This study involves a daily pill which is a commercially available drug named tenofovir DF (TDF) for the treatment of chronic Hepatitis B virus. This drug TDF will be given alone or in combination with a weekly shot of another commercially available drug called Pegylated Interferon alfa (PEG). Both drugs have been shown to be good at lowering the amount of virus in the blood on their own. This study will see if they work better together than they do alone.
- Anti-HBV treatment naïve subjects. Subjects who have taken < 12 weeks of oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
- HBV DNA HBeAg- and HBeAg+ subjects ≥ 20,000 IU/ml
- Creatinine clearance rate ≥ 70 mL/min
- Known bridging fibrosis or cirrhosis and/or decompensated liver disease
- Evidence of hepatocellular carcinoma
- Co-infection with HIV, HCV or HDV
Your participation in this study will last about 120 weeks (2⅓ years) not including the screening visit and includes about 22 visits. TDF tablets are taken by mouth once a day. Peginterferon alfa 2a (Pegasys® or PEG) must be injected under the skin at a dose of 180 μg/0.5 mL (about 1/10 teaspoon) once a week. The first injection will be done at the study doctor’s office and the study team can show you how to do this at home for future injections if you prefer.
At the screening visit you will need to have a CT scan or ultrasound of your liver taken. Blood will be drawn at each visit with the maximum volume of 48 mL (slightly more than 3 tablespoons) taken each time.