Published 2020
| Version v1
Journal article
Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study
Creators
- Asselah, Tarik
- Pol, Stanislas
- Hezode, Christophe
- Loustaud-Ratti, Veronique
- Leroy, Vincent
- Ahmed, Si Nafa Si
- Ozenne, Violaine
- Bronowicki, Jean-Pierre
- Larrey, Dominique
- Tran, Albert
- Alric, Laurent
- Nguyen-Khac, Eric
- Robertson, Michael N.
- Hanna, George J.
- Brown, Deborah
- Asante-Appiah, Ernest
- Su, Feng-Hsiu
- Hwang, Peggy
- Hall, Jessie Durrand
- Guidoum, Amir
- Hagen, Karin
- Haber, Barbara A.
- Talwani, Rohit
- Serfaty, Lawrence
Contributors
Others:
- Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)) ; Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
- Service d'hépatologie médicale [CHU Cochin] ; Hôpital Cochin [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
- Biomécanique cellulaire et respiratoire (BCR) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Centre National de la Recherche Scientifique (CNRS)
- Ciblage individuel et prévention des risques de traitements immunosupresseurs et de la transplantation (IPPRITT) ; CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST) ; Université de Limoges (UNILIM)-Université de Limoges (UNILIM)
- Institut Mondor de Recherche Biomédicale (IMRB) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)
- Hôpital Lariboisière-Fernand-Widal [APHP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
- CRHU Nancy
- Hôpital Saint-Éloi [Montpellier] ; Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
- Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB) ; Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)
- Centre méditerranéen de médecine moléculaire (C3M) ; Université Nice Sophia Antipolis (1965 - 2019) (UNS) ; COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Côte d'Azur (UCA)
- CHU Toulouse [Toulouse]
- Groupe de Recherche sur l'alcool et les pharmacodépendances - UMR INSERM_S 1247 (GRAP) ; Université de Picardie Jules Verne (UPJV)-Institut National de la Santé et de la Recherche Médicale (INSERM)
- Whitehouse Station
- Centre de Recherche Saint-Antoine (CRSA) ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)
Description
Background & Aims Hepatitis C virus (HCV) genotype (GT) 4 infection is prevalent in sub-Saharan Africa and the Middle East, particularly in Egypt. This study evaluated the safety and efficacy of elbasvir/grazoprevir administered for 8 and 12 weeks in participants with HCV GT4 infection. Methods In this partially randomized, open-label multicentre study conducted in France (NCT03111108; Protocol MK5172-096), treatment-naive participants with GT4 infection and F0-F2 fibrosis were randomized 2:1 to elbasvir (50 mg)/grazoprevir (100 mg) for 8 or 12 weeks. Treatment-naive participants with F3-F4 fibrosis and all treatment-experienced participants (F0-F4) were assigned to elbasvir/grazoprevir for 12 weeks. The primary endpoint was sustained virologic response (SVR) 12 weeks after the end of therapy. Results One hundred and seventeen participants were enrolled. Among treatment-naive participants with F0-F2 fibrosis, SVR was achieved by 94% (50/53) and 96% (26/27) of those receiving elbasvir/grazoprevir for 8 or 12 weeks, respectively, and four participants relapsed. In the 12-week arm, 95% (35/37) achieved SVR and two participants relapsed. NS5A resistance-associated substitutions were present at baseline and virologic failure in five of the participants with relapse. Drug-related adverse events occurred in 42% (n = 22) and 50% (n = 32) of participants receiving 8 and 12 weeks of treatment, respectively. No participant discontinued treatment owing to an adverse event. Conclusion These data confirm the efficacy of elbasvir/grazoprevir administered for 12 weeks in treatment-experienced individuals with HCV GT4 infection and those with advanced fibrosis. Treatment-naive individuals with mild fibrosis can be treated effectively with an 8-week regimen.
Abstract
International audienceAdditional details
Identifiers
- URL
- https://hal-u-picardie.archives-ouvertes.fr/hal-03590858
- URN
- urn:oai:HAL:hal-03590858v1