HBsAg decline and clearance with peg-IFN therapy added to nucleos(t)ide analogues: an individual participant data meta-analysis of prospective trials (PROSPER)

作者：Edo J. Dongelmans, Lesley A. Patmore, Seng Gee Lim, Marc Bourlière, Shaowen Jiang, Nathalie Ganne‐Carrié, Willem Pieter Brouwer, Jordan J. Feld, Yuxian Huang, J.A. Carrión, Teresa Broquetas, Qiankun Hu, Scott Fung, Fabrice Carrat, Fabien Zoulim, Bettina E. Hansen, Qing Xie, Harry L.A. Janssen, Milan J. Sonneveld · 发表于：Gut · 年份：2025 · DOI：10.1136/gutjnl-2025-336251 · 被引用次数：4 · 研究领域：Hepatitis B Virus Studies、Rheumatoid Arthritis Research and Therapies、Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis

BACKGROUND: Peg-interferon (peg-IFN) plays an increasingly important role in HBV cure strategies, either in combination with novel antivirals, as a lead-in or as consolidation treatment. OBJECTIVE: We aimed to provide estimates of hepatitis B surface antigen (HBsAg) decline and clearance that can be achieved with peg-IFN addition to nucleos(t)ide analogue (NA) therapy. DESIGN: This is a post hoc meta-analysis of individual participant data from eight clinical trials involving chronic hepatitis B patients on NA therapy who received peg-IFN add-on. The primary endpoint was HBsAg loss at end of follow-up (EOF, 6-12 months after end of peg-IFN). Secondary analyses focused on HBsAg decline. RESULTS: 581 patients were included. At the start of peg-IFN therapy (SOT), 44% were hepatitis B envelope antigen (HBeAg) positive, mean HBsAg level was 3.03 log10 IU/mL (HBsAg<100: 12%; 100-1000: 28%; ≥1000: 60%), and planned duration of peg-IFN was 48 weeks in 496 patients (85%).At EOF, 50 (8.6%) patients achieved HBsAg loss (HBsAg<100/100-1000/≥1000: 37.7/9.8/2.3%, p<0.001) Findings were consistent across ethnicities (Caucasian: 30.0/8.7/3.6%; Asian: 39.3/9.2/2.2%). In patients with SOT HBsAg≥1000 IU/mL, levels <1000 and <100 were achieved in 29.7% and 8.9% at 24 weeks and in 47.5% and 16.3% at 48 weeks of peg-IFN therapy, respectively. CONCLUSION: Peg-IFN add-on results in HBsAg loss in 18% of patients with SOT HBsAg<1000 IU/mL, and in 38% if SOT HBsAg<100 IU/mL. Among patients with higher ...