Hepatitis B in subjects treated with a drug containing immunoglobulins.


In late 1974 and early 1975, several cases of viral hepatitis were reported in Italy among subjects who had received subcutaneous injections of a drug containing human immunoglobulins that was prescribed for the treatment of allergies. Epidemiologic and laboratory investigations provided evidence that the original immunoglobulins, the series of the drug containing these immunoglobulins, and sera from a number of patients were all positive for hepatitis B surface antigen (HBs Ag) of the adw subtype, which is relatively rare in Italy. Some sera from patients and healthy subjects treated with the HBs Ag-positive drug were also found to be positive for antibody to HBs Ag of the adw subtype. The clinical course of the disease was consistent with typical forms of icteric hepatitis in all patients examined. The average length of the possible incubation period was 111-143 days, and an inverse relation was observed between the number of doses administered and the length of the incubation period. The possibility that immunoglobulins can be responsible for the transmission of viral hepatitis raises a number of theoretical and practical problems concerning control and use of these blood products.


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