Long-term tolerance and recovery of beta-propiolactone/ultraviolet (beta PL/UV) treated PPSB in chimpanzees

Recent experiments have shown that a preparation of PPSB (factor IX concentrate) derived form beta PL/UV treated plasma was not infectious in chimpanzees with respect to hepatitis B and non-A, non-B. To answer the question whether the beta PL/UV treatment influences the tolerance and efficacy of the PPSB-concentrate, long-term application of PPSB-Biotest was carried out in chimpanzees. After 10 applications of 25 U factor IX/kg at weekly intervals, no signs of intolerance were observed by measurement of blood pressure during i.v. application and by means of skin-testing. Determination of coagulation factor activity during the application period revealed the same factor IX recovery at the beginning and at the end of the study.