HepResearcher reg. Alinia

[ladywhy]

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

[jmjm530]

Obviously, I'm not HR, but will comment anyway.

Given your stats, I don't understand why your doctor allowed you to continue beyond week 24 with a postive viral load. Actually, don't understand why he allowed you to continue beyond week 12 with a "high viral load" as per your profile. And frankly, having you double the Pegasys at week 24 seems to be adding insult to injury. On what basis is he doing this? Seems like that type of approach should have been done a long, long time ago if warranted. I'm not going to comment on Alinia, but given you only have moderate liver damage (stage 2) I think continuing on -- single or double dose peg -- at this point will do you more harm than good. Keep in mind, given your very late response -- actually no full response yet -- you probably would be looking at two years or more on pegalayted interferon for any chance of SVR, and not sure you have any reasonable chance.

Sorry if I seem so negative but that is how things struck me. Are you treating with a liver specialist (hepatologist)? If not, getting a second opinion from one would be a minium measure to take before continuing on longer.

All the best,

-- Jim

[jmjm530]

I'd also like to add that going from stage 0 to stage 2 in 10 years, is of itself no cause for alarm. First, biopsy reports can be off up to two stages for three primary reasons: relative sample size, absolute sample size and operator bias. I had the same biopsy slides read by three pathologists and got: stage 3, stage 2, and stage 2.5. This is not unusual from what I understand. In other words, it's possible that your first biopsy was actually closer to a stage 1 and your last closer to a stage 1.5. Of course, I'm just making this up and the only way to know for sure would be to have both sets of slides re-read by different pathologists and then do some averaging. And even with that, you're only taking into consideration one of the three variables.

My suggestion, other than what was mentioned, would be to up the frequency of the "watch" portion of "watch and wait". Either with biopsy, or better with Fibroscan. Only avaialble at a few places now -- Boston, Miami, Midwest somewhere and with HR -- hopefully it will start being distributed nationwide within the next year or so. Lots of new drugs out there in trial that would in my estimation give you a much better risk-reward profile than continuing on now, regardless of what you double up or add.

-- Jim

[Hepatitis Researcher]

The results from the upcoming PCR might partially guide your decisions. Many considerations to ponder as Jim has pointed out.

There are obviously no results re the usefulness of late add on Alinia for slow/partial  responders available, everything would be just hopeful conjecture from the known results.

But, if you do decide to continue with the current protocol, you could ask your doc, pointing at the results from the AASLD, if he would be willing to add the Alinia for one "test month", where you test again with PCR after one month add on. This could bring surprising results and seems worth a try.

There is a slight chance of  rendering Alinia  less useful for future purposes by this approach. But its resistance chances at the current low viral load and its inherent low propensity for resistance should be small enough to warrant the risk of that particular aspect.

The abstract ( #178)  re NTZ from the AASLD 2007 does not contain the 12wk SVR results ( for geno4 only of course) that have been actually presented at the conference itself, but they are well known  ( and the HIV and Hepatitis.com website has them) and your doc might even have been there.
Also abstract T1821 from the DDW 2006 has important info re NTZs in vitro power compared with IFN and Riba, might be of interest to your doc.

[jmjm530]

I understand why HR might not want to take a definitive position in this instance, as he's a medical doctor  -- but again, I really don't get what's going on with your medical care. You say you were detectible at week 24, but why no follow-up viral load tests? I would imagine that week 24 would have been the latest time to think about changing meds (like double dosing), not at week 38? And why no viral load tests between week 24 and now? Makes no sense. Personally, I wouldn't waste my time convincing/educating  my current doctor anything -- rather, I would take the time to find a good outside consult (hepatolgoist) who can educate you in your best next steps.

I've been surprised here before, but I'd be very surprised if any good hepatologist will have you continue on at this point, be it with your current regimen, double dosing or with Alinia.

-- Jim

[ladywhy]

Thank you

[ladywhy]

I did start @ 25th week DD
and I am travelling to see a Hepatologist at a Univ. Hosp.in Philadelphia

[ladywhy]

I also have an appt. with another Hep...couldn't get in to see him 'til January...

[ladywhy]

at my 6th week of tx...I changed from a gastro to a hep Dr.. primarily 'cause I had to fight/beg for a 4 wk PCR..........

[jmjm530]

I'm surprised then -- and it's unfortunate -- that you didn't have weekly viral load tests after you started DD at week 25. Not that it would be my personal choice, but if one does choose that unbeaten path, then at least weekly viral load tests will give you some indication of how the virus reacted to a change in meds. If you're UND at your next test ( I assume sometimes after week 38) one dilemma for your new hepatologist is how soon after week 25 did you actually become UND. As long as you're going this road -- what you might want to do right now -- is get a very sensitive viral load test, the day before your next injection, or the day of your next injection, but before the injection. I would either get a "Heptimax" test from Quest Diagnositics or the test HR has recommended from LabCorp which is a Quant that goes down to 2 IU/ml. That way you will have something to walk in with. Lastly, if there's any way at all you can speed up your appointment with the Philadelphia Hepatologist, that would be great. I'd hate to see you stay on these drugs, at these doses, unless there was a reason. Appointment secretary's sometimes only can do so much. If you can't speak to the doctor directly, ask if you can email or fax him a letter in which you would outline your tx history and ask if he could squeeze you in a little sooner.

All the best,

-- Jim

[ladywhy]

That is who has been txing me...the Hep Dr. in Philadelphia. I see him on the 17th of Dec. When I got the 24th wk. PCR done. I went in and said I guess that's that...ready to stop tx
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Hep Dr. advised at that time to DD..

[zazza]

Correct me if I am wrong, but I seem to remember you have had PCR's done later than 24th week? And that you were still detectable?

[jmjm530]

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

[Ginger12521]

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)

[ladywhy]

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!

[copyman]

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.

[Hepatitis Researcher]

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.

[motheroffour]

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.

[ladywhy]

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.

[Hepatitis Researcher]

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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[zazza]

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

[Myown]

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!!

[ladywhy]

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

[ladywhy]

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.

[Hepatitis Researcher]

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.