Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B (DUAL)

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring nucleoside analogues, tenofovir, telbivudine, quantitative HBsAg, combination therapy Read More

Inclusion Criteria:

• Presence of positive HBsAg or HBV DNA for at least 6 months.
• Documented HBeAg positive or HBeAg negative.
• On any NA (lamivudine, adefovir, entecavir, tenofovir or combination of any of these four) for ≥ 1 year
• HBV DNA viral load ≤1.0 x 10^5 copies/ml at screening
• ALT ≤ 1 x ULN (upper limit normal) U/L
• A transient elastography (Fibroscan®) to evaluate the fibrosis stage will be performed at screening if it is not done in the past 6 months prior to screening. -Patient with compensated cirrhosis are permitted for this study.
• eGFR ≥ 50 mL/min, as calculated by CKI-EPI equation.
• 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 potential age must have a negative serum (ß-HCG) pregnancy test taken within 14 days of starting therapy
• Lactating/breastfeeding female subjects must agree to discontinue nursing before initiation of study medication(s).

Exclusion Criteria:

• Evidence of decompensated liver disease defined as direct (conjugated) bilirubin >1.2xULN, prothrombin time (PT) >1.5x upper limit of normal (ULN), serum albumin <35 g/L, or prior history of clinical hepatic decompensation (egs. ascites, encephalopathy, variceal hemorrhage).
• Evidence of hepatocellular carcinoma (HCC).

• Have any of the following laboratory tests within 4 weeks of study entry:

  • Active co-infection with HIV antibody or HCV antibody or HDV antibody positivity
  • Evidence of chronic renal insufficiency as defined by an eGFR (by CKD-EPI equation of < 50 mL/min).
• Previous treatment with any form of interferon, Immunomodulators, systemic cytotoxic agents, or systemic corticosteroids within 6 months prior to screening.
• 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.
• Current or known history of malignant disease within 5 years of trial entry.
• Patients with a history of or currently known muscle related disease.
• Liver or any other organ transplant other than cornea and hair.
• Women who are pregnant and who are not practicing adequate birth control measures, or who are lactating.
• Patients with specific contraindications to study drugs according to their Singapore Package Insert.