HCV InfectionNCT06928259
Drug-Drug Intercations and Direct Acting Antiviral Agents Against HCV
An observational study of HCV Infection, run by University of Seville at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HCV Infection
- How many people
- 728 participants
- Where
- 4 sitesSpain
- Study dates
- 30 Apr 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 recruiting
- Not yet recruiting
Unidad de Enfermedades Infecciosas Hospital Universitario Puerto Real.
Cadiz
Francisco Téllez, MD, +34 955 01 85 36, francisco.tellez.perez@gmail.com
- Not yet recruiting
Unidad de Enfermedades Infecciosas. Hospital Universitario Reina Sofía de Córdoba.
Córdoba
Angela Camacho, MD, +34 955 01 85 36, acamachoespejo@gmail.com
- Not yet recruiting
Unidad de Enfermedades Infecciosas. Hospital Universitario Juan Ramón Jiménez.
Huelva
Miguel Raffo-Márquez, MD, +34 955 01 85 36, xhalveyxx@hotmail.com
- Recruiting
Departamento de Medicina. Universidad de Sevilla Hospital Universitario Virgen de Valme.
Seville
Juan Macías, MD, PhD, +34 355 01 85 36, jmacias7@us.es
About this study
Official title: Clinical Relevance of Drug-drug Interactions (DDI) With the Currently Used Direct-acting Antiviral Therapy (DAA) Against Hepatitis C Virus (HCV)
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
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SOF/VEL | Treatment with SOF/VEL (n=485) | |
| GLE/PIB | Treatment with GLE/PIB (n=243) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days before treatment, 8-12 weeks of treatment, 24 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Responsible party
- Principal investigator, Juan Macías, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928259
- Sponsor's protocol ID
- CO-ES-342-7138
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Drug-drug Interactions (DDI) With the Currently Used Direct-acting Antiviral Therapy (DAA) Against Hepatitis C Virus (HCV)
- ClinicalTrials.gov ID
- NCT06928259
- Acronym / sponsor ID
- CO-ES-342-7138
- Conditions
- HCV Infection
- Keywords
- HCV, SOF/VEL, GLE/PIB, drug-drug interactions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOF/VEL | – | –Treatment with SOF/VEL (n=485) |
| GLE/PIB | – | –Treatment with GLE/PIB (n=243) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- HCV treatment-experienced patients will be excluded.
- Patients without any comedication or recreational drug use
- Those who have attended private health care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Main Study End Point
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCV Infection, run by University of Seville at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Macías, MD, PhD (+34 955 01 85 36, jmacias7@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Study End Point (time frame: 90 days before treatment, 8-12 weeks of treatment, 24 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.