Source: Lung Cancer Online  |  Posted 4 years ago

OTTAWA, CANADA -- February 21, 2007 -- 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.

SOURCE: Health Canada