Health Canada examining information linking antiviral drug to development of treatment-resistant HIV

Source: Health Canada

February 21, 2007
For immediate release

OTTAWA - Health Canada is informing Canadians of new information submitted by the manufacturer of the antiviral drug Baraclude that suggests the drug may be linked to the development of a treatment-resistant strain of HIV in one patient with HIV.

Baraclude (the brand name for the drug entecavir) has been authorized in Canada since June 2006 for the treatment of active chronic infection with Hepatitis B virus in adults. This new information consists of a U.S. 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 Baraclude. In addition, this is one of three U.S. reports submitted by the manufacturer, Bristol-Myers Squibb Canada, concerning HIV patients who experienced a decrease in their HIV virus levels while using Baraclude, despite not being treated with HIV drugs. To date, studies of Baraclude do not suggest that the drug has any activity against HIV. Drugs which have activity against HIV may be associated with increased risk of developing treatment-resistant forms of HIV.

Health Canada is following up on this information and will provide Canadians with any new safety recommendations which may be warranted for the use of Baraclude when the review is completed.

Canadians taking Baraclude should consult with their physician if they have any questions or concerns.

Consumers requiring more information about this Information Update can contact Health Canada’s public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

Any serious or unexpected adverse reactions in patients receiving Baraclude or any other drug should be reported to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
email: cadrmp@hc-sc.gc.ca

The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site.