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A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection

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Trial Profile

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Mar 2017

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At a glance

  • Drugs Ledipasvir/sofosbuvir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ION-4
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 16 Feb 2017 Results assessing correlation between urinary biomarkers and renal toxicity presented at the 24th Conference on Retroviruses and Opportunistic Infections.
    • 25 May 2016 Results of the retreatment substudy (n = 9) published in the Clinical Infectious Diseases.
    • 17 Apr 2016 Pooled analysis results from this trial and ION-4 trial with other 7 trial presented at The International Liver Congress™ 2016

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