Hepatitis
Conditions
Brief summary
The study aims to collect information on the current treatment patterns for Hepatitis C in participating countries. There is also a focus on patients receiving a daclatasvir-containing treatment regimen who will be followed prospectively for 12 months after treatment initiation to collect real-world data on effectiveness and safety of the treatment. Additional analysis will differentiate between selected subpopulations.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Adult (≥18 years at inclusion) * Diagnosed with a chronic hepatitis C infection * Whose physician has already decided to initiate a new HCV treatment or a new daclatasvir-containing regimen * Informed consent to participate in the study
Exclusion criteria
* Participation in a clinical trial or an early access program for HCV therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantify effectiveness of daclatasvir (DCV) containing regimen overall and in subgroups (GT1, non GT1 and cirrhotic patients) by measuring sustained virologic response (SVR12) | Upto week 12 after the end of HCV treatment (SVR12) | SVR12 defined as a documented undetectable viral load on or after week 12 following the end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients on DCV-containing regimens achieving SVR12 in real-life compared with SVR12 rates in clinical trials | Upto week 12 after the end of HCV treatment (SVR12) | — |
| Safety of DCV-containing regimens in real-life measured by the incidence of (S)AEs and the incidence leading to treatment discontinuation | Until completion of study | — |
| SVR12 in patients treated with DCV-containing regimens in real-life by treatment regimen, genotype, cirrhosis stage, HCV-treatment experience, HIV coinfection, and previous LTx (if present) | Upto week 12 after the end of HCV treatment (SVR12) | — |
| Comparison of demographic and clinical characteristics of patients starting a new HCV treatment regimen (with or without DCV) by treatment regimen and to identify factors associated with the initiation of different regimens | Baseline (single assessment) | — |
| SVR 24 in patients treated with DCV-containing regimens in real-life clinical care, change of Child-Pugh Score and Metavir score as well as change of patient related outcomes (EQ-5D and SF-36 questionnaires measuring quality of life) | Upto week 24 after the end of HCV treatment (SVR24) | Metavir score (liver function and histology) |
| Demographic and clinical characteristics and treatment patterns of patients starting a new HCV treatment regimen (with or without DCV), overall and by treatment regimen,GT,cirrhosis stage,HCV-treatment experience,HIV co-infection,and previous LTx | Baseline (single assessment) | Previous LTx (if present) |
Countries
Germany
Outcome results
None listed