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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
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TitleAntiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease
 
AuthorsYuen, MF3
Han, KH4
Um, SH5
Yoon, SK2
Kim, HR1
Kim, J1
Kim, CR1
Lai, CL3
 
Issue Date2010
 
PublisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/
 
CitationHepatology, 2010, v. 51 n. 3, p. 767-776 [How to Cite?]
DOI: http://dx.doi.org/10.1002/hep.23462
 
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.
 
ISSN0270-9139
2012 Impact Factor: 12.003
2012 SCImago Journal Rankings: 4.260
 
DOIhttp://dx.doi.org/10.1002/hep.23462
 
ReferencesReferences in Scopus
 
DC FieldValue
dc.contributor.authorYuen, MF
 
dc.contributor.authorHan, KH
 
dc.contributor.authorUm, SH
 
dc.contributor.authorYoon, SK
 
dc.contributor.authorKim, HR
 
dc.contributor.authorKim, J
 
dc.contributor.authorKim, CR
 
dc.contributor.authorLai, CL
 
dc.date.accessioned2012-09-05T05:29:50Z
 
dc.date.available2012-09-05T05:29:50Z
 
dc.date.issued2010
 
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.
 
dc.description.natureLink_to_subscribed_fulltext
 
dc.identifier.citationHepatology, 2010, v. 51 n. 3, p. 767-776 [How to Cite?]
DOI: http://dx.doi.org/10.1002/hep.23462
 
dc.identifier.doihttp://dx.doi.org/10.1002/hep.23462
 
dc.identifier.eissn1527-3350
 
dc.identifier.epage776
 
dc.identifier.issn0270-9139
2012 Impact Factor: 12.003
2012 SCImago Journal Rankings: 4.260
 
dc.identifier.issue3
 
dc.identifier.pmid20091678
 
dc.identifier.scopuseid_2-s2.0-77950606642
 
dc.identifier.spage767
 
dc.identifier.urihttp://hdl.handle.net/10722/163301
 
dc.identifier.volume51
 
dc.languageeng
 
dc.publisherJohn Wiley & Sons, Inc. The Journal's web site is located at http://www.hepatology.org/
 
dc.publisher.placeUnited States
 
dc.relation.ispartofHepatology
 
dc.relation.referencesReferences in Scopus
 
dc.subject.meshAdult
 
dc.subject.meshDna, Viral - Blood
 
dc.subject.meshDrug Resistance, Viral
 
dc.subject.meshFemale
 
dc.subject.meshGuanine - Adverse Effects - Analogs & Derivatives - Therapeutic Use
 
dc.subject.meshHepatitis B E Antigens - Blood
 
dc.subject.meshHepatitis B Virus - Genetics
 
dc.subject.meshHepatitis B, Chronic - Blood - Drug Therapy - Immunology
 
dc.subject.meshHumans
 
dc.subject.meshLamivudine - Therapeutic Use
 
dc.subject.meshMale
 
dc.subject.meshMiddle Aged
 
dc.subject.meshPhosphonic Acids - Adverse Effects - Therapeutic Use
 
dc.subject.meshReverse Transcriptase Inhibitors - Therapeutic Use
 
dc.subject.meshYoung Adult
 
dc.titleAntiviral activity and safety of LB80380 in hepatitis B e antigen-positive chronic hepatitis B patients with lamivudine-resistant disease
 
dc.typeArticle
 
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<contributor.author>Yoon, SK</contributor.author>
<contributor.author>Kim, HR</contributor.author>
<contributor.author>Kim, J</contributor.author>
<contributor.author>Kim, CR</contributor.author>
<contributor.author>Lai, CL</contributor.author>
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<description.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&lt;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 &gt;2 log10 copies/mL, and 11.5% of patients had undetectable HBV DNA levels (&lt;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 &#169; 2010 by the American Association for the Study of Liver Diseases.</description.abstract>
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<subject.mesh>Adult</subject.mesh>
<subject.mesh>Dna, Viral - Blood</subject.mesh>
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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