DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients after Direct-Acting Antiviral Therapy

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:
  Other
• Non-interventional study design, other:
  Observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SOFOSBUVIR

  VELPATASVIR

  VOXILAPREVIR

  ELBASVIR

  GRAZOPREVIR

  GLECAPREVIR

  PIBRENTASVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AX14) daclatasvir

  daclatasvir

  (J05AX16) dasabuvir

  dasabuvir

  (J05AX67) ombitasvir, paritaprevir and ritonavir

  ombitasvir, paritaprevir and ritonavir

  (J05AE14) simeprevir

  simeprevir

  (J05AX15) sofosbuvir

  sofosbuvir

  (J05AX65) sofosbuvir and ledipasvir

  sofosbuvir and ledipasvir

  (J05AX69) sofosbuvir and velpatasvir

  sofosbuvir and velpatasvir
• Medical condition to be studied:
  Hepatocellular carcinoma

Population studied

• Short description of the study population:
  Prospective Cohort; The prospective DAA-PASS cohort will include a subset of HCV RNA positive participants in the TARGET-HCC study who meet entry criteria including hepatitis C (with no prior history of DAA therapy) and newly diagnosed Barcelona Clinic Liver Cancer (BCLC) Stage A HCC. Participants will be enrolled in the countries participating in TARGET-HCC which will include the United States (US), France, Germany, Italy, and Spain.; ; Historical Cohort; The historical cohort will be derived from the ITA.LI.CA database, which includes data on all consecutive patients with HCC who were managed within participating centers in Italy. The historical cohort will include patients from the ITA.LI.CA database who have active HCV infection who were not treated for HCV (IFN-based or DAA-based regimens) during the followup period, with initial HCC diagnosis BCLC Stage A, and subsequent successful treatment of HCC with curative therapy.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 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:
  35

Study design details

• Main study objective:
  Estimate the risk of early HCC recurrence associated with DAA therapy exposure relative to no DAA therapy exposure in the prospective DAA-PASS cohort.
• Outcomes:
  Time to recurrence of HCC, A. Number of events (early HCC recurrence)
• Data analysis plan:
  risk estimation