latest vertex press release

[it'sallgood]

-HCV: Rolling submission of New Drug Application for telaprevir expected to begin in summer of 2010; first Phase 3 SVR data expected in second quarter 2010 from ADVANCE trial-

"Vertex continues to make important advancements across the business as we prepare to submit a New Drug Application for telaprevir in the second half of 2010," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex Pharmaceuticals.

"Our Phase 3 registration program for telaprevir in hepatitis C virus infection is nearing completion, and this quarter, we expect to receive the first Phase 3 SVR registration data from the ADVANCE trial in treatment-naïve patients, followed by additional Phase 3 SVR registration data from the REALIZE trial in treatment-failure patients in the third quarter," continued Mr. Emmens.

"Importantly, we now plan to submit our NDA for telaprevir on a rolling basis beginning this summer and expect to complete the NDA submission in the second half of 2010 with clinical data from Phase 3 trials in both treatment-naïve and treatment-failure patients. Our commercial and launch preparation activities remain a key focus for 2010, and we are on track to achieve important milestones in the NDA submission process.

[willing]

ps:
it's also interesting that if you just look at the total for how many non-responders got to SVR among the rollover group you get (3+ 16)/51 = 37% which  closely matches the original PROVE3 results.

The 'exit' rules for who was kicked out differed, so it's hard to get a direct comparison, but that 57% looks like it not only requires  the best possible light, but also turning off a few other lights...

[willing]

agreed about the need for skepticism in looking at these results -  VRTX has got a lot riding on this. As best I can tell the accounting looks OK and (almost) matches what McHutchison et al reported 4/15 at EASL (though the counts on the EASL abstract and on the VRTX press release are slightly different ?!) .

The main hidden gotcha is that all 117 patients in this study had just completed and failed a previous attempt in one of the PROVE3 arms.  Whether this 'sensitized' them towards success in round 2 is a reasonable hypothesis - but unprovable. What we  know is that the responses for prior non-responders and relapsers in the main round of PROVE3 were quite a bit lower than  among the 117 who failed, and were offered a roll-over. Also, they  don't give baseline data for the rollovers, so it could have been an easier-to treat mix.

Among the main PROVE3 :
"The rates of sustained virologic response among patients with no previous response were 39% in the T12PR24 group, 38% in the T24PR48 group, and 11% in the T24P24 group, and the rates among patients with a previous relapse were 69% in the T12PR24 group, 76% in the T24PR48 group, and 42% in the T24P24 group. In the PR48 group, the rates were 9% among patients with previous nonresponse and 20% among patients with a previous relapse."
from the NEJM Prove3 paper:
http://www.ncbi.nlm.nih.gov/pubmed/20375406

so null responders SVR rates did not quite reach 40%. From their table1 there were between 57 and 50  non-responders in each of the 4 arms.

On the other hand for the roll-over it looks like  they started with 51 non-responders all of whom had T12/PR24.  Of these 23 did not meet VL drop criteria and were kicked out at w24 and the remaining 28 went on for another 24w of P&R. In first group only 3 got to SVR but in the second 16 did justifying the 57% claim.  

The samples are still on the small side, but my hunch is that the previous treatment or a different patient mix accounts for the better showing among rollovers. Prove3 was a well-designed prospective  study, whereas the rollover phase included whoever came along.  Overall, the original Prove3 numbers seem the more reliable indicator of what odds to expect as a non-responder.

[Cory255]

There's a lot of people in this boat.  It will be interesting acquiring this 3rd drug to the cocktail.  Cory.

[IAmTheWalrus]

Thanks for the input. I am glad you stopped before becoming a victim. The more I hear about Infergen, the less I like it. I found out that is what Elaine's Nick was taking and DebC also. I think DebC cleared though.

I am glad I can wait for Bocep/Telap - revir!

[Magnum]

Infergen was working better than the other three traditional treatments I failed. However, and please remember this, at the overdose of 24mcg. instead of the traditional 15mcg. daily injections, it was a race to see who would be killed first, the virus or me. As the doctor found out after three months of this, it would have been me...

I rest my case...

Magnum

[IAmTheWalrus]

I am excited by the prospect of seeing many SVRs in the future with Telaprevir and Boceprevir!

I am a little confused about retreatment with Infergen. I have heard several comments about this recently. It strikes me as odd that one would consider this treatment with PI drugs on the horizon. Are the results of treatment with Infergen very good with relapsers? I never got that impression.

Brent

[burned74]

This is great news.  Many of us will be cured in the next few years.

I was thinking about adding Vit D to the tx if I am lucky enough to get Teleprevir next year.

[Magnum]

Appeal to the pharmaceutical company for a "compassionate use" of the drug once it’s licensed for release to the public. They may well help you to forgo the expense, especially if you tell them you will contact CNN and tell them the tale of their generosity. You have nothing to lose at that point.

I know that Dr. Robert Gish has said he is going to try and help a friend of mine with no insurance, to get the drug once it's licensed...

Mag

[susan400]

Waiting on Telaprevir (not my choice), or Boce..., is not the issue for me.  The issue is the way to be able to pay for it.  I don't have the money to come up with the $5,000 out of my own pocket before the GAP/catastropic will start paying and then, after they'd start paying is would be a horrendous co-pay (and this is just for Pegasys/Riba)..., the new drug would not be covered as it's not going to be a part of their formulary.  That's the issue for me...

Susan400

[can-do-man]

BTW, you might want to read magnums post here.
http://www.medhelp.org/posts/Hepatitis-C/Infergen-Torture/show/92085

Or donnierayes post on the social side on treating with infergen and talk with your doctor about this.

[can-do-man]

Sure you have time to wait, i'm stage 4 (cirrhosis) and waited a year to tx again. At your stage and depending on when you become und with one of these new PI's treating time would most likely be 24 weeks.

Everyone has to do what they think is best for them, but if i was you without a doubt i would wait....... Good luck

[agatha56]

Thanks.He wants me to start on Infergen but I may wait for the new one. What do you think. I was a stge 2 grade 2 in Dec 2008 begore I did tx. Do I have time to wait?

[can-do-man]

Hi, i'm not trin shes better looking then i am...... But any way, once its FDA approved and ducks are in a roll doctors will have access to it.

Your doctor might mean doing the same thing would be useless, thats how my doctor felt but by adding one of the PI's its a hole new ball game. I was in the relapser trial with boceprevir and now SVR.......... Best to you

Cando

[agatha56]

Does that mean that Telapravir will be released to most gastro and liver docs by the end of the year and if you have already relapsed on riba/inf can you try this. My doctor said that riba/inf would be useless to me to tx again with.

[banarep]

mu study doc indicated to me that those that were on the no riba might be able to do telaprevir again.  

[JennyPenny2009]

"Early results with TVR and pegintron + riba, show nearly 100% SVR for relapsers with 24 week treatment and an impressive 60% SVR for prior non-responders with 36 week treatment: "

I wonder if they are counting the dropouts in those stats. At the last Telaprevir meeting they talked about a 31% SVR for previous Geno 1 non-responders. We have to be careful with the stats. They are often quite skewed depending on who they are counting.

[Trinity4]

I running in the pack with all of you and hoping my liver doesn't begin protesting.  I'm so ready to start treating again and wish the PI's were here.  I like the boce too but I'll take which ever comes around first.

Trin

[Magnum]

Because of what I heard of trial results at Cedar-Sinai's clinical trial, Boce has an edge over Tele and does not have the horrible rash syndrome. However, you and I and others must insist the doctor does a timely blood work to keep an eye on Anemia.

Now that Vertex has announced they will apply this year, not to be outdone, I'm positive Schering will speed up their effort to apply.

Here's some interesting reading on the subject in the link below, although there is always politics involved when it comes to the final reaping of cash by these companies. It wouldn't shock me at all if there's a kick-back on sales to the government. Politicians being crooked? What a shocker!

http://www.eatg.org/eatg/Global-HIV-News/Hepatitis/Telaprevir-may-be-viewed-more-positively-by-clinicians-than-boceprevir-for-hepatitis-C-virus-treatment-following-their-launches-in-2011


Magnum

[HectorSF]

Go to know. So the Spring 2011 date that I have heard appears to be feasible.
Very good news for me as time is running out to retreat. Signs of decompressed cirrhosis are rearing their ugly little heads. Yuck!

Anyway heard of a time table for Boceprevir?

HectorSF

[HCVhost]

Early results with TVR and pegintron + riba, show nearly 100% SVR for relapsers with 24 week treatment and an impressive 60% SVR for prior non-responders with 36 week treatment:
http://finance.yahoo.com/news/59-Percent-of-Patients-bw-3833118686.html?x=0&.v=1

The down side is the itching and rash people have been dropping out for.

Abe

[susan400]

That's nice for some of you.  I myself, can't do Telaprevir as I've been exposed to it..., in trial, didn't clear and got the horrible rash 2 wks into it.  I know it was Telaprevir since I didn't get Riba in the mix, I was in the 'no Riba' group.  I know Tele works great for some people though.  I'm hoping that Boce  is not too far from being approved and I'll try it using all 3 drugs, IF and this is a BIG IF, I can find some way to pay for it.

Susan400