Immunoglobulin Safety Related to Testing for Antibody to Hepatitis C Virus

A study was performed to determine whether the safety of intravenous immunoglobulin (IGIV) would be compromised if units of plasma reactive for antibody to hepatitis C (anti-c100-3) were withheld from pools from which IGIV is manufactured. Initially, two chimpanzees were infused with 25 ml/kg of unprocessed, pooled plasma from 2887 donors nonreactive for anti-c100-3. These animals became infected with hepatitis C virus (HCV). Subsequently three chimpanzees were each infused with 1000 mg/kg of IGIV manufactured from the same pooled plasma units. These three animals did not show any evidence of infection with HCV 15 months after inoculation. Two of these animals were then challenged with human non-A, non-B infectious plasma; both showed evidence of HCV infection.