The antiviral drug entecavir is not recommended for use in patients coinfected with HIV and hepatitis B who are not receiving highly active antiretroviral therapy, because this may promote HIV resistance, according to revised labeling for entecavir.
The black box warning for entecavir now includes the statement that “limited clinical experience suggests there is a potential for the development of resistance” to HIV 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.”
Baraclude is the trade name for entecavir, marketed by Bristol-Myers Squibb for treating chronic hepatitis B infection in adults.
Other changes in the labeling include the recommendation to offer HIV antibody testing to all patients before starting treatment with entecavir. The changes are summarized in a “Dear Healthcare Professional” letter issued in August by Bristol-Myers Squibb.
The letter and MedWatch summary are available at www.fda.gov/medwatch/safety/2007/safety07.htm#Baraclude