Results of up to 2 years of entecavir vs lamivudine therapy in nucleoside-naïve HBeAg-positive patients with chronic hepatitis B

T. T. Chang, Y. C. Chao, V. V. Gorbakov, K. H. Han, R. G. Gish, R. De Man, H. Cheinquer, F. Bessone, H. Brett-Smith, R. Tamez

Research output: Contribution to journalArticle

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Abstract

Entecavir is a potent inhibitor of hepatitis B virus (HBV) polymerase. The efficacy and safety of entecavir in nucleoside-naïve patients with hepatitis B virus e antigen (HBeAg)-positive chronic hepatitis B was established in a large, international, double-dummy study (ETV-022) where patients were randomized to entecavir 0.5 mg/day (n = 354) or lamivudine 100 mg/day (n = 355) once daily. ETV-022 had a 52-week blinded treatment phase, followed by an extended blinded treatment phase for up to 44 additional weeks (96 weeks total). Treatment was discontinued for patients achieving a protocol-defined response as determined by patient management criteria that intended to test the possibility of finite therapy, which has not previously been studied for entecavir or other anti-HBV agents in a large trial. Early results from this study have been previously presented/published separately. This paper compiles the results of up to 2 years of treatment for protocol-defined responders, virologic responders and nonresponders. For responders who discontinued therapy (per protocol), 24-week off-treatment evaluation is presented to provide a more 'complete picture' of what clinicians can expect when treating nucleoside-naïve HBeAg-positive patients with chronic hepatitis B. For patients who discontinued therapy because of nonresponse (nonresponders) and subsequently entered the rollover study ETV-901, follow-up results, including resistance profile, are provided.

Original languageEnglish
Pages (from-to)784-789
Number of pages6
JournalJournal of Viral Hepatitis
Volume16
Issue number11
DOIs
Publication statusPublished - 2009 Nov 1

Fingerprint

Lamivudine
Hepatitis B e Antigens
Chronic Hepatitis B
Nucleosides
Hepatitis B virus
Therapeutics
Clinical Protocols
entecavir
Safety

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Infectious Diseases
  • Virology

Cite this

Chang, T. T. ; Chao, Y. C. ; Gorbakov, V. V. ; Han, K. H. ; Gish, R. G. ; De Man, R. ; Cheinquer, H. ; Bessone, F. ; Brett-Smith, H. ; Tamez, R. / Results of up to 2 years of entecavir vs lamivudine therapy in nucleoside-naïve HBeAg-positive patients with chronic hepatitis B. In: Journal of Viral Hepatitis. 2009 ; Vol. 16, No. 11. pp. 784-789.
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abstract = "Entecavir is a potent inhibitor of hepatitis B virus (HBV) polymerase. The efficacy and safety of entecavir in nucleoside-na{\"i}ve patients with hepatitis B virus e antigen (HBeAg)-positive chronic hepatitis B was established in a large, international, double-dummy study (ETV-022) where patients were randomized to entecavir 0.5 mg/day (n = 354) or lamivudine 100 mg/day (n = 355) once daily. ETV-022 had a 52-week blinded treatment phase, followed by an extended blinded treatment phase for up to 44 additional weeks (96 weeks total). Treatment was discontinued for patients achieving a protocol-defined response as determined by patient management criteria that intended to test the possibility of finite therapy, which has not previously been studied for entecavir or other anti-HBV agents in a large trial. Early results from this study have been previously presented/published separately. This paper compiles the results of up to 2 years of treatment for protocol-defined responders, virologic responders and nonresponders. For responders who discontinued therapy (per protocol), 24-week off-treatment evaluation is presented to provide a more 'complete picture' of what clinicians can expect when treating nucleoside-na{\"i}ve HBeAg-positive patients with chronic hepatitis B. For patients who discontinued therapy because of nonresponse (nonresponders) and subsequently entered the rollover study ETV-901, follow-up results, including resistance profile, are provided.",
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Chang, TT, Chao, YC, Gorbakov, VV, Han, KH, Gish, RG, De Man, R, Cheinquer, H, Bessone, F, Brett-Smith, H & Tamez, R 2009, 'Results of up to 2 years of entecavir vs lamivudine therapy in nucleoside-naïve HBeAg-positive patients with chronic hepatitis B', Journal of Viral Hepatitis, vol. 16, no. 11, pp. 784-789. https://doi.org/10.1111/j.1365-2893.2009.01142.x

Results of up to 2 years of entecavir vs lamivudine therapy in nucleoside-naïve HBeAg-positive patients with chronic hepatitis B. / Chang, T. T.; Chao, Y. C.; Gorbakov, V. V.; Han, K. H.; Gish, R. G.; De Man, R.; Cheinquer, H.; Bessone, F.; Brett-Smith, H.; Tamez, R.

In: Journal of Viral Hepatitis, Vol. 16, No. 11, 01.11.2009, p. 784-789.

Research output: Contribution to journalArticle

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T1 - Results of up to 2 years of entecavir vs lamivudine therapy in nucleoside-naïve HBeAg-positive patients with chronic hepatitis B

AU - Chang, T. T.

AU - Chao, Y. C.

AU - Gorbakov, V. V.

AU - Han, K. H.

AU - Gish, R. G.

AU - De Man, R.

AU - Cheinquer, H.

AU - Bessone, F.

AU - Brett-Smith, H.

AU - Tamez, R.

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