Low Risk for Hepatitis C in Hemophiliacs Given a High-Purity, Pasteurized Factor VIII Concentrate

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Abstract
Study Objective: To assess whether the hepatitis B virus (HBV), the hepatitis C virus (HCV), and the human immunodeficiency virus (HIV) are transmitted to hemophiliacs by a high-purity factor VIII concentrate in which the method of virus inactivation is pasteurization. Design: Hepatitis B virus markers, the antibody to HCV (anti-HCV), the antibody to HIV (anti-HIV), and aminotransferases were measured on serum samples collected before the first concentrate infusion and at regular time intervals thereafter. Setting: Seventeen hemophilia centers in Italy, the Federal Republic of Germany, Belgium, Austria, and the Democratic Republic of Germany. Patients: Twenty-nine patients with hemophilia A who had not received a previous transfusion with blood products and who had normal alanine and aspartate aminotransferases (ALT and AST) were included in the final analysis. Measurements and Main Results: No patient became positive for anti-HCV or anti-HIV or developed sustained increases in aminotransferase levels. Similarly, none of the 15 unvaccinated patients developed markers of HBV infection. Conclusion: This prospective study conducted in previously untransfused hemophiliacs highly susceptible to developing post-transfusion hepatitis shows that a large-pool clotting factor concentrate treated with pasteurization carries a low risk for transmitting HCV, the major causative agent of post-transfusion hepatitis.