The aims of the study were: (i) to evaluate the prevalence of hepatitis C v
irus (HCV) antibodies (third generation tests) and RNA (standardized ultras
ensitive RT-PCR assay) in a large cohort of hemodialysis patients, and (ii)
to correlate HCV markers with bioclinical features and alanine-aminotransf
erase (ALT) activity. Antibodies were assayed by two methods in 1,323 patie
nts (60% men, median age 65 years, median hemodialysis duration 3 years) at
tending 25 French hemodialysis centers including 9 self-care units. RNA was
assayed using the Cobas Amplicor 2.0 method in pooled samples from 10 anti
-HCV(-/-) patients and on individual samples from the other patients. Of th
e 16.3% patients (range 0-44%) tested (+/+) for HCV antibodies (anti-HCV),
2.3% tested (+/-) and 81.4% tested (-/-). 70% of the anti-HCV(+/+) patients
and 3% of the HCV(+/-) patients were RNA(+). Pooled analysis revealed that
5/1077 anti-HCV(-/-) patients (0.5%) were RNA(+); all 5 displayed subseque
ntly an increase in ALT and became anti-HCV(+/+). Mean ALT was higher (mult
iple of nor mat) in anti-HCV(+/+) RNA(+) patients than in anti-HCV(+/+) RNA
(-) patients (0.46 +/- 0.08 vs. 0.22 +/- 0.07, P < 0.0001) and similar in a
ll the RNA(-) patients, whatever their HCV antibody status. Multivariate an
alysis demonstrated that HCV status was linked to hemodialysis duration, pr
evious kidney transplantation and positive anti-HBc. To summarize, the dete
rmination of the RNA status of anti-HCV(+/-) patients may have clinical rel
evance if a policy of isolation is contemplated. Standardized ultrasensitiv
e RT-PCR assay combined with a pooling strategy is a promising method for u
se in epidemiological studies. J. Med. Virol. 61:44-51, 2000. (C) 2000 Wile
y-Liss, Inc.