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Clin Infect Dis. 2018 Mar 19;66(7):1013-1018. doi: 10.1093/cid/cix916.

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.

Author information

1
Hepatology Unit, University Hospital, CHU Bordeaux, Pessac.
2
INSERM, Université Bordeaux, UMR1053 Bordeaux Research in Translational Oncology, BaRITOn.
3
CHU Rennes, Service Pharmacologie, and INSERM, CIC 1414.
4
Service d'Hépatologie, CHU Henri-Mondor, AP-HP, Université Paris-Est, INSERM U955, Créteil.
5
Université Paris Descartes, Hepatology Department, Cochin Hospital, APHP, INSERM U1223, UMS-20 and Center for Translational Science, Institut Pasteur.
6
Université Rennes 1, Faculté de médecine, laboratoire de pharmacologie.
7
Department of Internal Medicine and Digestive Diseases, CHU Purpan, UMR 152, IRD Toulouse 3 University.
8
Hepatology Unit and INSERM 1183, CHU Montpellier.
9
Hepatology Unit, CHU Purpan, Toulouse.
10
Institut National de la Santé et de la Recherche Médicale (INSERM), U1065, Team 8, "Hepatic Complications in Obesity," and University Hospital of Nice, Digestive Centre, Cedex.
11
Hepatology Unit, CHU Rennes.
12
Hepatology Unit, APHP Paul Brousse, Villejuif.
13
Hepatology Unit, Hospices Civils de Lyon, and INSERM U1052, Paris.
14
France Recherche Nord & Sud Sida-HIV Hépatites, Paris.
15
Hepatology Unit, Hôpital Saint Joseph, Marseille.
16
National Reference Center for Viral Hepatitis B, C, and D, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, and INSERM U955, Créteil, France.

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.

Clinical Trials Registration:

NCT02647632.

PMID:
29077864
DOI:
10.1093/cid/cix916
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