PRELIMINARY CLINICAL-EXPERIENCE - PHARMACOKINETICS AND TOLERANCE OF A DOUBLE-VIRUS-INACTIVATED FACTOR-VIII PREPARATION

The incorporation of viral inactivation steps into the manufacture of factor VIII concentrates has markedly improved the safety margin of the product, but in order that viruses, such as hepatitis A, are not transmitted by infusion of factor VIII preparations, some manufacturers include a further process step, such as heat inactivation. There is the possibility that such a step will change the final factor VIII product and it was investigated whether there are any pharmacokinetic differences between the products Octavi S/D and Octavi S/D + heat treatment. It is concluded that Octavi S/D + heat treatment can be given in doses equal to Octavi S/D or other factor VIII concentrates.