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Avatar universal

HR - Question about retreatment

HR, if you have finished digesting your Thanksgiving turkey, I have something to ask you.  I am a male, 56, 300lbs, 6'4 Geno 1a, Biopsy, is 2-3 - completed treatment on June 1, 06 after 48 weeks of Peg 180 and Riba 1200.  Cleared at 4 weeks, and stayed clear througout tx including clear on Heptimax on Sept 1.  PCR on 11/17/06 indicated a HCV RNA of 66,200.  All other blood levels within normal limits.  During tx had some reduction of Hgb but not treated for anemia.  No rescue drugs at all.  Most blood tests were OK during tx.  Doc says to lose weight, down to 200 or so and retreat for 72 weeks using same protocol.

My first question, is it possible that this result is in error? Am I wrong to want this confirmed by another test?  My doc thinks so.  Is it possible that this is a spike that the immune system could handle? In other words, is it possible that these small spikes occur but are handled by the immune system or is this amount (66000) an indication that the battle is lost?  Have you ever seen a viral load at the end of tx that goes back to undet without tx?

As to retx, losing weight is going to take a while for sure.  My thought is that I would like to go back after this thing while its down.  I dont like the idea of letting virus do more damage and making me harder to treat. Seems like it would offset the weight loss. Upping the Riba is not popular because of toxicity.  What about using same amount for longer period of time but start it now?  Is that a resonable way to approach this?  Any thoughts, ideas would be most welcome.
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Avatar universal
I am concerned about your strategy.  I will be very straight forward in my opinion, for whatever it is worth.  I think that going 24 weeks after relapse is a very 'iffy' plan, with little to support it.  If your current relapse has indeed taken you back to full scale chronic infection, then you need to get clear first, and use the appropriate amounts of tx drugs and length of tx to achieve SVR.  This will doubtless mean much more on the Riba side.  

Also, though the interferon truly does contribute a good deal to the anemia, the Ribavirin is also well proven to be a major culprit as well.  It can be demonstrated during tx, when red cell counts are falling to dangerous levels, just decreasing the amount of Riba usually brings the red cell count right back up.  Procrit is there for these issues, and the Ribavirin needs to be affecting the plasma hemo. counts pretty aggressively, for it to have the desired effect, and prevent relapse by sufficiently genetically scrambling the remaining viral copies.  

I also honestly believe that you will need to do an extended tx to be on the high probability side of the SVR curve.  I have seen and heard about far too many cases of relapse from just not going long enough.  A friend on his second tx went 18 months, and relapsed.  He did a full 2 years on his third attempt, and has now been clear for over 20 months after ending his third tx.

I would be very careful about assuming that a 24 week course is going to do the trick for you, without lots more study findings to support this approach.  I understand your concern about the length of tx and long term sides, but I would not let that concern dictate your therapy.  I really do not believe that you would want to go through another relapse.  If you just take it week by week, often you can cover great distances without all the stress of thinking about how much total time must be done.  

Good luck, and really spend some time with a highly experienced HCV doc. who has been through this issue many times before with his own patients.  And one who has been successful in getting them to SVR.

Best wishes.

DoubleDose
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96938 tn?1189799858
For what it's worth...double-dosing Pegasys for the first 4 weeks this time was not as bad as I had expected. TX#1 was peg-Intron and the double pegasys was about the same as single PegInrton for those 4 weeks. As you know, people react differently to the pegs so there's risk of feeling like real doo-doo. The key does seem to be und asap and then ride it out. Back-burner stuff though, enjoy the break.
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Avatar universal
FL -- ha ha -- get HCV out of my head???  How the heck do you do that?  I fear it is here to stay, my friend.  Physically I feel real good right now.  Last night, as I was laying on the couch sleeping thru a tv show (Studio 60) I was thinking I really missed the anemia that allowed me to do that every night.  Now how stupid is that?  I think what I was missing was the false comfort of curling up and having a reason for it. Does that make sense?

Return - know what you mean about the extended season.  We were busy until October, and we do a lot of estates and trusts too but most are calendar.  Still, with the age of our clients I anticipate a 706 or so this next year.  I could have gotten in to see the specialist in February but opted for April 23rd.  I hope that isn't a mistake, but I really don't want to start right back up.  

I read the study.  Interesting. Table #3 was very good.  What I got out of it was anyone with over 2 million copies and genotype 1 who wasn't clear at 3 months (like me)- even with extended time - had less than a 50% chance.  So the hard part would be to get UND by 12 weeks and I don't think that would happen with me unless I bumped up the INF or did non-pegalyted daily.  It is an interesting thought, tho to only do 24 if I can get UND by 4 or 12. Thanks for the link
kathy
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96938 tn?1189799858
Good luck in whatever you decide.  The time between tx1 and tx2 was great for me.  I felt great, was energetic, rejoined the the human race and the family like me again. So, if it's in the cards that you sit on the sidelines for a while - enjoy it.  As you've read there are several re-tx approaches that you can take but my suggestion would be to get yourself as physically and emotionally healthy as you can and get hcv out of your head for a while (to the extent you can).  At least it sounds like your becoming reconciled to the situation.
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Avatar universal
Kath - Ditto for me on tax season but with these automatic extensions going to Ocotber now, it seems that tax season never ends for me. LOL Besides with all our estate and trust work coming on fiscal year ends, the tax season really doesnt end.

One thing I read that might be relevant to our situation, and that I mentioned in another post, not sure if you saw it, is a 2001 study by Shiffman regarding the use of Riba at the end of a combo therapy.  They treated relapsers with Riba/Pef for 24 weeks and then stopped half and continued half for another 24 but only with Riba.  The Riba continuance did NOT result in any additional benefit or SVRs.  Additionally, the anemia of patients resolved when using Riba alone, leading Shiffman to the conclusion that Interferon - in its effect on bone marrow - was the main culprit for anemia.  

What I get from this article, which I hope you will read for its direct assessment of relapsers,
http://www.journals.uchicago.edu/JID/journal/issues/v184n4/010102/010102.html
is that continued treatment for those who relapse is quite successful (50% success) even if it only lasts 24 weeks.  I also get that Riba is not useful as an monotherapy even if it is used at the end of tx on a nondet. patient.  Also, Riba and anemia are not the partners that people think they are and therefore, looking for anemia as a measurement of Riba dosing seems unfounded.

Since I came so close to SVR I am inclined to ask the BCLD, after April 16, 2007, about treating with additional Peg and the same amount of Riba for 24 weeks.  I am concerned about going too long on tx which for me is any longer than 24 weeks.  Since I just completed 48, I pretty much know that adding an additional year or two is asking for trouble with this stuff and I am barely recovered from my previous tx.  

By doing 24, I give myself a half decent chance to clear. I am exposed to the drugs for less time.  I can monitor things very closely with monthly PCRs and if I clear the virus within 4 weeks or get a 2 log drop within that time, on one of the ultra sensitive PCRs, then I do 24 and stop.  If nothing else, I get an additional 6 months of no virus and get an additional chance at success with less chance of permanent sides and that much closer to the new drugs.  Maybe I can add some agent like Alinia to the mix as well as was suggested by HR.  What do you think of that taxing strategy?  
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Avatar universal
My last riba was 08/11 and the 3 month PCR was 11/3.  I can get into the specialist in February - that is her earliest appointment - I just chose to wait until after my busy time at work.

As for hitting it hard while it is low - that is what I want to find out -- if it makes any difference to start right away or wait.

You were not clear at 10 weeks, right?  I would consult with a specialist right away (I think you are doing that, aren't you)
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Avatar universal
MEDICAL PROFESSIONAL
The notion that treatment at a lower vl has better chances for success is  alogical and accepted one. And beyond that, as I outlined above, there are conceptual enhancements to the SOC like "induction" therapy that are sometimes being used by individual HCV treaters - they come also with increased pain, risk, and expense.While some of these enhancements have been tested in small trials, the participant numbers are usually too small to allow firm enough conclusions to add them to the SOC.SOC also takes off the burden of responsibility for such treatment enhancements/variations from the Dr. so it is understandable that most just stick with it. It is always some game of chance with very high stakes and noone wants to take the blame for a negative outcome.
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96938 tn?1189799858
Just a thought, not a suggestion.  If you go for more tx I imagine it would be for more than a year.  How many consectutive tax seasons could you do on tx?  Actually, it's a question, not a thought.  Take care Kathy.
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131817 tn?1209529311
Yes, I have a tentative appt. set for the beginning of Dec. From all I have heard and read, it would be best to tx while the VL is low and before you have a flare up. From hearing here about many VL flares, higher than before tx, after tx ends when the immune system is weakened it seems it would be best to get to it while low for a better chance of SVR. Why don't you ask HR. He explained it to me, but I dont' want to mess it up!
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Avatar universal
I can't do any more tax seasons on tx -- or at least I think I need this one year break.  Then If I start in May 07 I would only have one tx during tax season.  I am going to ask for that PCR to see if the vl is rising or stable.  When they say hit it when the vl is low - I am just not sure --680,000 almost a month ago - may be more now -- just doesn't see all that low.
kath
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131817 tn?1209529311
When did you relapse? I know it wasn't long ago. My take is to hit the virus again before it has a chance to flare up again. Therefore causing less fibrosis etc. I don't think I would wait until April. Not meaning I wouldn't go to that appt., but if your VL is low now hit it now! just my two cents. I am probably in the same boat and still wondering about extending....rather than doing it again.
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Avatar universal
As far as I remember, the women that became PCR pos after 8 years being undetected, shortly afterwards became neg again and has remained neg. She also had a condition called hypergamma something.

I am not certain that was the case you are referring to.

Ivette, we just talked about that case. Anything else you can remember?

Ina

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Avatar universal
As another recent 1a relapser I am reading your answers to RTS with heightened interest.  If I read correctly, the most effective way may be to use non-pegalated interferon and increased riba if necessary to achieve rapid intense suppression.

I started with 1.52 million IU/mL.  At 4 weeks it was 2820 IU/mL and at 12 weeks 40 IU/mL (QuantaSure sensitive to 2IU/mL). My first UND by sensitive PCR was at week 20 (QuantaSure) (had a UND test at 16 weeks but it was only to <50) and was clear throughout the rest of a 56 week treatment.  My 3 month PCR was 680,000 IU/mL (QuantaSure). (100% compliant)

My start weight was 173 and I took standard Pegasys and 1200 mg Ribavirin (Copegasys until switched to generic by the insurance co).  My weight dropped as low as 153 during tx so I was overdosed for the riba most of tx.

Now what?  My SOC GI will suggest daily infergen (appt on Thurs).  I have an appt with a hepatologist in Dallas in April.  Should I wait to confer with the hepatologist?  Should I try infergen now?  Both my ANC and HGB dropped during tx but I didn't have many of the severe side effects I hear others refer to and suspect I was underdosed with interferon.  I am trying to gather all the information I can before Thursday's meeting.  By the way, my biopsy was G1/S1.
frijole
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Avatar universal
Thanks for the clarification.

In Mike's case, I believe he was detectible only by special tests done on liver cells, not by tradtional serum VL tests. RTSs post was somewhat disconcerting as he apparently relapsed after being non-detectible 3 months post treatment by Heptimax. He mentions some dental surgery as a possible cause. I have a tooth implant procedure coming up and while my rational mind says no problem, I'm playing around with the idea of delaying it until I've been viral negative for at least a year. Right now It's nine months.


-- Jim
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Avatar universal
It's always a little unsettling when something that "should" have happened doesn't. RTS "should" have been non-detectible at six months based on being non-detectible at 3 months. They correlate very closely, but still not the same thing.

If RTS had said he relapsed 3 months after SVR (the nine month mark) then that would have been really unsettling since it would challenge the durability of SVR.

I remember emaling my doctor that I was about to pop the cork after my 3 month post tx SVR. He emailed back that I shouldn't celebrate just yet. I guess relapses between the 3 and 6 month post mark, while unusual, do happen.

I'll see about delaying that dental surgery as I'm only about three months from the 1 year mark. I think my chances of relapsing after that are worse than being hit by lightning.

-- Jim
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Avatar universal
I am of course referring to the couple of cases that were highlighted in the HCV medical press in the past few years where patients were placed on immunosuppressive medication therapy for other disorders, and saw a full return of the HCV virus in their blood and liver.  I think one person was an SVR for over 8 years, and had documented PCR negative blood tests many times over the years since their SVR.  The other was a similar case where the person was a 7 year SVR, and saw the virus return after doing immunosuppressive therapy.

Now some of the doctors that I know would interject that maybe these persons were somehow 'reinfected' with HCV, but that seems to be a very weak response to me.  Both cases were identical, and both individuals redeveloped the HCV viral positive state, by PCR, after immunosuppressive therapy. In your wildest dreams would you think that these two people, many years SVR would be playing around with HCV infected drug equipment....and doing immunosuppressive therapy to boot???? In my book, that is a relapse.  These cases also demonstrate the concept that the virus goes into 'remission' after SVR, rather than eradication.  Both cases should be fully investigated by the HCV medical community (if they are interested in really knowing) in order to validate or to cast doubt on the viral persistence/remission theories that have become popular.  If they see reason to question the relapses in question, then I would like to hear what it is!  I have heard nothing to the contrary from any HCV experts to date.

I do believe that Mike Simon recently dealt with a minor episode of this sort of viral behavior, where immunosuppressive meds caused a flare of the virus in the liver,after being SVR, for him.

DoubleDose
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Avatar universal
Boy these are difficult decisions, not like what's for dinner tonight?

Greg retreated within weeks of his relapse. His VL came back at only 3,000 so his doctor immediately ordered another PCR and it came back at 100,000+, clearly it was on the upward move.

Greg was very aggressive in retreating, not really sure why, I think those are thoughts that only run through the mind of the person who is faced with having to make the decision. He's a quiet man, didn't say a lot about it or why he chose the Infergen and the dosing strategy. We did discuss options but in the end he seemed to have his mind made up. Greg did say that once he had made the decision he felt better about doing it, I guess getting your mind made up is the hard part.

We think improved liver histiology, low VL and quick aggressive retreatment led to this undetectable status. That's just a guess though. He did just get his 6 month PCR back (this time we waited 26 weeks to do the test rather than 24 weeks) and of course, we are cautiously optimistic since he relapsed at 1 year last time, but our hope is that it couldn't happen twice.

I wish I had some words to help you. Just know that so many care.

Hoping for you and yours,
Debbe
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Avatar universal
DD:If you know of any approaches that seem to be of help, please do let me know. I fear doing anything that might 'retard' the immune system, knowing that the few late relapses out there seem to have come from that very same type of medical treatment.
-----------------------------------------------------------
Could you please expand/clarify what you mean by "doing anything tht might 'retard' the immune system". Are you talking about drugs, alcohol, diet, what?

What "few late relapses" are you referring to? Are these post SVR relapsers? And if so, are you talking classical relapse, i.e serum negative to serum positive, or are you talking about finding virus in compartments other than serum post SVR?

I mention this because it still appears that relapse -- as defined by finding virus in serum -- after SVR is quite rare.

All the best,

-- Jim
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Avatar universal
8 yrs ago the PCR tests were not as sensitive as today's.  Snook man has reported a few negative PCRs throughout the yrs, when in reality he had a very low VL that was not detectable by the tests of those days.  It could be that with some folks, the vl remains extremely low, and thus they are not truly SVR. One theory. A more sensitive qualitative test might have shed light as to the presence of continuing infection.
As for Mike, it was the reduction of immunosuppresive medications, not its introduction, that induced elevated enzymes which led to liver tissue testing that produced a positive result.  He mentioned that his immune system activation by the antirejection drugs reduction is what elevated his results.  SO it does not seem to follow the same pattern as the late 'relapsers'.
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Avatar universal
Child,

I'm doing fine, thanks for asking. Just trying to pick up my life where I left off close to two years ago. While never incarcerated, I imagine it's like coming out of prison or a Rip Van Winkle state. For me everything stopped when I started treating -- work, relationships, sports, activities, etc -- and just recently getting back.  I view this as very positive, almost like a re-birth.

Return,

Thanks for your well wishes and no worries here about "rub off". What will be will be. Just think you have a great opportunity/motivation to lose all that weight which can't be good for your general health. Additional bonuses would be a better chance of SVR plus by then newer drugs like Vertex may have proven themselves in trial. Of course this assumes that you're still stage 2-3. If things have progressed then the more agressive approaches might make sense. Take some time to think this all through and I'm sure the right course will present itself.

Be well,

-- Jim
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87972 tn?1322661239
From C-20 above:

"You said you lost 64 pounds between txs. Was this purposeful or just a tx side?"

Naw, that would have been to easy :-). I can assure you that the weight loss was intentional. Prior to treatment, I was told by two doctors that it was OK to put my diabetes control on the 'back burner', with Tx becoming the priority. I stopped testing my BG during treatment, and allowed my sugar to rise to unacceptable levels. When I began checking again after completion of Tx, I was shocked to find that my fasting BG levels were above 300 mg/dL (ref range 70-120). So, after reviewing the facts: out-of-control blood glucose, possible fatty infiltration of hepatic stellate cells (steatosis), post Tx relapse of HCV, and a host of other reasons I decided to put down the snickers bars and lose some weight. Diet modification including portion control took care of quite a bit, but I needed to get some much-needed exercise going to help out with the remainder.

"Do you attribute your improved LFTs to the weight loss?"

Boy, that's a tough one to answer. As I mentioned above, my doctor hypothesized that steatosis might have been at play as a separate but parallel process to HCV. However, after 56 weeks of Tx I might have experienced improved liver histology. The doctors were hesitant to re-biopsy between treatments because I obviously intended to re-treat ASAP. For what it's worth, I was initially diagnosed with hepatosplenomegaly per ultrasound. Another subsequent U/S between Tx showed a marked reduction in spleen size, suggesting improved liver architecture. As to your question, I'm sure that losing a few pounds didn't hurt the liver any, but there are too many factors at play to consider.

"After 56 weeks of tx, were your post tx sides gone before you started again in Sept?"

RTS, my post Tx sides were almost non-existent. Although during the initial treatment I experienced a 4-month bout with GI issues, including moderate to severe diarrhea; and the typical depression associated with IFN, they pretty much disappeared within 5-7 days after my final ribavirin, and I was 100% within three weeks or so.

"Is your experience the second time around similar to the first in terms of sides?"

Simply put, this 2nd round has been a breeze so far. At 12 weeks into treatment, I'm happy to report that the sides are minimal at most. Honestly, if this is bad as they get, I could see doing this indefinitely if necessary. However, I've switched from Pegasys to Peg-Intron for this Tx, so that might have made a difference too. I'm actually off label with the Peg-Intron as well. Although my assigned dosage is 150 mcg/week, I'm on record with my doctor for "squeezing" the Peg-Intron vial; in other words, by injecting the full syringe instead of the directed .50 ml I'm able to draw up about .68 ml for a total of 202 mcg/week. This requires the use of vials; I don't think this is an option available with SP's Ready-Pen.

"Is the use of such high amounts of Riba something insurance companies definitely wont pay for?"

From what I gather, the insurance co's (and their actuaries) are beginning to soften up their position on off label riba dosing. More and more doctors are prescribing 1400 and sometimes 1600 mg riba in an effort to achieve therapeutic plasma concentration for us big boys. Although I believe I'm the highest dosed patient my doctor has, the insurance approved with no questions asked. That said, the same insurance co denied my request for 1800 mg last year, so go figure. If you and your doctor choose to go this route, you might plant the seed in your doc's head in advance that he might need to write a letter or two on your behalf. My doctors strategy is to play fair with the first request, then if a letter of denial shows up, he has staff that absolutely *bury* the insurance co with studies, some which are relevant and some just to add bulk; he says that quite often does the trick ;-).

Hope that helps a little, and again, feel free to run any further questions by me if they arise. I'll try to watch for your posts. Again, take real good care--

Bill

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Avatar universal
Hey buddy, didnt see your post there, thanks for your thoughts. Good to see you, hope you are well.  Dont worry my relapse wont rub off, I am having it stuffed to place on my mantle.  Your advice about waiting and getting health in order is good and certainly something I will consider.  Hope to see you around more, I always like seeing your comments here.
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Avatar universal
I would very much like to hear more from you about possible therapeutic modalities for the 'post-tx hyperimmune syndrome' as you described it.  You are right, some of us used the sledgehammer approach to therapy, and for me it was because I literally had to.  My VL was slow to reach undetected in both tx'es, and in the first led to ever increasing amounts of interferon (and varieties), almost to the point of absurdity....but I really was the one pushing all the way for the most radical approach possible.

On the 2'nd round I used the most inf. that I could squeeze from every vial of Peg-Intron (using the largest vials available as well), and went the full 18 months, limping to the finish with Procrit and full Riba, etc.  So I was not shocked to see the plethora of post-tx syndromes develop, although part of me was hoping for a blissful, 'feel-great' state of SVR, where everything would work properly again, and I would be rejuvenated.  Of course it was anything but!  (Oddly, for about one month after ending tx, I felt better than I had in 30 years, almost symptom free!!!!)

So, indeed I would like to know what others in my 'boat' might be doing to mitigate the effects of all this immune system over-stimulation.  I feel like the poster child for 'wastebasket' autoimmune disease, without any specific label to hang on it, and no doctors with any really practical answers, much less treatments!  The rheumatologist acknowledges that the inf. tx often provokes this 'autoimmune' type syndrome, and then says 'keep an eye on things' take care now....

If you know of any approaches that seem to be of help, please do let me know.  I fear doing anything that might 'retard' the immune system, knowing that the few late relapses out there seem to have come from that very same type of medical treatment.  I also am concerned about ongoing immune system over response eventually leading to issues like lymphoma, or MS type illness....as well as the expected issues like Lupus, or similar AI type diseases. I continue to experience a mild parotid swelling, that is chronic, and always there. (like Sjogren's)

Thank you for your interest and all the time you have spent responding to our forum members.  I like to think we are all working toward advancing the knowledge base relating to HCV and its treatment.  With community efforts, often 1+1+1+1 can end up equaling 16 rather than four.  Pooling all our inputs, and experiences, while not pure empirical science, still can unearth new insights.  Thanks for being a part of the discussions.

Any feedback on the post-tx issues will be welcomed!

DoubleDose
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Avatar universal
You said you lost 64 pounds between txs.  Was this purposeful or just a tx side?  Do you attribute your improved LFTs to the weight loss?  After 56 weeks of tx, were your post tx sides gone before you started again in Sept?  Is your experience the second time around similar to the first in terms of sides?  Is the use of such high amounts of Riba something insurance companies definitely wont pay for?  

Cuteus - sorry about the "f" word, I rarely use it but it slipped out - lets just say I shop at the "Big and Tall" section of Sears.   Thanks for your research but it occurred to me that there will be no studies or guidance on my situation because, as you said, it is so unique.  Noone is going to retreat if they are clear at 3 months.  And usually if you are clear at 3 you are going to wait till 6 to retest.  So as a practical matter, noone who is in my situation would have ever gone back in before 6 months.  The guidance I have to find is for someone like Greg who relapsed after a year or someone who failed the 6 mos test. How long did they wait to retreat and how did they retreat.  Greg went back in with a vengence and lots of Infergen.  I dont quite have the stomach for Infergen and wonder whether it is necessary for me given my great reaction to Peg.  I have always cleared the virus with interferon, even when I first treated with it in 1996 - I became undet back then almost immediately.  I have always had problems maintaining the SVR.  At any rate,  I will probably have to be a trendsetter here blocking once again for other former football players seeking the goal line of SVR.  Once a lineman always a lineman.
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