Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort - Centre de recherche Bichat-Beaujon Accéder directement au contenu
Article Dans Une Revue BMC Infectious Diseases Année : 2019

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

1 Département d'hépatologie [CHU Cochin]
2 Immunobiologie des Cellules dendritiques
3 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
4 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
5 Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB)
6 BCR - Biomécanique cellulaire et respiratoire
7 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
8 Service d’Hépatologie [Hôpital Beaujon]
9 CRB3 - Centre de recherche biomédicale Bichat-Beaujon
10 Service d'hépatologie et de gastroentérologie [Hôpital Saint-Joseph - Marseille]
11 INSERM U823 - Institut d'oncologie/développement Albert Bonniot de Grenoble
12 Pathologies biliaires, fibrose et cancer du foie [CRSA]
13 PHARMA-DEV - Pharmacochimie et Biologie pour le Développement
14 U1162 - Génomique Fonctionnelle des Tumeurs Solides
15 CHU Angers - Centre Hospitalier Universitaire d'Angers
16 NGERE - Nutrition-Génétique et Exposition aux Risques Environnementaux
17 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
18 CHU Rouen
19 CHR Metz-Thionville - Centre hospitalier régional Metz-Thionville
20 CHRO - Centre Hospitalier Régional d'Orléans
21 CHU Estaing [Clermont-Ferrand]
22 ISIT - Image Science for Interventional Techniques
23 CHU Saint-Antoine [AP-HP]
24 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
25 Foie, métabolismes et cancer
26 CHB - Centre hépato-biliaire
27 C3M - Centre méditerranéen de médecine moléculaire
28 PIST - Pharmacologie des Immunosuppresseurs et de la Transplantation
29 ANRS France Recherche Nord & sud Sida-hiv hépatites
Paul Calès
Ghassan Riachi
  • Fonction : Auteur

Résumé

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.Conclusion: In this real life, observational, prospective cohort study, the 12-week sofosbuvir/simeprevir+/−ribavirin combination appears to be efficient and safe.
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hal-02120879 , version 1 (23-05-2019)

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Anne Laurain, Sophie Metivier, Georges Haour, Dominique Larrey, Céline Dorival, et al.. Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort. BMC Infectious Diseases, 2019, 19 (1), pp.300. ⟨10.1186/s12879-019-3923-5⟩. ⟨hal-02120879⟩
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