Recurrence and influencing factors of hepatitis B surface antigen seroclearance induced by peginterferon alpha-based regimens

BACKGROUND The long-term stability of hepatitis B surface antigen (HBsAg) seroclearance following peginterferon alpha (peg-IFN-α)-based therapy has not been extensively studied, leaving the full potential and limitations of this strategy unclear. AIM To assess HBsAg recurrence after seroclearance ac...

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Published in	World journal of gastroenterology : WJG Vol. 30; no. 44; pp. 4725 - 4737
Main Authors	Lu, Rui, Zhang, Meng, Liu, Zi-Han, Hao, Miao, Tian, Yan, Li, Mei, Wu, Feng-Ping, Wang, Wen-Jun, Shi, Juan-Juan, Zhang, Xin, Jia, Xiao-Li, Jiang, Zi-Cheng, Li, Xue-Mei, Xu, Guang-Hua, Li, Ya-Ping, Dang, Shuang-Suo
Format	Journal Article
Language	English
Published	United States Baishideng Publishing Group Inc 28.11.2024
Subjects	Adult Antiviral Agents - adverse effects Antiviral Agents - therapeutic use China - epidemiology DNA, Viral - blood Female Follow-Up Studies Hepatitis B Surface Antigens - blood Hepatitis B Surface Antigens - immunology Hepatitis B virus - drug effects Hepatitis B virus - immunology Hepatitis B virus - isolation & purification Hepatitis B, Chronic - blood Hepatitis B, Chronic - diagnosis Hepatitis B, Chronic - drug therapy Hepatitis B, Chronic - immunology Hepatitis B, Chronic - virology Humans Interferon-alpha - therapeutic use Male Middle Aged Observational Study Polyethylene Glycols - adverse effects Polyethylene Glycols - therapeutic use Prospective Studies Recombinant Proteins - administration & dosage Recombinant Proteins - therapeutic use Recurrence Treatment Outcome Viral Load China Peginterferon alpha Chronic hepatitis B Hepatitis B surface antigen recurrence Clinical cure Hepatitis B surface antigen seroclearance
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ISSN	1007-9327 2219-2840 2219-2840
DOI	10.3748/wjg.v30.i44.4725

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Summary:	BACKGROUND The long-term stability of hepatitis B surface antigen (HBsAg) seroclearance following peginterferon alpha (peg-IFN-α)-based therapy has not been extensively studied, leaving the full potential and limitations of this strategy unclear. AIM To assess HBsAg recurrence after seroclearance achieved by peg-IFN-α regimens. METHODS This prospective, multicenter, observational study was conducted from November 2015 to June 2021 at three Chinese hospitals: The Second Affiliated Hospital of Xi’an Jiaotong University, Ankang Central Hospital, and The Affiliated Hospital of Yan’an University. Participants who achieved HBsAg seroclearance following peg-IFN-α-based treatments were monitored every 4-12 weeks post-treatment for hepatitis B virus (HBV) markers, HBV DNA, and liver function. The primary outcome was HBV recurrence, defined as the reemergence of HBsAg, HBV DNA, or both, at least twice within 4-8 weeks of follow-up. RESULTS In total, 121 patients who achieved HBsAg seroclearance were enrolled. After a median follow-up of 84.0 (48.0, 132.0) weeks, four subjects were lost to follow-up. HBsAg recurrence was detected in 16 patients. The cumulative HBsAg recurrence rate in the intention-to-treat population was 15.2%. Multivariate logistic regression analysis demonstrated that consolidation time < 12 weeks [odds ratio (OR) = 28.044, 95%CI: 4.525-173.791] and hepatitis B surface antibody disappearance during follow-up (OR = 46.445, 95%CI: 2.571-838.957) were strong predictors of HBsAg recurrence. HBV DNA positivity and decompensation of liver cirrhosis and hepatocellular carcinoma were not observed. CONCLUSION HBsAg seroclearance following peg-IFN-α treatment was durable over 84 weeks of follow-up with a cumulative recurrence rate of 15.2%.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-Review-4 content type line 23 ObjectType-Undefined-3 Co-first authors: Rui Lu and Meng Zhang. Supported by National Key Research and Development Program of China, No. 2023YFC2308105. Author contributions: Lu R, Dang SS and Li YP conceptualized and designed the research. Li YP, Dang SS, Wu FP, Li M, Shi JJ, Wang WJ, Zhang X, and Jia XL were responsible for the enrollment and follow-up of the observed subjects. Tian Y, Liu ZH, Hao M and Zhang M were responsible for collecting the data. Jiang ZC, Li XM and Xu GH contributed to collecting a portion of the data. Lu R performed the analysis with assistance from Wu FP and Li YP. Both Dang SS and Li YP have played important and indispensable roles in the experimental design, data interpretation and manuscript preparation as the co-corresponding authors. Dang SS and Li YP applied for and obtained the funds for this research project. Dang SS conceptualized, designed, supervised the whole process of the project, and was responsible for submission of the current version of the manuscript. Li YP was instrumental and responsible for data re-analysis and re-interpretation, figure re-plotting, comprehensive literature search, and preparation of the current version of the manuscript. This collaboration between Li YP and Dang SS is crucial for the publication of this manuscript. All authors contributed to the article and approved the submitted version. Corresponding author: Shuang-Suo Dang, PhD, Professor, Department of Infectious Diseases, The Second Affiliated Hospital of Xi’an Jiaotong University, No. 157 Xiwu Road, Xi’an 710004, Shaanxi Province, China. dang212@126.com Co-corresponding authors: Ya-Ping Li and Shuang-Suo Dang.
ISSN:	1007-9327 2219-2840 2219-2840
DOI:	10.3748/wjg.v30.i44.4725