use or non-use of epoetin beta in patients infected by chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: 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

Keywords: chronic hepatitis c peginterferon ribavirin epoetin beta