Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C

The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.

Show that the correction of anemia by epoetin beta (NeoRecormon®) able to maintain a optimal dose of ribavirin (Copegus®). The study compares two therapeutic strategies : use or non-use of epoetin beta (NeoRecormon®) in patients infected by chronic hepatitis C and treated by combination therapy Peginterferon alfa-2a (Pegasys®) plus ribavirin (Copegus®). The main judgement criteria are :

* Sustained Viral Response (Week 72)
* Viral Response at the End of Treatment (Week 48)
* Quality of life
* Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods
* Clinical and biological tolerance

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years old or above
* Patient with French social security or other equivalent health assurance
* Patient with informed consent
* Serologic evidence of chronic hepatitis C by detectable anti-HCV antibodies
* Patient infected by HCV genotype 1, 4, 5 or 6
* Compensated liver disease (Child-Pugh ≤ 6)
* Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior the enrollment in the study
* All fertile males and females receiving ribavirin must have effective contraception during treatment and during the 6 following months
* Patient naive of treatment with installation of treatment by investigator following criteria for use Peginterferon alfa-2a (Pegasys) and ribavirin (Copegus)

Exclusion Criteria:

* Women with ongoing pregnancy or breast feeding
* Male partner of pregnancy woman
* Minor
* Major protected by French law for biomedical study
* Co-infection by HBV or HIV
* History or other evidence of decompensated liver disease or Child-Pugh score \> 6
* Clinical or radiological evidence (abdominal ultrasound, CT scan or MRI) of hepatocellular carcinoma
* IFN or ribavirin at any previous time
* Patient who received an erythropoetin within 2 months before inclusion
* History of epilepsy (during the last 6 months)
* Chronic cardiac insufficiency (stage III or IV in classification from the New York Heart Association \[NYHA\])
* Not controlled portal hypertension
* Antecedents or risk of venous thrombosis
* Surgery within 3 months before inclusion
* Serum creatinine level \>15 mg/mL (130µmol/L)
* Deficiency in vitamin B9 and/or B12 (suspected with macrocytosis \> 105 µm3)
* Thrombocytosis (platelets \> 500 000/mm3)
* Chronic inflammatory syndrome (CRP \> 10 mg/L)
* Deficiency not corrected in iron :
* Ferritin blood level \< 10 µg/L Or - Transferrin saturation coefficient \< 20 %
* History of neoplasia (except basocellular epithelioma and cervical cancer)
* Contraindications to use epoetin beta or an excipient from molecule to study (urea, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, benzoic acid, benzyl alcohol)
* Absence of written informed consent
* Exclusion time for another biomedical study
* Patient with blood concentration of hemoglobin lower or equal to 12 g/dL for male or lower or equal to 11 g/dL for female