The Impact of Ledipasvir/Sofosbuvir on Patient-Reported Outcomes in Cirrhotic Patients with Chronic Hepatitis C: The SIRIUS Study.
Fiche publication
Date publication
juin 2015
Auteurs
Membres identifiés du Cancéropôle Est :
Pr BRONOWICKI Jean-Pierre
Tous les auteurs :
Younossi ZM, Stepanova M, Pol S, Bronowicki JP, Carrieri MP, Bourliere M
Lien Pubmed
Résumé
BACKGROUND: Interferon- and ribavirin (RBV)-free regimens can improve patient-reported outcomes (PROs) during treatment. AIM: To compare PROs during treatment with ledipasvir and sofosbuvir (LDV/SOF) to placebo and to LDV/SOF+RBV. METHODS: Treatment-experienced CH-C genotype 1 patients with compensated cirrhosis (N=154) were randomized to receive 24 weeks of LDV/SOF or 12 weeks of placebo followed by 12 weeks of LDV/SOF+RBV (the SIRIUS clinical trial). While blinded to their HCV RNA level and study treatment, patients completed PRO questionnaires (SF-36, FACIT-F, CLDQ-HCV, WPAI:SHP) at baseline, during and post-treatment. RESULTS: Baseline PRO scores were similar between the two study arms. Patients receiving LDV/SOF showed improvement in a number of PROs (predominantly related to mental health) starting as early as 4 weeks after treatment initiation; no PRO decrement from baseline were noted, and no PRO scores were inferior to placebo (all p>0.05). In the second 12 weeks, patients who were receiving LDV/SOF continued to improve PROs (up to +9.2% from a 100% maximum possible score, p
Référence
Liver Int. 2015 Jun 9