Eur J Gastroenterol Hepatol. 2023 Aug 14. doi: 10.1097/MEG.0000000000002627. Online ahead of print.
ABSTRACT
OBJECTIVES: Pegylated interferon α-2b (PegIFNα-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 PegIFNα-2b monotherapy and PegIFNα-2b-based immunotherapy for IHCs.
METHODS: This exploratory, prospective, single-center, randomized controlled trial enrolled 40 IHCs who were randomized into group A (PegIFNα-2b treatment for 68 weeks) and group B (two cycles of PegIFNα-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 log10 IU/ml were significantly associated with HBsAg loss in FAS population (P < 0.05). Multivariate analysis showed that only 24-week HBsAg decline ≥2 log10 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 PegIFNα-2b-based therapy could result in a high HBsAg loss rate. The HBsAg loss rate of combined immunotherapy was similar to that of PegIFNα-2b monotherapy, and the safety was good.
CLINICALTRIALSGOV ID: NCT05451420.
PMID:37577817 | DOI:10.1097/MEG.0000000000002627
