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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

TitleThree years of continuous entecavir therapy in treatment-nave chronic hepatitis B patients: VIRAL suppression, viral resistance, and clinical safety
Authors
Issue Date2011
PublisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/ajg/index.html
Citation
American Journal Of Gastroenterology, 2011, v. 106 n. 7, p. 1264-1271 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/137385
ISSN
2023 Impact Factor: 8.0
2023 SCImago Journal Rankings: 2.391
ISI Accession Number ID
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.

References

 

DC FieldValueLanguage
dc.contributor.authorYuen, MFen_HK
dc.contributor.authorSeto, WKen_HK
dc.contributor.authorFung, Jen_HK
dc.contributor.authorWong, DKHen_HK
dc.contributor.authorYuen, JCHen_HK
dc.contributor.authorLai, CLen_HK
dc.date.accessioned2011-08-26T14:24:12Z-
dc.date.available2011-08-26T14:24:12Z-
dc.date.issued2011en_HK
dc.identifier.citationAmerican Journal Of Gastroenterology, 2011, v. 106 n. 7, p. 1264-1271en_HK
dc.identifier.issn0002-9270en_HK
dc.identifier.urihttp://hdl.handle.net/10722/137385-
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.en_HK
dc.languageengen_US
dc.publisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/ajg/index.htmlen_HK
dc.relation.ispartofAmerican Journal of Gastroenterologyen_HK
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 safetyen_HK
dc.typeArticleen_HK
dc.identifier.emailYuen, MF: mfyuen@hku.hken_HK
dc.identifier.emailSeto, WK: wkseto2@hku.hken_HK
dc.identifier.emailFung, J: jfung@sicklehut.comen_HK
dc.identifier.emailWong, DKH: danywong@hku.hken_HK
dc.identifier.emailLai, CL: hrmelcl@hku.hken_HK
dc.identifier.authorityYuen, MF=rp00479en_HK
dc.identifier.authoritySeto, WK=rp01659en_HK
dc.identifier.authorityFung, J=rp00518en_HK
dc.identifier.authorityWong, DKH=rp00492en_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1038/ajg.2011.45en_HK
dc.identifier.pmid21364549-
dc.identifier.scopuseid_2-s2.0-79960059346en_HK
dc.identifier.hkuros189853en_US
dc.identifier.hkuros211264-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-79960059346&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume106en_HK
dc.identifier.issue7en_HK
dc.identifier.spage1264en_HK
dc.identifier.epage1271en_HK
dc.identifier.isiWOS:000292511100011-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridYuen, MF=7102031955en_HK
dc.identifier.scopusauthoridSeto, WK=23390675900en_HK
dc.identifier.scopusauthoridFung, J=23091109300en_HK
dc.identifier.scopusauthoridWong, DKH=7401535819en_HK
dc.identifier.scopusauthoridYuen, JCH=7102620480en_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.issnl0002-9270-

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