title: Health-Related Quality of Life in Chronic HCV-Infected Patients Switching to Pegylated-Interferon-Free Regimens (ANRS CO20 CUPIC Cohort Study and SIRIUS Trial).
abstract: 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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: 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.|ORS PACA (Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur), Marseille, France.
authors.forename: Maria Patrizia
authors.initials: MP
authors.lastname: Carrieri
authors.affiliation: 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. camelia.protopopescu@inserm.fr.|ORS PACA (Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur), Marseille, France. camelia.protopopescu@inserm.fr.
authors.forename: Camelia
authors.initials: C
authors.lastname: Protopopescu
authors.affiliation: Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, Annandale, VA, 22039, USA.
authors.forename: Zobair
authors.initials: Z
authors.lastname: Younossi
authors.affiliation: 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.|ORS PACA (Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur), Marseille, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Vilotitch
authors.affiliation: INSERM, U1016, Hôpital Cochin, 27 rue du Faubourg Saint Jacques, 75014, Paris, France.|Hepatology Unit, Groupe hospitalier Cochin-Hôtel Dieu, AP-HP, Paris, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Fontaine
authors.affiliation: Unit for Basic and Clinical Research on Viral Hepatitis, ANRS (France Recherche Nord and Sud Sida-HIV Hépatites FRENSH), Paris, France.
authors.forename: Ventzislava
authors.initials: V
authors.lastname: Petrov-Sanchez
authors.affiliation: 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.|ORS PACA (Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur), Marseille, France.
authors.forename: Fabienne
authors.initials: F
authors.lastname: Marcellin
authors.affiliation: Sorbonne Universities, UPMC University of Paris 06, INSERM, Pierre Louis Institute of Epidemiology and Public Health (IPLESP UMRS 1136), Paris, France.|Public Health Unit, Hôpital Saint-Antoine, AP-HP, Paris, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Carrat
authors.affiliation: Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, AP-HP, University of Paris-Est, INSERM, U955, Créteil, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Hézode
authors.affiliation: Department of Hepato-Gastroenterology, Hôpital Saint Joseph, Marseille, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Bourlière
mesh_terms: D000367:Age Factors; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006304:Health Status; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000523:psychology*; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use; D000071066:Patient Reported Outcome Measures; D011092:Polyethylene Glycols; D011392:Proline / Q000031:analogs & derivatives / Q000627:therapeutic use; D011788:Quality of Life; D012720:Severity of Illness Index; D012737:Sex Factors; D000069474:Sofosbuvir; D000072230:Sustained Virologic Response; D014542:Uridine Monophosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; D009842:Oligopeptides; C000595958:ledipasvir, sofosbuvir drug combination; D011092:Polyethylene Glycols; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: Mental Component Summary; Mental Component Summary Score; Physical Component Summary; Sustained Virologic Response; Telaprevir