Direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C virus (HCV) infection and the risk of hepatocellular carcinoma (HCC) recurrence: A protocol for a systematic literature review

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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:
  Systematic review and meta-analysis

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J05AP) Antivirals for treatment of HCV infections

  Antivirals for treatment of HCV infections
• Medical condition to be studied:
  Chronic hepatitis C

  Hepatocellular carcinoma

Population studied

• Short description of the study population:
  Adult patients who were treated with DAA therapy for chronic HCV.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The objective of the systematic review is to estimate the comparative risk of early HCC recurrence in individuals who were successfully treated for HCC and subsequently treated with DAAs versus not treated with DAAs for chronic HCV. A meta-analysis of the main outcomes will be performed if the data are available.
• Outcomes:
  Risk of early HCC recurrence (proportion or percentage, relative risk or risk ratio), Incidence of HCC recurrence (rate or hazard/rate ratio)
• Data analysis plan:
  Pairwise meta-analysis with subgroup and sensitivity analyses if deemed feasible