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

Bristol-Myers Squibb230 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

230

Conditions

Hepatitis B, Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Herne, Germany

Outcomes

Primary Outcomes

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.

Time frame: After 2 years

Secondary Outcomes

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)

Time frame: After 2 years

Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence)

Time frame: 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)

Time frame: After 2 years

Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs

Time frame: After 2 years

Number of participants with occuring resistances based on results from resistance tests

Time frame: After 2 years

Assessment of Health Status (SF-12® Health Survey)

Time frame: Assessment of Health Status (SF-12 Health Survey) at year 1

Data from ClinicalTrials.gov

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