Practicalities of Using Boceprevir and Early Responses to Treatment: Experience of the First Eighteen Months In the UK. The Boceprevir Real LIfe Treatment (BRIT) study

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Hepatitis C

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  Explore how clinical management of HCV patients on triple therapy with boceprevir is being implemented in the UK, outside of the clinical trial setting.
• Outcomes:
  Assess PCR turnaround times, limits of detection (LOD) of PCR assays, and the length of the lead-in period, in clinical practice, estimate the proportion of subjects with early virologic responses at Weeks 4 (≥1 log10 drop), 8 and 12, determine the proportion of subjects adhering to futility rules (patients who discontinue all treatment at Week 12 due to insufficient viral response)
• Data analysis plan:
  Descriptive analysis. Centre information and patient demographics summarised using tables and summary statistics.