Aa
VL showing 715 andTMA Pos at Week 24 (after being TMA Neg since wk 4)
Am 60 yr. old, geno 2b, VL was 2,387,610 at beginning of 24-week treatment in July ’07. Did INT 180mcg, 1200 Riba until 10/2, then 1000 Riba daily for rest of tx. Results of tx had been ideal from the start – was UND (HCV RNA <615) and TMA negative at 4 weeks (8/29) and continued same at weeks 8, 12, and 16. Then, at week 20, I tested HCV RNA<615 and TMA positive, retested at week 22 and the HCV RNA is at 715, TMA positive. I did my last injection (of 24) last Friday and am on my last week of riba. I have an appointment with my doctor today to discuss. I am having another fasting blood test this week. Has anyone had a similar experience, and do these recent results mean the tx is not working after all and that I should stop tx and wait for a better treatment down the road? I have one refill of 4 injections of INT left I could use, plus enough riba for another 4 weeks. Would an additional 4 weeks tx with an increased dose of riba (1200-1400 daily) make a difference with the results I’m getting right now? I’m sure my Dr. and I will discuss this today, but I wanted to have an idea of what others have to say. Thanks for your help! Skip
It would have been extremely helpful to you if your doctor had given you a much better sensitivity level on your PCRs. 615 is old and is way too high. Because of that you will never know if you were really and truly UND all along or not. Most of us insist on a much better test. I don't know why a doctor would do this to his patient.
I'd have a retest and see what the number reads - it could be a false positive but it's pretty unlikely. If it truly is a positive then the extra four weeks won't matter and I'm sure your doctor would advise you to stop. After week 24...your chance of success goes down drastically.
If you do choose to retreat - I'd advise getting a doctor who is more up to date. Because he ordered the archaic test you will never know for real if you had gotten to UND or not.
PS My last test was down to <2. And even with that there is no 'guarantee'.
Baseline 568,000 Geno 1A and Geno 1B Stage 3 Grade 2
72 weeks treatment - SVR post tx 11 months.
Good luck, Skip.
I'd have a retest and see what the number reads - it could be a false positive but it's pretty unlikely. If it truly is a positive then the extra four weeks won't matter and I'm sure your doctor would advise you to stop. After week 24...your chance of success goes down drastically.
If you do choose to retreat - I'd advise getting a doctor who is more up to date. Because he ordered the archaic test you will never know for real if you had gotten to UND or not.
PS My last test was down to <2. And even with that there is no 'guarantee'.
Baseline 568,000 Geno 1A and Geno 1B Stage 3 Grade 2
72 weeks treatment - SVR post tx 11 months.
Good luck, Skip.
thanks for your comments. The HCV RNA test is current and shows if you are <615, plus the TMA test gets me down to <50 as I've been told. My doctor is at the forefront of the current research and I'm sure the test is not an archaic one. I'll confirm that today. We are going to talk about retesting. What test is there that gets you down to <2? I knew going into this that there was always a chance of relapse or treatment failure so I've reconciled that in my head. If the treatment is failed then at least I've found out right away rather than having false hope for six months to find I relapsed. Hoping to find out some options today. Thanks again, and Congrats on your SVR!. Skip
This is from Clinical Care Options and can be found at: http://tiny.cc/G8ajI
You must be registered to view but it's free and easy to register. It seems as though there doesn't seem that PCR sensitivity makes much difference once you get down to 50 IU/ml.
"The COBAS Amplicor assay had a HCV RNA lower limit of quantification cutoff of 50 IU/mL whereas the COBAS TaqMan assay lower limit of quantification cutoff of 15 IU/mL and a qualitative cutoff of undetectable HCV RNA (truly negative or yes/no). RVR and complete EVR rates were similar when determined by either lower limit < 50 IU/mL or < 15 IU/mL or by truly undetectable HCV RNA, and this effect was independent of HCV genotype. Higher SVR rates were not observed when the more sensitive PCR assays were used to detect and define RVR. Therefore, no meaningful differences were observed between these 2 assays.
Mitchell L. Shiffman, MD:
There was a strong correlation of EVR designation and baseline HCV RNA measures between assays. Sustained virologic response rates were within 0-6 percentage points when COBAS Amplicor and COBAS TaqMan were compared. I think this study basically tells us that when assessing the response to treatment, virtually no patients have persistent HCV RNA between 15 IU/mL and 50 IU/mL for long periods of time. If patients are going to respond to treatment, by and large HCV RNA will become undetectable regardless of which assay is used, so differences in sensitivity are not significant. I would note, however, that although relapse rates were within 4-5 percentage points of each other, the relapse rates were lower when end-of-treatment response was defined by the more sensitive cutoffs.
Mark S. Sulkowski, MD:
The current goal of therapy is for patients to achieve undetectable HCV RNA levels as quickly as possible, ideally by 4 weeks. The question is: Which assay should clinicians be using to assess HCV RNA undetectability? Many laboratories use the COBAS TaqMan assay with a lower limit of detection of 10-30 IU/mL, whereas others use another transcription-mediated amplification assay with a reported lower limit of detection of 5 IU/mL. I have often wondered whether there is any clinical value in being able to discern between the 2 levels. This particular study reassures me that it is probably sufficient to use either assay in clinical practice to define an RVR or a complete EVR, without having to resort to a more sensitive, secondary test."
Mike
You must be registered to view but it's free and easy to register. It seems as though there doesn't seem that PCR sensitivity makes much difference once you get down to 50 IU/ml.
"The COBAS Amplicor assay had a HCV RNA lower limit of quantification cutoff of 50 IU/mL whereas the COBAS TaqMan assay lower limit of quantification cutoff of 15 IU/mL and a qualitative cutoff of undetectable HCV RNA (truly negative or yes/no). RVR and complete EVR rates were similar when determined by either lower limit < 50 IU/mL or < 15 IU/mL or by truly undetectable HCV RNA, and this effect was independent of HCV genotype. Higher SVR rates were not observed when the more sensitive PCR assays were used to detect and define RVR. Therefore, no meaningful differences were observed between these 2 assays.
Mitchell L. Shiffman, MD:
There was a strong correlation of EVR designation and baseline HCV RNA measures between assays. Sustained virologic response rates were within 0-6 percentage points when COBAS Amplicor and COBAS TaqMan were compared. I think this study basically tells us that when assessing the response to treatment, virtually no patients have persistent HCV RNA between 15 IU/mL and 50 IU/mL for long periods of time. If patients are going to respond to treatment, by and large HCV RNA will become undetectable regardless of which assay is used, so differences in sensitivity are not significant. I would note, however, that although relapse rates were within 4-5 percentage points of each other, the relapse rates were lower when end-of-treatment response was defined by the more sensitive cutoffs.
Mark S. Sulkowski, MD:
The current goal of therapy is for patients to achieve undetectable HCV RNA levels as quickly as possible, ideally by 4 weeks. The question is: Which assay should clinicians be using to assess HCV RNA undetectability? Many laboratories use the COBAS TaqMan assay with a lower limit of detection of 10-30 IU/mL, whereas others use another transcription-mediated amplification assay with a reported lower limit of detection of 5 IU/mL. I have often wondered whether there is any clinical value in being able to discern between the 2 levels. This particular study reassures me that it is probably sufficient to use either assay in clinical practice to define an RVR or a complete EVR, without having to resort to a more sensitive, secondary test."
Mike
Don't know much at all about your history, including how much liver damage, etc. But from a purely "get-rid-of-the-virus" point of view, there was a recent study that addressed TMA positives like yours, that occur during treatment. I'll try to find it later, but briefly it suggested that treatment failure was likely. I'm sure your doc is up on all this because of what you state and because he's testing you monthly, which at least to me suggests excellent care. Curious, was there any decrease in peg or riba prior to week 20 that may have caused what looks like a viral breakthrough? I'm assuming your're on weight-based riba, but how much riba are you taking and what is your weight? Also, what was your pre-tx hemoglobin and how has it been during treatment?
If I understand you correctly, you took your last injection (number 24) on Friday and are continuing with the riba. So in effect, you are still on treatment, unless you don't inject this Friday. For that reason it's important you have a good talk with your doctor before Friday as how to proceed. My guess is that the options are either termination of treatment (with likely relapse) or extending another 24 weeks.
If he suggests the latter, my question to the doc would be how can we change something to get me back UND and keep me there. Otherwise, the same scenario may keep on presenting itself, i.e. low level viremia which will lead to relapse.
-- Jim
If I understand you correctly, you took your last injection (number 24) on Friday and are continuing with the riba. So in effect, you are still on treatment, unless you don't inject this Friday. For that reason it's important you have a good talk with your doctor before Friday as how to proceed. My guess is that the options are either termination of treatment (with likely relapse) or extending another 24 weeks.
If he suggests the latter, my question to the doc would be how can we change something to get me back UND and keep me there. Otherwise, the same scenario may keep on presenting itself, i.e. low level viremia which will lead to relapse.
-- Jim
You might want to print out and go over these studies, pertaining to TMA detected breakthroughs during tx -- and perhaps discuss with your doctor, before Friday. Sounds like an important decision, so ideally you'd get a sit-down, rather than a phone chat.
http://www.ncbi.nlm.nih.gov/pubmed/16871570
http://lib.bioinfo.pl/pmid:17701845
http://www.ncbi.nlm.nih.gov/pubmed/16871570
http://lib.bioinfo.pl/pmid:17701845
three tests confirming RNA, one of them a low-sensitivity PCR, pretty much rules out false positives and points to a definite break-through. Very sorry about the bad news after such a promising RVR start. I doubt the dr will opt to continue under the current regimen - more likely a new tx, possibly infergen.
Thanks for all your help. I saw my doc today and we discussed what she said definitely appears to be a breakthrough in treatment that occurred somewhere between week 16 and 20. Said it is atypical for this to happen in a case like mine where my results have been so good up through week 18. Background: Biopsy showed no fibrosis etc., no liver damage at beginning of treatment, did the whole course with INT 180mcg/wk and started out on 1200 riba, switching to 1000 riba at week 16 due to low CBC issues. I was not weight-based (am 6'4", 238 at start of treatment, am at 215 now), and there is an earlier discussion about the fact that we switched me to 1000 riba (my doc's reasons were very persuasive) and the pros and cons of that. I suppose that reduced dose may be a factor, but the fact of the TMA positives may have happened regardless. Something I'll never know, I guess. Better to know now than live with false hope and have it happen later. We are doing a followup HCV RNA test and a genotype test since apparently the genotype test only shows a dominant strain and if I have two strains of HCV then we may have just treated 2b and not the other. The options will be that I will stop the current treatment and do a new, longer treatment regimen or wait for awhile for new possibile tx down the road. Evidently, there are many trials out there involving shortened treatment regimens. My CBCs and other tests have been good throughout tx, and have had very little problems with sides. Meanwhile, until the tests come back, I'm continuing the next 2-4 weeks with INT180 and riba 1200. Will meet my doc again at that time.
Jim, I'll print and read the studies, and I'll check out the Clinical Care options, Mike. You all are speaking in a language I barely know yet, but I appreciate the input. skip
Jim, I'll print and read the studies, and I'll check out the Clinical Care options, Mike. You all are speaking in a language I barely know yet, but I appreciate the input. skip
Pure conjecture, but it may not be coincidence that your breakthrough coincided with a reduction in ribavirin. The trend among some of the better docs seems to be weight-based even for geno 2's, and weight-based in your case would have been 1400 mg/day. Then, at week 16, your dose was further reduced to 1000, way under weight based. In spite of a recent study that suggests OK to reduce riba in geno 2's after UND, seems like too much of a reduction here, which also begs the question why didn't your doc suggest Procrit (epo) instead?
At this point, if you had significant liver damage, I could see upping the riba to 1400 in concert with epo and continuing on another 24 weeks with frequent VL testing. But given no fibrosis, probably better just to stop at 24 and wait for better drugs.
That said, assuming you've been tolerating treatment well, a compromise might be to convince your doc to bring you up to weight-based now (1400mg/day) and start you on Procrit at the same time while monitoring VL every two weeks. If you get UND within 4 weeks, then continue to run out the balance of the 12 weeks as long as you remain UND. If you breakthrough again, then stop. I have absolutely no study data related to what I've suggested, just an opinion, and the kind of conversation I might have with my doctor if in your position.
-- Jim
At this point, if you had significant liver damage, I could see upping the riba to 1400 in concert with epo and continuing on another 24 weeks with frequent VL testing. But given no fibrosis, probably better just to stop at 24 and wait for better drugs.
That said, assuming you've been tolerating treatment well, a compromise might be to convince your doc to bring you up to weight-based now (1400mg/day) and start you on Procrit at the same time while monitoring VL every two weeks. If you get UND within 4 weeks, then continue to run out the balance of the 12 weeks as long as you remain UND. If you breakthrough again, then stop. I have absolutely no study data related to what I've suggested, just an opinion, and the kind of conversation I might have with my doctor if in your position.
-- Jim
got to congratulate you on keeping such a great attitude! The Dr's question about the multiple genos is interesting - this seems rare but does happen - here's a recently published case:
http://www.ncbi.nlm.nih.gov/pubmed/17631045
Since your last pcr got up to 715 there should be enoug RNA to test for genotype.
You might also want to look at a recent study on weight-based dosing and duration for 2s:
http://www.ncbi.nlm.nih.gov/pubmed/17894303
note that neither weight-based rbv nor extension to 48 made much of a difference in svr rates (and this was a big patient group).
However, the ifn was weight-based ifn-alpha-2b at 1.5 microg/kg/week (schering) rather than the one-size fits (roche). Did you use pegasys?
http://www.ncbi.nlm.nih.gov/pubmed/17631045
Since your last pcr got up to 715 there should be enoug RNA to test for genotype.
You might also want to look at a recent study on weight-based dosing and duration for 2s:
http://www.ncbi.nlm.nih.gov/pubmed/17894303
note that neither weight-based rbv nor extension to 48 made much of a difference in svr rates (and this was a big patient group).
However, the ifn was weight-based ifn-alpha-2b at 1.5 microg/kg/week (schering) rather than the one-size fits (roche). Did you use pegasys?
The think you want to keep in mind when reading a study like this, is how the study group matches up to your stats. My guess is that there weren't many 238 pound men in those studies meaning a much greater disparity between the riba dose Skip was treating, given his weight -- and at least for me, the conincidental breakthough coinciding with the riba reduction must be given some consideration in an individual case.
Bottom line is that an increase in riba either will, or will not have an effect on Skip's viral load. If it does, then it seems reasonable to go ahead as I suggested with the compromise plan since 24 weeks has already been invested, and assuming no significant side effects. Just an option to consider. Stopping is certainly another option.
-- Jim
Bottom line is that an increase in riba either will, or will not have an effect on Skip's viral load. If it does, then it seems reasonable to go ahead as I suggested with the compromise plan since 24 weeks has already been invested, and assuming no significant side effects. Just an option to consider. Stopping is certainly another option.
-- Jim
jim - can't get to the study content (argh!) which presumably includes detailed patient demographics, but note that the abstract makes a point of indicating 1400mg/day was found appropriate for those in Skip's 108kg weight group with geno 1s but they nevertheless observed no benefit in more rbv for 2/3s.
skip - just to clarify my last comment above, your references to 180mg IFN sounds like pegasys. I'm not sure what evidence there is for this but have read that the Schering weight-based dosing may be more effective than roche's one-size-fits all above a certain weight
skip - just to clarify my last comment above, your references to 180mg IFN sounds like pegasys. I'm not sure what evidence there is for this but have read that the Schering weight-based dosing may be more effective than roche's one-size-fits all above a certain weight
Willing's "Pegasys" comment is germane, but it should also be pointed out that the study language states that weight-based ribavirin "is more effective" even with genotype 2's and uses the word "adequate" when referring to weight based.
In reference to the same study, Science Daily makes the following point specific to "higher weight" patients like Skip:
For patients infected with genotype 2 or 3, a 24 week course of treatment with flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with better tolerability, and in the overall study population flat dosing of ribavirin was as effective as weight-based ribavirin. However, within the flat-dose cohort of patients with genotypes 2 and 3, sustained response rates showed a slight decline in the higher weight patients given flat-dosed ribavirin.
http://www.sciencedaily.com/releases/2007/12/071227183754.htm
In reference to the same study, Science Daily makes the following point specific to "higher weight" patients like Skip:
For patients infected with genotype 2 or 3, a 24 week course of treatment with flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with better tolerability, and in the overall study population flat dosing of ribavirin was as effective as weight-based ribavirin. However, within the flat-dose cohort of patients with genotypes 2 and 3, sustained response rates showed a slight decline in the higher weight patients given flat-dosed ribavirin.
http://www.sciencedaily.com/releases/2007/12/071227183754.htm
Willing's "Pegasys" comment is germane, but it should also be pointed out that the study language states that weight-based ribavirin "is more effective" even with genotype 2's and uses the word "adequate" when referring to weight based.
In reference to the same study, Science Daily makes the following point specific to "higher weight" patients like Skip:
For patients infected with genotype 2 or 3, a 24 week course of treatment with flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with better tolerability, and in the overall study population flat dosing of ribavirin was as effective as weight-based ribavirin. However, within the flat-dose cohort of patients with genotypes 2 and 3, sustained response rates showed a slight decline in the higher weight patients given flat-dosed ribavirin.
http://www.sciencedaily.com/releases/2007/12/071227183754.htm
In reference to the same study, Science Daily makes the following point specific to "higher weight" patients like Skip:
For patients infected with genotype 2 or 3, a 24 week course of treatment with flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with better tolerability, and in the overall study population flat dosing of ribavirin was as effective as weight-based ribavirin. However, within the flat-dose cohort of patients with genotypes 2 and 3, sustained response rates showed a slight decline in the higher weight patients given flat-dosed ribavirin.
http://www.sciencedaily.com/releases/2007/12/071227183754.htm
Willing's "Pegasys" comment is germane, but it should also be pointed out that the study language states that weight-based ribavirin "is more effective" even with genotype 2's and uses the word "adequate" when referring to weight based.
In reference to the same study, Science Daily makes the following point specific to "higher weight" patients like Skip:
For patients infected with genotype 2 or 3, a 24 week course of treatment with flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with better tolerability, and in the overall study population flat dosing of ribavirin was as effective as weight-based ribavirin. However, within the flat-dose cohort of patients with genotypes 2 and 3, sustained response rates showed a slight decline in the higher weight patients given flat-dosed ribavirin.
http://www.sciencedaily.com/releases/2007/12/071227183754.htm
In reference to the same study, Science Daily makes the following point specific to "higher weight" patients like Skip:
For patients infected with genotype 2 or 3, a 24 week course of treatment with flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with better tolerability, and in the overall study population flat dosing of ribavirin was as effective as weight-based ribavirin. However, within the flat-dose cohort of patients with genotypes 2 and 3, sustained response rates showed a slight decline in the higher weight patients given flat-dosed ribavirin.
http://www.sciencedaily.com/releases/2007/12/071227183754.htm
I have to agree with everyone here who says that you have to insist on a sensitive test to really know if you were UND, (and early testing in the treatment process is so important as well. Its almost equally important to know at exactly what point in treatment you go UND, and some docs still wait and test for the first time at 12 weeks), although apparently this was not an issue you faced with your doc, I just wanted to throw that out there as an additional concern as regards the testing.
my doctor's office is by no means a place ruled by experts in HCV, I've begun to find, but they DO USE a sensitive taqman for testing with the following cutoff:
TaqMan assay lower limit of quantification cutoff of 10 IU/mL to 50,000,000
IU/mL (1.00 to 7.70 log IU/mL).
I am now in week 14 but, my specific 4 week results read exactly as follows, not a word changed:
HCV RNA Detect/Quant, S Negative
HCV RNA not detected.
Dynamic range of this assay is 10 IU/mL to 50,000,000
IU/mL (1.00 to 7.70 log IU/mL).
Testing was done by PCR method using the TagMan HV analyte-specific reagents.
Analyte Specific Reagent
This test was developed and its performance characteristics determined by Laboratory
Medicine and Pathology, Mayo Clinic, Rochester, MN.
my doctor's office is by no means a place ruled by experts in HCV, I've begun to find, but they DO USE a sensitive taqman for testing with the following cutoff:
TaqMan assay lower limit of quantification cutoff of 10 IU/mL to 50,000,000
IU/mL (1.00 to 7.70 log IU/mL).
I am now in week 14 but, my specific 4 week results read exactly as follows, not a word changed:
HCV RNA Detect/Quant, S Negative
HCV RNA not detected.
Dynamic range of this assay is 10 IU/mL to 50,000,000
IU/mL (1.00 to 7.70 log IU/mL).
Testing was done by PCR method using the TagMan HV analyte-specific reagents.
Analyte Specific Reagent
This test was developed and its performance characteristics determined by Laboratory
Medicine and Pathology, Mayo Clinic, Rochester, MN.
It finally hits me that I've spent 6 months with incentive that the tx was working and now am about to be considered a non-responder.
Willing, yes, I have been doing the Roche Peg-IFN and Riba combo. thanks for the info. As I go forward I will again be talking to my Doc about the reasoning. It looks like the future holds more tx and at least I'll be more knowledgeable going in.
Certain of my test results from yesterday came back: AST 27; ALT 25; WBC 3.2; ANC 1.47; Platelets 192; Hgb 13.4; Hct 39. Am weighing 217.5 today. The ANC is the lowest it has been thru tx. I've started back on 1200 riba yesterday and have four weeks supply of IFN so will continue treatment at least until the tests are back. The genotyping and "HCV RNA by BDNA" tests won't be back for 7-10 days. I woke up this morning and thought why am I continuing with this if ultimately it is not working?
Jim, as you suggested, I believe the goal the doc and I decided is to see after a couple of weeks how my VL is doing and if it is worse then I will stop tx, then, if better, we will discuss again. I'm having a hard time justifying another 24 weeks at work. I made the mistake of telling them I was through with tx this week, and this morning gave them the news that there are few weeks to go. At 217lbs, am I still weight-based for 1400 riba? I sure don't feel very heavy these days! I was small-boned and skinny up until I was 35yrs - 6'4", 135lbs - am still small-boned. Am I to understand that the breakthrough in tx means that for future tx the IFN-riba combo probably won't work? I guess if my genotype comes back a 1 instead of 2 it will be a whole new ballgame. This is my first time with this, and more and more it appears I am going to be going through this again down the road. My doc mentioned that since my liver is in good shape she is inclined to have me wait for trials she will sign me up for when she finds the right ones. My recall is not all that great but she mentioned certain trials involving new drugs that allow for shortened treatment time.
This is all new to me. Nice to know you guys are an email away with all this great information and encouragement. It is a comfort. thanks again. skip
Willing, yes, I have been doing the Roche Peg-IFN and Riba combo. thanks for the info. As I go forward I will again be talking to my Doc about the reasoning. It looks like the future holds more tx and at least I'll be more knowledgeable going in.
Certain of my test results from yesterday came back: AST 27; ALT 25; WBC 3.2; ANC 1.47; Platelets 192; Hgb 13.4; Hct 39. Am weighing 217.5 today. The ANC is the lowest it has been thru tx. I've started back on 1200 riba yesterday and have four weeks supply of IFN so will continue treatment at least until the tests are back. The genotyping and "HCV RNA by BDNA" tests won't be back for 7-10 days. I woke up this morning and thought why am I continuing with this if ultimately it is not working?
Jim, as you suggested, I believe the goal the doc and I decided is to see after a couple of weeks how my VL is doing and if it is worse then I will stop tx, then, if better, we will discuss again. I'm having a hard time justifying another 24 weeks at work. I made the mistake of telling them I was through with tx this week, and this morning gave them the news that there are few weeks to go. At 217lbs, am I still weight-based for 1400 riba? I sure don't feel very heavy these days! I was small-boned and skinny up until I was 35yrs - 6'4", 135lbs - am still small-boned. Am I to understand that the breakthrough in tx means that for future tx the IFN-riba combo probably won't work? I guess if my genotype comes back a 1 instead of 2 it will be a whole new ballgame. This is my first time with this, and more and more it appears I am going to be going through this again down the road. My doc mentioned that since my liver is in good shape she is inclined to have me wait for trials she will sign me up for when she finds the right ones. My recall is not all that great but she mentioned certain trials involving new drugs that allow for shortened treatment time.
This is all new to me. Nice to know you guys are an email away with all this great information and encouragement. It is a comfort. thanks again. skip
skip
Just so you know - I have two genotypes 1A and 1B and the doctor told me it doesn't really make a difference (even though my BRAIN tells me it would be harder to get rid of one than the other). But it's not true. After 72 weeks I am SVR.
Because you have such little liver damage and your alt/ast are so good if I was you I'd take a nice long rest before deciding to treat again. I can't imagine how hard it is ... I just can't.
You have time so make sure you continue with your liver enzyme tests and follow up biopsies just to make sure - I'd wait too probably. However I had no choice really at stage 3.
it is interesting the timing of the riba reduction and the breakthrough - so many docs are SO adament about no reductions and all that but remember...treatment is a giant crapshoot regardless and that's all.
I hope you enjoy the new year and get about life again quickly!
Best of luck.
Just so you know - I have two genotypes 1A and 1B and the doctor told me it doesn't really make a difference (even though my BRAIN tells me it would be harder to get rid of one than the other). But it's not true. After 72 weeks I am SVR.
Because you have such little liver damage and your alt/ast are so good if I was you I'd take a nice long rest before deciding to treat again. I can't imagine how hard it is ... I just can't.
You have time so make sure you continue with your liver enzyme tests and follow up biopsies just to make sure - I'd wait too probably. However I had no choice really at stage 3.
it is interesting the timing of the riba reduction and the breakthrough - so many docs are SO adament about no reductions and all that but remember...treatment is a giant crapshoot regardless and that's all.
I hope you enjoy the new year and get about life again quickly!
Best of luck.
skip
Just so you know - I have two genotypes 1A and 1B and the doctor told me it doesn't really make a difference (even though my BRAIN tells me it would be harder to get rid of one than the other). But it's not true. After 72 weeks I am SVR.
Because you have such little liver damage and your alt/ast are so good if I was you I'd take a nice long rest before deciding to treat again. I can't imagine how hard it is ... I just can't.
You have time so make sure you continue with your liver enzyme tests and follow up biopsies just to make sure - I'd wait too probably. However I had no choice really at stage 3.
it is interesting the timing of the riba reduction and the breakthrough - so many docs are SO adament about no reductions and all that but remember...treatment is a giant crapshoot regardless and that's all.
I hope you enjoy the new year and get about life again quickly!
Best of luck.
Just so you know - I have two genotypes 1A and 1B and the doctor told me it doesn't really make a difference (even though my BRAIN tells me it would be harder to get rid of one than the other). But it's not true. After 72 weeks I am SVR.
Because you have such little liver damage and your alt/ast are so good if I was you I'd take a nice long rest before deciding to treat again. I can't imagine how hard it is ... I just can't.
You have time so make sure you continue with your liver enzyme tests and follow up biopsies just to make sure - I'd wait too probably. However I had no choice really at stage 3.
it is interesting the timing of the riba reduction and the breakthrough - so many docs are SO adament about no reductions and all that but remember...treatment is a giant crapshoot regardless and that's all.
I hope you enjoy the new year and get about life again quickly!
Best of luck.
skip
Just so you know - I have two genotypes 1A and 1B and the doctor told me it doesn't really make a difference (even though my BRAIN tells me it would be harder to get rid of one than the other). But it's not true. After 72 weeks I am SVR.
Because you have such little liver damage and your alt/ast are so good if I was you I'd take a nice long rest before deciding to treat again. I can't imagine how hard it is ... I just can't.
You have time so make sure you continue with your liver enzyme tests and follow up biopsies just to make sure - I'd wait too probably. However I had no choice really at stage 3.
it is interesting the timing of the riba reduction and the breakthrough - so many docs are SO adament about no reductions and all that but remember...treatment is a giant crapshoot regardless and that's all.
I hope you enjoy the new year and get about life again quickly!
Best of luck.
Just so you know - I have two genotypes 1A and 1B and the doctor told me it doesn't really make a difference (even though my BRAIN tells me it would be harder to get rid of one than the other). But it's not true. After 72 weeks I am SVR.
Because you have such little liver damage and your alt/ast are so good if I was you I'd take a nice long rest before deciding to treat again. I can't imagine how hard it is ... I just can't.
You have time so make sure you continue with your liver enzyme tests and follow up biopsies just to make sure - I'd wait too probably. However I had no choice really at stage 3.
it is interesting the timing of the riba reduction and the breakthrough - so many docs are SO adament about no reductions and all that but remember...treatment is a giant crapshoot regardless and that's all.
I hope you enjoy the new year and get about life again quickly!
Best of luck.
skip
Just so you know - I have two genotypes 1A and 1B and the doctor told me it doesn't really make a difference (even though my BRAIN tells me it would be harder to get rid of one than the other). But it's not true. After 72 weeks I am SVR.
Because you have such little liver damage and your alt/ast are so good if I was you I'd take a nice long rest before deciding to treat again. I can't imagine how hard it is ... I just can't.
You have time so make sure you continue with your liver enzyme tests and follow up biopsies just to make sure - I'd wait too probably. However I had no choice really at stage 3.
it is interesting the timing of the riba reduction and the breakthrough - so many docs are SO adament about no reductions and all that but remember...treatment is a giant crapshoot regardless and that's all.
I hope you enjoy the new year and get about life again quickly!
Best of luck.
Just so you know - I have two genotypes 1A and 1B and the doctor told me it doesn't really make a difference (even though my BRAIN tells me it would be harder to get rid of one than the other). But it's not true. After 72 weeks I am SVR.
Because you have such little liver damage and your alt/ast are so good if I was you I'd take a nice long rest before deciding to treat again. I can't imagine how hard it is ... I just can't.
You have time so make sure you continue with your liver enzyme tests and follow up biopsies just to make sure - I'd wait too probably. However I had no choice really at stage 3.
it is interesting the timing of the riba reduction and the breakthrough - so many docs are SO adament about no reductions and all that but remember...treatment is a giant crapshoot regardless and that's all.
I hope you enjoy the new year and get about life again quickly!
Best of luck.
Don't have my calculator handy, but from the WIN-R study --
85 to < 105 kg - 1200 mg/day, and 105-125 kg - 1400 mg/day.
Please do the math, but I suppose at your new weight, you'd be marginal 1200-1400 -- however, many of us stay at the same dose we started treatment at -- and perhaps the studies do that to too? -- so factoring that thought in (a lot of folks lose wgt during tx) then that argues for 1400 mg/day.
However, it's not just the dose, but your overall strategy. If you decide to committ to extended treatment based on getting UND in the next few weeks, then I personally would push the envelope to 1400 and depending on side effects,etc, perhaps start Procrit (epo) at the same time. After that, as already posted, I would have my VL tested religiously every two weeks and stop if another breakthrough. Equally reasonable is simply stopping now as NYGirl and others have suggested.
All the best,
-- Jim
85 to < 105 kg - 1200 mg/day, and 105-125 kg - 1400 mg/day.
Please do the math, but I suppose at your new weight, you'd be marginal 1200-1400 -- however, many of us stay at the same dose we started treatment at -- and perhaps the studies do that to too? -- so factoring that thought in (a lot of folks lose wgt during tx) then that argues for 1400 mg/day.
However, it's not just the dose, but your overall strategy. If you decide to committ to extended treatment based on getting UND in the next few weeks, then I personally would push the envelope to 1400 and depending on side effects,etc, perhaps start Procrit (epo) at the same time. After that, as already posted, I would have my VL tested religiously every two weeks and stop if another breakthrough. Equally reasonable is simply stopping now as NYGirl and others have suggested.
All the best,
-- Jim
Thanks for the well wishes. I believe we are going to do my VL in two weeks so will know if things are getting worse or better. If worse then quitting and taking a nice long rest sounds just right! My doc mentioned that as the option she is leaning toward. We will see how the next month plays out. I've been trying to avoid epo or the other injection (can't remember the name) and I think my counts are ok right now. I adjusted to 1200 easily at the beginning so will consider 1400 going forward. Not clear what to expect from higher dose.
Anxious to have the genotyping test back. NYGirl, how did they determine you have 1a and 1b? From one test? I'm wondering if I have two strains could I have found that out long ago and done tx differently. Am told the test only shows the dominant strain (in my case, 2b), but is there a way to know if you have another. If my test comes back a different genotype than 2b, it will be a whole new ballgame I guess. That would seem to say that I cleared 2b and the new dominant strain would be the other. I have no idea what I'm talking about, but that's my logic. Don't know how the test works.
Will find out soon at any rate.
thanks again all.
skip
Anxious to have the genotyping test back. NYGirl, how did they determine you have 1a and 1b? From one test? I'm wondering if I have two strains could I have found that out long ago and done tx differently. Am told the test only shows the dominant strain (in my case, 2b), but is there a way to know if you have another. If my test comes back a different genotype than 2b, it will be a whole new ballgame I guess. That would seem to say that I cleared 2b and the new dominant strain would be the other. I have no idea what I'm talking about, but that's my logic. Don't know how the test works.
Will find out soon at any rate.
thanks again all.
skip
adjusting to this new screen format is going to take effort - seems the % of screen space left for thread content has dwindled to less than a third..
one reason to stay on the meds until the geno test results are in is learning the identity of the survivors. The tx failure is more likely due to garden-variety breakthough that to mutiple strains... but it's still worth getting those results. Genotype tests require VL above a certain level. If they couldn't run a successful test you may need to do another draw. If in the meantime you stop the meds, the suppressed strain is quite likely to return and may quickly outcompete the recently emerged survivors (which is why they didn't show up on the original test).
I believe Jim meant to write that the abstract uses the word "adequate" with respect to flat-dose in his post above (see the last sentence of the abstract). Also, I finally got access to the journal text and am including the following excerpt which may be of interest to other g2/3s:
"In the current study, 48 weeks of therapy offered no apparent advantage over 24 weeks for patients with G2/3; WBD RBV, although achieving a numerically higher SVR (61.8% versus 59.5%), offered no overall statistical advantage over FD RBV. The trend toward lower efficacy of FD RBV in heavier patients (Fig. 2) may not have been sufficient to affect the results in the overall cohort because of sample size, but this issue warrants further evaluation in other studies. The current study, with its larger patient population and identical PEG-IFN doses in both treatment arms, establishes more firmly the conclusions about the equivalence of 24 and 48 weeks of treatment in patients with G2 and G3 reached by Hadziyannis et al.[10] in their study of PEG-IFN alfa-2a. "
The 61.8 vs 59.5 is noise, but the data presented in their Figure 2 makes a somewhat more compelling argument for WBD even for some g2/g3s. Under WBD, the three weight groups experienced near-same SVR rates (64,59,61) whereas under flat there was a somewhat wider discrepancy (63,55,55). It could be noise - but those two 55s look a bit under-dosed (and your HgB value of 13.4 looks a bit too healthy for a riba victim!) Anyway, something to think about for your next round . Best wishes.
PS: another point from that study (and this was a BIG patient group and very careful stats) is that extending to 48 for g2/g3s sure doesn't seem to gain much. Focusing on different dosage seems the more promising approach for re-tx.
one reason to stay on the meds until the geno test results are in is learning the identity of the survivors. The tx failure is more likely due to garden-variety breakthough that to mutiple strains... but it's still worth getting those results. Genotype tests require VL above a certain level. If they couldn't run a successful test you may need to do another draw. If in the meantime you stop the meds, the suppressed strain is quite likely to return and may quickly outcompete the recently emerged survivors (which is why they didn't show up on the original test).
I believe Jim meant to write that the abstract uses the word "adequate" with respect to flat-dose in his post above (see the last sentence of the abstract). Also, I finally got access to the journal text and am including the following excerpt which may be of interest to other g2/3s:
"In the current study, 48 weeks of therapy offered no apparent advantage over 24 weeks for patients with G2/3; WBD RBV, although achieving a numerically higher SVR (61.8% versus 59.5%), offered no overall statistical advantage over FD RBV. The trend toward lower efficacy of FD RBV in heavier patients (Fig. 2) may not have been sufficient to affect the results in the overall cohort because of sample size, but this issue warrants further evaluation in other studies. The current study, with its larger patient population and identical PEG-IFN doses in both treatment arms, establishes more firmly the conclusions about the equivalence of 24 and 48 weeks of treatment in patients with G2 and G3 reached by Hadziyannis et al.[10] in their study of PEG-IFN alfa-2a. "
The 61.8 vs 59.5 is noise, but the data presented in their Figure 2 makes a somewhat more compelling argument for WBD even for some g2/g3s. Under WBD, the three weight groups experienced near-same SVR rates (64,59,61) whereas under flat there was a somewhat wider discrepancy (63,55,55). It could be noise - but those two 55s look a bit under-dosed (and your HgB value of 13.4 looks a bit too healthy for a riba victim!) Anyway, something to think about for your next round . Best wishes.
PS: another point from that study (and this was a BIG patient group and very careful stats) is that extending to 48 for g2/g3s sure doesn't seem to gain much. Focusing on different dosage seems the more promising approach for re-tx.
Yes, the word "adequate" was used referring to flat riba dosage, but at the same time weight-based was considered "more effective" -- and esp for those in the heavier weight group.
The other point, is that -- and not sure if you are -- we may be comparing apples and oranges with the "48 weeks not more effective than 24" treatise. My understanding is that this refers to treatment cohorts as a group, and not sub-chorts who treat for 24 weeks, have a viral breakthrough, re-group perhaps with a change in meds -- and then treat for another 12 or 24 weeks. One could argue that the latter might be considered a version of re-treatment, as opposed to simply treating 48 weeks from the get go.
In other words, say Skip was in one these studies. What probably would have happened is that all these interim viral load test would not have been taken, an RVR therefore would have been assumed, he would have treated 48 weeks on the same dosages (assuming he was in that cohort) and he would most probably have relapsed.
This, of course, is not what I was suggesting so I really don't think the repetition of the 48 week study is germane in this case. One member I can think of, who followed something close -- but not exact to Ski's, situation, was Kalio, although in her case I believe there was around a one week gap between treatments.
Just want to be clear that I'm not recommending that Skip extend (or re-treat immed) another 12 or 24 weeks, esp since he has zero liver damage. But what I am saying is that since he's already invested almost 24 weeks, consideration should be given to such a strategy and I'm throwing out a 12 week compromise plan that assumes he will be UND within the next couple of weeks. The plan includes uppint the riba to 1400, possibly Procrit (epo) and very frequent VL test (every 2 weeks) with the understanding that treatment stops with another breakthrough via sensitive TMA.
As you probably know, I'm a big fan of cutting losses (esp no significant liver damage) when the odds are stacked against you in treatment. Cutting losses to treat another day. I just feel in this individual case, given his weight and prior dosing, and relapse coincidental with the riba reduction -- that this may be a correctable (and measurable) mistake -- and with 24 weeks invested, another 12 might be a reasonable stab at SVR.
BTW, haven't been following this geno thing -- and not sure I have the energy left to start scrolling up on this new format :) -- but from what I do remember, really don't see the focus on this. Why would skip have more of a chance of a double-genotype than anyone else? He's certainly not the first RVR to relapse. Anyway, it may be academic, because hopefully the upped riba will bring him below the level where genotype can be measured -- the UND level that is.
-- Jim
The other point, is that -- and not sure if you are -- we may be comparing apples and oranges with the "48 weeks not more effective than 24" treatise. My understanding is that this refers to treatment cohorts as a group, and not sub-chorts who treat for 24 weeks, have a viral breakthrough, re-group perhaps with a change in meds -- and then treat for another 12 or 24 weeks. One could argue that the latter might be considered a version of re-treatment, as opposed to simply treating 48 weeks from the get go.
In other words, say Skip was in one these studies. What probably would have happened is that all these interim viral load test would not have been taken, an RVR therefore would have been assumed, he would have treated 48 weeks on the same dosages (assuming he was in that cohort) and he would most probably have relapsed.
This, of course, is not what I was suggesting so I really don't think the repetition of the 48 week study is germane in this case. One member I can think of, who followed something close -- but not exact to Ski's, situation, was Kalio, although in her case I believe there was around a one week gap between treatments.
Just want to be clear that I'm not recommending that Skip extend (or re-treat immed) another 12 or 24 weeks, esp since he has zero liver damage. But what I am saying is that since he's already invested almost 24 weeks, consideration should be given to such a strategy and I'm throwing out a 12 week compromise plan that assumes he will be UND within the next couple of weeks. The plan includes uppint the riba to 1400, possibly Procrit (epo) and very frequent VL test (every 2 weeks) with the understanding that treatment stops with another breakthrough via sensitive TMA.
As you probably know, I'm a big fan of cutting losses (esp no significant liver damage) when the odds are stacked against you in treatment. Cutting losses to treat another day. I just feel in this individual case, given his weight and prior dosing, and relapse coincidental with the riba reduction -- that this may be a correctable (and measurable) mistake -- and with 24 weeks invested, another 12 might be a reasonable stab at SVR.
BTW, haven't been following this geno thing -- and not sure I have the energy left to start scrolling up on this new format :) -- but from what I do remember, really don't see the focus on this. Why would skip have more of a chance of a double-genotype than anyone else? He's certainly not the first RVR to relapse. Anyway, it may be academic, because hopefully the upped riba will bring him below the level where genotype can be measured -- the UND level that is.
-- Jim
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