Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort
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 t...
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2019-04-01
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Series: | BMC Infectious Diseases |
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Online Access: | http://link.springer.com/article/10.1186/s12879-019-3923-5 |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Anne Laurain Sophie Metivier Georges Haour Dominique Larrey Céline Dorival Christophe Hezode Fabien Zoulim Patrick Marcellin Marc Bourliere Jean-Pierre Zarski Dominique Thabut Laurent Alric Nathalie Ganne-Carrie Paul Cales Jean-Pierre Bronowicki Ghassan Riachi Claire Geist Xavier Causse Armand Abergel Olivier Chazouilleres Philippe Mathurin Dominique Guyader Didier Samuel Albert Tran Véronique Loustaud-Ratti Ventzislava Petrov-Sanchez Alpha Diallo Clovis Luzivika-Nzinga Hélène Fontaine Fabrice Carrat Stanislas Pol on behalf of the ANRS/AFEF HEPATHER study group |
spellingShingle |
Anne Laurain Sophie Metivier Georges Haour Dominique Larrey Céline Dorival Christophe Hezode Fabien Zoulim Patrick Marcellin Marc Bourliere Jean-Pierre Zarski Dominique Thabut Laurent Alric Nathalie Ganne-Carrie Paul Cales Jean-Pierre Bronowicki Ghassan Riachi Claire Geist Xavier Causse Armand Abergel Olivier Chazouilleres Philippe Mathurin Dominique Guyader Didier Samuel Albert Tran Véronique Loustaud-Ratti Ventzislava Petrov-Sanchez Alpha Diallo Clovis Luzivika-Nzinga Hélène Fontaine Fabrice Carrat Stanislas Pol on behalf of the ANRS/AFEF HEPATHER study group 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 Direct acting antivirals Hepatitis C virus Real life cohort Simeprevir Sofosbuvir |
author_facet |
Anne Laurain Sophie Metivier Georges Haour Dominique Larrey Céline Dorival Christophe Hezode Fabien Zoulim Patrick Marcellin Marc Bourliere Jean-Pierre Zarski Dominique Thabut Laurent Alric Nathalie Ganne-Carrie Paul Cales Jean-Pierre Bronowicki Ghassan Riachi Claire Geist Xavier Causse Armand Abergel Olivier Chazouilleres Philippe Mathurin Dominique Guyader Didier Samuel Albert Tran Véronique Loustaud-Ratti Ventzislava Petrov-Sanchez Alpha Diallo Clovis Luzivika-Nzinga Hélène Fontaine Fabrice Carrat Stanislas Pol on behalf of the ANRS/AFEF HEPATHER study group |
author_sort |
Anne Laurain |
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 |
title_short |
Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort |
title_full |
Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort |
title_fullStr |
Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort |
title_full_unstemmed |
Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort |
title_sort |
safety and efficacy of the combination simeprevir-sofosbuvir in hcv genotype 1- and 4-mono-infected patients from the french anrs co22 hepather cohort |
publisher |
BMC |
series |
BMC Infectious Diseases |
issn |
1471-2334 |
publishDate |
2019-04-01 |
description |
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. |
topic |
Direct acting antivirals Hepatitis C virus Real life cohort Simeprevir Sofosbuvir |
url |
http://link.springer.com/article/10.1186/s12879-019-3923-5 |
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doaj-7d26ddf8a567415e8bf3ac4e315b2fa72020-11-25T03:17:08ZengBMCBMC Infectious Diseases1471-23342019-04-0119111210.1186/s12879-019-3923-5Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohortAnne Laurain0Sophie Metivier1Georges Haour2Dominique Larrey3Céline Dorival4Christophe Hezode5Fabien Zoulim6Patrick Marcellin7Marc Bourliere8Jean-Pierre Zarski9Dominique Thabut10Laurent Alric11Nathalie Ganne-Carrie12Paul Cales13Jean-Pierre Bronowicki14Ghassan Riachi15Claire Geist16Xavier Causse17Armand Abergel18Olivier Chazouilleres19Philippe Mathurin20Dominique Guyader21Didier Samuel22Albert Tran23Véronique Loustaud-Ratti24Ventzislava Petrov-Sanchez25Alpha Diallo26Clovis Luzivika-Nzinga27Hélène Fontaine28Fabrice Carrat29Stanislas Pol30on behalf of the ANRS/AFEF HEPATHER study groupUniversité Paris Descartes ; APHP, Unité d’Hépatologie, Hôpital Cochin ; INSERM U-818 et USM20, Institut PasteurDepartment of Hepatology and Gastroenterology, CHU PurpanSorbonne Université, INSERM, Institut Pierre Louis d’épidémiologie et de Santé PubliqueLiver unit-IRB-INSERM1040, Hôpital Saint EloiSorbonne Université, INSERM, Institut Pierre Louis d’épidémiologie et de Santé PubliqueDepartment of Hepatology and Gastroenterology, Hôpital Henri Mondor, AP-HP, Université Paris-Est, INSERM U955Department of Hepatology, Hospices Civils de Lyon, INSERM U1052, Université de LyonDepartment of Hepatology, Hôpital Beaujon, AP-HP, Université Paris-Diderot, INSERM CRB3Department of Hepatology and Gastroenterology, Hôpital Saint JosephDepartment of Hepatology and Gastroenterology, Centre Hospitalo-Universitaire, INSERM U823Department of Hepatology and Gastroenterology, Groupe Hospitalier Pitié-Salpétrière, AP-HP, Université Pierre et Marie Curie Paris 6Internal Medicine-Digestive Department CHU Purpan, UMR152, IRD, Toulouse 3 UniversityFunctional Genomics of Solid Tumors, Hepatology Unit, Hôpital Jean Verdier, Bondy, AP-HP, University Paris 13, Sorbonne Paris CitéLiver-Gastroenterology Department, CHU AngersDepartment of Hepatology and Gastroenterology, Centre Hospitalier Universitaire de Nancy, Université de Lorraine, INSERM U954Department of Hepatology and Gastroenterology, CHU Charles NicolleDepartment of Hepatology and Gastroenterology, Centre Hospitalier RégionalDepartment of Hepatology and Gastroenterology, CHR d’OrléansDepartment of Digestive and Hepatobiliary Diseases, Estaing University HospitalDepartment of Hepatology, Hôpital Saint-Antoine, AP-HP, Université Pierre et Marie Curie Paris 6Department of Hepatology and Gastroenterology, Centre Hospitalier Régional et Universitaire Claude HuriezLiver disease unit, CHU Rennes, Université de Rennes 1, INSERM U991Centre Hépato-Biliaire, Hôpital Paul Brousse, AP-HP, UMR-S785, Université Paris-Sud, INSERM U785Digestive Center, Centre Hospitalier Universitaire de Nice, INSERM U1065-8Department of Hepatology and Gastroenterology, CHU Limoges, U850 INSERM, Univ. LimogesANRS (France Recherche Nord&sud Sida-hiv Hépatites), Unit for Basic and Clinical Research on Viral HepatitisANRS (France Recherche Nord&sud Sida-hiv Hépatites), Clinical Trial Safety and Public HealthSorbonne Université, INSERM, Institut Pierre Louis d’épidémiologie et de Santé PubliqueUniversité Paris Descartes ; APHP, Unité d’Hépatologie, Hôpital Cochin ; INSERM U-818 et USM20, Institut PasteurSorbonne Université, INSERM, Institut Pierre Louis d’épidémiologie et de Santé PubliqueUniversité Paris Descartes ; APHP, Unité d’Hépatologie, Hôpital Cochin ; INSERM U-818 et USM20, Institut PasteurAbstract 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.http://link.springer.com/article/10.1186/s12879-019-3923-5Direct acting antiviralsHepatitis C virusReal life cohortSimeprevirSofosbuvir |