Food and Drug Administration - February 26, 2007
Richard Klein & Kimberly Struble

FDA and Bristol-Myers Squibb are notifying 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 (entecavir), a nucleoside analog used in the treatment of chronic hepatitis B virus (HBV).

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 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.

You can read the manufacturer's Dear Healthcare Provider Letter at: www.aegis.org/files/fda/2007/FD070201_baraclude.pdf

The revised labeling can be found at: www.aegis.org/files/fda/2007/FD070201_baraclude_label.pdf

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
070226
FD070201

SOURCE: Food and Drug Administration (FDA).

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