Use of Diagnostic Testing for Managing Hepatitis C Virus Infection

 

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Serological and virological testing for the hepatitis C virus (HCV) is essential in the management of patients with chronic HCV infection. Recent advances in molecular virology tests and the development of a new international unit standard have greatly simplified the use and interpretation of these tests. In the absence of treatment, baseline serum HCV RNA does not change over time and does not correlate with the severity of hepatic inflammation or fibrosis on liver biopsy. In contrast, changes in serum HCV RNA level are important predictors of virological response to treatment with pegylated interferon and ribavirin.

REFERENCES

• 1 Choo Q L, Kuo G, Weiner A J et al.. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome.  Science. 1989;  244 359-362
  CrossrefPubMedGoogle Scholar
• 2 Kuo G, Choo Q L, Alter H J et al.. An assay for circulating antibodies to the major etiologic virus of human non-A, non-B hepatitis.  Science. 1989;  244 362-364
  CrossrefPubMedGoogle Scholar
• 3 Alter H J, Purcell R H, Shih J W et al.. Detection of antibody to hepatitis C virus in prospectively followed transfusion recipients with acute and chronic non-A, non-B hepatitis.  N Engl J Med. 1989;  321 1494-1500
  CrossrefPubMedGoogle Scholar
• 4 Gretch D R. Use and interpretation of HCV diagnostic tests in the clinical setting.  Clin Liver Dis. 1977;  1 543-557
  PubMedGoogle Scholar
• 5 Zaaijer H L, Cuypers H T, Reesink H W et al.. Reliability of polymerase chain reaction for detection of hepatitis C virus.  Lancet. 1993;  341 722-724
  CrossrefPubMedGoogle Scholar
• 6 Saldanha J, Lelie N, Heath A. Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA. WHO collaborative study group.  Vox Sang. 1999;  76 149-158
  CrossrefPubMedGoogle Scholar
• 7 Simmonds P. Variability of hepatitis C virus.  Hepatology. 1995;  21 570-583
  CrossrefPubMedGoogle Scholar
• 8 Fried M W, Hadziannis S. Treatment of chronic hepatitis C infection with peginterferons plus ribavirin.  Semin Liver Dis. 2004;  24(suppl 2) 47-54
  Article in Thieme ConnectPubMedGoogle Scholar
• 9 Schiff E R, de Medina M, Kahn R S. New perspectives in the diagnosis of hepatitis C.  Semin Liver Dis. 1999;  19 3-15
  PubMedGoogle Scholar
• 10 Gretch D R. Diagnostic tests for hepatitis C.  Hepatology. 1997;  26(suppl) 43S-47S
  CrossrefPubMedGoogle Scholar
• 11 Kao J H, Lai M Y, Hwang Y T et al.. Chronic hepatitis C without anti-hepatitis C antibodies by second-generation assay: a clinicopathologic study and demonstration of the usefulness of a third-generation assay.  Dig Dis Sci. 1996;  41 161-165
  PubMedGoogle Scholar
• 12 Barrera J, Prancis B, Ercilla G et al.. Improved detection of anti-HCV in post-transfusion hepatitis by a third-generation ELISA.  Vox Sang. 1995;  68 15-18
  PubMedGoogle Scholar
• 13 Fried M W, Draguesku J O, Shindo M et al.. Clinical and serological differentiation of autoimmune and hepatitis C virus-related chronic hepatitis.  Dig Dis Sci. 1993;  38 631-636
  CrossrefPubMedGoogle Scholar
• 14 Alter M J. The epidemiology of acute and chronic hepatitis C.  Clin Liver Dis. 1997;  1 559-568
  PubMedGoogle Scholar
• 15 Thio C L, Nolt K R, Astemborski J et al.. Screening for hepatitis C virus in human immunodeficiency virus -infected individuals.  J Clin Microbiol. 2000;  38 575-577
  PubMedGoogle Scholar
• 16 Colin C, Lanoir D, Touzet S et al.. Sensitivity and specificity of third-generation hepatitis C virus antibody detection assays: an analysis of the literature.  J Viral Hepat. 2001;  8 87-95
  CrossrefPubMedGoogle Scholar
• 17 Pawlotsky J M. Use and interpretation of hepatitis C virus diagnostic assays.  Clin Liver Dis. 2003;  7 127-137
  PubMedGoogle Scholar
• 18 Alter H J, Tegtmeier G, Jett B et al.. The use of recombinant immunoblot assay in the interpretation of anti-hepatitis C virus reactivity among prospectively followed patients, implicated donors and random donors.  Transfusion. 1991;  31 771-776
  CrossrefPubMedGoogle Scholar
• 19 Evans C, Tobler L, Polito A et al.. Comparative evaluations of supplemental hepatitis C virus antibody test systems.  Transfusion. 1992;  32 408-414
  CrossrefPubMedGoogle Scholar
• 20 Bouvier-Alias M, Patel K, Dahari H et al.. Clinical utility of total HCV core antigen quantification: a new indirect marker of HCV replication.  Hepatology. 2002;  36 211-218
  CrossrefPubMedGoogle Scholar
• 21 Lagging L M, Garcia C E, Westin J et al.. Comparison of serum hepatits C virus RNA and core antigen concentrations and determination of whether levels are associated with liver histology or affected by specimen storage time.  J Clin Microbiol. 2002;  40 4224-4229
  CrossrefPubMedGoogle Scholar
• 22 Vellion P, Payan C, Picchio G et al.. Comparative evaluation of the total hepatits C virus core antigen, branched-DNA, and Amplicor monitor assays in determining viremia for patients with chronic hepatits C during interferon plus ribavirin combination therapy.  J Clin Microbiol. 2003;  41 3212-3220
  CrossrefPubMedGoogle Scholar
• 23 Sarrazin C. Highly sensitive hepatitis C virus RNA detection methods: molecular backgrounds and clinical significance.  J Clin Virol. 2002;  25(Suppl 3) S23-S29
  PubMedGoogle Scholar
• 24 Pawlotsky J M. Molecular diagnosis of viral hepatitis.  Gastroenterology. 2002;  122 1554-1568
  PubMedGoogle Scholar
• 25 Zaaijer H L, Cuypers H T, Reesink H W et al.. Reliability of polymerase chain reaction for detection of hepatitis C virus.  Lancet. 1993;  341 722-724
  CrossrefPubMedGoogle Scholar
• 26 Nolte F S, Fried M W, Shiffman M L et al.. Prospective multicenter clinical evaluation of AMPLICOR and COBAS AMPLICOR hepatitis C virus tests.  J Clin Microbiol. 2001;  39 4005-4012
  CrossrefPubMedGoogle Scholar
• 27 Komurian-Pradel F, Paranhos-Baccala G, Sodoyer M et al.. Quantitation of HCV RNA using real-time PCR and fluorimetry.  J Virol Methods. 2001;  95 111-119
  CrossrefPubMedGoogle Scholar
• 28 Kleiber J, Walter T, Haberhausen G et al.. Performance characteristics of a quantitative, homogeneous TaqMan RT-PCR test for HCV RNA.  J Mol Diagn. 2000;  2 158-166
  PubMedGoogle Scholar
• 29 Kawai S, Yokosuka O, Kanda T et al.. Quantification of hepatitis C virus by TaqMan PCR: comparison with HCV Amplicor Monitor assay.  J Med Virol. 1999;  58 121-126
  CrossrefPubMedGoogle Scholar
• 30 Hendricks D A, Friesenhahn M, Tanimoto L et al.. Multicenter evaluation of the VERSANT HCV RNA qualitative assay for detection of hepatitis C virus RNA.  J Clin Microbiol. 2003;  41 651-656
  CrossrefPubMedGoogle Scholar
• 31 Hill C S. Molecular diagnostic testing for infectious diseases using TMA technology.  Expert Rev Mol Diagn. 2001;  1 445-455
  CrossrefPubMedGoogle Scholar
• 32 Sarrazin C, Teuber G, Kokka R, Rabenau H, Zeuzem S. Detection of residual hepatitis C virus RNA by transcription mediated amplification in patients with complete virologic response according to polymerase chain reaction-based asays.  Hepatology. 2000;  32 818-823
  CrossrefPubMedGoogle Scholar
• 33 Urdea M S, Horn T, Fultz T J et al.. Branched DNA amplification multimers for the sensitive, direct detection of human hepatitis viruses.  Nucleic Acids Symp Ser. 1991;  24 197-200
  PubMedGoogle Scholar
• 34 Pawlotsky J M, Martinot-Peignoux M, Poveda J D et al.. Quantification of hepatitis C RNA in serum by branched chain DNA-based signal amplification assays.  J Virol Methods. 1999;  79 227-235
  CrossrefPubMedGoogle Scholar
• 35 Fang J WS, Chow V, Lau J NY. Virology of hepatitis C virus.  Clin Liver Dis. 1997;  1 493-514
  PubMedGoogle Scholar
• 36 Stuyver L, Wyseur A, van Arnhem W et al.. Hepatitis C virus genotyping by means of 5′-UR/core line probe assays and molecular analysis of untypable samples.  Virus Res. 1995;  38 137-157
  CrossrefPubMedGoogle Scholar
• 37 Stuyver L, Wyseur A, van Arnhem W, Hernandez F, Maertens G. Second-generation line probe assay for hepatitis C virus genotyping.  J Clin Microbiol. 1996;  34 2259-2266
  PubMedGoogle Scholar
• 38 Zheng X, Pang M, Chan A et al.. Direct comparison of hepatitis C virus genotypes tested by INNO-LiPA HCV II and TRUGENE HCV genotyping methods.  J Clin Virol. 2003;  28 214-216
  CrossrefPubMedGoogle Scholar
• 39 Anderson J C, Simonetti J, Fisher D G et al.. Comparison of different HCV viral load and genotyping assays.  J Clin Virol. 2003;  28 27-37
  CrossrefPubMedGoogle Scholar
• 40 Nakao T, Enomoto N, Takada N, Takada A, Date T. Typing of hepatitis C virus genomes by restriction fragment length polymorphism.  J Gen Virol. 1991;  72 2105-2112
  PubMedGoogle Scholar
• 41 De Cock L, Vranckx R. Serotyping and genotyping of hepatitis C virus in Belgium.  Infection. 2003;  31 92-97
  CrossrefPubMedGoogle Scholar
• 42 Pawlotsky J M, Prescott L, Simmonds P et al.. Serological determination of hepatitis C virus genotype: comparison with a standardized genotyping assay.  J Clin Micrbiol. 1997;  35 1734-1739
  PubMedGoogle Scholar
• 43 Pawlotsky J M, Bouvier-Alias M, Hezode C et al.. Standardization of hepatitis C virus RNA quantification.  Hepatology. 2000;  32 654-657
  CrossrefPubMedGoogle Scholar
• 44 Shiffman M L, Ferreria-Gonzalez A, Reddy K R et al.. Comparison of three commercially available assays for HCVRNA utilizing the international unit standard: Implications for management of patients with chronic hepatitis C virus infection in clinical practice.  Am J Gastroenterol. 2003;  98 1159-1166
  CrossrefPubMedGoogle Scholar
• 45 Krajden M, Ziermann R, Khan A et al.. Qualitative detection of hepatitis C virus RNA: comparison of analytical sensitivity, clinical performance, and workflow of the Cobas Amplicor HCV test version 2.0 and the HCV RNA transcription-mediated amplification qualitative assay.  J Clin Microbiol. 2002;  40 2903-2907
  CrossrefPubMedGoogle Scholar
• 46 Yu M L, Chuang W L, Dai C Y et al.. Clinical evaluation of the automated Cobas Amplicor HCV Monitor test version 2.0 for quantifying serum hepatitis C virus RNA and comparison to the Quantiplex HCV Version 2.0 test.  J Clin Microbiol. 2000;  38 2933-2939
  PubMedGoogle Scholar
• 47 Nguyen T, Sedghi-Vaziri A, Wilkes L et al.. Fluctuations in viral load (HCV RNA) are relatively insignificant in untreated patients with chronic HCV infection.  J Viral Hepat. 1996;  3 75-78
  PubMedGoogle Scholar
• 48 Fried M W, Shiffman M L, Reddy K R et al.. Combination of peginterferon alfa-2a plus ribavirin in patients with chronic hepatitis C virus infection.  N Engl J Med. 2002;  347 975-982
  CrossrefPubMedGoogle Scholar
• 49 Davis G L, Wong J B, McHutchison J G et al.. Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C.  Hepatology. 2003;  38 645-652
  PubMedGoogle Scholar
• 50 Shiffman M L, Hofmann C M, Thompson E B et al.. Relationship between biochemical, virologic and histologic response during interferon treatment of chronic hepatitis C.  Hepatology. 1997;  26 780-785
  PubMedGoogle Scholar
• 51 Shiffman M L, Hofmann C M, Contos M J et al.. A randomized, controlled trial of maintenance interferon for treatment of chronic hepatitis C non-responders.  Gastroenterology. 1999;  117 1164-1172
  CrossrefPubMedGoogle Scholar
• 52 Lee S. Histological response to interferon alfa-based therapies in hepatitis C.  Semin Liver Dis. 2004;  24(suppl 2) 55-60
  Article in Thieme ConnectPubMedGoogle Scholar
• 53 Shiffman M L, Hofmann C M, Thompson E B et al.. Relationship between biochemical, virologic and histologic response during interferon treatment of chronic hepatitis C.  Hepatology. 1997;  26 780-785
  PubMedGoogle Scholar
• 54 Zeuzem S, Heathcote E J, Shiffman M L et al.. Twelve weeks of follow-up is sufficient for the determination of sustained virologic response in patients treated with interferon alpha for chronic hepatitis C.  J Hepatol. 2003;  39 106-111
  PubMedGoogle Scholar

Mitchell L ShiffmanM.D. 

Hepatology Section, Virginia Commonwealth University Health System

Box 980341, Richmond, VA 23298

Email: mshiffma@hsc.vcu.edu