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Comparison of PI vs PI

Comparison of PI vs PI

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Comparison of PI vs PI

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  1. Comparison of PI vs PI • ATV vs ATV/r BMS 089 • LPV/r mono vs LPV/r + ZDV/3TC MONARK • LPV/r QD vs BIDM02-418M05-730A5073 • ATV/r vs FPV/rALERT • FPV/r vs LPV/r KLEAN • SQV/r vs LPV/r GEMINI • ATV/r vs LPV/r CASTLE • DRV/r vs LPV/r ARTEMIS

  2. ALERT ALERT Study: ATV/r QD vs FPV/r QD,in combination with TDF/FTC Randomisation* 1:1 Open-label • Design N = 53 FPV/r 1400/100 mg QD + TDF/FTC fdc QD Adults > 18 years ARV-naïve or < 14 days prior ART HIV RNA > 1,000 c/mL Any CD4 cell count N = 53 ATV/r 300/100 mg QD + TDF/FTC fdc QD *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 Smith KY. AIDS ResTher 2008;5:5

  3. ALERT ALERT Study: ATV/r QD vs FPV/r QD,in combination with TDF/FTC Baseline characteristics and patient disposition * In 2 of the 4 patients, detection at baseline of pre-existing resistance to FPV or TDF/FTC Smith KY. AIDS ResTher 2008;5:5

  4. ALERT ALERT Study: ATV/r QD vs FPV/r QD,in combination with TDF/FTC Outcome at week 48 HIV RNA < 50 c/mL Safety % FPV/r ATV/r • 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 = 1 100 92 89 83 75 80 60 40 20 0 ITT, M/D = F Observed data Mean CD4 increase at W48:170/mm3 (FPV/r) vs 183/mm3 (ATV/r) (p = 0.4) M/D = F : Missing/Discontinuation equals Failure Smith KY. AIDS ResTher 2008;5:5

  5. ALERT ALERT Study: ATV/r QD vs FPV/r QD,in combination with TDF/FTC • Summary - Conclusion • Similar virologic and immunologic outcome at W48 with FPV/r1400/100 mg QD and ATV/r 300/100 mg QD, in combination withTDF/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 Smith KY. AIDS ResTher 2008;5:5