The annual consumption of factor VIII (FVIII) using the recombinant product rVIII-SingleChain is comparable to that of another recombinant product, recombinant FVIII Fc fusion protein (rFVIIIFc), in patients with hemophilia A. However, it is significantly lower than that of recombinant anti-hemophilic factor-protein-free method (rAHF-PFM), but maintains a similar bleeding rate.
This is according to a study published in Advances in Therapy that aimed to compare the efficacy and consumption of different recombinant FVIII products for the prophylactic treatment of hemophilia A. These findings attest to the long-acting nature of rVIII-SingleChain.
It is difficult to directly compare the efficacy of different recombinant FVIII products in treating hemophilia A due to the low number of patients with the disease. However, it is important to better understand the efficacy of rVIII-SingleChain, a third-generation, long-acting recombinant product that enables longer intervals between injections, therefore reducing the injection burden.
In the present study, a team of researchers led by Sandra Santos, Director of EU Market Access at CSL Behring, used a method called a matching-adjusted indirect comparison to compare rVIII-SingleChain with 2 other recombinant FVIII products, rAHF-PFM and rFVIIIFc.
They found that the annual consumption of rVIII-SingleChain was comparable to that of rFVIIIFc, but it was significantly lower than that of rAHF-PFM in patients with hemophilia A. They also found that routine prophylaxis with rVIII-SingleChain maintained a similar annualized bleeding rate and percentage of patients with 0 bleeds.
The researchers stated, “The indirect treatment comparisons presented in this study contribute to the better understanding of the efficacy and factor consumption of rVIII-SingleChain as routine prophylaxis in previously treated adolescents/adults with severe haemophilia A, as compared to two other established and/or emerging rFVIII products.”
rVIII-SingleChain is a recombinant FVIII marketed under the brand name Afstyla® by CSL Behring. It was developed using single-chain technology to improve the pharmacokinetic profile of recombinant FVIII and has been shown to have a moderate increase in half-life compared to standard-acting recombinant FVIII products.
Bonanad S, Núñez R, Poveda JL, et al. Matching-adjusted indirect comparison of efficacy and consumption of rVIII-SingleChain versus two recombinant FVIII products used for prophylactic treatment of adults/adolescents with severe haemophilia A. Adv Ther. Published online August 8, 2021. doi:10.1007/s12325-021-01853-0