Year: 2026
Type: article
Study design: Clinical Trial
Abstract: Objective To evaluate the efficacy of pegylated interferon (PEG-IFN) α-2b and further explore predictive factors for HBsAg clearance or seroconversion in treatment-naïve patients with HBeAg-negative chronic hepatitis B (CHB) and normal alanine aminotransferase (ALT). Methods This nationwide, multicenter clinical study employed a retrospective and prospective design.Treatment-naïve patients with HBeAg-negative CHB and normal ALT levels who met the inclusion and exclusion criteria were enrolled and administered subcutaneous injections of PEG-IFN-α-2b (180 μg) once a week. HBV DNA, HBsAg, anti-HBs, routine blood tests, serum biochemical indicators, and thyroid function were monitored at baseline and during the treatment course. HBsAg clearance rates were calculated. Predictive factors for HBsAg clearance were analyzed. Adverse reactions occurring during treatment were recorded. Normally distributed data were compared between groups using independent samples t-tests (with Welch's correction applied for unequal variances), while non-normally distributed data were compared using the Mann-Whitney U test. Categorical variables were expressed as counts and percentages, and intergroup comparisons were performed using chi-square tests. Binary logistic regression was used to identify independent predictors of HBsAg clearance. Receiver operating characteristic (ROC) curves were plotted. The optimal cutoff value was determined using the maximum Youden index, along with evaluation of predictive efficacy. Results A total of 261 patients were enrolled across 20 sub-centers, of whom 229 were included in the analysis. The rate of HBV DNA negativity was 97.8% at week 48. The HBsAg clearance rates were 28.8% and 41.9% at weeks 48 and 96, respectively. Independent predictors associated with HBsAg clearance included baseline quantitative HBsAg, ALT levels, platelet count, and thyroid-stimulating hormone (TSH) levels. A reduction of HBsAg ＞93.9% from baseline at week 24 was an independent predictor of HBsAg clearance. Patients with HBsAg ＜100 IU/mL who continued treatment had a further increased clearance rate of up to 55.4% at 48 weeks. Patients with HBsAg <11.68 IU/mL at week 48 had an HBsAg clearance rate of 81.8%. Adverse reactions were generally tolerable, and 7.9% of patients discontinued treatment early due to adverse effects. Conclusion PEG-IFN-α-2b therapy has high HBsAg clearance rates with tolerable adverse reactions, representing an effective approach for pursuing clinical cure in treatment-naïve patients with HBeAg-negative CHB and normal ALT.
Source: PubMed Central
Institution: Sheng Jing Hospital
Language: Chinese
Topic: Hepatitis B Virus Studies
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7225292337