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This will be a Phase III, randomized, double-blind, parallel-group, active-control, multi-center trial of 96-week duration. Subjects will be assigned to receive either clevudine 30 mg once daily or adefovir 10 mg once daily for 96 weeks. At Week 48, subjects will be assessed for HBV DNA levels, and normalization of ALT. Subjects will then continue to be followed based on results: • CONTINUE THERAPY: All subjects initially randomized to adefovir will continue therapy for 96 weeks regardless of 48 week assessment. • DISCONTINUE FOR EFFICACY AT WEEK 72: Subjects initially assigned to receive clevudine who are PCR negative and have normalized ALT between Weeks 48 and 72 (inclusive) will be re-randomized in a blinded fashion to: o Discontinue their assigned treatment of clevudine 30 mg once daily and switch to placebo for an additional 24 weeks (up to Week 96) o Continue their assigned treatment of clevudine 30 mg once daily for an additional 24 weeks (up to Week 96). • CONTINUE THERAPY: Patients initially randomized to clevudine and who respond only virologically (<300/mL), and have persistently abnormal ALT, will continue on blinded therapy. • DISCONTINUE FOR FAILURE: Patients who have not achieved a > 2 log decrease in HBV DNA by Week 24 will be considered a treatment failure. Patients whose HBV VL is suppressed below the level of detection (<300 copies/mL) and rebounds to > 1 log from nadir (“Rebounders”) on two separate occasions (confirmatory VL required) will also be considered treatment failures. Subjects whose HBV DNA remains >1000 copies/mL at Weeks 48 or 96 will also be considered treatment failures. Preclinical in vitro viral susceptibility testing shows a reduction in the potency of clevudine when the N236T mutation, which can be selected during adefovir therapy, is present. Therefore, subjects meeting failure criteria will not be permitted to switch to the alternate blinded therapy and should be switched to an approved anti-HBV drug, as determined by the investigator and based upon the preclinical viral susceptibility data. All subjects will have liver biopsies performed at screening (or within 6 months prior to the Baseline visit) and at Week 48 for histology and intrahepatic cccDNA quantitation. Subjects will also be asked to consider undergoing a liver biopsy at Week 96. Subjects completing 96 weeks of treatment will be eligible to continue participating in a roll-over study for long-term evaluation of safety, efficacy and durability of viral suppression on or off therapy. Any subject withdrawing from therapy will be followed for safety and viral load for a minimum of 6 months.

Males and females Subjects diagnosed with chronic hepatitis B who have received previous monotherapy treatment with any form of alpha interferon and HBsAg+ for ? 6 months.
Subjects who are coinfected with HIV, HCV or HDV will be excluded

Study Summary:

Detailed Study Description:

Study Design: Observational
Phase of Study: Phase III
Study Type: Observational
Condition or Study Focus: Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus
Intervention Type: Clevudine Compared with Adefovir
Intervention Name: Clevudine
Gender: Male and Female
Age group: Observational
Sponsor: Pharmasset, Inc