Treatment Decisions Are So Hard Based On Study Info

[skersj]

At week 42 and with Hgb hanging in the 8's even with Procrit I am really tired. Procrit has got me to low 9's 3 times in the last couple of months but then it goes back down to low 8's. Hct has been 23 - 28. Platelets hanging around 55. All this makes it really hard to function let alone make life changing decisions. And yet it is time to decide 48 vs 72. Can't put it off any longer. My doctor doesn't think it is worth 72.  With a 12 week VL of 950 & wk 16 of 55, I don't think I have a rat's chance if stopping at 48 (wish I hadn't been so hard headed at wk 12 & figured this out then) and I only think I have a hair of rat's chance even if I go 72 (which I can't even get my doctor to consider until I prove I can even finish 48). I really feel the 2009 SUCCESS study is biased toward the funder who wants the government to get new drugs approved - which I am all for. I am thinking that if I have to go 6 more months, maybe wait for new drugs for better success & hopefully go only 6 months (yea I know wishful thinking). More wishful thinking is the 2009 EASL study that the greater drop in Hb decline is associated with higher likelihood of SVR but I have seen too many posts here of SVR people that didn't drop below 10 to really believe that.  48 weeks sure was a lot of stress/misery invested for nothing.  Worst sides now are anxiety and fatigue. Anxiety mostly due to worrying about collateral damage from meds - can't be good for heart, lungs, brain, etc with Hgb, Hct & platelets so low.
I would like to hear from this forum opinions on the 2009 EASL studies.
Stage 1 Fibrosis
1A probably 30 years
2 M base VL
4 wk 197,000
8wk  10,000
12 wk 950
16 wk  
24 wk lab error
25 wk UND since

Thanks for listening, All of you are great! I could not have made it this far without you!

[skersj]

I also want to mention that I am also very thankful for the warriors that went 72 weeks so that I even have that option. I know it works for some and if I had a lower 12 week VL I would be even more likely to keep going. I still don't know if I will extend or not. Just going to try to make it thru the next 6 weeks and see.

[skersj]

Thanks for the information. There is no easy decision for those that fall in the same category as I. My opinion from all the studies I have read is that Yes going 72 weeks works in a small persentage but that one would have a greater chance if on the new drugs. If the odds were greater for going 72 now I would take it hands down. I am truly thankful for those going through the trials now so that others like me have hope. They are heros in my book.

[newleaf09]

Boceprevir is shooting for 28 wks for people who cleared and stayed clear at 8 wks.  The 4 extra weeks is for priming the system with 4 wks SOC before adding the PI.  I think teleprevir may actually be 28, also.  Still a vast improvement and with more studies they may be able to shorten it more.  Then there are the second generation PI's in Phase 2 testing now.  Studies are also looking at non-interferon TX but my doc, an infectious disease researcher, believes you cannot defeat a virus without a hyped up immune system.  Look all new drug reports up on NATAP at http://www.natap.org/hcv.htm

This from the study you are referring to (found at http://www.natap.org/2009/EASL/EASL_89.htm)  I can see why it's confusing.

"Conclusions: This, the largest prospective study among G1 slow responders, demonstrated no statistically significant difference between 48 and 72 weeks of treatment. However, in these true slow responders, extending PEG-IFN alfa-2b/WBD ribavirin treatment is associated with better SVR and a similar incidence of adverse events. These results are in line with those observed in other WBD ribavirin trials in slow responders. "
They seemed to have been reluctant to stick their necks out and take a stand.

[copyman]

just to clarify it is vertex's PI telaprevir that is shooting for a 24 week tx. I  think Boceprevir is still looking at 48 weeks

[merryBe]

correction...sheesh I'm brain dead today...for some reason I saw the 24 and was thinking 12..or 3 months...how's that for fuzzy math...sorry. 24 is the current time frame for the PI's....boy do I need to proof read and have some coffee.

mb

[merryBe]

I'm with NY girl, no reason you shouldn't be given more procrit. they told me that more than 60,000 doesn't work, in a weeks time, but they gave me that max...I could have broken it up, 40,000 once, and 20,000 once, since that was the way they were sending it to me,,,one vial of each per week.
Now that she said that, break up the doses, it makes sense...would keep you more ahead of the curve....several times I thought of doing it that way, but never did...too much a creature of "take as directed" I guess....but the logic of 2 doses does seem more reasonable.

I managed to stay between 10 and 11.5 even using the as directed method. They started me on procrit at 10.5...with a little coaxing on my part....The problem is they should never have let you get that low to start with...it seems if patients don't protest many doc figure they are tolerating the low oxygen...but losing 1/3 to 1/2 your original oxygen carrying supply is never wisdom....so now, you may need to add more iron to your diet...it depends on whether you have enough free transferrin... of course some folks get iron overload with the virus, so you have GOT to have your blood checked before you start eating more iron, and know if your biopsy showed any iron already in your liver. If not, eating some red meat will help the procrit work better. It can't build you new blood cells if there's no iron present.
At stage one, I doubt you have any iron deposits in your liver, hemochromatosis; but it's good to read your biopsy to be sure. Never ask a nurse what your results were...I can't tell you how many times I've asked for results and been told, Oh they are fine, when they were really NOT fine by nurses, enough times to have lot count. Always read your own results. Ask for a copy to be sent to you. Sign a form at the time of each scan or procedure to see the full results, and then read them as look up the words you don't know. It's the only way to be sure that things that need attention are noticed. I've even been told things are fine when having a tumor...so this is why you must read reults for yourself....doc skim results as do nurses.

as to the treating, it is a tough call to be sure. On the one hand, you've knocked the viral load to UND, and more time spent treating while UND, asuming no viral breakthrough is a predictivetive of outcome as is early response in recent studies. Yet copyman has a point also. Since odds are not a good with current SOC the temptation to not endure an extra 6 months would be significant. Especially at stage one. Yet reality is, you will still have to do another 6 months or more again with the telprevir. The things I've read suggest it causes more blood tanks than current SOC, so either way you may be in for a rocky ride.

If it' any consolation, I had a worse time between month 10 and 11 than for the last 6 months. That varies from person to person of course, but going through a rough patch doesn't mean the entire duration of tx would necesarily be as bad.

I'm not sure why copyman referrence 24 wks. The rate of SVR with the new PI's is 75% if you are type 1a, which I'm assuming you are...but if that is the case, I thought the majority were still treating for 48 wks, if type 1a. Perhaps that's changed now with more studys, I've not kept up on that. Maybe Copyman can clear that up for us?

In any case, it's clearly a very difficult call for you. I'd tend to agree with copyman's point given your stage, except for I'd want to know could your blood be brought up, and also how secure is your insurance situation. If you have any doubts as to whether you will still have coverage in a year or two (since not all are equally job secure this is a big issue and don't hold your breath for universal coverage, every president from Jimmy Carter on has promised some version of this and no one has delivered)...so I'd also say you have to weigh that into your decision.
The problem with this treatment is no matter which way you slice it, in the end tx is the proverbial literal beating of a dead horse....whinnie and snort. It plain hurts.

I opted to continue TX even though not UND until 20 wks, but then, I was late stage and that plays a huge part and limits ones options. I'd not recommend anyone stop tx in stage 3 or 4 because one could advance a whole stage more in the time between now and when the PI's are available!  Reason being is every advancement in stage also lowers one chances of a successful tx by a few percentile points.

I'm orry to hear you are having to deal with this, but will be praying you make the right decision for you, whatever that may be.

mb

[copyman]

I would not continue beyond 48 weeks. having only stage 1 fibrosis I would take my chances doing 48 weeks. if I relapsed I would regroup and wait for the new drugs and the possibility of doing only 24 weeks. There is no way I would do damage to my body for 72 weeks having only stage 1 fibrosis !!!
I wish you the best whatever you decide.

[skersj]

Thanks. I guess I will take it one day at a time right now. I am just trying to get my mind wrapped around failing. I was so confident given my health at the beginning. Such naivetivity then! Thank you HCA telling me about the platelets. I wish I would quit obcessing about them!

[HCA]

Your platelets-55 at week 42-are sustainable.
I have been as low as 30 on current treatment.

[Marc1955]

I do not know whether I am SVR since I just stopped. I am genotype 1. Started at 900,000 had a two log drop by week 12 and cleared by week 24. The docs I've consulted peg my chances of clearing at about 50/50.

I know exactly how you feel. Having put in all this time, it's impossible to just give up. But guess what? You'd have the same problem at week 72. Your chances would not be that much higher and you'd still have to cross that point. Some people extend beyond 72 weeks, but there's no evidence to base that on. Since you're stage 1, you really need to think carefully. The success rates reported for previous relapsers with Teleprevar were 75% at 48 weeks. In a few years they will know even more about successful approaches to treatment. OTOH I know how hard it is to let go after you've gone through so much. I did it. Tore the hell out of me mentally and physically. I'm happy now to be repairing my life regardless of whether I achieve SVR. I figure I'll return to the issue in a few years.

[HCA]

I saw one study-wish I could find it for you-that said that of 150 geno 1 patients none who had viral load of >750 at 12 weeks had SVR after 48 weeks.treatment.
The honest truth is I think you have somewhat better chances if you extend.
Detectable viral serum at 12 weeks ,however low is worrying.
I was pos. at week 12 and relapsed.(Now treating again in Telaprevir study)
Extended treatment was all the vogue,but recent studies have cast doubt.
With regard to the new drugs it looks like it may be a 48 week regime for non-naives anyway.
The truth is,48 or 72,it's 50/50-you either clear or you don't.
I hope you make the right decision and get the SVR.

[skersj]

Nygirl,
I think you are right about twice weekly. I will ask my doctor. I am taking Procrit 40,000 once a week. I take it on Friday morning and have noticed I feel bad about Thurs - Sunday then better Mon -  Wed.  I take Peg on Sunday morn. CBC every Tuesday morn. Do you remember what size needle you used? The pharmacy has given me 25 gauge and insulin needles which are 31 gauge. The 25 gauge are not sharp enough to get thru my skin easily - most time I have to push it deeper and the 31 gauge seem to small for the thickness of Procrit. I wish I could get 27 gauge like Peg comes in but I can't find any.

Marc1955
Do you know yet whether you are SVR? What were your initial drops in VL? I have heard people here who had 40 VL at 12 wks & didn't clear afer 72 and people here with higher that did clear (but not as high as my 950). I wish someone could figure out why.
I am considering stopping and waiting since I am stage 1 - IF BX was correct. I am having a very difficult time stopping at 48 though; I mean what if 72 would work!  It did for alot of others here. I already imagine the post tx PCR and how I will handle the word RELAPSE. That is hard to prepare for. I feel I can make it to 72 mentally but I cannot control my blood chemistry. I hope every week that my lab will come back showing improvement. I have tried eating every thing under the sun to raise hgb and taking vitamins. I have kept up small amount of exercise in hopes of bouncing back quickly.On the weeks my labs are good I increase intensity. I would have quit at 12 weeks too knowing what I know now but back then I was too naive and scared. For some reason now I am having alot of anxiety about the platelets and what if I get hurt. Dumb huh? No mention of PT & PTT from doctor.

[Marc1955]

Although there are people on this board who are big proponents of extending to 72 weeks, I don't think the science is so clear. I've looked at all the available research. The studies are far from decisive.

Clearly one of the problems with 72 week treatment regimens is that they have a higher drop out rate than shorter regimens. People just can't do it. That leaves aside the issue of potential long-term damage from so much interferon which is an unknown.

I guess what I'd really like to say to you is that my heart is full of sympathy for your situation. What a terrible thing – to have suffered and struggled through treatment now only to have to consider a questionable likelihood of success. I don't think there is an easy answer. Even if you treat for 72 weeks, your likelihood of success will not go up that much.

For what it's worth, I just completed 72 weeks. My sides were much less serious than yours. If I had to do it again, I would've stopped at 12 weeks when I didn't clear and waited for new treatments. The suffering to myself and my family was not worth the extended treatment. But everyone needs to make this choice for herself and a major factor is your current level of liver damage. Good luck.

[nygirl7]

Are you only taking procrit once a week?  My doctor finally gave me - instead of one huge shot - (I was on epo so the numbers are different) 40 twice a week.  This helped me level out somehow and maintain in the 10s.  How much Procrit are you on? Can you talk to him about raising it and doing it 2x a week to see if it will help you go up?

Seriously you are a perfect candidate for having to do 72 weeks but living in the 8s I don't even want to think about. God, ouch.

I'd see if he is willing to help you fix the hemo problem and you still have a few weeks to decide what exactly you are going to do. I would say continue of course but boy I"m not the one feeling the effects of anemia any longer and believe me 72 is not an easy road (I did it but my hemo was again in the 10s).

Good luck.