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446474 tn?1446347682

Some STAT C results given at AASLD Meeting

This is some of the data presented at the AAASLD Meeting in Boston October 29-November 2, 2010
This data contains the SVR rates and treatment duration for Telaprevir and Boceprevir vs SOC Peg/Riba.


Illuminate Trial – Teleprevir (treatment naïve)

72% achieved SVR
When UND between weeks 4-12 SVR of 90+%
SVR equally high at 24 weeks vs 48 weeks

2/3 of patients will be eligible for 24 weeks of treatment.

Boceprevir (treatment naïve)

Patients that because UND by week 8 and remained negative through week 24 are eligible for shorten therapy of 28 weeks. SVR of 90+%

Half of patients will be eligible for shortened course of therapy.

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Trials of people who FAILED previous treatment with SOC

Response II trial - Boceprevir

In patients who failed previous treatment whether relapsers or nonresponders –
66% achieved SVR
21% for control group using SOC

40 - 52% prior nonresponders had SVR
7 % SVR in control group

69  – 75% SVR for relapsers
29% for control group using SOC

Half of patients could shorten therapy form 48 weeks to 36 weeks.

Teleprevir data for prior treatment failure patients not available now. Will be available in next few months.


hectorsf
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Avatar universal
Thanks for posting this.  I will be anxiously waiting for the Teleprevir data for pror TX failures.  Joe will never make it on Boceprevir because his hgb goes way too low and you can hardly keep it up even with lots of Procrit.  His skin is generally not overly sensitive though so this is the one we are hoping for.  
Hope you are doing OK still.
Thanks for all you do for people around here even when you probably don't feel that great. You've offered a lot of good help for many. Your brain seems very sharp despite your faultering liver.  
Ev
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1420486 tn?1384793153
impressive!
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Avatar universal
thanks fot the summary -  the results are indeed impressive and reason to cheer!

However since both Vertex and Merck are under enormous financial pressure at this point (particularly Vertex) I think there is also good reason to skeptically  scrutinize the announcements rather than swallow the marketing spin hook, line and sinker. Some details (the actual abstracts , LB-2 for ILLUMINATE and 216 for RESPOND-2, are available on the AASLD site).

ILLUMINATE. They started with 540 naives. Overall SVR 71.9%  Of the group 2/3 (65.2%) were eligible for shortened tx but the eligibility criteria was not UND between 4 and 12 but "UND at 4 and 12" (eRVR). Which is saying that that 90% of RVRs (who didn't have breakthrough)  go to SVR regardless of 24 or 48w - this is not news. The good news seems to be that the 65.2% fraction that got to RVR is notably higher than with SOC. But what about the third that was not eligible for shortened tx? They don't seem to give that number (wonder why?) but if total SVR was 72% and SVR among the eRVRs is 90% it follows SVR among the non-eRVRs is 54% - same as plain old SOC.  Also, 94 pts quit for AEs, a whopping 17.4%.

RESPOND-2: they start with 504 tx failures. Overall SVR is 62% (from line 3 of table) vs 21% for SOC. There seems to be a BIG difference between partial and null responders where null is  lt 1log at w4. For nulls even with boce SVR odds were only 33-34% in the two arms whereas for partials they were as good as (or better) than for relapsers. However, as with ILLUMINATE, Merck doesn't spell out the stats among those not eligible for   the shortened tx (because they still had VL at w8). By reading between the lines of the two press-releases this seems to add up to 35% to 42% (see
http://www.medhelp.org/posts/Hepatitis-C/A-couple-of-good-links-regarding-Telaprevir-and-Boceprevir/show/1382103)

caveat emptor. Still a big improvement but that SVR on the horizon mat be farther than it seems if you don't UND quickly enough with 1st gen PIs.

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Avatar universal
it's a good thing I don't need to pass pre-algebra. If 59.6% of ILLUMINATE pts were randomized and SVR was 90%  among those randomized and 71.9% overall, then among those not randomized SVR must have been 45% (not 54% as I wrote above).
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Avatar universal
That's what I'm seeing too willing.  It's all in the how fast the UND response time is.
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Avatar universal
but isn't that a bit strange?  if up to one third of naives will see no improvement in outlook  with a PI you'd think there would be more discussion/awareness on that point.
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Avatar universal
Telaprevir's the one that didn't have the lead in.  AND it generally produces a rapid/dramatic reduction in viral load initially.  The 24 week TX was 12 weeks of SOC/PI and then the other 12 weeks of SOC.  

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