Recurrent HepC in post liver transplant

[acaba]

I am new to this (or any) forum.  I need advise badly.  I am 2-years, post liver transplant, and now have recurrent HCV (hepC) found in a recent biopsy (grade & stage 2).  Naturally, I've been on immune suppressents (cyclosporum etal) during this time.  

I have been somewhat frantic about finding treatment A.S.A.P., preferrably a Clinical Trial here in S.F. utilizing interferon-free medications, if at all possible.  This virus moves quite quickly when immune suppressed.

My problem (one of 'em anyway) is that my only resource has been ClinicalTrials.gov.  On that site I have only found one such study for post-transplant, and it was full by the time I read about it (U.C.S.F. & Gilead).

Does anyone have any advise or leads for me?  I do not have much time to wait before becoming cirrohic once again.  The only treatment that has been offerred to me, so far, is Interferon, Ribavirin+nucleotide for a full treatment year.  I am not very excited about this option, particularly now being immune suppressed.  I have only recently felt recovered from the surgery and illness , and do NOT wish to go down that road again.

I could really use some advise and leads; thanks for any help you may have to offer.

[acaba]

Is there anyone out there that will respond to my question?

This is a first time post to a forum, perhaps, I did not enter the information correctly and it is not being seen?

Please respond so that I know that this has successfully posted, but there is just no one that can help.

Thanks in advance,  James

[rivll]

I think people a lot of ppl who can help are currently offline.
Specifically for S.F. you should hear from HectorSF and Orphanhawk. They can most likely help you.
I really am not knowledgeable in this area but I will tell you that if you can see a Hepatologist at UCSF, that will be your best shot at getting what you need.
I am sure as soon as they check in, they will reply to you.
If it takes awhile, I will post again to bump you up so your question isn't lost.
Good luck to you and in the meantime look at Hector's profile.

[rivll]

One more thing, there will be  clinical trial with ribavirin, sobusovir (sp?) and another Gilead drug in the Spring, at Quest clinical trials in S.F.. However, I am not sure the criteria includes post transplant. It is worth calling them though.

[Bill200]

Hmm... very interesting and good they are already doing a trial for OLT folks.

Acaba I was in the same boat as you.  Started with half-doses of INF and Riba and also Incivek.  I cleared or at least UND and have 6 months to go.  It's not too bad.  I certainly feel better than I did before starting treatment if you can believe that.  If you can make it through the Incivek (12 weeks) then I think you can do the rest.  The Incivek was tough for me but it is only three months to tough out.  The doctor can easily prescribe those drugs even though they are all off-label but if he'll work with you on your blood counts on everything and you can get labs once a week or more in the beginning then you can do it.  

[acaba]

thank you so much for your reply.  I thought that I may have entered my post incorrectly - I see that is not the case!

I will take your advise and watch for HectorSF and Orphanhawk for their insights.

I just met Dr. Terrault M.D. at U.C.S.F, a wonderful &  knowedgable practioner who is willing to take me on as a patient!  However, her current Post-Transplant Trial is already full.  

She will be using  Ribavirin and a nucleotide as an interferon-free trial. [that is where I would love to be right now]  Currently, It is being suggessted that I go ahead with the interferon, ribafirin,inhibitor for a year, which as said earlier, I am not to eager to do, especially  since all of the new drugs are so very close.   James

[acaba]

If you have the time could you please send to me the contact information so that I can follow this up: [Gilead drug in the Spring, at Quest clinical trials in S.F]. Who do I contact?  Any legwork with help me out alot.

thanks again, james

[can-do-man]

"I am not to eager to do, especially  since all of the new drugs are so very close."

I am guessing your a genotype 1, not sure where you get they are that close, Even if one thinks 3 years are close being your post TP thats along ways away as I am sure you know people post TP can move fairly quick. Plus they have no ideal how well they will work with even just cirrhotics. You have a very good doctor, myself Its her advise I would follow.... Again best to you.

[acaba]

Thanks for your reply can-do-man.  Actually, it is this Clinical Trial that is the only trial I have been able to find on clinicaltrials.com.  That will treat  post liver transplantees with recurrent HCV.   I followed it up and spoke with Dr.Terrault M.D. who is running this trial.  Unfortuanety, it was already full.  My frustration is how am I to find such trails (such as this one, which would be - perfect), in a timely manner?  By the time it was posted on the official webpage, it was already full of participants.

[can-do-man]

Well keep in mind this trial is only into phase 2 so if all goes well there will be a phase 3 but I would guess were at least a year and a half away from that... something you might want to ask her about and if she thinks you should wait.

[HectorSF]

I think I can help you...

The trial you mentioned is the only post-transplant hep C trial I have ever heard of with the next generation of all oral non-interferon therapy. As you probably know post transplant patients are the most difficult of all hep C patients to treatment. Response is poor and adverse events often require transfusions and constant monitoring to prevent further damage to the donor liver.

"Study to Investigate GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant"

Conditions: Recurrent Chronic Hepatitis C Virus;  Post Liver Transplant
Interventions:
Drug: GS-7977;   Drug: Ribavirin

This upcoming trial is a phase 2 trial with only 50 people world-wide. My UCSF hepatologist, who I have been working with at UCSF for over 5 years, is leading all the Gilead and other hepatitis related studies at UCSF. She is the head of hepatitis research and transplantation and is internationally known for her work in the fields of hepatitis and liver transplantation.
She has already picked the 3 or so patients at UCSF.

If this phase 2 trial is successful there should be a phase 3 trial later next year which will include hundreds of patients world-wide and of course more at UCSF. My hepatologist has worked for years with Gilead in Foster City here in the Bay Area so we at UCSF have a special relationship that should allow UCSF to be involved in many of the future trials for Gilead. She is looking for new solutions for the many folks with recurrent hep c which is rapidly destroying there donor livers.

I’m currently in the pre-transplant Gilead trial for us awaiting transplant with hep C and HCC (liver cancer). An Open-Label Study to Explore the Clinical Efficacy of GS 7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
Conditions: Hepatitis C;   Hepatocellular Carcinoma
Intervention: Drug: GS-7977+RBV

* Where did you have your transplant performed?
* What options have they given you about treating?
* Interferon, Ribavirin + nucleotide”? What nucleotide?
* Did you treat your hep C before transplant.
* How did you respond to treatment? Relapser, partial responder, null responder?

Send me a private message and I can tell you were things stand at UCSF currently as far as future trials by Gilead, Abbott etc.

Either way you should treat soon. We have seen too many either not being able to treat or getting too sick to treat. I don't have to tell you what the consequences are...

Hang in there. You have options available that weren't available even 2 years ago.

HectorSF

[acaba]

Wait indeed.  It has been near impossible to find out just how much time I can afford to wait, already being, post-transplant, immune suppressed, with the recurrent HCV at grade & stage 2. (no crystal balls to look into I guess).

Politically, the suggestion is to start now with the Interferon, Ribavirin & nucleotide for 48 months; thereafter, if I am not cured or have dropped out from side effects, then at least, I would have a more probable opportunity to be selected for an interferon-free clinical trial.

In a perfect world I would prefer to wait (without getting worse) and then taking only the interferon-free treatment down the line.  But, I don't think I have that sort  of time...

[acaba]

Hector, thanks for your post.  I was able to meet with Dr.Terault, U.C.S.F.,at the beginning of this week.  Although she had no more room in this study-of-interest i.e.  fOR PATIENTS with Recurrent HCV  in Post Liver Transplant Patients; she did say that she was willing to take me on as a patient!

Two treatment strategies were discussed: 1) wait and monitor the progression of fibrosis in lue of other interferon-free studies to come about, and 2) treat now with interferon, ribavirin & nucleotide for 48 weeks.

I don't have a crystal ball hence no way of  knowing whether I would be making a big mistake by waiting (for #1-above).  If there were a way to find out just when some more of these studies are to open, well, that would be valuable news for me.  If necessary, I will start the tx therapy (#2-above) but would much prefer to try the interferon-free trial first.

My genotype is 1a.  I was transplated at Methodist Hospital in   Memphis,Tennennsee 2-years ago. I was given no HCV treatment prior to the transplant nor since.  A current biopsy uncovered grade & stage  2 fibrosis.

I look foward to hearing back from you; one of the most difficult aspects of this life challenging event(s) is finding timely & relevent information on which decisions can be made.

Sincerely,
james

[HectorSF]

Don't worry my friend. If you are in the Bay Area I highly advice becoming Norah's patient. She is one of the leaders in the field. And in the Bay Area numero uno. #1
I mean I could rattle off all of her achievement and credentials but what I can personally tell you is Dr. Terrault besides being known to all in the liver transplant world is also one of the most compassionate, carrying and warm persons you will ever meet. May be alright have seen that.

I have seen her once a week for the last two weeks and she was the one who told me last Tuesday that I will be getting a transplant within the next 11 weeks at most. Happy day!!! Lots of hugs all around after my 5 year journey with cirrhosis and hepatitis C at UCSF.

I can frankly tell you I probably would not be alive if I had any other doctor. She has saved my life more than one and given me options in the darkest of hours.

All I can say is I don't know of anyone who will support and advocate for you like she will. She will tell you the pros and cons, she wouldn't sugar coat anything if that is you doctor - patient style isl. You will know exactly where you stand and then you can make the best choices for YOU based on the options available. I can't say enough good things about her and all of the wonderful people that work for her.  

I know the system at UCSF so I can help you navigate your way around.

By the way I have a friend who is going through peg-IFN and ribavirin post transplant treatment now. And another friend who complete triple therapy with Incivek post transplant and was cure. I believe they both had stage 2 liver disease a few years after transplant.

FYI:
We have our Transplant Support Meeting every Tuesday between 1-2 pm at UCSF. Except Christmas and New Years. If you can come by you will meet other transplant folks you can share your story with and get feedback on. My buddy Jim is usually there and he can tell you about his experience working with Dr. Terrault and currently treating post transplant. He is just of 3 years post now.

Hang in there!
“If my mind can conceive it, and my heart can believe it - then I can achieve it.”  - Muhammad Ali

hector

[orphanedhawk]

Hi,
I was gone most of yesterday or I would have replied.
Hector is truly more knowledgeable than I on the new treatments.

What I can do is share my story.
Like you, I am post transplant.
In the summer of 2011, at 2+ years post tp, I was bridging to stage 2. Although I'd relapsed on interferon tx while cirrhotic, my hepatologist said he thought I should do treatment. He said even if it wasn't successful, it would help my liver.
Like you, I really wanted to do the new orals especially as I knew the fabulous results they were having for geno 2.
But I was frightened.
So, I jumped right in, did tx, was undetected at week 4, completed 24 weeks of treatment and now am finally free of that insidious virus.

The best thing I can suggest is to follow Dr. T's advice. Although she isn't my doctor, I know of her reputation and you couldn't be in better hands.

Best of luck going forward.

[acaba]

Thanks for your reply(s); it is good to know that there is an actual community out there, and that my instincts are reaffirmed that Dr. Terrault is indeed 'a miracle in motion', I was very impressed and releived  to meet her!  I've had a difficult time navagating though this HCV journey.
  
My hepC journey has been one of isolation coursing 40 years.  First the years of spotty fatigue with no diagnosis; later, healthful, productive years being told that there was no cure and, "hey you're healthy right?!"; then, those decades of 'nose to the  grindstone', building a design/build firm while single parenting, with no time to 'get off of the treadmill' to treat something that, "is not even bothering you"; and then collapse, like going off of a cliff in a broken hanglider; I went from seemingly healthy & active to bloated and discorporating in a six month period; I was evaluated then & told that I was cirrhotic and at MELD 15, not 'sick enough' to list for transplant.  Six weeks later I found myself halfway across the continent in a hepatic coma in a hospital in Tennessee!  Four weeks later I was not only listed but transplanted as well.  The hosipal cut me loose 5-days after the surgery and I lived in a mothball motel room for three months of follow-up, before moving back home to the west coast.  Back in the hands of my State's transplant clinic I was only seen once a  year for the past two years, with one hospital stay for rejection treatments.

In this lone journey I have never met or spoken to another person that has had a transplant, not pre or post transplant.  It's as if it never happened, but it did, and I live with the challenges each and every day.  Anyway, this is my way of saying thanks for being out there; I look foward to meeting you all.  I think that could be 'cathartic'.

I look foward towards treatment by Dr. Terrault, (as much as anyone can look foward to electively choosing to feel worse in order to feel better).   But, I am now comforted knowing that there IS an end-game to all of this, and that there ARE others to interact with, and that I will have the best treatment possible.

See you on Tuesday.        James

[rivll]

Thank you for sharing your story.
I am so happy you found the forum and Dr. Terrault.
You are no longer alone with this.
Good luck and all the best to you.

[acaba]

Hi, and thanks for your reply to my post.  I just posted a reply to HectorSF that I hope you read.

I would like to hear more about your post-transplant, 24-week tx therapy.  How you felt along that 6 months time line; I have no idea just what to expect or how best to prepare.  I never fully recovered from becoming so ill or from the surgery, in terms of gaining post surgical weight back (I'm now 130lbs but ran at 155lbs for  40 years).  So, I still feel weak (and cold most of the time).  I wonder just how well I will do on tx in this condition?  Perhaps, my inability to regain weight & muscle is due to the recurrent hepC?

How long did you take Incivek, how did the therapy change after stopping it but continuing with Peg/Rib? (assuming that was the cocktail).  I read once that those of us who have become so ill as to require a transplant are 'hardened up' and better able to handle further treatment; as if our pain or tolerance levels have risen?  Did you find this to be true?  (it sounds like a crock to me, but, perhaps not).  I realize that each individual responds differently, however, I'd like to hear what you have to say about this.

Well, I should save the rest of such questions til Tuesday.  It is nice to finally be able to communicate with folks with similiar questions and experiences.

james

[orphanedhawk]

You are more than welcome to ask me anything. You won't see me on Tuesday as I don't go to those meetings and aren't a patient at UCSF.

I did recover from my transplant rather well despite needing to have three ERCPs the first year due to bile duct issues.
My energy levels dropped during about the 6 months prior to beginning treatment, I think because of my liver being damaged by hep C.

I'm on prograf, not cyclosporin and having had genotype 2, I did interferon and ribavirin therapy not the triple treatment. Comparing my treatment this time to the first time, when I had decompensated cirrhosis, I can say it was much, much easier.
I think it was easier because my liver was so much healthier than the first time around.

My doctor advised me to gain weight prior to beginning treatment which I was barely able to do no matter how much I ate.
I'm small, weighed 100~ got up to 105 and dropped the 5 lbs during treatment. Now, I've picked up a few pounds again, maybe 3?

You might want to write down you questions for Tuesday.

Hector is a great guy and quite knowledgeable. You're fortunate to have him giving you support.

Feel free to send me a private message if you like.

[Advocate1955]

You are in the right place.  You have found a wonderful forum with great people who will share information.  Orphaned Hawk and Hector will be excellent resources for you since they live in your area and have both had transplants.  You have found one of the best hepatologists in the country, so you're in good hands.  I encourage you to be in communication with both OH and Hector as they can answer your questions and share their experiences.
As you have already discovered there are rarely clinical trials for post transplant patients as they are in a group of difficult to treat patients.  The risks are high for post transplant patients.  But the other side of the story is that Hep C may damage the new liver more quickly than it did the old liver. I think it is a balance between monitoring your status carefully and waiting to see when a trial designed for post transplant becomes available that your doctor recommends, treating now while you're still f2, or waiting for new meds that are currently being tested.  Whatever you and your doctor decide, I'm sure will be the right decision for you.
You're very lucky to be with an excellent hepatologist at a transplant center.  She will take good care of you.
Keep us posted.
Advocate1955

[Advocate1955]

Which nucleotide is your doctor considering combining with IFN and RBV, if you decide to treat now?
Advocate1955

[acaba]

Saturday Morning,

I appreciate your reply; I learn from each interaction with others. As I mentioned in an earlier post, I have had absolutely no contact with other post-transplant patients, primarily due to having been ill, transplanted and followed-up in varying geographic areas, and I live in a remote area, 5 hours from the hospital.  So, having this opportunity to speak with folks, such as yourself, is truely beneficial!

I have a question that you or perhaps someone else might be able to help me with; maybe I should pose it as a new thread/question?  While looking for post transplant, interferon free therapy the only resource I found was clinicaltrials.gov.  By the time I found a possible Trial to suit my needs, it was already filled.  I imagine that this will occur again even if I'm able to wait for treatment for six months plus.

So, the question is this: how can I  find future Trials or practioners that will be running interferon-free treatment before they fill up with existing patients already connected?

Any ideas?
Thanks in advance,
James

[can-do-man]

Anybodys best bet to get into a trial is through their doctor, they are made a where of them long before any site or patient is... So Dr. Terrault would be the way to go..........

[orphanedhawk]

Can-do is right~Dr T is the way to go. Ask her.
Hector is in a very small trial now for pre-transplant patients because of his connection with her.

Post transplant patients are the last to have trials as they want to stop the virus before people need transplant, and there are less of us. I'd have flown around the world if I thought I could have gotten my hands on 7977 and avoided doing interferon again.
As it is, I'm glad I did it simply because now I'm hep C free.

I've lived in remote places myself and understand exactly what you're referring to. In fact the only reason I'm close to SF now is due to doing tx last winter.
I'll be moving to north of here soon~