Aa
Encouraging(Interim results) of Vertex (All Oral) Zenith trial
Small 46 patient study of The combo of a polymerase (VX-222) + INCI + Riba.
Will
http://hepatitiscnewdrugs.blogspot.com/
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced interim data from two treatment arms of the Phase 2 ZENITH study evaluating an interferon-free (all-oral) treatment regimen of the non-nucleoside polymerase inhibitor VX-222 in combination with INCIVEK ® (telaprevir) tablets and ribavirin in people with genotype 1a or 1b hepatitis C who were new to treatment. Interim data showed that viral loads were below the lower limit of quantification ( < 25 IU/mL: < LLOQ) for 80 percent (37/46) of patients with genotype 1 hepatitis C at week two and 83 percent (38/46) of patients with genotype 1 at week 12.
Will
http://hepatitiscnewdrugs.blogspot.com/
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced interim data from two treatment arms of the Phase 2 ZENITH study evaluating an interferon-free (all-oral) treatment regimen of the non-nucleoside polymerase inhibitor VX-222 in combination with INCIVEK ® (telaprevir) tablets and ribavirin in people with genotype 1a or 1b hepatitis C who were new to treatment. Interim data showed that viral loads were below the lower limit of quantification ( < 25 IU/mL: < LLOQ) for 80 percent (37/46) of patients with genotype 1 hepatitis C at week two and 83 percent (38/46) of patients with genotype 1 at week 12.
The other thing I am seeing is that.....if you look at the table at the vertex site..... now look at the two arms combined (G1a was in a distinct arm from G-1b).
Both arms E and F had response rates of 19/23 (cEVR) and totalled
meant that 38 of 46 total trial participants had experienced at least 12 weeks of TX and were clear. If one patient has been lost to followup and 2 experienced virologic failure, I am inferring that probably all are done treating the triple therapy.
What seems to remain is that 11 qualified for stopping at 12 weeks, 9 of which have SVR4.
What we don't know is the final percentage of rapid responders that can stop at week 12. All we can see is that there were about 25% so far who did and that 9 of the 11 were SVR4's
This doesn't equate to SVR 12's,
nor do we know if there are some who qualified but who are not yet SVR4 yet, but may be in coming weeks
Nor do we know the ultimate success/failure rate for the aggregate of the complete group.
I see however that arms C and D had SOC followup for slower responders, that did not meet early response guidelines (I *think* it was UND at week 2 and 8) had a 12 week follow-up course of SOC; IFN &RBV.
Slower response in Arms E and F meant a 24 week followup with SOC, meaning a 36 week total course of TX, 24 weeks of which was SOC.
In my copy and paste above this post they assert that the goal is interferon free treatments and that the next study will NOT be response guided. So I am wondering what that all means. No doubt there will be more elaboration and by EASL there may be more official data and interpretation of what it means. I am trying to be careful not to jump to any conclusions.
PS....if anyone else noticed Vertex started phase 1 trials of their 2 nuc's; the dosing has begun and results of that out in the second quarter 2012, and they may try dosing w/ VX-222 and Incivek in the 2nd 1/2 of 2012 in trials.
willy
Both arms E and F had response rates of 19/23 (cEVR) and totalled
meant that 38 of 46 total trial participants had experienced at least 12 weeks of TX and were clear. If one patient has been lost to followup and 2 experienced virologic failure, I am inferring that probably all are done treating the triple therapy.
What seems to remain is that 11 qualified for stopping at 12 weeks, 9 of which have SVR4.
What we don't know is the final percentage of rapid responders that can stop at week 12. All we can see is that there were about 25% so far who did and that 9 of the 11 were SVR4's
This doesn't equate to SVR 12's,
nor do we know if there are some who qualified but who are not yet SVR4 yet, but may be in coming weeks
Nor do we know the ultimate success/failure rate for the aggregate of the complete group.
I see however that arms C and D had SOC followup for slower responders, that did not meet early response guidelines (I *think* it was UND at week 2 and 8) had a 12 week follow-up course of SOC; IFN &RBV.
Slower response in Arms E and F meant a 24 week followup with SOC, meaning a 36 week total course of TX, 24 weeks of which was SOC.
In my copy and paste above this post they assert that the goal is interferon free treatments and that the next study will NOT be response guided. So I am wondering what that all means. No doubt there will be more elaboration and by EASL there may be more official data and interpretation of what it means. I am trying to be careful not to jump to any conclusions.
PS....if anyone else noticed Vertex started phase 1 trials of their 2 nuc's; the dosing has begun and results of that out in the second quarter 2012, and they may try dosing w/ VX-222 and Incivek in the 2nd 1/2 of 2012 in trials.
willy
It looks to me as though there could be several forms of interferon free treatment on or about 2015; Vertex, Gilead, possibly BMS or Abbott and possibly a few others.
----------------------------------------------------
Good insight....
Will
----------------------------------------------------
Good insight....
Will
I would warn that this is preliminary data. Response doesn't equal cure.(SVR), but it is a good start.
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=650944
The whole thing is a good read but check out this line;
"Vertex Advances INCIVEK, VX-222 and Ribavirin Combination Regimen
Based on these data, and pending discussions with regulatory agencies, the company intends to pursue a Phase 2b study evaluating multiple interferon-free combination regimens of INCIVEK, VX-222 and ribavirin with total treatment durations as short as 12 weeks in people with genotype 1 (1a and 1b) hepatitis C who are new to treatment. The new study will not use response-guided treatment criteria. If successful, data from this study will be used to design a Phase 3 program with the goal of submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Vertex's first interferon-free regimen for genotype 1 (1a and 1b) patients by the end of 2014 or beginning of 2015, pending regulatory discussions. "
It looks to me as though there could be several forms of interferon free treatment on or about 2015; Vertex, Gilead, possibly BMS or Abbott and possibly a few others.
willy
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=650944
The whole thing is a good read but check out this line;
"Vertex Advances INCIVEK, VX-222 and Ribavirin Combination Regimen
Based on these data, and pending discussions with regulatory agencies, the company intends to pursue a Phase 2b study evaluating multiple interferon-free combination regimens of INCIVEK, VX-222 and ribavirin with total treatment durations as short as 12 weeks in people with genotype 1 (1a and 1b) hepatitis C who are new to treatment. The new study will not use response-guided treatment criteria. If successful, data from this study will be used to design a Phase 3 program with the goal of submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Vertex's first interferon-free regimen for genotype 1 (1a and 1b) patients by the end of 2014 or beginning of 2015, pending regulatory discussions. "
It looks to me as though there could be several forms of interferon free treatment on or about 2015; Vertex, Gilead, possibly BMS or Abbott and possibly a few others.
willy
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