FDA approve entecavir for HBV

On March 29, 2005, FDA approved entecavir (Baraclude) 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.

Limited data about entecavir in patients with HIV/HBV co-infection who received prior lamivudine therapy are presented in the label. Please refer to the label and the Special Population section under Description of Clinical Studies for information on HIV/HBV co-infected patients.

Source: FDA listserve, March 2005

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