Gastroenterology
Volume 133, Issue 5 , Pages 1437-1444 , November 2007

Entecavir Therapy for up to 96 Weeks in Patients With HBeAg-Positive Chronic Hepatitis B

Presented in part at the 56th annual meeting of the American Association for the Study of Liver Diseases, November 11–15, 2005.

  • Robert G. Gish

      Affiliations

    • Division of Hepatology and Complex GI, California Pacific Medical Center, San Francisco, California
    • Corresponding Author InformationAddress requests for reprints to: Robert G. Gish, MD, Division of Hepatology and Complex GI, California Pacific Medical Center, 2340 Clay Street, San Francisco, California 94115. fax: (415) 776-0292.
    • ,
  • Anna S. Lok

      Affiliations

    • Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan
    • ,
  • Ting–Tsung Chang

      Affiliations

    • Department of Internal Medicine, National Cheng Kung University Medical College, Tainan, Taiwan
    • ,
  • Robert A. de Man

      Affiliations

    • Department of Gastroenterology and Hepatology, Erasmus Medical Center, University Hospital Rotterdam, Rotterdam, The Netherlands
    • ,
  • Adrian Gadano

      Affiliations

    • Sección Hepatología, Hospital Italiano, Buenos Aires, Argentina
    • ,
  • José Sollano

      Affiliations

    • Section of Gastroenterology, University of Santo Tomas, Manila, Philippines
    • ,
  • Kwang–Hyub Han

      Affiliations

    • Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
    • ,
  • You–Chen Chao

      Affiliations

    • Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan
    • ,
  • Shou–Dong Lee

      Affiliations

    • Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
    • ,
  • Melissa Harris

      Affiliations

    • Bristol-Myers Squibb, Research and Development, Plainsboro, New Jersey
    • ,
  • Joanna Yang

      Affiliations

    • Bristol-Myers Squibb, Research and Development, Wallingford, Connecticut
    • ,
  • Richard Colonno

      Affiliations

    • Bristol-Myers Squibb, Research and Development, Wallingford, Connecticut
    • ,
  • Helena Brett–Smith

      Affiliations

    • Bristol-Myers Squibb, Research and Development, Wallingford, Connecticut

Received 25 May 2007 ,Accepted 26 July 2007.

  • Image Result

    Study design and protocol-defined outcomes through 96 weeks. Patients entered the second year of treatment at week 52, based on the results of week 48 HBV DNA by bDNA assay and HBeAg status. ETV, ente

    Study design and protocol-defined outcomes through 96 weeks. Patients entered the second year of treatment at week 52, based on the results of week 48 HBV DNA by bDNA assay and HBeAg status. ETV, entecavir; LVD, lamivudine; R, responder (HBV DNA level <0.7 MEq/mL and HBeAg negative); VR, virologic responder (HBV DNA level <0.7 MEq/mL and HBeAg positive); NR, nonresponder (HBV DNA level ≥0.7 MEq/mL). Only VRs were to continue blinded therapy into the second year.

  • Image Result
    Distribution of HBV DNA levels through week 96 in the second-year treatment cohort (entecavir [ETV], 243; lamivudine [LVD], 164). Circle diameters are proportional to the percent of patients at the sp

    Distribution of HBV DNA levels through week 96 in the second-year treatment cohort (entecavir [ETV], 243; lamivudine [LVD], 164). Circle diameters are proportional to the percent of patients at the specified HBV DNA level, with the circles in each column totaling 100%. EOD (end of dosing) is defined as the last observation on-treatment.

 The study was sponsored by Bristol-Myers Squibb. The sponsor designed the study in collaboration with expert hepatologists. The sponsor also collected the data, monitored study conduct, performed the statistical analyses, and coordinated writing of the manuscript with all authors. The study was conducted in accordance with the ethics principles of the Declaration of Helsinki and in line with Good Clinical Practice guidelines and applicable local regulatory requirements. Written informed consent was obtained from all participants, and financial disclosures were documented and submitted to the U.S. Food and Drug Administration. Statistical analyses were performed in accordance with the Good Clinical Practice guidelines, and the product was subsequently approved by the U.S. Food and Drug Administration. R.G.G. had full access to all the data and accepts full responsibility for the veracity of the data and analysis.

 The authors declare the following conflicts of interest: R.G.G. received a research grant from, and is an advisor to, Bristol-Myers Squibb, A.S.L. received a research grant from Bristol-Myers Squibb, A.S.L., A.G., and K.-H.H. are advisors for Bristol-Myers Squibb, and M.H., J.Y., R.C., H.B.-S. are employees of Bristol-Myers Squibb. T.-T.C., R.A.D., J.S., Y.-C.C., and S.-D.L. have no financial arrangements to disclose.

PII: S0016-5085(07)01482-5

doi: 10.1053/j.gastro.2007.08.025

Gastroenterology
Volume 133, Issue 5 , Pages 1437-1444 , November 2007

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