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Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study

Tarik Asselah 1 Stanislas Pol 2 Christophe Hezode 3 Veronique Loustaud-Ratti 4 Vincent Leroy 5 Si Nafa Si Ahmed Violaine Ozenne 6 Jean-Pierre Bronowicki 7 Dominique Larrey 8, 9 Albert Tran 10 Laurent Alric 11 Eric Nguyen-Khac 12 Michael N. Robertson George J. Hanna Deborah Brown Ernest Asante-Appiah Feng-Hsiu Su Peggy Hwang 13 Jessie Durrand Hall Amir Guidoum Karin Hagen Barbara A. Haber Rohit Talwani Lawrence Serfaty 14
1 CRI (UMR_S_1149 / ERL_8252 / U1149) - Centre de recherche sur l'Inflammation
2 Service d'hépatologie médicale [CHU Cochin]
3 BCR - Biomécanique cellulaire et respiratoire
4 IPPRITT - Ciblage individuel et prévention des risques de traitements immunosupresseurs et de la transplantation
5 IMRB - Institut Mondor de Recherche Biomédicale
6 Hôpital Lariboisière-Fernand-Widal [APHP]
7 CRHU Nancy
8 Hôpital Saint-Éloi [Montpellier]
9 Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB)
10 C3M - Centre méditerranéen de médecine moléculaire
11 CHU Toulouse [Toulouse]
12 GRAP - Groupe de Recherche sur l'alcool et les pharmacodépendances - UMR INSERM_S 1247
13 Whitehouse Station
14 CRSA - Centre de Recherche Saint-Antoine
Abstract : 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.
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https://hal-u-picardie.archives-ouvertes.fr/hal-03590858
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Soumis le : lundi 28 février 2022 - 11:11:05
Dernière modification le : vendredi 13 mai 2022 - 03:17:38

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U-PICARDIE | GRAP | UNILIM | IMRB | U938 | UPEC-UPEM | UPEC | BS | UNIV-MONTPELLIER | UNIV-COTEDAZUR | IPPRITT | GEIST | SORBONNE-UNIVERSITE | SU-MEDECINE | C3M | UP-SANTE | CNRS | UNIV-PARIS | PT | OMEGAHEALTH

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Tarik Asselah, Stanislas Pol, Christophe Hezode, Veronique Loustaud-Ratti, Vincent Leroy, et al.. Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study. Liver International, Wiley-Blackwell, 2020, 40 (5), pp.1042-1051. ⟨10.1111/liv.14313⟩. ⟨hal-03590858⟩

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