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Clinical Trials in Spain / NCT06928259
Recruiting Observational

Drug-Drug Intercations and Direct Acting Antiviral Agents Against HCV

NCT06928259 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Seville
Phase
Observational
Started
2025-04-30
Last updated
2025-04-15

Condition(s) studied

HCV Infection

Study summary

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 showing a lower risk of significant DDI than GLE/PIB. Thus the objective of this study is to compare the percentage of comedication switch, withdrawal, or dose reduction at treatment initiation and during treatment with GLE/PIB or SOF/VEL.

Methods: The patients will be enrolled from the GEHEP 001/HEPAVIR cohort. "The HEPAVIR-DAA cohort (NCT02057003)", includes HIV/HCV-coinfected patients, and "the GEHEP-MONO cohort (NCT02333292)", that includes HCV mono-infected individuals, are ongoing prospective multicenter cohorts of patients receiving DAA combinations prescribed in clinical practice, outside clinical trials. Main Study End Point will be the frequency of comedication switch, withdrawal or dose reduction at treatment initiation (index date) and during treatment with GLE/PIB or SOF/VEL.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Main Study End Point — 90 days before treatment, 8-12 weeks of treatment, 24 weeks post treatment
    Frequency of comedication switch, withdrawal or dose reduction at treatment initiation (index date) and during treatment with GLE/PIB or SOF/VEL.

Trial sites (4)

FacilityCityRegionStatus
Unidad de Enfermedades Infecciosas Hospital Universitario Puerto Real. Cadiz Spain Not Yet Recruiting
Unidad de Enfermedades Infecciosas. Hospital Universitario Reina Sofía de Córdoba. Córdoba Spain Not Yet Recruiting
Unidad de Enfermedades Infecciosas. Hospital Universitario Juan Ramón Jiménez. Huelva Spain Not Yet Recruiting
Departamento de Medicina. Universidad de Sevilla Hospital Universitario Virgen de Valme. Seville Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06928259 on ClinicalTrials.gov ↗ ← All trials in Spain