A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.

PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks 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 patients, 18-70 years of age;
• chronic hepatitis B;
• Hepatitis B Virus (HBV) DNA >100,000 copies/mL.

Exclusion Criteria:

• previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
• evidence of decompensated liver disease;
• history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
• coinfection with hepatitis A, C or D, or HIV.