Continuous infusion of simoctocog alfa in haemophilia A patients undergoing surgeries

Abstract

Introduction There are two major principles for coagulation factor replacement in the clinical management of surgical procedures in patients with haemophilia, repetitive bolus injections every 6‐12 hours or administration of coagulation factor concentrates by continuous infusion. Aim The aim was to investigate the efficacy of simoctocog alfa (human‐cl rhFVIII) delivered by continuous infusion for bleeding prophylaxis during surgery in patients with haemophilia A. Methods We investigated the use of continuous infusion with simoctocog alfa in haemophilia A patients undergoing major surgical procedures at Oslo University Hospital from September 2015 to March 2018. The objectives were haemostatic outcome, in vivo recovery, stability over time at room temperature (3 days) and inhibitor development. Results Simoctocog alfa demonstrated treatment success in terms of haemostatic efficacy in 100% of major surgeries used as CI: 87% (n=21) excellent; 13% (n=3) good. No erythrocyte transfusions were required in any patient, no adverse events occurred and no inhibitors developed. The product was stable for 3 days at room temperature without loss of activity. Mean in vivo recovery was 1.8 (0.3) (IU/mL/IU/kg). Conclusion Continuous infusion with simoctocog alfa was found to achieve good/excellent haemostatic efficacy in all procedures. No adverse events occurred and no inhibitors developed.

Evaluation of anti‐factor VIII antibodies in haemophilia A subjects switching products following a provincial tender

“…Even if slight differences were noted for mean FVIII recovery measured by one-stage clotting assay at visit 1 between children and adults (all products-combined; p = 0.0003; 1.95, 1.76, 1.8 respectively at visit 1, 2, 3 for children; 2.61, 2.40, 2.40 respectively at visit 1, 2, 3 for adults) as well as between Nuwiq® and Zonovate® (p = 0.0042; 2.09, 1.74, 1.9 respectively at visit 1, 2, 3 for Nuwiq®; 2.65, 2.38, 2.38 respectively at visit 1, 2, 3 for Zonovate®), all values were still comparable to previous reports, [4][5][6][7] considering that 49.6% of our subjects were obese (20.1%) or overweight (29.5%) 8,9 and that 73% of the children in our cohort were switched to Nuwiq®. 7 As previously observed in clinical trials for Nuwiq® and Zonovate® in previously treated PWHA, [10][11][12][13] no inhibitors were detected upon study entry by Nijmegen-modified Bethesda (NBA) assay or enzyme-linked immunosorbent assay (ELISA; used as a complementary approach to detect both neutralizing and non-neutralizing antibodies) even in the 3 subjects with less than 50 ED.…”

“…Clémence Merlen 1 Arnaud Bonnefoy 1 Julie Gauthier 2,3 Jean-François Castilloux 4 Janie Charlebois 4 Stéphanie Cloutier 5 Christine Demers 5 Christine A. Sabapathy 6 Jean St-Louis 1,7 Catherine Vézina 6 Margaret Warner 6 Georges-Étienne Rivard…”

Managing Relevant Clinical Conditions of Hemophilia A/B Patients

“…From the sharing of experiences, it emerges that the major obstacle to the implementation of CI is the lack of pieces of evidence: it is an off-label treatment. In any case, there is a significant amount of literature that provides support for the use of CI [ 2 , 6 , 10 , 11 , 12 ]. The CI of moroctocog alpha has been shown to provide safe hemostasis, with lower factor consumption and an excellent postoperative outcome in 92% of patients as assessed during the first postsurgery week [ 13 ].…”

Continuous Infusion of Factor VIII and von Willebrand Factor in Surgery: Trials with pdFVIII LFB or pdVWF LFB in Patients with Bleeding Disorders

“… 7 8 Advantages are likely the improvement of the protection from excessive bleeding, and easier monitoring. Efficacy and safety of CI remain deeply investigated for management of patients with severe HA 9 10 11 12 13 14 15 16 17 18 19 20 and VWD 21 22 23 undergoing major surgery. Causes influencing CI rates are the product, its adsorption in the infusion system, its dilution, the type of surgery, and the inter-patient pharmacokinetic (PK) variability.…”