       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).

