In vitro and in vivo Characterization of
Factor VIII Preparations

Allain, J.P.; Verroust, F.; Soulier, J.P.

doi:10.1159/000466963

Cited by 22 publications

(28 citation statements)

References 27 publications

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“…One of the 4 products randomly assigned to 13 patients in this study was not heat-treated and used before October 1985, when both HIV antibody screening of donors and viral inactivation of coagulation factor concentrates became mandatory in France. From a previous study, the presence of infective HIV particles in the French factor VIII concentrate used here was demon strated, since a yearly prevalence of HIV seroconversion was calculated at 37% in a similarly treated population [10], Index parameters in this group remained similar to the other 3 groups at each of the 2 or 3 check-ups, and no significant difference was observed between the initial and the final examinations. When results were analysed with the score system, the outcome of patients in the group infused with the non-heat-treated product ap peared rather stable ( fig.…”

Section: Resultsmentioning

confidence: 73%

“…Two products (factor VIII concentrate CNTS and Hemofil T) had a relatively low specific activity (0.6 and 0.9 IU/mg of factor VIII protein, respectively) and contained similar contaminating proteins in various proportions. Methods to study proteins in factor VIII concentrates were previously described [10]. Fibrinogen represented 50 and 36% of total proteins; fibronectin 15and 40%;IgG lOand 6%; IgM 2 and 1.3%, and albumin 15 and 1%, respectively.…”

Section: Replacement Therapymentioning

confidence: 99%

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The Role of HIV Infectivity and Composition of Factor VIII Concentrates on the Immunity of Haemophiliacs Positive for HIV Antibodies

Allain¹,

Frommel²,

Bosser³

et al. 1987

Vox Sanguinis

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Forty-six subjects (44 HIV antibody-positive) with some degree of immune deficiency (at least TH/TS ratio below 1 ) were randomly distributed into 4 treatment groups. Each group was assigned to 1 of 4 products to be used exclusively for a 1-year period: 1 concentrate was of intermediate purity and not heat-treated, and 3 were heat-treated in order to inactivate HIV, 2 of them being of higher purity. At 4-6-month intervals, check-ups, including as markers clinical examination, platelet, lymphocyte and T cell subset counts, IgG levels and delayed hypersensitivity test, were carried out. At entry as well as at the end of the study, groups were not statistically distinguishable. No intra- nor inter-group differences were demonstrable for any of the markers. In contrast, using a scoring system for each marker and the results of check-up at entry as reference, significant differences between groups appeared on subsequent check-ups. Patients receiving intermediate-purity factor VIII, whether heat-treated or not, were mostly steady, while groups receiving heat-treated concentrates of a higher purity significantly worsened. This surprising outcome was no related to differences in anti-HIV titers or specificities. From this study, the potential long-term predictive value of this scoring system could not be established.

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Section: Resultsmentioning

confidence: 73%

Section: Replacement Therapymentioning

confidence: 99%

The Role of HIV Infectivity and Composition of Factor VIII Concentrates on the Immunity of Haemophiliacs Positive for HIV Antibodies

Allain¹,

Frommel²,

Bosser³

et al. 1987

Vox Sanguinis

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“…The titration curves in the IRMA did not parallel those of normal plasma, thus indicating the presence of complexes. (27). Ordinate: log plasma concentration of IX:C and IX:Ag.…”

Section: Resultsmentioning

confidence: 99%

Induction of split tolerance and clinical cure in high-responding hemophiliacs with factor IX antibodies.

Nilsson¹,

Berntorp²,

Zettervall³

1986

Proc. Natl. Acad. Sci. U.S.A.

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An approach to the problem of inducing tolerance in patients with hemophilia complicated by highresponding antibodies is described. Thus, in four patients with severe hemophilia B and high-responding antibodies against factor IX, it has been possible to modify the immune response by giving high doses of intravenous IgG in combination with cyclophosphamide and factor IX, followed by regular factor IX treatment. In three of the patients, the in vivo recovery and half-life of infused factor IX coagulant activity (IX:C) are now normal, while the fourth patient has been converted to a low responder. Hip replacement surgery has been performed successfully in one patient. The tolerant state in these four patients is characterized, and they have all been found to have complexes between factor IX antigen and a "new" antibody without IX:C inhibitory activity. The disappearance rate of the complexed factor IX antigen (i.e., lacking IX:C activity) is considerably prolonged, and the persistence in the circulation of this (probably modified) factor IX molecule may be crucial, since tolerance to factor IX treatment was only induced when immunocomplexes were produced. Since earlier treatment of the patients with cyclophosphamide and factor IX, but without IgG, failed to induce tolerance, it appears to be the IgG that is the prerequisite.

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“…Although they generally contain considerable amounts of vWf: Ag and sometimes a high level of ristocetin cofac tor [ 11 ], most intermediate and high-purity FVIII concen trates are unsuitable in vWD. Their failure to correct bleeding time in vWD patients [12] reflected by their inability to induce platelet adhesion to subendothelium [13] is generally thought to be related to their lack of high molecular weight forms of vWf.…”

Section: Discussionmentioning

confidence: 99%

In vitro and in vivo Evaluation of a Factor VIII Concentrate Heat-Treated to Inactivate HTLV-III/LAV Viruses

Mazurier¹,

Romeuf²,

Parquet-Gernez³

et al. 1987

Vox Sanguinis

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We report here the results of our evaluation of the effects of a dry heat treatment (96 h at 68 °C) to eliminate LAV/HTLV-III virus on factor Vili (FVIII) and von Willebrand factor (vWf) present in an intermediatepurity concentrate. This thermal inactivation appears to have little effect on FVIII. There is an acceptable loss (12.3 ± 3.6%; n = 25) in FVIII coagulant activity (FVIII: C) and a good in vivo performance in haemophilia A patients. A precise analysis of vWf indicates that whereas the vWf antigen and its ristocetin cofactor activity decrease during heating, there is an increase in potentially functional forms of vWf. Heat treatment induces an increase in high molecular weight forms of vWf and an enhancement in platelet adhesion to collagen. These changes probably explain the correcting effect on the bleeding time of the heated FVIII concentrate in patients with von Willebrand’s disease. Thus, this heat-treated concentrate appears to be equivalent to the untreated product in haemophilia A. with the additional benefit of being efficient for the treatment of von Willebrand’s disease.

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In vitro and in vivo Characterization of Factor VIII Preparations

Cited by 22 publications

References 27 publications

The Role of HIV Infectivity and Composition of Factor VIII Concentrates on the Immunity of Haemophiliacs Positive for HIV Antibodies

The Role of HIV Infectivity and Composition of Factor VIII Concentrates on the Immunity of Haemophiliacs Positive for HIV Antibodies

Induction of split tolerance and clinical cure in high-responding hemophiliacs with factor IX antibodies.

In vitro and in vivo Evaluation of a Factor VIII Concentrate Heat-Treated to Inactivate HTLV-III/LAV Viruses

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