Summary
To assess the sterilization efficacy of a combined Tween 80®, β-propiolactone and ultraviolet irradiation procedure applied to a FVIII preparation to which an estimated 105.9 chimpanzee infectious doses (CID50) of hepatitis B virus had been added per ml, two chimpanzees were inoculated with 10 ml each of treated and untreated preparations. The untreated preparation, which was obtained from donors with normal alanine aminotransferase (ALT) levels, induced non-A, non-B hepatitis in both recipient animals, and delayed hepatitis B infection in one of these. Neither animal receiving the treated preparation developed either type of hepatitis. When subsequently challenged with the untreated material, both of the latter animals developed non-A, non-B and hepatitis B infection, proving their susceptibility to both types of infection.
It was concluded that the combined procedure inactivated an estimated 106.9 CID50 of hepatitis B virus and an unknown quantity of a non-A, non-B virus.
The finding of non-A, non-B virus infectivity in a pooled FVIII preparation despite careful ALT screening of plasma donors emphasizes the necessity of subjecting such preparations to sterilization procedures.
Keywords
Hepatitis B virus - Non-A, non-B hepatitis - Factor VIII - Virus inactivation - β-propiolactone - Ultraviolet irradiation
