Entecavir

Background:

Entecavir (Baraclude) received FDA approval in March 2005 for the treatment of chronic hepatitis B virus (HBV) infection in adults with active viral replication and either persistent elevations in hepatic transaminases or histologically active disease. A guanosine nucleoside analogue, entecavir is triphosphorylated to its active form and competes with deoxyguanosine triphosphate, thus inhibiting HBV polymerase (reverse transcriptase).

Spectrum of Action:

Entecavir demonstrates activity against HBV (wild-type, lamivudine-resistant, and adefovir-resistant strains) but has no activity against HIV.

Clinical Trials:

Double-blind phase III studies have been completed in nucleoside-naive (HBe antigen–positive [n=709] and HBe antigen–negativ…