{"title":"FVIII half-life products: A real-world experience","authors":"Ezio Zanon , Annamaria Porreca , Angela Napolitano , Chiara Simion , Paolo Simioni","doi":"10.1016/j.thromres.2025.109306","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Haemophilia A is a genetic coagulation disorder requiring prophylactic Factor VIII (FVIII) treatment to prevent joint damage and enhance quality of life. The introduction of extended half-life (EHL) FVIII products represents a major advancement, addressing patient needs for reduced infusion frequency, improved efficacy, and enhanced safety.</div></div><div><h3>Methods</h3><div>This single-centre observational study examined the real-world use of FVIII products among 124 male patients treated at the Haemophilia Centre of Padua from January 2018 to December 2023. Data on patient characteristics, treatment regimens, and pharmacokinetic profiles were analyzed.</div></div><div><h3>Results</h3><div>Among the FVIII products used, Advate®, Elocta®, and Jivi® showed median half-lives of 11.25 [10.75–12.25], 16.50 [13.75–17.75], and 15.38 [13.38–18.63] hours, respectively. Esperoct® exhibited the longest half-life at 19.75 [16.00–24.50] hours, enabling reduced infusion frequency. EHL products showed significantly lower weekly infusion rates compared to standard half-life (SHL) products (1.4 [1.0–2.0] vs. 2.0 [2.0–3.0], <em>p</em> < 0.001), with comparable bleeding control among the different FVIII-EHL.</div></div><div><h3>Conclusions</h3><div>EHL FVIII products offer significant clinical benefits, reducing the burden of frequent infusions and improving adherence while maintaining effective bleeding control. Despite these advancements, comprehensive evaluations of cost, safety, and long-term outcomes are essential to optimize their integration into haemophilia care.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"249 ","pages":"Article 109306"},"PeriodicalIF":3.7000,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Thrombosis research","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0049384825000556","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Haemophilia A is a genetic coagulation disorder requiring prophylactic Factor VIII (FVIII) treatment to prevent joint damage and enhance quality of life. The introduction of extended half-life (EHL) FVIII products represents a major advancement, addressing patient needs for reduced infusion frequency, improved efficacy, and enhanced safety.
Methods
This single-centre observational study examined the real-world use of FVIII products among 124 male patients treated at the Haemophilia Centre of Padua from January 2018 to December 2023. Data on patient characteristics, treatment regimens, and pharmacokinetic profiles were analyzed.
Results
Among the FVIII products used, Advate®, Elocta®, and Jivi® showed median half-lives of 11.25 [10.75–12.25], 16.50 [13.75–17.75], and 15.38 [13.38–18.63] hours, respectively. Esperoct® exhibited the longest half-life at 19.75 [16.00–24.50] hours, enabling reduced infusion frequency. EHL products showed significantly lower weekly infusion rates compared to standard half-life (SHL) products (1.4 [1.0–2.0] vs. 2.0 [2.0–3.0], p < 0.001), with comparable bleeding control among the different FVIII-EHL.
Conclusions
EHL FVIII products offer significant clinical benefits, reducing the burden of frequent infusions and improving adherence while maintaining effective bleeding control. Despite these advancements, comprehensive evaluations of cost, safety, and long-term outcomes are essential to optimize their integration into haemophilia care.
期刊介绍:
Thrombosis Research is an international journal dedicated to the swift dissemination of new information on thrombosis, hemostasis, and vascular biology, aimed at advancing both science and clinical care. The journal publishes peer-reviewed original research, reviews, editorials, opinions, and critiques, covering both basic and clinical studies. Priority is given to research that promises novel approaches in the diagnosis, therapy, prognosis, and prevention of thrombotic and hemorrhagic diseases.