Pharmacokinetics of plasma‐derived vs. recombinant FVIII concentrates: a comparative study

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Pharmacokinetics of plasma-derived vs. recombinant FVIII concentrates: a comparative studyM. Morfini1,*, E. Marchesini2, E. Paladino1, C. Santoro3, E. Zanon4 andA. Iorio5Article first published online: 2 OCT 2014

DOI: 10.1111/hae.12550

© 2014 John Wiley & Sons Ltd

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

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How to CiteMorfini, M., Marchesini, E., Paladino, E., Santoro, C., Zanon, E. and Iorio, A. (2014), Pharmacokinetics of plasma-derived vs. recombinant FVIII concentrates: a comparative study. Haemophilia. doi: 10.1111/hae.12550

Author Information1

Agency for Haemophilia, University Hospital of Florence, Florence, Italy

2

Haemophila Centre of University Hospital Santa Maria della Misericordia, Perugia, Italy

3

Haematology Department of Biotechnology and Haematology, Sapienza University of Rome, Rome, Italy

4

Haemophilia Center of University Hospital, Padua, Italy

5

Health Information Research Unit, Department of Clinical Epidemiology and Biostatistic and Hemophilia Clinic, Department of Medicine, McMaster University, Hamilton, ON, Canada

* Correspondence: Massimo Morfini, Dr.-Agency for Haemophilia, AOU Careggi, Largo G.A. Brambilla n.3, I-50134 Firenze, Italy.
Tel.: +39-348-2306928; fax: +39-055-473218;
e-mail: massimo.morfini@unifi.it

Publication HistoryArticle first published online: 2 OCT 2014Manuscript Accepted: 23 AUG 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 (121K)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 (121K) Keywords:factor VIII;haemophilia;half-life;pharmacokinetics;switchingSummary

Only very few pharmacokinetic (PK) studies comparing plasma derived FVIII (pd-FVIII) against recombinant FVIII (rFVIII) concentrates are available. The studies have been generally conducted to demonstrate the bioequivalence of a new product with an old one. The switch from a plasma-derived FVIII (pd-FVIII) to a rFVIII concentrate is a good moment to enrol the patients in a comparative PK study. To achieve information on the PK characteristics of two different classes of FVIII concentrates, according to two different designs: a 10 FVIII concentration/time point design and a reduced 4-point design. A single dose PK comparing pd- and rFVIII concentrates has been performed in four Haemophilia Centres of Italy. Seventeen haemophilia A patients underwent two subsequent single dose PK studies at the moment of switching. Two-compartment- and Non-compartment-analysis did not show significant differences between the outcomes of PK of pd-FVIII and rFVIII, due to inter-patient variability. In vivo recovery (IVR) of rFVIII was slightly higher than that of pd-FVIII and rFVIII/pd-FVIII AUC ratio was 1.37 in 11/17 patients. The difference is only due to the initial distribution phase because after the first 10 h from the end of the infusion, the two decay curves are overlapping. The elimination half-life of the concentrates was very similar even though a complete bioequivalence was not demonstrated because of a higher AUC of rFVIII concentrates, limited to the distribution phase. The higher Cmax and IVR of rFVIII may be due to the presence of heterodimers activated forms of the recombinant molecules.

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