Week 2 VR - good news and bad

[StainedGlass]

Got my 2nd VR and got another log drop!  One per week!
baseline 3,020,000
week  1 - 277,000
week  2 - 8,720
My bad news is that the R1626 Trial masters have saddled me with a 25% dose reduction on my Pegasys!  Sort of brought me down a bit as I am just going into week 4 and  want to keep things optimized to attain a 4wk RVR.  A bit disconcerting.
Neutrophils have dropped a bit but as my study nurse explained, the Trial tends to be conservative with monitoring / dose reductions - especially with Neutrophils and R1626.
Neutrophils:  ref range 40.9 - 77.0 %
                 week 1 - 42.9
                 week 2 - 37.8
Neutorphils, ABS: ref range 2.03 - 8.36 x10E9/L
                 week 1 - 2.02
                 week 2 - 1.25
WBC,HEMO,HEMOCRIT,+ RBC have all dropped slightly to just at the cusp of their respective low ref range.
The Question?  What can I do to elevate Neut's.  I am still trying to put together in my mind all the different factors that is the cats cradle of this treatment and I would like to keep things optimized as much as is in my hands to get an eventual SVR.  I know being in a Trial takes some of it out of my hands but I knew that going in.
What is so counter intuitive is that through my TX so far I have been feeling relatively good. I have been able to keep up my usual swimming regime and the biggest SX's so far has been night sweats and a moderate Sunday fatigue - 2 days after my peg injection.  The treatment can be as insidious as the Virus?
Sorry if this is more appropriate to the HepC forum.
cheers
B

[Emilio44]

G'day

I have reactivated Trish's thread 'week 1 R1626....' and posted my week 1 & 2 viral loads there.  SG your thread is so easy to find with the big yellow smiley face, can't miss it. Feeling well with minimal sides. Back to Sydney on Friday for the parmakenetic sub trial and week 4 bloods.  Are you guys on this PK sub trial as well? Regards Emi

[LaurieChrstmn]

By the way....Thanks Emi, there are very nice people here! :)

[LaurieChrstmn]

They may be realizing that a few of us have crashed very quickly and they are responding to it faster.

I think I'm about 2 weeks or a little more a head of you, so there are a few of us who are further in. I'd love to know how many of us, at 6-7 weeks have crashed.

I'd really love to know which arm I'm in also! (of course thats not going to happen)

Anyway, it's good that they are acting quickly with you. I'll tell you that those 2 weeks where a living hell and not anything that I would wish on anyone!

Take care all,
((Hugs))
Laurie

[LaurieChrstmn]

I always get copies of the tests just so that I can go over them and understand all of this better.

If I get into trouble, I want to know. I want to understand so that I can deal with it all better.

Week 3 was:
WBC 3.9
ANC 2.60
Platelet 42
Haemoglobin 8.9

Then it all crashed between week 3 and week 4

My viral load started at 4,000,000 and went to 354 by week 2. At week 3 I was undectable and as of my visit to Hershey Yesterday, I'm still undectable.

By the way, they didn't like my WBC at week 3, but I think that they thought it would level off....it didn't. They called WBC below 10 not good and under 6 - danger.

I went to .90 in days and they began to panick.

But I think I'm out of the deep dark hole now and hopefully the procrit and Nuepogen will keep me out of that hole. We will see.

[Trish77]

Further question ... do you get copies of your VL tests and your blood tests each week?  Wondering what your ANC is per week.  Thanks.. and apologies again for so many "data" questions. It fills in the blank spots in the canvas for me.

Take care.

Trish

[Trish77]

Thanks for the update, Laurie.  Appreciated.  Wee note .. I think your Procrit is for your hemoglobin - red blood cells, and your Neupogen is for your WBC.  Those are astonishingly low numbers, considering where you started.  


What exactly did they call a danger zone?  I'm astonished that your WBC count got down to .09 at 4 weeks.  What was it at 3 weeks?  I'm sorry to ask so many questions of you but it's becoming a real puzzle to see how they'll respond and when, to the results of our CBC's.  

B. got a dosage reduction when his WBC hit 1250, mine hit 890 in the second week and we're monitoring, no dosage reduction.  I'm personally not concerned until it starts getting down to 500, but based on your numbers, you were allowed to get down to .. 90? in Week 4?  So that's why I ask what were you at Week 3?

I don't know WHAT to say about your platelet count.  

Now that you've had rescue drugs, where are you sitting now?

Congratulations that you are UND!!  What was your starting VL and what week did you go UND?

Hang in there and welcome to our small but growing group.  :)

Trish

[StainedGlass]

Hi Laurie,
Welcome.  Your experience is very enlightening.  I am just in week 6 and have the  same dose reductions for Peg + Study drug (no riba reduct.) but have not had the drastic falls that you have experienced.  My heart goes out to you.   Glad to hear you are feeling better.
In my case they intervened very quickly:
-  Pegasys reduction when neutophils came down to  12.5 (wk 2)
-  study drug reduction when 3 days later when they dropped to only .99 (wk 3)
-  current (week4) reading is .75.
So as you see they are being much more cautious with me.  My platelets are low but no where near the dangerous level you reached.  Currently I am at 83.
This week I am hoping to find out a more specific explanation as to why they are being so cautious in my particular case.  So far I have just been told it is the Neutrophil #'s but I am curious if there are any other factors in my condition that are contributing to this approach.
Did they wait till your wk 4 and give you all the reductions at one time?
Again - glad to hear things are getting better.  Also glad they didn't have to stop your treatment.
Let us know how things proceed.
cheers
B

[LaurieChrstmn]

Hi Trish! :)

For me this has already become a very long road and I'm only at 6 weeks.

My pre-tx counts where:
WBC - 6.5
Haemogloben - 15.4
Neutrophils - 64.1
Platelet - 246

These began to slowly drop  during the first 2 weeks but then took a nose dive during the 3rd week.
By week 4 my counts became:

WBC -.09
Haemogloben - 6.0
Platlet - 14

Not sure which arm I'm in because it's double blinded. I've been reduced to 75 Peg. 4Riba's and they've change my taking the study drug to X& Y in am and Y&Z in pm.

All I  know is that this is nasty stuff!!!

[Emilio44]

Well you obviously found us Laurie, and that's fantastic, our little group is ever expanding.  It is so cool that we can share notes and as a consequence influence our own tx decisions from being educated by others in the same trial. Welcome we should stay in touch. Regards Emi

[Trish77]

Hi Laurie .. you say "long road" as if you've been on the trial for some time... those of us that I know are in this R1626 Phase IIb trial are only about 4 weeks in.   Can you please explain more about where you're at?

I'm surprised you're getting rescue drugs and wondering if that's perhaps unique to you, because you absolutely needed them?  How fast did your levels drop?  A matter of weeks?  What were your levels when you started?

If you're done the trial do you know what dosages of the trial drug you had?  I did read that a very high percentage of those in the 3000mg group had very high rates of neutropenia, like upper 70%ile.

Would appreciate more info if you would, please.  I'm glad to know you're doing much better now.

Regards,

Trish

[LaurieChrstmn]

Hi Everyone!
I have a new friend who posted this site on my blog so I thought I'd stop in to check it out.

I have the blog Binkyslife.blogspot.com

This trial has been a long road so far, but I'm doing much better now. :)

I think that they are starting to play with dosages more now than when the trial first started because too many of us crashed very very quickly. With me they didn't reduce anything until I was in a danger zone. I don't think that they meant to wait that long. I think that they thought I would level out and then when I continued to crash I think that they tried to put the breaks on it by stopping everything. It was too late, I continued to fall.
By the time the Procrit and Nuepogen arrived my WBC and Platelets had pretty much almost hit bottom.
Procrit acted pretty fast as it only had to nudge my bone marrow into releasing my WBC's. But the Nuepogen takes longer as it coaxes my body into making new Red Blood cells and Platelets. Thus the blood transfussion. My Platelet count had dropped to 14 and bleed out occurs at 10....we had no choice.
2 injections of Procrit and Nuepogen later and I am feeling sooo much better!
I go today for my 6 week bloodwork. I'm praying that my viral load is still undectable after all of this craziness!
But like I said, I think that Roche is now playing with dosages in order to find the right level to kill the virus and not the patient.
One more note. At the beginning of this trial Roche refussed to allow rescue drugs! As you can see from me....they changed their minds. Thank God because I really need to complete this thing.
My prayers are with you all.
God Bless
((Hugs))
Laurie

[Trish77]

Week 2 results for me...sort of.   My VL results haven't come in yet.  My HGB has dropped from 12.9 last week to 11.2 this week.  Still okay, just a bit of a drop in one week.  The more significant drop is my WBC.  It went from 4.10 to 0.89.  That seems like a helluva drop to me.  I knew I was alot more tired this week but wasn't sure if it was just me pushing the envelope a bit much or the drugs.  I am bloody tired this week and yet still managing to push through quite a bit.  In bed at 8pm two nights in a row is not my norm though!

They talked about possibly reducing my INF but they're not doing it yet.  They're going to wait on further results from today's blood draw it seems, so my INF dosage for tmw holds.  

How's things on your end?   Emi?  Any results yet?

Hope you're both well.

Trish

[Emilio44]

Another US based trial paricipant that I know of has cleared at week 2.  I have found this out from a friend who visits my home site.  Baseline 4,000,000+, Week 1 350, Week 2 UND, amazing drops.  Unfortunately her WBC, neutrofils and platelets have crashed and they have taken her off the PEG and given her rescue drugs. The study people sent her Neupogen to bring up her WBC, which worked pretty fast, and Procrit for the Hgb, which didn't work that well, so yesterday she had to have 2 units of blood transfused. Will start back on PEG today.  Can you believe this tx management and so different to yours SG.  What the hell is taking someone off PEG for 2 weeks going to achieve.  This has really pissed me off, I just can't believe it.  Anyway I'm assuming she is on big dose of everything with those drops 'freakin nuclear bomb man'.  A PEG reduction should have been the order, what do others think?  And maybe a reduction of trial drug (clincial teams can get tx arm information in these circumstances).  Roche obviously doen't want to vary any trial drug doses and I don't know why not, isn't Phase II about getting dosing right.  Starting to feel like a lab rat people. regards Emi  

[Emilio44]

Canada sounds fantastic to me, what a beautiful country and the best health promoters in the world.   I'd like to put in a speculator now but won't lock in just yet.  I think I'm in d, e, or f (90mg Peg IFN) and also not the top dose of trial drug and I forget which one is the highest group for that, so 1000 or 2000mg daily. This is only being due to how well I am tollerating the tx to date and that the fact that my neuts and WBC remain solid.  Not much to go on I guess, so week 8 sounds good to lock in.  regards Emi

[Trish77]

I would be surprised if your doc knows what arm you're in, simply because this trial is double blind.  Neither the researchers nor us are to know what arm we are in, to my understanding of that.

A wager...never could say no to those!  I think the odds of Emi coming to Canada have just increased...lol  :)   I say at Week X results, we decide what arm we think we're in.  You're almost there, B.  What do you say?  Pick a week to shoot for .. Week 8?  Maybe we could start, like, a hockey pool on it.. ;->

[StainedGlass]

"if you are the sensitive type. "
LOL yeah... I am a bit sensitive - but I think the riba will take care of that ;-)  

Thanks for the encouragement.  There are so many variables in all of this I guess we just jump on and see where we get spit out at the end.
cheers
B

[StainedGlass]

I also had an increase between screening and baseline VL readings.  Was told this is very typical and as Trish said ... its what happens from here.
Emi - It is great to here you are doing well and your WBC is holding steady so far.
  My study nurse claims she is not informed of what arm of the trial I am in - not sure about the Doc.  He is the principal investigator for our region of the trial and head of dept. at the University so I would guess he might but I am sure he will not tell me.  Cosmetically, it almost sounds like you are in a different trial.  Having to lobby to get your VL results sounds crazy.  Here I have been having my blood draw on thursdays and usually get a phone call monday or sometimes tuesday with my VL results and discussion of my panel + chem and then pick them up on the next thurs.  I have been actually surprised by the level of personal care.  
Initially I took the dose reduction as a bit of a hit but when I stop and think of it,  I was never thinking of a RVR in terms of getting out of this at 24wks. It is more that the success rate of clearing this seems much higher when there is a RVR.  In my mind it has always been the longhaul.  Thanks to Trish's query at her study, I will start to lobby for an increase of my Pegasys but 1st I await my  wk 4 results!
Yeah a little wager on which arm of the trial we are in - do we ever find out for sure?  Boy a trip to Australia next winter would be nice ;-)
cheers,
B

[Trish77]

Emi:  Interestingly I went from a screen VL of 3,900,000 to baseline 4,800,000 not sure what that is about?  All I can put it down to is the biopsy in between the two?
--------------------------------------------------------------------------------------------------------------------
Both the docs I had told me VL doesn't fluctuate but I keep reading on these boards from many people who have fluctuating VL's.  My VL went the other way.. screening was 2,100,000 and baseline is 1,650,000.  I'd be surprised if the biopsy had any impact on VL.  At this point .. I wouldn't worry about it .. not like you can do anything about it and now you are virus-killing!  

Thanks for the encouragement on the drop ... I suppose it's simply that the three others I know of had a more significant drop than that but someone's gotta be lowest and it's still a good drop for Week 1.  All those who know better than me tells me that's good so I'll go with that.

What does it mean to group Bloods 1 and 2?

Nice to hear from you, Emi.  Take care.

Trish

[Emilio44]

Hi

Correction on my baseline it's actually 4,480,000 not 4,800,000.  I would be pleased with 1 log drop at this stage. Need an editing tool on this site. Regards  Emi

[dointime]

It might encourage you to know that there was a guy on my trial who got dose reductions on interferon and riba and he was still one of the few who went on to SVR.  His rational was that his body was very reactive to all meds and he would get blasted on a fraction of the dose that anybody else needed.  He had a bad time with both his WBC and RBC dropping and felt bad throughout his tx but he made it.  Whereas my bloods didn't drop much on double the dose he was getting, I didn't feel half as bad as he did but I failed tx.  So things can turn out in unexpected ways and you shouldn't lose heart about these dose reductions.

If you are like him then the shitakes really could help.  They might work doubly well on you if you are the sensitive type.    

dointime        

[Emilio44]

When I had the suppliment discussion with the trial coordinator she said I definately can't take milk thistle which I had been in the lead up to tx and that vitamin C and flaxseed oil were okay.  I'm taking occasional vitamin C but unsure about the flaxseed? I take this becasue I react to fish oil, but want the omegas. Any advice would be much appreciated. REgards Emi

[Emilio44]

Hi Everyone

Pretty encouraging reults SG and Trish, I hoping for a decent drop and the waiting is doing my head in.  Apparently Roche have asked our site to group our bloods week 1 and 2 to better deal with the extra load this trial is creating.  Well that's what I was told anyway?  Trish you seemed a little disappointed with your result, but do remember the R1626 shows absolute resistance and good drops should continue. My other results are encouraging reduced lft's and WBC/Neutrofils steady.  Interestingly I went from a screen VL of 3,900,000 to baseline 4,800,000 not sure what that is about?  All I can put it down to is the biopsy in between the two?  We will have to have a little wager on identification of what groups we're in? I've already got my owns suspicions.  SG I;m sorry to hear about your reductions, however the reductions gives me a sense that you were on the top peg dose and reasonable PI, does the trial team know what group you're in?  Anyway mate you're in for the long haul with a 3 log drop and once bloods are sorted you could always increase dose. Take care co-pilots. Emi

[StainedGlass]

We have a large asian community and fresh shitakes are available most everywhere.  We do use them on occasion but not recently.  Thanks for the tip.  As I started with a fairly low WBC at baseline,  I need all the help I can get and would like to avoid more dose reductions bettering my chances to beat this.
thanks
B

[Trish77]

Susan, I can see I'm being a bit anal about this...lol..a number of things could impact, couldn't they.  If it was all THAT important, they'd give us a complete diet plan and ask us to write down what we ate every day, wouldn't they!!

Trish