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Chapter 89 : Hepatitis C Virus

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Abstract:

Hepatitis C virus (HCV) is classified within the family in its own genus, . Phylogenetic analysis of helicase sequences has been used to probe its relatedness to other viruses in the family. The data suggest that HCV is most closely related to the nonpathogenic human virus GBV-C. Viremia clearance kinetics are also important predictors of virologic response (VR), relapse rate, and sustained virologic response (SVR). Signs of hepatitis during acute infection are actually positive indicators as they represent early, vigorous T-cell responses associated with spontaneous virus clearance; these responses are minimal or absent in individuals who progress to chronicity. Unlike other chronic viral infections such as HIV and hepatitis B virus, virologic parameters including viral load and genotype do not predict disease progression or indicate disease severity in chronic hepatitis C. The cutoff of 400,000 IU/ml is the viral load that optimally differentiates high from low probability of SVR in Gt1-infected individuals as shown by receiver operator characteristic (ROC) analysis of data. Nucleic acid tests (NATs) are the cornerstones of chronic HCV treatment since therapeutic tailoring is based on genotype and viral load determinations. Any discussion of HCV NATs must first address nucleic acid extraction due to its contribution to assay performance characteristics. Assays based on 5' untranslated regions (UTR) sequences are generally acceptable for genotype determination but must be carefully designed for subtyping due to the degree of sequence conservation among different viruses. The diagnosis of chronic HCV infection is usually established with serology assays.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89

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TaqMan Real-Time PCR Assay
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Figures

Image of FIGURE 1
FIGURE 1

HCV genome and protein coding scheme. E, envelope; NS, nonstructural gene; nuc, nucleotide; pos, position; aa, amino acid; gp, glycoprotein. Numbering is according to references and .

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
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Image of FIGURE 2
FIGURE 2

Clinical features of acute hepatitis C following exposure to low viral inoculum such as occupational needlestick exposure or community-based exposure ( ). Characteristics following higher-dose exposure (transfusion with contaminated blood products) may be different. The intermittent viremia phase was estimated from needlestick exposure ( ). Kinetics of other characteristics were derived from seroconversion panels ( ). ALT, alanine aminotransferase. Dashed lines indicate potential viremia patterns as defined by HCV RNA levels in peripheral blood. Adapted from reference .

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
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Image of FIGURE 3
FIGURE 3

Individualized chronic hepatitis C therapy algorithms based on genotype, baseline viral load, and response kinetics. Rx wk, treatment week; LVL, low baseline viral load (,400,000 IU/ml); HVL, high baseline viral load (<400,000 IU/ml); UD, undetectable; 1, detectable HCV RNA. Adapted from reference .

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
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Image of FIGURE 4
FIGURE 4

Antigens in serology tests and supplemental RIBA currently available commercially in the United States. Abbott HCV EIA 2.0 is the only second-generation screening test currently available. AxSYM, Architect, Ortho 3.0 EIA, Ortho Vitros, and Advia Centaur are third-generation HCV antibody screening tests. HC34, recombinant antigen containing HCV core protein (amino acids [aa] 1 to 150); HC31, recombinant antigen containing NS3 (aa 1192 to 1457) and NS4 (aa 1676 to 1931) separated by an 8-aa linker. c100-3, recombinant antigen containing NS3-4 (aa 1569 to 1931). HCr43, fusion protein of two noncontiguous antigens, c33c and core protein (aa 1 to 150). c200, recombinant antigen containing NS3-4 (aa 1192 to 1931). NS5, recombinant antigen (aa 2054 to 2995). c22-3, recombinant antigen containing core protein (aa 2 to 120). c22p, peptide containing core protein major epitope (aa 10 to 53). 5-1-1p and c100p, NS4 peptides (aa 1694 to 1735 and aa 1920 to 1935, respectively). SOD, superoxide dismutase. First-generation RIBA contained c100-3 and 5-1-1p expressed as a recombinant antigen. Second-generation RIBA contained these two antigens plus c33c and c22-3. Compared to RIBA 2.0, RIBA 3.0 contains an additional antigen (NS5) and peptides have replaced recombinant core and NS4 antigens.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
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Image of FIGURE 5
FIGURE 5

RIBA interpretation. (A) Interpretive criteria; (B) illustrations of sample results. Lane 1, illustration of band locations for human IgG (LI, level one, low-concentration IgG control; LII, level two, high-concentration IgG control), hSOD, and HCV recombinant antigens and peptides. Lanes 2 to 9, sample results. Lanes 2 to 4, RIBA positive. Lanes 5 to 7, RIBA negative. Lanes 8 and 9, RIBA indeterminate. See Fig. 4 for location of HCV antigens/peptides.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
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Image of FIGURE 6
FIGURE 6

Algorithms for HCV antibody screening and confirmation. Interpretations and suggested follow-up are indicated by boxed, italicized text. Derived from www.cdc.gov/hepatitis/HCV/ LabTesting.htm.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
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Tables

Generic image for table
TABLE 1

Response and milestone definitions in chronic hepatitis C treatment

As detected by assay with limit of detection of ≤50 IU/ml.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
Generic image for table
TABLE 2

HCV RNA qualitative tests

All tests are FDA approved and Conformité Européenne (CE) marked according to European In Vitro Diagnostic Directive 98/79/EC.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
Generic image for table
TABLE 3

Commercial HCV RNA quantification tests

Lower limit of quantification to upper limit of quantification of undiluted specimens.

1 IU/ml 5 copies/ml..

All products are Conformité Européenne (CE) marked and approved according to European In Vitro Diagnostic Directive 98/79/EC. U.S. regulatory status is shown.

LOD, 10 IU/ml.

Analytical measuring range. Expanded clinical reportable range (43–6.9 × 10 IU/ml) can be obtained by maximum dilution of 1:100. LOD, 18 IU/ml.

ND, not determined. The test was developed after universal institution of IU.

LOD reported as genotype dependent, from 6 IU/ml for Gt4 to 18 IU/ml for Gt5.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
Generic image for table
TABLE 4

Commercial HCV RNA genotyping tests

Genotypes 1 through 6 can be determined with all assays.

Available globally as RUO product.

CE marked and approved according to European In Vitro Diagnostic Directive 98/79/EC.

U.S. regulatory status, RUO.

Available for sale outside the United States only.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
Generic image for table
TABLE 5

User-defined HCV RNA genotyping tests

Abbreviations: RFLP, restriction fragment length polymorphism; PSEA, primer-specific extension analysis; PSMEA, primer-specific mispair extension analysis; FRET, fluorescent resonance energy transfer.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
Generic image for table
TABLE 6

Recommendations for chronic hepatitis C screening

Synopsized from reference .

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89
Generic image for table
TABLE 7

Serologic assays for the detection of anti-HCV antibodies

All assays approved for diagnostic use by U.S. Food and Drug Administration.

>95% of samples with S/CO ratios above indicated threshold predicted to be confirmed positive.

Expressed in package insert as percent positive agreement.

Expressed in package insert as percent negative agreement.

NA, not available.

Citation: Forman M, Valsamakis A. 2011. Hepatitis C Virus, p 1437-1455. In Versalovic J, Carroll K, Funke G, Jorgensen J, Landry M, Warnock D (ed), Manual of Clinical Microbiology, 10th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555816728.ch89

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