Randomized Study for the Assessment of Silibinin (Legalon® SIL) in the Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C

Inclusion Criteria: * Patient must be willing to give written informed consent * Male and female patients; age between 21 and 45 years inclusive * Chronic hepatitis C infection with genotype 4 confirmed by genotypic testing at screening or within 6 months of screening period * Patients eligible to be treated with RBV and Peg-IFN as per the instructions present in their prescribing information documents * No history of prior interferon therapy (treatment naïve) * Detectable HCV-RNA levels * Normal BUN and creatinine * Ability to communicate, participate, and comply with the requirements of the entire study Exclusion Criteria: * Liver transplant patients * Co-Infection with HIV and/or HBV * ALT \>10-fold the upper limit of normal i.e. \> 400 U/L * Evidence of hepatocellular carcinoma (HCC) * Fibroscan® at screening with a score ≥ 14.5 kPa * Evidence of liver disease due to causes other than chronic HCV infection * Evidence of poorly controlled diabetes (defined as HbA1c \> 8%) * History of alcohol or drug abuse within the last 12 months * History or clinical evidence of liver decompensation, e.g. presence of ascites or encephalopathy, or bleeding from esophageal varices * Serum albumin levels \< 3.2 g/dL * INR \> 1.3 N * Total Bilirubin levels \> 2.0 mg/dL unless explained by Gilbert's disease * Platelet Count \< 100,000 µL * Absolute Neutrophil counts \< 1500 µL (mm3) * Active or suspected non-hepatic malignancy or history of malignancy within the last 5 years * Body Mass Index \< 16 or \> 35 kg/m2 * Females of childbearing potential: * Pregnancy (i.e. positive urine pregnancy test at screening) or lactation * Failure to agree to practice adequate contraception methods (e.g. oral contraceptives, intra-uterine device (IUD), transdermal contraceptive patch) * Male patients not vasectomized, who do not agree to abstain from intercourse or who do not use a condom