Aa
INF free tx maybe in 10 years ?
http://ihlpress.com/pdf%20files/hepdart09_presentations/optimizing/2_Benhamou%20VF.pdf
another presentation on this, with more detail on timing, is Dr Nelson's assessment of tx options in the 2012-2015 range:
http://ihlpress.com/pdf%20files/hepdart09_presentations/hcv_management/2_nelson_HepDart%20Nelson%20HCV.pdf
note slide 4 in particular. I agree with CanDo about that tricky "objects are further than they seem" effect, but the calendar behind that slide seems to be
r7128 phase 2b enrolling now, complete by April 2011. Phase 3 starts then and completes April 2012. File June 2012, approval June 2013?
There will be multiple protease options by then; r7128 will likely be the first polymerase.
http://ihlpress.com/pdf%20files/hepdart09_presentations/hcv_management/2_nelson_HepDart%20Nelson%20HCV.pdf
note slide 4 in particular. I agree with CanDo about that tricky "objects are further than they seem" effect, but the calendar behind that slide seems to be
r7128 phase 2b enrolling now, complete by April 2011. Phase 3 starts then and completes April 2012. File June 2012, approval June 2013?
There will be multiple protease options by then; r7128 will likely be the first polymerase.
That is what Vertex is projecting; 2014 or 15. They probably have a handle on what it will take.
There has been talk about the FDA utilizing a SVR12 instead of "official" 24 week/6 month EOT PCR's. For the most past the 12 week results mirror the 24 week EOT official results.
Also note that the TX very well could become 12 weeks. That is a far cry from the 48 week SOC comparator. The soon to be comparator will likely be the triple therapy (24 weeks as opposed to the 48 week IFN/RVB SOC control arm) Therefore the actual trials will take increasingly less time to perform.
Finally, since many in the demographic are aging and approaching increased liver disease the FDA may fast track some trials so as to get the drugs available to those who need them most. The approval process speed may increase along with the time that it takes to physically cure people.
If it is such that the drugs used to treat people are less toxic the need to weigh toxicology issues may take less time; less agonizing during the NDA final approval process. It could be a no-brainer, thus assuring a quicker approval.
best,
Willy
There has been talk about the FDA utilizing a SVR12 instead of "official" 24 week/6 month EOT PCR's. For the most past the 12 week results mirror the 24 week EOT official results.
Also note that the TX very well could become 12 weeks. That is a far cry from the 48 week SOC comparator. The soon to be comparator will likely be the triple therapy (24 weeks as opposed to the 48 week IFN/RVB SOC control arm) Therefore the actual trials will take increasingly less time to perform.
Finally, since many in the demographic are aging and approaching increased liver disease the FDA may fast track some trials so as to get the drugs available to those who need them most. The approval process speed may increase along with the time that it takes to physically cure people.
If it is such that the drugs used to treat people are less toxic the need to weigh toxicology issues may take less time; less agonizing during the NDA final approval process. It could be a no-brainer, thus assuring a quicker approval.
best,
Willy
Myself i think 5 years is asking for alot, these trials take time. I remember over 3 years ago people were saying telaprevir would be here in 2 years and were still a good year and a half away. Just my opinion.
can
can
5 years ?
That`s what my PA told me is the average progression rate for one stage.
hmmmmmmm.
That`s what my PA told me is the average progression rate for one stage.
hmmmmmmm.
Google "Inform 1, HCV".
I think you'll see a presentation on it at this years EASL.
There are about 3 Stat C dual acting antiviral trials started or just about to start. Vertex is one.
It remains to be seen if these trials will allow IFN +/or RBV to be eliminated or reduced from TX.
Yeah, almost certainly in 10 years but for some unknown percentage it could also be as soon as 4-5 years. Vertex claims they will show results in the second half of the year, but it would be impossible to show SVR rates, but response rates could be revealed (like 2 or 4 week or even 12 week response rates).
Willy
I think you'll see a presentation on it at this years EASL.
There are about 3 Stat C dual acting antiviral trials started or just about to start. Vertex is one.
It remains to be seen if these trials will allow IFN +/or RBV to be eliminated or reduced from TX.
Yeah, almost certainly in 10 years but for some unknown percentage it could also be as soon as 4-5 years. Vertex claims they will show results in the second half of the year, but it would be impossible to show SVR rates, but response rates could be revealed (like 2 or 4 week or even 12 week response rates).
Willy
They are already running trials for non-IFN treatments. Probably 5 years for Geno 1 and longer for other genos...
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