HEALTH CANADA EXAMINING LINK BETWEEN HEPATITIS B DRUG, DRUG-RESISTANT HIV

Health Canada has announced that new information submitted by Bristol-Myers Squibb on the antiviral drug Baraclude suggests the drug may be linked to the development of a treatment-resistant strain of HIV.

Baraclude (entecavir) has been approved in Canada since June 2006 for the treatment of active chronic hepatitis B virus infection in adults. Earlier this month Quebec opted to begin reimbursing the drug for use in patients with hepatitis B.

The new information comes from a report of a U.S. patient, infected with both HIV and hepatitis B, whose HIV infection became resistant to one of the more commonly used HIV treatment drugs while the individual was taking only Baraclude.

This is one of three U.S. reports submitted by the drugmaker 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 that have activity against HIV may be associated with increased risk of developing treatment-resistant forms of HIV.