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. 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

Anne Laurain  1 , Sophie Metivier  2 , Georges Haour  3 , Dominique Larrey  4 , Céline Dorival  3 , Christophe Hezode  5 , Fabien Zoulim  6 , Patrick Marcellin  7 , Marc Bourliere  8 , Jean-Pierre Zarski  9 , Dominique Thabut  10 , Laurent Alric  11 , Nathalie Ganne-Carrie  12 , Paul Cales  13 , Jean-Pierre Bronowicki  14 , Ghassan Riachi  15 , Claire Geist  16 , Xavier Causse  17 , Armand Abergel  18   19 , Olivier Chazouilleres  20 , Philippe Mathurin  21 , Dominique Guyader  22 , Didier Samuel  23 , Albert Tran  24 , Véronique Loustaud-Ratti  25 , Ventzislava Petrov-Sanchez  26 , Alpha Diallo  27 , Clovis Luzivika-Nzinga  3 , Hélène Fontaine  28 , Fabrice Carrat  3   29 , Stanislas Pol  30 ; ANRS/AFEF HEPATHER study group
Collaborators, Affiliations

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 et al. BMC Infect Dis. .

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.

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Conflict of interest statement

Ethics approval and consent to participate

Written informed consent was obtained from each patient before enrolment. The protocol was performed in accordance with the Declaration of Helsinki and French law for biomedical research and was approved by the “CPP Ile de France 3” Ethics Committee (Paris, France) and the French Regulatory Authority (ANSM).

Consent for publication

not applicable.

Competing interests

The ANRS CO22 HEPATHER cohort is sponsored and funded by Inserm-ANRS and conducted in collaboration with Association Française pour l’étude du Foie (AFEF). The cohort received supports from ANR (Agence Nationale de la Recherche), DGS (Direction Générale de la Santé) and MSD, Janssen, Gilead, Abbvie, BMS, Roche. The public/private partnership is built in total transparency through a specific contract. The pharmaceutical companies are not involved in the scientific decisions.

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Figures

Fig. 1
Fig. 1
Flow diagram
Fig. 2
Fig. 2
Percentages of SVR12 in subgroups of patients by genotype
See this image and copyright information in PMC

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