{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T04:42:41Z","timestamp":1785300161707,"version":"3.55.0"},"reference-count":10,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T00:00:00Z","timestamp":1760659200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Hematology Reports"],"abstract":"<jats:p>Objective: This study aimed to analyze pharmacokinetic and clinical parameters (bleeding rates and joint health) before and after switching from standard half-life (SHL) factor VIII (FVIII) to extended half-life (EHL) PEGylated turoctocog alfa pegol in patients with severe\/moderate hemophilia A (HA) on prophylaxis, one year prior to and following the switch in a real-world setting. Methods: A single-center, comparative, observational, sequential, retrospective, multidisciplinary study was designed. The population pharmacokinetic parameters were estimated using the WAPPS-Hemo\u00ae platform. The annualized bleeding rate (including total and joint bleeds), joint health (Hemophilia Joint Health Score), FVIII consumption, administration frequency, and treatment costs were analyzed. Results: Eight patients with severe (n = 7) or moderate (n = 1) HA on prophylaxis were included after switching to turoctocog alfa pegol. With this regimen, the median FVIII half-life was 16.8 (15.2\u201319.1) hours, the area under the curve (AUC) was 18,182 (12,879\u201321,214) IU\u00b7h\/dL, and the incremental recovery was 2.2 IU\/dL per (1.6\u20132.4) IU\/kg. The patients required a median of 2.0 infusions per week (2.0\u20132.0), corresponding to a weekly consumption of 57.8 (54.2\u201361.1) IU\/kg. Clinically, the prophylactic regimen was associated with fewer infusions per week, stable joint health, and a reduction in overall treatment costs. Conclusions: Prophylaxis with turoctocog alfa pegol provided the expected pharmacokinetic profile of an EHL-FVIII concentrate, enabled a lower infusion frequency, and was linked to a decreased treatment burden and cost while maintaining joint health.<\/jats:p>","DOI":"10.3390\/hematolrep17050053","type":"journal-article","created":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T10:28:36Z","timestamp":1760696916000},"page":"53","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Real-World Assessment of Pharmacokinetics, Clinical Outcomes, and Costs After Switching from Standard Half-Life to Extended Half-Life FVIII in Well-Controlled Hemophilia A Patients"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-3169-5253","authenticated-orcid":false,"given":"Maria","family":"Chov\u00ed-Trull","sequence":"first","affiliation":[{"name":"Pharmacy Department, Hospital Universitari i Polit\u00e8cnic La Fe, 46026 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0369-5341","authenticated-orcid":false,"given":"Juan Eduardo","family":"Meg\u00edas-Vericat","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Hospital Universitari i Polit\u00e8cnic La Fe, 46026 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8390-8211","authenticated-orcid":false,"given":"Santiago","family":"Bonanad-Boix","sequence":"additional","affiliation":[{"name":"Hemostasis and Thrombosis Unit, Hospital Universitari i Polit\u00e8cnic La Fe, 46026 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9295-4714","authenticated-orcid":false,"given":"Saturnino","family":"Haya-Guaita","sequence":"additional","affiliation":[{"name":"Hemostasis and Thrombosis Unit, Hospital Universitari i Polit\u00e8cnic La Fe, 46026 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1193-9924","authenticated-orcid":false,"given":"Ana Rosa","family":"Cid-Haro","sequence":"additional","affiliation":[{"name":"Hemostasis and Thrombosis Unit, Hospital Universitari i Polit\u00e8cnic La Fe, 46026 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5541-0662","authenticated-orcid":false,"given":"Marta","family":"Aguilar-Rodriguez","sequence":"additional","affiliation":[{"name":"Fisioterapia en Movimiento, Grupo de Investigaci\u00f3n Multiespecialidad (PTinMOTION), Universitat de Fisioterapia de Val\u00e8ncia, 46010 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1632-9674","authenticated-orcid":false,"given":"Tom\u00e1s","family":"Palanques-Pastor","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Hospital Universitari i Polit\u00e8cnic La Fe, 46026 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Garcia-Pellicer","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Hospital Universitari i Polit\u00e8cnic La Fe, 46026 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1800-6198","authenticated-orcid":false,"given":"Jose Luis","family":"Poveda-Andr\u00e9s","sequence":"additional","affiliation":[{"name":"Management Department, Hospital Universitari i Polit\u00e8cnic La Fe, 46026 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,10,17]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1111\/hae.14046","article-title":"WFH guidelines for the management of hemophilia, 3rd edition","volume":"26","author":"Srivastava","year":"2020","journal-title":"Haemophilia"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1419","DOI":"10.1111\/hae.14866","article-title":"Targeting higher factor VIII levels for prophylaxis in haemophilia A: A narrative review","volume":"29","author":"Malec","year":"2023","journal-title":"Haemophilia"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"883","DOI":"10.1080\/17474086.2019.1645002","article-title":"Pharmacokinetic and safety considerations when switching from standard to extended half-life clotting factor concentrates in hemophilia","volume":"12","author":"Morfini","year":"2019","journal-title":"Expert Rev. Hematol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"670","DOI":"10.1111\/jth.12161","article-title":"Enhancing the pharmacokinetic properties of recombinant factor VIII: First-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A","volume":"11","author":"Tiede","year":"2013","journal-title":"J. Thromb. Haemost."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1111\/hae.13712","article-title":"Once-weekly prophylaxis with glycoPEGylated recombinant factor VIII (N8-GP) in severe haemophilia A: Safety and efficacy results from pathfinder 2 (randomized phase III trial)","volume":"25","author":"Curry","year":"2019","journal-title":"Haemophilia"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"384","DOI":"10.1111\/hae.13977","article-title":"Development and evalua-tion of the population pharmacokinetic models for FVIII and FIX concentrates of the WAPPS-Hemo project","volume":"26","author":"Hajducek","year":"2020","journal-title":"Haemophilia"},{"key":"ref_7","unstructured":"CIMA (2025, September 21). FICHA T\u00c9CNICA ESPEROCT 500 UI POLVO Y DISOLVENTE PARA SOLUCI\u00d3N INYECTABLE. Available online: https:\/\/cima.aemps.es\/cima\/dochtml\/ft\/1191374001\/FT_1191374001.html."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"2461","DOI":"10.1111\/jth.13867","article-title":"Estimating and interpreting the pharmacokinetic profiles of individual patients with hemophilia A or B using a population pharmacokinetic approach: Communication from the SSC of the ISTH","volume":"15","author":"Iorio","year":"2017","journal-title":"J. Thromb. Haemost."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1493","DOI":"10.1080\/13696998.2020.1828092","article-title":"A systematic review evaluating the efficacy and factor consumption of long-acting recombinant factor VIII products for the prophylactic treatment of hemophilia A","volume":"23","author":"Graf","year":"2020","journal-title":"J. Med. Econ."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"3001","DOI":"10.2147\/PPA.S394216","article-title":"Real-World Experience of People with Hemophilia A Receiving Turoctocog Alfa Pegol (N8-GP): Results from a Patient Experience Survey","volume":"17","author":"Eichler","year":"2023","journal-title":"Patient Prefer. Adherence"}],"container-title":["Hematology Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2038-8330\/17\/5\/53\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T11:21:47Z","timestamp":1760700107000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2038-8330\/17\/5\/53"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,17]]},"references-count":10,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2025,10]]}},"alternative-id":["hematolrep17050053"],"URL":"https:\/\/doi.org\/10.3390\/hematolrep17050053","relation":{},"ISSN":["2038-8330"],"issn-type":[{"value":"2038-8330","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,17]]}}}