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
Median values of fasting lipids, mg/dL :
W0-W36: all patients received induction therapy with ABC/3TC + ATV/r
.
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