Titre :

Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis c virus genotype 1, 2, 4, and 6 infection

Auteur(s) :

Asselah, Tarik [Auteur]
Shafran, Stephen D. [Auteur]
Bourgeois, Stefan [Auteur]
Lai, Ching-Lung [Auteur]
Mathurin, Philippe [Auteur]
Willems, Bernard [Auteur]
Nguyen, Mindie H. [Auteur]
Davis, Mitchell N. [Auteur]
Huang, K. C. [Auteur]
Svarovskaia, Evguenia [Auteur]
Osinusi, Anu [Auteur]
Mcnally, John [Auteur]
Brainard, Diana M. [Auteur]
Shaikh, Obaid S. [Auteur]
Tran, Tram T. [Auteur]

Titre de la revue :

Journal of viral hepatitis

Nom court de la revue :

J. Viral Hepat.

Date de publication :

2019-06-19

ISSN :

1365-2893

Mot(s)-clé(s) en anglais :

direct-acting antivirals
pangenotypic activity
NS5B inhibitor
NS5A inhibitor

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Sofosbuvir-velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection. In this single-arm, open-label, phase 3, deferred treatment study, we investigated the efficacy and safety of sofosbuvir- ...
Lire la suite >Sofosbuvir-velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection. In this single-arm, open-label, phase 3, deferred treatment study, we investigated the efficacy and safety of sofosbuvir-velpatasvir among patients randomized to the placebo group in the ASTRAL-1 study. Patients received sofosbuvir-velpatasvir (400/100 mg) once daily for 12 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response 12 weeks after the end of therapy (SVR12). The primary safety endpoint was any adverse events (AEs) leading to the permanent discontinuation of study drug. Overall, 108/111 (97%, 95% confidence interval [CI], 92%-99%) achieved SVR12, and only one patient had virological failure. SVR12 was achieved by 61/63 (97%, 95%CI, 89%-100%) genotype 1 patients, 20/20 (100%; 95%CI, 83%-100%) with genotype 2, 19/19 (100%; 95%CI, 82%-100%) with genotype 4 and 8/9 (89%; 95% CI, 52%-100%) with genotype 6. All (19/19; 95%CI, 82-100) patients with cirrhosis and all (31/31, 95%CI, 89-100) with prior treatment experience achieved SVR12. The safety profile during treatment was similar to that observed in patients receiving placebo treatment. The most common AEs were headache, fatigue and nausea. One patient (1%) discontinued treatment due to an AE of gallbladder carcinoma, which was not considered related to treatment. Of five reported serious AEs, none were considered related to study drug. Sofosbuvir-velpatasvir for 12 weeks was effective and well tolerated among untreated and previously treated patients with HCV genotype 1, 2, 4 or 6 infection, including those with compensated cirrhosis (ClinicalTrials.gov NCT02346721).Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

CHU Lille
Inserm
Université de Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Date de dépôt :

2024-01-30T10:27:48Z