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Patients’ monitoring during and after treatment   |   31

                                   positive results, due to passive antibodies transfer from the
                                   mother).
                                    Nucleic acid testing (NAT) – detection of presence and/or
                                   amount (viral load – VL) of HCV RNA in the blood, reflects the
                                   actual viral replication. These tests are the hallmark of HCV
                                   diagnosis in both antibody-positive and negative patients, with
                                   unexplained ALT elevations or liver disease documented by liver
                                   biopsy (LB). A high VL is a negative predictor of therapeutic
                                   success. Sequential VL measurements with the same method
                                   during treatment (at weeks 4, 12, 24/48) and 6 month after
                                   treatment completion inform response-guided therapy (RGT).


                                   Table 2.1  –  Blood tests for hepatitis C
                                   Test/Type        Application         Comments
                                   EIA              Indicates past or present  Does not differentiate
                                   (enzyme immunoassay)  infection      between acute and
                                                                        chronic infection
                                   All positive EIA results should be checked with a supplemental HCV RNA
                                   assay:
                                   HCV RNA qualitative  Detects virus as early as 1-2 Presence of circulating
                                   (RT-PCR)         weeks after infection.  HCV RNA might be
                                                    Useful for reduction of  intermittent
                                                    residual risk associated to
                                                    transfusions*
                                   A single negative RT-PCR is not conclusive
                                   HCV RNA quantitative  Determines concentration  Useful for assessing the
                                   (Real-time PCR)  of HCV RNA (VL)     response to therapy
                                   HCV RNA genotyping  Groups isolates of HCV  Determines the length
                                                    based on major genetic  of treatment and
                                                    types and subtypes  prediction of SVR rate
                                   * screening by Versant™ (Siemens Health Care Diagnostics) and Procleix™ HIV-
                                   1/HCV assays (Gen-Probe).
                                    Determination of HCV genotype. The molecular
                                   characterization of genotypes and subtypes of HCV is
                                   particularly important for the response to treatment and disease
                                   prognosis (Scott 2007). There are 6 major genotypes of HCV and
                                   more than 50 subtypes.
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