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

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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

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Infectious Diseases
  • Virology

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    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. (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, 16(11), 784-789. https://doi.org/10.1111/j.1365-2893.2009.01142.x