{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T18:51:47Z","timestamp":1787251907990,"version":"build-2736575974"},"reference-count":37,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,3,29]],"date-time":"2024-03-29T00:00:00Z","timestamp":1711670400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008322","name":"CSL Behring","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Consensus over the definition of recombinant factor VIII (rFVIII) product classification in haemophilia A is lacking. rFVIII products are often classified as standard half\u2010life (SHL) or extended half\u2010life (EHL); despite this, no universally accepted definition currently exists. One proposed definition includes half\u2010life, area under the curve, and technology designed to extend half\u2010life; however, the International Society on Thrombosis and Haemostasis defines activity over time as the most intuitive information for building treatment regimens and the World Federation of Hemophilia describes rFVIII product classification in terms of infusion frequency.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To summarise published data on the clinical and pharmacokinetic criteria used to define rFVIII product classification.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>PubMed and EMBASE database searches of English\u2010language articles (2002\u20132022) were conducted using search strings to identify the relevant population, intervention, and outcomes (e.g., clinical and pharmacokinetic parameters). Articles then underwent title\/abstract and full\u2010text screens.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 1147 identified articles, 62 were included. Half\u2010life was the most widely reported outcome with no clear trends or product groupings observed. No clear groupings emerged among other outcomes, including infusion frequency, consumption, and efficacy. As activity over time was reported in few articles, further investigation of its relevance to rFVIII product classification is warranted.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The findings of this systematic literature review suggest that parameters other than half\u2010life might be important for the development of a comprehensive and clinically relevant rFVIII product classification definition. There seems to be an opportunity to consider parameters that are clinically meaningful and useful for shared decision\u2010making in haemophilia A treatment.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hae.15001","type":"journal-article","created":{"date-parts":[[2024,3,29]],"date-time":"2024-03-29T07:15:08Z","timestamp":1711696508000},"page":"577-588","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Classification of recombinant factor VIII products and implications for clinical practice: A systematic literature review"],"prefix":"10.1111","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2607-9717","authenticated-orcid":false,"given":"Cihan","family":"Ay","sequence":"first","affiliation":[{"name":"Clinical Division of Haematology and Haemostaseology, Department of Medicine I Medical University of Vienna  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariasanta","family":"Napolitano","sequence":"additional","affiliation":[{"name":"PROMISE Department University of Palermo  Palermo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abel","family":"Hassoun","sequence":"additional","affiliation":[{"name":"Haemophilia Treatment Center Simone Veil Hospital, GH Eaubonne\u2010Montmorency  Eaubonne France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Radovan","family":"Tomic","sequence":"additional","affiliation":[{"name":"CSL Behring  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cedric","family":"Martin","sequence":"additional","affiliation":[{"name":"CSL Behring  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wilfried","family":"Seifert","sequence":"additional","affiliation":[{"name":"CSL Behring  Marburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Pinachyan","sequence":"additional","affiliation":[{"name":"CSL Behring  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1585-4100","authenticated-orcid":false,"given":"Johannes","family":"Oldenburg","sequence":"additional","affiliation":[{"name":"Institute of Experimental Hematology and Transfusion Medicine University Hospital Bonn, Medical Faculty University of Bonn  Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,3,29]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.14046"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13438"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2013-10-529974"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.12161"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.12506"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2016-04-713289"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtha.2023.01.013"},{"issue":"4","key":"e_1_2_10_9_1","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0124930","article-title":"FcRn rescues recombinant factor VIII Fc fusion protein from a VWF independent FVIII clearance pathway in mouse hepatocytes","volume":"10","author":"Flier A","year":"2015","journal-title":"PLoS One"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.12116"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.13867"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.thromres.2020.05.005"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-0716-3175-1_37"},{"key":"e_1_2_10_14_1","unstructured":"World Federation of Hemophilia (WFH) Online registry of clotting factor concentrates. 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