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Article: Safety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infection

TitleSafety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infection
Authors
Issue Date2001
PublisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/
Citation
Hepatology, 2001, v. 34 n. 3, p. 578-582 How to Cite?
AbstractEntecavir is an oral antiviral drug with selective activity against hepatitis B virus (HBV). We conducted a randomized, placebo-controlled, dose-escalating study in patients with chronic hepatitis B infection in which we evaluated the efficacy and safety of entecavir given for 28 days. Follow-up was 24 weeks. All doses of entecavir (0.05 mg, 0.1 mg, 0.5 mg, and 1.0 mg) showed a pronounced suppression of replication of the HBV with a 2.21, 2.29, 2.81, and 2.55 mean log10 reduction of viral load, respectively. Approximately 25% of patients on entecavir showed a decline of HBV DNA below the limit of detection of the Chiron HBV-DNA assay (<0.7 MEq/mL). In the postdosing follow-up period patients who were treated with 0.5 and 1.0 mg of entecavir showed a considerably slower return in their HBV DNA levels to baseline compared with those patients treated with lower dosages (P < .05). All doses of entecavir were well tolerated with no significant difference between treated patients and those receiving placebo. No significant changes in alanine transaminase (ALT) levels within the dose groups and the placebo group between baseline and the end of treatment were observed. Three patients (9%) (1 each in the 0.05-, 0.1-, and 0.5-mg groups) experienced asymptomatic hepatitis flares 16 weeks (2 patients) and 24 weeks (1 patient) after withdrawal of entecavir. In conclusion, in this 28-day study of entecavir a pronounced decrease of HBV DNA was observed and there were no significant side effects in entecavir patients in comparison with placebo-treated patients.
Persistent Identifierhttp://hdl.handle.net/10722/78210
ISSN
2015 Impact Factor: 11.711
2015 SCImago Journal Rankings: 4.752
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorDe Man, RAen_HK
dc.contributor.authorWolters, LMMen_HK
dc.contributor.authorNevens, Fen_HK
dc.contributor.authorChua, Den_HK
dc.contributor.authorSherman, Men_HK
dc.contributor.authorLai, CLen_HK
dc.contributor.authorGadano, Aen_HK
dc.contributor.authorLee, Yen_HK
dc.contributor.authorMazzotta, Fen_HK
dc.contributor.authorThomas, Nen_HK
dc.contributor.authorDeHertogh, Den_HK
dc.date.accessioned2010-09-06T07:40:22Z-
dc.date.available2010-09-06T07:40:22Z-
dc.date.issued2001en_HK
dc.identifier.citationHepatology, 2001, v. 34 n. 3, p. 578-582en_HK
dc.identifier.issn0270-9139en_HK
dc.identifier.urihttp://hdl.handle.net/10722/78210-
dc.description.abstractEntecavir is an oral antiviral drug with selective activity against hepatitis B virus (HBV). We conducted a randomized, placebo-controlled, dose-escalating study in patients with chronic hepatitis B infection in which we evaluated the efficacy and safety of entecavir given for 28 days. Follow-up was 24 weeks. All doses of entecavir (0.05 mg, 0.1 mg, 0.5 mg, and 1.0 mg) showed a pronounced suppression of replication of the HBV with a 2.21, 2.29, 2.81, and 2.55 mean log10 reduction of viral load, respectively. Approximately 25% of patients on entecavir showed a decline of HBV DNA below the limit of detection of the Chiron HBV-DNA assay (<0.7 MEq/mL). In the postdosing follow-up period patients who were treated with 0.5 and 1.0 mg of entecavir showed a considerably slower return in their HBV DNA levels to baseline compared with those patients treated with lower dosages (P < .05). All doses of entecavir were well tolerated with no significant difference between treated patients and those receiving placebo. No significant changes in alanine transaminase (ALT) levels within the dose groups and the placebo group between baseline and the end of treatment were observed. Three patients (9%) (1 each in the 0.05-, 0.1-, and 0.5-mg groups) experienced asymptomatic hepatitis flares 16 weeks (2 patients) and 24 weeks (1 patient) after withdrawal of entecavir. In conclusion, in this 28-day study of entecavir a pronounced decrease of HBV DNA was observed and there were no significant side effects in entecavir patients in comparison with placebo-treated patients.en_HK
dc.languageengen_HK
dc.publisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/en_HK
dc.relation.ispartofHepatologyen_HK
dc.rightsHepatology. Copyright © John Wiley & Sons, Inc.en_HK
dc.subject.meshAdministration, Oralen_HK
dc.subject.meshAntiviral Agents - administration & dosage - adverse effects - therapeutic useen_HK
dc.subject.meshDNA, Viral - analysisen_HK
dc.subject.meshDose-Response Relationship, Drugen_HK
dc.subject.meshDouble-Blind Methoden_HK
dc.subject.meshDrug Administration Scheduleen_HK
dc.subject.meshGuanine - administration & dosage - adverse effects - analogs & derivatives - therapeutic useen_HK
dc.subject.meshHepatitis B virus - geneticsen_HK
dc.subject.meshHepatitis B, Chronic - drug therapy - virologyen_HK
dc.subject.meshHumansen_HK
dc.subject.meshLiver - enzymologyen_HK
dc.subject.meshSafetyen_HK
dc.subject.meshTransaminases - metabolismen_HK
dc.titleSafety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infectionen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0270-9139&volume=34&issue=3&spage=578&epage=582&date=2001&atitle=Safety+and+efficacy+of+oral+entecavir+given+for+28+days+in+patients+with+chronic+hepatitis+B+virus+infection.en_HK
dc.identifier.emailLai, CL:hrmelcl@hku.hken_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1053/jhep.2001.26815en_HK
dc.identifier.pmid11526545-
dc.identifier.scopuseid_2-s2.0-0034867425en_HK
dc.identifier.hkuros66980en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0034867425&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume34en_HK
dc.identifier.issue3en_HK
dc.identifier.spage578en_HK
dc.identifier.epage582en_HK
dc.identifier.isiWOS:000170679200018-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridDe Man, RA=7006113112en_HK
dc.identifier.scopusauthoridWolters, LMM=6603759738en_HK
dc.identifier.scopusauthoridNevens, F=7006163976en_HK
dc.identifier.scopusauthoridChua, D=19642531900en_HK
dc.identifier.scopusauthoridSherman, M=7402148225en_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.scopusauthoridGadano, A=7003915650en_HK
dc.identifier.scopusauthoridLee, Y=8525696700en_HK
dc.identifier.scopusauthoridMazzotta, F=7005614967en_HK
dc.identifier.scopusauthoridThomas, N=36914249100en_HK
dc.identifier.scopusauthoridDeHertogh, D=6601941025en_HK

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