Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C

A Prospective Observational Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C

This study evaluates the incidence of monoclonal B-cell lymphocytosis MBL) in patients with chronic hepatitis C and to determine if monoclonal b-cell lymphocytosis is affected by treatment for hepatitis C.

PRIMARY OBJECTIVES:

I. To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with directly acting antiviral (DAA), and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic.

II. To determine the correlation between the specific subtype of MBL (CD5- MBL, atypical CLL-phenotype MBL and CLL-phenotype MBL) relative to the hepatitis C virus (HCV) genotype.

III. To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy with DAA.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and have medical records reviewed throughout study.

Inclusion Criteria:

• Individuals with chronic hepatitis C who are to begin therapy with DAA

  • Willing to submit a peripheral blood sample at baseline, end of therapy, 12 weeks after the end of therapy, and 52 weeks from baseline

Exclusion Criteria:

• Individuals with chronic hepatitis C who have cirrhosis

  • Individuals with chronic hepatitis C who have a past history of a lymphoproliferative disorder AND for which they received chemotherapy