Aa
Double dose interferon
How many weeks do people usually DD if that's the path that they are to take?
I have nothing more to add myself...I simply don't know enough to make any useful contribution here. I am very interested in the discussion however and I think I'd best simply sit back, read and learn.
I have nothing more to add other than to say that Jim and I are in total agreement on this issue. Mike
Here is a possible tatto for MO!
skinu.com/site/search/style_skinu%7C20578/search.htm
skinu.com/site/search/style_skinu%7C20578/search.htm
CS: its no accident that those who complain about the drugs toxic effects have mostly done extended Tx.
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Assuming this is true, and I have a hunch it may be, it doesn't change at least what some of us have been saying. It's not solely a matter of toxicity (double-dosing for a shorter period of time verus single-dosing for extended) but of efficacy. From my experience, sure, I'd rather double dose for 4-6 weeks and treat for 24 as opposed to single-dosing for 48 weeks. BUT only if something told me that the double-dosing would give me a better shot of SVR. If not, then it's really academic.
-- Jim
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Assuming this is true, and I have a hunch it may be, it doesn't change at least what some of us have been saying. It's not solely a matter of toxicity (double-dosing for a shorter period of time verus single-dosing for extended) but of efficacy. From my experience, sure, I'd rather double dose for 4-6 weeks and treat for 24 as opposed to single-dosing for 48 weeks. BUT only if something told me that the double-dosing would give me a better shot of SVR. If not, then it's really academic.
-- Jim
Hey! if myown post a picture with crossed amo belts... I'm outta here, lol!
I did not extend that far but see my journal and hopefully myown will too.
jasper
I did not extend that far but see my journal and hopefully myown will too.
jasper
I asked HR about DD'ing infergon, he said he didn't recommend it. He said they did a study doing just that and hardly anyone made it through! It was so harsh. I'm not so sure about the extension of these toxic drugs as being the thing people on tx complain the most. I am sure it isn't great, but it sure seems some of us really experience more sx than others. Also, it seems that those who don't end up with anemia or lower HGB, end up not clearing. Of course this is anecdotal, but I remember Fishdoc's Dr. had her up her Riba as she wasn't getting enough and didn't get UND, until she upped it over what was weight based. Possibly some non responders aren't getting enough IFN?
Trish
Then why not triple or quadruple dose then? Why not load up on the riba and take it 4x a day instead of 2x? Double or triple dose the riba too...and if you can take it as you go, just keep increasing the amounts. Shock and awe, right?
Yeh it is shock and awe, and to some extent its been done. Tx is a compromise, you have to be able to tolerate it, having a life during Tx comes into to.
High Dosing Riba is risky you will end up in Hospital needing a tranfusion, but in at least one study (Lyndal - spelling) taking up to 3600 mg it does work 90% G1 SVR rate. But god it was harsh. All patients needed EPO and several needed transfusions.
Jim and others are right these drugs are toxic but to my way of thinking its no accident that those who complain about the drugs toxic effects have mostly done extended Tx.
CS
Then why not triple or quadruple dose then? Why not load up on the riba and take it 4x a day instead of 2x? Double or triple dose the riba too...and if you can take it as you go, just keep increasing the amounts. Shock and awe, right?
Yeh it is shock and awe, and to some extent its been done. Tx is a compromise, you have to be able to tolerate it, having a life during Tx comes into to.
High Dosing Riba is risky you will end up in Hospital needing a tranfusion, but in at least one study (Lyndal - spelling) taking up to 3600 mg it does work 90% G1 SVR rate. But god it was harsh. All patients needed EPO and several needed transfusions.
Jim and others are right these drugs are toxic but to my way of thinking its no accident that those who complain about the drugs toxic effects have mostly done extended Tx.
CS
Trish, I believe MO had a very sensitive test throughout last tx. As we also know about 2's and 3's is that sometimes that 24 weeks just isn't enough. I agree that hit those critters at first, but will that be enough? I know both Flguy and Kalio did things differently. Flguy did the Riba a week before tx. Kalio did 1 1/2 doses of INF about midway through tx along with oxymatrine, another thing to perhaps add to SOC. I believe Flguy DD'ed the first few weeks. Both are SVR now. Of course we don't want to kill the patient! As CS pointed out, INF can be taken in much higher doses and is for cancers. So why not us? Perhaps even those non responders weren't getting enough INF. YOu know that everyone's body has different tolerences. I am sure one could tell pretty quickly how much is too much. Kalio was more tired doing the extra INF, but she was okay.
I agree with Cocksparrow about shock and awe, but not to the point where one has to stop tx because one took too much. By the time we finish tx the first time, we do sort of have an idea how much we can handle. After that first shot, I didn't feel many sx from them besides the fatigue. So I would do DD in a second tx, at least for the 4 weeks and possibly 1 1/2 for awhile, besides the tapering at the end. Yes, I think a Dr. needs to be on board and keeping a close eye!
Linda
I agree with Cocksparrow about shock and awe, but not to the point where one has to stop tx because one took too much. By the time we finish tx the first time, we do sort of have an idea how much we can handle. After that first shot, I didn't feel many sx from them besides the fatigue. So I would do DD in a second tx, at least for the 4 weeks and possibly 1 1/2 for awhile, besides the tapering at the end. Yes, I think a Dr. needs to be on board and keeping a close eye!
Linda
You're an exceptionally fast learner, but still relatively new to this, and "terms" more than matter :)
Not sure where what study you picked up the 80% figure from, but no doubt it was a geno 1 study. MO is a genotype 2, meaning she has aournd an 80% chance of SVR from the start, not just if she achieves RVR, which a majority of geno 2's do.
As to the rest, MO used a very sensitive test, down to 5 IU/ml if I remember correctly.
As to what causes relapse, anyone here who can say with certainty is a lot smarter than me or any doctor that I've read.
But yes, as you suggest, all the "critters" don't go away when we're UND or we could stop treating as soon as we become UND. As to what's really going on, theories abound, including the sensitivity of the tests themselves and the dance of the immune system.
Remember, interferon -- unlike the PI's -- does not directly kill the virus. What it does it stimulate the immune system to kill the virus. For this reason, some liken it to a sludgehammer trying to hit a tiny nail, because no doubt the sludghammer will hit more than the nail, but I digress :)
Because of this indirect action, the concept of double-dosing in previous RVRs is questionable because the immune system has already demontrated it reacts well to the interferon. What is more reasonable is that the interferon immune system training may not have been long enough. Therefore the concept of treating non-responders hard early (double-dosing as one example) to foster RVR, but treating relapsers (those who responded like MO) longer because they so to speak needed more time in summer school to graduate.
Did you go over to the Clincal Care Options site and listen to some of the teaching modules. Not that re-inventing the wheel with HCV treatment isn't reasonable given so much muddle in this field -- but always good to see how the wheel was invented in the first place by today's top wheel builders.
You ask "Is there really any harm in choosing a period of double dosing in the beginning as long as you are monitoring effectively and stringently all the way through?"
First, and this should not be taken lightly, these drugs are toxic and have consequences, so simply adding a drug (or increasing dosage) should never be taken lightly.
But that aside -- and it's a big aside -- my problem from the get go hasn't been so much that MO wants to double-dose, but that her medical team seems to be hanging their hat on this approach. In other words, a *better* approach might be to extend, whether one double-doses or not.
In a way I'm saying that the continued focus of this thread on double-dosing for a previous geno 2 rapid responder may be missing the point entirely, which is what is the best way for MO to approach her second treatment.
As stated, I'm skeptical that this is the right approach, and if in MO shoes I would "test" this approach with one or more hepatologists that I've mentioned and that MO has access to. They may agree with her current team, they may not, but no doubt they will add information to the decision-making process. Of course this suggestion reflects as much who I am as what I'm suggesting, because this is how I approached my treatment -- testing one approach against another using study data and what the collective wisdom of several top hepatologists, who did not always agree.
-- Jim
Not sure where what study you picked up the 80% figure from, but no doubt it was a geno 1 study. MO is a genotype 2, meaning she has aournd an 80% chance of SVR from the start, not just if she achieves RVR, which a majority of geno 2's do.
As to the rest, MO used a very sensitive test, down to 5 IU/ml if I remember correctly.
As to what causes relapse, anyone here who can say with certainty is a lot smarter than me or any doctor that I've read.
But yes, as you suggest, all the "critters" don't go away when we're UND or we could stop treating as soon as we become UND. As to what's really going on, theories abound, including the sensitivity of the tests themselves and the dance of the immune system.
Remember, interferon -- unlike the PI's -- does not directly kill the virus. What it does it stimulate the immune system to kill the virus. For this reason, some liken it to a sludgehammer trying to hit a tiny nail, because no doubt the sludghammer will hit more than the nail, but I digress :)
Because of this indirect action, the concept of double-dosing in previous RVRs is questionable because the immune system has already demontrated it reacts well to the interferon. What is more reasonable is that the interferon immune system training may not have been long enough. Therefore the concept of treating non-responders hard early (double-dosing as one example) to foster RVR, but treating relapsers (those who responded like MO) longer because they so to speak needed more time in summer school to graduate.
Did you go over to the Clincal Care Options site and listen to some of the teaching modules. Not that re-inventing the wheel with HCV treatment isn't reasonable given so much muddle in this field -- but always good to see how the wheel was invented in the first place by today's top wheel builders.
You ask "Is there really any harm in choosing a period of double dosing in the beginning as long as you are monitoring effectively and stringently all the way through?"
First, and this should not be taken lightly, these drugs are toxic and have consequences, so simply adding a drug (or increasing dosage) should never be taken lightly.
But that aside -- and it's a big aside -- my problem from the get go hasn't been so much that MO wants to double-dose, but that her medical team seems to be hanging their hat on this approach. In other words, a *better* approach might be to extend, whether one double-doses or not.
In a way I'm saying that the continued focus of this thread on double-dosing for a previous geno 2 rapid responder may be missing the point entirely, which is what is the best way for MO to approach her second treatment.
As stated, I'm skeptical that this is the right approach, and if in MO shoes I would "test" this approach with one or more hepatologists that I've mentioned and that MO has access to. They may agree with her current team, they may not, but no doubt they will add information to the decision-making process. Of course this suggestion reflects as much who I am as what I'm suggesting, because this is how I approached my treatment -- testing one approach against another using study data and what the collective wisdom of several top hepatologists, who did not always agree.
-- Jim
Now that I've got my terms straightened out...mostly...
If I recall right, the odds of SVR for a person reaching RVR increase not to 100% but pd close to somewhere around 80 - 90%. So there is still that leftover + or minus 10% that will not SVR after an RVR at 4 weeks. And MO falls into that group.
Makes me wonder, MO, what sensitivity of test was used to monitor you all along and how often? I'm just curious about that.
Aside from that......if a person relapses, then all the critters didn't go away. It's not a re-infection, correct?
And if all the critters didn't go away ... when would you most like to kill off as many as are detectible? I think I would prefer to dose harder and dose earlier to once again hit RVR and extend that for awhile...beyond UND. And if one is not achieving RVR at double dosing...which would take only 4 weeks to find out.. then I would potentially cut back on the extra dosages at SOME point and move to extending treatment with regular SOC. Is there really any harm in choosing a period of double dosing in the beginning as long as you are monitoring effectively and stringently all the way through? I'm asking rather than suggesting.
Trish
If I recall right, the odds of SVR for a person reaching RVR increase not to 100% but pd close to somewhere around 80 - 90%. So there is still that leftover + or minus 10% that will not SVR after an RVR at 4 weeks. And MO falls into that group.
Makes me wonder, MO, what sensitivity of test was used to monitor you all along and how often? I'm just curious about that.
Aside from that......if a person relapses, then all the critters didn't go away. It's not a re-infection, correct?
And if all the critters didn't go away ... when would you most like to kill off as many as are detectible? I think I would prefer to dose harder and dose earlier to once again hit RVR and extend that for awhile...beyond UND. And if one is not achieving RVR at double dosing...which would take only 4 weeks to find out.. then I would potentially cut back on the extra dosages at SOME point and move to extending treatment with regular SOC. Is there really any harm in choosing a period of double dosing in the beginning as long as you are monitoring effectively and stringently all the way through? I'm asking rather than suggesting.
Trish
Cocksparrow: “Trish77 - I'm not suggesting ANYONE, including MO take a "scattergun" approach and hit it with whatever is in the arsenal”
I am. Shock and Awe is the way to go. Scare the little buggers to death.
Double Dosing for 4 weeks isn’t that high a dose anyway.
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Then why not triple or quadruple dose then? Why not load up on the riba and take it 4x a day instead of 2x? Double or triple dose the riba too...and if you can take it as you go, just keep increasing the amounts. Shock and awe, right? I'm being ridiculous but the point I was making in the first place is that while I agree with "hit it hard out of the gate" there has to be some intelligence to the approach and some thought put into it. You want sustainability, SVR, and you also don't want to kill the patient as Jim keeps saying. So I prefer a calculated risk approach. Believe me, I'd rather take some risks, push the limits and kill the buggers. You talking about double dosing for 4 weeks is actually conservative to me.
I'm thinking that both Jim and Mike don't see the need for double-dosing in this particular instance for MO. I don't think they'd necessarily be against it across the board. I'm sure they'll correct me if I'm wrong on that interpretation. :)
I am. Shock and Awe is the way to go. Scare the little buggers to death.
Double Dosing for 4 weeks isn’t that high a dose anyway.
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Then why not triple or quadruple dose then? Why not load up on the riba and take it 4x a day instead of 2x? Double or triple dose the riba too...and if you can take it as you go, just keep increasing the amounts. Shock and awe, right? I'm being ridiculous but the point I was making in the first place is that while I agree with "hit it hard out of the gate" there has to be some intelligence to the approach and some thought put into it. You want sustainability, SVR, and you also don't want to kill the patient as Jim keeps saying. So I prefer a calculated risk approach. Believe me, I'd rather take some risks, push the limits and kill the buggers. You talking about double dosing for 4 weeks is actually conservative to me.
I'm thinking that both Jim and Mike don't see the need for double-dosing in this particular instance for MO. I don't think they'd necessarily be against it across the board. I'm sure they'll correct me if I'm wrong on that interpretation. :)
“Trish77 - I'm not suggesting ANYONE, including MO take a "scattergun" approach and hit it with whatever is in the arsenal”
I am. Shock and Awe is the way to go. Scare the little buggers to death.
Double Dosing for 4 weeks isn’t that high a dose anyway.
The following comes from the Pegasys Insert;
Overdoses with PEGASYS involving at least two injections on consecutive days (instead of weekly) up to daily injections for one week (i.e. 1260 μg/week have been reported
None of these patients experienced unusual, serious or treatment-limiting events. Weekly doses of up to 540 and 630 μg have been administered in renal cell carcinoma and myelogenous leukaemia clinical trials, respectively.
Dose-limiting toxicities were fatigue, elevated liver enzymes, neutropenia and thrombocytopenia consistent with interferon therapy.
Now if you didn’t have the above dose limiting toxicities, why would you have them the second time round. We arent talking about daily shots here. Only 360ug and then only for a relatively short period.
Anyone up for daily Pegasys, god that would have to hurt.
To my way of thinking it’s the length of time on the drugs that causes most of the serious AEs.
From the Pegasys Insert;
In comparison to 48 weeks of treatment with PEGASYS and COPEGUS 1000/1200 mg, reducing treatment exposure to 24 weeks and daily dose of COPEGUS to 800 mg resulted in a reduction in the serious adverse reactions (11% vs. 3%), premature withdrawals for safety reasons (13% vs. 5%) and the need for COPEGUS dose modification (39% vs. 19%).
For me doing 48 weeks or longer is of more concern that Double Dosing for short periods.
CS
I am. Shock and Awe is the way to go. Scare the little buggers to death.
Double Dosing for 4 weeks isn’t that high a dose anyway.
The following comes from the Pegasys Insert;
Overdoses with PEGASYS involving at least two injections on consecutive days (instead of weekly) up to daily injections for one week (i.e. 1260 μg/week have been reported
None of these patients experienced unusual, serious or treatment-limiting events. Weekly doses of up to 540 and 630 μg have been administered in renal cell carcinoma and myelogenous leukaemia clinical trials, respectively.
Dose-limiting toxicities were fatigue, elevated liver enzymes, neutropenia and thrombocytopenia consistent with interferon therapy.
Now if you didn’t have the above dose limiting toxicities, why would you have them the second time round. We arent talking about daily shots here. Only 360ug and then only for a relatively short period.
Anyone up for daily Pegasys, god that would have to hurt.
To my way of thinking it’s the length of time on the drugs that causes most of the serious AEs.
From the Pegasys Insert;
In comparison to 48 weeks of treatment with PEGASYS and COPEGUS 1000/1200 mg, reducing treatment exposure to 24 weeks and daily dose of COPEGUS to 800 mg resulted in a reduction in the serious adverse reactions (11% vs. 3%), premature withdrawals for safety reasons (13% vs. 5%) and the need for COPEGUS dose modification (39% vs. 19%).
For me doing 48 weeks or longer is of more concern that Double Dosing for short periods.
CS
Mike: And by characterizing her outcome as "non-responded against the high odds of SVR for RVR's" is rather loose language in the HCV vernacular. Using "non responder" to describe a "relapser" sort of begs the question. If she truly was a non responder then double dosing Peg would be a reasonable approach - but she wasn't - she relapsed.
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On that then, I am speaking entirely out of turn and the article is improper. I'm at least relieved that I refrained from commentary on the misapplied article. I thought MO was a non-responder in my head...and I confess, sometimes I get mixed up between the two terms - non-responder and relapser - although, a little bit of thought would make it clear what each term refers to. Obviously I need to go back to the classroom.
Jim: I've often talked before about how many of us go into "warrior mode" around the time we start treating and during treatment. And while warriror mode can often make the difference, it can also allow some of us to over-treat. If SVR is the only goal then it doesn't matter, but a careful reading of the archives here shows that these drugs are not without risks.
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Well....I'm not suggesting ANYONE, including MO take a "scattergun" approach and hit it with whatever is in the arsenal. I did suggest that she plot out what dosage she would start out at, what the plan would be if she had to reduce that dosage and to make sure that careful monitoring takes place as she goes along. The suggestion to have a plan in place in the event she needs to reduce dosage would, I hope, be a carefully thought out approach that has viability...rather than an on-the-fly approach because one just loaded it on in what you call "warrior" mode. I know I've talked of slathering on blue warpaint and all that in the past ... but I DID leave that out of my suggestions here. :) Anyway...your points are well taken and I happen to agree. No dispute with what you've said at all. I do think none of this is anything to be taken lightly. If I inferred otherwise, then I worded my comments poorly.
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On that then, I am speaking entirely out of turn and the article is improper. I'm at least relieved that I refrained from commentary on the misapplied article. I thought MO was a non-responder in my head...and I confess, sometimes I get mixed up between the two terms - non-responder and relapser - although, a little bit of thought would make it clear what each term refers to. Obviously I need to go back to the classroom.
Jim: I've often talked before about how many of us go into "warrior mode" around the time we start treating and during treatment. And while warriror mode can often make the difference, it can also allow some of us to over-treat. If SVR is the only goal then it doesn't matter, but a careful reading of the archives here shows that these drugs are not without risks.
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Well....I'm not suggesting ANYONE, including MO take a "scattergun" approach and hit it with whatever is in the arsenal. I did suggest that she plot out what dosage she would start out at, what the plan would be if she had to reduce that dosage and to make sure that careful monitoring takes place as she goes along. The suggestion to have a plan in place in the event she needs to reduce dosage would, I hope, be a carefully thought out approach that has viability...rather than an on-the-fly approach because one just loaded it on in what you call "warrior" mode. I know I've talked of slathering on blue warpaint and all that in the past ... but I DID leave that out of my suggestions here. :) Anyway...your points are well taken and I happen to agree. No dispute with what you've said at all. I do think none of this is anything to be taken lightly. If I inferred otherwise, then I worded my comments poorly.
Yes, I agree with Mike's take, as well. To a point! Let's say that RVR is 4 weeks...that is the gold standard these days, right? So, if perhaps we do Flguy's riba pre tx for a week, DD until we get to UND, then go back, perhaps slowly (half doses) for a few weeks to not shock our systems. That sounds prudent to me. I am not talking about non-responders. That could be a whole new ball of wax, or not. Relapsers, or slow responders (like me) possibly could become RVR if doing DD for a few weeks, as described above. Non-responders could do the same and if there is still NO response....stop! I don't want to kill the patient (me) just give a better chance of response. Now, I am not sure about how slow responders once UND, hopefully at week 4 will respond once that DD is no longer given. Perhaps a 1 1/2 dose for longer. I know Kalio did this. We are in uncharted waters, as we know, but what is wrong with the patients who understand this stuff a bit to mix it up a bit? As a slow responder and someone who had lots of problems, if I were to re tx, I would certainly do at least a bit of DD'ing at first, then slow it down. Do those weekly PCR's at first and not let the Dr. or ins. co tell me only every 12 week PCR's. This is too important for others to make these sometimes stupid decsions. I was unaware last time, I listened to some idiot, instead of learning enough to begin with. I won't make that mistake again. I also won't make the mistake of not taking some risks on tx to get to SVR, that many Dr's won't do. I certainly won't take enough chances to kill me, I will have CBC's every week or less, and PCR's every week. I hope when and if I do re tx, I have a Dr that will go somewhat along the lines of what I believe is the best course of tx, as MO does.
Linda
Linda
Let me just re-phrase part of that last paragraph to say that "If SVR is the only goal then it *often* doesn't matter". I added the "often" because in addition to the risks of xtra drugs to our system, there is also the risk that higher doses might put some of us in a position where we actually have to dose reduce or even go off the drugs and not complete the course.
Pretty much agree with Mike's wrap up. So, putting aside the added risks of more interferon, if MO does decide to proceed, what might be useful would be to test vl weekly as before, to see if the viral decline with DD gives her an earlier RVR. Frankly, and this is anecdotal like so much of this stuff, I think she'd be better off pre-dosing riba like FLGuy, not only to possibly achieve an earlier RVR (FLGuy was UND at week 2) but because riba is often talked about in terms of it's role in preventing relapse. The riba also might be maximized to a certain extend as well, but again more drugs, more risk.
What I see the downside to her doctor's approach is if he thinks that double-dosing will replace extending to 48 weeks, which I'm not clear if he thinks it will. If so, I'd definitely speak to someone else, but I've said that before and MO doesn't want to.
Trish, your point about changing something when tx doesn't work the first time is spot on and covered quite well at the Clinical Care Options web site. You might start with "Doc Eye for the Hep Guy" with Drs Dieterich and Jensen. I'ts an excellent site to see how many top clinicians are extrapolating current trial data in to actual treatment programs. http://www.clinicaloptions.com/ But as Mike suggests, you want to change the right thing to give it your best shot. No doubt a shot-gun approach has the greatest probability of SVR but it also has the greatest probability of doing harm, perhaps long-term harm to the patient.
I've often talked before about how many of us go into "warrior mode" around the time we start treating and during treatment. And while warriror mode can often make the difference, it can also allow some of us to over-treat. If SVR is the only goal then it doesn't matter, but a careful reading of the archives here shows that these drugs are not without risks.
-- Jim
What I see the downside to her doctor's approach is if he thinks that double-dosing will replace extending to 48 weeks, which I'm not clear if he thinks it will. If so, I'd definitely speak to someone else, but I've said that before and MO doesn't want to.
Trish, your point about changing something when tx doesn't work the first time is spot on and covered quite well at the Clinical Care Options web site. You might start with "Doc Eye for the Hep Guy" with Drs Dieterich and Jensen. I'ts an excellent site to see how many top clinicians are extrapolating current trial data in to actual treatment programs. http://www.clinicaloptions.com/ But as Mike suggests, you want to change the right thing to give it your best shot. No doubt a shot-gun approach has the greatest probability of SVR but it also has the greatest probability of doing harm, perhaps long-term harm to the patient.
I've often talked before about how many of us go into "warrior mode" around the time we start treating and during treatment. And while warriror mode can often make the difference, it can also allow some of us to over-treat. If SVR is the only goal then it doesn't matter, but a careful reading of the archives here shows that these drugs are not without risks.
-- Jim
Non response is not the same as relapse. If I am understanding the African American article correctly, the study cohort was comprised of non responders to interferon and ribavirin - I don't believe that they were non responsive to pegylated interferon which, as we know, is a more effective treatment drug than regular interferon. Regardless, they were not relapsers - they were non responders.
I am not adverse to any treatment approach that has some basis to believe will be effective. I just do not see a reason to believe that double dosing Peg will improve her outcome. She did become undetectable at 4 weeks so it seems to me as though the Peg did the job. Had she had a slower response I would see some basis to believe that an increase of Peg might be beneficial but, that is not the case here. We can speculate that becoming undetectable earlier (say at week 2 or 3) might result in a better outcome - it does seem intuitive - but we really don't have any substantial data on which to base that conclusion. And I am not certain the double dosing has been shown to accelerate HCV clearance in previous RVR relapsers - I haven't seen anything that suggests that. The vast amount of data available suggests that 4 weeks is the critical time at which to determine the likelihood of a positive outcome and, since she satisfied that criteria (UND at week 4) the Peg/ribavirin worked as it should work. In type 1s it has been shown that extending treatment and maximizing ribavirin exposure gives relapsers the best chance of achieving SVR. Although 2s seem in some ways to be distinct from 1s it appears to me as though, in this scenario, extending treatment seems like the most reasonable approach. Having said that, aside from the side effects that might accompany double dosing Peg, I can see no harm, insofar as treatment response is concerned, that could result from double dosing. But side effects can be a serious issue. I just don't see the upside in that approach but, if it is tolerable without any serious side effects, I don't think it would hurt her chances of SVR.
You said that: "If it was me...and I had RVR'd and then non-responded against the high odds of SVR for RV R's...I'd be looking at what I think was the culprit last time and do it differently this time myself."
I agree but I think that the amount of time spent undetectable is more likely the culprit with relapse and RVR and that is what I would do differently - extend treatment. I would do 48 weeks and standard dose of Peg-interferon and the optimal dose of ribavirin.
And by characterizing her outcome as "non-responded against the high odds of SVR for RVR's" is rather loose language in the HCV vernacular. Using "non responder" to describe a "relapser" sort of begs the question. If she truly was a non responder then double dosing Peg would be a reasonable approach - but she wasn't - she relapsed.
Mike
I am not adverse to any treatment approach that has some basis to believe will be effective. I just do not see a reason to believe that double dosing Peg will improve her outcome. She did become undetectable at 4 weeks so it seems to me as though the Peg did the job. Had she had a slower response I would see some basis to believe that an increase of Peg might be beneficial but, that is not the case here. We can speculate that becoming undetectable earlier (say at week 2 or 3) might result in a better outcome - it does seem intuitive - but we really don't have any substantial data on which to base that conclusion. And I am not certain the double dosing has been shown to accelerate HCV clearance in previous RVR relapsers - I haven't seen anything that suggests that. The vast amount of data available suggests that 4 weeks is the critical time at which to determine the likelihood of a positive outcome and, since she satisfied that criteria (UND at week 4) the Peg/ribavirin worked as it should work. In type 1s it has been shown that extending treatment and maximizing ribavirin exposure gives relapsers the best chance of achieving SVR. Although 2s seem in some ways to be distinct from 1s it appears to me as though, in this scenario, extending treatment seems like the most reasonable approach. Having said that, aside from the side effects that might accompany double dosing Peg, I can see no harm, insofar as treatment response is concerned, that could result from double dosing. But side effects can be a serious issue. I just don't see the upside in that approach but, if it is tolerable without any serious side effects, I don't think it would hurt her chances of SVR.
You said that: "If it was me...and I had RVR'd and then non-responded against the high odds of SVR for RV R's...I'd be looking at what I think was the culprit last time and do it differently this time myself."
I agree but I think that the amount of time spent undetectable is more likely the culprit with relapse and RVR and that is what I would do differently - extend treatment. I would do 48 weeks and standard dose of Peg-interferon and the optimal dose of ribavirin.
And by characterizing her outcome as "non-responded against the high odds of SVR for RVR's" is rather loose language in the HCV vernacular. Using "non responder" to describe a "relapser" sort of begs the question. If she truly was a non responder then double dosing Peg would be a reasonable approach - but she wasn't - she relapsed.
Mike
Here is a study I've been meaning to post to you that I won't even comment on, I'll just leave it to you to determine if it has any value to you. It's a study of the impact of double-dosing of INF on African American non-responders, who, as we all know, are in the harder to treat category.
http://www.natap.org/2005/ddw/ddw_6.htm
Yes, you were RVR at 4 weeks. That should have put you in the 80%ile or higher category for SVR. But you relapsed. That makes you an exception. If it was me in your situation, I would double-dose too if I could take it....and I would start with a higher dose of riba. Others have brought their riba down to a reasonable level but not to a below recommended dosage level. The drug trial I'm in gives the trial drug for 26 weeks and then regular SOC for the remaining 26 weeks. Perhaps your extra dosages are like giving yourself a trial drug.
All of this comes with risk, even regular SOC does. If you know you are going to choose an alternate uncharted route of treatment, then I'd hope you plan to monitor yourself all the more stringently and have a pre-plan in place for what you will do if you hit danger territory.
If it was me...and I had RVR'd and then non-responded against the high odds of SVR for RVR's...I'd be looking at what I think was the culprit last time and do it differently this time myself.
I wish you good luck with your decision.
Trish
http://www.natap.org/2005/ddw/ddw_6.htm
Yes, you were RVR at 4 weeks. That should have put you in the 80%ile or higher category for SVR. But you relapsed. That makes you an exception. If it was me in your situation, I would double-dose too if I could take it....and I would start with a higher dose of riba. Others have brought their riba down to a reasonable level but not to a below recommended dosage level. The drug trial I'm in gives the trial drug for 26 weeks and then regular SOC for the remaining 26 weeks. Perhaps your extra dosages are like giving yourself a trial drug.
All of this comes with risk, even regular SOC does. If you know you are going to choose an alternate uncharted route of treatment, then I'd hope you plan to monitor yourself all the more stringently and have a pre-plan in place for what you will do if you hit danger territory.
If it was me...and I had RVR'd and then non-responded against the high odds of SVR for RVR's...I'd be looking at what I think was the culprit last time and do it differently this time myself.
I wish you good luck with your decision.
Trish
If I could, just weigh in here on this discussion.... I feel that there is no 'set in stone', and/or 'cookie cutter' approach to treating this disease. Everybody needs to have individualized treatment, catered to their own needs, issues, etc. While one person may be a chronic non-responder with damage already present in their liver..... and another might be a naive for TX patient and another might have cirrhosis, and on and on and on. Some people may have thyroid issues, others may not. Some people may have anemia issues, others may not. Some people may have Neutropenia, others may not. I've treated these 9 times and my thyroid has not failed. I'm not on any thyroid replacement. I've not been on antidepressants either. However, my white blood cells have been an issue for me with about every treatment. Even with that, I still treated. Just make sure that you contact your doctor and completely understand his recommendations. Make sure that you stay on top of your labwork and keep your appts. When you're going into uncharted terrritory, it's extra important to stay on top of things and not let serious issues develop. I agree, that you don't want to kill the patient, but you do want to get your SVR. God knows, I understand wanting to get SVR! Otherwise, I wouldn't still be keeping my ears open for something that would be available for me, that would actually work!
Blessings to you,
Susan
Blessings to you,
Susan
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