Causality assessment of suspected virus transmission by human plasma products

Transfusion

Volumn 41, Issue 8, 2001, Pages 1020-1029

  Schosser, Rudolf ^a   Keller Stanislawski, Brigitte ^b   Nübling, C Micha ^b   Löwer, Johannes ^b  

^a Baxter Deutschland GmbH   (Germany)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS DNA;

ADULT; ALGORITHM; ARTICLE; BLOOD; BLOOD TRANSFUSION; CASE REPORT; DECISION TREE; DISEASE TRANSMISSION; DNA SEQUENCE; EPIDEMIOLOGY; GENOTYPE; HUMAN; INFECTION; MALE; RISK ASSESSMENT; SAFETY; VALIDATION STUDY; VIROLOGY;

ADULT; ALGORITHMS; BLOOD TRANSFUSION; CAUSALITY; CONSUMER PRODUCT SAFETY; DECISION TREES; DNA, VIRAL; GENOTYPE; HUMANS; INFECTION; MALE; RISK ASSESSMENT; SEQUENCE ANALYSIS, DNA;

EID: 0035432075     PISSN: 00411132     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1537-2995.2001.41081020.x     Document Type: Article

References (80)

1. Burnouf T. Safety aspects in the manufacturing of plasma-derived coagulation factor concentrates. Biologicals 1992;20:91-100.
2. Suomela H. Inactivation of viruses in blood and plasma products. Transfus Med Rev 1993;7:42-57.
3. Fricke WA, Lamb MA. Viral safety of clotting factor concentrates. Semin Thromb Hemost 1993;19:54-61.
4. Chamberland M, Khabbaz RF. Emerging issues in blood safety. Infect Dis Clin North Am 1998;12:217-29.
5. Nübling CM, Chudy M, Löwer J. Virus testing of plasma pools and blood products by nucleic acid amplification. Hämostaseologie 1996;16(Suppl):274-6.
6. Zerlauth G, Igel H. Polymerase chain reaction and viral safety of plasma products: a manufacturer's view. Infusionsther Transfusionsmed 1998;25:136-8.
7. Yei S, Yu MW, Tankersley DL. Partitioning of hepatitis C virus during Cohn-Oncley fractionation of plasma. Transfusion 1992;32:824-8.
8. Mannucci PM. Clinical evaluation of viral safety of coagulation factor VIII and IX concentrates. Vox Sang 1993;64:197-203.
9. Horowitz B, Ben-Hur E. Strategies for viral inactivation. Curr Opin Hematol 1995;2:484-92.
10. Edwards IR, Biriell C. Harmonisation in pharmacovigilance. Drug Saf 1994;10:93-102.
11. Hollinger FB, Ticehurst JR. Hepatitis A virus. In: Fields BN, Knipe DM, Howley PM, et al., eds. Fields virology. 3rd ed. Philadelphia: Lippincott-Raven, 1996:735-82.
12. Hollinger FB. Hepatitis B virus. In: Fields BN, Knipe DM, Howley PM, et al., eds. Fields virology. 3rd ed. Philadelphia: Lippincott-Raven, 1996:2739-807.
13. National Institutes of Health. Management of Hepatitis C. NIH Consensus Statement 1997;15:1-41.
14. Hirsch MS, Curran J. Human immunodeficiency viruses. In: Fields BN, Knipe DM, Howley PM, et al., eds. Fields virology. 3rd ed. Philadelphia: Lippincott-Raven, 1996:1953-75.
15. Guo ZP, Yu MW. Hepatitis C virus RNA in factor VIII concentrates. Transfusion 1995;35:112-6.
16. Yu MW, Mason BL, Guo ZP, et al. Hepatitis C transmission associated with intravenous immunoglobulins. Lancet 1995;345:1173-4.
17. Pisani G, Cristiano K, Wirz M, et al. Hepatitis C virus RNA in tetanus intramuscular immune globulin (letter). Transfusion 1997;37:986-7.
18. Lefrere JJ, Mariotti M, Trepo C, et al. Testing for HCV-RNA in commercial intravenous immunoglobulins. Lancet 1993;341:834-5.
19. Yu MYW, Mason BL, Tankersley DL. Detection and characterization of hepatitis C virus RNA in immune globulins. Transfusion 1994;34:596-602.
20. Jantsch-Plunger V, Beck G, Maurer W. PCR detection of a low viral load in a prothrombin complex concentrate that transmitted hepatitis B virus. Vox Sang 1995;69:352-4.
21. Nübling CM, Willkommen H, Löwer J. Hepatitis C transmission associated with intravenous immunoglobulins (letter). Lancet 1995;345:1174.
22. Gangneux JP, Traineau R, Tuveri R, et al. Transmission of hepatitis C virus in allografted patients: use of viral genotyping as an epidemiological marker. Bone Marrow Transplant 1996;18:1131-3.
23. Garson JA, Tuke PW, Makris M, et al. Demonstration of viraemia patterns in haemophiliacs treated with hepatitis-C-virus-contaminated factor VIII concentrates. Lancet 1990;336:1022-5.
24. Soucie JM, Robertson BH, Bell BP, et al. Hepatitis A virus infections associated with clotting factor concentrate in the United States. Transfusion 1998;38:573-9.
25. Makris M, Garson JA, Ring CJ, et al. Hepatitis C viral RNA in clotting factor concentrates and the development of hepatitis in recipients. Blood 1993;81:1898-902.
26. Mannucci PM, Gdovin S, Gringeri A, et al. Transmission of hepatitis A to patients with hemophilia by factor VIII concentrates treated with organic solvent and detergent to inactivate viruses. The Italian Collaborative Group. Ann Intern Med 1994;120:1-7.
27. Yap PL, McOmisch F, Webster AD, et al. Hepatitis C virus transmission by intravenous immunoglobulin. J Hepatol 1994;21:455-60.
28. Bjoro K, Froland SS, Yun Z, et al. Hepatitis C infection in patients with primary hypogammaglobulinemia after treatment with contaminated immune globulin. N Engl J Med 1994;331:1607-11.
29. Kedda MA, Kew MC, Cohn RJ, et al. An outbreak of hepatitis A among South African patients with hemophilia: evidence implicating contaminated factor VIII concentrate as the source. Hepatology 1995;22:1363-7.
30. Chudy M, Budek I, Keller-Stanislawski B, et al. A new cluster of hepatitis A infection in hemophiliacs traced to a contaminated plasma pool. J Med Virol 1999;57:91-9.
31. Power JP, Lawlor E, Davidson F, et al. Molecular epidemiology of an outbreak of infection with hepatitis C virus in recipients of anti-D immunoglobulin. Lancet 1995;345:1211-3.
32. Kupfer B, Oldenburg J, Brackmann HH, et al. ß-propiolactone UV inactivated clotting factor concentrate is the source of HIV-infection of 8 hemophilia B patients: confirmed. Thromb Haemost 1995;74:1386-7.
33. Smith DB, Lawlor E, Power J, et al. A second outbreak of hepatitis C virus infection from anti-D immunoglobulin in Ireland. Vox Sang 1999;76:175-80.
34. Nucleic acid amplification techniques. Guidelines for validation of nucleic acid amplification technology (NAT) for the detection of hepatitis C virus (HCV) RNA in plasma pools. PA/PH/OMCL(98)22,DEF. Geneva: Council of Europe Press, 1999.
35. Nübling CM, Löwer J. The role of nucleic acid amplification techniques (NATs) in viral safety testing of blood and blood products. Biotest Bull 1997;5:377-81.
36. Eyster ME, Sherman KE, Goedert JJ, et al. Prevalence and changes in hepatitis C virus genotypes among multitransfused persons with hemophilia. The Multicenter Hemophilia Cohort Study. J Infect Dis 1999;179:1062-9.
37. Healey CJ, Sabharwal NK, Daub J, et al. Outbreak of acute hepatitis C following the use of anti-hepatitis C virus-screened intravenous immunoglobulin therapy. Gastroenterology 1996;110:1120-6.
38. Weiner AJ, Thaler MM, Crawford K, et al. A unique, predominant hepatitis C virus variant found in an infant born to a mother with multiple variants. J Virol 1993;67:4365-8.
39. Manzin A, Solforosi L, Petrelli E, et al. Evolution of hypervariable region 1 of hepatitis C virus in primary infection. J Virol 1998;72:6271-6.
40. Sakamoto N, Enomoto N, Kurosaki M, et al. Sequential change of the hypervariable region of the hepatitis C virus genome in acute infection. J Med Virol 1994;42:103-8.
41. Prince AM, Brotman B. Biological and immunological aspects of hepatitis C virus infection in chimpanzees. Curr Stud Hematol Blood Transfus 1998;250-65.
42. Marion PL. Use of animal models to study hepatitis B virus. Prog Med Virol 1988;35:43-75.
43. Balayan MS. Natural hosts of hepatitis A virus. Vaccine 1992;10(Suppl 1):S27-31.
44. Tabor E, Gerety RJ. Transmission of hepatitis B by immune serum globulin. Lancet 1979;2:1293.
45. Biswas RM, Nedjar S, Wilson LT, et al. The effect on the safety of intravenous immunoglobulin of testing plasma for antibody to hepatitis C. Transfusion 1994;34:100-4.
46. Hollinger FB, Dolana G, Thomas W, Gyorkey F. Reduction in risk of hepatitis transmission by heat-treatment of a human factor VIII concentrate. J Infect Dis 1984;150:250-62.
47. Kleim JP, Bailly E, Schneweis KE, et al. Acute HIV-1 infection in patients with hemophilia B treated with betapropiolactone-UV-inactivated clotting factor (letter). Thromb Haemost 1990;64:336-7.
48. Norley SG, Löwer I, Kurth R. Insufficient inactivation of HIV-1 in human cryo poor plasma by beta-propiolactone: results from a highly accurate virus detection method. Biologicals 1993;21:251-8.
49. Lever AM, Webster AD, Brown D, Thomas HC. Non-A, non-B hepatitis occurring in agammaglobulinaemic patients after intravenous immunoglobulin. Lancet 1984;2:1062-4.
50. Ochs HD, Fischer SH, Virant FS, et al. Non-A,non-B hepatitis and intravenous immunoglobulin. Lancet 1985;1:404-5.
51. Iwarson S, Wejstal R, Ruttimann E, et al. Non-A,non-B hepatitis associated with the administration of intravenous immunoglobulin-transmission studies in chimpanzees. Serodiagn Immunother 1987;1:261-6.
52. Björkander J, Cunningham-Rundles C, Lundin P, et al. Intravenous immunoglobulin prophylaxis causing liver damage in 16 of 77 patients with hypogammaglobulinemia or IgG subclass deficiency. Am J Med 1988;84:107-11.
53. Gomperts ED. Gammagard and reported hepatitis C virus episodes. Clin Ther 1996;18(Suppl B):3-8.
54. Power JP, Lawlor E, Davidson F, et al. Hepatitis C viraemia in recipients of Irish intravenous anti-D immunoglobulin. Lancet 1994;344:1166-7.
55. Gerritzen A, Schneweis KF, Brackmann HH, et al. Acute hepatitis A in haemophiliacs. Lancet 1992;340:1231-2.
56. Peerlinck K, Vermylen J. Acute hepatitis A in patients with haemophilia A. Lancet 1993;341:179.
57. Temperley IJ, Cotter KP, Walsh TJ, et al. Clotting factors and hepatitis A. Lancet 1992;340:1466.
58. Willkommen H. Experimental experience with virus validation studies. Dev Biol Stand 1996;88:317-8.
59. Note for guidance on virus validation studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses. Committee for Proprietary Medicinal Products/Blood Working Group. CPMP/BWP/268/95 1995. Available at: www.emea.eu.int/pdfs/human/bwp/026895en.pdf.
60. Erstad BL. Viral infectivity of albumin and plasma protein fraction. Pharmacotherapy 1996;16:996-1001.
61. Lawlor E, Graham S, Davidson E, et al. Hepatitis A transmission by factor IX concentrates. Vox Sang 1996;71:126-8.
62. Mosley JW. Is safe always safe? Pooled plasma derivates and viral hepatitis. Gastroenterology 1996;110:1307-10.
63. Horowitz B, Prince AM, Hamman J, Watklevicz C. Viral safety of solvent/detergent-treated blood products. Blood Coagul Fibrinolysis 1994;5(Suppl 3):21-30.
64. Lemon SM, Murphy PC, Smith A, et al. Removal/neutralization of hepatitis A virus during manufacture of high purity, solvent/detergent factor VIII concentrate. J Med Virol 1994;43:44-9.
65. Kaul A. [Molecular biological investigations of a hepatitis A-virus epidemic in Marburg.] Tübingen, Germany: Tübingen University, 1996. Master's thesis.
66. Cristiano K, Pisani G, Wirz M, et al. More evidence on safety of intramuscular immune serum globulin produced from plasma unscreened for anti-hepatitis C virus antibodies (letter). Arch Intern Med 1998;158:807-8.
67. Piazza M, Sagliocca L, Tosone G, et al. Sexual transmission of the hepatitis C virus and efficacy of prophylaxis with intramuscular immune serum globulin. A randomized controlled trial. Arch Intern Med 1997;157:1537-44.
68. Lawlor E, Power J, darson J, et al. Transmission rates of hepatitis C virus by different batches of a contaminated anti-D immunoglobulin preparation. Vox Sang 1999;6:138-43.
69. Hilfenhaus J, Gröner A, Nowak T, Weimer T. Analysis of human plasma products: polymerase chain reaction does not discriminate between live and inactivated viruses. Transfusion 1997;7:935-40.
70. Hellstern P. Clinical experience with the viral safety of immunoglobulins. Blood Coagul Fibrinolysis 1994;5(Suppl 3):31-4.
71. Lane HS. Non-A,non-B hepatitis from intravenous immunoglobulin. Lancet 1983;2:974-5.
72. Meyboom RH, Hekster YA, Egberts AC, et al. Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf 1997;17:374-89.
73. Meyboom RH, Egberts AC, Edwards IR, et al. Principles of signal detection in pharmacovigilance. Drug Saf 1997;16:355-65.
74. Yap PL. Intravenous immunoglobulin and hepatitis C virus: an overview of transmission episodes with emphasis on manufacturing data. Clin Ther 1996;18(Suppl B):43-58.
75. Hart H, Jones A, Cubie H, et al. Distribution of hepatitis A antibody over a process for the preparation of a high-purity factor VIII concentrate. Vox Sang 1994;67(Suppl 1):51-5.
76. Girard M. Testing the methods of assessment for adverse drug reactions. Adverse Drug React Acute Poisoning Rev 1984;4:237-44.
77. Pere JC, Begaud B, Haramburu F, Albin H. Computerized comparison of six adverse drug reaction assessment procedures. Clin Pharmacol Ther 1986;40:451-61.
78. Benichou C, ed. Adverse drug reactions: a practical guide to diagnosis and management. Chichester, UK: John Wiley & Sons, 1994.
79. Robertson BH, Normann A, Graff J, et al. Hepatitis A virus and polymerase chain reaction amplification: methodology and results. Blood Coagul Fibrinolysis 1995;6(Suppl 2):S27-31.
80. Robertson BH, Friedberg D, Normann A, et al. Sequence variability of hepatitis A virus and factor VIII associated hepatitis A infections in hemophilia patients in Europe. An update. Vox Sang 1994;67(Suppl 1):39-46.