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

Transfusion. 1993 Oct;33(10):814-8. doi: 10.1046/j.1537-2995.1993.331094054617.x.

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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Alanine Transaminase / blood
  • Antiviral Agents / pharmacology
  • Child
  • Child, Preschool
  • Detergents / pharmacology
  • Factor VIII / adverse effects*
  • HIV Infections / prevention & control
  • HIV Infections / transmission
  • Hemophilia A / therapy*
  • Hepatitis A Antibodies
  • Hepatitis Antibodies / blood
  • Hepatitis B / prevention & control
  • Hepatitis B / transmission
  • Hepatitis C / prevention & control
  • Hepatitis C / transmission
  • Hepatovirus / immunology
  • Humans
  • Infant
  • Middle Aged
  • Prospective Studies
  • Reference Values
  • Solvents / pharmacology

Substances

  • Antiviral Agents
  • Detergents
  • Hepatitis A Antibodies
  • Hepatitis Antibodies
  • Solvents
  • Factor VIII
  • Alanine Transaminase