PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)

Pusan National University Yangsan Hospital

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis C

Treatments: Drug: Peginterferon alfa-2a and Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01056172

PNUYH-CHC001

Details and patient eligibility

About

This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Full description

In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age older than 18 years old
2. Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
3. Detectable serum quantitative HCV-RNA
4. HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))
5. Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin

Exclusion criteria

1. Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)
2. History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
3. Decompensated liver disease (Child-Pugh class B or C)
4. Neoplastic disease within 5 years
5. Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
6. Women with ongoing pregnancy or breast feeding
7. Hgb < 11 g/dL in women or < 12 g/dL in men at screening
8. Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening
9. Serum creatinine level > 1.5 times the upper limit of normal at screening
10. Serum alpha-fetoprotein > 100 ng/mL
11. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
12. History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
13. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
14. History of a severe seizure disorder or current anticonvulsant use
15. Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
16. Inability or unwillingness to provide informed consent or abide by the requirements of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

A. 24 weeks in RVR patients.

Active Comparator group

Description:

Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR.

Treatment:

Drug: Peginterferon alfa-2a and Ribavirin

Drug: Peginterferon alfa-2a and Ribavirin

B. 16 weeks in RVR patients.

Experimental group

Description:

Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR.

Treatment:

Drug: Peginterferon alfa-2a and Ribavirin

Drug: Peginterferon alfa-2a and Ribavirin