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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...

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Autores principales: 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
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
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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.
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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
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