1 week R1626 results - help with interpreting pls

My first week results on the R1626:

Baseline:

VL  2,100,000 IU/ml
ALT  45
AST 31
HGB 132
WBC 6.4
Platelets (which refers to what?)  276
ANC (Neuts?)  4.52  (why is everyone else's in different numbers like thousands?)

1st week
VL 3.06 E5  - what the heck is that?  She said 500,000 IU/ml approx
ALT 27
AST 22
HGB 129
WBC 6.0
Plat  300
ANC 4.10

I'm stunned at the drop in my ALT/AST level - it was never all that bad but .. wow.  

Not much change in my HGB .. which is good in the one sense... and in the other sense.. looking at the low drop in my VL (at least seems low to me compared to others in this trial and others not on this trial) makes me wonder if the Riba is doing it's job.  I'm so sick of peanut butter it isn't funny and it's one of my favourite things.

I'd appreciate some help understanding this, please.  I confess, I'm tired and lacking the patience at the moment but I want to understand.  A long day at the hospital, long day driving through rush hour to get there and rush hour to get back, 8 hours in all ... and I confess....the seeming low drop in my VL has me just a wee bit down at the moment until I can do the necessary attitude adjustment.  I know it's just week one ... was hoping for some of the spectacular drops I've been reading about.

Thanks for your patience.

Trish

[Trish77]

Actually .. my baseline VL is something else, I guess.  My screening VL was 2,100,000 IU /ml.   My baseline VL three weeks later is at 1.65 E6 whatever that is.  Seems like quite a fluctuation between the two weeks.  Then Week 1 VL is 3.06 E5.

Thanks again.

Trish

[FlGuy]

Take a look at this thread.  In particular, the reference to Janis in the comment I posted.  But even better, look at CockSparrow's explanation several comments down.
So, even though you're tired you can come back to it a little later to wrap your head around it a little more.

http://www.medhelp.org/posts/show/457538

Congrats on getting through the first week.

I think that everyone else from Canada is down here.  Traffic there can't be so bad.

[Lady Lauri]

Fl...... I'm pulling up a post on breaking a tail bone?

Trish...no clue on that either??? Somebody decipher that!!

LL

[sldb]

Platelets are what cause your blood to clot. Your count is well within in normal range.  Great start at 300.  If iam am not mistaken Riba causes platelets to drop. I see you are doing the R1626 protocol and i have no idea what that is.(which drugs are included in the study)  Your alt and ast are in great shape also. Normal after only 1 week but you have minimal liver damage which helps, this is GREAT!!!! I see your hbg. is 13, but you forgot to post your hct which is probably around 38 or 39 judging by your hgb. You have Great starting labs, good luck.  How long will your tx last?  

[sldb]

Forgot to add that Neuts are a form of wbc that ingest microorganisms.  These are important b/c they fight off infection.  LOW NEUTS = LOW IMMUNITY  HI NEUTS = GOOD IMMUNE RESPONSE .    

[sldb]

I must have brain fog seriously today, correction Normal neuts = good immune response, hi neuts = infectious process going on in the body.  I cant post anymore tonight there is no telling what my brain will tell my fingers to type. Good Luck and best wishes.

[HARRYBEADS]

Everything looks good to me, and you dropped GREAT FOR ONE WEEK.Watch your HGB and WBC levels. The lower the HGB the lower your oxygen in take, so breathing rate increases and you will get the feeling you ran a marathon. Why I bring this up is your base level is a little low, 100 is the standard limit but ,the study may be different.
  Thought this study was about drugs that don't effect the HGB level that much, have you heard that?

Call your study nurse and get her email address, then send your concerns to her and she will answer ASAP. Mine got to know me well and would send scripts to the pharmacy, same day, and email me when blood work came in .

How are you feeling any side effects?

Harry

[Lady Lauri]

Elaine...good one! I missed that! That IS good for one week!!

Harry...agree on the NP e-mail addy. Also had mines cell phone and she always got back to me ASAP. She is great. Get a good relationship with NP!

sldb....lol. you sound like me on Liz'z post at 3 AM the other night!
Good info tho.

LL

[Trish77]

Okay...now that I've had a wee nap right after I posted that....

I read the post you referenced, read the Janis page, then opened my calculator on my computer and there is an Exp key and when I type in 3.06 and hit Exp I can then enter the exponent which, in this case, is 5.  Then it becomes, as per Cocksparrow's explanation in the thread you referenced, 306,000.

So my VL is 306,000 IU/ml, correct?  

Thanks for the congrats...I actually just started my 3rd week today ...did my third injection just before I posted that.  It's going just fine so far....aside from me being grumpy from a long day.  True enough...could have been worse .. thanks for diverting all the Canadians to Florida this week...they'll be back with a vengeance next week!   But then my appt is back to 8am instead of midday, easy peasy. :)

[Trish77]

Elaine, LL .... thank you for weighing in, appreciate your thoughts.

sldb ... no hct on my results?  There is:

ALT, AST, ALP, Bili, Alb, INR, Creat, Gluc, TSH, HG, WBC, Plat, ANC, HCV, Polyl/RBV

Does that make any sense?

The R1626 protocol ensures I'm doing 1200mg Riba daily, either 90ml or 180ml INF weekly and an unknown amount of study drug R1626 in amounts of either 0mg, 500mg, 1000mg or 1500mg bid.

Harry - 300,000 does make me feel better than 500,000.  I'm good with that for the first week.  I would have liked less but I'm okay with that.  Still three weeks of results to go until that 4th week.  Yes, you are right.. these study drugs more impact the WBC, so while they monitor the HGB, the concern for the study drug is the WBC.  

No real side effects....I haven't been looking for any and they haven't come up to bite me.  I've just been pushing through.  If anything, I'm working extra hours and on a bit of overdrive.  I never could slow down and life has been busy.  If I'm going to have sides, they'll have to knock me flat on my a$$ for me to slow down.  That's not to say that I'm not trying to fit in rest where I can, I am...but so far I'm good.  Mind you .. I've been looking forward to this weekend to just relax.  I've been pushing it a bit hard lately.

[Lady Lauri]

I never could slow down and life has been busy...............

That was me too!

My bet is your on 180 peg with that drop, but than with little sides??? Course 3 shots in hard to say. Intersting range in the 2 drugs.
I knew my dose's in it, think the curiosity would drive me nuts!

Ll

[StainedGlass]

Congrats Trish - after all is explained, it looks like you are doing well.  You are starting from a very decent #'s for WBC / Neutrophil.  Well above my baseline so hopefully you will have a bit more fight to avoid the dose reductions I have been getting.
I get the same neutrophil calculations but was told to drop the decimal point and ad a zero to get the common number.   Have you been getting complete print outs of your lab results?  I was wondering if they are using the same labs for the study.  My VL is being done by Cenetron Central Labs in Texas and my blood panel / chemistry is processed by Quintiles labs in Georgia.  I looked over my various VL results and the E5 / E6 calc. is not present on any of them and these are unedited reports from the lab.? Just tell them to tell it to you straight! ;)
cheers
B

[Trish77]

Hi B.,

First I want to say it is *so nice* to have someone to compare and discuss the ins and outs of this trial with!!

I didn't get any results last week...the usual trial nurse was away and her replacement didn't have any.  So I got caught up this week.  She's overworked...and getting worse.  I asked her for a copy of my blood tests as per usual and she balked this time, said something about paper costs so I took a copy of the ongoing chart instead.  I think I'll bring her a package of paper and a reasonable donation to cover the cost.. and tell her I would like the actual results please.  She didn't take my urine this week either..she forgot.  Not that big a deal...just that she's way too busy.   Good Friday is coming so she's cramming the Friday people in with the Thursday people.  I will have to put some thought into how I can get what I want without causing too much trouble.  Has to be a balance there somewhere, eh?  

Thanks for explaining on the neutrophil calculations.  I'll look at them that way.  

Yes, my VL test is being done out of Cenetron Labs in Texas and the other out of Quintiles Lab in Georgia.  So that is consistent...so I wonder why they then take those results and turn them into exponential form?  Strange.  Perhaps that's how they want them on the charts at the hospital I go to.  Odd.  Anyway...now I know how to do the calculations, thanks to the good people here...so I'm good again.

I guess I'm doing well....I would have liked the same drops as others..but it's still a good drop for a first week.  I'll see how it goes from here and it will be what it will be, eh?  Just like everyone.  

I'm spending the weekend catching up on my rest .. have been working 12 days straight with overtime in the mix .. that catches up to a person regardless of on tx or not, eh? :)

Take care, B.

Trish

[dointime]

It is interferon that is primarily responsible for the drop in viral load, not riba, although they do work synergystically.  Lack of enough riba in blood serum is more seen as a reason for viral breakthrough or relapse.

" Good Friday is coming so she's cramming the Friday people in with the Thursday people.  I will have to put some thought into how I can get what I want without causing too much trouble.  Has to be a balance there somewhere, eh? "

This syndrome of difficulty with getting copies of test results, and medical staff being  too busy, really hits a nerve with me.  You have a right to CAUSE TROUBLE.  You are giving your body to these people to be used.  You are risking your health and maybe even your life.  You are entitled to a minimum standard of care and in my opinion this includes copies of your labs and a nurse that is not too busy to deal with your concerns.  Clinical trials centres get paid for every person they treat so don't let them cut corners with you.    

I felt like you when I was going through my trial.  I didn't want to be 'a bother'.  Also I felt dependent on the medical staff and so I didn't want to upset them.  Now when I look back I feel angry with the haphazard way we were all treated.  Don't let any of these 'lovely' medical people fool you.  The trial is just big business getting done, so you should make sure that your end of it gets done too.

End of rant,

dointime.                

[Trish77]

That is my feeling... that I have the lower dose of INF which means some amount of trial drug.  I already know what my riba is.  That's not a secret on this trial.  However, I don't feel any side effects after taking my injection. Three injections does not a scientific conclusion make.. but that's my feeling. Then again.. I don't feel anything after taking the riba and XYZ pills either. It will be interesting to find out at the end.

I felt bad for her being so busy and we do get along very well. She knows I drive in from out of town and that I work, so she tries to schedule the appointments for 8am for me as often as she can.  I appreciate that, as it takes about two hours to get there due to traffic. She answers all my questions as much as she can.  When she was not going to be there on the one Friday, she called to let me know it would be someone else taking her place. Nice touch.  As for copies of things...my first appt, it was her who told me that my medical records belong to me so I'm entitled to copies of everything.  Since she *knows* I want copies of everything and she has to make one for my chart.. she might as well make one for me at the same time.  You are right.  It is not too much to ask to have copies of my blood tests each time I go.  Thanks for the rant.. I needed that. :)

Trish

[dointime]

I can't say I really had sides from my full dose interferon either, except red inflammation round injection sites.  It's the riba that's really tricky for sides, which happen slowly but usually manifest by around week 7.  That stuff is definitely psychotropic, I don't care what anybody says.  

I don't know if you can draw any conclusion about which arm you are in from your stats.  You had an almost 1 log drop in VL in one week, so what you can do is breathe a sigh of relief that you are getting a respectable interferon response.  Now you just need to maintain this downward trend to stay in the game.  

dointime.                

[Emilio44]

So does baseline of 1.65 E6 mean that you had a basline of 1,650,000 VL?.  Just trying to understand the E5 - E6. Regards Emi

[Trish77]

Yes, you have that right.  That was my VL the first day of treatment so that's considered my baseline.

How are you doing yourself?  No stats for you until week 12 or 24?  I can't remember.  Hope you are doing well.

Trish

[Emilio44]

No, the latest is that we will receive our results.  The explanation as to why I haven't received mine was that they are now batching 2 weeks at a time.  Doesn't make sense when I see what's going on elsewhere.  Anyway I wont push the issue, as things are still a little cold after me raising the issue of trial equity with regards to VL results being blinded.  This is a great site with some well informed individuals,including yourself.  It can get firey in here as well, I love it. I just wont a 2 log drop by week 12 (worst case scenario).  I'd love to know the contents of xyz.  Stay strong my friend. Emi  

[Proactive]

glad you figured out the vl given in exponential format...It is really quite simple. E5...move the decimal point 5 place to the right, E6, 6 places to the right, etc.

[Trish77]

Okay...now I understand what you meant by batching Bloods 1 and 2.  I'm glad to know that you'll be getting some results.  It's helpful to know how you're doing as you go along and to be able to monitor your own health.  So good on you for speaking up and you're probably the reason they made the change.  

I'd like to know the contents of XYZ too...but guess we'll have to wait til Christmas morning, eh?  :)

You hang in there too, my friend....will be awaiting your own results.  Glad it's going well so far.  

Take care, Emi.

Trish

[foofighter]

Just noticed you replied on the other side to an older thread of mine that got bumped up by drofi. I rarely come over to this side but I have to remember to do so as I am missing medical news such as your trial info.

I passed on participating in this trial to wait for Vertex Phase 3 but I just noticed they are still recruiting (unless it is an error) at my trial site. I have to read all your posts to see how you and the other R1626ers are doing labs wise. I think that if there is a problem for this one, it is wbc's. My problem is low platelets so maybe this trial would be an okay fit for me. I skimmed the above and it seems so far, so good for you.

I will get up to speed this afternoon and stay tuned for more info!

[StainedGlass]

I have low platelets and am into my 5th week of the r1626 trial.  My screening  + baseline platelets were below range and this didn't exclude me from the trial so that may not  be an issue for you.  My week 3 panel showed me at 75 (ref range 140 - 450),  and they do not seem to be too concerned when I asked about it.
Good luck on getting into the trial you want.
cheers
B

[Isobella]

Happy St Patricks Day!  

I hope this week finds you all well and hopefully low on the sx.  Thanks for keeping us updated on your progress-we are all pulling for ya.  

Stay strong and fight the good fight!

I hope to be right behind you in Phase 3.
Foofighter-maybe we will be able to compare notes if we both get in.

Good thoughts and lots of prayers-Izzy

[Emilio44]

Well, week 1 and 2 pcr is in:

Baseline
AST 37, ALT 37, GGT 39, WBC 7.2, HGB 164, H’CRIT 0.49 , RBC 5.1, PLATE 226, NEUTS 59.9, NEUTS ABS 4.31, ANC 4.31 - Baseline VL 4,800,000

Week 1
AST 33, ALT 27, GGT 36, WBC 7.6, HGB 168, H’CRIT 0.50, RBC 5.2, PLATE 235, NEUTS 64.8, NEUTS ABS 4.92, ANC 4.92 - Week 1 VL 495,000

Week 2
AST 32, ALT 21, GGT 33, WBC 6.3, HGB 160, H’CRIT 0.47, RBC 5.0, PLATE 195, NEUTS 59.2, NEUTS ABS 3.73, ANC 3.73 - Week 2 VL 307,000

Equates to a 1.2 log drop which in standard terms isn't too bad.  My bloods at that point were pretty solid and some don't start tx with those stats.  Anyway not the massive drops that I am seeing elsewhere but hey I'm pretty happy.  No real sides to speak of and still able to work full-time.  RVR at 4 weeks may be a stretch for me, but EVR at 12 real doable.  My speculation of 90mg PegIFN, Riba and trial drug 1000,2000mg, still stands..  Maybe placebo?? I think I would be getting more sx from 180 PEG. Is it the case that PEG is the killer and riba, PI stop replication? If so I wish I had a bit more killer in me. But moderate drops are okay.  Regards Emi

[Isobella]

Congratulations!  It is good to hear you are doing well.  Thanks for keeping us posted.

Isobella

[Trish77]

Congrats on that drop!  I'm still bringing up the rear here and don't mind a bit looking at all you guys ahead of me doing so well, keeps a body going and hopeful.  :)  Still waiting for my Week 2 VL, they hadn't arrived when I was there last week so wondering if I'll get a "two-fer" when I go in this week. I'm also thinking I'm not going to pull an RVR but definitely shooting for that 12 week UND if not before.

That's what I'm thinking for myself, Emi.  That I pulled a 90 straw, based on the same thing.  Little side effects except for fatigue that was heavy last week but comes and goes this week. Other than that, I'm good. Dunno what I think about the trial drug, going to keep an eye on my  ANC for awhile and see how that goes.  

Keep on keepin' on, Emi.  :)

Regards,

Trish

[LaurieChrstmn]

Emi that's a nice drop!

You really are only looking for the Log 10 drop by 12 weeks. There really is no need for us to go undectable as soon as I did because I still have the same 48 weeks to muddle through and I think that the sides I've got are coming hand and hand with the fast viral response. urrrrrr   It gets ruff.

A big part of me would rather have a slower viral drop and a whole lot less sides then to spend 48 weeks feeling the way I have been.

Of course that would be a different story if the tx would be shorter. If I could tx for 12 weeks with clearing at week 3, I'd take all the sides in one shot. 48 weeks of this will be tuff.

Again, congratulations on your drop!

You Are Kickin' It's Little Butt!!!!

:)

((Hugs))
Laurie

[Trish77]

You could be out of this in 26 weeks, if you drew Arm 3 since you are definitely RVR.   Here's hoping for you, particularly since your sides have been so rough.  For those of us who don't RVR at 4 weeks, it's the whole 48, which it would be for 6/7ths of us anyway. :)  

[Emilio44]

Laurie, great news that you are still UND even with the 2 week Peg break.  That must make you feel a little more confident that you will go on to SVR.  I know it's early days but all the 'what ifs' consume our thoughts on tx.   Hey Trish, any word on your 2 week bloods.   regards Emi

[Emilio44]

All prayers are greatfully excepted and thank you for your support.  Any word on the telaprevir phase III? I hear they are also going to put in some 90 Peg tx arms as well, best of luck at dodging those.  Regards Emi

[Trish77]

Emi,

I just have my hemo and ANC from Week 2, but not my VL.  Hemo went to 11.2 and ANC went to 0.89.  I go to my Week 4 appt tomorrow morning, so I'm hoping I get two weeks worth of results then.  Thanks for asking and I'll let you know.

Trish

[StainedGlass]

Hey Emi,
  Quit a good drop for 2 wks!  And such strong blood counts!    You have a lot of reserve to fight the meds and avoid any dose reductions.  ... EVR looks good.
Congrats.
---"My speculation of 90mg PegIFN, Riba and trial drug 1000,2000mg, still stands.."
Do you mean 1000,1200mg?  
As you mentioned in a previous post, I am probably in Group A,B or C.  I suspect group A as in spite of my dose reductions my VL has maintained a fairly steady drop.  
Earlier in the week I got my wk 5 blood work back (no VL in wk5)  most everything has stabilized (on the low side across the board) with a slight rebound in my ANC.  I am up to .9, - pretty much where you are Trish, - but they are not going to roll back my dose reductions yet.  
  My study nurse (who discussed it with the Roche study monitor) confirmed there is a trial protocol re: dose reductions and Neutrophil levels starting at 1.5 ANC !! - and any situation that they are not doing the dose reductions they are violating trial protocol.  That said,  our ultimate care is in the hands of our doctor / principal investigator and in my case I guess my doc is holding more conservatively with the protocol.  
  Picked up my 2nd installment of meds thursday and had my wk 6 blood work done so I await my VL  and ANC results early next week.
  
Trish - we await your VL readings -- many crossed fingers hoping for good results!

Laurie - so, so, happy that through all you have been through you are still UND !!  Hope things continue to get better.
Cheers
B

[Trish77]

SG.. NO VL at 5 weeks??  Did I read that right????  You are UND at 5 weeks?  I'll wait for your confirmation before getting any more excited for you than this..lol  :)  What were you at 4 weeks?  Did we get that report??

Emi .. B., .......drum roll.....My Week 1 VL was 300,000 .. my Week 2 is...5,050!!!!!!  Now I know that's not UND ... but hot damm !  I wasn't expecting it to drop like that!  I thought of you, Emi .. .so hang in there for Week 3 and 4!!  Suddenly the RVR I didn't expect to get after a low Week 1 drop comparatively seems possible now!

Now, they're still behind on my "bloods" .. so I've gone for Week 4 appt, but don't have Week 3 VL yet.  Now I don't go for another two weeks but I will call next week for my VL.  If  I'm UND, I want to know!!!

I do know that my HGB went from 11.0 in Week 2 (my memory thought 11.2 but I was wrong) to 11.1 in Week 3.  The very weird part is that my ANC went from 0.89 in Week 2 to 2.99 in Week 3.  Does that make sense to you??

B., I think your team is more correct than my team about the dosage protocol in this trial.  This week, the trial co-ordinator nurse went over the dosage reductions with me because she said alot of people were getting dosage reductions because they had strict protocols to follow in this trial - a bit of a departure from her prior assertion that there were no trial protocols for it, eh?  So there you go.  Still .. odd then that they didn't whack me with a dosage reduction last time but they're a bit disorganized it seems with Good Friday and the Friday this week closed for a conference they're all going to and I hope they get their sheep together soon.

I had to wait to see the doc this time, for the Week 4 appt.  I went and got the ECG done first because he wasn't ready for me.. that took about an hour and I came back upstairs and it was still not my turn so I waited nearly another hour only to have the study nurse bring me into his office and have him not even say hello to me but walk past me and over to her and say to her that he doesn't need to see me, that everything looks good and he has another patient that's been waiting since 10am (it was now 12 noon).  So she just looks at him in astonishment, then looks at me and says "Trish, do you have any questions or concerns?", something he never bothered to ask me.  All I could muster was "No, none."  I heard what he said about that poor woman waiting .. I knew all was good.. and all I really wanted to know was what sensitivity the blood test would be on the 4 week test and I knew I could ask her that.  So he looks at me and says "you're my patient, I remember you.  I'm glad you're doing well."  And I tell him that coffee on his desk with the milk, cream and sugar on the side is for him and I go.  I waited nearly two hours .. for that.  This is the same doc I saw just before I got in the drug trial who brushed off all my questions after telling me to come to this appt ready to ask my questions and told me that I was lucky I had a coffee ( I always have a TH one with me when I go there) because he hadn't even had breakfast that day (that's why I brought him a coffee this time) .. that I waited two hours to see.. and didn't want to answer many questions because I might get into the drug trial so he just rushed me in and out. Upset me alot at the time and he passed me over to his NP to ask questions.  I know they're busy and I know I'm doing well .. but geez.  He could take two minutes with me even and THEN rush me out, eh?  Ah well.

Thank you so much for the good thoughts, B.  I'm glad to hear that you're doing well!!!   .9 is an excellent rebound to your ANC!  Now we will have to wait two weeks for Emi's next results.  

Laurie, I hope you continue to improve and I'm very pleased for you that you are UND.

Take care, all. :)

Trish

[Trish77]

Emi, I had dinner with my Australian friend, his name is Mo.  Do you know him? :)

Only just kidding....there's a beer commercial that played here in Canada like that a few years back, someone meeting a Canadian in a bar and asking them if they know Dave, or something like that. :)

Anyway..he comes from "Alice Springs" - now, it's probably not called Alice Springs, maybe Allus or something else, but when he says it, it always sounds like Alice Springs to me.  Does that mean anything to you?

Hope all is well with you, Emi.

Trish

[StainedGlass]

Hey Trish
Congrats - those are very positive drops!  This is looking good for you. I imagine you were getting a little impatient waiting for results.  Now it must feel like - something is happening -.

Wow that was quite a fluctuation with your ANC.  I don't know what to say about that except, I am jealous.

No - No I didn't UND.  There is no VL test on week 5 in fact there wasn't to be any tests for week 5 but they are wanting to follow my ANC closely so they had me in for just my blood panel.  My week 4 VL was 1,770.  Just had wk 6 tests on thursday so I may know the results tomorrow or tuesday.

It sounds like your med team is a bit swamped at this time.  It is good that things are going well for you so far as I can only imagine that one would feel like being in a canoe without a paddle if things are not going well and you get stonewalled by your caregivers due to overwork or disorganization.  I have been lucky so far.  Although I haven't seen my doc since the first 2 weeks of the trial,  he has been fairly good at explaining the various details of the treatment and especially my biopsy results.  My study nurse has been very good - personable,  and although she does not always have the answers right there, she does get them for me.  And she has been very patient with me haranging about my dose reductions.
Hoping your weekend is restfull
cheers
B

[Trish77]

To be honest... I'm not quite believing the numbers I'm being given on the CBC's.  Due to the overwork and resulting disorganization, I am missing Week 2 VL results on paper and got them verbally and was given them in IU/ml this time whereas before I'm getting them in Exponential format.  I'm missing Week 2 CBC results on paper and I'm being told the numbers. I'm missing Week 3 VL results on paper because they don't have the results yet and have Week 3 CBC results instead.  I asked for Week 2 results and she said she'd give them to me next time.  Before my Week 6 appt, I'm going to call ahead and let her know what I'm missing and what I'll want at that appointment.  

I am so sorry for blathering on and misunderstanding your intent of no VL at 5 weeks.  I knew there was no test then but I didn't twig on to your meaning.. doh.  I am sorry you didn't get the RVR, I know we can't help but wish for that considering the implications of it.  You are dropping well though, it seems.  And it looks in good stead to still have 8 weeks ahead of you till Week 12 for an EVR.  You and I have both crossed that required Week 12 drop to keep us on treatment for the duration, however....and for that, for both of us, I am very pleased.  Here's hoping the same for you as well, Emi.

I'm glad your team is treating you well.  My NP is too .. she's just not being given sufficient resources to work with, seems to me .. and she's doing the best she can under the circumstances.  Doesn't make the circumstances acceptable however I know my NP is doing the best she can for me and I appreciate that.  I do need to address this in a constructive manner, however.  I'll have to put some thought into that.

Enjoyed my weekend, thanks. Learning to do the pacing thing. I enjoy blues and one of my favourite blues guitarists was playing just up the street from me last evening.   I went later with a friend, stayed up late and slept late to compensate.  He is one kicka$$ guitarist.  I probably should not say this but of course, I'm going to ... every time I watch him play, I wonder if he can do to a woman what he does with that guitar...lol  :)

Hope your weekend was good also, B. and that you are keeping well in every way.

Carpe Diem, my trial buddy.

Trish

[StainedGlass]

Ah the guitarist's swoon...
For me its a womens voice... can reach in and grab you by the heart...  :)
B

[Emilio44]

Of course, Alice Springs is like the traditional heart of Australia and the last frontier.  Ayres Rock (Ularu) is just up the road about 400kms. Just known as Alice to most.  While it is a large remote tourist town full of history and bush characters, the impact of colonization on the traditional owners is the saddest thing you will see.  Small pockets of fringe dwellers, living in river bed camps, alcohol, infectious diseases, family dysfunction, devoid of any real social determinants.  I'm sure in the US and Canada there are similar situations. Emi

[Emilio44]

Wow! Fantastic Trish, I am so please for you.  That is a really good drop, RVR is a real possibility for you. Congratulations.

SG, with regards to the 1000/2000mg in a previous post, I was referring to trial drug dosage and not riba dose, sorry if I confused it.  I am on 1000 daily riba and suspect 1 or 2k for the trial drug. Trial drug dosing is 1,2,3K daily.

Regards Emi (Trish I'm so pleased)

[Trish77]

Emi - interesting stuff on Alice Springs.  Sadly, yes...in Canada we have similar.  Here the impact of colonization is seen on the native reserves and many bleak situations there.  Shameful of both my government's inability to deal with this situation properly over many years and shameful of native government who could do better for their own people.  That's my view of it anyway.

Emi/SG ... in giving the trial protocol a look again .. dosages of trial drugs are either 500mg, 1000mg or 1500mg twice a day with either 90 or 180 of the Interferon once a week combined with each of those and either 1000 or 1200 mg of Riba daily to make 6 arms - and then the control arm of course to make 7.  Sound about right?

Thanks for your congrats, Emi.  Within the realm of your possibilities also as a result and here's hoping.

Regards,

Trish

[Emilio44]

I achieved a 1.0 log drop week 1 and then only a 0.2 log second week.  In my case I hope that's not as good as it gets and I hope I get some 0.2+ drops over the comming weeks.  I received my 3 week bloods back (not PCR) and my ALT had only dropped 1 unit from 21 to 20.  I know there's no correlation between ALT and VL but I'm wondering how low one could expect their LFT's to drop before they steady? Trish, SG, Laurie where were you LFT's at 3&4 weeks? Always doin head miles with this tx stuff. Regards Emi

[Trish77]

Well, Week 3 is in.  I have dropped from 5,050IU/ml to 615 IU/ml.
No VL for Week 4 until a week tomorrow on the Friday when I go back for Week 6 tests.

My HGB has dropped to 10.8 in Week 4.  No dosage change yet and as far as I'm concerned, it's not needed. I'm walking to and from work when I can and trying to pace myself.  NO running.  

My ANC has remained at 2.41.  Don't know what that .89 was in Week 2 but it went back up to the 2.** in Week 3 and remains there in Week 4.  

Emi, with regards to your question on our LFT's, they have been so haphazard in getting my results to me that I'll have to wait til next week to give you a full overview.  I do know though they have dropped below the 20's around Week 2 and they were in the 40's when I started which was only slightly elevated to begin with.  

I wouldn't mind having a Week 4 overview from each of you with your numbers for the first four weeks and I think I'll email you each separately about that.  I think it would be interesting to compare and then at the end when we know what's behind "Door XYZ" then it will be even more interesting.

My question to each of you is how is your HGB and how are you managing with pacing yourselves also?

I hope you are all doing well.  

Regards,

Trish

[dointime]

A drop in HGB to 10 or thereabouts is actually good.  That is because it is a sign that the ribavirin is being absorbed sufficiently into your system to cause that level of anemia.  It is very important to have a high enough concentration of riba in your blood serum, as not enough riba can be the cause of breakthroughs or relapses.  

My hgb never fell much below 12 and I had a breakthrough.  I've read about others who have had this same pattern and relapsed.  It's not an exact science while the riba concentration is not being measured directly but still.  You can read it that the riba is being absorbed correctly and so it should be doing it's job.  That is very good news.  

dointime  

          

[Trish77]

Thanks for the feedback.  If I felt worse, I'd be more concerned.  It's the trial co-ordinator who I think wants my hgb up because of the no rescue drug thing and so I don't go lower and end up with a dosage reduction.  I'm okay with things as they are.  I figure there's time to stabilize yet too.  Was a little surprised at the Folic Acid thing really.. that she'd suggest that.  It's going okay .. I'm at 615 IU/ml at Week 3 so .. here's hoping for Week 4 which I get results of on April 11.  

Thanks for the encouragement, appreciated. :)

Trish

[dointime]

My tx doc gave me folic acid 5mg tabs.  I was puzzled by that too, seeing as my folic acid was not low in the first place.  He just said that it ensures that the body has the building blocks to produce the red blood cells that it needs.  He said that he gives it to pregnant women too and it was really ok.  

You seem to be doing fine as you are, but maybe that suggestion would be worth revisiting if your hgb were to fall below 10.  

dointime

[StainedGlass]

Wow Trish - That is a great VL drop for your wk 3!  The drum rolls till wk 4 results!
Glad to hear that your ANC drop was just an anomaly.  

Emi - Great wk 1 ... hope your wk 2 VL is just an anomaly also. I wouldn't overthink your LFT's as your numbers are so good.  Wait till you see mine...

The good news on my front is that they have lifted all my dose reductions.  Monday my study nurse called with my wk 6 results and as my ANC had risen back up to 1.1 they lifted the study drug dose reduction.  Then on friday (in time for my weekly Peg) they raised the Pegasys back up to full dosage.  Our study team has been in talks with the Roche safety board re: dose reduction protocol and the balance to give patients a fair chance at clearing the virus.  Apparently it is being overhauled but thats about all I know.  It seems that there has been some movement.

The down side for me is the effects of the dose reductions.  I had very little movement in my VL between wk 4 and wk 6. I'll list my  VL's since baseline:

Baseline - 3,020,000
Wk 1           277,000
Wk 2               8,720
Wk 3               4,070
Wk 4               1,770
Wk 6               1,410

As you see there has probably been a price with the dose reductions.

My Hemo reached its lowest at wk 4 with 10.8  and is up to 11.5 at wk 6.
While my energy levels are certainly lower,  I feel like I am doing pretty well though.  The routine of the work week is no problem in spite of the 60hr week  and I am still swimming 3 times a week.  My week ends are definately more fatigued as it seems that that is my regular SX from my peg injection

As for my LFT's, well - high but lower:
Baseline - AST 95 - ALT 152 - GGT 104
Wk 4     - AST  53 - ALT 86 - GGT 67
Wk 6     - AST 55 - ALT 74 - GGT  82
Points to my high level of liver damage and possibly how intrenched the Virus is.

Heres to some great week 4 results Emi / Trish.
And Laurie, hope you are still on the upswing and smiling with you UND :)
cheers trial buds
B

[Trish77]

B, that is some AWEsome news that your dose reductions have been lifted.  I am very pleased for you.  I'm sorry that it came at a cost and I am hoping AND expecting that the increase will yield noticeably improved results for you.  You are actually very close and you are at six weeks.  I'm holding out great hope for you.

Your ALT/AST actually looks not bad to me .. your numbers are coming down well it seems when I look at your Week 6 compared to your baseline and if you keep up at this rate, it will only continue.  Again, I am so *pleased* that you get to increase your dosage!!  I smiled large upon reading that news!!  It seems we are all doing well in various regards and I am happy for all of us.

I would guess...that you have the higher dosage of INF and I have the lower one.  My Week 6 injection last night and my weekends are actually not bad.  Friday evenings are much of a write-off and I sleep later on Saturday mornings than I'm used to but no significant energy hit beyond that. So I'm thinking lower dose of INF.  The encouraging thing about that, if that happens to be so ... is to get that kind of drop in my VL even at a lower dosage.  That potentially says interesting things about this triple therapy and I'll be impatient to see all the data at the end!!

If your HGB was 10.8 at Week 4 and you've gone up in later weeks, as seems to be the common experience, this is like a temporary drop in mine and I shall see how it goes.  

So next is Week 8 results, B., yes?

Emi ... you and I get Week 4 results this Friday ... here's hoping for both of us.

Laurie .. please drop in, let us know how you're making out.

And then there's Rinica.. her husband is on this trial too and I do believe he's UND now.  Will have to find out.

Hope you all have an absolutely lovely weekend..... gorgeous here and requires a walk. :)

Trish  

[Emilio44]

Trish, you are going great and I will keep my fingers crossed for your week 4 results.  My HGB at week 3 is 150 down from 164 at baseline, so after hearing what dointime had to say about riba absorbtion, I hope I am absorbing okay.  I do ensure to take my meds with fat, such as p'butter, yoghurt, milk etc and usually take meds with meals anyway.  SG, I sense that if they had not been so conservative with your dose reduction your results would be better and most likely UND.  But hey, your in for the long haul now with good log drops.  With your tx back to full dose, I reckon UND by week 7/8, fingers crossed.  Laurie's currently on holidays in Vegas/Grand Canyon but posting on her blogg still.   I have acquired a couple of rash spots which aren't that itchy but annoying and uncomfortable.  Energy levels are okay, I walked the dog yesterday and did a brisk 3km walk, so not too bad.  Sleeping well now and really enjoying not having to do the Sydney trip this weekend.  .Anyway buddies, hope tx sx are doable for you and you remain strong, I'm always thinking of you guys, the head miles are wicked on this ****. Regards Emi

[dointime]

I read that your VL is coming down but slowly, also that your HGB has not dropped by very much.  I also see that you are on 1000 riba.  Riba can take a while to reach maximum concentration.  Some people say 2 weeks and I've heard others say as much as 8 weeks.  It probably depends on the person.  

If it were me and with no trial constraints I would up the riba to 1200 right away.  I don't know if your trial doc would be allowed to do that but I would certainly ask.

Best wishes,
dointime

    

[Emilio44]

Thanks for this information dointime, it is interesting!  I was 76kg prior to getting myself really fit pre tx and fell to 74 at screen and remain.  Had I been able to get 1.1kg of weight back on I would have been dosed at 1200.  So I could address this by puting on a kg and they would have to increase I guess.  My week 3/4 are in and a little strange??

BL 4,800,000
W1  495,000
W2 307,000
W3 495,000
W4 57,500

Week 3 is a bit strange, is this common to see a jump upwards? Anyway I'm just about at 2 log at 4 weeks so going okay.  I hope Tierry has emailed this right and will double check.  He is a Frenchman and stuggles with written English to a degree.  Lets hope I don't see this sort of jump again. I need to get my riba dose up to 1200, well that's the plan.  I'm locking in at 90PegIFN, 1000mg x 2 daily of Trial Drug and of course 1000 riba.  I think it is group F but will double check. I want more freakin PEG, a 180 shot could just about destroy this filth. Regards Emi

[Emilio44]

Correction with the trial drug dose, meant to write 500mg x 2 daily.

[dointime]

I was going to ask about your weight.  I deliberately maintained my weight at 76kg throughout in order to get 1200mg.  So start packing your face with pizzas and burgers.  In fact, some people on this forum did that pre tx because they had reason to believe that increasing the 'bad' fat in your body increased the chances for tx success.

I have seen it happen, especially in the first weeks, that VL does not go down in a straight line (talking log numbers here) but starts to level off.  That is the virus mounting a resistance to the drugs.  Your week 4 result suggests that it lost that particular fight (very good news!) but it is not a pushover.  Never mind, you are still in the game.  Get the riba up ASAP and fingers crossed that the trial drug makes the difference.  That drug looks to work slow and steady so it could be just right for the job (rather than VX950 which was very fast but rapidly lost efficacy due to resistance developing).

By the way - can you think of any reason why you might not be absorbing enough riba?  Are you throwing up?  Are you getting the runs?  Is your digestive system working normally as far as you can tell?  This is a question I asked myself but never came up with an answer.  Some people just seem to be less 'absorbent' than others.

dointime
      

[dointime]

PS - when you get weighed next, keep your shoes on and wear your most heavy footwear.  Tie lead weights to your belt if you have to.  Don't worry about taking the 1200mg dose, you've miles to go before anemia becomes a consideration.

dointime

[Emilio44]

Thanks, I had already thought of the lead weight situation and I'm going to use.  I am having riba with small amount of fat and eat and drinking well.  No digestive problems.  I am now noticing a rash in places which came on at about week 3/4, so maybe this is the riba kicking in, I hope so.  Wouldn't mine having these haemotology stats at EOT but for now it is about killing the virus, so I don't mind some drops in haemotology. Thanks dointime, your advice is valuable to me. Regards Emi

[dointime]

I had the riba rash as well.  I don't think it says much about the riba concentration in your blood serum.  Only your hgb will give you a rough guide to that.

By the way, that rash can get to be a nightmare.  You probably should ask your doc for some steroid cream/lotion to control it before it gets to be a real problem, especially as you are upping the riba.

You are welcome to what little knowledge I picked up on my way here.  Doing a trial is quite a unique and testing experience.  Others on this forum helped me a lot when I was where you are now.

dointime    

[fretboard]

Glad I finally ran into this post and I'm glad you're doing well!  I've must have come across it a couple of times before I'm sure, finally I looked in.  It's so stange cause I was wondering about you.  God Bless

[Trish77]

Thanks fret, I appreciate your thought, it means alot.  Oddly enough I just sent you a message too.  You should have it now.

Trish

[Trish77]

Emi, that's a really good drop between Week 3 and Week 4.  I'm really pleased for you.  Even with your "bloods" showing minimal impact, look where your VL is at.  This is good.  Keep in mind you still have time.  I'm very hopeful for you, Emi, after seeing that Week 4 result.  Keep it up .. I hope you get the riba increase you want .. don't worry about the INF... "accept the things we cannot change", that sort of thing.  You have other weapons in the arsenal and just hang in there.  I'm going to hang in there a couple weeks more to see if I start getting any sides after the INF shots.. so far not so much .. before I shoot a prediction out there. :)

I get Week 4 results on Thursday morning.  Was supposed to be Friday and they called to change my appt to 7:30am on Thursday.  Means I'm up and out the door just that much earlier .. around 5:45am.  Argh.  But also means I miss less work this way too.  

Will let you know how Week 4 shakes out when I have the info.

Take care, Emi.

Trish

[Trish77]

Well, no UND and therefore no RVR.  It did look promising there for a bit, didn't it.  I went from 615 in Week three to 448 in Week 4.  Must be the Scottish ones that are left, they'd be the most stubborn ones.  So .. guess I'm duking it out one-on-one with the remaining virons til I slay the little buggers.  

HGB is either 10.3 or 10.8.  Gawd.  Doc says 10.3 in American units whatever that means and Trial Co-ord tells me 10.8.  So .. ??  ANC is holding nicely in the 2.** range so no issues there.

I actually got to have a conversation with a doctor today, what a novelty.  So back to the Folic Acid discussion.  He tells me to take Folic Acid and I say "well, I did some research and it seems to say that Folic Acid doesn't make a difference in ribavirin-induced anemia" and he says "generally it doesn't but in 10 - 15% of the cases it CAN make a difference and since you don't want a dosage reduction, then ... Folic Acid can't hurt.. might help."

I was pretty satisfied with his response so in light of THAT,  "can't hurt, might help" works for me in this case. I have no worries about B12 deficiency so no worries about Folic Acid masking it.  And I'll take peanut butter cups too just because I like 'em.

Starting to feel nauseous after I eat and just vaguely all the time but nothing serious.  Getting used to the randomness of the fatigue finally, I think.  Still working, still studying, still keeping on with the activities of daily life.  And crashing as necessary.

Hope you're all doing well.

Hoping you get your riba uptake, Emi ... because you want it.

Regards,

Trish

[Willy50]

Trish, just stay the course.  Sometimes the response seems to flatten out and people still can go on to clear.  I would look at your viral load more as a hestiation or stall than as a rebound.  The difference between the 2 weeks is slight; almost negligible.  Next weeks viral load may be more telling but I think that it could go down as easily as it could go up.  Hang in there and keep doing everything to the best of your ability.  

I know that you are busy but don't forget to also rest.

Hang in there,

Willy

[Trish77]

Thank you for the encouragement, Willy.  I haven't gone running since the 9K the first weekend I started treatment.  I am pretty much forced to rest, like most people, because when the fatigue hits it really hits.  And then I rest.  When I have a good day I make the most of my energy.  I'm not really doing exercise other than walking and keeping on the move for work and life.  It actually keeps me mentally positive I think and that's a good thing.  

No worries, Willy.  Definitely staying the course and the little buggers are doing down.

Take care and thank you for your thoughts.

Trish

[jmjm530]

I was also flat (and detectible)  between weeks 3 and 4, but did clear at week 6 and went on to SVR. Also read similar here. Not a lot of published data on weekly viral load testing, so hopefully it's just part of the UND process.

-- Jim

[Trish77]

I know RVR isn't everything.  I just would have liked it.  Moving on.  Thanks Jim.

Trish

[Trish77]

Thanks Elaine...hugs from you always make me feel better. :)   I kind of wanted those increased odds that an RVR brings you but if I'm SVR in the end, the fact that I didn't RVR isn't going to matter at that point at all.

Thanks for your thoughts, appreciated.  Hope you and Nick are having good days.

Regards,

Trish

[Emilio44]

Well back from Sydney after a 4.30am start this morning and shot 7 in.  Had the professor alter my riba to 1200mg but he then spoke with sponsor and was advised that the protocol for dose increase is based on a percentage of weight gained rather than going from 74 to 75kg.  He phoned me on my way home with the bad news - so no increase: Week 4 CBC - ALT 21  (LFT's seem to have stabilized around 20's)
WBC 5.3
HGB 150
RBC 4.6
Plate 185
Neuts 65.9
ANC 3.49
VL 57,500

Bloods remaining really solid.  Prof said that this is a really good thing and considering that I am getting 1log drop every 2 weeks.  Anyway that's 64 hours travel time since screen.  Cant wait for monthly visits.  Anyway I got to have 1200mg of riba today and I got an extra 5 points? of PegIFN out of the vial (some have a little extra). Trish it must be frustrating to have so little to clear and it's hanging around.  Anyway what is the difference between UND at 4, 5 or 6 weeks, I'm sure no-one has even measured the differences with regards to to svr. Stay strong.  Regards Emi

[dointime]

"Not a lot of published data on weekly viral load testing, so hopefully it's just part of the UND process."

That's a good point you make Jim.  I remember when the VL results came out for the Vertex people and we puzzled over why some alternated for a while between UND and very low numbers, and what that might imply for SVR.  That may indeed turn out to be fairly normal for the UND process.

dointime      

[dointime]

"was advised that the protocol for dose increase is based on a percentage of weight gained rather than going from 74 to 75kg."

Well, I never heard of that protocol and it is not what was used either in my trial or by my local doctor.  I would really challenge this.  Is it specific to your trial or is it an interpretation of the weight-based dosage rules for ribavirin?  I think some research is in order.  This soooo sounds like a mistake to me.  

Anybody - is this how weight-based riba is supposed to be dosed?

dointime        

[Emilio44]

I was advised it is the protocol to this particular trial.  I will investigate this further and as I said previously it was a phone call while I was on the road.  The prof didn't have a problem with the increase until he spoke with the sponsor or so he said.  I have read the protocol document completely and can't find any reference to it.  So they (sponsor) could be just making a discretionary decision. Not sure.  I'm starting to feel a little used throughout this process, trials are so cold. Anyway I just want their drugs.  Regards Emi

[Trish77]

"Anyway what is the difference between UND at 4, 5 or 6 weeks, I'm sure no-one has even measured the differences with regards to to svr."

Well, the impact of being UND at 4 weeks has been measured and that's where the RVR comes from and why you're considered RVR if you are UND at 4 weeks. Statistically, the chances of SVR go up dramatically if you are UND/RVR at 4 weeks. Neither you nor me nor SG are in that category.  

I think it was simply assumed by me that it would be a piece of cake to drop from 615 to UND in one week based on my previous numbers.  I wasn't expecting to drop by only a mere 200 and a bit little virons.   So .. what I have learned.. is that it ain't over til it's over.  And NOW when I take my Week 7 INF shot today, my riba and my XYZ...I'm going to be saying "Here it comes, you .. " well I'll insert my word of choice there!

I also keep saying to you and SG .. well, it's early yet and encouraging you to keep your chins up .. so now I take my own advice, eh? :)

Sorry for your riba troubles, Emi.  I'd push that a bit too.  You're no further behind.  You either get the yes for pushing or the same no you've already got.

Take care, Emi.

Trish

[Trish77]

Well correct that... 615 - 448 = a drop of 167.  Math is a little off.  

[Emilio44]

Well I guess what I meant by my reference to 4,5 or 6 weeks was that while they have measured the effectiveness of UND at 4 weeks against svr but probably haven't measured the same for 5 or 6 weeks (only against 12 weeks).  With regards to the riba increase, I think I will just wait and see what happens.  I will get the increase at 24 weeks once we go to SOC also an increase in PEG if my hunch is correct.  That's assuming that I respond.  My concern with this is that if I'm going okay on a reduced dose of Peg and continue to be UND at 24 weeks.  What would be the point then of doubling my peg dose (there's nothing to kill) and increasing riba with the likelyhood of further compromising my immune system at EOT.  Can't stop thinking of HR's discussion around tappering and the 'immune deficiency window' at EOT. Maybe the post 12 weeks is just as important as the first 12 weeks.  Is it correct that if we get to EOT UND then we have a 75% chance of clearance.  You're almost there Trish hang in there.  Take care Emi

[willing]

>Not a lot of published data on weekly viral load testing
you OK Jim? not yourself lately...

>Here it comes, you ..
that's the spirit! onwards..

[StainedGlass]

return from the vortex...
greetings trial buds. et al
Have had a whirlwind couple of weeks and haven't been able to check in.
But first thing first...
Trish, Emi sorry to here you didn't make RVR.  I know you weren't holding onto that to hard Emi but Trish you seemed so close.  It is hard not to invest some emotion in the 4th week as it is such a strong indicator of success in the end.  And as you say Emi - what about wk 5,6... I guess you both have wk 6 coming soon.  UND - the sooner the better!  
Emi I hope you have m
anaged to get your Riba dosage upped.  We seem to be following the same weight except I managed to squeak into the upper dosage with 75.5 kg at base line.  I am currently at 72.5kg but they have told me they will not change my Riba dosage unless I have some very dramatic drops in my Hemo.  I was wondering,  does your nurse actually read the scale?  You made me think - I usually just read the scale reading out to the nurse and she marks it down. ;)

Well the week immediately following the lifting of my dose reduction was by far the toughest so far for me.  24hrs after my Peg injection I felt a tap on my shoulder and whisper in my ear " I'm Back!  You little boy, go lay down on the couch there while I kick some viral butt..."  It was all i could do but get up to get food in me and go to the washroom for 2 days.  Along with that came a full week of very intense chest pain.  My study nurse had mentioned it earlier in the trial that this is a SX that some people in the trial had been getting.  I don't know if there is an official diagnosis but she discribed it as a "type of chest wall myalgia."  Intermitent sharp pains moving around my chest, front and back.  Managed to get through the work week and my wk 8  VL test which came back at 54!  Wk 6 was 1410.  Not UND but at least it seams like the painful week had a payoff.
The next week - almost nothing. Which was great as my folks were just returning from 5 months in Costa Rica and I had yet to let them know about my health status as they were away when I was diagnosed and  I did not want to inform them from such a distance.  
In general I am feeling like the Riba is hitting a deeper saturation.  Like you Trish, there is a general nausea and eating is getting to be more of an issue as I will start out with great ambition and quickly loss my appetite and feel like I have to force myself through the meal.  Having to be conscious of keeping my weight up and that has never been a concern for me.  
Hope you are all doing well.  Finding rest... and kicking viral butt.
cheers
B

[Trish77]

Hi B.!!  I'm relieved to hear from you actually .. been wondering how you're doing.  While I'm sorry to hear you're getting the "sheep" kicked out of you somewhat, I was incredibly thrilled to read your Week 8 results...I read your note right before I went to work this morning and couldn't respond .. but did sit there staring at the screen just feeling so very very pleased for you.  What terrific news to start my day on and thank you for sharing that.  

Sorry about your general nausea .. not so fun...manageable but not so fun.  Hard to come up with food to eat with my riba and XYZ these days because very little is appealing.  Ah well.  I knew there could be days like this and so there is.

How are your "bloods" holding up?  (Forever dubbed as "bloods" thanks to Emi. :)

I hope your folks had a lovely time in Costa Rica ... and even more .. I hope things went okay with you breaking your news to them.  That would be a tough thing for both of you and I'm glad that you have good results to share with them and a reason for them to be hopeful for a good outcome for you.  So nice that you had a week of feeling good to spend with them.  That's awesome. :)  

Emi ...... how are you holding up?  Week 6 results for us this Friday.  Not as chomping at the bit for results as I usually am.  What will be will be and I figure .. no point in me getting bent out of shape one way or another til I know which way I need to bend. Already did that.. learned my lesson.

Good to see you, B. ... you have been in my thoughts.  Hope you are well, Emi.

Trish

[Trish77]

Okay.  B., you've had Week 8 results.

Lay your prediction on the line.  What arm do you think you're in?

Emi and I have a ways to go yet.  We won't get Week 8 for another month.

So... stakes.  I got thinking about that and as much as I'd like to fly Emi here to Canada .. well, maybe I can fly a little of Canada to Emi.

Sooo.....here's what I'm suggesting.  There's a big difference between Vancouver, B.C., Australia and "near Toronto" where I'm at in Ontario.  So I'm suggesting that the loser(s) send the winner(s) something very reflective and unique about where they live.  Can be any size, I don't want this to be a financial hardship, just alot of fun out of our circumstances.  Emi, count on something maple in the mix...lol  :)  Do you have maple trees in B.C., B.  ?  I know that's a bad question.. but I dunno.  Quebec, yes.. but B.C.?

Let me know what you guys think .... and waiting on your prediction, B.  :)

(Laurie, if you're still around and you want in .. jump in! :)

Regards,

Trish

[Wassup]

I've just read my way through 80 comments (gaining info. bit by bit). Appreciating all of your , plural, posts and trying to wrap my head around all the technical data.  Sincerely!

I must be tired, cause I almost scratched a hole in my monitor, trying to get the sleepers out of your happy faces eye. LOL

Sorry, I just couldn't help myself.  Laughter= Medicine?

Trish,  Fall in Vancouver is a GALA of color: Maples, Birches; Reds, Yellows and oranges that are so brilliant they scream at you,(beautifully), as you drive by!!!!

Hugs to all y'all, Ant B

[StainedGlass]

Ok - I'll lay down my prediction... I'll have to say trial group B / C.  Is that in the rules?  Since they have the same dosage except for the 24 week follow through. OK,ok,ok...  Group B.  There we have it.  
Now Emi - I expect nothing less than a silver plated jar of Vegemite. Or maby a wombat doll.
And Trish - now lets see... a beer coaster from the old El Mocambo?  Could be hard to find.

My bloods have been Ok, generally low accross the board but nothing causing alarms.  Which is good.  Since they have relaxed their dose reduction protocol, and my wk 8 readings weren't too bad, we agreed to not test for wk 9 and unless I feel bad, we will wait till the scheduled wk 12 tests.  A nice break as I have been having weekly visits since before baseline.
So I am on the long wait till my big wk 12 VL.  
Here's looking to your wk 6's.
cheers
B

[Trish77]

B.,   I love a challenge!  I think I'll look for that regardless just cause you said it was hard to find...lol  :)

Ooooohhhhhh!!  A wombat doll.. that's even adorable just to SAY that!!!  (wombat, wombat, wombat .... )

I'll post my stakes when I post my prediction.  And yeah, B. .. you can have Arm  B / C.  Same meds, just different duration....seems fair.  Okay by you, Emi?

(Okay.. I've really cut back on caffeine the last month and tonight I've been drinking coffee to help me get my studying time in and here I am at 1am, wide awake, fingers flying and no signs of falling asleep any time soon.  Argh!!!! )  

Good to know your bloods have stabilized .. low but stable is good .. you can adapt around that more easily.  

When is Week 12, B. ?  Four weeks from when?

Always nice to see your smiley, B. .. kinda lights up the place. :)

Regards,

Trish

[StainedGlass]

I see you have ventured up to our neck of the woods...  Vancouver can be very beautiful at times.  Except for the freak snow we had last weekend!  Aside from that, spring is well entrenched and there are blossoms everywhere.

The smiley is from the graphic novel "Watchmen" of the '80's - coming to a theater near you...

thanks for your happy thoughts
B

[StainedGlass]

My wk 12 is scheduled for May 8th... tic toc, tic toc,
Now watch the coffee scramble fingers. :)
cheers
B

[Emilio44]

Good to hear from you both, things are still going okay for me with tx sx.  Hanging out for my wk 6 pcr (bloods he he) like you Trish and an 8 hour round trip to Sydney tomorrow.  SC so so close to UND, definately next result! I've been saying for a while now I believe I'm in group F and still think so.  Maybe E I hope so.  So I've had a 1 log drop each fortnight and if that remains true then hopefully I should be somewhere around under 5,000-10,000 at wk 6 anywhere around there would be a fantastic result for me.  While I have a degree of brain fog I really think there is also something that is good about what tx is doing to me.  Hard to describe but it's around being forced to think in a more organised, processed and measured way I guess.  Not to mention the empowerment of doing major harm to this virus.  I'll have to give some thought to my Australian winners prize, vegemite (too salty), kangaroo, crowded house cd (do you know of the crowdies, maybe not), didgeridoo.  Anyway stay strong and talk with you soon. Regards Emi

[Emilio44]

Well not so good news VL wk 6 207,000. Down, down, up, down, up - there seems to be a battle raging within me and while this result is very disappointing a can't remain negative about it as it is only week 6.  If I were on SOC all I would know would be wk 4 VL 57,000 and would think that I'm going okay.  Anyway if this is not going to work for me then I hope that its at 12 weeks rather than 24 so that I can switch straight over to SOC and do 60 weeks rather than 72. If I am correct and I am on 90 PegIFN what do you call someone that doesn't respond at 12 week?  Am I a slow responder or someone who just didn't have enough bullets?  Heaps of stuff going on in my head ,all a bit negative a the moment and I probably shouldn't be posting.  Maybe all I've done here is develop a resistant virus, who knows?? This is like water torture.  Trish I went a day early to Sydney because it is ANZAC day here and a Public Holiday. Stay strong. Emi

[Trish77]

Hi Emi,

You make a good point, that if we were on regular treatment, we wouldn't know what the weekly ups and downs are .. we'd get milestones.  It's a bit torturous getting weekly results in one way but particularly when they're up and down like yours are.  I read back to your past results and you didn't go up as much as the other times and if you can take any solace in that at all, you went up less than half what you went up before.  I will be happy to see UND for you, however you ARE STILL IN THE GAME.  You are doing the best you can ... and try not to let this eat at you.  I finally had to step away from obsessively going after my results.  I'm taking my meds, have altered my life habits, I'm doing what I can .. and I'll tough it out.

I go in the morning for my own results, about 12 hours from now.  

You stay strong too, Emi.  I'm thinking of you.

Trish

[dointime]

"Am I a slow responder or someone who just didn't have enough bullets? "

That's a good question Emi.  I am sorry to say that I agree with you, your week 6 result does not look good.  If it were me, I'd be considering my choices right now but it's not easy.  I'd want to be sure that I was getting enough bullets, and we already know that you are light on the riba.  But to do that you'd have to switch to SOC and forgo the possibility of getting the trial drug.  

How long before your next VL result?  If the number is the same or higher than your week 6 I'd take that as confirmation that what you are getting is not working and I'd have a planB ready.  But that's me.  Either way no guarantees.  Sometimes this whole business just sucks.    

Good luck
dointime
                  

[dointime]

It happens often enough in trials that the goals of the participant (SVR) diverge from the goals of the study (to study the study drug combo).  Your study doctor is paid for every participant that he takes through the trial, therefore he is not impartial and his advice will generally be in line with the guidelines of the study, ie. not necessarily your best chance of SVR.  So now is the time when you should be doing your own independent research to at least inform yourself on what would be your best options for SVR, should your VL numbers go up from here.  

dointime      

[Emilio44]

Thanks, you both make some good points.  I will receive my next vl in about 1 week that is from my week 8 bloods that I had yesterday.  I could just pull the plug now however, Roche is offering me a 48 weeks SOC if I fail at 12/24, so I really need their drugs and may need to hang around. In Australia we only get one tx opportunity through our medicare system and I don't want to use that opportunity up just yet. I still have hope but the next result will be the clincher.  At least I'm giving my liver a break and **** happens you know. Regards Emi

[Trish77]

Emi .. I would hang in there until that 12 week mark.  Let the drugs do battle til then.  Studies have been done on the significance of results at 4 weeks and at 12 weeks but not at 8 weeks, as you pointed out to me yourself in an earlier post. :)  That is a normal SOC milestone AND a Roche milestone in this trial so you hit both of them that way, also with regards to qualifying for SOC drugs as you mentioned.  I have the same situation in my own country.  I totally understand you riding a rollercoaster along with the rollercoaster that is your results.  Just hang in there, my trial buddy.  

Regards,

Trish

[dointime]

I understand what you are saying about the medicare system.  I am in UK where much the same constraints apply.

I believe that you need to get a 2-log VL drop at week 12 to pass the trial at that point?  If my figures are correct then your base line VL was log 6.68 and your 6 week VL is 5.32, ie. not yet a 2-log drop.  If you are not clear at week 12 but do get a 2-log drop on the current regime then it is hard to say whether you would be better off to continue or switch to SOC.  I guess the trial does not really give you that choice though, so that makes it difficult.  If I switched to SOC I'd go overweight on the riba and find a doc who would also prescribe Alinia, if that is possible where you are,

I've been through this whole thing and I know how agonizing it can be, so I sympathize.  All the best,

dointime    

        

[Aquila]

Very disappointing result indeed, although there is still some hope.

I agree with the others.  Hang in for the 12 week test and see how you go then.  It's only another month.  If you get the 2 log drop and can continue on, it just might work for you.

I wish you could convince them to give you the extra riba though.  That would help.

All the best, Emi.

[Trish77]

Okay..every time I try and say this I get emotional.  So here it is.

UND at Week 6 to a sensitivity of <15.  

Sh*t .. all kinds of things I want to say but all I can do is well up with tears.  You can tell when something is emotionally overwhelming because I'm at a loss for words, a rare occurrence for me...even though I bet that comes as a TOTAL surprise.  Ahem. :)

Emi .... StainedGlass /B. ... a girl couldn't ask for two better trial buddies.  I'm with you all the way to SVR all around.

My hats off and humble thanks to all the great people on this forum....could not get through this nearly as well without all of you.

Regards,

Trish

[jmjm530]

You do realize that "week 6" is the magical week to become UND. At least it was for me. Congratulations!

-- Jim

[Emilio44]

That is wonderful news congratulations. UND at 6 weeks sound pretty bloody good to me.  SG I'm hoping you get over the line next time. And for me will I just hope I get a drop and not a rise. Thanks for your kind words Trish you're the best. Regards Emi