Halting Nucleoside Analogues in Chronic Hepatitis B

Laborértékek

• • Evidence of liver cirrhosis based on liver biopsy, fibroscan score >10.5 kpa, or MRE score>5.5kpa, or clinical evidence of cirrhosis demonstrated by presence of esophageal varices, obvious features of cirrhosis on ultrasound within the last 12 months
  • Evidence of decompensated liver disease or hepatocellular carcinoma.
  • HIV antibody or HCV antibody or HDV antibody positivity
  • Creatinine > 1.5 times upper limit of normal
  • INR > 1.5, uncorrected by Vitamin K therapy.
  • Any interferon, Immunomodulators, systemic cytotoxic agents, or systemic corticosteroids within 6 months before trial entry.
  • Prolonged exposure to known hepatotoxins such as alcohol or drugs.
  • History of clinically relevant psychiatric disease, seizures, central nervous system dysfunction, severe pre-existing cardiac, renal, hematological disease or medical illness that in the investigator's opinion might interfere with therapy.
  • Malignant disease within 5 years of trial entry.
  • Women who are pregnant and who are not practicing adequate birth control measures, or who are lactating

• • Between 21 and 75 years old.
  • Documented to be HBsAg positive for ≥ 6 months.
  • On any NA (lamivudine, adefovir, entecavir, telbivudine tenofovir) for ≥ 1 year
  • HBV DNA <15 IU/ml at screening (undetectable)
  • Quantitative HBsAg <100 IU/ml
  • Patient has agreed not to take any other investigational drug or systemic anti-viral, cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies unless clinically indicated.
  • Patient is able to give written consent prior to study start and to comply with the study requirements.
  • Women of childbearing age must have a negative serum (ß-HCG) pregnancy test taken with 14 days of starting therapy