ANRS HB 05 Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepatitis B, naïve to Anti-VHB Therapy

Inclusion Criteria: * Male and female patients over 18 years of age * Chronic hepatitis B, HBs Ag-positive for over 6 months, anti HBs negative * Patients with HBeAg- negative chronic hepatitis B (CHB) and anti-HBe positive at screen * Patients naïve to anti-HBV nucleoside or nucleotide and any other experimental nucleoside/nucleotide analog for HBV * Serum HBV-DNA quantifiable over 2000 IU/mL at screening * ALT over 1.25 ULN and below 10 ULN * Liver biopsy (baseline or within prior 6 months) with evidence of chronic hepatic inflammatory injury (Metavir Activity score over 1 ; Knodell necroinflammatory score over 3, Ishak score over 1) Exclusion Criteria: * Cirrhosis or bridging fibrosis on liver biopsy * Subjects who have received any form of alpha interferon in the past 6 months prior to the first administration of randomized treatment * Any systemic anti-viral, anti-neoplastic or immuno-modulatory treatment (including supraphysiologic doses of steroids and radiation) below 6 months prior to the first dose of randomized treatment and during the study (except for below 10 days of acyclovir for herpetic lesions, or prednisone below 10 mg/days for below 10 days more than 1 month) * Women with ongoing pregnancy or breast feeding * Positive test at screening for anti-HAV IgM Ab, anti-HIV Ab, anti-HCV Ab, HCV RNA, anti-HDV Ab * History or other evidence of a medical condition associated with chronic liver disease other than HBV (e.g., hemochromatosis, autoimmune hepatitis, met…