In a preclinical study to determine the virus inactivating efficacy of vapor heating, samples of bulk Anti-Inhibitor Coagulant Complex, Feiba Immuno 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 nonA, nonB hepatitis in intensively followed patients naive to blood product administration.

The safety and efficacy of Anti-Inhibitor Coagulant Complex, Feiba Immuno has been demonstrated by two prospective clinical trials ^5-7.The first, conducted by Sixma and collaborators during 1979 and early 1980, was a randomized double-blind study comparing the effect of Anti-Inhibitor Coagulant Complex, Feiba Immuno, 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 IMMUNO Units per kg of body weight was used uniformly for treatments with Anti-Inhibitor Coagulant Complex, Feiba Immuno. The study showed that, based on subjective patient evaluation, Feiba Immuno 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 was a multiclinic study conducted by Hilgartner et al. It was designed to evaluate the efficacy of Feiba Immuno 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 cooperating hemophiliacenters),489 single doses were given for the treatment of 165 bleeding episodes. The usual dosage was 50 IMMUNO 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. These anamnestic rises have not been observed to interfere with the efficacy of Anti-Inhibitor Coagulant Complex, Feiba Immuno.

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