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

Anne Laurain 1, 2, * Sophie Metivier 3 Georges Haour 4 Dominique Larrey 5 Céline Dorival 4 Christophe Hezode 6 Fabien Zoulim 7 Patrick Marcellin 8, 9 Marc Bourlière 10 Jean-Pierre Zarski 11 Dominique Thabut 12 Laurent Alric 13 Nathalie Ganne-Carrié 14 Paul Calès 15 Jean-Pierre Bronowicki 16, 17 Ghassan Riachi 18 Claire Geist 19 Xavier Causse 20 Armand Abergel 21, 22 Olivier Chazouilleres 23 Philippe Mathurin 24 Dominique Guyader 25 Didier Samuel 26 Albert Tran 27 Véronique Loustaud-Ratti 28 Ventzislava Petrov-Sanchez 29 Alpha Diallo 29 Clovis Luzivika-Nzinga 4 Hélène Fontaine 1, 2 Fabrice Carrat 4 Stanislas Pol 1, 2, *
* Corresponding author
12 Inserm UMR_S 938 - Pathologies biliaires, fibrose et cancer du foie
CR Saint-Antoine - Centre de Recherche Saint-Antoine, CHU Saint-Antoine [AP-HP]
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.
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Submitted on : Thursday, May 23, 2019 - 5:07:10 PM
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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, BioMed Central, 2019, 19 (1), pp.300. ⟨10.1186/s12879-019-3923-5⟩. ⟨hal-02120879⟩



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