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. 2025 Jul;31(4):634-645.
doi: 10.1111/hae.70050. Epub 2025 May 10.

Efficacy and Safety of rVIII-SingleChain in Surgical Prophylaxis

Faraizah Abdul Karim  1 , Johnny Mahlangu  2 , Claudia Djambas Khayat  3 , Jeannie Ong  4 , Stephanie P'Ng  5 , Johannes Oldenburg  6 , Cindy Leissinger  7   8 , Samantha Lucas  9 , Amy Suen  9 , Blanca Salazar  9 , Ingrid Pabinger  10
Affiliations

Efficacy and Safety of rVIII-SingleChain in Surgical Prophylaxis

Faraizah Abdul Karim et al. Haemophilia. 2025 Jul.

Abstract

Introduction: RVIII-SingleChain is a B-domain-truncated factor VIII construct with a covalent bond between the factor VIII heavy and light chains.

Aim: We report on the efficacy and safety of rVIII-SingleChain in subjects with severe haemophilia A undergoing surgery.

Methods: Surgery, elective or emergent, was defined as all procedures requiring general, spinal, or regional anaesthesia. rVIII-SingleChain was administered as a bolus or continuous infusion during the perioperative period, dosed individually at the discretion of the investigator based upon the type of surgery and clinical status of the patient. The investigator rated haemostatic efficacy on a 4-point scale (excellent, good, moderate or poor/no response), where treatment success was defined as excellent or good.

Results: Overall, 36 subjects underwent 48 surgeries: 41 surgeries in 30 adult/adolescent (mean age 34 [range 12-64] years) and 7 in 6 paediatric subjects (mean age 8 [5-11] years). rVIII-SingleChain was administered during 24 orthopaedic and 17 non-orthopaedic surgeries in adults/adolescents and 7 non-orthopaedic surgeries in paediatrics. Haemostatic efficacy was rated as excellent (n = 36, 88%) or good (n = 5, 12%) in adult/adolescent surgeries and as excellent (n = 7, 100%) in paediatric surgeries. In adults/adolescents, mean (standard deviation [SD]) blood loss was lower than predicted (68.6 [99.9] mL vs. 196.7 [292.8] mL); values were comparable in paediatric subjects (2.1 [2.7] mL vs. 2.9 [2.7] mL). No serious or related adverse events (AEs) were reported during the perioperative period.

Conclusion: Perioperative administration of rVIII-SingleChain effectively achieves and maintains haemostatic control in adult/adolescent and paediatric subjects with haemophilia A undergoing surgery.

Keywords: factor VIII; haemophilia A; haemostasis; perioperative period; surgery.

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Conflict of interest statement

J.M.: grant/research support from Baxalta, Catalyst Bioscience, CSL Behring, Freeline Therapeutics, Pfizer, Novo Nordisk and Roche and consultancy for Amgen, Biotest, Baxalta, Novo Nordisk and Roche. F.A.K., C.D.K., J. Ong and S.P.: no conflicts to declare. J. Oldenburg: research funding from Bayer, Biotest, CSL Behring, Octapharma, Pfizer, Swedish Orphan Biovitrum and Takeda; consultancy, speakers bureau, honoraria, scientific advisory board and travel expenses from Bayer, Biogen Idec, BioMarin, Biotest, Chugai, CSL Behring, Freeline, Grifols, LFB, Novo Nordisk, Octapharma, Pfizer, Roche, Sanofi, Spark Therapeutics, Swedish Orphan Biovitrum and Takeda. C.L.: grant/research support from Biomarin and Roche and consultancy for Advisory Board meetings from Bayer, Catalyst Bioscience, CSL Behring, Roche, Sanofi and Takeda. S.L., A.S. and B.S. are employees at CSL Behring. I.P.: grant/research support from Biotest, CSL Behring, Novo Nordisk and Shire and consultancy for lectures and/or Advisory Board meetings from Bayer, Biotest, CSL Behring, Shire/Takeda, Octapharma, Pfizer and Roche.

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