Four-year study of entecavir efficacy and safety in nucleos(t)ide-naïve HBeAg positive chronic hepatitis B patients.

Entecavir is a guanosine analogue with activity against hepatitis B virus. The aim of this 4-year trial was to evaluate entecavir treatment in nucleos(t)ide-naïve HBeAg-positive chronic hepatitis B patients. Forty-nine patients received entecavir and nine of them withdrew from the trial at the end of week 96. The initial mean value of alanine aminotransferase was 79.4 +/- 41.5 IU/L, and at the end of the 4-year study period, 90% of patients had alanine aminotransferase values within the normal range. At week 96, 91.7% of patients had HBV DNA < 300 copies; at month 48, 90% of patients had HBV DNA < 50 IU/mL. HBeAg loss was recorded in 7.1% of patients at week 96 and in 12.5% at month 48. The rate of HBeAg seroconversion was 4.8% at week 96 and 7.5% at month 48. The rate of HBsAg seroconversion was 2.1% at week 96 and 2.5% at month 48. Entecavir as a potent and safe agent leading to continuous viral suppression proved to be safe and well tolerated therapy.