Hepatitis B, Chronic
Conditions
Brief summary
The purpose of this observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.
Detailed description
Sampling Method: Probability Sample (consecutive patient sampling)
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female treatment naïve or pre-treated CHB patients of at least 18 years of age * Written informed consent
Exclusion criteria
* All relevant conditions according to Summary of product characteristics (SmPC) * Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis D virus (HDV) co-infection * Patients currently included in any investigational trial on CHB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting. | After 2 years | A patient will be defined as non-persistent if he misses all his doses in more than 30 subsequent days or if he fails to show up at more than one subsequent visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence) | After 2 years | — |
| Proportion of patients with HBV DNA below the limit of detection (according to local lab standard), mean log reduction of HBV DNA from baseline, proportion of subjects with normal ALT and with e antigen (eAg)/Surface antigen (sAg) seroconversion/loss | After 2 years | Hepatitis B virus (HBV), desoxyribonucleic acid (DNA), Alanine aminotransferase (ALT) |
| Adherence rates using administrative measures (continuous multiple-interval medication gaps, continuous single interval medication availability), and self-report measures, 8-item self-report Morisky Medication Adherence Scale (MMAS) | After 2 years | — |
| Number of participants with occuring resistances based on results from resistance tests | After 2 years | — |
| Assessment of Health Status (SF-12® Health Survey) | Assessment of Health Status (SF-12 Health Survey) at year 1 | — |
| Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs | After 2 years | — |
Countries
Germany
Outcome results
None listed