Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.

Inclusion criteria

• 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;
• Agreement to undergo two liver biopsies during the study;
• Negative pregnancy test within 24 hours before the first liver biopsy (for childbearing-age females); and subjects (both male and female) should use effective contraception during the study period.

Exclusion criteria

• 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;
• Prothrombin time (PT) or INR > ULN;
• Participation in other interventional trial studies within 3 months before screening or other conditions deemed unsuitable for inclusion by the investigator.