High rates of viral suppression after long-term entecavir treatment of Asian patients with hepatitis B e antigen-positive chronic hepatitis B

Clin Gastroenterol Hepatol. 2012 Sep;10(9):1047-1050.e1. doi: 10.1016/j.cgh.2012.03.016. Epub 2012 Apr 1.

Abstract

There are limited data on the effects of long-term entecavir therapy in Asian patients with chronic hepatitis B (CHB). We performed a post hoc analysis of 94 Asian hepatitis B e antigen-positive (HBeAg+), nucleos(t)ide analogue-naive patients who received 5 years of therapy with entecavir (up to 2 years in study ETV-022 and the remainder in study ETV-901). Among patients completing week 240, 95% (63 of 66) had levels of hepatitis B virus DNA <300 copies/mL, and 76% (50 of 66) had normalized levels of alanine aminotransferase. In addition to patients who achieved a serologic response during ETV-022, a further 40% (26 of 65) achieved HBeAg loss, and 18% (12 of 65) underwent HBeAg seroconversion through year 5 of entecavir therapy. No resistance to entecavir was detected, and the safety profile was consistent with previous reports. The long-term efficacy and safety of entecavir are therefore comparable between Asians and the overall population of HBeAg+ patients with CHB.

Publication types

  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alanine Transaminase / blood
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects
  • Asian People
  • DNA, Viral / blood
  • Drug Resistance, Viral
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Female
  • Guanine / administration & dosage
  • Guanine / adverse effects
  • Guanine / analogs & derivatives*
  • Hepatitis B e Antigens / blood*
  • Hepatitis B virus / isolation & purification*
  • Hepatitis B, Chronic / drug therapy*
  • Hepatitis B, Chronic / virology
  • Humans
  • Male
  • Treatment Outcome
  • Viral Load*

Substances

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