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

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
[+] Article, Author, and Disclosure Information

Other members of the International Study Group are G. Auerswald, Bremen, Federal Republic of Germany; V. Carnelli, Milano, Italy; A. Gringeri, Milano, Italy; D. Gunther, Saarlouis, Federal Republic of Germany; H. Lenk, Leipzig, German Democratic Republic; G. Mancuso, Palermo, Italy; G. Mariani, Rome, Italy; M. Morfini, Florence, Italy; U. Mittler, Magdeburg, German Democratic Republic; W. Muntean, Graz, Austria; F. Rodeghiero, Vicenza, Italy; B. Schmeltzer, Potsdam, German Democratic Republic; and P. Fondu, Bruxelles, Belgium.

Current Author Addresses: Drs. Mannucci and Colombo: A. Bianchi Bonomi Hemophilia and Thrombosis Center and Institute of Internal Medicine, University of Milan, via Pace 9, 20122 Milan, Italy.

Dr. Schimpf: Rehabilitation Hospital and Hemophilia Center, Postfach 101409, D-6900 Heidelberg, Federal Republic of Germany.

Dr. Brettler: The Medical Center of Central Massachusetts-Memorial, 119 Belmont Street, Worcester, MA 01605.

Dr. Ciavarella: Hemophilia and Thrombosis Center, Ospedale Policlinico, 70124 Bari, Italy.

Dr. Haschke: Universitats-Kinderklinik, Wahringer Gurtel 18-20, A-1090 Vienna, Austria.

Dr. Lechner: Medizinische Universitats-Klinik, Lazarettgasse 14, A-1090, Vienna, Austria.

Dr. Lusher: Children's Hospital of Michigan, Wayne State University School of Medicine, 3901 Beauboin Boulevard, Detroit, MI 48201.

Dr. Weissbach: Carl Gustave Cams Medizinische Academische, Fetscherstrasse 74, Dresden 8019, German Democratic Republic.

© 1990 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1990;113(1):27-32. doi:10.7326/0003-4819-113-1-27
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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.





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