Switch studies in virologically suppressed patients

Switch to FTC + ddI + EFV
ALIZE Study
Original article : J Infect Dis. 2005 Mar 15;191(6):830-9 – JM Molina
Last update : 28/03/2014

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

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

Design :


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

Baseline characteristics and patient disposition :


Outcome at Week 48 :

Virologic response

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%)

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)

Median change from baseline in fasting lipids (mg/dL) :

 

   

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