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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03566966
Acronym
BIOEPA
Enrollment
191
Registered
2018-06-25
Start date
2015-07-01
Completion date
2017-03-31
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapy Adverse Effect, Viral Hepatitis C

Keywords

hepatitis C virus infection, non-organ-specific antibodies, prognostic value, sustained virological response

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.

Interventions

BIOLOGICALNon-organ-specific Ab positive

Antiviral administration and evaluation of SVR24 and side effects

BIOLOGICALNon-organ-specific Ab negative

direct-acting antiviral agents

Sponsors

University of Bari
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Sustained virological response24 weeks after the end of antiviral therapyEvaluation of HCV-RNA levels

Secondary

MeasureTime frameDescription
Disappearance of non-organ-specific antibodies24 weeks after the end of antiviral therapyEvaluation of anti nuclear antibodies, anti smooth muscle antibodies, liver kidney microsome antibodies
Side effects24 weeks after the end of antiviral therapyClinical manifestations and laboratory alterations

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026