The EMEA’s Committee for Medicinal Products for Human Use ( CHMP ) reminds healthcare professionals that Baraclude ( Entecavir ) has not been evaluated for the treatment of patients with chronic hepatitis B virus ( HBV ) infection who are co-infected with the human immunodeficiency virus ( HIV ) and are not receiving highly active anti-retroviral therapy ( HAART ).

The Marketing Authorisation Holder for Baraclude has transmitted to the EMEA information regarding a case report in which the selection of a HIV variant containing the M184V resistance substitution was documented during Baraclude treatment in an HIV-HBV co-infected patient who was not simultaneously receiving HAART.

This case was reported among three cases of HIV-HBV co-infected patients not receiving HAART in whom a 1-log10 reduction in HIV RNA had been noted while receiving Baraclude as treatment for chronic HBV infection.

Based on the new data the EMEA advises healthcare professionals that:

• Baraclude has not been evaluated in HIV-HBV co-infected patients not simultaneously receiving effective HIV treatment.

• When considering therapy with Baraclude in an HIV-HBV co-infected patient not receiving HAART, you should be aware that there appears to be a risk of developing HIV resistance.

Source: EMEA, 2007


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