Efficacy and Safety of the Combination Vitamin D With Standard of Care in Egyptian Patients With Untreated Chronic Hepatitis C

Inclusion Criteria: Common with National Program for Viral Hepatitis * Age: 18 years to 60 years * Positive HCV antibodies using a third generation test * Detectable HCV RNA by PCR * Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3 * Naïve to treatment with PEG-IFN and RBV * HBs antigen negative * Prothrombin time ≥60 %, normal bilirubin, alpha-foeto protein \< 3\*normal range of the laboratory, anti-nuclear antibodies\<1/160 Effective contraception during the treatment period; no breast-feeding Specific to the trial * Prior approval from the Ministry of Health to be treated as part of the National Program with allocation to Peg-IFN α2b treatment * Living \<100 km from Cairo and able to come to the centre every week for the treatment * Signed informed consent and willingness to participate in the trial * Naïve to treatment with vitamin D (received vitamin D less than 30 consecutive days in the 3 months preceding inclusion) * Biopsy slide validated by NHTMRI pathologist Exclusion Criteria: Common with National program for Viral Hepatitis * Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C\>8%) , chronic obstructive pulmonary disease * Major uncontrolled depressive illness * Solid transplant organ (renal, heart, or lung) * Untreated thyroid disease * History of previous anti-HCV therapy * Body mass index (BMI) greater than 30 kg/m² * Known human immunodeficiency virus (HIV) coinfection: although HIV testing will not be proposed or done, patients with known HIV coinfection will not be included in the trial * Anti-HCV therapy contraindications: * hypersensitivity to one of the two drugs (PEG-IFN, RBV) * pregnancy or unwilling to comply with adequate contraception * breast-feeding * neutropenia (\<1500/mm3) * anaemia (\<11g/dL for women ; \<12g/dL for men) * thrombocytopenia (\<100,000/mm3) * elevated creatinin (\>1.5mg/dL) * concomitant liver disease other than hepatitis C (immuno-active chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease) * liver biopsy showing severe steatosis (\>66%) and steatohepatitis; decompensated cirrhosis (Child Pugh\>A); hepatocellular carcinoma, METAVIR score F4. * TSH\>5 mU/L Specific to the trial * Patients allocated to Peg-IFN alpha 2a treatment * Hypersensitivity to vitamin D * Vitamin D contraindications: * hypercalcaemia (fasting calcaemia \>105 mg/L or 2.62 mmol/L) * ratio calciuria / creatininuria (fasting ratio \>1 mmol Ca/mmol creatinin) * hyperphosphatemia (\>1.5 mmol/L) * calcium lithiasis * patients being treated with thiazide diuretics (risk of hypercalcaemia with vitamin D treatment) * patients being treated with glucocorticoïds (decrease in vitamin D efficacy) * postmenopausal women treated by vitamin D and calcium for osteoporosis * Treatment by vitamin D more than 30 consecutive days in the 3 months preceding inclusion in the trial.