Safety of intravenous immunoglobulin with regard to hepatitis c virus

Yu, Meng-Lin; Mason, Bobby L.; Guo, Zheng; Tankersley, Donald L.

doi:10.1016/s0149-2918(96)80197-4

Cited by 6 publications

(3 citation statements)

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“…Many reports suggest the possibility of transmitting viruses including hepatitis B and C viruses, human immunodeficiency virus and human parvovirus B19. However, those findings have mostly been from studies in immunodeficient or immunocompromised patients 17,19–21 . Information is lacking on the immunocompetent population in which the possibility of transmission could be considered lower.…”

Section: Discussionmentioning

confidence: 99%

Intramuscular immunoglobulin for recalcitrant suppurative diseases of the skin: a retrospective review of 63 cases

Goo

Chung

et al. 2007

Br J Dermatol

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Section: Discussionmentioning

confidence: 99%

Intramuscular immunoglobulin for recalcitrant suppurative diseases of the skin: a retrospective review of 63 cases

Goo

Chung

et al. 2007

Br J Dermatol

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“…The possible role of manufacturing methods in the transmission of NANBH/HCV has been described [ 63 , 64 ], and, while most of the reported transmissions have been with products manufactured with some deviations from potentially viricidal steps in the Cohn method, the finding that Cohn Fraction II, from which all immunoglobulin products were derived, which is the parent fraction of all immunoglobulin products, contained HCV viral nucleic acid [ 65 , 66 ], indicated that the long-standing comfort in the safety of immunoglobulin derived from Cohn fractionation had been misplaced. Yu et al [ 67 , 68 ] have postulated that the removal of anti-HCV-complexing antibodies through early generations of anti-HCV screening tests altered the properties of HCV present in the plasma pool and led to free, uncomplexed HCV partitioning into Fraction II, rather than precipitating, as an antibody–virus complex, into Fraction III, resulting in infectious products. Countering this hypothesis, it should be noted that the first reports of HCV infective intravenous immunoglobulin occurred prior to the introduction of screening tests [ 69 ].…”

Section: The Development Of Effective Measures For Assuring Plasma Pr...mentioning

confidence: 99%

The Evolution of the Safety of Plasma Products from Pathogen Transmission—A Continuing Narrative

Farrugia

2023

Pathogens

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Chronic recipients of plasma products are at risk of infection from blood-borne pathogens as a result of their inevitable exposure to agents which will contaminate a plasma manufacturing pool made up of thousands of individual donations. The generation of such a pool is an essential part of the large-scale manufacture of these products and is required for good manufacturing practice (GMP). Early observations of the transmission of hepatitis by pooled plasma and serum led to the incorporation of heat treatment of the albumin solution produced by industrial Cohn fractionation of plasma. This led to an absence of pathogen transmission by albumin over decades, during which hepatitis continued to be transmitted by other early plasma fractions, as well as through mainstream blood transfusions. This risk was decreased greatly over the 1960s as an understanding of the epidemiology and viral aetiology of transfusion-transmitted hepatitis led to the exclusion of high-risk groups from the donor population and the development of a blood screening test for hepatitis B. Despite these measures, the first plasma concentrates to treat haemophilia transmitted hepatitis B and other, poorly understood, forms of parenterally transmitted hepatitis. These risks were considered to be acceptable given the life-saving nature of the haemophilia treatment products. The emergence of the human immunodeficiency virus (HIV) as a transfusion-transmitted infection in the early 1980s shifted the focus of attention to this virus, which proved to be vulnerable to a number of inactivation methods introduced during manufacture. Further developments in the field obviated the risk of hepatitis C virus (HCV) which had also infected chronic recipients of plasma products, including haemophilia patients and immunodeficient patients receiving immunoglobulin. The convergence of appropriate donor selection driven by knowledge of viral epidemiology, the development of blood screening now based on molecular diagnostics, and the incorporation of viral inactivation techniques in the manufacturing process are now recognised as constituting a “safety tripod” of measures contributing to safety from pathogen transmission. Of these three components, viral inactivation during manufacture is the major contributor and has proven to be the bulwark securing the safety of plasma derivatives over the past thirty years. Concurrently, the safety of banked blood and components continues to depend on donor selection and screening, in the absence of universally adopted pathogen reduction technology. This has resulted in an inversion in the relative safety of the products of blood banking compared to plasma products. Overall, the experience gained in the past decades has resulted in an absence of pathogen transmission from the current generation of plasma derivatives, but maintaining vigilance, and the surveillance of the emergence of infectious agents, is vital to ensure the continued efficacy of the measures in place and the development of further interventions aimed at obviating safety threats.

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“…Other works showed that the Cohn system did not clear HCV from the final therapeutic fraction ( 26 ). After investigating the Gammagard incident ( 41 ), the FDA scientists hypothesized that the exclusion of anti-HCV antibodies against HCV envelope proteins through the use of second and third generation anti-HCV tests had affected the portioning of HCV during fractionation, to result in free, viable virus being deposited in the Ig fraction, which otherwise would have been neutralized by antibodies to HCV ( 42 , 43 ). Although the data available make this hypothesis persuasive, it is regrettable that a specific viral inactivation step, which had been under development for this product for some years had not been introduced in time to obviate any viral transmission.…”

Section: The Gammagard Incident – ………Is Paved With Good Intentions”mentioning

confidence: 99%

Manufacture of Immunoglobulin Products for Patients with Primary Antibody Deficiencies â€“ The Effect of Processing Conditions on Product Safety and Efficacy

Farrugia

Quinti

2014

Front. Immunol.

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Early preparations of immunoglobulin (Ig) manufactured from human plasma by ethanol (Cohn) fractionation were limited in their usefulness for substitution therapy in patients with primary antibody deficiencies (PAD), as Ig aggregates formed during manufacture resulted in severe systemic reactions in patients when given intravenously. Developments in manufacturing technology obviated this problem through the capacity to produce concentrated solutions of intact monomeric Ig, revolutionizing PAD treatment and improving patient life expectancy and quality of life. As the need for Ig has grown, manufacturers have refined further manufacturing technologies to improve yield from plasma and produce therapies, which are easier and less expensive to deliver. This has led to the substitution, partly or wholly, of ethanol precipitation by other techniques such as chromatography, and has also stimulated the production of highly concentrated solutions capable of rapid infusion. Ig products have been associated, since their inception, with certain adverse events, including infectious disease transmission, hemolysis, and thromboembolism. The introduction of standardized manufacturing processes and dedicated pathogen elimination steps has removed the risk of infectious disease, and the focus of attention has shifted to other problems, which appear to have increased over the past 5 years. These include hemolysis and thromboembolism, both the cause for substantial concern and the subject of recent regulatory scrutiny and actions. We review the development of manufacturing technology and the emerging evidence that changes for the optimization of yield and convenience has contributed to the recent incidents in certain adverse events. Industry measures under development will be discussed in terms of their potential to improve safety and optimize care for patients with PAD.

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Safety of intravenous immunoglobulin with regard to hepatitis c virus

Cited by 6 publications

References 0 publications

Intramuscular immunoglobulin for recalcitrant suppurative diseases of the skin: a retrospective review of 63 cases

Intramuscular immunoglobulin for recalcitrant suppurative diseases of the skin: a retrospective review of 63 cases

The Evolution of the Safety of Plasma Products from Pathogen Transmission—A Continuing Narrative

Manufacture of Immunoglobulin Products for Patients with Primary Antibody Deficiencies â€“ The Effect of Processing Conditions on Product Safety and Efficacy

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