Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB

Exclusion Criteria

• •Known cirrhosis
• •Evidence of fibrosis \>= Stage 3 (METAVIR) on liver biopsy or Fibroscan \> 10 kPa within 6 months prior to screening
• •Documentation of confirmed episodes (i.e., 2 consecutive values) of HBV DNA \> 400 copies/mL within 3.5 years prior to screening
• •History of decompensated liver disease (defined as direct \[conjugated\] bilirubin \> 1.5 x upper limit of normal, prothrombin time (PT) \> 1.5 x upper limit of normal, platelets \< 75,000/mm³, serum albumin \< 3.0 g/dL
• •History of clinical hepatic decompensation in the judgement of the investigator
• •Evidence of hepatocellular carcinoma
• •Significant bone disease (in the judgment of the investigator)
• •Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection
• •Known hypersensitivity to TDF, its metabolites, or formulation excipients
• •Concomitant therapy with disallowed medications
• •History of malignant disease
• •Lactating females
• •Females wishing to became pregnant during the duration of the stud
• •Subjects participating in another clinical trial can only be enrolled at the discretion of the Medical Monitor