Haemate® P von Willebrand factor/factor VIII concentrate: 25 years of clinical experience

Haemophilia

Volumn 14, Issue SUPPL. 5, 2008, Pages 3-10

  Schramm, Wolfgang ^a  

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

Author keywords

Factor VIII; Haemophilia A; Pasteurization; Von Willebrand disease; Von Willebrand factor; VWF FVIII concentrate

Indexed keywords

BERIATE HS; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 8 CONCENTRATE; DESMOPRESSIN; UNCLASSIFIED DRUG; VON WILLEBRAND FACTOR; COAGULATING AGENT;

BLEEDING; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTINUOUS INFUSION; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG USE; EXPERIENCE; FOLLOW UP; HEMOPHILIA A; HEPATITIS B VIRUS; HEPATITIS C VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; IMMUNOLOGICAL TOLERANCE; LONG TERM CARE; NONHUMAN; PASTEURIZATION; PRIORITY JOURNAL; PROPHYLAXIS; REVIEW; VIRUS INACTIVATION; VON WILLEBRAND DISEASE; ARTICLE; HISTORY; IMMUNOLOGY;

COAGULANTS; FACTOR VIII; HISTORY, 20TH CENTURY; HUMANS; IMMUNE TOLERANCE; VIRUS INACTIVATION; VON WILLEBRAND DISEASE; VON WILLEBRAND FACTOR;

EID: 51349168248     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2008.01847.x     Document Type: Review

References (93)

1. von Willebrand EA. Hereditär pseudohemofili. Finska Läkaresällskapets Handlingar 1926; 67: 87-112.
2. Minot G. A familial hemorrhagic condition associated with prolongation of the bleeding time. Am J Med Sci 1928; 175: 301-6.
3. von Willebrand EA, Jürgens R. Über ein neues vererbbares Blutungsübel: Die konstitutionelle Thrombopathie. Dtsch Archiv Klin Med 1933; 175: 453-83.
4. Nilsson IM, Blomback M, Jorpes E, Blomback B, Johansson SA. Von Willebrand's disease and its correction with human plasma fraction 1-0. Acta Med Scand 1957; 159: 179-88.
5. Nilsson IM, Blomback M, Blomback B, Ramgren O. The use of human AHF (Fraction I-0) in haemophilia A. Blut 1962; 8: 92-101.
6. Nilsson IM. Treatment of hemophilia A and v. Willebrand's disease. Bibl Haematol 1965; 23: 1307-12.
7. Ahlberg A. Haemophilia in Sweden. VII. Incidence, treatment and prophylaxis of arthropathy and other musculo-skeletal manifestations of haemophilia A and B. Acta Orthop Scand Suppl 1965; 77: 3-132.
8. Schwartz B, Landbeck G. Australia-SH-Antigen und -Antikörper nach Mehrfachtransfusionen bei Kindern und Jugendlichen mit schwerer und mittelschwerer Hämophilie. Dtsch Med Wochenschr 1973; 98: 2016-9.
9. Mannucci PM, Capitanio A, Del Ninno E, Colombo M, Pareti F, Ruggeri ZM. Asymptomatic liver disease in haemophiliacs. J Clin Pathol 1975; 28: 620-4.
10. Iwarson S, Kjellman H, Teger-Nilsson AC. Incidence of viral hepatitis after administration of factor IX concentrates. Vox Sang 1976; 31: 136-40.
11. Schimpf K, Zimmermann K, Thamer G, Rüdel J. Hepatitishäufigkeit, HBs-Antigen- und Anti-HBs-Frequenz bei Patienten des Hämodialysezentrums Heidelberg. Verh Dtsch Ges Inn Med 1976; 1: 414-7.
12. Sultan Y, Maisonneuve P, Simeon J, Intrator L. Modifications of factor VIII related antigen in hemophiliacs with acute hepatitis and sub-clinical liver disease. Scand J Haematol Suppl 1977; 30: 16-26.
13. Yannitsiotis A, Bossinakou I, Louizou C, Panayotopoulou C, Mandalaki T. Jaundice and hepatitis B surface antigen and antibody in Greek haemophiliacs. Scand J Haematol Suppl 1977; 30: 11-15.
14. Heimburger N, Schwinn H, Mauler R. Faktor VIII-Konzentrat - hepatitissicher: Fortschritte in der Behandlung der Hämophilie A. Gelben Hefte 1980; 4: 165-74.
15. Hilfenhaus J, Weidmann E. Pasteurization as an efficient method to inactivate blood borne viruses in factor VIII concentrates. Arzneimittelforschung 1986; 36: 621-5.
16. Heimburger N, Schwinn H, Gratz P, Lüben G, Kumpe G, Herchenhan B. Faktor VIII-Konzentrat, hochgereinigt und in Lösung erhitzt. Arzneimittelforschung 1981; 31: 619-22.
17. Chandra S, Groener A, Feldman F. Effectiveness of alternative treatments for reducing potential viral contaminants from plasma-derived products. Thromb Res 2002; 105: 391-400.
18. Kreuz W, Auerswald G, Brückmann C et al. Prevention of hepatitis C virus infection in children with haemophilia A and B and von Willebrand's disease. Thromb Haemost 1992; 67: 184.
19. Heimburger N, Karges HE, Weidmann E. Virus safety of pasteurized factor VIII and factor IX concentrates: Study in virgin patients. Dev Biol Stand 1987; 67: 303-10.
20. Schimpf K, Mannucci PM, Kreuz W et al. Absence of hepatitis after treatment with a pasteurized factor VIII concentrate in patients with hemophilia and no previous transfusions. N Engl J Med 1987; 316: 918-22.
21. Muntean W, Zenz W, Falger J et al. Sixteen years of treatment with pasteurized human clotting factor concentrates in children and adolescents: A pharmacosurveillance investigation comprising 727 patient years. Semin Thromb Hemost 2002; 28 (Suppl. 1): 63-74.
22. Pollmann H, Richter H. Status of infection in young hemophilia patients in Münster. Semin Thromb Hemost 2002; 28 (Suppl. 1): 47-50.
23. Kreuz W, Auerswald G, Roggendorf M et al. Anti-HCV und Anti-B 19 Prävalenz nach Substitution mit pasteurisierten Gerinnungspräparaten bei bisher unbehandelten Patienten. In: Landbeck G, Scharrer I, Schramm W, eds. 21es Hämophilie-Symposion Hamburg 1990. Berlin: Springer-Verlag, 1990: 164-8.
24. Kreuz W, Auerswald G, Auberger K et al. Anti-HCV prevalence in children with haemophilia and other coagulation disorders - results of the first and second generation test. Ann Hematol 1993; 66 (Suppl. 1): A49.
25. Pollmann H, Richter H, Kahl B, Peters G. 15 years experience with virus safety of pasteurized factor VIII concentrates in Germany. Haemophilia 1996; 2 (Suppl. 1): 24.
26. Klarmann D, Kreuz W, Auerswald G et al. Hepatitis C and pasteurised factor VIII and IX concentrates. Thromb Haemost 1995; 73: 736-7.
27. Hilfenhaus J, Mauler R, Friis R, Bauer H. Safety of human blood products: Inactivation of retroviruses by heat treatment at 60 degrees C. Proc Soc Exp Biol Med 1985; 178: 580-4.
28. Hilfenhaus J, Herrmann A, Mauler R, Prince AM. Inactivation of the AIDS-causing retrovirus and other human viruses in antihemophilic plasma protein preparations by pasteurization. Vox Sang 1986; 50: 208-11.
29. Mauler R, Merkle W, Hilfenhaus J. Inactivation of HTLV-III/LAV, hepatitis B and non-A/non-B viruses by pasteurization in human plasma protein preparations. Dev Biol Stand 1987; 67: 337-51.
30. Schimpf K, Brackmann HH, Kreuz W et.al. Absence of anti-human immunodeficiency virus types 1 and 2 seroconversion after the treatment of hemophilia A or von Willebrand's disease with pasteurized factor VIII concentrate. N Engl J Med 1989; 321: 1148-52.
31. Kreuz W, Klarmann D, Auerswald G et al. Absence of hepatitis A after treatment with pasteurised factor VIII concentrates in children with haemophilia A and von Willebrand disease. Lancet 1993; 341: 446.
32. Kreuz W, Becker S, Auerswald G, Kurnick K, Kröniger A, Klarmann D. Virus safety of pasteurized clotting factor concentrates. Semin Thromb Hemost 2002; 28 (Suppl. 1): 57-62.
33. Schäfer W, Mehdi S, Gröner A. Human parvovirus B19 is inactivated by pasteurization, a dedicated virus reduction step in the manufacturing procedure of plasma derivatives. Haemophilia 2004; 10 (Suppl. 3): 137.
34. Schäfer W, Vey M, Gröner A. Removal of prions by the manufacturing process of the VWF/FVIII coagulation concentrate Haemate P/ Humate P. Haemophilia 2006; 12 (Suppl. 2): 6.
35. Köhler M, Hellstern P, Wenzel E. The use of heat-treated Factor VIII-concentrates in von Willebrand's disease. Blut 1985; 50: 25-27.
36. Scharrer I, Vigh T. Comparison between cryoprecipitate and a wet treated-factor VIII concentrate in the treatment of von Willebrand's disease. Ric Clin Lab 1986; 16: 231.
37. Takahashi H, Tatewaki W, Nagayama R et al. Heat-treated factor VIII/von Willebrand factor concentrate in platelet-type von Willebrand's disease. Haemostasis 1987; 17: 353-60.
38. Berntorp E, Nilsson IM. Biochemical and in vivo properties of commercial virus-inactivated factor VIII concentrates. Eur J Haematol 1988; 40: 205-14.
39. Czapek EE, Gadarowski JJ Jr, Ontiveros JD, Pedraza JL. Humate-P for treatment of von Willebrand disease. Blood 1988; 72: 1100.
40. Fukui H, Nishino M, Terada S et al. Hemostatic effect of a heat-treated factor VIII concentrate (Haemate P) in von Willebrand's disease. Blut 1988; 56: 171-8.
41. Berntorp E, Nilsson IM. Use of highly purified factor VIII concentrate (Hemate-P) in von Willebrand disease. Vox Sang 1989; 56: 212-7.
42. Lethagen S, Carlson M, Hillarp A. A comparative in vitro evaluation of six von Willebrand factor concentrates. Haemophilia 2004; 10: 243-9.
43. Berntorp E. von Willebrand factor containing factor VIII concentrates. Haemophilia 1999; 5 (Suppl. 2): 60-63.
44. Furlan M. Von Willebrand factor: Molecular size and functional activity. Ann Hematol 1996; 72: 341-8.
45. Fricke WA, Yu MY. Characterization of von Willebrand factor in factor VIII concentrates. Am J Hematol 1989; 31: 41-45.
46. Lawrie AS, Harrison P, Armstrong AL, Wilbourn BR, Dalton RG, Savidge GF. Comparison of the in vitro characteristics of von Willebrand factor in British and commercial factor VIII concentrates. Br J Haematol 1989; 73: 100-4.
47. Mannucci PM, Tenconi PM, Castaman G, Rodeghiero F. Comparison of four virus-inactivated plasma concentrates for treatment of severe von Willebrand disease: A cross-over randomized trial. Blood 1992; 79: 3130-7.
48. Metzner HJ, Hermentin P, Cuesta-Linker T, Langner S, Müller HG, Friedebold J. Characterization of factor VIII/von Willebrand factor concentrates using a modified method of von Willebrand factor multimer analysis. Haemophilia 1998; 4 (Suppl. 3): 25-32.
49. Favaloro EJ, Bukuya M, Martinelli T et al. A comparative multi-laboratory assessment of three factor VIII/von Willebrand factor concentrates. Thromb Haemost 2002; 87: 466-76.
50. Suiter T, Budde U, Metzner HJ, Muysers C, Walter O. Comparison of von Willebrand factor activities measured by ristocetin cofactor assay and two different VWF-collagen-binding-assays in VWF/FVIII-concentrates. J Thromb Haemost 2003; 1 (Suppl. 1): P1667.
51. Walter O, Budde U, Muysers C, Metzner HJ, Suiter TM. Determination of High-Molecular Weight von Willebrand factor multimers and their impact on specific VWF-activities in VWF/FVIII-concentrates. J Thromb Haemost 2003; 1 (Suppl. 1): P1673.
52. Scharrer I, Vigh T, Aygören-Pürsün E. Experience with Haemate P in von Willebrand's disease in adults. Haemostasis 1994; 24: 298-303.
53. Rose E, Forster A, Aledort LM. Correction of prolonged bleeding time in von Willebrand's disease with Humate-P. Transfusion 1990; 30: 381.
54. Aledort LM. Treatment of von Willebrand's disease. Mayo Clin Proc 1991; 66: 841-6.
55. Rodeghiero F, Castaman G, Meyer D, Mannucci PM. Replacement therapy with virus-inactivated plasma concentrates in von Willebrand disease. Vox Sang 1992; 62: 193-9.
56. Scott JP, Montgomery RR. Therapy of von Willebrand disease. Semin Thromb Hemost 1993; 19: 37-47.
57. Kreuz W, Mentzer D, Becker S, Scharrer I, Kornhuber B. Haemate P in children with von Willebrand's disease. Haemostasis 1994; 24: 304-10.
58. Alusi GH, Grant WE, Lee CA, Pasi KJ, Stearns MP. Bleeding after tonsillectomy in severe von Willebrand's disease. J Laryngol Otol 1995; 109: 437-9.
59. Blanchette V, Israels SJ, Akabutu J, Bergman GE. Report of the efficacy and safety of Haemate P in Canadian von Willebrand disease (vWD) patients. Thromb Haemost 1997; 77 (Suppl.): 513-4.
60. Naqvi A, Endres-Brooks J, Montgomery RR et al. Successful cardiac surgery in a young girl with type 2a von Willebrand disease using continuous infusion of Haemate-P. Thromb Haemost 1997; 77 (Suppl.): 514.
61. Caliezi C, Tsakiris DA, Behringer H, Kühne T, Marbet GA. Two consecutive pregnancies and deliveries in a patient with von Willebrand's disease type 3. Haemophilia 1998; 4: 845-9.
62. Dobrkovska A, Krzensk U, Chediak JR. Pharmacokinetics, efficacy and safety of Humate-P in von Willebrand disease. Haemophilia 1998; 4 (Suppl. 3): 33-39.
63. Lethagen S. Haemostatic treatment in connection with surgery in patients with von Willebrand disease. Haemophilia 1999; 5 (Suppl. 2): 64-67.
64. Lubetsky A, Schulman S, Varon D et al. Safety and efficacy of continuous infusion of a combined factor VIII-von Willebrand factor (vWF) concentrate (Haemate-P) in patients with von Willebrand disease. Thromb Haemost 1999; 81: 229-33.
65. Nitu-Whalley IC, Miners AH, Lee CA. Audit of clinical management of von Willebrand disease during 1997 at a single institution and review of treatment patterns between 1980 and 1997. Haemophilia 1999; 5: 327-33.
66. Frank RD, Kunz D, Wirtz DC. Acquired von Willebrand disease-hemostatic management of major orthopedic surgery with high-dose immunoglobulin, desmopressin, and continuous factor concentrate infusion. Am J Hematol 2002; 70: 64-71.
67. Auerswald G, Auberger K, Kreuz W et al. Continuous infusion of factor VIII after elective surgery in children with haemophilia A and von Willebrand disease. Haemophilia 1996; 2 (Suppl. 1): 145.
68. Auerswald G. Kontinuierliche Infusion von Faktoren-Konzentraten nach Operation bei Kindern mit Hämophilie. Gelben Hefte 1997; 37: 191-8.
69. Metzner HJ, Watzka B, Müller H-G et al. Stabilität von Faktor VIII-Präparaten: Voraussetzung für die kintinuierliche Infusion. Gelben Hefte 1997; 37: 183-90.
70. Kühne T, Imbach P, Marbet GA, Caliezi C, Devay J. Continuous infusion of von Willebrand factor and factor VIII after elective heart surgery in a 12-year-old girl with von Willebrand disease type 3. Pediatr Hematol Oncol 1999; 16: 551-6.
71. Auerswald G, Escuriola Ettingshausen C, Heilmeier T, Kreuz W, Martinez I, Sutor AH. Continuous infusion of pdFVIII during and after elective surgery in 13 patients with von Willebrand's disease type 3. Haemophilia 2000; 6: 226-7.
72. Walter O, Budde U. Stability of the VWF/FVIII concentrate Haemate P/ Humate P after reconstitution: Influences on VWF multimers, VWF:RCo, VWF:CB, FVIII and FVIII-binding activities. Haemophilia 2004; 10 (Suppl. 3): 12.
73. Lethagen S, Berntorp E, Nilsson IM. Pharmacokinetics and hemostatic effect of different factor VIII/von Willebrand factor concentrates in von Willebrand's disease type III. Ann Hematol 1992; 65: 253-9.
74. Messori A, Morfini M, Blomback M et.al. Pharmacokinetics of two pasteurized factor VIII concentrates by different and multicenter assays of factor VIII activity. Thromb Res 1992; 65: 699-708.
75. Federici AB, Mannucci PM. Optimizing therapy with factor VIII/von Willebrand factor concentrates in von Willebrand disease. Haemophilia 1998; 4 (Suppl. 3): 7-10.
76. Luboshitz J, Lubetsky A, Schliamser L, Kotler A, Tamarin I, Inbal A. Pharmacokinetic studies with FVIII/von Willebrand factor concentrate can be a diagnostic tool to distinguish between subgroups of patients with acquired von Willebrand syndrome. Thromb Haemost 2001; 85: 806-9.
77. Franchini M, Rossetti G, Tagliaferri A et al. Efficacy and safety of factor VIII/von Willebrand factor concentrate (Haemate-P) in preventing bleeding during surgery or invasive procedures in patients with von Willebrand's disease. Haematologica 2003; 88: 1279-83.
78. Lillicrap D, Poon MC, Walker I, Xie F, Schwartz BA, Association of Hemophilia Clinic Directors of Canada. Efficacy and safety of the factor VIII/von Willebrand factor concentrate, haemate-P/humate-P: Ristocetin cofactor unit dosing in patients with von Willebrand disease. Thromb Haemost 2002; 87: 224-30.
79. Gill JC, Ewenstein BM, Thompson AR, Mueller-Velten G, Schwartz BA, Humate-P Study Group. Successful treatment of urgent bleeding in von Willebrand disease with factor VIII/VWF concentrate (Humate-P): Use of the ristocetin cofactor assay (VWF:RCo) to measure potency and to guide therapy. Haemophilia 2003; 9: 688-95.
80. Michiels JJ, Berneman ZN, van der Planken M, Schroyens W, Budde U, van Vliet HH. Bleeding prophylaxis for major surgery in patients with type 2 von Willebrand disease with an intermediate purity factor VIII-von Willebrand factor concentrate (Haemate-P). Blood Coagul Fibrinolysis 2004; 15: 323-30.
81. Thompson AR, Gill JC, Ewenstein BM, Mueller-Velten G, Schwartz BA, Humate-P Study Group. Successful treatment for patients with von Willebrand disease undergoing urgent surgery using factor VIII/VWF concentrate (Humate-P). Haemophilia 2004; 10: 42-51.
82. Mannucci PM, Kyrle P, Holmstroem M, Haertel S, Knaub S, Lethagen S. Treatment of VWD patients requiring elective surgery with a pasteurized von Willebrand Factor/FVIII concentrate (Haemate ® P)-the use of a PK guided approach. Blood 2005; 106: 1781.
83. Berntorp E, Petrini P. Long-term prophylaxis in von Willebrand disease. Blood Coagul Fibrinolysis 2005; 16 (Suppl. 1): S23-S26.
84. Coppola A, Cimino E, Conca P et al. Long-term prophylaxis with intermediate-purity factor VIII concentrate (Haemate P) in a patient with type 3 von Willebrand disease and recurrent gastrointestinal bleeding. Haemophilia 2006; 12: 90-94.
85. Kreuz W, Ehrenforth S, Funk A et al. Immune tolerance therapy in paediatric hemophiliacs with factor VIII inhibitors: 14 years follow-up. Haemophilia 1995; 1: 24-32.
86. Kreuz W, Escuriola Ettingshausen C, Auerswald G et al. Immune tolerance induction (ITI) in haemophilia A - patients with inhibitors - the choice of concentrate affecting success. Haematologica 2001; 86 (Suppl. 4): 16-20.
87. Auerswald G, Spranger T, Brackmann HH. The role of plasma-derived factor VIII/von Willebrand factor concentrates in the treatment of hemophilia A patients. Haematologica 2003; 88: EREP05.
88. Kreuz W, Joseph-Steiner J, Mentzer D, Auerswald G, Beeg T, Becker S. Successful immune tolerance therapy of FVIII-inhibitor in children after changing from high to intermediate purity FVIII concentrate. Ann Hematol 1996; 72 (Suppl.1): A85.
89. Mentzer D, Kreuz W, Auerswald G. Enfolgreiche Faktor VIII-Hemmkörperelimination nach Wechsel von "high" zu "intermediate-purity" Faktor VIII Konzentrat bei Kindern mit Hämophilie A. In: Scharrer I, Schramm W, eds. 27es Hämophilie-Symposium Hamburg 1996. Berlin: Springer-Verlag, 1998: 187-94.
90. Kreuz W, Ettingshausen CE, Auerswald G, Saguer IM, Becker S, Funk M et al. Epidemiology of inhibitors and current treatment strategies. Haematologica 2003; 88: EREP04.
91. Berntorp E, Ekman M, Gunnarsson M, Nilsson IM. Variation in factor VIII inhibitor reactivity with different commercial factor VIII preparations. Haemophilia 1996; 2: 95-99.
92. Suzuki T, Arai M, Amano K, Kagawa K, Fukutake K. Factor VIII inhibitor antibodies with C2 domain specificity are less inhibitory to factor VIII complexed with von Willebrand factor. Thromb Haemost 1996; 76: 749-54.
93. Federici AB. The factor VIII/von Willebrand factor complex: Basic and clinical issues. Haemotologica 2003; 88: 3-12.