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Volunteer Blood Donors with Antibody to Hepatitis C Virus: Clinical, Biochemical, Virologic, and Histologic Features

A. Obaid Shakil, MBBS, MRCP; Cathy Conry-Cantilena, MD; Harvey J. Alter, MD; Paul Hayashi, MD; David E. Kleiner, MD, PhD; Valeria Tedeschi, PhD; Krzysztof Krawczynski, MD, PhD; Hari S. Conjeevaram, MD; Richard Sallie, MD, FRACP; Adrian M. Di Bisceglie, MD, the Hepatitis C Study Group*
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From the National Institutes of Health, Bethesda, Maryland, and the Centers for Disease Control and Prevention, Atlanta, Georgia. Acknowledgments: The authors thank Dr. David Herion of the National Institute of Alcohol Abuse and Alcoholism of the National Institutes of Health for help with assessing alcohol consumption and the nursing staff of the 9E patient care unit of the Warren Magnusen Clinical Center for their help in caring for these participants. Requests for Reprints: Jay H. Hoofnagle, MD, Liver Diseases Section, National Institutes of Health, Building 10, Room 4D52, Bethesda, MD 20892-1372. Current Author Addresses: Dr. Shakil: Division of Transplantation Medicine, University of Pittsburgh Medical Center, 200 Lothrop Street, Pittsburgh, PA 15213-2582.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1995;123(5):330-337. doi:10.7326/0003-4819-123-5-199509010-00002
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Objective: To assess the clinical significance of antibody to hepatitis C virus (anti-HCV) in volunteer blood donors.

Design: Prospective cohort study.

Setting: National Institutes of Health Clinical Center, a tertiary referral research hospital.

Patients: 60 anti-HCV-positive blood donors, divided into three groups of 20 persons each: Group I had normal alanine aminotransferase levels, group II had levels elevated to values less than twice the normal range, and group III had levels elevated to values greater than twice the normal range.

Measurements: Medical history, results of laboratory and virologic testing, and percutaneous liver biopsy findings.

Results: Participants with normal alanine amino-transferase levels were older and more often female than those with abnormal levels. The source of infection, duration of disease, symptom score, and amount of alcohol consumed were similar in the three groups. Hepatitis C virus RNA was detectable in 85% of participants, more commonly in the groups with elevated alanine aminotransferase levels (95%) than in the group with normal levels (65%); however, titers were similar in all groups. Examination of liver biopsy specimens showed chronic hepatitis in 54 participants (90%) and cirrhosis in 1 participant. The only normal liver biopsy specimens (n = 3) were those from participants who were HCV RNA negative and had normal alanine aminotransferase levels.

Conclusions: Most blood donors with anti-HCV have chronic hepatitis C regardless of their serum alanine aminotransferase levels. Donors with normal alanine aminotransferase levels and no HCV RNA in their serum generally have normal liver histologic findings or minimal changes and have probably recovered from HCV infection.

*Members of the Hepatitis C Study Group include Jacqueline C. Melpolder, MT, and Jay H. Hoofnagle, MD, National Institutes of Health, Bethesda, Maryland.


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Figure 1.
Alanine aminotransferase (ALT) levels (top) and histologic activity index scores (bottom) in viremic and nonviremic volunteer blood donors.t

Fifty-one donors were positive on at least one occasion for hepatitis C virus RNA in serum by polymerase chain reaction [PCR], and 9 donors were repeatedly negative for hepatitis C virus RNA by PCR. Values shown are the maximal recorded during the screening period; the interrupted line indicates the upper limit of the normal range, and the horizontal bars represent the means. Analysis was done using the Student -test). To convert alanine aminotransferase values to µkat/L, multiply by 0.01667.

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