74113117/01/2022Validated04/02/2022Camille Bachothttp://epidemiologie-france.aviesan.fr/en/content/view/full/90997http://epidemiologie-france.aviesan.fr/en/ccontent/xml/(NodeId)/90997Prospective cohort study on the impact of insulin resistance on sustained virological response to Pegasys® and Copegus® treatment in patients with Chronic Hepatitis-CORPHEEML22790Infectious diseasesNoChronic hepatitis-CMedicineCopegus® treatmentMedical data centerdata_sharing_france@roche.comRoche SASNoPrivateRoche SASPrivateYesStudy databasesCohort studyA selection of health institutions and servicesMedication(s) takenNoPrimary objective : To describe in real-life conditions the insulin resistance and its impact on SVR in patients presenting with chronic hepatitis C and treated with Pegasys® and Copegus®.
Secondary objectives :
- To describe patients’ characteristics at inclusion
- To describe the predictive factors influencing virological response under treatment at W4 (rapid virological response, RVR), at W12 (early virological response, EVR), and 24 weeks after the end of treatment with Pegasys® (sustained virological response, SVR)
- To describe the constitutive parameters of metabolic syndrome during the study period
- To describe the management of chronic hepatitis C and insulin resistance
- To describe the changes in patients’ quality of life during the study period
- To describe the serious and non-serious adverse events occurring during the study period.Inclusion criteria :
- Adult patient (age >=18 years)
- Suffering from chronic hepatitis C (detectable blood HCV RNA)
- For whom the specialist had decided to initiate dual therapy with Pegasys® and Copegus®
- Who received both oral and written information about the study, without any objections for the use of his/her personal data.Adulthood (19 to 24 years)Adulthood (25 to 44 years)Adulthood (45 to 64 years)Elderly (65 to 79 years)Great age (80 years and more)Sick populationB15-B19 - Viral hepatitisMaleWomanNational20102013[1000-10 000[ individuals1150Data collection completedClinical dataMedical registrationValidation of selection criteria ; Patients’ demographics (age and sex) ; Pregnancy test for women of childbearing age ; Clinical data ; Co-morbidities and associated factors ; History of chronic C hepatitis ; Most recent biological data ; Most recent histological data ; Treatment with Pegasys® and Copegus® ; Date of permanent discontinuation of Pegasys® treatment and reason(s) ; Lifestyle and therapeutic recommendations, concomitant treatments ; Adverse events ; Date and reason of early study withdrawal ; Quality of life questionnaire (HQLQ).NoGCP/GVPYesMonitoring by contact with the referring doctorNohttp://epidemiologie-france.aviesan.fr/enhttps://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.htmlAccess on specific project onlyAccess on specific project only