ANDES Study: DRV/r + 3TC vs DRV/r + 3TC/TDF

Figueroa MI CROI 2018, Abs. 489

Type of ARV Trial
Head-to-head comparative trials for first line ART since 2006
» PI vs PI
» DRV/r + 3TC vs DRV/r + 3TC/TDF
Drugs
DRV/r, TDF, 3TC

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  • DRV/r + 3TC dual therapy was virologically non inferior to a standard therapy of DRV/r + 3TC/TDF in naïve patients
  • Similar virologic response of the 2 regimens in patients with HIV RNA > 100 000 c/mL at enrolment
  • Only 1 case of virologic failure (DRV/r + 3TC/TDF) with no emergence of resistance
  • Incidence of gastro-intestinal adverse events higher in triple therapy group
  • Lipid elevations higher in the DRV/r + 3TC group, significantly higher than in DRV/r + 3TC/TDF group for total cholesterol

Design


*Randomisation was stratified by HIV RNA (≤ or > 100 000 c/mL) at screening

Objective

  • Non inferiority of DRV/r + 3TC at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis

Baseline characteristics and patient disposition

Efficacy outcome at W48

Safety at W48