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Entecavir Stada

Treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently elevated liver enzyme values, and histologically active disease, including those resistant to lamivudine.

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Description

Entecavir Stada (Entecavir Stada) is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older 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 Entecavir Stada:

• In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and lamivudine-resistant subjects with HBeAg-positive and HBeAg-negative HBV infection and compensated liver disease and a more limited number of subjects with decompensated liver disease.

• In pediatric patients 2 years of age and older, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and in a limited number of lamivudine-experienced subjects with HBeAg-positive chronic HBV infection and compensated liver disease