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Health Canada issues warning on use of Baraclude alone in HIV/hepatitis B coinfected
Health Canada has issued a warning that the use of the hepatitis B drug entecavir (Baraclude) has been associated with the development of a treatment-resistant strain of HIV in one patient.
The Canadian health agency said yesterday that it had received information from entecavir’s manufacturer, Bristol Myers Squibb.
This new information consists of a US report of a patient, infected with both HIV and hepatitis B virus, whose HIV infection became resistant to one of the more commonly used HIV treatment drugs while the individual was taking only entecavir. In addition, this is one of three US reports submitted by the manufacturer, Bristol-Myers Squibb Canada, concerning HIV patients who experienced a decrease in their HIV virus levels while using entecavir, despite not being treated with HIV drugs.
To date, studies of entecavir do not suggest that the drug has any activity against HIV, unlike some other agents used in hepatitis B treatment such as lamivudine (3TC, Epivir) and emtricitabine (FTC, Emtriva). Use of these drugs as monotherapy for HBV treatment in people coinfected with HIV is not recommended due to the risk that HIV will develop resistance to these drugs.
Health Canada is following up on this information and will provide new safety recommendations which may be warranted for the use of entecavir when the review is completed.
The Canadian health agency said yesterday that it had received information from entecavir’s manufacturer, Bristol Myers Squibb.
This new information consists of a US report of a patient, infected with both HIV and hepatitis B virus, whose HIV infection became resistant to one of the more commonly used HIV treatment drugs while the individual was taking only entecavir. In addition, this is one of three US reports submitted by the manufacturer, Bristol-Myers Squibb Canada, concerning HIV patients who experienced a decrease in their HIV virus levels while using entecavir, despite not being treated with HIV drugs.
To date, studies of entecavir do not suggest that the drug has any activity against HIV, unlike some other agents used in hepatitis B treatment such as lamivudine (3TC, Epivir) and emtricitabine (FTC, Emtriva). Use of these drugs as monotherapy for HBV treatment in people coinfected with HIV is not recommended due to the risk that HIV will develop resistance to these drugs.
Health Canada is following up on this information and will provide new safety recommendations which may be warranted for the use of entecavir when the review is completed.
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