Long-term Real-world Study of Pegylated Interferon -2b Combined with Nucleostide Analogues in Families with Chronic Hepatitis B and Unfavorable Prognosis Clusters

What this Trial Is About

Researchers are investigating the long-term outcomes of antiviral treatments for chronic hepatitis B CHB in families where the infection has unfavorable prognoses, such as cirrhosis and liver cancer. This study focuses on patients from two consecutive generations of blood relatives affected by hepatitis B virus HBV infection, who face a higher risk of developing serious liver complications. The goal is to compare the effects of pegylated interferon alpha-2b Peg IFN u03b1-2b combined with first-line nucleoside analogues NAs versus NAs alone, to provide evidence-based guidance for managing this difficult-to-treat population. The study observes two patient groups one receiving combination therapy with Peg IFN u03b1-2b and NAs, and the other receiving NAs monotherapy. Peg IFN treatment lasts at least 48 weeks with doses tailored by clinicians, while NAs include drugs such as entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or tenofovir amibufenamide. Patients may switch or add NAs if virological breakthrough occurs. This is a non-interventional, prospective, multicenter cohort study where treatments are chosen by doctors and patients. Data on antiviral therapies, laboratory tests, medical examinations, adverse events, and concomitant medications are collected over a 7-year follow-up period. Participants will undergo regular evaluations including lab tests and medical assessments at defined time points during the study. Researchers will monitor the incidence of cirrhosis, hepatocellular carcinoma HCC, seroconversion rates, viral load levels, and overall survival. Patient adherence is supported through education, reminders, and follow-up tracking. Safety monitoring includes recording adverse events and changes in clinical parameters, with data quality ensured through standardized procedures and audits. The study plans to enroll both non-cirrhotic and compensated cirrhosis patients to analyze long-term outcomes and provide global clinical data for improved treatment decisions.

Real-world Study Evaluating the Long-term Outcomes of Pegylated Interferon α-2b Treatment in the Families With Clusters of HBV Infection and Unfavorable Prognosis - A Prospective, Controlled, Multicenter, Cohort Study