EClinicalMedicine · 2025
Real-world effectiveness of initial antiviral regimens in children with chronic hepatitis B: an age-stratified cohort study.
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Li Sisi, Yang Meng, Ye Ling, Gu Yingping, Kuang Yiying, Gao Cai, Lai Huimin, Peng Songxu
Аннотация
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).
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).