Revisions to Baraclude Annonunced by the FDA and Bristol Myers

Food and Drug Adminstrartion, Feb 26, 2007

FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the Microbiology / Antiviral Activity and Indications And Usage-Description of Clinical Studies/Special Populations sections of the prescribing information for Baraclude.

The revised labeling is the result of a case report in which a human immunodeficiency virus (HIV)  variant containing the M184V resistance substitution was documented during Baraclude treatment for chronic hepatitis B virus (HBV) infection in an HIV/HBV co-infected patient who was not simultaneously receiving highly active antiretroviral therapy (HAART).

Current treatment guidelines recommend Baraclude as an option for treatment of HBV in the HIV/HBV co-infected adult patient who does not qualify for HAART. Healthcare professionals are advised that when considering therapy with Baraclude in an HIV/HBV co-infected patient not receiving HAART, the risk of developing HIV resistance cannot be excluded based on current information.