Revised Treatment Guidelines for Use of Entecavir in HIV-HBV Coinfected Patients

On April 30, 2007 the Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents released a supplement to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents concerning use of entecavir (Baraclude) in HIV-HBV coinfection.

The revision was prompted by recent reports indicating that entecavir may be active against HIV as well as HBV and thus could promote the development of drug-resistant HIV if used as monotherapy.

Entecavir Use in Hepatitis B Virus Patients Coinfected with HIV

Previously, the guidelines recommended entecavir (Baraclude) as an option for patients who required treatment for Hepatitis B virus (HBV) but not HIV infection. This recommendation was based on laboratory data showing no significant activity of entecavir against HIV-1.[1]

However, in a recent case series of 3 patients who received entecavir without concomitant antiretroviral therapy, patients experienced a 1 log₁₀ decline in HIV-RNA levels, and emergence of the M184V mutation -- associated with resistance to 3TC (Epivir) and emtricitabine (Emtriva) -- in 1 patient.[2]

Based on these preliminary findings, the panel recommends that, “For HBV/HIV coinfected patients, entecavir should not be used for the treatment of HBV infection without concomitant treatment for HIV.”

05/11/07

Source

DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents (October 10, 2006). Supplement: Entecavir in Hepatitis B Virus (HBV)/HIV Coinfected Patients. April 30, 2007.

Bristol-Myers Squibb. Important Information Regarding BARACLUDE (entecavir) in Patients Co-infected with HIV and HBV. Letter to Health Care Providers. February 2007.

1. Bristol-Myers Squibb. Baraclude Product Label. March 2005.

2. M McMahon, B Jilek, T Brennan and others. 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. Los Angeles, February 25-28, 2007. Abstract 136LB.