Archives of Disease in Childhood, Vol 64, 1463-1467, Copyright © 1989 by Archives of Disease in Childhood.
Safety trial of heated factor VIII concentrate (8Y)
KJ Pasi and FG Hill
Department of Haematology, Children's Hospital, Birmingham.
Seventeen previously untreated boys with haemophilia A were treated with
high purity heat treated factor VIII concentrate (8Y) for up to 36 months.
Liver function tests were assessed monthly. No boy's serum has been shown
to contain HIV antibodies and no increases in alanine transaminase activity
have been detected. In only one patient was a single rise in aspartate
transaminase activity noted, and this was without a corresponding rise in
alanine transaminase. A second patient's serum contained hepatitis B core
antibody transiently. It was thought likely in both cases that the
abnormalities reflected intercurrent infections rather than disease
associated with transfusion. The physical treatments used in the production
of 8Y seem to inactivate the agent(s) responsible for non-A, non-B
hepatitis and HIV transmission by transfusion of factor VIII has been
abolished. There are, however, problems associated with conducting safety
trials in young haemophiliac patients.
