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

NRTI-Sparing
SPARTAN Study: ATV + RAL BID vs ATV/r + TDF/FTC QD
Original article : HIV Clin Trials. 2012 May-Jun;13(3):119-30 - MJ Kozal
Last update : 09/10/2014

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • ATV + RAL BID achieved virologic response rate comparable to current standard of care for treatment-na├»ve subjects
  • ATV + RAL was associated with
    • Emergence of resistance to RAL in case of virologic failure
    • Higher rates of severe hyperbilirubinemia compared with ATV/r 300/100 mg QD
      • Could be related to higher ATV exposure
    • No new or unexpected safety signals
  • Study was early terminated and regimen of ATV 300 mg BID + RAL 400 mg BID considered not to be optimal for further clinical development

Design :


*Randomisation was stratified by HIV RNA (< or ≥ 100,000 c/mL)

Efficacy endpoint :

  • Primary : HIV RNA < 50 copies/mL at week 24 by mITT (confirmed virologic response (CVR) with non completers counted as failure)
  • Other assessments : CVR with non completers counted as missing, virologic response-observed

Baseline characteristics and patient disposition :

Response rate at week 24 :

Resistance data :


* N = 1 with Q148R, N = 1 with Q148Q/R + T97T/A, 2 with N155H

Adverse events through week 24 :

 

 

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