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Article: Treatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir: A randomized trial

TitleTreatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir: A randomized trial
Authors
Issue Date2007
PublisherAmerican College of Physicians. The Journal's web site is located at http://www.annals.org
Citation
Annals Of Internal Medicine, 2007, v. 147 n. 11, p. 745-754 How to Cite?
Abstract
Background: The efficacy of nucleoside and nucleotide analogues for hepatitis B has been linked to the magnitude and durability of hepatitis B virus (HBV) suppression. Objective: To compare the antiviral efficacy of telbivudine and adefovir dipivoxil, and the effects of switching from adefovir to telbivudine, in hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B. Design: Randomized, controlled, open-label trial. Setting: 16 outpatient clinics. Patients: 135 treatment-naive, HBeAg-positive adults with chronic hepatitis B. Intervention: Patients were randomly assigned in a 1:1:1 ratio to 52 weeks of telbivudine (group A) or adefovir (group B), or 24 weeks of adefovir and then telbivudine for the remaining 28 weeks (group C). One hundred thirty-one patients completed 52 weeks of treatment. Measurements: The primary efficacy comparison was serum HBV DNA reduction at week 24, with a secondary comparison at week 52. Results: At week 24, mean HBV DNA reduction was greater in group A than in pooled groups B and C (-6.30 vs. -4.97 log 10 copies/mL; difference, -1.33 log 10 copies/mL [95% CI, -1.99 to -0.66 log 10 copies/mL]; P < 0.001), and more patients in group A were polymerase chain reaction-negative (39% vs. 12%; odds ratio, 4.46 [CI, 1.86 to 10.72]; P < 0.001). At week 52, the mean residual HBV DNA level was lower in group A and group C than in group B (3.01 log 10 copies/mL [group A] and 3.02 log 10 copies/mL [group C] vs. 4.00 log 10 copies/mL [group B]; difference, -0.99 log 10 copies/mL [CI, -1.67 to -0.32 log 10 copies/mL] and -0.98 log 10 copies/mL [CI, -1.64 to -0.32 log 10 copies/mL]; P = 0.004). Adverse events were similar across groups; the most common were upper respiratory symptoms, headache, back pain, and diarrhea. Limitations: The trial was open-label and was not of sufficient size or duration to compare clinical outcomes and long-term efficacy. Conclusion: Telbivudine demonstrated greater and more consistent HBV DNA suppression than adefovir after 24 weeks of treatment. After 52 weeks, HBV DNA suppression was greater in patients who had received continuous telbivudine or were switched to telbivudine after 24 weeks than in those who received continuous adefovir. © 2007 American College of Physicians.
Persistent Identifierhttp://hdl.handle.net/10722/76419
ISSN
2013 Impact Factor: 16.104
ISI Accession Number ID

 

Author Affiliations
  1. University of Manitoba
  2. The University of Hong Kong
  3. Yonsei University
  4. Prince of Wales Hospital Hong Kong
  5. Pusan National University, College of Medicine
  6. Monash University
  7. California Pacific Medical Center
  8. Toronto Western Hospital University of Toronto
  9. Princess Alexandra Hospital Brisbane
  10. Triservice General Hospital Taiwan
  11. Novartis
  12. Health Sciences Centre Calgary
  13. National University Hospital, Singapore
  14. null
  15. Idenix Pharmaceuticals, Inc.
  16. Hopital Beaujon
  17. Phramongkutklao College of Medicine
  18. University of Miami Leonard M. Miller School of Medicine
DC FieldValueLanguage
dc.contributor.authorChan, HLYen_HK
dc.contributor.authorHeathcote, EJen_HK
dc.contributor.authorMarcellin, Pen_HK
dc.contributor.authorLai, CLen_HK
dc.contributor.authorCho, Men_HK
dc.contributor.authorMoon, YMen_HK
dc.contributor.authorChao, YCen_HK
dc.contributor.authorMyers, RPen_HK
dc.contributor.authorMinuk, GYen_HK
dc.contributor.authorJeffers, Len_HK
dc.contributor.authorSievert, Wen_HK
dc.contributor.authorBzowej, Nen_HK
dc.contributor.authorHarb, Gen_HK
dc.contributor.authorKaiser, Ren_HK
dc.contributor.authorQiao, XJen_HK
dc.contributor.authorBrown, NAen_HK
dc.contributor.authorCrawford, Den_HK
dc.contributor.authorLim, SGen_HK
dc.contributor.authorChutaputti, Aen_HK
dc.contributor.authorPoynard, Ten_HK
dc.date.accessioned2010-09-06T07:21:02Z-
dc.date.available2010-09-06T07:21:02Z-
dc.date.issued2007en_HK
dc.identifier.citationAnnals Of Internal Medicine, 2007, v. 147 n. 11, p. 745-754en_HK
dc.identifier.issn0003-4819en_HK
dc.identifier.urihttp://hdl.handle.net/10722/76419-
dc.description.abstractBackground: The efficacy of nucleoside and nucleotide analogues for hepatitis B has been linked to the magnitude and durability of hepatitis B virus (HBV) suppression. Objective: To compare the antiviral efficacy of telbivudine and adefovir dipivoxil, and the effects of switching from adefovir to telbivudine, in hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B. Design: Randomized, controlled, open-label trial. Setting: 16 outpatient clinics. Patients: 135 treatment-naive, HBeAg-positive adults with chronic hepatitis B. Intervention: Patients were randomly assigned in a 1:1:1 ratio to 52 weeks of telbivudine (group A) or adefovir (group B), or 24 weeks of adefovir and then telbivudine for the remaining 28 weeks (group C). One hundred thirty-one patients completed 52 weeks of treatment. Measurements: The primary efficacy comparison was serum HBV DNA reduction at week 24, with a secondary comparison at week 52. Results: At week 24, mean HBV DNA reduction was greater in group A than in pooled groups B and C (-6.30 vs. -4.97 log 10 copies/mL; difference, -1.33 log 10 copies/mL [95% CI, -1.99 to -0.66 log 10 copies/mL]; P < 0.001), and more patients in group A were polymerase chain reaction-negative (39% vs. 12%; odds ratio, 4.46 [CI, 1.86 to 10.72]; P < 0.001). At week 52, the mean residual HBV DNA level was lower in group A and group C than in group B (3.01 log 10 copies/mL [group A] and 3.02 log 10 copies/mL [group C] vs. 4.00 log 10 copies/mL [group B]; difference, -0.99 log 10 copies/mL [CI, -1.67 to -0.32 log 10 copies/mL] and -0.98 log 10 copies/mL [CI, -1.64 to -0.32 log 10 copies/mL]; P = 0.004). Adverse events were similar across groups; the most common were upper respiratory symptoms, headache, back pain, and diarrhea. Limitations: The trial was open-label and was not of sufficient size or duration to compare clinical outcomes and long-term efficacy. Conclusion: Telbivudine demonstrated greater and more consistent HBV DNA suppression than adefovir after 24 weeks of treatment. After 52 weeks, HBV DNA suppression was greater in patients who had received continuous telbivudine or were switched to telbivudine after 24 weeks than in those who received continuous adefovir. © 2007 American College of Physicians.en_HK
dc.languageengen_HK
dc.publisherAmerican College of Physicians. The Journal's web site is located at http://www.annals.orgen_HK
dc.relation.ispartofAnnals of Internal Medicineen_HK
dc.titleTreatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir: A randomized trialen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0003-4819&volume=147&spage=745&epage=54&date=2007&atitle=Treatment+of+hepatitis+B+e+antigen+positive+chronic+hepatitis+with+telbivudine+or+adefovir:+a+randomized+trialen_HK
dc.identifier.emailLai, CL:hrmelcl@hku.hken_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.pmid17909201-
dc.identifier.scopuseid_2-s2.0-38449093445en_HK
dc.identifier.hkuros149251en_HK
dc.identifier.volume147en_HK
dc.identifier.issue11en_HK
dc.identifier.spage745en_HK
dc.identifier.epage754en_HK
dc.identifier.isiWOS:000251539100001-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridChan, HLY=16038785900en_HK
dc.identifier.scopusauthoridHeathcote, EJ=16232754400en_HK
dc.identifier.scopusauthoridMarcellin, P=7102079502en_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK
dc.identifier.scopusauthoridCho, M=7401727448en_HK
dc.identifier.scopusauthoridMoon, YM=7203054967en_HK
dc.identifier.scopusauthoridChao, YC=23117629900en_HK
dc.identifier.scopusauthoridMyers, RP=35407742800en_HK
dc.identifier.scopusauthoridMinuk, GY=35406269900en_HK
dc.identifier.scopusauthoridJeffers, L=35421644600en_HK
dc.identifier.scopusauthoridSievert, W=7004049384en_HK
dc.identifier.scopusauthoridBzowej, N=6602102815en_HK
dc.identifier.scopusauthoridHarb, G=19835385800en_HK
dc.identifier.scopusauthoridKaiser, R=7202231602en_HK
dc.identifier.scopusauthoridQiao, XJ=23474654800en_HK
dc.identifier.scopusauthoridBrown, NA=7403548663en_HK
dc.identifier.scopusauthoridCrawford, D=7403085506en_HK
dc.identifier.scopusauthoridLim, SG=7404081127en_HK
dc.identifier.scopusauthoridChutaputti, A=6603176195en_HK
dc.identifier.scopusauthoridPoynard, T=7103155394en_HK

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