title: Efficacy of telbivudine compared with entecavir in hepatitis B virus-related cirrhosis: 2 year follow-up data.
abstract: OBJECTIVE
  Entecavir (ETV) is effective in the treatment of chronic hepatitis B virus (HBV) infections, even in patients with underlying cirrhosis. However, there is little information on the effect of telbivudine (TBV) in chronic hepatitis B patients with cirrhosis.This study compared the antiviral efficacy of TBV and ETV in HBV-related cirrhosis.
  
  
  METHODS
  We consecutively enrolled 151 treatment-naïve patients with HBV-related cirrhosis who started antiviral therapy with TBV (n = 61) or ETV (n = 90).
  
  
  RESULTS
  After 24 months of treatment, per-protocol analysis showed similar virological response rates (HBV DNA <20 IU/ml) in the TBV group (80.6%, 25/31) and in the ETV group (90.2%, 74/82) (P = 0.167). However, intention-to-treat analysis showed lower virological response rates in the TBV group (41.7%, 25/60) than in the ETV group (83.1%, 74/89) (P = 0.001). Mean reduction in HBV DNA levels was greater in the ETV group (-3.72 ± 1.94 vs. -4.87 ± 1.57 respectively, P = 0.001). Serologic and biochemical response rates at month 24 did not differ significantly between the groups. Child-Turcotte-Pugh score was significantly improved after 24 months compared to the pretreatment state without difference between the groups. During 24 months of therapy, 15 patients (27.3%) showed antiviral resistance to TBV while no resistance (0%) was reported in the ETV group (P = 0.001).
  
  
  CONCLUSIONS
  Compared to ETV, TBV therapy shows lower efficacy in viral suppression and higher risk of antiviral resistance despite comparable effect on improvement of hepatic function for the treatment of HBV-related cirrhosis.
authors.affiliation: Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
authors.forename: Hae Rim
authors.initials: HR
authors.lastname: Kim
authors.forename: Hyung Joon
authors.initials: HJ
authors.lastname: Yim
authors.forename: Seonghee
authors.initials: S
authors.lastname: Kang
authors.forename: Sang Jun
authors.initials: SJ
authors.lastname: Suh
authors.forename: Seung Young
authors.initials: SY
authors.lastname: Kim
authors.forename: Jong Jin
authors.initials: JJ
authors.lastname: Hyun
authors.forename: Ja Seol
authors.initials: JS
authors.lastname: Koo
authors.forename: Ji Hoon
authors.initials: JH
authors.lastname: Kim
authors.forename: Yeon Seok
authors.initials: YS
authors.lastname: Seo
authors.forename: Jong Eun
authors.initials: JE
authors.lastname: Yeon
authors.forename: Sang Woo
authors.initials: SW
authors.lastname: Lee
authors.forename: Kwan Soo
authors.initials: KS
authors.lastname: Byun
authors.forename: Soon Ho
authors.initials: SH
authors.lastname: Um
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012189:Retrospective Studies; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077712:Telbivudine; C413685:entecavir; D006147:Guanine; D013936:Thymidine
keywords: cirrhosis; entecavir; hepatitis B; telbivudine