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A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

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Trial Profile

A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Dec 2022

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At a glance

  • Drugs Sofosbuvir/velpatasvir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASTRAL-5
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 08 Nov 2022 Results of post-hoc analysis of Phase 3 trials with SOF/VEL 12 weeks without ribavirin (RBV) (ASTRAL 1-5, and POLARIS4) presented at The Liver Meeting 2022: 73rd Annual Meeting of the American Association for the Study of Liver Diseases
    • 13 Nov 2018 Integrated analysis results of pooled data presented at The Liver Meeting 2018: 69th Annual Meeting of the American Association for the Study of Liver Diseases
    • 30 May 2018 According to a Gilead Sciences media release, China Drug Administration approved EPCLUSA for the treatment of adults with genotype 1-6 chronic hepatitis C virus infection based on results from five international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4 and ASTRAL-5.
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