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.