Baraclude approved for chronic hepatitis B with decompensated liver disease

Bristol-Myers Squibb announced the approval of Baraclude (entecavir tablets) for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease. This approval was based on data from a controlled, ongoing, open-label Phase 3b study (ETV-048) that compared Baraclude 1mg once daily to adefovir 10mg once daily in CHB patients with decompensated liver disease. Data demonstrated that Baraclude showed greater viral suppression compared to adefovir at 48 weeks following treatment initiation, 57% versus 20%, respectively.

Baraclude, a nucleoside analog, is already indicated for the treatment of CHB 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.

For more information call (800) 321-1335 or visit www.baraclude.com.