Incidence of Viral Hepatitis after Administration of Factor IX Concentrates

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Abstract
A high frequency of viral hepatitis was reported after treatment with the human factor IX concentrate Konyne. Clinical trials with Konyne and a similar factor IX concentrate, Preconativ, were started in Sweden in 1969. During the first 2 yr, 26 patients were treated with 1 or both preparations. Nine patients developed viral hepatitis within 6 mo. of treatment. Preconativ alone was introduced on the Swedish market in 1971. From 1971-1974, another 26 hemophiliacs were treated but only 2 cases of hepatitis occurred. Selection of donors and screening for hepatitis B surface antigen in donor blood used for the manufacturing of Preconativ might be contributing factors to this low hepatitis incidence.