Page 44 - The Flying Publisher Guide to Hepatitis C Treatment
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44   | Hepatitis C Treatment

                                    –  the correctable factors of treatment failure during the
                                      previous course of therapy.
                                    Consistent with the change in HCV RNA during the previous
                                   course of therapy, four different patterns of treatment failure
                                   – with crucial implications for the regimen, duration and
                                   likelihood of response to retreatment – can be distinguished:
                                   1.  Patients with less than 2 log 10 UI/ml decline in HCV RNA
                                      from baseline to treatment week 12 are defined as non-
                                      responders. Within this group, null responders show a
                                      minimal reduction in HCV RNA level (usually less than 1
                                      log 10 UI/ml), being considered the most refractory group to
                                      treatment with pegylated interferon alfa (PegIFN) and
                                      ribavirin (RBV). SVR rates during retreatment rarely
                                      surpass 15% in this population. Therefore, unless other
                                      compelling reasons impose therapy in these patients (such
                                      as control of extrahepatic manifestations or advanced liver
                                      disease), the best option may be to closely monitor them
                                      while waiting for triple therapy (PegIFN/RBV + a direct-
                                      acting antiviral).
                                   2.  Patients with ≥2 log 10 UI/ml decline in HCV RNA from
                                      baseline to treatment week 12, who remain HCV RNA
                                      detectable at week 24 are partial virological responders.
                                   3.  Breakthrough is defined as detectable HCV RNA during
                                      therapy, after an initial virologic response (HCV RNA
                                      undetectable or ≥2 log 10 UI/ml decline at week 12).
                                   4.  In contrast to previous categories, relapsers are those who,
                                      during therapy, achieved and maintained undetectable HCV
                                      RNA (measured by a high sensitive assay), but HCV RNA
                                      become again measurable during the first 6 months after the
                                      end of therapy. Relapsers have the best chance of
                                      achieving SVR during retreatment with PegIFN/RBV, with a
                                      SVR rate of approximately 40%. Triple therapy with a
                                      protease inhibitor further increase this rate.
                                   Numerous host and virological factors strongly influence the
                                   response to therapy. A complex constellation of fixed factors
                                   related to virus, such as genotype 1 or high pre-therapeutic viral
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