Effect of high-dose ribavirin treatment versus standard-dose treatment in patients infected with chronic hepatitis C virus genotype 3 and high viral load without response at week 4 - DARGEN-3

INTERVENTION: Trade Name: pegasys (peginterferon alfa 2a) Pharmaceutical Form: Solution for injection INN or Proposed INN: pegylated interferon 2 alfa Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180‐180 Trade Name: copegus ribavirina Pharmaceutical Form: Tablet INN or Proposed INN: Rivabirina Other descriptive name: Ribavirin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐200 Trade Name: Neorecormon Product Name: epoetin Pharmaceutical Form: Solution for injection INN or Proposed INN: epoetin beta Other descriptive name: epoetin beta Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 30000‐30000 CONDITION: Patients infected with chronic hepatitis C virus, genotype 3 and high load Primary Outcome: Main Objective: To evaluate the effect of high-dose ribavirin versus standard-dose ribavirin on sustained viral response (SVR = undetectable HCV RNA 24 weeks after completion of treatment) in patients infected with chronic hepatitis C virus genotype 3 and high viral load who do not have a defined rapid viral response with undetectable HCV RNA at week 4. Primary endpoint(s): Percentage of patients with undetectable HCV RNA at 24 weeks after completion of treatment in each arm. Secondary Objective: To evaluate the effect of both treatment regimens on rapid viral response (RVR = undetectable HCV RNA at week 4); To evaluate the safety of this treatment with epoetin β support (450 IU/kg/week). Inclusion Criteria: Men and women *18 years of age. ? Detectable HCV RNA in serum and > 600,000 IU/ml. ? Chronic hepatitis C with compensated liver disease (according to Child-Pugh Class A clinical classification) (Appendix 2). ? Genotype 3. ? In women of childbearing potential, negative pregnancy test. ? Effective contraception during treatment and for 6 months after the end of treatment. Are the trial subjects under 18? No. Number of subjects for this age range: F.1.2 Adults (18–64 years) Yes. F.1.2.1 Number of subjects for this age range. F.1.3 Elderly (>=65 years)