title: Entecavir treatment for chronic hepatitis B: adaptation is not needed for the majority of naïve patients with a partial virological response.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands.
authors.forename: Roeland
authors.initials: R
authors.lastname: Zoutendijk
authors.forename: Jurriën G P
authors.initials: JG
authors.lastname: Reijnders
authors.forename: Ashley
authors.initials: A
authors.lastname: Brown
authors.forename: Fabien
authors.initials: F
authors.lastname: Zoulim
authors.forename: David
authors.initials: D
authors.lastname: Mutimer
authors.forename: Katja
authors.initials: K
authors.lastname: Deterding
authors.forename: Jörg
authors.initials: J
authors.lastname: Petersen
authors.forename: Wolf Peter
authors.initials: WP
authors.lastname: Hofmann
authors.forename: Maria
authors.initials: M
authors.lastname: Buti
authors.forename: Teresa
authors.initials: T
authors.lastname: Santantonio
authors.forename: Florian
authors.initials: F
authors.lastname: van Bömmel
authors.forename: Pierre
authors.initials: P
authors.lastname: Pradat
authors.forename: Ye
authors.initials: Y
authors.lastname: Oo
authors.forename: Marc
authors.initials: M
authors.lastname: Luetgehetmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Berg
authors.forename: Bettina E
authors.initials: BE
authors.lastname: Hansen
authors.forename: Heiner
authors.initials: H
authors.lastname: Wedemeyer
authors.forename: Harry L A
authors.initials: HL
authors.lastname: Janssen
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; C413685:entecavir; D006147:Guanine