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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-organ-specific Ab positive | Patients who had detectable circulating autoantibodies before treatment with antivirals. |
| |
| Non-organ-specific Ab negative | Patients who did not have detectable circulating autoantibodies before treatment with antivirals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-organ-specific Ab positive | Biological | Antiviral administration and evaluation of SVR24 and side effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response | Evaluation of HCV-RNA levels | 24 weeks after the end of antiviral therapy |
| 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 |
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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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo Di Leo, MD, PhD | University of Bari | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinic Hospital | Bari | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30375693 | Derived | 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. |
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It depends on the possibility to merge similar data and produce a multicentric study
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Serum samples for antibodies determination
| Non-organ-specific Ab negative | Biological | direct-acting antiviral agents |
|
Clinical manifestations and laboratory alterations
| 24 weeks after the end of antiviral therapy |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |