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

Casa Sollievo della Sofferenza IRCCS1,150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,150

Conditions

Chronic Hepatitis

Interventions

Peginterferon alpha-2a + RibavirinDRUG

Administration of ribavirin at a dosage of 1000 or 1200 mg per day based on body weight \< or \> 75 kg for 24 weeks (Arm A). Treatment duration of 48 weeks with standard fixed dose of ribavirin (800 mg/day) (Arm B). These schedules will be compared with diagram of standard therapy with 800 mg daily of ribavirin for 24 weeks (Arm C)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (35)

Outcomes

Primary Outcomes

Sustained virological Response (SVR)

The primary measure of efficacy will be HCV RNA not detectable in serum samples 24 weeks after the end of therapy (SVR).

Time frame: 6 months after the end of treatment

Secondary Outcomes

Rapid virological response (RVR)

proportion of patients with undetectable HCV RNA 4 weeks after the start of treatment

Time frame: On treatment week 4

Data from ClinicalTrials.gov

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