Efficacy and safety of a monoclonal purified factor VIII concentrate: 5-year follow-up in previously treated HIV-negative haemophiliacs.

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Efficacy and safety of a monoclonal purified factor VIII concentrate: 5-year follow-up in previously treated HIV-negative haemophiliacs.

Haemostasis. 1995 Sep-Oct;25(5):229-36. Unique Identifier : AIDSLINE MED/96022610
Smid WM; van der Meer J; Halie MR; Department of Haematology, University Hospital Groningen, The; Netherlands.

Abstract: The efficacy and safety of a monoclonal purified factor VIII concentrate (Hemofil M) were assessed in a historically controlled study in 22 HIV-negative patients with haemophilia A, previously treated with various concentrates. Data from 5 years of follow-up were compared with those from the preceding 6 months. Factor VIII consumption remained unchanged. A temporary increase in the number of reported bleedings was attributed to more frequent follow-up visits in the first year. Allergic reactions, inhibitor formation and HIV infection were not seen. Liver function parameters fluctuated in individual patients, and were not related to the ultrapure concentrate used. No clinical evidence of liver insufficiency was seen. The number of CD4-positive lymphocytes was stable, while platelet numbers showed a remarkable increase. We conclude that in previously treated HIV-negative haemophiliacs, treatment with a monoclonal purified factor VIII concentrate is efficacious and safe with regard to HIV transmission, allergic reactions, induction of inhibitors, and deterioration of immune abnormalities.

Keywords: Adolescence Adult Antibodies, Monoclonal/IMMUNOLOGY Child Comorbidity Cytomegalovirus Infections/EPIDEMIOLOGY CD4 Lymphocyte Count Factor VIII/ADVERSE EFFECTS/IMMUNOLOGY/ISOLATION & PURIF/ *THERAPEUTIC USE Follow-Up Studies Hemarthrosis/EPIDEMIOLOGY/PREVENTION & CONTROL Hemophilia/COMPLICATIONS/EPIDEMIOLOGY/*THERAPY Hemorrhage/EPIDEMIOLOGY/PREVENTION & CONTROL Hepatitis, Viral, Human/EPIDEMIOLOGY Herpesviridae Infections/EPIDEMIOLOGY Herpesvirus 4, Human Human HIV Seronegativity Immunosorbent Techniques Liver Function Tests Male Middle Age Safety JOURNAL ARTICLE
960330
M9630707

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