Evidence map›Paper›PMID 28353221›Full record

Trial reportThe patient2017

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

Maria Patrizia Carrieri, Camelia Protopopescu, Zobair Younossi, Antoine Vilotitch, Hélène Fontaine, Ventzislava Petrov-Sanchez, Fabienne Marcellin, Fabrice Carrat, Christophe Hézode, Marc Bourlière and 1 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The patient, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 2 countries.

Maria Patrizia CarrieriFaculté 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 ProtopopescuFaculté 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.
Zobair YounossiDepartment of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, Annandale, VA, 22039, USA.
Antoine VilotitchFaculté 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.
Hélène FontaineINSERM, U1016, Hôpital Cochin, 27 rue du Faubourg Saint Jacques, 75014, Paris, France.
Ventzislava Petrov-SanchezUnit for Basic and Clinical Research on Viral Hepatitis, ANRS (France Recherche Nord and Sud Sida-HIV Hépatites FRENSH), Paris, France.
Fabienne MarcellinFaculté 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.
Fabrice CarratSorbonne Universities, UPMC University of Paris 06, INSERM, Pierre Louis Institute of Epidemiology and Public Health (IPLESP UMRS 1136), Paris, France.
Christophe HézodeDepartment of Hepatology and Gastroenterology, Hôpital Henri Mondor, AP-HP, University of Paris-Est, INSERM, U955, Créteil, France.
Marc BourlièreDepartment of Hepato-Gastroenterology, Hôpital Saint Joseph, Marseille, France.
CUPIC Study Group
Inserm · FRAgence Nationale de Recherches sur le Sida et les Hépatites Virales · FRHôpital Saint Joseph · FRInova Fairfax Hospital · USInstitut Mondor de Recherche Biomédicale · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe 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).

methodsTwo 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.

resultsAmong 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.

conclusionsThese 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.

Indexed as

Quality of LifeAgedAge FactorsAntiviral AgentsBenzimidazolesCohort StudiesComorbidityDouble-Blind MethodFemaleFluorenesHealth StatusHepatitis C, ChronicHumansMaleMental HealthMiddle AgedAntiviral AgentsBenzimidazolesFluorenesledipasvir, sofosbuvir drug combinationN-(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-carboxamideOligopeptidesPolyethylene GlycolsProlineSofosbuvirtelaprevirUridine MonophosphateMental Component SummaryMental Component Summary ScorePhysical Component SummarySustained Virologic ResponseTelaprevir

Identifiers

PMID28353221
OpenAlexW2603575803

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.