Treatment Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B

Inclusion criteria

• Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
• Adult male and non-pregnant, non-lactating female subjects, 19 years of age and older, based on the date of the screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential (unless surgically sterile or greater than 2 years post-menopausal).
• Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months)
• Chronic hepatitis B with the following:

• HBeAg-positive and HBeAb negative at Screening
• Screening HBV DNA ≥ 1x 105 copies/mL
• Screening serum ALT level ≥ ×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR
• HBeAg-negative and HBeAb positive at Screening
• Screening HBV DNA ≥ 1x 104 copies/mL
• Screening serum ALT level ≥ ×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR
• Cirrhosis at Screening
• Screening HBV DNA ≥ 1x 104 copies/mL in HBeAg negative or
• Screening HBV DNA ≥ 1x 105 copies/mL in HBeAg positive
• Screening serum ALT level ≥ ×ULN and ≤ 10 ×ULN (by center laboratory range)
• A patient who treating with TDF as a treatment-naïve for Hepatitis B. Treatment naïve subjects defined as no history of antiviral therapy or < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue, including lamivudine or adefovir, clevudine, telbivudine, entecavir
• Decompensated liver cirrhosis defined based on a Child-Turcotte-Pugh (CTP) score ≥ 7 (Child B and C) or presence with at least one episode of ascites, jaundice, hepatic encephalopathy or variceal bleeding
• Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit
• Must be willing and able to comply with all study requirements.

Exclusion criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in the study.

• Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
• Co-infection with HCV, HIV
• Evidence of hepatocellular carcinoma (e.g. α-fetoprotein> 50 ng/mL or as evidenced by recent ultrasound or other standard of care measure)
• Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible
• Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
• Currently receiving therapy with cytotoxic agent, nephrotoxic agents, or agents capable of modifying renal excretion
• Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.