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Chemiluminescence enzyme immunoassay for monitoring hepatitis C virus core protein during interferon‐α2b and ribavirin therapy in patients with genotype 1 and high viral loads
Author(s) -
Enomoto Masaru,
Nishiguchi Shuhei,
Tamori Akihiro,
Kohmoto Modoka,
Habu Daiki,
Sakaguchi Hiroki,
Takeda Tadashi,
Kawada Norifumi,
Seki Shuichi,
Shiomi Susumu
Publication year - 2005
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.20416
Subject(s) - ribavirin , virology , viral load , hepatitis c virus , interquartile range , immunoassay , medicine , chemiluminescence , interferon , hepatitis c , hepacivirus , virus , immunology , antibody , chemistry , organic chemistry
Abstract This study evaluated an updated chemiluminescence enzyme immunoassay (CLEIA) for hepatitis C virus (HCV) core protein for monitoring viral kinetics during treatment with interferon (IFN)‐α and ribavirin. Using the CLEIA, serum levels of HCV core protein were measured in 17 patients with genotype 1 and high baseline viral loads during the first 4 weeks of combination therapy. HCV RNA was measured by the Amplicor Monitor test for comparison. At the start of therapy, the median HCV level (interquartile range) was 700 (540–940) kIU/ml of viral RNA and 11,310 (5,528–14,238) fmol/L of core protein. HCV RNA was above the upper limit of the linear range of the Amplicor Monitor test in 13 of the 17 patients, while the core protein level was within the linear range of the CLEIA in all patients. During therapy, the proportion of patients with HCV levels below the cutoff values at each time point was less with the Amplicor Monitor test than with CLEIA. Serum HCV core protein level decreased rapidly during the first 24 hr of therapy and more slowly thereafter, with median exponential decays of 1.08 and 0.046 log10/day, respectively. In the second phase, between day 1 and 28, the median decrease in HCV core protein level was higher in four patients with sustained virologic response (0.13 log10/day) than in 13 patients with no response (0.028 log10/day, P = 0.042). The wide linear range of the HCV core protein assay is appropriate for measuring viral loads during therapy with IFN‐α and ribavirin. J. Med. Virol. 77:77–82, 2005. © 2005 Wiley‐Liss, Inc.