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Article: Three years of continuous entecavir therapy in treatment-nave chronic hepatitis B patients: VIRAL suppression, viral resistance, and clinical safety
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TitleThree years of continuous entecavir therapy in treatment-nave chronic hepatitis B patients: VIRAL suppression, viral resistance, and clinical safety
 
AuthorsYuen, MF1
Seto, WK1
Fung, J1
Wong, DKH1
Yuen, JCH1
Lai, CL1
 
Issue Date2011
 
PublisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/ajg/index.html
 
CitationAmerican Journal Of Gastroenterology, 2011, v. 106 n. 7, p. 1264-1271 [How to Cite?]
DOI: http://dx.doi.org/10.1038/ajg.2011.45
 
AbstractObjectives: We aimed to determine the antiviral potency, viral resistance rate, and clinical safety of 3-year continuous entecavir treatment. Methods: We determined the cumulative rates of undetectable hepatitis B virus DNA (HBV DNA) levels (12 IU/ml), hepatitis B e antigen (HBeAg) seroconversion, alanine aminotransferase (ALT) normalization, and entecavir signature mutations (using the sensitive line probe assay) and monitored any side effects for 222 treatment-nave chronic hepatitis B (CHB) patients (40.5% HBeAg positive) on continuous entecavir treatment for 3 years. Results: The median age and follow-up duration were 45 years and 25.1 months, respectively. In all, 222, 188, and 101 patients had been followed up for at least 1, 2, and 3 years, respectively. There were incremental increases in the rates of HBV DNA undetectability, HBeAg seroconversion, and ALT normalization reaching to 92.1, 43.9, and 90.4% at year 3, respectively. In all, 100 and 76.5% of patients with baseline HBV DNA levels and 8 logs copies/ml, respectively, had undetectable HBV DNA at year 3. The cumulative rate of entecavir-resistant mutations was 1.2% at year 3. Three patients experienced virologic breakthrough, one with resistance development, one with subsequent HBeAg seroconversion, and one with subsequent decline in HBV DNA. Two patients with baseline rt204I mutations responded to entecavir treatment. There were no serious adverse events. Conclusions: Using very sensitive HBV DNA and viral resistance assays, continuous entecavir treatment for treatment-nave CHB patients for 3 years was associated with 90% chance of undetectable HBV DNA and only 1.2% chance of emergence of entecavir-resistant mutations. © 2011 by the American College of Gastroenterology.
 
ISSN0002-9270
2012 Impact Factor: 7.553
2012 SCImago Journal Rankings: 2.574
 
DOIhttp://dx.doi.org/10.1038/ajg.2011.45
 
ISI Accession Number IDWOS:000292511100011
Funding AgencyGrant Number
Bristol-Myers Squibb Company
GlaxoSmithKline
Novartis
Gilead Sciences
Bristol Myers Squibbs
Funding Information:

The assays used to determine the HBV DNA levels (Cobas Taqman assay) and viral resistance (Line probe assay) which were performed at our own laboratory were supported by an unrestricted grant from Bristol-Myers Squibb Company.

 
ReferencesReferences in Scopus
 
DC FieldValue
dc.contributor.authorYuen, MF
 
dc.contributor.authorSeto, WK
 
dc.contributor.authorFung, J
 
dc.contributor.authorWong, DKH
 
dc.contributor.authorYuen, JCH
 
dc.contributor.authorLai, CL
 
dc.date.accessioned2011-08-26T14:24:12Z
 
dc.date.available2011-08-26T14:24:12Z
 
dc.date.issued2011
 
dc.description.abstractObjectives: We aimed to determine the antiviral potency, viral resistance rate, and clinical safety of 3-year continuous entecavir treatment. Methods: We determined the cumulative rates of undetectable hepatitis B virus DNA (HBV DNA) levels (12 IU/ml), hepatitis B e antigen (HBeAg) seroconversion, alanine aminotransferase (ALT) normalization, and entecavir signature mutations (using the sensitive line probe assay) and monitored any side effects for 222 treatment-nave chronic hepatitis B (CHB) patients (40.5% HBeAg positive) on continuous entecavir treatment for 3 years. Results: The median age and follow-up duration were 45 years and 25.1 months, respectively. In all, 222, 188, and 101 patients had been followed up for at least 1, 2, and 3 years, respectively. There were incremental increases in the rates of HBV DNA undetectability, HBeAg seroconversion, and ALT normalization reaching to 92.1, 43.9, and 90.4% at year 3, respectively. In all, 100 and 76.5% of patients with baseline HBV DNA levels and 8 logs copies/ml, respectively, had undetectable HBV DNA at year 3. The cumulative rate of entecavir-resistant mutations was 1.2% at year 3. Three patients experienced virologic breakthrough, one with resistance development, one with subsequent HBeAg seroconversion, and one with subsequent decline in HBV DNA. Two patients with baseline rt204I mutations responded to entecavir treatment. There were no serious adverse events. Conclusions: Using very sensitive HBV DNA and viral resistance assays, continuous entecavir treatment for treatment-nave CHB patients for 3 years was associated with 90% chance of undetectable HBV DNA and only 1.2% chance of emergence of entecavir-resistant mutations. © 2011 by the American College of Gastroenterology.
 
dc.description.naturelink_to_subscribed_fulltext
 
dc.identifier.citationAmerican Journal Of Gastroenterology, 2011, v. 106 n. 7, p. 1264-1271 [How to Cite?]
DOI: http://dx.doi.org/10.1038/ajg.2011.45
 
dc.identifier.doihttp://dx.doi.org/10.1038/ajg.2011.45
 
dc.identifier.epage1271
 
dc.identifier.hkuros189853
 
dc.identifier.hkuros211264
 
dc.identifier.isiWOS:000292511100011
Funding AgencyGrant Number
Bristol-Myers Squibb Company
GlaxoSmithKline
Novartis
Gilead Sciences
Bristol Myers Squibbs
Funding Information:

The assays used to determine the HBV DNA levels (Cobas Taqman assay) and viral resistance (Line probe assay) which were performed at our own laboratory were supported by an unrestricted grant from Bristol-Myers Squibb Company.

 
dc.identifier.issn0002-9270
2012 Impact Factor: 7.553
2012 SCImago Journal Rankings: 2.574
 
dc.identifier.issue7
 
dc.identifier.pmid21364549
 
dc.identifier.scopuseid_2-s2.0-79960059346
 
dc.identifier.spage1264
 
dc.identifier.urihttp://hdl.handle.net/10722/137385
 
dc.identifier.volume106
 
dc.languageeng
 
dc.publisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/ajg/index.html
 
dc.publisher.placeUnited States
 
dc.relation.ispartofAmerican Journal of Gastroenterology
 
dc.relation.referencesReferences in Scopus
 
dc.subject.meshAntiviral Agents - adverse effects - therapeutic use
 
dc.subject.meshDNA, Viral - blood
 
dc.subject.meshHepatitis B virus - genetics
 
dc.subject.meshHepatitis B, Chronic - drug therapy - virology
 
dc.subject.meshMutation
 
dc.titleThree years of continuous entecavir therapy in treatment-nave chronic hepatitis B patients: VIRAL suppression, viral resistance, and clinical safety
 
dc.typeArticle
 
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<contributor.author>Yuen, JCH</contributor.author>
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Author Affiliations
  1. The University of Hong Kong