Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B
Abstract Background Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood. Methods This is an international multicenter cohort study of...
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| Published in | The Journal of infectious diseases Vol. 224; no. 11; pp. 1890 - 1899 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
US
Oxford University Press
01.12.2021
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0022-1899 1537-6613 1537-6613 |
| DOI | 10.1093/infdis/jiab241 |
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| Abstract | Abstract
Background
Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood.
Methods
This is an international multicenter cohort study of treatment-naive patients with chronic hepatitis B who started ETV or TDF treatment without baseline cancer. Patients were observed for HBsAg seroclearance until death or loss to follow-up. We calculated the incidences and explored the baseline determinants of HBsAg seroclearance using competing risk regression.
Results
The analysis included 4769 patients (median age, 50 years; 69.05% male), with a median follow-up of 5.16 years (26 614.47 person-years). HBsAg clearance occurred in 58 patients, yielding a 10-year cumulative incidence of 2.11% (95% confidence interval, 1.54%–2.88%) and an annual rate of 0.22% (.17%–.28%). Baseline predictors included low-level viremia with hepatitis B virus DNA <2000 IU/mL (adjusted subdistribution hazard ratio, 3.14 [95% confidence interval, 1.80–5.49]), elevated serum alanine aminotransferase >200 U/L (3.68 [2.07–6.53]), serum bilirubin (1.11 per mg/dL; [1.06–1.17 mg/dL]), and fatty liver (1.84 [1.03–3.29]).
Conclusion
HBsAg seroclearance rarely occurs in patients with chronic hepatitis B treated with ETV or TDF and is associated with low-level viremia, alanine aminotransferase flare, bilirubin level, and fatty liver.
Functional cure of hepatitis B virus infection rarely occurred at an average annual rate of 0.22% during first-line oral antiviral treatment, with higher chances observed in patients with low-level viremia, high-level aminotransferase flare, elevation of serum bilirubin, and fatty liver. |
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| AbstractList | Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood.BACKGROUNDLong-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood.This is an international multicenter cohort study of treatment-naive patients with chronic hepatitis B who started ETV or TDF treatment without baseline cancer. Patients were observed for HBsAg seroclearance until death or loss to follow-up. We calculated the incidences and explored the baseline determinants of HBsAg seroclearance using competing risk regression.METHODSThis is an international multicenter cohort study of treatment-naive patients with chronic hepatitis B who started ETV or TDF treatment without baseline cancer. Patients were observed for HBsAg seroclearance until death or loss to follow-up. We calculated the incidences and explored the baseline determinants of HBsAg seroclearance using competing risk regression.The analysis included 4769 patients (median age, 50 years; 69.05% male), with a median follow-up of 5.16 years (26 614.47 person-years). HBsAg clearance occurred in 58 patients, yielding a 10-year cumulative incidence of 2.11% (95% confidence interval, 1.54%-2.88%) and an annual rate of 0.22% (.17%-.28%). Baseline predictors included low-level viremia with hepatitis B virus DNA <2000 IU/mL (adjusted subdistribution hazard ratio, 3.14 [95% confidence interval, 1.80-5.49]), elevated serum alanine aminotransferase >200 U/L (3.68 [2.07-6.53]), serum bilirubin (1.11 per mg/dL; [1.06-1.17 mg/dL]), and fatty liver (1.84 [1.03-3.29]).RESULTSThe analysis included 4769 patients (median age, 50 years; 69.05% male), with a median follow-up of 5.16 years (26 614.47 person-years). HBsAg clearance occurred in 58 patients, yielding a 10-year cumulative incidence of 2.11% (95% confidence interval, 1.54%-2.88%) and an annual rate of 0.22% (.17%-.28%). Baseline predictors included low-level viremia with hepatitis B virus DNA <2000 IU/mL (adjusted subdistribution hazard ratio, 3.14 [95% confidence interval, 1.80-5.49]), elevated serum alanine aminotransferase >200 U/L (3.68 [2.07-6.53]), serum bilirubin (1.11 per mg/dL; [1.06-1.17 mg/dL]), and fatty liver (1.84 [1.03-3.29]).HBsAg seroclearance rarely occurs in patients with chronic hepatitis B treated with ETV or TDF and is associated with low-level viremia, alanine aminotransferase flare, bilirubin level, and fatty liver.Functional cure of hepatitis B virus infection rarely occurred at an average annual rate of 0.22% during first-line oral antiviral treatment, with higher chances observed in patients with low-level viremia, high-level aminotransferase flare, elevation of serum bilirubin, and fatty liver.CONCLUSIONHBsAg seroclearance rarely occurs in patients with chronic hepatitis B treated with ETV or TDF and is associated with low-level viremia, alanine aminotransferase flare, bilirubin level, and fatty liver.Functional cure of hepatitis B virus infection rarely occurred at an average annual rate of 0.22% during first-line oral antiviral treatment, with higher chances observed in patients with low-level viremia, high-level aminotransferase flare, elevation of serum bilirubin, and fatty liver. Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood. This is an international multicenter cohort study of treatment-naive patients with chronic hepatitis B who started ETV or TDF treatment without baseline cancer. Patients were observed for HBsAg seroclearance until death or loss to follow-up. We calculated the incidences and explored the baseline determinants of HBsAg seroclearance using competing risk regression. The analysis included 4769 patients (median age, 50 years; 69.05% male), with a median follow-up of 5.16 years (26 614.47 person-years). HBsAg clearance occurred in 58 patients, yielding a 10-year cumulative incidence of 2.11% (95% confidence interval, 1.54%-2.88%) and an annual rate of 0.22% (.17%-.28%). Baseline predictors included low-level viremia with hepatitis B virus DNA <2000 IU/mL (adjusted subdistribution hazard ratio, 3.14 [95% confidence interval, 1.80-5.49]), elevated serum alanine aminotransferase >200 U/L (3.68 [2.07-6.53]), serum bilirubin (1.11 per mg/dL; [1.06-1.17 mg/dL]), and fatty liver (1.84 [1.03-3.29]). HBsAg seroclearance rarely occurs in patients with chronic hepatitis B treated with ETV or TDF and is associated with low-level viremia, alanine aminotransferase flare, bilirubin level, and fatty liver.Functional cure of hepatitis B virus infection rarely occurred at an average annual rate of 0.22% during first-line oral antiviral treatment, with higher chances observed in patients with low-level viremia, high-level aminotransferase flare, elevation of serum bilirubin, and fatty liver. Background Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood. Methods This is an international multicenter cohort study of treatment-naive patients with chronic hepatitis B who started ETV or TDF treatment without baseline cancer. Patients were observed for HBsAg seroclearance until death or loss to follow-up. We calculated the incidences and explored the baseline determinants of HBsAg seroclearance using competing risk regression. Results The analysis included 4769 patients (median age, 50 years; 69.05% male), with a median follow-up of 5.16 years (26 614.47 person-years). HBsAg clearance occurred in 58 patients, yielding a 10-year cumulative incidence of 2.11% (95% confidence interval, 1.54%–2.88%) and an annual rate of 0.22% (.17%–.28%). Baseline predictors included low-level viremia with hepatitis B virus DNA <2000 IU/mL (adjusted subdistribution hazard ratio, 3.14 [95% confidence interval, 1.80–5.49]), elevated serum alanine aminotransferase >200 U/L (3.68 [2.07–6.53]), serum bilirubin (1.11 per mg/dL; [1.06–1.17 mg/dL]), and fatty liver (1.84 [1.03–3.29]). Conclusion HBsAg seroclearance rarely occurs in patients with chronic hepatitis B treated with ETV or TDF and is associated with low-level viremia, alanine aminotransferase flare, bilirubin level, and fatty liver. Functional cure of hepatitis B virus infection rarely occurred at an average annual rate of 0.22% during first-line oral antiviral treatment, with higher chances observed in patients with low-level viremia, high-level aminotransferase flare, elevation of serum bilirubin, and fatty liver. Abstract Background Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood. Methods This is an international multicenter cohort study of treatment-naive patients with chronic hepatitis B who started ETV or TDF treatment without baseline cancer. Patients were observed for HBsAg seroclearance until death or loss to follow-up. We calculated the incidences and explored the baseline determinants of HBsAg seroclearance using competing risk regression. Results The analysis included 4769 patients (median age, 50 years; 69.05% male), with a median follow-up of 5.16 years (26 614.47 person-years). HBsAg clearance occurred in 58 patients, yielding a 10-year cumulative incidence of 2.11% (95% confidence interval, 1.54%–2.88%) and an annual rate of 0.22% (.17%–.28%). Baseline predictors included low-level viremia with hepatitis B virus DNA <2000 IU/mL (adjusted subdistribution hazard ratio, 3.14 [95% confidence interval, 1.80–5.49]), elevated serum alanine aminotransferase >200 U/L (3.68 [2.07–6.53]), serum bilirubin (1.11 per mg/dL; [1.06–1.17 mg/dL]), and fatty liver (1.84 [1.03–3.29]). Conclusion HBsAg seroclearance rarely occurs in patients with chronic hepatitis B treated with ETV or TDF and is associated with low-level viremia, alanine aminotransferase flare, bilirubin level, and fatty liver. Functional cure of hepatitis B virus infection rarely occurred at an average annual rate of 0.22% during first-line oral antiviral treatment, with higher chances observed in patients with low-level viremia, high-level aminotransferase flare, elevation of serum bilirubin, and fatty liver. |
| Author | Liu, Li Peng, Cheng-Yuan Hoang, Joseph Buti, Maria Kozuka, Ritsuzo Lee, Dong-Hyun Riveiro-Barciela, Mar Tsai, Pei-Chien Nguyen, Mindie H Preda, Carmen Accarino, Elena Vargas Dai, Chia-Yen Trinh, Huy Yeo, Yee Hui Hsu, Yao-Chun Istratescu, Doina Wong, Vincent Wai-Sun Cheung, Ka-Shing Yeh, Ming-Lun Wong, Grace Lai-Hung Cheung, Ramsey Wu, Jia-Ling Chen, Chien-Hung Xie, Qing Chuang, Wan-Long Huang, Jee Fu Huang, Chung-Feng Yu, Ming-Lung Enomoto, Masaru Yuen, Man-Fung |
| Author_xml | – sequence: 1 givenname: Yao-Chun surname: Hsu fullname: Hsu, Yao-Chun organization: Center for Liver Diseases and School of Medicine, E-Da Hospital/I-Shou University, Kaohsiung, Taiwan – sequence: 2 givenname: Ming-Lun surname: Yeh fullname: Yeh, Ming-Lun organization: Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan – sequence: 3 givenname: Grace Lai-Hung surname: Wong fullname: Wong, Grace Lai-Hung organization: Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong SAR, China – sequence: 4 givenname: Chien-Hung surname: Chen fullname: Chen, Chien-Hung organization: Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan – sequence: 5 givenname: Cheng-Yuan orcidid: 0000-0001-9030-6086 surname: Peng fullname: Peng, Cheng-Yuan organization: Center for Digestive Medicine, China Medical University Hospital, Taichung, Taiwan – sequence: 6 givenname: Maria surname: Buti fullname: Buti, Maria organization: Liver Unit, Department of Internal Medicine, Hospital Universitari Valle d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain – sequence: 7 givenname: Masaru surname: Enomoto fullname: Enomoto, Masaru organization: Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan – sequence: 8 givenname: Qing surname: Xie fullname: Xie, Qing organization: Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China – sequence: 9 givenname: Huy surname: Trinh fullname: Trinh, Huy organization: San Jose Gastroenterology, San Jose, California, USA – sequence: 10 givenname: Carmen surname: Preda fullname: Preda, Carmen organization: Institutul Clinic Fundeni-Gastroenterologie si Hepatologie, Bucuresti, Romania – sequence: 11 givenname: Li surname: Liu fullname: Liu, Li organization: Department of Infection Disease, Third Hospital of Kumming City, Kumming, China – sequence: 12 givenname: Ka-Shing surname: Cheung fullname: Cheung, Ka-Shing organization: Department of Medicine, University of Hong Kong, Hong Kong SAR, China – sequence: 13 givenname: Yee Hui surname: Yeo fullname: Yeo, Yee Hui organization: Department of Medicine, Stanford University Medical Center, Palo Alto, California, USA – sequence: 14 givenname: Joseph surname: Hoang fullname: Hoang, Joseph organization: Department of Medicine, Stanford University Medical Center, Palo Alto, California, USA – sequence: 15 givenname: Chung-Feng surname: Huang fullname: Huang, Chung-Feng organization: Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan – sequence: 16 givenname: Mar surname: Riveiro-Barciela fullname: Riveiro-Barciela, Mar organization: Liver Unit, Department of Internal Medicine, Hospital Universitari Valle d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain – sequence: 17 givenname: Ritsuzo surname: Kozuka fullname: Kozuka, Ritsuzo organization: Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan – sequence: 18 givenname: Doina surname: Istratescu fullname: Istratescu, Doina organization: Institutul Clinic Fundeni-Gastroenterologie si Hepatologie, Bucuresti, Romania – sequence: 19 givenname: Pei-Chien orcidid: 0000-0002-5044-6727 surname: Tsai fullname: Tsai, Pei-Chien organization: Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan – sequence: 20 givenname: Elena Vargas surname: Accarino fullname: Accarino, Elena Vargas organization: Liver Unit, Department of Internal Medicine, Hospital Universitari Valle d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain – sequence: 21 givenname: Dong-Hyun surname: Lee fullname: Lee, Dong-Hyun organization: Department of Gastroenterology, Good Gang-An Hospital, Busan, South Korea – sequence: 22 givenname: Jia-Ling surname: Wu fullname: Wu, Jia-Ling organization: Department of Public Health, National Cheng Kung University, College of Medicine, Tainan, Taiwan – sequence: 23 givenname: Jee Fu surname: Huang fullname: Huang, Jee Fu organization: Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan – sequence: 24 givenname: Chia-Yen orcidid: 0000-0003-2296-3054 surname: Dai fullname: Dai, Chia-Yen organization: Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan – sequence: 25 givenname: Ramsey surname: Cheung fullname: Cheung, Ramsey organization: Department of Medicine, Stanford University Medical Center, Palo Alto, California, USA – sequence: 26 givenname: Wan-Long surname: Chuang fullname: Chuang, Wan-Long organization: Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan – sequence: 27 givenname: Man-Fung surname: Yuen fullname: Yuen, Man-Fung organization: Department of Medicine, University of Hong Kong, Hong Kong SAR, China – sequence: 28 givenname: Vincent Wai-Sun orcidid: 0000-0003-2215-9410 surname: Wong fullname: Wong, Vincent Wai-Sun organization: Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong SAR, China – sequence: 29 givenname: Ming-Lung orcidid: 0000-0001-8145-1900 surname: Yu fullname: Yu, Ming-Lung organization: Hepatitis Center and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan – sequence: 30 givenname: Mindie H surname: Nguyen fullname: Nguyen, Mindie H email: mindiehn@stanford.edu organization: Department of Medicine, Stanford University Medical Center, Palo Alto, California, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33999179$$D View this record in MEDLINE/PubMed |
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| Copyright_xml | – notice: The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com. 2021 – notice: The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com. |
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| Keywords | hepatitis B surface antigens entecavir functional cure REAL-B tenofovir hepatitis B virus |
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| License | This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com. |
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Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir... Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir... Background Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or... |
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| SubjectTerms | Alanine Alanine transaminase Alanine Transaminase - blood Antiretroviral drugs Antiviral Agents - therapeutic use Antiviral drugs Bilirubin Bilirubin - blood China - epidemiology Cohort Studies Confidence intervals DNA viruses DNA, Viral Fatty Liver Female Guanine - analogs & derivatives Guanine - therapeutic use Hepatitis Hepatitis B Hepatitis B surface antigen Hepatitis B Surface Antigens - blood Hepatitis B virus - genetics Hepatitis B virus - isolation & purification Hepatitis B, Chronic - drug therapy Hepatitis B, Chronic - epidemiology Humans Incidence Interferon Male Middle Aged Patients Tenofovir Tenofovir - therapeutic use Treatment Outcome Viremia |
| Title | Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B |
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