Human recombinant DNA-derived antihemophilic factor (Factor VIII) in the treatment of hemophilia A

Abstract

Background. Plasma-derived factor VIII concentrates used in the treatment of hemophilia A have the potential danger of transfusion-associated viral disease. The safety and efficacy of a recombinant factor VIII preparation for the treatment of this disorder were evaluated in this study. Methods. We compared the pharmacokinetics of plasma-derived and recombinant factor VIII in 12 previously treated subjects with severe hemophilia A. Results. The recovery and elimination half-lives of the recombinant factor VIII were equal to those of plasma-derived factor VIII. It was well tolerated via parenteral therapy, and only two mild adverse reactions (5%) were reported. No evidence of new viral infection was noted during the study period with the recombinant factor VIII. Conclusions. The biologic activity of the recombinant factor VIII is comparable with that of plasma factor VIII concentrate. It is safe and efficacious for the treatment of hemophilia A.