Autoantibodies and Direct-acting Antivirals

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Viral Hepatitis C, Therapy Adverse Effect

Intervention / Treatment
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* Biological: Non-organ-specific Ab positive
* Biological: Non-organ-specific Ab negative


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C virus infection, non-organ-specific antibodies, prognostic value, sustained virological response