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Switch to LPV/r monotherapy

Switch to LPV/r monotherapy. Pilot LPV/r M03-613 LPV/r Mono KalMo OK OK04 KALESOLO MOST HIV-NAT 077. OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy. Design. Randomisation 1 : 1 Open-label. W48. N = 21. 42 HIV+ ≥ 18 years On 2 NRTIs + LPV/r > 4 weeks

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Switch to LPV/r monotherapy

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

  2. OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy • Design Randomisation 1 : 1 Open-label W48 N = 21 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 • 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 Arribas J, JAIDS 2005;40:280-7 OK

  3. OK Study: Switch LPV/r + 2NRTIs to LPV/r monotherapy Baseline characteristics and patient disposition Arribas J, JAIDS 2005;40:280-7 OK

  4. % 95 90.5 81 81 100 75 50 25 123 123 129 127 N= 0 95% CI for the difference= - 33.4 ; 4.9 95% CI for the difference= - 30.5 ; 11.4 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) Time to loss of virologic suppression 100 80 60 Percent with suppression 40 20 0 0 12 24 36 48 Weeks * All patients with HIV RNA < 500 c/mL were < 50 c/mL LPV/r + 2 NRTIs LPV/r mono Arribas J, JAIDS 2005;40:280-7 OK

  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 weeksin 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 Arribas J, JAIDS 2005;40:280-7 OK

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