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Article: Telbivudine versus lamivudine in patients with chronic hepatitis B

TitleTelbivudine versus lamivudine in patients with chronic hepatitis B
Authors
Issue Date2007
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal Of Medicine, 2007, v. 357 n. 25, p. 2576-2588 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/57525
ISSN
2014 Impact Factor: 55.873
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLai, CLen_HK
dc.contributor.authorGane, Een_HK
dc.contributor.authorLiaw, YFen_HK
dc.contributor.authorHsu, CWen_HK
dc.contributor.authorThongsawat, Sen_HK
dc.contributor.authorWang, Yen_HK
dc.contributor.authorChen, Yen_HK
dc.contributor.authorHeathcote, EJen_HK
dc.contributor.authorRasenack, Jen_HK
dc.contributor.authorBzowej, Nen_HK
dc.contributor.authorNaoumov, NVen_HK
dc.contributor.authorDi Bisceglie, AMen_HK
dc.contributor.authorZeuzem, Sen_HK
dc.contributor.authorMoon, YMen_HK
dc.contributor.authorGoodman, Zen_HK
dc.contributor.authorChao, Gen_HK
dc.contributor.authorConstance, BFen_HK
dc.contributor.authorBrown, NAen_HK
dc.date.accessioned2010-04-12T01:39:08Z-
dc.date.available2010-04-12T01:39:08Z-
dc.date.issued2007en_HK
dc.identifier.citationNew England Journal Of Medicine, 2007, v. 357 n. 25, p. 2576-2588en_HK
dc.identifier.issn0028-4793en_HK
dc.identifier.urihttp://hdl.handle.net/10722/57525-
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.en_HK
dc.languageengen_HK
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/en_HK
dc.relation.ispartofNew England Journal of Medicineen_HK
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.en_HK
dc.subject.meshAntiviral Agents - adverse effects - therapeutic useen_HK
dc.subject.meshLamivudine - adverse effects - therapeutic useen_HK
dc.subject.meshHepatitis B, Chronic - drug therapyen_HK
dc.subject.meshNucleosides - adverse effects - therapeutic useen_HK
dc.subject.meshPyrimidinones - adverse effects - therapeutic useen_HK
dc.titleTelbivudine versus lamivudine in patients with chronic hepatitis Ben_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0028-4793&volume=357&issue=25&spage=2576&epage=2588&date=2007&atitle=Telbivudine+versus+lamivudine+in+patients+with+chronic+hepatitis+Ben_HK
dc.identifier.emailLai, CL:hrmelcl@hku.hken_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturepublished_or_final_versionen_HK
dc.identifier.doi10.1056/NEJMoa066422en_HK
dc.identifier.pmid18094378en_HK
dc.identifier.scopuseid_2-s2.0-37349120537en_HK
dc.identifier.hkuros149250-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-37349120537&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume357en_HK
dc.identifier.issue25en_HK
dc.identifier.spage2576en_HK
dc.identifier.epage2588en_HK
dc.identifier.eissn1533-4406-
dc.identifier.isiWOS:000251728900008-
dc.publisher.placeUnited Statesen_HK
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dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.scopusauthoridGane, E=7003720102en_HK
dc.identifier.scopusauthoridLiaw, YF=7202451038en_HK
dc.identifier.scopusauthoridHsu, CW=36120244800en_HK
dc.identifier.scopusauthoridThongsawat, S=6508083588en_HK
dc.identifier.scopusauthoridWang, Y=35313627100en_HK
dc.identifier.scopusauthoridChen, Y=7601442337en_HK
dc.identifier.scopusauthoridHeathcote, EJ=16232754400en_HK
dc.identifier.scopusauthoridRasenack, J=7004379558en_HK
dc.identifier.scopusauthoridBzowej, N=6602102815en_HK
dc.identifier.scopusauthoridNaoumov, NV=7006460467en_HK
dc.identifier.scopusauthoridDi Bisceglie, AM=7101900804en_HK
dc.identifier.scopusauthoridZeuzem, S=7103125178en_HK
dc.identifier.scopusauthoridMoon, YM=7203054967en_HK
dc.identifier.scopusauthoridGoodman, Z=35418729400en_HK
dc.identifier.scopusauthoridChao, G=36643443300en_HK
dc.identifier.scopusauthoridConstance, BF=36643537200en_HK
dc.identifier.scopusauthoridBrown, NA=7403548663en_HK

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