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, Y11
Chen, Y4
Heathcote, EJ13
Rasenack, J14
Bzowej, N9
Naoumov, NV1
Di Bisceglie, AM8
Zeuzem, S10
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
2011 Impact Factor: 53.298
2011 SCImago Journal Rankings: 3.412
DOIhttp://dx.doi.org/10.1056/NEJMoa066422
ISI Accession Number IDWOS:000251728900008
ReferencesReferences in Scopus
DC Field
Value
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.epage2588
dc.identifier.hkuros149250
dc.identifier.isiWOS:000251728900008
dc.identifier.issn0028-4793
2011 Impact Factor: 53.298
2011 SCImago Journal Rankings: 3.412
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
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. null
  11. Third Military Medical University
  12. Chang Gung University
  13. University of Toronto
  14. Universität Freiburg im Breisgau
  15. Idenix Pharmaceuticals, Inc.