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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.
Sampling Method: Probability Sample (consecutive patient sampling)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment naïve and pre-treated CHB patients | subanalysis with migrant and non-migrant patients |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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CHB Patients treated by Gastroenterologists/Hepatologists
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Herne | 44623 | Germany |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 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 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |