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
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
DRV/r, TDF, 3TC
- 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