Clinical trial NCT03566966: Autoantibodies and Direct-acting Antivirals
Official title: Clinical Relevance of Serum Non-organ-specific Antibodies in Hepatitis C Virus Patients Receiving Direct-acting Antiviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Hepatitis C
Therapy Adverse Effect
Keywords: hepatitis C virus infection
non-organ-specific antibodies
prognostic value
sustained virological response
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sustained virological response
timeFrame: 24 weeks after the end of antiviral therapy
Secondary outcomes:
measure: Disappearance of non-organ-specific antibodies
timeFrame: 24 weeks after the end of antiviral therapy
measure: Side effects
timeFrame: 24 weeks after the end of antiviral therapy
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinic Hospital
Study officials:
affiliation: University of Bari
name: Alfredo Di Leo, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.