Therapy Adverse Effect, Viral Hepatitis C
Conditions
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
Antiviral administration and evaluation of SVR24 and side effects
direct-acting antiviral agents
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Sustained virological response | 24 weeks after the end of antiviral therapy | Evaluation of HCV-RNA levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Side effects | 24 weeks after the end of antiviral therapy | Clinical manifestations and laboratory alterations |
Countries
Italy