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Distribution of Hepatitis C Virus Genotypes Determined by Line Probe Assay in Patients with Chronic Hepatitis C Seen at Tertiary Referral Centers in the United States

Johnson Y.N. Lau, MD; Gary L. Davis, MD; Linda E. Prescott, BSc; Geert Maertens, PhD; Karen L. Lindsay, MD; KePing Qian, PhD; Masashi Mizokami, MD; Peter Simmonds, PhD, the Hepatitis Interventional Therapy Group*
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For author affiliations and current author addresses, see end of text. *For a listing of additional members of the Hepatitis Interventional Therapy Group, see the Appendix. Acknowledgments: The authors thank Janice A. Kolberg, PhD, and Mickey S. Urdea, PhD (Chiron Corp., Emeryville, California); and Janet Mellor, PhD, and Fiona McOmish, PhD (University of Edinburgh, Edinburgh, United Kingdom) for their assistance and advice. Robert G. Gish, MD (California Pacific Medical Center, San Francisco, California) generously provided serum specimens. Grant Support: The clinical studies on the use of interferon-α were funded by Schering-Plough, Kenilworth, New Jersey, and Clinical Research Center grants from the Public Health Service to the University of Florida (5M01RR00082), University of California at Los Angeles (RR-00865), and Massachusetts General Hospital (M01RR01066). The genotyping assays were supported in part by grants DSR-D-15 and DSR-RDA-1-15 from the Division of Sponsored Research, University of Florida, Gainesville (to Dr. Lau); the American Liver Foundation Hans Popper Liver Scholar Award (to Dr. Lau); the Glaxo Institute of Digestive Health Clinical Investigator Award (to Dr. Lau), and Murex Diagnostics P.L.C., Dartford, Kent, United Kingdom (to Ms. Prescott). The line probe assay was supplied by Innogenetics, Ghent, Belgium. Requests for Reprints: Johnson Y.N. Lau, MD, Section of Hepatobiliary Diseases, Department of Medicine, University of Florida, PO Box 100214 J. Hillis Miller Health Center, Gainesville, FL 32610. Current Author Addresses: Drs. Lau, Davis, and Qian: Section of Hepatobiliary Diseases, Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, University of Florida, PO Box 100214 J. Hillis Miller Health Center, Gainesville, FL 32610.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1996;124(10):868-876. doi:10.7326/0003-4819-124-10-199605150-00002
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Objective: To 1) verify the validity of a new line probe assay for hepatitis C virus [HCV] genotyping and 2) determine the distribution of HCV genotypes and the association between HCV genotype and clinical variables in patients with chronic hepatitis C seen in tertiary referral centers in the United States.

Design: Retrospective cross-sectional analysis.

Patients: 438 patients with chronic hepatitis C from 10 tertiary referral centers.

Measurements: The validity of the line probe assay was first verified against a panel of serum specimens that had previously been characterized by six different HCV genotyping methods. Specimens from all 438 patients were then genotyped using this line probe assay. The associations between HCV genotype and clinical variables were examined using analysis of variance. Pairwise testing was used when the F test showed a statistically significant difference. Nonparametric alternatives were used for variables for which normality could not be assumed.

Results: The line probe assay was quick and reproducible, and it showed good concordance with other tests. In our sample, the proportions of patients with HCV types 1, 2, 3, and 4 were 71.5%, 13.5%, 5.5%, and 1.1%, respectively. Subtypes 1a and 1b were seen in approximately equal proportions of patients with HCV type 1. Mixed infection was detected in 3.7% of specimens, and 4.8% of specimens either had negative results on polymerase chain reaction or could not be typed. A higher proportion of patients with HCV type 1 than of patients with HCV-type 1 had acquired HCV through transfusion of blood products (50% compared with 25%; P < 0.001). Patients with HCV type 1 also had a longer estimated duration of infection compared with patients with HCV type 3 (P = 0.004) and type 4 (P = 0.049). Disease activity did not differ among patients infected with HCV types 1, 2, or 3. Levels of viremia were similar in patients with HCV types 1, 2, or 3, but patients with HCV type 4 had a lower level of viremia than did patients with HCV type 1 (P = 0.047).

Conclusions: The line probe assay can be used in patients with chronic HCV infection in the United States. In patients with chronic hepatitis C referred to tertiary centers in the United States, type 1 is the most common HCV genotype. Disease activity and viremia levels do not differ among patients chronically infected with HCV types 1, 2, or 3.





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