Abstract: Objective To analyze the clinical efficacy and outcome differences of switching to interferon α-2b treatment in chronic hepatitis B (CHB) patients poor responsiveness to nucleos(t)ide analogs (NAs). Methods A total of 114 CHB patients poor responsiveness to NAs treatment were collected from January 2022 to June 2024 in our hospital. Based on their previous treatment response, the patients were divided into a drug-resistant group (n=58) and a partial responder group (n=56). All patients were switched to pegylated interferon α-2b treatment for 48 weeks. The clinical efficacy, HBV DNA negativity rate, HBsAg negativity rate, HBeAg negativity rate, anti-HBs positivity rate, anti-HBe positivity rate, alanine aminotransferase (ALT) normalization rate, liver function, blood routine, and safety were compared between the two groups of patients. Results After treatment, the overall clinical efficacy of the drug-resistant group and the partial responder group (48.28% vs. 58.93%) showed no significant statistical difference (P>0.05). After 12, 24, and 48 weeks of treatment, the HBV DNA negativity rate (12 w: 31.03% vs. 44.64%; 24 w: 43.10% vs. 58.93%; 48 w: 55.17% vs. 66.07%), HBsAg negativity rate (12 w: 3.45% vs. 5.36%; 24 w: 6.90% vs. 12.50%; 48 w: 10.34% vs. 17.86%), HBeAg negativity rate (12 w: 39.66% vs. 46.43%; 24 w: 44.83% vs. 51.78%; 48 w: 53.45% vs. 62.50%), anti-HBs positivity rate (12 w: 0% vs. 1.78%; 24 w: 3.45% vs. 10.71%; 48 w: 8.62% vs. 17.86%), anti-HBe positivity rate (12 w: 39.66% vs. 46.43%; 24 w: 43.10% vs. 50.00%; 48 w: 48.28% vs. 58.93%), and ALT normalization rate (12 w: 37.93% vs. 51.78%; 24 w: 60.34% vs. 71.43%; 48 w: 70.69% vs. 82.14%) showed significant improvement in relative to baseline, with no significant difference between the two groups (P>0.05). After 48 weeks of treatment, the ALT [(41.15±13.03) U/L vs. (38.12±12.17) U/L], aspartate aminotransferse (AST) [(38.67±10.92) U/L vs. (36.45±8.36) U/L], total bilirubin (TBil) [(15.42±3.73) μmol/L vs. (14.86±3.95) μmol/L], alkaline phosphatase (ALP) [(82.36±20.14) U/L vs. (78.63±22.47) U/L], γ-glutamyl transpeptidase (GGT) [(41.17±11.32) U/L vs. (38.25±10.64) U/L], white blood cells count (WBC) [(3.88±1.04)×10⁹/L vs. (4.02±1.11)×10⁹/L], platelet count (PLT) [(122.63±21.35)×10⁹/L vs. (128.47±19.82)×10⁹/L], and hemoglobin (Hb) [(122.37±12.45) g/L vs. (124.16±11.93) g/L] levels showed no significant difference between the two groups (P>0.05), but all were significantly lower than baseline (P<0.05). The total incidence of adverse events was not significantly different between the two groups (13.79% vs. 10.71%, P>0.05). Conclusion For CHB patients poor responsiveness to NAs treatment, switching to interferon α-2b treatment can significantly improve virological and biochemical markers. However, there was no significant difference in the treatment efficacy between the two groups, suggesting that interferon α-2b has similar effects on patients with different types of treatment response, although it has a certain degree of safety. The hematological toxicity related to interferon treatment needs close monitoring.

Key words: Interferon α-2b, Chronic hepatitis B, Nucleos(t)ide analogs, Outcome