A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)

Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (Pegasys®) in Patients With HBeAg-Positive Chronic Hepatitis B

This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• Adult participants between 18 to 65 years of age
• HBeAg-positive chronic HBV
• Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.

Exclusion Criteria:

• Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
• Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
• Evidence of decompensated liver disease
• Medical condition associated with chronic liver disease other than viral hepatitis.