Autoantibodies and Direct-acting Antivirals (BIOEPA)

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

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.

Study Overview

• Status: Completed
• Conditions: Viral Hepatitis C; Therapy Adverse Effect
• Intervention / Treatment: Biological: Non-organ-specific Ab positive; Biological: Non-organ-specific Ab negative

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 Type: Observational
• Enrollment (Actual): 191

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Policlinic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Caucasian patients affected by chronic hepatitis C virus infection who were consecutively admitted as outpatients to the Gastroenterology Unit, Policlinic Hospital, Bari, Italy, from July 2015-August 2016 to receive a treatment with second generation direct-acting antivirals.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-organ-specific Ab positive; Patients who had detectable circulating autoantibodies before treatment with antivirals.	Biological: Non-organ-specific Ab positive; Antiviral administration and evaluation of SVR24 and side effects; Other Names: direct-acting antiviral agents
Non-organ-specific Ab negative; Patients who did not have detectable circulating autoantibodies before treatment with antivirals.	Biological: Non-organ-specific Ab negative; direct-acting antiviral agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained virological response	Evaluation of HCV-RNA levels	24 weeks after the end of antiviral therapy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Bari
• Investigators: Study Chair: Alfredo Di Leo, MD, PhD, University of Bari

Publications and helpful links

General Publications

• Shahini E, Iannone A, Romagno D, Armandi A, Carparelli S, Principi M, Viggiani MT, Ierardi E, Di Leo A, Barone M. Clinical relevance of serum non-organ-specific antibodies in patients with HCV infection receiving direct-acting antiviral therapy. Aliment Pharmacol Ther. 2018 Nov;48(10):1138-1145. doi: 10.1111/apt.14999.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: sustained virological response; hepatitis C virus infection; non-organ-specific antibodies; prognostic value
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Anti-Infective Agents; Antiviral Agents
• Other Study ID Numbers: Policlinic Hospital 3, Bari

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It depends on the possibility to merge similar data and produce a multicentric study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No