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Observational Study
. 2025 May 19;22(1):146.
doi: 10.1186/s12985-025-02761-3.

Recurrence risk factors for chronic hepatitis B virus-infected patients who achieve functional cure with pegylated interferon-α-2b-based therapy: a multicenter pilot study

Li-Jun Chang  1 , Chun-Qiu Hao  2 , Gui-Rong Rao  3 , Lin-Li Xu  4 , Jing Li  2 , Yan Cheng  2 , Li-Jun Zheng  1 , Cun-Wen Wu  5 , Han-Xian Chen  5 , Ze-Ren Chen  5 , Jian-Qi Lian  2 , Shi-Hong Wu  6 , Li-Min Luo  7 , Wei-Lu Zhang  8 , Ye Zhang  9
Affiliations
Observational Study

Recurrence risk factors for chronic hepatitis B virus-infected patients who achieve functional cure with pegylated interferon-α-2b-based therapy: a multicenter pilot study

Li-Jun Chang et al. Virol J. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Clinical trial registration: This trial is a part of ZhuFeng Project (ClinicalTrials.gov, identifier NCT04035837) and a part of E-Cure Study (ClinicalTrials.gov, identifier NCT05182463).

Keywords: Chronic hepatitis B; Functional cure; Pegylated interferon-α; Recurrence.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study protocol was approved by the Institutional Review Board of Tangdu Hospital (202301-06), Yuncheng Central Hospital (YXLL2024072), and Air Force Hospital of Southern Theatre Command (2024-01). The Ethics Committees waived the requirement of written informed consent for participation from the participants or the participants’ legal guardians/next of kin because this was a retrospective study, and only characteristics and laboratory indicators were collected. We used an anonymized database for all analyses, and all potentially identifying variables were removed. The study involving human participants was conducted in accordance with the ethical standards of the institutional and national research committees and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This trial is a part of ZhuFeng Project (The Clinical Cure Project of Chronic Hepatitis B in China; ClinicalTrials.gov, identifier: NCT04035837) and a part of E-Cure Study (Real World Study of Peginterferon α-2b Treatment for Inactive Chronic Hepatitis B Patients; ClinicalTrials.gov, identifier NCT05182463). Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

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