Drugs Xagena
The EMEAs 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
XagenaMedicine_2007
