French Patients with Hepatitis C Treated ...
Document type :
Article dans une revue scientifique
PMID :
Permalink :
Title :
French Patients with Hepatitis C Treated with Direct-Acting Antiviral Combinations: The Effect on Patient-Reported Outcomes.
Author(s) :
Cacoub, Patrice [Auteur]
Sorbonne Université [SU]
Bourliere, Marc [Auteur]
Asselah, Tarik [Auteur]
De Ledinghen, Victor [Auteur]
Mathurin, Philippe [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Hezode, Christophe [Auteur]
Henry, Linda [Auteur]
Stepanova, Maria [Auteur]
Younossi Zobair, M [Auteur]
Sorbonne Université [SU]
Bourliere, Marc [Auteur]
Asselah, Tarik [Auteur]
De Ledinghen, Victor [Auteur]
Mathurin, Philippe [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Hezode, Christophe [Auteur]
Henry, Linda [Auteur]
Stepanova, Maria [Auteur]
Younossi Zobair, M [Auteur]
Journal title :
Value in Health
Abbreviated title :
Value Health
Volume number :
21
Pages :
1218-1225
Publication date :
2018-10
Keyword(s) :
health utility
work productivity
health-related quality of life
fatigue
direct-acting antivirals
work productivity
health-related quality of life
fatigue
direct-acting antivirals
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
Background
In addition to high efficacy, new anti–hepatitis C virus (HCV) regimens improve patient-reported outcomes (PROs), which must be considered by policymakers in different countries when deciding upon treatment ...
Show more >Background In addition to high efficacy, new anti–hepatitis C virus (HCV) regimens improve patient-reported outcomes (PROs), which must be considered by policymakers in different countries when deciding upon treatment coverage. Objective To assess PROs of French patients with HCV treated with different antiviral regimens. Methods French patients with HCV from 11 clinical trials were included. PROs were measured before, during, and after treatment (Short Form-36 version 2, Functional Assessment of Chronic Illness Therapy-Fatigue, Chronic Liver Disease Questionnaire-HCV, and Work Productivity and Activity Index: Specific Health Problem). Results A total of 931 subjects (age 54 ± 10 years, 60.3% males, 55% employed, 33.5% cirrhotic, 50% treatment-naive, and 45.6% genotype 1) were treated with a combination of interferon, ribavirin, and sofosbuvir (IFN + RBV + SOF) (N = 11; excluded from comparisons), SOF/RBV ± ledipasvir (LDV) (N = 202), IFN/RBV-free (LDV/SOF, SOF/velpatasvir, or SOF/velpatasvir/voxilaprevir) (N = 594), or placebo (N = 124). The sustained virologic response 12 (SVR-12) rates were 87.1% for IFN-free RBV-containing regimens, 97.6% for IFN/RBV-free regimens, and 0% for placebo. Baseline PRO scores were not different across the treatment groups (all P > 0.10). At the end of treatment, patients treated with IFN-free SOF/RBV ± LDV experienced moderate declines in their PRO scores (up to −7.9% of a PRO range size; P < 0.05), and placebo-treated group did not have significant changes in their PROs (P > 0.05). In contrast, the IFN/RBV-free group experienced significant on-treatment improvement in most PROs (up to +7.9%; P < 0.05). Despite those on-treatment differences, most PROs improved with SVR-12 and SVR-24 regardless of the regimen. In comparison with matched controls from the United States treated with the same regimens, French subjects had lower baseline PROs but similar or greater post-SVR PRO improvements. Conclusions The use of IFN- and RBV-free regimens leads to significant PRO improvement during treatment and after SVR in French patients with HCV.Show less >
Show more >Background In addition to high efficacy, new anti–hepatitis C virus (HCV) regimens improve patient-reported outcomes (PROs), which must be considered by policymakers in different countries when deciding upon treatment coverage. Objective To assess PROs of French patients with HCV treated with different antiviral regimens. Methods French patients with HCV from 11 clinical trials were included. PROs were measured before, during, and after treatment (Short Form-36 version 2, Functional Assessment of Chronic Illness Therapy-Fatigue, Chronic Liver Disease Questionnaire-HCV, and Work Productivity and Activity Index: Specific Health Problem). Results A total of 931 subjects (age 54 ± 10 years, 60.3% males, 55% employed, 33.5% cirrhotic, 50% treatment-naive, and 45.6% genotype 1) were treated with a combination of interferon, ribavirin, and sofosbuvir (IFN + RBV + SOF) (N = 11; excluded from comparisons), SOF/RBV ± ledipasvir (LDV) (N = 202), IFN/RBV-free (LDV/SOF, SOF/velpatasvir, or SOF/velpatasvir/voxilaprevir) (N = 594), or placebo (N = 124). The sustained virologic response 12 (SVR-12) rates were 87.1% for IFN-free RBV-containing regimens, 97.6% for IFN/RBV-free regimens, and 0% for placebo. Baseline PRO scores were not different across the treatment groups (all P > 0.10). At the end of treatment, patients treated with IFN-free SOF/RBV ± LDV experienced moderate declines in their PRO scores (up to −7.9% of a PRO range size; P < 0.05), and placebo-treated group did not have significant changes in their PROs (P > 0.05). In contrast, the IFN/RBV-free group experienced significant on-treatment improvement in most PROs (up to +7.9%; P < 0.05). Despite those on-treatment differences, most PROs improved with SVR-12 and SVR-24 regardless of the regimen. In comparison with matched controls from the United States treated with the same regimens, French subjects had lower baseline PROs but similar or greater post-SVR PRO improvements. Conclusions The use of IFN- and RBV-free regimens leads to significant PRO improvement during treatment and after SVR in French patients with HCV.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Inserm
Université de Lille
CHU Lille
Université de Lille
CHU Lille
Research team(s) :
Inflammatory digestive disease : pathophysiology and therapeutic targets developement
Submission date :
2019-03-01T14:34:30Z
2024-03-15T10:15:22Z
2024-03-15T10:15:22Z