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

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medicinal product name, other

Viekira Pak, Technivie

Medical condition to be studied

Chronic hepatitis C
Population studied

Short description of the study population

Patients with HCV treated with AbbVie 2-DAA or 3-DAA regimens and enrolled in the HCV-TARGET disease registry.

Criteria for the selection of patients are as follows:
Inclusion Criteria:
1. Anonymized records of consecutive patients in the HCV-TARGET database who are at least 18 years of age, males and females, all races and ethnicities.
2. Have a diagnosis of hepatitis C virus infection and be treated with the AbbVie 2-DAA or 3-DAA regimen.
3. Have at least one dose of the AbbVie 2-DAA or 3-DAA regimen outside of a clinical trial.
4. Have a baseline ALT laboratory value as defined by HCV-TARGET prior to start of the AbbVie 2-DAA or 3-DAA regimen and a least one ALT laboratory value after the date of the start of the regimen and during the treatment interval.
5. Treated for hepatitis C infection at a site in the US, EU, Canada, or Israel.

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
Renal impaired

Estimated number of subjects

875
Study design details

Main study objective

Evaluate and characterize ALT elevations and obtain more information regarding off-label use, contraindicated medication use, and data in populations with limited information for the AbbVie DAA regimen in the real world setting. The impact of ALT elevation on outcome of treatment including specific hepatic outcomes will be examined.

Outcomes

-Difference in proportions of clinical outcomes(liver failure/transplantation/decompensation)hospitalization for liver injury, all cause death)-Proportion of Grade 3+ALT elevations-Difference in proportions of treatment decisions(interruption/discontinuation/completion)-Determine the difference in proportions of clinical outcomes assessed as being at leastpossibly related to DAA therapy, -Assess frequency of off-label use in patients who have received the AbbVie 2-DAA or3-DAA regimen in in a real world setting:i.Use of DAA regimen in patients with genotypes other than HCV GT1 or GT4.ii.Use in other DAA combinations-Assess frequency of use of contraindicated medications in patients during treatment-Proportion of underrepresented patient populations in clinical trials

Data analysis plan

For the statistical analysis of the primary objectives, difference of proportions of subjects with each grade of ALT elevation versus no such elevation and of patients with clinical outcomes and treatment decisions by Grade 3+ ALT elevation versus no such elevation will be reported along with their 95% confidence intervals. Subgroup analysis of the difference in the proportion of subjects with Grade 3+ elevation versus no such elevation and the difference in proportions of subjects with clinical outcomes according to potential risk factors affecting treatment response included in the primary objective above will be performed. The frequency and proportion of subjects with these clinical outcomes, individually and as a composite occurring within 6 months of stopping the AbbVie regimen will be compared between those who had each grade of ALT elevations versus no such elevation within the treatment interval.