treatment options

Am stage 4 (metavir) with portal hypertension, varices developing (fortunately not osoephogeal yet) - also have high bp (managed by meds) and brain aneurism (aneurysm). Platelets 76, neuts 1.8, hgb 13.9. Was intending to commence current SOC in 2 months - told I had up to 25% success probability. It has since been suggested I might wait for Telaprevir - which would apparently give me up to 50% success probability and possibly shorter tx period. I see the "positives" being the higher success probability and if RVR lucky a shorter tx period - with less longer term tx drug damage (important at my mature age). The "negatives" - triple tx tends apparently to have fiercer sx and poorer tolerance by many subjects, and personally a potential problem for me then might be - my already compromised blood levels, a system generally highly sensitive to various drug side effects and the further deterioration which might occur whilst I wait longer. Any views and feedback would be appreciated.

[Mary4now]

Have you taken the test to determine your alelle?  

[Archer_]

Yes - expect result in 2 weeks

[Bill1954]

Tough decisions, huh?

I imagine given your advanced liver disease your overall statistical odds of long term treatment success (SVR) are rather low; this obviously needs to be weighed against further progression of cirrhosis, and perhaps prevent future IFN-based therapy.

One way to look at this might be to attempt currently available combo therapy; and if you achieve robust response (undetectable) at the four week juncture, it’s predictive of SVR. If you don’t have encouraging news at four weeks, you could always reassess then.

Treatment failure with IFN doesn’t preclude future treatment attempts with protease inhibitor-inclusive therapy to my knowledge so you’re not burning any bridges to speak by trying.

With platelets at 76,ooo you might be pushing things as it is; I’m not sure I’d wait much longer, particularly for drugs that haven’t received approval yet.

You didn’t mention if you’ve treated in the past; if so, it’s unlikely that you’d qualify for reduced treatment period; in fact, to my knowledge, truncated therapy will be available to a select patient group only, based on clinical trial results.

Obviously discuss all this with your physician and work with them to come up with a well-laid plan.

Good luck and stay strong—

--Bill

[Bali05]

Hi Archer.
Nice to see you, heard about the floods are you ok ?
So happy you can do the IL28b it will be another piec e of the puzzle
and help in making decisions.

I would through everything I can at the virus and go for the gold.
It will be a battle either way and once you are in it you will be glad
to have the best weapons to win.

Have you found an experienced hepatologist you are comfortable with?
Communications and a good medical support team goes a long way.

[HectorSF]

From what little I know, I would think a brain aneurysm is much more critical to your health in the near term. You could have cirrhosis for many years before your liver fails. So I would imagine you would concentrate on managing that first?

It is important to wait for the IL28b report to come back as it is the best indicator of how you will respond to treatment. Based on that you can predict the odds of SVR.

As Bill stated being stage 4 reduces your chance of SRV with either drug regiment. At the same time once you are no longer able to treat your HCV the only option will be a liver transplant.  

As Bill mentioned your platelet count is rather low and peg-interferon will make it drop further. It could get so low the doctor will stop treatment so if is very important to work with a hepatologist who works with cirrhotic patients at a transplant center if at all possible. Ask them how low they will let you platelet count get before stopping. (This happened to me where my platelets went below 20,000). They will be more likely to help you manage and issues you might have with treatment. Most gastroenterolgisst and not versed in treating HCV patients with cirrhosis.

Because you have a brain aneurysm you must let the doctor know this.

The new meds will give you better odds of ridding you of the virus. But you have other factors involved that only a medical professional can counsel you on. It is a tough decision. There is no easy option.

Best of luck.
Hectorsf

[Archer_]

Thanks everyone  - much appreciated. My prognosis isn't ideal. To answer your queries - Bill; No, I haven't treated before. If I trialled current SOC and don't UND by week 4 I might be inclined to step back and wait for Telaprevir - but not sure where I would stand on eligibility if I haven't completed 12 weeks. Bali - thanks, nice to hear from you, went ok in the floods because at the end they didnt rise quite as high as predicted. Thank goodness - don't need any more pressure. Hector - despite unfavourable family history the aneurysm is small and not posing a present threat. So I see the specialist tomorrow - am informed the decision is mine. Poss a coin - this is a real crap shoot.  

[evangelin]

Archer,
So glad to hear the flood didn't get you.  
You sure have some tough decisions to make.  Let us know what you find out from your allele test.  That should at least give you some guidance on whether to wait for a P.I.  Wouldn't it be awesome if you turned out to be a super responder ?  I know the platelets are worrisome but that could be OK too.  Joe started in the 60's and they never changed much at all during his last TX.   His last lab before stopping TX showed them at a higher reading than he had seen in several years.  They are back to what he started with now.  You just don't know what to expect until you are in it.  Everyone responds so differently that you can't know how to prepare.  In the end, TX turns out to be a "one day at a time" adventure.  Adventure puts a positive spin on it.:>)  I can think of one person in particular that I know pretty well, that worried feircley before hand about the possibilities of calamity around TX and this person turned out to have a really good response with very tolerable SX which means all that worry was for nothing.  Granted, they don't have the liver damage that you and Joe have but still, you might turn out to be one of the people it turns out very well for.  You might as well bask in the sunny thoughts for now until you know different.  You have lots of people on at least 2 forums that will be pulling for you and lots of smart TXers with ready advice.  You are also a very bright person and you weigh  your decisions well.
Sending you a hug and a prayer,
Ev

[Archer_]

Thanks Ev, Life has been frenetic with work & all else. Havent posted on the other forum for a long time. Felt terrible to find you were so concerned & I hadnt got back to you - not accustomed to being cared about. Ive been deeply moved by others' responses & kindeness. Yes, this decision is tough because after so many recent posts about the damage sustained from tx itself - I find myself trying to target tx success prospects as a priority but also taking account of potential tx damage (ie length of tx etc). At my mature age I suspect the systemic assault of tx is likely more salient. Am planning to raise Alinia with Dr today, think I would be pushing the envelope to also mention pre-dosing. Have already made one previous Dr angry with my queries exceeding SOC. I take your point about retaining optimism - Im operating on the principle of hoping for the best - but preparing for the worst. Hope Joe is travelling ok. much regard Archer_

[Cory255]

Welcome to the Forum Archer_
I see you've taken steps to pursue the IL28-B test.  I'm assuming you're Geno 1 since you're getting the IL28b?  
Here are research study results that may be helpful.  They have determined the IL-28b genotypes (alleles) respond to TX w/ PegIFN/Riba differently.
CC genotypes are thought to respond to PegIFN/Riba TX best, CT is in the middle and TT is the worst.
These are the research study results (RVR's and SVR percentages) for Geno 1's.
CC reached RVR (rapid virologic response- viral clearance 4 weeks into treatment) 40% and reached SVR 85%. CT reached RVR 13% and SVR 45%. TT reached RVR 4% and SVR 41%.
So in this study- being a CC is considered a “favorable genotype” to PegIFN/Riba TX; being a TT is considered a “high risk genotype” with CT being somewhere in the middle.
Also, it's important to know that CT was the most common, CC is a close second and TT is more rare.
Hope that helps.  Cory.  

[evangelin]

Archer,
If you go with standard SOC, I think Alinia could be a great idea.  Joe's best TX response was with Alinia.  It was the only time he ever had a 2 log drop by 12 weeks.  Willing is taking it now and his TX response has been much , much better with Alinia also.( I think he takes Sam-E as specified by Cocksparrow too) Maybe he will stop by and comment but he is a wealth of information on most any HCV topic.  Instead of predosing Riba, you might see if you could at least  have a pre-approved way to get Procrit and/or Neup. so you wouldn't be messed up by a dose reduction. Too much Riba reduction caused a viral breakthrough on Joe's 2nd TX.  There is still the possibility that you will be a fabulous responder with just the standard TX.
I know some people have left over issues after TX but lots and lots of people don't.  HR's protocol fixed Joe back up afterwards.  Your kind of like Joe in that your boxed in to where you almost have to try because in the event that you do get a transplant...you still have the stupid virus. Very frustrating when there is no perfectly safe way to go. Take it a day at a time and just keep doing the next thing.  When I start doing more than that, my circuits blow every time.:>)
Keep in mind, if your early response doesn't look promising, you can choose to stop. Looking back, letting Joe go 15 months without becoming undetectable was probably insane.  We would cut our losses much sooner next time.
I'm Cheering for you!
Ev

[eureka254]

"If I trialled current SOC and don't UND by week 4 I might be inclined to step back and wait for Telaprevir - but not sure where I would stand on eligibility if I haven't completed 12 weeks."

If I'm understanding correctly, and you mean SOC with a physician and not a trial, I think it would be an important question to pose to your physician:  if you WERE to start SOC and decided to stop at week 4 due to insufficient/null response, would s/he treat you with PIs all the same?  I would think that being you are a cirrhotic patient, the answer should be "yes," but  what alternatives would be available to you after electing current options is an important variable to establish.

I agree with Evangelin about adding Alinia if you decide to treat; for those who have progressed disease, exploring possibilities to boost response is worth discussing with your physician.  My husband was naive (geno 1) and his doctor did agree to prescribe it off-label.  There was a greater than 3 log drop at week 4, and though we can't say for sure whether Alinia made the difference or not, we don't think it hurt any.  

The fact that you are dealing with portal hypertension and developing varices does make me incline to think the sooner the better.  It's already an uphill battle with Stage 4 disease, and the odds for successful treatment diminish further with progressing decompensation.  If your doctor is amenable to out-of-the-box thinking, you can ask for VL tests even earlier than week 4 to check for response, and follow those results closely and in conjunction to tolerability, take it a block at a time.

Wishing you the best whichever your decision. ~eureka

[merryBe]

Wait for your interleukin results, and I like the idea of boosting your platelets, maybe predosing blood builders, (hard sell to docs), or, if you aren't a transplant candidate you could even look at transfusions. (your age and other health facts play in here) I'd find this all out before deciding. Transfusions can lower your chances of qualifying for a transplant later, so this has to be weighed carefully. However, it is one method of boosting low platelets should the tx prove deleterious.
In the general public the odds of ever getting a liver transplant vary. They can be as high as 50% but the variables include our sge, tissue type, blood type, and the region we live in.
There are only half as many livers as folks that need them.
Add to this the fact that those on medicare are only getting approved 5% of the time.
This is probably a factor of age, and what medicare pays the hospitals (though no one will admit that).
If you are of an advanced age, then I would think one stategy, regardless of which tx you choose, would be to look at transfusion as an option. I'm not certain if the health care contiues down it's current path if any of us can be certain we'll get the Neupo, or Epo when we need it, so I'm just throwing ideas out there.

I just talked again to my hepatologist this week...he said that he hates to say when the PI will come, but he expects by summer, and maybe even late spring. That's assuming the fast trac its on doesn't get derailed somehow. If your meld is not too high, I would think long and hard therefore. You would be increasing your chances substantially and especially if your alleles aren't optimum, so again wait for the IL2 to return.

The dilemna, besides time that you face, is that the trade off is more platelets loss with the PI, which is why I mentioned an option.
However, you would increase odds of SVR, and also lower your tx time perhaps to only 6 months...so there's the crux of it.
I'm sure once you know your IL results you'll be able to decide with your doctors help.

mb

[Archer_]

Thanks everyone for your very helpful info. Well, been back to the specialist. I checked re Telaprevir - he agrees that it is unlikely to be available before next year and doesnt appear as keen to have me wait as I thought he was on my last visit and I think we are now more inclined to start SOC. In 2months when I will have hopefully decreased my HOMA score and am ready (as one can be for tx). He then wants me to first see a haemotologist to see if we can improve my bloods (ie neuts, platelets) before tx - using growth factors or whatever else might be suggested. My confusion set in when he said that then the tx might be dosed lower than usual and raised gradually, monitoring my bloods. I nodded but did manage to say that I was a little concerned because my understanding was that it was hitting the virus hard in the early stage was most conducive to SVR. He nodded back but Im not sure where it went from there. I guess we can re-visit that strategy next time. Evangelin and Eureka - I did ask him about Alinia and pre-dosing. He seemed more inclined to stay with SOC - given my status. However, he did ask a little more about it - and when I offered him my articles; he said he could get his own (lol).He was prepared to ask more questions about why I wanted it to be considered. I also referred to Bali's comments on another thread stating that his platelets increased with Riba pre-dosing - and if i recall correctly, he agreed that could happen, I think he said, because the bone marrow production gets stimulated. I also said I understood it took at least 2 weeks for serum saturation levels to occur and I ideally wanted that before my first shot of Ifn. He nodded. Im trying not to offend this Dr (ive upset one already) and though he is inclined toward conservatism and I feel a bit on egg shells with him, he does seem reasonable and prepared to at least consider what I am saying. So the upshot seems that in 2 months the journey does begin in earnest, though with a haematological assessment first. This may all change of course over the next 2 weeks - tomorrow I get my cardiology result and Cory -hopefully next week my allele result. Meanwhile I need to keep my blood sugars and apprehension in check. MerryBe you mention medicare, transfusions and transplants - I thought medicare was only in OZ? I dont know about transfusions, I was of the understanding that unfortunately the value of those was only for a brief window and perhaps not sufficient for tx. If/when my status deteriorates sufficiently - & I suspect the eligibility criteria would render my likelihood of a transplant very low - they are in acute demand. Any tx advice always welcome. Meanwhile I take my supps, watch my diet, take each step as it comes & cross my fingers. Like I said - a crap shoot. Take care.              

[Ozgirl707]

Archer, looking forward to those results.
yes i think treating as soon as possible will be the go.
I really think you should qualify for the Platelets and neuts builder.
Hope your haemotologist can help you.
Remember i'm just a P.M. away, if you want to talk,
best of luck,
Luv cindi xx ( Ozgirl)

[Bali05]

"Im trying not to offend this Dr (ive upset one already) and though he is inclined toward conservatism and I feel a bit on egg shells with him"

I don`t know how many good hepatologists you have access to where you are but I would
go about researching and interviewing as many as you can. Call it third and fourth
opinion if you will.
In my view one should never have to be afraid  offending or upsetting a doctor by simply asking
very educated questions.That situation in my experience happens a lot with doctors who either
have a big ego or who are simply ignorant to what you are asking.
Just my 2 cents.......

"He nodded back but Im not sure where it went from there."

To me he is evading your question. Not good. He obviously had a very different protocol
in mind (starting with lower dose) than you did  and he did not answer this very
important question. Nodding means nothing !
When he writes your first rx and it is a lower dose what are you going to say to him ?
"He nodded a couple of months ago ?"

I understand he wants to play it as safe as possible but I think a cutting edge more
agressive approach with a very experienced hepa will help you more in the end.
The risks are what they are and the biggest risk is going thru tx and not clearing the virus
in my view.

Remember Ross`s statement from the other forum:
"Think of what the virus would want you to do and than do the opposite"

This is simply my impression to some of what you wrote and I could be completely
wrong since I have no clue who this doctor is.

[evangelin]

When I was trying to get my Dr. to approve Alinia, I talked to the Dr. at Alinia (Unless it has changed, he is a very nice man and I have his name written down and can give it to you later, It has been a while and I don't know if he is still there)  Anyway, they faxed my Dr. reams of  the latest information about Alinia.  The Dr.'s office had to request it but I just gave them the number to call and the rest was easy.  Of course, until you try it, you can't know if you are one of the "lucky winners" of the diarrhea SX that Alinia can cause in some people.  Joe had that problem , but didn't stop taking it since we already knew TX wouldn't work for him without it.  It wasn't fun though.  Some people don't have this unpleasant symptom at all.  CS had to stop taking it for that reason.  I wish this were easier.  If you come back with a happy allele report, maybe you will respond easily anyway.  

The only Dr. I know of that thinks starting up slow with TX and gradually increasing is the way to go is Dr. Cecil Bennett.  He has a website and talks about it a bit.  He is an interesting man actually.  I know he has treated an awful lot of HCV cases.  I used to hear his name come up a lot.  If you requested some more information on his TX idea, he strikes me as the type of caring person that would answer you.  He has done a lot of work towards treating the HCV prison population here in the U.S.  I will search for the name of his website and let you know later.
Hang in there and breathe deeply :>)
Ev

[Bali05]

The first hepa I asked about Alinia after reading about the trials in the Hepatology Mag.
said it was unethical if he gave it to me because it was outside  SOC and he could not
support that. The second one outright laughed at me saying his copy was still  shrinkwrapped , he never got to read it and that I was looking for
the "Dreamteam" of hepatologists Ha Ha Ha.....
I than went on to my GP who agreed to write me a rx for Alinia. After the weekend I went
over to his office to pick it up and he had me come into his office to tell me that he
was sorry he could not do it anymore since he phoned some hepatologist friend
of his who advised him against it. However he replied if I got some higher up Professor
at a research clinic
to back him up he could change his mind.I went straight to Romark , got a hold of
Dr. Emmet Keefe who is Chief hepatlogist and involved in Alinia trials and got him to
talk to my GP.
BINGO ! Got my rx.
That was 1.5 years ago and in the meantime we had a FDA approved trial for GT1
in the US so there is more data now.
Long story short Alinia did improve SVR rates but not as much as for GT4 in Egypt.
Where we currently stand with that is that given the fact that Alinia
is very safe it is worth adding it. Higher dosage beyond 2x500mg have shown much
better results but brought on gastro problems which is why Romark is currently
developing a higher dose version up to 1350mg that is time released and better
tolerated.
I am taking it for a long time with no problem at all.
The biggest issue with Alinia is availability by country and price !
If your insurance won`t cover it is very expensive. I am sure CS can help
you with some info regarding that.
If you can get your hands on it what`s the big deal really ? Worse case you have
to stop it which is very rare.