Long-Term Telbivudine Treatment Results in Resolution of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B
INTRODUCTION: The long-term goal of chronic hepatitis B (CHB) treatment is improvement of liver disease and prevention of cirrhosis. The aim of this study was to assess whether prolonged telbivudine treatment improves liver inflammation and fibrosis. The primary objective was to evaluate the proport...
Autores principales: | , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4572721/ https://www.ncbi.nlm.nih.gov/pubmed/26329749 http://dx.doi.org/10.1007/s12325-015-0232-2 |
_version_ | 1782390438626328576 |
---|---|
author | Hou, Jin-Lin Xu, Daozheng Shi, Guangfeng Wan, Mobin Goodman, Zachary Tan, Deming Xie, Qing Chen, Chengwei Wei, Lai Niu, Junqi Wang, Qinhuan Ren, Hong Wang, Yuming Jia, Jidong Bao, Weibin Dong, Yuhong Trylesinski, Aldo Naoumov, Nikolai V. |
author_facet | Hou, Jin-Lin Xu, Daozheng Shi, Guangfeng Wan, Mobin Goodman, Zachary Tan, Deming Xie, Qing Chen, Chengwei Wei, Lai Niu, Junqi Wang, Qinhuan Ren, Hong Wang, Yuming Jia, Jidong Bao, Weibin Dong, Yuhong Trylesinski, Aldo Naoumov, Nikolai V. |
author_sort | Hou, Jin-Lin |
collection | PubMed |
description | INTRODUCTION: The long-term goal of chronic hepatitis B (CHB) treatment is improvement of liver disease and prevention of cirrhosis. The aim of this study was to assess whether prolonged telbivudine treatment improves liver inflammation and fibrosis. The primary objective was to evaluate the proportion of patients with absence/minimal inflammation (Knodell necroinflammatory score ≤3) on liver biopsy at Year 5. METHODS: Fifty-seven patients aged 16–70 years with a clinical history of CHB and active viral replication (38 hepatitis B e antigen [HBeAg] positive and 19 HBeAg negative) were followed for 6 years: 33 received telbivudine 600 mg/day continuously for 5 years; 24 received lamivudine 100 mg/day for 2 years and then telbivudine for 3 years. Liver biopsies were taken pre-treatment and after 5 years of treatment. RESULTS: At baseline, mean (standard deviation) serum hepatitis B virus (HBV) DNA load was 8.5 (1.7) log(10) copies/mL, Knodell necroinflammatory score was 7.6 (2.9), and Ishak fibrosis score was 2.2 (1.1). After antiviral treatment (median duration: 261 weeks), liver histology improved with increased proportions of patients with absence/minimal liver inflammation (Knodell necroinflammatory score ≤3), from 16% (9/57) at baseline to 98% (56/57), and absence/minimal fibrosis (Ishak score ≤1), from 25% (14/57) at baseline to 84% (48/57). At Year 5, HBV DNA load was <300 copies/mL for all patients; cumulative HBeAg loss and seroconversion rates were 88% and 77%, respectively. At Year 6, 95% of patients with abnormal baseline glomerular filtration rate (60–90 mL/min/1.73 m(2)) improved to normal GFR (>90 mL/min/1.73 m(2)). CONCLUSION: Long-term telbivudine treatment with profound and durable viral suppression significantly improved liver histology, thus achieving the long-term goals of CHB treatment. FibroScan(®) results after 5 and 6 years of treatment (in almost 20% of patients) were consistent with this information. FUNDING: Novartis and National Science and Technology Major Project (2012ZX10002003). TRIAL REGISTRATION: ClinicalTrials.gov # NCT00877149. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-015-0232-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4572721 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-45727212015-09-23 Long-Term Telbivudine Treatment Results in Resolution of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B Hou, Jin-Lin Xu, Daozheng Shi, Guangfeng Wan, Mobin Goodman, Zachary Tan, Deming Xie, Qing Chen, Chengwei Wei, Lai Niu, Junqi Wang, Qinhuan Ren, Hong Wang, Yuming Jia, Jidong Bao, Weibin Dong, Yuhong Trylesinski, Aldo Naoumov, Nikolai V. Adv Ther Original Research INTRODUCTION: The long-term goal of chronic hepatitis B (CHB) treatment is improvement of liver disease and prevention of cirrhosis. The aim of this study was to assess whether prolonged telbivudine treatment improves liver inflammation and fibrosis. The primary objective was to evaluate the proportion of patients with absence/minimal inflammation (Knodell necroinflammatory score ≤3) on liver biopsy at Year 5. METHODS: Fifty-seven patients aged 16–70 years with a clinical history of CHB and active viral replication (38 hepatitis B e antigen [HBeAg] positive and 19 HBeAg negative) were followed for 6 years: 33 received telbivudine 600 mg/day continuously for 5 years; 24 received lamivudine 100 mg/day for 2 years and then telbivudine for 3 years. Liver biopsies were taken pre-treatment and after 5 years of treatment. RESULTS: At baseline, mean (standard deviation) serum hepatitis B virus (HBV) DNA load was 8.5 (1.7) log(10) copies/mL, Knodell necroinflammatory score was 7.6 (2.9), and Ishak fibrosis score was 2.2 (1.1). After antiviral treatment (median duration: 261 weeks), liver histology improved with increased proportions of patients with absence/minimal liver inflammation (Knodell necroinflammatory score ≤3), from 16% (9/57) at baseline to 98% (56/57), and absence/minimal fibrosis (Ishak score ≤1), from 25% (14/57) at baseline to 84% (48/57). At Year 5, HBV DNA load was <300 copies/mL for all patients; cumulative HBeAg loss and seroconversion rates were 88% and 77%, respectively. At Year 6, 95% of patients with abnormal baseline glomerular filtration rate (60–90 mL/min/1.73 m(2)) improved to normal GFR (>90 mL/min/1.73 m(2)). CONCLUSION: Long-term telbivudine treatment with profound and durable viral suppression significantly improved liver histology, thus achieving the long-term goals of CHB treatment. FibroScan(®) results after 5 and 6 years of treatment (in almost 20% of patients) were consistent with this information. FUNDING: Novartis and National Science and Technology Major Project (2012ZX10002003). TRIAL REGISTRATION: ClinicalTrials.gov # NCT00877149. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-015-0232-2) contains supplementary material, which is available to authorized users. Springer Healthcare 2015-09-02 2015 /pmc/articles/PMC4572721/ /pubmed/26329749 http://dx.doi.org/10.1007/s12325-015-0232-2 Text en © The Author(s) 2015 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Hou, Jin-Lin Xu, Daozheng Shi, Guangfeng Wan, Mobin Goodman, Zachary Tan, Deming Xie, Qing Chen, Chengwei Wei, Lai Niu, Junqi Wang, Qinhuan Ren, Hong Wang, Yuming Jia, Jidong Bao, Weibin Dong, Yuhong Trylesinski, Aldo Naoumov, Nikolai V. Long-Term Telbivudine Treatment Results in Resolution of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B |
title | Long-Term Telbivudine Treatment Results in Resolution
of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B |
title_full | Long-Term Telbivudine Treatment Results in Resolution
of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B |
title_fullStr | Long-Term Telbivudine Treatment Results in Resolution
of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B |
title_full_unstemmed | Long-Term Telbivudine Treatment Results in Resolution
of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B |
title_short | Long-Term Telbivudine Treatment Results in Resolution
of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B |
title_sort | long-term telbivudine treatment results in resolution
of liver inflammation and fibrosis in patients with chronic hepatitis b |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4572721/ https://www.ncbi.nlm.nih.gov/pubmed/26329749 http://dx.doi.org/10.1007/s12325-015-0232-2 |
work_keys_str_mv | AT houjinlin longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT xudaozheng longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT shiguangfeng longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT wanmobin longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT goodmanzachary longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT tandeming longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT xieqing longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT chenchengwei longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT weilai longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT niujunqi longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT wangqinhuan longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT renhong longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT wangyuming longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT jiajidong longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT baoweibin longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT dongyuhong longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT trylesinskialdo longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb AT naoumovnikolaiv longtermtelbivudinetreatmentresultsinresolutionofliverinflammationandfibrosisinpatientswithchronichepatitisb |