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148588 tn?1465778809

merryBe

Please check out the slide set by Dr. Mitchell Shiffman released today at Clinical Care Options.

clinicaloptions.com
29 Responses
Avatar universal
Thanks for the heads up. Haven't had time to wade through the slide set, but here are the conclusions and a few comments:

Summary of Clinical Implications

    * A patient must respond virologically and achieve undetectable HCV RNA (< 50 IU/mL) to achieve an SVR.
    * Patients who do not respond virologically cannot achieve an SVR by continuing the same treatment for a longer period of time.
    * Patterns of virologic response and nonresponse be recognized by assessing HCV RNA at monthly intervals until the HCV RNA has become undetectable or a nonresponse pattern has been defined (Week 24).
    * Up to 90% of patients with RVR achieve SVR if they remain on treatment for 48 weeks for HCV genotype 1 infections and 24 weeks for HCV genotype 2 and 3 infections.
    * Rates of SVR in patients with genotype 1 infection who achieve an RVR do not appear to be affected by reduction of ribavirin dose.
    * The initial management strategy for patients with RVR who develop adverse events should be to consider reduction of the doses of ribavirin and/or peginterferon alfa so that these patients can hopefully complete the recommended duration of therapy.
    * It is important to continue to monitor HCV RNA through Week 24 even if the patient does not achieve undetectable HCV RNA during that time to allow for identification of partial virologic response.
    * It has been hypothesized that some patients with a partial treatment response may achieve undetectable HCV RNA if switched to or retreated with a more intensive peginterferon alfa regimen.
    * Patients who do not achieve an EVR will not achieve undetectable HCV RNA with continued treatment and are defined as having a null response. This is an indication for stopping treatment.
    * An important reason for viral breakthrough may be missing doses of peginterferon alfa and/or ribavirin.
    * Patients fail to achieve SVR for several different reasons. All but one of these factors, null response, can potentially be overcome during retreatment.
    * Only those patients who have a known and correctable reason for their previous treatment failure should be considered for retreatment.
    * The outcomes of retreatment may be maximized by improving education and awareness about adverse effects of peginterferon alfa and ribavirin, having a stronger commitment to therapy, or seeking care from a more experienced and/or attentive treatment provider.

Avatar universal

   (1) Rates of SVR in patients with genotype 1 infection who achieve an RVR do not appear to be affected by reduction of ribavirin dose.
    (2)  The initial management strategy for patients with RVR who develop adverse events should be to consider reduction of the doses of ribavirin and/or peginterferon alfa so that these patients can hopefully complete the recommended duration of therapy.
    (3) It has been hypothesized that some patients with a partial treatment response may achieve undetectable HCV RNA if switched to or retreated with a more itensive peginterferon alfa regimen.
    (4) Patients who do not achieve an EVR will not achieve undetectable HCV RNA with continued treatment and are defined as having a null response. This is an indication for stopping treatment.
   (5) An important reason for viral breakthrough may be missing doses of peginterferon alfa and/or ribavirin.
    
------------
I think the key finding here in your situation is #4, which once again suggests that if you don't have a two-log drop by week 12, then not much is going to work, including extending treatment. Again -- haven't gone though all the slides so I'm assuming Dr. F. is using standard definitions of EVR and Non-response, etc.

I find #'s 1,2 and 5 in conflict. If breakthough can be caused by missed doses, why not make all attempts for a patient to stay on full-doses by using helper drugs, especially in those with signficant liver damage. Again, haven't seen the whole slide set, so just extrapolating here.
233616 tn?1312787196
I would normally already concur, and having missed no doses did give this my best shot.

One wrench though is having that secondary infection show up, and then throwing back amoxicillin for over two weeks, and again today (each dental visit)...which I cannot believe di not lower my white count, mess with interferon, and perhaps stop the forward progress.

Also wondering how a woman doctor in France got a 90% SRV by monitoring serum Riba levels and yet no one here has the kahunas to treat this way??

not ready to throw it in until I know it's hopeless.
still appreciate the info, but it changes weekly.

also shwartz (2nd opinion) said 20% more will cure with extended tx...latest info...so it looks like new stats are showing up.
Mary
Avatar universal
You are talking about the small Swedish Pilot Study where 9 out of 10 genotype 1 participants were SVR.

Special HPLC testing (not available here) was used to help measure a pre-determined serum riba level originally established by a pharmakentic formula based on kidney function as opposed to weight.

The treatment was very rough, with 2 out of the 10 particpants requiring two blood transfusions each.

But that aside, the riba was high-dosed from the start of treatment, not later in treatment as would be your case as a null responder. And even if you wanted to try high doses per the study, unless you had access to these specialized tests, you wouldn't have an accurate way of figuring out your serum riba levels, with the degree of anemia being the only measure, and much cruder than the actual HPLC tests.

That said, an HPLC test at this point might be of some interest -- perhaps for the future -- in terms of seeing how much riba you did absorb, but finding the test will not be easy and may require either  a trip to Europe (while still on the riba) or somehow shipping it to a lab frozen, I presume. This could end up being a small undertaking.

Personally, I'd go with the advice your liver specialist on this one, as if I remember correctly you've been classified as a null responder.

-- Jim
148588 tn?1465778809
I hope K. Lindahl can do a larger study someday. You've worked those ten anemic Swedes pretty hard this last year and they need a rest.
Lindahl may be a pioneering genius in the field of HCV tx, but she'll never get the recognition she deserves with numbers that small. The UCSF pot study had way more patients and showed way better results - 3x as many SVRs among occasional smokers over non-smokers - Lindahl merely doubled response rates.

Which only goes to show small studies don't have a lot of significance statistically.
179856 tn?1333547362
I don't care what anyone says to ME I wouldn't drop any riba no matter WHAT since riba serum levels seem to be so indicative in later data - this seems to be a bit archaic to me, no?  Both can't hold true unless someone is truly UND when the dose reduction comes?

so many different things that we've read to factor in to making decisions.  It's not as simple as open and closed case because it just seems to me so many things totally CONTRADICT each other?

HepC treatment is still nothing but a giant crapshoot and you have to roll EVERY dice you can find.

In Merry's case the only good news I could find up there would have been if somehow she had been able to adjust her inf upwards in time.  Maybe for round two?

I also agree with desrt - small studies while informative really don't have much significance statistically - certainly not enough to risk success on.

Avatar universal
Since you seem to be following my posts on Lindahl, you probably know that the first thing I would personally do if treating right now would be to contact Lindahl to see if more data has been developed other than the 10 from the small pilot study.

That said, and while I still see VHDR (very high dose ribavirin) as some benefit in a very select group -- I'm pretty sure that if I were treating today, I'd be more interested in the PI trials rather than VHDR, because of toxicity issues both with riba and Peg with VHDR.

No doubt, this (toxicity) is one reason VHDR has not been pursued in this country very much, i.e. the major researchers have been busy with the PI trials which they feel is a better, less toxic approach.

Keep in mind that one of the problems with SOC is toxicity and QOL during tx. In concept the PI's deal with both, VHDR makes both worse.

On the other hand VHPLC testing can still nevertheless be useful within SOC to make sure "optimum" riba levels are being maintained. And I use quote marks around optimum because I'm now using it in the sense of optimum for SOC and not "optimum" as used in the VHDR studies. Problem is, I don't think there is much data on what optimum serum riba levels are for SOC, so that would have to be developed/researched more.

-- Jim
Avatar universal
Here is an exerpt from some commentary on the Lindahl VHDR study that deals with the toxicity issues of VHDR per the Lindahl study. It therefore seems to me that anyone thinking about VHDR versus a PI trial, for example, should have some very well thought reasons for such an undertaking. I know I did in '05 when I thought I could handle VHDR, but in '05 I didn't know what a PI or Telaprevir was. As discussed before, my little experiment with VHDR failed for a number of reasons, but in the end I barely was able to tolerate the 1200 mg/day of ribavirin from SOC.

"... The results of this study are indeed striking but a note of caution must be struck. Foremost is the issue of safety. One of the major limitations to combination therapy is the high frequency of side effects, some of which may be serious and life-threatening. In the two large multicenter registration trials, 10% to 14% of patients required discontinuation of therapy and 32% to 42% required dose modification for serious or severe side effects.[1][2] Higher doses of ribavirin would undoubtedly lead to more side effects. Hemolytic anemia is the major risk associated with ribavirin, and, if defined as a hemoglobin level less than 10g/ dL, occurred in 7 of 10 patients. All patients required hemopoetic growth factor, two required blood transfusion and four required dose reduction or temporary discontinuation of the drug to manage side effects. Furthermore, all patients experienced a reduction in ability to work, although, quality-of-life was not specifically assessed. The need for erythropoietin, blood transfusion, and loss of work are not trivial matters particularly in the typical patient with hepatitis C who has few if any symptoms and is largely fully functional. Anemia caused by ribavirin can induce cardiovascular and cerebrovascular incidents in susceptible patients. Thus, even with intensive monitoring this high-dose ribavirin regimen can be life-threatening..."

http://www.hepcnet.net/boards/medsforum/index.cgi?noframes;read=1412
Avatar universal
Here is an exerpt from some commentary on the Lindahl VHDR study that deals with the toxicity issues of VHDR per the Lindahl study. It therefore seems to me that anyone thinking about VHDR versus a PI trial, for example, should have some very well thought reasons for such an undertaking. I know I did in '05 when I thought I could handle VHDR, but in '05 I didn't know what a PI or Telaprevir was. As discussed before, my little experiment with VHDR failed for a number of reasons, but in the end I barely was able to tolerate the 1200 mg/day of ribavirin from SOC.

"... The results of this study are indeed striking but a note of caution must be struck. Foremost is the issue of safety. One of the major limitations to combination therapy is the high frequency of side effects, some of which may be serious and life-threatening. In the two large multicenter registration trials, 10% to 14% of patients required discontinuation of therapy and 32% to 42% required dose modification for serious or severe side effects.[1][2] Higher doses of ribavirin would undoubtedly lead to more side effects. Hemolytic anemia is the major risk associated with ribavirin, and, if defined as a hemoglobin level less than 10g/ dL, occurred in 7 of 10 patients. All patients required hemopoetic growth factor, two required blood transfusion and four required dose reduction or temporary discontinuation of the drug to manage side effects. Furthermore, all patients experienced a reduction in ability to work, although, quality-of-life was not specifically assessed. The need for erythropoietin, blood transfusion, and loss of work are not trivial matters particularly in the typical patient with hepatitis C who has few if any symptoms and is largely fully functional. Anemia caused by ribavirin can induce cardiovascular and cerebrovascular incidents in susceptible patients. Thus, even with intensive monitoring this high-dose ribavirin regimen can be life-threatening..."

http://www.hepcnet.net/boards/medsforum/index.cgi?noframes;read=1412
Avatar universal
Last paragraph, two posts back, should read in part:

On the other hand HPLC (high performance liquid chromatography) testing for serum riba levels can still nevertheless be useful within SOC to make sure "optimum" riba levels are being maintained.
233616 tn?1312787196
on the one hand, the overdosing doesn't make much sense based on those stats does it,

I'm confused as to how she got to a 90% cure with such a drop out.dose reduction  rate.
Not knowing how the numbers are skewed, I can only assume that number is based on only those who finished tx. No other way to get there. You can't take that drop out rate and dose reduction group, and still reach 90% any other way except to exclude them from the final numbers.

Which makes the whole doubling up thing pretty scary in my mind. Many won't continue, many will be transfused....
Not that a procrit or a transfusion doesn't appeal over 4th stage liver disease....
but then you have the Alagirl's of our world proving one thing continually can lead to another, and another...

On the other hand Teleprevir is causing worse sides in some ways isn't it?
I mean....
How do we know the teleprevir isn't just a stronger Ribaesque molecule that creates all the same issues, and then some......while it achieves a faster cure maybe....OK....but faster at the patient's expense, and the only real winner may then be the insurances in this case. Getting there 6 months quicker and saving big bucks.

I think maybe if HR HR HR HR

HR could or would explain how these molecules, Ribavirin/teleprevir differ it would help many.

this is all pretty frustrating.

Avatar universal
I think you have to take the study for what it is -- and yes, there were only ten participants (total) and only one drop out. You can find the details you want by ordering up a full-text version if so motivated. I have it on one of my hard disks but not able to supply a link.

As to Telaprevir, again, it is what it is. So far, it appears 60% SVR in 24 weeks, and that's without helper drugs. That's a better rate than SOC in less than half the treatment time which means half the exposure to the drugs, the biggie IMO being less exposure to interferon.

Telaprevir, certainly isn't the end all, just one example of perhaps a better alternative now, to for example very high dose ribavirin, for reasons previously cited.

Did you finally take your week 12 test? Any resuts? Last I remember you sitll had less than a one log drop at week 10. The time for higher dose (riba or otherwise)  intervetion IMO would have been back around week 4, when you still had less than a one-log drop. At this point, especially if you don't have a dramatic drop at week 12, I think you seriously have to listen to your doctors and stop. Rest up. And then fight another day, with whatever appears to be the best approach at that time. And given you were given no heads-up at week 4 with such a weak response -- in fact, weren't you told things were "OK"? -- I think treating with a new set of doctors next time would be a reasonable decision.

-- Jim
Avatar universal
Not sure if you've seen my response to you in this thread which has floated down a bit:
http://www.medhelp.org/posts/show/359691

No need to respond, just wanted you to see it as it relates to this discussion.
---------------------------------------
Any movement on getting your son another viral load test? I don't know what they use in-house, but those two tests I mentioned are pretty good, and maybe you can just have his PCP order them up, if the liver center gives you a hard time. No rush, as I believe he tested UND recently? But follow-up seems in order, since a level of uncertainty seems to exist.

233616 tn?1312787196
thanks for the bump, didn't see your response. Yes, I got the OK to go ahead for 6 months, but am still angry they gave me the no heads up at 4 weeks, only at 8...by which time it was not even possible to reason with them....sheesh

the excuses were lame...we didn't tell you so you wouldn't lose hope....we assume the insurance won't pay....we forgot you said you could pay....etc.  why say "you are fine" say what you mean people!!

I figure at this point I've got nothing to loose by going a couple more weeks just to see if now that the bad infection is about gone my body will begin to fight the HCV virus instead again...

If I continue then to hover, or make no downward progress, then OK, rest and regroup it is.
However, I think it was telling them what Shwartz said, about the  6 month UND's that went out 72 weeks having a 20% better shot that may have at least got me a reprieve if not heavier dosing.

At this point, almost side effect free, what's one more month if things might heat back up.
Otherwise I'll be in line for the PI, and you are right, weighing in the kidney failures, etc with all the other stuff I already have....the study is just too small for me to run off to sweden for.

though shipping my blood before the riba ends will still be an option.
and, I can wean myself off INF, and pretreat with Riba next go around...like we should all be doing, so that's my back up plan.

Son came back negative on the TMA, thanks for asking. So we have 2 pos. 2 negs, now.
which means, basically we test again in a couple months and hope for the best and meanwhile live in limboland not knowing what else to do with so many opposing results.

Did you see my thread on Europe cutting off retreaters options?
Avatar universal
Wondeful news about your son. If I remember correctly, both his viral load tests were UND so I would be very optimistic at this point.

As to your extension, I do question the article Schwartz mentioned, that you seem to be basing your decision on, at least partly.

Have you seen it? I couldn't find it in this month's "Gastroenterology". In any event, the only studies I'm aware of for extending tx are for slow responders, i.e. those with <2 logs at week 12 but UND at week 24.

Unless you have a significant decline at week 12, you would be considered a null responder (I believe you currently have <1 log drop at week 10?) which means extended tx doesn't offer any benefits according to the studies I've read. Anyway, always good to get hold of, and read the full-text of any study you're making a treatment descision on.

I did see your thread, but the link took me to a study for treatment naive HCV/HIV co-infected patients. Maybe you're referring to a different article?

Be well,

-- Jim


Avatar universal
Third paragraph should have read in part:

"In any event, the only studies I'm aware of for extending tx are for slow responders, i.e. those with >2 logs at week 12 but UND at week 24.  That means you need at least a two-log drop by week 12 to continue on.
Avatar universal
Yikes. Brain not functioning at this hour. I'll try that sentence one more time:

"In any event, the only studies I'm aware of for extending tx are for slow responders, i.e. those with >2 log drop at week 12 (but still detectible) and then becoming UND at week 24.  In other words, that  means you need at least a two-log drop by week 12 to continue on.
233616 tn?1312787196
OK, I get that you don't think it will happen, but now I have to add to the infection quotient the fact that I eat a ton of fiber, albeit with fat added for my riba meals, no one told me not to,
And I had been adding simethicone because again until todays thread, I had no idea this would interfere and with inflammed liver and spleen, any normal gas was causing real discomfort.

So now I have not one, not two, but 4 possible reasons my Riba absorption was compromised and/or my viral resistance got lower.

If you had all those variables Jim, are you still saying you would not give yourself a couple more weeks to see if things change??

I have a call into Shwartz for the article. Hoping to hear back soon!!
Avatar universal
MB:   OK, I get that you don't think it will happen,
----------------------------------------------------------------------
Let me tighten that up a little.

First, as I mentioned before, in spite of the fact that you had less than a one-log drop by week 10, I thought it reasonable to do a few more weeks and do a week 12 PCR. Did you do that yet?

Now, if you're UND at week 12, or have at least a two log drop, then I also think it reasonable to continue on to week 24, with perhaps some medication tweaks to get you UND as soon as possible. In fact, I believe I suggested you do this at week 4, and the last time you posted at week 10.

What I am leery -- not sure if that's the best word -- but what I am lerry about is how far you should continue -- if at all -- past week 12, if you do not have a two log drop, because that would label you a non-responder, not a partial responder. And if in fact, you still have a one-log (or less) drop at week 12, well, that's really no response at all.

Now, I understand your argument that maybe some factors played into your non-response such as your bacterial infections or now the fiber thing. Personally, I wouldn't bet the house on either, but I'm not a doctor and I'm not a seer, and it's your liver, not my liver.

What I do believe however, is if you do indeed intend to enter very uncharted waters -- assuming less than a two-log drop at week 12 -- then you want to carefully examine your reasoning and you want to carefully monitor your viral load moving forward to see if any treatment adjustments are actually working.

Getting hold of that article would be part of "examining your reasoning" because I don't think it says what you think it says. And WEEKLY viral load test from here on out would be very reasonable IMO in terms of monitoring your viral load progress per any changes in treatment protocol.

Asssuming you keep going, at some point you will have to make a decision as to whether or not to continue based on these viral load tests.

All the best,

-- Jim
Avatar universal
MB, I can feel your pain. Been there, done that. I did so much interferon/riba, so many times because I didn't know (they didn't know), that null responders wouldn't respond no matter what you do. All it got me was some pretty bad bouts of autoimmune arthritis and a neutrophil count of 9. You don't want to go there honey. Please believe me on that. That will kill you qicker than the hep will.

The bottom line here, is I totally agree with what Shiffman has said, as well as Jim. Some of us will need better drugs to couple with those PI's.

Antibiotics should not interfere with SOC either. In fact both times I ended up with infections and had to take Cipro or one of the other antibiotics, I had a subsequent big, for me, reduction in VL. In fact I know someone who got their only undetected on Leva quin. Very odd.
Avatar universal
Well put from someone that has been there. If you have time and inclination, you might want to check out this thread. I believe St George would be going on his 4th try. Maybe he should speak to someone like Shiffman.
http://www.medhelp.org/posts/show/381390

-- Jim
233616 tn?1312787196
Jim, at 4 weeks I started a thread called "1 log drop at 4 wks"....woo woo I'll take it!!

and as I recall no one in here said one word to me, like that's not enough, or you need to talk to the doc or anything,....if someone had told me to get on that, believe me I would have...

all that doc Kent Benner said was...you are doing fine..
and come back in a month.  So my assumtion, based on him, and no reaction in here was, well, "I guess I'm just a slow responder".....maybe I just posted on a day everyone was resting..?  : 0

I remember thinking it was weird no one congratulated me in here....maybe they just didn't want to be the bearer of bad news...who knows...water under the bridge.

the ONLY reason I found out that I wasn't doing good is because I happened to get that infection and had to go in a little early....and you know what has ensued since. The VL had gone back up some, etc etc.

obviously the clinic RN excused everyone from alerting me at their end...and were not only reluctant but insistant that no changes would help!!.

However, as you pointed out I still need to see the article...as Jim pointed out, having someone quote it to me, who HIMself admitted he hadn't really read only skimmed it (due to his time constraints).....doesn't really help me in the decision process either.

If nothing changes in the PCR that I'll draw on the 26th, then It is my intention to just wean
myself off the INF
perhaps taking half a shot each week for 2 weeks...or what would you recommend??
and quit the Riba cold turkey is OK as per reading in here, right?

live to fight another day, believe me not a glutton for punishment here.

My only other choice would be to defy the docs and up my own dosing just because I could now with a 3 month supply...
and suffer the benefits or consequences if and or when they do find out....which without blood work would be stupider than hell...and so they would find out...which would basically disqualify me for any further treatments, being non-compliant with doc instructions.

My other option is to find someone to draw, freeze and mail my serum to Sweden...
just to discover how low my absorption may have been all this time.
Since I had many more Riba symptoms the first month, I wonder if when the symptoms all went away is when I stopped absorbing it well, for whatever reason.
Quest will not do this draw and mail my blood, already checked.

So does anybody have suggestions for how to wean off the INF dosage wise...
because my spleen is already inflammed and enlarged, I want to cause the least backlash possible.

I also think, because I had no pituitary function for years is why I gained a lot of weight.
(in rat experiments rats with no HGH grow to 3 times the size of normal rats on the exact same calorie count and excersise level).
This excess weight may be part of why they don't consider my chances good.
However, since going on the HGH i can now lose weight on 1200 calories a day, even though before I never could. So now I've dropped 40 lbs, and will get the other 40 off in another year I'm sure.
So, this should at least then give me a shot at retreating, which being too protective at this point never will.
this might also give me time to at least consider at stint in another city if I cannot find a flexible doc or good trial here.

It was a little impossible when at nine wks in tx folks said, you should have done something at 4 weeks.......and I'm dealing with "authorities" who basically have done it long enough to have their minds made up.....they've crunched the numbers....and there aren't enough exceptions to make adjustments is not only the felling I got, but the very core of their belief system.

Frankly in a field that despite infentesimal research funding is learning by leaps and bounds, it seems odd to have seen such resistance to anything but SOC.

However, assuming I might go on to become a liver transplant candidate at some point,
I have to assume that if I do not adhere to the Portland docs dosing restrictions and requirements that in and of itself may classify me a rouge and not a good candidate, even IF I was motivated by the latest research. Am I correct, if I mess with my doses without the Pope's blessing I'm skirewd right?

Mary

Avatar universal
I don't remember that thread now, so perhaps a more accurate statement would have been that I told you that your medical team should have said something to you at week 4. You might re-read my response to you a month ago, here:
http://www.medhelp.org/posts/show/359691

Also, to correct what you're saying, you did not have a one-log drop at week 4, at least according to your post in the thread just mentioned.

In that thread, you  state your pre-treatment  viral load as 1.4 million and your week 4 viral load as 300,000. That is less than a one log drop. A one-log drop would have been 140,000 IU/ml.

Don't really have too much to add going forward from my last post, other than again,  I'm pretty sure you will find out that your doctor really didn't understand what the article really said, and frankly, he should do more than "skim" an article where an important
tx decision may be concerned.

You have a real fighting spirit and I really do feel for you. I pray that your week 12 test will surprise us all.

All the best,

-- Jim
Avatar universal
MB, it is the rare physician that has actually caught on to the 4 week RVR at this point. It takes about 18 months for the info to get to all the docs. In fact, some of us know way before our doctors what is going on in the field.

The RVR (Undetected at 4 weeks) is an excellent parameter for SVR. But, there are many people who only have a 2 log drop by 12 weeks who still go on to SVR. I'm not sure what you mean about your statement that no one said anything to you that you didn't have enough of a drop at 4 weeks. There is nothing to say at that point if there is no drop. It's way too early. It's only meaningful if you get the RVR.

I'd also like to respectfully ask if you are upset with me for any reason? It seems as though you aren't "talking" to me. Or am I imagining that?
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