Activated Prothrombin Complex or Factor VIIa for Refractory Hemophilia?

In most people with classic hemophilia, administration of factor VIII concentrates is very effective for controlling bleeding. However, one patient in five develops inhibitory antibodies and becomes resistant to treatment. For treatment of patients with such inhibitors, two products that bypass factor VIII in the clotting cascade have been approved by the FDA: activated prothrombin complex concentrate (FEIBA) and recombinant human factor VIIa (NovoSeven). Whether these products have equivalent efficacy has been unclear.

In an investigator-initiated, prospective, open-label trial (FENOC), patients with refractory hemophilia from 27 centers in Europe and North America were randomized to receive either FEIBA (75–100 U/kg) or NovoSeven (90–120 μ…