Absence of hepatitis A after treatment with pasteurised factor VIII concentrates in children with haemophilia A and von Willebrand disease

Kreuz, W.; Klarmann, Dieter; Auerswald, Günter; Auberger, K.; Gürtler, Lutz; Rabenau, Holger F.; Doerr, Wilhelm

doi:10.1016/0140-6736(93)93050-b

Cited by 17 publications

(9 citation statements)

References 3 publications

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“…Thus, the potential risk for transmission of HAV was 0 to 3.2% for Factor VIII HS or Factor VIII:C HS and 0 to 17% for Factor IX HS (95% confidence intervals). 21 Of all children who received pasteurized products, 2.7% were anti-HAV IgG-positive. This prevalence was lower than the prevalence in healthy children; 3 of 77 healthy children (3.9%) who never received any blood products were anti-HAV IgG-positive (Table 2).…”

Section: Virus Safety With Regard To Hepatitis a Virusmentioning

confidence: 99%

Virus Safety of Pasteurized Clotting Factor Concentrates

Kreuz¹,

Becker²,

Auerswald³

et al. 2002

Semin Thromb Hemost

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Section: Virus Safety With Regard To Hepatitis a Virusmentioning

confidence: 99%

Virus Safety of Pasteurized Clotting Factor Concentrates

Kreuz¹,

Becker²,

Auerswald³

et al. 2002

Semin Thromb Hemost

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“…Dry-heating, used for most concentrates in the 1980s, may have been effective. Pasteurization [ 19] for HAV and dry-heating at 80° C for 72 h [20] for polio virus and canine parvovirus have been reported effec tive.…”

Section: Potential Séroconversionsmentioning

confidence: 99%

Hepatitis A Virus Transmission by Blood Products in the United States

Mosley¹,

Nowicki²,

Kasper³

et al. 1994

Vox Sanguinis

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To address the question of HAV prevalence and seroconversion in relation to clotting factor concentrates, we assayed an early serum for 339 hemophiliacs followed every 6 months by the Transfusion Safety Study in the period from mid-1985 until mid-1992. We found 58.4% positive around entry, with an age-specific prevalence that did not vary with age. In comparison to rates for anti-HIV-negative blood donors, they were significantly higher. Based on testing of subsequent sera, 11 hemophiliacs (7.8% of 141 susceptibles) changed their anti-HAV status from negative to positive. In 9 instances, positivity immediately followed the first dose of intravenous immune globulin. A possible seroconversion followed treatment with blood components, and a possible seroconversion followed intermediate-purity, solvent/detergent(SD)-treated factor VIII concentrate. Neither of these 2 patients was anti-HAV IgM positive, so that passively transferred antibody is possible. The high prevalence among hemophiliacs at entry must be further investigated by determining the expected background rate in a US population similar to the hemophilia patients, and by comparing anti-HAV prevalence associated with SD-treated and heat-inactivated concentrates.

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“…The SD method is by definition not able to inactivate any nonenveloped virus, whereas HAV inactivation can be achieved by pasteurization, thus freeing any factor VIII concentrate of infectious HAV. This conclusion is sup ported by a retrospective study in hemophilia patients conducted by Kreuz et al [12], who did not find any sero conversion to HAV as a result of long-term treatment with pasteurized factor VIII concentrates.…”

Section: Resultsmentioning

confidence: 75%

Inactivation of Hepatitis A Virus by Pasteurization and Elimination of Picornaviruses during Manufacture of Factor VIII Concentrate

Hilfenhaus¹,

Nowak²

1994

Vox Sanguinis

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Hepatitis A virus (HAV) infections have been reported among hemophiliacs who received factor VIII concentrates which had been purified by ionexchange chromatography and treated by the solvent detergent (SD) method. Since the virus inactivation procedure of our manufacturing process is heat treatment of the stabilized, aqueous protein solution at 60 °C for 10 h (pasteurization), we investigated whether this method inactivated picornaviruses such as HAY and poliovirus type 1, which we routinely use as a test virus for non-enveloped viruses. HAV was substantially inactivated by pasteurization but the stabilizers used in the manufacturing process of the commercial products considerably delayed HAV inactivation. Residual infectious HAV was found even after 10 h heat treatment of the stabilized preparation. Thus HAV is more stable in the presence of stabilizers than poliovirus type 1. Furthermore, we studied stage by stage the elimination of poliovirus type 1 by the manufacturing procedure of these pasteurized factor VIII concentrates. Three other stages of the manufacturing process apart from pasteurization eliminated poliovirus by approximately three orders of magnitude each. Taking into account this efficient elimination of the picornavirus poliovirus and the substantial inactivation of HAV by pasteurization, we conclude that a high margin of safety exists for pasteurized factor VIII concentrates regarding HAV. This conclusion is supported by the fact that no HAV infection has been reported in hemophilia patients treated with pasteurized factor VIII concentrates. Furthermore, in a retrospective study, none of 95 patients subjected to a long-term treatment with pasteurized factor VIII concentrates had developed anti-HAV seroconversion as a result of this treatment.

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Absence of hepatitis A after treatment with pasteurised factor VIII concentrates in children with haemophilia A and von Willebrand disease

Cited by 17 publications

References 3 publications

Virus Safety of Pasteurized Clotting Factor Concentrates

Virus Safety of Pasteurized Clotting Factor Concentrates

Hepatitis A Virus Transmission by Blood Products in the United States

Inactivation of Hepatitis A Virus by Pasteurization and Elimination of Picornaviruses during Manufacture of Factor VIII Concentrate

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