Liver histological reversibility of lamivudine in treatment-naïve children with chronic hepatitis B: a retrospective cohort study from a single center Shanghai China

BACKGROUND: Low viral load of hepatitis B virus (HBV) infection may also result in serious liver complications. Whether long-term suppression of HBV replication has beneficial effects on the reversibility of the liver histology associated with chronic hepatitis B (CHB) in children is unclear. This study assessed the histological response of lamivudine (LAM) in CHB children. METHODS: Treatment-naïve CHB patients who 1≤ aged <18 years, indicating the immune-active phase, and receiving LAM were enrolled. Demographics, biochemical value, virology and histology, and safety were retrospectively analysed. Patients visit the hospital at baseline, every 12 weeks during treatment, and every 24 or 48 weeks after treatment withdrawal. Histological inflammatory improvement was defined as a ≥1-point decrease in the inflammatory score. Fibrosis regression was defined as a decrease of ≥1 point or no worsening of the fibrosis score. RESULTS: Total 35 children enrolled, 13 of them were lost, and 22 patients remained in the study up to 10 years after treatment. Liver biopsy results both at baseline and before treatment withdrawal were available for 14 of the 22 patients. Of the 14 children, 78.6% were male and 78.6% were HBeAg-positive. At baseline, the mean age was 7.3±5.2 years. The serum HBV DNA level of 13 subjects was 7.3±1.3 log(10) IU/m. and alanine aminotransferase (ALT) was 142±102 U/L. The mean inflammation score was 2.9±0.7. The mean fibrosis score was 3.7±0.8. The mean duration was 96.0±23.6 weeks (median 96 weeks). All patients (100%) had a normal ALT after a median 12-week treatment; after 24-week, HBV DNA were <1,000 IU/mL in 92.9%. At a median of 30-week, 100% of the HBeAg-positive patients showed HBeAg seroconversion; 7.1% exhibited HBsAg seroconversion after 24-week treatment. After a mean of 96-week, the 14 patients (100%) exhibited a mean 2.2-point inflammatory improvement from baseline (P<0.001), and 92.9% exhibited a mean 2.1-point fibrosis reduction (P<0.001). No virological breakthroughs or serious adverse events occurred. CONCLUSIONS: This study showed that 96-week mean duration of LAM may reverse advanced inflammation and fibrosis/cirrhosis in young CHB children.