Article first published online: 3 FEB 2011
Copyright © 2011 American Association for the Study of Liver Diseases
Volume 53, Issue 3, pages 774–780, March 2011
How to Cite
Garg, H., Sarin, S. K., Kumar, M., Garg, V., Sharma, B. C. and Kumar, A. (2011), Tenofovir improves the outcome in patients with spontaneous reactivation of hepatitis B presenting as acute-on-chronic liver failure . Hepatology, 53: 774–780. doi: 10.1002/hep.24109
Potential conflict of interest: Nothing to report.
This study was presented in the oral plenary session in the AASLD Boston 2009 Trial registered with Clinicaltrials.gov NCT01074645.
- Issue published online: 2 MAR 2011
- Article first published online: 3 FEB 2011
- Accepted manuscript online: 14 DEC 2010 03:29PM EST
- Manuscript Accepted: 30 NOV 2010
- Manuscript Received: 18 JUN 2010
Vol. 54, Issue 3, 1144–1114, Article first published online: 2 JUL 2011
Spontaneous reactivation of chronic hepatitis B (CHB) is an important cause of acute-on-chronic liver failure (ACLF). Antiviral drugs may help reduce the high morbidity and mortality in such patients, especially in places where liver transplant is not available. The aim was to evaluate the efficacy of tenofovir and to determine the predictors of mortality in patients with spontaneous reactivation of CHB with ACLF. Consecutive patients of ACLF due to spontaneous reactivation of CHB were randomized to receive either tenofovir or placebo. The primary endpoint was survival at 3 months. Of the 90 patients with ACLF of different etiologies, 27 (26%) were due to reactivation of CHB and were enrolled. The median baseline hepatitis B virus (HBV) DNA level was 9 × 105 IU/mL. Fourteen patients received tenofovir and 13 placebo. At 3 months the probability of survival was higher in the tenofovir than the placebo group (8/14 [57%] versus 2/13 [15%], respectively; P = 0.03). The cause of death in the 15 patients was progressive liver failure leading to multiorgan failure. Liver transplantation could not be offered due to its nonavailability. In the surviving patients, there was a significant improvement in the Child-Turcotte Pugh (CTP) and model for endstage liver disease (MELD) scores and significant decline in the HBV DNA levels in the tenofovir group, whereas these parameters did not change significantly in the placebo group. More than 2 log reduction in HBV DNA levels at 2 weeks was found to be an independent predictor of survival. Conclusion: Tenofovir significantly reduces HBV-DNA levels, improves CTP and MELD scores, and reduces mortality in patients with severe spontaneous reactivation of CHB presenting as ACLF. Reduction in HBV-DNA levels at 2 weeks should be a desirable goal and is a good predictor of survival. (HEPATOLOGY 2011;.)