A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

A Phase IV Study of the Antiviral Activity and Safety of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen in Korea

Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Inclusion Criteria:

• Nucleoside and nucleotide-naive subjects with chronic HBV infection
• Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
• Detectable HBsAg
• HBV DNA ≥ 105 copies/mL by PCR
• ALT 1.3 to 10 x the ULN
• HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status