Baraclude warning issued for coinfected patients

August 22, 2007

Entecavir (Baraclude, Bristol-Myers Squibb) should not be used in patients coinfected by HIV and hepatitis B virus (HBV) who are not also receiving highly active antiretroviral therapy (HAART), according to an FDA-issued warning to healthcare professionals.

Entecavir (Baraclude, Bristol-Myers Squibb) should not be used in patients coinfected by HIV and hepatitis B virus (HBV) who are not also receiving highly active antiretroviral therapy (HAART), according to an FDA-issued warning to healthcare professionals. The change is based on the potential for the development of resistance to nucleoside reverse transcriptase inhibitors if entecavir is used to treat chronic HBV infection in patients with HIV that is not being treated. The new information is also reflected in updates to the Microbiology, Precautions, and Patient Information sections of the prescribing information. Entecavir is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease.

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