Dr. Kappos said that hepatic abnormalities were more common among those on DAC HYP, but were reversible. The rate of ALT/AST greater than five times the upper limit of normal (ULN) was 6% among those on the DAC HYP vs. 3% among those on IFN beta-1a; but the rate of ALT greater than three times the ULN and total bilirubin more than twice the ULN was less than 1% in each group. There was one case that met the “Hy’s law” criteria in each group.
Biogen Idec and AbbVie Biotherapeutics funded the study. Dr. Kappos disclosed that University Hospital Basel has received research support from steering committee/consulting fees, and speakers fees from pharmaceutical companies that include Biogen.