Long-term efficacy and safety of emtricitabine plus tenofovir DF vs. tenofovir DF monotherapy in adefovir-experienced chronic hepatitis B patients

  • Berg T
  • Zoulim F
  • Moeller B
 et al. 
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Abstract

Background & Aims Suboptimal virologic response to nucleos(t)ide analogs may represent a significant risk factor for resistance development in patients with chronic hepatitis B virus infection; treatment options have not been well studied. We evaluated long-term efficacy and safety of tenofovir alone and in combination with emtricitabine in a prospective, placebo-controlled trial in patients who remained viremic on adefovir therapy. Methods Hepatitis B e antigen-positive and -negative patients with hepatitis B virus DNA ≥1000 copies/ml despite up to 96 weeks of adefovir were randomized to double-blind tenofovir or emtricitabine/tenofovir for 168 weeks. Patients with hepatitis B virus DNA ≥400 copies/ml (≥69 IU/ml) at or after week 24 could switch to open-label emtricitabine/tenofovir. Results Overall, 90/105 (86%) patients (46/53 tenofovir and 44/52 emtricitabine/tenofovir) completed the 168-week study period, including 74/105 (70%) patients (35/53 tenofovir and 39/52 emtricitabine/tenofovir) who completed the study on their initial randomized treatment. Long-term viral suppression (hepatitis B virus DNA

Author-supplied keywords

  • Adefovir
  • Combination treatment
  • Emtricitabine
  • Hepatitis B
  • Monotherapy
  • Mutations
  • Resistance
  • Tenofovir

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Authors

  • Thomas BergSection of Hepatology, University Clinic Leipzig, Germany

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  • Fabien Zoulim

  • Bernd Moeller

  • Huy Trinh

  • Patrick Marcellin

  • Sing Chan

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