Hepatitis surface B antigen clearance induced by long-term tenofovir disoproxil fumarate monotherapy in chronic hepatitis B treatment: a meta-analysis and longitudinal modeling analysis
Abstract Background Chronic hepatitis B (CHB) is a significant global health challenge, with tenofovir disoproxil fumarate (TDF) widely used as an effective treatment option. Despite TDF’s efficacy in suppressing hepatitis B virus (HBV) DNA, it rarely achieves functional cure, requiring hepatitis B...
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2025-05-01
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| Online Access: | https://doi.org/10.1186/s12985-025-02788-6 |
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| author | Weizhe Jian Yalin Yin Junsheng Xue Rong Chen Jingwen Feng Jiayao Zeng Ruoyi He Tianyan Zhou |
| author_facet | Weizhe Jian Yalin Yin Junsheng Xue Rong Chen Jingwen Feng Jiayao Zeng Ruoyi He Tianyan Zhou |
| author_sort | Weizhe Jian |
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| description | Abstract Background Chronic hepatitis B (CHB) is a significant global health challenge, with tenofovir disoproxil fumarate (TDF) widely used as an effective treatment option. Despite TDF’s efficacy in suppressing hepatitis B virus (HBV) DNA, it rarely achieves functional cure, requiring hepatitis B surface antigen (HBsAg) clearance or seroconversion, which are an optimal goal of CHB treatment. This study aimed to evaluate the long-term effects of TDF monotherapy on HBsAg clearance rates through a systematic review and meta-analysis, combined with a longitudinal modeling analysis to investigate HBsAg dynamics. Methods Eligible studies published between January 1st, 2008, and September 28th, 2023, in PubMed, EMBASE, and Web of Science were included in the systematic review and meta-analysis. The longitudinal model was developed based on data from 123 subjects in a Phase III trial cohort. Results Twenty-three studies were selected for meta-analysis. The summarized HBsAg clearance rate was near zero and unlikely to increase with extended treatment. The longitudinal model of HBsAg dynamic in CHB patients receiving TDF monotherapy showed a good fitting performance and extrapolation predictive ability. Model-based simulation confirmed that HBsAg clearance remained unlikely with prolonged therapy, with median HBsAg levels reducing by 21% after 168 weeks. Conclusions The consistency between meta-analysis and model simulation outcomes indicated that TDF monotherapy can achieve a limited reduction in HBsAg levels but did not result in functional cure, which reinforced the limited role of TDF monotherapy in comprehensive CHB management. Graphical abstract |
| format | Article |
| id | doaj-art-0f47c17574814e1f9d7b646e686e9dbc |
| institution | Kabale University |
| issn | 1743-422X |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Virology Journal |
| spelling | doaj-art-0f47c17574814e1f9d7b646e686e9dbc2025-08-20T03:48:19ZengBMCVirology Journal1743-422X2025-05-0122111110.1186/s12985-025-02788-6Hepatitis surface B antigen clearance induced by long-term tenofovir disoproxil fumarate monotherapy in chronic hepatitis B treatment: a meta-analysis and longitudinal modeling analysisWeizhe Jian0Yalin Yin1Junsheng Xue2Rong Chen3Jingwen Feng4Jiayao Zeng5Ruoyi He6Tianyan Zhou7Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking UniversityXiamen Amoytop Biotech Co., LTDDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking UniversityDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking UniversityXiamen Amoytop Biotech Co., LTDXiamen Amoytop Biotech Co., LTDXiamen Amoytop Biotech Co., LTDDepartment of Pharmaceutics, School of Pharmaceutical Sciences, Peking UniversityAbstract Background Chronic hepatitis B (CHB) is a significant global health challenge, with tenofovir disoproxil fumarate (TDF) widely used as an effective treatment option. Despite TDF’s efficacy in suppressing hepatitis B virus (HBV) DNA, it rarely achieves functional cure, requiring hepatitis B surface antigen (HBsAg) clearance or seroconversion, which are an optimal goal of CHB treatment. This study aimed to evaluate the long-term effects of TDF monotherapy on HBsAg clearance rates through a systematic review and meta-analysis, combined with a longitudinal modeling analysis to investigate HBsAg dynamics. Methods Eligible studies published between January 1st, 2008, and September 28th, 2023, in PubMed, EMBASE, and Web of Science were included in the systematic review and meta-analysis. The longitudinal model was developed based on data from 123 subjects in a Phase III trial cohort. Results Twenty-three studies were selected for meta-analysis. The summarized HBsAg clearance rate was near zero and unlikely to increase with extended treatment. The longitudinal model of HBsAg dynamic in CHB patients receiving TDF monotherapy showed a good fitting performance and extrapolation predictive ability. Model-based simulation confirmed that HBsAg clearance remained unlikely with prolonged therapy, with median HBsAg levels reducing by 21% after 168 weeks. Conclusions The consistency between meta-analysis and model simulation outcomes indicated that TDF monotherapy can achieve a limited reduction in HBsAg levels but did not result in functional cure, which reinforced the limited role of TDF monotherapy in comprehensive CHB management. Graphical abstracthttps://doi.org/10.1186/s12985-025-02788-6CHBTDFHBsAg clearanceHBsAg seroconversionModel-based simulation |
| spellingShingle | Weizhe Jian Yalin Yin Junsheng Xue Rong Chen Jingwen Feng Jiayao Zeng Ruoyi He Tianyan Zhou Hepatitis surface B antigen clearance induced by long-term tenofovir disoproxil fumarate monotherapy in chronic hepatitis B treatment: a meta-analysis and longitudinal modeling analysis Virology Journal CHB TDF HBsAg clearance HBsAg seroconversion Model-based simulation |
| title | Hepatitis surface B antigen clearance induced by long-term tenofovir disoproxil fumarate monotherapy in chronic hepatitis B treatment: a meta-analysis and longitudinal modeling analysis |
| title_full | Hepatitis surface B antigen clearance induced by long-term tenofovir disoproxil fumarate monotherapy in chronic hepatitis B treatment: a meta-analysis and longitudinal modeling analysis |
| title_fullStr | Hepatitis surface B antigen clearance induced by long-term tenofovir disoproxil fumarate monotherapy in chronic hepatitis B treatment: a meta-analysis and longitudinal modeling analysis |
| title_full_unstemmed | Hepatitis surface B antigen clearance induced by long-term tenofovir disoproxil fumarate monotherapy in chronic hepatitis B treatment: a meta-analysis and longitudinal modeling analysis |
| title_short | Hepatitis surface B antigen clearance induced by long-term tenofovir disoproxil fumarate monotherapy in chronic hepatitis B treatment: a meta-analysis and longitudinal modeling analysis |
| title_sort | hepatitis surface b antigen clearance induced by long term tenofovir disoproxil fumarate monotherapy in chronic hepatitis b treatment a meta analysis and longitudinal modeling analysis |
| topic | CHB TDF HBsAg clearance HBsAg seroconversion Model-based simulation |
| url | https://doi.org/10.1186/s12985-025-02788-6 |
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