Title :

Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort.

Author(s) :

Laurain, Anne [Auteur]
Université Paris Descartes - Paris 5 [UPD5]
Metivier, Sophie [Auteur]
Haour, Georges [Auteur]
Sorbonne Université [SU]
Larrey, Dominique [Auteur]
Dorival, Celine [Auteur]
Sorbonne Université [SU]
Hezode, Christophe [Auteur]
Université Paris-Est [UPE]
Zoulim, Fabien [Auteur]
Université de Lyon
Marcellin, Patrick [Auteur]
Université Paris Diderot - Paris 7 [UPD7]
Bourliere, Marc [Auteur]
Zarski, Jean-Pierre [Auteur]
Thabut, Dominique [Auteur]
Université Pierre et Marie Curie - Paris 6 [UPMC]
Alric, Laurent [Auteur]
Université Toulouse III - Paul Sabatier [UT3]
Ganne-Carrie, Nathalie [Auteur]
Université Paris 13 [UP13]
Cales, Paul [Auteur]
Bronowicki, Jean-Pierre [Auteur]
Université de Lorraine [UL]
Riachi, Ghassan [Auteur]
Geist, Claire [Auteur]
Causse, Xavier [Auteur]
Abergel, Armand [Auteur]
Université Clermont Auvergne [2017-2020] [UCA [2017-2020]]
Chazouilleres, Olivier [Auteur]
Université Pierre et Marie Curie - Paris 6 [UPMC]
Mathurin, Philippe [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Guyader, Dominique [Auteur]
Université de Rennes [UR]
Samuel, Didier [Auteur]
Université Paris-Sud - Paris 11 [UP11]
Tran, Albert [Auteur]
Loustaud-Ratti, Veronique [Auteur]
Université de Limoges [UNILIM]
Petrov-Sanchez, Ventzislava [Auteur]
Diallo, Alpha [Auteur]
Luzivika-Nzinga, Clovis [Auteur]
Sorbonne Université [SU]
Fontaine, Helene [Auteur]
Université Paris Descartes - Paris 5 [UPD5]
Carrat, Fabrice [Auteur]
Sorbonne Université [SU]
Pol, Stanislas [Auteur]
Université Paris Descartes - Paris 5 [UPD5]

Journal title :

BMC Infectious Diseases

Abbreviated title :

BMC Infect. Dis.

Volume number :

19

Pages :

300

Publication date :

2019-04-02

ISSN :

1471-2334

English keyword(s) :

Simeprevir
Direct acting antivirals
Hepatitis C virus
Real life cohort
Sofosbuvir

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

BACKGROUND: Although real-life results of sofosbuvir/simeprevir have been extensively reported from the United States, data from other geographical areas are limited. In the French observational cohort, ANRS CO22 HEPATHER, ...
Show more >BACKGROUND: Although real-life results of sofosbuvir/simeprevir have been extensively reported from the United States, data from other geographical areas are limited. In the French observational cohort, ANRS CO22 HEPATHER, 9432 patients were given the new oral antivirals from December 2013 to June 30, 2018. We report the results of sofosbuvir/simeprevir in genotypes 1- and 4-infected patients. METHODS: Demographics and history of liver disease were collected at entry in the cohort. Clinical, adverse events, and virological data were collected throughout treatment and post-treatment follow-up. The choice of treatment duration or addition of ribavirin was left up to the physician. RESULTS: Five hundred ninety-nine HCV (467 genotype 1 and 132 genotype 4) mono-infected, naïve for all oral-DAAs regimen patients were given sofosbuvir/simeprevir with (n = 63) or without ribavirin (n = 536) for 12 or 24 weeks; 56% had cirrhosis (4% decompensated) and 71% had prior treatment failure to interferon-based regimen. 7 patients (1.16%) were lost to follow-up. The overall SVR12 rate was 92.6%. The SVR12 was 90% in GT1a, 94.2% in GT1b and 91.6% in GT4 with no significant difference for genotype, treatment duration or ribavirin addition. Severity of liver disease was not associated with a lower SVR12 rate on multivariate analysis but was associated with a higher rate of severe side effects. Early treatment discontinuations were rare; no new safety signals were reported. CONCLUSIONS: In this real life, observational, prospective cohort study, the 12-week sofosbuvir/simeprevir+/-ribavirin combination appears to be efficient and safe. BACKGROUND: Trial registration with ClinicalTrials.gov NCT01953458 .Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Inserm
Université de Lille

Collections :

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

Submission date :

2019-10-22T08:17:00Z
2024-04-23T13:35:18Z