Head-to-head comparative trials for first line ART since 2006

NRTI-Sparing
RADAR Study: DRV/r + RAL vs DRV/r + TDF/FTC
Original article : PLoS One. 2014 Aug 29;9(8):e106221 - RJ Bedimo
Last update : 18/07/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • The NRTI-sparing regimen RAL+ DRV/r did not achieve similar week 48 virologic efficacy compared with TDF/FTC + DRV/r, but was better with regard to markers of bone health
  • The two regimens achieved comparable immunologic response
  • Patients in the TDF/FTC arm had smaller increases in total cholesterol
  • Limitations
    • Small sample size
    • Unpowered to establish non-inferiority
    • AEs self-reported, open-label unblinded design
    • No site-specific BMD evaluation

Design

Objective

  • Primary endpoint: time to loss of virologic response until W24 (ITT, TLOVR)
  • Definition of failure: the earliest of any of the following events: death, permanent discontinuation of the study drug, loss to follow-up, or plasma HIV-1 RNA concentrations > 48 copies/ml obtained at 2 consecutive visits or one value > 48 copies/ml followed by permanent discontinuation of the study drug or loss to follow-up

Baseline characteristics (mean), and disposition

Virologic efficacy

Resistance testing: no treatment-emergent resistance-associated mutations

Lipid parameters, renal function, body fat and bone mineral density
Mean changes from baseline (95% CI)


Grade 3 or higher clinical or laboratory adverse event: 5 in the RAL arm vs 2 in the TDF/FTC arm

 

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