Virus Safety of Pasteurized Clotting Factor Concentrates

Long-term efficacy and safety of a pasteurized, plasma-derived factor VIII concentrate (Beriate® P) in patients with haemophilia A

“…Our results support previous observations that virus-inactivated, human plasma-derived coagulation factor concentrates have an excellent safety profile [7][8][9][10][11][12]. Although only 36 patients received Beriate ® P during the 10-years of observation in this study, over 27 million IUs of the product were administered without transmission of viruses or the development of inhibitors in PTPs or the PUP.…”

“…In a longitudinal study of 113 patients with haemophilia A or B, von Willebrand disease, or factor X deficiency receiving only pasteurized concentrates, again, no seroconversion for HIV was observed over a follow-up period of up to 11 years [13].…”

“…Kreuz and colleagues have previously published the results of a virus safety study of pasteurized clotting factor concentrates [7,10] and reported no transmission of HAV, HBV or HCV [7], and no cases of seroconversion to HIV-1 or HIV-2 [10]. In contrast, of 99 patients with haemophilia A or von Willebrand disease who had been treated with human-plasma-derived clotting products not including specific steps to inactivate or remove viruses, a positive reaction for HIV-1 or HIV-2 antibodies was detected in 59 patients [7,10].…”

Hereditary and acquired angioedema: Problems and progress: Proceedings of the third C1 esterase inhibitor deficiency workshop and beyond

“…384 The high margin of virus safety of Berinert P and other pasteurized products by Aventis Behring has continuously been confirmed in clinical publications over the years. [385][386][387][388][389] In conclusion, on the basis of virus validation studies and testing the starting material for relevant viruses, the currently established safety and quality standards at Aventis Behring meet all requirements as documented in postmarketing surveillance data regarding the virus safety of Berinert P. Exceeding the requirements established by authorities, Aventis Behring is testing the starting material for Berinert P for HBV, HIV-1, HAV, and B19V via NAT/ PCR. 390 Therefore, management of donations (eg, as long as 6 months quarantine for donations from first-time donors [applicant donors], and 60 days inventory hold of donations from repeat donors [qualified donors] to discard a donation before entering the fractionation process based on Look Back procedure); NAT/PCR testing for HAV, HBV, HCV (HCV is mandatory in Europe), HIV-1, and B19V; quality assurance reviewing current Good Manufacturing Practice; and the internal release procedures overseen by Aventis Behring's quality control as well as external ones by the competent authority Paul-Ehrlich-Institut all facilitate the virus reduction capacity of the manufacturing procedure, improving the margin of safety beyond the numbers reported for the overall virus reduction factors.…”

Emergency treatment of acute attacks in hereditary angioedema due to C1 inhibitor deficiency: what is the evidence?

“…The pasteurised plasma‐derived products that have been most widely tested are for haemophilia. Extensive clinical trials in haemophiliacs treated with FVIII concentrates, produced using a pasteurisation step in a method similar to C1‐INH, have shown these products to be safe (20–22).…”