Condition: HCV Infection · Sponsor: University of Seville
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, outsi…
This description comes directly from the study's public registry record.
Juan Macías, MD, PhD · +34 955 01 85 36 · jmacias7@us.es
Always discuss trial participation with your own doctor first.
| 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 |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06928259