Abstract
Objective: This study was designed to determine the efficacy and safety of Entecavir (ETV) after 96 weeks treatment in patients with chronic viral hepatitis B (CHB).
Methods: Thirty-eight patients were included into the study. The criteria for starting ETV treatment were as follows: elevated ALT levels >upper limit of normal (ULN) two times, with HBV-DNA levels ≥5 log10 copies/ml (≥20000 IU/mL), in HBe Ag positive patients, ≥4log10 copies/ml (≥2000IU/mL) in HBe Ag negative patients and liver damage was confirmed by histopathology (Knodell HAI ≥4 or fibrosis ≥1). Patients were followed up every 12 weeks by virological and biochemical tests.
Results: Twenty-four of 38 patients (63.2%) were male. Mean age of patients were 38.6 years, 14 of them were HBeAg positive (36.8%). At baseline, median ALT level was detected as 106.7 IU/ml, median HBV DNA levels were 4.8 x 107 copy/ml, and mean Knodell HAI score was nine.
Eleven of 14 HBe Ag positive patients (78.6%) were treatment-naïve. No resistance mutation was determined during treatment. Biochemical responses (BR) at 48th and 96th week were 100% and virologic response (VR) were 57.1%, and 50%, respectively. Serological response (SR) at 48th and 96th weeks were 35.7% and 42.8% respectively.
Fifteen (62.5%) of 24 HBe Ag negative patients were treatment-naïve; two patients were detected to have lamivudine resistance mutation. At 48th and 96th week, BR was 95.8%, and 100%, respectively; and VR were 83.3% both.
Conclusion: In our study, virologic response was significantly high after two years of therapy with Entecavir in HBe Ag negative patients. J Microbiol Infect Dis 2013;3(4): 176-180

Key words: Chronic hepatitis B, Entecavir, therapy