Yıl: 2022 Cilt: 28 Sayı: 1 Sayfa Aralığı: 32 - 38 Metin Dili: İngilizce DOI: 10.4274/vhd.galenos.2022.2021-3-2 İndeks Tarihi: 10-05-2023

Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment

Öz:
Objectives: Recently, with the use of direct-acting antivirals (DAA) for treating chronic hepatitis C (CHC), the success rate has exceeded 90%. The implementation of these strong therapies has reduced the role of monitoring therapy with hepatitis C virus (HCV)- RNA tests. The current study compares the HCV-core antigen test (HCV-Ag) with HCV-RNA in terms of correlation, effectiveness and cost in patients who started DAA and to evaluate the usability of HCV-Ag as a routine laboratory test. Materials and Methods: This study includes 76 patients with CHC. Patients with positive HCV-RNA, over 18 years old and who will initiate DAA are included. HCV-Ag level was studied in all samples by using ARCHITECT core antigen measurement Abbott method. HCV-RNA and anti-HCV levels compared with HCV-Ag levels. Results: Of the 76 patients, 44 (57%) were males, 48 (63%) were treatment experienced and 21 (27%) were cirrhotic. All patients were started with DAAs. When compared before and after treatment, HCV-RNA level, HCV-Ag level was found to be significantly different (p<0.001). Before treatment, HCV-RNA and HCV-Ag levels were found to be positive correlations (correlation coefficient: 0.419). Conclusion: The use of DAAs in HCV therapy has eliminated the need for response-guided therapy. It has been demonstrated in the study that HCV-Ag measurement is very successful and cost effective in detecting viremic patients and evaluating virological response, which are the two most important factors in the management of CHC.
Anahtar Kelime:

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
  • Lavanchy D. The global burden of hepatitis C. Liver Int. 2009;29 (Suppl 1):74-81.
  • Alter MJ. Epidemiology of hepatitis C virus infection. World J Gastroenterol. 2007;13:2436-2441.
  • Tozun N, Ozdogan O, Cakaloglu Y, Idilman R, Karasu Z, Akarca U, Kaymakoglu S, Ergonul O. Seroprevalence of hepatitis B and C virus infections and risk factors in Turkey: a fieldwork TURHEP study. Clin Microbiol Infect. 2015;21:1020-1026.
  • RazaviH,WakedI,SarrazinC,MyersRP,IdilmanR,CalinasF,Vogel W, Mendes Correa MC, Hézode C, Lázaro P, Akarca U, Aleman S, Balık I, Berg T, Bihl F, Bilodeau M, Blasco AJ, Brandão Mello CE, Bruggmann P, Buti M, Calleja JL, Cheinquer H, Christensen PB, Clausen M, Coelho HS, Cramp ME, Dore GJ, Doss W, Duberg AS, El-Sayed MH, Ergör G, Esmat G, Falconer K, Félix J, Ferraz ML, Ferreira PR, Frankova S, García-Samaniego J, Gerstoft J, Giria JA, Gonçales FL Jr, Gower E, Gschwantler M, Guimarães Pessôa M, Hindman SJ, Hofer H, Husa P, Kåberg M, Kaita KD, Kautz A, Kaymakoglu S, Krajden M, Krarup H, Laleman W, Lavanchy D, Marinho RT, Marotta P, Mauss S, Moreno C, Murphy K, Negro F, Nemecek V, Örmeci N, Øvrehus AL, Parkes J, Pasini K, Peltekian KM, Ramji A, Reis N, Roberts SK, Rosenberg WM, Roudot- Thoraval F, Ryder SD, Sarmento-Castro R, Semela D, Sherman M, Shiha GE, Sievert W, Sperl J, Stärkel P, Stauber RE, Thompson AJ, Urbanek P, Van Damme P, van Thiel I, Van Vlierberghe H, Vandijck D, Wedemeyer H, Weis N, Wiegand J, Yosry A, Zekry A, Cornberg M, Müllhaupt B, Estes C. The present and future disease burden of hepatitis C virus (HCV) infection with today’s treatment paradigm. J Viral Hepat. 2014;21(Suppl 1):34-59.
  • Tanaka E, Ohue C, Aoyagi K, Yamaguchi K, Yagi S, Kiyosawa K, Alter HJ. Evaluation of a new enzyme immunoassay for hepatitis C virus (HCV) core antigen with clinical sensitivity approximating that of genomic amplification of HCV RNA. Hepatology. 2000;32:388-393.
  • Aoyagi K, Ohue C, Iida K, Kimura T, Tanaka E, Kiyosawa K, Yagi S. Development of a simple and highly sensitive enzyme immunoassay for hepatitis C virus core antigen. J Clin Microbiol. 1999;37:1802- 1808.
  • Seme K, Poljak M, Babic DZ, Mocilnik T, Vince A. The role of core antigen detection in management of hepatitis C: a critical review. J Clin Virol. 2005;32:92-101.
  • Pol S, Lagaye S. The remarkable history of the hepatitis C virus. Microbes Infect. 2019;21:263-270.
  • Morgan RL, Baack B, Smith BD, Yartel A, Pitasi M, Falck-Ytter Y. Eradication of hepatitis C virus infection and the development of hepatocellular carcinoma: a meta-analysis of observational studies. Ann Intern Med. 2013;158:329-337.
  • WHO Guidelines on Hepatitis B and C Testing (2017) (Access date: 05.10.2021). http://apps.who.int/iris/bitstre am/10665/254621/1/9789241549981-eng.pdf?ua=1
  • European Association for Study of Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2014;60:392-420.
  • Sağlık Uygulama Tebliği Güncellemesi (2019). (Access date: 05.10.2021). https://www.teb.org.tr/news
  • Ishak K, Baptista A, Bianchi L, Callea F, De Groote J, Gudat F, Denk H, Desmet V, Korb G, MacSween RN, et al. Histological grading and staging of chronic hepatitis. J Hepatol. 1995;22:696-699.
  • Morota K, Fujinami R, Kinukawa H, Machida T, Ohno K, Saegusa H, Takeda K. A new sensitive and automated chemiluminescent microparticle immunoassay for quantitative determination of hepatitis C virus core antigen. J Virol Methods. 2009;157:8-14.
  • Mederacke I, Wedemeyer H, Ciesek S, Steinmann E, Raupach R, Wursthorn K, Manns MP, Tillmann HL. Performance and clinical utility of a novel fully automated quantitative HCV-core antigen assay. J Clin Virol. 2009;46:210-215.
  • Ross RS, Viazov S, Salloum S, Hilgard P, Gerken G, Roggendorf M. Analytical performance characteristics and clinical utility of a novel assay for total hepatitis C virus core antigen quantification. J Clin Microbiol. 2010;48:1161-1168.
  • Medici MC, Furlini G, Rodella A, Fuertes A, Monachetti A, Calderaro A, Galli S, Terlenghi L, Olivares M, Bagnarelli P, Costantini A, De Conto F, Sainz M, Galli C, Manca N, Landini MP, Dettori G, Chezzi C. Hepatitis C virus core antigen: analytical performances, correlation with viremia and potential applications of a quantitative, automated immunoassay. J Clin Virol. 2011;51:264-269.
  • Ottiger C, Gygli N, Huber AR. Detection limit of architect hepatitis C core antigen assay in correlation with HCV RNA, and renewed confirmation algorithm for reactive anti-HCV samples. J Clin Virol. 2013;58:535-540.
  • Bouvier-Alias M, Patel K, Dahari H, Beaucourt S, Larderie P, Blatt L, Hezode C, Picchio G, Dhumeaux D, Neumann AU, McHutchison JG, Pawlotsky JM. Clinical utility of total HCV core antigen quantification: a new indirect marker of HCV replication. Hepatology. 2002;36:211-218.
  • Heidrich B, Pischke S, Helfritz FA, Mederacke I, Kirschner J, Schneider J, Raupach R, Jäckel E, Barg-Hock H, Lehner F, Klempnauer J, von Hahn T, Cornberg M, Manns MP, Ciesek S, Wedemeyer H. Hepatitis C virus core antigen testing in liver and kidney transplant recipients. J Viral Hepat. 2014;21:769-779.
  • Chevaliez S, Soulier A, Poiteau L, Bouvier-Alias M, Pawlotsky JM. Clinical utility of hepatitis C virus core antigen quantification in patients with chronic hepatitis C. J Clin Virol. 2014;61:145-148.
  • Freiman JM, Tran TM, Schumacher SG, White LF, Ongarello S, Cohn J, Easterbrook PJ, Linas BP, Denkinger CM. Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection: A Systematic Review and Meta-analysis. Ann Intern Med. 2016;165:345-355.
  • Kesli R, Polat H, Terzi Y, Kurtoglu MG, Uyar Y. Comparison of a newly developed automated and quantitative hepatitis C virus (HCV) core antigen test with the HCV-RNA assay for clinical usefulness in confirming anti-HCV results. J Clin Microbiol. 2011;49:4089-4093.
  • ErgünayK,SenerB,AlpA,KarakayaJ,HasçelikG.Utilityofacommercial quantitative hepatitis C virus core antigen assay in a diagnostic laboratory setting. Diagn Microbiol Infect Dis. 2011;70:486-491.
  • EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol. 2017;66:153-194.
  • Muerhoff AS, Jiang L, Shah DO, Gutierrez RA, Patel J, Garolis C, Kyrk CR, Leckie G, Frank A, Stewart JL, Dawson GJ. Detection of HCV core antigen in human serum and plasma with an automated chemiluminescent immunoassay. Transfusion. 2002;42:349-356.
  • Shah DO, Chang CD, Jiang LX, Cheng KY, Muerhoff AS, Gutierrez RA, Leary TP, Desai SM, Batac-Herman IV, Salbilla VA, Haller AS, Stewart JL, Dawson GJ. Combination HCV core antigen and antibody assay on a fully automated chemiluminescence analyzer. Transfusion. 2003;43:1067-1074.
  • Mederacke I, Wedemeyer H, Ciesek S, Steinmann E, Raupach R, WursthornK,MannsMP,TillmannHL.Performanceandclinicalutility of a novel fully automated quantitative HCV-core antigen assay. J Clin Virol. 2009;46:210-215.
  • Hassanin TM, Abdelraheem EM, Abdelhameed S, Abdelrazik M, Fouad YM. Detection of hepatitis C virus core antigen as an alternative method for diagnosis of hepatitis C virus infection in blood donors negative for hepatitis C virus antibody. Eur J Gastroenterol Hepatol. 2020;32:1348-1351.
  • Chevaliez S, Feld J, Cheng K, Wedemeyer H, Sarrazin C, Maasoumy B, Herman C, Hackett J, Cohen D, Dawson G, Pawlotsky JM, Cloherty G. Clinical utility of HCV core antigen detection and quantification in the diagnosis and management of patients with chronic hepatitis C receiving an all-oral, interferon-free regimen. Antivir Ther. 2018;23:211- 217.
  • Heidrich B, Pischke S, Helfritz FA, Mederacke I, Kirschner J, Schneider J, Raupach R, Jäckel E, Barg-Hock H, Lehner F, Klempnauer J, von Hahn T, Cornberg M, Manns MP, Ciesek S, Wedemeyer H. Hepatitis C virus core antigen testing in liver and kidney transplant recipients. J Viral Hepat. 2014;21:769-779.
  • Freiman JM, Tran TM, Schumacher SG, White LF, Ongarello S, Cohn J, Easterbrook PJ, Linas BP, Denkinger CM. Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection: A Systematic Review and Meta-analysis. Ann Intern Med. 2016;165:345-355.
  • Şahin A, Bayram H, Namıduru M, Karaoğlan İ, Harman R, Bakır G, Daldal A, Balkan Y. Evaluation of 53 Cases with Chronic Hepatitis C Receiving Telaprevir-Based Triple Therapy. Klimik Dergisi. 2017;30:126- 130. Tillmann HL. Hepatitis C virus core antigen testing: role in diagnosis, disease monitoring and treatment. World J Gastroenterol. 2014;20:6701- 6706. Barut HŞ, Günal Ö. Global and National Epidemiology of Hepatitis C. Klimik Dergisi. 2009;22:38-43.
  • Akkaya O, Kiyici M, Yilmaz Y, Ulukaya E, Yerci O. Clinical significance of activity of ALT enzyme in patients with hepatitis C virus. World J Gastroenterol. 2007;13:5481-5485.
  • Grottenthaler JM, Werner CR, Steurer M, Spengler U, Berg T, Engelmann C, Wedemeyer H, von Hahn T, Stremmel W, Pathil A, Seybold U, Schott E, Blessin U, Sarrazin C, Welker MW, Harrer E, Scholten S, Hinterleitner C, Lauer UM, Malek NP, Berg CP. Successful direct acting antiviral (DAA) treatment of HCV/HIV-coinfected patients before and after liver transplantation. PLoS One. 2018;13:e0197544. Miedouge M, Saune K, Kamar N, Rieu M, Rostaing L, Izopet J. Analytical evaluation of HCV core antigen and interest for HCV screening in haemodialysis patients. J Clin Virol. 2010;48:18-21.
  • Moini M, Ziyaeyan M, Aghaei S, Sagheb MM, Taghavi SA, Moeini M, Jamalidoust M, Hamidpour L. Hepatitis C virus (HCV) Infection Rate among Seronegative Hemodialysis Patients Screened by Two Methods; HCV Core Antigen and Polymerase Chain Reaction. Hepat Mon. 2013;13:e9147.
APA toygar deniz m, CETIN AKHAN S, SAYAN M, Sonmez Tamer G, Azak E (2022). Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. , 32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
Chicago toygar deniz müge,CETIN AKHAN SILA,SAYAN MURAT,Sonmez Tamer Gulden,Azak Emel Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. (2022): 32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
MLA toygar deniz müge,CETIN AKHAN SILA,SAYAN MURAT,Sonmez Tamer Gulden,Azak Emel Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. , 2022, ss.32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
AMA toygar deniz m,CETIN AKHAN S,SAYAN M,Sonmez Tamer G,Azak E Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. . 2022; 32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
Vancouver toygar deniz m,CETIN AKHAN S,SAYAN M,Sonmez Tamer G,Azak E Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. . 2022; 32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
IEEE toygar deniz m,CETIN AKHAN S,SAYAN M,Sonmez Tamer G,Azak E "Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment." , ss.32 - 38, 2022. 10.4274/vhd.galenos.2022.2021-3-2
ISNAD toygar deniz, müge vd. "Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment". (2022), 32-38. https://doi.org/10.4274/vhd.galenos.2022.2021-3-2
APA toygar deniz m, CETIN AKHAN S, SAYAN M, Sonmez Tamer G, Azak E (2022). Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. Viral Hepatitis Journal, 28(1), 32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
Chicago toygar deniz müge,CETIN AKHAN SILA,SAYAN MURAT,Sonmez Tamer Gulden,Azak Emel Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. Viral Hepatitis Journal 28, no.1 (2022): 32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
MLA toygar deniz müge,CETIN AKHAN SILA,SAYAN MURAT,Sonmez Tamer Gulden,Azak Emel Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. Viral Hepatitis Journal, vol.28, no.1, 2022, ss.32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
AMA toygar deniz m,CETIN AKHAN S,SAYAN M,Sonmez Tamer G,Azak E Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. Viral Hepatitis Journal. 2022; 28(1): 32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
Vancouver toygar deniz m,CETIN AKHAN S,SAYAN M,Sonmez Tamer G,Azak E Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment. Viral Hepatitis Journal. 2022; 28(1): 32 - 38. 10.4274/vhd.galenos.2022.2021-3-2
IEEE toygar deniz m,CETIN AKHAN S,SAYAN M,Sonmez Tamer G,Azak E "Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment." Viral Hepatitis Journal, 28, ss.32 - 38, 2022. 10.4274/vhd.galenos.2022.2021-3-2
ISNAD toygar deniz, müge vd. "Evaluation of HCV-Core Antigen in Diagnosis of Chronic Hepatitis C Patients under Direct-Acting Antiviral Treatment". Viral Hepatitis Journal 28/1 (2022), 32-38. https://doi.org/10.4274/vhd.galenos.2022.2021-3-2