Entecavir For Patients With Hepatitis B Decompensated Liver Disease Or Liver Failure:A Meta Analysis

Background:In the latest clinical practice guidelines made by European association for the study of the liver(EASL), approximately one third of the word’s population has serological evidence of past or present infection with hepatitis B virus (HBV) and HBV-related end stage liver diseases or hepatocellular carcinoma(HCC) are responsible for over0.5-1million deaths per year. The guideline of prevention and treatment for chronic hepatitis (2010version) of China points that about7.18%of the population aged1to59years old in China are chronic HBV surface antigen(HBsAg) carriers, according to the epidemiological investigate nationwide. Now, there are about0.1billion people who are HBsAg carriers based on the epidemiological studies. Morbidity and mortality in chronic hepatitis (CHB) are linked to peristence of viral replication. Entecavir(ETV) is a nucleoside analog(more specifically, a guanosine analogue) that inhibits reverse transcription, DNA replication and transcription in the viral-eplication process, which was approved by the U.S.FDA in March2005, and approved by SFDA in the same year. There are many random control trials on ETV used for patients with hepatitis B decompensated liver disease or liver failure, but system review and Meta-analysis are rare.Objective:To assess the treatment outcomes of ETV in participants with lepatitis B decompensated liver disease or liver failure. Search methods and Data collection:A computerized search of The Cochrane Library (CENTRAL,2013), PubMed(1966-April2013), EMbase (1974-April2013), CNKI (1978-April2013), WANFANG (1998-2013.4),VIP (1989-2013.4), CBM (1978-2013.4) databases was conducted. Studies were selected according to prespecified inclusion and exclusion criteria and then subjected for quality assessment and data extraction. Meta-analysis was performed using the statistical software (RevMan5.1.1) provided by the Cochrane Collaboration and the evidence quality was evaluated by Grading of Recommendations Assessment, Development and Evaluation’s(GRADE) guideline.Results:A total of8studies, all of which were randomized clinical trials (RCTs), involving769patients with severe hepatitis B were included. Subgroup analyses by control group and treatment duration were conducted. The quality of the evidence was classified from very low to moderate by the GRADED approach for all the included RCTs. Meta-analysis showed that patients were significantly more likely to experience HBV-DNA loss(P<0.00001), have normalized alanine aminotransferase levels(ALT)(P<0.0001) and have a low mortality ratez(P<0.0001) when treated with entecavir versus control groups for either48or96weeksConclusion:Entecavir appeared to be more effective than other therapies in reducing serum HBV-DNA load, normalizing ALT and reducing mortality in patients with severe hepatitis B. However, the small sample size, short period of follow-up, and high risk of bias in the included trials limited the credibility ofresults. Therefore, adequately powered randomised trials with low risk of bias and long periods of follow-up and assessing all of the important outcomes for patients and professionals were in great need.