A PHASE 2b, RANDOMIZED, MULTI-CENTER, ACTIVE-CONTROLLED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALBUFERON (RECOMBINANT HUMAN ALBUMIN-INTERFERON ALFA FUSION PROTEIN) IN COMBINATION WITH RIBAVIRIN IN INTERFERON ALFA NAIVE SUBJECTS WITH CHRONIC HEPATITIS C GENOTYPE 1

INTERVENTION: Product Name: Albuferon Pharmaceutical Form: Powder for solution for injection Current Sponsor code: Albuferon Other descriptive name: Recombinant Human Albumin‐Interferon Alfa Fusion Protein Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.7‐ Trade Name: Copegus Product Name: Copegus Pharmaceutical Form: Film‐coated tablet Current Sponsor code: Ribavirin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: Pegasys Product Name: Pegasys Pharmaceutical Form: Solution for injection Current Sponsor code: Pegasys Other descriptive name: pegylated interferon alpha 2a Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 180‐ CONDITION: Hepatitis type C chronic PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of Albuferon in combination with ribavirin in IFNa treatment‐naïve subjects with chronic hepatitis C genotype 1.; To evaluate the safety of Albuferon in combination with ribavirin in IFNa treatment‐naïve subjects with chronic hepatitis C genotype 1.; Primary end point(s): Primary Efficacy Endpoint: Sustained virologic response (SVR), defined as undetectable ; HCV RNA at 24 weeks after the end of therapy. ; Safety Endpoints: The major safety endpoints are the common side effects of IFNa therapy including flu‐like symptoms, depression, and hematologic abnormalities. Flu‐like symptoms include fever, chills, headache, fatigue, malaise, nausea, vomiting, arthralgia, and myalgia. The incidence, severity, and duration of these major endpoints will be summarized through Week 24 and Week 48, as well as at the 12‐week follow‐up visit. Secondary Objective: INCLUSION CRITERIA: 1. Have the ability to understand the requirements of the study, provide written informed consent (including consent for use and disclosure of research‐related health information) and comply with the study protocol procedures. 2. Age 18 to 65 years inclusive. 3. Have a clinical diagnosis of chronic hepatitis C established on the basis of: • detectable hepatitis C virus (HCV RNA) during the screening period, and • at least a 6 month history of exposure to risk factors for HCV with a positive serum antibody test to HCV. 4. Are infected with HCV genotype 1. 5. Subjects must interferon naïve, i.e., have never been treated with an interferon alfa (IFNa) product (eg, INTRON®A, Infergen®, Roferon® or a pegylated IFNa product) or an IFNa combination product (eg, Rebetron® or a pegylated IFNa combination product). Subjects who previously received 2 doses of Albuferon in a treatment naïve dose finding study (ALFR‐HC03CA protocol) are eligible provided