T-cell Dysfunction in Chronic HBV Infection (VHB-Roche)

This is an interventional prevention trial for Chronic Hepatitis B Virus focused on measuring T lymphocytes, Exhaustion, Molecular signature Read More

Inclusion Criteria:

1. For all patients

   • Compensated liver disease defined by the following criteria: Conjugated bilirubin level ≤ 1.2 x upper limit of normal (ULN), TP / INR ≤ 1.2 × ULN, platelets ≥ 150 x 109 / L, serum albumin ≥ 35 g / L, and no history of clinical hepatic decompensation (ascites, jaundice, encephalopathy, variceal hemorrhage) (results from a blood test dating up to 8 months before inclusion).
   • Adequate haematological function: platelets ≥ 150x109 / L, Hb ≥ 12 g / dL (male) or ≥ 11 g / dL (female), white blood cells ≥4x109 / L and <11x109 / L, except for ethnic neutropenia (these values must be obtained at least 8 months before inclusion)
   • Male or female between 20 and 69 years of age, inclusive
   • 18.5 ≤BMI ≤ 35 kg / m²
   • Patients who dated and signed informed consent

2. For patients chronically infected with NUC treatment for more than 6 months:

   • HBV DNA <25 IU / mL
   • HBsAg-positive (≥100 IU / mL)
   • HBeAg-negative or positive
   • ALT <1.5x ULN

3. For chronically infected, untreated patients:

   • HBsAg positive (≥100 IU / mL)
   • negative or positive HBeAg
   • HBV DNA> 2000 IU / mL
   • ALT <2 x ULN

Exclusion Criteria:

• Use of steroids or other immunosuppressive agents that would affect the number and / or function of immune cells in the last 4 weeks

  •,Any disease or other major medical disorder or condition that , that, in the judgment of the investigator, would interfere with results of the study (including, but not limited to: cancer, systemic lupus erythematosus, rheumatoid arthritis or other autoimmune disease, etc. ...)

• Major surgery or traumatic injury (including blood transfusion) in the last 4 weeks

  -• Use of an experimental drug in the last 12 weeks

• Positive test for Hepatitis C, HIV, Hepatitis D, or Hepatitis A (anti-HAV IgM) at the time of inclusion
• Significant acute infection such as influenza or other clinically significant illness in the last 2 weeks
• History of drug abuse in the last year
• positive pregnancy test for women of childbearing age
• Breast-feeding women

• Patients presenting:

  1. a medical history or signs of cirrhosis defined by a biopsy result or any other non-invasive validated test showing cirrhosis, OR
  2. Either during the selection visit: a transient elastography value ≥ 10.5 kPa OR a Fibrotest® / Fibrosure® score ≥ 0.48 and an APRI score ≥1 .

Note: If a biopsy or a non-invasive test for cirrhosis has never been performed in the patient, then the medical examinations described in b) must be performed during the selection visit.

• History of ascites, digestive hemorrhage and / or encephalopathy
• Any co-morbidity that could lead to liver damage as judged by the investigator (excessive alcohol consumption, hemochromatosis, Wilson's disease, autoimmune hepatitis, inflammatory colitis ...)
• Patients unable or unwilling to comply with the protocol requirements
• Patient unable to give informed consent