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Abstract
In Sweden, 44 patients were reported to have contracted hepatitis C virus (HCV) infections
from treatment with intravenous immunoglobulin. Gammagard® was the product implicated in HCV transmission in 12 patients; 8 of these 12 patients
were HCV ribonucleic acid (RNA)—negative during the 2 years before Gammagard was administered
and 10 showed clustering by sequencing of the HCV core gene. Further studies are being
conducted to correlate the sequenced HCV RNA with specific batches of Gammagard. Nine
patients who received Gammonativ® in 1983 and 1984 had a strong time-related possibility of HCV infection. Sequencing
analyses are being performed in these patients as is being done for the patients who
received Gammagard. Another 21 patients who received Gammonativ from 1982 to 1985
are probably infected with HCV, but confirmation of implicated batches is lacking.
The association between Sandoglobulin® and HCV is questionable in two patients, although plausible because of a time relationships.
In Norway, relationships between Gammonativ and the incidence of HCV infection are
similar to those in the 21 sporadic cases in Sweden. Also in Denmark and Finland,
HCV infection appears to be related to the lack of additional viral inactivation steps
used in the preparation of intravenous immunoglobulin. Clearly, there is a need for
increased antiviral inactivation and antiviral screening in the production of intravenous
immunoglobulin products.
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References
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© 1996 Published by Elsevier Inc.
