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



This article is corrected by:

  1. Errata: Corrections: Entecavir treatment for chronic hepatitis B: Adaptation is not needed for the majority of naïve patients with a partial virological response Volume 54, Issue 6, 2281–2282, Article first published online: 30 November 2011

  • Potential conflict of interest: Jurrien Reijnders has received speaker's honoraria from Novartis and Bristol-Myers Squibb. Fabien Zoulim is consultant for Bristol-Myers Squibb, Gilead, Roche, and Novartis. David Mutimer has received honoraria and grants from Bristol-Myers Squibb. Jörg Petersen is a consultant for Bristol-Myers Squibb and received research support. Maria Buti has received speaker's honoraria and an advisory board fee from Bristol-Myers Squibb. Florian van Bommel has received travel grants from Roche and Gilead. Thomas Berg is a consultant for, advises, is on the speakers' bureau of, and has received grants from Gilead, Roche, Novartis, Merck, Tibotec, and Vertex. Heiner Wedemeyer received research grants and speaker's honoraria from Bristol-Myers Squibb, Gilead, Roche, and Novartis. Harry Janssen received grants from and is a consultant for Bristol-Myers Squibb, Gilead Sciences, Novartis, Roche, and Merck.

  • Supported by the Foundation for Liver and Gastrointestinal Research Rotterdam. The study was conducted with support from the European Network of Excellence for Vigilance against Viral Resistance and a research grant from Bristol-Myers Squibb. (Bristol-Myers Squibb was not involved in data collection, data analysis, writing of the manuscript, or decision to publish.)


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. (HEPATOLOGY 2011;)