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

An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B

This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Inclusion Criteria:

• adult patients, 18-65 years of age;
• HBeAg negative chronic hepatitis B;
• treated with lamivudine for >=6 months;
• demonstrated lamivudine resistance;
• compensated liver disease.

Exclusion Criteria:

• severe hepatic dysfunction;
• previous treatment with antivirals other than lamivudine;
• immunosuppressant treatment in past 6 months;
• co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
• medical condition associated with chronic liver disease.