Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B

In this study, comparisons will be made between the treatment group (which will receive pegylated interferon alfa-2b treatment) and the observation group (which will receive no drug treatment or be treated with nucleos(t)ide analogs). The primary objectives are to address the following questions: compare the efficacy evaluation indicators (with clinical cure rate as the primary one) between the pegylated interferon alfa-2b treatment group and the observation group; assess whether pegylated interferon alfa-2b treatment improves the clinical cure rate in patients with chronic hepatitis B virus (HBV) infection aged 3 years and above but under 18 years (adolescents and children); and explore optimized antiviral treatment regimens for adolescents and children with chronic HBV infection. The secondary objectives are to address the following questions: compare the immune response characteristics between adolescents and children with chronic HBV infection who achieved functional cure after pegylated interferon alfa-2b treatment and those who did not; investigate the immune mechanism underlying the achievement of functional cure in adolescents and children with chronic HBV infection treated with pegylated interferon alfa-2b; and identify plasma markers associated with treatment efficacy for predicting therapeutic outcomes.

This study is a prospective, multicenter study. A total of 113 subjects (adolescent and pediatric patients with chronic hepatitis B virus \[HBV\] infection) were recruited and divided into a treatment group and an observation group. After collecting baseline data from both groups, the treatment group was administered pegylated interferon alfa-2b, while the observation group received no drug treatment or was treated with nucleos(t)ide analogs. Blood samples were collected at different follow-up time points to detect relevant indicators. By comparing the baseline data with follow-up data during treatment, indicators such as HBV DNA negativity rate, HBeAg seroconversion rate, and HBsAg clearance rate were observed in adolescent and pediatric patients with chronic HBV infection. This was done to evaluate whether pegylated interferon alfa-2b treatment improves the clinical cure rate in this patient population and to explore optimized antiviral treatment regimens for adolescent and pediatric patients with chronic HBV infection. Additionally, the immune response characteristics were compared between adolescent and pediatric patients with chronic HBV infection who achieved functional cure after pegylated interferon alfa-2b treatment and those who did not. This comparison aimed to investigate the immune mechanism underlying functional cure achieved by pegylated interferon alfa-2b in adolescent and pediatric patients with chronic HBV infection, as well as to identify plasma markers associated with treatment efficacy for predicting therapeutic outcomes.