• The subject is a 43 year-old woman with
history of injection drug use, alcoholism, and hepatitis C who received
MVC for 203 days. On enrollment,
she was HBsAg negative, HBcAb negative, HCV RNA positive, and reported drinking
5 alcoholic beverages per week. Her
baseline AST and ALT were elevated at 101 and 43 IU/L. There were no substantive increases from these
baseline LFT values through Day 169. Her baseline total
bilirubin was normal at 1.1 mg/dL, but peaked at 5.2 mg/dL on
Day 15. The bilirubin subsequently decreased from the peak
level and was normal at the last measurement on Day 169. Of note, her total bilirubin was 2.3 mg/dL 41 days prior to
starting MVC (peak direct and indirect bilirubin levels were
abnormal at 3.3 and 1.9 mg/dL, respectively). She started atazanavir 537 days prior to
MVC, and stopped on the day that MVC was started. She had 3 reported liver AEs during
her study participation (grade 3 increase in bilirubin on two occasions, and
grade 1 hepatosplenomegaly once).
•