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Caution on Baraclude Therapy for Certain HBV Patients

Posted on April 29, 2008

Bristol-Myers Squibb has notified healthcare professionals about a new boxed warning for the antiviral drug Baraclude (entecavir). Baraclude is approved to treat certain patients with chronic hepatitis B.

The boxed warning says that patients infected with both hepatitis B virus and HIV who are being treated with Baraclude for their hepatitis can develop resistance to certain HIV drugs unless the HIV infection is treated at the same time. Because of this, Baraclude is not recommended for HBV patients who also have HIV unless they're receiving highly active antiretroviral therapy.

The labeling also says that patients should be offered HIV antibody testing before starting Baraclude therapy. They should be told that if they have HIV and are not being treated for it, taking Baraclude could increase the chance of their becoming resistant to certain HIV medications.

Additional Information:

FDA MedWatch Safety Alert. Baraclude (entecavir) Tablets and Oral Solution. August 16, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Baraclude

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