Variation analysis of six HCV viral load assays using low viremic HCV samples in the range of the clinical decision points for HCV protease inhibitors

Medical Microbiology and Immunology

Volumn 204, Issue 4, 2015, Pages 515-525

  Wiesmann, F ^a   Naeth, G ^a   Sarrazin, C ^b   Berger, A ^b   Kaiser, R ^c   Ehret, R ^d   Knechten, H ^a   Braun, P ^a  

^a Praxen Zentrum Blondelstrasse   (Germany)

^b GOETHE UNIVERSITY   (Germany)

^c UNIVERSITY OF COLOGNE   (Germany)

^d Medical Laboratory Berg   (Germany)

Author keywords

COBAS; HCV; Quantification; RealTime; TaqMan; Viremia

Indexed keywords

PROTEINASE INHIBITOR; ANTIVIRUS AGENT;

ARTICLE; ASSAY; CLINICAL ARTICLE; CONTROLLED STUDY; CORRELATION ANALYSIS; DILUTION; GENOTYPE; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; INTERMETHOD COMPARISON; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MEASUREMENT ACCURACY; MEDICAL DECISION MAKING; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REFERENCE VALUE; STANDARD; VIREMIA; VIRUS LOAD; VIRUS LOAD ASSAY; BLOOD; COMPARATIVE STUDY; EVALUATION STUDY; HEPACIVIRUS; HEPATITIS C, CHRONIC; ISOLATION AND PURIFICATION; PROCEDURES; REPRODUCIBILITY; VIROLOGY;

ANTIVIRAL AGENTS; BLOOD; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; PROTEASE INHIBITORS; REPRODUCIBILITY OF RESULTS; VIRAL LOAD;

EID: 84938292866     PISSN: 03008584     EISSN: 14321831     Source Type: Journal    
DOI: 10.1007/s00430-014-0364-z     Document Type: Article

References (26)

1. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J (2002) Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 347(13):975–982
2. Davis GL, Wong JB, McHutchison JG, Manns MP, Harvey J, Albrecht J (2003) Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C. Hepatology 38(3):645–652
3. Sarrazin C, Berg T, Cornberg M, Dollinger M, Ferenci P, Hinrichsen H, Klinker H, Kraus M, Manns M, Mauss S, Peck-Radosavljevic M, Schmidt H, Spengler U, Wedemeyer H, Wirth S, Zeuzem S (2012) Expertenempfehlungen zur Triple-Therapie der HCV-Infektion mit Boceprevir und Telaprevir. Z Gastroenterol 50:57–72
4. Berg T, Weich V, Teuber G, Klinker H, Moeller B, Rasenack J, Hinrichsen H, Gerlach T, Spengler U, Buggisch P, Balk H, Zankel M, Sarrazin C, Zeuzem S (2007) Time to HCV RNA negativation in hepatitis C virus (HCV) type 1-infection during PEG-interferon-alpha-2B plus ribavirin therapy. Differences in relation to the assay sensitivity. Hepatology 46360A
5. Ferenci P, Fried MW, Shiffman ML, Smith CI, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Chaneac M, Reddy KR (2005) Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40 KD)/ribavirin. J Hepatol 43(3):425–433
6. Jensen DM, Morgan TR, Marcellin P, Pockros PJ, Reddy KR, Hadziyannis SJ, Ferenci P, Ackrill AM, Willems B (2006) Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon alpha-2a (40 kd)/ribavirin therapy. Hepatology 43(5):954–960
7. Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S (2007) Utility of virological response at weeks 4 and 12 in the prediction of SVR rates in genotype 2/3 patients treated with peginterferon-alfa-2a (40KD) plus ribavirin: findings from ACCELERATE. N Engl J Med 357(2):124–134
8. Jülicher P, Dhein J (2014) The range of uncertainty: a tool for efficiently addressing result variability around clinical decision points for hepatitis C response-guided therapy. Biomark Insights 9:9–13
9. Wachtel TJ, Reuben DB, Fulton JP, Wartman SA (1985) The use of the “range of uncertainty”. Med Decis Making 5(3):325–334
10. Maasoumy B, Cobb B, Bremer B, Luk K, Halfon P, Aslam S, Manns MP, Cornberg M, Wedemeyer H (2014) Detection of low HCV viraemia by repeated HCV RNA testing predicts treatment failure to triple therapy with telaprevir. Aliment Pharmacol Ther 39:85–92
11. Pockros PJ (2013) A prospective pilot trial of 3 different COBAS TaqMan assays OF HCV RNA for DAA treatment shows differences in week 4 and 12 RGT Results. American Association for the Study of Liver Diseases (AASLD) 2013. Abstract 1922
12. Fevery B, Susser S, Lenz O, Cloherty G, Perner D, Picchio G, Sarrazin C (2014) HCV RNA quantification with different assays: implications for protease inhibitor-based response-guided therapy. Antivir Ther. doi:10.3851/IMP2760
13. Vermehren J, Aghemo A, Falconer K, Susser S, Lunghi G, Zeuzem S, Colombo M, Weiland O, Sarrazin C (2014) Clinical significance of residual viremia detected by two real-time PCR assays for response-guided therapy of HCV genotype 1 infection. J Hepatol
14. Ogawa E, Furusyo N, Murata M, Toyoda K, Eiraku K, Shimizu M, Harada Y, Mitsumoto F, Takayama K, Okada K, Kainuma M, Hayashi J (2013) Early phase viral kinetics of chronic hepatitis C patients receiving telaprevir-based triple therapy: a comparison of two real-time PCR assays. Antiviral Res 99(2):119–124
15. Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio B, De Meyer S (2013) Appropriate use of Abbott RealTime HCV RNA assay in the management of HCV patients treated with telaprevir-based regimen: a retrospective analysis of the OPTIMIZE study. HepDART 2013; Poster no. 121
16. Drexler JF, Reber U, Wuttkopf A, Eis-Hübinger AM, Drosten C (2012) Performance of the novel Qiagen artus QS-RGQ viral load assays compared to that of the Abbott RealTime system with genetically diversified HIV and hepatitis C Virus plasma specimens. J Clin Microbiol 50(6):2114–2117
17. Vermehren J, Kau A, Gärtner BC, Göbel R, Zeuzem S, Sarrazin C (2008) Differences between two real-time PCR-based hepatitis C virus (HCV) assays (RealTime HCV and Cobas AmpliPrep/Cobas TaqMan) and one signal amplification assay (Versant HCV RNA 3.0) for RNA detection and quantification. J Clin Microbiol 46(12):3880–3891
18. Michelin BD, Muller Z, Stelzl E, Marth E, Kessler HH (2007) Evaluation of the Abbott RealTime HCV assay for quantitative detection of hepatitis C virus RNA. J Clin Virol 38(2):96–100
19. Sarrazin C, Gartner BC, Sizmann D, Babiel R, Mihm U, Hofmann WP, von Wagner M, Zeuzem S (2006) Comparison of conventional PCR with real-time PCR and branched DNA-based assays for hepatitis C virus RNA quantification and clinical significance for genotypes 1 to 5. J Clin Microbiol 44(3):729–737
20. LaRue H, Rigali L, Balada-Llasat JM, Pancholi P (2012) Performance of the Abbott RealTime and Roche Cobas TaqMan hepatitis C virus (HCV) assays for quantification of HCV genotypes. J Clin Microbiol 50(5):1769–1772
21. Saldanha J, Heath A, Aberham C, Albrecht J, Gentili G, Gessner M, Pisani G (2005) World Health Organization collaborative study to establish a replacement WHO international standard for hepatitis C virus RNA nucleic acid amplification technology assays. Vox Sang 88(3):202–204
22. Saldanha J, Lelie N, Yu MW, Heath A (2002) Establishment of the first World Health Organization international standard for human parvovirus B19 DNA nucleic acid amplification techniques. Vox Sang 82(1):24–31
23. Kessler HH, Hübner M, Konrad PM, Stelzl E, Stübler MM, Baser MH, Santner BI (2013) Genotype impact on HCV RNA levels determined with the VERSANT HCV RNA 1.0 assay (kPCR). J Clin Virol 58:522–527
24. Chevaliez S, Bouvier-Alias M, Brillet R, Pawlotsky JM (2007) Overestimation and underestimation of hepatitis C virus RNA levels in a widely used real-time polymerase chain reaction-based method. Hepatology 46(1):22–31
25. Fried MW, Buti M, Dore GJ, Flisiak R, Ferenci P, Jacobson I, Marcellin P, Manns M, Nikitin I, Poordad F, Sherman M, Zeuzem S, Scott J, Gilles L, Lenz O, Peeters M, Sekar V, De Smedt G, Beumont-Mauviel M (2013) Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naïve genotype 1 hepatitis C: the randomized PILLAR study. Hepatology 58(6):1918–1929
26. Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Müllhaupt B, Gane E, Schuchmann M, Lohse AW, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Nehmiz G, Kukolj G, Böcher WO, Mensa FJ (2013) Faldaprevir (BI 201335), BI 207127 and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results. Antivir Ther 18(8):1015–1019