Investigating drug interactions with antiviral agents for HCV
Clinical Relevance of Drug-drug Interactions (DDI) With the Currently Used Direct-acting Antiviral Therapy (DAA) Against Hepatitis C Virus (HCV)
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 |
|---|---|
| Enrollment | 728 (estimated) |
| Sex | All |
| Sponsor | University of Seville Academic / other |
| Locations | 4 sites (Cadiz and 3 other locations) |
| Trial ID | NCT06928259 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are treatment-experienced or those not using any comedications or recreational drugs will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cadiz and 3 other locations
- 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)
Study contacts
- Study coordinator: Juan Macías, MD, PhD
- Email: jmacias7@us.es
- Phone: +34 955 01 85 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.