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

Daniel Shouval, Ching Lung Lai, Ting Tsung Chang, Hugo Cheinquer, Paul Martin, Giampiero Carosi, Steven Han, Sabahattin Kaymakoglu, Ricardo Tamez, Joanna Yang, Daniel Tenney, Helena Brett-Smith

Research output: Contribution to journalArticle

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Abstract

Background/Aims: To evaluate the off-treatment durability of response in HBeAg-negative chronic hepatitis B patients who achieved a protocol-defined 'Response' (HBV-DNA < 0.7 MEq/mL and ALT < 1.25 × ULN) with entecavir at 48 weeks and the efficacy of entecavir in patients treated beyond one year. Methods: Entecavir-treated and lamivudine-treated patients who achieved a protocol-defined 'Response' were evaluated off-treatment for HBV-DNA < 300 copies/mL and ALT normalisation. Entecavir- and lamivudine-treated patients who achieved a protocol-defined 'Virological Response' (HBV-DNA < 0.7 MEq/mL but ALT ≥ 1.25 × ULN) at 48 weeks, continued blinded treatment until they achieved Response or 96 weeks, whichever came first. Results: Among 'Responders' who discontinued treatment after 48 weeks, 7/257 (3%) entecavir-treated and 10/201 (5%) lamivudine-treated patients sustained HBV-DNA below 300 copies/mL at 24-weeks off-treatment. Among the 54 patients who continued blinded treatment in the second year, 7/26 (27%) entecavir-treated and 6/28 (21%) lamivudine-treated patients normalised ALT and 22/26 (85%) entecavir-treated and 16/28 (57%) lamivudine-treated patients maintained HBV-DNA < 300 copies/mL at end-of-dosing. The safety profiles of both drugs remained comparable through a second year of treatment. Conclusions: The majority of protocol-defined Responders relapsed after 1 year when treatment was discontinued. Treatment with entecavir beyond 1 year provided continued virological and biochemical benefit.

Original languageEnglish
Pages (from-to)289-295
Number of pages7
JournalJournal of Hepatology
Volume50
Issue number2
DOIs
StatePublished - Feb 1 2009

Fingerprint

Hepatitis B e Antigens
Chronic Hepatitis B
Hepatitis B
Antiviral Agents
Lamivudine
Recurrence
DNA
Therapeutics
entecavir
Safety

Keywords

  • Antiviral treatment
  • Chronic hepatitis B
  • Entecavir
  • HBeAg-negative

ASJC Scopus subject areas

  • Hepatology

Cite this

Relapse of hepatitis B in HBeAg-negative chronic hepatitis B patients who discontinued successful entecavir treatment : The case for continuous antiviral therapy. / Shouval, Daniel; Lai, Ching Lung; Chang, Ting Tsung; Cheinquer, Hugo; Martin, Paul; Carosi, Giampiero; Han, Steven; Kaymakoglu, Sabahattin; Tamez, Ricardo; Yang, Joanna; Tenney, Daniel; Brett-Smith, Helena.

In: Journal of Hepatology, Vol. 50, No. 2, 01.02.2009, p. 289-295.

Research output: Contribution to journalArticle

Shouval, D, Lai, CL, Chang, TT, Cheinquer, H, Martin, P, Carosi, G, Han, S, Kaymakoglu, S, Tamez, R, Yang, J, Tenney, D & Brett-Smith, H 2009, 'Relapse of hepatitis B in HBeAg-negative chronic hepatitis B patients who discontinued successful entecavir treatment: The case for continuous antiviral therapy', Journal of Hepatology, vol. 50, no. 2, pp. 289-295. https://doi.org/10.1016/j.jhep.2008.10.017
Shouval, Daniel ; Lai, Ching Lung ; Chang, Ting Tsung ; Cheinquer, Hugo ; Martin, Paul ; Carosi, Giampiero ; Han, Steven ; Kaymakoglu, Sabahattin ; Tamez, Ricardo ; Yang, Joanna ; Tenney, Daniel ; Brett-Smith, Helena. / Relapse of hepatitis B in HBeAg-negative chronic hepatitis B patients who discontinued successful entecavir treatment : The case for continuous antiviral therapy. In: Journal of Hepatology. 2009 ; Vol. 50, No. 2. pp. 289-295.
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abstract = "Background/Aims: To evaluate the off-treatment durability of response in HBeAg-negative chronic hepatitis B patients who achieved a protocol-defined 'Response' (HBV-DNA < 0.7 MEq/mL and ALT < 1.25 × ULN) with entecavir at 48 weeks and the efficacy of entecavir in patients treated beyond one year. Methods: Entecavir-treated and lamivudine-treated patients who achieved a protocol-defined 'Response' were evaluated off-treatment for HBV-DNA < 300 copies/mL and ALT normalisation. Entecavir- and lamivudine-treated patients who achieved a protocol-defined 'Virological Response' (HBV-DNA < 0.7 MEq/mL but ALT ≥ 1.25 × ULN) at 48 weeks, continued blinded treatment until they achieved Response or 96 weeks, whichever came first. Results: Among 'Responders' who discontinued treatment after 48 weeks, 7/257 (3{\%}) entecavir-treated and 10/201 (5{\%}) lamivudine-treated patients sustained HBV-DNA below 300 copies/mL at 24-weeks off-treatment. Among the 54 patients who continued blinded treatment in the second year, 7/26 (27{\%}) entecavir-treated and 6/28 (21{\%}) lamivudine-treated patients normalised ALT and 22/26 (85{\%}) entecavir-treated and 16/28 (57{\%}) lamivudine-treated patients maintained HBV-DNA < 300 copies/mL at end-of-dosing. The safety profiles of both drugs remained comparable through a second year of treatment. Conclusions: The majority of protocol-defined Responders relapsed after 1 year when treatment was discontinued. Treatment with entecavir beyond 1 year provided continued virological and biochemical benefit.",
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AU - Lai, Ching Lung

AU - Chang, Ting Tsung

AU - Cheinquer, Hugo

AU - Martin, Paul

AU - Carosi, Giampiero

AU - Han, Steven

AU - Kaymakoglu, Sabahattin

AU - Tamez, Ricardo

AU - Yang, Joanna

AU - Tenney, Daniel

AU - Brett-Smith, Helena

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AB - Background/Aims: To evaluate the off-treatment durability of response in HBeAg-negative chronic hepatitis B patients who achieved a protocol-defined 'Response' (HBV-DNA < 0.7 MEq/mL and ALT < 1.25 × ULN) with entecavir at 48 weeks and the efficacy of entecavir in patients treated beyond one year. Methods: Entecavir-treated and lamivudine-treated patients who achieved a protocol-defined 'Response' were evaluated off-treatment for HBV-DNA < 300 copies/mL and ALT normalisation. Entecavir- and lamivudine-treated patients who achieved a protocol-defined 'Virological Response' (HBV-DNA < 0.7 MEq/mL but ALT ≥ 1.25 × ULN) at 48 weeks, continued blinded treatment until they achieved Response or 96 weeks, whichever came first. Results: Among 'Responders' who discontinued treatment after 48 weeks, 7/257 (3%) entecavir-treated and 10/201 (5%) lamivudine-treated patients sustained HBV-DNA below 300 copies/mL at 24-weeks off-treatment. Among the 54 patients who continued blinded treatment in the second year, 7/26 (27%) entecavir-treated and 6/28 (21%) lamivudine-treated patients normalised ALT and 22/26 (85%) entecavir-treated and 16/28 (57%) lamivudine-treated patients maintained HBV-DNA < 300 copies/mL at end-of-dosing. The safety profiles of both drugs remained comparable through a second year of treatment. Conclusions: The majority of protocol-defined Responders relapsed after 1 year when treatment was discontinued. Treatment with entecavir beyond 1 year provided continued virological and biochemical benefit.

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