Tenofovir versus Adefovir for the treatment of HBeAg positive chronic hepatitis B

Inclusion Criteria1

• Adult patients (18-69 years of age) with HBeAg positive chronic hepatitis B (HBsAg positive for more than 6 months) with serum HBV DNA >10 to the 6 copies /mL, ALT levels >2 x ULN and less than or equal to 10x ULN and a Knodell necroinflammatory score of greater than or equal to 3 and a Knodell fibrosis score < 4. However, up to 96 patients with cirrhosis, i.e. knodell fibrosis score equal to 4, will be eligible for enrollment. Patients who have not had a bopisy within 6 months at baseline must agree to undergo a liver biopsy prior to randomisation. No evidence of hepatocellular carcinoma (HCC) ie. fetoptotein 50 ng/mL at screening. Patients are wligible if they are treatment naive, ie less than 12 weeks of prior nucleoside or nucleotide (adefovir, dipivoxil or tenofovir DF) treatment. Any previous treatment with nucleosides and nucleotides (eg up to 12 weeks) and interferon (pegylated or not) must have ended at least 6 months prior to the pre-treatment biopsy.