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Article: Treatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir: A randomized trial
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TitleTreatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir: A randomized trial
 
AuthorsChan, HLY4
Heathcote, EJ8
Marcellin, P16
Lai, CL2
Cho, M5
Moon, YM3
Chao, YC10
Myers, RP12
Minuk, GY1
Jeffers, L18
Sievert, W6
Bzowej, N7
Harb, G11
Kaiser, R15
Qiao, XJ15
Brown, NA15
Crawford, D9
Lim, SG13
Chutaputti, A17
Poynard, T14
 
Issue Date2007
 
PublisherAmerican College of Physicians. The Journal's web site is located at http://www.annals.org
 
CitationAnnals Of Internal Medicine, 2007, v. 147 n. 11, p. 745-754 [How to Cite?]
 
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.
 
ISSN0003-4819
2013 Impact Factor: 16.104
 
DC FieldValue
dc.contributor.authorChan, HLY
 
dc.contributor.authorHeathcote, EJ
 
dc.contributor.authorMarcellin, P
 
dc.contributor.authorLai, CL
 
dc.contributor.authorCho, M
 
dc.contributor.authorMoon, YM
 
dc.contributor.authorChao, YC
 
dc.contributor.authorMyers, RP
 
dc.contributor.authorMinuk, GY
 
dc.contributor.authorJeffers, L
 
dc.contributor.authorSievert, W
 
dc.contributor.authorBzowej, N
 
dc.contributor.authorHarb, G
 
dc.contributor.authorKaiser, R
 
dc.contributor.authorQiao, XJ
 
dc.contributor.authorBrown, NA
 
dc.contributor.authorCrawford, D
 
dc.contributor.authorLim, SG
 
dc.contributor.authorChutaputti, A
 
dc.contributor.authorPoynard, T
 
dc.date.accessioned2010-09-06T07:21:02Z
 
dc.date.available2010-09-06T07:21:02Z
 
dc.date.issued2007
 
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.
 
dc.description.natureLink_to_subscribed_fulltext
 
dc.identifier.citationAnnals Of Internal Medicine, 2007, v. 147 n. 11, p. 745-754 [How to Cite?]
 
dc.identifier.epage754
 
dc.identifier.hkuros149251
 
dc.identifier.issn0003-4819
2013 Impact Factor: 16.104
 
dc.identifier.issue11
 
dc.identifier.openurl
 
dc.identifier.pmid17909201
 
dc.identifier.scopuseid_2-s2.0-38449093445
 
dc.identifier.spage745
 
dc.identifier.urihttp://hdl.handle.net/10722/76419
 
dc.identifier.volume147
 
dc.languageeng
 
dc.publisherAmerican College of Physicians. The Journal's web site is located at http://www.annals.org
 
dc.publisher.placeUnited States
 
dc.relation.ispartofAnnals of Internal Medicine
 
dc.titleTreatment of hepatitis B e antigen-positive chronic hepatitis with telbivudine or adefovir: A randomized trial
 
dc.typeArticle
 
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<contributor.author>Marcellin, P</contributor.author>
<contributor.author>Lai, CL</contributor.author>
<contributor.author>Cho, M</contributor.author>
<contributor.author>Moon, YM</contributor.author>
<contributor.author>Chao, YC</contributor.author>
<contributor.author>Myers, RP</contributor.author>
<contributor.author>Minuk, GY</contributor.author>
<contributor.author>Jeffers, L</contributor.author>
<contributor.author>Sievert, W</contributor.author>
<contributor.author>Bzowej, N</contributor.author>
<contributor.author>Harb, G</contributor.author>
<contributor.author>Kaiser, R</contributor.author>
<contributor.author>Qiao, XJ</contributor.author>
<contributor.author>Brown, NA</contributor.author>
<contributor.author>Crawford, D</contributor.author>
<contributor.author>Lim, SG</contributor.author>
<contributor.author>Chutaputti, A</contributor.author>
<contributor.author>Poynard, T</contributor.author>
<date.accessioned>2010-09-06T07:21:02Z</date.accessioned>
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<description.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 &lt; 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 &lt; 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. &#169; 2007 American College of Physicians.</description.abstract>
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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