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%

1. Randomized controlled multicenter study
2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
3. 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

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