Molina JM. J Infect Dis. 2005 Mar 15;191(6):830-9
Type of ARV Trial
Switch studies in virologically suppressed patients
» Switch PI to NNRTI
» FTC + ddI + EFV
Switch studies in virologically suppressed patients
» Switch PI to NNRTI
» FTC + ddI + EFV
Drugs
EFV, FTC, ddI
EFV, FTC, ddI
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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) :
