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; Claire Laforest; Christophe Hezode; Stanislas Pol; Alain Renault; Laurent Alric; Dominique Larrey; Sophie Métivier; Albert Tran; Caroline Jézéquel; Didier Samuel; Fabien Zoulim; Christelle Tual; Aurélie Pailhé; Séverine Gibowski; Marc Bourlière; Eric Bellissant; Jean-Michel Pawlotsky

doi:10.1093/cid/cix916

Journal articles

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, 2, *} Claire Laforest ³ Christophe Hezode ⁴ Stanislas Pol ^{5, 6, 7} Alain Renault ^{8, 3} Laurent Alric ⁹ Dominique Larrey ¹⁰ Sophie Métivier ¹¹ Albert Tran ¹² Caroline Jézéquel ⁸ Didier Samuel ¹³ Fabien Zoulim ¹⁴ Christelle Tual ³ Aurélie Pailhé ¹⁵ Séverine Gibowski ¹⁵ Marc Bourlière ¹⁶ Eric Bellissant ^{3, 8} Jean-Michel Pawlotsky ⁴

* Corresponding author

1 Inserm, UMR-1053; Université de Bordeaux, Bordeaux, F-33076, France

2 Département d'hépatologie et de gastroentérologie [CHU Bordeaux]

3 CIC - Centre d'Investigation Clinique [Rennes]

4 IMRB - Institut Mondor de Recherche Biomédicale

5 Immunobiologie des Cellules dendritiques

6 UPD5 - Université Paris Descartes - Paris 5

7 CRT - Centre de Recherche Translationnelle

8 CHU Pontchaillou [Rennes]

9 PHARMA-DEV - Pharmacochimie et Biologie pour le Développement

10 Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB)

11 CHU Purpan

12 C3M - Centre méditerranéen de médecine moléculaire

13 Hôpital Paul Brousse

14 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon

15 ANRS France Recherche Nord & sud Sida-hiv hépatites

16 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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Journal articles

Domain :

Life Sciences [q-bio] / Human health and pathology / Infectious diseases

Life Sciences [q-bio] / Human health and pathology / Hépatology and Gastroenterology

Life Sciences [q-bio] / Pharmaceutical sciences / Pharmacology

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Submitted on : Friday, April 13, 2018 - 11:16:53 AM
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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

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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

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