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Efficacy, effectiveness, and safety of extended half-life factor VIII products for the treatment of hemophilia A: protocol of a systematic review

1Federal University of Minas Gerais, Juiz de Fora, Minas Gerais, Brazil, 2Faculty of Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands, Belo Horizonte, Minas Gerais, Brazil, 3Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

Abstract Number: PB0216

Meeting: ISTH 2022 Congress

Theme: Hemophilia and Rare Bleeding Disorders » Novel Biotherapeutics in Hemophilia

Background: The treatment of people with hemophilia A (PwHA) consists of replacing the deficient clotting factor with factor VIII (FVIII) products, intravenously infused either as prophylaxis (to avoid bleedings) or on-demand (after a bleeding episode). Until recently, frequent infusions were required to reach and maintain the desirable plasma FVIII-clotting activity, due to its pharmacokinetics. Extended half-life (EHL) products were developed to provide a more flexible posology.

Aims: To evaluate the efficacy, effectiveness, and safety of EHL-FVIII for the treatment of PwHA.

Methods: The systematic review was approved by PROSPERO (CRD42021281642) and is being conducted using the PRISMA 2020 statement. Structured search strategies were performed in the PubMed, Embase, Cochrane Library, LILACS, and CRD databases, validated in sequence through the Epistemonikos database and Google Scholar. No language nor publication period were used as restrictions. Randomized controlled trials, non-randomized controlled trials, and observational studies (prospective cohort, retrospective cohort, and cross-sectional) that evaluated the prophylaxis with EHL-FVIII in PwHA compared with standard half-life FVIII or other EHL-FVIII are being included. Two independent reviewers will select the articles and extract the data using standardized forms. Disagreement will be resolved by a third reviewer. The methodological quality assessment tools will be adopted according to the specific research design of each included study. Likewise, the certainty of the evidence will also be evaluated, using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool (Image 1).

Results: A total of 6,068 articles were retrieved in the initial search. After excluding duplicates, 4,999 articles are under evaluation. We expect this review will be complete by the date of the congress.

Conclusion(s): It is expected that our findings will contribute to filling a knowledge gap regarding the EHL-FVIII products for prophylaxis in PwHA.

Image 1

Methodology Flow Chart of the Systematic Review

To cite this abstract in AMA style:

Araujo M, Camelo R, Barbosa M, Muniz R, Álvares-Teodoro J. Efficacy, effectiveness, and safety of extended half-life factor VIII products for the treatment of hemophilia A: protocol of a systematic review [abstract]. https://abstracts.isth.org/abstract/efficacy-effectiveness-and-safety-of-extended-half-life-factor-viii-products-for-the-treatment-of-hemophilia-a-protocol-of-a-systematic-review/. Accessed October 1, 2023.

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