Entecavir vs lamivudine therapy for naïve patients with spontaneous reactivation of hepatitis B presenting as acute-on-chronic liver failure.
OBJECTIVE
To investigate the short-term and long-term efficacy of entecavir versus lamivudine in patients with spontaneous reactivation of hepatitis B presenting as acute-on-chronic liver failure (ACLF).


METHODS
This was a single center, prospective cohort study. Eligible, consecutive hospitalized patients received either entecavir 0.5 mg/d or lamivudine 100 mg/d. All patients were given standard comprehensive internal medicine. The primary endpoint was survival rate at day 60, and secondary endpoints were reduction in hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) levels, and improvement in Child-Turcotte-Pugh (CTP) and model for end-stage liver disease (MELD) scores at day 60 and survival rate at week 52.


RESULTS
One hundred and nineteen eligible subjects were recruited from 176 patients with severe acute exacerbation of chronic hepatitis B: 65 were included in the entecavir group and 54 in the lamivudine group (full analysis set). No significant differences were found in patient baseline clinical parameters. At day 60, entecavir did not improve the probability of survival (P = 0.066), despite resulting in faster virological suppression (P < 0.001), higher rates of virological response (P < 0.05) and greater reductions in the CTP and MELD scores (all P < 0.05) than lamivudine. Intriguingly, at week 52, the probability of survival was higher in the entecavir group than in the lamivudine group [42/65 (64.6%) vs 26/54 (48.1%), respectively; P = 0.038]. The pretreatment MELD score (B, 1.357; 95%Cl: 2.138-7.062; P = 0.000) and virological response at day 30 (B, 1.556; 95%Cl: 1.811-12.411; P =0.002), were found to be good predictors for 52-wk survival.


CONCLUSIONS
Entecavir significantly reduced HBV DNA levels, decreased the CTP and MELD scores, and thereby improved the long-term survival rate in patients with spontaneous reactivation of hepatitis B presenting as ACLF.
Yang Zhang, Xiao-Yu Hu, Sen Zhong, Guo Chen, Yan-Yan Wang, Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan Province, China.
Yang
Y
Zhang
Yang Zhang, Xiao-Yu Hu, Sen Zhong, Guo Chen, Yan-Yan Wang, Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan Province, China.
Xiao-Yu
XY
Hu
Yang Zhang, Xiao-Yu Hu, Sen Zhong, Guo Chen, Yan-Yan Wang, Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan Province, China.
Sen
S
Zhong
Yang Zhang, Xiao-Yu Hu, Sen Zhong, Guo Chen, Yan-Yan Wang, Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan Province, China.
Fang
F
Yang
Yang Zhang, Xiao-Yu Hu, Sen Zhong, Guo Chen, Yan-Yan Wang, Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan Province, China.
Tao-You
TY
Zhou
Yang Zhang, Xiao-Yu Hu, Sen Zhong, Guo Chen, Yan-Yan Wang, Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan Province, China.
Guo
G
Chen
Yang Zhang, Xiao-Yu Hu, Sen Zhong, Guo Chen, Yan-Yan Wang, Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan Province, China.
Yan-Yan
YY
Wang
Yang Zhang, Xiao-Yu Hu, Sen Zhong, Guo Chen, Yan-Yan Wang, Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan Province, China.
Jian-Xing
JX
Luo
D065290:Acute-On-Chronic Liver Failure / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002681:China; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006515:Hepatitis B virus / Q000187:drug effects* / Q000235:genetics / Q000254:growth & development; D019694:Hepatitis B, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D014775:Virus Activation / Q000187:drug effects*
D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D019259:Lamivudine; C413685:entecavir; D006147:Guanine; D000410:Alanine Transaminase
Acute-on-chronic liver failure; Entecavir; Hepatitis B; Lamivudine; Survival