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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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Presentation on theme: "Switch to LPV/r monotherapy - Pilot LPV/r - M03-613 - American Study - KalMo - OK - OK04 - KALESOLO - MOST - HIV-NAT 077."— Presentation transcript:

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

2 Design Endpoints –Primary: proportion of patients with HIV-1 RNA < 50 c/mL at W96 (ITT-exposed, previous-failure = failure analysis) ; 80% power to detect a difference of 25% in response rate –Secondary: lipoatrophy (> 20% loss in limb fat) at W96 ; 70% power to detect a 20% difference in the mean change in limb fat percentage LPV/r 400/100 mg bid + ZDV/3TC EFV 600 mg QD + ZDV/3TC Randomisation 2 : 1 Open-label HIV+, ARV-naïve HIV-1 RNA > 1000 c/mL Any CD4 cell count No documented resistance N = 51 N = 104 W96 Cameron DW, JID 2008;198: M * Patients with HIV-1 RNA < 50 c/mL on 3 consecutive measures between W24 and W48 discontinued ZDV/3TC and remained on LPV/r monotherapy M Study: Switch to LPV/r monotherapy LPV/r 400/100 mg bid monotherapy *

3 79% of patients were male 65% were white Mean age was 38 years Mean baseline HIV-1 RNA was 4.9 log 10 c/mL Patients in the LPV/r group had a higher mean baseline HIV-1 RNA and a higher mean age 112 patients (57% in the LPV/r group and 69% in the EFV group) completed their assigned treatment regimen out to week 96 In the LPV/r group, after a median of 24 weeks, 92 patients (88%) simplified to LPV/r monotherapy Cameron DW, JID 2008;198: M M Study: Switch to LPV/r monotherapy Baseline characteristics and patient disposition

4 Outcome at week 96 * Confirmed virologic failure before W96 and reintensified therapy with NRTIs were ignored EFV + ZDV/3TC LPV/r mono Confirmed HIV-1 RNA < 50 c/mL after 72 weeks post-simplification 91% 57% (Kaplan-Meier estimate, p < 0.001) Confirmed virologic rebound (HIV-1 RNA > 500 c/mL) - N = 12 4/7 achieved HIV-1 RNA < 50 c/mL after NRTI intensification Mean change in CD4/mm 3 at W (p = 0.12) Development of resistance to EFV, N = 1 to PI, N = 4 (3 on LPV/r mono*, 1 on LPV/r + ZDV+3TC*) Cameron DW, JID 2008;198: M M Study: Switch to LPV/r monotherapy EFV LPV/r mono ITT-ENon completion = failure analysis* % % CI for the difference = - 29% ; 4% % CI for the difference = - 19% ; 13% HIV-1 RNA < 50 c/mL HIV-1 RNA < 50 c/mL * major PI mutations in all 4 cases

5 Cameron DW, JID 2008;198: M M Study: Switch to LPV/r monotherapy % Weeks % Weeks HIV-1 RNA > 500 copies/mL HIV-1 RNA copies/mL HIV-1 RNA < 50 copies/mL Discontinued LPV/r or EFV LPV/r EFV HIV-1 RNA level and discontinuation status, by visit, through 96 weeks

6 Cameron DW, JID 2008;198: M M Study: Switch to LPV/r monotherapy Median percent change from baseline in limb fat and trunk fat Scatter plot of percent change from baseline to W96 in limb fat vs trunk fat EFV limb fat LPV/r trunk fat EFV trunk fat LPV/r limb fat Weeks * * p < *

7 Most common (frequency > 5%) moderate or severe adverse events related to treatment –LPV/r monotherapy group Diarhoea: 15% Nausea: 14% –EFV group Asthenia: 12% Dizziness: 12% Insomnia: 12% Rash: 10% Depression: 6% Most frequent grade 3 or 4 laboratory abnormalities –LPV/r monotherapy group Total cholesterol > 7.8 mmol/L: 12% ; Triglycerides > 8.5 mmol/L: 7% Amylase > 2 ULN: 6% –EFV group Amylase > 5 ULN: 10% ALAT > 5 ULN: 6% Adverse events Cameron DW, JID 2008;198: M M Study: Switch to LPV/r monotherapy

8 Conclusions –LPV/r monotherapy was less effective than EFV + ZDV/3TC in maintaining virologic suppression: time to confirmed virologic rebound was shorter with LPV/r monotherapy –Lipoatrophy was significantly lower in the LPV/r monotherapy group Cameron DW, JID 2008;198: M M Study: Switch to LPV/r monotherapy


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