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Screening and Testing Testing ÎThree classes of assays are used in the diagnosis and management of HCV infection: > Serologic assays that detect specific antibody to HCV (anti-HCV) > Molecular assays that detect viral nucleic acid > Patient genotyping for IL28B polymorphisms Comments: The specificity of current enzyme immunoassays (EIAs) for anti-HCV is greater than 99%. All currently available HCV RNA assays have excellent specificity, in the range of 98% to 99%. IL28B genotype is a robust pretreatment predictor of SVR to peginterferon (PegIFN) alfa and ribavirin (RBV) as well as to protease inhibitor (PI) triple therapy in patients with genotype 1 chronic HCV infection. ÎPersons who are at risk should be tested for the presence of HCV infection (I-B). ÎPatients suspected of having acute or chronic HCV infection should first be tested for anti-HCV (I-B). ÎHCV RNA testing should be performed in: a) Patients with a positive anti-HCV test (I-B) b) Patients for whom antiviral treatment is being considered, using a sensitive quantitative assay (I-A) c) Patients with unexplained liver disease whose anti-HCV test is negative and who are immunocompromised or suspected of having acute HCV infection (I-B) ÎHCV genotyping should be performed in all HCV-infected persons prior to interferon-based treatment in order to plan the dose and duration of therapy and to estimate the likelihood of response (I-A). ÎIL28B genotype testing may be considered when the patient or provider wishes additional information on the probability of treatment response or on the probable treatment duration needed (IIa-B). > The likelihood of achieving an SVR with PegIFN and RBV and of spontaneous resolution of HCV infection differs depending on the nucleotide sequence near the gene for IL28B or lambda interferon 3 on chromosome 19. One single nucleotide polymorphism that is highly predictive is detection of the C or T allele at position rs12979860. The CC genotype is found more than twice as frequently in persons who have spontaneously cleared HCV infection than in those who had progressed to chronic hepatitis C (CHC). > The predictive value of IL28B genotype testing for SVR is superior to that of the pretreatment HCV RNA level, fibrosis stage, age, and gender, and is higher for HCV genotype 1 virus than for genotypes 2 and 3 viruses. There are other polymorphisms near the gene for IL28B that also predict SVR, including detection of the G or T allele at position rs8099917, where T is the favorable genotype, and essentially provides the same information in Caucasians as C at rs12979860. 1

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