Liver, Pancreas, and Biliary TractThe impact of interferon plus ribavirin on response to therapy in black patients with chronic hepatitis C☆,☆☆
Section snippets
Patient selection
We evaluated individual patient data from 1744 patients enrolled in 2 randomized trials described in detail previously.9, 10 All patients were randomized to 1 of 4 treatment groups, allowing for balance and stratification based on the presence or absence of cirrhosis, pretreatment serum HCV-RNA level, and HCV genotype. The 4 groups received interferon alfa-2b (Intron A; Schering Plough, Kenilworth, NJ) plus placebo, either for 24 (n = 231) or 48 weeks (n = 503), or the combination of interferon
Results
Of the 1744 patients who were randomized and treated, 1600 were white, 53 were black, 27 were Asian, 32 were Hispanic, and 32 were of other racial origins. The demographic characteristics of the 4 racial groups are summarized in Table 1.Empty Cell White (n = 1600) Black (n = 53) Asian (n = 27) Hispanic (n = 32) Mean age [yr (range)] 43 (19–75)a 46 (32–59)b 45 (21–79) 45 (32–68) Sex (M/F) 1042/558 36/17 22/5 24/8 Estimated length of infection (yr)e 17 18 21 21 Weight (kg) 79
Discussion
Understanding factors that aid in predicting response to therapy in HCV infection is important. Baseline viral factors have consistently been identified as predictors of response to interferon-based therapies.9, 10, 18, 19 A recent report shows that black patients have low response rates when treated with interferon.11 In our analysis of the largest group of black patients to date, we confirmed the poor response rate to interferon monotherapy in black patients. No black patients achieved a
Acknowledgements
The authors thank Dr. Z. D. Goodman (Armed Forces Institute of Pathology, Washington, D.C.) for acting as the pathologist for this study; B. Sangheve for statistical analyses; and Elvia Nunez (Scripps Clinic) for editing and preparing the manuscript.
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Address requests for reprints to: John G. McHutchison, M.D., Division of Gastroenterology/Hepatology (203N), Scripps Clinic and Research Foundation, 10666 North Torrey Pines Road, La Jolla, California 92037. e-mail: [email protected]; fax: (858) 554-9947.
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Supported in part by research grants from Schering Plough Corp. (Kenilworth, New Jersey) and the General Clinical Research Center grants at Scripps Clinic (MO1-RR00833) and the Massachusetts General Hospital (MO-1RR01066).