Huimin Liu, Hongmei Gong, Zhaoxia Tan, Yanyan Wu, Lijian Ran, Qing Mao, Guohong Deng, Li Jiang, Jie Xia
{"title":"短期聚乙二醇化干扰素在超低HBsAg慢性HBV患者中的应用:一项回顾性研究","authors":"Huimin Liu, Hongmei Gong, Zhaoxia Tan, Yanyan Wu, Lijian Ran, Qing Mao, Guohong Deng, Li Jiang, Jie Xia","doi":"10.3389/fcimb.2025.1582997","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and aims: </strong>Hepatitis B surface antigen (HBsAg) clearance-defined as an HBsAg level below the lower limit of detection-is critical for the functional cure of chronic hepatitis B (CHB). This study evaluated the efficacy of short-term pegylated interferon alpha (Peg-IFNα) therapy in achieving HBsAg clearance in CHB patients with ultra-low HBsAg levels (<50 IU/ml).</p><p><strong>Methods: </strong>A total of 378 CHB patients with HBsAg levels <50 IU/ml were enrolled, including 206 nucleos(t)ide analogue (NUC)-treated patients and 172 inactive HBsAg carriers (IHCs). The NUC-treated cohort was divided into 83 patients receiving additional Peg-IFNα treatment (NUC add-on Peg-IFNα group) and 123 patients continuing NUC monotherapy (NUC group). The IHC cohort was divided into 86 patients receiving Peg-IFNα treatment (Peg-IFNα group) and 86 untreated patients (untreated group). The primary endpoint was the HBsAg clearance rate at week 24.</p><p><strong>Results: </strong>At week 24, the HBsAg clearance rates in the NUC add-on Peg-IFNα group and Peg-IFNα group were 69.88% and 55.81%, respectively (p = 0.059), both significantly higher than the zero clearance rates in the NUC and untreated groups (p < 0.001). Patients with baseline HBsAg <10 IU/ml achieved higher clearance rates [81.82% vs. 73.81% (p = 0.144)]. A decline of ≥95.8% in HBsAg levels from baseline to week 12 predicted HBsAg clearance at week 24 (AUC ≥0.9, sensitivity 0.765, specificity 0.961).</p><p><strong>Conclusions: </strong>Short-term Peg-IFNα therapy achieved high and comparable HBsAg clearance rates within 24 weeks in NUC-treated patients and IHCs with ultra-low HBsAg levels.</p><p><strong>Clinical trial registration: </strong>https://www.medicalresearch.org.cn/login, identifier MR-50-24-011565.</p>","PeriodicalId":12458,"journal":{"name":"Frontiers in Cellular and Infection Microbiology","volume":"15 ","pages":"1582997"},"PeriodicalIF":4.8000,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12446322/pdf/","citationCount":"0","resultStr":"{\"title\":\"Short-term pegylated interferon alpha in chronic HBV patients with ultra-low HBsAg: a retrospective study.\",\"authors\":\"Huimin Liu, Hongmei Gong, Zhaoxia Tan, Yanyan Wu, Lijian Ran, Qing Mao, Guohong Deng, Li Jiang, Jie Xia\",\"doi\":\"10.3389/fcimb.2025.1582997\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and aims: </strong>Hepatitis B surface antigen (HBsAg) clearance-defined as an HBsAg level below the lower limit of detection-is critical for the functional cure of chronic hepatitis B (CHB). This study evaluated the efficacy of short-term pegylated interferon alpha (Peg-IFNα) therapy in achieving HBsAg clearance in CHB patients with ultra-low HBsAg levels (<50 IU/ml).</p><p><strong>Methods: </strong>A total of 378 CHB patients with HBsAg levels <50 IU/ml were enrolled, including 206 nucleos(t)ide analogue (NUC)-treated patients and 172 inactive HBsAg carriers (IHCs). The NUC-treated cohort was divided into 83 patients receiving additional Peg-IFNα treatment (NUC add-on Peg-IFNα group) and 123 patients continuing NUC monotherapy (NUC group). The IHC cohort was divided into 86 patients receiving Peg-IFNα treatment (Peg-IFNα group) and 86 untreated patients (untreated group). The primary endpoint was the HBsAg clearance rate at week 24.</p><p><strong>Results: </strong>At week 24, the HBsAg clearance rates in the NUC add-on Peg-IFNα group and Peg-IFNα group were 69.88% and 55.81%, respectively (p = 0.059), both significantly higher than the zero clearance rates in the NUC and untreated groups (p < 0.001). Patients with baseline HBsAg <10 IU/ml achieved higher clearance rates [81.82% vs. 73.81% (p = 0.144)]. A decline of ≥95.8% in HBsAg levels from baseline to week 12 predicted HBsAg clearance at week 24 (AUC ≥0.9, sensitivity 0.765, specificity 0.961).</p><p><strong>Conclusions: </strong>Short-term Peg-IFNα therapy achieved high and comparable HBsAg clearance rates within 24 weeks in NUC-treated patients and IHCs with ultra-low HBsAg levels.</p><p><strong>Clinical trial registration: </strong>https://www.medicalresearch.org.cn/login, identifier MR-50-24-011565.</p>\",\"PeriodicalId\":12458,\"journal\":{\"name\":\"Frontiers in Cellular and Infection Microbiology\",\"volume\":\"15 \",\"pages\":\"1582997\"},\"PeriodicalIF\":4.8000,\"publicationDate\":\"2025-09-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12446322/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Frontiers in Cellular and Infection Microbiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3389/fcimb.2025.1582997\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in Cellular and Infection Microbiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3389/fcimb.2025.1582997","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
Short-term pegylated interferon alpha in chronic HBV patients with ultra-low HBsAg: a retrospective study.
Background and aims: Hepatitis B surface antigen (HBsAg) clearance-defined as an HBsAg level below the lower limit of detection-is critical for the functional cure of chronic hepatitis B (CHB). This study evaluated the efficacy of short-term pegylated interferon alpha (Peg-IFNα) therapy in achieving HBsAg clearance in CHB patients with ultra-low HBsAg levels (<50 IU/ml).
Methods: A total of 378 CHB patients with HBsAg levels <50 IU/ml were enrolled, including 206 nucleos(t)ide analogue (NUC)-treated patients and 172 inactive HBsAg carriers (IHCs). The NUC-treated cohort was divided into 83 patients receiving additional Peg-IFNα treatment (NUC add-on Peg-IFNα group) and 123 patients continuing NUC monotherapy (NUC group). The IHC cohort was divided into 86 patients receiving Peg-IFNα treatment (Peg-IFNα group) and 86 untreated patients (untreated group). The primary endpoint was the HBsAg clearance rate at week 24.
Results: At week 24, the HBsAg clearance rates in the NUC add-on Peg-IFNα group and Peg-IFNα group were 69.88% and 55.81%, respectively (p = 0.059), both significantly higher than the zero clearance rates in the NUC and untreated groups (p < 0.001). Patients with baseline HBsAg <10 IU/ml achieved higher clearance rates [81.82% vs. 73.81% (p = 0.144)]. A decline of ≥95.8% in HBsAg levels from baseline to week 12 predicted HBsAg clearance at week 24 (AUC ≥0.9, sensitivity 0.765, specificity 0.961).
Conclusions: Short-term Peg-IFNα therapy achieved high and comparable HBsAg clearance rates within 24 weeks in NUC-treated patients and IHCs with ultra-low HBsAg levels.
期刊介绍:
Frontiers in Cellular and Infection Microbiology is a leading specialty journal, publishing rigorously peer-reviewed research across all pathogenic microorganisms and their interaction with their hosts. Chief Editor Yousef Abu Kwaik, University of Louisville is supported by an outstanding Editorial Board of international experts. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
Frontiers in Cellular and Infection Microbiology includes research on bacteria, fungi, parasites, viruses, endosymbionts, prions and all microbial pathogens as well as the microbiota and its effect on health and disease in various hosts. The research approaches include molecular microbiology, cellular microbiology, gene regulation, proteomics, signal transduction, pathogenic evolution, genomics, structural biology, and virulence factors as well as model hosts. Areas of research to counteract infectious agents by the host include the host innate and adaptive immune responses as well as metabolic restrictions to various pathogenic microorganisms, vaccine design and development against various pathogenic microorganisms, and the mechanisms of antibiotic resistance and its countermeasures.