Pulido F. Clin Infect Dis 2017; 65:2112-8
Type of ARV Trial
Head-to-head comparative trials for first line ART since 2006
» 2 drugs vs 3 drugs
» DRV/r + 3TC vs DRV/r + 3TC/TDF
Head-to-head comparative trials for first line ART since 2006
» 2 drugs vs 3 drugs
» DRV/r + 3TC vs DRV/r + 3TC/TDF
Drugs
DRV/r, FTC/TDF, ABC/3TC, TDF, ABC, FTC, 3TC
DRV/r, FTC/TDF, ABC/3TC, TDF, ABC, FTC, 3TC
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- Dual therapy with DRV/r plus 3TC was non-inferior regarding maintenance of viral suppression and equally well tolerated as DRV/r plus TDF/FTC (or ABC/3TC)
- Persistent virological suppression was maintained after switching to dual therapy with DRV/r plus 3TC
- These results reinforce the efficacy of dual therapy with a fully active boosted PI and 3TC for maintenance of virological suppression
Design
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Randomisation was stratified by baseline nucleos (t)ides
Objective
- Non inferiority of DRV/r + 3TC at W48: % HIV RNA < 50 c/mL by intention to treat-exposed, snapshot analysis (lower margin of the 2-sided 95% CI for the difference = - 12%, 80% power)
Baseline characteristics and disposition at W48
Efficacy results (HIV RNA < 50 c/mL by ITT-e, snapshot) at W48
Virologic outcome at W48
Virologic failure
- HIV RNA > 50 c/mL in the W48 window
- Discontinuation before W48 due to lack of efficacy
Virologic failure and viral blips
HIV- 1 RNA > 400 c/mL and emergence of resistance
Adverse events, %
Percent mean change in fasting lipids according to NRTI backbone at screen
Mean change in eGFR (Cockroft-Gault), mL/min
