Comparison of PI vs PI
ALERT Study: ATV/r QD vs FPV/r QD, in combination
with TDF/FTC
Original article : AIDS Res Ther. 2008 Mar 28;5:5 - KY Smith
Last update :
17/03/2009
Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK
- Similar virologic and immunologic outcome at W48 with FPV/r 1400/100 mg QD and ATV/r 300/100 mg QD, in combination with TDF/FTC fdc
- Higher gastrointestinal intolerance with FPV/r
- High incidence of increased bilirubin with ATV/r
- Higher triglycerides increase with FPV/r; total, HDL- and LDL-cholesterol changes similar in both groups
- Limitation: small size of the study
Design :
* Randomisation was stratified on HIV RNA < or ≥ 100,000 c/mL
Objective :
- Primary endpoint: HIV RNA < 50 c/mL at W48
- No power calculation due to limited sample size
Note: FPV/r and TDF/FTC were administered with or without food; ATV/r with food
Substitution of ABC/3TC fdc for TDF/FTC was allowed
Baseline characteristics and patient disposition :
Outcome at week 48 :
HIV RNA < 50 c/mL
Safety
- Diarrhoea and nausea were more frequent in the FPV/r
- Grade 3-4 hyperbilirubinemia in ATV/r group = 28%
- GFR decline > 25% was similar in both groups; TDF/FTC was discontinued in 3 patients (FPV/r group) for GFR decrease to < 50 mL/min
- Median changes in total cholesterol, LDL- cholesterol and HDL-cholesterol were similar in both groups; triglycerides increase was higher in the FPV/r group; use of lipid-lowering agents: FPV/r = 7 vs ATV/r = 1
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