Patients in this cohort were nucleoside naive e-antigen (HBeAg)-positive patients with chronic hepatitis B infection. HBeAg is a viral protein identified as a marker of active replication of the hepatitis B virus. Patients in this cohort were initially treated with Baraclude 0.5 mg in study ETV-022 and continued treatment with Baraclude 1 mg by enrolling in study ETV- 901 with a less than or equal to 35 day treatment gap.
At week 192 of Baraclude (entecavir) treatment, 91% of nucleoside-naive chronic HBeAg-positive patients in this cohort achieved undetectable viral load (HBV DNA <300 copies/mL) and 86% of patients achieved ALT normalization (ALT less than or equal to 1 times the upper limit of normal). During years three and four, an additional 41% of patients lost HBeAg and 16% of patients achieved HBeAg seroconversion. Baraclude is a nucleoside analogue indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication with either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.