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Need some advice

I am going to discuss my bx with my Gastro-enterolgist(?)in a couple of days. I have genotype 1b and my vl is 2.4mil. After raeding many posts here and much research on the internet the chances for SVR for HCV genotype 1 are 50-50 or less. This does not seem good. Since this may be the case, would it be a good idea for me to pursue a group test where the shelf life is much longer than the pegalated interferone of today. I would only need to take a shot every 2-4 weeks, because this brand of interferone stays bilogically longer in the system. I understand people are given this  new tx when they don't clear after 48-72 weeks with pegalated interferone/ribi. I know there may be some risks invovled, but I would be willing to take a chance. The SVR rate is higher with this new tx for genotype 1's. Please let me know if this is worth discussing with my Dr.
Thanks all.
CIGASO.
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Avatar universal
Everything is relative. When I first tx'ed back in 1992, the SVR rate was 10% or less for geno 1's. So the 50% figure of today is a HUGE step up and forward. Also, as you pass certain milestones during tx (eg - being clear at week #12), those odds continue upward.

As far as going into an Albuferon trial (which I assume is the type interferon you are referring to), the first thing to look at regarding existing test results is the number of patients used in the trial(s) that these increased SVR results are based upon. And what were their negative predictors going in (viral load, age, genotype, extent of liver damage, etc)? What SVR rates did each sub-group end up with? And what was their length of treatment? If they have results only based upon a small sample population or narrow sub-groups, the SVR data may be unreliable. I can pay to dig into the numbers and the data.

As far as the trial you might be interested in, some questions to ask are: what are the restrictions? Would you be guarenteed to receive Albuferon? At full dose? Would you get the proper weight-based dosage of riba? Would they go the extra mile to keep you at full dosage (i.e. - via Neupogen and Procrit, if need be)? Would they extend your tx if you don't meet certain milestones (clear at week #12, etc) or is it 48 weeks and out?

I wouldn't be too overly sold on an interferon based solely upon it staying in your system longer. The current peg versions stay in your system longer than the original mono interferon. Yet the trade-off for the pegs in gaining longer half-life was a decrease in overall potency.

Is it worth discusiing with your doctor? Sure is. Never hurts to learn more and get a professional's opinion. You can also ask him about any trials that involve adding Zadaxin to the existing peg/riba mix, though there are some mixed results so far as to it's effectiveness.


TnHepGuy
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Avatar universal
I was a 1B and finished 48 wks of tx mid-September this past year.  Still clear as far as I know......will have my 6-mo PCR in mid-March.

My doc explained that we start with a 50% chance.  If we have a 2-log drop or more at 12 wks, our chances are increased to 60%; then 70% at 24 wks if we are undetectable at that time.  If still clear at 48 wks, our chances increase to 80%.  And if still clear at 6-month post-tx, we are 90+% of staying clear.
Hope that helps.

Good luck to you.
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Avatar universal
The chronology that Lynn 5477 presented above -- does anyone have this info for geno 2b's?  I've gotten a bit lost in the discussions about when the pcr's are to be done, how often is best to have them and what they're supposed to tell you.  Lynn's chronology was great--just wonder what it is for my genotype.

Also--I received my first biopsy results over the phone, I was told stage 2 grade 2, described as "moderate".  He says he is fine with me putting off treatment for awhile if need be, and I'm considering waiting until after my busy season (Aug. 1).  I was going to ask him for pegasys rather than the pegintron, because my impression is that the sides aren't as bad ?...but that there may be a trade off with potency ?(or maybe not?)--that there isn't really a clear choice between the 2 types?.  Can someone verify or clarify these impressions?  I am a 57 yr old female diagnosed 2000, geno 2b, VL (11/9/04) 1,440,000 ALT 259 AST 199.

Thanks to all of you for being there.
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Avatar universal
Ten, yes you are correct. It is Albuferon. Good advice. I will check and see if the data was from a limited sub-group. And the shelf life info you gave is very important. If I recall correctly, the study stated that there was a greater reduction in AST, ALT and vl from Albuferon. I'm going to do more research. Ten, you sound like you have had a tough time. I hope things get better. Thanks.

Lynne, I am glad to hear you are one of the 50% who cleared. It sounds encouraging. Thanks.
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Avatar universal
SVR odds for geno 2's are 90%+. Truly wonderful odds. And the tx regime is half the length of time of geno 1's (24 vs. 48 weeks).

Working in your favor is the fact you are female, have a low viral load and (believe it or not) have a relatively high ALT quotient (which is defined as your actual beginning ALT divided by normal-high, usually given as 52. So in your case your ALT quotient would be: 259/52 = 4.98). One negative factor is your age. As far as your bx goes it would probably be considered a wash to slightly negative, since you are at mid-level in terms of liver damage.

As far as when to have PCR's done. If I were a geno 2 I would want to be tested no later than week #4. And would look to be clear at that point in time, too. If I wasn't, I would consider extending beyond 24 weeks since the majority of 2's show serum clearance by then.

The jury is still out (and may be for a long, long time) on actual SVR differences between Pegasys and Peg-Intron, since no head-to-head studies have been done. The pharmaceutical companies are reluctant to do so since the 'loser' would end up dropping market share.

So, to sum up: as a geno 2 you have great odds of acheiving SVR. Try and not get too caught up in the details and the minutiae (like I tend to .. ahahahha). Keep your focus on the big picture, which is to do what needs to be done to achieve the goal of SVR. And to that end, when you do go to treat, make sure your doc is behind you 100% and you are both on the same page. That he/she will rx you Procrit and Neupogen to keep you at full dosage rather than cutting it. That he/she will extend your tx if the circumstances call for it, etc. Call your pharmacy to be sure that they will both carry and timely get to you all of the drugs you might need (including the Neupogen and Procrit). Call your insurance company to verify they will cover these medications. As much of this type of thing you can take care of ahead of time, ensures that no last minute crises crop up which might end up hurting your SVR odds via a dose reduction.


Best to you.

TnHepGuy
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Avatar universal
Good heavens.  you could have been, more than likely, celebrating your 3rd yr SVR-cured!

how sick do you wnat to get?  I was transfused and recieved hep c in 1967.  I was finally dx in 2001-late Sept 2001 AFTER MY LIVER FAILED.  How sick is that?  B/c of ammonia levels., i was in a coma in icu 9-12-2001. b/c of low platletts I almost bled to death, and lost the sight in one eye.  every little thing became major-fast.

I'm a 2b who was sent home to die b/a dif doc put me into a study for end stage liver disease, Schering supplied all the meds and I cleared the virus in 18 days.  that was 2 1/2 yrs ago.

I fin 24wks, had mild sides and now am healthier than I've been in 25yrs.  and i'm about your age.

Why wait?  you could be done by your busy season and you doctor is an idiot.  You have a chronic, progressive fatal disease and a cure just waiting.

go figure
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Avatar universal
Your post to laika was excellent. I think you should hang a shingle. Mike
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Avatar universal
Hey there,

I think I can help a little with information on Albuferon.  I have been a participant in a clinical trial using this for about 8 weeks now.  These trials are set up as dose testing and contain 3 arms, a low level dose and a higher level dose administered every 2 weeks are the first two arms.  The third is a higher level dose administered once a month.  All these doses including the lower every 2 weeks one are higher then the ranges given by TnHepGuy.  Support drugs such as Neupogen and Procrit are included in the protocol.  I have not heard any results yet but my docs at the Mayo clinic are hopeful.  This is the first long term trial using Albuferon and is designed to go on for 48 weeks.  Previous to this the longest anybody had been on this interferon was 1 month (two doses) at a level of around half the lowest level being tested.  Let me know if you would like any more information.

One thing I can tell you, the sx are a breeze.  This is my third time on tx.  Peg/riba combo the first time and daily infergen/gamma interferon/riba combo the second time.  The sx with Albuferon are a cakewalk.

Best to you and all,

Steve
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Avatar universal
Thanks for the information Steve and I want to wish you the best. Mike
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Avatar universal
Forgot to mention, all arms are combo with weight based riba and all meds, visits, tests and other related medical services are paid for by Human Genome Sciences.

Steve
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Avatar universal
Hi Mike,

Thanks, and right back at you.  Although I don't post much I try to keep myself updated and have watched your struggle and progress for several years now.  Can't tell you how happy I am to see you doing better.  Also wanted to thank you for all the info and support you have provided to so many people over the years.  Although it is not often expressed, we really, really do appreciate it.

Best,
Steve
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Avatar universal
I will take advantage of Chevy's intro and post the latest happenings:
On Wednesday, since I have been feeling run down this week, I decided to call Quest and ask if all the results were back, after a positive answer that included the PCR results, I decided I did not want to drive back home with bad news fresh in my mind.
I hate driving on the Long Island Expressway, always have, the monthly drive to the GI has been a torture; 1-2 hrs RT, in a road cluttered with 18 wheelers and maniacs(besides me).
I called the GI and told them I wanted the results before my appt today, as I did not want to endanger anyone on the road. The recept. stated that Bernstein does not want results given if the appt is within a week and it was up to the NP to decide if she would.
I kept dreading to drive on bad news so I called back to reschedule a week from today and requested the PCR results mailed if need be.
I just got a call back from the NP; 5 wk (12/30) post tx test:
Undetectable still. I am one step closer, but not out of the woods, I know.
72 wks of peg and riba+two 1/2 peg, many forgotten ribas, lowered riba for months, 1a, low vl, detectable at 12 wks, stage one damage;  and negative after 5 wks.
I could have been a negative after 48 wks, but who truly knows and why take the chance?
I know all, or most, of you are happy with me, but I ask that you save the congrats for the 3, or better yet, 6 month PCR! I don't want to jinx it too much with too many congrats, pretty please?
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Avatar universal
I will take advantage of Chevy's intro and post the latest happenings:
On Wednesday, since I have been feeling run down this week, I decided to call Quest and ask if all the results were back, after a positive answer that included the PCR results, I decided I did not want to drive back home with bad news fresh in my mind.
I hate driving on the Long Island Expressway, always have, the monthly drive to the GI has been a torture; 1-2 hrs RT, in a road cluttered with 18 wheelers and maniacs(besides me).
I called the GI and told them I wanted the results before my appt today, as I did not want to endanger anyone on the road. The recept. stated that Bernstein does not want results given if the appt is within a week and it was up to the NP to decide if she would.
I kept dreading to drive on bad news so I called back to reschedule a week from today and requested the PCR results mailed if need be.
I just got a call back from the NP; 5 wk (12/30) post tx test:
Undetectable still. I am one step closer, but not out of the woods, I know.
72 wks of peg and riba+two 1/2 peg, many forgotten ribas, lowered riba for months, 1a, low vl, detectable at 12 wks, stage one damage;  and negative after 5 wks.
I could have been a negative after 48 wks, but who truly knows and why take the chance?
I know all, or most, of you are happy with me, but I ask that you save the congrats for the 3, or better yet, 6 month PCR! I don't want to jinx it too much with too many congrats, pretty please?
Need a shot of Expresso, see ya after lunch!
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Avatar universal
sorry, I thought I hit the 'stop' button on time, the window was still visible, fast posting!
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Avatar universal
Okay, no congratulations, but a big thought balloon floating your way that reads Woohoooo!   What a wonderful sign of better and better things to come.
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Avatar universal
Ok,,,,if you insist,,,I will keep it toned down and save the big whoo hoo for 3 month mark.  But a small yippee should be acknowledged....LOL  
That is wonderful,,,,honestly,,,,so many say if virus is coming back,,,,will show up first 4 weeks,,,,but since we are still keeping it low key,,,,We will save for 7 more weeks!
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Avatar universal
We drive the LIE too, and with test results/drs appts lingering it can be quite a drive...but you seem to be on the right road!
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Avatar universal
Ok .... if congratulations are to be held off, then I must tell you:


STOP DRIVING LIKE A FRIGGIN' MANIAC!!!!

Do you want to end up like Harry Chapin?


TnHepGuy
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Avatar universal
Wow
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Avatar universal
Yes, yes, yes.  I admit it, I was in denial for years.  I didn
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Thanks for refreshing my memory on your stats.  Hopefully, it will help me keep my eye on the prize while I
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Avatar universal
Thank you for the kind words.

Though it seems to stand logic on it's head, a higher ALT quotient is a positive predictor when it comes to SVR. Though this <a href="http://www.natap.org/2004/EASL/easl_17.htm">SVR Calculator Model</a> is based upon studies involving geno 1's, it discusses (and uses) the ALT quotient as a factor. And under their "PROBABILITY OF ACHIEVING A SUSTAINED VIROLOGIC RESPONSE" sub-section they predict that for their definition of a 'standard patient', who has an ALT quotient of 2.0 (that is, a starting ALT level of 104), the SVR odds are 52%. For the same theorectical patient who has an ALT quotient of 1.0 (that is, a starting ALT level of 52), the SVR odds drop to 45%. Take that same patient and make the ALT quotient 4.0 (that is, a starting ALT level of 208), and the SVR odds jump up to 64%.

Is an ALT quotient much to think about? Nope. Just one of many factors that the researchers have looked at in trying to determine who may or may not achieve SVR, and overall odds.


Some other questions to ask your doc when you visit include:

- how often will I be having regular lab work done during tx?

- how will I be receiving the results? phone? mail? in-person?

- who will I be meeting with during the course of my tx? You (the doctor)? nurse practioner? nurse?

- how often will I be meeting in-office with this person?

- if I have questions about my tx between visits, who should I direct them to? How quickly can I expect my calls to be returned?

- what medicines do you rx for tx-related sleep issues?

- how often will my TSH (Thyroid Stimulating Hormone) be tested during tx?


TnHepGuy
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Avatar universal
The Alt quotient continues to sound mysterious (anything with the word "quotient" in it will always be mysterious to me) but I'm glad it appears to be a positive indicator.

The list of questions are a treasure.  I assumed that a TSH would be part of the blood test given last Nov., as it has been included in the previous blood tests and seemed logical for them to test the thyroid prior to treatment. Wrong. I also have 2 sisters and a daughter that are hypothyroid, so I really wanted to know.  I will make sure to get a TSH when I see the dr. next.  My blood test in 2003, the dr didn't even ask for a viral load!  Seems like the patient needs to go over a checklist to make sure the doctor is asking for all the tests they should.

I am not optimistic about the arrangements for communication in this clinic.  I was told it takes 2 weeks for labs to make it into the chart and a doctor to call.  It was the young disinterested intern who called with the blood test results.  The real dr called with the biopsy results.  Obviously, I would prefer to have the test results in my hand when I talk to him--I don't have the opportunity to look at it, think about it and ask thoughtful questions (let alone consult with my experts at the forum!)  I will push for what I'm sure would be "special treatment", but I have the feeling the clinic has its procedures for processing us, and it will be more difficult than dealing with with a private physician.  I hope that this doctor (the only hepatologist in the Tampa Bay area)is worth putting up with this clinic.

Another question:  am I correct in the understanding that, if I only have to go the 24 weeks, that I am likely to escape some of the sides?  That was a suggestion I read somewhere along the line, and it makes sense.  But the realities of this disease and treatment often don't make sense. I guess I am pursuing a vain attempt to see into the future on treatment, and I've already been told THERE ARE NO PREDICTORS.  

It's been an illuminating day.  Thank you so much.
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Avatar universal
Just had to say congrats.. My dancing shoes are on, so let me know when to start!!!
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