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

[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