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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

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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: 16 Jun 2022

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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

  • 26 Jun 2021 Results (n=343) data derived from ad- hoc subgroup analyses of the EXPEDITION-8 study and from 9 pooled, phase II/III studies presented at The International Liver Congress 2021
  • 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.

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