Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

A Study of the Safety and Efficacy of Entecavir Plus Tenofovir in Adults With Chronic Hepatitis B Virus Infection With Previous Nucleoside/Nucleotide Treatment Failure

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

Inclusion Criteria:

• Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e antigen(HBeAg)-negative or HBeAg-positive
• Subjects must have a treatment failure to their current nucleoside/ nucleotide treatment regimen
• Prior entecavir and/or tenofovir monotherapy is allowed
• Subjects must have compensated liver function

Exclusion Criteria:

• Women who are pregnant or breastfeeding
• Evidence of decompensated cirrhosis
• Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
• Moderate or severe renal impairment
• Recent history of pancreatitis
• Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of being assigned to study drug into this study
• Prior entecavir/tenofovir combination therapy