NCT03566966

Autoantibodies and Direct-acting Antivirals

Clinical Relevance of Serum Non-organ-specific Antibodies in Hepatitis C Virus Patients Receiving Direct-acting Antiviral Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 191 (actual)
• Sponsor: University of Bari · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment response and prognostic value. To achieve this goal patients with hepatitis C virus related advanced liver disease, with detectable circulating autoantibodies on at least two determinations before treatment, were enrolled.

Detailed description

About 40-70% of hepatitis C virus patients develop at least an autoimmune extra-hepatic disorder presumably due to the interaction between hepatitis C virus E2 envelope protein and B lymphocyte Cluster of Differentiation-81 receptor. In addition, the same interaction is responsible for the production of different serum non-organ-specific antibodies. The clinical significance of the latter phenomenon has not been fully understood except for the presence of liver kidney microsome-1 antibody, which is linked to a molecular mimicry between the cytochrome enzyme CYP2D6, primarily expressed in the liver, and hepatitis C virus proteins in genetically predisposed subjects. Actually, no data are available about the prevalence and clinical significance of serum non-organ-specific antibodies in hepatitis C virus patients treated with second generation direct-acting antivirals.

Conditions

• Viral Hepatitis C
• Therapy Adverse Effect

Interventions

Type	Name	Description
BIOLOGICAL	Non-organ-specific Ab positive	Antiviral administration and evaluation of SVR24 and side effects
BIOLOGICAL	Non-organ-specific Ab negative	direct-acting antiviral agents

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-08-31
• Completion: 2017-03-31
• First posted: 2018-06-25
• Last updated: 2023-12-05

Locations

1 site across 1 country: Italy