Baraclude Labeling Updated to Include Data on African Americans, Liver Transplant Recipients with HBV

The labeling for Baraclude (entecavir; Bristol-Myers Squibb) has been updated to include data on African Americans and liver transplant recipients with chronic hepatitis B infection. The current labeling update was accepted based on one study in African-American patients and one study in post-liver transplant recipients, each investigating Baraclude in these populations.

In Study 085, the safety and efficacy of Baraclude 0.5mg once daily were assessed in nucleoside-naïve African-American patients (n=40) and Hispanic patients (n=6) with chronic HBV infection.  Thirty-two of 46 (70% of patients) achieved an HBV DNA <50 IU/mL (approximately 300 copies/mL). Due to low enrollment, safety and efficacy were not established in Hispanic patients. Hepatitis B infection remains an area of concern among African Americans. In the United States, approximately 1.4 to 2.0 million individuals are chronically infected with chronic hepatitis B.

In Study 109, the safety and efficacy of Baraclude 1mg once daily were assessed in 65 patients who received a liver transplant for complications of chronic HBV infection.  Fifty three of these patients (82% of all 65 treated patients) completed the trial and had HBV DNA measurements at or after 72 weeks treatment post-transplant. All 53 patients achieved an HBV DNA <50 IU/mL (approximately 300 copies/mL). Patients with chronic hepatitis B and end-stage liver disease may undergo a liver transplantation as a treatment option. However, recurrence of a disease that caused the need for a liver transplant, such as chronic hepatitis B, can damage the new liver.

Baraclude, a nucleoside analogue, is indicated for the treatment of chronic hepatitis B virus (HBV) 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.

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