Entecavir treatment for chronic hepatitis B: adaptation is not needed for the majority of naïve patients with a partial virological response

Roeland Zoutendijk, Jurriën G P Reijnders, Ashley Brown, Fabien Zoulim, David Mutimer, Katja Deterding, Jörg Petersen, Wolf Peter Hofmann, Maria Buti, Teresa Santantonio, Florian van Bömmel, Pierre Pradat, Ye Htun Oo, Marc Luetgehetmann, Thomas Berg, Bettina E Hansen, Heiner Wedemeyer, Harry L A Janssen, VIRGIL Surveillance Study Group

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130 Citations (Scopus)


UNLABELLED: Entecavir (ETV) is a potent inhibitor of viral replication in nucleos(t)ide analogue (NA)-naïve chronic hepatitis B (CHB) patients. The aim of this study was to investigate the long term efficacy and safety of ETV in NA-naïve CHB patients, particularly in those with detectable hepatitis B virus (HBV) DNA after 48 weeks, in whom treatment adaptation is suggested by current guidelines. In a multicenter cohort study, we investigated 333 CHB patients treated with entecavir monotherapy. The NA-naïve population consisted of 243 patients, whereas 90 were NA-experienced. Virological response (VR) (HBV DNA<80 IU/mL) was achieved in 48%, 76%, and 90% of hepatitis B e antigen (HBeAg)-positive and in 89%, 98%, and 99% of HBeAg-negative NA-naïve patients at weeks 48, 96, and 144, respectively. Thirty-six of 175 (21%) NA-naïve patients with at least 48 weeks of follow-up had a detectable load at week 48 (partial virological response [PVR]). Twenty-nine (81%) patients with PVR reached VR during prolonged ETV monotherapy, and none of them developed ETV-resistance. Among 22 patients with HBV DNA<1,000 IU/mL at week 48, VR was achieved in 21 (95%) patients, compared with eight of 14 (57%) patients with HBV DNA≥1,000 IU/mL. Continuous HBV DNA decline was observed in most patients without VR during follow-up, and in three patients adherence was suboptimal according to the treating physician. ETV was safe and did not affect renal function or cause lactic acidosis.

CONCLUSION: ETV monotherapy can be continued in NA-naïve patients with detectable HBV DNA at week 48, particularly in those with a low viral load because long-term ETV leads to a virological response in the vast majority of patients.

Original languageEnglish
Pages (from-to)443-51
Number of pages9
Issue number2
Early online date11 May 2011
Publication statusPublished - 25 Jul 2011


  • Adult
  • Antiviral Agents
  • Cohort Studies
  • Female
  • Guanine
  • Hepatitis B, Chronic
  • Humans
  • Male
  • Prospective Studies
  • Time Factors
  • Treatment Outcome


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