4 years ago

Estimating and interpreting individual patients’ pharmacokinetic profiles in persons with Hemophilia A or B using a population pharmacokinetic approach: communication from the SSC of the ISTH

Peter Collins, Victor Blanchette, Alfonso Iorio, Jan Blatny, Ellis Neufeld, Kathelijn Fischer,
The ISTH SSC on Factor VIII/IX has previously issued guidelines for studies assessing the pharmacokinetics (PK) of factor concentrates [1,2]. They suggested drawing 10 or 11 blood samples over a period of 32-48h or 50-72h, after infusing 25-50 or 50-75 IU/kg, respectively for factor VIII (FVIII) or factor IX (FIX), in cohorts of 12-15 patients with a crossover design. Such PK studies are not ideal for tailoring the treatment of individual patients, mostly for the requirement of several blood samples. Due to broad inter-individual variation, the individual disposition of FVIII and FIX cannot be predicted from morphometric characteristics and average PK parameters, but requires empirical assessment in each individual [3–6]. Previous guidance of this ISTH SSC described the PK methodology for the prediction of individual trough levels of FVIII [7]. The present communication, building on recent advancements in the population PK (PopPK) of FVIII and FIX [8], adds to the former documents. This article is protected by copyright. All rights reserved.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/jth.13867

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