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BMC Infect Dis. 2019 Apr 2;19(1):300. doi: 10.1186/s12879-019-3923-5.

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 information

1
Université Paris Descartes ; APHP, Unité d'Hépatologie, Hôpital Cochin ; INSERM U-818 et USM20, Institut Pasteur, Paris, France. anne.laurain@aphp.fr.
2
Department of Hepatology and Gastroenterology, CHU Purpan, Toulouse, France.
3
Sorbonne Université, INSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique, F75012, Paris, France.
4
Liver unit-IRB-INSERM1040, Hôpital Saint Eloi, Montpellier, France.
5
Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, AP-HP, Université Paris-Est, INSERM U955, Créteil, France.
6
Department of Hepatology, Hospices Civils de Lyon, INSERM U1052, Université de Lyon, Lyon, France.
7
Department of Hepatology, Hôpital Beaujon, AP-HP, Université Paris-Diderot, INSERM CRB3, Clichy, France.
8
Department of Hepatology and Gastroenterology, Hôpital Saint Joseph, Marseille, France.
9
Department of Hepatology and Gastroenterology, Centre Hospitalo-Universitaire, INSERM U823, Grenoble, France.
10
Department of Hepatology and Gastroenterology, Groupe Hospitalier Pitié-Salpétrière, AP-HP, Université Pierre et Marie Curie Paris 6, INSERM UMR-S938, Paris, France.
11
Internal Medicine-Digestive Department CHU Purpan, UMR152, IRD, Toulouse 3 University, Toulouse, France.
12
Functional Genomics of Solid Tumors, Hepatology Unit, Hôpital Jean Verdier, Bondy, AP-HP, University Paris 13, Sorbonne Paris Cité, Bobigny; Inserm UMR-1162, F-93000, Paris, France.
13
Liver-Gastroenterology Department, CHU Angers, Angers, France.
14
Department of Hepatology and Gastroenterology, Centre Hospitalier Universitaire de Nancy, Université de Lorraine, INSERM U954, Vandoeuvre-les-Nancy, France.
15
Department of Hepatology and Gastroenterology, CHU Charles Nicolle, Rouen, France.
16
Department of Hepatology and Gastroenterology, Centre Hospitalier Régional, Metz, France.
17
Department of Hepatology and Gastroenterology, CHR d'Orléans, Orléans, France.
18
Department of Digestive and Hepatobiliary Diseases, Estaing University Hospital, Clermont-Ferrand, France.
19
UMR Auvergne University/CNRS 6284 ISIT (Image Sciences for Innovations Techniques), Clermont-Ferrand, France.
20
Department of Hepatology, Hôpital Saint-Antoine, AP-HP, Université Pierre et Marie Curie Paris 6, Paris, France.
21
Department of Hepatology and Gastroenterology, Centre Hospitalier Régional et Universitaire Claude Huriez, Lille, France.
22
Liver disease unit, CHU Rennes, Université de Rennes 1, INSERM U991, Rennes, France.
23
Centre Hépato-Biliaire, Hôpital Paul Brousse, AP-HP, UMR-S785, Université Paris-Sud, INSERM U785, Villejuif, France.
24
Digestive Center, Centre Hospitalier Universitaire de Nice, INSERM U1065-8, Nice, France.
25
Department of Hepatology and Gastroenterology, CHU Limoges, U850 INSERM, Univ. Limoges, F-87000, Limoges, France.
26
ANRS (France Recherche Nord&sud Sida-hiv Hépatites), Unit for Basic and Clinical Research on Viral Hepatitis, Paris, France.
27
ANRS (France Recherche Nord&sud Sida-hiv Hépatites), Clinical Trial Safety and Public Health, Paris, France.
28
Université Paris Descartes ; APHP, Unité d'Hépatologie, Hôpital Cochin ; INSERM U-818 et USM20, Institut Pasteur, Paris, France.
29
Assistance Publique-Hôpitaux de Paris, Hôpital Saint Antoine, Unité de Santé Publique, F-75012, Paris, France.
30
Université Paris Descartes ; APHP, Unité d'Hépatologie, Hôpital Cochin ; INSERM U-818 et USM20, Institut Pasteur, Paris, France. stanislas.pol@aphp.fr.

Abstract

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.

TRIAL REGISTRATION:

Trial registration with ClinicalTrials.gov NCT01953458 .

KEYWORDS:

Direct acting antivirals; Hepatitis C virus; Real life cohort; Simeprevir; Sofosbuvir

PMID:
30940090
PMCID:
PMC6446259
DOI:
10.1186/s12879-019-3923-5
[Indexed for MEDLINE]
Free PMC Article

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