title: Mortality, liver transplantation, and hepatocellular carcinoma among patients with chronic hepatitis B treated with entecavir vs lamivudine.
abstract: OBJECTIVE
  Little is known about whether the antiviral agent entecavir is more effective than a less potent drug, lamivudine, in reducing the risk of death and hepatocellular carcinoma (HCC) in patients with chronic hepatitis B.
  
  
  METHODS
  We performed a retrospective analysis of data from 5374 consecutive adult patients with chronic hepatitis B, treated with entecavir (n = 2000) or lamivudine (n = 3374), at a tertiary referral hospital in Seoul, Korea, from November 1, 1999, through December 31, 2011. Data were collected from patients for up to 6 years and analyzed by a multivariable Cox proportional hazards model for the entire cohort and for propensity score-matched cohorts.
  
  
  RESULTS
  During the study period, 302 patients (5.6%) died, 169 (3.1%) received a liver transplant, and 525 (9.8%) developed HCC. Multivariable analyses showed that compared with lamivudine, entecavir therapy was associated with a significantly lower risk of death or transplantation (hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.38-0.64), but a similar risk of HCC (HR, 1.08; 95% CI, 0.87-1.34). In the 1792 overall propensity-matched pairs, entecavir again was associated with a significantly lower risk of death or transplantation (HR, 0.49; 95% CI, 0.37-0.64) and a similar risk of HCC (HR, 1.01; 95% CI, 0.80-1.27). Entecavir also reduced the risk of death or transplantation, compared with lamivudine, in 860 pairs of patients with cirrhosis (HR, 0.42; 95% CI, 0.31-0.57) but there were no differences in risk for HCC (HR, 1.00; 95% CI, 0.78-1.28). However, entecavir and lamivudine did not have significantly different effects on clinical outcome in 878 pairs of patients without cirrhosis.
  
  
  CONCLUSIONS
  In a retrospective study of 5374 patients with chronic hepatitis B virus infection, entecavir therapy was associated with a significantly lower risk of death or transplantation than lamivudine. However, the drugs did not have different effects on HCC risk.
authors.affiliation: Department of Gastroenterology, Liver Center, Asan Medical Center, Seoul, Republic of Korea. Electronic address: limys@amc.seoul.kr.
authors.forename: Young-Suk
authors.initials: YS
authors.lastname: Lim
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Seungbong
authors.initials: S
authors.lastname: Han
authors.affiliation: Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea.
authors.forename: Nae-Yun
authors.initials: NY
authors.lastname: Heo
authors.affiliation: Department of Gastroenterology, Liver Center, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Ju Hyun
authors.initials: JH
authors.lastname: Shim
authors.affiliation: Department of Gastroenterology, Liver Center, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Han Chu
authors.initials: HC
authors.lastname: Lee
authors.affiliation: Department of Gastroenterology, Liver Center, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Dong Jin
authors.initials: DJ
authors.lastname: Suh
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000453:epidemiology*; D005260:Female; D005500:Follow-Up Studies; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000401:mortality* / Q000601:surgery; D006801:Humans; D015994:Incidence; D019259:Lamivudine / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000453:epidemiology*; D016031:Liver Transplantation / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D056910:Republic of Korea; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D019259:Lamivudine; C413685:entecavir; D006147:Guanine
keywords: Comparative Effectiveness; HBV; Liver Cancer; Survival