Hepatitis C transmission associated with intravenous immunoglobulins

Yu, Meng-Lin; Mason, Bobby L.; Guo, Z.P.; Tankersley, Donald L.; Nedjar, Sayah; Mitchell, Freddie; Biswas, Robin; Nübling, C. Micha; Willkommen, Hannelore; Löwer, Johannes

doi:10.1016/s0140-6736(95)91002-6

Cited by 102 publications

(37 citation statements)

References 6 publications

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“…In contrast, HCV RNA was rarely detected in Gammagard lots made from either unscreened plasma or plasma screened with the relatively insensitive EIA-1 test (9,15). The lots derived from plasma screened with the more sensitive EIA-2 test were associated with many reported cases of hepatitis C transmission.…”

Section: Discussionmentioning

confidence: 99%

“…Historically, U.S.-licensed immune globulins prepared by ethanol fractionation of plasma had a remarkable safety record until one commercial IGIV product, Gammagard, prepared from anti-HCV (EIA-2)-screened plasma was withdrawn worldwide in February 1994 because of HCV transmission to recipients (8)(9)(10)(11)(12). Before 1993, globulin-related transmission of hepatitis C by licensed products had not been reported in the U.S.…”

Section: Discussionmentioning

confidence: 99%

“…The lots derived from plasma screened with the more sensitive EIA-2 test were associated with many reported cases of hepatitis C transmission. (ii) Gammagard was the only IGIV product implicated (8)(9)(10)(11)(12)15). All other IGIV products were not similarly affected because of deliberately incorporated viral inactivation steps or other manufacturing (e.g., purification) procedures that fortuitously inactivated or removed virus.…”

Section: Discussionmentioning

confidence: 99%

“…U.S.-licensed immune globulin products were historically considered safe with respect to hepatitis transmission until the ''Gammagard incident,'' which began in late 1993 (8)(9)(10)(11)(12): one commercial i.v. immune globulin (IGIV) product prepared from pooled plasma from which anti-HCV-positive plasma donations were excluded transmitted HCV to recipients.…”

mentioning

confidence: 99%

“…immune globulin (IGIV) product prepared from pooled plasma from which anti-HCV-positive plasma donations were excluded transmitted HCV to recipients. Epidemiologic and laboratory studies suggested that such screening might have removed complexing and͞or Nt Abs from plasma and hence compromised the safety of the immune globulins (9,(11)(12)(13)(14)(15)(16).…”

mentioning

confidence: 99%

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Neutralizing antibodies to hepatitis C virus (HCV) in immune globulins derived from anti-HCV-positive plasma

Bartosch

Zhang

et al. 2004

Proc. Natl. Acad. Sci. U.S.A.

143

115

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The role of humoral immunity in hepatitis C virus (HCV) infections is uncertain. Nevertheless, there is increasing evidence for neutralizing antibodies to HCV in the serum or plasma of chronically infected individuals. Immune globulins prepared by ethanol fractionation of plasma had long been considered safe until a commercial immune globulin product, Gammagard, prepared from plasma from which units containing anti-HCV had been excluded, transmitted HCV to recipients. Studies suggested that the exclusion might have removed neutralizing antibodies from the plasma and hence compromised the safety of the resulting immune globulins. In the present study, by using chimpanzees and a recently validated in vitro system based on neutralization of infectious HCV pseudoparticles, we found broadly reactive neutralizing and protective antibodies in experimental immune globulin preparations made from anti-HCV-positive donations. Neutralizing antibodies were also found in Gammagard lots made from unscreened plasma that did not transmit hepatitis C but not in Gammagard lots, which were prepared from anti-HCV-screened plasma, that did transmit hepatitis C. The results provide an explanation for the mechanism by which the safety of this product was compromised. Immune globulins made from anti-HCV-positive plasma and containing broadly reactive neutralizing antibodies may provide a method of preventing HCV infection.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

See 3 more Smart Citations

Neutralizing antibodies to hepatitis C virus (HCV) in immune globulins derived from anti-HCV-positive plasma

Bartosch

Zhang

et al. 2004

Proc. Natl. Acad. Sci. U.S.A.

143

115

View full text Add to dashboard Cite

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Hepatitis C Virus and Intravenous Immune Globulin-Reply

Bresee¹

1997

JAMA

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Dr Babb calls our attention to the heel-drop jarring test, which may be a powerful predictor of peritoneal inflamma¬ tion. We were unable to meta-analyze several important physi¬ cal examination maneuvers owing to their being evaluated in 1 or fewer studies. For example, our article also did not evaluate any components of the pelvic examination, the cough test mentioned by Moustafa and Newton, or the abdominal wall tenderness test.1 Dr Alvarado correctly points out our exclusion of the white blood cell count in our meta-analysis. Whether The Rational Clinical Examination series should include routine laboratory studies and radiographie examinations is an interesting ques¬ tion. Correctly or not, we elected to exclude the white blood cell count because it is not part of the history and physical examination, even though the white blood cell count has been shown to be a significant predictor of appendicitis in many studies. A review2 of several diagnostic scores for appendi¬ citis noted that the white blood cell count was commonly included in such scores. This same article1 concluded that the MANTRELS score3 was 1 of the 2 scores identified as war¬ ranting further study in large-scale testing.Dr Hall feels we dismissed abdominal computed tomogra¬ phy prematurely and offers recent data on the improved value of CT. He cites a reference using a helical 5-mm slicing with intraluminal contrast which appears particularly prom¬ ising. To clarify our position, we believe the question is not "if" CT scanning should be performed, but "when." We be¬ lieve the most appropriate time is after a careful clinical examination, as guided by data in our article. Abdominal CT is clearly an invaluable resource for patients in whom the diagnosis of appendicitis is unclear. Dallas 1. Thomson H, Francis DMA. Abdominal-wall tenderness: a useful sign in the acute abdomen.

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Follow-up of four HIV-infected individuals after administration of hepatitis C virus and GBV-C/hepatitis G virus contaminated intravenous immunoglobulin: Evidence for HCV but not for GBV-C/HGV transmission

Berger

Scharrer²,

Weber

1997

J. Med. Virol.

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In 1994, hepatitis C virus (HCV) infection was transmitted to four HIV seropositive patients attending the Department of Angiology, University Clinics, Frankfurt am Main, by the administration of Gammagard. The patients were suffering from thrombocytopenia and received betweeen 20 and 30 g of the contaminated lot 93F21AB11. GBV-C/HGV RNA could be amplified from the Gammagard lot 93F21AB11 using 5'NCR and NS5 primer pairs. All the four patients were negative in the GBV-C/HGV RT-PCR prior to therapy and until the end of the follow-up period. GBV-C/HGV IgG antibodies to the putative envelope (E2) were detected using the E2 HGV-env kit (Boehringer-Mannheim, Germany) in Gammagard lot 93F21AB11 and in one patient before donation of immunoglobulin. Anti-E2 seroconversion was observed in one recipient, the other two patients remained anti-E2 seronegative until the end of the observation period. It is concluded that there is no direct evidence for transmission of GBV-C/HGV by contaminated intravenous immunoglobulin since GBV-C/HGV RNA was not detected in the recipients up to 1 year after administration.

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Hepatitis C transmission associated with intravenous immunoglobulins

Cited by 102 publications

References 6 publications

Neutralizing antibodies to hepatitis C virus (HCV) in immune globulins derived from anti-HCV-positive plasma

Neutralizing antibodies to hepatitis C virus (HCV) in immune globulins derived from anti-HCV-positive plasma

Hepatitis C Virus and Intravenous Immune Globulin-Reply

Follow-up of four HIV-infected individuals after administration of hepatitis C virus and GBV-C/hepatitis G virus contaminated intravenous immunoglobulin: Evidence for HCV but not for GBV-C/HGV transmission

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