Low‐dose factor VIII infusion in Chinese adult haemophilia A patients: pharmacokinetics evidence that daily infusion results in higher trough level than with every‐other‐day infusion with similar factor VIII consumption

Hua, Baolai; Lee, A.; Fan, Linyuan; Li, K.; Zhang, Y.; Poon, Man‐Chiu; Zhao, Yongqiang

doi:10.1111/hae.13182

Cited by 5 publications

(4 citation statements)

References 15 publications

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“…The substantial differences in PK profiles lead to FVIII dosing discrepancies compared with traditional fixed dosing regimens. 11,12,18,[23][24][25][26][27] The median t 1/2 observed in our study was similar to the half-life of Koate-DVI reported in the published data from Grifols (16.13 h). 28 The t 1/2 in our study would differ if a different concentrate was used.…”

Section: Discussionsupporting

confidence: 90%

“…This finding is similar to those of other studies that evaluated the PK profiles of HA patients on prophylaxis with a standard regimen or LDP of FVIII. The substantial differences in PK profiles lead to FVIII dosing discrepancies compared with traditional fixed dosing regimens 11,12,18,23–27 …”

Section: Discussionmentioning

confidence: 99%

“…PK profiles were constructed using the WAPPS‐Hemo program with the generic plasma population PK model for Koate‐DVI (https://www.wapps-hemo.org/). 23 Data submitted to the WAPPS‐Haemo include patient characteristics, infusion data (type of concentrate, total dose administered, unit dose per kg, and infusion time), and prior infusion data (total dose administered and date of infusion).…”

Section: Methodsmentioning

confidence: 99%

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Pharmacokinetic profile of children with haemophilia A receiving low‐dose FVIII prophylaxis in Indonesia: A single centre experience

et al. 2022

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Background Pharmacokinetic (PK) studies of low‐dose prophylaxis (LDP) of coagulation factor VIII (FVIII) in children with severe haemophilia A (SHA) are scarce. Objective This study aims to investigate the PK profile of children with SHA receiving LDP of FVIII. Methods Paediatric patients receiving FVIII infusions (10 IU/kg twice weekly) were included. PK profiles were estimated using the Web Accessible Population Pharmacokinetic Service for Haemophilia (WAPPS‐Haemo). The primary outcomes were the terminal half‐life (t1/2), concentration–time profile, and time to reach an FVIII level of < 1%. The secondary outcome was the suggested dosing interval of FVIII prophylaxis based on the individual PK profile. Results Twenty‐five patients were recruited; their mean age was 12.3 ± 3.0 years. The t1/2 differed among patients receiving LDP of FVIII twice weekly, with a median of t1/2 was 14.8 h (IQR 12.6–16). The median time to reach an FVIII level of < 1% was 73.8 h (IQR 58.8–80.3). Most patients could maintain a trough level of FVIII > 1% longer than 48 h. At 72–96 h, patients needed a second dose of FVIII infusion because the FVIII level was < 1%. The suggested dosing interval of FVIII prophylaxis ranged from daily to every 96 h, depending on the individual PK profile. Conclusion Our study identified inter‐individual differences in the PK parameters using LDP of FVIII twice weekly. The inter‐individual results in different dosing intervals advise the timing of LDP. Estimating individual PK parameters enables the identification of the optimal prophylaxis frequency to prevent bleedings.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Pharmacokinetic profile of children with haemophilia A receiving low‐dose FVIII prophylaxis in Indonesia: A single centre experience

et al. 2022

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“…showed that an FVIII level of 1% may still have more than five annual joint bleeds, while levels of 10%-12% or more have zero joint bleeds [29]. Studies have also shown that daily prophylaxis of 5 IU/kg achieved double the FVIII trough levels compared with 10 IU/kg every alternate day with same amount of factor consumption [30]. suggesting that there is a high heterogeneity among haemophilia patients [25].…”

Section: Studies With Personalized and Frequency Escalation Protocolsmentioning

confidence: 99%

Low‐dose prophylaxis and its impact on the health of haemophilia patients

et al. 2022

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Background and Objectives: There is convincing evidence to show that low-dose prophylaxis (LDP) results in reduction in annualized bleeding rate (ABR) and better health-related quality of life (HRQoL) compared with on-demand or episodic treatment (ET) in haemophilia patients. The aim is to review various LDP protocols practised for the treatment of haemophilia, specifically in resource-limited countries.Methods: A literature survey was made of articles published in English language in PubMed and EMBASE without any time limit using keywords 'low dose', 'prophylaxis' and 'haemophilia' in different combinations.Results: A total of 19 reports involving LDP in patients with haemophilia were included in this review. Almost all studies reported reduction in ABR, improvement in joint function, pain and HRQoL compared with ET, but this did not fully translate into significant improvement in structural arthropathy already caused by earlier bleeds, suggesting that LDP may be less or ineffective in either stopping or reversing the damage. Individualized dose escalation protocols based on pharmacokinetic (PK) or clinical parameters were found to be superior to fixed LDP protocols and costeffective compared with standard dose protocols. Conclusion:The developing countries can initiate LDP as the first step of prophylaxis, but certainly this should not be the final goal of the health care system in any country. Due to the complex pathophysiological mechanisms underlying haemophilic arthropathy, long-term data on LDP in haemophilia patients are warranted.

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Report on the diagnosis and treatment of hemophilia in China (Version 2024)

Xue,

Dai,

Chen

et al. 2024

LabMed Discovery

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Low‐dose factor VIII infusion in Chinese adult haemophilia A patients: pharmacokinetics evidence that daily infusion results in higher trough level than with every‐other‐day infusion with similar factor VIII consumption

Abstract: Our PK study shows low-dose factor VIII daily infusion results in higher trough level than with EOD infusion with similar factor VIII consumption in Chinese adult haemophilia A patients.

Cited by 5 publications

References 15 publications

Pharmacokinetic profile of children with haemophilia A receiving low‐dose FVIII prophylaxis in Indonesia: A single centre experience

Pharmacokinetic profile of children with haemophilia A receiving low‐dose FVIII prophylaxis in Indonesia: A single centre experience

Low‐dose prophylaxis and its impact on the health of haemophilia patients

Report on the diagnosis and treatment of hemophilia in China (Version 2024)

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