Aa
All oral trial failed (for me). On to rescue arm.
Gilead all oral study with gs-5885, gs-9551, gs-9190, and Riba. UND by day 7. Breakthrough reported somewhere around the 6-8 week mark. Yeah, it's a bummer. So now I'm going into the rescue arm. It's all the mentioned drugs without gs-9190 (Tegobuvir) plus PEG. First shot is tomorrow. Nervous as hell. My doc thinks it's a better idea to stay on the polymerase inhibitors with PEG and Riba than to stop and go directly to Tela/Riba or Bocep/Riba. Any opinions on that? All comments and prayers welcome! Wish me luck!
Congrats Adamben, for all the folks screaming about interferon is of the devil - what a real life difference it can be huh? I am so glad for you...great news. :D
Gene, Sorry to hear about the rough week. Great on the UND news. I'm actually on the schedule for the full 48 weeks of the rescue due to the fact that I didn't go back to UND until week 4 or 6. Anyway, I'm fine with that. I feel great. No side effects at all. No one would ever know I was on week 13 of PEG if I didn't tell them. Even my trial coordinators are amazed.
Glad to hear you're still UND! Being undetectable on both week 4 and 12 means only 24 weeks.Good luck.
So, it's been two weeks for me, just did my third shot. So far, the good news is that I went back to UND after the very first week of PEG! On the other hand this first week was rather rough on me - I had 101+ fever for most of the first four days and was totally exhausted as the result. The second week was much more gentle, let's see what this third one will bring.
So, it's been two weeks for me, just did my third shot. So far, the good news is that I went back to UND after the very first week of PEG! On the other hand this first week was rather rough on me - I had 101+ fever for most of the first four days and was totally exhausted as the result. The second week was much more gentle, let's see what this third one will bring.
Good luck! What I learned is the shots are not bad at all. also, I've been very lucky with side effects. Nothing other than some minor red irritation/rash near my injection sites on my stomach. Nothing worth complaining about. The PEG didn't take effect for 4 weeks. We think maybe the PEG got corrupted but will never know. But today is 12 weeks on the rescue and I've been UND for 8. You will be too. Also, when they take the 9190 out of the mix, you will feel better. Seems the 9190 caused some shortness of breath and nervousness for me.
Adam,
Thanks for all your contributions and have a wonderful holidays!
I'm in exactly the same shoes as you, only you're about nine weeks ahead of me on this path. Had a long talk with my Doc yesterday, made my mind. Starting the rescue arm and my first PEG shot today.
--E
Thanks for all your contributions and have a wonderful holidays!
I'm in exactly the same shoes as you, only you're about nine weeks ahead of me on this path. Had a long talk with my Doc yesterday, made my mind. Starting the rescue arm and my first PEG shot today.
--E
Hey Adam. Glad to hear you are feeling better. Best of luck and thanks for letting us know what the doc said.
Hey everyone. wow, that's a lot of armchair quarterbacks...hehe. I'm in a better mood tonight. Kind of got freaked out by the whole mutations conversations. Went in today and I did take about 15 questions in with me to my Hepa doc. He was impressed with the questions and their logic. However he made a few things clear. Based on previous studies, mutations like the ones I'm experiencing are common with protease inhibitors without PEG. He believes strongly that the Polymerase Inhibitors are much stronger. Because we have found the outbreak quickly he believes we have a great chance of using PEG to kill those mutations. Other studies have actually shown that while the mutations exist, they are relatively weak. Without going through each of the questions I asked and his answers, he definitely knew his stuff and made me feel like adding PEG is the way to go. It may not be 100% effective but it's the best thing going. Hopefully the 1, 2 and 4 week VL tests show some very positive results. Thanks again for everyone's comments. Adam
Unfortunately Adam nor any other trial participants don't get to sit down and meet with the researchers(at least I never got to)..would be nice but they are too busy .........researching. We are left to chat with the nurses and doctors they employ..who often at this stage unfortunately don't know that much more than anyone else when it comes to the complex subject of resistance profiles
In the meantime some of us will participate in their experiments and when they get it right or at least unravel some more of the mysteries in that regard we should all be in better positions.
Again ..good luck Adam,,hope this works out for you..
Will
In the meantime some of us will participate in their experiments and when they get it right or at least unravel some more of the mysteries in that regard we should all be in better positions.
Again ..good luck Adam,,hope this works out for you..
Will
.. and perhaps Adam would get more useful information about his situation if he spares the busy doctors the debate on whether this forum contains armchair medicine or not. I think it is without question armchair medicine but that doesn't mean it has no value.
If I read the thread correctly there seems to be a suggestion that the researchers were deliberately trying to develop a resistence scenario for study purposes. Despite all my cencerns about the pharmaceutical industry being the primary drivers of research, I would still think that they were trying to find out how to overcome the resistence problem rather than creating it. Anyway, a comment here and there on the medical ethics applied to clinical trials might also be of interest to all of us.
More than anything though, if Adam gets some answers from the doctors conducting the trial he can relax a bit about his situation and have more information to make a decision about how to proceed. If he doesn't, we can all get really angry, kick up a storm, and warn others to be careful with Gilead trials in the future. I think he will get good answers though.
If I read the thread correctly there seems to be a suggestion that the researchers were deliberately trying to develop a resistence scenario for study purposes. Despite all my cencerns about the pharmaceutical industry being the primary drivers of research, I would still think that they were trying to find out how to overcome the resistence problem rather than creating it. Anyway, a comment here and there on the medical ethics applied to clinical trials might also be of interest to all of us.
More than anything though, if Adam gets some answers from the doctors conducting the trial he can relax a bit about his situation and have more information to make a decision about how to proceed. If he doesn't, we can all get really angry, kick up a storm, and warn others to be careful with Gilead trials in the future. I think he will get good answers though.
I wouldn't like to comment on the advice given but I would sure like to hear what the researchers have to say about drug resistence profiles. Which ones have higher or lower resistence barriers and their reasoning behind various combinations.
I agree .. downloading the " excellent "armchair advice " you got here would be good for the doctors perusal.
Possibility they would be interested in something that the many knowledgeable members here observed.
Seems to happen all the time when they are presented with such...
Good luck Adam...
Possibility they would be interested in something that the many knowledgeable members here observed.
Seems to happen all the time when they are presented with such...
Good luck Adam...
Downloading the thread and asking the researchers for advice sounds like a very good idea to me. Then Adam can tell us the response. It could be really interesting. What a great idea Curious.
Adam. I hope you are doing alright. I am sure everyone here is wishing the best for you.
Adam. I hope you are doing alright. I am sure everyone here is wishing the best for you.
"Adam, Before being spooked by some of the armchair medicine that is practiced on this forum."
It seems there have been some posts provided you that I would interpret as armchair medicine. Perhaps you wouldn't mind explaining that comment?
It seems there have been some posts provided you that I would interpret as armchair medicine. Perhaps you wouldn't mind explaining that comment?
Adam, Before being spooked by some of the armchair medicine that is practiced on this forum, I hope you will at least download the thread and bring it to your physician(s) for comment and explanation.
"Don't you think the addition of PEG will help in killing the mutations while the existing RIBA and PIs continue to suppress the virus? I know it's not 100% shot but it's got to be better than just the PIs. Thoughts?"
Our posts crossed and when I wrote my last post to you I had not seen this one from you. However I had already recommended SOC as your best chance of SVR. So I am confused as to why you are still asking me about the addition of peg. Maybe you don't understand that ifn = interferon = peg? Maybe you don't understand that SOC = peg + riba? The abbreviations can be confusing.
Anyway to say it again - yes I do think that PEG with riba (SOC) is your best chance, if not your only chance currently, of killing the mutations and getting to SVR.
In addition, the PI's are now virtually useless to you because your viral population is resistant to them. Gilead is keeping you on them to test whether there is any advantage in it at all. This has never been done before and nobody knows. If you SVR then all's well that ends well. If you don't SVR then it is possible that your mutated strain of the virus will become more fit and stable the longer you stay on the PI's.
dointime
Our posts crossed and when I wrote my last post to you I had not seen this one from you. However I had already recommended SOC as your best chance of SVR. So I am confused as to why you are still asking me about the addition of peg. Maybe you don't understand that ifn = interferon = peg? Maybe you don't understand that SOC = peg + riba? The abbreviations can be confusing.
Anyway to say it again - yes I do think that PEG with riba (SOC) is your best chance, if not your only chance currently, of killing the mutations and getting to SVR.
In addition, the PI's are now virtually useless to you because your viral population is resistant to them. Gilead is keeping you on them to test whether there is any advantage in it at all. This has never been done before and nobody knows. If you SVR then all's well that ends well. If you don't SVR then it is possible that your mutated strain of the virus will become more fit and stable the longer you stay on the PI's.
dointime
I know you must be terribly disappointed, the SOC sounds like a safety net. Stay strong, think positive, do some self nurturing things, be gentle with you.
Good luck on PEG, sending you light and good vibes.
Good luck on PEG, sending you light and good vibes.
Thanks for all the support! I'm definitely scared of possible viral outbreak even on PEG. Anyone have a good specialist I might be able to confer with. So tough to make a decision on this stuff even after researching it for a year or two. Not to mention that there's no silver bullet yet. Keep me in your thoughts. Starting PEG in a few hours. Thanks
I'm sorry Adamben but I do agree with the others, if you are a g1 the interferon is the best thing in the arsenal that you have. Sometimes having a low VL seems to work against us for some reason (immunity is already ramped up?) I don't really know why but it's just a fact of life. It seems contrary that folks with a VL in the millions can have it easier to clear and stay clear but it's not always the case.
I hope in your case that SOC gets you to SVR and I am so sorry this happened. That is why they are called trials I guess. ***** either way.
I hope in your case that SOC gets you to SVR and I am so sorry this happened. That is why they are called trials I guess. ***** either way.
"Thank everyone for the comments. Yes, the rescue is meant to continue with the quad therapy, adding PEG. The hope is that while the PIs and RIBA are working hard to contain the virus, the PEG will come in and squash it. At this point, I don't see much else to do. "
There's nothing else you can do except leave the study and go on to SOC alone. If it were me, I'd stick with the study for the first 4 weeks until you can gauge your ifn response. With a good ifn response you will still get to SVR, especially as you have the big advantage of starting the ifn with a low vl.
At this point it may be wise to ask if you will be allowed the SOC rescue drugs, ie. procrit and neupogen, if you need them?
Your viral population now most likely consists entirely of resistant mutations. The wild type virus against which the DAA's are effective, will be entirely gone now. So you might as well be eating jelly babies as continuing with the DAA's except that their presence will close the escape route to the virus of reverting back to wild-type. It is possible that this will give an advantage over SOC alone, and Gilead obviously wants to study the possibility.
Best wishes to you. Please let us know how you are doing and how your 4 week results with ifn come in,
dointime
There's nothing else you can do except leave the study and go on to SOC alone. If it were me, I'd stick with the study for the first 4 weeks until you can gauge your ifn response. With a good ifn response you will still get to SVR, especially as you have the big advantage of starting the ifn with a low vl.
At this point it may be wise to ask if you will be allowed the SOC rescue drugs, ie. procrit and neupogen, if you need them?
Your viral population now most likely consists entirely of resistant mutations. The wild type virus against which the DAA's are effective, will be entirely gone now. So you might as well be eating jelly babies as continuing with the DAA's except that their presence will close the escape route to the virus of reverting back to wild-type. It is possible that this will give an advantage over SOC alone, and Gilead obviously wants to study the possibility.
Best wishes to you. Please let us know how you are doing and how your 4 week results with ifn come in,
dointime
I think your doctors advice is good and I am sorry about the breakthrough Adam.
Hopefully adding interferon will work, but if it doesn't work my guess is that you would have to wait before using Incivek or victrelis possibly a couple of years. It all depends on the type of resistance you've developed from the drugs you've been taking of course and how long before your virus returns to wild type.
The good news still as before is that your liver is in good condition and hopefully the prosed rescue arm will work.
Good luck my friend,
Dave
Hopefully adding interferon will work, but if it doesn't work my guess is that you would have to wait before using Incivek or victrelis possibly a couple of years. It all depends on the type of resistance you've developed from the drugs you've been taking of course and how long before your virus returns to wild type.
The good news still as before is that your liver is in good condition and hopefully the prosed rescue arm will work.
Good luck my friend,
Dave
Don't you think the addition of PEG will help in killing the mutations while the existing RIBA and PIs continue to suppress the virus? I know it's not 100% shot but it's got to be better than just the PIs. Thoughts?
Thanks Adam for posting the Trial link .
And thanks again for participating in it .. Good or bad , the data that emerges is for a very worthwhile cause !
Can see now the 2 arms, no placebo .. They are prepared for breakthrough's .. and studying resistance issues ...
Rescue Therapy Substudy SVR [ Time Frame: 24 Weeks ]
To evaluate the antiviral efficacy (as defined by SVR) of the addition of pegylated interferon (PEG) for 24 weeks to GS-5885, GS-9451, tegobuvir and RBV in subjects who experience viral breakthrough on treatment.
Emergence of viral resistance [ Time Frame: 12 or 24 weeks ]
To evaluate the emergence of viral resistance during treatment with GS-9451, Tegobuvir and RBV when given with 30 mg or 90 mg GS-5885 for 12 or 24 weeks.
Best results !
And thanks again for participating in it .. Good or bad , the data that emerges is for a very worthwhile cause !
Can see now the 2 arms, no placebo .. They are prepared for breakthrough's .. and studying resistance issues ...
Rescue Therapy Substudy SVR [ Time Frame: 24 Weeks ]
To evaluate the antiviral efficacy (as defined by SVR) of the addition of pegylated interferon (PEG) for 24 weeks to GS-5885, GS-9451, tegobuvir and RBV in subjects who experience viral breakthrough on treatment.
Emergence of viral resistance [ Time Frame: 12 or 24 weeks ]
To evaluate the emergence of viral resistance during treatment with GS-9451, Tegobuvir and RBV when given with 30 mg or 90 mg GS-5885 for 12 or 24 weeks.
Best results !
Just wanted to say so sorry to hear of the viral breakthrough. I would also like to say thank you very much for letting us know about it.
Best wishes. At least you have top people on your case and more options for treatment than just IFN/RIBA.
Best wishes. At least you have top people on your case and more options for treatment than just IFN/RIBA.
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