The Common Factor, no. 8

June 1994

The Common Factor

*19

June 1994 The Common Factor *19

indicative of the problems that still
plague the federal regulatory system.
The 1980s-Non-A, Non-B Hepatitis
The fractionation process had
been improved and physicians once
again believed that immune globulins were safe from viral transmission. Up until this time the majority
of immune globulins were administered into the muscle (IM). New
preparations were developed that allowed for intravenous (IV) administration containing larger doses.
A clinical trial in England in 1982
found that all twelve persons who
received immune globulins IV developed non-A, non-B hepatitis
(NANBH). None of those that received globulins IM got hepatitis.
In a U.S. study that began in 1982
seven of sixteen recipients of IVIG
developed NANBH. In Sweden, 16
out of 77 recipients of IVIG contracted symptomatic hepatitis-five
of whom died of liver disease.
Other cases were reported in

Scotland, where the transmissions
occurred with a product that included a low pH pepsin step that
was previously thought to completely inactivate the NANBH virus.
These incidents challenged the
notion that cold ethanol fractionation
is sufficient to eliminate all viruses.
They also raised questions about increased risk due to IV administration. These cases all happened before
blood was screened for antibodies to
hepatitis C (the name given to
NANBH after the virus was isolated).
The 1990s-Hepatitis C
After the virus that causes hepatitis C (HCV) was isolated new arguments arose about whether or not
to screen blood for antibodies to
HCV. Some have claimed that the existence of antibodies can inactivate
(neutralize) whatever small amounts
of virus may remain in an IVIG product after it is fractionated.
Officials at the FDA argued that
it was important to not screen out

HCV-positive blood so that blood
products would retain the antibodies to hopefully neutralize any viruses that survived fractionation.
The problem is that not all antibodies are able to neutralize a virus.
Despite the history of HCV
(NANBH) transmission by IVIG
products and factor concentrates, and
retrospective studies that showed
that a high percentage of HCV transmission could have been prevented
by screening for hepatitis C antibodies, the FDA advised against the use
of such screening implementation.
After conclusive studies were
done in chimpanzees, the Blood
Products Advisory Committee to the
FDA recommended in September
1991 that plasma be screened for
HCV antibodies. The screening was
not generally implemented until
April 1992.
In 1991 there was an outbreak of
HCV in Great Britain in eight bone
marrow transplant patients who
used IVIG produced in the U.S. by

If you have any Gammagard at home, you should contact your physician or clinic to find
out how to properly dispose of it. Do not use any left-over Gammagard.
If you have any other information or have questions about IVIG, please call COTT.