Andrew J. Muir, Jeffrey D. Bornstein, Paul G. Killenberg, Southeastern Hepatitis Treatment Group, Durham, NC

Previous studies have suggested lower response rates for African American patients treated for chronic hepatitis C infection with interferon alpha-based regimens. In a study by Reddy et al published in Hepatology 1999 there was a 2% SVR seen in a study of 40 African American patients. Higher prevalence of genotype 1 infection among African Americans has been suggested as a potential explanation for the lower response rates. All of these studies, however, included few African American patients. Thus, no study to date has definitively determined if response rates diverge between African American and non-Hispanic white patients. Objective: To compare the sustained virologic response rates of African American and non-Hispanic white patients with chronic hepatitis C infection treated with pegylated interferon alfa-2b and ribavirin.

Patients were enrolled into dual cohorts of African American and non-Hispanic white patients with chronic hepatitis C infection. Exclusion criteria included decompensated liver disease and any previous therapy with interferon alpha. All patients received pegylated interferon alfa-2b 1.5 mcg/kg per week for 48 weeks plus ribavirin 1000 mg/day x 12 weeks followed by 800 mg/day for 36 weeks. Results: One hundred patients were enrolled into each cohort. The baseline characteristics of the African American group were: 67% male, mean age 47.5 years, and mean duration of infection 19.3 years. The baseline characteristics of the non-Hispanic white group were: 53% male, mean age 44.2 years, and mean duration of infection 18.8 years. In both groups, 98% of the patients had genotype 1 infection. The African American patients had a greater mean weight (89.0 vs. 81.6 kg, p = 0.01) and a greater prevalence of diabetes mellitus (23% vs. 6%, p < 0.001). Abnormal ALT’s were not part of the inclusion criteria however no patients enrolled had normal ALT’s. This is interesting as in previous studies there have been suggestions that African American patients have disproportionately been represented due to a higher incidence of normal ALT’s among African Americans. The main reason for being excluded in the non-African American group was not having genotype 1 hepatitis C.

To date, 168 have completed at least 12 weeks of therapy, and 139 patients have completed at least 24 weeks. The results are summarized in the table. The complete 24-week results will be presented at the meeting. Conclusions: These preliminary results suggest a lower response rate among African American patients when compared to non-Hispanic white patients. These findings do not suggest that the lower response rate is related to the genotype. The findings support the need for continued investigation examining the explanation for the lower response rate among African American patients with chronic hepatitis C infection. A couple of postulations could be that the African American patients were considerably heavier and steatosis of the liver was not ruled out.