Clotting factor concentrates and immune function in haemophilic patients

Haemophilia

Volumn 4, Issue 5, 1998, Pages 704-713

  Hoots, K ^a   Canty, D ^b  

^a Gulf States Hemophilia and Thrombophilia Center   (United States)

^b NEW YORK UNIVERSITY   (United States)

Author keywords

CD4 lymphocytes; Factor concentrates; Haemophilia; HCV; HIV; Immunomodulation

Indexed keywords

ACTIVATED PROTHROMBIN COMPLEX; BLOOD CLOTTING FACTOR 8 CONCENTRATE; BLOOD CLOTTING FACTOR 9 COMPLEX; BLOOD CLOTTING FACTOR 9 CONCENTRATE; BLOOD CLOTTING FACTOR CONCENTRATE; CD4 ANTIGEN; FIBRINOGEN; FIBRONECTIN; IMMUNOGLOBULIN; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9; UNCLASSIFIED DRUG;

DISEASE COURSE; DRUG CONTAMINATION; DRUG PURIFICATION; DRUG PURITY; HEMOPHILIA; HEPATITIS C VIRUS; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE DEFICIENCY; LYMPHOCYTE COUNT; PRIORITY JOURNAL; REVIEW;

BLOOD COAGULATION FACTORS; BLOOD PROTEINS; HEMOPHILIA A; HUMANS; IMMUNE TOLERANCE; VIRUSES;

EID: 0031717985     PISSN: 13518216     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2516.1998.00172.x     Document Type: Review

References (85)

1. Davignon GF. Understanding the hemophilias: factor VIII deficiency (hemophilia A). Hemalog 1991; 4: 10-2. Published by Armour Pharmaceutical Company, produced by SCI/MED/TECH Publications and Graphics, Denver CO.
2. Handin RI. Disorders of coagulation and thrombosis. In: Wilson JD, Braunwald E, Isselbacher KJ, Petersdorf RG, Martin JB, Fauci AS, Root RK, eds. Harrison's Principles of Internal Medicine, 12th edn. New York: McGraw Hill Inc. 1991: 1505-11.
3. Schimpf K, Brackmann HH, Kreuz W, et al. Absence of anti-human immunodeficiency virus types 1 and 2 seroconverstion after the treatment of hemophilia A or von Willebrand's disease with pasteurized factor VIII concentrate. N Engl J Med 1989; 321: 1148-52.
4. Brettler DB. A multicentre study to determine the hepatitis safety of Monoclate. Presented at: Replacement Therapy in Haemophilia - Problems and Solutions. Nov 3-4 1988; Lisbon, Portugal.
5. Gomperts ED, de Biasi R, De Vreker R. The impact of clotting factor concentrates on the immune system in individuals with hemophilia. Trans Med Revs 1992; VI: 44-54.
6. NHF/MASAC, (National Hemophilia Foundation/ Medical, Scientific Advisory Council). Recommendations concerning HIV infection, hepatitis, and other transmissable agents in the treatment of hemophilia. Hemophilia Information Exchange: Medical Bulletin no. 226 (Revised March, 1995).
7. Mannhalter JW, Zlabinger GJ, Ahmad R, et al. A functional defect in the early phase of the immune response observed in patients with hemophilia A. Clin Immunol Immunopathol 1986; 38: 390-7.
8. Antonaci S, Jirillo E, Stasi D, De Mitrio V, La Via MF, Bonomo L. Immunoresponsiveness in haemophilia: lymphocyte and phagocyte mediated functions. Diagn Clin Immunol 1988; 5: 318-25.
9. Ruffault R, Genetet N, Berthier AM, et al. Interferon production in severe hemophiliacs with and without HIV antibodies. J Interferon Res 1988; 8: 89-94.
10. Matheson DS, Green BJ, Poon M-C, Fritzler MJ, Hoar DI, Bowen TJ. Natural killer cell activity from hemophiliacs exhibits differential responses to various forms of interferon. Blood 1986; 67: 164-7.
11. Brieva JA, Sequi J, Zabay JM, et al. Abnormal B cell function in haemophiliacs and their relationship with factor concentrate administration. Clin Exp Immunol 1985; 59: 491-8.
12. Schulman S. Effect of factor VIII concentrates on the immune system in hemophilic patients. Ann Hematol 1991; 63: 145-51.
13. Hollán SR, Fust G, Nagy K, et al. Immunological alteration in anti-HTLV-III negative haemophiliacs and homosexual men in Hungary. Immunol Lett 1985; 11: 305-10.
14. Madhok R, Gracie A, Lowe GDO, et al. Impaired cell mediated immunity in haemophilia in the absence of infection with human immunodeficiency virus. Br Med J 1986; 293: 978-80.
15. Levine PH, Factor VIII. c purified from plasma via monoclonal antibodies: Human studies. Semin Hematol 1988; Suppl. 1: 25: 38-41.
16. Brettler DB, Forsberg AD, Brewster F, Sullivan JL, Levine PH. Delayed cutaneous hypersensitivity reactions in hemophilic subjects treated with factor concentrates. Am J Med 1986; 81: 607-11.
17. Ludlam CA, Carr R, Veitch E, Steel CM. Disordered immune regulation in haemophiliacs not exposed to commercial factor VIII. Lancet 1983; I: 1226.
18. Froebel KS, Madhok R, Forbes CD, Lennie SE, Lowe GDO, Sturrock RD. Immunological abnormalities in haemophilia: are they caused by American factor VIII concentrate? Br Med J 1983; 287: 1091-3.
19. Carr R, Veitch SE, Edmond E, et al. Abnormalities of circulating lymphocyte subsets in haemophiliacs in an AIDS-free population. Lancet 1984; 8392: 1431-4.
20. Freedman I, Mazaheri R, Read S, Garvey MB, Teitel J. Humoral and cellular immune abnormalities in adult hemophiliacs followed over a two-year period. Diagn Clin Immunol 1987; 5: 30-40.
21. Ragni MV, Winkelstein A, Kingsley L, Spero JA, Lewis JH. 1986 update of HIV seroprevalence, AIDS incidence and immunologic correlates of HIV infection in patients with haemophilia A and B. Blood 1987; 70: 786-90.
22. 4 lymphocyte counts to survival in a cohort of hemophiliacs infected with HIV. JAIDS 1994; 10: 1095-8.
23. Aledort LM, Hilgartner MW, Pike MC, et al. (on behalf of the Transfusion Safety Study Group). Variability in serial CD4 counts and relation to progression of HIV-1 infection to AIDS in haemophilic patients. BMJ 1992; 304: 212-6.
24. Ho D, Pomerantz RJ, Kaplan JC. Pathogenesis of infection with human immunodeficiency virus. N Engl J Med 1987; 317: 278-86.
25. Weimer R, Schweighoffer T, Schimpf K, Opelz G. Helper and suppressor T-cell function in HIV-infected hemophilia patients. Blood 1989; 74: 298-302.
26. Sjamsoedin-Visser LJM, Heijnen CJ, Zegers BJM, Stoop JW. Defect in B cell function in HTLV III/LAV positive hemophilia patients. Blood 1987; 69: 1388-93.
27. Sjamsoedin-Visser LJM, Heijnen CJ, Zegers BJM, Stoop JW. Defective T suppressor-inducer cell function in human immune deficiency virus-seropositive hemophilia patients. Blood 1988; 72: 1474-7.
28. de la Barrera SS, Olabuenaga SE, Soria A, Felippo M, Bianco RP, de Bracco MME. HIV infection and natural killer cytotoxicity in hemophilic patients. Immunol Lett 1990; 24: 207-16.
29. Anh-Tuan N, Novak E, Hollan SR. Hepatitis B surface antigen circulating immune complexes (HBsAg-CICs) in patients with bleeding disorders. Vox Sang 1981; 40: 12-6.
30. Gomperts ED. Clotting factors isolated with monoclonal antibodies. In: Albertini A, Lenfant CL, Mannucci PM, Sixma JJ, eds. Biotechnology of Plasma Proteins. Curr Stud Hematol Blood Transfus 1991; 58: 52-8.
31. 1, hepatitis delta, and HBV infections. Hepatol 1990; 12: 964.
32. Webster A, Lee CA, Cook DG, et al. Cytomegalovirus infection and progression towards AIDS in haemophiliacs with human immunodeficiency virus infection. Lancet 1989; II: 63-6.
33. Eyster ME, Diamondstone LS, Lien JM, Ehmann WC, Quan S, Goedert JJ. Natural history of hepatitis C virus infection in multitransfused hemophiliacs: effect of coinfection with human immunodeficiency virus. J Acquir Immune Defic Syndr 1993; 6: 602-10.
34. Telfer PT, Brown D, Devereux H, Lee CA, DuShieko GM. HCV RNA levels and HIV infection: evidence for a viral interaction in hemophilia patients. Br J Haematol 1994; 88: 897-9.
35. Evans JA, Pasi JK, Hill FGH. Evidence for the aetiological role of blood-borne virus infections in causing reduced lectin-induced T-cell proliferation in haemophilic boys. Br J Haematol 1995; 91: 197-202.
36. Pasi KJ, Evans JA, Wadhwa M, Thorpe R, Hill FGH. Association of changes in monocyte antigen presentation and cytokine production in haemophilic boys with treatment and blood-borne virus infection. Br J Haematol 1995; 91: 191-6.
37. Tamara K, Shibata Y, Matsuda Y, Shimizu Y. Isolation and characterization of an immunosuppressive acidic protein from ascitic fluids of cancer patients. Cancer Res 1981; 41: 3244-52.
38. 1-acidic glycoprotein. Am J Obstet Gynecol 1986; 154: 1165-6.
39. Heiner DC. Significance of immunoglobulin subclasses, Am J Med 1984; Suppl. 3A: 76: 1-6.
40. Eibl MM, Ahmad R, Wolf HM, Linnau Y, Göetz E, Mannhalter JW. A component of factor VIII preparations which can be separated from factor VIII activity down modulates human monocyte functions. Blood 1987; 69: 1153-60.
41. Mannhalter JW, Ahmad R, Lebl H, Göttlicher J, Wolf HM, Eibl MM. Comparable modulation of human monocyte functions by commercial factor VIII concentrates of varying purity. Blood 1988; 71: 1662-8.
42. Mannhalter JW, Ahmad R, Eibl MM, Leibl H. Modulation of human monocyte functions by factor VIII - anti factor VIII complexes present in an affinity-purified factor VIII product. Blood 1990; 75: 810-1.
43. Eyster ME, Nau ME. Particulate material in antihemophilic factor (AHF) concentrates. Transfusion 1978; 18: 576-81.
44. Ludlam CA. Effects of allogens in blood products on immunity. Semin Hematol 1988; Suppl. I: 25: 3-7.
45. Proctor RA, Prendergast E, Mosher DF. Fibronectin mediates attachment of Staphylococcus aureus to human neutrophils. Blood 1982; 59: 681-7.
46. Mosher DF, Williams EM. Fibronectin concentration is decreased in plasma of severely ill patients with disseminated intravascular coagulation. J Lab Clin Med 1978; 91: 729-35.
47. Pasi KJ, Hill FGH. Correlation between increasing product purity and reduced inhibition of monocyte phagocytic function. In: Mannucci PM, ed. Replacement Therapy in Haemophilia - Problems and Solutions. Lisbon: Alden Press, 1988: 116-9.
48. Roy G, Pardo A, Leyva-Cobián F. Phenotypic and functional abnormalities in monocytes from patients with haemophilia A treated with factor VIII concentrates. Acta Haematol 1988; 79: 26-32.
49. Matsuda J, Tsukamoto M, Gotoh M, Gohchi K, Saitoh N, Kinoshita T. Increased levels of serum intercellular adhesion molecule 1 in hemophiliacs irrespective of human immunodeficiency virus type 1 infection. Blood 1993; 82: 2258-9.
50. Allersman DP, Smid WM, van der Does JA, van der Meer J, Briel E. Effects of chronic factor VIII substitution on immune parameters in HIV seronegative haemophiliacs: a comparison between cryoprecipitate and factor VIII concentrate. Thromb Haemost 1996; 75: 261-6.
51. Glöckel U, Gromball J, Kobatsch B, Leppik KH, Leibold W, Beck JD. Influence of factor VIII, factor IX and immunoglobulin preparations of proliferative responses of mitogen-activated lymphocytes. Immun Infect 1987; 15: 62-5.
52. Schreiber AB, Gillette R, Hrinda MR. In vitro immune parameters of Monclate, a monoclonal antibody purified human plasma factor VIII.c therapeutic preparation. Thromb Haemost 1987; 58: 346.
53. Hay CRM, McEvoy P. The variable effect of diverse clotting factor concentrates on lymphocyte function in vitro. Thromb Haemost 1989; 62: 453.
54. Lederman MM, Saunders C, Toossi Z, Lemon N, Everson B, Ratnoff OD. Antihemophilic factor (factor VIII) preparations inhibit lymphocyte proliferation and production of interleukin-2. J Lab Clin Med 1986; 107: 471-8.
55. Thorpe R, Dilger P, Dawson NJ, Barrowcliffe TW. Inhibition of interleukin-2 secretion by factor VIII concentrates: a possible cause of immunosuppression in haemophiliacs. Br J Haematol 1989; 71: 387-91.
56. Madhok R, Gracie JA, Smith J, Lowe GDO, Forbes CD. Capacity to produce interleukin 2 is impaired in haemophilia in the absence and presence of HIV-1 infection. Br J Haematol 1990; 76: 70-4.
57. Beddall AC, Hill FGH, George RH, Williams MD, Al-Rubei K. Unusually high incidence of tuberculosis among boys with haemophilia during an outbreak of the disease in hospital. J Clin Pathol 1985; 38: 1163-5.
58. Wadhwa M, Dilger P, Tubbs J, Barrowcliffe T, Mahon B, Thorpe R. Mechanisms of inhibition of T cell IL-2 secretion by factor VIII concentrates. Br J Haematol 1992; 82: 575-83.
59. Wadhwa M, Dilger P, Tubbs J, Mire-Sluis A, Barrowcliffe T, Thorpe R. Identification of transforming growth factor-beta as a contaminant in factor VIII concentrates: a possible link with immunosuppressive effects in hemophiliacs. Blood (USA) 1994; 84: 2021-30.
60. Batchelor A, Steel CM, Ludlam CA. Enhancement of human T cell responses to allogeneic simuli by factor VIII concentrates. Br J Haematol 1992; 82: 94-8.
61. Berntorp E. Lectin-induced lymphocyte transformation after infusion of factor VIII concentrates. In: Mannucci PM, ed. Replacement Therapy in Haemophilia - Problems and Solutions. Lisbon: Alden Press, 1988: 129.
62. Schreiber A. The preclinical characterization of Monoclate factor VIII.c antihaemophilic factor (human). Semin Haematol 1988; Suppl. 1: 25: 27-32.
63. Janco L, Puryear PJ. Commercial factor VIII concentrates alter human monocyte functions in vitro. Pediatr Res 1989; 25: 152A.
64. Vermot-Desroches C, Rigal D, Blourde C, Bernaud J. Immunosuppressive property of a very high purity antihaemophilic preparation: a low molecular weight component inhibits an early step of PHA induced cell activation. Br J Haematol 1992; 80: 370-7.
65. Fukutake K, Hada M, Ikematsu S, et al. Multicenter study on the influence of long-term continous use of ultrapurified factor VIII preparation on the immunological status of HIV infected and non-infected hemophilia A patients. XIXth International Congress of the World Federation of Hemophilia. Washington, DC, 1990: abstr 124.
66. Mannucci PM, Brettler DB, Aledort LM, Hurst D, Schwartz RS, Lusher JM. Immune status of human immunodeficiency virus seropositive and sernegative hemophiliacs infused for 3.5 years with recombinant factor VIII. Blood 1994; 83: 1958-62.
67. Green D, Deutsche J, Tang M, Goldsmith J. Effect of HIV-1 infection on CD4 cells in a hemophilia cohort. Haematologica 1990; Suppl. 5: 75: 132-41.
68. Hilgartner MW, Buckley JD, Operskalski EA, Pike MC, Mosley JW. (for the Transfusion Safety Study Group). Purity of factor VIII concentrates and serial CD4 counts. Lancet 1993; 341: 1373-4.
69. Sabin C, Pasi J, Phillips A, Elford J, Janossy G, Lee C. CD4+ counts before and after switching to monoclonal high-purity factor VIII concentrate in HIV-infected haemophilic patients. Thromb Haemost (Germany) 1994; 72: 214-7.
70. Goldsmith JM, Deutsch J, Tang M, Green D. CD4 cells in HIV-1 infected haemophiliacs: effect of factor VIII concentrates. Thromb Haemostas 1991; 66(4): 415-9.
71. di Biasi R, Rocino A, Miraglia E, Mastrullo L, Quirino AA. The impact of a very high purity factor VIII concentrate on the immune system of human immunodeficiency virus-infected hemophiliacs: a randomized, prospective, two-year comparison with an intermediate purity product. Blood 1991; 78: 1919-22.
72. Farrugia A, di Biasi R, Rocino A. Purity of factor VIII concentrates and immune function in hemophiliacs. Blood 1992; 79: 2800-1.
73. Seremetis S, Aledort LM, Bergman GE, et al. Threeyear randomized study of high-purity or intermediate-purity factor VIII concentrates in symptom-free HIV-seropositive haemophiliacs: effects on immune status. Lancet 1993; 342: 700-3.
74. Schwarz HP, Kunschak M, Engl W, Eibl J. High-purity factor concentrates in prevention of AIDS. Lancet 1994; 343: 478-9.
75. Mannucci PM. Effects of factor VIII concentrates on the immune system of patients with hemophilia. Thromb Haemostas 1995; 74: 437-9.
76. Varon D, Schulman S, Dardik R, Barzilai A, Bashari D, Martinowitz U. High versus ultra-high purity factor-VIII concentrate therapy: prospective evaluation of immunological and clinical parameters in HIV sero-negative and seropositive hemophiliacs. Thromb Haemostas 1994; 72: 359-62.
77. Smid WM, van der Meer J, Smit W, Halie MR. The course of preexistent immune abnormalities in HIV negative haemophiliacs treated for two years with a monoclonal purified factor VIII concentrate. Thromb Haemost 1993; 69: 306-10.
78. Evans JA, Pasi JK, Williams MD, Hill FGH. Consistently normal CD4+, CD8+ levels in haemophilic boys only treated with a virally safe factor VIII concentrate. Br J Haematol 1991; 79: 457-61.
79. Gjerset GF, Pike MC, Mosley JW, et al., the Transfusion Safety Study Group. Effect of low- and intermediate-purity clotting factor therapy on progression of human immunodeficiency virus infection in congenital clotting disorders. Blood 1994; 84: 1666-71.
80. Hassett J, Gjerset GF, Mosley JW, et al. Effect on lymphocyte subsets of clotting factor therapy in human immunodeficiency virus-1-negative congenital clotting disorders. The Transfusion Safety Study Group. Blood 1993; 82: 1351-7.
81. Eichinger S, Pabinger I, Kyrle PA, et al. Factor VIII concentrates in HIV-1-positive hemophiliacs - is pure better? Haemostasis 1992; 22: 25-31.
82. Mannucci PM, Grigeri A, de Biasi R, Baudo F, Morfini M, Ciavarella N. Immune status of asymptomatic HIV-infected hemophiliacs: randomised, prospective two-year comparison of treatment with a high-purity or an intermediate-purity factor FVIII concentrate. Thromb Haemostas 1992; 67: 310-3.
83. Goedert JJ, Cohen AR, Kessler CM, et al. Risks of immunodeficiency, AIDS, and death related to purity of factor VIII concentrates. Lancet 1994; 344: 791-2.
84. O'Brien WA, Hartigan PM, Martin D, et al. Changes in plasma HIV RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. N Engl J Med 1996; 334: 426-31.
85. O'Brien TR, Blattner WA, Waters D, et al. Serum HIV-1 RNA levels and time to development of AIDS in the Multicenter Hemophilia Cohort Study. JAMA 1996; 276: 105-10.