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Article: Telbivudine versus lamivudine in patients with chronic hepatitis B
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TitleTelbivudine versus lamivudine in patients with chronic hepatitis B
 
AuthorsLai, CL3
Gane, E7
Liaw, YF12
Hsu, CW12
Thongsawat, S6
Wang, Y10
Chen, Y4
Heathcote, EJ13
Rasenack, J14
Bzowej, N9
Naoumov, NV1
Di Bisceglie, AM8
Zeuzem, S11
Moon, YM5
Goodman, Z2
Chao, G15
Constance, BF15
Brown, NA15
 
Issue Date2007
 
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
 
CitationNew England Journal Of Medicine, 2007, v. 357 n. 25, p. 2576-2588 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa066422
 
AbstractBACKGROUND: Reducing hepatitis B virus (HBV) replication to minimal levels is emerging as a key therapeutic goal for chronic hepatitis B. METHODS: In this double-blind, phase 3 trial, 1370 patients with chronic hepatitis B were randomly assigned to receive 600 mg of telbivudine or 100 mg of lamivudine once daily. The primary efficacy end point was noninferiority of telbivudine to lamivudine for therapeutic response (i.e., a reduction in serum HBV DNA levels to fewer than 5 log 10 copies per milliliter, along with loss of hepatitis B e antigen [HBeAg] or normalization of alanine aminotransferase levels). Secondary efficacy measures included histologic response, changes in serum HBV DNA levels, and HBeAg responses. RESULTS: At week 52, a significantly higher proportion of HBeAg-positive patients receiving telbivudine than of those receiving lamivudine had a therapeutic response (75.3% vs. 67.0%, P = 0.005) or a histologic response (64.7% vs. 56.3%, P = 0.01); telbivudine also was not inferior to lamivudine for these end points in HBeAg-negative patients. In HBeAg-positive and HBeAg-negative patients, telbivudine was superior to lamivudine with respect to the mean reduction in the number of copies of HBV DNA from baseline, the proportion of patients with a reduction in HBV DNA to levels undetectable by polymerase-chain-reaction assay, and development of resistance to the drug. Elevated creatine kinase levels were more common in patients who received telbivudine, whereas elevated alanine aminotransferase and aspartate aminotransferase levels were more common in those who received lamivudine. CONCLUSIONS: Among patients with HBeAg-positive chronic hepatitis B, the rates of therapeutic and histologic response at 1 year were significantly higher in patients treated with telbivudine than in patients treated with lamivudine. In both the HBeAg-negative and the HBeAg-positive groups, telbivudine demonstrated greater HBV DNA suppression with less resistance than did lamivudine. (ClinicalTrials.gov number, NCT00057265.) Copyright © 2007 Massachusetts Medical Society.
 
ISSN0028-4793
2013 Impact Factor: 54.420
 
DOIhttp://dx.doi.org/10.1056/NEJMoa066422
 
ISI Accession Number IDWOS:000251728900008
 
ReferencesReferences in Scopus
 
DC FieldValue
dc.contributor.authorLai, CL
 
dc.contributor.authorGane, E
 
dc.contributor.authorLiaw, YF
 
dc.contributor.authorHsu, CW
 
dc.contributor.authorThongsawat, S
 
dc.contributor.authorWang, Y
 
dc.contributor.authorChen, Y
 
dc.contributor.authorHeathcote, EJ
 
dc.contributor.authorRasenack, J
 
dc.contributor.authorBzowej, N
 
dc.contributor.authorNaoumov, NV
 
dc.contributor.authorDi Bisceglie, AM
 
dc.contributor.authorZeuzem, S
 
dc.contributor.authorMoon, YM
 
dc.contributor.authorGoodman, Z
 
dc.contributor.authorChao, G
 
dc.contributor.authorConstance, BF
 
dc.contributor.authorBrown, NA
 
dc.date.accessioned2010-04-12T01:39:08Z
 
dc.date.available2010-04-12T01:39:08Z
 
dc.date.issued2007
 
dc.description.abstractBACKGROUND: Reducing hepatitis B virus (HBV) replication to minimal levels is emerging as a key therapeutic goal for chronic hepatitis B. METHODS: In this double-blind, phase 3 trial, 1370 patients with chronic hepatitis B were randomly assigned to receive 600 mg of telbivudine or 100 mg of lamivudine once daily. The primary efficacy end point was noninferiority of telbivudine to lamivudine for therapeutic response (i.e., a reduction in serum HBV DNA levels to fewer than 5 log 10 copies per milliliter, along with loss of hepatitis B e antigen [HBeAg] or normalization of alanine aminotransferase levels). Secondary efficacy measures included histologic response, changes in serum HBV DNA levels, and HBeAg responses. RESULTS: At week 52, a significantly higher proportion of HBeAg-positive patients receiving telbivudine than of those receiving lamivudine had a therapeutic response (75.3% vs. 67.0%, P = 0.005) or a histologic response (64.7% vs. 56.3%, P = 0.01); telbivudine also was not inferior to lamivudine for these end points in HBeAg-negative patients. In HBeAg-positive and HBeAg-negative patients, telbivudine was superior to lamivudine with respect to the mean reduction in the number of copies of HBV DNA from baseline, the proportion of patients with a reduction in HBV DNA to levels undetectable by polymerase-chain-reaction assay, and development of resistance to the drug. Elevated creatine kinase levels were more common in patients who received telbivudine, whereas elevated alanine aminotransferase and aspartate aminotransferase levels were more common in those who received lamivudine. CONCLUSIONS: Among patients with HBeAg-positive chronic hepatitis B, the rates of therapeutic and histologic response at 1 year were significantly higher in patients treated with telbivudine than in patients treated with lamivudine. In both the HBeAg-negative and the HBeAg-positive groups, telbivudine demonstrated greater HBV DNA suppression with less resistance than did lamivudine. (ClinicalTrials.gov number, NCT00057265.) Copyright © 2007 Massachusetts Medical Society.
 
dc.description.naturepublished_or_final_version
 
dc.identifier.citationNew England Journal Of Medicine, 2007, v. 357 n. 25, p. 2576-2588 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa066422
 
dc.identifier.doihttp://dx.doi.org/10.1056/NEJMoa066422
 
dc.identifier.eissn1533-4406
 
dc.identifier.epage2588
 
dc.identifier.f10001098824
 
dc.identifier.f10001098824
 
dc.identifier.f10001098824
 
dc.identifier.hkuros149250
 
dc.identifier.isiWOS:000251728900008
 
dc.identifier.issn0028-4793
2013 Impact Factor: 54.420
 
dc.identifier.issue25
 
dc.identifier.openurl
 
dc.identifier.pmid18094378
 
dc.identifier.scopuseid_2-s2.0-37349120537
 
dc.identifier.spage2576
 
dc.identifier.urihttp://hdl.handle.net/10722/57525
 
dc.identifier.volume357
 
dc.languageeng
 
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
 
dc.publisher.placeUnited States
 
dc.relation.ispartofNew England Journal of Medicine
 
dc.relation.referencesReferences in Scopus
 
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License
 
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.
 
dc.subject.meshAntiviral Agents - adverse effects - therapeutic use
 
dc.subject.meshLamivudine - adverse effects - therapeutic use
 
dc.subject.meshHepatitis B, Chronic - drug therapy
 
dc.subject.meshNucleosides - adverse effects - therapeutic use
 
dc.subject.meshPyrimidinones - adverse effects - therapeutic use
 
dc.titleTelbivudine versus lamivudine in patients with chronic hepatitis B
 
dc.typeArticle
 
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<contributor.author>Thongsawat, S</contributor.author>
<contributor.author>Wang, Y</contributor.author>
<contributor.author>Chen, Y</contributor.author>
<contributor.author>Heathcote, EJ</contributor.author>
<contributor.author>Rasenack, J</contributor.author>
<contributor.author>Bzowej, N</contributor.author>
<contributor.author>Naoumov, NV</contributor.author>
<contributor.author>Di Bisceglie, AM</contributor.author>
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<contributor.author>Goodman, Z</contributor.author>
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<description.abstract>BACKGROUND: Reducing hepatitis B virus (HBV) replication to minimal levels is emerging as a key therapeutic goal for chronic hepatitis B. METHODS: In this double-blind, phase 3 trial, 1370 patients with chronic hepatitis B were randomly assigned to receive 600 mg of telbivudine or 100 mg of lamivudine once daily. The primary efficacy end point was noninferiority of telbivudine to lamivudine for therapeutic response (i.e., a reduction in serum HBV DNA levels to fewer than 5 log 10 copies per milliliter, along with loss of hepatitis B e antigen [HBeAg] or normalization of alanine aminotransferase levels). Secondary efficacy measures included histologic response, changes in serum HBV DNA levels, and HBeAg responses. RESULTS: At week 52, a significantly higher proportion of HBeAg-positive patients receiving telbivudine than of those receiving lamivudine had a therapeutic response (75.3% vs. 67.0%, P = 0.005) or a histologic response (64.7% vs. 56.3%, P = 0.01); telbivudine also was not inferior to lamivudine for these end points in HBeAg-negative patients. In HBeAg-positive and HBeAg-negative patients, telbivudine was superior to lamivudine with respect to the mean reduction in the number of copies of HBV DNA from baseline, the proportion of patients with a reduction in HBV DNA to levels undetectable by polymerase-chain-reaction assay, and development of resistance to the drug. Elevated creatine kinase levels were more common in patients who received telbivudine, whereas elevated alanine aminotransferase and aspartate aminotransferase levels were more common in those who received lamivudine. CONCLUSIONS: Among patients with HBeAg-positive chronic hepatitis B, the rates of therapeutic and histologic response at 1 year were significantly higher in patients treated with telbivudine than in patients treated with lamivudine. In both the HBeAg-negative and the HBeAg-positive groups, telbivudine demonstrated greater HBV DNA suppression with less resistance than did lamivudine. (ClinicalTrials.gov number, NCT00057265.) Copyright &#169; 2007 Massachusetts Medical Society.</description.abstract>
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Author Affiliations
  1. UCL
  2. Armed Forces Institute of Pathology
  3. The University of Hong Kong
  4. Zhejiang University
  5. Yonsei University College of Medicine
  6. Chiang Mai University
  7. Middlemore Hospital, Auckland
  8. St. Louis University
  9. Sutter Health
  10. Third Military Medical University
  11. null
  12. Chang Gung University
  13. University of Toronto
  14. Universität Freiburg im Breisgau
  15. Idenix Pharmaceuticals, Inc.