P. M. Mannucci, MD; K. Schimpf, MD; D. B. Brettler, MD; N. Ciavarella, MD; M. Colombo, MD; F. Haschke, MD; K. Lechner, MD; J. Lusher, MD; G. Weissbach, MD; International Study Group
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.
Mannucci PM, Schimpf K, Brettler DB, et al, International Study Group. Low Risk for Hepatitis C in Hemophiliacs Given a High-Purity, Pasteurized Factor VIII Concentrate. Ann Intern Med. 1990;113:27–32. doi: https://doi.org/10.7326/0003-4819-113-1-27
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Published: Ann Intern Med. 1990;113(1):27-32.
Gastroenterology/Hepatology, Infectious Disease, Liver Disease.
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