title: Meta-analysis: oral anti-viral agents in adults with decompensated hepatitis B virus cirrhosis.
abstract: BACKGROUND
  The optimal oral anti-viral agent to use in patients with decompensated HBV cirrhosis remains unclear.
  
  
  OBJECTIVE
  We performed a meta-analysis of the oral nucleos(t)ide analogues in patients with decompensated HBV cirrhosis.
  
  
  METHODS
  One year efficacy and safety outcomes in 22 studies published in English between '95 and 2010 were analysed.
  
  
  RESULTS
  Substantial heterogeneity was noted in the inclusion/exclusion criteria, controls, and sensitivity of the HBV DNA assay used. Pooled 1-year data showed benefit favouring lamivudine (LAM) vs. untreated controls for Child-Turcotte-Pugh (CTP) score improvement by ≥2 (OR: 117 (15 921), P ≤ 0.0001) and transplant-free survival (OR: 3.2 (1.2, 9), P = 0.022). Adefovir (ADV) led to undetectable HBV DNA at 1-year in 41% compared to 83% with LAM and 80% with entecavir (ETV). Overall, 1-year transplant-free survival rates varied from 78% with LAM to 95% and 94% with Tenofovir (TDF) and Telbivudine (TBV), respectively. The 1-year incidence of drug resistant HBV was 0% with ADV, ETV and TDF and 11% with LAM although TBV was associated with a 29% incidence at 2 years. Drug-related adverse events were infrequently reported.
  
  
  CONCLUSIONS
  All the oral anti-viral agents were associated with improved virological, biochemical and clinical parameters at 1-year. However, the efficacy of lamivudine and telbivudine is limited by drug resistance, and adefovir is limited by its potency and slower onset of action. Additional studies of tenofovir and entecavir are needed to determine the optimal agent(s) for treatment naïve patients and in those with drug-resistant decompensated HBV cirrhosis.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, USA.
authors.forename: A K
authors.initials: AK
authors.lastname: Singal
authors.forename: R J
authors.initials: RJ
authors.lastname: Fontana
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D024882:Drug Resistance, Viral / Q000187:drug effects; D004359:Drug Therapy, Combination; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006509:Hepatitis B / Q000188:drug therapy; D006515:Hepatitis B virus / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000821:virology; D009705:Nucleosides / Q000008:administration & dosage / Q000009:adverse effects; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects; D011744:Pyrimidinones / Q000008:administration & dosage / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000077712:Telbivudine; D000068698:Tenofovir; D013936:Thymidine / Q000031:analogs & derivatives; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D009705:Nucleosides; D063065:Organophosphonates; D011744:Pyrimidinones; D018894:Reverse Transcriptase Inhibitors; D000077712:Telbivudine; D019259:Lamivudine; C413685:entecavir; D006147:Guanine; C053001:adefovir; D000068698:Tenofovir; D000225:Adenine; D013936:Thymidine