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Drug-Drug Intercations and Direct Acting Antiviral Agents Against HCV

Recruitingn/aAges any - anyAllUniversity of Seville
NCT06928259 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Currently used direct-acting antivirals (DAA) share pharmacokinetic pathways with many comedications commonly used in patients with chronic hepatitis C virus (HCV) infection, therefore drug-drug interactions (DDI) might exist. Although extensive (DDI) verification is recommended by most clinical practice guidelines, real-world studies have shown that approximately one-tenth of patients on DAA therapy also take concomitant medication with the potential for significant interactions. Despite the risk of significant DDI when patients are administered DAA and a concomitant medication, to date, there is very little information on whether these interactions translate into changes in the toxicity or efficacy of any involved DAA or comedication in clinical practice. Clarifying this issue is a critical point, as the DDI profile of the currently used DAA is not the same, with SOF/VEL sh

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Treatment naive patients who received therapy with GLE/PIB or SOF/VEL between April 1st, 2018, and July 1st, 2023, receiving ≥ 1 comedication or recreational drug. 2. Attended in a hospital with electronic clinical records allowing access to all clinical visits and prescribed medications, both in all hospitals and in primary care institutions of the corresponding Spanish region during the study period. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study: 1. HCV treatment-experienced patients will be excluded. 2. Patients without any comedication or recreational drug use 3. Those who have attended private health care
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What it tests

  • Not listed
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Where

4 sites
Unidad de Enfermedades Infecciosas Hospital Universitario Puerto Real.
Cadiz, Spain
Unidad de Enfermedades Infecciosas. Hospital Universitario Reina Sofía de Córdoba.
Córdoba, Spain
Unidad de Enfermedades Infecciosas. Hospital Universitario Juan Ramón Jiménez.
Huelva, Spain
Departamento de Medicina. Universidad de Sevilla Hospital Universitario Virgen de Valme.
Seville, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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