Journal of Hepatology
Volume 50, Issue 2 , Pages 289-295 , February 2009

Relapse of hepatitis B in HBeAg-negative chronic hepatitis B patients who discontinued successful entecavir treatment: The case for continuous antiviral therapy

  • Daniel Shouval

      Affiliations

    • Liver Unit, Hadassah – Hebrew University Hospital, Ein-Kerem, P.O. Box 12000, Jerusalem 91120, Israel
    • Corresponding Author InformationCorresponding author. Tel.: +972 2 6777 337; fax: +972 2 6420 338.
    • ,
  • Ching-Lung Lai

      Affiliations

    • Department of Medicine, University of Hong Kong, Hong Kong
    • ,
  • Ting-Tsung Chang

      Affiliations

    • Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan
    • ,
  • Hugo Cheinquer

      Affiliations

    • Universidade Federal Do Rio Grande Do Sul, Porto Alegre, Brazil
    • ,
  • Paul Martin

      Affiliations

    • Center for Liver Diseases, University of Miami, FL, USA
    • ,
  • Giampiero Carosi

      Affiliations

    • Spedali Civili, Clinica di Malattie Infettive e Tropicali, Brescia, Italy
    • ,
  • Steven Han

      Affiliations

    • Division of Digestive Disease, UCLA School of Medicine, LA, CA, USA
    • ,
  • Sabahattin Kaymakoglu

      Affiliations

    • Division of Gastroenterology, Istanbul University, Istanbul, Turkey
    • ,
  • Ricardo Tamez

      Affiliations

    • Bristol-Myers Squibb, Research & Development, Princeton, NJ, USA
    • ,
  • Joanna Yang

      Affiliations

    • Bristol-Myers Squibb, Research & Development, Wallingford, CT, USA
    • ,
  • Daniel Tenney

      Affiliations

    • Bristol-Myers Squibb, Research & Development, Wallingford, CT, USA
    • ,
  • Helena Brett-Smith

      Affiliations

    • Bristol-Myers Squibb, Research & Development, Wallingford, CT, USA

Received 1 April 2008 ,Revised 20 August 2008 ,Accepted 24 October 2008.

References 

  1. Yim HJ, Lok ASF. Natural history of chronic hepatitis B virus infection: what we knew in 1981 and what we know in 2005. Hepatology 2006;43:S173–S181.
  2. Manesis EK. HBeAg-negative chronic hepatitis B: from obscurity to prominence. J Hepatol. 2006;45:343–346
  3. Funk ML, Rosenberg DM, Lok ASF. World-wide epidemiology of HBeAg-negative chronic hepatitis B and associated precore and core promoter variants. J Viral Hepatitis. 2002;9:52–61
  4. Hadziyannis SJ, Vassilopoulos D. Hepatitis B e antigen-negative chronic hepatitis B. Hepatology. 2001;34:617–624
  5. Hadziyannis SJ. Hepatitis B e antigen negative chronic hepatitis B: from clinical recognition to pathogenesis and treatment. Viral Hepatitis Rev. 1995;1:7–36
  6. Papatheodoridis GV, Hadziyannis SJ. Current management of chronic hepatitis B. Aliment Pharmacol Ther. 2004;19:25–37
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  8. Di Marco V, Marzano A, Lampertico P, Andreone P, Santantonio T, Almasio PL, et al. Clinical outcome of HBeAg-negative chronic hepatitis B in relation to virologic response to lamivudine. Hepatology. 2004;40:883–891
  9. Lai CL, Shouval D, Lok AS, Chang TT, Cheinquer H, Goodman Z, et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Eng J Med. 2006;354:1011–1020
  10. Levine S, Hernandez D, Yamanaka G, Zhang S, Rose R, Weinheimer S, et al. Efficacies of entecavir against lamivudine-resistant hepatitis B virus replication and recombinant polymerases in vitro. Antimicrob Agents Chemother. 2002;46:2525–2532
  11. Chang TT, Gish RG, Hadziyannis SJ, Cianciara J, Rizzetto M, Schiff ER, et al. A dose-ranging study of the efficacy and tolerability of entecavir in lamivudine-refractory chronic hepatitis B patients. Gastroenterology. 2005;129:1198–1209
  12. Colonno RJ, Rose RE, Baldick CJ, Levine S, Pokornowski K, Yu CF, et al. Entecavir resistance is rare in nucleoside naive patients with hepatitis B. Hepatology. 2006;44:1657–1665
  13. Lok ASF, McMahon BJ. Chronic hepatitis B. Hepatology. 2007;45:507–539
  14. Keeffe EB, Dietrich DT, Han S-HB, Jacobson IM, Martin P, Schiff ER, et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: An update. Clin Gastroenterol Hepatol. 2006;4:936–962
  15. Liaw Y-F, Leung N, Guan R, Lau GKK, Merican I, McCaughan G, et al. Asian-pacific consensus statement on the management of chronic hepatitis B: a 2005 update. Liver Int. 2005;25:472–489
  16. Hadziyannis SJ, Tassopoulos NC, Heathcote J, Chang TT, Kitis G, Rizzetto M, et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B. N Eng J Med. 2005;352:2673–2681
  17. Tassopoulos NC, Volpes R, Pastore G, Heathcote J, Buti M, Goldin RD, et al. Efficacy of lamivudine in patients with hepatitis B virus DNA-positive (precore mutant) chronic hepatitis B. Lamivudine precore mutant study group. Hepatology. 1999;29:889–896
  18. Santantonio T, Mazzola M, Iacovazzi T, Miglietta A, Guastadisegni A, Pastore G. Long-term follow-up of patients with anti-HBe/HBV DNA-positive chronic hepatitis B treated for 12 months with lamivudine. J Hepatol. 2000;32:300–306
  19. Shouval D, Lai CL, Chang TT, et al. Three years of Entecavir (ETV) re-treatment of HBeAg(-) ETV patients who previously discontinued ETV treatment: Results from study 901. Hepatology. 2008;48(Suppl.):927A
  20. Shaw T, Bartholomeusz A, Locarnini S. HBV drug resistance: mechanisms, detection, and interpretation. J Hepatol. 2006;44:593–606
  21. Lai CL, Gane E, Hsu CW, Thongsawat S, Wang Y, Chen Y, et al. Two-year results from the Globe trial in patients with hepatitis B: greater clinical and antiviral efficacy for telbivudine (LdT) vs. lamivudine. Hepatology. 2006;44(Suppl 1):222A
  22. DiBisceglie A, Lai CL, Gane E, Chen Y-C, Thongsawat S, Wang Y, et al. Telbivudine Globe trial: early HBV suppression is predictive of optimal two-year efficacy in nucleoside-treated hepatitis B patients. Hepatology. 2006;44(Suppl 1):230A
  23. Tenney DJ, Pokornowski KA, Rose R, et al. Entecavir at five years shows long-term maintenance of high genetic barrier to hepatitis B virus resistance. Hepatol International. 2008;2(Suppl.):76A

☆ (www.clinicaltrials.gov identifier: NCT00035789). Grant Support: The study was sponsored by Bristol-Myers Squibb. The sponsor designed the study in collaboration with a panel of expert hepatologists. The sponsor also collected the data, monitored study conduct, performed the statistical analyses, and coordinated writing of the manuscript with all authors. Employees of Bristol-Myers Squibb: Ricardo Tamez: employee of Bristol-Myers Squibb, Research & Development, Princeton, NJ, USA, Joanna Yang: employee of Bristol-Myers Squibb, Research & Development, Wallingford, CT, USA, Daniel Tenney: employee of Bristol-Myers Squibb, Research & Development, Wallingford, CT, USA, Helena Brett-Smith: employee of Bristol-Myers Squibb, Research & Development, Wallingford, CT, USA. Financial Disclosure Information: Daniel Shouval: BMS: grant support, Ching-Lung Lai: Investigator: BMS, LG Lifesciences; Advisory Board: BMS, Idenix Pharmaceuticals, GSK; Speaker Bureau: BMS; Unrestricted grant: BMS, Ting-Tsung Chang: Nothing to disclose, Hugo Cheinquer: BMS consultant, Paul Martin: BMS: consultant, speaker, investigator, Giampiero Carosi: Nothing to disclose, Steven Han: BMS: consultant, speakers bureau and research grant, Sabahattin Kaymakoglu. Nothing to disclose.

PII: S0168-8278(08)00715-0

doi: 10.1016/j.jhep.2008.10.017

Journal of Hepatology
Volume 50, Issue 2 , Pages 289-295 , February 2009

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