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