Real-world effectiveness of initial antiviral regimens in children with chronic hepatitis B: an age-stratified cohort study.

BACKGROUND

Interferons (IFN-α) and nucleos(t)ide analogues (NAs) are currently the primary treatment options for children with chronic hepatitis B (CHB), but the efficacy of different initial antiviral regimens in children with different ages remains unclear.

METHODS

This study included 483 treatment-naïve children with CHB who received initial antiviral therapy at Hunan Children's Hospital between June 2015 and November 2023. According to the initial 24-week regimens, patients were divided into (Peg) IFN-α monotherapy, NAs monotherapy, and combination therapy groups, and stratified by age of treatment initiation (1-7 years vs. ≥ 7 years). The study outcome was HBsAg loss. Propensity score matching (PSM) was used to adjust for confounding factors, and a sensitivity analysis was performed to assess the robustness of the results.

FINDINGS

Of the 483 subjects, 294 (60.87%) were male, with a median age of 5 years. Median (interquartile range) follow-up duration was 90 (53, 156) weeks. 158 (32.71%), 56 (11.59%), and 269 (55.69%) participants were assigned to (Peg) IFN-α monotherapy, NAs monotherapy, and combination therapy groups, respectively. After adjusting for other covariates, HBsAg loss rates were comparable in the (Peg) IFN-α monotherapy group and the combination treatment group in children aged 1-7 years ((Peg) IFN-α: Reference group, NAs: HR (95% CI) 0.47 (0.23-0.96), Combination: 1.31 (0.94-1.82)); while HBsAg loss rate was significantly higher in the combination treatment group compared to the other two groups in children aged ≥7 years group (NAs: 0.70 (0.23-2.19), Combination: 3.02 (1.42-6.45)). PSM and sensitivity analyses observed similar findings.

INTERPRETATION

Initial combination therapy had a significant advantage over HBsAg loss in CHB children. In children aged 1-7 years, (Peg) IFN-α monotherapy and combination therapy achieved comparable efficacy; in children aged ≥7 years, combination therapy was more advantageous. Antiviral therapy for children with CHB should be individualized according to the age at treatment initiation to optimize clinical benefit.

FUNDING

The National Natural Science Foundation of China, grant number (82103861); The Natural Science Foundation of Hunan Province, China (2024JJ5457).