Prove 3 results

[burned74]

I just saw this on HCV Advocate. Vertex is announcing that they had 51 per cent success in Prove 3 for non responders vs, 14 per cent for SOC.

[Willy50]

But you'll notice that the article was from June 2008; 9 months ago.  At that point they already had all the SVR 12 data.  In theory, it's possible that they could have released the data in the fall AASLD but it didn't happen.  Anyway; the blinded and randomized arms all started at the same time.  The SVR 12 data was 9 months ago.  Just my opinion but I think this is all inclusive of all the treatment arms.

EASL is the 3rd week in April but I would venture that we may see some discussion about the posted results before then since as the most recent article noted..... the results are posted on line.  If it is the case I'm certain that there will be commentary about the 12 & 12 vrs the 24 & 24 form of triple therapy.  I had thought I had read/heard that the results were insignificant between the two arms but that for slow responders/null responders they were interested in protracted SOC TX times to see if they could tease out a higher success rate.

I think we'll soon see one way or another.

best,
Willy

[Andiamo1]

"They started all the arms at the same time"  

But they didn't all end at the same time and the article you posted said ".........There is a control arm in the PROVE 3 study, but these patients are still being followed. At this point, 8% of these patients retreated with standard therapy (interferon and ribavirin) had undetectable levels of virus after 12 weeks of treatment. After 36 weeks of treatment, the undetectable level rose to 30%. ....."

The arm I was in is the same length as the control arm and all the data are definitely not in.  In addition, although the arms started at the same time, the 24 + 24 patients did not all start at the same time and many have not completed 48 weeks post treatment.

Aside from all this, a friend of mine in the rollover study was advised to go an additional 24 weeks, due to her age and the fact she relapsed.  That sure leads me to believe that the extra 24 weeks makes a difference for relapsers and Vertex knows it.

[SnoWav]

That sounds great 24 weeks would be a walk in the park compared to 48 weeks or more. looking forward to that day. only 6 in of snow left here spring is comming.

[Willy50]

I don't think that I am incorrect (but I've been wrong before  ; ) ).  I believe that they included the 24 & 24 results (SVR12) in the june article.  Now about 9 months has since elapsed.  I believe that the complete results have been posted.  They started the Prove 3 trial ....all arms at the same time.  Would the 24 & 24's not be done if the SOC's are all done?
(2 links provided and snatches of quotes.  Please visit the link for the complete article- Willy)
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http://www.thestreet.com/story/10420415/1/vertex-unveils-more-upbeat-hep-c-drug-data.html

Vertex Unveils More Upbeat Hep C Drug Data
06/09/08 - 10:28 AM EDT

.......The new data on telaprevir come from the PROVE 3 study, a phase II clinical trial that enrolled 453 hepatitis C patients who failed to respond to prior treatment. This is an interim analysis, which means that, to date, telaprevir patients have only been followed for 12 weeks post-treatment........



..........There is a control arm in the PROVE 3 study, but these patients are still being followed. At this point, 8% of these patients retreated with standard therapy (interferon and ribavirin) had undetectable levels of virus after 12 weeks of treatment. After 36 weeks of treatment, the undetectable level rose to 30%. .....



http://www.thestreet.com/_yahoo/story/10474626/1/vertex-hep-c-drug-improves-cure-rate-in-study.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

Vertex Hep C Drug Improves Cure Rate in Study
03/19/09 - 10:31 AM EDT

The new data come from Vertex's PROVE 3 study, which enrolled 453 patients who had failed prior treatment with the current standard drug regimen for hepatitis C -- a 48-week course of long-acting interferon plus ribavirin. In the phase II study, these patients were randomized to receive either treatment with a combination of telaprevir plus the standard therapy or retreatment with the standard therapy alone.

[Andiamo1]

I forgot to mention that the 24/48 week comparison data you are looking at are probably from the naive trial.  If you assume that 50% of that trial would not reach SVR with SOC, then the difference would probably at least double with a non responder only trial as I was in.

If you broke the failure to respond data into null, relapser and breakthrough, you would probably see an even greater difference in the 24/48 week comparison.  I am fairly certain that these data are not released yet.

[Andiamo1]

It is not possible for all the results to be in.  The trial continued to start new patients for three months following my first pill.  

Has Vertex posted the 24 + 24 results?  I did not see that on their website.

[jacksonblue]

i believe willy is correct i was told if not neg by 4 weeks but neg by 12 carry on to 48 weeks there is also predosing trial once rescue drugs come into play i think this will help yahoo last pill tonite

[Marcia2202]

YAY!!! That is fantastic news!!!

[Willy50]

I could be wrong but the final results of prove 3 were held up pending the final outcomes of the SOC arm.

The arm that you were in had the same duration as the SOC arm, therefore I would guess that they are all in.  Further, if the papers say; "final" results, I would suppose that this is inclusive of your arm.

I had also thought that there was little difference in outcomes between the 12 &12 compared to the 24 & 24.  (I could always be wrong about this; some time has elapsed)

The issue that is being explored now in 2 more phase 3 FDA trials is possibly if treating any triple therapy slower responders to longer periods of SOC could help in the ultimate success rate.  

It's another topic.... but one of those trials also will explore the effects of predosing with SOC (4 weeks I think) before starting the TVR.

best,
Willy

[Andiamo1]

I was one of the first to start the 24+24 arm and I am now just 48 weeks post treatment.  Based on that, I expect the results from the arm I was in  to be made public in a few more months.

[jacksonblue]

thanks in 12 week triple 12 double looks like about 41 percent non responders 44 in breakthrew and 73 percent in relapsers numbers may go up on 48 week arm i have relapsed 3 times once from 72 weeks regards steve

[can-do-man]

Thanks

BTW, your news looks great. Looks like SVR for you..... Best to you

[jacksonblue]

4 arms group a control arm soc  up to 48 weeks
group b pegasys rib telaprevir 24 weeks soc for  24 weeks erics arm
group c pegasys telaprevir no rib 24 weeks
group d pegasys rib telaprevir 12 weeks soc 12 weeks this was a phase 2 study
i was on arm a relapsed after 48 weeks i finish rollover arm 12 weeks triple 12 weeks double tommorrow been negative since week 2

[can-do-man]

I'm confused, (no surprise there), These prove 3 results don't include you? or was there also another prove3 trial you were in that had different arms?

Background: PROVE3 is a randomized, placebo-controlled Phase 2 study assessing safety and efficacy of telaprevir (T) plus Peginterferon-alfa-2a (P) ± Ribavirin (R) in HCV genotype 1 patients who previously failed PR treatment.
Methods: Randomization was 1:1:1:1 to: T/PR for 12-wks, then PR for 12-wks (T12/PR24); T/PR for 24-wks, then PR for 24-wks (T24/PR48); T/P for 24-wks (T24/P24); or placebo/PR (P 180µg/wk, R 1000-1200mg/day) for 24-wks, then PR for 24-wks (PR48).

[Andiamo1]

These results are from only one arm of prove 3 -- the 24 week arm.  The results of the arm I was in will be released next.  I was in the 24 + 24 week arm and I think these results will show a higher SVR rate.  

I was one of the first patients enrolled and I just passed the 48 week post treatment date, so it will probably be a couple of months before the results are made public.

[can-do-man]

http://www.abstractserver.com/easl2009/planner/sp.php?go=abstract&action=abstract_iplanner&absno=2670&

This don't sound right...............235 (52%) patients completed assigned treatment.

[jmjm530]

Thanks for posting. 3.5 times the success rate in one half the time, meaning half the exposure to interferon and riba with only 12 weeks exposure to Telaprevir.  Impressive. Will be interesting to see how the 51% breaks down in terms of prior non-responders versus relapsers. To take the other side, the 14% (SOC) figure probably could have been improved with extended or a more agressive tx regimen than SOC, but that would have meant even more drug exposure.
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Vertex Pharmaceuticals'(VRTX Quote - Cramer on VRTX - Stock Picks) experimental hepatitis C drug telaprevir is capable of significantly improving cure rates in the most difficult-to-treat patients, according to final results from a phase II study released Wednesday afternoon.

The new data come from Vertex's PROVE 3 study, which enrolled 453 patients who had failed prior treatment with the current standard drug regimen for hepatitis C -- a 48-week course of long-acting interferon plus ribavirin. In the phase II study, these patients were randomized to receive either treatment with a combination of telaprevir plus the standard therapy or retreatment with the standard therapy alone.
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In all, 51% of patients treated with a 24-week regimen that included 12 weeks of telaprevir reported undetectable levels of the hepatitis C virus six months after treatment. In hepatitis C parlance, that's known as a sustained virologic response, or SVR. Simply stated, these patients are considered cured of hepatitis C.

By comparison, only 14% of the patients retreated with 48 weeks of standard therapy alone achieved an SVR, or cure, six months after treatment.

http://www.hcvadvocate.org/news/newsRev/2009/NewsRev-301.html#_Vertex_Hep_C