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Abstract
A number of episodes of non-A, non-B hepatitis (NANB) have been associated in the
recent past with the administration of intravenous immunoglobulin (IGIV). It now appears
that hepatitis C virus (HCV) is the cause of NANB, although not all the factors leading
to HCV transmission by IGIV are completely understood. Nevertheless, based on a retrospective
analysis of two episodes of HCV transmitted by anti-Rh D immunoglobulin (anti-D),
cold ethanol fractionation clearly is important in ensuring viral safety; both of
these intravenous anti-D preparations were manufactured without benefit of this purification
step. Other episodes of HCV transmission have been associated with IGIV produced using
chromatography (particularly DEAE-Sephadex® chromatography), with has been used after cold ethanol fractionation to further purify
immunoglobulin G. DEAE-Sephadex chromatography may have only a marginal partitioning
capacity, such that infective HCV virions are not further fractionated into waste
fractions. All IGIV preparations associated with HCV transmission were formulated
as lyophilized preparations, which may be important in stabilizing HCV before administration
to patients. The role of anti-HCV screening in improving the viral safety of IGIV
preparations remains unclear, but additional viral inactivation steps, such as solvent-detergent
treatment or incubation at pH 4.0, probably are required for IGIV manufactured using
chromatographic procedures.
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© 1996 Published by Elsevier Inc.
