Background. An outbreak of hepatitis A (HAV) occurred in 1992 in Irish
haemophilia A patients treated with high purity solvent-detergent (SD
) treated factor VIII. Similar outbreaks were reported in Italy, Germa
ny and Belgium. The aim of this study was to investigate the outbreak,
and to test the hypothesis that it was caused by exposure to SD-treat
ed factor VIII. Methods. A case-control study was started in early 199
3. Haemophilia A cases with acute HAV (n = 29) were compared with haem
ophilia A controls for exposure to SD-treated factor VIII and other en
vironmental factors. Details of factor VIII usage were obtained from t
he National Haemophilia Register and environmental data were obtained
by a telephone-administered questionnaire. The response rate was appro
ximately 90%. Results. The incidence of acute HAV infection among haem
ophilia A patients exceeded the notified national incidence of HAV by
a factor of approximately 300. The incidence was higher in younger pat
ients and those with more severe bleeding disorders, Contact with hepa
titis, with children, and exposure to factor VIII were associated with
increased risk. The association with factor VIII was the strongest ri
sk factor after controlling for other factors (odds ratio = 27.6, 95%
confidence interval [CI] 6.5-117.3). A dose-response effect was demons
trated. Conclusions. Although person-to-person transmission is likely
to have caused a few of the cases, the results of our investigation su
ggest that the major contributing factor was exposure to certain batch
es of SD-treated factor VIII.