Outbreak of acute hepatitis C following the use of anti-hepatitis C virus--screened intravenous immunoglobulin therapy

Gastroenterology. 1996 Apr;110(4):1120-6. doi: 10.1053/gast.1996.v110.pm8613001.


Background & aims: Hepatitis C virus (HCV) infection has been associated with intravenous (IV) immunoglobulin (Ig), and plasma donations used to prepare IV Ig are now screened to prevent transmission. Thirty-six patients from the United Kingdom received infusions from a batch of anti-HCV antibody-screened intravenous Ig (Gammagard; Baxter Healthcare Ltd., Thetford, Norfolk, England) that was associated with reports of acute hepatitis C outbreak in Europe. The aim of this study was to document the epidemiology of this outbreak.

Methods: Forty-six patients from the United Kingdom treated with Gammagard (34 exposed and 12 unexposed to the batch) returned epidemiological questionnaires.

Results: Eighty-two percent of the exposed patients (28 of 34) became positive for HCV RNA. Eighteen percent of the patients (6 of 34) who had infusions with this batch tested negative for HCV RNA, but 2 of the patients had abnormal liver function and subsequently seroconverted to anti-HCV antibody positive. Twenty-seven percent of the patients (9 of 34) developed jaundice, and 79% (27 of 34) had abnormal liver transferase levels. Virus isolates (n=21), including an isolate from the implicated batch, were genotype 1a and virtually identical by sequence analysis of the NS5 region, consistent with transmission from a single source.

Conclusions: Hepatitis C infection can be transmitted by anti-HCV-screened IV Ig. Careful documentation of IV Ig batch numbers and regular biochemical monitoring is recommended for all IV Ig recipients.

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Child
  • Disease Outbreaks*
  • Female
  • Follow-Up Studies
  • Genotype
  • Hepacivirus / genetics
  • Hepacivirus / immunology
  • Hepacivirus / isolation & purification
  • Hepatitis C / epidemiology*
  • Hepatitis C / transmission
  • Hepatitis C / virology
  • Hepatitis C Antibodies / analysis*
  • Humans
  • Immunoglobulins, Intravenous / adverse effects*
  • Immunoglobulins, Intravenous / immunology
  • Male
  • Middle Aged
  • Polymerase Chain Reaction
  • RNA, Viral / analysis
  • United Kingdom / epidemiology


  • Hepatitis C Antibodies
  • Immunoglobulins, Intravenous
  • RNA, Viral