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Helixate® FS Factor VIII Efficacy

In clinical studies involving surgeries for previously treated and untreated hemophilia patients, 100% of patient responses with Helixate® FS were rated as excellent/good. In untreated or minimally treated patients, only 15% of patients developed an inhibitor 1 in patients who had previously received factor therapy, none of the patients developed a new inhibitor.2

In a study of 61 infants and young children with hemophilia who had not previously received factor therapy or who had been minimally treated1:

  • Helixate® FS effectively treated the majority of bleeding episodes with only 1 or 2 infusions
  • The incidence of inhibitor development was only 15%
  • Helixate® FS was used in 27 surgical procedures with minimal blood loss in all cases; no procedure required transfusion of blood or blood derivatives
  • An independent analysis of the study population supports the inhibitor formation data
    • Patients had a risk mutation profile typical of patients with severe hemophilia A and comparable to the profile of previously untreated patients in other rFVIII studies3

In a study of 71 patients who had previously received factor therapy2:

  • 94% of 2,585 bleeding episodes were treated successfully with 1 or 2 infusions of Helixate® FS
  • The incidence of new inhibitor development in these patients was 0%
  • Adverse events (ie, side effects) were reported in less than 1% of infusions, with no patients discontinuing therapy because of adverse effects

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1. Kreuz W, Gill JC, Rothschild C, et al, and the International Kogenate-FS Study Group. Full-length sucrose-formulated recombinant factor VIII for treatment of previously untreated or minimally treated young children with severe haemophilia A; results of an international clinical investigation. Thromb Haemost. 2005;93:457-467.

2. Abshire TC, Brackmann H-H, Scharrer I, et al, and the International Kogenate-FS Study Group. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy.

3. Oldenburg, Johannes; Thrombosis and Haemostasis; May 2006.