322.

DISORDERS OF COAGULATION OR FIBRINOLYSIS | DECEMBER 07, 2017

Switching Kogenate FS® to Kovaltry® for the Treatment of Severe

Haemophilia A Patients: A Successful Single Center Experience
*,1
Teresa Álvarez-Roman, Paula Acutilde accent is not displayed approve
*,1 *,1 *,1 *,1
the letter na, Nora Butta, Mónica Martín, María Isabel Rivas Pollmar,
*,1 2 *,3
Ihosvany Fernandez-Bello, Miguel A. Canales, Victor Jimenez-Yuste
1
Hospital Universitario La Paz-Idipaz, Madrid, Spain
2
Hospital Univesitario La Paz, Madrid, Spain
3
La Paz University Hospital, Madrid, Spain

Blood blood (2017) 130 (Suppl_1) : 4882.

http://doi.org/10.1182/blood.V130.Suppl_1.4882.4882

Abstract
Background: Haemophilia A is an X-linked hereditary disorder caused by deficient levels of the
coagulation protein factor VIII (FVIII). Standard therapy for haemophilia A comprises replacement of
FVIII with plasma-derived or recombinant FVIII concentrate, which can be administered as on-demand
or prophylaxis regimen. The most challenging complication of replacement therapy in hemophilia A is the
occurrence of alloantibodies against infused factor FVIII, thus predisposing the patients to an increased
morbidity and disability. Historically, first FVIII was isolated from cryoprecipitated plasma concentrates.
Thirty years ago, after the cloning of F8 gene, therapy for hemophilia A patients underwent a new exciting
era that developed technological strategies aimed to improve haemostatic efficacy and safety of the
®
replacement factor. In this line, a new recombinant FVIII, BAY 81-8973 (octocog alfa; Kovaltry , Bayer)
®
has recently been introduced onto pharmaceutical market for treatment of these patients. Kovaltry is an
unmodified, full-length, recombinant FVIII concentrate with the same amino acid sequence as Kogenate
®
FS (Bayer), but produced with innovative manufacturing technologies that include production without
addition of human- or animal-derived raw materials from purification or formulation processes, inclusion
of a higher degree of sialic acid capping of N-terminal glycans on the molecular surface, coexpression
of the human chaperone protein heat shock protein 70, and a 20-nm nanofiltration step to remove small
non-enveloped viruses and potential protein aggregates. On this basis we considered beneficial for our
® ®
patients changing Kogenate FS therapy for Kovaltry .

® ®
Objective: We aimed to demonstrate that switching from Kogenate FS to Kovaltry could be easily
performed without increasing the risk of bleeding or FVIII consumption in severe haemophilia A patients.

Methods: Sixty two adult and pediatric patients with severe haemophilia A, without inhibitors, treated with
®
Kogenate FS either on on-demand treatment (n=13) or on prophylaxis regimen (n=49), were recruited.
® ®
On November 2016, we began to switch Kogenate FS treatment to Kovaltry in these patients.

®
The trend of prophylaxis with Kovaltry was evaluated by determining mean injection frequency (per
week), mean dose of each injection (IU/kg), mean total dose injected/week (IU), baseline and post-
®
infusion levels of FVIII and annual bleeding rate (ABR). Same data for Kogenate FS were collected
retrospectively from clinical histories of patients.

For determining baseline and post-infusion levels of Kovaltry®, whole blood was collected in 3.2% sodium
citrate tubes (BD Vacutainer, Becton Dickinson, San José, CA, USA) at pre-dosing and 30 minutes after
®
Kovaltry infusion. Plasma FVIII:C was measured by chromogenic assay.

® ®
Results: Switching from Kogenate FS to Kovaltry caused no changes, except in two patients, either in
mean injection frequency or mean dose of each injection or mean total dose injected/week or baseline
and post-infusion levels of FVIII or annual bleeding rate. Increment observed in mean total dose injected/
week in two of the pediatric patients was due to an increased physical activity (patient 2) and to weight
gain (patient 8). For sake of example, Table 1 shows these variables for 10 pediatric patients under
prophylactic treatment.

None of the patients treated with Kovaltry® developed inhibitors.

 ® ®
Conclusion: Changing severe haemophilia A treatment from Kogenate FS to Kovaltry can be performed
®
easily and did not pose any risk to the patient since Kovaltry proved to be equally effective than
®
Kogenate FS to prevent bleeding episodes and did not induce the occurrence of inhibitors.

Disclosures
Álvarez-Roman: Novo Nordisk: Consultancy; Shire: Consultancy. Jimenez-Yuste: Novo Nordisk:
Consultancy, Honoraria, Research Funding; Roche: Consultancy.

Author notes
*Asterisk with author names denotes non-ASH members.

© 2017 by the American Society of Hematology