Mortality, Liver Transplantation, and Hepatocellular Carcinoma Among Patients With Chronic Hepatitis B Treated With Entecavir vs Lamivudine

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 147; no. 1; pp. 152 - 161
• Main Authors: Lim, Young–Suk, Han, Seungbong, Heo, Nae–Yun, Shim, Ju Hyun, Lee, Han Chu, Suh, Dong Jin
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2014
• Subjects: Adult; Antiviral Agents - therapeutic use; Carcinoma, Hepatocellular - epidemiology; Comparative Effectiveness; Female; Follow-Up Studies; Gastroenterology and Hepatology; Guanine - analogs & derivatives; Guanine - therapeutic use; HBV; Hepatitis B, Chronic - drug therapy; Hepatitis B, Chronic - mortality; Hepatitis B, Chronic - surgery; Humans; Incidence; Lamivudine - therapeutic use; Liver Cancer; Liver Neoplasms - epidemiology; Liver Transplantation - statistics & numerical data; Male; Middle Aged; Proportional Hazards Models; Republic of Korea; Retrospective Studies; Risk Factors; Survival; Survival Rate; Treatment Outcome; Republic of Korea; chronic hepatitis B; CI; hepatitis B virus; HBeAg; HCC; Liver Cancer; HR; Survival; hepatitis B e antigen; Comparative Effectiveness; hazard ratio; confidence interval; CHB; HBV; hepatocellular carcinoma
• ISSN: 0016-5085; 1528-0012
• DOI: 10.1053/j.gastro.2014.02.033

Background & Aims 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.