Title
100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
The Response of Reducing Dose of Peginterferon Alfa-2a in Koreans With Chronic Hepatitis C Genotype 1; Randomized Controlled Multicenter Study 100% Versus 80%
Phase
Phase 4Lead Sponsor
Catholic University of KoreaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Sustained Virologic Response IL28B PolymorphismIntervention/Treatment
interferon alpha-2b ...Study Participants
178Randomized controlled multicenter study
The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
IL28B polymorphism in Koreans with CHC
The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.
-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).
So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.
There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.
-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a
dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
Inclusion Criteria: chronic hepatitis C (anti HCV+, HCV RNA +) Genotype 1 over 18 year-old Pregnancy test negative if women of childbearing age Exclusion Criteria: pregnant women or breast feeding women systemic chemotherapy or steroid therapy before 6 months of trial Coinfection with HAV, HBV, and HIV Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis Hepatocellular carcinoma Evidence of decompensation such as variceal bleeding,ascites, encephalopathy ANC less than 1500, platelet less than 90k Cr more than 1.5 of UNL Severe psychiatric problem Poorly controlled thyroid disease Severe retinopathy
| Event Type | Organ System | Event Term | 100% Dosage Group of Peginterferon Alfa 2a | 80% Dosage Group of Peginterferon Alfa 2a |
|---|
We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.
We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.
