ALERT Study: ATV/r QD vs FPV/r QD, in combination with TDF/FTC

Smith KY. AIDS Res Ther. 2008 Mar 28;5:5

Type of ARV Trial
Head-to-head comparative trials for first line ART since 2006
» PI vs PI
» ATV/r + FTC/TDF vs FPV/r + FTC/TDF


  • 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


  • 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