Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE)

RCT Comparing Different Ribavirin Dosages and Durations of Treatment in Combination With Peginterferon in HCV Genotypes 2 and 3 (WRITE)

WRITE study aim at identifying the effectiveness of an innovative individualized schedule of treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.

The investigators are going to compare weight-based dosages of ribavirin, in combination with Peginterferon alpha-2a, with standard fixed dosages of 800 mg. Patients will be evaluated at week 4 with an assay of sensitivity of 15 IU/ml. Patients with week 4 response will discontinue treatment at week 12 in both arms. Patients with HCV RNA still detectable at week 4 and receiving 1000-1200 mg of ribavirin in arm A will discontinue treatment at week 24, whereas patients with HCV RNA still detectable at week 4 and receiving 800 mg of ribavirin in arm B will be treated till week 48.

A standard treatment arm (C) including patients treated for 24 weeks with Peginterferon alpha-2a and fixed 800 mg ribavirin dosage will be used as control arm.

Inclusion Criteria:

• Patients with chronic hepatitis C virus (HCV) infection (both HCVAb and HCV RNA positive)
• Patients with HCV genotype 2 or 3
• Age 18-70 years
• Naïve patients or previously treated only with standard interferon monotherapy
• Female patients of childbearing age who agree to avoid pregnancy during the period of treatment and 24 weeks after the end of treatment

Exclusion Criteria:

• Previous treatment with ribavirin
• Cirrhosis (CHILD PUGH B and C)
• Evidence of Hepatocellular carcinoma
• Pregnancy
• Retinopathy class I or II
• Alcohol consumption > 40 gr/day
• Chronic cardiac or respiratory diseases
• HIV or HBsAg or HDV positivity
• Hemoglobin < 8.5 gr/dL
• WBC < 3.500/mm3
• PLT < 80.000/mm3