Beriate P (human plasma derived coagulation factor VIII) / CSL Behring - LARVOL DELTA

Impact of Extended Half-Life Factor VIII on Pharmacokinetics and Bleeding Rates in Hemophilia A (ISTH 2025) - "Patients initially treated with SHL FVIII (Beriate®, Immunate®, Octanate®, Advate®, Novoeight®, Hemophil M®, Xyntha®) and later switched to EHL FVIII (Adynovate®, Jivi®) were included. A weak, non-significant negative correlation existed between spontaneous bleeding and T1/2 for both SHL (r=-0.23, IC 95% -0.51 to 0.09, p>0.05) and EHL (r=-0.24, IC 95% -0.49 to 0.05, p>0.05). A significant positive correlation was observed between AUC and T1/2 (r=0.79, IC 95% 0.7 to 0.86, p<0.05) Table or Figure Upload"

PK/PD data • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Assay of modified factor VIII is modulated by von Willebrand factor. What should we measure ? (ISTH 2022) - "For Advate and Beriate activities were similar in both assays. For normal plasma FVIII and Advate, clotting activity of free and complexed FVIII is similar. However, for modified FVIII (Refacto, Eloctate, Adynovi) added VWF (Wilfactin) inhibits their coagulation activities. For Eloctate and Refacto this concerns a maximal inhibition of 74 and 52%."

[VIRTUAL] DRAWBACKS OF PERSONALIZATION OF PROPHYLAXIS AMONG ADULT MEN WITH HEMOPHILIA A (HEMO 2021) - "Five men with HA (2 receiving Beriate®, 1 moderate and 1 severe; and 3 receiving Fanhdi®, 2 moderate and 1 severe) were included. We believe personalization of therapy is important to guarantee joint health and quality of life of PwHA. However, based on the analyses of the individual cases we reported, adherence to treatment may be an important impacting factor to consider among adult PwHA."

Clinical • Hematological Disorders • Hemophilia • Human Immunodeficiency Virus • Infectious Disease • Rare Diseases • Rheumatology

RESIST NAIVE: Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (clinicaltrials.gov) - P=N/A; N=0; Withdrawn; Sponsor: City of Hope Medical Center; N=148 ➔ 0; Active, not recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Hematological Disorders • Hemophilia • Rare Diseases

Twenty years of treatment with Beriate P (Thromb Res) - Abstract not available.

Clinical • Hemophilia

The history of haemophilia - a short review (Thromb Res) - "The availability of pasteurized, and therefore virus-safe, plasma-derived, clotting factor concentrates, such as Haemate P® and Beriate® P in Germany and other countries, dramatically improved the quality of life and life expectancy of haemophilia patients."

Review • Hemophilia

Therapy of severe hemophilia A with emicizumab (Hemlibra®) (GTH 2020) - "For this reason, a poorly compliant adult male was switched from Beriate® to Hemlibra®, and a 2-year-old boy first switched to Hemlibra®. The desired plasma levels of Hemlibra® are well achieved if the proposed regimen is met. In the case of the 2-year-old boy, substitution was unfortunately carried out 4 weeks too late in the recruitment phase, as a result of which the level fell to 33 mg / l. Due to the poor compliance on average, only a level of 33 mg / l could be achieved in the adult male. The results reflect the reality in a hemophilia center."

Quantitative HLA-class-II/Factor VIII (FVIII) Peptidomic Variation in Dendritic Cells Correlates with the Immunogenic Potential of Therapeutic FVIII Proteins in Hemophilia A. (PubMed, J Thromb Haemost) - "Our results provide HLAcII peptidomic level explanations for several important clinical observations/issues including the differential immunogenicity of distinct FVIIIs and the role of HLAcII genetics in inhibitor development."

Journal

FXII Activation Leading to Kallikrein and Bradykinin Formation in Vitro Induced by Some Plasma Derived FVIII Concentrates, but Not by Recombinant FVIII (ISTH 2019) - " Five pdFVIII products (Octanate®, HaemateP®, Immunate, Haemoctin® and Beriate®) and two rFVIII products (Kovaltry® and Advate®) were studied. As the FXII/kallikrein pathway is proinflammatory and as its product bradykinin activates signaling pathways resulting in increased vasodilation, vascular permeability, edema formation and chemotaxis of neutrophils as well as inducing pain, our findings might be of clinical interest. Further research aims to investigate the effect of factor VIII products ex vivo."

Preclinical

Some plasma derived FVIII concentrates activated FXII leading to kallikrein and bradykinin formation in vitro, while recombinant FVIII concentrates did not (GTH 2019) - "Methodology: Five pdFVIII products (Octanate, HaemateP, Immunate, Haemoctin and Beriate ) and two rFVIII products (Kovaltry and Advate) were studied. As the FXII/kallikrein pathway is proinflammatory and as its product bradykinin activates signaling pathways resulting in increased vasodilation, vascular permeability, oedema formation and chemotaxis of neutrophils as well as inducing pain, our findings might be of clinical interest. Further research aims to investigate the effect of factor VIII products ex vivo. This work was supported by a grant of Bayer Vital GmbH, 51368 Leverkusen, Germany"

Preclinical

Previously untreated patients with hemophilia: a single center experience (EAHAD 2019) - "Four of the 25 patients whom were getting primary prophylaxis, were treated with plasma derived factors (beriate, octanate) and the other 21 patients were treated with recombinant factors (refacto, advate). Hemophilia is a serious congenital bleeding disorder that requires early diagnosis, intensive family and patient education, and regular comprehensive care to prevent life-threatening complications and potentially lifelong disability."

Clinical