A. Rossini et al., LONG-TERM FOLLOW-UP OF AND INFECTIVITY IN BLOOD-DONORS WITH HEPATITIS-C ANTIBODIES AND PERSISTENTLY NORMAL ALANINE AMINOTRANSFERASE LEVELS, Transfusion, 35(2), 1995, pp. 108-111
Background: Little is known about the prevalence of serum hepatitis C
virus (HCV) RNA In blood donors with HCV antibodies and persistently n
ormal alanine aminotransferase (ALT) levels. Study Design and Methods:
Thirty-nine anti-HCV-positive donors with normal ALT on four determin
ations at 3-month intervals were further tested monthly for 6 months,
and they had normal ALT values. The presence of HCV RNA was determined
in these 39 donors. Results: Serum HCV RNA was detected in 16 of 39 d
onors, 14 of 14 who reacted on second-generation recombinant immunoblo
t assay (RIBA-2) and 2 of 15 who were indeterminate. None of the 10 RI
BA-2-nonreactive donors had evidence of viremia. The 15 RIBA-2-indeter
minate samples were tested with third-generation RIBA (RIBA-3); the re
sults showed reactivity in 5 (including the 2 HCV RNA positive), an in
determinate pattern in 7, and nonreactivity in 3 (all RNA negative). A
mong HCV RNA-positive subjects, mean age (p<0.05), mean ALT (p<0.01),
signal-to-cutoff (S:CO) ratio on second-generation enzyme-linked immun
osorbent assay(p<0.001), and gamma globulin levels (p<0.05) were highe
r than those among HCV RNA-negative subjects. During 6 additional mont
hs of ALT monitoring, completed by 36 of 39 donors, Increased values w
ere detected in 6 (5 HCV RNA positive). In 4 of those 6, however, ALT
levels were less than 1.5-fold the upper normal limit. HCV RNA results
were unchanged at the end of 1-year follow-up. Conclusion: Forty-one
percent of anti-HCV-positive donors with persistently normal ALT had a
ctive HCV infection. Long-term ALT monitoring allowed the detection of
significantly increased enzyme values in only 2 of 16 viremic donors.
Reactivity on RIBA-2 or -3, greater age, mean ALT levels In the upper
range of normal, higher S:CO ratio on second-generation enzyme-linked
immunosorbent assay, and higher gamma globulin levels were predictive
of viremia.