Is rFVIIIFc Really Safe for Long-Term Use in Adults and Adolescents with Severe Hemophilia?

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Is rFVIIIFc Really Safe for Long-Term Use in Adults and Adolescents with Severe Hemophilia?

A new medication for treating hemophilia A, called recombinant factor VIII Fc fusion protein (rFVIIIFc), is confirmed by ongoing research to be effective and well-tolerated in treating this disease.

Two studies have already shown that a hemophilia treatment option is safe and effective, but researchers from the United Kingdom took an in-depth look to confirm these outcomes.

Prophylaxis with replacement factor VIII (FVIII) is the standard care for those with hemophilia A. Since this method requires infusions three to four times per week, an extended half-life version was created, recombinant factor VIII Fc fusion protein (rFVIIIFc). The team analyzed the phase three A-LONG study and ongoing ASPIRE extension study, which have already evaluated the medication, and detailed their findings in a poster session at the 57th American Society of Hematology Annual Meeting (ASH 2015) in Orlando, Florida.

The A-LONG study consisted of 165 males (at least 12 years of age) who had been previously treated for hemophilia A. The majority of patients (118) had one treatment arm in pre-study prophylactic or episodic treatment of rFVIIIFc – day one: 25 IU/kg, day four: 50 IU/kg  to start followed by 25 to 65 IT/kg every three to five days to keep levels between one and 3 IU/dL or higher if necessary. Twenty four patients also had two treatment arms for weekly prophylaxis of 65 IU/kg of rFVIIIFc and 23 patients had three treatment arms for episodic (on-demand) treatment of 10 to 50 IU/kg of rFVIIIFc as needed.

Next up for assessment was the ASPIRE extension study (interim ASPIRE results are already published) which included 167 patients on one of four treatment regimens. The median duration of treatment, regardless of which one of the four, was around 25 months.

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