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Current treatment options for hepatitis B virus (HBV) infection include interferon, lamivudine, adefovir, and entecavir. This last agent is a recently approved nucleoside analogue that is a highly selective inhibitor of HBV DNA polymerase. Investigators compared the efficacy and safety of entecavir versus lamivudine in two studies of patients with chronic HBV infection.
Both studies were international, phase 3, double-blind, double-dummy, randomized controlled trials, sponsored by the maker of entecavir. One study focused on hepatitis B e-antigen (HBeAg)-positive patients, and the other on HBeAg-negative patients. In each study, patients received daily entecavir (0.5 mg) or lamivudine (100 mg) for 52 weeks. The primary endpoint was the propo…