Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT

Summary

Entecavir (ETV) has shown superior ability to suppress hepatitis B virus (HBV) replication, histology improvement as well as low rate of emergence of resistant mutants. Out of range of clinical recommendations for treatment of chronic hepatitis B (CHB), chronic HBV carriers with persistently normal ALT and viral load more than 10\^5 copies/mL have progression of liver disease during long-term follow-up. In addition, certain proportions of these patients do have significant inflammation and fibrosis in liver histology. This study will be able to identify who are at risk of liver disease progression and evaluate efficacy of ETV regarding improvement of liver histology during short-term (1-year) and long-term ETV treatment (3-year).

Timeline

Start

2008-09

Primary completion

2014-11

Completion

2015-05

Publications

• Tseng KC, Chen CY, Tsai HW, Chang TT, Chuang WL, Hsu PI, Liu WC, Cheng PN. Efficacy of entecavir in chronic hepatitis B patients with persistently normal alanine aminotransferase: randomized, double-blind, placebo-controlled study. Antivir Ther. 2014;19(8):755-64. doi: 10.3851/IMP2754. Epub 2014 Feb 28.

Drugs

Indications