A practical, one-clinic visit protocol for pharmacokinetic profile generation with the ADVATE® myPKFiT® dosing tool in severe hemophilia A subjects.

Abstract:

:Standard pharmacokinetic (PK) assessments are demanding for persons with hemophilia A, requiring a 72hr washout and 5-11 timed blood samples. A no-washout, single-clinic visit, sparse sampling population PK (PPK) protocol is an attractive alternative. Here, we compared PK parameters obtained with a traditional washout, 6-sampling time point PPK protocol with a no-washout, single-clinic visit, reverse 2-sampling time point PPK protocol in persons with severe hemophilia A (SHA) receiving ADVATE®. 39 inhibitor-negative males with SHA (FVIII:C<2%) were enrolled in a prospective sequential design PK study. Participants completed a washout, 6-sampling time point PPK protocol as well as a no-washout, reverse 2-sampling time point protocol, with samples taken during a single 3hr clinic visit 24hr-post home infusion of FVIII and then 3hr-post infusion in clinic. FVIII:C levels were analyzed by one-stage and chromogenic assays; blood group and VWF:Ag were determined; and PK parameters were analyzed using the ADVATE® myPKFiT® dosing tool. There was moderate to almost perfect agreement for the PK parameters obtained with the 2- and the 6-point PPK protocols using a one-stage FVIII:C assay and a substantial to almost perfect agreement using a chromogenic FVIII:C assay. Significant associations between specific PK parameters and blood group and VWF:Ag were observed. The no-washout, single-clinic visit, reverse 2-sampling time point PPK protocol can be used in the routine clinical setting since it demonstrates sufficient accuracy compared to the more demanding and less practical washout, 6-sampling time point PPK protocol in persons with SHA receiving ADVATE®.

journal_name

Thromb Haemost

authors

Blanchette V,Zunino L,Grassmann V,Barnes C,Carcao M,Curtain J,Jackson SC,Khoo L,Komrska V,Lillicrap D,Morfini M,Romanova G,Stephens D,Zapotocka E,Rand ML,Blatny J

doi

10.1055/a-1376-0970

subject

Has Abstract

pub_date

2021-01-27 00:00:00

eissn

0340-6245

issn

2567-689X

pub_type

临床试验
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