Baraclude is 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.
FDA has granted approval based on the virologic, biochemical, serologic and safety data from a controlled, ongoing, open-label Phase IIIb study (ETV-048), which compares Baraclude (1mg once daily) to adefovir (10mg once daily) in CHB patients with decompensated liver disease.
Reportedly, in the study Baraclude was effective in this patient population and the drug also showed greater viral suppression compared to adefovir at 48 weeks following treatment initiation.
John A Burns School of Medicine at the University of Hawaii, Honolulu professor of medicine Naoky Tsai said that the additional indication for Baraclude is important news as it is proven to be an effective treatment option for physicians to help in managing chronic hepatitis B patients with decompensated liver disease.