How do we put pressure on Gilead/Bristol??

[UKgirl55]

That's my question because this just makes me sick!

http://hepatitiscresearchandnewsupdates.blogspot.com/2012/04/gilead-bristol-put-profits-ahead-of.html

[Willy50]

The EASL results have not been in long.  I am not that up on things myself.  And so I did a little reading tonight.

=========================
http://hepatitiscresearchandnewsupdates.blogspot.co.uk/2012/04/easl-2012-all-oral-combination-of.html

I believe i also read that this group was comprised of a 44% il-28b CC genetic marker;  But 3 different arms with 3 different regimens, but each arm achieved a 100% SVR-4  I believe that 1/2 of the 88 participants were G-1 for a total of 44 total, and so the sub-sets of groups will be pretty small and subjective.  I'm not sure that you had enough cirrhotics/ null responders, etc, to draw much in conclusions.  No discontinuations due to sides it appears.
--------------------------------------------------

http://www.natap.org/2012/EASL/EASL_45.htm

"Why the disparity between the strong Electron results and weaker Quantum results using the same treatment regimen? Electron enrolled easier to treat patients -- 44% had the IL28B "CC" genetic variant of the hepatitis C virus which is known to respond better to treatment. By comparison, only 16% of the patients in the Quantum study carried the "CC" genetic variant."

This may mean that the results while 100% were in a statistically too small group, and that the il-28 predisposed it to success.
I think that it was exciting seeing the 100% SVR rate, but the outcome may not be quite so robust in larger trials.
----------------------------------------------------

I believe there is currently a trial collaboration between Gilead and BMS with null responders that is at approaching a month in., and so they may have a handle on a percentage of RVR's in nulls, or soon should.  I am not sure that given the size of the Electron study that one could conclude a lot about other factors which affect response and SVR rates.

It is a good start and given that some of the DDA's I have seen have been so-so, the collaboration seems to have great potential.

Anyway..... here is a little information. I'm not totally positive it is correct.  I had to shop for it; perhaps I made an error in transcribing or understanding;
Loooong day. : )

willy

[mdudley]

Excellent post...and frightening at the same time!  I hope people will not underestimate the power of the internet when it comes to signing the petition, posting it on facebook, twitter, etc..  Remember the Arab Spring?

http://www.thenational.ae/news/uae-news/facebook-and-twitter-key-to-arab-spring-uprisings-report

Facebook and Twitter key to Arab Spring uprisings: report
the "Arab Spring"

Social media – its rise and its new activist uses – have “played a critical role in mobilisation, empowerment, shaping opinions and influencing change,” the report said.

Perhaps this could be the start of the "Hepper Spring"!  Petition link below:

http://www.change.org/petitions/gilead-sciences-a-phase-iii-collaboration-for-the-treatment-of-hepatitis-c

Heppers Unite!

[SusieS2010]

Your above post was excellent. Your point about the people with late stage disease is well taken. But I have a question. The BMS drug + 7977 has a phenomenal SVR rate. But who was in that study? Were there Stage 4 patients involved? I don't honestly know. That makes a huge difference for those of us in the hardest to treat segment of the population. And what about previous null responders? Am I wrong or was the BMS/Gilead study just for treatment naive patients? Often drugs look much better in trial than they do in "real" life, especially when they are only given to patients with a really good profile.

I still don't think a petition is the best way to go abouth this. Letters to the pharma company work much better. On-line petitions are not very well thought of by any group whether it is government or the private sector. At change.org they often have a note saying that signers should follow up with a letter to their legislators or to the people they want to reach.

If you know my answer to who was enrolled in that study, I'd appreciate it. I was horrifically disappointed when 7977 + ribavirn that I was waiting for was canned due to such a dismal rate of failure in us cirrhotic patients while it did so well with treatment naive.

[UKgirl55]

Now that was the most well written post I've ever read. It has literally moved me to tears.

[FaithforHealing]

Just posting the link to the petition again to keep it at the forefront so everyone has a chance to see it and sign it.

Regardless of Gilead's real motives, good or bad, we need to keep the chatter alive....silence is deadly.

http://www.change.org/petitions/gilead-sciences-a-phase-iii-collaboration-for-the-treatment-of-hepatitis-c

[Willy50]

Thank you for the compliment. : )

I often read that 8-10,000 die annually from HCV.  
As this group of people die, other decompensating patients move to take their places.  
And so each year there is not a decent cure, a large number of people die.  The numbers aren't in quite yet, but this 10,000 per year mortality rate is a large percentage of the number who have treated this year since triple therapy has been approved.

I mentioned that it is still too early to know what Gilead will do, but in the race for getting drugs or drug combinations approved, it does not seem that Gilead is in any hurry to partner with Bristol Myers.  You have to wonder about the numbers of people who will be affected by this lack of cooperation.

Many of the people who will be affected are too liver compromised to be able to treat with SOC.  The odds of success for normal HCV infected patients are *better* with triple therapy, but that sad fact remains that the most cirrhotic are the least likely to be able to survive an even tougher and longer treatment.  Cirrhotics have increased mortality risk, a lower success rate and many of them are past treatment failures; non or null responders.

The dual acting antivirals, such as the ones partnered with Gilead and Bristol Myers Squib have a 100% SVR rate and a lower side effects profile.  This is a drug that seems to have the greatest chance of curing this group of 11th hour patients.  These people are not only in the 11th hour, but in the last 15 minutes of the hour.

I think that one can infer that if Gilead does not partner with BMS on the next step in getting the combination through FDA approval that for a certain number of these people the clock will run out.

If Gilead recruits from within with their own drug to partner with 7977, then I would guess that they would need to start with Phase 2a trials again, as they would with any new partnering.  I won't attempt to guess at the amount of delay that would involve, but a safe estimate would be a greater than 1 year delay.

When the drug company uses a "wait and see" answer about the potential partnership, I wonder if this is indeed a race.  
When they mention waiting to see results, I wonder if they don't already have the needed results.  In this age of SVR4's one knows a lot in just weeks after EOT, and I would wager that companies understand the viral kinetics of a compound or treatment in short weeks after commencing.  

I would venture that a trial could be started tomorrow, one with a 12, 16 and 24 week arm or if they had intended to partner; it would have been already set up, or some other trial configuration.  
I don't see plans, haven't read about any plans however...... other than waiting.  

As another sage member wrote; they have 11 billion reasons.....
This is not the type of response one would have expected from the leading HIV drug company.

This is just one guy's viewpoint.  I don't have all the facts, there isn't a lot of data, we don't know what Gilead will do, or Bristol, but to me it looks a lot like the mythical 100 MPG+ carburetor that have the rights bought up and was removed from the market.  
Here is a highly successful (don't come much better than 100%) drug partnership poised ready to enter further trials....phase 3?  Instead, the partnership sits on the side of the tracks like an empty railroad boxcar while people die.

I don't think Gilead would give much weight to my one signature on a petition, and so here I am today; venting and hoping that I am terribly wrong about all of this.

willy