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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?
Abstract
We 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
2013 Impact Factor: 11.190
ISI Accession Number ID
References

 

Author Affiliations
  1. LG
  2. The Catholic University of Korea
  3. The University of Hong Kong
  4. Yonsei University College of Medicine
  5. Korea University
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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