Virus safety of beta-propiolactone treated plasma preparations. Clinical experiences

Sterilization of human plasma with beta-propiolactone and UV-irradiation (cold sterilization) has been shown to be effective for a number of common pathogenic viruses. We have published data on the hepatitis safety of cold sterilized factor IX concentrates (PPSB) in healthy volunteers. This study has now been extended to include 6 virgin hemophilia B patients, who have been treated with cold sterilized PPSB for a period of up to 5 years. None of these volunteers or patients exhibited clinical symptoms or laboratory data indicating the transmission of either viral hepatitis (B or NANB) or acquired immunodeficiency syndrome (AIDS). Hyperimmunoglobulin (HIg) preparations from cold sterilized plasma, offering protection against hepatitis B and NANB are also safe regarding HTLV-III virus transmission, even though these preparations may contain HTLV-III antibody titers up to 1:1000.