FVIII half-life products: A real-world experience

Abstract

Background: Haemophilia A is a genetic coagulation disorder requiring prophylactic Factor VIII (FVIII) treatment to prevent joint damage and enhance quality of life. The introduction of extended half-life (EHL) FVIII products represents a major advancement, addressing patient needs for reduced infusion frequency, improved efficacy, and enhanced safety.

Methods: This single-centre observational study examined the real-world use of FVIII products among 124 male patients treated at the Haemophilia Centre of Padua from January 2018 to December 2023. Data on patient characteristics, treatment regimens, and pharmacokinetic profiles were analyzed.

Results: Among the FVIII products used, Advate®, Elocta®, and Jivi® showed median half-lives of 11.25 [10.75-12.25], 16.50 [13.75-17.75], and 15.38 [13.38-18.63] hours, respectively. Esperoct® exhibited the longest half-life at 19.75 [16.00-24.50] hours, enabling reduced infusion frequency. EHL products showed significantly lower weekly infusion rates compared to standard half-life (SHL) products (1.4 [1.0-2.0] vs. 2.0 [2.0-3.0], p < 0.001), with comparable bleeding control among the different FVIII-EHL.

Conclusions: EHL FVIII products offer significant clinical benefits, reducing the burden of frequent infusions and improving adherence while maintaining effective bleeding control. Despite these advancements, comprehensive evaluations of cost, safety, and long-term outcomes are essential to optimize their integration into haemophilia care.

Keywords: FVIII-EHL; FVIII-SHL; Haemophilia A; Pharmacokinetics.