Persistence, Adherence and Clinical Effectiveness of Entecavir in Chronic Hepatitis B Patients

Study Overview
=================
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)

Official Title
-----------------
Persistence, Adherence and Clinical Effectiveness in Patients With Chronic Hepatitis B Viral Infection Treated With Entecavir in Real Life

Conditions
-----------------
Hepatitis B, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment naïve and pre-treated CHB patients<br>subanalysis with migrant and non-migrant patients | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | After 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | Hepatitis B virus (HBV), desoxyribonucleic acid (DNA), Alanine aminotransferase (ALT) | After 2 years | 
| Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs |  | 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 | 
| Assessment of Health Status (SF-12® Health Survey) |  | Assessment of Health Status (SF-12 Health Survey) at year 2 |