A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B

A Study on Optimizing HBeAg Seroconversion in HBeAg Positive CHB Patients With Combination or Sequential Treatment of Pegylated Interferon Alpha-2a and Entecavir

This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.

Inclusion Criteria:

• Adult patients, >=18 and </= 65 years of age
• HBeAg positive chronic hepatitis B
• Pre-treatment with entecavir for 9-36 months

Exclusion Criteria:

• Antiviral, antineoplastic or immunomodulatory treatment
• Co-infection with active hepatitis A, C or D, or HIV
• Evidence of decompensated liver disease
• History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis