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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 - M03-613 - 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;198:234-40 M03-613 * 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 M03-613 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;198:234-40 M03-613 M03-613 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 W96 + 240 + 289 (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;198:234-40 M03-613 M03-613 Study: Switch to LPV/r monotherapy EFV LPV/r mono ITT-ENon completion = failure analysis* 63 60 % 0 20 40 60 80 100 95% CI for the difference = - 29% ; 4% 61 48 95% 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;198:234-40 M03-613 M03-613 Study: Switch to LPV/r monotherapy % 0 20 40 60 80 100 0163248648096 Weeks % 0 20 40 60 80 100 0163248648096 Weeks HIV-1 RNA > 500 copies/mL HIV-1 RNA 50-500 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;198:234-40 M03-613 M03-613 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 -30 -20 -10 0 10 20 30 024487296 EFV limb fat LPV/r trunk fat EFV trunk fat LPV/r limb fat Weeks * * p < 0.001 *

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;198:234-40 M03-613 M03-613 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;198:234-40 M03-613 M03-613 Study: Switch to LPV/r monotherapy


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