Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Other
Safety study (incl. comparative)

If ‘other’, further details on the scope of the study

Persistence on treatment

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
PEGINTERFERON ALFA-2A
PEGINTERFERON ALFA-2B
RIBAVIRIN

Medical condition to be studied

Chronic hepatitis C
Population studied

Short description of the study population

Chronic hepatitis C genotype 1 infected patients with Boceprevir added to Peginterferon plus Ribavirin in Italy.

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

210
Study design details

Main study objective

To estimate participant persistence on treatment in a real-life setting.

Outcomes

Treatment persistence (Yes/No), duration of therapy to fallout (months), proportion of time participant was on treatment vs prescribed or expected treatment duration. Score on Medication Adherence Scale, boceprevir dose adherence, Health Related Quality of Life questionnaire score, work productivity and activity impairment, compliance with visit schedule.

Data analysis plan

Statistical analysis will be descriptive using mean and standard deviation, median with maximum and minimum, or percentage as appropriate.