This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.
Voluntarily enroll in the study, able to understand and voluntarily sign the informed consent form;
Aged 18-65 years (inclusive), no gender restriction;
A history of HBsAg positivity for at least 6 months or other evidence suggesting chronic hepatitis B;
First observed clinical cure after treatment with peginterferon α-2b (PegIntron®), either as monotherapy or in combination with NAs, defined as serum HBsAg negative (<0.05IU/ml), HBV DNA undetectable (HBV DNA<20IU/ml), and HBeAg negative, within a 4-week window from the first observed day of clinical cure at the time of screening;
Lactating women;
Evidence of acute severe liver injury: such as ALT > 10 ULN, or significantly elevated ALT with significantly elevated bilirubin;
Evidence of decompensated liver disease: such as ascites, esophageal varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or history of decompensated cirrhosis;
Evidence of hepatocellular carcinoma;
Single group
Peginterferon α-2b based injection
DrugPeginterferon α-2b injection, 180 μg administered subcutaneously in the abdomen or thigh once weekly, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks.
Changes in intrahepatic cccDNA and peripheral blood pgRNA levels
Clearance rate of intrahepatic cccDNA
Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy
Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy
Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy
Changes in intrahepatic cccDNA levels
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