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RO4588161 - NEED INFO!!
My husband is set to receive his first shot of tx this week in the Roche clinical trial for RO4588161 Double-Blinded Dose Finding Study Phase II. I have read some of the posts and I need some clarifying of "viral breakthrough"
His last two viral loads have been 48,000 and 95,000 which I guess are very low. His biopsy was a Stage I. His ALT's are always slightly elevated, between 69-95. He his currently asymptomatic, with an immune system that I could only dream of (never sick).
Is is possible w/ tx that he could get a "super HCV" more resistant mutation of the virus and could end up going way up with his viral loads?
I am really frightened. Any help would be greatly appreciated!! Thanks so much for all your great posts!
His last two viral loads have been 48,000 and 95,000 which I guess are very low. His biopsy was a Stage I. His ALT's are always slightly elevated, between 69-95. He his currently asymptomatic, with an immune system that I could only dream of (never sick).
Is is possible w/ tx that he could get a "super HCV" more resistant mutation of the virus and could end up going way up with his viral loads?
I am really frightened. Any help would be greatly appreciated!! Thanks so much for all your great posts!
THANK YOU SO MUCH FOR YOUR HELP !! This forum is a blessing to anyone going through this. My husband & I spoke last night and he has decided to go ahead with the tx. First shot is scheduled for the AM. One more question please!! My husband usually works long hours on his feet and I am trying to help to get someone to cover him for when he feels side effects the most. Any suggestions on that? Weekends are his busiest, but he is off most of Saturday and all of Sunday. WHen should we do that shot?
You are all so helpful and caring. I will keep you all in my prayers and thoughts. Stay strong and thanks for helping me to.
OOps, another quick one, are any of you taking liver supplements, milk thistle, etc??
Thanks again!!
You are all so helpful and caring. I will keep you all in my prayers and thoughts. Stay strong and thanks for helping me to.
OOps, another quick one, are any of you taking liver supplements, milk thistle, etc??
Thanks again!!
there are also folks pulled due to liver toxicity to INF, and Kidney toxins caused by Riba,
so none of these things are without some risk. That is part of what makes it important to try different dosages. They need to ascertain, how much can be tolerated that will work well, without causing to much malfunction and reaction.
think of these drugs as weed killers......we go in to spray for dandelions, and we want the grass to stay healthy and intact. If we use the right dilution we should be able to kill the weeds and leave the grass standing, as we designed the molecule to go after dandelion tissue, not grass tissue.....but we still need the right mix....or we could damage plants we don't want to damage.
It would be interesting to here HR explain how the polymerase inhibitors differ from the protease ones.....maybe next month we can ask him.
anyway, I think the inhibitors are the first thing in years to show real and immediate results...so great promise there. To be in such a trial is at least glass half full stuff...
which is the same as for SOC......only 50/50 shot there.
If you read up on ANY drug, even ones in the marketplace right now, you will see a certain number of heart attacks/strokes/deaths associated with that drug. It may be one in a million, or one in ten thousand but it's true of any drug. Mostly, the folks who have these reactions are ones who already had weakened conditions to begin with, and so one cannot in most cases say it was the drug that created the condition anyway. Yes sometimes there are allergic reactions.....but if a patient tries a new heart med, and he already takes 5 meds and has blocked arteries then how does one know that the new treatment killed, and not the years of bacon?
in any case, I think folks can get really fearful when one reads up on risks and side effects. Just remember, they have to list every symptom....and folk with HCV often have many other conditions and prescriptions that can influence how they tolerate the additional meds.
Best advice is to keep thinking positive, as if stuff comes up that is too difficult, get help dealing with it.
so none of these things are without some risk. That is part of what makes it important to try different dosages. They need to ascertain, how much can be tolerated that will work well, without causing to much malfunction and reaction.
think of these drugs as weed killers......we go in to spray for dandelions, and we want the grass to stay healthy and intact. If we use the right dilution we should be able to kill the weeds and leave the grass standing, as we designed the molecule to go after dandelion tissue, not grass tissue.....but we still need the right mix....or we could damage plants we don't want to damage.
It would be interesting to here HR explain how the polymerase inhibitors differ from the protease ones.....maybe next month we can ask him.
anyway, I think the inhibitors are the first thing in years to show real and immediate results...so great promise there. To be in such a trial is at least glass half full stuff...
which is the same as for SOC......only 50/50 shot there.
If you read up on ANY drug, even ones in the marketplace right now, you will see a certain number of heart attacks/strokes/deaths associated with that drug. It may be one in a million, or one in ten thousand but it's true of any drug. Mostly, the folks who have these reactions are ones who already had weakened conditions to begin with, and so one cannot in most cases say it was the drug that created the condition anyway. Yes sometimes there are allergic reactions.....but if a patient tries a new heart med, and he already takes 5 meds and has blocked arteries then how does one know that the new treatment killed, and not the years of bacon?
in any case, I think folks can get really fearful when one reads up on risks and side effects. Just remember, they have to list every symptom....and folk with HCV often have many other conditions and prescriptions that can influence how they tolerate the additional meds.
Best advice is to keep thinking positive, as if stuff comes up that is too difficult, get help dealing with it.
this looks like fresh info in this blog;
http://binkyslife.blogspot.com/
I don't think that resistance is going to be an issue but a small percentage of treatment failures are predicted to null responders. IF he has responded in the past but experienced viral breakthrough he would likely respond again this time. In the presence of a stronger antiviral treatment he could very well succeed this time.
Since this appears to be a polymerase inhibitor I would also warn you that one was pulled from trials this summer due to liver toxicity. You can google HCV796. I'm going from memory but I believe I'm correct. Overall the drug was actually very successful. There were a few elevated liver enzymes and I think just one serious case but they didn't immediately resolve after the treatment ended. I never hear any followup on the results but I would almost bet that some people may ultimately SVR or would have if treatment had continued. Technically, some of them may have since I believe the FDA stopped the trial in early August. I'm not trying to over worry you; only a VERY small percent (like 1%) had serious liver toxicity issues but they were serious enough that they stopped the trial.
It's a different drug and the blog shows positive results. I just wanted to give you some positive and a little negative to also think about.
best,
Willy
http://binkyslife.blogspot.com/
I don't think that resistance is going to be an issue but a small percentage of treatment failures are predicted to null responders. IF he has responded in the past but experienced viral breakthrough he would likely respond again this time. In the presence of a stronger antiviral treatment he could very well succeed this time.
Since this appears to be a polymerase inhibitor I would also warn you that one was pulled from trials this summer due to liver toxicity. You can google HCV796. I'm going from memory but I believe I'm correct. Overall the drug was actually very successful. There were a few elevated liver enzymes and I think just one serious case but they didn't immediately resolve after the treatment ended. I never hear any followup on the results but I would almost bet that some people may ultimately SVR or would have if treatment had continued. Technically, some of them may have since I believe the FDA stopped the trial in early August. I'm not trying to over worry you; only a VERY small percent (like 1%) had serious liver toxicity issues but they were serious enough that they stopped the trial.
It's a different drug and the blog shows positive results. I just wanted to give you some positive and a little negative to also think about.
best,
Willy
every reason for concern, yet you must keep in mind that only a few years ago everyone was in trials for Riba and INF....and that's the only reason that more than half the people with this disease are successfully being rid of this virus. Before that, there was nothing.
Now, medicine is looking for a way to get a better result than 50 percent, with new medicines, or to get at least AS good of a result, with less toxic medicines.
Before a trial reaches Phase II there's a lot done with animals and small human trials, so the idea that the researchers are "blind" about what the expactations might be in not quite accurate. Of course the only way to know for sure if the addition of the new inhibitor will have just as successful a result with less of the old drug is to try the different dosages.
the thing that might help you to know is this.
1. 1000 mg of Riba is not a low dose, it's not the highest, true enough, but it is not low either. 1200 is SOC. Obviously the research thinks less of this badboy is OK when the new drug is present. So you are OK there.
2. Interferon is made by the body anyway. In fact, those on the highest doses have their bodies almost stop making it entirely, because so much is being added. However, that also means, if on a lower INF dose, ones body may keep producing some of it's own. Hopefully this is also part of what is being researched here, is how much extranINF do we need to add in the presense of 2 additional antiviral drugs.
3. Unless a person ended up in the worst grouping....meaning placebo AND low doses of INF/Riba, and if he is 1a especially... then there would be no need to worry.
While there is no way to know definitively that that could not happen, it is also true that there is only a one in 8 chance of that happening. What you are by LAW allowed to do is to ask for your records at any time. Just say you are still not feeling well and you and your doctor need to know your bloodwork results to continue your other health care wisely.
CAUTION here: viral loads will jump around, and so I would not be too eager to do this, but if it turns out that say 3 months down the road your husband feels no real side effects, (which could indicate low dosages), and you have some means such as health insurance, whereby you could go and get upped to a regular dosage SOC by a liver doctor, assuming his viral load had not responded to the trial drugs, then it would be your right to do so.
CAUTION again, unless you know how to read the results of the blood tests etc. I wouldn't advise this, as once you are in the trial, it would be difficult to find a doctor willing to immediately treat, and you do nt want there to be a GAP in your treatment, as that is when the concerns regarding mutation go up.
You best bet would be to stick out the trial as hubby sounds healthy enough to retreat if neccessary. Remember than research has shown that even some time on SOC has helped even those that do not clear the virus, just knocking it back some can be beneficial, although obviously a cure is what everyone is after.
It's natural to have some fears around all this, but just remember every decade advances the cure. Also, remember if Jonas Salk had worried about mutations our children would still be busy contracting polio. At some point we all have to just buck up, and try to be brave, and know that medicine is doing it's best to come up with a reliable and bearable treatment for this disease, and be grateful that there are even chances to have these better drugs and odds.
Hope you both do well.
MaryB
Now, medicine is looking for a way to get a better result than 50 percent, with new medicines, or to get at least AS good of a result, with less toxic medicines.
Before a trial reaches Phase II there's a lot done with animals and small human trials, so the idea that the researchers are "blind" about what the expactations might be in not quite accurate. Of course the only way to know for sure if the addition of the new inhibitor will have just as successful a result with less of the old drug is to try the different dosages.
the thing that might help you to know is this.
1. 1000 mg of Riba is not a low dose, it's not the highest, true enough, but it is not low either. 1200 is SOC. Obviously the research thinks less of this badboy is OK when the new drug is present. So you are OK there.
2. Interferon is made by the body anyway. In fact, those on the highest doses have their bodies almost stop making it entirely, because so much is being added. However, that also means, if on a lower INF dose, ones body may keep producing some of it's own. Hopefully this is also part of what is being researched here, is how much extranINF do we need to add in the presense of 2 additional antiviral drugs.
3. Unless a person ended up in the worst grouping....meaning placebo AND low doses of INF/Riba, and if he is 1a especially... then there would be no need to worry.
While there is no way to know definitively that that could not happen, it is also true that there is only a one in 8 chance of that happening. What you are by LAW allowed to do is to ask for your records at any time. Just say you are still not feeling well and you and your doctor need to know your bloodwork results to continue your other health care wisely.
CAUTION here: viral loads will jump around, and so I would not be too eager to do this, but if it turns out that say 3 months down the road your husband feels no real side effects, (which could indicate low dosages), and you have some means such as health insurance, whereby you could go and get upped to a regular dosage SOC by a liver doctor, assuming his viral load had not responded to the trial drugs, then it would be your right to do so.
CAUTION again, unless you know how to read the results of the blood tests etc. I wouldn't advise this, as once you are in the trial, it would be difficult to find a doctor willing to immediately treat, and you do nt want there to be a GAP in your treatment, as that is when the concerns regarding mutation go up.
You best bet would be to stick out the trial as hubby sounds healthy enough to retreat if neccessary. Remember than research has shown that even some time on SOC has helped even those that do not clear the virus, just knocking it back some can be beneficial, although obviously a cure is what everyone is after.
It's natural to have some fears around all this, but just remember every decade advances the cure. Also, remember if Jonas Salk had worried about mutations our children would still be busy contracting polio. At some point we all have to just buck up, and try to be brave, and know that medicine is doing it's best to come up with a reliable and bearable treatment for this disease, and be grateful that there are even chances to have these better drugs and odds.
Hope you both do well.
MaryB
I haven’t been following the progress of this trial, but did find a recent thread from Medhelp that addresses some of your concerns:
http://www.medhelp.org/posts/show/423505?post_id=post_2452904
Good luck,
Bill
http://www.medhelp.org/posts/show/423505?post_id=post_2452904
Good luck,
Bill
The viral load is not directly dependent on whether or not there are resistant mutations present. Also, viral load does not directly correlate to liver damage. So viral load is not the thing to be most concerned about.
Your husband is in the trial of R1626. I have not seen any data released on the resistance profile of this drug although there may be some that I have missed - anybody? You need to know whether it does produce resistant mutations before worrying about this aspect. The worry is not that his viral load would go up but that the drug would then be ineffective if it became necessary to re-treat.
As you have read previous posts on viral breakthrough, what is it that you would like to be clarified?
This whole crappy business is frightening for everyone, and trials are even more of an unknown, so you are not alone with your fears. There's usually somebody here who's been through it and can help so please keep on writing and asking. Your husband is lucky to have you to be involved and to help him. Make sure that you also get the support that you need and you'll both be fine.
dointime
Your husband is in the trial of R1626. I have not seen any data released on the resistance profile of this drug although there may be some that I have missed - anybody? You need to know whether it does produce resistant mutations before worrying about this aspect. The worry is not that his viral load would go up but that the drug would then be ineffective if it became necessary to re-treat.
As you have read previous posts on viral breakthrough, what is it that you would like to be clarified?
This whole crappy business is frightening for everyone, and trials are even more of an unknown, so you are not alone with your fears. There's usually somebody here who's been through it and can help so please keep on writing and asking. Your husband is lucky to have you to be involved and to help him. Make sure that you also get the support that you need and you'll both be fine.
dointime
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