THE EFFECT ON THE SAFETY OF INTRAVENOUS IMMUNOGLOBULIN OF TESTING PLASMA FOR ANTIBODY TO HEPATITIS-C

Background: The safety of intravenous immunoglobulin (IGIV), manufactu red from units testing negative for antibody to hepatitis C virus !ant i-HCV), was investigated. Study Design and Methods: A study involving five chimpanzees was performed to determine whether the safety of IGIV would be compromised if units of plasma that reacted for anti-HCV wer e withheld from pools from which IGIV is manufactured. In the first ph ase of the experiment, two chimpanzees were infused with 25 mt per kg of unprocessed, pooled plasma from 2887 donors who did not react for a nti-HCV in single-antigen (c100-3) enzyme-linked immunosorbent assays. In the second phase, each of three chimpanzees was Infused with 1000 mg per kg of IGIV manufactured from the same plasma units. The immunog lobulin was made by seven United States-licensed manufacturers, each u sing its own approved method. Each chimpanzee received an equal dose o f each manufacturer's IGIV. Results: The two chimpanzees that received anti-c100-3-nonreactive, unprocessed pooled plasma became infected wi th HCV. The three chimpanzees infused with IGIV did not show any evide nce of infection with HCV 15 months after inoculation. Two of these an imals were challenged with human non-A,non-B hepatitis-infectious plas ma, and both subsequently showed evidence of HCV infection. Conclusion : These studies demonstrate that, as determined by infectivity for chi mpanzees, 1) the withholding of plasma units that react for anti-c100- 3 from pools from which plasma products are manufactured does not rend er the source material noninfectious, and 2) the safety of IGIV manufa ctured from such plasma pools is not compromised by withholding the un its that react for anti-c100-3.