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Abstract
Since first licensed in the United States in 1986, Gammagard®, an intravenous immunoglobulin produced by the Hyland Division of Baxter Healthcare
Corporation, had been considered an effective and safe form of immunoglobulin. Its
safety had been proved in patients with immunoglobulin A (IgA) deficiency, including
those with the complication of anti-IgA antibodies. However, in early 1994, there
were reported episodes of hepatitis C virus transmission associated with administration
of Gammagard manufactured during April 1993 and thereafter. The investigations into
the mechanisms to account for these events, including the manufacturing processes,
are reviewed. The results of studies and analyses by both Baxter and the US Food and
Drug Administration, including first- and second-generation enzyme-linked immunosorbent
assays, polymerase chain reaction analyses, and the solvent-detergent viralinactivation
manufacturing step, are discussed. Evaluations of donor histories identified a group
of donors who contributed to three target lots of the agent and who were subsequently
excluded from donor pools. The classification scheme and criteria for all patient
reports of hepatitis associated with administration of Gammagard, as well as the classification
of all hepatitis C virus episodes, are presented.
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© 1996 Published by Elsevier Inc.
