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Has Hep C ever returned after Incivek?
Has Hep C virus ever returned after being undetected at end of Incivek treatment?
Yes, unfortunately, according to the results of the trial studies, there were some people who had viral breakthrough (defined as someone whose Hep C virus is detected before the end of treatment) after their last dose of Incivek but while still on treatment with Ribavirin and Interferon.
According to the ADVANCE trials, non SVR rates for treatment naive subjects were:
on treatment virologic failure=7%
relapse=4%
other=11%
(other is defined as subjects with detectable HCV-RNA at the time of the last dose of the trial drug but did not have a viral breakhough)
According to the REALIZE study, on treatment virologic failure rates among previously treated subjects were:
Prior relapsers=1%
Prior partial responders=15%
Prior null responders=50%
On-treatment virologic failure included subjects who met a protocol-defined virologic stopping rule OR who had detectable HCV-RNA at the time of their last dose of Incivek AND subjects who had viral breakthrough on peginterferon alfa/ribavirin.
As hrsepwrguy said above, the eRVR results are a good predictor for success.
http://pi.vrtx.com/files/uspi_telaprevir.pdf
Advocate1955
According to the ADVANCE trials, non SVR rates for treatment naive subjects were:
on treatment virologic failure=7%
relapse=4%
other=11%
(other is defined as subjects with detectable HCV-RNA at the time of the last dose of the trial drug but did not have a viral breakhough)
According to the REALIZE study, on treatment virologic failure rates among previously treated subjects were:
Prior relapsers=1%
Prior partial responders=15%
Prior null responders=50%
On-treatment virologic failure included subjects who met a protocol-defined virologic stopping rule OR who had detectable HCV-RNA at the time of their last dose of Incivek AND subjects who had viral breakthrough on peginterferon alfa/ribavirin.
As hrsepwrguy said above, the eRVR results are a good predictor for success.
http://pi.vrtx.com/files/uspi_telaprevir.pdf
Advocate1955
Best I can tell you were treatment naive if you were UND at wks 4 & 12 your chances are pretty good
Trial 108 (ADVANCE)
SVR in eRVR subjects
92% (195/212)
http://pi.vrtx.com/files/uspi_telaprevir.pdf
Trial 108 (ADVANCE)
SVR in eRVR subjects
92% (195/212)
http://pi.vrtx.com/files/uspi_telaprevir.pdf
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