Cargando…
Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienced NA
BACKGROUND AND AIMS: A functional cure, or hepatitis B virus (HBV) surface antigen (HBsAg) loss, is difficult to achieve in patients with hepatitis B virus e antigen (HBeAg)-positive chronic hepatitis B. The HBV vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF) have been reported...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
XIA & HE Publishing Inc.
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10412713/ https://www.ncbi.nlm.nih.gov/pubmed/37577218 http://dx.doi.org/10.14218/JCTH.2022.00413 |
_version_ | 1785086973985161216 |
---|---|
author | Jia, Hongyu Yu, Guodong Yu, Jiong Zhang, Xiaoli Yang, Lisha Wang, Bin Zhang, Jiming Bai, Lang Zhang, Xinxin Wang, Kai Zhao, Ping Yang, Dongliang Zhao, Yingren Yu, Yanyan Zhang, Yimin Gu, Jueqing Ye, Chanyuan Cai, Huan Lu, Yingfeng Xiang, Dairong Yu, Liang Lian, Jiangshan Hu, Jianhua Zhang, Shanyan Jin, Ciliang Yang, Yida |
author_facet | Jia, Hongyu Yu, Guodong Yu, Jiong Zhang, Xiaoli Yang, Lisha Wang, Bin Zhang, Jiming Bai, Lang Zhang, Xinxin Wang, Kai Zhao, Ping Yang, Dongliang Zhao, Yingren Yu, Yanyan Zhang, Yimin Gu, Jueqing Ye, Chanyuan Cai, Huan Lu, Yingfeng Xiang, Dairong Yu, Liang Lian, Jiangshan Hu, Jianhua Zhang, Shanyan Jin, Ciliang Yang, Yida |
author_sort | Jia, Hongyu |
collection | PubMed |
description | BACKGROUND AND AIMS: A functional cure, or hepatitis B virus (HBV) surface antigen (HBsAg) loss, is difficult to achieve in patients with hepatitis B virus e antigen (HBeAg)-positive chronic hepatitis B. The HBV vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF) have been reported to help reduce HBsAg levels and promote HBsAg loss. In this prospective randomized trial, we evaluated HBsAg loss in patients receiving pegylated interferon-α2b (PEGIFN-α2b) and tenofovir disoproxil fumarate (TDF), with and without GM-CSF and HBV vaccination. METHODS: A total of 287 patients with HBeAg positive chronic hepatitis B and seroconversion after nucleot(s)ide analog treatment were assigned randomly to three treatment groups for 48 weeks, TDF alone (control), PEGIFN-α2b + TDF, and PEGIFN-α2b + TDF + GM-CSF + HBV vaccine. The primary endpoints were the proportions of patients with HBsAg loss and seroconversion at 48 and 72 weeks. RESULTS: The cumulative HBsAg loss rates in the control, PEGIFN-α2b + TDF, and PEGIFN-α2b + TDF + GM-CSF + HBV vaccine groups at week 48 were 0.0%, 28.3%, and 41.1%, respectively. The cumulative HBsAg seroconversion rates in these groups at week 48 were 0.0%, 21.7%, and 33.9%, respectively. Multivariate regression analysis showed that GM-CSF use plus HBV vaccination was significantly associated with HBsAg loss (p=0.017) and seroconversion (p=0.030). CONCLUSIONS: In patients with HBeAg-positive chronic hepatitis B and seroconversion after nucleot(s)ide analog treatment, immunomodulatory/antiviral treatment regimens effectively improved HBsAg loss, and the regimen including GM-CSF and HBV vaccination was most effective. |
format | Online Article Text |
id | pubmed-10412713 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | XIA & HE Publishing Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-104127132023-08-11 Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienced NA Jia, Hongyu Yu, Guodong Yu, Jiong Zhang, Xiaoli Yang, Lisha Wang, Bin Zhang, Jiming Bai, Lang Zhang, Xinxin Wang, Kai Zhao, Ping Yang, Dongliang Zhao, Yingren Yu, Yanyan Zhang, Yimin Gu, Jueqing Ye, Chanyuan Cai, Huan Lu, Yingfeng Xiang, Dairong Yu, Liang Lian, Jiangshan Hu, Jianhua Zhang, Shanyan Jin, Ciliang Yang, Yida J Clin Transl Hepatol Original Article BACKGROUND AND AIMS: A functional cure, or hepatitis B virus (HBV) surface antigen (HBsAg) loss, is difficult to achieve in patients with hepatitis B virus e antigen (HBeAg)-positive chronic hepatitis B. The HBV vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF) have been reported to help reduce HBsAg levels and promote HBsAg loss. In this prospective randomized trial, we evaluated HBsAg loss in patients receiving pegylated interferon-α2b (PEGIFN-α2b) and tenofovir disoproxil fumarate (TDF), with and without GM-CSF and HBV vaccination. METHODS: A total of 287 patients with HBeAg positive chronic hepatitis B and seroconversion after nucleot(s)ide analog treatment were assigned randomly to three treatment groups for 48 weeks, TDF alone (control), PEGIFN-α2b + TDF, and PEGIFN-α2b + TDF + GM-CSF + HBV vaccine. The primary endpoints were the proportions of patients with HBsAg loss and seroconversion at 48 and 72 weeks. RESULTS: The cumulative HBsAg loss rates in the control, PEGIFN-α2b + TDF, and PEGIFN-α2b + TDF + GM-CSF + HBV vaccine groups at week 48 were 0.0%, 28.3%, and 41.1%, respectively. The cumulative HBsAg seroconversion rates in these groups at week 48 were 0.0%, 21.7%, and 33.9%, respectively. Multivariate regression analysis showed that GM-CSF use plus HBV vaccination was significantly associated with HBsAg loss (p=0.017) and seroconversion (p=0.030). CONCLUSIONS: In patients with HBeAg-positive chronic hepatitis B and seroconversion after nucleot(s)ide analog treatment, immunomodulatory/antiviral treatment regimens effectively improved HBsAg loss, and the regimen including GM-CSF and HBV vaccination was most effective. XIA & HE Publishing Inc. 2023-10-28 2023-03-10 /pmc/articles/PMC10412713/ /pubmed/37577218 http://dx.doi.org/10.14218/JCTH.2022.00413 Text en © 2023 Authors. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 4.0 International License (CC BY-NC 4.0), permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Jia, Hongyu Yu, Guodong Yu, Jiong Zhang, Xiaoli Yang, Lisha Wang, Bin Zhang, Jiming Bai, Lang Zhang, Xinxin Wang, Kai Zhao, Ping Yang, Dongliang Zhao, Yingren Yu, Yanyan Zhang, Yimin Gu, Jueqing Ye, Chanyuan Cai, Huan Lu, Yingfeng Xiang, Dairong Yu, Liang Lian, Jiangshan Hu, Jianhua Zhang, Shanyan Jin, Ciliang Yang, Yida Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienced NA |
title | Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienced NA |
title_full | Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienced NA |
title_fullStr | Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienced NA |
title_full_unstemmed | Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienced NA |
title_short | Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienced NA |
title_sort | immunomodulatory and antiviral therapy improved functional cure rate in chb patients with high hbsag level experienced na |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10412713/ https://www.ncbi.nlm.nih.gov/pubmed/37577218 http://dx.doi.org/10.14218/JCTH.2022.00413 |
work_keys_str_mv | AT jiahongyu immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT yuguodong immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT yujiong immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT zhangxiaoli immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT yanglisha immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT wangbin immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT zhangjiming immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT bailang immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT zhangxinxin immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT wangkai immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT zhaoping immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT yangdongliang immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT zhaoyingren immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT yuyanyan immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT zhangyimin immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT gujueqing immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT yechanyuan immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT caihuan immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT luyingfeng immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT xiangdairong immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT yuliang immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT lianjiangshan immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT hujianhua immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT zhangshanyan immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT jinciliang immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna AT yangyida immunomodulatoryandantiviraltherapyimprovedfunctionalcurerateinchbpatientswithhighhbsaglevelexperiencedna |