Back From The Doctor

[TeeTom]

Today was the day I got my eyes opened and now I have decisions to make.

I have the Test results which are as follows;
Blood Test Results
TYPE= 1a ALT = 164 AST= 119 HCV QNT= 759,312 IU Log10= 5.88 IU
Biopsy Tests
Chronic Hep, Consistant with Viral hep C, mildly active (grade 2/4)
- moderate steatosis with mild steatohepatitis
- Bridging fibrosis (stage 3/4)

So there you have it. Guess I bound for trouble in the near future.

I got two invitations for study.
The first one is Roche RO5024048, Pegasys, and Copegus.
The second one is Medtronic COPE-HCV Continuous Interferon Delivery via Paradigm Pump Infusion System

Wow, what a load.

Any and all input is welcome.

Tommy

[GoofyDad]

Let's take note that this does not appear to be graded as 3-to-4 transitioning, but rather 3-out-of-4. Depending on where Tommy falls in the "3" he may have some wiggle room,  timing wise.  

Tommy - I had my biopsy re-read by a top-notch specialist and received good news. Not excellent news, but his notes basically called the first pathologist to task for what I took to be sloppy work - and I walked away with a less dire fortune than I previously had.

My insurance covererd this - otherwise it would have been about $550. Are you in Birmingham AL? I'd bet dollars to donuts that there are some good hepatologists around. Dr. Rogert Gish would probably help you find one: http://www.cpmc.org/advanced/liver/contact/default.html

[charm27]

I too am rooting for you, wishing you the best of luck and hope to see future posts from you as to your tx progress.

Wishing you all the strength and Luck in your future.

Charm

[TeeTom]

"Wow, Tommy—

Have you spoken to the Patient Assistance Programs for the drugs yet?

Pegassist (Roche Pegasys system): 1-877-734-2797

Commitment to Care (Schering- Plough PEG-Intron system): 1-800-521-7157 "

I talked with the Dr's office today and they told me all the slots for the RO5024048 may be full. I wont know till the end of the week.

I just got off the phone with Pegassist and they said my income is too much. My wife and I are the only ones living at home and our combined income is over the limit.

I checked on line for Pegasys and Copegus and  a 48 week treatment for both will run about $42,000.00 that is 48 shots of Pegasys @ $606.50 per shot and Copegus is $6.33 per 200ml tablet and I figured 6 tabs a day to make the 1200ml per day dosage.

What a drag.... but I aint give up yet. I'm waiting on my insurance to tell me something and I still haven't heard from the VA.

Tommy

[TeeTom]

Well I started my little documentary endeavor today. Any input or criticisms are welcome. Check it out here. (it is not perfect)

http://www.youtube.com/user/tc4tat

Thanks to all of you.

Tommy

[Trish77]

I like your approach to this.  You're obviously capable of gathering all the information and then making a decision that's right for YOU and that's a relief.  You'll be fine.  At some point, you have to make a decision and hope for the best.  

Here's the interesting thing about contributing to the cause.  I liked that part of it too, that being in a trial meant that it was potentially making things better for others coming along.  It's interesting how that gets tested when things start going wrong.  When they started reducing my drugs on the trial - first time at 13 weeks - it really got me thinking.  About my children, my life, my obligations to them and to others - the whole deal.  There were at least two points during the trial where I had to reassess if my thinking on this was skewed or not and it presented me with quite the moral dilemma.  So be careful about that part of it.  Ultimately, your goal is to save your life.  If you can contribute to "the cause" while you do that, great - but I'm going to submit to you that it should not be one of the factors upon which you base your decision, particularly when your stats are what they are.  "The cause" doesn't want you dead, to be blunt.  I did end up staying on my trial until they pulled the plug on the trial as a whole but it sure taught me a number of lessons and perspectives that would have been impossible for me to learn any other way, I think.  

It's good to have the input of others who have been on the same trial as you.  I have always liked the R7128 possibilities.  If this trial had been available when I signed on for R1626, I would have taken R7128 instead.  (I get confused between R1728 and R7128 - which is it???? Always thought it was R1728, perhaps because in my mind it logically increments up from R1626...)  I was ready for treatment at that time in my life so I would have done treatment without a trial and was preparing to do just that when I got offered the R1626.  The trial got pulled and treatment stopped abruptly for me at 36 weeks - however, I'm now SVR.  

Good luck with this, Tom.  Rooting for you big time.

Trish

[DragonSlayer45]

Should have read anger not nager

[DragonSlayer45]

Tom,

I agree with most of the above statements. There are some real good people here and you will get some pretty good advice and opinions.

I also did a lot of research prior to participating in the Phase I trial of R7128. I came close to participating in 2 other trials only to decided to against them because I was not comfortable with the drugs or certain aspects of them. Both times I turned out to be right as they were both pulled because of those issues.

I also looked hard at Boceprevir and Telaprevir and decided against them as well as they had some things in their profiles I did not care for. I decided on the R7128 as it looked to be the most promising to me. I do not regret my decision. I cleared at 4 weeks with a 6 log drop and stayed there. I have my 6 month post coming up this week, which I know will come back good as well. I have slain my dragon!

I always thought that the R7128 would be reduced to a 24 week trial with the SOC. In mine and Epi's trial it was 4 weeks R7128 with Peg and Riba followed by an additional 4 weeks of just Peg and Riba. You were then given the option of continuing for an additional 40 weeks of peg and riba.

The R7128 in itself had no adverse effects but the peg and Riba more than made up for that. It should also be noted that this drug shows promise as it not only has been successfully used to treat naive geno 1's but also cleared geno 2 and 3 non-responders. It has as Epi mentioned earlier showed no viral mutations in any trails to date.

I was allowed rescue drugs in my trail. I was given Ambien to sleep along with AD's and benzo's for the nager issues that cropped up from the Interferon. I was also given Tri-cor for my cholesterol, as the interferon made my cholesterol shoot up to over 600.

I am coming up on 6 months post and have resumed a normal life. I feel great and I am back running all over with the kids.

One thing to keep in mind. If you do decide to do the trial which is a decision only you can make, that even if you get the placebo you will still be getting the Peg and Riba. Good luck in your decision in whether or not to participate in the trial as it is a tough one to make.  Judging by your biopsy results you will have to make a treatment decision soon whether it is a trial or SOC.

[WriteItDown]

Tommy, I just want to say that I admire the way you're going about making a decision here, and I'm rooting for you.  And looking forward to seeing your videos. Best of luck whatever you do.

[newleaf09]

Lots of good advice here.  In the trial, worst case scenario is that you would be in the placebo arm, which is what you would be doing anyway.  Exclusion of rescue drugs might be an issue, but your study team would be watching you closely, more closely than a regular doctor's office.  At 3/4, you really should do something to stop any further progression of fibrosis and getting rid of the HCV is the primary route to accomplishing that.  

I will get the official SVR declaration in a month, when I do my 6 mos. followup visit.  My doctor feels very strongly that the 12 week post TX UD PCR will become the norm for declaring SVR in the near future, and I sailed through that.  I have other signs that the liver is recovering: platelets coming back up to normal, PT/ PTT time normalizing, very low liver enzymes, if I have a glass of wine at the rare dinner out, I don't get a buzz, which I definitely did with my seriously damaged liver before diagnosis & TX.  I'll do another biopsy 1 yr. after EOT.  Most folks don't do that and doctors don't recommend it after the viral assault is over. I just need it for my own peace of mind.  There was a study released a few months ago that showed that 10% of lucky SVR cirrhotics had reversed their liver damage all the way back to 0 when biopsied 4-5 yrs. later.  Find a write-up of the study at:
http://www.eurekalert.org/pub_releases/2009-06/aga-abm052909.php

[TeeTom]

I don't know the words to say to make you guys understand how appreciative I am of the information you are providing me. Bill, Epi, and Trish you guys are awesome. You have provided me more information than anything or person. The time you took just to give us on this board your attention is worth more than any currency.

I am a very technical person in the internet data transport world and I know how invaluable  a person is that has on the job experience. That is you. You guys have a combined amount of experience that you share with the people on this board that no Doctor could ever provide.

I have been through three Doctors in the past 10 years, not by my choice. Two of them transfered to other hospitals. The one I have now has been my Doctor for about six months and I have never seen him. I went for a meeting this past thursday and My wife and I talked to his nurse. He never showed. She is the one who gave me the applications for the trials. I tried to find someone else in my neighborhood but they all refered me back to UAB in Birmingham. So basically I would have to move to find a more hands on environment.

I feel like I am more on my own in this boat but there is hope cause I got you guys to help me where my Doctor is failing. I will be making a decision by the end of next week as to what route I will take. Here are my three options...

1 - I called my Pharmacy Insurance provider and asked them (myself) what I would have to pay for the medication Pegasys and Copegus to see what SOC would cost me. They are supppose to call me by Wednesday to let me know. So that told me there is some coverage.

2 - Call Roche Patient Assistance (havent been here yet)

3 - Do the R7128 trial and hope for the best. By the way from what I have read I believe this one would work for me if I got the real stuff.

4 - Do nothing

I am leaning toward the trial for a few reasons. I can contribute to the cause, the extra attention from the Doctors sounds good to me, all the results I've read are positive, I can't wait for phase III because of my status, I believe in new technology.

As soon as I can I'm going to post my biopsy and last blood analysis for review. I am all for the cause so I will be visiting this board and posting as I go. I hope to get started by January or February of 2010 on treatment. I will also be utilizing youtube to post video before, during and after tx. If the board will allow it I'll be revisiting this post and updating. There is already some excellent advice and information in this post.

One more time, you guys are AWESOME!!!!

Tommy

[Bill1954]

Just a quick note, Tommy; you’re receiving invaluable advice here; I don’t think this stuff is available anywhere else, even if you were willing to pay for it. Explore your options carefully and thoroughly; we’re around to answer questions as you develop them. One more time; here’s the address for Janis and Friends for review:

http://janis7hepc.com/

Best—

Bill

[Trish77]

Thanks for the document.

In that doc, it says that in Arm A, B or C, if you are RVR then treatment will be stopped for you at 24 weeks.  In Arm D, you'd have the trial drug and go to 48 weeks.  Arm E, you'd be on regular SOC treatment and go to 48 weeks.

That is a big consideration, if you are willing to have treatment stopped at 24 weeks.  An RVR - being UND by 4 weeks - is certainly a good indicator and your chances of success increase considerably with an RVR - and it also means you would have had the trial drug in various doses as well, adding to your chances of SVR.  Both would boost your chance of success.  Stopping treatment at 24 weeks is still being studied and most of us would prefer to go the 48 weeks to give it all the guns we can.  This is something you are really going to have to think about if you go on this trial.  You will no longer be treatment naive which would preclude you from other trials where that is the requirement, IF this trial is not successful.  

Your ribavirin dosage won't get any higher than 1200mg on the trial.  That is sufficient for alot of people, I don't know if it is sufficient for you. I don't know what your weight is and I'm not an expert on this.  I'll try to dig up some information on how much ribavirin persons should have at various weights and you can determine if your ribavirin dosage will be sufficient on this trial.  I'm a FIRM believer in that the ribavirin dosage MUST be adequate, particularly in the early stages of treatment to give someone the best shot at a successful outcome.  That dosage is probably sufficient, you just need to be sure.

If someone else has that information more readily available than me - the weight-based ribavirin dosages, can you post it please?  I'll be looking for it also.

I noticed that the approach they're taking on this trial is to reduce dosage at lesser rates than are generally recommended if your white or red blood counts get low.  Interesting.  They are taking the approach to reduce in smaller increments to keep your treatment drugs as close to max as possible. That's better than usual and particularly if they're not going to allow rescue drugs, they're taking the approach to reduce drugs as little as possible.  That's a positive.

I didn't notice any mention of rescue drugs other than a comment that no other drugs are allowed to be taken during this trial other than the study drugs - I would suggest, again, that you clarify on that point if rescue drugs will be allowed and what your doctor's approach is on that.

I would also suggest that you contact the #'s that Bill has given you to find out if you would be able to get the treatment drugs for free from the drug companies.  It will give you an idea of what your options are.

In your situation, a Phase III trial with full dosage for 48 weeks would seem to be a better case scenario or treatment where you are able to tailor it specifically to what your own circumstance dictates as you go through treatment.  A better case scenario may not be what you have available to you, however so you take a best case scenario and work with it, don't you.

These decisions are SO difficult to make.  Please keep asking questions until you have all the information you need - I have my own perspective limited to my own experiences and understanding and I wish you good luck in weighing out all the contributions we all make with what you know of your own circumstances to come up with what is good for you.

Trish

[epiphiny]

So this is the trial I was on for 4 weeks with a follow up of SOC to a total of 48 weeks.  It was a Phase 1B trial when I enrolled (May 2008) and I have heard other people advise folks to run not just walk away from any Phase 1 trials.

I only have good things to say about the drug and the trial I was involved in.  I noticed a few 'side effects' but absolutely nothing unpleasant.  I had previously treated with SOC for 24 weeks with no response so I was very aware of what were side effects from SOC and what were from the study drug.

We didn't have access to rescue drugs here in NZ and I had to take a couple of Riba reductions throughout my 48 weeks which I wasn't too happy about, however I am now SVR so I guess it worked out OK.  The good thing about R7128 is that it didn't seem to hasten any anemia which has been one of the side effects with Teleprevir and Boceprevir.

You have received some excellent advice here that's for sure and indeed it is good to weigh your options.  For me, I had NO options as I was considered a treatment failure and enrolling in the trial was the only hope I had in the present times to beat the virus.  I made my decision within 36 hours and I absolutely do not regret my decision in any way.

I'm glad I didn't have time to think too much about, I just went for it and it worked out very well for me.  As far as I know, no-one else in my study had any serious adverse effects from the study drug.

The other thing that is very positive about R7128 is that so far, in human subjects, the virus has not created a resistance to the drug!  This is a major difference between the protease inhibitors and the polymerase inhibitors.

In response to notes about the renal issues detected in monkeys; I too had to sign this consent and the study doctors explained it all to me.  Yes this happened in monkeys however the doses given to the monkeys are vastly different (much much higher) than what is given to the humans. I was extremely well monitored for any renal dis-function and all my creatanine levels came completely normal with every safety blood draw they did.  I was tested every 3 days for the duration of the time I was on the study drug after my initial 3 days in which they tested me every hour.

I would feel very comfortable in participating in this trial again (except I don't need to!).  The other great thing about doing this trial is that you will get the new 'miracle' drug 7 - 10 years earlier than anyone else.  10 years of restored health is an amazingly long time and a wonderful gift!

I hope this info helps you and if there are any questions about the trial or my experience with the drug I would be most happy to try and answer them.

All the best!

Epi :)

[TeeTom]

Thanks again for responding,

I have posted the consent of the trial on google. You can read it and let me know what you think. Here is the link.

http://docs.google.com/fileview?id=0B9IWInszSBIfZDc4MTBkYTAtM2M5NS00NGExLTg2ZmItMzhiMDBmMTVhZTgy&hl=en

Tommy

[Trish77]

You had a good doctor, Can-do.  I've read alot of trial experiences here and yours does not seem to be the norm to me.  However, you point out that there are exceptions and the point is to ask the questions on where the doc stands on rescue drugs, etc before starting and know as much as you can prior to starting the trial.

[can-do-man]

Trish......... On a trial, if your red or white counts drop below the levels determined ahead of time in the trial, then there is NO choice on the part of your medical team, they will need to reduce your drugs
------------------------------------------------------------

Thats not always true. I just finish the boceprevir trial with schering, before i started i talked to a rep there and my hepo. My doctor had the final call. My doctor got me in the trial with lower platelets then was stated. Rescue drugs was allowed and they payed for the procrit. My HGB got as low as 8 and my platelets went down to 29. Though schering sent alot of faxes about my numbers my doctor made the calls and not once did schering make me dose reduce. One needs to talk to their doctor in any trial and find out WHO makes the final call and if hes willing to go the max with you.

TeeTom, best of luck to you on what you decide, just make sure you understand as much as you can before starting.

Cando

[Trish77]

Roche trials seem to offer rescue drugs more readily than Schering-Plough trials.  Even if a trial offers rescue drugs, you still have to get your doc to agree to give them to you.

You want rescue drugs to bring up low red counts or low white counts so that dosage reductions are not necessary.  On a trial, if your red or white counts drop below the levels determined ahead of time in the trial, then there is NO choice on the part of your medical team, they will need to reduce your drugs. On trials, their cutoff point is sooner than on regular treatment as trials will take less chances with adverse effects happening and will step in to dosage reduce sooner than would happen on regular treatment. Rescue drugs help to be pro-active about that and help to avoid or mitigate that.  

I would talk to your primary care physician on this trial and see what his/her attitude is about rescue drugs, find out if the trial permits it and if they're prepared to use them to avoid dosage reductions, particularly in the first 12 weeks and I'd say the first 24 weeks.  All the way through is best but I'm saying particular attention to 1 through 12 weeks primarily and critically and on to 24 primarily.  

Will the insurance company cover the rescue drugs?  Trials will allow for rescue drugs but not all trials pay for rescue drugs - mine allowed them but didn't pay for them.  So I'd ask your doc that too, who pays for the rescue drugs if the trial allows them.

If you go ahead with the trial, will they tell you your results at the test intervals?  If not, you might want to get tested privately at 4 weeks and 12 weeks and I'd do 4, 8 and 12 if your insurance company will do it.  If you're clear at 4 weeks, then you know your odds have just jumped up around that 75 - 80% chance of success rate.

If you're doing dismally at key points, you can drop off the trial.  I don't advocate that for everybody but you're further along in your progression.  I feel that people have a moral obligation to stick with a trial but docs also know that those with advanced progression of disease are going on a trial to fight for their life with greater urgency than someone like me who went on a trial at Stage 1, Grade 1.

If any of that is confusing, please just ask.

Phase III trials are better in your situation than a Phase II trial but the timing isn't always our timing, is it.

[eureka254]

Sorry to hear you have to deal with such trouble, but sounds like you've got focus and a good clear view.  Better though that you got this info sooner rather than later.

Lots of pros and cons to weigh, for sure.

When trial results are coming in at 88% undetected in 4 weeks for a geno 1s, it is certainly very encouraging.  My husband is geno 1 on SOC plus Alinia, but he's doing it outside of a trial.  His doc didn't think as Stage 4 with previous hcc he would be a good candidate for trial, but as a stage 3, you still have options.  It took my husband 13 weeks to get to undetected, so he's doing a course of 72 weeks.  

However, he's been able to somewhat call the shots (so to say) -- he doesn' t HAVE to have office visits at set intervals, and he's allowed rescue drugs (without which he probably would not have been able to continue ).  He could have tried going thru the VA, but we found it more convenient and less red tape to just go thru insurance.  But, even with excellent coverage, it's hundreds of dollars a month between the injections and rescue drugs.  

Hope that input helps, and best wishes, whatever your decision. ~eureka

[Bill1954]

Wow, Tommy—

Have you spoken to the Patient Assistance Programs for the drugs yet?

Pegassist (Roche Pegasys system): 1-877-734-2797

Commitment to Care (Schering- Plough PEG-Intron system): 1-800-521-7157

[TeeTom]

Yes they have been paying for the labs, visits, and everything else that I can think of. It's just the medication they are bucking on.

[Trish77]

Sometimes the drug companies themselves will provide the drugs for free.  Would your insurance company cover the tests and doctor visits, etc. if the drugs were covered?  

I did a Phase II polymerase inhibitor trial and before I comment further, wondering the answer to that question.

[Bill1954]

Yeah, the liver can regenerate to a point. Cirrhosis can alter the ‘architecture’ of the liver to the point where this is no longer possible; but we really don’t know precisely where this point is yet. Most clinicians suspect that even patients with early cirrhosis will be OK; but as the organ begins to decompensate, all bets are off, I believe,

Bill

[TeeTom]

I have read that the liver is the only organ in the human body that can regenerate itself. I figured that if I take the treatment and become clear them me ole liver can recover.

Tommy

[Bill1954]

Hi Tommy,

Current thinking is that once the insult has been removed from a liver (assuming no decompensated cirrhosis) which in our case is HCV, then fibrosis will no longer advance. In some cases, reversal has been noted, and even near complete reversal is possible. The thing is, biopsy is an invasive procedure, so long term studies on this are rather rare.

I was stage 3-4, and the transplant center I treated with is no longer concerned about fibrosis in my case. They do continue to monitor for HCC, or primary liver cancer; while they can remove the threat of fibrosis, the slight increase in risk for cancer remains long term.

This risk is monitored by blood test and ultrasound scans twice yearly… no big deal to get it done.

Best,

Bill