Just Spoke To Vertex

[Magnum]

I have a contact at Vertex. We spoke at length about Telepravir and the "compassionate" use. That means use now (without placebo) for Cirrhotic victims. While he couldn't give me a definite time line for the compassionate release, he did say that telepravir being in Phase III, they are seeking approval by the FDA in the second half of 2010, and making it available through prescription instead of the current clinical trials.

Interestingly, he added a comment that we could hopefully expedite the "compassionate" use approval by the FDA if we write them an email stating the urgency for those who need this NOW.

Here is a direct link, with phone number to the FDA: http://www.fda.gov/comments.html

Write to them and continue to bombard them with emails until they give in. This is a battle to be sure, but if the government sees that we are desperately seeking a compassionate release of Telepravir, they could rethink this whole matter. Write an email now...

Magnum

[Willy50]

Sorry; got in late.

You wrote;
"Also the next few years should be the peak of annual deaths as the infection rate has seriously gone down since almost no one gets it from transfusions anymore due to blood screening."
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The compassionate care or the early approval specifically addresses the needs of people in the next 2 years....give or take.  I don't think we should get side tracked with the demographics of the next 10-25 years.  Yes, after the boomers die or are cured there will be many less HCV patients.  I think that is a reason that HCV is sometimes called a self limiting disease.  I think if is was transmitted more easily we would have seen more funding.  : )  

If you think 2006 is old I'm glad that I didn't post this;   (lol; but I will now.  ; ) )
(Hey; it has only been 2009 for 2.5 months....... : )

http://www.hhs.state.ne.us/dpc/hep_c.htm
(about is from about 2003)

HCV Statistics

1 out of 50 Americans are infected with HCV.

3 out of 4 don't realize they are infected with HCV.

CDC predicts 4 fold increase of chronic HCV infections by 2015.

15,000 deaths/year in U.S. caused by HCV.

3 fold increase in annual death toll expected by 2010.

HCV is 4 times more common than HIV.

1 out of 3 people infected with HIV are also infected with HCV.

Hepatitis C is the leading cause of death for those individuals infected with HIV.

U.S. averages 35,000 new infections annually.

HCV financial burden is $15 billion/year.

Disease burden predicted to increase to $26 billion/year by 2021.
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I don't want to hijack a thread.  If this is off topic I would be glad to continue the discussion elsewhere.

I think the actual numbers are hard to define since deaths get coded in various ways.  For me it is somewhat besides the point; would the numbers be more *acceptable* if they were halved?  Feel free to post the *actual number* ......but I think that we are speaking somewhat about principle.

This is not about getting a special treatment for one person who has gout. It is about thousands of people who will die if they do not get treatment SOON.  A treatment exists that will about triple (I'm guessing) the success rate for past TX failures.  It might be as little as twice as effective or up to 4 times as effective as current SOC would be in retreating that group.  The stats are blinded but will not be for much longer.  Vertex is seeking entering into talks about early approval for a certain group of patients and the FDA will respond.  I don't think that Vertex would seek to enter into talks with the FDA if they were not ready to treat these people or if they didn't want to.  

My point is that there is a huge need for a drug to help this population.  (I believe) The drug exists.  There is a HUGE expense in delaying approval.  This can be quantified in lives and in dollars (and we can argue about the mortality numbers or current or projected expense but halve the amount and it's still staggering).

I'm open to another thread unless this expansion of the topic is OK with Magnum.  

I am sorry if I ended up diverting it.  (I thought that early approval might also be as good or better than compassionate care, and might still provide earlier treatment)

best,
Willy

[BelB64]

The article you quote from was written in 2006. That number of 30,000 to 40000 deaths per year is an estimate and only the actual numbers next year will bear out or refute this guess. The good news(if there ever is from these type of numbers) is that it is still quite evident that the vast majority of people with this disease will die from something else. If there are 4,000,000 with the disease and thousands more each year infected it would take 100+ years for everyone to die at these rates. Also the next few years should be the peak of annual deaths as the infection rate has seriously gone down since almost noone gets it from transfusions anymore due to blood screening. Hopefully new medications and treatments will reduce deaths to near zero annually in the coming years.

[Rockerforlife]

I recieved a reply to my letter:

Thank you for writing to the Division of Drug Information in the Center
for Drug Evaluation and Research (CDER).  Your inquiry has been
forwarded to our office for assistance.

Please note that under the U.S. Freedom of Information Act (FOIA), we
cannot comment on products that have not been approved.  However, we can
provide information on the drug review process.  There is a mechanism to
access products that have not been approved.  This would involve a
physician willing to file a single patient or emergency Investigational
New Drug (IND) application and this must be done with the cooperation
and permission of the drug supplier.  If you know of anyone seeking
information on accessing products not yet approved for specific health
condtion, please forward the below links to them.  Thank you.

For more information accessing unapproved products and single
patient/emergency IND, please visit the sites at
http://www.fda.gov/cder/cancer/access.htm and
http://www.fda.gov/cder/cancer/singleIND.htm  

[Magnum]

Just returned from the banding of 4 Esophageal Verices. Still a little grogy, but I want to add that the doctor predicts 4 more procedures to band them all. I mentioned this before. Everyone with Hep C should get tested for Esophageal Verices. This, the doctor agrees with.

I presented the doctor with the protocol for applying for a "compassionate" release of Telepravir. Stay tuned... I will report...

Magnum

[CoWriter]

She was IR.  That is one of the biggest things that makes people fail tx.  You can't expect tx to work if you don't fix the IR.

Co

[Willy50]

In 2 years a lot can happen.......
Just data, no argument.

http://www.nationalhepatitiscinstitute.org/Data/Transmission/CDCdeathrate2010.htm

The National Association of Community Health Centers, Inc. (NACHC) There are approximately 30,000 cases of acute hepatitis C each year in the U.S. Around 55 percent to 85 percent of people who are exposed to the virus become chronically infected. The Centers for Disease Control and Prevention (CDC) estimates that the number of deaths from end-stage liver disease in the U.S. alone will reach 30,000 to 40,000 annually by the year 2010.


--------------------------------------------------------------------------------

AS MANY AS 26,000 PEOPLE WILL DIE
because of Hepatitis C in 2006

This means
EACH HOUR OF EVERY DAY 3 PEOPLE DIE

[Rockerforlife]

How about in cases like , Susan,she has treated 10 TIMES....if  she cant get the 'compassion drugs"...there seems to be a problem with this picture.

[Magnum]

Thanks for your input. After PegIntron failed twice, Pegasys failed once, Infergen failed once, I bring attention to your own comment...

"First of all, you have to prove that the drug you want to use is the ONLY option because there are no other available treatments that are satisfactory.  That would be very difficult to prove in the case of Telaprevir.  There ARE other drugs that can be used to treat Hep C, like Infergen, etc."

I four failed treatments with every immaginable drug offered so far isn't proof that nothing works for me and others on this board, then?

Thanks,

Magnum

[CoWriter]

I worked in Clinical Research as a Study coordinator for 11 years so perhaps I can shed some light on the "compassionate use" process.

In 11 years that I worked in research, we obtained FDA approval for compassionate use of a medication only twice.  

The first case was a patient who had severe gouty arthritis which was causing severe deformities to feet and hands...worse case ever seen by any of the universities that were consulted and the patient even had several toes amputated because the gout had caused huge lumps.  The patient was severely allergic to all gout meds (anaphylactic reaction/respiratory failure) so there was nothing else that could be used.

The doctor wanted to use an old gout medication that wasn't even used anymore.  He  contacted the drug company and convinced them to let him have the medication to treat the patient.  Then we had to take the case to our hospital's IRB (Institutional Review Board) and get them to approve treating the patient with it.  

An Institutional review Board is an ethics committee.  Their goal is to protect the rights and welfare of research subjects (they're the ones that approve any studies done at a  research facility along with the consent that will be used).

We had to prove to them that we were doing everything in our power to make sure the patient would be safe.  Since she was so allergic to all other gout meds, the doctor made arrangements to have the patient be hospitalized to receive the first few doses of the med.  Also have a Pulmonary/Allergist doctor be on the case.  He would take care of allergic reactions if they happened.  

We had to get the "protocol" approved and also a consent that the patient had to sign saying that the hospital, doctors and drug company were not responsible if anything happened to her and would not pay for anything if she had any problems.  Mind you, that doesn't mean that if something bad happens the doctor is off the hook.  The doctors were responsible for taking care of side effects, etc.   We were also responsible for giving updates to the IRB and letting them know immediately (within 24 hours) if the patient had any side effects.

Once we had the IRB approval, we submitted it to the drug company...got FDA approval....and the drug company then sent us the drug.

By the way, drug for compassionate use is FREE to the patient.

------------------------------------

As you can see, the process for getting a drug approved for compassionate use is not as simple as you thought.  First of all, you have to prove that the drug you want to use is the ONLY option because there are no other available treatments that are satisfactory.  That would be very difficult to prove in the case of Telaprevir.  There ARE other drugs that can be used to treat Hep C, like Infergen, etc.

The doctor is the one that starts the process to obtain FDA approval for compassionate use of a drug.  And most doctors are not willing to go through all the hassle when they're not getting anything out of it.  Even if you sign a consent saying that you don't hold anybody responsible, the doctor is still responsible for your well being, stopping the drug if there are problems, getting IRB approval (which BTW, costs money if an IRB not associated with a hospital is used.  We're talking HUNDREDS of dollars), maintaining records, keeping drug accountability records, sending updates to the IRB and FDA, and also sending letters to the IRB and FDA regarding any serious adverse events caused by Telaprevir in any drug trials (the drug company would be responsible for letting the doctor know about them).


I read some of the emails you're sending to the FDA and with all due respect, some of the things you said will work against you.  When you said.....

"As you well know, doctors see dozens of patients per day. The mountainous paperwork they must fill out at the end of the day with blood shot eyes, does not propel a doctor to do this. He’s tired, wants to be with his family and have dinner, have a couple of martinis, plan his next day, maybe watch a show and hit the hay.

If however, you were to make the paperwork simpler and more to the point, they may capitulate and write such a letter. I'm not saying I don't trust doctors, but they have been known to accidentally kill people and as you know, there are some in federal prisons now for other devious deeds. "

You basically told the FDA that doctors don't have the capability or the time to comply with the guidelines for obtaining a drug for compassionate use.  You truly did yourself no favors by saying all that.


I think you misunderstood your contact at Vertex.  What you should be trying to do is get the FDA to FAST TRACK approval for cirrhotics to user Telaprevir.  In other words, to give approval for only cirrhotics to use it before it's approved for everybody else.  Sort of like they did with eltrombopag (the drug that raises platelets).  The FDA granted approval for use ONLY on ITP patients thanks to the unanimous recommendation by the FDA ADVISORY PANEL.

And that is who I think you should be sending all your emails to.  They're the ones that make recommendations to the FDA to fast track a certain drug for a specific group of patients.  

http://www.fda.gov/oc/advisory/default.htm

Best of luck to you.

Co
P.S.  Do I believe that Telaprevir should be fast tracked?  No.  I think there's still alot about that drug that we don't know about.  For example, Tippyclubb and Bklnboy are both in the same Telaprevir trial and they both have high uric acid levels which is associated with insulin resistance, oxidative stress, high blood pressure (and Bklnboy recently developed high blood pressure needing medication) and renal disease.

[CoWriter]

"Some herbs and supplements, such as St. John's Wort and garlic supplements, can affect the level of protease inhibitors in your blood. "
--------------------------

St John's Wort should NOT be used together with any type of interferon since it interferes with its effect.  And garlic can cause/increase bleeding.

Co  

[HCA]

Willy and all,
I think the overiding concern for Vertex and their partners,Johnson&Johnson,Roche ect is providing shareholder return on investment.
In order to achieve maximum profit the telaprevir brand needs to achieve proprietory superiority over it's rival boceprevir.
I think both parties are playing cat and mouse over the data,each wanting to gain the edge.The fact that their are two leading contenders neck and neck may have slowed things a little
Vertex,the FDA and everyone in the industry know about the pressing need for the drug to get to market-they are quite well aware of the human cost of passing time and don't need to be reminded by patient groups.
As business corporations who have invested billions of dollars in getting this incredible drug this far down the line they now want to reap the rewards in an orderly and sustainable way and I don't blame them.There is additionally the safety diligence.
Anyone who has a problem with this is quite entitled to invent their own cure.
As has been stated numerous times the market expects Vertex to file for approval late next year.
Compassionate release for those who cannot wait can be petitioned on a case basis by individual doctors,although I don't believe Vertex has yet referenced a compassionate programme.
The drug companies know that the boom sales time for the protease inhibitors is quite a small window and want the patients to have the drug and spend the money rather than to progress to a stage where they can't treat.
I don't think there is much of a conflict of interest here,and those who are worried will get treatment in time as the natural history of Hepatitis C cirrhosis is slow with upto 70% of compensated cases remaining compensated ten years post cirrhosis diagnosis.
These are my last words on this thread although I'll continue to follow the debate.

[Willy50]

One does not need to "talk" to anyone at Vertex.  They have been saying for about a year that they plan to provide the FDA with the data from Prove 3 as a registration run and enter into talks with the FDA on the possibility of an early release for past TX failures.  That should occur by mid year.  They have thus far refused to speculate further on much more about those talks.  My *assumption* is that if they didn't want an early release or that if they didn't think it possible or desirable that they would not initiate talks.

Maybe I'm missing something......

Willy

[can-do-man]

prior post.......What i don't understand if you have a good contact at vertex and a doctor with the status of dr Gish who says treat with telaprevir WHEN it comes to market why not go through them and get this done??? The FDA allows it.
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With Dr Gish and help from a contact to get this done now maybe would open the door for other hepatologists to go for it as it seems dr. has alot of respect.

[can-do-man]

I have talked to vertex, have you??? Back in july when magnum first posted about the trial me and kathy from here were interested, as time went on nothing so i talked to my hepatologist, he said that both pi's would be starting a new trial soon. Told me the critria and vertex was not allowing rescue drugs. He would not choose one drug over the other.

I had read about this time last year where vertex might go for early approval, knowing i needed procrit early on and was a relapser and not wanting a dose reduction i called vertex and talked with two different people. I was told by them that vertex plans was now to do this prove 3 trial. After explaining being stage 4 and needing rescue drugs i asked about this compassionate care. (Which magnum had also posted about back then) I was again told to try and get in a trial as that was how they were proceeding. I took that as a NO.

So if vertex is not interested how can the FDA force this on them???

What i don't understand if you have a good contact at vertex and a doctor with the status of dr Gish who says treat with telaprevir WHEN it comes to market why not go through them and get this done??? The FDA allows it.

[Trinity4]

Wonder if Pegylated Interferon went through the same approval processes and how it was viewed by those treating with alpha interferon only and how and when the introduction of Ribavirin was considered during that time.


Treatment Timelines

1991 - FDA approves first alfa interferon (Schering's Intron A) to treat hepatitis C.
1992 - FDA approves first interferon (Schering- Intron A) to treat hepatitis B.
1996 - FDA approves alfa interferon (Roche- Roferon A ) to treat hepatitis C.
1997 - FDA approves consensus interferon (Amgen- now InterMune-Infergen) to treat hepatitis C.

The general treatment protocol was to inject 3 million units of interferon, three times a week for 48 weeks. Sustained virological response rates (negative viral load 6 months post-treatment) were approximately 9% for genotype 1 and 30% for genotypes 2 and 3.

Treatment Breakthrough

1998 - FDA approves Rebetron (Schering's Intron A plus ribavirin) for the treatment of hepatitis C.

Ribavirin is a synthetic nucleoside analogue with a broad spectrum of antiviral activity that was initially developed as a possible treatment of HIV. As it turned out, ribavirin was not effective against HIV, but it was found that it did have antiviral activity against several flaviviruses (a family of viruses that includes hepatitis C), and it was studied as a single agent for the treatment of hepatitis C. In some small studies, ribavirin was found to reduce serum ALT levels, but that it had no effect on the hepatitis C virus. The clinical findings that ribavirin reduced ALT levels led to the studies of combination ribavirin and interferon therapy. It was found that ribavirin when combined with interferon produced a snygery that proved to be a major breakthrough for treating hepatitis C. Ribavirin (in a mist form) is also approved for the treatment of respiratory syncytial virus (RSV) infection in children.

The treatment with combination therapy consists of interferon (Intron A - 3 million units thrice weekly) plus ribavirin (800-1200mg/day). The clinical trials conducted on combination therapy also determined the duration of treatment for genotype 1 as 48 weeks and 24 weeks for genotypes 2 and 3. Overall sustained virological response rates are genotype 1 - 29% (high viral load - 27%); genotypes 2 and 3 - 62% (high viral load - 60%).

A New Era in the Treatment of Hepatitis C

Synthetic interferon is a protein that is broken down rapidly by the body within 12 to 24 hours after injection. The standard protocol for interferon was to inject 3 times a week. The synthetic interferon was eliminated by the body, and, without further interferon available, the body could not suppress or kill the virus.

Pegylation is a process that attaches polyethylene glycol (a biologically inert compound) strands to the interferon molecule making it less likely to be cleared from the bloodstream. The benefit of increased concentrations of interferon levels is that these help to constantly suppress the virus and increase the likelihood of a sustained virological response.

2001

Peg-Intron (Schering’s pegylated interferon alpha-2b) was the first pegylated interferon FDA approved to treat hepatitis C. Peg-Intron is a powder that needs to be reconstituted (with a sterilized solution) before it can be injected. Peg-Intron also needs to be dosed by a person's body weight.

The sustained virological response rates for Peg-Intron monotherapy are 14% for genotype 1, and 47% for genotypes 2 and 3.

PEG-Intron plus Rebetol (ribavirin) was also approved in 2001 to treat hepatitis C. Sustained virological response rates are 42% for genotype 1 (high viral load - 30%) and 82% for genotypes 2 and 3.

2002

Pegasys (Roche's pegylated interferon alpha-2a) was approved to treat hepatitis C in 2002. Pegasys comes in a ready made solution (does not need to be reconstituted) and in a dose fixed at 180 micrograms regardless of a person's weight.

The sustained virological response (SVR) rate for Pegasys is 28% for genotype 1, and 56% for genotypes 2 and 3. People with advanced fibrosis or compensated cirrhosis (a group that is more difficult to treat) achieved a SVR of 20%. This clinical trials on cirrhotic patients also showed that Pegasys reduced liver inflammation and scarring in treatment responders and, to a lesser degree, in non-responders. Data from this trial and other conventional interferon clinical trials led to the NIH HALT C trial that is studying the role of interferon in reducing liver inflammation and slowing or 'stopping/halting' liver disease progression.

In 2002 Pegasys plus Copegus (Roche's brand of ribavirin) was also approved for treatment of hepatitis C. Sustained virological response rates for genotype 1 are 46-51% (high viral load 41-45%) and 76-78% for genotypes 2 and 3.

[Willy50]

"Then why isn't VERTEX pushing for this??? Because they are not. Hmmmmm"
------------------------------------------------------------

I can't read their minds.  I can't "read" the FDA.  I don't know even what you are thinking.  : )

Are you suggesting that Vertex should?  And in the absence of Vertex doing so it means something?

We are *reading tea leaves* here but here's my take on it;

1)  They don't cause they can't
2)  they don't cause they shouldn't
3)  they don't because the risks of seeming "pushy" could cause the FDA to slow things down further
4)  It might even protect them if early approval came and some unforeseen issue came up, such as Portann alluded to with Thalidomide or I mentioned with Vioxx.

Understand; the fact that they are not doing it is open to interpretation.  Reading between the lines if a *Vertex rep* suggested that Magnum write the FDC then you might have a glimpse at what they may hope for.

I personally think that it would be a double edged sword.  They may not actually be in favor of it because they are not quite ready.... not set up to manage a "commitment to care" type operation.  On the other hand I would guess that their stock would SOAR.  It would be a wonderful "problem" to have; OH DRAT!!!! Profit during a depression..... D*mn; first to market!!!  : (

....  Just my guess.

While guessing...... I just feel that they have run their trial process very carefully.  They didn't allow rescue drugs in phase 2 when other companies did.  They ran a far more blinded study than any of the other companies did; at least for Scherring (boce) or the recent Roche (r1626) studies.  Could it be that they are bending over backwards to get approval?  If Roche or Scherring got delayed or thrown out of trials their company would continue.  It would be a catastrophe of the first order for Vertex.  My FEELING is that they will not risk offending the FDA nor would they risk in any way compromising their current favorable position by applying pressure to the FDA.  It would probably be counter productive.  What's your opinion?

Finally, keep in mind that ones personal goals are not always perfectly aligned with either Vertex or the FDA.  They want a smooth transition.  
(and on the other hand) ...Some of us might want to not slide into decompensation.  Both Vertex and the FDA have to take a detached and "long" view.  That doesn't mean that one cannot or should not try to impact upon the approval process.  IF indeed it is at a tipping point public demand could allow it to move one way.  If the end point audience doesn't care...... well..... perhaps no one else will either.  If the drug is not safe, then no amount of banners or slogans will make it become approved.

My opinion only....

Willy

[can-do-man]

Then why isn't VERTEX pushing for this??? Because they are not. Hmmmmm

[Rockerforlife]

Cool article you published...well written.

[Willy50]

Good point and of course, Vioxx was much more recent.  One needs to keep in mind that this is a disease or treatment in which there are NO other elective therapies which exist with any significant hope of cure.  There exists no path such as maintenance therapy which provides a means of prevention of continued damage.

People with advanced liver staging face a daunting list of hurdles.  Since the cure rate drops for that population they often must do higher dosing or much longer treatments.  They have generally speaking less reserve in the ability to take drugs as they approach decompensation, indeed, doing chemotherapy could cause them to decompensate.  They face a myriad of complications as they move towards ESL and even more issues after (and if) they get a transplant.  For this group there is a window of time which they can treat and after which are too liver compromised to treat.  Allowing the natural course of FDA approval when there exists a solution is a death sentence for some of these people,  For others it may force them to go thru the ESLD (encelepathy, banding of ascites, draining of fluid from stomach, ect) before getting a transplant, after which one is on anti-rejection meds for life and constant medical monitoring.

Some of these patients could merely be allowed to treat with a drug which by most estimates will certainly be approved and offers dramatic efficacy improvements over current treatments.  Making some of this group of people wait 2 years will certainly allow some to die and others to await a liver.

Early approval is allowed by the FDA in it's own guidelines.  It has to meet standards of safety, efficacy (I think these two are virtually guaranteed with current data), and finally..... the need.  Does the NEED exist?  Do the rewards outweigh the risks?  Perhaps we cannot answer that question without being doctors, having actuarial tables and projections for the population group ate risk who could benefit.

From the trenches..... from where I sit.... the early approval looks like a wise and humane thing to consider.  It looks like it could save lives and untold amounts of dollars through the early CURING of people instead of treating them in ESLD or post TP.

Sometimes the standard can be used; what would you want for your child....for your parent if given this choice?

This equation is not about exposing unborn children to risk.  It is about refusing to allow people a drug that could save their lives or forestall the risk of entering into ESLD.  The FDA does not have to allow this drug to proceed down the normal pathways and chutes which will almost certainly make it approved in 2 years.  They have the latitude to allow it's early approval.  At minimum they have the ability to expedite or simplify "compassionate care" provisions.

best,
Willy

[Rockerforlife]

Now i just found out the PI`s used for HIV are different than the PC`s used for HCV...different animal all together...

[Rockerforlife]

Little  of topic...but still interesting


Some herbs and supplements, such as St. John's Wort and garlic supplements, can affect the level of protease inhibitors in your blood.

http://www.aegis.org/factshts/network/simple/protease.html

[Rockerforlife]

PI drugs have been used for HIV patients for years now...i dont think the SX from these drugs are  dangerous...i say lets "push" the PI`s now.

[portann]

I'm entirely out of my depth here but went to school with a thalidomide boy. Doctors in Europe, Australia, New Zealand and Canada were prescribing thalidomide left and right to pregnant women with morning sickness.  The U.S. stood alone in deciding it was potentially dangerous to approve it and avoided countless tragedies.

I'm very excited about the PI's and wish I'd waited for them myself.  I think until the final results are in, though, the current policy is the most reasonable one. It serves people with cirrhosis very efficiently, at the same time that it makes clear the final results are still in the making. Emotions and anecdotes don't make a drug safe.

[Willy50]

As mentioned...... Telaprevir has a unique opportunity to be approved or treatment failures only based on, at least in part the results of Prove 3 (which was for past treatment failures).  I'm sure that they look at the toxicology reports of other trials; not only the single trial.  Currently over 2000 patients have been treated with Telaprevir, so the FDA has a decent file on it's safety profile.

My understanding is that the FDA will look at the safety records and efficacy rates and at least has the opportunity to provide early release for past treatment failures based on the fact that no other form of treatment exists with a close efficacy/safety profile.  We still don't have the official SVR rates but the SVR12 rates suggested a comfortable improvement over current SOC.  

INSTEAD of causing doctors to write letters, investigate "compassionate care" (which I wager is a means of treating that a fraction of a decimal point of doctors are familiar with) the FDA could simply approve the drug for the wholesale use without special appeals, paperwork, the learning curve in filing compassionate care papers.  I don't think the current system is favorable to accommodate the vast numbers of people who could benefit from an improved form of treatment.

*  It could be a speedy, or relatively speedy process.
*  Inherent risk would be outweighed by the greater good.
*  It could cause a reduction in the number of people awaiting TP.  
*  It could in addition to reducing liver damage reduce other co-morbidities/ extra hepatic diseases and damages associated with advanced liver damage.
*  Provide the most cost effective means of treating this group- curing them instead of treating the effects of cirrhosis.
*  Dramatic reduction in healthcare; it is far easier to treat a patient and cure them than to allow them to proceed into liver failure, transplant them, then keep them on anti-rejection meds for life and THEN retreat them for HCV.  That is folly.  It's inhuman.  It is unacceptable.
*  Early approval for past TX failures is a humane and compassionate act.
*  The early approval of Telaprevir would make a drug available for a large group of people with minimal paperwork and with no other reasonable means of treating.

It's the right thing to do and the right time to do it.

best,
Willy