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Health-Related Quality of Life in Chronic HCV-Infected Patients Switching to Pegylated-Interferon-Free Regimens (ANRS CO20 CUPIC Cohort Study and SIRIUS Trial)

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Abstract

Objective

We aimed to compare health-related quality of life (HRQL) during and after hepatitis C virus (HCV) treatment in patients receiving pegylated-interferon (PEG-IFN)-containing therapy (including boceprevir or telaprevir—ANRS CO20 CUPIC cohort) who subsequently switched to PEG-IFN-free regimens (sofosbuvir + ledipasvir with or without ribavirin [RBV]—SIRIUS trial).

Methods

Two analyses were performed. The first compared physical (PCS) and mental (MCS) HRQL (MOS SF-12) scores during treatment between CUPIC and SIRIUS. The second compared PCS and MCS scores after treatment end between CUPIC and SIRIUS. The analyses used linear regression mixed models adjusted for pre-treatment HRQL scores, gender, and age at each visit.

Results

Among patients enrolled successively in both studies, 43 (corresponding to 212 HRQL assessments) and 43 (82 HRQL assessments) were eligible for the ‘during’ and ‘post’ treatment analyses, respectively. In the ‘during-treatment’ analysis, we found significantly higher PCS and MCS values during PEG-IFN-free treatment than for PEG-IFN-containing treatment. In the ‘post-treatment’ analysis, results showed significantly higher MCS values after PEG-IFN-free treatment than after PEG-IFN-containing treatment. No significant difference was found for PCS in the post-treatment analysis.

Conclusions

These results highlight an improvement in both physical and mental HRQL during HCV treatment, but no major improvement in physical HRQL after treatment end, when comparing PEG-IFN-free regimens with PEG-IFN-containing regimens. This suggests that in the PEG-IFN-free regimens era, screening and comprehensive care of comorbidities and residual somatic symptoms during treatment, and especially after HCV clearance, are still needed to improve patient outcomes.

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Acknowledgements

We thank all the members of the CUPIC Study Group. We especially thank all the patients who agreed to participate in the two studies and who completed the self-administered questionnaires. We thank Bérengère Davin (PhD, Health Economist, ORS PACA, Marseille, France) for suggestions about data analyses and interpretation of the results. Finally, we thank Jude Sweeney (Milan, Italy) for the English revision and editing of our manuscript.

The CUPIC Study Group: Eric Poncin, MD, Service d’Hépatologie et Gastroentérologie, Centre Hospitalier, Dax, France. Danièle Botta-Friedland, MD, Service d’Hépatologie et Gastroentérologie, Hôpital de la Conception, Marseille, France. Thierry Fontanges, MD, Bourgoin-Jallieu, France. Jean-Pierre Arpurt, MD, Service d’Hépatologie et Gastroentérologie, Centre Hospitalier, Avignon, France. Yannicq Bacq, MD, Service d’Hépatologie et Gastroentérologie, Centre Hospitalier Universitaire Trousseau, Tours, France. Paul Calès, MD, Service d’Hépatologie et Gastroentérologie, Centre Hospitalier Universitaire, Angers, France. Patrick Delasalle, MD, Service d’Hépatologie et Gastroentérologie, Clinique du Palais, Grasse, France. Denis Ouzan, MD, Service d’Hépatologie et Gastroentérologie, Institut Arnaud Tzanck, Saint-Laurent du Var, France. Jean-Baptiste Nousbaum, MD, Service d’Hépatologie et Gastroentérologie, Centre Hospitalier Universitaire de la Cavale Blanche, Brest, France. Christine Sylvain, MD, Service d’Hépatologie et Gastroentérologie, Centre Hospitalier Universitaire, Poitiers, France. Didier Ribard, MD, Service d’Hépatologie et Gastroentérologie, Centre Hospitalier Universitaire Caremeau, Nîmes, France. Gilles Gatineau-Sailliant, MD, Centre Hospitalier, Meaux, France. Stéphanie de Montigny-Lenhardt, MD, Centre Hospitalier Edmond Garcin, Aubagne, France. Philippe Renard, MD, Centre Hospitalier Victor Dupouy, Argenteuil, France. Christophe Pilette, MD, Centre Hospitalier, Le Mans, France. Jacques Denis, MD, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France. Caroline Lascoux-Combe, MD, Service de Maladies Infectieuses, Hôpital Saint-Louis, AP-HP, Paris, France. Laurent Abel, MD, Unité de génétique, INSERM U550, Paris, France. Matthew Albert, PhD, Unité d’Immunologie, Institut Pasteur, Paris, France. Olivier Chazouillères, MD, Service d’Hépatologie, Hôpital Saint-Antoine, AP-HP, Paris, France. Jean Dubuisson, PhD, Unité de Virologie, INSERM U1019, CNRS UMR8204, Lille, France. Francesco Negro, MD, Hôpital Cantonal, Geneva, Switzerland. Georges-Philippe Pageaux, MD, Hôpital Saint Eloi, Montpellier, France. Valérie Paradis, MD, Service d’anatomopathologie, Hôpital Beaujon, AP-HP, Clichy, France. Bruno Spire, PhD, Santé Publique, Sciences Humaines et Sociales, INSERM, Marseille, France. Anne-Marie Taburet, MD, Pharmacologie, Hôpital Bicêtre, AP-HP, Le Kremlin-Bicêtre, France. Jean-Claude Trinchet, MD, Service d’Hépatologie, Hôpital Jean Verdier, AP-HP, Bondy, France. Yazdan Yazdanpanah, MD, Economie de la Santé, Hôpital Bichat, AP-HP, Paris, France. Cécilie Dufour, INSERM UMR-S 707, Université Pierre et Marie Curie Paris 6, Paris, France. Céline Fréhaut, INSERM UMR-S 707, Université Pierre et Marie Curie Paris 6, Paris, France. Marion Pirot, INSERM UMR-S 707, Université Pierre et Marie Curie Paris 6, Paris, France. Aurélie Lesel, INSERM UMR-S 707, Université Pierre et Marie Curie Paris 6, Paris, France. Nathalie Zahraa, INSERM UMR-S 707, Université Pierre et Marie Curie Paris 6, Paris, France. Frédéric Chau, INSERM UMR-S 707, Université Pierre et Marie Curie Paris 6, Paris, France.

Author information

Author notes

  1. M. P. Carrieri and C. Protopopescu have contributed equally to the work.

Authors and Affiliations

  1. Faculté de Médecine, Aix Marseille University, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l’Information Médicale, 27 Bd. Jean Moulin, 13385, Marseille Cedex 5, France

    Maria Patrizia Carrieri, Camelia Protopopescu, Antoine Vilotitch & Fabienne Marcellin

  2. ORS PACA (Observatoire Régional de la Santé Provence-Alpes-Côte d’Azur), Marseille, France

    Maria Patrizia Carrieri, Camelia Protopopescu, Antoine Vilotitch & Fabienne Marcellin

  3. Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, Annandale, VA, 22039, USA

    Zobair Younossi

  4. INSERM, U1016, Hôpital Cochin, 27 rue du Faubourg Saint Jacques, 75014, Paris, France

    Hélène Fontaine

  5. Hepatology Unit, Groupe hospitalier Cochin-Hôtel Dieu, AP-HP, Paris, France

    Hélène Fontaine

  6. Unit for Basic and Clinical Research on Viral Hepatitis, ANRS (France Recherche Nord and Sud Sida-HIV Hépatites FRENSH), Paris, France

    Ventzislava Petrov-Sanchez

  7. Sorbonne Universities, UPMC University of Paris 06, INSERM, Pierre Louis Institute of Epidemiology and Public Health (IPLESP UMRS 1136), Paris, France

    Fabrice Carrat

  8. Public Health Unit, Hôpital Saint-Antoine, AP-HP, Paris, France

    Fabrice Carrat

  9. Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, AP-HP, University of Paris-Est, INSERM, U955, Créteil, France

    Christophe Hézode

  10. Department of Hepato-Gastroenterology, Hôpital Saint Joseph, Marseille, France

    Marc Bourlière

Authors
  1. Maria Patrizia Carrieri
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  2. Camelia Protopopescu
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  3. Zobair Younossi
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  4. Antoine Vilotitch
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  5. Hélène Fontaine
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  6. Ventzislava Petrov-Sanchez
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  7. Fabienne Marcellin
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  8. Fabrice Carrat
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  9. Christophe Hézode
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  10. Marc Bourlière
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Consortia

The CUPIC Study Group

  • Eric Poncin
  • , Danièle Botta-Friedland
  • , Thierry Fontanges
  • , Jean-Pierre Arpurt
  • , Yannicq Bacq
  • , Paul Calès
  • , Patrick Delasalle
  • , Denis Ouzan
  • , Jean-Baptiste Nousbaum
  • , Christine Sylvain
  • , Didier Ribard
  • , Gilles Gatineau-Sailliant
  • , Stéphanie de Montigny-Lenhardt
  • , Philippe Renard
  • , Christophe Pilette
  • , Jacques Denis
  • , Caroline Lascoux-Combe
  • , Laurent Abel
  • , Matthew Albert
  • , Olivier Chazouillères
  • , Jean Dubuisson
  • , Francesco Negro
  • , Georges-Philippe Pageaux
  • , Valérie Paradis
  • , Bruno Spire
  • , Anne-Marie Taburet
  • , Jean-Claude Trinchet
  • , Yazdan Yazdanpanah
  • , Cécilie Dufour
  • , Céline Fréhaut
  • , Marion Pirot
  • , Aurélie Lesel
  • , Nathalie Zahraa
  •  & Frédéric Chau

Contributions

Maria Patrizia Carrieri and Camelia Protopopescu designed the study and discussed the analysis plan. Camelia Protopopescu and Antoine Vilotitch conducted the statistical analysis. Maria Patrizia Carrieri and Camelia Protopopescu drafted the manuscript. All authors contributed to the interpretation of the results and commented on drafts of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Camelia Protopopescu.

Ethics declarations

Funding

The ANRS CO20 CUPIC cohort study was sponsored and funded by The National Agency for Research on AIDS and Viral Hepatitis (ANRS). The ANRS CO20 CUPIC cohort study was conducted with the support and participation of the Association Française pour l’Etude du Foie (AFEF). This work was supported by the French ANRS, with the participation of Gilead Sciences.

Conflict of interest

Zobair Younossi: research support and consultant for Gilead Sciences. Hélène Fontaine: speaker fees from MSD, Janssen, Roche, BMS. Christophe Hézode: consultancy fees from Abbott, MSD, Roche, Janssen, BMS, Gilead, and speaker fees from MSD, Janssen, Roche, BMS. The other authors (Maria Patrizia Carrieri, Camelia Protopopescu, Antoine Vilotitch, Ventzislava Petrov-Sanchez, Fabienne Marcellin, Fabrice Carrat, and Marc Bourlière) declare that they have no conflict of interest.

Informed consent

Written informed consent was obtained from all patients included in the study.

Ethical approval

All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committees (the ‘Ile de France IX’ Ethics Committee, Créteil, France, for CUPIC and the ‘Comité de Protection des Personnes Sud Méditerranée’, CHU Nice, France, for SIRIUS) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Carrieri, M.P., Protopopescu, C., Younossi, Z. et al. Health-Related Quality of Life in Chronic HCV-Infected Patients Switching to Pegylated-Interferon-Free Regimens (ANRS CO20 CUPIC Cohort Study and SIRIUS Trial). Patient 10, 605–614 (2017). https://doi.org/10.1007/s40271-017-0232-1

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