Meta-analysis: oral anti-viral agents in adults with decompensated hepatitis B virus cirrhosis
Article first published online: 19 JAN 2012
© 2012 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 35, Issue 6, pages 674–689, March 2012
How to Cite
Singal, A. K. and Fontana, R. J. (2012), Meta-analysis: oral anti-viral agents in adults with decompensated hepatitis B virus cirrhosis. Alimentary Pharmacology & Therapeutics, 35: 674–689. doi: 10.1111/j.1365-2036.2011.04990.x
- Issue published online: 20 FEB 2012
- Article first published online: 19 JAN 2012
- Manuscript Accepted: 27 DEC 2011
- Manuscript Revised: 23 DEC 2011
- Manuscript Revised: 5 AUG 2011
- Manuscript Received: 7 JUL 2011
The optimal oral anti-viral agent to use in patients with decompensated HBV cirrhosis remains unclear.
We performed a meta-analysis of the oral nucleos(t)ide analogues in patients with decompensated HBV cirrhosis.
One year efficacy and safety outcomes in 22 studies published in English between95 and 2010 were analysed.
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.
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.