Background and purpose
The optimal management strategy for adults with chronic immune tolerance (IT) hepatitis B infection remains to be defined. This study aimed to investigate the efficacy and predictive factors of pegylated interferon (Peg-IFN)-based therapeutic strategies in IT patients with chronic HBV infection.
method
In this pilot, open-label, prospective study, 286 patients aged 18 to 60 years with IT characteristics were enrolled and assigned to one of three groups. The combination group received Peg-IFN for 48 to 96 weeks, and tenofovir disoproxil fumarate (TDF) was started at week 12 and continued through week 96 (n = 103). The monotherapy group received TDF monotherapy only (n = 125), and the control group was monitored without any therapeutic intervention (n = 58).
result
Patients in the control group did not meet predefined efficacy endpoints. Intention-to-treat analysis showed that patients in the combination group achieved a significantly higher virologic response rate (71.8% vs. 53.6%). p = 0.005), hepatitis B e antigen seroconversion rate (15.5% vs. 1.6%, p < 0.001), hepatitis B surface antigen (HBsAg) loss rate (10.7% vs. 0%, p < 0.001) compared with the monotherapy group at 96 weeks. In the combination arm, the cumulative rate of HBsAg reduction was 5.4% at 48 weeks, increasing to 11.8% by 96 weeks. An independent predictor of achieving either hepatitis B e antigen seroconversion or HBsAg reduction was baseline age <30 years (odds ratio = 0.217, 95% confidence interval: 0.048 to 0.976, p = 0.046), reduction in HBsAg levels by >1 log10 IU/mL by week 24 (odds ratio = 13.976, 95% confidence interval: 2.506 to 77.932, p = 0.003).
conclusion
In conclusion, compared to patients receiving NUC monotherapy, response rates may be higher in IT stage patients younger than 30 years receiving Peg-IFN-based therapy. Additionally, patients who achieve a reduction in HBsAg levels of >1 log10 IU/mL compared to baseline by week 24 may be considered for extending the duration of Peg-IFN treatment to 72 to 96 weeks. In China, Peg-IFN-based therapy is not routinely used in adults with IT stage of chronic HBV infection. This study provides evidence to inform and refine clinical decision-making in patients at this under-researched IT stage.
sauce:
Reference magazines:
Liu, M. others. (2026). Pegylated interferon-based therapy improves response rates in immunotolerant chronic hepatitis B patients: a prospective study. Journal of Clinical and Translational Hepatology. DOI: 10.14218/jcth.2025.00712. https://www.xiahepublishing.com/2310-8819/JCTH-2025-00712
