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Null responder needs advice.
I am a null responder with early cirrhosis- liver function so far is quite good. Have been waiting patiently for telaprevir approval and just received devastating news from my consultant that for people like me telaprevir is very disappointing- only 14% chance of SVR ( based on data released at EASL 2011).
This very depressing news was given alongside warnings about viral resistance and potential exclusion from other trials further down the line because of failure with a protease inhibitor (if I do fail).
My consultant was talking about quad therapy like the Roche trial now in phase 2 and believes quad therapy is the future treatment of choice for null responders. The Roche phase 3 quad therapy trial won't come around until the end of 2012. I can't wait that long, but nor do I want to be excluded from more promising treatments that are on the horizon.
I feel utterly stuck and damned either way- any advice or alternative ways of viewing this situation would be really welcome.
I now have to try to glean information from those who know and also keep watching how other people choose to deal with these difficult decisions and try to make some sort of informed choice. Can anyone lend a hand as I can't think straight now !
Hope everyone's well.
Thanks
Paul.
This very depressing news was given alongside warnings about viral resistance and potential exclusion from other trials further down the line because of failure with a protease inhibitor (if I do fail).
My consultant was talking about quad therapy like the Roche trial now in phase 2 and believes quad therapy is the future treatment of choice for null responders. The Roche phase 3 quad therapy trial won't come around until the end of 2012. I can't wait that long, but nor do I want to be excluded from more promising treatments that are on the horizon.
I feel utterly stuck and damned either way- any advice or alternative ways of viewing this situation would be really welcome.
I now have to try to glean information from those who know and also keep watching how other people choose to deal with these difficult decisions and try to make some sort of informed choice. Can anyone lend a hand as I can't think straight now !
Hope everyone's well.
Thanks
Paul.
Best Answer
Hi ev no haven't had vit D checked but am taking it in supplement form along with tmg, same, ala,,milk thistle etc.
Ev...... several things worth mentioning; First, they didn't use much anemia helpers in the Vertex trial, but did in the Boceprevir trial, so some things can be compared and some things not.
Second, I believe the PI's in and of themselves may also create more anemia, even without the SOC. If Joe's issue was anemia it will probably continue to be so, except possibly worse. In such cases a sharp doctor or even a hemotologist may be another useful consult or back up if the issue were to pop up again. If one can weather thru the first 12 weeks without reduction the chances of success are far greater.
Third, since it appears that Joe is improving in some respects.... is it possible that waiting a little might even mean a better outcome?
If one looks at alcohol use...... just stopping right before TX does not really impact response rates dramatically. Somehow the body takes some time to recover before the absence of alcohol starts to impact on increasing the response rate. It could be that over time Joe may have a different response profile than his earlier one.
This is kind of muddy and there isn't a lot of data supporting this but it could be that some of these lifestyle and supplement changes are something that need to accumulate, and are not something that one can start the night before TX, just to reduce this concept to the absurd. If so, like my friend who succeeded on her third TX both Joe and 22hamilton may have a more successful run next time around.
willy
Second, I believe the PI's in and of themselves may also create more anemia, even without the SOC. If Joe's issue was anemia it will probably continue to be so, except possibly worse. In such cases a sharp doctor or even a hemotologist may be another useful consult or back up if the issue were to pop up again. If one can weather thru the first 12 weeks without reduction the chances of success are far greater.
Third, since it appears that Joe is improving in some respects.... is it possible that waiting a little might even mean a better outcome?
If one looks at alcohol use...... just stopping right before TX does not really impact response rates dramatically. Somehow the body takes some time to recover before the absence of alcohol starts to impact on increasing the response rate. It could be that over time Joe may have a different response profile than his earlier one.
This is kind of muddy and there isn't a lot of data supporting this but it could be that some of these lifestyle and supplement changes are something that need to accumulate, and are not something that one can start the night before TX, just to reduce this concept to the absurd. If so, like my friend who succeeded on her third TX both Joe and 22hamilton may have a more successful run next time around.
willy
Have you had your vitamin D checked?
Hey thanks some great responses here. In comparison to my last failed attempt with SOC I feel in some ways better equipped now- over two stones lighter, careful diet and all mentioned supps apart from PPC.
I will digest the wisdom and make my case with specialist in two weeks time.
Thanks guys, stay well all.
I will digest the wisdom and make my case with specialist in two weeks time.
Thanks guys, stay well all.
Willy- The riba dose reductions during trials is an angle I'd not thought of. That would have to make a big impact on those with lots of liver damage. The damage alone keeps Joe in a state of low hgb before you throw riba at him. His first two TX were doomed to fail because of riba reductions. If Procrit isn't waiting in the wings ready to use, I wouldn't even want Joe to think about starting TX. As some of these things become clear, I'm so glad he didn't make it in to prove 3 although I was quite sad at the time. It likely would have been another discouragment.
Willing and Mike716 -Do you remember the explanation HR gave as to why plain lecithin would not be effective but PPC would? I know he went in to it in a lot of detail and put great emphasis on the fact that it needed to be Polyenelphosphatidylcholine and not just choline or lecithin. I remember a study he made reference to that had increased SVR's using the PPC form during TX. It is certainly an example of how important the fine details can get, especially to the marginal responders.
Ev
Willing and Mike716 -Do you remember the explanation HR gave as to why plain lecithin would not be effective but PPC would? I know he went in to it in a lot of detail and put great emphasis on the fact that it needed to be Polyenelphosphatidylcholine and not just choline or lecithin. I remember a study he made reference to that had increased SVR's using the PPC form during TX. It is certainly an example of how important the fine details can get, especially to the marginal responders.
Ev
Some good replies. I particularly like willings last summary of a few replies.
First of all, there could be a large difference between cirrhotic null responders and a null responder with *the beginning* of cirrhosis.
Segundo..... there may be a difference in being able to treat with a PI in a trial and being denied a rescue drug versus treating with an approved PI and being able to use rescue drugs. Vertex ran very tight trials and in some cases they would do a riba dose reduction when anemia hit a certain point. In the first 6-12 weeks of TX this was really a critical time and..... people ultimately failed triple therapy. Who knows what the SVR rate would have been in such cases with rescue drug intervention? I don't, but it *could* make a difference.
Third..... I have a friend who just SVR'ed on the 3rd go around. Empirical evidence suggested that she would fail here third time.
THIS TIME.....she lost weight, exercised, did milk thistle, vit D and a few other adjuncts. Guess what? This time after failing a 65ish week and 48 week TX ...........she achieved a RVR and an ultimate SVR.
IF you do nothing to differentiate yourself from the average TX'er you'll tend to get average results. Try doing everything right; I'd bet you'll see better results too.
4th.... Unless your consultant is clairvoyant they really don't know if you are going to be accepted into a trial, if you can get into one of the really good ones and if you will end up in a rock star trial arm. you could, in some trials end up in one of the under-dosed, too short of TX, arms of a trial and end up with an ultimate fail. Trials after all are designed to differentiate outcomes. That means some will fail. Do you really need to wait a year or two for some game of chance? If so....start scouting; some trials are better than others. Some offer better odds. Clearly a 3a or 3b/ post approval trial may be one of the best options.
I am hopeful that some future trials will switch to triple therapy as the "control/ placebo arm" and we will see improved response rates in these trials.
best,
willy
First of all, there could be a large difference between cirrhotic null responders and a null responder with *the beginning* of cirrhosis.
Segundo..... there may be a difference in being able to treat with a PI in a trial and being denied a rescue drug versus treating with an approved PI and being able to use rescue drugs. Vertex ran very tight trials and in some cases they would do a riba dose reduction when anemia hit a certain point. In the first 6-12 weeks of TX this was really a critical time and..... people ultimately failed triple therapy. Who knows what the SVR rate would have been in such cases with rescue drug intervention? I don't, but it *could* make a difference.
Third..... I have a friend who just SVR'ed on the 3rd go around. Empirical evidence suggested that she would fail here third time.
THIS TIME.....she lost weight, exercised, did milk thistle, vit D and a few other adjuncts. Guess what? This time after failing a 65ish week and 48 week TX ...........she achieved a RVR and an ultimate SVR.
IF you do nothing to differentiate yourself from the average TX'er you'll tend to get average results. Try doing everything right; I'd bet you'll see better results too.
4th.... Unless your consultant is clairvoyant they really don't know if you are going to be accepted into a trial, if you can get into one of the really good ones and if you will end up in a rock star trial arm. you could, in some trials end up in one of the under-dosed, too short of TX, arms of a trial and end up with an ultimate fail. Trials after all are designed to differentiate outcomes. That means some will fail. Do you really need to wait a year or two for some game of chance? If so....start scouting; some trials are better than others. Some offer better odds. Clearly a 3a or 3b/ post approval trial may be one of the best options.
I am hopeful that some future trials will switch to triple therapy as the "control/ placebo arm" and we will see improved response rates in these trials.
best,
willy
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-- PIs (protease inhibitors like Boceprevir and Telaprevir) are not the only game in town. There are all sorts of other drugs now in trials. One of the more promising (to my mind) is Globeimmune's GI-5005 immunogen, which has recently reported some trial success with null responders (see the news articles at Globeimmune-dot-com), and also particularly with people who have the IL28B T/T genotype.
-- Have you tried to find out why you are a null responder? Knowing the cause of a condition is the first step in dealing with it. Cause and effect is the basis of all knowledge, and knowledge is power.
-- Trying to get rid of the virus is only half the fight. The other half is keeping up your liver function. There are things you yourself can do for that. Some are: diet, exercise, and alternative meds (silibin, PPC, ALA, Vitamin E, SAMe, Lactoferrin, etc., and especially the immune system boosters). Believe it or not, some of them do work.
Maybe you know all this stuff. If so, I apologize for wasting your time. However, I'm a firm believer in self-help. It keeps you from slipping into a dependence syndrome. Taking action is one of the best medicines around.
Good luck.
Mike