Prognostic Marker For Cryoglobulinemic Vasculitis And B Cell Malignancies In HCV Infected Patients

Abstract

The invention provides methods and compositions for early diagnosis and treatment of a disease associated with a specific antibody by employing the detection of a cross-idiotypic epitope on the specific antibody to detect the cells that produce the antibody before the development of clinical symptoms of the disease.

What is claimed is: 
     
         1 .- 13 . (canceled) 
     
     
         14 . A method of treating cryoglobulinemic vasculitis and B cell malignancy associated with HCV in a subject comprising:
 providing a sample from a subject infected with hepatitis C virus (HCV);   administering an anti-WA antibody to said subject if WA Xid+B cells-are detected in said sample,   thereby treating said cryoglobulinemic vasculitis or B Cell malignancy in said subject.   
     
     
         15 . The method of  claim 14 , wherein said patient lacks a clinical symptom of cryoglobulinemic vasculitis or B Cell malignancy. 
     
     
         16 . A method of identifying a subject who is at the risk of developing malignancy associated with hepatitis C virus (HCV), comprising:
 providing a sample from a subject infected with HCV;   detecting in said sample non-WA cross-idiotype positive (non-WA Xid+) B cells; thereby identifying a subject who is at the risk of developing malignancy associated with hepatitis C virus (HCV).   
     
     
         17 . The method of  claim 16 , wherein said non-WA Xid+B cells are detected by identifying an immunoglobulin nucleic acid sequence from a clonally expanded B cell population, wherein said immunoglobulin nucleic acid sequence is associated with specific non-WA Xid. 
     
     
         18 . The method of  claim 17 , wherein said specific non-WA Xid+B cells are detected with an isolated anti-non-WA Xid antibody. 
     
     
         19 . The method of  claim 16 , wherein said diagnosis is an early diagnosis. 
     
     
         20 . The method of  claim 19 , wherein said early diagnosis is after initial HCV infection, but prior to the manifestation of sign or symptoms associated B cell malignancies. 
     
     
         21 . The method of  claim 16 , wherein said sample is a biological fluid comprising whole blood. 
     
     
         22 . A kit comprising a set of first primers and second primers, and instructions for prognosis of cryoglobulinemic vasculitis and B cell malignancy associated with HCV-infection based on the detection of the immunoglobulin nucleic acid sequences associated with WA Xid comprising IgH V1-69 or IgH V 3-7 or related germ line genes, VK325 or VK 328, JH4 or JH3, Jk1, and SEQ ID NO: 1 (consensus 1) or SEQ ID NO: 2 (consensus 2), wherein said set of first primers and second primers comprises a first primer and a second primer that flank the complementary determining region 3 (CDR3) sequence, a first primer and a second primer that flank the VH-D-JH sequence and a first primer and a second primer that flank VK-JK sequence in Ig-encoding transcripts.