WEUSKOP7136: A global, prospective cohort study to evaluate the real-world use of eltrombopag in adult patients with chronic Hepatitis C Virus infection who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia (201111)

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

  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ELTROMBOPAG
• Medical condition to be studied:
  Hepatitis C

  Thrombocytopenia

Population studied

• Short description of the study population:
  Patients aged ≥ 18 years with Hepatitis C Virus (HCV) who were unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia.; Patients with diagnosis of HCV verified by the presence of detectable HCV RNA, initiation of first-time treatment with eltrombopag no more than 3 months prior to study enrolment, unable to initiate, maintain, or restart optimal interferon-based therapy due to thrombocytopenia prior to initiating eltrombopag, currently undergoing interferon-based antiviral therapy planned, willing and able to provide written informed consent were included.
• 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:
  200

Study design details

• Main study objective:
  The aim of this study is to assess the safety and effectiveness of eltrombopag in routine clinical practice in patients with HCV who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia.
• Outcomes:
  The primary objective of the study is to assess and compare the incidence of hepatic decompensation and mortality at 3 years in patients who achieve sustained viral response (SVR) with patients who do not achieve SVR. To assess the incidence of thromboembolic events among new users of eltrombopag and treatment effectiveness with respect to initiating, maintaining and completing antiviral therapy and achieving SVR. All-cause and cause-specific mortality risk will be evaluated and factors related to the risk of hepatic decompensation and thromboembolic events will be explored in users.
• Data analysis plan:
  Descriptive analyses will include tables and figures showing patient demographics and characteristics of study patients including medical/disease history, virology, and laboratory information, at baseline and at 6 months, 12 months, 18 months, 24 months and 36 months of follow-up. Information will be presented for all patients and stratified by subgroups of interest, to the extent allowed by the data.Kaplan-Meier survival estimates will be calculated for 6, 12, 18, 24, and 36 month observation periods for the outcomes of hepatic decompensation, thromboembolic events and all-cause mortality. Cumulative incidence rates will be calculated for the occurrence of hepatic decompensation and thromboembolic events, as separate events, over the same observation periods. For hepatic decompensation or mortality at 3 years (as separate events), incidence rate ratios comparing patients who did and did not attain SVR will be calculated, along with 95% confidence intervals (CIs).