Investigating drug interactions with antiviral agents for HCV
Official title: Clinical Relevance of Drug-drug Interactions (DDI) With the Currently Used Direct-acting Antiviral Therapy (DAA) Against Hepatitis C Virus (HCV)
Run by University of Seville · NCT06928259 · Data updated 2026-11-12
This study is testing how different medications and recreational drugs interact with new treatments for hepatitis C to help ensure they are safe for patients starting therapy.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 728 (estimated) |
| Sponsor | University of Seville Academic / other |
| Locations | 4 sites (Cadiz and 3 other locations) |
| Status | Recruiting |
| Started | April 30, 2025 |
| Main results expected | December 2025 |
| Study ends | March 2026 |
| Registry record updated | April 15, 2025 |
| Trial ID | NCT06928259 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are treatment-naive patients with HCV who are receiving GLE/PIB or SOF/VEL along with at least one comedication or recreational drug.
✕Probably not a fit
Patients who are treatment-experienced or those not using any comedications or recreational drugs will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the drug-drug interactions (DDI) between direct-acting antiviral agents (DAA) used for treating hepatitis C virus (HCV) infection and concomitant medications or recreational drugs. It focuses on treatment-naive patients who received either GLE/PIB or SOF/VEL therapies between April 2018 and July 2023. The study will analyze real-world data from hospitals in Spain to determine how these interactions affect the efficacy and toxicity of the DAAs. By comparing the DDI profiles of the two antiviral regimens, the study seeks to provide insights into safe medication practices for HCV patients.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of HCV treatments by identifying significant drug interactions.
How similar studies have gone: While there is limited information on this specific approach, previous studies have highlighted the importance of understanding drug interactions in patients receiving DAAs, indicating a need for this type of research.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Departamento de Medicina. Universidad de Sevilla Hospital Universitario Virgen de Valme.
Seville, Spain Recruiting -
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
Study contacts
- Study coordinator: Juan Macías, MD, PhD
- Email: jmacias7@us.es
- Phone: +34 955 01 85 36
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.