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Article Dans Une Revue Liver International Année : 2020

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

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Vincent Leroy
Si Nafa Si Ahmed
  • Fonction : Auteur
Michael N. Robertson
  • Fonction : Auteur
George J. Hanna
  • Fonction : Auteur
Deborah Brown
  • Fonction : Auteur
Ernest Asante-Appiah
  • Fonction : Auteur
Feng-Hsiu Su
  • Fonction : Auteur
Peggy Hwang
  • Fonction : Auteur
Jessie Durrand Hall
  • Fonction : Auteur
Amir Guidoum
  • Fonction : Auteur
Karin Hagen
  • Fonction : Auteur
Barbara A. Haber
  • Fonction : Auteur
Rohit Talwani
  • Fonction : Auteur
Lawrence Serfaty

Résumé

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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Dates et versions

hal-03590858 , version 1 (28-02-2022)

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Citer

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, 2020, 40 (5), pp.1042-1051. ⟨10.1111/liv.14313⟩. ⟨hal-03590858⟩
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