Chang Li-Jun, Hao Chun-Qiu, Rao Gui-Rong, Xu Lin-Li, Li Jing, Cheng Yan, Zheng Li-Jun, Wu Cun-Wen, Chen Han-Xian, Chen Ze-Ren, Lian Jian-Qi, Wu Shi-Hong, Luo Li-Min, Zhang Wei-Lu, Zhang Ye
Department of Infectious Diseases, Yuncheng Central Hospital Affiliated to Shanxi Medical University, 3690 Hedong East Rd, Yuncheng, Shanxi Province, 044000, China.
Department of Infectious Diseases, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Rd, Baqiao District, Xi'an, Shaanxi Province, 710038, China.
Virol J. 2025 May 19;22(1):146. doi: 10.1186/s12985-025-02761-3.
Hepatitis B surface antigen (HBsAg) clearance is an achievable treatment endpoint for chronic hepatitis B virus (HBV)-infected patients. Pegylated interferon-α (PEG-IFN-α) induces higher rate of HBsAg clearance than nucleos(t)ide analogues. However, the influencing factors associated with HBsAg recurrence have not been fully elucidated. The aim of this study was to evaluate the risk factors for recurrence in chronic HBV-infected patients who achieved functional cure with PEG-IFN-α-2b-based treatment.
A multicenter retrospective study was conducted. All patients received PEG-IFN-α-2b-based therapy, achieved HBV DNA negativity and HBsAg clearance, and were followed-up for at least 48 weeks after discontinuation of medications. The demographic data, as well as virological, serological, and biochemical indicators, were collected at baseline, therapy cessation, and during followed-up. Logistic regression analysis was subsequently performed.
A total of 101 chronic HBV-infected patients who achieved HBsAg loss with PEG-IFN-α-2b-based therapy were enrolled. The median treatment time was 24.00 (14.50, 37.50) weeks, and the median consolidation time was 11.00 (0.00, 24.00) weeks. HBsAg recurrence was found in 16 patients after a median 70.00 (48.00, 96.00) week follow-up, with a cumulative recurrence rate of 15.84%. A higher platelet count was associated with a slightly increased HBsAg recurrence risk at therapy cessation, whereas a shorter consolidation time was associated with an elevated HBsAg recurrence risk during followed-up. The appearance of anti-HBs presented a robustly reduced HBsAg recurrence risk at both therapy cessation and followed-up. No HBV DNA positivity or occurrence of end-stage liver disease was observed during treatment or followed-up.
The cumulative HBsAg recurrence rate was 15.84% after discontinuation of medications in chronic HBV-infected patients who achieved functional cure with PEG-IFN-α-2b-based therapy. The presence of anti-HBs reduced the HBsAg recurrence risk.
This trial is a part of ZhuFeng Project (ClinicalTrials.gov, identifier NCT04035837) and a part of E-Cure Study (ClinicalTrials.gov, identifier NCT05182463).
乙肝表面抗原（HBsAg）清除是慢性乙型肝炎病毒（HBV）感染患者可实现的治疗终点。聚乙二醇化干扰素-α（PEG-IFN-α）诱导的HBsAg清除率高于核苷（酸）类似物。然而，与HBsAg复发相关的影响因素尚未完全阐明。本研究旨在评估接受基于PEG-IFN-α-2b治疗实现功能性治愈的慢性HBV感染患者复发的危险因素。
进行了一项多中心回顾性研究。所有患者均接受基于PEG-IFN-α-2b的治疗，实现了HBV DNA阴性和HBsAg清除，并在停药后至少随访48周。在基线、治疗结束时及随访期间收集人口统计学数据以及病毒学、血清学和生化指标。随后进行逻辑回归分析。
共有101例接受基于PEG-IFN-α-2b治疗实现HBsAg消失的慢性HBV感染患者入组研究。中位治疗时间为24.00（14.50，37.50）周，中位巩固时间为11.00（0.00，24.00）周。中位随访70.（48.00，96.00）周后，16例患者出现HBsAg复发，累积复发率为15.84%。较高的血小板计数与治疗结束时HBsAg复发风险略有增加相关，而较短的巩固时间与随访期间HBsAg复发风险升高相关。抗-HBs的出现使治疗结束时及随访期间的HBsAg复发风险显著降低。治疗期间或随访期间未观察到HBV DNA阳性或终末期肝病的发生。
接受基于PEG-IFN-α-2b治疗实现功能性治愈的慢性HBV感染患者停药后，HBsAg累积复发率为15.84%。抗-HBs的存在降低了HBsAg复发风险。
本试验是珠峰项目（ClinicalTrials.gov，标识符NCT04035837）的一部分，也是E-Cure研究（ClinicalTrials.gov，标识符NCT05182463）的一部分。
