LICAVIR Study Synopsis and Table Shells

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  MAVIRET
• Medical condition to be studied:
  Chronic hepatitis C

Population studied

• Short description of the study population:
  Patients with chronic HCV infection, who developed HCC up to the end of 2019.
• Age groups:
  Adults (46 to < 65 years)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  397

Study design details

• Main study objective:
  To characterize the de novo HCC cases that occurred with and without DAA treatment.
• Data analysis plan:
  A descriptive analysis of patients treated with any DAA who develop HCC after DAA initiation and patients who develop HCC without DAA treatment. No direct comparisons of treatment groups will be performed. Summary statistics were provided as mean (SD) for continuous variables, for all individuals with non-missing values, and N (%) for categorical variables. Patient characteristics were assessed over the period from data start through 1 day prior to HCC diagnosis. For characteristics with multiple measurements or assessments (i.e. labs, fibrosis stage, etc.), the value closest but prior to HCC diagnosis was selected.