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Article: Antiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease

TitleAntiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease
Authors
Issue Date2010
PublisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/
Citation
Hepatology, 2010, v. 51 n. 3, p. 767-776 How to Cite?
AbstractWe aimed to determine the antiviral activity and safety of a new nucleotide analogue, LB80380, in chronic hepatitis B (CHB) patients with lamivudine-resistant virus. Sixty-five patients with lamivudine-resistant virus were randomized to receive five ascending daily doses (30, 60, 90, 150, 240 mg) of LB80380. LB80380 was given together with lamivudine for the first 4 weeks, followed by 8 weeks of LB80380 monotherapy. This was then followed by 24 weeks of adefovir. Hepatitis B virus (HBV) DNA levels, serology, liver biochemistry, and safety were monitored. The extent of the HBV DNA reduction at week 12 was dose-dependent. The mean reduction from baseline was 2.81, 3.21, 3.92, 4.16, and 4.00 log10 copies/mL for the five ascending dose groups. The dose-proportionate effect was statistically significant (P<0.001) with a decrease of HBV DNA levels by an average of 1.54 log10 copies/mL for every 1-unit increase in log10 dose of LB80380. In 93.4% of patients, HBV DNA decreased by >2 log10 copies/mL, and 11.5% of patients had undetectable HBV DNA levels (<300 copies/mL) by week 12. HBV DNA suppression was maintained during the 24 weeks of adefovir treatment. Hepatitis B e antigen seroconversion and normalization of alanine aminotransferase were seen in 14.6% and 24.6% of patients, respectively, at week 12; 44.6% of patients experienced mild and self-limiting adverse events, none of which were attributed to the study drug. Conclusion: LB80380 at doses of up to 240 mg is safe, well tolerated, and effective at reducing viral load in CHB patients with lamivudine-resistant virus for a period of 12 weeks. Copyright © 2010 by the American Association for the Study of Liver Diseases.
Persistent Identifierhttp://hdl.handle.net/10722/163301
ISSN
2014 Impact Factor: 11.055
2014 SCImago Journal Rankings: 4.310
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorYuen, MFen_US
dc.contributor.authorHan, KHen_US
dc.contributor.authorUm, SHen_US
dc.contributor.authorYoon, SKen_US
dc.contributor.authorKim, HRen_US
dc.contributor.authorKim, Jen_US
dc.contributor.authorKim, CRen_US
dc.contributor.authorLai, CLen_US
dc.date.accessioned2012-09-05T05:29:50Z-
dc.date.available2012-09-05T05:29:50Z-
dc.date.issued2010en_US
dc.identifier.citationHepatology, 2010, v. 51 n. 3, p. 767-776en_US
dc.identifier.issn0270-9139en_US
dc.identifier.urihttp://hdl.handle.net/10722/163301-
dc.description.abstractWe aimed to determine the antiviral activity and safety of a new nucleotide analogue, LB80380, in chronic hepatitis B (CHB) patients with lamivudine-resistant virus. Sixty-five patients with lamivudine-resistant virus were randomized to receive five ascending daily doses (30, 60, 90, 150, 240 mg) of LB80380. LB80380 was given together with lamivudine for the first 4 weeks, followed by 8 weeks of LB80380 monotherapy. This was then followed by 24 weeks of adefovir. Hepatitis B virus (HBV) DNA levels, serology, liver biochemistry, and safety were monitored. The extent of the HBV DNA reduction at week 12 was dose-dependent. The mean reduction from baseline was 2.81, 3.21, 3.92, 4.16, and 4.00 log10 copies/mL for the five ascending dose groups. The dose-proportionate effect was statistically significant (P<0.001) with a decrease of HBV DNA levels by an average of 1.54 log10 copies/mL for every 1-unit increase in log10 dose of LB80380. In 93.4% of patients, HBV DNA decreased by >2 log10 copies/mL, and 11.5% of patients had undetectable HBV DNA levels (<300 copies/mL) by week 12. HBV DNA suppression was maintained during the 24 weeks of adefovir treatment. Hepatitis B e antigen seroconversion and normalization of alanine aminotransferase were seen in 14.6% and 24.6% of patients, respectively, at week 12; 44.6% of patients experienced mild and self-limiting adverse events, none of which were attributed to the study drug. Conclusion: LB80380 at doses of up to 240 mg is safe, well tolerated, and effective at reducing viral load in CHB patients with lamivudine-resistant virus for a period of 12 weeks. Copyright © 2010 by the American Association for the Study of Liver Diseases.en_US
dc.languageengen_US
dc.publisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/en_US
dc.relation.ispartofHepatologyen_US
dc.subject.meshAdulten_US
dc.subject.meshDna, Viral - Blooden_US
dc.subject.meshDrug Resistance, Viralen_US
dc.subject.meshFemaleen_US
dc.subject.meshGuanine - Adverse Effects - Analogs & Derivatives - Therapeutic Useen_US
dc.subject.meshHepatitis B E Antigens - Blooden_US
dc.subject.meshHepatitis B Virus - Geneticsen_US
dc.subject.meshHepatitis B, Chronic - Blood - Drug Therapy - Immunologyen_US
dc.subject.meshHumansen_US
dc.subject.meshLamivudine - Therapeutic Useen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshPhosphonic Acids - Adverse Effects - Therapeutic Useen_US
dc.subject.meshReverse Transcriptase Inhibitors - Therapeutic Useen_US
dc.subject.meshYoung Adulten_US
dc.titleAntiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant diseaseen_US
dc.typeArticleen_US
dc.identifier.emailYuen, MF:mfyuen@hkucc.hku.hken_US
dc.identifier.emailLai, CL:hrmelcl@hku.hken_US
dc.identifier.authorityYuen, MF=rp00479en_US
dc.identifier.authorityLai, CL=rp00314en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1002/hep.23462en_US
dc.identifier.pmid20091678en_US
dc.identifier.scopuseid_2-s2.0-77950606642en_US
dc.identifier.hkuros174347-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-77950606642&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume51en_US
dc.identifier.issue3en_US
dc.identifier.spage767en_US
dc.identifier.epage776en_US
dc.identifier.eissn1527-3350-
dc.identifier.isiWOS:000275472300008-
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridYuen, MF=7102031955en_US
dc.identifier.scopusauthoridHan, KH=7402963689en_US
dc.identifier.scopusauthoridUm, SH=7005044023en_US
dc.identifier.scopusauthoridYoon, SK=7404036291en_US
dc.identifier.scopusauthoridKim, HR=36019302500en_US
dc.identifier.scopusauthoridKim, J=9744730600en_US
dc.identifier.scopusauthoridKim, CR=7409872688en_US
dc.identifier.scopusauthoridLai, CL=7403086396en_US

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