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A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naive Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Compensated Cirrhosis

Trial Profile

A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naive Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Compensated Cirrhosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2020

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At a glance

  • Drugs Glecaprevir/pibrentasvir (Primary)
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms EXPEDITION-8
  • Sponsors AbbVie; AbbVie Germany
  • Most Recent Events

    • 06 Mar 2020 According to an Enanta Pharmaceuticals, the European Commission has granted marketing authorization for MAVIRET(glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naive, compensated cirrhotic, chronic HCV patients with genotype 3 infection. The EC approval is supported by data from this Phase 3b EXPEDITION-8 study.
    • 31 Jan 2020 According to an AbbVie media release, MAVIRET is currently indicated as an 8-week, pan-genotypic (GT1-6), once-daily regimen for treatment-naive HCV patients without cirrhosis, and as an 8-week, once-daily regimen for treatment-naive GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis. Final European Commission decision expected in 2020.
    • 31 Jan 2020 According to an AbbVie media release, based on the data of this study, the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a change to the marketing authorization for MAVIRET (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naive, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection.
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