treat or not treat...info on trials?

[smaug48]

Hi everyone, I'm a newbie here.  All the posts to JodyLynn's "all bloodwork is back" is prompting me to write.  First, here's some background.

I got hep c in 1981 when I was 17 during a blood transfusion (one of several I had while receiving a bone marrow transplant for treatment of AML). I've known about the hep c since 2002 - had a biopsy done and diagnosed then as a stage 2 on the old 1-6 scale, genotype 1, not sure if a or b. Gastro recommended treatment but I didn't do it because a friend told me horror stories about the side effects (48 weeks of potential misery for a 50% chance of clearance is a tough sell for me).

I had another biopsy done last spring during surgery for a burst appendix, but the biopsy was done near a fat nodule so stage diagnosis is difficult (so I am told). My (new) gastro thinks I am stage 2-3
now and that I've had the hep c too long and I am too young (43) not to have serious health effects if I don't treat it. Because of the leukemia/bone marrow transplant I don't have a normal immune system, but no doctor/gastro has said that is a factor (although personally I am quite concerned about the possible anemia side effects of the tx). I'm rearranging my life to do the treatment starting next January, but am still having 2nd thoughts, especially when I read about promising treatments being developed.

All along I have felt OK and have been living a normal life (although I totally cut off alcohol after being diagnosed in 2002). Because I feel OK I'm wondering if I should wait, but then reading katerika's post about being stage 2 in 2002 and teetering on stage 4 in 2007 scares the heck out of me.

I welcome everybody's 2 cents on whether I should wait or not wait.  Someone in the "All my bloodwork is back" string suggested getting more information on trials - where can I get such information?

Thanks in advance - it's so great to have this support!!!!!!!!!!!!!

[zazza]

Nope, the Swedish doctors I have been in contact with seem to do it by the book. Haven't heard anything about high-dose ribavirin here either.  As usual I learnt more on the forum. And since PegIntron and Rebetol seem to be the most often used brands here, ribavirin actually gets dosed lower since the range here is 1000 mg for 65-85 kg for Rebetol, but 1200 mg for >75 kg for Copegus. But we are a country where all citizens have very good health benefits, so once you get your treatment approved, your medication is totally free of charge since HCV goes by the Law of Contagious Diseases. And any and all doctor's appointments, biopsies, etc. with or without treatment are free of charge. Zazza

[smaug48]

Thanks for all your comments, they are a big help.  Certainly I have to do more research (at minimum to find out the meaning of all those acronyms you guys use!).  At this point I am still leaning toward doing the treatment.

Best,

Smaug

[jmjm530]

Yes, I throw in the extra "e" to make you and other Sweeds smile :)  Now that I see you're from Sweeeden, you must be taking a lot of ribavirin :) Speaking of which, does Lindahl and Company get more press with the Swedish docs than here? Haven't seen anything new published lately on high-dose ribavirin.

All the best,

Jiim

[zazza]

Jim, I smile every time I see you write "Sweedish". I am from Sweden and I am Swedish. LOL, Zazza

[jmjm530]

LOL. Both my doc and NP were pretty surprised as well. Like I said, had I known the results of my 1 week PCR before double-dosing Peg/high-dosing riba, I probably wouldn't have -- or at least shouldn't have. For whatever reason, I responded very quickly. BTW I listened to some "healing" tapes by Chopra I ordered from Amazon. Hey, you never know :)

All the best,

-- Jim

[CockSparrow]

Sure you arent a G3 with that viral kinetics. LOL
Still havnt quite got my head around RVR v Non RVR.
Not convinced its all viral, or more precisely an easier strain.
CS

[bobbyullc]

no one is suggesting you wait till stage 4.

but, as you have had it for 26 years and are only a stage 2 you are a slow responder and it looks like one more year watching the trial news will not make a big difference. being only one year older will not mean a thing either. if you started tx now it would be 2years before you get started, treated and waited for results. in that 2 years i believe the trial results will show for sure if vx950 or the others will work or not.
i had it for 37 years before choosing to tx and wonder now if it was a good decision. i did clear but lost a year of my life to tx. good luck.

please do not tx out of fear of what may not ever come to pass.

[jmjm530]

CS: ut I wish I had done what you did and worked out how to increase SVR odds, before starting Tx.
-----------------------------
I'll take a little less credit than you give me, as what I did to increase my odds of SVR was more on the fly, than premeditated. I started tx with doctor "x" who pretty much did it by the book and in fact suggested 800 mg/day of riba because of a family cardiac history. I knew enough to say "no" to the "800" but not much more. Through some quick research, luck and fear (the fear being that the research showed me to  around a 40% chance of SVR given my stats) I switched to Doc "Y" at week 2. This doc was amenable both to double-dosing peg , weekly viral load testing, and allowing me to try and emulate the Sweedish study -- which I actually over-emulated (too much riba too soon even by their standards) with not so great consequences -- ER and off riba for a week (around week 3 of tx).

One question is did my xtra measures help get me to SVR? Of course, no way of really answering that but looking back with the advantage of all the numbers, etc, -- I don't think so. I say this because my week 1 PCR was 16,000 (very close to a two-log drop pre-treatment). This PCR was the result of SOC (1200 mg/.day riba) and not the 2000mg I took after. Of course, I didn't know what the result was when I started higher-doses, not that anyone could have taken the xtra riba out of my hands in those days. LOL. In any event, looking back, my guess is that the die was cast before I treated, meaning that whatever strain of the virus I had was quickly knocked down by the peg/riba and perhaps some genetics. Again, we'll never know. Week 2 PCR was <600 (on higher riba then) and non-detectible by week 6. Guess is I would have been non-detectible by week 3 or 4 had I not had to go off of riba for a week.
I also think I could have stopped treating at week 36 but not of the doctors I consulted with liked that idea and the shorter course studies for geno 1's were just starting to come out, or perhaps not out yet.

-- Jim

[CockSparrow]

Jim same page. Depends on which bits you read really dont it. But I get your point.
However SVR in stage 3 to 4 was significantly increased in the WBD group ( 282 / 657; 43%) compared to the FD group ( 242 / 657; 37%); p = 0.02.
If you look at the Accelerate Study it had F3/4 lumped together with 58% SVR, so its not just old studies that lump them together. And 58% vs 74% = harder to treat to me.

I would prefer to treat at stage 2 rather than wait till stage 3. Why because you are more likely to SVR the earlier you treat. Whether this is age, time since infection or stage or all combined not sure. I think it’s a little misleading to look at a single response predictor in isolation anyway. They add to each other. I cant give a link for this but I would bet that if you were F3 say with HVL your SVR rate would be lower than having either F3 or HVL on its own. I haven’t seen a study breakdown that does this but geez it would be useful.

As for whether to treat early or monitor and wait,. both have merits.
For me I think I am better off without the virus, but if it isnt doing me any harm I can also wait. I’m in no hurry to treat again but I will and probably b4 VX-950 or HCV-796 are approved.
The problem I have with waiting is that you can become complacent and not monitor that often. You feel alright so nothing to worry about.

I think VX-950 will be approved also, just not confidant it will be in 09.
Doesnt matter much, its out when its out. Tell then were both guessing.

Say one thing, we may disagree on whether to treat or wait but I wish I had done what you did and worked out how to increase SVR odds, before starting Tx. I really like the way you went about that.
I wouldnt have taken 2000 mg Riba though. I had seen the abstract of that study and went nah.
What interested me was the person who withdrew at 36 weeks or whatever it was and still SVRed. Shorter Tx by half killing yourself was my conclusion.
CS

[jmjm530]

CS: Waiting till stage 4 just makes it too hard to kill the little buggers even with VX-950.
--------------------------------------------
I hope you're not suggesting that's what I  said. What I did say was that "Smaug" appears to be a long way from stage 4, not that he should wait until stage 4 before treating.  Big difference and that is where a program of monitoring comes in with periodic biposies, blood marker tests, Fibroscans, etc.  

CS: My view is that the worse the liver damage then the harder to treat.
F1 easier F2 Little Hard F3 Hard F4 really hard. Just my view.
--------------------------------------------------------------------------------------
You are entitled to you view of course, but please take this study into consideration.
http://www.hivandhepatitis.com/2006icr/ddw/docs/052306_e.html

"...In the entire population of patients logistic regression showed no statistically significant difference in SVR rates between Stage 0 (44%), Stage 1 (46%), Stage 2 (44%) and Stage 3 (44%)...."

As prev stated, the reason stage 3 is often associated with lower rates of SVR may have to do with previous studies:

"...Fibrosis is a predictor of sustained virological response (SVR) in hepatitis C (HCV). The majority of prior studies do not involve enough patients with cirrhosis to truly define the contribution of advanced fibrosis to SVR and nearly all combine Stage 3 and Stage 4 in their analyses...."

CS: wish i had your confidence on VX-950 being out in 09 but i will believe it when I see it.
----------------------
No guarantees of course, but I think based on what we've seen so far, it's more reasonable to be confident of FDA approval than not to be confident.

[CockSparrow]

Sounds like you're a long way off from stage 4.
-------------------------------------------------------------------
And you should treat a long way b4 stage 4.
Waiting till stage 4 just makes it too hard to kill the little buggers even with VX-950.
You really would be relying on INF reversing scaring and at best thats a maybe and by no means certain. Treating earlier at least buys some time even when it fails.

I had wondered about the F3 F4 thing though.
My view is that the worse the liver damage then the harder to treat.
F1 easier F2 Little Hard F3 Hard F4 really hard. Just my view.

I wish i had your confidence on VX-950 being out in 09 but i will believe it when I see it.

I'm gunna give up on stats with this disease. Still cant get my head around why i keep seeing different figures for Accelerate. Doesnt help when they mix and match ITT with Per Protocol stats in the same study either. I'll leave the 80% stats alone for now, put it down to misreading the combined stats, but I may come back to it at a later time.
CS

[jmjm530]

Smaug,

Sounds like you're a long way off from stage 4, even if you're using a 4-step scale like Metavir. Further still, if you're using a 6 stage scale. In any event, my suggestion is to sit back and evaluate the trial results of Telaprevir. These results should be in by end of year and if all goes as hoped, Telaprevir will be on the market in 2009, hopefully with double the SVR rate with half the treatment time. In 5-10 years, it's even possible that interferon will not be part of the mix. In the meanwhile, you might want to do periodic blood marker tests like Fibrosure or the Fibroscan device when it becomes more locally available. Another liver biopsy is also an option if the last one is inconclusive. Are you being seen by a liver specialist (hepatologist)? They can also make educated guesses based on other factors including physical exam, size of spleen, platelet count, etc.

CS and Mike,

I side more with Mike on this. SVR rate is closer to 40-50% for gentotype 1's, pre treatment. Not sure what the rate changes to with 80/80 but that's a loaded figure because no one knows how compliant they are able to be until they start treatment. Also, newer studies suggest that only stage 4 (on a 4 stage system, i.e. Metavir) is a negative predictor of SVR. Stage 3 isn't. Apparently, older studies lumped 3's and 4's together and that's where the notion that stage 3's have lower rates came from.

[Bill1954]

Hi there, and welcome to the discussion group. You’ve received good info already above; I just wanted jump in regarding clinical trial locations. Here is a service provided by the U.S. National Institute of Health:

http://clinicaltrials.gov/

The instructions on the home page are self-explanatory; for example, try entering “HCV, San Francisco” let's say in the search engine to check your area, and then expand as needed.

Take care,

Bill

[mikesimon]

You said: "The G1 SVR rate is around 60-65% if  80% of the drugs are taken at least 80% of the time. The 80 80 80 rule."

Where did you get those  figures - 60-65%?

My understanding is that it's closer to 50% for genotype 1 with Peg and ribavirin.

Mike

[CockSparrow]

Firstly I’ll state that I am pro Tx. However the decision to treat is a personal one. Its your liver, your disease and only you can decide if Tx is right for you.

I have had HepC for about 25 years and am probably Stage 2. I also have felt OK most of the time. Its strange, I would have said prior to Tx that I didn’t have any symptoms of HepC. I did, just didn’t recognise them at the time.

HepC is a slow moving disease but progression is not linea. You can go decades without much liver damage and in the space of a few years liver damage rapidly worsens.
People can feel OK and have cirrhosis, so you cant judge liver damage based on how well you feel.

Some things to also consider are the known poor predictors of response.
Male,
Age >40/45,
Viral Load >400K/800K,
Fibrosis stage F3/F4,
Genotype 1/4
and possibly Steatosis.

There more PPRs you have the more difficult you are to treat. In other words the earlier you treat the higher the chance of SVR. The G1 SVR rate is around 60-65% if  80% of the drugs are taken at least 80% of the time. The 80 80 80 rule.

Now for some reasons not to treat.
These drugs basically suck. Tx could well be the hardest thing you have ever done, but not everyone suffers really bad sides. Its not easy to tell who will have minimal Sx and who will suffer badly from them, until they occur. Most fall in the middle and have some Sx. Me I had hardly any.

New drugs are coming and promise shorter Tx times with much higher SVR rates.
Waiting for these definately makes sense, but only if your liver damage doesnt worsen.

Ribavirin destroys red blood cells and Interferon suppresses bone marrow, so you have reason to be concerned about anemia. However there are drugs that can boost production of both your Red and White blood cells such as EPO and Neupagen.

As Meki said a 50% chance is better than none but one of the benefits of Tx is that it can buy you some time even if it doesn’t work.

Hope this helps
CS

[meki]

There are a lot of trials going on - just about any time.

You can google HCV or Hepatitis C Trials - and a lot will come back.

Scroll through those - and come ask questions about them.

50% chance - is better than NO CHANCE.

And will you get healthier enough to treat later on in life?

What happens if you massively start to have growth or damage over a short period of time - are you willing to hope that you don't... instead of hoping that you can CURE the disease - at least 50% of a chance?

It's up to you - each person reacts differently to the meds. Most of the people on this board have had issues ---- but that is because when you get symptoms - you get scared and you go look it up --- and you find forums with people who have had the same problems you had --- and that grows exponentially into a large group... A large group of people who all had issues or have them...

So don't be frightened. There are people out there (thousands of them) who have had no side effects.. or very mild ones.

Just remember this: To treat or not to treat is a very personal decision. But once you make it - stand by it.

Meki