Hepatic abnormalities were more common among those on DAC HYP, but were reversible, Dr. Kappos said. The rate of aspartate aminotransferase/alanine aminotransferase (AST/ALT) greater than five times the upper limit of normal (ULN) was 6% among those on DAC HYP, compared with 3% among those on IFN β-1a. 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 in each group that met Hy’s law criteria, which are used to predict the potential of drugs to cause serious liver injury.
Biogen Idec and AbbVie Biotherapeutics funded the study.
—Elizabeth Mechcatie