ASSESSMENTS OF:   - EFFICACY Primary Treatment Endpoints at the end of follow-up: • HBV DNA reduction 10-fold Secondary Treatment Endpoints at the end of treatment and follow-up: • (1) HBV DNA <400 copies/ml • (2) HBsAg seroconversion (HBsAg neg, anti-HBs+) • (3) Normalisation of ALT • Sustained HBe seroconversion defined as: Loss of HBeAg and presence of anti-HBe for HBeAg-positive patients - SAFETY All patients receiving at least one dose of PEGASYS® have to be included in a descriptive safety analysis (adverse events, vital signs and clinical laboratory parameters)

Table 1: Criteria for dose modification or withdrawal from treatment.