But secondary analyses of large databases derived from clinical trials of various antiviral agents suggest that racial disparities may exist in response to therapy for hepatitis C, particularly when interferon is used as a single agent. In one such analysis, for example, sustained virological response occurred in only 2 percent of African-Americans in the trial, compared with twelve percent of Caucasian participants.
These trials, however, were not designed to study race as a factor in response to therapy. Moreover, few African-Americans have been included as study subjects, despite the high prevalence of hepatitis C in this population.
Not everyone chronically infected with hepatitis C will be studied. Only those with hepatitis C genotype 1 and having quantifiable blood levels (600 IU/ml) of its RNA will participate.
"Those with genotype 1 have the most difficult to treat type of hepatitis C. It is also the most prevalent genotype in the United States," Fried said, noting that it accounts for approximately seventy-five percent of hepatitis C infections. It also affects ninety-one percent of African-Americans with hepatitis C compared to sixty-seven percent of Caucasians.
Participants will be treated for 48 weeks with 180 micrograms a week of pegylated interferon alpha-2a plus 1000-1200 milligrams a day of ribavirin. They will be followed for an additional 48 weeks after cessation of therapy. Sustained virological response rates (undetectable hepatitis C RNA in serum 24 weeks post-treatment) and durable sustained virological response rates (undetectable hepatitis C RNA in serum 48 weeks post
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Contact: Leslie H. Lang
llang@med.unc.edu
919-843-9687
University of North Carolina School of Medicine
15-May-2002