Treatment stopped - options?

[Trish77]

They have stopped my treatment permanently.  I got the call at 4pm yesterday but haven't been able to do much but be a stun bunny since then.

My CD4 counts that monitor my immune system were too low and they lymphocyte counts never recovered enough so everyone on the trial in my position has had their treatment stopped permanently.  I found out yesterday around 4pm and I've just been in a bit too much shock and still am.  I wasn't expecting this at all.  

I just started Week 34 and I went UND at 6 weeks. My VL was 217 at 4 weeks. I've been on 75% of interferon for about most of 10 weeks now since about Week 25.    One week of ribavirin reduction at Week 15.  

I just started the neupogen last week.  I begin to wonder if there would have been a difference if they'd have let me start the neupogen earlier.

I guess the rumours that have been floating around are true and it's not looking good for R1626 going forward.  They did have someone die on the trial and someone has fallen quite ill and I guess that's as much risk as this trial incurs now and they've pulled us riskier people off.

I don't know what my options are really.  I'm processing and not coming up with much, can't say that I'm really able to think clearly.  My doctor won't let me flip over into SOC because he won't treat me with my immune system in this shape.  But....I'm checking.  I don't know at this point and if anyone has any suggestions, I'm open to it.

My CD4 counts have been 200, 160 and 180 and my lymphocytes have been at .3 and .4  I'm on antibiotics to keep me from getting an infection of any kind.  I've been trying to understand the implications of my CD4 counts other than my treatment team telling me how serious this is supposed to be and I'm just not grasping it yet.  I *feel* fine,  you know?

I confess it's all a little surreal at this point.  That's really all I've got right now.

Trish

[HARRYBEADS]

I agree with some of the others, regain your strength and try again. Western has a great clinic with Dr. Jenny Heathcote and TG has Dr. Morris Sherman both top players.
  

Harry

[Mikkimoe]

Hey gal - so sorry about having to throw in the towel early - I sure know how it feels as I only made it to 13 weeks when my immune system went bizerk and I had to stop...still trying to recover from it but have been UND...holding my breath for my 6 month PCR in Jan.

The odds seem very good for you and it's so nice to get off those horrible meds.

Hang in there - I'm cheering you on!

Mikkimoe

[IAmTheWalrus]

Fingers crossed! Tusks crossed too!

CrossTuskedWalrus

[Lady Lauri]

I can't read all the post right now (what wonderful responses tho! Here's that med help spirit!) but wanted to add I agree with Fl gator and others in don't kill yourself for the cure, you were pulled as it's getting dangerous for you. I was reduced twice and while it was upsetting, worriesome, it was what my body needed. I can't quote anyone right now...but I know many feel that triple therapy can be less time on tx, with great chances of SVR. You made it to 34 weeks and I truly feel that is a very good shot at SVR. You need to heal, get your immune and counts back up and know that you DID YOUR BEST in this. There simply comes a point in this tx, especially the trials, when the risk is too high to continue. Really Trish, you still have a very good chance of SVR. I'm sure the sides, brain fog/confusion is not helping at all in this. It's such a roller coaster as is.

The hope here is SVR and you will be one that had less exposure to these drugs to achieve it.

Hang in there, heal up and I hope to see continued UND, SVR from you.

[Trish77]

Dear Susan.....thanks for the words of encouragement even though your own disappointments have been many and far beyond my understanding.  I definitely have much to be thankful and hopeful about and good reason to maintain a positive outlook.  

I'm really hoping things turn around for you ... both personally and healthwise.  You've had a very difficult time and I'm hoping that boceprevir or R1726 gives you some hope .. keep looking for the beauty in your own life and live to that. I'm wishing you many lemonade days ahead...lord knows you've had enough lemons to make quite a supply.  Holding out hope for your health and happiness, Susan.  

Hugs to you.

Trish

[susan400]

Trish,

I am sorry that you have had this news about having to stop the trial earlier than expected.  I know how upsetting that can be.  And while, (NOT TO MINIMIZE) your concern, you do have the good news of having reached viral clearance before being pulled off, so that may at least be enough for you to keep going SVR.  Please hold on to that.  Your treatment team of Dr.'s seem to be very good.  I am impressed that they offer you counsel/psychiatrist, etc., in your despair over this disappointment.  I had no real comfort of that offered to me in all of my being booted out of treatment..., other than here on the message boards I mean.   Basically, my doctor would just say, "sorry you're not undetected you have to stop"; I was pulled from the trial and sent on my way.  About a month later; come back in for follow-up labs and basically, it's just like wam-bam, grab your blood work say the standard, "wait for better drugs, blah, blah, blah," and send me on my way.  So, I get left with this overwhelming depression and sense of failure.   It takes me several months to get past that and then, I regroup and start searching again for something else to try.  But, you have this great team to encourage you and also, viral clearance!  So, you do have alot to hang on to, right?   However, I do also know how disappointed you must feel.   Susan400

[Trish77]

Thanks for the note, merryBe, appreciated.  I'm not co-infected.  I have HCV only. I only included that reference as the only place I really found CD4 information was in reference to HIV/AIDS.   I'm sure I'll do the woulda, coulda shoulda's from time to time but trying hard not to do that to myself and to stay focused on those positives while I wait out the PCR results.

Hope you are keeping your head above water on your tx, merryBe.  Take care.

Trish

[merryBe]

I hope you do really well sweetie...let's keep thinging positive. Half the people on the new drug treated half the time and did well...you went longer still. Pleanty to be hopeful for.

the CD$ could have been up from a cold or any number of viruses, but if you are HIV coinfected then they don't want you that low cause real scary other infections can creep in...so I think maybe it was the safe call for you.. The idea is not to kill the patient in the process of trying to cure them...so there will always be those judgments we may not understand or agree with.

anyway, I still think your glass looks way more than half full.
prayers and well wishes.

mb

[pKinCA]

I sleuthed and sleuthed and couldn't find a *perfect* comparison for SVR odds for you because your treatment was so specific and not like any studied yet... ( ...well, until your ex-study is complete, that is...)  But thought I'd paste this link here because I think it would give any RVR Geno 1 who did shortened tx some hope.  Even though you were UND *maybe* a few weeks later than "true" RVR I believe there is a lot to be said for your tx (especially because you eradicated not one but two genotypes, correct?)  

The article basically says tx for Geno 1's for total of 24 weeks SOC has pretty high SVR rates...  

Again, not an exact comparison... but to give you some perspective... I find this study very interesting and very exciting!

pK

http://hivandhepatitis.com/hep_c/news/2008/101408_b.html

[meNtoby]

Trish, here's hoping you stay UND and go on to SVR.  I'm pulling for you, but had no experience to relay on the matter.  You've got the right attitude, sometimes you just have to roll with it, and see what happens.  Live to fight another day if necessary.....

Best of luck as you move forward with your life for now!
cathy

[Trish77]

Tallahassee and Elaine and Ladywhy and rita (hugs to all of you :)...thank you for the encouragement. :)  It's been a helluva rollercoaster the last few days and it always helps to come in here and read and get strengthened.

Jim....thanks for weighing in, your opinion is something I highly value and it helps me think....and calms me.  You have been part of my treatment team whether you knew it or not.  Lousy pay though, eh? :)  Gratitude doesn't pay the bills .. I just hope it matters to know how much of a positive difference it makes to have you onboard.  Words are so weak sometimes.

Frijole and alagirl.....thanks for the backup information and additional perspective.  That was the impression I was getting too from reading different things and that I was heading into this unknown risk zone and not something I wanted to play with. Thanks for being there with your own perspectives and information, it has helped.

dointime ... thanks for putting out an alternate perspective and daring to beat a different drum.  We need those people who question so that we can make sure we're on the right track and your questioning just cements that for me.  I didn't "throw in the towel" or get "treatment weary".  I was in full fighting mode and I was prepared to go the distance and had even been entertaining extending lately because of the dosage reductions.  As far as blindly accepting what the trial team is telling me .. well....lol ... I haven't really done that all along and I've fought to push the limits of the trial as much as I could to get my rescue drugs to keep me on track within trial parameters.  I've been a pain in the a$$.  :)  

I did my research on this, asked about being flipped over to SOC, considered going for the second opinion and after reading up on CD4's and the risks when they get low ..figured it's just time to accept this is it.  maybe you call that throwing in the towel.  I call it accepting my reality. This was not an easy place to come to and if I thought I should keep fighting it, I would.  I think I'd be crossing the line into reckless and I have three kids who deserve better than that.  So this is where I stop.

nygirl7....Deb.....what do I say to you.  You have become a cherished friend.  Thanks so much for your passion and compassion in building me up and making sure I'm okay.  So I just want to tell you that I AM okay.  You can relax.  :)  The only stats that matter at this point are my own so I'm going to wait out my PCR's and see how it goes.  I'm not going to worry about *anything* before it's time.  Not a thing.  It's ALL out of my hands now.  I'm UND at the moment and will take each PCR as it comes now.  As for warrior....well Deb ... I don't hold a candle to you, gong 72 weeks with all you endured both in public and in private.  But thanks anyway. :)

I'll post my PCR's as they come.  Thank you *all* for being there.  I would NOT have made it through the last few days without your support.  I treasure all of you.  

Alrighty then ... there are all of YOU who are considering treatment, starting treatment, enduring treatment, waiting for results, watching and waiting while you live with and manage your HCV and those who are just learning they have HCV ...lots to focus on here on the forum.  Lots to do.  

Hanging in there and hoping the very best for all of you.

Trish

[dointime]

I PM'd you,
dointime

[nygirl7]

I'm busy proving that your thyroid problem means SVR so hang in there!  If I say it, it must be so as you know because I am so rarely rarely wrong! ;)

I too think it's time to just put the stuff away and just go go go get back to life my friend.  Too many people are rooting too hard for you for you not to already have SVR.

Like I told you - even if you finished it still is a chore to put the meds down - when you want something so bad it's just hard to stop.

You have shown us all what a warrior you are.  Some people whine and cry and make such a big scene for so little - but you, never ever did that and THAT is a true inspiration to others.  You gotta know how many people will now stand strong and have courage in the face of hard times - all because of YOU.

Continue to be strong.  You ARE the warrior - don't ever forget it for a minute.

deb

[frijole]

Are you saying that someone on a VErtex trial GOT Procrit and Neupogen, or just needed it.  I thought they didn't allow them in Telaprevir studies.
frijole

[rita863]

Trish,

I just so this, I am so sorry!!!! I dont even know what to say.. I am sorry....

peace
rita

[dointime]

On the Vertex Prove2 trial that I was on there was a guy who was sick all the way through.  He got dose reductions to 135mg peginf. and 600mg riba most of the way and also needed procrit and neupogen.  He did 39 weeks treatment before he threw in the towel.  He worked it out as 3 weeks to UND plus 36 weeks (Drusano study).  So for you it would be 6 weeks to UND plus 36 = 42 weeks.  He got his SVR.  Could you make it to 42 weeks with procrit and neupogen?

dointime    

[dointime]

Well color me a sceptic but I just don't trust the assumption that the trial doctors do what is best for the patient.  They are paid to do what is best for the drug company and the aims of the trial.  

You obviously do have health issues, but who doesn't on tx?  I'd try to find a doctor who would give you an independent 2nd opinion fast, and who would be confident and expert enough to take you through to 48 weeks if that were at all feasible.  

I know that by 34 weeks we all feel very drained and low and there is nothing more appealing than the idea of stopping the drugs.  But just make sure if you do stop that it's really unavoidable because of your health, and not just some line in the sand drawn arbitrarily by the drug company.

Good luck,
dointime              

[Texas714]

I'm sorry for you...
I know what disappointment taste like...I just had a big ol' dose if it myself.
Like others have said this may have been enough to do the trick.  And it sounds like you have the time to fight another day.
Good Luck to you.

  

[alagirl]

This is all so difficult.  I am with everyone here in being so hopeful that you already have SVR.

I can tell you that I also had a difficult time stopping tx earlier than my tx'ing physician wanted me to, such that I spent time tx'ing that I shouldn't have until I got a second opinion that said to stop (it took longer than usual for my second opinion due to my hospitalizations, and probably, my own ambivalence).  The point is, by that time my immune system was toast and I was in the hospital right after tx multiple times for various things, with many infections - one of them limb threatening.  You can drive your system into that and that wouldn't be good either - and hopefully in your case the additional tx time would be unnecessary as well.

My hematologist told me that the neupogen is extremely short-term per shot - that's why some people on chemo have to take so many of them, much different than procrit.  So I think whatever help you get you would see quickly - just so you aren't lamenting the what if about having started earlier.  Not certain that would have helped.  

If you are seriously troubled and can't get around it, then perhaps get a second opinion from another hepatologist just so you can tell yourself that you turned over every rock.  Then let it go and we'll all be praying (and crossing our fingers) for your SVR.  

[jmjm530]

The decision to stop makes a lot of sense given your total circumstance including both your confidence in your medical team along with your minimal liver damage. The whole idea of treatment is to do more good than harm and right now that line is starting to become blurry at best. As many have stated, you probably have a very good chance of already being SVR and just waiting to find out. The really good news is that it's ALL OVER. If it were me, I'd go out and celebrate. (Sensibly of course :) )

Be well,

-- Jim

[ladywhy]

Read your post yesterday..just before leaving for a dr.s appt. Initially, I couldn't or didn't know how to respond. Like so many others have said...you do have a fightin' chance for SVR. I can easily imagine the shock...and I am sorry. Thankfully, you are feeling ok. physically and with your inner strength..I know you will be ok emotionally as well. (Actually, you sound like you are already)
You know I wish you the best Trish.
Sincerely,
yvonne

[frijole]

I am sorry that you have been pulled.  However, I did a little googling last night on the CD4 and yours is well below normal.  The fact that they actually have you on a preventative antibiotic is a pretty strong signal that they are worried.  CD4 is a type of T Cell very instrumental in immune issues.  You really need to get off the INF to build those back up.   I understand the "I feel fine, really" issue -- I think it is that way with most of us who have had ANC lows on treatment.  I believe, especially since we don't feel that bad when our white counts tank, that we need to rely on the medical professionals.

Our friend Willing does the heavy lifting on translating those pesky PI issues and he sounds pretty positive for your SVR.  I would feel pretty comfortable after reading his post.

Just relax and try to let your body rest.  I am sorry that you were pulled but amn optimistic about your progress.
frijole

[Tallahassee]

Yes, Trish, you will have a nice B-day present -- SVR!!!

All the best to you all the way to SVR!!!

[Trish77]

I took my riba yesterday ... I couldn't help it.  I wasn't done thinking yet and just when I thought I was ready to let go, down went three more riba...lol  :)  Today is another day and after reading through all the posts with the collective wisdom here that helps you think straight when your emotions are too involved to do so reliably for yourself, I've been able to "land".  Looked at my sharps box this morning and started to cry, realizing it's time to snap the lid shut.  Couldn't do it just yet...but give it a few days when it's time to clean up my kitchen (it hides behind a cookie jar on my counter, weird huh?) and I'll snap the lid shut and be done with it.  

I guess that pretty much clarifies my decision.  It's just time to stop.  I found this link dealing with HIV/AIDS and CD4 counts, treatment and opportunistic infections and after reading this and other things....well, it's just time to stop.

http://www.avert.org/antiretroviral.htm

I think to continue now would be reckless.  I did think about getting a second opinion....but it's just simply time to stop.  I need to get my immune system back into recovery and make sure I keep the same advice I've doled out .. you don't kill the patient while you're killing the virus.  

If I have to treat again, I would want the same doctor to treat me.  We've developed a good relationship and I respect him and even though I've been a pain in the a$$, we've developed a synergy that I've come to appreciate and I would want him to treat me next time.  The whole team there is developing into something I respect - the psychiatrist on staff who treats people specifically for the mental impact of HCV treatment and their ongoing efforts to treat the whole person with HCV and all their needs which is not easy to do in a universal health care system.  I don't want to alienate this team just to be a cowboy with limited returns that are potentially reckless.

There ARE alot of positives as so MANY of you have said.  I have UND at Week 6 in my favour and continuously.  That's what I am now.  UND.  That's what I'm going to stay until a PCR tells me otherwise and now it's EOT and I wait it out like everybody else.  Did call and request my EOT PCR though..

I've been in total shock the last 24 hours ... I had to go to work but had a hard time focusing on things.  This is not how I envisioned treatment ending .. it was supposed to end on my birthday, January 30th, when my last dosage of riba was scheduled, all symbolic-like, you know?  :)   Not with a thud and a bodyslam to the floor like *this*...lol  :)

What has kept me going the last 24 hours .. is coming in here and reading all the supportive and heartfelt comments from all of you.  I have only had time and mental energy to read...but I've BEEN reading .. and your comments and support have sustained me... each and EVERY comment .. and I mean EVERY comment...has given me a gift that has made me stronger the last 24 hours and helped me keep it together and helped me think.  I've gone back and RE-read the comments a number of times because it makes me stronger to have your wisdom, encouragement and support.  It's what we do best here and why this place is such an incredible treasure.  Thank you so much for being there to ALL of you.

So anyway....I'm not quite in "kay sirrah sirrah" mode (for all you people who remember Doris Day's little ditty) but I'm getting there.  The snow is flying out my window and I'm starting to realize...I'm done.  I'll get to lace up my running shoes sooner than I thought and head out for that winter run I've been aiming for since I started treatment.  My kids will have their mom back at full strength alot sooner and I'll be able to get my life back faster than I expected.  I start to get excited thinking about   all the things that are suddenly no longer "on hold" and I'm anxious to fly again.

If I have to fight another day, I will.  As of now, I am UND.  And that's what I'll be until I get definitive proof otherwise....and I'm holding out hope that the UND becomes SVR.

Willing...you summed it up very well.  And hey...I'll know by January.  Looks like I might be due for a birthday present after all, eh?  We shall see. :)

Love you all.

Trish