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HEBECAVIR (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The following points should be considered when initiating therapy with HEBECAVIR: a. This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult patients HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.
b. Virologic, biochemical, serologic and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease.
c. Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy.
