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

Casa Sollievo della Sofferenza IRCCS

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis

Treatments: Drug: Peginterferon alpha-2a + Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01380938

EPAT-01-2010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,150 participants in 3 patient groups

Arm C. Standard duration

No Intervention group

Description:

Patients will be randomly assigned in 3:3:1 ratio to three treatment arms. In the standard treatment group (Arm C), patients will be treated for 24 weeks independently of the HCV RNA status at week 4 with Peginterferon alpha-2a at a dose of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 800 mg/day. Patients enrolled in Arm C will be treated for standard 24 weeks duration of treatment.

Arm A

Experimental group

Description:

Patients enrolled in Arm A will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 1000 mg/day for patients with a body weight \< 75 kg or 1200 mg/day for those with a body weight \> 75 kg. Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm A), whereas those without RVR will be treated for 24 weeks (Arm A)

Treatment:

Drug: Peginterferon alpha-2a + Ribavirin

Arm B

Experimental group

Description:

Patients enrolled in Arm B will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 800 mg/day. Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm B), whereas those without RVR will be treated for 48 weeks (Arm B)

Treatment:

Drug: Peginterferon alpha-2a + Ribavirin