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

NRTI-Sparing
A4001078 Study: ATV/r + MVC vs ATV/r + TDF/FTC
Original article : J Acquir Immune Defic Syndr. 2013 Feb 1;62(2):164-70 - A Mills
Last update : 18/07/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • This open-label study in treatment-naive patients with CCR5-tropic virus showed that a high proportion of patients in the MVC and TDF/FTC treatment groups achieved and maintained viral suppression through 48 weeks of treatment
    • Low potential for resistance or loss of susceptibility to study drugs at treatment failure
  • When stratified by plasma HIV-1 RNA concentration at baseline, the number of patients who achieved plasma HIV-1 RNA < 50 c/mL at W48 was higher in the TDF/FTC + ATV/r treatment arm compared with the MVC + ATV/r group
  • CD4 cell counts increased from baseline in both treatment groups
  • The frequency of treatment-limiting hyperbilirubinemia was greater than expected
  • Limitations
    • Unpowered to establish non-inferiority

Design

Objective

  • Primary endpoint: % with HIV RNA < 50 c/mL at W48 (ITT, missing, discontinued = failure), not powered to show a difference
  • Protocol-defined treatment failure: < 1.0 log10 c/mL decrease from baseline in plasma HIV RNA at W4 or thereafter; failure to achieve plasma HIV RNA < 400 c/mL at W24; or rebound in plasma HIV RNA > 1 000 c/mL on 2 consecutive measurements ≤ 14 days apart in patients having achieved levels < 400 c/mL on 2 consecutive visits

Baseline characteristics (mean), and disposition

HIV-1 RNA < 50 c/mL at W48, ITT, missing/discontinuation = failure

Genotype analysis :
3 patients in each group with HIV RNA ≥ 500 c/mL at time of discontinuation :

  • no resistance to any component
  • no change in tropism in MVC group

Median change from baseline in CD4 cell count/mm 3 at W48: + 173 for MVC vs + 187 for TDF/FTC

Safety at W48

 

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