Entecavir in Hepatitis B Virus (HBV)/HIV Co-Infected Patients

Supplement to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents -- October 10, 2006

Previously, the guidelines recommended entecavir as an option for patients who required treatment for Hepatitis B virus (HBV) but not HIV infection. This recommendation was based on in vitro data showing no significant activity of entecavir against HIV-1.1 A recent case series of three patients who received entecavir without concomitant antiretroviral therapy reported a 1 log10 decline in HIV-RNA levels and emergence of M184V mutations in one patient who was studied in detail.2

Based on these preliminary findings, the Panel recommends that:

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


  1. Baraclude (Product Labelling, Bristol-Myers Squibb). March 2005.
  2. McMahon M, Jilek B, Brennan T, et al. The anti-hepatitis B drug entecavir inhibits HIV-1 replication and selects HIV-1 variants resistant to antiretroviral drugs. 14th Conference on Retroviruses and Opportunistic Infections; Feb 25-28, 2007; Los Angeles, CA. Abstract 136LB.