Durability of Hepatitis B Surface Antigen Loss With Nucleotide Analogue and Peginterferon Therapy in Patients With Chronic Hepatitis B
In patients with chronic hepatitis B (CHB), loss of hepatitis B surface antigen (HBsAg) is considered a functional cure. However, HBsAg loss is uncommon with existing therapies, and predictive factors associated with HBsAg seroreversion are unknown. Using pooled data from three phase 3 clinical tria...
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| Published in | Hepatology communications Vol. 4; no. 1; pp. 8 - 20 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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United States
Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
01.01.2020
John Wiley & Sons Inc John Wiley and Sons Inc Wolters Kluwer Health/LWW |
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| Abstract | In patients with chronic hepatitis B (CHB), loss of hepatitis B surface antigen (HBsAg) is considered a functional cure. However, HBsAg loss is uncommon with existing therapies, and predictive factors associated with HBsAg seroreversion are unknown. Using pooled data from three phase 3 clinical trials of patients with CHB treated with nucleos(t)ide analogue (NUC) monotherapy or peginterferon (Peg‐IFN) ± NUC combination therapy, we conducted a retrospective analysis to characterize patients who achieved sustained HBsAg loss, the predictors of HBsAg seroreversion, and the impact of hepatitis B surface antibody (anti‐HBs) seroconversion on durability of HBsAg loss. In these three international trials, 1,381 adults with CHB received either NUC monotherapy for up to 10 years or Peg‐IFN‐containing regimens for up to 1 year. A total of 55 patients had confirmed HBsAg loss, defined as two or more consecutive negative‐qualitative HBsAg results, with a minimum of one repeat result after the end of treatment. Throughout a median of 96 (quartile [Q]1, Q3, 46, 135) weeks follow‐up after HBsAg loss, HBsAg loss was durable in 82% (n = 45) of patients, with 10 patients experiencing HBsAg seroreversion. Anti‐HBs seroconversion was observed during follow‐up in 78% of patients who lost HBsAg and in 60% of those who subsequently seroreverted. In analyzing predictors of HBsAg seroreversion, study treatment was significant, yet anti‐HBs seroconversion and treatment duration after initial HBsAg loss were not. Risk of HBsAg seroreversion was observed to be lower if HBsAg loss was sustained through the off‐treatment week 24 visit (8/10 seroreversions occurred by posttreatment week 24). Conclusion: HBsAg loss after NUC or Peg‐IFN‐containing regimens was durable in 82% of patients with CHB. Anti‐HBs seroconversion and treatment duration after initial HBsAg loss were not significantly associated with durability of HBsAg loss. |
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| AbstractList | In patients with chronic hepatitis B (CHB), loss of hepatitis B surface antigen (HBsAg) is considered a functional cure. However, HBsAg loss is uncommon with existing therapies, and predictive factors associated with HBsAg seroreversion are unknown. Using pooled data from three phase 3 clinical trials of patients with CHB treated with nucleos(t)ide analogue (NUC) monotherapy or peginterferon (Peg‐IFN) ± NUC combination therapy, we conducted a retrospective analysis to characterize patients who achieved sustained HBsAg loss, the predictors of HBsAg seroreversion, and the impact of hepatitis B surface antibody (anti‐HBs) seroconversion on durability of HBsAg loss. In these three international trials, 1,381 adults with CHB received either NUC monotherapy for up to 10 years or Peg‐IFN‐containing regimens for up to 1 year. A total of 55 patients had confirmed HBsAg loss, defined as two or more consecutive negative‐qualitative HBsAg results, with a minimum of one repeat result after the end of treatment. Throughout a median of 96 (quartile [Q]1, Q3, 46, 135) weeks follow‐up after HBsAg loss, HBsAg loss was durable in 82% (n = 45) of patients, with 10 patients experiencing HBsAg seroreversion. Anti‐HBs seroconversion was observed during follow‐up in 78% of patients who lost HBsAg and in 60% of those who subsequently seroreverted. In analyzing predictors of HBsAg seroreversion, study treatment was significant, yet anti‐HBs seroconversion and treatment duration after initial HBsAg loss were not. Risk of HBsAg seroreversion was observed to be lower if HBsAg loss was sustained through the off‐treatment week 24 visit (8/10 seroreversions occurred by posttreatment week 24). Conclusion: HBsAg loss after NUC or Peg‐IFN‐containing regimens was durable in 82% of patients with CHB. Anti‐HBs seroconversion and treatment duration after initial HBsAg loss were not significantly associated with durability of HBsAg loss. In patients with chronic hepatitis B (CHB), loss of hepatitis B surface antigen (HBsAg) is considered a functional cure. However, HBsAg loss is uncommon with existing therapies, and predictive factors associated with HBsAg seroreversion are unknown. Using pooled data from three phase 3 clinical trials of patients with CHB treated with nucleos(t)ide analogue (NUC) monotherapy or peginterferon (Peg-IFN) ± NUC combination therapy, we conducted a retrospective analysis to characterize patients who achieved sustained HBsAg loss, the predictors of HBsAg seroreversion, and the impact of hepatitis B surface antibody (anti-HBs) seroconversion on durability of HBsAg loss. In these three international trials, 1,381 adults with CHB received either NUC monotherapy for up to 10 years or Peg-IFN-containing regimens for up to 1 year. A total of 55 patients had confirmed HBsAg loss, defined as two or more consecutive negative-qualitative HBsAg results, with a minimum of one repeat result after the end of treatment. Throughout a median of 96 (quartile [Q]1, Q3, 46, 135) weeks follow-up after HBsAg loss, HBsAg loss was durable in 82% (n = 45) of patients, with 10 patients experiencing HBsAg seroreversion. Anti-HBs seroconversion was observed during follow-up in 78% of patients who lost HBsAg and in 60% of those who subsequently seroreverted. In analyzing predictors of HBsAg seroreversion, study treatment was significant, yet anti-HBs seroconversion and treatment duration after initial HBsAg loss were not. Risk of HBsAg seroreversion was observed to be lower if HBsAg loss was sustained through the off-treatment week 24 visit (8/10 seroreversions occurred by posttreatment week 24). Conclusion: HBsAg loss after NUC or Peg-IFN-containing regimens was durable in 82% of patients with CHB. Anti-HBs seroconversion and treatment duration after initial HBsAg loss were not significantly associated with durability of HBsAg loss. In patients with chronic hepatitis B (CHB), loss of hepatitis B surface antigen (HBsAg) is considered a functional cure. However, HBsAg loss is uncommon with existing therapies, and predictive factors associated with HBsAg seroreversion are unknown. Using pooled data from three phase 3 clinical trials of patients with CHB treated with nucleos(t)ide analogue (NUC) monotherapy or peginterferon (Peg‐IFN) ± NUC combination therapy, we conducted a retrospective analysis to characterize patients who achieved sustained HBsAg loss, the predictors of HBsAg seroreversion, and the impact of hepatitis B surface antibody (anti‐HBs) seroconversion on durability of HBsAg loss. In these three international trials, 1,381 adults with CHB received either NUC monotherapy for up to 10 years or Peg‐IFN‐containing regimens for up to 1 year. A total of 55 patients had confirmed HBsAg loss, defined as two or more consecutive negative‐qualitative HBsAg results, with a minimum of one repeat result after the end of treatment. Throughout a median of 96 (quartile [Q]1, Q3, 46, 135) weeks follow‐up after HBsAg loss, HBsAg loss was durable in 82% (n = 45) of patients, with 10 patients experiencing HBsAg seroreversion. Anti‐HBs seroconversion was observed during follow‐up in 78% of patients who lost HBsAg and in 60% of those who subsequently seroreverted. In analyzing predictors of HBsAg seroreversion, study treatment was significant, yet anti‐HBs seroconversion and treatment duration after initial HBsAg loss were not. Risk of HBsAg seroreversion was observed to be lower if HBsAg loss was sustained through the off‐treatment week 24 visit (8/10 seroreversions occurred by posttreatment week 24). Conclusion: HBsAg loss after NUC or Peg‐IFN‐containing regimens was durable in 82% of patients with CHB. Anti‐HBs seroconversion and treatment duration after initial HBsAg loss were not significantly associated with durability of HBsAg loss. In patients with chronic hepatitis B (CHB), loss of hepatitis B surface antigen (HBsAg) is considered a functional cure. However, HBsAg loss is uncommon with existing therapies, and predictive factors associated with HBsAg seroreversion are unknown. Using pooled data from three phase 3 clinical trials of patients with CHB treated with nucleos(t)ide analogue (NUC) monotherapy or peginterferon (Peg-IFN) ± NUC combination therapy, we conducted a retrospective analysis to characterize patients who achieved sustained HBsAg loss, the predictors of HBsAg seroreversion, and the impact of hepatitis B surface antibody (anti-HBs) seroconversion on durability of HBsAg loss. In these three international trials, 1,381 adults with CHB received either NUC monotherapy for up to 10 years or Peg-IFN-containing regimens for up to 1 year. A total of 55 patients had confirmed HBsAg loss, defined as two or more consecutive negative-qualitative HBsAg results, with a minimum of one repeat result after the end of treatment. Throughout a median of 96 (quartile [Q]1, Q3, 46, 135) weeks follow-up after HBsAg loss, HBsAg loss was durable in 82% (n = 45) of patients, with 10 patients experiencing HBsAg seroreversion. Anti-HBs seroconversion was observed during follow-up in 78% of patients who lost HBsAg and in 60% of those who subsequently seroreverted. In analyzing predictors of HBsAg seroreversion, study treatment was significant, yet anti-HBs seroconversion and treatment duration after initial HBsAg loss were not. Risk of HBsAg seroreversion was observed to be lower if HBsAg loss was sustained through the off-treatment week 24 visit (8/10 seroreversions occurred by posttreatment week 24). HBsAg loss after NUC or Peg-IFN-containing regimens was durable in 82% of patients with CHB. Anti-HBs seroconversion and treatment duration after initial HBsAg loss were not significantly associated with durability of HBsAg loss. In patients with chronic hepatitis B (CHB), loss of hepatitis B surface antigen (HBsAg) is considered a functional cure. However, HBsAg loss is uncommon with existing therapies, and predictive factors associated with HBsAg seroreversion are unknown. Using pooled data from three phase 3 clinical trials of patients with CHB treated with nucleos(t)ide analogue (NUC) monotherapy or peginterferon (Peg-IFN) ± NUC combination therapy, we conducted a retrospective analysis to characterize patients who achieved sustained HBsAg loss, the predictors of HBsAg seroreversion, and the impact of hepatitis B surface antibody (anti-HBs) seroconversion on durability of HBsAg loss. In these three international trials, 1,381 adults with CHB received either NUC monotherapy for up to 10 years or Peg-IFN-containing regimens for up to 1 year. A total of 55 patients had confirmed HBsAg loss, defined as two or more consecutive negative-qualitative HBsAg results, with a minimum of one repeat result after the end of treatment. Throughout a median of 96 (quartile [Q]1, Q3, 46, 135) weeks follow-up after HBsAg loss, HBsAg loss was durable in 82% (n = 45) of patients, with 10 patients experiencing HBsAg seroreversion. Anti-HBs seroconversion was observed during follow-up in 78% of patients who lost HBsAg and in 60% of those who subsequently seroreverted. In analyzing predictors of HBsAg seroreversion, study treatment was significant, yet anti-HBs seroconversion and treatment duration after initial HBsAg loss were not. Risk of HBsAg seroreversion was observed to be lower if HBsAg loss was sustained through the off-treatment week 24 visit (8/10 seroreversions occurred by posttreatment week 24). Conclusion: HBsAg loss after NUC or Peg-IFN-containing regimens was durable in 82% of patients with CHB. Anti-HBs seroconversion and treatment duration after initial HBsAg loss were not significantly associated with durability of HBsAg loss.In patients with chronic hepatitis B (CHB), loss of hepatitis B surface antigen (HBsAg) is considered a functional cure. However, HBsAg loss is uncommon with existing therapies, and predictive factors associated with HBsAg seroreversion are unknown. Using pooled data from three phase 3 clinical trials of patients with CHB treated with nucleos(t)ide analogue (NUC) monotherapy or peginterferon (Peg-IFN) ± NUC combination therapy, we conducted a retrospective analysis to characterize patients who achieved sustained HBsAg loss, the predictors of HBsAg seroreversion, and the impact of hepatitis B surface antibody (anti-HBs) seroconversion on durability of HBsAg loss. In these three international trials, 1,381 adults with CHB received either NUC monotherapy for up to 10 years or Peg-IFN-containing regimens for up to 1 year. A total of 55 patients had confirmed HBsAg loss, defined as two or more consecutive negative-qualitative HBsAg results, with a minimum of one repeat result after the end of treatment. Throughout a median of 96 (quartile [Q]1, Q3, 46, 135) weeks follow-up after HBsAg loss, HBsAg loss was durable in 82% (n = 45) of patients, with 10 patients experiencing HBsAg seroreversion. Anti-HBs seroconversion was observed during follow-up in 78% of patients who lost HBsAg and in 60% of those who subsequently seroreverted. In analyzing predictors of HBsAg seroreversion, study treatment was significant, yet anti-HBs seroconversion and treatment duration after initial HBsAg loss were not. Risk of HBsAg seroreversion was observed to be lower if HBsAg loss was sustained through the off-treatment week 24 visit (8/10 seroreversions occurred by posttreatment week 24). Conclusion: HBsAg loss after NUC or Peg-IFN-containing regimens was durable in 82% of patients with CHB. Anti-HBs seroconversion and treatment duration after initial HBsAg loss were not significantly associated with durability of HBsAg loss. |
| Author | Flaherty, John F. Zoulim, Fabien Buti, Maria Ghany, Marc G. Yang, Jenny C. Chan, Henry L.Y. Gaggar, Anuj Subramanian, G. Mani Marcellin, Patrick Wu, George Dusheiko, Geoffrey Lok, Anna S. Locarnini, Stephen |
| AuthorAffiliation | 3 Kings College Hospital University College London Medical School London United Kingdom 5 Vall d’Hebron Hospital Barcelona Spain 8 Victorian Infectious Diseases Reference Laboratory Melbourne Australia 9 Hôpital Beaujon Université de Paris Diderot Clichy France 2 Hospices Civils de Lyon and INSERM Unit 1052 Lyon France 1 University of Michigan Ann Arbor MI 6 National Institutes of Health Bethesda MD 7 Gilead Sciences, Inc. Foster City CA 4 Chinese University of Hong Kong Hong Kong S.A.R |
| AuthorAffiliation_xml | – name: 3 Kings College Hospital University College London Medical School London United Kingdom – name: 5 Vall d’Hebron Hospital Barcelona Spain – name: 7 Gilead Sciences, Inc. Foster City CA – name: 6 National Institutes of Health Bethesda MD – name: 8 Victorian Infectious Diseases Reference Laboratory Melbourne Australia – name: 4 Chinese University of Hong Kong Hong Kong S.A.R – name: 9 Hôpital Beaujon Université de Paris Diderot Clichy France – name: 2 Hospices Civils de Lyon and INSERM Unit 1052 Lyon France – name: 1 University of Michigan Ann Arbor MI |
| Author_xml | – sequence: 1 givenname: Anna S. surname: Lok fullname: Lok, Anna S. email: aslok@med.umich.edu organization: University of Michigan – sequence: 2 givenname: Fabien surname: Zoulim fullname: Zoulim, Fabien organization: Hospices Civils de Lyon and INSERM Unit 1052 – sequence: 3 givenname: Geoffrey surname: Dusheiko fullname: Dusheiko, Geoffrey organization: University College London Medical School – sequence: 4 givenname: Henry L.Y. surname: Chan fullname: Chan, Henry L.Y. organization: Chinese University of Hong Kong – sequence: 5 givenname: Maria surname: Buti fullname: Buti, Maria organization: Vall d’Hebron Hospital – sequence: 6 givenname: Marc G. surname: Ghany fullname: Ghany, Marc G. organization: National Institutes of Health – sequence: 7 givenname: Anuj surname: Gaggar fullname: Gaggar, Anuj organization: Gilead Sciences, Inc – sequence: 8 givenname: Jenny C. surname: Yang fullname: Yang, Jenny C. organization: Gilead Sciences, Inc – sequence: 9 givenname: George surname: Wu fullname: Wu, George organization: Gilead Sciences, Inc – sequence: 10 givenname: John F. surname: Flaherty fullname: Flaherty, John F. organization: Gilead Sciences, Inc – sequence: 11 givenname: G. Mani surname: Subramanian fullname: Subramanian, G. Mani organization: Gilead Sciences, Inc – sequence: 12 givenname: Stephen surname: Locarnini fullname: Locarnini, Stephen organization: Victorian Infectious Diseases Reference Laboratory – sequence: 13 givenname: Patrick surname: Marcellin fullname: Marcellin, Patrick organization: Université de Paris Diderot |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31909352$$D View this record in MEDLINE/PubMed https://hal.science/hal-03932571$$DView record in HAL |
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| ContentType | Journal Article |
| Copyright | 2019 The Authors. Hepatology Communications published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases. 2020. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. Distributed under a Creative Commons Attribution 4.0 International License |
| Copyright_xml | – notice: 2019 The Authors. Hepatology Communications published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases. – notice: 2020. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: Distributed under a Creative Commons Attribution 4.0 International License |
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| DOI | 10.1002/hep4.1436 |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 PMCID: PMC6939500 Supported by Gilead Sciences. SEE EDITORIAL ON PAGE https://doi.org/10.1002/hep4.1476 Potential conflict of interest: Dr. Locarnini consults for Gilead, Clear‐B, and I‐Hep/Janssen. Dr. Dusheiko consults for and received grants from Gilead. Dr. Buti consults for and advises Gilead. Dr. Subramanian, Dr. Yang, Dr. Wu, Dr. Flaherty, and Dr. Gaggar own stock in and are employed by Gilead. Dr. Chan consults for and is on the speakers’ bureau for Gilead and Roche. Dr. Marcellin consults for and received grants from Gilead, Merck, and Eiger; he consults for Hebaziz, is on the speakers’ bureau for Mylan, and received grants from AbbVie. Dr. Zoulim received grants from and consults for Roche; he consults for Janssen and Gilead and received grants from Evotec. Dr. Lok advises and received grants from Gilead and Target; she advises Huahui, Roche, SpringBank, and Viravaxx and received grants from Assembly and BMS. Dr. Ghany has nothing to report. |
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| References | 2017; 2 2019; 70 2006; 119 2017; 66 2016; 144 2018; 63 2012; 18 2018; 67 2014; 63 2013; 381 2016; 36 2009; 49 2014; 3 2009; 50 2015; 61 2013; 51 2002; 123 2019 2016; 63 2008; 359 2017 2011; 26 2011; 140 2016; 150 2016; 44 (hep41436-bib-0016-20240114) 2002; 123 (hep41436-bib-0019-20240114) 2019; 70 (hep41436-bib-0014-20240114) 2018; 63 (hep41436-bib-0006-20240114) 2008; 359 (hep41436-bib-0022-20240114) 2006; 119 (hep41436-bib-0025-20240114) 2009; 49 (hep41436-bib-0010-20240114) 2014; 3 (hep41436-bib-0015-20240114) 2019 (hep41436-bib-0009-20240114) 2016; 36 (hep41436-bib-0026-20240114) 2015; 61 (hep41436-bib-0024-20240114) 2013; 51 (hep41436-bib-0004-20240114) 2018; 67 (hep41436-bib-0023-20240114) 2012; 18 (hep41436-bib-0017-20240114) 2011; 26 (hep41436-bib-0012-20240114) 2016; 44 (hep41436-bib-0005-20240114) 2016; 150 (hep41436-bib-0020-20240114) 2016; 144 (hep41436-bib-0003-20240114) 2017; 66 (hep41436-bib-0021-20240114) 2017 (hep41436-bib-0011-20240114) 2009; 50 (hep41436-bib-0008-20240114) 2013; 381 (hep41436-bib-0013-20240114) 2017; 2 (hep41436-bib-0007-20240114) 2011; 140 (hep41436-bib-0002-20240114) 2016; 63 (hep41436-bib-0018-20240114) 2014; 63 |
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clearance of addition of pegylated interferon alfa‐2a to nucleos(t)ide analogue therapy versus nucleos(t)ide analogue therapy alone in patients with HBe antigen‐negative chronic hepatitis B and sustained undetectable plasma hepatitis B virus DNA: a randomised, controlled, open‐label trial publication-title: Lancet Gastroenterol Hepatol doi: 10.1016/S2468-1253(16)30189-3 – volume: 67 start-page: 1560 year: 2018 ident: hep41436-bib-0004-20240114 article-title: Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance publication-title: Hepatology doi: 10.1002/hep.29800 – volume: 70 start-page: 361 year: 2019 ident: hep41436-bib-0019-20240114 article-title: HBsAg seroclearance further reduces hepatocellular carcinoma risk after complete viral suppression with nucleos(t)ide analogues publication-title: J Hepatol doi: 10.1016/j.jhep.2018.10.014 – volume: 140 start-page: 132 year: 2011 ident: hep41436-bib-0007-20240114 article-title: Three‐year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B publication-title: Gastroenterology doi: 10.1053/j.gastro.2010.10.011 – volume: 51 start-page: 3484 year: 2013 ident: hep41436-bib-0024-20240114 article-title: Application of a newly developed high‐sensitivity HBsAg chemiluminescent enzyme immunoassay for hepatitis B patients with HBsAg seroclearance publication-title: J Clin Microbiol doi: 10.1128/JCM.00726-13 – volume: 144 start-page: 2648 year: 2016 ident: hep41436-bib-0020-20240114 article-title: Time to seroconversion of HBsAg to anti‐HBs in individuals who lost HBsAg during follow‐up publication-title: Epidemiol Infect doi: 10.1017/S0950268816001217 – year: 2019 ident: hep41436-bib-0015-20240114 article-title: Durability of interferon‐induced hepatitis B surface antigen seroclearance publication-title: Clin Gastroenterol Hepatol |
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| Snippet | In patients with chronic hepatitis B (CHB), loss of hepatitis B surface antigen (HBsAg) is considered a functional cure. However, HBsAg loss is uncommon with... |
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| SubjectTerms | Antigens Cancer Clinical trials Deoxyribonucleic acid DNA Enzymes Hepatitis Hepatitis B Immunoassay Infections Interferon Laboratories Life Sciences Liver cancer Original Studies |
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| Title | Durability of Hepatitis B Surface Antigen Loss With Nucleotide Analogue and Peginterferon Therapy in Patients With Chronic Hepatitis B |
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