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A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of a 12- or 8-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve and -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection Without Cirrhosis

Trial Profile

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of a 12- or 8-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve and -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection Without Cirrhosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jan 2018

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At a glance

  • Drugs Simeprevir (Primary) ; Sofosbuvir (Primary)
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIMIST-1
  • Sponsors Janssen Infectious Diseases BVBA; Janssen R&D Ireland
  • Most Recent Events

    • 18 Jan 2018 Results of pooled post-hoc analysis assessing impact of pharmacokinetic interaction between simeprevir and concomitant medications by using data from nine studies (SONET, OPTIMIST-1, OPTIMIST-2, COMMIT, GALAXY, OSIRIS, IMPACT, PLUTO and SATURN) published in the British Journal of Clinical Pharmacology.
    • 09 May 2017 Results (n=521) of IMPACT,OPTIMIST-1,OPTIMIST-2 and ACCORDION studies presented at the Digestive Disease Week 2017.
    • 02 Nov 2016 Results of pooled analysis from IMPACT, OPTIMIST-1 and OPTIMIST-2 studies assessing patients reported outcomes (n=437) presented at the 19th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
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