De novo combination antiviral therapy in e antigen-negative chronic hepatitis B virus-infected paediatric patients with advanced fibrosis

To date, studies that focus on treatment of e antigen-negative chronic hepatitis B virus-infected children with advanced fibrosis are extremely limited. This puts these patients at risk of rapid disease progression. Our study aimed to investigate the efficacy of combination antiviral therapy in this population. We prospectively enrolled treatment-nai''ve paediatric patients between 1 year and 12 years of age who had e antigen-negative chronic hepatitis B and histologically proven advanced fibrosis. All patients received de novo combination therapy with lamivudine (LAM) and interferon-alpha (IFN) for 12 months and then were clinically followed up. The main outcome measure was rate of serum hepatitis B surface antigen (HBsAg) loss at month 12 of treatment. A total of 14 paediatric patients were enrolled, including 9 boys and 5 girls. All patients achieved undetectable HBV DNA levels at month 9 of treatment. A total of 5 patients (35.7%) achieved HBsAg loss at month 12 and finally developed HBsAg seroconversion. Four patients who did not clear HBsAg underwent second liver biopsy, and histological evaluation revealed significant improvements in all of them. As a serum fibrosis marker, aspartate aminotransferase-to-platelet ratio index after 12-month treatment in the 14 patients showed a significant improvement compared with that at baseline (P = .0021). No serious adverse events were observed during the study. Combination antiviral therapy is beneficial to e antigen-negative chronic hepatitis B virus-infected paediatric patients with advanced fibrosis. Further studies with larger cohorts are required.