Autoantibodies and Direct-acting Antivirals — BIOEPA  

Viral Hepatitis C Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Therapy Adverse Effect
• Viral Hepatitis C

• NCT number: NCT03566966
• Study type: Observational [Patient Registry]
• Source: University of Bari
• Status: Completed
• Start date: July 1, 2015
• Completion date: March 31, 2017