This is a real-world, prospective, multicenter, non-randomized, controlled study. It aims to investigate the efficacy and safety of pegylated interferon α-2b (PEG IFN α-2b) monotherapy versus its combination with nucleos(t)ide analogs (NAs) regarding hepatitis B surface antigen (HBsAg) clearance in interferon-experienced patients with chronic hepatitis B (CHB). Subjects will receive either interferon-based therapy or NAs monotherapy based on their personal willingness and physicians' professional recommendations, with a uniform 48-week treatment course for all enrolled patients.
• Voluntary participation and ability to understand and provide written informed consent.
Age 18-65 years (inclusive), either gender.
Documented HBsAg positivity for at least 6 months, or other evidence confirming chronic hepatitis B (CHB).
Prior interferon therapy before enrollment (treatment discontinuation ≥ 3 months), with HBsAg level at the end of prior treatment reduced by ≥ 50% from baseline.
• Pregnant or lactating women, or subjects with a pregnancy plan during the study period.
Subjects with neuropsychiatric disorders, in particular a history of depression, anxiety, mania, schizophrenia, or a family history of psychiatric disorders (especially a history of depression or depressive tendency).
Concurrent active infection with hepatitis A, hepatitis C, hepatitis E and/or HIV, or chronic liver disease due to other causes (e.g., alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, etc.).
Evidence of acute severe liver damage: e.g., ALT > 10 × ULN, or marked ALT elevation accompanied by significant hyperbilirubinemia.
Chronic hepatitis B patients who received pegylated interferon alpha for the first time and achieved a good response.
Cohort
Prospective
PEG IFNα-2b monotherapy or combination therapy with NAs
DrugPeginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
NAs monotherapy group
DrugPeginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
Percentage of subjects with undetectable HBsAg
Percentage of subjects with undetectable HBV DNA
Number of patients with a decrease in HBV DNA from baseline
Proportion of subjects with HBV DNA below the lower limit of detection
Number of patients with a decrease in HBsAg from baseline
Proportion of HBsAg seroclearance
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xieqing
Lead sponsor
Ruijin Hospital
Sponsor institution
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