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Article: Entecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infection

TitleEntecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infection
Authors
Issue Date2002
PublisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro
Citation
Gastroenterology, 2002, v. 123 n. 6, p. 1831-1838 How to Cite?
AbstractBackground & Aims: Entecavir is a novel and selective nucleoside analogue with potent activity against hepatitis B virus (HBV). Methods: In a 24-week, double-blind, randomized, multicenter, phase II clinical trial, the safety and efficacy of entecavir (0.01 mg/day, 0.1 mg/ day, or 0.5 mg/day orally) were compared with lamivudine (100 mg/day orally). Patients (n = 169) chronically infected with HBV (hepatitis B e antigen [HBeAg]-positive and -negative) were evaluated for efficacy. Results: Compared with lamivudine, entecavir reduced HBV DNA by an additional 0.97 log10 at the 0.1-mg/day dose and an additional 1.28 log10 at the 0.5-mg/day dose (P < 0.0001). A clear dose-response relationship was observed for entecavir with the higher doses showing significantly greater viral suppression. In patients treated with entecavir 0.5 mg/day, 83.7% had an HBV-DNA level below the lower limit of detection of the Quantiplex branched DNA (bDNA) assay (Bayer-Versant Diagnostics, formerly Chiron Diagnostics, Emeryville, CA), compared with 57.5% treated with 100 mg/day lamivudine (P = 0.008). In both treatment arms, very few patients achieved HBeAg loss and/or seroconversion by week 22. More patients treated with the 0.1-mg/day and 0.5-mg/day doses of entecavir had normalization of alanine transaminase (ALT) levels at week 22 compared with lamivudine (P = not significant). Entecavir was well tolerated; most adverse events were mild to moderate, transient, and comparable in all study arms. Conclusions: This study showed that entecavir has potent antiviral activity against HBV at 0.1-mg/day and 0.5-mg/day doses, both of which were superior to lamivudine in chronically infected HBV patients.
Persistent Identifierhttp://hdl.handle.net/10722/162643
ISSN
2015 Impact Factor: 18.187
2015 SCImago Journal Rankings: 7.170
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLai, CLen_US
dc.contributor.authorRosmawati, Men_US
dc.contributor.authorLao, Jen_US
dc.contributor.authorVan Vlierberghe, Hen_US
dc.contributor.authorAnderson, FHen_US
dc.contributor.authorThomas, Nen_US
dc.contributor.authorDehertogh, Den_US
dc.date.accessioned2012-09-05T05:21:59Z-
dc.date.available2012-09-05T05:21:59Z-
dc.date.issued2002en_US
dc.identifier.citationGastroenterology, 2002, v. 123 n. 6, p. 1831-1838en_US
dc.identifier.issn0016-5085en_US
dc.identifier.urihttp://hdl.handle.net/10722/162643-
dc.description.abstractBackground & Aims: Entecavir is a novel and selective nucleoside analogue with potent activity against hepatitis B virus (HBV). Methods: In a 24-week, double-blind, randomized, multicenter, phase II clinical trial, the safety and efficacy of entecavir (0.01 mg/day, 0.1 mg/ day, or 0.5 mg/day orally) were compared with lamivudine (100 mg/day orally). Patients (n = 169) chronically infected with HBV (hepatitis B e antigen [HBeAg]-positive and -negative) were evaluated for efficacy. Results: Compared with lamivudine, entecavir reduced HBV DNA by an additional 0.97 log10 at the 0.1-mg/day dose and an additional 1.28 log10 at the 0.5-mg/day dose (P < 0.0001). A clear dose-response relationship was observed for entecavir with the higher doses showing significantly greater viral suppression. In patients treated with entecavir 0.5 mg/day, 83.7% had an HBV-DNA level below the lower limit of detection of the Quantiplex branched DNA (bDNA) assay (Bayer-Versant Diagnostics, formerly Chiron Diagnostics, Emeryville, CA), compared with 57.5% treated with 100 mg/day lamivudine (P = 0.008). In both treatment arms, very few patients achieved HBeAg loss and/or seroconversion by week 22. More patients treated with the 0.1-mg/day and 0.5-mg/day doses of entecavir had normalization of alanine transaminase (ALT) levels at week 22 compared with lamivudine (P = not significant). Entecavir was well tolerated; most adverse events were mild to moderate, transient, and comparable in all study arms. Conclusions: This study showed that entecavir has potent antiviral activity against HBV at 0.1-mg/day and 0.5-mg/day doses, both of which were superior to lamivudine in chronically infected HBV patients.en_US
dc.languageengen_US
dc.publisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastroen_US
dc.relation.ispartofGastroenterologyen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAlanine Transaminase - Blooden_US
dc.subject.meshDna, Viral - Metabolismen_US
dc.subject.meshDose-Response Relationship, Drugen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshFemaleen_US
dc.subject.meshGuanine - Administration & Dosage - Adverse Effects - Analogs & Derivatives - Therapeutic Useen_US
dc.subject.meshHepatitis B E Antigens - Analysisen_US
dc.subject.meshHepatitis B Virus - Drug Effects - Geneticsen_US
dc.subject.meshHepatitis B, Chronic - Drug Therapy - Genetics - Pathology - Virologyen_US
dc.subject.meshHumansen_US
dc.subject.meshLamivudine - Administration & Dosage - Adverse Effects - Therapeutic Useen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshReverse Transcriptase Inhibitors - Administration & Dosage - Adverse Effects - Therapeutic Useen_US
dc.subject.meshTreatment Outcomeen_US
dc.subject.meshViral Loaden_US
dc.titleEntecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infectionen_US
dc.typeArticleen_US
dc.identifier.emailLai, CL:hrmelcl@hku.hken_US
dc.identifier.authorityLai, CL=rp00314en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1053/gast.2002.37058en_US
dc.identifier.pmid12454840-
dc.identifier.scopuseid_2-s2.0-0036892435en_US
dc.identifier.hkuros80562-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0036892435&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume123en_US
dc.identifier.issue6en_US
dc.identifier.spage1831en_US
dc.identifier.epage1838en_US
dc.identifier.isiWOS:000179545300014-
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridLai, CL=7403086396en_US
dc.identifier.scopusauthoridRosmawati, M=6505773499en_US
dc.identifier.scopusauthoridLao, J=19735235300en_US
dc.identifier.scopusauthoridVan Vlierberghe, H=7005932120en_US
dc.identifier.scopusauthoridAnderson, FH=26633500100en_US
dc.identifier.scopusauthoridThomas, N=36914249100en_US
dc.identifier.scopusauthoridDehertogh, D=6601941025en_US

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