Improvement of health-related quality of life and psychological well-being after HCV eradication with direct-acting antiviral agents. Real life setting data of an Italian cohort valued by Hepatitis Quality of Life Questionnaire (HQLQv2)
- Gaetano Bertino Hepatology Unit, Policlinic "G. Rodolico", Department of Clinical and Experimental Medicine, University of Catania, Italy.
- Rosalia Ragusa Health Technology Assessment Committee, University Hospital "G. Rodolico", Catania, Italy.
- Liberato Simone Corsaro Biologist, Master of Science in Clinical Trial Governance, University of Catania, Italy.
- Evelise Frazzetto Hepatology Unit, Policlinic "G. Rodolico", Department of Clinical and Experimental Medicine, University of Catania, Italy.
- Vincenzo Messina Infectious Disease Unit, Azienda Ospedaliera “S. Anna e S. Sebastiano” of Caserta, Italy.
-
Lucio Inguscio
|
lucio.inguscio@uniroma1.it
Department of Dynamic and Clinical Psychology, University of Rome La Sapienza, Rome, Italy.
- Carlo Lai Department of Dynamic and Clinical Psychology, University of Rome La Sapienza, Rome, Italy.
- Marilena Maglia Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), Department of Clinical and Experimental Medicine, University of Catania, Italy.
- Andrea Nunnari School of Medicine, Course of Rehabilitation Science for Health Professions, Università di Catania, Italy.
- Pasquale Caponnetto 6Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), Department of Clinical and Experimental Medicine, University of Catania, Italy.
Abstract
HCV (Hepatitis C Virus) decreases Health-Related Quality of Life with detriments to physical, mental and social health domains. Interferon and Ribavirin treatment is associated with depression and anxiety that further impairs HRQoL (Health- Related Quality of Life). IFN-free (interferon-free) regimes (Direct Acting Antivirals, DAAs) are safe and highly effective drugs, with improvement also of HRQoL and related Psychological Well-Being. Our aim is to describe how the latest generation IFN-free treatment can change quality of life and related Psychological Well-Being in Italian Chronic Hepatitis C/Cirrhosis affected patients. SF-36v2 (Short Form Health Survey is a 36-item, patient-reported survey of patient health) – HQLQv2 (Hepatitis Quality of Life Questionnaire) was administered at two time points: baseline (n=72) and 12 weeks after the end of therapy [n=72, SVR=72 - Sustained Virologic Response (SVR)]. Patients with chronic HCV undergoing DAAs treatment from two Italian centers were enrolled. The overall average of the answers is configured for most of the domains that make up the questionnaire, with scores above 50. The quality of life of this sample is very close to the average of the US population, with a minimum average score of 45.9 for the Role Emotional scale and an average maximum score of 56.4 for the Vitality scale. Both are significant results from statistical analysis. It seems that DAAs treatment therapy does not affect but improves the general quality and psychological state of adult patients with Chronic HCV infection.
Downloads
Download data is not yet available.
References
AASLD (2017). Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology, 62:932–954.
Bansal S, Singal AK, McGuire BM and Anand BS. (2015). Impact of all oral anti-hepatitis C virus therapy: A meta-analysis. World J Hepatol, 7(5):806-13.
Bayliss MS, Gandek B, Bungay KM, Sugano D, Hsu MA and Ware JE Jr. (1998). A questionnaire to assess the generic and disease-specific health outcomes of patients with chronic hepatitis C. Qual Life Res, 7(1):39-55.
Belfer I. (2017). Pain in women. Agri, 29(2):51-54.
Bernstein D, Kleinman L, Barker CM, Revicki DA and Green J. (2002). Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients. Hepatology, 35: 704-708
Bertino G, Ardiri A, Proiti M, Rigano G, Frazzetto E, et al. (2016). Chronic hepatitis C: This and the new era of treatment. World J Hepatol, 8(2):92-106.
Bertino G, Malaguarnera G, Frazzetto E, Sciuto A, et al. (2018). Responsibility of hepatitis C virus in the development of hepatocellular carcinoma: From molecular alterations to possible solutions. World J Hepatol, 10(6):448-45.
Bethea ED, Chen Q, Hur C, Chung RT and Chhatwal J. (2018). Should we treat acute hepatitis C? A decision and cost-effectiveness analysis. Hepatology, 67(3):837-846.
Bullinger M, Alonso J, Apolone G, Leplège A, Sullivan M, et al. (1998). Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International Quality of Life Assessment. J ClinEpidemiol, 51(11):913-23.
Cabibbo G, Celsa C, Calvaruso V, Petta S, Cacciola I, et al. (2019). Direct acting antivirals after successful treatment of early hepatocellular carcinoma improve survival in HCV-cirrhotic patients. J Hepatol, S0168-8278(19)30221-1.
Cabibbo G, Petta S, Calvaruso V, Cacciola I, Cannavò MR, et al. (2017). Is early recurrence of hepatocellular carcinoma in HCV cirrhotic patients affected by treatment with direct-acting antivirals? A prospective multicenter study. Aliment Pharmacol Ther, 46(7):688-695.
Calvaruso V, Cabibbo G, Cacciola I, Petta S, Madonia S, et al. (2018). Incidence of Hepatocellular Carcinoma in Patients With HCV-Associated Cirrhosis Treated With Direct-Acting Antiviral Agents. Gastroenterology, 155(2):411-421.e4.
Calvaruso V, Cacciola I, Licata A, Madonia S, et al. (2019). Is Transient Elastography Needed for Noninvasive Assessment of High-Risk Varices? The REAL Experience. Am J Gastroenterol, 114(8):1275-1282.
Cartabellotta F, Di Marco V, Raimondo G, Craxì A, Bertino G, et al. (2016). The HCV Sicily Network: a web-based model for the management of HCV chronic liver diseases. European Review For Medical And Pharmacological Science, 20 (1 Suppl.): 11-16.
Corsaro LS and Ragusa R. (2018). Oral Direct Acting Agent Clinical Trials for Hepatitis C Virus Infection: An Updated Meta-Analysis. EC Gastroenterology and Digestive System, 5(6): 447-455.
Di Matteo M, Lepper HS and Croghan TW. (2000). Depression is a risk factor for noncompliance with medical treatment: Meta-analysis of the effects of anxiety and depression on patient adherence. Archives of Internal Medicine, 160(14):2101–7
Ebrahim S. (1995). Clinical and public health perspectives and applications of health-related quality of life measurement. Social Science and Medicine, 41:1383–94.
European Association for the Study of the Liver. (2018). EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol, 69(2):461-511.
Gold MR, Patrick DL, Torrance GW, Fryback D, Hadorn DC, et al. (1996). Identifying and valuing outcomes. In: Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-effectiveness in health and medicine. Oxford: Oxford University Press.
Horsmans Y. (2006). Interferon-induced depression in chronic hepatitis C. J Antimicrob Chemother, 58:711-3.
Katon W, Lin EHB and Kroenke K. (2007). The association of depression and anxiety with medical symptom burden in patients with chronic medical illness. General Hospital Psychiatry, 29(2):147–55
Keefe B. (2007). Interferon-induced depression in hepatitis C: an update. Curr Psychiatry Rep, 9:255-61.
Kuna L, Jakab J, Smolic R, Wu GY and Smolic M. (2019). HCV Extrahepatic Manifestations. J Clin Transl Hepatol, 7(2):172-182.
Mandorfer M, Payer BA, Scheiner B, et al. (2014). Health-related quality of life and severity of fatigue in HIV/HCV co-infected patients before, during, and after antiviral therapy with pegylated interferon plus ribavirin. Liver Int, 34(1):69-77.
Maruish ME (Ed.). (2011). User’s Manual for the SF-36v2 Health Survey (3rd ed.), QualityMetric Incorporated, Lincoln, RI (2011)
McHutchison JG, Manns M, Patel K, Poynard T, et al. (2002). Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology, 123: 1061-1069
Peasgood T, Brazier J, Mukuria C and Rowen D. (2014). A conceptual comparison of well-being measures used in the UK. Policy Research Unit in Economic Evaluation of Health and Care Interventions. Universities of Sheffield & York. EEPRU Research Report 026. Policy paper/document 01/09/2014.
Pieretti S, Di Giannuario A, Di Giovannandrea R, Marzoli F, Piccaro G, et al. (2016). Gender differences in pain and its relief. Ann Ist Super Sanita, 52(2):184-9
Polo ML and Laufer N. (2017). Extrahepatic manifestations of HCV: the role of direct acting antivirals. Expert Rev Anti Infect Ther, 15(8):737-746.
Quelhas R and Lopes A. (2009). Psychiatric problems in patients infected with hepatitis C before and during antiviral treatment with Interferon-alpha: a review. J Psychiatr Pract, 15:262-81.
Ragusa R, Bertino G, Bruno A, Frazzetto E, et al. (2018). Evaluation of health status in patients with hepatitis c treated with and without Interferon. Health Qual Life Outcomes, 16(1):17.
Ragusa R, Corsaro LS, Frazzetto E, Bertino E, et al. (2020). Hepatitis C Virus Infection in Children and Pregnant Women: An Updated Review of the Literature on Screening and Treatments. AJP Rep, 10(1): e121-e127.
Scheiner B, Schwabl P, Steiner S, et al. (2016). Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease: A retrospective study. Medicine (Baltimore), 95(27): e4061
Ware JE Jr, Kosinski M, Bayliss MS, McHorney CA, Rogers WH and Raczek A. (1995). Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care, 33 (Suppl.):AS264-79.
Wei L and Huang YH. (2019). Long-term outcomes in patients with chronic hepatitis C inthe current era of direct-acting antiviral agents. Expert Rev Anti Infect Ther, 17(5):311-325.
World Health Organization. (2014). Constitution of the World Health Organization. 48th ed. Basic documents of the World Health Organization. Geneva.
Younossi Z and Henry L. (2015). Systematic review: patient-reported outcomes in chronic hepatitis C–the impact of liver disease and new treatment regimens. Aliment PharmacolTher, 41:497–520.
Bansal S, Singal AK, McGuire BM and Anand BS. (2015). Impact of all oral anti-hepatitis C virus therapy: A meta-analysis. World J Hepatol, 7(5):806-13.
Bayliss MS, Gandek B, Bungay KM, Sugano D, Hsu MA and Ware JE Jr. (1998). A questionnaire to assess the generic and disease-specific health outcomes of patients with chronic hepatitis C. Qual Life Res, 7(1):39-55.
Belfer I. (2017). Pain in women. Agri, 29(2):51-54.
Bernstein D, Kleinman L, Barker CM, Revicki DA and Green J. (2002). Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients. Hepatology, 35: 704-708
Bertino G, Ardiri A, Proiti M, Rigano G, Frazzetto E, et al. (2016). Chronic hepatitis C: This and the new era of treatment. World J Hepatol, 8(2):92-106.
Bertino G, Malaguarnera G, Frazzetto E, Sciuto A, et al. (2018). Responsibility of hepatitis C virus in the development of hepatocellular carcinoma: From molecular alterations to possible solutions. World J Hepatol, 10(6):448-45.
Bethea ED, Chen Q, Hur C, Chung RT and Chhatwal J. (2018). Should we treat acute hepatitis C? A decision and cost-effectiveness analysis. Hepatology, 67(3):837-846.
Bullinger M, Alonso J, Apolone G, Leplège A, Sullivan M, et al. (1998). Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International Quality of Life Assessment. J ClinEpidemiol, 51(11):913-23.
Cabibbo G, Celsa C, Calvaruso V, Petta S, Cacciola I, et al. (2019). Direct acting antivirals after successful treatment of early hepatocellular carcinoma improve survival in HCV-cirrhotic patients. J Hepatol, S0168-8278(19)30221-1.
Cabibbo G, Petta S, Calvaruso V, Cacciola I, Cannavò MR, et al. (2017). Is early recurrence of hepatocellular carcinoma in HCV cirrhotic patients affected by treatment with direct-acting antivirals? A prospective multicenter study. Aliment Pharmacol Ther, 46(7):688-695.
Calvaruso V, Cabibbo G, Cacciola I, Petta S, Madonia S, et al. (2018). Incidence of Hepatocellular Carcinoma in Patients With HCV-Associated Cirrhosis Treated With Direct-Acting Antiviral Agents. Gastroenterology, 155(2):411-421.e4.
Calvaruso V, Cacciola I, Licata A, Madonia S, et al. (2019). Is Transient Elastography Needed for Noninvasive Assessment of High-Risk Varices? The REAL Experience. Am J Gastroenterol, 114(8):1275-1282.
Cartabellotta F, Di Marco V, Raimondo G, Craxì A, Bertino G, et al. (2016). The HCV Sicily Network: a web-based model for the management of HCV chronic liver diseases. European Review For Medical And Pharmacological Science, 20 (1 Suppl.): 11-16.
Corsaro LS and Ragusa R. (2018). Oral Direct Acting Agent Clinical Trials for Hepatitis C Virus Infection: An Updated Meta-Analysis. EC Gastroenterology and Digestive System, 5(6): 447-455.
Di Matteo M, Lepper HS and Croghan TW. (2000). Depression is a risk factor for noncompliance with medical treatment: Meta-analysis of the effects of anxiety and depression on patient adherence. Archives of Internal Medicine, 160(14):2101–7
Ebrahim S. (1995). Clinical and public health perspectives and applications of health-related quality of life measurement. Social Science and Medicine, 41:1383–94.
European Association for the Study of the Liver. (2018). EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol, 69(2):461-511.
Gold MR, Patrick DL, Torrance GW, Fryback D, Hadorn DC, et al. (1996). Identifying and valuing outcomes. In: Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-effectiveness in health and medicine. Oxford: Oxford University Press.
Horsmans Y. (2006). Interferon-induced depression in chronic hepatitis C. J Antimicrob Chemother, 58:711-3.
Katon W, Lin EHB and Kroenke K. (2007). The association of depression and anxiety with medical symptom burden in patients with chronic medical illness. General Hospital Psychiatry, 29(2):147–55
Keefe B. (2007). Interferon-induced depression in hepatitis C: an update. Curr Psychiatry Rep, 9:255-61.
Kuna L, Jakab J, Smolic R, Wu GY and Smolic M. (2019). HCV Extrahepatic Manifestations. J Clin Transl Hepatol, 7(2):172-182.
Mandorfer M, Payer BA, Scheiner B, et al. (2014). Health-related quality of life and severity of fatigue in HIV/HCV co-infected patients before, during, and after antiviral therapy with pegylated interferon plus ribavirin. Liver Int, 34(1):69-77.
Maruish ME (Ed.). (2011). User’s Manual for the SF-36v2 Health Survey (3rd ed.), QualityMetric Incorporated, Lincoln, RI (2011)
McHutchison JG, Manns M, Patel K, Poynard T, et al. (2002). Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology, 123: 1061-1069
Peasgood T, Brazier J, Mukuria C and Rowen D. (2014). A conceptual comparison of well-being measures used in the UK. Policy Research Unit in Economic Evaluation of Health and Care Interventions. Universities of Sheffield & York. EEPRU Research Report 026. Policy paper/document 01/09/2014.
Pieretti S, Di Giannuario A, Di Giovannandrea R, Marzoli F, Piccaro G, et al. (2016). Gender differences in pain and its relief. Ann Ist Super Sanita, 52(2):184-9
Polo ML and Laufer N. (2017). Extrahepatic manifestations of HCV: the role of direct acting antivirals. Expert Rev Anti Infect Ther, 15(8):737-746.
Quelhas R and Lopes A. (2009). Psychiatric problems in patients infected with hepatitis C before and during antiviral treatment with Interferon-alpha: a review. J Psychiatr Pract, 15:262-81.
Ragusa R, Bertino G, Bruno A, Frazzetto E, et al. (2018). Evaluation of health status in patients with hepatitis c treated with and without Interferon. Health Qual Life Outcomes, 16(1):17.
Ragusa R, Corsaro LS, Frazzetto E, Bertino E, et al. (2020). Hepatitis C Virus Infection in Children and Pregnant Women: An Updated Review of the Literature on Screening and Treatments. AJP Rep, 10(1): e121-e127.
Scheiner B, Schwabl P, Steiner S, et al. (2016). Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease: A retrospective study. Medicine (Baltimore), 95(27): e4061
Ware JE Jr, Kosinski M, Bayliss MS, McHorney CA, Rogers WH and Raczek A. (1995). Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care, 33 (Suppl.):AS264-79.
Wei L and Huang YH. (2019). Long-term outcomes in patients with chronic hepatitis C inthe current era of direct-acting antiviral agents. Expert Rev Anti Infect Ther, 17(5):311-325.
World Health Organization. (2014). Constitution of the World Health Organization. 48th ed. Basic documents of the World Health Organization. Geneva.
Younossi Z and Henry L. (2015). Systematic review: patient-reported outcomes in chronic hepatitis C–the impact of liver disease and new treatment regimens. Aliment PharmacolTher, 41:497–520.
Published
2021-01-20
Keywords:
Health care; health psychology; QoL; phycological wellbeing; illness perception; chronic illness
Statistics
- Abstract views: 262
- PDF: 87
How to Cite
Bertino, G., Ragusa, R., Corsaro, L. S., Frazzetto, E., Messina, V., Inguscio, L., Lai, C., Maglia, M., Nunnari, A., & Caponnetto, P. (2021). Improvement of health-related quality of life and psychological well-being after HCV eradication with direct-acting antiviral agents. Real life setting data of an Italian cohort valued by Hepatitis Quality of Life Questionnaire (HQLQv2). Health Psychology Research, 8(3). https://doi.org/10.4081/hpr.2020.9450
Copyright (c) 2020 the Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
