February 22, 2007
Health Canada reported Wednesday that the manufacturer of an antiviral used to treat hepatitis B said the drug may be linked to the development of drug-resistant HIV in one patient. Baraclude (entecavir) in June received Canadian approval for use by adults with active chronic hepatitis B infection.
Bristol-Myers Squibb Canada has informed Health Canada that a US patient co-infected with hepatitis B and HIV developed resistance to one of the more commonly used HIV medications while taking Baraclude alone. BMSC has reported to Health Canada three cases in which US patients taking Baraclude, and no HIV drugs, experienced a drop in HIV levels.
No study has documented that Baraclude has any anti-HIV properties. Medications that are effective against the AIDS virus can be associated with an increased risk of drug resistance.
Health Canada will provide any necessary safety recommendations once a review of Baraclude is concluded. In the meantime, Canadians taking the antiviral should direct any questions to their physicians or to Health Canada: telephone 613-957-2991 or 866-225-0709.