FDA News Release   

Entecavir should not be used for the
treatment of HBV infection without
concomitant treatment for HIV for
HBV/HIV co-infected patients.



 

A supplement to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents (treatment guidelines) was added on April 30, 2007, discussing use of Entecavir in Hepatitis B/HIV Co-infected patients. 

Based on preliminary findings from a recent case series of three patients, the Treatment Guidelines Panel now recommends that: For HBV/HIV co-infected patients, entecavir should not be used for the treatment of HBV infection without concomitant treatment for HIV.

The supplement is available from AIDSinfo a
t http://www.aidsinfo.nih.gov/contentfiles/EntecavirInHIV.pdf   


The complete Adult and Adolescent Guidelines can be found on the AIDSinfo web site at
http://www.aidsinfo.nih.gov/Guidelines/GuidelineDetail.aspx?MenuItem=Guidelines&Search=Off&GuidelineID=7&ClassID=1

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

 

 



Entecavir should not be used for the treatment of HBV infection without
concomitant treatment for HIV for HBV/HIV co-infected patients.

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