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Retreatment With Sofosbuvir Plus Grazoprevir/Elbasvir Plus Ribavirin of Patients With Hepatitis C Virus Genotype 1 or 4 Who Previously Failed an NS5A- or NS3-Containing Regimen: The ANRS HC34 REVENGE Study

Victor de Ledinghen 1, * Claire Laforest 2 Christophe Hezode 3 Stanislas Pol 4, 5, 6 Alain Renault 7, 2 Laurent Alric 8 Dominique Larrey 9 Sophie Métivier 10 Albert Tran 11 Caroline Jézéquel 7 Didier Samuel 12 Fabien Zoulim 13 Christelle Tual 2 Aurélie Pailhé Séverine Gibowski Marc Bourlière 14 Eric Bellissant 2, 7 Jean-Michel Pawlotsky 3
* Corresponding author
1 Physiopathologie du cancer du foie
2 CIC - Centre d'Investigation Clinique [Rennes]
3 IMRB - Institut Mondor de Recherche Biomédicale
4 Immunobiologie des Cellules dendritiques
5 UPD5 - Université Paris Descartes - Paris 5
6 CRT - Centre de Recherche Translationnelle
7 CHU Pontchaillou [Rennes]
8 PHARMA-DEV - Pharmacochimie et Biologie pour le Développement
9 Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB)
10 CHU Purpan
11 C3M - Centre méditerranéen de médecine moléculaire
12 Hôpital Paul Brousse
13 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
14 Hôpital Saint-Joseph [Marseille]
Abstract : Background: Failure to achieve sustained virological response (SVR) with hepatitis C virus (HCV) direct-acting antiviral (DAA)–based regimens is commonly associated with emergence of resistance-associated substitutions (RASs). Retreatment of patients who failed prior DAAs remains challenging. The aim of this prospective and randomized study was to evaluate the efficacy (primary endpoint: SVR 12 weeks after end of treatment [SVR12]) and safety of sofosbuvir + grazoprevir/elbasvir + ribavirin for 16 or 24 weeks in patients who had failed to achieve SVR on previous NS5A- or NS3-based therapy and with evidence of RASs at failure. Methods: Patients were chronically infected with HCV genotype 1 or 4. Most of them had advanced fibrosis or compensated cirrhosis (liver stiffness 5.8–48.8 kPa). Results: All patients achieved HCV RNA below the lower limit of quantification (either target detected [unquantifiable] or target not detected) during treatment. SVR12 was achieved by 25 of 26 patients. The only patient who did not reach SVR was a patient who died, but HCV RNA was negative at this time (5 weeks after stopping treatment). No patient discontinued treatment because of adverse events or virological failure. Globally, treatment was well tolerated. Conclusions: Our findings support the concept of retreating with sofosbuvir + grazoprevir/elbasvir + ribavirin, for 16 weeks, genotype 1 or 4 DAA-experienced patients with proven NS5A or NS3 RASs.
Keywords : sofosbuvir hepatitis C grazoprevir/elbasvir RAS DAA
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Submitted on : Friday, April 13, 2018 - 11:16:53 AM
Last modification on : Thursday, January 14, 2021 - 4:22:10 PM

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UNIV-RENNES1 | UR1-UFR-SVE | BIOSIT | CIC203 | UPEC-UPEM | IMRB | CNRS | CIC | UNIV-RENNES | BS | UNIV-MONTPELLIER | CRCL | UNIV-LYON1 | IRD | UNICE | PASTEUR | UNIV-COTEDAZUR | UNIV-PARIS5 | USPC | UNIV-TLSE3 | UPEC | INC-CNRS | UDL | UNIV-PARIS | POLITIQUES-PUBLIQUES | SHMESP

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Victor de Ledinghen, Claire Laforest, Christophe Hezode, Stanislas Pol, Alain Renault, et al.. Retreatment With Sofosbuvir Plus Grazoprevir/Elbasvir Plus Ribavirin of Patients With Hepatitis C Virus Genotype 1 or 4 Who Previously Failed an NS5A- or NS3-Containing Regimen: The ANRS HC34 REVENGE Study. Infectious Diseases in Clinical Practice, Lippincott, Williams & Wilkins, 2018, 66 (7), pp.1013-1018. ⟨10.1093/cid/cix916⟩. ⟨hal-01743768⟩

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