week of UND + 36 approach to extended tx

[wyntre9]

I'm continuing to weaken and considering cutting TX short; instead of the 72 weeks for slow responders I'm thinking about the study (can't remember the name) that said to add 36 weeks to the date of UND (mine was week 17).

Does anyone know the name of that study and does anyone have feedback about that approach?

wyntre

[jmjm530]

You're thinking of the Drusano Model, abstract here: http://tinyurl.com/yxrrqf  
It was also cited by my tx team, although my doc used a 48-week add-on variation, but I was RVR. Also keep in mind that Drusano says the model needs further investigation. These are difficult decisions especially when one is having significant side effects.

-- Jim

[wyntre9]

guess I'm getting desperate - can't stand much more of this.  Need to know what my good days are so i can schedule stuff but it's all a$$ backwards from what it used to be (Tuesday through Friday).  now the 1 or 2 decent days fall between Saturday through Monday.

I'm gonna keep going 'til January gastro visit and until i get final 3 months of meds in the fridge.  After that . . . . dunno . . .

Thanks for the link.  i KNOW i saved it to my pc but couldn't remember the name.

48 + 17 would be 65 weeks, just shy of the 72 scheduled.

oh, joy.  :(

wyn

[Proactive]

just sent you a PM.....;^)

[wyntre9]

ok.  Thanks.  gonna check now.

wyn

[Proactive]

keep in mind the drusano model was done in 2003-2004 I believe, and the Berg study done later ('06?)...There is a few years of knowledge gained between the 2....anyhow, you can read it over...........;^)pro

[wyntre9]

Yeah - I realized that when Jim posted the abstract.  Still, at least I'll read it and then i can tell myself I'm exploring options and that's better than doing nothing.

thanks, pro,

wyn

[jmjm530]

There are lots of "if, and, and buts" in most of these studies, when you try to match up your stats to the study stats. Berg, for example (if memory serves me) did not use weight-based ribavirin, while Wyn is.

That said, I think what you're doing at this point is not trying to figure out the ideal number of weeks to treat, but to find a reasonable compromise between the risks of continuing on with your current side effects versus the rewards (chance of SVR) for "x" given weeks of treatment.

So many factors play into this including how much is at risk (stage of fibrosis) and what are the symptons -- and possible ramifications -- of the side effects you're now experiencing.

Still, it does make sense to get the most complete data available so any decisions will at least be  based on the best guestimates of what your chances of SVR are for a given number of weeks treating.

Frankly, I forgot most of your stats and how happy you are (or are not) with your treatment team and if you've had some outside consults. But if you haven't, you're not too far from Dr. J. and D. in NYC and Dr. A. in Boston. Visiting one or two of them might help clarify things.

--- Jim

[Proactive]

I agree there are plenty of variables..In fact I happened to glance at the Berg study and had forgotten that the 12 week pcr only had a lower limit of 600 iu/ml....(myself I was 256 @ 13 weeks-Za was even less @ 12) and end of treatment and svr pcr's had a lower limit of 50....but yet in some of the charts <50 was quoted at weeks 4 and 12 ..so it gets a bit confusing....or at least confuses me (g)

Patient Evaluation:
"All patients were evaluated as outpatients for safety,
tolerance, and efficacy. HCV-RNA level as the primary efficacy
variable was assessed at weeks 4, 12, 24, 48, and 72 (group B)
and again during the follow-up period at weeks 12 and 24. The
HCV-RNA level was quantified by PCR assay (Amplicor
Monitor HCV v. 2.0; Roche Molecular Systems; lower limit of
detection, 600 IU/mL). End-of-treatment and SVRs were assessed
by qualitative PCR assay (Amplicor HCV; Roche Molecular
Systems; lower limit of detection, 50 IU/mL). HCV
genotyping was performed by reverse hybridization (Inno
LiPA HCV; Innogenetics, Gent, Belgium)."

[wyntre9]

Thanks for the referrals, jim.

At this point, I'm not gonna change Doctors until I've got the last 3 month batch of meds tucked away, at the end of January.

I believe my gastro has done as well, if not better, than most gastros but I also now realize that perhaps if i had been seeing someone who was more of a specialist in hep-c that the riba might have been increased when i didn't reach UND at week 12.
(got it at week 17)

But who knows.  Even if that had been the case, i still would not have finished 48 week SOC until mid-November and would not know SVR results until mid-February . . . so I'm playing the hand I've got, trying to do the 72 since I'm a 1A, slow responder, and if I can't finish the 72, at least I'll have a head start on meds for the next time, if there is a next time.

On the other hand, if i do get SVR from this TX, i won't need another opinion.  Point is, it doesn't make sense for me to consult anyone else until this round is finished.  i COULD be one of the lucky ones.   XXXXX (crossing fingers)

wyn

btw - read the drusano - yup, it's an older study but it does say tack on either 32 or 36 weeks to the point of UND if before 24.

I guess the 48 concept is in another study?

[jmjm530]

Not another study, it was just a variation of Drusano, my treating doc sometimes uses. Sort of an "on the fly" adjustment, in my case because of age (59 then) and histology (stage 3). He suggested  the Drusano group was younger and less fibrotic, but I really haven't checked, nor did two other consults agree with him. They were of the mind that my RVR trumped all, and onluy recommended the standard 48 weeks. The other thing about Drusano that is confusing is their average 30.4 weeks to UND. Sounds like an awful lot of slow responders to me. Maybe the full-text version supplies some more answers.

-- Jim

[kcrandy]

whatever you decide i hope everything works out for the best.

[wyntre9]

Thanks all.

The full text does explain but I don't understand it (yet).  *LOL*  I'll let you know when I know or, better yet, maybe i should send it to you, too?  Just some light reading.

BTW - I'm in drusano country!  I'm gonna try and find him.

Thanks KC.

Elaine,

eyes are ok - haveta see a retinal specialist next Friday, just to double check retinal condition.

I'm considering stopping, elaine, coz I'm extrememly weak and dizzy; can't drive, can't do grocery shopping, can't handle common everyday tasks . . . i mean, I DO, but with tremendous effort.  Plus I'm whining coz it's friday night and I'm sick of this TX.

hugs for you and nick,

wyn

[jamimapuddle]

Hang in there wyn

[kittyface]

I feel for you, Woman.  Is there anybody that can help you with the simple tasks?

Thinking of you,

Kittyface

[Rangle]

I live in the day....I'm new to treatment but been knocking around a long time....I just  don't worry about tomorrow I keep this in the day,... 24hrs ... tomorrow I can make the decision to continue or not. as long as tomorrow is not here I don't worry about it ....Hang in there we're pulling for ya

I'm not sure if you haven't heard this before,I'm not in your shoes...gl  

[wyntre9]

Thanks all.

Kitty,

Well, i could conceivably hire someone a couple of days per week to come in and help with errands and shopping and Dr.'s appointments but it's been my experience, what with this summer's handyman/cottage renovation fiasco, that having a stranger in my space is even MORE stressful than toughing it out alone.  *LOL*  but true.

I'm worn out.  Worst case scenario is I do another 5 injections for a total of 60 weeks or I get my second wind and do 3 months beyond that for a total of 72 weeks.

I need to have an OUT and a plan, just in case.

Thanks for the encouragement and support,

wyn

[CockSparrow]

You might be interested in the following article from Sweden. It uses a more individualized approach to extending Tx based on your viral kinetics. I found it quite interesting. Its free.
A link to download a PDF is at the end of the article.

Response Prediction and Treatment Tailoring for Chronic Hepatitis C Virus Genotype 1 Infection
http://jcm.asm.org/cgi/content/full/45/8/2439#F5

I have the Drusano study and an interesting one from Poordad that summarises what is known about extending Tx. I'll flick them to you if you like

All the Best
CS

[Lonestar823]

Wyn, You are right about bringing in outsiders.  Those of us who have done the long haul or are at the point you're at now know this.  This many weeks into treatment is nightmare country. We can't even stand the phone or doorbell ringing. I'd have to take naps in my grocery parking lot before I had the strength to go inside.  I think New York did this too.  Like it or not, for me anyway, the only way to finish this is to find the willpower and strength to go on.  Week by week then day by day then hour by hour.  Now may be a good time to pull out that poem Invictus I gave to you.  When I look back through my old calendars I see hen scratches about the Drusano and Berg studies.  I'd count 36 weeks, then add a couple more, then a couple more and then more still.  Intellectually you already know what you must do for your best chance of success.  I know you do. I'd picture myself in a Nike ad, "Just do it," to the very best you are able.  My very best for you Wyn.

[wyntre9]

CS,

Thanks for the link.  I'm gonna check it.

What do you mean, the Poordad studY?  But if you have it would love to see it.

lonestar,
'
You're right that I'm in nightmare country.

I was fortunate to get a reprieve today, for a couple of hyours, and actually managed to take a pleasure-drive and admire this gorgeous area I moved to coz of TX.

Thing that gets me the most is the complete randomness of it all - nothing is preductable anymore - and that makes it hard to conserve and preserve and mange time coz ya never know how much of that there's gonna be in any particular day, or week, or month !!!!!

And I'm NOT a control-freak - i swear.  

"We can't even stand the phone or doorbell ringing."

*LOL* - I didn't even put a doorbellIN the cottage and I only gave out the new phone number to a couple of people; plus I put the ringer on soft and the fewest number of rings.

you're right that the only way to finish is to find the willpower.  I do need ocassional reminders, however, like today, to give me hope.

thanls to everyone who chimed in on thie thread and gave some to an exhausted, worn-outfellow hepper.

119 more days to go for the 72 weeks.

wyn

[CockSparrow]

The article I was referring to is below. It not free, it discusses a lot more than RVR. Goes into when 72 weeks should be considered.

Rapid Virologic Response: A New Milestone in the Management of Chronic Hepatitis C
Fred Poordad, K. Rajender Reddy, and Paul Martin
Clinical Infectious Diseases 2008;46:78–84
http://www.journals.uchicago.edu/doi/full/10.1086/523585

The Dusano article is also available from The Journal of Infectious Diseases 2004;189:964–970
http://www.journals.uchicago.edu/doi/full/10.1086/382279

A 48‐Week Duration of Therapy with Pegylated Interferon α2b plus Ribavirin May Be Too Short to Maximize Long‐Term Response among Patients Infected with Genotype‐1 Hepatitis C Virus
G. L. Drusano and S. L. Preston

Ordway Research Institute, Albany, New York

But it too isnt free. Let me know if want copies.

cs

[amazzon]

Hi Wyn!  I am new to this forum.  I have been on my tx for 43 weeks and also was considering getting off of it again.  First time I had to stop 24 weeks in my tx because my gastro was not monitoring me properly and I developed severe hypothyroidism which landed me in the hospital for a week because of a stroke and a heart attack.  In the hospital it was discovered that my thyroid levels were astronomically high at 149.  Needless to say, I recovered from that (thank God) and looked for another gastro.  This time I did my homework and found one that actually knew what he was doing.  I have been through so much but like Lonestar said, "just do it."  You have to keep your chin up and know that you are not doing this in vain.  If you have undetectable VL, why stop now? There is so much to live for.  People who have not seen me in months comment on how different I look.  I look and feel like **** everyday but I try not to let people see how I really feel.  I somehow get the energy to put on makeup and dress up so that my kids don't worry about me.  People tell me I don't look sick.  I am always smiling even when I feel like crying.  I have lost so much hair I always have it in a pony tail.  I have lost teeth.  I lost my gallbladder.  I have a hiatal hernia with gastritis and erosive esophagitis. I also inject myself with Neuopogen, which hurts like hell soon after you take it.  I cannot stand up for one day sometimes more. Now, at this late stage in the game, I have developed an allergic reaction to the interferon.  My doc told me to get off the tx.  I said no.  I will not do this again.  I can't! It's too hard!  I can't put my family through this.  I saw an immunologist and she decided to help me through this to the end.  She gave me a protocol.  She started my on Prednisone 3 pills before my injection with 2 Benadryl one hour before my injection.  She gave me Symbicort inhaler for everyday and Albuterol for bad days.  She will be monitoring me during the rest of my treatment.  I break out in hives and my lips and eyelids hands and toes swell up.  She also gave me a couple of Epi-pens in case I go into anaphylactic shock.  My family is scared to death but supportive nonetheless.  You need your support group.  You need to know that we, although we have never met, support you.  We know what you are going through.  It's hard...damn hard but you have to have faith.  I put my life in God's hands everyday.  I tell him to do with me as He wills.  I am only a servant.  I figure this to be just another test of faith and I will be rewarded in the end.  I am sending you a big {{{{{{HUG}}}}}.  Please know that I will be praying for you and will ask God to carry you through this.  I also say to myself that the pain I am going through right now does not compare to the pain Christ went through for me.  That alone puts me in check.  You take care and God be with you and everybody else in this forum.  

Amazzon

[wyntre9]

Thanks for the info, CS.

Ironically, I moved 7 months ago and I'm not within an hour of the Ordway research institute.  i don't think Drusano sees patients but I may call over here to get a couple of referrals.

Thanks very much,

wyntre

PS - I'm going to check the Poordad  (what a name  :) article and see if I feel it's worth my while to download it.   Someone sent me the entire Drusano article.

[wyntre9]

meant I'm NOW within an hour of Ordway.

[wyntre9]

Thanks for the kind words.  It sounds like you have been tortured by SX!   Far worse than me.  That's another reason I post this type of thread, I think, to understand how much worse others have it and try to put my measly discomfort level in perspective.

Still, I NEED to express, vent, connect, at least on Fridays when i do the shot!  *LOL*  

Elaine, you picked up on that!  It seems to be the ONLY predictable thing about TX right now.

Amazon, are you scheduled for the 72 week TX?  What is your genotype and VL?

wyntre