{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T19:32:15Z","timestamp":1778182335655,"version":"3.51.4"},"reference-count":45,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2023,3,13]],"date-time":"2023-03-13T00:00:00Z","timestamp":1678665600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>The half life of recombinant factor VIII-Fc (rFVIII-Fc) for people with hemophilia A (PwHA) varies greatly. Understanding the factors influencing the variation and assessment of rFVIII-Fc half life is important for personalized treatment. Eighty-five severe-type PwHA with rFVIII-Fc treatment receiving an evaluation of half life by the Web-Accessible Population Pharmacokinetic (PK) Service\u2014Hemophilia during 2019\u20132021 were retrospectively enrolled. The 50-patient PK profiles before 2021 were used for analysis and developing prediction models of half life, and the 35-patient PK profiles in 2021 were used for external validation. The patients in the development cohort were aged 8\u201364, with a median rFVIII-Fc half life of 20.75 h (range, 8.25\u201341.5 h). By multivariate linear regression analysis, we found two, four, and five predictors of rFVIII-Fc half life for the blood groups non-O, O patients, and overall patients, respectively, including baseline VWF:Ag, BMI, VWF:activity\/VWF:Ag ratio, body weight, O blood group, inhibitor history, HCV infection, and hematocrit. The three prediction equations of rFVIII-Fc half life (T) were respectively developed as T for non-O group patients = \u22120.81 + 0.63 \u00d7 (BMI, kg\/m2) + 6.07 \u00d7 (baseline VWF:Ag, IU\/mL), T for O group patients = \u22120.68 + 13.30 \u00d7 (baseline VWF:Ag, IU\/mL) + 0.27 \u00d7 (BW, kg) \u2212 1.17 \u00d7 (BMI, kg\/m2) + 16.02 \u00d7 (VWF:activity\/VWF:Ag ratio), and T for overall patients = \u22121.76 + 7.24 \u00d7 (baseline VWF:Ag, IU\/mL) \u2212 3.84 \u00d7 (Inhibitor history) + 2.99 \u00d7 (HCV infection) \u2212 2.83 \u00d7 (O blood group) + 0.30 \u00d7 (Hct, %), which explained 51.97%, 75.17%, and 66.38% of the half life variability, respectively. For external validation, there was a significant correlation between the predicted and observed half lives in the validation cohort. The median half life deviation was +1.53 h, +1.28 h, and +1.79 h for the equations of non-O group, O group, and overall group patients, respectively. In total, eight predictors influencing rFVIII-Fc half life were identified. Prediction equations of rFVIII-Fc half life were developed for the non-O and O blood groups and overall PwHA with a good degree of external validation. The equations could be applied to patients aged 8\u201364 without the need for PK blood sampling and clinically valuable for personalized therapy.<\/jats:p>","DOI":"10.3390\/jcm12062207","type":"journal-article","created":{"date-parts":[[2023,3,13]],"date-time":"2023-03-13T03:03:57Z","timestamp":1678676637000},"page":"2207","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Clinical Predictors and Prediction Models for rFVIII-Fc Half Life in Real-World People with Severe Hemophilia A"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0408-2993","authenticated-orcid":false,"given":"Chia-Yau","family":"Chang","sequence":"first","affiliation":[{"name":"Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei 110, Taiwan"},{"name":"Division of Pediatric Hematology\/Oncology, Department of Pediatrics, Taipei Medical University Hospital, Taipei 110, Taiwan"},{"name":"Hemophilia Center, Taipei Medical University Hospital, Taipei 110, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7639-9116","authenticated-orcid":false,"given":"Shyh-Shin","family":"Chiou","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan"},{"name":"Division of Hematology and Oncology, Department of Pediatrics, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Te-Fu","family":"Weng","sequence":"additional","affiliation":[{"name":"Division of Pediatric Hematology\/Oncology, Department of Pediatrics, Chun-Shan Medical University Hospital, Taichung 408, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pei-Chin","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan"},{"name":"Division of Hematology and Oncology, Department of Pediatrics, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shiue-Wei","family":"Lai","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei 114, Taiwan"},{"name":"Hemophilia Care and Research Center, Tri-Service General Hospital, Taipei 114, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chen-Hua","family":"Tsai","sequence":"additional","affiliation":[{"name":"Hemophilia Center, Taipei Medical University Hospital, Taipei 110, Taiwan"},{"name":"Department of Hematology\/Oncology, Cheng Hsin General Hospital, Taipei 112, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7571-3123","authenticated-orcid":false,"given":"Yen-Lin","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei 110, Taiwan"},{"name":"Division of Pediatric Hematology\/Oncology, Department of Pediatrics, Taipei Medical University Hospital, Taipei 110, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jung-Tzu","family":"Ku","sequence":"additional","affiliation":[{"name":"Division of Pediatric Hematology\/Oncology, Department of Pediatrics, Taipei Medical University Hospital, Taipei 110, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu-Mei","family":"Liao","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Department of Pediatrics, Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jia-Ruey","family":"Tsai","sequence":"additional","affiliation":[{"name":"Hemophilia Center, Taipei Medical University Hospital, Taipei 110, Taiwan"},{"name":"Division of Hematology\/Oncology, Taipei Medical University Hospital, Taipei 110, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shu-Hsia","family":"Hu","sequence":"additional","affiliation":[{"name":"Hemophilia Center, Taipei Medical University Hospital, Taipei 110, Taiwan"},{"name":"Hemophilia Care and Research Center, Tri-Service General Hospital, Taipei 114, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3487-9511","authenticated-orcid":false,"given":"Chao-Neng","family":"Cheng","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, National Cheng Kung University Hospital, Tainan 704, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yeu-Chin","family":"Chen","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei 114, Taiwan"},{"name":"Hemophilia Care and Research Center, Tri-Service General Hospital, Taipei 114, Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,3,13]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1056\/NEJMoa067659","article-title":"Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia","volume":"357","author":"Abshire","year":"2007","journal-title":"N. 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