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Avatar universal

Good news for all - plans for 7977

There is great news for here everybody. By everybody, I mean all genotypes regardless of degree of liver damage or prior null response to interferon.

http://www.gilead.com/swf/fireside_chat.mp3

For those that don’t want to listen to the whole audio presentation, I have listed up the points that caught my attention most of all. There is much more information in the presentation.

-- Gilead expects filing for FDA approval of GS 7977 in late 2013 with approval to quickly follow in early 2014.

-- FDA has made regulatory pathways much easier to negotiate. The combination of dosing periods lasting only 12 weeks and FDA standards for SVR reduced to 12 weeks post treatment is ensuring quicker approval times. A 2013 release date for GS 7977 is a reasonable estimate of time rather than a "best" case scenario.

-- GS 7977 has displayed no significant side effects or adverse drug interactions to date. It is very safe.

-- Gilead is preparing to run 7977 trials for harder to treat Hepatitis C conditions without waiting for data from the other trials. These will include all the varieties of pre transplant conditions in Phase III. The goal is to release GS 7977 to be used for treating all genotypes at all stages of HCV disease progression from the start.

-- Gilead has a drug GS5885 which is effective for genotypes 1 and 4 which is a candidate for testing with GS 7977.

-- Trials involving GS 7977 will no longer necessarily involve an interferon arm but rather a placebo arm which turns around to a treatment arm after a period of time.

-- GS will try to pair some of the other GS drugs with GS 7977 or ribavirin with it.

-- Combining GS 7977 with BMS was not ruled out and studies continue.

-- Treatments involving Interferon will become unnecessary. In the near future Hep C will be treated with a two-drug combo lasting 12 weeks. Initially this may include Ribavirin but that will be replaced quickly by a number of less toxic alternatives. The treatment will be safe and simple so that many more people can be treated by a wider range of medical professionals.

Enjoy the new future. It is much much brighter!
28 Responses
1995824 tn?1330379049
Wow! Just wow!
Avatar universal
Oops I made a typo in one spot there. Should be appllication for approval in late 2013 and actual release in 2014.

It certainly is wow, just wow and wow again.
Avatar universal
Wow, sounds like a miracle compared to triple.
2004810 tn?1365153611
when can we expect this to be available f.ex in Europe?
Avatar universal
I don't know. I live in Australia and we are usually 6 months behind the U.S., or more sometimes. In the circumstances I think governments in countries with public health systems would be quite keen to fast track non toxic treatments that will save money. I have no idea what the new treatment will cost but it will definitely be less of a burden on health systems as well as being more effective across all genotypes.

I intend to write to my health minister and ask them to be proactive.
2004810 tn?1365153611
So when will this be released in the U.S.? Sorry if I have missed something that was already written in your posts...am having a bad day today..reading this great news makes me wanna quit triple tx and get the poison feeling out of my body (and brain).
190885 tn?1333025891
thanks for the update! this is exciting.....billy
Avatar universal
So when will this be released in the U.S.? Sorry if I have missed something that was already written in your posts...am having a bad day today..reading this great news makes me wanna quit triple tx and get the poison feeling out of my body (and brain).
-----------------------------------------
Certainly do not do that....this presentation above was given to investors by a representative of the drug company on there "supposed  and hopful time lines.

The presenter said they "hope to file for approval in the first half of 2014    ..with a approx. 6 months approval timeline to follow.

This takes the process into late 2014 which is still aprrox. 3 years away and he "repeatedly mentioned 'IF" the trial data goes the way they "HOPE"

I am not onee to rain on the parade of new modalities(I am hoping to be able to wait myself.) coming down the line and I for one believe the landscape will change in the future for HCV therapy...however in a best case scenario this  looks like still very well could be 3-5 years away ..(hopefully closer to 3)

For anyone treating currently ..in my opinion you are doing  absolutely the right thing ..with your doctors advice and any one who has moderate and certainly advanced fibrosis currently should certainly be conversing with your doctors about treating with the  approved triple therapy that are having excellent results..

Again...thinking about quitting therapy because of one  drug executives "opinion is never wise  IMHO...

Will
Avatar universal
Thx. for posting.  It is always good to hear everyones opinions on the future landscape of HCV therapy.

Best to you..
Will
Avatar universal
Wow that's great
When r the next trials?

How come all the people who were inhales on 7977 do not pot here anymore? Are they not allowed to talk about the results?

Sounds very good for the future
1722607 tn?1335747858
What's 7977???
Avatar universal
Hi summer  ... 7977   is  an experimental polymerase inhibitor (in the direct antiviral class)  that was developed by Pharmaset that is now owned by Gilead Sciences.

This drug has had good mid - stage trial results and could very well be one of the drugs used for HCV in the future,hopefully in the next 3  -5 years.

Will
179856 tn?1333547362
Certainly do not do that....this presentation above was given to investors by a representative of the drug company on there "supposed  and hopful time lines."

Yes please do NOT stop triple!!!!!  when we first heard about incivek way back when i was just starting to treat in 2005 it was called Vx-950.  It was supposed to be coming out, soon. Then it was pushed back and back and back and was only just approved late last year as you know.  Things can happen, drugs can fail to be approved or take much longer than originally anticipated.

If this drug is approved within the next five years that would be a tremendous marvelous wonderful thing.

Never go by an investor report to decide any medical treatment, raising money is one thing - killing the disease is quite another.



Avatar universal
Actually will, I made the same mistake.  I think it was due to the order in which the estimate was given.

The actual quote takes place at 21:00 in the presentation.  The rep says approval by mid 2014, the submittal in late 2013 and about a 6 month wait for FDA approval process.  It sounds as if it is possible that.....if the drug were approved in march 2015 and for the sake of ease.....lets call this March 2012, then it could be very close to 3 years.

willy
163305 tn?1333668571
Thanks for the post.
We all remain hopeful~the future of hep C treatment does indeed look bright.
Avatar universal
I am also going to mention that I was approved to participate in Phase 3 of the Vertex telaprevir trial.  I applied and was accepted in June 2008.  That was the first of the Phase 3 trials for Telaprevir. (I dropped without dosing when my biopsy showed 1/6 ishak staging)

If you recall..... telaprevir (incivek) was approved and available in June 2011.  In actuality..... the trial I was accepted into did not start dosing until later in the summer.....delays.....in starting.

This means that from beginning of the Phase 3 trial until approval was actually under 3 years.

People who listened to the presentation also understand that things have changed since I was in the trial;

These drugs will no longer have a SOC arm as a comparator.  The trial I was in had a SOC arm of 48 weeks and a "official" 24 week EOT PCR.

These new trial will not have the long comparator arms of 18 months.

The new protocols are for a SVR12 EOT PCR and most of the arms will be 12 and 24 weeks; not 48.

So the question is...... if the vertex Phase 3 trial was completed and the drug approved in under 3 years...... given the new approval protocols and trial designs...... how could approval time take longer?  

Would it not seem *reasonable* to expect 3 and possibly less time for approval than 3 years?  5 years could almost be doubling what may be the actual approval time.  Obviously, we will see what we get, but I wanted to explain how and why I view 3 years as totally possible and likely.

It could easily be less than 3 years.

willy
179856 tn?1333547362
Are they already at phase 3 in the trials?
Avatar universal
Folks before you stop treatment a few things you should know, as was noted Incivek (then vx-950) was fast tracked in 2005.
FDA Grants Fast Track Designation to Vertex's Investigational Oral Hepatitis C Virus Protease Inhibitor VX-950
http://investors.vrtx.com/releasedetail.cfm?releaseid=190509

And then we had VERTEX claiming this.... From our insider " couldn't think of a nickname"

"To set the record straight, VRTX  has said they anticipate filing for approval in 2008 (mid at the earliest I think), and it would be subject to expedited review, which is 6 months, instead of the normal year that is taken. That would take place after phase 3 is completed."

http://www.medhelp.org/posts/Hepatitis-C/Vertex-VX950-good-news/show/94488#post_728202

As you can see, fast tracked in 2005, vertex claiming filing for approval in 2008, so you can see why some hear don't get to excited when investors and even the drug company themselfs speak.... What was expected was 2008, what happened was mid 2011.







163305 tn?1333668571
I don't think anyone should stop treatment but if your liver can wait a few years, you might choose to delay it.

For those with little or no damage, this is great news.
Avatar universal
Yea Zacks is an Investment and Research Co so it totally makes sense that the Pharma companies wine and dine them and throw them their pitch.  But Zacks is not the one to say...ok we approve this drug(s). It's the FDA and they are not concerned with the pharma's stock price.  

Hopefully in the near future they will be able to approve less toxic drugs but in the meantime if you are tx I sure as hell wouldn't stop.    
Avatar universal
Can do,
I have listened to many of the Vertex presentations; I never heard them mention a date.  Rather, they would go out of their way to avoid mentioning dates or time tables.  They were very conservative.  No forecasts, they left info blinded more than other companies.  People should have little to chastise them about.  They were really very accurate.  The ONLY time I heard one was about early 2008...... by Josh Boger, at the time the CEO of Vertex who thought that interferon might not be required by 2015.  He was talking also about the VX-222 collaboration w/ telaprevir.  You'll  note thatthose 2 compounds are in Phase 2 trials, now with riba and there will be a presentation at EASL in April about the results.  My guess is that VX-222 w/ Telaprevir and Riba may provide a measure of interferon free success in treating G-1 patients.  I don't know if or when it could be approved, but if that trial is in phase 2 trials, phase 3 completion may be in the cards as well.  I am not seeing that he was dramatically off base.  (although time will tell)

I think that is in the area of correct.  
One can read all sorts of nonsense on boards, but it is always from members.  The stuff one hears in company presentations has been pretty accurate, from my experience.

Deb;
http://www.gilead.com/pr_1632335

"Pharmasset currently has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company's lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog,


has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients.


Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014."
(I could not BOLD FACE this and so I provided spacing for emphasis-willy)

willy
Avatar universal
Not so fast willy...

Because hepatitis C has few treatment options, analysts have estimated the worldwide market for drugs such as VX-950 could be as high as $8 billion. If the clinical trials go smoothly, Vertex has said it could be ready to file for FDA approval in 2008.

http://www.natap.org/2006/HCV/020806_06.htm
Avatar universal
As you can see, not just internet rumor..... But from josh boger and vertex themselfs.

VX-950 recently entered Phase II clinical trials. Boger said that the company hopes to be able to start Phase III testing in 2007. If the trials go smoothly, the company may be ready to file for regulatory approval as early as 2008



http://www.marketwatch.com/story/vertex-gets-fast-track-for-hepatitis-c-drug
Avatar universal
Thanks, I had to look a few times but found it; an analyst quoting an unnamed source.  
You get my point also I'm sure.  I didn't see Ian Smith or Josh Boger providing the information.  I would still repeat I never heard them mention dates or timelines in presentations, they would be very vague about what info would be presented in what conference.

Thanks for providing the link to the old thread; I had to go back and make sure it wasn't me that made the prediction.  : )

I think as members we are problematic sources.  We have the disease (or had it, or have a family member/ loved one with HCV) and so we are very attached to our views/ hopes and understandings of what we hear.  I think that being so affected it is hard for us (myself certainly included) to be objective.

I think it's impossible to predict, but it is still worthwhile trying to talk about such things.  Information is subject to change, but imperfect is better than no info.

My point is that for a few reasons given approval for GS-7977 looks viable in the time frame provided in the presentation, particularly given the experience we have seen with approval of Telaprevir, boceprevir and in light of a few of the streamlining processes made by the FDA.  As the trial arm durations get shorter, does it not make sense that the time to perform such trials gets shorter as well?  

1) trial arms will be 12-24 weeks instead of the norm of 48 weeks.
2) SVR 12 is accepted now instead of SVR24 (from what I heard)
3) Trial arms will not have SOC comparator arms (which take 48 &24 weeks for "official") SVR
4)  Pan genotype trial arms may be seen; treating multiple genotypes in one trial.

Looks to me that there are reasons approvals may take less time in the future.  We will see what we end up with.  : )

willy
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