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

doi:10.1059/0003-4819-113-1-27

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; and
International Study Group

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.

Article and Author Information

For current author addresses and locations of other members of the International Study Group, see end of text.
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.