Terminator 2 Register
Terminator 2 Register
All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues,
 who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines
 shall be included in the present study. The aim is to evaluate the clinical outcome
 (virological relapse, HBsAg decline) and associated virological and immunological parameters.
Inclusion Criteria:

 1. Male and female patients with chronic hepatitis B virus infection documented by
 detectable HBsAg.

 2. Age > 18 years

 3. Ongoing antiviral therapy with Entecavir or Tenofovir (TDF)

 4. At least 3 years HBV-DNA < 20 IU/ml (=100 copies/ml)

 5. HBeAg negative

 6. Willingness to give written informed consent and willingness to participate and to
 comply with the protocol.

 Exclusion Criteria:

 1. HIV infection, persistent HDV-infection, persistent HCV infection

 2. History or other evidence of a medical condition associated with chronic liver disease
 other than HBV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic
 liver disease, toxin exposures).

 3. History or other evidence of bleeding from esophageal varices or other conditions
 consistent with decompensated liver disease

 4. Patients with advanced liver fibrosis and liver cirrhosis (fibroscan >10.0 kPa)

 5. Patients with hepatocellular carcinoma

 6. History of major organ transplantation or other immunosuppressive conditions

 7. History or other evidence of severe illness, malignancy or any other conditions which
 would make the patient, in the opinion of the investigator, unsuitable for the study

 8. History of any systemic anti-neoplastic or immunomodulatory treatment (including
 supraphysiologic doses of steroids and radiation) 12 months prior to cessation of
 antiviral therapy or the expectation that such treatment will be needed at any time
 during the study

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