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Measuring G-protein-coupled Receptor Signaling via Radio-labeled GTP Binding
10:13

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GS-4104 Gilead Sciences Inc.

A Billich1

  • 1Novartis Research Institute, General Dermatology, PO Box 80, Brunner Strasse 59, A-1235, Vienna, Austria. andreas.billich@pharma.novartis.com

Idrugs : the Investigational Drugs Journal
|May 10, 2008
PubMed
Summary

GS-4104, a neuraminidase inhibitor, significantly reduced influenza symptom duration by nearly 50% in phase II trials. Prophylactic use prevented detectable virus levels, demonstrating its potential for influenza treatment and prevention.

Area of Science:

  • Virology
  • Pharmacology
  • Infectious Diseases

Background:

  • Influenza virus infections pose a significant global health burden.
  • Neuraminidase inhibitors are a key class of antiviral medications for influenza.
  • GS-4104 is an investigational neuraminidase inhibitor developed by Gilead and Roche.

Purpose of the Study:

  • To evaluate the efficacy and safety of GS-4104 for the treatment and prevention of influenza A and B virus infections.
  • To assess the impact of GS-4104 on symptom duration and viral load in infected individuals.
  • To determine the prophylactic efficacy of GS-4104 in preventing influenza virus detection.

Main Methods:

  • International phase II/III, double-blind, placebo-controlled trials involving over 1500 patients.

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  • Studies included treatment arms (5-day regimen) and prophylaxis arms (6-week regimen) with once- or twice-daily dosing.
  • Phase II studies involved intranasal exposure to influenza A, with patients receiving oral GS-4104 or placebo.

    • Main Results:

    • GS-4104 decreased influenza symptom duration by nearly 50% in phase II treatment studies.
    • Prophylactic administration of GS-4104 resulted in no detectable virus levels in 100% of patients, compared to 50% in the placebo group.
    • Phase I trials indicated GS-4104 was well-tolerated with favorable oral absorption and distribution.

    Conclusions:

    • GS-4104 demonstrates significant potential as a treatment for influenza by reducing symptom duration.
    • Prophylactic use of GS-4104 effectively prevents detectable influenza virus replication.
    • The drug is well-tolerated, supporting its further development for influenza management.