Continuous long-term entecavir therapy in naïve chronic hepatitis B patients showing partial virologic response

Gut Liver. 2013 Nov;7(6):712-8. doi: 10.5009/gnl.2013.7.6.712. Epub 2013 Aug 14.

Abstract

Background/aims: We investigated the efficacy of continuous long-term entecavir 0.5 mg treatment in naïve chronic hepatitis B patients showing a partial virologic response (PVR).

Methods: A total of 227 patients were included. PVR was defined as a more than 1 log10 IU/mL decline in detectable serum hepatitis B virus (HBV) DNA by polymerase chain reaction (PCR; ≥20 IU/mL) at week 48. A complete virologic response (CVR) was defined as undetectable serum HBV DNA by PCR (<20 IU/mL) at week 48.

Results: At week 48, the rate of the PVR was 64/227 (28.2%). Among patients with PVR, the cumulative rates of virologic response (serum HBV DNA <20 IU/mL) at weeks 96 and 144 were 45.2% and 73.8%, respectively. The cumulative rates of genotypic resistance were not significantly different between patients with a PVR and patients with a CVR (p=0.057). However, the cumulative rates of virologic breakthrough were higher in patients with PVR than in patients with CVR (4% vs 0% and 11.2% vs 0% at weeks 96 and 144, respectively; p<0.001).

Conclusions: Long-term continuous entecavir 0.5 mg treatment in patients with a PVR resulted in an additional virologic response without a significant increase in genotypic resistance. However, the rate of virologic breakthrough was higher in the partial responders.

Keywords: Chronic; Entecavir; Hepatitis B; Partial; Response.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alanine Transaminase / blood
  • Antiviral Agents / administration & dosage*
  • DNA, Viral / blood*
  • Drug Resistance, Viral / genetics
  • Female
  • Guanine / administration & dosage
  • Guanine / analogs & derivatives*
  • Hepatitis B e Antigens / blood
  • Hepatitis B virus* / genetics
  • Hepatitis B, Chronic / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Time Factors
  • Viral Load

Substances

  • Antiviral Agents
  • DNA, Viral
  • Hepatitis B e Antigens
  • entecavir
  • Guanine
  • Alanine Transaminase