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Pharmacokinetic mod...
Pharmacokinetic modelling and validation of the half-life extension needed to reduce the burden of infusions compared with standard factor VIII
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- Hermans, C. (författare)
- Saint-Luc University Hospital
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- Mahlangu, J. (författare)
- University of the Witwatersrand
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- Booth, J. (författare)
- Shire
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- Schütz, H. (författare)
- BEBAC
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- Santagostino, E. (författare)
- Maggiore Hospital Policlinico
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- Young, G. (författare)
- University of Southern California
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- Lee, H. Y. (författare)
- Shire Switzerland GmbH
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- Steinitz-Trost, K. N. (författare)
- Shire, Vienna
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- Blanchette, V. (författare)
- Hospital for Sick Children, Toronto
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- Berntorp, E. (författare)
- Lund University,Lunds universitet,Klinisk koagulationsmedicin, Malmö,Forskargrupper vid Lunds universitet,Clinical Coagulation, Malmö,Lund University Research Groups
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(creator_code:org_t)
- 2018-05-06
- 2018
- Engelska.
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Ingår i: Haemophilia. - : Wiley. - 1351-8216. ; 24:3, s. 376-384
- Relaterad länk:
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Introduction: Currently, no universally accepted definition of extended half-life (EHL) recombinant FVIII (rFVIII) exists. Identifying the minimum half-life extension ratio required for a reduction in dosing frequency compared with standard rFVIII could enable a more practical approach to decisions around prophylaxis with EHL rFVIII. Aim: To identify the half-life extension ratio required to decrease rFVIII dosing frequency by at least 1 day while maintaining the proportion of patients with plasma rFVIII levels above 1 IU/dL and without increasing the total weekly dose. Methods: A previously published population pharmacokinetic model for standard rFVIII was used to estimate the percentage of patients with factor VIII (FVIII) levels always >1 IU/dL using various benchmark regimens. Using modelling, dosing frequency was reduced while rFVIII half-life was extended until the percentage of patients with FVIII >1 IU/dL equalled that of the benchmark regimen. Results: Benchmark 3×/wk dosing totalling 100 IU/kg/wk of rFVIII resulted in 56.6% of patients with FVIII levels always >1 IU/dL. With 2×/wk dosing, totalling 80 or 90 IU/kg/wk, half-life extensions required to maintain 56.6% of patients at FVIII levels >1 IU/dL were 1.30 and 1.26, respectively. A half-life extension ratio of 1.33 was required to change dosing from every 48 hours to every 72 hours (both at 105 IU/kg/wk) while maintaining 92.8% of patients with FVIII >1 IU/dL. Conclusion: Based on this investigation, EHL rFVIII products should have a minimum half-life extension ratio of 1.3 to provide a reduction in dosing frequency from 3× to 2×/wk compared with standard rFVIII products while maintaining the same minimum FVIII trough level.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinsk bioteknologi -- Biomedicinsk laboratorievetenskap/teknologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Medical Biotechnology -- Biomedical Laboratory Science/Technology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
Nyckelord
- Administration and dosage
- Factor VIII
- Haemophilia A
- Half-life
- Pharmacokinetics
- Quality of life
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Hermans, C.
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Mahlangu, J.
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Booth, J.
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Schütz, H.
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Santagostino, E.
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Young, G.
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visa fler...
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Lee, H. Y.
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Steinitz-Trost, ...
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Blanchette, V.
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Berntorp, E.
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