Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3) (genotype-3)

Casa Sollievo della Sofferenza IRCCS

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis

Treatments: Drug: Peg Interferon alpha2b + Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01121705

2007-00437470

Details and patient eligibility

About

The study aimed at evaluating whether current 24 weeks length of combination treatment is appropriate or not for patients with HCV genotype 3 infection.

Full description

Patients are randomized to standard length of treatment or to a variable duration: 12 weeks for patients with undetectable HCVRNA at week 4 or 24 or 36 weeks for those with detectable HCV RNA at week 4.

Enrollment: 360 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Naive HCV patients
• HCVRNA positive
• Normal TSH
• ANA <1:160

Exclusion criteria

• Portal hypertension
• Renal failure
• HBsAg or HIV
• Alcohol consumption >30 g/day
• Active IV drug use
• Chronic systemic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

A1. standard duration

No Intervention group

Description:

Patients were randomly assigned in a 1:1 ratio to two treatment arms. In the standard treatment group (A1), patients were treated for 24 weeks irrespective of the HCV RNA status at week 4 with Peg-interferon alfa-2b at a dose of 1.5 mcg per kilogram of body weight weekly in combination with oral ribavirin administered at a dose of 1000 mg/day for patients with a weight \<75 kg or 1200 mg/day for those with a weight of ≥75 kg. Patients enrolled in Arm A1 will be treated for standard 24 weeks duration of treatment with standard dosages of PegInterferon alpha 2b and weight-based dosages of ribavirin.

B 1 I or II

Experimental group

Description:

In the variable treatment group, patients with a virologic response at week 4 will receive treatment for 12 weeks and those without a virologic response at 4 weeks treatment for 36 weeks. Patients without RVR will be treated for 24 or 36 weeks and labelled (B1I) or (B1II, respectively Intervention: different durations of treatment for patients without RVR

Treatment:

Drug: Peg Interferon alpha2b + Ribavirin