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...

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Autores principales: 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.
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
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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.
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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
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