Clinical Trial Number: (http://clinicaltrials.gov NCT00704106)
The efficacy of entecavir therapy in chronic hepatitis B patients with suboptimal response to adevofir
Version of Record online: 1 AUG 2011
© 2011 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 34, Issue 7, pages 767–774, October 2011
How to Cite
Sheen, E., Trinh, H. N., Nguyen, T. T., Do, S. T., Tran, P., Nguyen, H. A., Nguyen, K. K., Garcia, R. T. and Nguyen, M. H. (2011), The efficacy of entecavir therapy in chronic hepatitis B patients with suboptimal response to adevofir. Alimentary Pharmacology & Therapeutics, 34: 767–774. doi: 10.1111/j.1365-2036.2011.04785.x
- Issue online: 6 SEP 2011
- Version of Record online: 1 AUG 2011
- Publication data Submitted 13 January 2011 First decision 31 January 2011 Resubmitted 29 June 2011 Accepted 4 July 2011 EV Pub Online 1 August 2011
Aliment Pharmacol Ther 2011; 34: 767–774
Background An increasing number of patients with chronic hepatitis B (CHB) have experienced treatment failure to adefovir (ADV) and their management poses a growing challenge. Very limited data are available on the efficacy of entecavir (ETV) in patients previously treated with ADV.
Aim To examine the effect of ETV monotherapy on HBV DNA and ALT levels in CHB patients previously treated with ADV, but switched to ETV due to suboptimal response.
Methods Study candidates were enrolled from five community gastroenterology clinics in the U.S. Each completed at least 12 months of ETV treatment after being previously treated with ADV and experiencing suboptimal response. Primary and secondary outcome measurements were complete viral suppression (CVS, HBV DNA <100 IU/mL) and biochemical response (BR, ALT <40 U/L), respectively.
Results A total of 60 patients were included in this analysis. Twelve were lamivudine (LAM)-experienced and none were LAM-resistant. At time of switch to ETV, no patients had experienced CVS. The CVS rate was 68% after 12 months of ETV therapy. The BR rate was 67% at switch to ETV and 80% after 12 months. There was no significant difference in response rates between LAM-experienced and naïve patients. Among the eight patients with ADV resistance, each achieved CVS after 12 months of ETV therapy and seven achieved BR.
Conclusions In patients with suboptimal response to adefovir, complete viral suppression and biochemical response can be achieved in the majority by 12 months after switching to entecavir, including patients with prior exposure to lamivudine and those with adefovir resistance.