Drug-Drug Intercations and Direct Acting Antiviral Agents Against HCV

NCT06928259 | Recruiting DMC

• 1 other identifier: CO-ES-342-7138
• Study Type: observational
• Target: 728
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HCV Infection

Keywords

HCV; SOF/VEL; GLE/PIB; drug-drug interactions

Outcome Measures

Primary Outcomes (1)

• Main Study End Point

  Frequency of comedication switch, withdrawal or dose reduction at treatment initiation (index date) and during treatment with GLE/PIB or SOF/VEL.

  90 days before treatment, 8-12 weeks of treatment, 24 weeks post treatment

Study Arms (2)

SOF/VEL

Treatment with SOF/VEL (n=485)

GLE/PIB

Treatment with GLE/PIB (n=243)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• HCV treatment-experienced patients will be excluded.
• Patients without any comedication or recreational drug use
• Those who have attended private health care

Sponsors & Collaborators

• University of Seville: lead
• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: collaborator

Study Sites (4)

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

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Juan Macías, MD, PhD

CONTACT

+34 955 01 85 36; jmacias7@us.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor de Medicina

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: April 30, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

ES (4)