Prospective study of the evaluation of hepatitis C virus infectivity in a high-purity, solvent/detergent-treated factor VIII concentrate: parallel evaluation of other markers for lipid-enveloped and non-lipid- enveloped viruses.

Authors

  • G. Mariani MD,

    v, Corresponding author
    1. Division of Hematology, Department of Human Biopathology, the Thrombosis and Haemostasis Research Center, University of Rome “La Sapienza,” Rome, Italy
    2. Blood Transfusion Institute, Belgrade, Confederation of Serbia and Montenegro
    3. Hemophilia Center, Ospedale di Careggi, Florence, Italy
    4. Angelo Bianchi Bonomi Hemophilia and Thrombosis Center (World Health Organization Collaborating Center) and Institute of Internal Medicine, Maggiore Hospital, and University of Milan, Milan, Italy.
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  • T Di Paolantonio,

    1. Division of Hematology, Department of Human Biopathology, the Thrombosis and Haemostasis Research Center, University of Rome “La Sapienza,” Rome, Italy
    2. Blood Transfusion Institute, Belgrade, Confederation of Serbia and Montenegro
    3. Hemophilia Center, Ospedale di Careggi, Florence, Italy
    4. Angelo Bianchi Bonomi Hemophilia and Thrombosis Center (World Health Organization Collaborating Center) and Institute of Internal Medicine, Maggiore Hospital, and University of Milan, Milan, Italy.
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    • 6

      Tiziana Di Paolantonio, MD, Fellow, Department of Hematology, University of Rome.

  • R. Baklaya,

    1. Division of Hematology, Department of Human Biopathology, the Thrombosis and Haemostasis Research Center, University of Rome “La Sapienza,” Rome, Italy
    2. Blood Transfusion Institute, Belgrade, Confederation of Serbia and Montenegro
    3. Hemophilia Center, Ospedale di Careggi, Florence, Italy
    4. Angelo Bianchi Bonomi Hemophilia and Thrombosis Center (World Health Organization Collaborating Center) and Institute of Internal Medicine, Maggiore Hospital, and University of Milan, Milan, Italy.
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    • 7

      Radmila Baklaya, MD, Professor, and Director, Blood Transfusion Center, Belgrade, Confederation of Serbia and Montenegro.

  • M. Morfini,

    1. Division of Hematology, Department of Human Biopathology, the Thrombosis and Haemostasis Research Center, University of Rome “La Sapienza,” Rome, Italy
    2. Blood Transfusion Institute, Belgrade, Confederation of Serbia and Montenegro
    3. Hemophilia Center, Ospedale di Careggi, Florence, Italy
    4. Angelo Bianchi Bonomi Hemophilia and Thrombosis Center (World Health Organization Collaborating Center) and Institute of Internal Medicine, Maggiore Hospital, and University of Milan, Milan, Italy.
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    • 8

      Massino Morfini, MD, Director, Hemophilia Center, Ospedale di Careggi, Florence, Italy.

  • P.M. Mannucci,

    1. Division of Hematology, Department of Human Biopathology, the Thrombosis and Haemostasis Research Center, University of Rome “La Sapienza,” Rome, Italy
    2. Blood Transfusion Institute, Belgrade, Confederation of Serbia and Montenegro
    3. Hemophilia Center, Ospedale di Careggi, Florence, Italy
    4. Angelo Bianchi Bonomi Hemophilia and Thrombosis Center (World Health Organization Collaborating Center) and Institute of Internal Medicine, Maggiore Hospital, and University of Milan, Milan, Italy.
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    • 9

      Pier Mannuccio Mannucci, MD, Professor and Chairman, Institute of Internal Medicine, University of Milan, Italy.

  • The Ad Hoc Study Group of the Fondazione dell'Emofilia

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    • 10

      Other members of the Study Group of the Fondazione dell'Emofilia are: A. Azzi (Florence), F. Baudo (Milan), M. Berrettini (Perugia), N. Ciavarella (Bari), M.B. Dolnicar (Lubljana), R. de Biasi (Naples), I. Elezovich (Belgrade), E. Gebauer (Novi Sad), A. Gringeri (Milan), G. Mancuso (Palermo), R. Musso (Catania), L. Perugini (Turin), A. Rocino (Naples), and M. Schiavoni (Bari).


Division of Hematology, Department of Human Biopathology, Thrombosis and Hemostasis Research Center, University of Rome “La Sapienza,” Via Chieti 7, I-00161, Rome, Italy

Abstract

This prospective study was carried out with the aim of evaluating the efficacy of solvent/detergent inactivation of the hepatitis C virus (HCV) as applied to a chromatographic factor VIII concentrate. In parallel, the markers for other viruses, either lipid-enveloped (human immunodeficiency virus types 1 and 2 [HIV-1 and -2] and hepatitis B virus [HBV]) or non-lipid-enveloped viruses (such as B19 parvovirus and hepatitis A virus [HAV]) were evaluated. The study included 14 hemophilia centers, which enrolled 36 previously untreated patients (median age, 3 years; range, 1–56). The length of follow-up was 12 months, during which HCV (first- and second-generation assays and recombinant immunoblot assay), HIV-1 and -2, HBV, HAV (IgG and IgM), and parvovirus (IgG and IgM) antibodies, as well as alanine aminotransferase values were evaluated. Thirty-one patients were analyzable; none seroconverted for HCV, HBV, or HIV after exposure to a total of 165,000 IU of factor VIII (41 different lots). In one patient, alanine aminotransferase values rose to 167 mU per mL, 6 weeks after the first concentrate infusion, and this patient seroconverted for HAV 1 week later. Furthermore, 10 patients seroconverted for parvovirus during follow-up. This study suggests that the solvent/detergent method of virus inactivation is efficient in relation to lipid-enveloped blood- borne viruses but not in relation to non-lipid-enveloped viruses.

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