VIRUS INACTIVATION AND COAGULATION FACTOR PREPARATIONS
Nonheat-treated factor concentrates were used for the therapy of congenital and acquired coagulation deficiencies until 1984. These unheated factor crticentrates, which are manufactured from pooled plasma obtained from between 2500 and 25,000 blood or plasma donors, have been epidemiologically implicated in exposure of large numbers of hemophilia patients to several viral infections Including human immunodeficiency virus (HIV), hepatitis B, and non-A non-B hepatitis. Of these, HIV has been fdund to be very heat labile. After the introduction in 1984-85 of heat treatment of concentrates to reduce the risk of! hepatitis to recipients, several studies documented a lack of HIV serconversion in patients treated with clotting-fadtor concentrates. However, subsequent reports described a few hemophilia patients who had seroconverted to HIV! after receiving heat-treated concentrate from unscreened donors. To determine the significance of these seroconvers(ions, an international survey was conducted on 11 hemophilia treatment centers in Europe, Canada, and the United Kingdcpn whose total patient population comprised more than 2300 hemophilia A patients and 400 hemophilia B patients. Only three patients were found who seroconverted beyond a 6-month period after switching to heat-treated material, a(nd no seroconversions have occurred in these centers between November 1985 and February 1987. In addition no cases of seroconversion on donor screened heat-treated concentrate have been reported since its widespread introduction to the hemophilia patients during 1985-1986. Other modes of viral inactivation are currently being tested, and they appeiar to be effective in inactivating HIV and hepatitis B virus. Some of these methods have shown some promise for the inactivation of non-A and non-B hepatitis, but more data are needed for final assessment of these methods.