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Relapse
by Bill1954, Apr 22, 2006 12:00AM
Well, it appears as though the virus has returned for an encore presentation. 30-day post Tx PCR shows a viral load of 112,000 IU/ML. These results are from a lab drawn 30 days after completion of ribavirin, 37 days after the final IFN injection.
The assay used was Quest # 354645X, real time PCR HCV RNA quant <50 IU/ML. My treating doctor is currently in Europe, and my next scheduled appt is May 1st.
Stats:
Male Caucasian
51 years old
HCV genotype 1a
Prior Tx baseline VL was 75,600 IU/ML
Biopsy on 1/22/05 indicated inflammation grade 2, fibrosis stage 3/4
6’ 1”, 240 lbs
Type 2 diabetes, semi-controlled with oral meds (non-insulin dependent)
I began treatment 2/18/05 with Pegasys/Copegus. At 12 week PCR, I was unable to achieve a 2-log drop, but became undetectable at 20 weeks. After discussing options with my doctor, we extended treatment to 56 weeks, and increased the ribaviron from my assigned dosage of 1200mg/day to 1800mg/day. I was Rx compliant throughout treatment with the exception of week 56, when I missed a riba dose, but compensated for the missing dose the following day. Additionally, my liver enzymes never normalized during Tx; although reduced from the post Tx baseline of ALT 275/AST 109, the final treatment results were 93/58, respectfully.
Reviewing my stats, we can see that multiple negative predictive factors are at play here; the obvious exception would be a low initial viral load. Another note being that increased ribaviron and Tx extension to 36 weeks past ND were not enough to push things over the top to SVR.
The assay used was Quest # 354645X, real time PCR HCV RNA quant <50 IU/ML. My treating doctor is currently in Europe, and my next scheduled appt is May 1st.
Stats:
Male Caucasian
51 years old
HCV genotype 1a
Prior Tx baseline VL was 75,600 IU/ML
Biopsy on 1/22/05 indicated inflammation grade 2, fibrosis stage 3/4
6’ 1”, 240 lbs
Type 2 diabetes, semi-controlled with oral meds (non-insulin dependent)
I began treatment 2/18/05 with Pegasys/Copegus. At 12 week PCR, I was unable to achieve a 2-log drop, but became undetectable at 20 weeks. After discussing options with my doctor, we extended treatment to 56 weeks, and increased the ribaviron from my assigned dosage of 1200mg/day to 1800mg/day. I was Rx compliant throughout treatment with the exception of week 56, when I missed a riba dose, but compensated for the missing dose the following day. Additionally, my liver enzymes never normalized during Tx; although reduced from the post Tx baseline of ALT 275/AST 109, the final treatment results were 93/58, respectfully.
Reviewing my stats, we can see that multiple negative predictive factors are at play here; the obvious exception would be a low initial viral load. Another note being that increased ribaviron and Tx extension to 36 weeks past ND were not enough to push things over the top to SVR.
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It seems like you did have contingency plans and daily infergen is definitely one way to go.
As I mentioned before, my current contingency plan as a stage 3 is to wait and then hopefully re-treat with newer drugs. This was the recommendation of two hepatologists I respect.
I understand your reluctance about another biopsy but you might consider getting a Fibroscan with Schiff in Miami or Afdhal in Boston: http://tinyurl.com/nbavn As you probably know, Fibroscan is different from the Fibrosure blood test -- sort of like a special ultrasound that measures liver stiffness and then correlates it with liver stage.
You may or may not qualify for their Fibroscan trial but I believe either would see you as a private patient. Fibroscan or not, you couldn't get a better second opinion than from either of the two.
All the best.
-- Jim
Beagle
My ALT/AST baseline numbers were 275/109, and EOT 93/58. No LFT’s available at time of relapse.
I’m really not floored that this occurred--I think I absorbed and accepted the odds and statistics in the weeks following initial diagnosis a year and a half ago. Thanks for the kind thoughts,
Bill
LOL! We *must* be kin!
From one who hasn't begun tx yet it helps to hear the stories of everyone regardless of the outcome. I am inspired by your story and wish the very best for you.
(In my individual case, anyway).
Looking forward, I plan to request an additional PCR for confirmation, then the next step will most likely be a Tx of daily Infergen/riba. This was our contingency plan as of my last appt.
Keeping in mind that there is more than one endpoint to treatment, hopefully I will have seen some histological improvement. At this point, however, I don’t see any advantage to an additional biopsy. As a late stage 3 going into the previous treatment, the best I could expect would be an improvement to stage 2; I’d still insist on treatment. At worst, (gulp) an advance to stage 4 would find me treating as well. To date my biochemical markers don’t indicate any hepatic decompensation; I expect this would become self evident were it to occur. To summarize, I just don’t feel I have enough wiggle room to wait for the possibility of upcoming PI’s--better to go with what’s available right now.
In closing, I think it’s important for anyone considering treatment to understand that there is success out there for many of us; don’t let this story deter you from trying. For the rest of us, well, we need to have this info for statistical purposes. .
Again, thanks for all your help over the last year or so; it looks like I’ll be around for a while longer,
Bill
As to treatment length not being enough, 36 weeks additional was a reasonable decision weighing risks against rewards. Nothing definitive to suggest that adding more time would have changed the outcome. I'll speculate that your main negative predictor was your slow viral response.
Two questions -- how sensitivity were the viral load tests you took during treatment? If you remember, Goofy posted a study that suggested that 50 IU/ml may not be sensitive enough and some folks passing that test may still harbor the virus. And secondly, do you know what your enzymes post treatment and at relapse?
I'm sure you haven't had time to look ahead, but the newer protease inhibitors now in trial like Vertex might be something to look at. My understanding after talking with a few in the know is that they potentially will be of great benefit to people like yourself who responded slowly to the current drugs. Given the current drugs and current doses, just don't see 72 weeks or 2 years of combo treatment as a first choice. Should I end up in your shoes when my next PCR comes in, it certainly would not be my first choice.
Again, so very sorry, but you're a fighter and will win.
-- Jim
God Bless you on what ever decision you make.
angie
slow
Bill______________________________________________
Mikesimon--Regarding hepatic architecture, what are your thoughts about histological improvement without ALT/AST normalization? My doctor hypothesized steatosis as a parallel running process, however the pathology report didn’t have any specific mention of fat deposits, etc. Thanks,
Bill_____________________________________________
Rogirl--Wow, thank you for the wonderful words (blush, blush!). Not quite sure I’ve earned all that praise, lol, but would be a fool to refuse it....
Can’t remember your HCV specifics, but I sincerely wish you all the luck in the world with your decisions. Stay in touch,
Bill________________________________________________
Golden, All-- Best of luck to all that are personally fighting or have been touched by this disease.... Keep the hammer down as we say in the carpentry business, and we’ll eventually prevail. Best wishes to all,
Bill________________________________________________
My docs had told me if I didn't initially respond fast with the Pegasys that they would switch me at 12 weeks to the pegintron. They did consider it a stronger drug, mainly based on the fact that (1) patients may respond better to pegintron when didn;t with the pegasys, and (2) the side effects did seem stronger and more unpredictibible as to timing. Have you considered trying the other peg before going on infergen? My docs seemed to have no problem with switching interferons mid stream if the first did not respond to their satisfaction. Just curious. did you have severe anemia while treating? Best of luck and keep us posted.
Regarding an additional biopsy or equivalent, I’m not sure of the value here. Although it would help satisfy my personal curiosity, I don’t see where it would alter my treatment plans. If you have any thoughts here, I’d love to hear them. So sorry to hear about your own post Tx battles, and I hope that they somehow resolve soon for you.
All the best,
Bill______________________________________
Califia--Aw, jeez, gal-thanks for the heartfelt atta-boy, as well as the condolences. I understand that you’ve had your own post Tx issues, but were recently able to resolve some with the addition of B-12?
My goodness, more praise (and more blushing!) I not sure what to do with all this. Thanks so much for your response, and I might “give you a call” one day. I still have your old addy at SBC. Still in service?
Hang in there, and take real good care,
Bill_________________________________________
I think you are correct in assessing that 36 wks past undetect was not enough in your case, and if you recall, the Drusano study from where this number is derived was theoretical and stated that confirmation was needed.
The actual studies out there paired 48 wks vs 72, with 72 having the best response for slow responders. My feeling is that going the longest your body can tolerate, with matching tx length to actual studies is the best way to go. Mikesimon and I both did 72 and so did dollface and others. It worked for us. In my case I went the 72 wks route because of my detectable status at wk 12. I believe that the two log drop "benefit" goes out the window when you are still detectable at wk 12. So far I read one study where the positive PCR at wk 12 is the key to consider extension. They and other studies do not mention the 36 wk post negative PCR. You could say that they seem to randomly select 72 wks as opposed to 36 beyond a negative, but if that is what they found to work the best in actual studies, that is what I would follow. What ever risks there might be going beyond 48 wks, do not seem to be a higher percentage in adverse events reports. I believe there was a 3% difference bt 48 wks and 72 in the study I read. I wish people would stop quoting the 36 wk as the gospel for extension, especially for slow responders.
Many re treaters do achieve SVR by doing tx with the same meds longer or the opposing med, ie if Pegasys was used, the next time is Pegintron and viceversa. Not all go the infergen route to achieve SVR.
I think you have a good shot, because you did respond to the meds, and if there is any validity to the virus becoming resistant upon recouping, you might not want to wait too long for a stronger mutation.
In the case of slow responders, if they are tolerating tx fairly well, they should do at least 18 months or at least a yr from clearance, maybe more. Again, if tx is tolerated well. THe so called risks with longer tx are statistically insignificant in at least one study I read ( I have the link at work). If someone is going to have an adverse event, it will happen within the first 6 months of tx, so it can happen to anyone, even the genotype 2.
best luck in your decission
Beagle
Now I did 14 months on my first tx, started with 3x/week intron, then went to daily intron, still could not get undetected, and at about month 8 I went to high dose daily infergen. I got undetected quickly, and was able to go for another five months, ending undetected. I relapsed in a month.
My second round was with high dose Peg-Intron, and full dose riba, and I got undetected at week 19. Late again, but more in the ballpark for potential SVR. I went a total of 72 weeks, using lots of Procrit, to keep the riba up, and finished undetected. I have been SVR now for two and a half years.
Duration makes a big difference for GT 1 late responders, and I believe that these patients need to stay on tx for at LEAST a full year after the undetected date, if not even longer.
Sorry for your relapse, but given your ability to get undetected, you most probably can get the SVR with the right dosing, AND the right duration. You may want to consider Peg-Intron on your next round. I truly believe (as does my doctor) that it is better in tough type-1 cases than Pegasys. It also has more side effects for most people, but is very doable. I think it is easier and more practical than daily infergen.
Best Wishes!!!!!
DoubleDose
I appreciate your thoughts and comments. Regarding the switch to Peg-intron, I would be more concerned with the duration of another Tx with any PEG-IFN (minimum of what, 72 weeks?) than the thought of Infergen treatment. I’m also not personally aware of any conclusive studies that show more efficacy between the two meds. The IDEAL study is currently underway to help define this, but I’m not convinced of the ethics involved in this comparison.
As to your question about anemia: I never required Procrit, and my Hgb stayed above 13.4 throughout treatment. Given that info, I’d say it’s safe to assume there certainly was an issue with riba absorption. When I researched the possibility of testing for plasma ribavirin concentration, I found that the test isn’t commercially approved for use by the FDA. It uses fairly simple HPLC-UV technology, the same methodology used for standard tox screens, but ribavirin hasn’t been included yet. At any rate, I’d like to wish you well, and stay in touch,
Bill_______________________________________
Rev--Yeah, from a purely objective standpoint I think we should ignore the LFT’s for SVR projection purposes, but I certainly know what you mean about the “gut feel”. I wasn’t at all surprised at this turn of events. Thanks for stopping in, and take good care,
Bill________________________________________
Is there ANY hard core studIES that prove this out? You know me...I am all for the MORE the MERRIER but I am wondering as strong as these drugs ARE and the fact that I already have gotten ONE AUTOIMMUNE disease as a result of them - is this really a supported FACT or a number we bandy about?
As someone who didn't clear until about week 20 as well AND a 1A and 1B ... I always thought to go at least 60 or 72 but I will need backup to convince my DOCTOR of this. And the insurance company as well.
It doesn't appear that doctors are really aware of this 36 week fact.
-------------------------
I wasn't going to bring up the riba issue right on top of your relapse but since you seem to be asking the question here...
Sweedish studies suggest that riba absorption is directly related to level of anemia. In your case, one could speculate that your serum riba levels were not at a therapeutic level regardless of the fact you took 1800mg/day. Some, I believe, in the Sweedish study took double that amount. In my case, my hgb ended up in the 11's but on 60,000 units/Procrit a week. This is not to say you should try a high-dose riba approach like in Sweeden. Their group was small, sides effects high, and we don't have the proper blood tests in this country to properly monitor serum riba. But I do offer it as a possible reason for relapse.
Regarding what some other have said...My understanding is that longer treatments are associated with more side effects, i.e more risk, and often higher drop out rates. I believe some of the shorter course studies have documented this.
As to the risk of more resistant virus/mutation while resting between treatments -- my hepatoloigst as well as others feel that folks will do better the second time with the 6 month or so rest between treatments as the immune system has time to recover and get stronger.
There is also speculation -- no studies I'm aware of -- that treatment and re-treatment has an accumulative effect, with one tx training the immune system for the second time. This also seems to argue the fact that resistant viral mutations take place between treatments.
As to your own personal decision, there is no right and wrong here, and no real study data to prove things one way or another. I thought I'd just balance out the discussion for others who may decide to approach it differently.
-- Jim
--------------------------------------------------------------
Unfortunatly, there's no magic in hep c treatment.
The 36 weeks came from a researcher named Drusano, and it's not a "rule" as some state but a model that Drusano himself needs further exploration. Still, it's commonly used by many hepatologists -- good hepatologists -- to extend treatment with some slow responders.
My doctor, for example, uses variations of the model and extended my treatment 48 weeks beyond non-detectible for a total of 54 weeks. He cited my age and histology as the reason to go beyond the 36 weeks. If he treated Bill, he probably would have also suggested 48 weeks beyond non-detectible. I should add here for balance that three other hepatologists I consulted only recommended I extend 36 weeks beyond week 12 -- which if you read he Drusano study very carefully is the minium point you should start adding in a conservative strategy, since the study didn't test before week 12.
We have an educated lot here and all the options are being put on the table -- Extend with current drugs, extend with another peg, daily infergen, wait for trials, the problem is the riba, treat right away, wait six months, etc, etc.
I believe any hepatologist honest with himself will tell you that at this point we really don't know enough to say what is the best approach for a relapser. So, in my opinion an awful lot depends on what the patient him/herself is up for. Bill is one of the smartest guys here and I have a feeling he's going to do exactly what's best for him. Even though I'd like him to wait for newer drugs :)
-- Jim
I think it was the best advise he ever got. (that isn't saying it is for everyone)
Good Luck to you!
Magnum
DD,
Check out ASmile's post in "Pre-tx Consultation" thread above this. In a nutshell, she's re-treating for the second time on Infergen and has a slow week 4 response. Wants to know her odds for success. I know the week 4 response is important with peg and riba but not sure with Infergen.
-- Jim
The Pegasys seems to be holding the virus down & I know that it is unlikely that I could attain SVR on it.
I am not sure of any side effects which you encountered, but I was one miserable person on both therapies and have been diagnosed with Neuropathy, a direct result of treatment. I had been told that sometimes the interferons can cause permanent sides, so I can't say I didn't know. My feet & legs go numb up to my knees, resulting in 8 falls. For me treatment is not the answer presently.
My Hepatologist has stated that I have at least 10 good years before virus might possibly cause problems. I am presently 62 & female. I have fought the battle for over 3 yrs. now & I want some kind of normalcy in my life, which has prompted me to stop therapies.
I know we all carry this disease differently, some easier than others and I am so thankful for that. I guess I am telling you my story to give you another view to contemplate. I know that the interferons did help some & I thank God every day for this.
I was a gung-ho, let's treat like their is no tomorrow, but the neuropathy has certainly changed my mind. At this point we are not sure if it is reversible or not & I am having epidurals, attempting to help.
This in no way means that you should not re-treat. I only mean it to be vital info for all who are on treatment. Just watch yourself closely as sometimes the meds are worse than the disease.
Bill, with your positive attitude I am sure that you will reach SVR. If I can be of any help regarding Infergen answers, I am here. Be Well & the decision you make will be the right one!
Sandy
Everyone in this forum should take a silent moment to give themselves a hand. The responses I’ve received here have run the gamut from heart-felt emotional support to technical advice and contemplations. I value each and every comment given here; none are taken lightly. Sometimes when a person takes a punch to the jaw, it takes a little while to think rationally again; the collective intelligence and compassion of this group really help bridge that gap. It’s difficult to articulate the gratitude I feel right now.
As far as the concept of viral relapse is concerned, it’s certainly a bear; BUT... the sun rose as scheduled this morning, the world is still firmly rooted on its axis, and the fight continues... I personally think we need to embrace these challenges and accept them as part of the journey.
As far as how, what, when and if to retreat; I do trust my doctor...He seems well versed and educated in dealing with this disease, and his aggressive approach and willingness to work off-label when necessary agrees quite well with me. We’ll start formulating a plan on May 1st, until then I’m going to try and just ‘chill’. I’ll post a plan as it avails itself,
until then--
Thanks again for your response,
Bill
Thank you for posting with the grace you've show in a difficult time.
Be Well,
Don
Where does this come from? I've seen facts that seem to contradict this position, but nothing supporting it.
Bill informs us that "when I researched the possibility of testing for plasma ribavirin concentration, I found that the test isn’t commercially approved for use by the FDA. It uses fairly simple HPLC-UV technology, the same methodology used for standard tox screens, but ribavirin hasn’t been included yet."
Simply stunning, isn't it? Arbitrary dosage assignments of an extraordinarily toxic drug, based on any number of _extra-medical considerations_, but a simple tool that would enable precision and medical accuracy in dosing? No FDA approval.
By the time we are able to truly learn from the Swedes about how to finesse the current interferon-ribavirin combo, it is likely that this drug paradigm will have been abandoned altogether for more efficacious and less toxic regimes. Let's hope that time comes very soon.