HBsAg Decline After Pegylated-interferon-α in e Antigen Positive Chronic Hepatitis B With Nucleoside Maintenance

Recruitment & Eligibility

Inclusion Criteria

Informed consent
Age over 20 years
HBeAg-positive CHB patients
Patients treated with all available nucleoside analogue monotherapy or combination in Korea except telbivudine ( e.g.entecavir monotherapy or lamivudine/adefovir combination , lamivudine, adefovir monotherapy) for ≥ 18months and patients who have undetectable HBV viral load at least one year HBV DNA undetectable (≤ 400 copies/ml ) Serum alanine transferase: ≤ 10 X upper limit of normal (ULN) Baseline HBsAg: ≥ 102 IU/ml
Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion.
Obtaining written informed consent form

Exclusion Criteria

Decompensated cirrhosis or other contraindications to interferon alfa 2a therapy following local label.
Concomitant or prior use of telbivudine.
Positive test at screening for hepatitis A virus immunoglobulin M Ab, Hepatitis C virus-RNA or hepatitis C virus Ab, hepatitis delta virus Ab or HIV Ab.
Diagnosed hepatic cellular carcinoma
Any evidence of decompensated liver disease (Childs B-C)
History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia).
Women with ongoing pregnancy or who are breast feeding.
Evidence of alcohol and/or drug abuse within one year of entry.
History of major organ transplantation with an existing functional graft.
Inability or unwillingness to provide informed consent or abide by the requirements of the study.
History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
Patients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months.
patients having hypersensitivities for peginterferon alfa-2a or NAs

Study & Design

Arm && Interventions

Group	Intervention	Description
PEG-interferon-alfa 2A	PEG-interferon-Alfa-2A	PEG-interferon-alfa 2A
Nucleosides	Nucleosides	Nucleosides

Primary Outcome Measures

Name	Time	Method
Change in log10 HBsAg titer during antiviral therapy	48 week	To evaluate whether pegylated-IFNα2a treatment lowers HBsAg levels and eventually leads to HBsAg loss in patients after long term NA therapy compared to continuing NA treatment.

Secondary Outcome Measures

Name	Time	Method
HBV DNA undetectability and below 400 IU/mL during antiviral therapy and follow-up	48 week, 96 week
Change in log10 HBsAg titer during follow-up	48 week, 96 week
HBsAg loss and HBsAg seroconversion at end of treatment and 1 and 2 years following end of treatment	48 week, 96 week
Mean change in log10 HBsAg titre over time, as estimated from the area between the baseline value and the curve of log10 HBsAg titre divided by the duration of treatment	48 week
HBeAg seroconversion and loss during antiviral therapy and at end of treatment and 1 and 2 years following end of treatment	48 week, 96 week

Recruitment & Eligibility