Efficacy and safety of 12 weeks-entecavir treatment in HBeAg-negative chronic hepatitis B patients with acute-on-chronic liver failure in comparison to lamivudine

Objective To compare the efficacy and safety of 12 weeks-entecavir (ETV) treatment in HBeAg-negative chronic hepatitis B patients with acute-on-chronic liver failure (HBV-ACLF) in comparison to lamivudine (LAM).Methods Ninety eight HBeAg-negative patients with HBV-ACLF who were nucleos(t) ide analogs treatment naive as well as with detectable serum HBV DNA were randomly divided into ETV group and LAM group,and each have 49 patients.Additional to the comprehensively basic internal medicine treatment,antiviral therapy with ETV (0.5 mg,qd) or LAM (0.1,qd) was performed,respectively.The differences of mortality rates,clinical improvement rates,complete virological response (CVR) rates and,adverse events between ETV group and LAM group were compared after 12 weeks of treatment.Results The baseline characteristics of patients in ETV group were comparable to those in LAM group.At week 12,a lower mortality rate of 28.6％ than that of LAM group (48.9％) was observed in ETV group (P ＜ 0.05).In terms of clinical improvement rate,ETV group indicated a higher tendency in total (65.3％ vs 48.3％,P =0.067) and a statistically significant value in subpopulation of model for end-stage liver disease scored no more than 30 than LAM group (75.6％ vs 52.5％,P ＜ 0.05).As expected,ETV group achieved a higher CVR rate than LAM group at week 12 (94.3％ vs 72％,P ＜0.05).Discontinuation of antiviral therapy occurred to none of the patients in both groups.Conclusions Comparing with LAM,ETV can safely inhibit HBV replication more intensively and reduce the 12 weeks mortality rate in HBeAg-negative patients with HBV-ACLF. Key words: Hepatitis B, chronic ;  Liver failure;  Lamivudine;  Entecavir