Aa
HepResearcher reg. Alinia
Hi HR
I am @ 38th week of tx. At 25th wk (vl 1350) my Hp Dr. doubled the pegasys. At my 10th week went from riba 1000 mg to 1400 mg. What I would like to know...is do you think Alinia, at this juncture, may be a benefit? ...and if so...is there some paper that I could bring to my dr.?
This is my 3rd time txing. I did monotherapy Intron-A, I was in clinical trials with riba/interferon bundles and became UND...I would appreciate your opinion.
In a little over 10 years...I went from zero liver damage to Stage 2, Grade 2-3 bridging fibrosis. I am 44 y.o and the future doesn't look so bright.
Thanks for anything you can tell me...or any suggestions will be much appreciated.
Sincerely
Yvonne
ps. Getting a PCR this week
I am @ 38th week of tx. At 25th wk (vl 1350) my Hp Dr. doubled the pegasys. At my 10th week went from riba 1000 mg to 1400 mg. What I would like to know...is do you think Alinia, at this juncture, may be a benefit? ...and if so...is there some paper that I could bring to my dr.?
This is my 3rd time txing. I did monotherapy Intron-A, I was in clinical trials with riba/interferon bundles and became UND...I would appreciate your opinion.
In a little over 10 years...I went from zero liver damage to Stage 2, Grade 2-3 bridging fibrosis. I am 44 y.o and the future doesn't look so bright.
Thanks for anything you can tell me...or any suggestions will be much appreciated.
Sincerely
Yvonne
ps. Getting a PCR this week
Couldn't help but read about your dilemma, and yes you are in the realm of difficult decision time. Not much to add beyond what's already been discussed, but if you do decide to take the alinia and give it a shot (for a month or beyond) make sure you get adequate PCR testing to help give you an idea if it's working. If I were in your shoes I'd get a sensitive PCR (at least 10 IU/ml and preferably 2 IU/ml) on the day of your first dose (taken just prior to your first alinia dosing). Then get PCR's taken basically as often as possible after that (as often as your insurance co will provide at least). Ideally I'd want a PCR just prior to the first dose, then another at day 3, then at week 1 and weekly thereafter until UND (if fortiunate enough to reach UND within a reasonable timeframe). And heck, if you can arrange it, maybe even get a PCR done daily for the first several days. If alinia turns out to do what we're all hoping it's going to do, then with any luck we'd see a marked drop in the virus directly corresponding with the commencement of the alinia dosage. And incidentally, this is also how new/experimental drugs are researched in drug trials. I was in the VX950 trial and they took several blood samples in one day after my initial dose of VX950 (and the other drugs too). We also had to come in afterwards on a frequent basis to keep getting our blood sampled to see how well the drug was working.
I would also research what is known about the pharmacokinetics of alinia, and perhaps HR has some insight into this as well. By pharmacokinetics I mean how quickly it is absorbed into the bloodstream and how quickly might its (probable) antiviral action be expected to take effect. This is important to know so that your frequent PCR testing can be properly interpreted. In other words, if alinia is suspected or known to be be quick acting, then you would expect to see relatively rapid viral decay results in your early PCR's. Conversely, if alinia is similar to ribavirin in the sense that it takes weeks for it to fully build up within the system and provide its full anti-viral effect, then that would also be important to know when interpreting your PCR results. The only caveat I would add is that since there isn't much research data available on alinia (in terms of anti-HCV pharmacokinetics) that I'm aware of, it's probable some guesswork will be in order. But I think you already realize that there are no guarantees here.
Anyway, hoping the best for you whatever course you take. I know it's not easy to think clearly on stressful matters like this while knee deep in tx. Been there done that, BELIEVE ME I empathize with the situation you're in. Good luck and keep us posted on your progress - especially your VL results should you go through with this.
I would also research what is known about the pharmacokinetics of alinia, and perhaps HR has some insight into this as well. By pharmacokinetics I mean how quickly it is absorbed into the bloodstream and how quickly might its (probable) antiviral action be expected to take effect. This is important to know so that your frequent PCR testing can be properly interpreted. In other words, if alinia is suspected or known to be be quick acting, then you would expect to see relatively rapid viral decay results in your early PCR's. Conversely, if alinia is similar to ribavirin in the sense that it takes weeks for it to fully build up within the system and provide its full anti-viral effect, then that would also be important to know when interpreting your PCR results. The only caveat I would add is that since there isn't much research data available on alinia (in terms of anti-HCV pharmacokinetics) that I'm aware of, it's probable some guesswork will be in order. But I think you already realize that there are no guarantees here.
Anyway, hoping the best for you whatever course you take. I know it's not easy to think clearly on stressful matters like this while knee deep in tx. Been there done that, BELIEVE ME I empathize with the situation you're in. Good luck and keep us posted on your progress - especially your VL results should you go through with this.
"I am sure you realize that all he Dr.As and Js and Ss do not have any secret weapons up their sleeve beyond max riba, max IFN, extended time." That about truely sums it up in a nutshell. Outside of SOC, it all is basically uncharted waters with very little info and boils down to the docs beliefs- are they aggressive or passive..My NP made a comment to me how different the various hep docs opinions are within their Gastro/hep dept..again the gambit runs from aggressive to passive soc to anywhere in between..(I am happy myself to have ended up on the aggressive end of the scale).
She says they have had some very spirited debates around the coffee pot (g)
Ladywhy, best of luck to you and please keep us posted..Pro
She says they have had some very spirited debates around the coffee pot (g)
Ladywhy, best of luck to you and please keep us posted..Pro
Funny you ask about pronounciation of Zazza. I am from Sweden you know, and in Sweden we do not distinguish between an "s" or a "z". A "z" just looks smarter. Also a double consonant indicates a short vowel instead of a long - we have 16 different vowel sounds.
So: SASA would be how you pronounce it. With the "a" pronounced as the "a" in "a woman". It's a name and a spelling my boyfriend and I made up ages ago - during our IV time, kind of appropriate I guess.
Okay, I admit, I am not only crazy about math but about languages as well! Come to think of it, I have had good use of both my math, English and German in my search for knowledge of hepatitis.
Yeah, I am doing fine, not counting heavy crying attacks each week. My kids are growing up, relationship problems, yada, yada... or could it be the meds?
I always look for your posts, hoping you are doing okay. Zazza
So: SASA would be how you pronounce it. With the "a" pronounced as the "a" in "a woman". It's a name and a spelling my boyfriend and I made up ages ago - during our IV time, kind of appropriate I guess.
Okay, I admit, I am not only crazy about math but about languages as well! Come to think of it, I have had good use of both my math, English and German in my search for knowledge of hepatitis.
Yeah, I am doing fine, not counting heavy crying attacks each week. My kids are growing up, relationship problems, yada, yada... or could it be the meds?
I always look for your posts, hoping you are doing okay. Zazza
HR: Beyond that what is there other than waiting for Vertex/definite geno1 Alinia results, she already has max riba and double dose IFN.
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If SVR is the only expectation I cannot disagree. But I see the expectation as coming out of treatment in better shape than going into treatment, not coming out worse. In Lady's case, that expectation has already taken a statistical hit by her slow viral response and would potentially take another hit by a very long treatment extension.
Again, if she was a late stage 3 and/or no promising drugs in the pipeline, then maybe go for it? But she has time, so I go back to the ole medical saying, "First, Do no harm" or as in cases lke this, "Do the least amount of harm as possible after weighing the odds and options".
-- Jim
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If SVR is the only expectation I cannot disagree. But I see the expectation as coming out of treatment in better shape than going into treatment, not coming out worse. In Lady's case, that expectation has already taken a statistical hit by her slow viral response and would potentially take another hit by a very long treatment extension.
Again, if she was a late stage 3 and/or no promising drugs in the pipeline, then maybe go for it? But she has time, so I go back to the ole medical saying, "First, Do no harm" or as in cases lke this, "Do the least amount of harm as possible after weighing the odds and options".
-- Jim
HR: Beyond that what is there other than waiting for Vertex/definite geno1 Alinia results, she already has max riba and double dose IFN.
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If SVR is the only expectation I cannot disagree. But I see the expectation as coming out of treatment in better shape than going into treatment, not coming out worse. In Lady's case, that expectation has already taken a statistical hit by her slow viral response and would potentially take another hit by a very long treatment extension.
Again, if she was a late stage 3 and/or no promising drugs in the pipeline, then maybe go for it? But she has time, so I go back to the ole medical saying, "First, Do no harm" or as in cases lke this, "Do the least amount of harm as possible after weighing the odds and options".
-- Jim
-------------------------------------------------------------------
If SVR is the only expectation I cannot disagree. But I see the expectation as coming out of treatment in better shape than going into treatment, not coming out worse. In Lady's case, that expectation has already taken a statistical hit by her slow viral response and would potentially take another hit by a very long treatment extension.
Again, if she was a late stage 3 and/or no promising drugs in the pipeline, then maybe go for it? But she has time, so I go back to the ole medical saying, "First, Do no harm" or as in cases lke this, "Do the least amount of harm as possible after weighing the odds and options".
-- Jim
Thanks for the nice words. Is that you or the Xanax talking now :) Doesn't matter, I'll take it either way.
In short, I'm unaware of any study data that supports continuing treatment in cases like yours. Closest that comes to mind is the study that says to extend to 72-weeks if you have > a two-log drop by week 12 and are UND by week 24. You don't meet those requirements.
So that brings us to why go into uncharted orders, or as HR says, ": Where is the downside to this beyond 4 more weeks added to 38 weeks, with the upside of having a real chance to a pleasant surprise?"
Well, if you were a late stage 3, a stage 4 and/or no promising drugs were in the pipeline, then I'd say the benefits fo the pleasant surprise might outweigh the risks of exposing yourself to all that Peg and ribavirin. But you're not a late stage 3, you're a stage 2 (moderate damage) and there are promising drugs in the pipeline that you do have time to wait for.
But back to the here an now -- So what is it that you are really looking at, say for example, you are UND at week 42 after let's saying doing a month of Peg, Riba and Alinia?
The only model I can think of is the kind of extended tx Dr. C. (I don't like to mention Dr's names but if you don't know who I'm talking about I'll send you a private message) of internet fame who has advocated for some -- which is extending tx in some cases up to three years.
My guess is he would tell you to stop as well, but if not, would recommend at least 2 years total (possiby 3) given your potentially very late UND and the fact that Alinia is unproven in a situation like yours.
I don't happen to be a fan of his -- because of these long tx programs -- but you could email him and I hear he does respond to emails.
So the downside as I see it -- is adding another 56 (104 total weeks - 48 weeks completed) weeks of interferon/ribavirin exposure (and all the potential risks that go with it) to someone who only has moderate liver damage (stage 2) with no real data to support the outcome, be it 25%, 50%, 75%. Who really knows?
BTW that cheessteak sandwhich happens to sound pretty good right about now :)
-- Jim
In short, I'm unaware of any study data that supports continuing treatment in cases like yours. Closest that comes to mind is the study that says to extend to 72-weeks if you have > a two-log drop by week 12 and are UND by week 24. You don't meet those requirements.
So that brings us to why go into uncharted orders, or as HR says, ": Where is the downside to this beyond 4 more weeks added to 38 weeks, with the upside of having a real chance to a pleasant surprise?"
Well, if you were a late stage 3, a stage 4 and/or no promising drugs were in the pipeline, then I'd say the benefits fo the pleasant surprise might outweigh the risks of exposing yourself to all that Peg and ribavirin. But you're not a late stage 3, you're a stage 2 (moderate damage) and there are promising drugs in the pipeline that you do have time to wait for.
But back to the here an now -- So what is it that you are really looking at, say for example, you are UND at week 42 after let's saying doing a month of Peg, Riba and Alinia?
The only model I can think of is the kind of extended tx Dr. C. (I don't like to mention Dr's names but if you don't know who I'm talking about I'll send you a private message) of internet fame who has advocated for some -- which is extending tx in some cases up to three years.
My guess is he would tell you to stop as well, but if not, would recommend at least 2 years total (possiby 3) given your potentially very late UND and the fact that Alinia is unproven in a situation like yours.
I don't happen to be a fan of his -- because of these long tx programs -- but you could email him and I hear he does respond to emails.
So the downside as I see it -- is adding another 56 (104 total weeks - 48 weeks completed) weeks of interferon/ribavirin exposure (and all the potential risks that go with it) to someone who only has moderate liver damage (stage 2) with no real data to support the outcome, be it 25%, 50%, 75%. Who really knows?
BTW that cheessteak sandwhich happens to sound pretty good right about now :)
-- Jim
No problem R, what a day you had! ..do you expect accumulation?
Well, again it is something we both have to look forward to..talking that is, and we will, when it is more convenient.
You are such a doll...thanks for thinking of me. Glad your Mum is home under the covers (even reluctantly : })...now maybe you can rest easier.
w/ Love & Gratitude
Y
Well, again it is something we both have to look forward to..talking that is, and we will, when it is more convenient.
You are such a doll...thanks for thinking of me. Glad your Mum is home under the covers (even reluctantly : })...now maybe you can rest easier.
w/ Love & Gratitude
Y
Like I said before, I know your hearts in the right place...and that's why I thanked you for wriitng. I would like if you would answer again on this thread. I need to go into Dr.s office w/ as much info. as I can.
As of late, I say things can't get much worse...and they do...
Jim I do respect your knowledge, and your willing to care and share with so many of us. Please know that. and again...Thank you.
Hey Jim, are you available to be in Philli on the 17th?? I sure could use an advocate.That would be great! I'll treat ya to a cheesesteak sandwich...or better. Just let me know!!!
As of late, I say things can't get much worse...and they do...
Jim I do respect your knowledge, and your willing to care and share with so many of us. Please know that. and again...Thank you.
Hey Jim, are you available to be in Philli on the 17th?? I sure could use an advocate.That would be great! I'll treat ya to a cheesesteak sandwich...or better. Just let me know!!!
I'm very sorry to have upset you, but I only had your best interests at heart. I think it appropriate I back off this discussion. HR- the answer to your question has already been written but I'll answer again, another time in another place.
-- Jim
-- Jim
Dear Lady, I've signed on late tonight. It was a long, long day. This moment I look at my clock and it's well past midnight. I know it's too late to call you. Hope you are tucked snug beneath your blankets and that you
sleep sweet.
Your,
R
MEDICAL PROFESSIONAL
Most hepatologist do not have high expectations from switching to daily infergen - it works only in a limited number of cases - it is another longshot, about as painful or promising as double dosing Pegasys. But yes, it works in some, it is a substantially different IFN, working partially on different IFN receptors.
Thank you. I so want us all to get rid of this virus...and move on with our lives. Your words are always a comfort to me. Is the correct pronunciation of your name like the actress with the name Gabore?
How are you holding up after 56 weeks?...and how is your Hemoglobin...rbc's?
Myown: This tx does seem to be somewhat like 'the luck of the draw'...that's what makes it all the more disturbing.
I trust things will get better...and you are right on...NOthing is impossible with GOD. Notice I didn't jump? :)
I thank you both....truly.
How are you holding up after 56 weeks?...and how is your Hemoglobin...rbc's?
Myown: This tx does seem to be somewhat like 'the luck of the draw'...that's what makes it all the more disturbing.
I trust things will get better...and you are right on...NOthing is impossible with GOD. Notice I didn't jump? :)
I thank you both....truly.
Thanks..I will ask him and if he can't tell me where he was @ 11:45...I'll try to fill him in. ;) I cannot thank you enough for taking the time to give me some ideas and some hope.. to walk in the dr's office and use this in our discussion. You've been a great help.
One more ?...if I may be so bold.
One on the forum here (Lonestar) switched from Peg to Infergen (@ 6 mos in tx)...she is now 1 year post SVR. I asked about switching to that rather than Doubling up the peg...and Dr. didn't have a good opinion of consensus infergen....What's your take on infergen?
Again thanks for your thoughts.
Sincerely,
Yvonne
One more ?...if I may be so bold.
One on the forum here (Lonestar) switched from Peg to Infergen (@ 6 mos in tx)...she is now 1 year post SVR. I asked about switching to that rather than Doubling up the peg...and Dr. didn't have a good opinion of consensus infergen....What's your take on infergen?
Again thanks for your thoughts.
Sincerely,
Yvonne
Ladywhy, routing for you sweety. Sometimes when things look great and you get a big thumbs up even from leading hepatologists - it still might not work out, - I know that:)
And sometimes when you get a big thumbs down and all studies say quit - things work out -"Lonestar" - she was given what something like a 17% chance AND SHE MADE IT!!!! YAHOOO
I was given a 90% chance to SVR and DIDN'T MAKE IT. But thats okay the fat lady didn't sing her song yet.
So keep your chin up!!!! Nothing is impossible with God and you know that!!
And sometimes when you get a big thumbs down and all studies say quit - things work out -"Lonestar" - she was given what something like a 17% chance AND SHE MADE IT!!!! YAHOOO
I was given a 90% chance to SVR and DIDN'T MAKE IT. But thats okay the fat lady didn't sing her song yet.
So keep your chin up!!!! Nothing is impossible with God and you know that!!
What can I say, Yvonne, you really are having a tough time, losing your job, and tx and all. I am on week 56 now, and I don't know either if tx is working for me, nobody does, right? So we all go through hell without knowing if there will be a reward at the end, we can just do our best. My thoughts are with you, as always, hope life will deal you an easier hand tomorrow. Zazza
MEDICAL PROFESSIONAL
If you are UND at this PCR, you could still ask him to add it to give you a better chance for SVR. The fact that none of the EOT UNDers in the Egyptian trial had a relapse at 12wk post tx ( again,only shown thus far in geno 4 patients!) gives rise to the hope for some stabilizing effect of NTZ on the UND status. Since he was at the AASLD he will have seen the presentation. He might or might not have been in the grand auditorium when this was presented at Tuesday 11:45am, so ask..
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HR: What about if I am UND?...what would you suggest? No Alinia??? If I could get dr. to prescribe and I 'm und...why not Alinia? Maybe a better chance at SVR?
Copyman No...but if you would be so kind as to send me a message privately with his name, I would appreciate it.
Copyman No...but if you would be so kind as to send me a message privately with his name, I would appreciate it.
ladywhy, good luck to you. My husband is on his second round of treatment. He was a slow responder during his first treatment and cleared well past week 24 can't remember exactlly but I think it was closer to 32 or 33. He responds quickly to Peg/Riba but once his viral load is under 1,000 he is very slow to clear to UND. His doctor felt that with his probable cirrohsis diagnosis from his biopsy that continuing on treatment would give his liver a rest. He relapsed within 2 weeks of stopping treatment and his doctor had him start again immediately. On this second round he still was showing a viral load of around 900 at 8 weeks and again he had a steep decline in viral load between week 1 and 8. He has been referred to the big U in our state and his appointment is this week. He is now in week 12 of the second round of treatment, so I'm assuming the new doc will schedule a PCR at the appointment. We do plan on asking if they would be willing to add Alinia (especially if this 12 week PCR still shows a low level of viral activity). My husband tolerates the Peg/Rib very well with just a few little side effects and it is definitely keeping his liver enzymes down and all his liver functions very stable. While your doctor may seem alittle unconventional in keeping you on the drugs although you have not cleared, he may be thinking that it's giving your liver some rest from inflamation or he may be just hoping beyond hope that you'll clear and be SVR and I'm sure you are. Docs are human too.
MEDICAL PROFESSIONAL
If your PCR comes back very low but not UND, then you could ask your hep to add the Alinia for one month - this should be free of the risks of not being able to use it later - and it might get you UND. If it gets you UND, then you continue.You have gone quite far, this holds a new and realistic chance to add an entirely different blockage for the virus, that is at this point already very weakened.
To Jim: Where is the downside to this beyond 4 more weeks added to 38 weeks, with the upside of having a real chance to a pleasant surprise? Beyond that what is there other than waiting for Vertex/definite geno1 Alinia results, she already has max riba and double dose IFN. I am sure you realize that all he Dr.As and Js and Ss do not have any secret weapons up their sleeve beyond max riba, max IFN, extended time.
To Jim: Where is the downside to this beyond 4 more weeks added to 38 weeks, with the upside of having a real chance to a pleasant surprise? Beyond that what is there other than waiting for Vertex/definite geno1 Alinia results, she already has max riba and double dose IFN. I am sure you realize that all he Dr.As and Js and Ss do not have any secret weapons up their sleeve beyond max riba, max IFN, extended time.
Hi, sorry you are going through this. Is the hepatologist you are seeing at the U of P last name start with an "R" ? If it is i'm susprised because he is suppose to be very good and up to date on the latest protocols. if your next test is detectable i would stop, regroup and then try and get into a trial for non-responders in the next year. sounds like you are a tough to treat and need a cocktail of drugs (present combo + new drugs) to beat this. hang in there and best of luck.
This is why I usually don't ask ?'s on this side...'cause believe me, I carry around enough anxiety...
I am doing everything I can. My txing Hep Dr. was @ the AASLD...I went over the NP's head and wrote to my dr..'cause I couldn't discuss studies w/her. ...and I was not too happy about travelling 2 hours (One Way) on public transport to spend all my time w/her and three minutes w/him.
I changed dr's (gastro to Hep) early in tx 'cause they didn't order a PCR before txing or at the 4th wk...though I did ask.
My last PCR vl was 1350 and yea, Zazza, it was after the 24th wk.. I was supposed to have one last week...I lost my job and wanted to jump from the nearest bridge..and didn't make it to Quest. I am gonna go tomorrow.
As soon as the results come in, I will e-mail my dr...and ask him why/what/when....what else can I do folks??? I am not willing to stop w/o Dr. giving me the ok....I've gone too far...to just take everything into my own hands/or those with much knowledge on forum, and make that decision...
I know you mean well Jim...but now I feel sick to my stomache and anxiety ridden and there's nothing I can do about this tonite. Well, maybe a xanax will help...
Y
PS Once again....after the 24 wk PCR...I asked to stop tx. If anyone thinks I'm a masochist (sp?)...and enjoying this horrible treatment...guess again. I have done all I can thus far and I am aware of what it's doing to my mind, my energy, my body, my gums, everything..i know. Double Dosing 'stinks.
The reason I didn't study to be a doctor was 'cause my brain (on a norm) is not wired for this....I'm more of a right brained kinda' gal and with this particular medical issue it seems that we all have to be. It stinks!
I am doing everything I can. My txing Hep Dr. was @ the AASLD...I went over the NP's head and wrote to my dr..'cause I couldn't discuss studies w/her. ...and I was not too happy about travelling 2 hours (One Way) on public transport to spend all my time w/her and three minutes w/him.
I changed dr's (gastro to Hep) early in tx 'cause they didn't order a PCR before txing or at the 4th wk...though I did ask.
My last PCR vl was 1350 and yea, Zazza, it was after the 24th wk.. I was supposed to have one last week...I lost my job and wanted to jump from the nearest bridge..and didn't make it to Quest. I am gonna go tomorrow.
As soon as the results come in, I will e-mail my dr...and ask him why/what/when....what else can I do folks??? I am not willing to stop w/o Dr. giving me the ok....I've gone too far...to just take everything into my own hands/or those with much knowledge on forum, and make that decision...
I know you mean well Jim...but now I feel sick to my stomache and anxiety ridden and there's nothing I can do about this tonite. Well, maybe a xanax will help...
Y
PS Once again....after the 24 wk PCR...I asked to stop tx. If anyone thinks I'm a masochist (sp?)...and enjoying this horrible treatment...guess again. I have done all I can thus far and I am aware of what it's doing to my mind, my energy, my body, my gums, everything..i know. Double Dosing 'stinks.
The reason I didn't study to be a doctor was 'cause my brain (on a norm) is not wired for this....I'm more of a right brained kinda' gal and with this particular medical issue it seems that we all have to be. It stinks!
First let me with you the best with the rest of your treatment! Hope you can add Alinia to the tx. Sounds so promising...
How about taking Alinia even AFTER INF treatment to ensure a permanent SVR? I mean, who knows? Maybe Alinia would work on releasing the rest of the wild traces of virions who may the culprit in those that relapse?
Just a crazy thought on my part...
Best wishes,
Ginger :o)
How about taking Alinia even AFTER INF treatment to ensure a permanent SVR? I mean, who knows? Maybe Alinia would work on releasing the rest of the wild traces of virions who may the culprit in those that relapse?
Just a crazy thought on my part...
Best wishes,
Ginger :o)
He advised you to DD with no follow-up viral load tests? And he's a hepatologist, not a gastro?
Anyway, given that you're already seeing him, he wouldn't qualify as a "second" consult. Maybe you can put a rush on your January appointment with the other hepatologist?
I still wouldn't wait on that viral load test. Maybe your primary care can write you an rx, if you treatment doctor won't.
-- Jim
Anyway, given that you're already seeing him, he wouldn't qualify as a "second" consult. Maybe you can put a rush on your January appointment with the other hepatologist?
I still wouldn't wait on that viral load test. Maybe your primary care can write you an rx, if you treatment doctor won't.
-- Jim
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