Label changes for BARACLUDE (entecavir) Tablets and Oral Solution

FDA approved revised labeling on July 24, 2007 for BARACLUDE (entecavir) 0.5 mg and 1.0 mg Film-Coated Tablets, and BARACLUDE (entecavir) 0.05 mg/mL Oral Solution for the treatment of chronic hepatitis B virus 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. The amended label includes safety information related to the use of entecavir (ETV) in patients with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfection who are not receiving simultaneous highly active antiretroviral therapy (HAART).  Specifically, a recommendation against the use of BARACLUDE in HIV/HBV co-infected patients who are not also receiving adequate therapy for their HIV were added to the Boxed Warnings and the WARNINGS sections of the label. Corresponding changes were made to PRECAUTIONS: Information for Patients section, and in the Patient Information (also referred to as the Patient Package Insert).

Added to the Boxed Warning: Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). See WARNINGS: Co-infection with HIV.

Added to WARNINGS section/ Co-infection with HIV: BARCLUDE has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment. Limited clinical experience suggests there is a potential for the development to resistance HIV nucleoside reverse transcriptase inhibitors if BARCLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. (see MICROBIOLOGY: Antiviral Activity, Antiviral Activity against HIV). Therefore, therapy with BARCLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). Before initiating BARCLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.

Added to PRECAUTIONS/Information for Patients: Patients should be offered HIV antibody testing before starting BARCLUDE therapy. They should be informed that if they have HIV infection and are not receiving effective HIV treatment, BARCLUDE may increase the chance of HIV resistance to HIV medication (see WARNINGS: Co-infection with HIV).

Added to Patient Information: If you have or get HIV (human immunodeficiency virus) infection be sure to discuss your treatment with your doctor. If you are taking BARCLUDE to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. You are advised to get an HIV test before you start taking BARCLUDE and anytime after that when there is a chance you were exposed to HIV. BARCLUDE will not help your HIV infection.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration