Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Patients (P08518)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  This is a drug utilisation study, however, we will also assess the occurence and management of pre-specified protocol defined HOIs (i.e. anemia, neutropenia, thrombocytopenia, and rash) in a real world clinical setting.
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  TELAPREVIR

  RIBAVIRIN

  PEGINTERFERON ALFA-2A

  PEGINTERFERON ALFA-2B
• Medical condition to be studied:
  Hepatitis C

  Anaemia

  Thrombocytopenia

  Neutropenia

  Rash

Population studied

• Short description of the study population:
  Physicians and patients infected with chronic Hepatitis C genotype-1 from atleast 4 European countries.
• 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:
  Describe drug utilization patterns, baseline patient and disease characteristics, and clinical management of pre-specified protocol-defined health outcomes of interest (HOI): anemia, neutropenia, thrombocytopenia and rash - among genotype-1 treatment-naive and/or previous treatment failure patients initiating treatment with Victrelis™ with P-R, Incivo™ with P-R, or P-R alone (without other DAA).
• Outcomes:
  1st Primary: Proportion of CHC patients initiating Victrelis™ with P-R relative to Incivo™ with P-R or P-R only. 2nd primary: Proportion of CHC patients initiating any of the treatment above by patient and disease characteristics. 3rd primary: Description of the occurrence & clinical management of HOI's in the treatment groups specified above. The secondary outcomes of interest are the incidence rates (per unit person time) for protocol defined anemia, neutropenia, thrombocytopenia and rash for the CHC treatment groups in the study.
• Data analysis plan:
  All data will be analyzed in a descriptive manner, no formal hypotheses will be tested. Frequencies and incidence rates of Health outcomes of interest (HOIs) will be summarized. Clinical characteristics of the study population will be analyzed by frequency and percentages for categorical variables and by mean, standard deviation, minimum, median, and maximum for continuous variables.