Viral Resistance to Antiviral Therapy of Chronic Hepatitis C

The Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (VIRAHEP-C) study is a multicenter clinical trial designed to test how African Americans respond to antiviral therapy for hepatitis C (HVC) compared to Caucasian patients. Reports of clinical trials for HVC demonstrate markedly worse response in African-American patients than in Caucasian patients with no clear explanation for the difference in outcome. A total of 400 patients, equally divided between African American and Caucasians, were enrolled at eight clinical centers throughout the United States. All participants were HCV genotype 1. Participants were treated for 48 weeks with pegylated interferon alfa-2a (180 mcg/week) plus ribavirin (1000-1200mg/day). Participants were followed for an additional 48 weeks after cessation of therapy. Sustained virological response rates (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 cohorts were compared to determine differences in treatment response between the two racial groups. Results showed that African Americans with chronic hepatitis C genotype 1 have lower rates of virologic response to pegylated interferon and ribavirin than Caucasian Americans, as hypothesized. Factors contributing to the differences in response between the groups remain unclear.