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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”

 

 

    

GAMMAGARD RESPONSIBLE FOR IGIV-ASSOCIATED INFECTIONS

Section: News Reports

Outbreaks (Hepatitis C Virus)

 

The intravenous immune globulin preparation Gammagard was solely responsible for a hepatitis C virus outbreak which occurred between 1993 and 1994, according to a report from the U.S. Centers for Disease Control and Prevention (CDC).

"Gammagard (Baxter Healthcare Corporation, Deerfield, IL) was the only intravenous immune globulin (IGIV) product implicated in the transmission of Hepatitis C Virus," researcher Joseph S. Bresee and colleagues wrote ("Hepatitis C Virus Infection Associated with Administration of IGIV," Journal of the American Medical Association, November 20, 1996;276(19): 1563-1567).

Beginning in October 1991, plasma used to make IGIV was screened using single-antigen (fast-generation) tests for antibody to hepatitis C virus (anti-Hepatitis C Virus), and anti-Hepatitis C Virus-positive units of plasma were discarded. More sensitive multiantigen (second-generation) tests were licensed in March 1992, and by November of 1992, IGIV was produced using plasma donations screened with these testing procedures. Intravenous immune globulin manufactured exclusively from second-generation screened plasma was fast distributed in early 1993.

    

"Several outbreaks of non-A, non-B hepatitis associated with IGIV administration have been reported," Bresee et al. wrote. "All but one of these outbreaks were associated with preparations of IGIV that were manufactured in Europe; one was associated with a prelicensure U.S. product. Retrospective analysis of these outbreaks confirmed these non-A, non-B hepatitis cases as Hepatitis C Virus infections. Immune globulin products (IGIV and intramuscular immune globulin) licensed in the United States have not been previously associated with transmission of bloodborne agents including Hepatitis C Virus."

In February of 1994, Baxter Healthcare Corporation issued a voluntary recall of its two IGIV preparations, Gammagard and Polygam, in response to reports of acute hepatitis C among persons who received Gammagard. As of January 1996, 134 cases of Hepatitis C Virus infection among Gammagard recipients had been reported to the CDC. As a result of these cases reports, CDC researchers initiated an investigation to determine the risk and risk factors for Hepatitis C Virus infection among persons who had received IGIV products in the United States.

In this report, Bresee et al. presented the results of a cohort study involving patients with immune deficiencies who received Gammagard and other manufacturers' IGIV products at a large immunology center.

Of 341 people who received IGIV between March 1, 1993 and February 22, 1994 at the Allergy/Clinical Immunology Program at Children's Hospital in Boston, Massachusetts, 278 (82 percent) were enrolled in the study.

Bresee et al. found that 23 of 210 participants who received IGIV Gammagard (11 percent) became infected; none of the 52 who received other IGIV products exclusively became infected. In a multivariate analysis, Hepatitis C Virus infection was associated only with Gammagard produced from plasma screened by second-generation (multiantigen) anti-Hepatitis C Virus tests (P = .03). Hepatitis C virus RNA was detected in Gammagard, and the risk of transmission to recipients increased with increasing quantity of Hepatitis C Virus RNA infused, from 0 percent for those who received no Hepatitis C Virus RNA-positive lots to 29 percent for the quartile of patients receiving the greatest amount (P < .001). At least nine different lots of Gammagard were required to account for all cases.

The researchers suggested that the data from this study are generalizable to other populations since the risk of infection was not limited to specific lots, but rather was associated with the type of plasma screening used in production.

    

'This outbreak serves as a reminder of the possible risks associated with the administration of blood products, even though multiple steps are taken to decrease the potential for transmission of viruses by these products," Bresee et al. wrote. "As the Food and Drag Administration has requested, all U.S.-licensed IGIV products now have viral inactivation steps included in the manufacturing process ... to further reduce the likelihood of viral transmission. Additionally, all immunoglobulin products (including those which have not been associated with hepatitis C) that lack a viral inactivation step(s) are now screened by PCR tests for Hepatitis C Virus RNA, and only product that is Hepatitis C Virus RNA negative is released for distribution. In this study, no persons who received only Hepatitis C Virus RNA-negative material became infected. Although the presence of Hepatitis C Virus RNA in immune globulin products may not necessarily correlate with infectivity, these safeguards should help prevent future transmission of Hepatitis C Virus by these products."

The corresponding author for this study is Eric E. Mast, Hepatitis Branch, U.S. Centers for Disease Control and Prevention, Mailstop G-37, 1600 Clifton Road, Atlanta, GA 30333.

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By Salynn Boyles, Senior Editor