Higher Dose Pegasys or Infergen 15mcg per day

[Bill1950]

Hi folks,
I've been lurking here for some time and have decided to join the great conversation.  I have hep C and went through 48 wks of  SOC Pegasys w/1200 ribavirin ending in May 2004.  I was undetectable at 12 wks, had a breakthrough to 212,000 at 24 weeks and was undetectable again at the end.  But 6 months post tx the virus was back, at 15 million as opposed to 3 million a year or so before I started.

I have had two biopsies.  In 2002 I was Stage 1 fibrosis and Grade 2-3 inflammation.  Then at the end of 2005 I had progressed to Stage 2, Grade 3.  

In the midst of all this, on 2-14-06 I had my left hip replaced due to a really serious injury I had back in 2002.  The metal hip is fine, all healed up and giving me no problems.

But lately I have been feeling a little rough and the symptoms feel like the hep C liver stuff I have heard others described.

I think it is now time to be retreated.  I was lined up for a clincal trial with VX 950 but at the time my wife was pregnant so that disqualified me.

I have exchanged some e-mails with a Dr. Cecil up in Detroit.  Back in 2005 he recommended that I retreat as soon as I get my hip problem fixed and he says I should consider going with a heavier dose of interferon adn treating for a longer period.  I think this makes sense.

He says if Pegasys, 270 mcg per week instead of SOC 180 mcg.

He says if Infergen 15 mcg per day.

Has anybody else here tried this?

I asked the doc at the clinical trial clinic and she wasn't interested.  Says I should wait.  But I don't think so.  I know of another doc near here, an infectious disease doc who would probably treat me.  Or, I could go to Detroit and get Dr. Cecil to do it.

I am a 58 year old male and live in Florida.


Any ideas?
Bill in Florida

[Bill1950]

Jim, you know I think there is one REAL risk to retreatment, or even the initial treatment, for that matter, if it doesn't work.

There is this "wild virus" business, which I have heard discussed at length by posters on another message board, some of these guys being researchers in the biotech field, and probaby in the HVC field.  

A good place to see some of this is the message boards here: www.investorvillage.com

Just go to the VRTX (Vertex Pharma) board and you will find some bright guys there (and some not so bright) who seem to really know this stuff well and work in the field on a research level.  In their off time they speculate in these biotech stocks like VRTX and the others and that is why they are posting.

There is some danger that every time you treat you accumulate a level of resistance.  And most folks, like me find their VL goes up post TX if there is relapse.

So, danged if you do, danged if you don't.  

One thing I get form the Investors village posters is that there is already a drug in the works that will really cure with no sides at all, but when will it be available?
Bill

[Bill1950]

I believe what Dr. C means is that with patient with no previous treatment he will do lots of VL testing in the first month and what he is trying to do is to achieve a 90% VL reduction per month, by raising the dose, if needed.  With me he never suggested I do this and this was back in 2005.  What he said I should do is to go with 270 Pegasys or 15 mcg Infergen from day one.  

I think he doesn't like the "cookie cutter" method and thinks that will a bit more effort lots of folks who fail TX the first go round would be cured.  

I am with him on that.  When I treated first time I had that breakthrough in the middle but still at the end of 48 weeks my doc, a "cookie cutter" guy if there ever was one wouldn't even consider continuing my TX any longer.  In this I think he was wrong.

I was tolerating the stuff very well and could have kept it up another six months or more easy enough.  There should have been some testing, of course.  

But Dr. C does like to lay on the meds heavy, no doubt.  As for the stage 3 patients he would probably still treat two years.

Anyway, looks like the new doc I am going to see in about a month does not TX with elevated Pegasys either but will use 15mcg per day Infergen.

On the timing FDA approval of open treatment with the new meds I am not so sure.  VX950 might be here in 2010 and there are problems with it.  Lots of stuff coming but when?
Bill

[jmjm530]

As an alternative choice, consider having another biopsy in '08 to get a better idea of rate of damage. One year, here or there, in general is  very little in the HCV cycle. Also, by that time the newer drugs will have shown more trial data that might help your decision. I would also suggest an alternate opinion to Dr. C. His dosing methods are unorthodox and of a coupe of years ago actually recommends 2 years for ghose with stage 3 fibrosis, regard, as well as staging up the Peg in the beginning as opposed to hitting the virus with full guns from the start. Both go against current thinking among cutting edge hepatologists. The fact that Dr. C apparently is so nice, giving and accessible is one thing -- the other is whether or not his treatment approach is the best for you.

--Jim

[Bill1950]

You may be right.  It is a rough choice.  As I didn't have lots of problems before on TX and from what I am told by Dr. Cecil and what I hear elsewhere, I am leaning in the direction of a retreat but with a bit higher dose.  I think I would rather go with the 270 or 360 Pegasys as that is a "known" with me to a degree.  And as r4C7 says, I am likely to respond again, as I did before.  

I had an odd breakthrough in the middle, but was UDT at 48 weeks.  At the time I was a bit suspect of the "generiic" Ribavirn I was getting.  I weighed some of the caps and there was more variation than there should have been.  I think next time I will try to  get the Copegus or branded Riba maybe.
Slagle

[Bill1950]

Thanks for the info about Roche.  I called them and they have a great clinical trials listing:
www.roche-trials.com

Doesn't look like they have anything current near me that would be much help though.  

On the Telepravir, I really screwed that one up.  I was in the office with the forms for the trial in front of me and I let it slip that my wife was pregnant.  Stupid me.  Now it looks like that the trials for Phase 3 will be for naive patients and that the stuff may not be on the market till 2010 maybe.  Just seems like I need to do something before then.

I'm going in about a month to a new doc for some guidance.  Maybe he will have some ideas.

I didn't have much problem with SOC Pegasys.  The nurse at the clinic had told me that I would have all these problems after the first shot, so I waited till about midnight, then went right to bed and went to sleep.  Nothing.  But over time I had some problems.  

About six months before I began TX I fell off a high ladder and broke my hip.  It was pinned back together in the emergency room and the bone fuse fine, but maybe after about two months of TX that hip REALLY started bothering me and slowed me down a lot.

SInce then I have had it replaced with a metal one so other than the worry of an infection there, I should be fine.

But WOW, can the TX cause you to have a short fuse if you have people problems of any sort.  

Good luck with the TX.
Bill

[Bill1950]

I will probably follow you with the Infergen.  Sorry to hear that you are having the bad sides but maybe that will pass.  

This whole thing is about "to treat or not to treat" isn't it?  I guess we know that in a few years there will be better meds, in fact they are probably here now, going through trials.  If we thought that we would be ok just waiting we would wait, I suppose.  But I am not so sure.  I have friends who met their match with this years ago.  

I am going to see another doc in about a month.  

[r4c7]

To answer you question, I'm in Colorado doing a trial through the University of Colorado Hospital put on by Hoffman-LaRoche, the makers of PEG and COPEG.  Great Hep doc, great nurses. I'm not a relapser, but this much I know about relapsers.  Relapsers have already proven they respond.  So the issue is are they getting the right dose.  I sense your characteristics and mine are similar, maybe you just need a little more dose in the beginning.

Jmjm makes an awfully good point about playing the clock and trying the Telepravir route.  I guess one thing I would consider is how you handled sides on the first go round. Some people have an awful time with post-treatment side effects, while others return to normal soon or in a few weeks or months.  I feel personally as though I can handle the INF and RIB, although there are days.  I also feel one should try to get cured as soon as possible with the FDA approved drugs, especially if your stage 2, but there are tons of people that would disagree, especially if they have suffered significantly from post-treatment side effects.      

Incidentally, I was feeling the same type of functioning issues you're experiencing right now and was getting pretty darn sick of it. That's another reason I decided to treat.

[hondapatches]

I tried interferon and peg about 6 years ago. I was a nonresponder. But my alt and ast stayed normal all this time. Now it started to go up again. So I decided to test the waters with the infergen, it is a shot every day, and riba 400 morning and 400 evening I know that the good Lord is gonna get me through this. Just have faith and go for it. It'can't do you any worse than things already are. And it will keep your liver from getting worse. My doctor says there is really nothing out there yet. He says it will be at least 5 years before any new drug will be approved.
Live, Love, Laugh
HondaPatches

[jmjm530]

You're using big canons and are only stage 2, you could get hurt. I would think about going along with your doc and waiting for the newer drugs, or if you really feel you want to treat now, perhaps enrolling in a Teleprevir trial for prior non-responders. I understand that going up a stage in 3 years may have you concerned. But have you really gone up a stage?

Absolute sample size, relative sample size and pathologist bias can offer make a difference of 1-2 stages. I had the same set of biopsy slides read by three pathologists and came out with stage 2, stage 3 and stage 2.5. You might therefore want to have your slides re-read to see if you're really went up a stage or if the a different pathologist would stage the same slide differently. I'm also assuming you had the same pathologist read both slides? If not, I'd suggest both be read by a new pathologist.

All the best,

-- Jim

[desrt]

Not splitting up a SOC dose but dosing every 4 or 5 days (rather than once a week) depending on which PEG you use and its halflife. I don't know of any studies done on this, but your PCR results are kinda strange.
As for your original question, given those two choices, I might try the Infergen. Tough call. How did you tolerate your first tx?

[Bill1950]

Yes, I guess that was a good thing, but I had a breakthrough in the middle of the TX  but then oddly was undetectable at the end.  And that has been quite a while since then, anyway.   Where I REALLY messed up was last March when I was there signing up for the VX 950 trial and mentioned that wife was pregnant.  I honestly didn't think that would be a problem, I knew that we couldn't have sex because of the meds, but heck, she was already pregnant.  Oh well, stupid me.

As for the "liver" symptoms, really I have had these for a long time, maybe ten years or more, it just seems that they have been getting slowly worse.  Sometimes a bit of digestive discomfort, a sort of "full" feeling on my right side.

Years ago I first noticed a little discomfort there if I rode on a bumpy riding motorcycle.  

If I eat fatty food it seems to not go down as well as it used to.

Oddly, I usually sleep on my right side and that is fine.  If I sleep on my left side, with my "liver" side up in the air it just feels funny sometimes.

And there is some fatigue, too.  But part of it is probably in my head.

I have had regular labs and nothing is unusual.  For maybe the last two years even my ALT and AST have been normal, though years ago before I treated they were often somewhat elevated.

Now that is a new approach.  You mean splitting up a SOC dose of Pegasys or Pegintron into several shots per week instead of one?  I have never heard of that but it makes sense.

You take Infergen that way, 15mcg daily, I think.  I hear that sometimes works well.

One downside to retreating, and the lady doc at the clinical trial clinic today brought this up, is that if they get soemthing new I have to be off interferon for six months to qualify for a trial.

Would love to hear any ideas on the off label approach.

Does anybody know any docs in the south to central florida area doing anything like this?
Bill

[desrt]

It's encouraging you were able to get to undetected with SOC. A couple questions:
Have you done anything to confirm your current symptoms are HCV related - another bx, other testing?
If you are willing to go the off-label route, have you considered more frequent dosing with one of the PEGs rather than a higher dose once a week?

[Bill1950]

Thanks for your reply.  I forgot to add that I am Geno 1 also.  Sounds like you are in a great program.  Where are you?  I am in Florida and the only trials I know of around here involve VX-950 and they are already enrolled.  Missed out on that one, sorry to say.

Are you are non-responder to an earlier treatment or did you relapse?  Dr. Cecil says you need a 90% per week initial drop in viral load and sounds like you surely have that.  

But Dr. Cecil is in Detroit, Michigan and I am in Florida.  He said he would treat me but I would of course have to go there.  There would be all sorts of problems with that, insurance, ect.  He suggests I find a local doc to try something besides the SOC and so far I have not found anyone.  Maybe I need to go to a big city hospital, maybe Tampa or Orlando.  

I really think I need to do something because, slowly, surely the hep symptoms have been getting worse.
Slagle

[r4c7]

Interesting post. I certaintly think Dr. Cecil is on the right track with you.  Our characteristics are similar: 55 yo, Grade 2, Stage 2, early periportal fibrosis.  I'm currently in an induction-dosing study that includes 12 weeks of double-dose Pegasys plus a higher doses of Copeg, followed by normal-dose Peg for the remaining 36 weeks, with a 24-week follow up.  Patients must be geno 1, > 85 kg in weight, > 800,000 viral load, treatment niave.

My viral load has gone from 22,100,000 down to 1.650 in three weeks, sides tolerable.  Although the study is double-blinded, so I really don't know what the doses are, based on the drop in viral load, I suspect I'm getting 360 mcg of Peg. (Incidentally, took shot #6 last night).

The bottom line Bill is that there are some people with characteristics that are hard to treat, but the higher doses seem to be more-than-sufficient to address to meet those challenges.

As far as Infergen is concerned, I know nothing about it. Anyway, hope this helps.