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Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half‐life factor VIII concentrates
BACKGROUND: BAY81‐8973 (Kovaltry; Bayer, Berkeley, CA, USA) was reported with enhanced pharmacokinetic (PK) profiles compared with some other standard half‐life (SHL) factor VIII (FVIII) concentrates. Limited head‐to‐head comparative studies were conducted in a real‐world setting. OBJECTIVE: To make...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8956787/ https://www.ncbi.nlm.nih.gov/pubmed/35356665 http://dx.doi.org/10.1002/rth2.12686 |
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author | Huang, Kun Zhen, Yingzi Li, Gang Wu, Xinyi Chen, Zhenping Wu, Runhui |
author_facet | Huang, Kun Zhen, Yingzi Li, Gang Wu, Xinyi Chen, Zhenping Wu, Runhui |
author_sort | Huang, Kun |
collection | PubMed |
description | BACKGROUND: BAY81‐8973 (Kovaltry; Bayer, Berkeley, CA, USA) was reported with enhanced pharmacokinetic (PK) profiles compared with some other standard half‐life (SHL) factor VIII (FVIII) concentrates. Limited head‐to‐head comparative studies were conducted in a real‐world setting. OBJECTIVE: To make head‐to‐head comparisons of PK and clinical outcomes between Kovaltry and three other SHL FVIII concentrates. METHODS: Forty‐seven boys with severe hemophilia A were enrolled and divided into three groups according to their previously used FVIII concentrates (Kogenate FS, N = 22; Advate, N = 14; GreenMono, N = 11). Two separate PK tests were conducted in each participant with a five‐point assay during the study period from 6 months before switching to 6 months after switching. FVIII levels were detected by one‐stage assay, and PK profiles were calculated by noncompartmental assay. Annualized bleeding rates were collected through participant’ bleed logs. RESULTS: Longer half‐life time (Kogenate FS group: 14.4 vs 11.9 hours, P < .0001; Advate group: 13.4 vs 9.7 hours, P < .0001; GreenMono group: 15.1 vs 10.7 hours, P < .001]) and lower clearance (Kogenate FS group: 3.3 vs 3.9 mL/kg/h, P < .01; Advate group: 3.7 vs 5.9 mL/kg/h, P < .01; GreenMono group: 3.0 vs 5.1 mL/kg/h, P < .01) were observed with Kovaltry. In addition, longer mean residential time (P < .01) and higher area under the curve (P < .01) were demonstrated. No statistical difference was found in in vivo recovery between Kovaltry and the other FVIII products. Participants who switched to Kovaltry from three other FVIII concentrates with the same dosing regimens obtained higher trough FVIII levels and better protection with reduced annualized bleeding rates. CONCLUSION: Compared with Kogenate FS, Advate, and GreenMono, Kovaltry showed enhanced PK profiles, which contributed to reduced bleeding rates. |
format | Online Article Text |
id | pubmed-8956787 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-89567872022-03-29 Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half‐life factor VIII concentrates Huang, Kun Zhen, Yingzi Li, Gang Wu, Xinyi Chen, Zhenping Wu, Runhui Res Pract Thromb Haemost Original Articles BACKGROUND: BAY81‐8973 (Kovaltry; Bayer, Berkeley, CA, USA) was reported with enhanced pharmacokinetic (PK) profiles compared with some other standard half‐life (SHL) factor VIII (FVIII) concentrates. Limited head‐to‐head comparative studies were conducted in a real‐world setting. OBJECTIVE: To make head‐to‐head comparisons of PK and clinical outcomes between Kovaltry and three other SHL FVIII concentrates. METHODS: Forty‐seven boys with severe hemophilia A were enrolled and divided into three groups according to their previously used FVIII concentrates (Kogenate FS, N = 22; Advate, N = 14; GreenMono, N = 11). Two separate PK tests were conducted in each participant with a five‐point assay during the study period from 6 months before switching to 6 months after switching. FVIII levels were detected by one‐stage assay, and PK profiles were calculated by noncompartmental assay. Annualized bleeding rates were collected through participant’ bleed logs. RESULTS: Longer half‐life time (Kogenate FS group: 14.4 vs 11.9 hours, P < .0001; Advate group: 13.4 vs 9.7 hours, P < .0001; GreenMono group: 15.1 vs 10.7 hours, P < .001]) and lower clearance (Kogenate FS group: 3.3 vs 3.9 mL/kg/h, P < .01; Advate group: 3.7 vs 5.9 mL/kg/h, P < .01; GreenMono group: 3.0 vs 5.1 mL/kg/h, P < .01) were observed with Kovaltry. In addition, longer mean residential time (P < .01) and higher area under the curve (P < .01) were demonstrated. No statistical difference was found in in vivo recovery between Kovaltry and the other FVIII products. Participants who switched to Kovaltry from three other FVIII concentrates with the same dosing regimens obtained higher trough FVIII levels and better protection with reduced annualized bleeding rates. CONCLUSION: Compared with Kogenate FS, Advate, and GreenMono, Kovaltry showed enhanced PK profiles, which contributed to reduced bleeding rates. John Wiley and Sons Inc. 2022-03-25 /pmc/articles/PMC8956787/ /pubmed/35356665 http://dx.doi.org/10.1002/rth2.12686 Text en © 2022 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH). https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) 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. |
spellingShingle | Original Articles Huang, Kun Zhen, Yingzi Li, Gang Wu, Xinyi Chen, Zhenping Wu, Runhui Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half‐life factor VIII concentrates |
title | Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half‐life factor VIII concentrates |
title_full | Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half‐life factor VIII concentrates |
title_fullStr | Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half‐life factor VIII concentrates |
title_full_unstemmed | Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half‐life factor VIII concentrates |
title_short | Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half‐life factor VIII concentrates |
title_sort | enhanced pharmacokinetics and reduced bleeds in boys with hemophilia a after switching to kovaltry from other standard half‐life factor viii concentrates |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8956787/ https://www.ncbi.nlm.nih.gov/pubmed/35356665 http://dx.doi.org/10.1002/rth2.12686 |
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