Efficacy and safety of pegylated interferon α-2b in treatment of patients with hepatitis B virus-related compensated liver cirrhosis： A real-world study
- VernacularTitle:聚乙二醇干扰素α-2b治疗乙型肝炎代偿期肝硬化效果和安全性的真实世界研究
- Author:
Yan WANG
1
;
Lihong LI
1
;
Anna WANG
1
;
Jing WEN
1
;
Jie YANG
1
;
Yinong FENG
1
;
Ye ZHANG
2
;
Qianhui WANG
1
Author Information
- Publication Type:Journal Article
- Keywords: Hepatitis B Virus; Liver Cirrhosis; Interferon-alpha; Therapeutics
- From: Journal of Clinical Hepatology 2026;42(7):1597-1606
- CountryChina
- Language:Chinese
- Abstract: ObjectiveTo investigate the antiviral efficacy of pegylated interferon α-2b （PEG-IFN-α-2b） in patients with HBV-related liver cirrhosis， to assess the safety and tolerability of this regimen， and to provide evidence-based medical evidence for optimizing the treatment strategies for patients with HBV-related compensated liver cirrhosis. MethodsA prospective study was conducted among 115 patients with HBV-related compensated liver cirrhosis and 114 patients with CHB who attended Third People’s Hospital of Taiyuan from January 2023 to March 2024. Treatment-naïve patients received PEG-IFN-α-2b monotherapy， while the patients once treated with nucleos（t）ide analogues （NAs） received PEG-IFN-α-2b add-on therapy. The patients with HBV-related compensated liver cirrhosis were followed up at baseline and at 12， 24， 36， and 48 weeks of treatment. Samples were collected from CHB patients at baseline and at the end of follow-up to assess virological indicators， routine blood test results， and liver function. The chi-square test was used for comparison of categorical data between groups； the independent samples t-test was used for comparison of normally distributed continuous data between two groups， and the one-way repeated measures analysis of variance was used for comparison among different time ponts within the same group，and the Bonferroni was applied for post-hoc pairwise comparisons； the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups， and the Friedman test was used for comparison across different time points within the same group， and the Nemenyi test was utilized for subsequent pairwise comparisons. The multivariate stepwise Logistic regression analysis was used to investigate the influencing factors for clinical cure. ResultsCompared with the CHB group， the HBV-related compensated liver cirrhosis group had a significantly higher mean age （43.50±9.97 years vs 40.90±8.16 years， t=2.160， P=0.032）， a significantly higher proportion of patients with hepatitis B e antigen at baseline （28.70% vs 15.79%， χ2=4.788， P=0.029）， and a significantly lower platelet level ［（178.67±55.07）×109/L vs （194.93±55.79）×109/L， t=2.217， P=0.028］. Compared with the CHB group at the end of follow-up， the HBV-related compensated liver cirrhosis group had significantly lower HBV surface antigen （HBsAg） clearance rate （10.38% vs 33.04%， χ2=14.988， P<0.001） and HBV surface antibody positive rate （0.00% vs 19.64%， χ2=21.041， P<0.001）. Compared with the CHB group at the end of follow-up，the HBV-related compensated liver cirrhosis group had significantly lower aminotransferase levels ［ALT： 31.00（19.00～47.50） U/L vs 40.00（27.00～57.00） U/L， Z=2.433， P<0.05； AST： 31.00（23.00～45.50） U/L vs 37.00（25.00～52.00） U/L， Z=1.963， P<0.05］， but significantly higher level of white blood cells （WBC） ［（4.02±1.56）×109/L vs （3.59±1.24）×109/L， t=2.272， P<0.05］， neutrophils ［（2.39±1.17）×109/L vs （1.87±0.94）×109/L， t=3.284， P<0.05］， and platelets ［（143.93±68.10）×109/L vs （121.88±49.72）×109/L， t=2.588， P<0.05］. A lower level of HBsAg （OR=0.997， 95%CI： 0.996 — 0.999， P<0.001） and previous treatment with NAs （OR=5.889， 95%CI： 2.195 — 17.330， P<0.001） were positive predictive factors for clinical cure， while liver cirrhosis （OR=0.177， 95%CI： 0.063 — 0.470， P<0.001） was a negative predictive factor for clinical cure. During follow-up， no patients experienced acute decompensation or progression to hepatocellular carcinoma， and the main adverse events included fever， fatigue， reductions in WBC and platelets， weight loss， alopecia， and thyroid dysfunction. In the subgroup analysis of HBV-related compensated liver cirrhosis， in both the treatment-naïve patients and the patients previously treated with NAs， there was a significant reduction in HBsAg level from baseline to week 36 of treatment ［treatment-naïve： 99.25 （5.87 — 1 212.35） IU/mL vs 403.47 （36.94 — 2 569.02） IU/mL， P<0.05； previously treated with NAs： 205.94 （14.00 — 737.80） IU/mL vs 427.03 （65.64 — 1 552.65） IU/mL， P<0.05］ and week 48 of treatment ［treatment-naïve： 85.45 （0.58 — 827.56） IU/mL vs 403.47 （36.94 — 2 569.02） IU/mL， P<0.05； previously treated with NAs： 45.28 （0.16 — 267.27） IU/mL vs 427.03 （65.64 — 1 552.65） IU/mL， P<0.05］. There were significant increases in the levels of aminotransferases during treatment， as well as significant reductions in the levels of WBC， neutrophils， platelets， and hemoglobin （all P<0.05）. ConclusionAlthough a finite course of PEG-IFN-α-2b therapy has achieved a relatively low rate of clinical cure in the treatment of HBV-related compensated liver cirrhosis， it can still significantly reduce the level of HBsAg， and this treatment regimen has good safety and tolerability， without accelerating disease progression.
