Wow 72 weeks of double dosing? Have you thought about one of the relapser trials with the P I's?
Wishing you the best.
Yes, protease inhibitors (such as Vertex) seem very promising but I prefer to wait a bit until it gets FDA approved and more feedback becomes available.
For the time being I decided to stick with the "old" interferon/riba therapies. Either 48 or 72weeks, but 48 would probably not be too helpful as it failed the first time around. Otherwise, I also considered the daily infergen injections as well but it seem even harsher than double dosing the pegylated interferon.
i'm with can do man on this one. not sure if there are studies to support a better response for relapsers that double dose interferon? i would give myself the best chance to beat the virus if i had to do treatment a 2nd time. And the best chance is one of the new PI's like telaprevir or boceprevir. You are right that we do not know what long term side effects we will get from the PI's, but we do know the damage that can be done from double dose of interferon. That is a fact! I have decided to take that chance and started the telaprevir study recently. best of luck
Wow - how did you get a doctor to approve 72 weeks of double interferon? Spcecoast just finished treatment with a double dose - his post was about a week ago. This was his third attempt. There are a lot of different methods for increasing doses. Why did you decide on this one. Some have started the Riba a couple of weeks before the INF. Some double up the Riba and INF until clear with a sensitive test.
On your first treatment what was your VL at 12 weeks and when did you clear?
To be brutally honest, I think it's an absolutely HORRIBLE idea for a stage 2, 40 year old, prior non-responder to re-treat with 72 weeks of double-dose peg. Probably one of the worst treatment strategies I've seen here in over 3 years.
The risk/reward ratio is simply much too high on the risk side with the potential toxicity and both short and long term side effects of such a treatment.
This idea is so bad that I can't believe a doctor -- or at least a hepatologist (liver specialist) is endorsing the concept -- so I just have to assume this is your own idea.
In any event, if you are determined to rid yourself of the virus at this point, I would seek out a competent liver specialist (hepatologist) and go over options which would be dependent on a thorough anaylsis of the specifics of your non-response/relapse which is difficult to differentiate without all your labs at hand.
If it were me, I'd wait for the newer drugs, as you have time on your side. That said, if you are determined to treat sooner, please do yourself a big favor and see a good liver specialist before starting on such a course.
But what do you really think?
You won't go for a protease inhibitor 'cos you are cautious and want to see data.
Instead you want to poison yourself with dangerous and unapproved dosage of interferon.
Makes perfect sense!
You and the doctor deserve each other.
Koala wasn't even a non-responder as per your post.
He was a relapser!!!!!!!!!!
Makes it even crazier.
Boy, unless your a 500 pound-er I would seriously reconsider doing the double dose for 72 weeks and then try to work to? hope you have a big bank account. I did a double shot the first week out of ignorance and paid for it somewhat dearly for the next three weeks and then 1 1/4 shot for two weeks close to the end of TX and paid for that too.
Although I'm in line for the Vertex VX-950 trial, if I don't get in by January, the doctor wants to double-dose me with Pegasys. However, let this be a cautionary tale for you. He wants to do WEEKLY bloodwork to see how the body reacts. I would insist that your doctor does the same thing.
The reason behind my Hepatologist's thinking is that if damage occurs, then damage control can best be handled right away as opposed to going through a near death scenario I went through with over-dosing with Infergen.
Not to discourage you, but here is verbatim, what the Hepatologist told me. The VX-950 has a better than 50% chance of clearing non-responders such as myself ( 4 time non-responder), but the double-dosing of Pegasys has a 15-20% of clearing non-responders.
The question then is: Can you and I wait for the final release of VX-950, which is purported to be 2010? I'm stage 3-4, beginning Cirrhosis. This is the question the doctor is best able to answer according to timely bloodwork. Let me know how you react to the treatment, and best of luck in clearing...
Unless someone posts all their viral load test stats, including sensitivities, it's difficult sometimes to figure out if someone was a relapser, non-responder, or victim of viral breakthrough for that matter. Even then, you sometimes can't draw a conclusive verdict unless viral load testing was both frequent and sensitive. That said, this ddose plan doesn't make any sense regardless.
My doc who is a liver specialist in a teaching hospital is also one that wanted me a relapser to go high dose for 72 weeks he believes anyone with hep c even with little or no damage should TX now. He acted like we were all solders on the war with hep C and the damage we might get from the TX drugs was worth the few that would SVR . Well I disagree and he works for me so I will wait out the new TX .
Don't get you!
Kaola says quite ckearly in his first post that he did 52 weeks treatment and then foiund from his 12 week post treatment PCR that he had relapsed.
He is a relapser-what's to discuss?
Koala prev: I responded well to my first TX (52 weeks of standard pegasys/riba) two years ago but relapsed after 3 months.
All he said was the above.
Does that mean he had a four week test? A 12 week test? An EOT test? No sensitivity is mentioned either.
Just one example for discussion's sake. Le'ts say he was UND by week 12 but did not do a sensitive (or not so sensitive) EOT test. So how do we know in this scenario he was a relapser as opposed to viral breakthrough?
I'm not saying he isn't a simple relapser -- all I'm saying is that it's unclear from his post because it's so general.
In any event, I think we both agree that a stage 2 double-dosing for 72 weeks doesn't make a whole lot of sense be he a relapser, slow responder or having had a viral breakthrough. Not sure what we're discussing then but please continue if you want :)
To Jim - Here are my VL stats:
40 year old. Hep C positive since I was born (most likely). Discovered infection in 2005. genotype 1B. Stage II fibrosis (from 2005 Biopsy).
Treated with Pegasys 180mcg+ riba 1200mg/day (weight: 175 pounds at the time).
Viral load: 2.6M IU/mL before treatment.
Dropped to 1310 IU/mL at +5 weeks
Became TMA negative af +12 weeks and remained TMA negative until the end of my treatment (+52 weeks). Relapsed 3 months after finishing TX.
Absolutely, my hepatologist is requiring the same thing: to get weekly blood work done to closely monitor anemia/side effects and put me on rescue drugs as soon as required.
I am patient at CPMC (Dr Gish team). They’ve been very proactive and helpful during my first TX.
Otherwise, yes I could wait 2010.
HCA, Geterdone, everyone else who is reading,
I think we’ve all been through this: What is the best decision to take? Wait or treat? What protocol? I am better off waiting for new drugs?
Unfortunately, every individual situation is different. Also, the disease progression is not necessarily linear. I don’t want to sit there doing nothing and wait until liver damage gets considerably worse and makes it much harder for me to treat later. I totally agree that it’s somehow contradictory to be cautious about (for instance) mutation risks of the virus as a result of using protease inhibitors and not about severe possible side effect of using Interferon. I guess this is also why I wrote this post, so I can get help from the group and hear from those who have tried extended treatments.
Side effects were relatively mild for me during my first TX but I can still change my mind based on the feedback I get.
It may have sounded so, but I am actually not trying to become SRV at ANY cost especially at the cost of not being able to work for a long time or not being able to retreat later with better drugs.
I am well aware that the odds of becoming SRV by retreating with Inf+Riba alone are not so high.
I am mainly trying to give my liver an other extended break until the new drugs currently in clinical trials become more widely available and long term effect better known.
Maybe I should just retreat for 72 weeks using standard Inf+Riba or only double dose for the first weeks until I become Und?
In any case, I appreciate all your feedback. This group remains invaluable to me and provided a lot of indirect support over the last few years :)
Are you saying the Gish team is recommending 72 weeks of double-dosing when newer drugs in trial are showing promising results for relapsers like yourself in only 24 weeks? I find that very hard to swallow and even harder if they are making that recommendation.
Have they looked into insulin resistance, fatty liver (you don't have to be overweight) or even your response to ribavirin (rate of hgb decline) -- as all possible factors in your relapse? (I'm assuming you did an EOT TMA here?) While better than flat-dose, weight-base riba dosing is still fairly crude compared to monitoring actual serum riba levels as have been done in certain European trials. Do you know your pre-tx hgb and how much it dropped very early in treatment? If it didn't drop much it's possible your body wasn't absorbing it well enough and you were in effect underdosed regardless of body weigh charts. And what about adding Alinia to a re-treament scenario? Or pre-dosing with riba like "FlGuy" did? Or possibly throwing some statins in the mix per some recent studies/ I'm certainly not recommending any of this because if it were me I wouldn't even treat as a stage 2 relapser at this point in history -- but if I would, I'd hope my medical team would come up with something a little more creative than sludgehammering me with a double-dose of Peg for 72 weeks.
All the best,
Koa: I am well aware that the odds of becoming SRV by retreating with Inf+Riba alone are not so high.
I am mainly trying to give my liver an other extended break until the new drugs currently in clinical trials become more widely available and long term effect better known. ---------------------
This sentence stuck out at me. Again, is this your evaluation or what your doctor has told you? I would be surprised if even an agressive medical team would suggest 72 weeks of double-dose Peg for someone with stage 2 liver damage for purposes other than a reasonable shot at SVR. As long as you're looking for feedback, why no see another medical group and get a fresh evaluaion from them?
"To be brutally honest, I think it's an absolutely HORRIBLE idea for a stage 2, 40 year old,"
Whoa for once this has got me on the same page as Jim! As someone who did a regular course of 72 weeks - I can tell you that the rewards just might not be worth the potential for problems here. 72 weeks of interferon did a number on me...and has left me with permanent autoimmune problems for the rest of my life. However as a stage 3 I did not feel I had any choice.
I wonder why you aren't looking to do at least a regular course of Infergen instead? Infergen has has good results for geno1 RELAPSERS.
Or upping the riba factor a bit even would make more sense to me and then see where you are at week 4 - perhaps going to 72 on those results.
What week did you go UND at? Little details like that might help us give you a better set of advice. I had an EVR at week 4 (almost 3 log drop) however I was not UND until somewhere after 12 and before 24. THIS is why I did 72 weeks. It has been shown to help those who are not UND at week 4 have better odds of success. However it hasn't been proven to really assist those who have relapsed after a few months. So double dosing AND extending seems a really drastic course when the other avenues have not been investigated first.
The consensus interferon (Infergen) is one option for a relapser and telepravir would be another - double dosing interferon for that long sounds like a last ditch effort and one that should be avoided at all cost if possible.
My docs never would have gone for it and both are extremely aggressive with treatment if you wish for them to be. Dr. Jacobson I don't believe ever would go for it in a million years but that is only my opinion.
Koala68, Just a curious question here, how much weight did you lose in the first 12 weeks?
"genotype 1B. Stage II fibrosis (from 2005 Biopsy). "
Thats three years ago remember I´m the walrus who in five years went to transplant.
And everybody is talking about telaprevir is gonna be here in 2010 , WTF does anybody knows about that.
Could be just rumors, it can very well take longer nobody can for certain say if its ever gonna be aproved.
My doc who is a researcher virologist specialist in infectious diseases author of articles leading studies about HCV etc told me in may this year, when i asked him when he thought telaprevir will be aproved, he said this is off the record but never, and the reason for that was that sx was to big in comparing with benefits he specifically mentioned the rash.
Maybe its wise not to be to certain when recomending waiting for something that you don´t know for sure when its gonna happen if ever.
PS I just wanna say I dont trust my docs predictions that much although hes good merits, hope hes wrong about telaprevir.
He has really said some strange things before such as he was certain I was stage 3
when the bx later showed stage 0 and he said he could predict that on my PK value which was 1.0 when I checked it, which is normal.
I double dosed peg for 55 weeks...blood work ok. I didn't advise my dr. I wanted this...he advised me. I am now back to 1 shot a week until Dec. BTW: My doctor is a hepatologist at a univ. hosp in a major city.
I am not advising you one way or another....just want you to know...it can be done and I wish you the best all the way to SVR...whatever you decide.
The are many color variations to the treatment rainbow that can be viewed through the Gish (or many other) prism holders. (BTW, I think Magnum is now in the Gish-Gang now, but wasn't for his Infergen extravaganza). Whether, it's double for the duration, double for a while and then more frequent Peg (ala Spaceman), big riba, waiting for the PI bus to come by, a maintenance Peg-only stretch or building an ensemble treatment there are a lot of options out there that might have merit. Koala seems to be astute about what he's facing, including possible risks. My take is that while considering the risk/benefit ledger a person needs to know that he is really 'fully informed' and not just swayed by excessive optimism.
Can't imagine after reading the many comments that koala will have 'excessive' optimism.
Not only did i dd...i also am doing 'big' riba. SOC would be 1000 mg..I've been doing since 10 week..1400 mg.
When I finish I will have been on tx for 22 mos.
I did a double dose course of Peg Intron/ Riba for 72 weeks, after having relapsed two years earlier immediately after a 15 month course of increasingly frequent Intron and Infergen dosing, along with Ribavirin. I relapsed within two months, and most likely because I had not stayed undetected for a long enough period of time (5 months undetected toward end of tx), and that I had to cut the Ribavirin down to less than half the optimum dose during the last few months of tx due to anemia. (no Procrit available at that time)
My second tx consisted of larger than normal weekly doses of PegIntron, which worked out to about double the recommended dose for my weight, on a weight based dosing formula. I was also able to keep the Ribavirin at mostly full dose throughout my tx by using procrit. Since I became undetected at about week 19 on this tx (technically a late responder), my doctor decided that 72 weeks were absolutely necessary to have a good shot at SVR. I fully agreed. I DID GET the SVR and its been over 5 years since I finished tx.
I do have some follow-on sx, and autoimmune problems, probably from all the months of high dose Inf. over two tx'es, but I would say that I am very happy that I did what I did. I feel much better having NO VIRUS, and normal liver functions, etc. I do not think that double dosing the interferon is as drastic as some might believe. Its not exactly additive on a 1+1 scale. Many cancer patients use much higher doses than the double dosing.
I sometimes think that for susceptable individuals, a low dose of inf. may be as problematic as a very high dose. It all depends on how YOUR body responds. I have read of some who did only ten or fifteen weeks of tx, and stopped due to drastic reactions, that lasted long term. Others have done five and six rounds of tx, and are still going strong. I have a friend that did three tx'es, his last was for two years, at high dose. He got the SVR, and now feels pretty good overall.
You may wish to discuss using another interferon with your doctor. Peg-Intron sometimes works better when Pegasys has failed (and vice-versa), and might get you and early undetected. You might be able to get the result you seek with only a minimal increase in standard Peg-Intron dosing...and you can determine whether it is working properly by testing at weeks 4, 8, and 12 during early tx. I think that full dose Ribavirin is also extremely important to avoiding post-tx relapse. This has been demonstrated time and time again. Using Procrit or other hemo-boosters can allow you to sail through the course of combined tx.
So, in all, yes you could wait for the green flag to use the newer coctail tx'es, but you will still be using interferion with it. The question of when it all becomes fully approved for patient use is still unclear. You may be able to get through an extended tx now, with minimal to moderate side effects, if you are lucky, and supervised well by your doctor. I would never advise someone NOT to go for the SVR. We know that extended tx, as well as customized dosing has indeed been shown to achieve much better results in a variety of recent studies. Our on-forum list of extended tx SVR's is a testament to that.
Just work closely with your doctor to find the very best solution for you, and what you want...balanced with your personal risks of progression of HCV, and where you are currently in medical terms. If you had minimal autoimmune and depressive problems from your first round, you might indeed be able to do the extended tx, at higher dosing without serious problems. Your doctor will need to monitor the tx closely as you go. Good luck and best wishes for a decision that ends up working best for you. See what your doctor thinks about Peg-Intron vs. Pegasys.