Page 67 - The Flying Publisher Guide to Hepatitis C Treatment
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Searching for new antiviral therapies   |   67

                                   for 12 weeks, followed by SoC therapy alone for another 24 - 48
                                   weeks. The recommended dose of Incivek is 750 mg orally 3
                                   times a day.
                                    Several phase II and III studies have assessed the efficacy and
                                   safety of telaprevir in treatment naive G1 patients, concluding
                                   that triple therapy yields a higher rate of SVR than current SoC
                                   and lower rates of relapse. The SVR for patients treated with
                                   Incivek across all studies, and across all patient groups, was
                                   between 20 and 45% higher than the current SoC (Hézode 2009,
                                   McHutchison 2009). RBV was shown to be an essential part of the
                                   therapeutic regimen, playing a critical role both in achieving
                                   superior RVR and SVR and in reducing the rates of virologic
                                   breakthrough due to drug resistance.
                                    The results of a response-guided therapy (RGT) study,
                                   ILLUMINATE (Sherman 2010) support a shorter course of
                                   treatment (from 48 to 24 weeks) for rapidly responsive naive-
                                   patients. Sixty percent of previously untreated patients achieved
                                   an EVR and received only 24 weeks of treatment. The SVR for
                                   these patients was 90%. In order to identify patients who may
                                   benefit from shorter duration of therapy, a new predictor of
                                   treatment response was proposed: extended RVR (eRVR),
                                   defined as undetectable HCV RNA at week 4 and 12. Among
                                   patients who achieved an eRVR, rates of SVR were comparable
                                   between those treated for a total duration of 24 or 48 weeks (92%
                                   vs. 88%, respectively). Among those who did not achieve eRVR,
                                   but continued treatment for 48 weeks, the SVR rate was lower,
                                   but still significant (64%). More recent studies have evaluated
                                   the use of triple therapy including telaprevir as a retreatment
                                   option for nonresponders and relapsers to previous SoC therapy,
                                   demonstrating synergistic effects in viral reduction and
                                   decreased emergence of resistance. SVR rates were higher
                                   among patients who previously experienced relapse versus
                                   nonresponders (McHutchison 2010).
                                    Rashes, pruritus, anemia and nausea were the most commonly
                                   reported AEs with the use of telaprevir. AEs rates resulting in
                                   treatment withdrawal were about 10% higher in telaprevir arms
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