title: Efficacy and safety of entecavir versus tenofovir treatment in chronic hepatitis B patients: A randomized controlled trial.
abstract: OBJECTIVE
  Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are considered among the most potent antiviral agents for the treatment of chronic hepatitis B infection. We aimed to compare treatment efficacy and safety of ETV and TDF in nucleoside-naïve chronic hepatitis B patients.
  
  
  METHODS
  Inclusion criteria were compensated chronic hepatitis B patients who were either hepatitis B e antigen (HBeAg)-positive or HBeAg-negative. Exclusion criteria were co-infection with hepatitis C virus and/or HIV, concurrent malignancy, and decompensated cirrhosis. Virological, biochemical, and serological end-points at week 96 and 144 were compared. Of 400 patients, 200 patients received ETV and 200 received TDF.
  
  
  RESULTS
  There were no significant differences between the two groups in baseline characteristics including age (41.6 ± 11.5 vs. 41.2 ± 11.6, mean baseline hepatitis B virus DNA (5.91 ± 1.79 vs. 5.94 ± 1.68 log10IU/mL), mean baseline alanine aminotransferase (68.1 ± 64.1 vs. 76.8 ± 79.8 U/L), and cirrhosis (15.5% vs. 14.5%). At week 144 of treatment, 91 and 94% of the ETV and TDF groups, respectively, achieved undetectable hepatitis B virus DNA. In HBeAg-positive patients, HBeAg seroconversion could be achieved in 27.4% and 33.7% at week 144 for ETV and TDF groups, respectively. Quantitative hepatitis B surface antigen dropped significantly over 144 weeks of treatment period but only 1.0 to 1.5% experienced hepatitis B surface antigen loss. Safety profiles were consistent with previous reports of monotherapy.
  
  
  CONCLUSIONS
  Both ETV and TDF showed potent antiviral activity against hepatitis B. Either ETV or TDF can be recommended as a treatment of choice for patients with chronic hepatitis B. Both drugs were safe and well tolerated.
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.|Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Tassanee
authors.initials: T
authors.lastname: Sriprayoon
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.|Chulabhorn Research Institute, Bangkok, Thailand.
authors.forename: Chulabhorn
authors.initials: C
authors.lastname: Mahidol
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.
authors.forename: Teerapat
authors.initials: T
authors.lastname: Ungtrakul
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.
authors.forename: Pattra
authors.initials: P
authors.lastname: Chun-On
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.
authors.forename: Kamonwan
authors.initials: K
authors.lastname: Soonklang
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.
authors.forename: Wanvisa
authors.initials: W
authors.lastname: Pongpun
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.|Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Charlie
authors.initials: C
authors.lastname: Laohapand
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.
authors.forename: Jiraporn
authors.initials: J
authors.lastname: Dechma
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.
authors.forename: Charinthip
authors.initials: C
authors.lastname: Pothijaroen
authors.affiliation: Chulabhorn Hospital, Bangkok, Thailand.|Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Chirayu
authors.initials: C
authors.lastname: Auewarakul
authors.affiliation: Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Tawesak
authors.initials: T
authors.lastname: Tanwandee
keywords: HBeAg seroconversion, efficacy; antiviral therapy; hepatitis B; safety profile