Chronic Hepatitis C Clinical Trial
Official title:
Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients
Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell
response, due to continuous pressure of high viral load. Treatment of chronic HCV patients
with ASV and DCV will result in a significant drop in HCV viral load. At present, no
information is available on the immunological effects of treatment with ASV and DCV, nor on
the early effects of viral load reduction caused by a compound that is thought not to
possess direct immunomodulatory effects. This information will be crucial for a better
understanding of the mechanisms that may limit the effectiveness of treatment, occurrence of
viral rebound or relapses during, at the end of treatment or during the follow up period.
Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV
patients before, during and after treatment with ASV and DCV, in an IFN-free regimen.
Study design: This is an investigator-initiated single center open label study with one arm
of 12 patients.
Study population: Adult chronic HCV patients with genotype 1b, who are previous
non-responders to the treatment.
Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV
and once daily a 60 mg DCV for 24 weeks.
Main study parameters/endpoints:
1. Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific
T cells, NK cells and monocytes
2. Gene expression levels of leukocyte populations before, during and after treatment
3. Gene expression levels of the type I IFN signaling pathway on whole blood samples
4. Serum cytokines levels using multiplex platforms
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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