Switch studies in virologically suppressed patients
Download the slides

Related articles :
Table of contents

Switch to ATV-containing regimen
ARIES
Original article : AIDS. 2010 Aug 24;24(13):2019-27 – KE Squires ; Squires K, IAS 2011; Abs. MOPE215
Last update : Epub 2007 Nov 13

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • ATV + ABC/3TC
    • Is potent and well tolerated in patients who have achieved initial virologic suppression on a 36 weeks induction regimen of ATV/r + ABC/3TC
    • Represents a viable treatment simplification strategy
  • Limitations Such a strategy is restricted to NRTI backbone
    • such as ABC/3TC (TDF may lead to decrease in ATV levels and is therefore not recommended)
    • Unboosted ATV may offer less forgiveness than ritonavir-boosted ATV

Design :


Endpoints :

  • Primary: non inferiority in the proportion of patients with HIV-1 RNA < 50 c/mL at W48 of the maintenance phase (intent-to-treat, exposed analysis), lower limit of the 95% CI for the difference = -12%, 90% power
  • Secondary: treatment failure, CD4, fasting lipids, adverse events

Baseline characteristics and patient disposition :

Outcome at week 48 of the maintenance phase


Other endpoints

  • HIV-1 RNA < 50 c/mL at W48 of the maintenance phase according to baseline plasma viral load

  • Per-protocol virologic failure (confirmed HIV-1 RNA > 400 c/mL after achieving < 400 c/mL)
    • ATV/r, N = 7
    • ATV, N = 1
    • No major PI-resistance mutations at failure

Grades 2 to 4 drug-related adverse events (frequency ≥ 3%) and serious adverse events (intent-to-treat exposed) :

Fasting lipids (mg/dL), observed analysis (intent-to-treat exposed) :

HIV RNA < 50 c/mL at W144, ITT :

Drug-related AE between W36-W144 :

Emergence of resistance mutations

  • ATV, N = 2
  • ATV/r, N = 1

Median values of fasting lipids, mg/dL :

W0-W36: all patients received induction therapy with ABC/3TC + ATV/r

.

dia dia dia
dia dia dia
dia dia dia

Back to Table of Contents

     
     
     
Copyright AEI 2017 | Links | Contact | Faculty and Disclosure | Terms of use aei