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1996-02-27
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Document 0695
DOCN M9630695
TI Efficacy and safety of a monoclonal purified factor VIII concentrate:
5-year follow-up in previously treated HIV-negative haemophiliacs.
DT 9603
AU Smid WM; van der Meer J; Halie MR; Department of Haematology, University
Hospital Groningen, The; Netherlands.
SO Haemostasis. 1995 Sep-Oct;25(5):229-36. Unique Identifier : AIDSLINE
MED/96022610
AB 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.
DE 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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).