Euroasian Journal of Hepato-Gastroenterology

Register      Login

VOLUME 7 , ISSUE 1 ( January-June, 2017 ) > List of Articles

ORIGINAL ARTICLE

Prediction of Sustained Virological Response to Peginterferon-based Therapy for Chronic Hepatitis C: Regression Analysis of a Cohort from Rio Grande do Sul, Brazil

Rafael V Picon, Lúcia Fendt, Karine Amaral, Paulo D Picon

Citation Information : Picon RV, Fendt L, Amaral K, D Picon P. Prediction of Sustained Virological Response to Peginterferon-based Therapy for Chronic Hepatitis C: Regression Analysis of a Cohort from Rio Grande do Sul, Brazil. Euroasian J Hepatogastroenterol 2017; 7 (1):27-33.

DOI: 10.5005/jp-journals-10018-1207

License: CC BY 3.0

Published Online: 01-06-2017

Copyright Statement:  Copyright © 2017; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Aim

Peginterferon plus ribavirin (peg-IFN/RBV) is still the standard of care for treatment of hepatitis C virus (HCV) in many countries. Given the high toxicity of this regimen, our study aimed to develop a prediction tool that can identify which patients are unlikely to benefit from peg-IFN/RBV and could thus postpone treatment in favor of new-generation direct-acting antivirals.

Materials and methods

Binary regression was performed using demographic, clinical, and laboratory covariates and sustained virological response (SVR) outcomes from a prospective cohort of individuals referred for therapy from 2003 to 2008 in a public HCV treatment center in Rio Grande do Sul, Brazil.

Results

Of the 743 participants analyzed, 489 completed 48 weeks of treatment (65.8%). A total of 202 of those who completed peg-IFN/RBV therapy achieved SVR (27.2% responders), 196 did not (26.4%), and 91 had missing viral load (VL) at week 72 (12.2% loss to follow-up). The remainder discontinued therapy (n = 254 [34.2%]), 78 (30.7%) doing so due to adverse effects. Baseline covariates included in the regression model were sex, age, human immunodeficiency virus, infection status, aspartate transaminase, alanine transaminase, hemoglobin, platelets, serum creatinine, prothrombin time, pretreatment VL, cirrhosis on liver biopsy, and treatment naivety. A predicted SVR of 17.9% had 90.0% sensitivity for detecting true nonresponders. The negative likelihood ratio at a predicted SVR of 17.9% was 0.16, and the negative predictive value was 92.6%.

Conclusion

Easily obtainable variables can identify patients that will likely not benefit from peg-IFN-based therapy. This prediction model might be useful to clinicians.

Clinical significance

To our knowledge, this is the only prediction tool that can reliably help clinicians to postpone peg-IFN/RBV therapy for HCV genotype 1 patients.

How to cite this article

Picon RV, Fendt L, Amaral K, Picon PD. Prediction of Sustained Virological Response to Peginterferon-based Therapy for Chronic Hepatitis C: Regression Analysis of a Cohort from Rio Grande do Sul, Brazil. Euroasian J Hepato-Gastroenterol 2017;7(1):27-33.


  1. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect 2011 Feb;17(2):107-115.
  2. Relatório técnico do estudo de prevalência de base populacional das infecções pelos vírus das hepatites A, B e C nas capitais do Brasil: dados preliminares. Brazil: Ministério da Saúde; 2010. [cited 2010]. Available from: http://www.aids.gov.br/sites/default/files/anexos/publicacao/2010/50071/estudo_prevalencia_hepatites_pdf_26830.pdf.
  3. The changing epidemiology of hepatitis C virus infection in Europe. J Hepatol 2008 Jan;48(1):148-162.
  4. Can eicosapentaenoic acid maintain the original ribavirin dose or affect the response during the treatment course of chronic hepatitis C virus (HCV) patients? Turk J Gastroenterol 2016 Jan;27:55-61.
  5. Ministério da Saúde. Suplemento 1. Protocolo clínico e diretrizes terapeuticas para hepatite viral C ecoinfecções. Manejo do paciente infectado cronicamente pelo genótipo 1 do HCV e fibrose avançada. Brazil: Ministério da Saúde; 2013. [cited 2013]. Available from: http://www.aids.gov.br/sites/default/files/anexos/publicacao/2011/49960/web_suplemento_protocolo_hep_c_2013_07_01_pdf_20444.pdf.
  6. S. Food and Drug Administration. Novel New Drugs 2013 summary. U.S. Food and Drug Administration; 2013. [cited Jan 2014]. Available from: http://www.fda.gov/downloads/drugs/developmentapprovalprocess/druginnovation/ucm381803.pdf.
  7. Protocolo Clínico e Diretrizes Terapêuticas para Hepatite C e Coinfecções. 2015. [cited May 2016]. Available from: http://conitec.gov.br/images/Consultas/Relatorios/2015/Relatorio_PCDT-HepatiteC-CP.pdf.
  8. Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: updated criteria and genotype assignment web resource. Hepatology 2014 Jan;59(1):318-327.
  9. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study oftreatment duration and ribavirin dose. Ann Intern Med 2004 Mar;140(5):346-355.
  10. Meta-analysis: the outcome of anti-viral therapy in HCV genotype 2 and genotype 3 infected patients with chronic hepatitis. Aliment Pharmacol Ther 2008 Aug;28(4): 397-404.
  11. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterol 2010 Jul;139(1):120-129.
  12. Ministério da Saúde. Protocolo clínico ediretrizes terapêuticas para Hepatite Viral C e Coinfecções. Brasil: Ministério da Saúde; 2011. Available from: http://bvsms.saude.gov.br/bvs/publicacoes/protocolos_diretrizes_ hepatite_viral_c_coinfeccoes.pdf.
  13. An algorithm for the grading of activity in chronic hepatitis C. the METAVIR Cooperative Study Group. Hepatology 1996 Aug;24(2):289-293.
  14. Safety, tolerability and efficacy of peginterferon alpha-2a and ribavirin in chronic hepatitis C in clinical practice: the German Open Safety Trial. J Viral Hepat 2007 Nov;14(11): 788-796.
  15. Safety and efficacy of combination therapy with peginterferon alfa-2a (40kD) and ribavirin in the outpatient setting: prospective analysis of 197 patients with chronic hepatitis C viral infection. Gastroenterol Clin Biol 2007 Jun;31(6-7): 566-572.
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.