Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B (EVD)

Inclusion Criteria:

• Documented compensated HBeAg-positive or negative chronic hepatitis B
• Increased viral load with a concentration of serum HBV-DNA of at least 10^4 copies/ml
• Proof of inflammatory activity in the liver: ALT ≥ 2 x ULN or histological evidence of inflammatory activity ≥ level I or fibrosis of ≥ I degrees (according to the Desmet classification)
• Negative urine pregnancy test with fertile women
• Willingness to use a recognized method of contraception
• Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

• Current or previous antiviral treatment of chronic hepatitis B with Nucleus(t)id analoga
• Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations
• Pregnant or breastfeeding women or women
• Simultaneous participation in other clinical trials or in the past three months
• Co-infected with HCV, HDV, HIV
• Other non HBV-related chronic liver disease: Autoimmune hepatitis, primary biliary cirrhosis, Hemochromatosis, alpha-1 antitrypsin deficiency, alcoholic hepatitis
• Evidence of hepatocellular carcinoma (alpha-fetoprotein levels> 100 ng/ml)
• Active drug use, including an excessive alcohol consumption during the last 6 months before participating in the clinical trial
• Use of systemic treatment with anti-neoplastic or immunomodulatory medication within the last 6 months before participating in the clinical trial and during the duration of the clinical examination
• Lack of willingness or inability to consent in writing
• Concurrent condition likely to preclude compliance with schedule of evaluations