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In a preclinical study to determine the virus inactivating efficacy of vapor heating, samples of bulk FEIBA IMMUNO (AICC) were spiked with 2 x 106/mL infectious units of HIV and subjected to vapor heat treatment. The residual virus titer was found to be less than 1 infectious unit/0.5 mL. A clinical study4 testing Antihemophilic Factor treated by a similar vapor heating procedure has shown none of 4 lots used in the study to produce non A, non B hepatitis in intensively followed patients naive to blood product administration.
The safety and efficacy of FEIBA IMMUNO (AICC) has been demonstrated by two prospective clinical trials5–7. The first, conducted by Sixma and collaborators during 1979 and early 1980, was a randomized double-blind study comparing the effect of FEIBA IMMUNO (AICC) and PROTHROMPLEX IMMUNO (a non-activated prothrombin complex concentrate) in 15 patients with hemophilia A and inhibitors to Factor VIII. A total of 150 bleeding episodes (primarily joint and musculoskeletal plus a few mucocutaneous) were treated. A single dose of 88 Units per kg of body weight was used uniformly for treatments with FEIBA IMMUNO (AICC). The study showed that, based on subjective patient evaluation, FEIBA IMMUNO (AICC) was fully effective in 41.0% and partly effective in 24.6% of episodes (i.e. combined effectiveness of 65.6%), while PROTHROMPLEX IMMUNO was rated fully effective in 25.0% and partly effective in 21.4% of episodes (i.e. combined effectiveness of 46.4%).
The second study with FEIBA IMMUNO (AICC) was a multiclinic study conducted by Hilgartner et al. It was designed to evaluate the efficacy of FEIBA IMMUNO (AICC) in the treatment of joint, mucous membrane, musculocutaneous and emergency bleeding episodes such as central nervous system hemorrhages and surgical bleedings. In 49 patients with inhibitor titers of greater than 5 Bethesda Units (from nine co-operating hemophilia centers), 489 single doses were given for the treatment of 165 bleeding episodes. The usual dosage was 50 Units per kg of body weight, repeated at 12-hour intervals (6-hour intervals in mucous membrane bleedings), if necessary. Bleeding was controlled in 153 episodes (93%). In 130 (78%) of the episodes, hemostasis was achieved with one or more infusions within 36 hours. Of these, 36% were controlled with one infusion within 12 hours. An additional 14% of episodes responded after more than 36 hours.
Of the 489 single doses, only 18 (3.7%) caused minor transient reactions in recipients. 10 out of 49 patients (20%) showed a rise in their inhibitor titers. In 5 of these patients (10%), the rise was tenfold or more. However, of these 10 patients, 3 had received Factor VIII or Factor IX concentrates within 2 weeks prior to treatment with FEIBA IMMUNO (AICC). These anamnestic rises have not been observed to interfere with the efficacy of FEIBA IMMUNO (AICC).
4. Mannucci P. M.: Personal communication
5. Sjamsoedin L. J. M., Heijnen L., Mauser-Bunschoten E. P., van Geijlswijk J. L., van Houwelingen H., van Asten P., Sixma J. J.: The Effect of Activated Prothrombin-Complex Concentrate (FEIBA) on Joint and Muscle Bleeding in Patients with Hemophilia A and Antibodies to Factor VIII. The New Engl. J. of Med. 305: 717, 1981.
6. Roberts H. R.: Hemophiliacs with Inhibitors: Therapeutic Options. The New Engl. J. of Med. 305:757, 1981.
7. Hilgartner M. W., Knatterud G. AND THE FEIBA STUDY GROUP: The Use of Factor-Eight-Inhibitor-ByPassing-Activity (FEIBA IMMUNO) Product for Treatment of Bleeding Episodes in Hemophiliacs with Inhibitors. Blood 61: 36, 1983.
Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.
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