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%.