Autoantibodies and Direct-acting Antivirals

Completed

• Conditions: Viral Hepatitis C; Therapy Adverse Effect
• Interventions: Biological: Non-organ-specific Ab negative; Biological: Non-organ-specific Ab positive

• Registration Number: NCT03566966
• Lead Sponsor: University of Bari

Brief 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.

Study Timeline

• Study Start: 2015-07-01
• Primary Completion: 2016-08-31
• Study Completion: 2017-03-31
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-06-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

HCV positive patients Presence of advanced liver fibrosis Eligibility to the treatment with direct-acting antiviral therapy.

Exclusion Criteria

History of autoimmune hepatitis and/or cholangitis Evidence of active hepatocellular carcinoma Human immunodeficiency virus coinfection Hepatitis B virus coinfection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-organ-specific Ab negative	Non-organ-specific Ab negative	Patients who did not have detectable circulating autoantibodies before treatment with antivirals.
Non-organ-specific Ab positive	Non-organ-specific Ab positive	Patients who had detectable circulating autoantibodies before treatment with antivirals.

Primary Outcome Measures

Name	Time	Method
Sustained virological response	24 weeks after the end of antiviral therapy	Evaluation of HCV-RNA levels

Secondary Outcome Measures

Name	Time	Method
Side effects	24 weeks after the end of antiviral therapy	Clinical manifestations and laboratory alterations
Disappearance of non-organ-specific antibodies	24 weeks after the end of antiviral therapy	Evaluation of anti nuclear antibodies, anti smooth muscle antibodies, liver kidney microsome antibodies

Trial Locations

Locations (1)

Policlinic Hospital; 🇮🇹 Bari, Italy