SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).

• Duration of treatment response [ Time Frame: Every 12 weeks, and after follow-up. ] [ Designated as safety issue: No ]
• Loss of HbsAg and seroconversion, and HBV DNA BLQ. [ Time Frame: At end of follow up ] [ Designated as safety issue: No ]
• Changes in liver fibrosis, AEs, lab parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4 therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.

• Experimental: 1
  Intervention: Drug: peginterferon alfa-2a [Pegasys]
• No Intervention: 2

Inclusion Criteria:

• adult patients, >=18 years of age;
• liver disease consistent with CHB;
• evidence of chronic HBeAg-negative CHB prior to initial course of interferon alfa;
• patients who have responded to previous 48 weeks treatment with interferon alfa.

Exclusion Criteria:

• coinfection with HCV, HDV or HIV;
• decompensated liver disease, hepatocellular cancer, or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
• any other systemic antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.