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Despite much discussion, consensus has not been reached on how to interpret high factor VIII activity.
The kinetics, duration and magnitude of AAV-mediated Factor VIII activity in individuals with hemophilia A will be determined and correlated to an appropriate BMN 270 dose.
In this case, the initial VWD testing panel identified significantly decreased plasma von Willebrand factor ristocetin cofactor activity (VWF:RCo), with a discordantly low ratio of VWF:RCo to von Willebrand factor antigen level (VWF:Ag) and normal coagulation factor VIII activity, suggesting types 2A, 2B, or 2M VWD (or acquired von Willebrand syndrome).
6-10 The reduction in factor VIII activity secondary to vWD was not ruled out by measuring the vWF:Ag and Ricof activity and since the BT may be normal in vWD we may have missed vWD in some instances.
Factor VIII activity levels increased in three patients above baseline, up to 4% of normal in one patient and up to 1%-2% of normal in two patients.
The product includes a recombinant analogue of porcine FVIII that allows physicians to manage the treatment's efficacy and safety by measuring factor VIII activity levels in addition to clinical evaluations.
Clotting factor VIII activity was below the detection limit (<5 IU/dL; reference interval, 70-150 IU/dL), and the activity of factor XII was slightly reduced (53 IU/dL, reference interval, 70-150 IU/dL).