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Comparison of PI vs PI
GARDEL Study: LPV/r + 3TC vs LPV/r + 2 NRTI
Original article : Lancet Infect Dis. 2014 Jul;14(7):572-80 - P Cahn
Last update : 09/10/2014

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • LPV/r + 3TC dual therapy was virologically non inferior to a standard therapy of LPV/r + 2 NRTI
  • Similar virologic response of the 2 regimens in patients with HIV RNA > 100 000 c/mL at enrolment
  • No resistance mutations to protease inhibitor at virologic failure in either group
    • 2 patients with M184V in dual therapy group
  • Incidence of adverse events higher in triple therapy group
  • Discontinuation because of adverse events mainly related to NRTI in the LPV/r + NRTI arm
  • Potential advantages of first-line LPV/r + 3TC
    • Cost
    • Less toxicity (might need less monitoring)
    • Spares the other NRTIs

Design :

*Randomisation was stratified by HIV RNA (<or > 100,000 c/mL) at screening
** Investigator-selected NRTI : ZDV/3TC = 54%, TDF/FTC = 37%, ABC/3TC = 9%

Objective :

  • Non inferiority of LPV/r + 3TC at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis (lower limit of the 95% CI for the difference = -12%, 85% power)

Baseline characteristics and patient disposition :

Response to treatment at week 48 :

HIV RNA < 50 c/mL








Median CD4/mm3 increase :
+ 227 (LPV/r + 3TC) vs
+ 217 (LPV/r + 2 NRTI)

Virologic failure definition

  • 2 consecutive HIV-1 RNA > 400 c/mL at or after W24
  • HIV-1 RNA ≥ 50 c/mL at W48

Resistance data at week 48

Adverse events


Selected grade 3-4 laboratory abnormalities occurred at the same frequency in both groups, except for hyperlipidemia (more frequent in dual therapy group)

 

   

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