Virus safety of a pasteurized antithrombin III concentrate. Preclinical and clinical data

Blood derived products carry the risk of virus transmission, especially for the hepatitis B virus (HBV), non-A/non-B virus(es) (NANBV) and human immunodeficiency virus (HIV). The precautionary measures for guaranteeing the virus safety of the pasteurized antithrombin III concentrate Kybernin HS/P are described and the efficacy of these measures is demonstrated by in vitro studies and by chimpanzee trials. The inactivation rate is greater than or equal to 10(6.7) for HIV, greater than or equal to 10(6.7) for HBV, and greater than or equal to 10(5.3) for NANBV (Hutchinson Pool). Clinically, virus safety was demonstrated by long-term drug surveillance as well as by both a retrospective and prospective clinical trial. The 13 participants of the prospective study were checked clinically and biochemically according to the standards of the International Committee of Thrombosis and Hemostasis (ICTH). Within an observation period of 12 months, no seroconversion has been detected for HIV or HBV. Neither have any increases in the transaminases occurred which would indicate NANB hepatitis.