extended tx decisions

[AK - Hepper]

After reading some of willing's links I'm kind of ambivalent about extending past 48 weeks, even though the studies all used less riba than most 1's are using. Anybody considering this actually made a decision yet?

[doll face]

Thanks for all the good advice. All my counts were low wbc 1.6 rbc 3.06 hemo 9.9. Refused to start me on procrit, so I will find out tomorrow what my new levels are. I am not going to lower my dosage without a fight. I have put up with the sides and feeling like s#*% way too long when the doctors could be giving me something to keep me going on tx. I did have an upper respitory infection couple of weeks ago but I guess I caught and treated it quickily enough.

[MajNeni]

You go!  I don't remember if it's your WBC or RBC that is low, or both.  Push for help if you are staying low... don't wait for a crisis.  

Low RBC's make you feel like a limp rag.  No muscle energy, no brains, no will power, no apetite, no fun, no YOU.
Procrit/Epoetin (for RBC's) takes about 3 weeks to kick in.  Doc might reduce Riba dosing temporarily while waiting for that effect.  Try to insist on Procrit instead of going down much on the riba, since it is an essential component of the combo tx.

Neupogen goes to work faster (for WBC's and low ANC).  If your WBC is very low, stay away from sick people and wash your hands a lot; maybe up your Vitamin C and other antioxidants.  Keep your hands away from your eyes, nose, mouth, etc.; don't scratch yourself raw; clean, smear w/antibiotic ointment, and cover any open wounds on your skin.

Maj Neni

[doll face]

I am on 1000mg riba (copegus) Just did shot 16 Sunday night. Having the worst side effects this week since I started. Going in for blood test this morning to see rbc & hemo counts, they still haven't started me on Procrit. If my counts are still very low I will be on his case to start me asap. Heard and read too many stories about having to discontinue tx due to low counts.

[AK - Hepper]

somebody else could better explain the scientific mumbo-jumbo, but I believe peg is short for poly(?) ethylene glycol and anti freeze is ethylene glycol. Maybe that'll keep me warm up here this winter?

[willing]

I tripped over that one too  - ethylene glycol is a common anti-freeze. The PEG molecule Roche tacks onto IFN to make Pegasys is polyethylene glycol. Different molecules - we're not injecting anti-freeze. On the other hand, polyethylene glycol is also toxic..

[oldhippiechick67]

She didnt mean that they really put antifreeze in the medicine, she meant it has something that slowly releases it over several days.  I dont want anyone to think the drug companies are poisoning us any worse than they already are!  But its for our own good, LOL.  Cheers all!  OHC

[AK - Hepper]

Thanks for the responses everyone, I still don't know what to do, though. 52 doesn't sound too bad, but 72 seems like forever. Hopefully some new numbers will come out before I get to that point.

Dollface, I hope things work out for you this time, sounds like you're off to a great start, though!

Willing, no new snow since that premature dusting a few weeks ago, but it can't be far off, snowline is steadily getting further down the mountains, it's usually pretty white around here by Halloween. Too bad about the furnace, might be kinda hard getting a 16 yr. old to chop wood these days. Thanks for all the links to the studies, nice to have somebody to shine some light for us drones...

DoubleDose, turn that dozer off and take a long rest, you earned it big time. Good luck on the SVR, sure sounds like you did all you could! How did you keep your wbc's from crashing with all that PEG?

Layla, you are about 2 weeks ahead of me. Nice that the sides are not treating you too awful bad, I guess mine are about low medium so far, every now and then I get hammered a little harder though. And yes, an extra 10 percent would be great, especially if we just happened to stumble into it...         Timbo

[layla]

I do think with pegintron, even with geno 1's, that 800 is the dose for some since it's weight based dosing. I'm on pegasys which isn't weight based. Hence creating more confusion! Have a good night. LL

[Jim55]

My heart goes out to you. I can't begin to know how ready you are to end the abuse. Lay down, take a rest and gather your thoughts. Oh and have fun soon.

God Bless

[shebee]

steve, the anit-freeze is why you only have to do shots on pegintron & pegasys 1 time a week.  Infergen must be done daily because they don't have the anti-freeze version out yet.  Hubby had hard sides on the others, but for him, the infergen seems to be easier.

willing...He is taking 15.(mcl's?)  They started him on the MAX because they want him to kick the hep this time.  So far his blood work is ok.  They have not had to put him on Procrit, so far.  I might mention that even though he is doing ok, he is unable to work right now.  He has spurts of working...about 30 minutes at a time.  I think at this point that if he pushes any harder, his platlets will go down even further.  He is at about 25 right now, which is not good.

He finally told the kids that he has been on chemo for a long time and that he needed their help.  Hopefully the kids will pitch in a bit more.  Teens can be so lazy!  LOL!

One day at a time,eh?  

DoubleDose....We should bake you a CAKE!!!!  WOW!  If I had to do as much as you have done, I would have been dead.  :)


P.S.  Our doctor has been have great response for his non-responders...using infergen.  He had a transplant patient that did not clear on Pegintron or Pegasys.  After transplant, he was put on infergen...and has CLEARED!!!!  

Best wishes to all,
Your,
Shebee

[DoubleDose]

Here is another small study which has been published on a number of HCV sites.  Admittedly it is a very small study, but the SVR rate for the nine patient group was extremely high.  The study was run by Dr. Buti, and provides some good details about patient response, log drops, and late clearance issues (12-24 week clearance)  See the attached link.

http://www.natap.org/2003/may/053103_1.htm

My doctor feels that not many extended tx studies have been done to date chiefly because the major players (Schering, Roche, etc.) are not excited about negative relapse data, and having to promote 72 week tx  to attain decent rates of SVR.  They would rather keep their heads in the sand, and just keep raking in the revenues.  There is a huge, immediate need for solid, well controlled studies to be done relating to Type 1 relapsers, late responders, non-responders, etc.  They need to fully explore high dose approaches, extended tx treatment intervals, and the corresponding rate of improvement in SVR as compared to current (standard ) studies.  I personally do not think that 32% to 50% SVR rates for people who get undetected after 12 weeks are very encouraging, or motivating.  We need to know how the rates can be substantially increased.  Hence the need for large, controlled studies NOW!

[layla]

This is one reason I think a more sensative test should be done a 12 weeks. If I hadn't asked for it myself I would have had the less sensative test (that is currently more standard at 12 wks) and thought I was undetectable but I in fact was not undetectable. I wish I had known what I know today before starting tx. I would have requested a higher dose for the first month. When I did start tx I was one of the first patients to take pegasys at the docs I go to since they were just doing a study that included using pegintron. They started me on 800 of riba which I think was a mistake since the standard suggested dose is 1000 or 1200. My 12 week was a 2 log drop but not ubdetectable (it was <600 ). Had I taken the recommended 1000 from the start would that have changed the outcome???? I wonder to this day. I did call them and have it increased within a couple weeks after doing some research. I don't want to be having similar questions if I don't do extended tx. Thanks for the article. LL

[DoubleDose]

I was only trying to point out the 'mind-set' of the major drug companies.  That seems to be one of using fairly conservative tx approaches, and then promoting the 'great' success rates (50% give or take, with Type 1's).  I think they may be reluctant to scare away potential patients, by talking about possible 18 month or even 24 month therapies.  Not many people will feel too inclined to jump into that commitment! Nor the higher dose therapies being tested in a handful of studies.

The relapse rate (for Type 1's) is not very encouraging in most studies, and the drug companies would love for everyone to focus on doing tx, and not worring about the crummy relapse rates.

It would be nice to have two week therapies, but the reality is that we may be 10 years or more, from being anywhere close to that kind of treatment.  I would be happy to see a combination of Inf./ Riba and Protease inhibitors, etc that would give you a 95% plus SVR rate, used for a couple of months.  But who knows how realistic even that approach will be.  The drugs are no where close to being ready, other than early stage trials.  There have been lots of disappointments so far in the various HCV 'inhibitor' development efforts.

All we really will have for quite some time is the combination of newer interferons, and Ribavirin related compounds, maybe with less anemia associated with their use.

[layla]

On the literature that came with my copegus/riba it reads that for genotype 1's recommended dosing is 1000 up to 165 lbs then 1200. For genotype 2 and 3's recommended dose is as you say 800.  LL

[odessit]

--- DoubleDose wrote ---
My doctor feels that not many extended tx studies have been done to date chiefly because the major players (Schering, Roche, etc.) are not excited about negative relapse data, and having to promote 72 week tx to attain decent rates of SVR. They would rather keep their heads in the sand, and just keep raking in the revenues.
---

What you suggest is that there will be no revenue for major players (Roche,Schering) if they recommend extending tx for 72 weeks??? Nonsense!
What we need is a better medicine, 1-2 weeks in duration, preferably no injections. You take the pills and after 2 weeks you forget about HCV.

[britgirl]

Sorry, I was thinking of 2s and 3s which are more common than genotype 1s here in the UK.

[britgirl]

I think 800 mg Riba is standard with Pegasys

[willing]

Congratulations on getting to the finish line! After getting through that ordeal you should let yourself crash for as long as you feel like it..

You've mentioned small studies showing good results with extended tx. I assume these are still unpublished since I haven't been able to find any more than these 2 (<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12753339&dopt=Abstract">Vrolijk</a>, <a href="http://www.natap.org/2000/nov/18monthsinterferon112200.htm">Brouwer</a>) and the two recent AASLD abstracts mentioned in the 10/10 "12-week RNA" thread below. If you have access to others (paticularly at standard dosage) it would be very interesting to read them: the results of the Berg study were pretty  surprising to me!

[layla]

I have decided to definately do extended tx.  If I get even an extra 10% I'm going to do it. I think this is an easier decision for me than most to decide since my sides are milder than what I typically read here. My doc is a hepatologist and when we met after my 24 week lab (undetectable) we decided to go ahead with this extended tx. This is my first tx and my labs were low to start, I'm a 44yr female infected probably about 27 years ago, 1a. Other than HCV I have been very healthy and active so I want to throw everthing I can at this thing now. At this point It would just kill me if I relapsed and hadn't done this. Maybe something will change my mind by the time my 52 weeks are up but right now it's a definite plan. I'm on week 33. I can imagine this is a hard decision for some but for me it wasn't and I am comfortable with it. LL

[DoubleDose]

I have indeed just finished 72 weeks of 'extended, and high-dose Peg-Intron/Riba therapy.  Today was shot #72, (I am still here!!!!) and this Saturday coming up will be my last day of Riba dosing.  So I am very excited about the possibilities, but will take it with a day-to-day, month-to-month attitude.

I am a 1-B, male, relapser (relapsed 1999-2000 tx)and have tried to push the 'envelope' as far as reasonable along with my doc.  He is one of the top known HCV docs, and has been very good in keeping me going in the right direction, and avoiding unproven or unsafe additions to tx.

His experience with difficult to treat 'Type Ones' in both major trials, and his private practice, has been that Peg-Intron/Riba has been MORE effective overall than Pegasys/Riba, although much harder to tolerate.  It has been very tough, especially the first 8 to 10 months of tx, but it has been do-able, and I have managed to run a business, and family (most days!) for the entire duration.

I am very ready to stop though, and it feels like hitting the finish line in a marathon, in that I 'bulldozed' my way through the last months, but upon completing the last few weeks (finish line) now feel like I just want to lay down and 'crash' for a few weeks!!!!  I can let go of the 'pit-bull' game face, and finally say 'IT IS OVER!

Now for the really scary part....waiting to see if it fully eradicated the virus!

I did two times the standard dose of Peg-Intron (3.0 mcg/kg of body weight) and 1,200 gms. of Riba for 52 weeks, and then finished out my 72 weeks  at 2.0 mcg./kg Peg-Intron, and 1000 /day Riba. I was down about 3-Logs at the 12 week point, and fully undetected at week #18, by ultra-sensitive PCR...and stayed undetected to the end. This was the reason for extended tx (72 weeks), since odds were not very encouraging had I only gone to 48-52 weeks . (Probably would have been odds in the 32% to 50% SVR range) There are only a few small studies so far for the 72 week tx approach, but those have been very encouraging.  I suspect you will continue to see new, and larger studies using extended tx for late responders (12-24 week undetected) and for difficult case type relapsers.

There is not a lot else out there to consider, and the viral kinetics (decline curve) in the early weeks and months seem to point to the probabilities of success, etc.

Best wishes to all those considering extending tx, or raising doses, etc. in order to provide 'better' odds.  We don't know yet what those odds are, but there is reason to be hopeful.
It is something that can be done!!!!!  Look at the other people on this board that are doing higher doses, and longer duration of tx, and continue to correspond with everyone.  Let's all lend our support and positive stories, for those who decide they may need to 'push onward' beyond the standard tx period.

[willing]

Hi Timbo - how's the snow these days? I disconnected our furnace this summer on one of my good days and now don't have the energy to  put it back together. I'm hoping my 16-year old will get out there and chop us some wood, but not much luck so far. Fortunately "cold" around here usually only means low 40s. The Berg study had a pretty strong impact on me. It's a reputable group of researchers and their numbers are in good agreement with other studies: the % of SVRs is very close to the % that cleared at 12 (<50iu), the relapse among those that cleared at EOT is about 30%, and  the % of responders (clear at 24) is about 70%. Two details that struck me were the higher breakthrough rate from 48 to 72 and the fact that the overall post-EOT relapse was about the same for the two groups. It's interesting to compare the Berg study with the Fried data which is a major influence in only treating 2-3s with 800riba for 24 weeks (<a href="http://hepatology2.aasldjournals.org/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=fullfree&id=ajhep036s121#head3">see Table3</a>: neither more time nor more riba has any overall impact on the 2-3 response rate. One year of tx may also be an upper bound on the efficacy of combo-tx for 1s.

Another interesting point was Avidan's success with his week 4 predictors. Getting to SVR is starting to look to me like hosing a  big spot off your driveway. If it's dirt you can tell within a couple of minutes that you'll be successful. If it's grease or paint you can stay out there all day with a firehose and get nowhere. In our case the variable is the sequence of our dominant strain.

As you point out they were using suboptimal riba - which in the Fried data accounts for about a 10% difference in outcome. If the heavier riba dosing applied a longer term  makes a big difference their study wouldn't have caught it..  Based on this I'm leaning towards stopping at 48.

Sheebee: glad to hear everything's working out so well. It's great he's tolerating the daily infergen without major problems. As far as I know the sides reported for IFN with/without the peg are the same so maybe the difference is due to using consensus IFN vs 2a/2b. What's his daily dose?

[Steve']

Are you serious, I've never heard the anti-freeze content thing before ... but anything is believable I suppose ...

[shebee]

Hi everyone!  This is the first time that I have had a minute to let everyone know how we are doing.  As you know, I am now working long hours & hubby is staying at home for a few months.
He started on the daily infergen & co-pegus.  So far he is doing very well on it.  He is exhausted and his legs hurt, but on the infergen, he still has a sex drive.  (Which is a nice plus!)  LOL!

The daily shots are a drag, but without the anti-freeze in them, they seem easier.  I wonder if it is the anti-freeze in the peg & pegasy that makes one so sick, and not the interferon?????

Our new dr. is wonderful & the nurses are great!  If any of you are not getting great tx, switch doctors.  It can make a big difference in your treatment.  

I am so tired all of the time, but we are all doing well, and we are a happy family, in spite of the difficult changes.  We are not starving, yet.  LOL!

At my new job, I am aiming for the top and almost there already. After I get off of work, I study more...and I come in early & stay late.   My incentive to excel is my family.  (Do you know how much they eat?  LOL!)  I love them all so very much.  At work my co-workers & boss think that I am a wonder.  Ha! Ha!  I had my review yesterday, and found that I am doing well as the seasoned workers, after only a few weeks.  I was told that this was quite unexpected.  Most wokrders take 5-6 months.  I push hard...so hard, and I am fair, honest, and refuse to gossip.  (LOL!.... although by now, I know everything that is going on!)

Anyway, I am not whining.  All will work out and hubby will be hep free in 2003!

Best wishes to all of you, my friends.  Thank you for your ear, your love, and advice.  Without you, we would have never made it.

Your, Shebee

[Dirac]

I am glad that you cleard at week 12. Now after you
have experience with peg-intron and pegasys, what is
difference between them regarding their side effects.
And when did you clear the virus the first time on peg-intron.
I wish you the best of luck.