316 Racial differences in patients with hepatitis C genotype 1

HEPATOLOGY, Vol. 38, No. 4, Suppl. 1, 2003

AASLD ABSTRACTS

Efficiency of clearance ( ~ ) at 72 hours was highly associated with actual viral clearance across all groups (p-0.001) but )t2 was not. Regression analysis failed to demonstrate a relationship between and baseline CD4+ count, HCV viral load or genotype. In contrast, #955;2 was significantly associated with genotype. Viral kinetic parameters were not predictive of SVR. CONCLUSION: Viral kinetic modeling demonstrated that the efficiency of clearance at 72 hours was significantly associated with viral clearance during treatment. Coinfection status did not affect key kinetic parameters. PEG-IFN was superior to standard interferon in terms of viral clearance efficiency, particularly in the coinfected group. Diminished SVR in coinfected patients may be related to immune factors that are operative after reduction of viral loads to undetectable levels.

Disclosures: ACTG 507115091 Study Group - No relationships to disclose Raymond T Chung - Roche: Investigator; Scientific Study/Trial Paul S Horn - No relationships to disclose Margaret J Koziel - No relationships to disclose Marion G Peters - No relationships to disclose Susan D Rouster - No relationships to disclose Kenneth E Sherman - Roche: Investigator; Scientific Study/Trial

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recruit 200 AA and 200 CA from 8 clinical centers in the United States. Hypothesizing that AA and CA patients differ by factors that influence SVR which could explain racial differences in SVR, we compare demographic, clinical, histological, virological and health-related quality of life variables (HRQOL) before treatment begins. Liver biopsies performed within 18 months of study entry were assessed without knowledge of patient race by a central pathologist. Results: Based on the first 155 participants recruited, age and sex distributions are similar in the two racial groups with patients averaging 48 years of age and 2/3 being male More than 80% of the cohort has at least a high school education, but AA are more likely to have less than a high school education. Body mass indices tend to be higher among AA than among CA (p-.06), though waistto-hip ratios are similar (mean 0.9 in each group). There are no racial differences in mode of HCV transmission, estimated duration of HCV infection, or baseline serum HCV RNA levels. AA a r e more likely to have sub-genotype l b (p-.004).The Ishak fibrosis score does not differ by race, but severe lobular inflammation is greater in AA patients (p-.03). Diabetes and hypertension a r e more common in AA. The SF-36 physical component score in CA is similar to the general population and higher than among AA (p-.002). The SF-36 mental component score is similar in the two racial groups and comparable to the general population. Summary/Conclusion: With few exceptions, pretreatment virological, clinical and liver biopsy findings were generally similar in the two racial groups. Differences in response are unlikely to be explained by these factors.

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316 RACIAL DIFFERENCES IN PATIENTS WITH HEPATITIS C GENOTYPE 1. Steven Belle, University of Pittsburgh, Pittsburgh, PA;

Haft S Conjeevaram, University of Michigan, Ann Arbor, MI; Lennox J Jeffers, University of Miami, Miami, FL The prevalence of chronic hepatitis C (HCV) infection is greater in African-Americans (AA) than in Caucasian-Americans (CA). However, small studies and post-hoc analyses of larger clinical trials have not found racial differences in disease severity at study entry, though indicate that interferon and ribavirin combination therapy is not as efficacious in AA as in CA. It is important to identify disease and patient characteristics that differ between AA and CA in a large study designed to ascertain whether the apparent racial difference in response to therapy can be explained. Aim: The Study of Viral Resistance to Antiviral Therapy in Chronic Hepatitis C (Virahep-C) is investigating reasons for the lack of sustained viral response (SVR) to pegylated interferon and ribavirin therapy in previously untreated patients chronically infected with HCV genotype 1. A key objective is to determine whether previously reported response rate differences between AA and CA exist in a large multi-center cohort. Methods: Virahep-C will

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_S~ _~t~L{~!~.n : ~ . ~ ..................._:~a_i~kt!)................~_~..~]]................~ . ~ : t,'~',........ Disclosures: Steven Belle - No relationships to disclose Hari S Conjeevaram - No relationships to disclose Lennox J Jeffers - No relationships to disclose