VIRAHEP-C

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Major advances have been made over the last decade in the field of therapy for chronic hepatitis C. Combination therapy with two medication namely interferon and ribavirin has improved chances of eradication rates (sustained virological response/SVR - undetectable hepatitis C virus/HCV RNA in serum 24 weeks after completing treatment) to nearly 40% compared to only 10-15% for patients treated with interferon alone. Unfortunately, response to therapy is not uniformly favorable. Results from previous trials have suggested that there may be racial disparities in response to therapy for hepatitis C. SVR in African American patients appear to be significantly less than in Caucasian patients treated with the same regimens. However, these trials were not designed specifically to study race as a factor in response to treatment and very few African Americans have been included as study subjects, despite the high prevalence of hepatitis C in this population. VIRAHEP-C is a multicenter, collaborative clinical trial, sponsored by the National Institutes of Health (NIH), designed to test whether African Americans respond less well to therapy than Caucasian patients. A total of 400 patients, equally divided between African American and Caucasians, will be enrolled at eight clinical centers throughout the United States. All participants will have hepatitis C virus type (HCV genotype) 1. Participants will be treated for 48 weeks with a new formulation of interferon (pegylated interferon alfa-2a) at a dose of 180 micrograms once a week (mcg/week) plus ribavirin capsules given at a dose of 1000-1200mg/day. Participants will be followed for an additional 48 weeks after stopping therapy. SVR (undetectable HCV RNA in serum 24 weeks post-treatment) and durable sustained virological response rates (undetectable HCV RNA in serum 48 weeks post-treatment) between the two groups will be compared to determine differences in treatment response between the two racial groups. Patient-related and virus-related factors that predict responses to treatment between the two racial groups will be studied. Additional studies (Ancillary studies), using serum and white blood cells (peripheral mononuclear cells) obtained from patients at various time points in this study. These studies will be performed to investigate potential mechanisms of how the virus is resistant to the immune system in the body and to the actions of these medications (antiviral resistance). They include viral kinetics (the rate at which HCV RNA is cleared from serum during therapy), immunological responses, measures of interferon actions, and host and viral genetics will be evaluated in relationship to treatment response. This comprehensive study that includes treatment along with additional studies of mechanisms of antiviral resistance will be important to answer important clinical questions about the treatment of chronic hepatitis C.