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Switch to FTC + ddI + EFV - ALIZE - Switch EFV to ETR

Switch to FTC + ddI + EFV - ALIZE - Switch EFV to ETR. ALIZE Study: Switch PI + r to FTC + ddI + EFV. Design. Randomisation 1 : 1 Open-label. W48. N = 177. 389 HIV+ adults ARV with PI±r + 2 NRTIs HIV-1 RNA < 400 c/mL > 6 months CD4 cell count ≥ 100/mm 3 NNRTI-naïve. N = 178.

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Switch to FTC + ddI + EFV - ALIZE - Switch EFV to ETR

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  1. Switch to FTC + ddI + EFV • - ALIZE • - Switch EFV to ETR

  2. ALIZE Study: Switch PI+r to FTC + ddI + EFV • Design Randomisation 1 : 1 Open-label W48 N = 177 389 HIV+ adults ARV with PI±r + 2 NRTIs HIV-1 RNA < 400 c/mL > 6 months CD4 cell count ≥ 100/mm3 NNRTI-naïve N = 178 • Objective • Non inferiority in the proportion of patients with HIV-1 RNA < 400 c/mL at W48 (Intent-to-treat analysis, missing = failure) ; upper limit of the 95% CI for the difference = 15%, 80% power Molina JM, JID 2005;191:830-9 ALIZE

  3. ALIZE Study: Switch PI+r to FTC + ddI + EFV Baseline characteristics and patient disposition Molina JM, JID 2005;191:830-9 ALIZE

  4. ITT, M = F On Treatment,M = F Kaplan-Meier(ITT) % 96 93.1 100 90.5 87.6 87 79 80 60 40 20 0 HIV-1 RNA < 200 c/mL HIV-1 RNA < 200 c/mL HIV-1 RNA < 50 c/mL Non inferiority Upper bound of the 95% CI for the ≠: 2,6% Upper bound of the 95% CI for the ≠: 1.2% p < 0.05 log rank test ALIZE Study: Switch PI+r to FTC + ddI + EFV Outcome at Week 48 Virologic response Continuation PI FTC + ddI + EFV M= F: missing= failure • Patients who had received prior suboptimal ARV therapy with mono- or dual-NRTIs alone were not a higher risk of virologic failure (10% vs 11%) Molina JM, JID 2005;191:830-9 ALIZE

  5. ALIZE Study: Switch PI+r to FTC + ddI + EFV CD4 response, resistance and safety • No differences in median CD4 cell counts over time between groups • 13/14 virologic failures had a genotype (5 in the FTC + ddI + EFV group,8 in the PI group) • FTC + ddI + EFV: R to EFV (K103N, N = 4, L100I, N = 2) + FTC (M184V) = 5/5 ; L74 V in 1/5 • PI group: major PI resistance mutation = 3/8, M184V = 5/8 • Trend towards a higher overall incidence of grade 2 to 4 adverse events in the FTC + ddI + EFV group (48% vs 38%, p = 0.06) • Related to neurosensorial reactions in first 4 weeks • And to higher increases in aminotransferase levels • Discontinuation for adverse events was similar in both groups: 10% vs 9%, for PI and FTC + ddI + EFV group, respectively • Lipoatrophy increased in the PI group (46% at baseline vs 60% at W48) and remained stable in the FTC + ddI + EFV group (43% vs 42%), p < 0.0001 • Full adherence (100% of the pills taken during the 4 days before all visits) through W48 was 63% vs 82%, respectively (p = 0.0002) Molina JM, JID 2005;191:830-9 ALIZE

  6. Total cholesterol 35 30 25 20 15 10 5 0 -5 -10 -15 -20 -25 Weeks 0 4 8 12 16 20 24 28 32 36 40 44 48 171 160 163 164 159 155 164 PI 173 168 166 171 166 166 169 FTC + ddI + EFV ALIZE Study: Switch PI+r to FTC + ddI + EFV Median change from baseline in fasting lipids (mg/dL) Continuation PI FTC + ddI + EFV Triglycerides HDL cholesterol 60 20 50 40 15 30 20 10 10 0 5 -10 -20 0 -30 -40 -5 -50 -60 -10 Weeks Weeks 0 4 8 12 16 20 24 28 32 36 40 44 48 0 4 8 12 16 20 24 28 32 36 40 44 48 171 160 164 163 158 154 163 PI 166 153 157 158 152 143 153 PI 173 168 166 171 167 165 168 FTC + ddI + EFV 171 162 157 164 162 160 159 FTC + ddI + EFV Molina JM, JID 2005;191:830-9 ALIZE

  7. ALIZE Study: Switch PI+r to FTC + ddI + EFV • Conclusions • Switching a PI-based regimen, in patients with virologic suppression, to a convenient once-daily combination of FTC + ddI + EFV is associated with • Sustained virologic suppression • Some adverse events, mainly neurosensorial and hepatic, usually not treatment-limiting • Improvement in HDL cholesterol • No worsening of lipoatrophy Molina JM, JID 2005;191:830-9 ALIZE

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