Emerging Hemofilia
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![Page 1: Emerging Hemofilia](https://reader035.fdocuments.in/reader035/viewer/2022062310/577c7d731a28abe0549ed690/html5/thumbnails/1.jpg)
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Moderator
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Panelists
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Learning Objectives
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Prophylaxis: Why > 1%?
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Optimal Use of Prophylaxis
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Factor Product Modification
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Extended Half-life Factor Products
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Monitoring: Changing Landscape?
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Advances in Monitoring Techniques
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Outline
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Case Presentation
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Factors to Weigh in Choosing Treatment Options
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Outline
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Early Findings With Prophylaxis
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Early Findings With Prophylaxis (cont)
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Joint Outcome Study
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Results of the Joint Outcome Study
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ESPRIT Study
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ESPRIT Study – Analyses
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Outcome Measures – Raising the Bar
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Outcome Measures – Raising the Bar (cont)
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Outcome Measures – Raising the Bar (cont)
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Outline
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Ongoing Issues
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When Should Prophylaxis Be Started?
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Which Regimen Should Be Used?
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Which Regimen Should Be Used? (cont)
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Which Regimen Should Be Used? (cont)
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Which Regimen Should Be Used? (cont)
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Regimens by Regions
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Regimens by Regions (cont)
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Regimens by Regions (cont)
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Outline
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Ongoing Issues
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What Needs To Be Investigated?
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When Should Prophylaxis Stop?
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When Should Prophylaxis Stop? (cont)
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Take-home Messages
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Return to Case
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Case Discussion
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Case Presentation
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Outline
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Current Outcomes
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Half-life Extension of Biologics
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Extended Half-life FIX Products
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Extended Half-life FVIII Products (cont)
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FVIII-VWF Interaction
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rFVIIIFc
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Phase 1 Trial of rFVIIIFc
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rFVIIIFc Phase 3 Trial Results
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rFVIIIFc Phase 3 in Children
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rFVIIIFc Assay Field Study
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BAY 94-9027
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Phase 1 Study of BAY 94-9027
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Phase 1 Study of BAY 94-9027 (cont)
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Phase 2/3 Study of BAY 94-9027
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BAY 94-9027 aPTT Study
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N8-GP Phase 3 Trial
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Glycopegylated FIX
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Phase 3 Results With N9-GP
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Clinical Trial Regimens
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What’s Next?
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Untested Regimens
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Return to Case
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Case Discussion
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Case Presentation
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Issues Involved in Switching
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Duration of Outcome Assessment Needs To Be Long (Decades) and Hampers Clinical Studies
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How to Make the Bridge From Standard to Extended Half-life Factor Products
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Determining Dose
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Effect of Half-life on FVIII Level Following Bolus Infusion
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Relationship Between Predicted Time With FVIII:C < 1% and Joint Bleeds
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Determining Thrombin Generation
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Thrombin Generation Assay vs Chromogenic Method: FVIII Values ≤ 0.05 IU/mL
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Correlation Between F8 Genotype and Bleeding Phenotype
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Group Level vs Individual Level
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Pharmacokinetics May Be the Key
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Pharmacokinetic Dosing With Prophylactic Treatment
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Concentrate Consumption in Dose Category
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Using Extended Half-life Factor Products
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T1/2 Extended: But What Is Most Important -- Dose Interval or Trough?
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A Vision of Future Hemophilia Treatment: 2 Scenarios
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How Many Samples Are Required?
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Pharmacokinetics of Recombinant Factor IX
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Factor VIII Pharmacokinetics
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Monitoring
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Arthropathy Is Individual, But Who Is Who?
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Potential Use of Sensitive Biomarkers
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Potential Biomarkers for Hemophilic Arthropathy
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Genomics in Hemophilia:What Potential Does It Have?
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Genomics and Hemophilic Arthropathy
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Radiologic Classification of Hemophilic Arthropathy
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MRI vs Ultrasound
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Ultrasound vs MRI vs X-ray
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Use of MSKUS
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Impact of MSKUS
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Assessment of Prophylaxis in Hemophilia: Summary
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Case Revisited
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Case Question Discussion
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Case Discussion
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