Recombinant full‐length factor VIII (FVIII) and extended half‐life FVIII products in prophylaxis – new insight provided by pharmacokinetic modelling

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You have full text access to this OnlineOpen articleRecombinant full-length factor VIII (FVIII) and extended half-life FVIII products in prophylaxis – new insight provided by pharmacokinetic modellingA. Gringeri*, M. Wolfsegger, K. N. Steinitz andA. J. ReiningerArticle first published online: 21 JAN 2015

DOI: 10.1111/hae.12605

© 2015 The Authors. Haemophilia Published by John Wiley & Sons Ltd.

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

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HaemophiliaEarly View (Online Version of Record published before inclusion in an issue)

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How to CiteGringeri, A., Wolfsegger, M., Steinitz, K. N. and Reininger, A. J. (2015), Recombinant full-length factor VIII (FVIII) and extended half-life FVIII products in prophylaxis – new insight provided by pharmacokinetic modelling. Haemophilia. doi: 10.1111/hae.12605

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Baxter Innovations GmbH, Vienna, Austria

* Correspondence: Alessandro Gringeri, Baxter Innovations GmbH, DC Tower 1 – Donau City Strasse 7, 1220 Vienna, Austria.
Tel.: +43 1 20100 2476226; fax: +43 1 20100 2475733;
e-mail: alessandro_gringeri@baxter.com

Publication HistoryArticle first published online: 21 JAN 2015Manuscript Accepted: 13 NOV 2014 SEARCH Search Scope All contentPublication titlesIn this journalIn this issue Search String Advanced >Saved Searches > SEARCH BY CITATION Volume: Issue: Page: ARTICLE TOOLSGet PDF (571K)Save to My ProfileE-mail Link to this ArticleExport Citation for this ArticleGet Citation AlertsRequest Permissions AbstractArticleReferencesCited By View Full Article (HTML) Enhanced Article (HTML) Get PDF (571K) Keywords:extended half-life;factor VIII;haemophilia;pharmacokinetics;prophylaxis;trough levelSummary

The pharmacokinetics (PK) of extended half-life factor VIII (FVIII) products might allow longer dosing intervals in prophylaxis, potentially affecting its efficacy. We used published population PK models of a recombinant full-length FVIII (rAHF-PFM) and a recombinant B-domain-deleted FVIII Fc fusion product (rFVIIIFc) to assess the time spent weekly with FVIII levels below 3 IU dL-1 or above 10 IU dL-1. These FVIII levels were chosen based on the observation that trough levels of 1 IU dL-1 may not be sufficient in all patients. This approach was applied to a simulated population of 1000 severe haemophilia A subjects with dosing regimens included in the prescribing information or evaluated in clinical trials. FVIII levels remained =3 IU dL-1 in 57% of patients treated with rAHF-PFM 30 IU kg-1 every 48 h compared with 41.1%, 18.3%, 0.9% and 0% of patients treated with rFVIIIFc 30 IU kg-1 every 72 h, 50 IU kg-1 every 96 h or 120 h and 65 IU kg-1 every 168 h respectively. Patients on rAHF-PFM 30 IU kg-1 every 48 h spent more time weekly with FVIII levels above 10 IU dL-1 than those on rFVIIIFc 50 IU kg-1 every 96 h or 120 h, and 65 IU kg-1 every 168 h. In conclusion, PK modelling indicates that choice and dosing intervals of standard and extended half-life FVIII products require careful evaluation of individual PK to allow more time at protective levels, especially in patients with active lifestyles.

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