Rm. Biswas et al., THE EFFECT ON THE SAFETY OF INTRAVENOUS IMMUNOGLOBULIN OF TESTING PLASMA FOR ANTIBODY TO HEPATITIS-C, Transfusion, 34(2), 1994, pp. 100-104
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.