Sixteen years of treatment with pasteurized human clotting factor concentrates in children and adolescents: a pharmacosurveillance investigation comprising 727 patient years.

Abstract

The main criteria for the quality of a clotting factor concentrate for treatment of congenital deficient patients are viral safety and low incidence of the development of inhibitors. Since the discovery of HIV, the viral safety of products has especially been dramatically improved, with the introduction of viral inactivation procedures. Many prospective studies show that plasma-derived products now can be regarded as safe in regard to HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV). On the other hand, not all viruses are inactivated by all methods, as is demonstrated, for example, by the transmission of human parvovirus B19 by plasma-derived concentrates virus inactivated by various methods and even by recombinant products.[1] [2] [3] [4] [5] [6] [7] [8] [9] [10]