Confirmation of viral safety of dry heated factor VIII concentrate (8Y) prepared by Bio Products Laboratory (BPL): a report on behalf of U.K. Haemophilia Centre Directors.
Twenty-seven factor VIII deficient patients who had previously not been treated with blood or blood products were studied after infusion of a total of 24 batches of NHS factor VIII (8Y) concentrate produced by Bio-Products Laboratory, Elstree. Follow-up was carried out according to guidelines laid down by the International Society for Thrombosis and Haemostasis. Serial estimations of amino transferase level carried out over a 26-week period revealed no elevation of these enzymes attributable to hepatitis. Studies of various virological markers found no evidence of infection with hepatitis C, hepatitis B or HIV following transfusion. This confirms a previous finding that severe dry heating of factor VIII at 80 degrees C for 72 h seems to reduce the risk of transmitting hepatitis C from approximately 90% to a rate of 0-11%.
Oxford Haemophilia Centre, Churchill Hospital.
C R
CR
Rizza
M L
ML
Fletcher
P B
PB
Kernoff
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004340:Drug Contamination / Q000517:prevention & control*; D005169:Factor VIII / Q000627:therapeutic use*; D005260:Female; D006526:Hepatitis C / Q000517:prevention & control / Q000635:transmission; D006358:Hot Temperature; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D013997:Time Factors
D005169:Factor VIII; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase