An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues

Study Overview
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Brief Summary
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This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.

Official Title
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Efficacy and Safety of Peginterferon Alfa-2a (40 KD) in Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment With Nucleoside (Nucleotide) Analogues - an Observational Study in Real-life Clinical Practice

Conditions
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Hepatitis B, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Positive HBsAg for more than 6 months before assignment to treatment with Pegasys Detectable HBV DNA (as measured by PCR) HBeAg positive and negative patients Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard Elevated serum alanine aminotransferase (ALT) Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation Exclusion Criteria: Contraindications to treatment with Pegasys according to the Summary of Product Characteristics Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment Planned other than Pegasys antiviral treatment during Pegasys therapy Chronic liver disease other than chronic hepatitis B Pregnant or breast-feeding women Inadequate hematologic function Autoimmunology disorders Co-infection with chronic hepatitis C or HIV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) |  | approximately 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBs levels in correlation with treatment outcome |  | approximately 2.5 years | 
| For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) |  | approximately 2.5 years | 
| For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization |  | approximately 2.5 years | 
| Safety: Incidence of adverse events |  | approximately 2.5 years |