BARACLUDE SUMMARY
Baraclude™
(entecavir)
Baraclude™ (entecavir) Tablets
Baraclude™ (entecavir) Oral Solution
BARACLUDE™ is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV).
BARACLUDE (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.
This indication is based on histologic, virologic, biochemical, and serologic responses after one year of treatment in nucleoside-treatment-naive and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease and on more limited data in adult patients with HIV/HBV co-infection who have received prior lamivudine therapy.
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