RSS-Feed abonnieren
DOI: 10.1055/s-0038-1650216
Safety Profile of Porcine Factor VIII and Its Use as Hospital and Home-Therapy for Patients with Haemophilia-A and Inhibitors: the Results of An International Survey
Publikationsverlauf
Received 01. Dezember 1994
Accepted after resubmission 28. September 1995
Publikationsdatum:
10. Juli 2018 (online)
![](https://www.thieme-connect.de/media/10.1055-s-00035024/199601/lookinside/thumbnails/10-1055-s-0038-1650216-1.jpg)
Summary
A multicentre retrospective survey was conducted to re-assess the use of porcine factor VIII (HYATE:C), its side effects and the selection of patients for regular or home-therapy. 15,152,000 units of HYATE:C were used by 154 patients. The median inhibitor cross-reactivity to porcine VIIIC of 137 patients was 15%, 27% of patients lacking cross-reactivity. An absent, intermediate or brisk specific antiporcine anamnestic response was observed in 29, 40 and 31% of patients respectively. Seven patients were treated on-demand as home-therapy for a median 6.2, range 1.5-13 years. 23 further patients were treated regularly in hospital for a median of 3, range 2-7 years. This group used 8,319,000 U of porcine VIIIC for 2,000 bleeding episodes.
The incidence of transfusion reactions was 0.001%, 0.64% and 2.3%, for domiciliary infusions, infusions in multiply treated inpatients, and unselected in-patient infusions, respectively. The risk of reactions was dose-related. A post-infusion fall in platelet count was common, but usually transient and clinically insignificant. This was also dose-related (r = -0.64, p = 0.002). Marked reductions in platelet count were occasionally seen, usually with intensive replacement therapy. The relative lack of side effects observed amongst patients treated at home is attributable to the low, median 33 U/kg, dose used by this group.
A subgroup of inhibitor patients, identifiable by their absent or modest anamnestic response to porcine factor VIII may be treated regularly and safely with this product in small doses, over a period of years.
-
References
- 1 Middleton S. Polyelectrolytes and preparation of factor VIII:C. In: Unresolved problems in haemophilia Forbes CP, Lowe GD. (eds) MTP Press; Lancaster: 1982. pp 109-120
- 2 Kemoff PBA, Thomas ND, Lilley PA. Clinical experience with polyelectrolyte-fractionated porcine FVIII concentrate in the treatment of haemophiliacs with antibodies to factor VIII. Blood 1984; 63: 31-41
- 3 Gatti L, Mannucci PM. Use of porcine factor VIII in the management of seventeen patients with FVIII antibodies. Thromb Haemost 1984; 51: 379-392
- 4 Brettler DB, Forsberg A, Levine PH, Buttler DB, Forsberg A, Levine PH, Aledort LM, Hilgartner MW, Kasper CK, Lusher JM, McMillan C, Roberts H. The use of porcine factor VIII: C in the treatment of patients with inhibitor antibodies to VIII: C: a multicenter US trial. Arch Intern Med 1989; 149: 1381-1385
- 5 Macfarlane RG, Biggs R, Bidwell E. Bovine antihaemophilic globulin for the treatment of haemophilia. Lancet 1954; i: 1316-1321
- 6 Bennet B, Ratnoff WD. Immunological relationships of antihaemophilic factor of different species detected by specific human and rabbit antibodies. Proc Soc Exp Biol Med 1973; 143: 701-706
- 7 Morrison AE, Ludlam CA, Kessler C. Use of porcine factor VIII in the treatment of patients with acquired hemophilia. Blood 1993; 81 (06) 1513-1520
- 8 Gringeri A, Santagostino E, Tradati F, Giangrande PLF, Mannucci PM. Adverse effects of treatment with porcine FVIII. Thromb Haemost 1991; 65: 245-247
- 9 Fukui H, Yoshioka A, Shima M, Mori K, Yorifuji H, Fukui H, Yoshioka A, Shima M, Mori K, Yorifuji H, Terada S, Morichika S. Multicenter clinical trial of a highly purified porcine factor VIII concentrate (MTI-9002 [HYATE:C]) in hemophilia A patients with inhibitors. Japanese J Thrombosis and Haemostasis 1991; 2 (06) 487-500
- 10 Erskine JG, Davidson JF. Anaphylactic reaction to low-molecular weight porcine factor VIII concentrates. Br Med J 1981; 282: 2011-2012
- 11 Hay CRM, Laurian Y, Verroust F, Preston FE, Kemoff PBA. Induction of immune-tolerance in patients with haemophilia A and inhibitors treated with porcine FVIII :C by home therapy. Blood 1990; 76: 882-886
- 12 Kemoff PBA. The clinical use of porcine factor VIII. In: Recent advances in haemophilia care Kasper KC. (ed) Alan R Liss Inc; 1990. pp 47-56
- 13 Kasper CK, Aledort LM, Counts RB, Edson JR, Frantoni JC, Green D, Hampton JR, Hilgartner MW, Lazerson J, Levine PH, McMillan CW, Pool JG, Shapiro SS, Shulman NR, Van Eys J. A more uniform measurement of factor VIII inhibitors. Thromb Diath Haemorrh 1975; 34: 869-872
- 14 Lozier JN, Mannucci PM, Kasper CK, Teitel JM, Hay CRM. The use of porcine factor VIII for surgical procedures in haemophilia A patients with inhibitors. Seminars in Haematology 1993 30. 02 suppl 1
- 15 Fiks-Sigaud M, Bendelac L, Parquet A, Verroust F, Torchet MF, Berthier AM, Fressinaud E, Guerois C, Aillaud MF, Boneu B, Derlon A, Subtil E, Bertrand MA, Borg JY, Laurian Y. Comparison of anti-porcine factor VIII inhibitor levels in 63 patients with severe haemophilia A. A French multi-centric study. Vox Sang 1993; 64: 210-214
- 16 Leyva WH, Knutson AP, Joist HJ. Disappearance of a high response factor VIII inhibitor in a haemophiliac with AIDS. Am J Clin Pathol 1988; 89: 414-416
- 17 Ragni MV, Bontempo FA, Lewis JH. Disappearance of inhibitor to factor VIII in HIV-infected hemophiliacs with progression to AIDS or severe ARC. Transfusion 1989; 29: 447-451
- 18 Kemoff PBA. The FVIII-related antigen and antibodies to FVIII. MD Thesis, University of London 1974
- 19 Altieri DC, Capitanio AM, Mannucci PM. Von Willebrand factor contaminating porcine FVIII concentrate (HYATE:C) causes platelet aggregation. Brit J Haematol 1986; 63: 703-711