French Patients with Hepatitis C Treated with Direct-Acting Antiviral Combinations: The Effect on Patient-Reported Outcomes.
Value Health
; 21(10): 1218-1225, 2018 10.
Article
em En
| MEDLINE
| ID: mdl-30314623
ABSTRACT
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.Palavras-chave
Texto completo:
1
Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Antivirais
/
Qualidade de Vida
/
Hepatite C
/
Medidas de Resultados Relatados pelo Paciente
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Systematic_reviews
Limite:
Adult
/
Female
/
Humans
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Male
/
Middle aged
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article