Aa
Relapse
Just done 28 weeks peg, rib, boceprevir. Was RGT naïve had all the best numbers.
Greater than One log drop week 2, greater two log week 4, cleared week 8. Stayed clear until week 12 post treatment. In the process of finding out about mutations. Any and all comments would be helpful.
Greater than One log drop week 2, greater two log week 4, cleared week 8. Stayed clear until week 12 post treatment. In the process of finding out about mutations. Any and all comments would be helpful.
thanks i did nt see the update that said not clear at wk12 post
thanks
again sorry for the sad news
thanks
again sorry for the sad news
The thing is he wasn't clear at 12 weeks post, he had relapsed.
leo, really sorry to hear this. Been there done that and its sure no fun......... Best to you.
cando
leo, really sorry to hear this. Been there done that and its sure no fun......... Best to you.
cando
sorry for your news
so much for the common belief that if you are clear 12 wks post tx then that it now considered to be as good as 24 wks post tx , obviously its not
so much for the common belief that if you are clear 12 wks post tx then that it now considered to be as good as 24 wks post tx , obviously its not
Again I am very sorry about your relapse. It's hard to imagine how it would feel to experience this let down after putting the time into tx.
When you said your biopsy was normal, did you mean you were stage 0? If so then at least you have time to try other things. I know this doesn't take away the disappointment, but there is a lot of hope.
Based on your log drop after the 4 week lead in of interferon and riba only. I would guess you are the IL28B genotype CT. it's good to know for future treatment that you respond decently to interferon which currently cannot be dismissed as playing a large role in defeating the virus.
Hopefully you will be able to treat with one of the other direct anti virals when they become available. The resistance you likely have developed to boce and tela should not effect the efficacy of one of the polymerase or other types of inhibitors currently being developed. Some of the BMS direct antivirals might work for you and are showing great results, or perhaps a four drug cocktail that will still include riba and interferon.
Although Merck will not release your personal sequencing data, there are several publications about which variants occur when and how long they last. From my understanding they are similar between boceprevir and telaprevir because they both use a similar mechanism to suppress the virus.
I am not sure who posted this information, but I thought if you hadn't read it already you might find it helpful. If you read the detailed information they seem to equate tela and boce regarding variants/mutants.
http://www.natap.org/2010/AASLD/AASLD_66.htm
"Telaprevir Resistance Disappears in 89% of Patients: Long-Term Follow-up of Patients with Chronic Hepatitis C Treated with Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin: Interim Analysis from the EXTEND Study"
If I was thinking of a plan for the future tx I would want to include possibly predosing and higher dose riba since you did not become anemic, and a doing a full 48 week treatment period. There is quite a difference between the data reported from previous boce trials regarding 28 and 48 week svr rates and the most current data.
I can not say what other people's experience with Merck was. Personally I went into the anemia trial having read the sequencing data and being well aware of the possibility of variants becoming dominant and long lasting. I decided to take a chance, who knows what the result will be for sure.
My doctor was clear with me about the trial parameters for continuing or stopping tx and what they considered to be viral variants breaking through. If I was not und by week 12 I would discontinue, if I had an increase of more the 1000 iu/ml I would be discontinued. If I had an increase in vl two labs in a row that was under 1000 iu/ml but I think over 100 iu/ml I would be discontinued.
You are probably well aware of all these things. I just thought more food for thought and planning can't hurt if there is anything helpful in there for you.
The best to you,
Dave
When you said your biopsy was normal, did you mean you were stage 0? If so then at least you have time to try other things. I know this doesn't take away the disappointment, but there is a lot of hope.
Based on your log drop after the 4 week lead in of interferon and riba only. I would guess you are the IL28B genotype CT. it's good to know for future treatment that you respond decently to interferon which currently cannot be dismissed as playing a large role in defeating the virus.
Hopefully you will be able to treat with one of the other direct anti virals when they become available. The resistance you likely have developed to boce and tela should not effect the efficacy of one of the polymerase or other types of inhibitors currently being developed. Some of the BMS direct antivirals might work for you and are showing great results, or perhaps a four drug cocktail that will still include riba and interferon.
Although Merck will not release your personal sequencing data, there are several publications about which variants occur when and how long they last. From my understanding they are similar between boceprevir and telaprevir because they both use a similar mechanism to suppress the virus.
I am not sure who posted this information, but I thought if you hadn't read it already you might find it helpful. If you read the detailed information they seem to equate tela and boce regarding variants/mutants.
http://www.natap.org/2010/AASLD/AASLD_66.htm
"Telaprevir Resistance Disappears in 89% of Patients: Long-Term Follow-up of Patients with Chronic Hepatitis C Treated with Telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin: Interim Analysis from the EXTEND Study"
If I was thinking of a plan for the future tx I would want to include possibly predosing and higher dose riba since you did not become anemic, and a doing a full 48 week treatment period. There is quite a difference between the data reported from previous boce trials regarding 28 and 48 week svr rates and the most current data.
I can not say what other people's experience with Merck was. Personally I went into the anemia trial having read the sequencing data and being well aware of the possibility of variants becoming dominant and long lasting. I decided to take a chance, who knows what the result will be for sure.
My doctor was clear with me about the trial parameters for continuing or stopping tx and what they considered to be viral variants breaking through. If I was not und by week 12 I would discontinue, if I had an increase of more the 1000 iu/ml I would be discontinued. If I had an increase in vl two labs in a row that was under 1000 iu/ml but I think over 100 iu/ml I would be discontinued.
You are probably well aware of all these things. I just thought more food for thought and planning can't hurt if there is anything helpful in there for you.
The best to you,
Dave
Personal history; 55 year old Caucasian diagnosed 11 years ago, contracted virus around 1979. Have never had elevated liver enzymes. First biopsy two years was normal. Symptoms; headache, ear lobe infections, vertigo. Treatment first week VL was 1,930,000. Week 4 was 59,400. Week 8 was 0. Stayed clear threw treatment. Clear week 4 post treatment. Relapsed week 12 VL count 800,000. Thanks everyone for your input.
And just to clarify things, PI's do not CAUSE mutations. They simply create an environment in which only copies of the virus with the particular resistance mutation can SURVIVE and MULTIPLY.
All my best to you leo_rex. I can really understand how frustrating, dissapointing, and heartbreaking it must be to relapse. I know from personal current experience how invested we get in curing ourselves. It's a real letdown to find out we were one of the unlucky ones.
Stay tough.
RBW
All my best to you leo_rex. I can really understand how frustrating, dissapointing, and heartbreaking it must be to relapse. I know from personal current experience how invested we get in curing ourselves. It's a real letdown to find out we were one of the unlucky ones.
Stay tough.
RBW
"Hmmm. Maybe Merck can spin the term "evidence of mutations" to their benefit. Really crummy as a trial participant to think you have to parse info on a consent. Don't you think?"
Oh believe me, I understand your frustration, and I'm no friend of the way corporate America operates. We both may be in the same boat here shortly.
As I struggle with deciding whether to continue in my study, or stop treating, I constantly have to remind myself that the purpose of the trial is not to cure me, or even to do what's in my best interest as a patient. Rather, their only goal is to complete a drug trial.
As long as they don't commit malpractice, there's nothing I can do.
:-(
Oh believe me, I understand your frustration, and I'm no friend of the way corporate America operates. We both may be in the same boat here shortly.
As I struggle with deciding whether to continue in my study, or stop treating, I constantly have to remind myself that the purpose of the trial is not to cure me, or even to do what's in my best interest as a patient. Rather, their only goal is to complete a drug trial.
As long as they don't commit malpractice, there's nothing I can do.
:-(
Don't worry you can hi Jack my thread anytime. I value your input.
I was in the anemia study.
I was in the anemia study.
If you don't mind me asking, did you actually reach SVR 12? Or did your 12 weeks post PCR come back positive.
I am asking, cause you would be the first person I heard of that tested negative week 12 post and then relapsed. It has often been mentioned that SVR 12 is as sure as SVR 24 and I would like to verify that.
Hang in there Leo!
I am asking, cause you would be the first person I heard of that tested negative week 12 post and then relapsed. It has often been mentioned that SVR 12 is as sure as SVR 24 and I would like to verify that.
Hang in there Leo!
RobertbeWell is right about mutations. And most likely merck will not give out the info on mutations caused by bocep. Lot of new drugs in pipe line,ever true. Study every study.
Oh lord, I have hijacked your thread. And I am rude and haven't said how sorry I am that you have relapsed. Terrible news.
Please post what your doc has to say about the next step for you. I think there was a post from the Liver Meeting (Willing?) that mentioned a poster session about mutations reverting back to wild type, but what that means is too soon to tell also. Actually there is a ton of stuff here on mutation but my brain is not my friend these days, so I need to spend some time going through posts again. What stage are you?
Robert I am thinking Leo is a Sprinter. Our trial was completed and unblinded this past September. And yes I realize, I probably have a bunch of NSO's.
Leo hang in there and keep us in the loop.
Please post what your doc has to say about the next step for you. I think there was a post from the Liver Meeting (Willing?) that mentioned a poster session about mutations reverting back to wild type, but what that means is too soon to tell also. Actually there is a ton of stuff here on mutation but my brain is not my friend these days, so I need to spend some time going through posts again. What stage are you?
Robert I am thinking Leo is a Sprinter. Our trial was completed and unblinded this past September. And yes I realize, I probably have a bunch of NSO's.
Leo hang in there and keep us in the loop.
My Doc assured me that I would know and as you point out, it doesn't say trial participants will be told--they got us both. I realize that. But I guess technically they really don't ever have to, which I hadn't thought of. As Bill commented it seems none of them want to give it up.
That being said, there were no changes to protocol for me (had an addition of procrit and compazine) and nurse said they never changed protocol for anyone based on info from Merck at my trial center. They are tweaked about not knowing.
And it was my doc that held the reins as far as me continuing, as long as I met trial response criteria. I did battle with him regarding sx, he was the guy that decided whether I could or could not continue on that front.
Hmmm. Maybe Merck can spin the term "evidence of mutations" to their benefit. Really crummy as a trial participant to think you have to parse info on a consent. Don't you think?
Or do you think I had no "evidence of mutations" in my 12 weeks, possibly? OMG that would be fantastic to not have any "numerous selected ones!" And it would wonderful for compadres at my center as well.
That being said, there were no changes to protocol for me (had an addition of procrit and compazine) and nurse said they never changed protocol for anyone based on info from Merck at my trial center. They are tweaked about not knowing.
And it was my doc that held the reins as far as me continuing, as long as I met trial response criteria. I did battle with him regarding sx, he was the guy that decided whether I could or could not continue on that front.
Hmmm. Maybe Merck can spin the term "evidence of mutations" to their benefit. Really crummy as a trial participant to think you have to parse info on a consent. Don't you think?
Or do you think I had no "evidence of mutations" in my 12 weeks, possibly? OMG that would be fantastic to not have any "numerous selected ones!" And it would wonderful for compadres at my center as well.
So sorry to hear about your relapse. Just happened to me as well.
Hang in there. Hopefully the new drugs will work and many of us who have relapsed will achieve SVR!!
Fashion
Hang in there. Hopefully the new drugs will work and many of us who have relapsed will achieve SVR!!
Fashion
Thank goodness we have you on this forum. You are becoming one of the "wise ones" we all look to, like my darling Bill1954.
Judy
Judy
"In my Sprint trial the consent form read:
If there is evidence of mutations, your treatment with Boceprevir will be stopped, and you will either continue treatment with PegIntron and ribavirin alone, or you will discontinue all study drugs and proceed to the follow-up period. Your study physician will decide what is in your best interest. "
Honestly, I don't think this means they WILL tell you that you HAVE mutations multiplying, only that your regimen may be changed or stopped - ie, no reason given. That's how my trial works anyway. If you're not "meeting study protocol" you are removed. Period. And they don't tell you why until after the entire trial is over. They simply say "Patient did not meet study protocol.". That's it.
I don't really think they can discuss it, if the trial is blinded, because that would compromise the "blind" factor yes?
If you got a PI, you had mutations. It doesn't work any other way. Mutations are naturally occurring because the virus doesn't "check for errors" during the replication process. In other words, your body is constantly filled with mutated virus - it's just that on a PI, the resistant ones are "selected" and become more numerous, because they are the only ones that can survive and replicate in the presence of the PI.
RBW
If there is evidence of mutations, your treatment with Boceprevir will be stopped, and you will either continue treatment with PegIntron and ribavirin alone, or you will discontinue all study drugs and proceed to the follow-up period. Your study physician will decide what is in your best interest. "
Honestly, I don't think this means they WILL tell you that you HAVE mutations multiplying, only that your regimen may be changed or stopped - ie, no reason given. That's how my trial works anyway. If you're not "meeting study protocol" you are removed. Period. And they don't tell you why until after the entire trial is over. They simply say "Patient did not meet study protocol.". That's it.
I don't really think they can discuss it, if the trial is blinded, because that would compromise the "blind" factor yes?
If you got a PI, you had mutations. It doesn't work any other way. Mutations are naturally occurring because the virus doesn't "check for errors" during the replication process. In other words, your body is constantly filled with mutated virus - it's just that on a PI, the resistant ones are "selected" and become more numerous, because they are the only ones that can survive and replicate in the presence of the PI.
RBW
"Do we mutate on SOC? "
There is some evidence that the more interferon resistant virus does become more "pronounced". I don't remember the exact details, but I do recall a couple abstracts that seemed to indicate some resistance was possible.
There is some evidence that the more interferon resistant virus does become more "pronounced". I don't remember the exact details, but I do recall a couple abstracts that seemed to indicate some resistance was possible.
Mutations are a fact of life with the PI's. Having said that, there are many, many more promising drugs just around the corner that will have no cross resistance with the current crop of PI's. So by no means should you give up hope. You have many reasons to be optimistic, especially with the good response you had.
Sorry to hear about the relapse man - I know that's gotta be TOUGH. I wish there were a guarantee, but unfortunately, at this time, there isn't. I'm struggling with the same issue myself - whether to continue on my currect tx, or wait.
Hang in there.
RBW
Sorry to hear about the relapse man - I know that's gotta be TOUGH. I wish there were a guarantee, but unfortunately, at this time, there isn't. I'm struggling with the same issue myself - whether to continue on my currect tx, or wait.
Hang in there.
RBW
This is freaking me out!! I'm beginning to think twice about tx with PI right out of the box. There is going to be lots of new scary things for me to worry about. The mutations issue is huge. Perhaps for those of us whose liver can afford to wait, do you think that is a good idea? I know these drugs are pretty effective, but I also know $ is #1 for the drug companies. I will certainly discuss the mutation issue with my new GI guy in March.
Hi Leo, what trial were you in?
Getting mutation info from Merck is not happening. They will not release any info for anyone at my trial center and to quote my doc, not abiding by the consent is "reprehensible behavior."
In my Sprint trial the consent form read:
If there is evidence of mutations, your treatment with Boceprevir will be stopped, and you will either continue treatment with PegIntron and ribavirin alone, or you will discontinue all study drugs and proceed to the follow-up period. Your study physician will decide what is in your best interest.
When I was qualifying, we discussed on multiple visits that I would be told about mutations when they occurred.
Because I never cleared and had no mutations I thought it was proof positive I received placebo. Actually in hindsight what a dumb thing to put in the consent. Wouldn't it automatically reveal that you had gotten the trial drug? I suppose if you didn't know what the mutations were, maybe not. Do we mutate on SOC?
Turns out NOT ONE of the 25 participants at my location was given any mutation info during the trial or after. My nurses at first said, well maybe no one developed any. Doc and nurses now feel differently. My nurse told me there were others who finished trial on the PI and did not clear, so I think they went 28 weeks. Willing you are up on this stuff, how long would it take to mutate? Odds are at least one of us should have been stopped.
I have been contacted by another participant who has been contacted by someone else to meet and discuss with others in the same boat. I don't know what we can do to get Merck to comply. For pete's sake, they don't follow the consent in a trial for a drug that is almost ready for prime-time?!? You would think they would not want any bumps in the road.
They have me in another IL28b study which I thought might give me some gold stars towards getting the mutation info and while going over the consent forms with Doc, I said what's the point if they don't abide by them anyway? He shook his head and said, "I agree with you."
I have a feeling that this study is more about mutations and people that didn't repsond than it is about IL28b. Fret, I know you quit pretty early, but they invited you to this study as I recall. How long did you take Bocep and did you get a decent log drop in that time? Have you received any info on mutations?
Maybe this FDA announcement will make something happen. I am going to start a new thread asking if anyone has gotten mutation info from Merck on any Boceprevir trial.
Thanks!
Foo
Getting mutation info from Merck is not happening. They will not release any info for anyone at my trial center and to quote my doc, not abiding by the consent is "reprehensible behavior."
In my Sprint trial the consent form read:
If there is evidence of mutations, your treatment with Boceprevir will be stopped, and you will either continue treatment with PegIntron and ribavirin alone, or you will discontinue all study drugs and proceed to the follow-up period. Your study physician will decide what is in your best interest.
When I was qualifying, we discussed on multiple visits that I would be told about mutations when they occurred.
Because I never cleared and had no mutations I thought it was proof positive I received placebo. Actually in hindsight what a dumb thing to put in the consent. Wouldn't it automatically reveal that you had gotten the trial drug? I suppose if you didn't know what the mutations were, maybe not. Do we mutate on SOC?
Turns out NOT ONE of the 25 participants at my location was given any mutation info during the trial or after. My nurses at first said, well maybe no one developed any. Doc and nurses now feel differently. My nurse told me there were others who finished trial on the PI and did not clear, so I think they went 28 weeks. Willing you are up on this stuff, how long would it take to mutate? Odds are at least one of us should have been stopped.
I have been contacted by another participant who has been contacted by someone else to meet and discuss with others in the same boat. I don't know what we can do to get Merck to comply. For pete's sake, they don't follow the consent in a trial for a drug that is almost ready for prime-time?!? You would think they would not want any bumps in the road.
They have me in another IL28b study which I thought might give me some gold stars towards getting the mutation info and while going over the consent forms with Doc, I said what's the point if they don't abide by them anyway? He shook his head and said, "I agree with you."
I have a feeling that this study is more about mutations and people that didn't repsond than it is about IL28b. Fret, I know you quit pretty early, but they invited you to this study as I recall. How long did you take Bocep and did you get a decent log drop in that time? Have you received any info on mutations?
Maybe this FDA announcement will make something happen. I am going to start a new thread asking if anyone has gotten mutation info from Merck on any Boceprevir trial.
Thanks!
Foo
No anemic for me. Being anemic is a very good thing. It helps kill the virus.
Take all the drug you can get.
Take all the drug you can get.
I am very sorry to hear of your relapse. I am sure this very difficult news for you.
I assume you were in the anemia trial, is that correct? I am in week 34 of this trial as I was und week 10. Did you become anemic, if so did did your riba get reduced?
I believe I signed something allowing them to do the sequencing data for mutations at the begining, I don't know if they will allow you to see the data but that would be important in possibly understanding where to go from here. Perhaps a different type of inhibitor will work for you.
Again I am very sorry about your news.
Take care, Dave.
I assume you were in the anemia trial, is that correct? I am in week 34 of this trial as I was und week 10. Did you become anemic, if so did did your riba get reduced?
I believe I signed something allowing them to do the sequencing data for mutations at the begining, I don't know if they will allow you to see the data but that would be important in possibly understanding where to go from here. Perhaps a different type of inhibitor will work for you.
Again I am very sorry about your news.
Take care, Dave.
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