Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study)

The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.

Inclusion Criteria:

• Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B
• Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening.

Other inclusion criteria may apply.

Exclusion Criteria:

• Patient is pregnant or breastfeeding
• Patient is co-infected with hepatitis C, hepatitis D or HIV
• Patient previously received nucleoside(tide) therapy other than adefovir
• Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months

Other exclusion criteria may apply.