The efficacy and safety of pegylated interferon -2b-based immunotherapy for inactive hepatitis B surface antigen carriers

Objectives Pegylated interferon alpha-2b (PegIFN alpha-2b) therapy can help inactive hepatitis B surface antigen (HBsAg) carriers (IHCs) achieve clinical cure. To explore and compare the efficacy, safety, and relevant influential factors of PegIFN alpha-2b monotherapy and PegIFN alpha-2b-based immunotherapy for IHCs. Methods This exploratory, prospective, single-center, randomized controlled trial enrolled 40 IHCs who were randomized into group A (PegIFN alpha-2b treatment for 68 weeks) and group B (two cycles of PegIFN alpha-2b treatment with a lead-in period of GM-CSF and vaccine treatment before each cycle). The primary endpoint was 68-week HBsAg loss rate. Results At week 68, the HBsAg loss rates were 45.45% [full analysis set (FAS)] and 46.67% [per-protocol set (PPS)]. There was no statistically significant difference in HBsAg loss rate between groups A and B (P > 0.05). Univariate analysis revealed that age <= 40 years old, baseline HBsAg < 200 IU/ml, and 24-week HBsAg decline < 2 log 10 IU/ml were significantly associated with HBsAg loss in FAS population (P < 0.05). Multivariate analysis showed that only 24-week HBsAg decline =2 log 10 IU/ml was the independent influencing factor in both FAS and PPS populations (P < 0.05). The adverse events were common and mild, and the therapies were well-tolerated. Conclusion Treatment of IHCs with PegIFN alpha-2b-based therapy could result in a high HBsAg loss rate. The HBsAg loss rate of combined immunotherapy was similar to that of PegIFN alpha-2b monotherapy, and the safety was good. ClinicalTrials.gov ID: NCT05451420. Eur J Gastroenterol Hepatol 35: 1216-1223 Copyright (c) 2023 Wolters Kluwer Health, Inc. All rights reserved.