My Doc Wants Me to Switch to Infergen

Just had my 12 week follow-up appointment yesterday and my doc said my VL had hit a plateau (only got as low as 240,000 from 2,910,000).  He suggests stopping the Peg-intron and starting with Infergen immediately.  Does anyone else have experience with this?  I really don't like the idea of daily injections, but if it will help I guess I'm willing.

Tim

[frijole]

If you are saying that you still have 240,000 IU/mL at 12 weeks it is definitley time for a new strategy.  Infergen is one of them but there other choices.

You had less than a 2 log drop at week 12 and that by itself is not a good prognosis.  May I ask, has your hemoglobin dropped much?  If it has not, it is possible that your body is resisitent to Ribavirin.  Are you taking weight based Riba ( under 165 pounds, 1000 mg, over 165 pounds, 1200 and I think at 185 pounds you should be taking 1400 mg.  Some members have increased their Ribavirin at week 12 -- some as high as 2000 mg/day.  Some have double-dosed the interferon at week 12.  You may also need to consider extending beyond the 48 weeks.

What is your liver damage?

frijole

[GrandmaBRZ]

I am almost in same boat.  Just to let you know you are not alone.  My VL see-sawed and i am waiting my 12 week test results which I should get next week..  My docs want me to start infergen  if I am a non responder.  Daily shots has no appeal but oh well.  They have mentioned other alternatives but not in detail.  If i find any specific info I will pass them on but you may have them already.

I looked at your profile and see you are in San Gabriel Valley.  I am in Inland empire, Rancho Cucamonga to be exact.  Interesting that wwe are both given the Infergen option.  But then maybe everyone is.

Frijole is very helpful.

Take care.  Jenn
                              

[wifern]

   hi I live in alta loma also. Im looking for a heptalagist in our area can you recommend a doc. take care  I wish you well.     Debi

[GrandmaBRZ]

Hi Debi
Dr. Julie Winn, who is in charge of my treatment is at Cedars Sinai.  My referring docs areDr. Kenneth Lee, my gastrointernist, referred me to Cedars because I also have cirrhosis.  He is in Pomona.  Dr. Roger Hall, Pomona, is my primary physician.  

I am not familiar with docs in Rancho, Alta Loma.  My primary was highly recommended by word of mouth & I don't mind the drive to Pomona.

With Cedars, I do most of my communication by phone.  The pharmacy sends my pegasys, packed in ice, via overnight delivery 1x month.  They send the ribavarin as well.  I see Dr. winn periodically to follow up.  If an MRI is needed I do it locally.  Blood work is done at Quest Diagnostics on San Bernardino Road in  Rancho.

I am on Intervalley Senior Health plan and they approved everything.  Of course, it gets pricey when I reach my drug limit & have to pay out of pocket.  However, I am now on catastrophic until the end of the year so my copays are very low.

Lots of luck to you in your search& take care  Jenn

[jmjm530]

Assuming you have significant liver damage, switching to Infergen is a reasonable next step. I also echo what Frijole has to say regarding increasing the ribavirin, if you're either not on weight-base, and/or you didn't have much of a hemoglobin drop pre-treament, and/or you and your doctor simply think you can tolerate some more riba.

That said, if you have little or no liver damage, now is the time to decide whether it makes sense to continue on, or to cut losses, then wait to fight another day, hopefully with better drugs. Since you are detectible at week 12 -- and assuming you're a geno 1 -- studies suggest you will now need 72 weeks of treatment if you clear by week 24.
That's an awfully long haul with Infergen for someone with little or no liver damage IMO.

-- Jim

[cruelworld]

at this stage you have discovered that you are fighting an extra strong enemy with less than ideal weapons. you are headed for what might be a 72 week heart break. dont willingly continue this questionable battle, you have too much to lose. in my opinion, you should stop and try again later with better medicines.

[Stiffneck]

Well, I got my 12 week results and I have acheived a 2-Log drop.  It looks like I'm sticking with the Peg-Intron.  My doctor said if I'm UND by week 16 we will just complete the 48 weeks.  If not we may need to extend.

My VL Numbers:

Baseline - 2,910,000
4 weeks  - 261,000
8 weeks  - 240,000
12 weeks - 51,000

I feel like I dodged a bullet!

Tim

[DoubleDose]

If you are undetected by week 16, I would definitely revisit the 48 week tx issue with your doc.  Having read lots of statistics and studies over the years, I think the general concensusis that getting undetected anytime after 12 weeks calls for a pretty lengthy extension, if you are after the SVR.  Doing 48 weeks and getting undetected near week 16 would drastically reduce your odds of sustaining the response.  I think if you do some research, you can come up with plenty of supporting documentation for your doctor.  My feeling has always been, why do tx unless you are going to really give yourself a realistic shot at SVR.

By the way, where did your nickname 'stiffneck' come from?  TX, or just from the HCV?  or unrelated?
Just curious, because I had that problem, on and off, for years from the HCV.

DoubleDose

PS  What may work even better for you is a 25%, or so, increase in the Peg-Intron dosage, to accelerate your viral decline curve.  That's exactly why I did a 'double sized dose' when I did my 72 week tx.  I got undetected at about week 18 or 19.  Went 72, and got the SVR.  I believe that the more rapid the VL decline curve that you establish, and maintain, the less you need to extend.  At the decline rate you are showing, and if you get undetected before 24 weeks, you will really need a hefty extension.  That 51 k still has a ways to go, to hit UNDETECTED.  Hopefully it will clear out more quickly.

[willing]

stiffneck: funny how recommendations for tx evolve. When I joined this board, 4-5 years ago, your post would have been answered with a resounding "solid 2-log by 12; go confidently on to 48". Now, unfortunately, it's a much more tentative "continue if you choose, but be prepared for disappointment". Thomas Berg is to blame for much of this. He started looking more carefully at the implications of any residual VL at 12 on outcome. Abstract  179 in next month's aasld'07 conference, which should be on the aasld site any day now,  has his most recent results; you might want to talk about these with your Dr.

In a fairly large study (N=433), among those with VL  above the bDNA detection limit of 615 at 12 weeks  he reports a 78% relapse rate among those who did 48 weeks and 75% among those who followed an extended protocol of 6X the bDNA und time point. For example, in your case,  if you first became  UND at 16 you would have been looking at 96 weeks. The message seems to be that if  the week 12 VL is high,  the extra time isn't going to help.  However you're still working with  a 25% success rate; if that looks worth shooting for going to 48 seems the right call, else drawing up a new plan of attack might be the way to go.

Good luck!

frijole: you may want to look up this one too. For bDna UND , TMA + at 12,  that is  VL between 5.3 and 615, that extended protocol had a 69% relapse rate versus 56% for  the 48 week group. I'd been waiting for more data at full riba to update the preliminary  Berg and Sanchez-Tapia data. If I'm reading this correctly, it sure doesn't seem to provide clear support for extending.

jim : Berg is pretty explicit about the importance of sensitive tests:

"Conclusion:  The application of the highly sensitive HCV RNA tests must be considered to be now mandatory because this new test helps to evaluate in a much more refined way treatment response as well as relapse rates and provides better clues for an individualized tailored treatment strategy. Thus our study clearly indicates
that patients even with a minimal amount of HCV RNA detected at week 12 can suffer from relapse rates greater than50%."

however...this still holds only at those time points where there's data to compare with.

[jmjm530]

Sensitive tests are important at every juncture. While hard data may only be availale at certain weeks, sensitive testing inbetween offers both a proactive opportunity to tweak treatment as well as an early warning system for breakthrough -- not to mention additional data for those doctors to will apply formulas like Drusano or variations thereof. BTW Sachez-Tapia, and some other extended studies, used fixed-dose riba which may have skewed results.

-- Jim

[willing]

well, we still don't agree on that one. A single VL 5 result at say 36 weeks after having had good results throughout gives one no useful information on which to base a decision since all the available data on breakthrough didn't use those tests. Likewise, in motheroffours H's case it's hard to see how having a TMA or a 600 iu test at EOT would have made any difference - what information is out there that distinguishes very low-level non-responders from "true" relapsers? Still, with comments like Berg's above, the days of the 600IU test seem short.

Re extended, that's why I've been surprised that no new results for extended tx with standard SOC-dosing  have come out in a while(Berg's original data was also on 800 riba). This new study  fixes that, but the conclusions seem pretty surprising, weird even!

[jmjm530]

There was a study that showed that a sizeable per cent of EOT PCR negatives were actually TMA positive. 100 per cent of that sub group relapsed. One can question "what difference" that might make, but it does make an early that a physician could use to jump back into treatment if keen on that approach.

As to using a sensitive test at week 36, I think a positive would indicate a breakthough, regardless if no study data for that particular week. There is data for EOT, so it just seems a reasonable extrapolation that any detectible after and UND spells trouble. In fact, my big shot hep made a point mentioning that being UND throughout treatment by *sensitive* TMA made a difference in terms of predicting my SVR.

I am also surprised on the dearth of studies out there, when one would think the data is there for the picking if someone just took the time to organize it. In fact, asked my doc -- who treats thousands -- if they ever databased everything so we could look up different match-ups. Just got a blank look. Tell you, if it was a real business they were running, everything would be in a computerized database.

-- Jim

[willing]

I think we fundamentally differ in the degree of insight we ascribe to physicians. In a condition like chronic HCV, where the fundamental mechanisms remain unknown and one is reduced to making judgements on the basis of  limited, probabilistic,  information,   I tend to assume the physician's extensive training doesn't  contribute to the quality of their decisions. Put more simply, for the typical HCV patient, a good odds-maker is likely to be a more valuable tx guide than a hepatologist.

Clearly being TMA UND throughout is better than coming up positive on one test. However, I just don't see any credible crystal ball that allows a physician to determine whether that one test result is or is not significant in the absence of any data that correlates such a spike with SVR outcome.

But faith in statistics may be getting me into trouble. When you said the 800RBV dosage in the earlier Berg and Sanchez-Tapia extended tx data "may have skewed results" what did you mean? It occurred me that one, rather dark, interpretation is that the clear benefits of extented tx shown in those studies were in fact no more than remediation for the inadequate riba. That is, if your RBV dosage was low, you could improve your odds by treating longer. However if you were already at full dose riba, longer tx just made you bump into the intrinsic limits on the success rate of current SOC.

The failure of the most recent Berg data to show any improvement for extended tx seems really disturbing; a lot of people have gone down the extended tx path on the basis of the promise of the original studies from a couple of years ago. Am I not reading Berg's new results correctly?

[jmjm530]

Willing: I think we fundamentally differ in the degree of insight we ascribe to physicians
---------------------------
And, of course, I think we fundamentally differ in the degre of insight we ascribe to indvidual/imperfect studies that very often do not "match up" to the patient/case at hand.
.
As to the physican thing again, I daresay I have a lower opinion of them -- in the context of hep C treatment as in general-- than you do. And because of this, I dare say, I've been to a lot of more of them, searching for answers. The very best still fall short -- partly for reasons that you state -- but the very best do read (and run) the very studies you often refer to. The difference is that they then meld these studies with their own cliinical experience (and that of their peers) into some sort of treatment soup. That is not to say that they're always on top of the latest and greatest -- I've brought studies to my docs opinion before he's seen them -- but they are a valuable tool in making these difficult decisions. Perhaps as valuable as the studies they run.

BTW I like that soup you mentioned in a thread recently for an idealized future treatment. As long as you're bringing in mulitiple weapons, how about pre-dosing with ribavirin 4-6 weeks prior to treating? With all the latest and greatest, archaic riba still seems the ingredient that allows it all to happen. As to the IV riba treatment mentioned, I think something similar (lower doses of course) would work for Hep C, but we will never see it due to cost, both financial and physical. But I still wouldn't call Lindahl's regimen "wimpy" or whatever you said. Those IV folks only did it for a few days or weeks. Lindahl's group did it for an entire year. Major difference, esp when it comes to riba.

-- Jim

[jmjm530]

To expand a little on my (versus your) faith in the docs. As stated, we may be a lot closer than you think, and the odds maker analogy you used was a good one. One of the short-comings of many docs is their apparent inablity to make creative use of the statistics at hand, often from the same studies they run.

Why for example, do we not see more docs using for example, a 4-week stop rule (if still detectible) for those with little or no liver damage?  Or at least presenting such an option upfront?

Still, as stated, a top notch hepatologist/researcher can often bridge gaps between the study lines. That doesn't mean of course that they have to be followed blindly and the very best I've seen have never pushed me to agree with them. Still when push came to shove, I ended up giving their opinions the most weight.

I know geography and other considerations prevail, but knowing you as I do, my hunch is that if you walked into a top-doc's office -- like Dr. J. in NYC for example -- with that "soup" plan you discussed for yourself , and the reasons you want to try it --  I think you might get his attention and possibly even some of the drugs. These top guys just love to push the envelope and try new things  -- it's just that they're often reluctant to do so -unless a strong part of the impetus comes from the patient. FWIW it was my idea to high dose riba, not my docs, but he fully supported the attempt.

-- Jim

-- Jim

[willing]

well, I wouldn't say I ascribe that much "truth" to any single  study, but I do fundamentally believe that where genuine, underlying causal relationships exist,  as opposed to just random white noise, they can be measured (ie they'll show up in the data).The trouble  with opinions, regardless of the caliber of the speaker, is they can too easily yield a "reality" that looks correct, consistent and sensible but has little bearing on those underlying causes. ( I'm not a lawyer, but imagine that discrepancy may also be  behind the hearsay exclusion in law). Where studies give different results, for example re the benefits of high-dose/induction tx, I think they still say something about the (small) magnitude of the effect being examined relative to the (large) inherent patient-to-patient variability.

For example, you mentioned the clinical-care-options talk in support of the value of higher dosing for re-tx. As best I can tell the talks are summaries of the slides and the slides are  extrapolations/opinions on a couple of underlying studies. With respect to high-dose riba, the benefits are based entirely on Shiffman's aasld'05 study

http://www.hivandhepatitis.com/2005icr/aasld/docs/112305_a.html

which (a)  dealt with tx-naive patients (b) showed an SVR rate of 45% in its most successful group, presumably because the patient population included a  larger %  of a hard-to-treat group (african-americans in this  case).  Getting from there to a recommendation for high riba in post-relapse re-tx seems a bit of a stretch...

Also, after reading a few more aasld'07 abstracts my panic in the above posts has settled down a bit: the benefits of  extended tx are real and apparent even in full-dose riba groups.  That Berg abstract (179) does in fact show quite poor results for individualized vs cookie-cutter-48 tx. However, their 6X(week at which UND-615) individualized rule meant shorter tx for many patients (und in weeks 1-7),  perhaps more than the number for whom the rule resulted in  extended tx (weeks 9-12). Frustratingly, they don't  give that break down.

However a couple of other abstracts report the "expected" results for extended tx. In abs. 1321, a comparison of std and extended among  Japanese patients reports:

"SVR rates were 56.0% (14/25) in standard group versus 81.1% (23/28). Especially, in patients who obtained HCV RNA negative at from week 12 to week 24, SVR rate was significantly higher in extended group (standard vs extended: 35.3% vs 78.9%, P<0.05). Conclusion: Extension of treatment with pegylated interferon plus ribavirin therapy significantly increased the SVR rate in patients with HCV RNA undetectable at 12-24 of treatment".

In abs. 1310,  re-tx of German relapsers with either daily CIFN or PEG both of which were administered for 72 weeks resulted in :

"At the end of treatment at week 72, a negative PCR was observed in 86 % in the CIFN group, and in 78% of the PEG IFN 180 ug group (diff. = n.s.). The sustained viral response rates (SVR) were 69% for the CIFN arm and 42 % for the PEG IFN a2a arm, respectively (diff. p<0.05), indicating a significantly higher relapse rate in patients being retreated with PEG IFN a2a."

thanks for the thoughts re my tentative "soup" recipe. However, I'm pretty skeptical Roche will make any R1626 available until it at least starts  phase II.

[jmjm530]

I remember presenting a study to my doc once. He looked at it and said, "I'm not surprised, that guy's a nut" -- referring to the author he apparently knows. Not sure if this is part of that "white noise" but sometimes it's good to have some human insight to help put things in perspective.

That story aside, one thing I've found is a seeming paradox in the medical community on studies. Many studies are met with a real skepticism, while others are grasped and then quoted and then end up on sites like ClinicalCareOptions. I'd like to think that the reason is because -- given the fact that many studies are conflicting -- the studies are filtered through the "nut" and other filters of people with a lot of research and field experience. Although sometimes I wonder how much it has to do with peer circle and established beliefs.

All said -- and maybe it's partially (but not entirely)  my own insecurity with the study data -- but I found bouncing these various studies off of the top liver specialists added a new dimension to my own thought process. But honestly, can't say I always agreed with the doctor's take or was even convinced he fully assimilated the study. Still, you work with what you got.

-- Jim

-- Jim

[Stiffneck]

Something tells me I'm on a track for an extended course.  Guess I'll just take it a day at a time.

Tim

[jmjm530]

Sorry to inform, but unlike you state, you did not get a two-log drop. A two-log drop would be 29,100 IU/ml or less. Unless you have signficant liver damage -- stage 3 or 4 -- I'd think twice about continuing on with treatment given the diminishing odds. Alternatives would be to stop now and then try to enroll in a Telaprevir trial, or if not much damage wait until Telaprevir or one of the newer drugs hits market.

-- Jim

[Tallahassee]

Stiffneck will not qualify for Telaprevir trial for non-responder --- he is a responder, just he doesn't respond very fast --- but personally would kill to see response curve as he has (considering that in my case, after 48 weeks of SOC, i didn't have a 2log reduction).

To qualify for Telaprevir trial, one should have less than 2log drop after 12 weeks of tx or relapsed after successful treatment.  People with viral beakthrough may not qualify at all --- "it is considered case by case".

Tim, you have many options, discuss with many Drs until you reach your comfort zone with your decision, but just remember - your glass is half full -- not half empty -- and you ARE a responder!
Congratulations on that.

All the best

[willing]

stiffneck: this does seems a good time to shop around a bit before you commit to your poison of choice for the remaining time. That 69% SVR rate for 72 weeks of daily CIFN on *relapsers* (abstract 1310) seems like one of the better bets available; relapse studies  tend to get less than half that result. And let me join  Tallahassee on congratulating you on the results so far; VL is  definitely moving in the right direction!

all: yet another interesting abstract, 1320. This is Shiffman weighing in on "THE EFFECT OF COMPLETE AND PARTIAL RESPONSE AT WEEK 12 ON SUSTAINED VIROLOGIC RESPONSE: RESULTS FROM CONTROLLED TRIALS IN NAïVE HCV GENOTYPE 1 PATIENTS TREATED WITH PEGYLATED
INTERFERON AND RIBAVIRIN". No new data, but they  went back, ala Berg and reanalyzed the week 12 VL from various previous studies using an ngi superquant (39 IU). Not clear whether the assay was run on saved frozen serum or had been available all along and...

"Conclusions: Approximately 56% of genotype 1 treatment-naïve patients treated with pegIFN/RBV became HCV RNA undetectable at week 12, and 74% of these
patients achieved SVR. In contrast, only 16% of patients with partial response at week 12 achieved SVR. A study to determine if SVR can be increased in partial responders (those with EVR but HCV RNA positive at week 12) by switching to a more aggressive IFN regimen at week 12 is, therefore, warranted."

The days of partial (2-log) at 12->48 seem numbered. I would have have been willing to put on a tutu and dance in exchange for data like this when I was trying to figure out whether to extend - and I bet frijole would have as well. The maddening thing is that these are not medical "breakthroughs" but simple  calculations that could be routinely run by anyone with a spreadsheet and access to the d***n data...

[zazza]

"The days of partial (2-log) at 12->48 seem numbered."

Could you interpret this for me please? Do you mean that "the days of partial response (at least a 2-log drop) at week 12 equals 48 weeks seem numbered" or "the days of partial response at week 12 equals more than 48 weeks seem numbered"?

[willing]

the former. The current SOC is nicely laid out in the diagram from Figure 2 of the following recent review:

http://tinyurl.com/2fx3wd

Geno 1s  with  a 2-log drop or better continue on to 48 provided they are UND by 24. This tx algorithm has been standard for about the past 5 years (previously, UND at 24 was a common criterion). However studies  like those reported by Shiffman  in abstract 1320  or by Berg in abstract 179 are consistently finding that any  detectible VL at 12 weeks is indicative of a higher likelihood of relapse than the standard 30%. Thus I would expect that the SOC algorithm will evolve to longer tx for partial responders (data supporting the benefits of extending is also piling up, as reported for example in abstract 1321). None of this is really news, just solidifying consensus.  

In hindsight some of these results look obvious, but the devil lurks in the details. For example, studies have repeatedly shown that extending tx duration from 24 to 48 does not affect the overall SVR rate for 2/3s. Berg's first study of the benefits of 72 weeks (which came out while I was on tx) found the same for 1s. Only  later did he examine the effect  on relapse odds for those not quite clear at 12 and reported that in this subgroup it made a big difference. Whether extending does anything for patients with significant VL at 12 remains open.

[zazza]

Thank you very much for your interesting posts above about extended tx. May I ask if you yourself were a slow responder detectable at week 12? I understand you relapsed, did you do 48 weeks? Did you have a small viral load at week 12? I was detectable but not quantifiable with a test of the sensitivity of 15 IU/ml, which means I had a viral load somewhere in the vicinity of 15 IU/ml. Between 5 to 20 IU/ml according to the lab doctor. UND at the next test week 15. Today is the first day of my extension to 72 weeks. Obviously I am very interested in the discussion above.

[willing]

my 12 week test, as I recall, was July '03 and showed UND at a sensitivity of 600IU, the standard test at the time.  None of the recent data on the importance of zero VL at 12 was available and Berg's initial study, as I mentioned above, indicated no overall SVR benefit for 72 weeks so I stopped at 48. Another forum member, lala who was in tx at the time,  had a very sensitive test at 12 which showed low-level VL continued to 72 and SVRd. Frijole, who hopefully will comment, had very low level at 12, stopped shortly after 48 and relapsed.

Treatment is shifting towards getting the most sensitive test available at 12 and continuing past 48 if there  is any VL.  Though I disagree with Jim about the value of high-sensitivity tests at other points in tx, the 12 week data point is a critical predictor. I know the prospect of 6 more months is harsh, and the value of that extra time is still being examined,  but given what  we know today I'd say continuing to 72 is the right call for you (whenever you're in doubt, pull out those relapse rates from abstracts 179 and 1320).

Good luck and best wishes.

[zazza]

Interesting. And thank you for your support. I can see that you are very knowledgeable and I so much value your opinion and support. Z.

[jmjm530]

Willing: Though I disagree with Jim about the value of high-sensitivity tests at other points in tx, the 12 week data point is a critical predictor.
----------------------------------------------------------------------------------
I'm glad we at least agree getting a sensitive 12-week test is important. Wasn't it not that long ago that you didn't think so? Hard to remember it all these days.

In any event, and you would know better than I, hasn't Berg recently written on the importance of the 4-week test (as well as the 12-week) , using <50 IU/ml? Isn't this another point in tx, or don't you consider it sensitive enough.

I guess what I 'm trying to say is that first we started with the 12-week studies, then the 4-week studies and no doubt later on there will be the 1 and 2 week studies. And the same with test sensitivity at these points.

As you know, I don't buy into the argument that just because a study hasn't used week "x" that week "x" isn't important, when we can extrapolate data in a reasonable manner. And I don't expect you to change your opinion based on my prior arguments, so let me try this.

If for no other reason -- and I've given other reasons -- than future studies may (and probably) will use very sensitive tests at various junctures other than week 12 -- wouldn't it then be prudent for anyone testing now to utilize sensitive tests so that their data can be retrospectively analyzed at a future time if/when they relapse and if/when studies pinpoint these other dates?  

-- Jim

[jmjm530]

Or in similar fashion -- say someone is treating today and is at week 4. And say they don't take a sensitive viral load test because no study data out yet. And say two week from now a blockbuster study using sensitive week 4 viral load data comes out. I think that the person has missed an opportunity because you can only test your week 4 viral load at week 4.

[jmjm530]

One last shot before I doze off.

We do have a study that shows that 100% of EOT PCR negative/TMA positives relapse after treatment.

Couldn't one very reasonable extrapolate -- assuming treatment in this case is 48 weeks -- that if one is PCR negative/TMA positive at week 36, they may be in trouble? Or at week 24? Certainly you have to say they're in trouble if they're TMA positive at week 44?

For this reason and others, some docs -- including mine -- test viral load monthy during treatment with sensitive TMA in order both make sure the virus indeed goes UND but that it stays UND.

As I've stated before, one of the primary arguments used by one of my consulting hepatologists in terms of me treating 48 weeks (instead of extending) is that I was TMA negative throughout treatment, as I was tested monthly. Both the frequency and test sensitivity scored points at least with one hepo.

Night all,

-- Jim

[willing]

zazza: I saw you and frijole are good buddies, that she's already given you "the talk", and that you're signed up for the duration - best wishes, it's not that much further.

jim: with Berg making pronouncements like "highly sensitive HCV RNA tests must be considered to be now mandatory " (sounds very Germanic doesn't it) I bet whoever's in charge of marketing for the 600IU detection tests is probably thinking about reformatting their resume... nevertheless, though at some point all tests will be at lower sensitivity, this field moves at a fairly stately pace and, for now, paying the approximately double cost for  high-senstivity tests throughout tx  just doesn't give you much value. The whole point of VL tests is  just to compare the result   with others - not to measure the absolute amount of virus in the body since clearly there's a lot of virus left long after it can no longer be detected. We're just starting to understand what it means to have a reading of 0 vs 5 vs 50 vs 5000 IU at 12 weeks and though we've known for a while what it means to have 5000 at 24 we still don't know, for example,  what 5 at 24 means (can we really say "they're in trouble"?).  It's wonderful your results were TMA UND at monthly intervals throughout  but I would be willing to  bet that (jelly-filled) doughnut again that had you come up with a TMA of 5 at 24 you would *not* have abandoned tx (and as I recall someone posted a while back with precisely that question). If you can't interpret that extra precision because you have nothing to compare it to, why pay the extra $200 for it? I don't have a TV so this analogy may be off-key but it seems like paying for a high-definition receiver before having access to the signal.

The "retrospective" argument is pretty good but amounts to investing in understanding your relapse before it happens - might be hard to sell that argument to an insurance company.

It's a bit strange I'm arguing for the accountants since I'm usually on the other side of these requests. When I last saw my liver  specialist I tried to talk him into both a sequence test (which they are set up to run if they wanted to) and an HBV VL. In trying to make sense of my relapse I'd like to compare my viral sequence with consensus entries in the  Los Alamos HCV database  and see where variations occur; also have become suspicious of  an occult HBV/HCV connection because of those articles. Nada: "So what are you going to do with the results?"

[jmjm530]

Willing: but I would be willing to  bet that (jelly-filled) doughnut again...
--------------------------------
Speaking of which, I'm a bit woozy now from falling off the wagon (food wagon that is). A stress-filled day and a wrong turn on the highway led me to one of my very infrequent visits to Burger King and I'm now an Angus  Burger and a Big Mac w/Cheeese and two large Fries the worse for wear, not to mention a trough size soda wash. Not sure I'll make a good argument from the lingering haze but if, for example someone did do monthly TMAs like myself, it would give them the opportunity (a positive result that is) to either re-evaluate treatment duration, dose, or even stop. Anyway, sounds like some pretty fancy testing you have in mind and I have no doubt that you will take the right tests for you next time treating. Well, think I better go for a bike ride or something and get the Angus out of the system.

-- Jim

[jmjm530]

How about helping an Angus/Big Mac impaired fellow MH member, negotiate the AASLD site. Tried to log-on/register, etc, and the system seems to recognize me but I'm in some sort of loop and I can't get at the abstracts, whereever they are. Last time there was something I think called an "Abstract Planner" where you could selectively pull up different studies, etc. Couldn't find that either.

-- Jim

[jmjm530]

nevermind. there seemed to be an overnight delay, but I got the intinerary planner working. just wondring, however, given that the site isn't the easiest to navigate -- how the hell will your average physician find anything? Most have the patience of a knat but that might be giving too much credit.

-- Jim

[frijole]

Thoughts come to mind…
Really, willing, 6x the weeks before clearing?  That would really throw all of us into the mire. 6x20 = 120 weeks ?  The ramifications from the interferon would be too severe!  I must read this whole study by Berg.  If extended time is not the answer, what is?  I have harbored thoughts that 72 weeks for me would not have made any difference – that my strain of virus is too resilient. However, the Berg study – the 05 one – only indicated that extension would benefit those with VL under 6000 at week 12.  However, I think, clearly, that the extended treatment has benefited many here.  Cuteus? NYgirl -- Maybe – or perhaps they would have cleared at 48 anyway.  Eisbeen and Lovedbygod – the two who did over a year – yes, I think extension did do the job.  Fishdoc?  She did it by increasing Ribavirin.  Zazza and Mikesimon have pointed out that treatment must exceed the lifecycle of the longest liver cell – perhaps as long as 500 days – do I have that right?  That thought has merit.

I absolutely agree with Berg if he is now saying tests must be sensitive.  Tests to 50 are not adequate, except when lower boundries do not come into play.
frijole -- will add more later

[frijole]

Isn't it all economic?  I agree with Jim that it would be nice to have the most sensitive test all the time.  But I agree with Willing that the more expensive tests are totally unnecessary some of the time.  However, once you have tested to have a low virus count I think it is necessary to continue with sensitive testing throughout treatment - or the TMA quantitative which, I guess, I never had.   I had my internist order a PCR last week in my annual physical (jim - i am feeling doomed or depressed with the big 6-0 looming close).  He just looked back at the test the GI had ordered last because he had never ordered one and asked if that was the right one (it was the <2 QuantaSure).  I said yes, but, really, I could have had the cheaper test.

Also, like Jim, I have gotten trapped in the same AASLD loop.  I too have registered for the aasld but can't get into the abstracts.  

Willing -- you said your 12 week test was only <615.  Then what am I remembering you to have said about "flat lining" -- that your viral load stayed the same between 2 testings (like nygirl's did)?  I seem to even recall a graph you made.

Now that I have found this thread, and it is a good one, I hve it bookmarked.  THanks, willing.
frijole

[jmjm530]

All the best luck with your "big 6". I'm assuming you were tested earlier and just being unduly (but quite understadably) nervous? In case you missed it, a new study correlates the 12 week 100% with SVR unless you're stage 4, and even then the correlation is pretty good.

As to the TMAs, cost is not as high as people think -- at least not what the insurance companies pay. If you have to pay yourself, always can negotiate. Won't go into all the reasons again why I think it makes sense -- at all points -- to do a sensitive test....

OK. That d*mn web site. Last night I couldn't. This morning it turned I was automatically still logged in and could.

Here's how to get to the abstracts:

After you're logged in, click on "abstracts" in left sidebar.  Then the words "abstract viewer" in the blue text under the green heading that says "abstract viewer". I believe it's the first sentence. (yes they make this difficult).

That takes you to the itinerary planner page. Now click on "Search" in the left sidebar. Now you're on the search page.

If you then just click on "Search" -- without filling in any fields you will get everything but the search filters are very good. For example, if you type in (under key words) Alinia you will get all the Alinia abstracts which actually you don't cause you have to type in "Nitazoxanide". LOL.

Let us know if you got IN and if you saw anything interesting. I haven't had time to do much looking yet.

-- Jim

[trams]

can i know how many money does one Peg-intron cost?

[frijole]

Did get into the abstracts finally. Thanks.   Now I would like to see the entire new Berg study.  I am somewhat perplexed about abstract 179.  Am I reading thia right -- it compares 48 weeks with 6x number of weeks to clear?  Seems a little out in left field to me.

The PCR test I am waiting for results on -- no , it is not the first post.  Last post-treatment test showed 3,700,000 copies - never did get the final with the IU correlation, but that should be about 1,400,000 IU/mL..  So this test is more for idle curiosity.
frijole

[zazza]

Yeah, I was also going: Will we have to treat forever now? 15x6=90 weeks! But then I saw this little sentence:

"In the latter group treatment duration was calculated by the time required to become for the first time HCV RNA negative as defined by bDNA assay (detection limit 615 IU/mL) multiplied by the factor 6."

That would make you and me clear by week 12, since we were below 615 IU/ml, and then we could do with just 72 weeks! Does this help any? I guess we still need to read that entire new Berg study to sort this one out.
Zazza

[nygirl7]

I absolutely agree with Berg if he is now saying tests must be sensitive.


Berg changed my entire course of treatment as everyone knows.  In my particular case not being UND at week 12 obviously I went on for the 72 weeks.  I've believed all along that for the critical tests you must have the most sensitive test possible to see if the results are truly viable or not.  I do not feel that an 8 week test would need be as sensitive as week 4, 12, 24 though.

"Willing -- you said your 12 week test was only <615.  Then what am I remembering you to have said about "flat lining" -- that your viral load stayed the same between 2 testings (like nygirl's did)?  I seem to even recall a graph you made"

Baseline 568,000
Week 4   411 (lookin good!)
Week 12  419 (not looking good!)
Week 24 UND
Week 46 UND <2 again

With the great log drop at week 4 things were awesome until I flatlined for all of those weeks between 4 and 24.  I'm glad I did the 72


By the way - leaving early to have my 8 month (well the 6 month technically at 8 months) PCR today.  Finally.  One way or the other - I figure it's time for me to find out if my UND has stuck and turned SVR or not.

wish me luck.

[susan400]

Yea-Good for you, you go girl!!  I'm proud of you for finally taken this step in getting retested.  I am wishing you luck and prayers!    Susan

[Lonestar823]

Susan, Did you ever become undetected on the infergen?  How long did you stay on it?  
NY/ I'll be thinking of you.  I went for my six month, six months late last Friday.  Think of me, okay?

[susan400]

I was on Infergen on 3 different tries.  The first time was when it first came out and back then, the thought was that the patient should do 'induction' therapy which is month #1 doing daily Infergen, followed by month's 2,3 and onward- with 3 times a week.  This was with the Ribavirin.  I did not clear after 24 weeks and was taken off.

The next time was in combination with Gamma Interferon (Actimmune), so I was on daily Infergen + once a week Gamma and Ribavirin.  I did not clear that time either.

The last time was when I was on double dose of Ribavirin, daily Infergen and Riba.  For me, for my body weight at the time, double dosing was 1600mg a day of Riba.  I did not clear.  I did 48 weeks.  

Please don't base your thoughts about whether to try Infergen, or not, on what happened in my case.  I've treated so many times and never cleared on anything, so it's not just a problem with any one particular drug.    On the last attempt that I was on with the Infergen, if was for 44 weeks before I was stopped.   Anyway, some people do clear with daily dosing of Infergen.

Susan

[Lonestar823]

Thank you Susan.  I don't always keep up with the board but I was pretty much aware of what you've been through.  Actually, I cried last time you were taken out of the trial.  I did six months of Peg in 2004 and didn't clear by week 24.  Six months later I did do the daily infergen and stayed on it for 73 weeks, a bit over a year after clearing.  I was undetected five months post but never went back, just couldn't think about it or deal with it for a long, long while after finishing.  S'pose I'll know within a week or so.  I did my blood work last Friday.  Very best to you Susan.
Rebecca

[susan400]

Rebecca,

That's very sweet of you....., to say that you cried over my disappointment, it makes me feel very touched.   Susan

[frijole]

I think we need that study.  i will try to "procure" it.  WHenever I see a <anything, whether it be <50 of <615, my mind translates that to <2 or whatever the most sensitive test I can find.
kathy

[willing]

zazza, frijole: here, by day,  are the aasld abstracts that contained the string "HCV" in the abstract text:
sat:  http://tinyurl.com/3dpr85
sun: http://tinyurl.com/2obe5p
mon: http://tinyurl.com/2nxls7
tue: http://tinyurl.com/3y9mzs
they'll only be there for a  day or so  so you may want to save them if you're planning to read through the pile. Berg's new study (abs 179) is scheduled for tues. As I read it their "individualized tx" arm looked at the week in which you became UND on a 615 bDNA test and multiplied this by 6. If this happened at week 8 one did the std. 48, if earlier  reduced time and if later extended time with the cutoff being 72 weeks for those that goto UND(615) at wks 9-12 (they only tested weekly up to 8). The big surprise for me was that the individualized tx (group B) seemed to be a big flop as judged by comparing the relative relapse rate, which I took to be % of EOT-UND who relapsed, with SOC duration (group A).  I first took this to be an indication that extended tx really doesn't help that much, but I now thing that's not the case since their table includes data on both extended tx and shortened.As noted in a previous post, a couple of other abstracts came out strongly on the benefits of extended. Anyway, am curious to hear any thoughts/opinions on this.

that vl graph I did from my tx is here:
http://tinyurl.com/yvqb75
The w 12 is plotted as 600 though it showed UND at that level The flattening is not as blatant nygirl's but clearly violates Cecil's Law (90% drop every week). Given what we now know it seems a pretty clear signal for extending...

nygirl : all the best possible wishes  - I think you did exactly the right thing

jim: my sympathies on that burger; I feel your pain. Control of the food supply is a big issue with me lately (rice and vegetables, AGAIN?). Saw an ad for the Wendy's baconator at lunch "beware, it can sense fear",  across the street and yes, I was afraid; I think it knew.

[frijole]

THanks.  I did manage to read the Berg Abstract but don't have it here, and I didn't see it in those links.  The abstract was in fact listed in the Tuesday aasld abstracts, but I just didnt' see it.  I will try later.  I am disappointed that the extended treatment was not more beneficial.  In fact, I don't really understand that and would like to read more.  Is the entire study out yet?  If it is could you send it to me?  And thanks for clarifying your graph!

Mikesimon has posted a  link to a new Clinical CAre Option today which may be valuable on who should retreat.  I am anxious to read that this evening.

frijole

[willing]

If you open the pdf for Tuesday, and use the acrobat search facility (click on the binoculars) to look for "179" that abstract should turn up as the 3rd item found.

Nothwithstanding the high relapse rates reported in 179 I don't believe it provides data against the value of extending. The study only seems to show that the particular  "individualized duration" rule used was not successful, presumably because a lot of patients ended up doing less than 48 to their detriment. It's unfortunate that they don't actually report how many did abbreviated and how many did extended as this would make the results clearer.Abstracts 1321 and 1310 (see 10/8 comment above ) provide strong support for extending.

[merryBe]

one thing I came across was a study on fat and absorption with riba. study varied fro, .75 to 1.46 better absorption with a fatty meal.

this got me to thinking:

ok, so part of the study had to do with lean muscle mass metabolism, and that fact that obesity seems to effect going UNG or SVR.

so, who here knows that fat circulation differs from normal leam muscle mass? Or that toxins are stored in the fat, not just the liver.

So here goes: Maybe the extended treatment works BECAUSE the little buggers can hide out in the fatty tissue for much longer than in the lean muscle mass and pounding bloodstream.

I mean, so you get down to UND, that still means in the BLOOD there are ten or less viral cells, or 50, depending on what test. that's not to say that you couldn't have them hiding out longer in a larger person.  google Ribavirin fat absorption and read up

sorry stiffneck, about the doc wanting you to change. I would hate it. question is, battle now or battle later I guess. You have to make the call. hard one.

hope that helps.  anybody comment on my theory????

[mikesimon]

It's silly. Mike

[nygirl7]

**** - now the stupid company here has blocked all things with tinyurl's saying "hacking/proxy avoidance".  God pretty soon I won't be able to viewv ANYTHING.

I'm very glad I extended - in my case it seemed at the time the perfect solution.  I'll find out if it was tomorrow or Monday but judging by the enzymes...the chances look great.

[jmjm530]

NY: *** - now the stupid company here has blocked all things with tinyurl's saying "hacking/proxy avoidance".  God pretty soon I won't be able to viewv ANYTHING.
--------------------------
Not sure what you mean, but I'm able to view "tinyurl's" posted here on my computer. Perhaps it's your system at home or at work where the problem lies. Just a thought.

-- Jim

[jmjm530]

Oh, I see you probably meant by "company", the company you work for? My guess is the reason they block tinyurl's is because their filters can't filter out the "bad" sites. Glad I don't work for a big company anymore :)