From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients

Inclusion Criteria

• •1. Age 18 - 60 years
• •2. Proven CHB for more than 6 months, based on serology (HBsAg positivity) and at screening a viral load of:
• •i) Group A: HBV DNA ≥200 IU/mL and \<20,000 IU/mL ii) Group B: HBV DNA \< 20 IU/mL
• •3. HBeAg-positive or HBeAg-negative
• •4. No current use of any antiviral medication (group A) or currently treated with tenofovir only, for \> 6 months (group B).
• •5. Normal liver function tests, assessed as follows:
• •i) Liver stiffness measurement using Fibroscan® of ≤ 7.0 kiloPascal (kPa) ii) Alanine aminotransferase (ALT) and/or aspirate aminotransferase (AST) at screening ≤ 1.25 x upper limit of normal (ULN) iii) Thrombocytes 150-400 10E9/L iv) Total bilirubin 0-17 µmol/L (elevated levels may be accepted if unconjugated portion is elevated in patients with Gilbert syndrome) v) Albumin within normal value (35 - 50 g/L) vi) Prothrombin Time (PT) within normal value (9,5 - 12.5 sec) vii) Alkaline phosphatase (ALP) and Gamma-glutamyltransferase (GGT) within normal values (40-120 U/L and 0-40 U/L respectively)
• •6. Body mass index (BMI): 17.0-35.0 kg/m2
• •7. Clinical chemistry, hematologic and coagulation tests at screening must be within normal limits or clinically non-significant, as by the investigator's assessment.
• •8. At screening, women of child bearing potential must be non-pregnant and non-lactating; a urine or serum pregnancy test will be performed at screening.
• •9. Female patients of child-bearing potential (with a fertile male sexual partner) and male patients (if not surgically sterilized) must be willing to use adequate contraception from screening until last study visit.
• •10. No recent (\<3 months) history of any clinically significant conditions, which, in the opinion of the investigator, would jeopardize the safety of the patient or impact the validity of the study results.
• •11. Written informed consent must be obtained before any study related interventions (including screening and enrollment) can be conducted.