No RVR on SOC

[foofighter]

Drum roll............HCV RNA iu/mL: 226

Nurse called with week 4 labs and I didn't clear. Kinda bummed, but I will be really bummed if I don't clear at 6 weeks as that will mean I got placebo. It is an official 4 log drop by week 4 though, so I am thankful for that.

And my platelets are a freak show. The are almost normal in the 120s and have been over 100 since I screened!! It is so confusing. My spleen is enlarged, HR had my Fibroscan at 21, I have varicies and my platelets are hanging in on tx. I know they fluctuate, but I am clearly interferon sensitive and yet it is not making my platelets tank. Go figure.

This does make for a weird situation as far as figuring out the placebo thing, though. Stormrider, did you ever get your 4 week labs? Were you clear at 4? If I am clear at 6, I will not know if it was just SOC or I got the Boceprevir.

If I am NOT clear, I feel that it means placebo, right? NYGirl hung at 400 forever on SOC. Even though it would be only two weeks of trial drug, there is only 226 of those suckers to kill. Also, if in placebo arm and you are clear at treatment week 24, I think (I have to look the week up again) you aren't offered the rollover to the real drug.

Another thing is my blood has been drawn about 44 hours after injection on 2 and 4. My week 6 will be next Wednesday, 96 hours post injection. Does that screw things up? Here are my labs to date:

TREATMENT WEEK 0 (Day 1)
HCV RNA iu/mL: 9,920,000
Bilirubin: 0.7
ALT: 44 AST: 41
Creatinine: 0.8
Hemoglobin: 15.75
WBC: 5.36
ANC: 3.7
Neutrophils: 69
Platelets: 137

TREATMENT WEEK 2
HCV RNA iu/mL: 2420
Bilirubin: 1.1
ALT: 21 AST: 30
Creatinine: 0.6
Hemoglobin: 12.2
WBC: 2.95
ANC: 1.67
Neutrophils: 56.7
Platelets: 127

TREATMENT WEEK 4
HCV RNA iu/mL:
Bilirubin: 0.7
ALT: 18 AST: 27
Creatinine: 0.6
Hemoglobin: 10.9
WBC: 1.78
ANC: 1.0
Neutrophils: 56.9
Platelets: 124

Nurse made no comment about anything and didn't ask how I was feeling (which, I realize now, doesn't matter to them after no help through the horror of the first three weeks). I have nurse appointments but do not see the doc until February. I thought a few things seemed a little low but I guess not enough to concern them. Just can't walk for more than 20 paces without having to sit down, but oh well (unless I am having chest pains or am ready to kill myself, there is no reaction). I guess the upside is my body is absorbing the hell out of the riba.

Super smiley sweet and nice nurses though! Plenty of nodding of the heads, "Oh gosh darn it, that's unfortunate, yes, those darn sides, cripes that's too bad, are you drinking enough water, oh, don't drink too much water, hmmm you should be feeling fine by now, because most people don't have many side effects at this center, you know a positive attitude really takes care of many of our patients side effects..." ARRRGGGHHH.

One thing that I don't get is the helper for whites getting pooh-poohed by two doctors I am dealing with. My main doc (big shot transplant guy, hcv expert) said they don't believe it works and don't prescribe it, and the trial doc says it isn't part of the trial. I know that shouldn't be a concern unless ANC would drop quite a bit lower, but I would like to know what the deal is. Wonder if I will have to be near heart attack to get Procrit.

I am due for my 6 month AFP and ultrasound for HCC that is through my main guy, maybe he will go ahead and prescribe whatever I need. I have the damn insurance.

Can you tell I am crabby? Anyone? Anyone? I guess that is enough venting/rambling for now. I will return before the New Year in a better mood.

Foo

[copyman]

I actually think you may be getting the real drug. The reason you didn't clear is because of your extensive liver damage. I think you will be clear in the next week or 2. Best wishes and Happy New Year.

[foofighter]

Thanks, I needed that slap in the face, copy. Forest through the trees.

Yes, it is a miracle that I have responded as well as I have on SOC considering odds for cirrhotics. I have only been taking the study drug for a little over a week now. Week 6 will be the first labs since I started the BBP diet (big blue pill).

I hope you are right. It would be so great if all our board buddies in the Blue Man Group get the real deal.

And best wishes and a happy new year to you.

Foo

[Myown]

Hey Foo,
I know its hard not to be disappointed, but I do believe you will clear real soon. The other thing I noticed, unless I am not seeing this clearly which is quite possible (my brain is tired at this point) .....you had your week 4 lab drawn 44 hrs after your injection and it left you with those virons,,,,,but if the injection was given a FULL WEEK to work, you just may have been UND. What I am trying to say is the shot was only given a couple days to work. Now the 6th week lab is going to be done 96 hrs after injection - which will give the meds a little bit more time to work, but still not a full week to see what the shot does. I don't know if I am making sense or understanding this correctly.

"most people don't have many side effects at this center, you know a positive attitude really takes care of many of our patients side effects..." ARRRGGGHHH. "

LOL, that nurse is an idiot. Well, the blues will come with these meds now and then. She should read the insert to the meds maybe.

Some doctors and nurses don't want to hear anything, thats why some want to pre-medicate with AD's - so you handle the treatment with "grace."  :o)  

They can keep the AD's. If my husband can deal with a mood swing now and then and then and then;o) so can they...Thank God my doc is good about all that - totally understands what the drugs do and that everyone is affected differently. I let him know sometimes I feel down for the count and other days I am on top of a mountain and that I wish "happy thoughts" could control what I feel. He said its the meds, they affect the mind. If he would have said something like your nurse said, I know I would have had a tantrum and yes I may not be the most patient person even off meds, but a tantrum I don't think I would throw if I wasn't on meds. Then again. Maybe I would throw a teenie weenie tantrum, but I don't count the teenie tantrums - my husband keeps track, I don't need to ;o)

Hang in there Foo. I think you are going to be fine. And no I don't think you were crabby at all!  Vent all you want!

[Marcia2202]

I also think you are doing really well!!! I must say that you had a drastic drop of hemo, that must be feeling really dizzy miss lizzy... Be careful in the bathroom!!!

Happy New Year!

[frijole]

Your labs look good.  Of course we all want to clear at 4 weeks but odds are that we won't.  I don't think you need Neupogen yet and maybe you won't -- ANC of 1.0 is actually pretty darn good.  But your HGB has tanked from 15. to 10.9 pretty d.. fast and I imagine you really do feel rotten.  I know the BOC trials do allow Procrit.   How low does your HGB have to be to have it rxed?  

Looking at your profile - love the R&R picture and your commetary of where everyone is now.  My how we change over time, eh?
frijole

[Willy50]

IF I'm reading it correctly you went from 9,920,000 to 226 ml/IU in 4 weeks?  That's an exceptional log drop!!!!!!!!  You are VERY close to clear from virtually 10 million (that's a lot of zeros) in 4 weeks.  I would feel very happy about that.  I surely wouldn't rule out being on triple therapy.  That is great expecially for a stage 4.

The trick of course, is clearing and staying clear.  You need to avoid dose reductions.  IF you can get some form of rescue drug it might nail this down regardless of whether you are on triple therapy or not.  You might remind them that you MUST clear and stay clear or your chance with protease inhibitors are used up (without resistance issues).  It could be that some pleading might work.  A hemotologist might also prescribe some form of rescue drug for you or know an alternative for you but the main thing is that you must resist dose reductions even if it means bed rest.  This is a very critical period.  I hope that the trial director might allow some amount of "fudge" in your case.  On the other hand you may find that you become acclimated to your lower scores and be able to continue to function with some allowances.  

Ask for help (cooking, driving, shopping,housework)
Simply do less of everything; rest, rest, rest,
Maintain a good diet
Is your iron OK?
IF procrit is not allowed, how about a transfusion to tide you through?
A hemotologist might be able to "overrule", sign off on responsibility or reason with your current doctors.

Crossing fingers for you.

Best,
Willy

[Rockerforlife]

You are coming along excellent for the SOC drugs...id say amazing if you ask me...and you are stage 4?...you are still in this ball game and scoring big time...the study results  for the BOC trials are based on the 8 week mark...thats 4 weeks with the BOC...if you are clear by week  your odds are up in the sky...im not familar tho with the results on cirrotcs,,stage 4 patients...im  still waiting on my 6 week BOC PCR...snow storms and holidays are keeping me in the dark....BE HAPPY....you are winning

[Rockerforlife]

I MEANT:..."if you are clear by week 8  your odds are up in the sky"...IF BY WEEK 6?....with theses odds go to vegas on the next flight

[susan400]

It sounds like, to me, that you've had a pretty significant viral load drop, which is very encouraging.  Try to keep positive thoughts, you can't go wrong with that.  On the other hand, I know from past experience how disappointing it is to hear that you haven't hit the UND number that you so desparately want to hear, at the very important 4 week marker point.  I hate it when these nurses are so unsympathetic.  Every now and then, I've ended up with one that was very caring, but the cold ones seem to be prevalant, too.  I think that sometimes they adopt that personality in order to cope with having to give out bad news to certain patients.  Maybe they get that way because they don't want to cry in front of the patient.  I try to put myself into their shoes and wonder how I would react if I had to stand in front of a patient and tell them, "I'm sorry, but you haven't cleared".  I would hope that I would be compassionate and caring, but could I continue on being that way if I was in the field for many, many years?  I just don't know.   I wish you the best at your 6 week results and I'm hoping that you come back on here and report that you are UNDETECTED!!  Susan400

[jmjm530]

not that familiar with your particular trial, but you are very close and that should be encouraging.

As to when the blood is being drawn for the tests. The protocol on familiar with, is to have blood drawn the day before the injection, or the day of the injection, but before the injection. Therefore, you should have had blood drawn for your week four test the day before your fifth injection.

it's possible, that your trial has a different protocol, but it does seem odd that one week they draw blood after 44 hours in the next week they drove blood after 96 hours. One would think, that in an ideal world, or in your case an ideal trial, there would be some consistency. Again, perhaps your trial does not think this is important. Alternatively, they are a fitting your blood draws into a schedule that works best for them and maybe not best for you. Personally, I would bring this up, and get blood drawn on the correct day, even if it meant making a separate trip to the office for the blood draw.

All the best

Jim

[foofighter]

Thanks to everyone for all the inspiring comments, suggestions and good wishes. This is what keeps us going. The great peeps! My arms wrapping back around you Elaine! I absolutely have much to be thankful for.

Willy, that 226 in 4 weeks was from the SOC lead-in, so YAY on the fact that I seem to be super responsive to interferon at stage 4 (after dragging my feet for two years). Week 6 labs will have the PI/placebo in the mix, so we will see.

They allow Procrit, but I have to go all Shirley McLain (Terms of Endearment Shirley) to get them to give me stuff it seems. I have a feeling I am below 10 now. Lose my breath when just talking (but I am gabby). Can you go low, low, low without procrit if you stay in bed? I have had such terrible sides from SOC that I don't want to take ANY more drugs if possible. I even pass on the Tylenol and choose my new invention of velcro straps holding ice packs on my head. Trying to keep my stomach to a dull roar. Where do you look for iron on your labs? Does it just say iron?

I haven't succumbed to anything except chocolate milk for comfort food (gave up the pumpkin pie guts after Thanksgiving) .

DIet has been okay, but more calories than I should eat getting all these pills down and keeping the dizziness at bay. Weight has always been a struggle for me and I am doomed to a 1400-1600 calorie per day limit (with a ton of walking, and believe me I haven't been walking).

I lost 8 pounds the first month through the horrible stomach problems, but checking today I have gained 10 in the last nine days! My ankles seem to be very swollen so this is something new to figure out. I had salty ham on Xmas, but that was a week ago. Hmmmm.

Good thing is that I have been craving "good" food. Salads and veggies and a freak about eggs. Eat a couple of hard-boiled over two-three days. Love them warm. Half a one seems to be perfect for riba dosing. Would love to have some chickens someday. Pets AND producers.

But I digress! Again Willy, Marcia, Frijole, MO, Copy and Child, your kind responses and gentle support is greatly appreciated.

Foo

[Rockerforlife]

LOL


I even pass on the Tylenol and choose my new invention of velcro straps holding ice packs on my head.

sorry but you made my day

[Rockerforlife]

do you have cups strapped to you neck to catch the dripping water?

[charm27]

Thats a great logdrop.. I wish you well. Your a very good responder!
Happy New Year.

Charm27

[foofighter]

You can add tinfoil to this headache relief device for X-file type protection, not to mention looking very avant garde.

No dripping going on as they are those blue gel packs which of course with the silver tinfoil...well, nuff said.

I'm working on a patent.

Thanks Susan, Rock, jim and Charm

[Rockerforlife]

ARE YOU SERIOUS?....cause i am rolling on the floor...banging my fists  and legs into the rug...and  crying ...i cant catch my breath either...sounds like a halloween mask

[sunspot]

I had the same 5 point drop in HGB in the first month so I know how you feel. Bed rest will not prevent HGB reduction but you won't be puffing and wheezing and need a nap after going to the kitchen.

Procrit did not help to raise my HGB but it may of helped so it did not drop any lower.

Best to you on your VL drop. That is a large drop.

Dana

[sunqueen]

Foo - What they said. Looks good from what I can tell!  

I'll be happy to make an aluminum foil deflector beanie to help hold the ice packs in place. I understand they help jamb out the conspiracy theorists who beam in mind-control carriers, as well.

[Rockerforlife]

my HBG  was 15.3 before tx...now at 11.9....thats im doing shot # 9 tommorrow...when i snezze tho i get dizzy real fast

[frijole]

Well, how on earth are you?  I haven't seen a post by you in ages.  Of course I don't post much myself these days.  How does life go?  I am glad to see you here.  Has life after hep C gotten better?  Seems like you were having a lot of dental work done right after tx.  All well there?
frijole - kathy

[can-do-man]

I find it odd also, sense i do my shots on monday night my Doctor made it clear i must have my labs drawn on Mondays before my next shot.

You would think schering would have a standard protocol for all... It could be different for the navie and relapser trials though..... Not sure how it will work once one becomes und.

Foo..... Really great news for a stage 4

[Rockerforlife]

IM all over the map when it comes to blood test times...i do shots on Friday and i have to wait two weeks for the next blood draw...which falls on a Friday morning....but this week im in for a blood draw 3 days early because of the holidays...i dont know how this works because i wont be getting my PCR test on the exact week 8...wont that screw up the sceduling...i thought week 8 was a milestone maker to determine when to go into the different arms of treatment...so my week 8 PCR will be actually 3 days early...i did ask my nurse and was told its ok...still wondering whats goin on

[can-do-man]

Week 12 pcr results is when you will be placed in the boceprevir arm if you have been in the placebo arm.... Thats really the most important one. While being und at week 6 or week 8 would be great sense were relapsers and geno 1 being lead-in RVR is not that common.

We just need to look at the big picture here SVR in the last trial was 74%. Them are still good odds.

It kinda shows though that even though we are in a trial study Doctors have some lead way on how they do things. Also make sure you talk with your trial nurse and doctor if your hgb starts to tank. I had that talk already so there will be no dose reduction.

[epiphiny]

If getting safety bloods done I was told protocol can be 2 days either side of shot day, according to my NP when I questioned her about the same thing.  However, I always make sure I get mine drawn as late as possible on the day of my shot.

On the Roche/Pharmasset trial I was on, VL bloods were taken 12 hours prior to next shot, very defines protocols as my study was specifically testing study drug's action on VL.  Once UND they said it reverts to the 2 days either side protocol.

[Rockerforlife]

This is the week 8 milestone mark i was referring too


Subjects in Arm 2 will be assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

http://clinicaltrials.gov/ct2/show/NCT00708500?recr=open&cond=%22Digestive+System+Diseases%22&rank=29

[Rockerforlife]

My blood was drawn 3 days before week 8...i guess if im clear at wk 7 and 1/2   its the same as wk 8...if im not clear by my 7 and 1/2 results...have i been cheated by being 3 days early...im keepn an eye on this...

[can-do-man]

I don't think we or the doctor will know what arm were in until that date comes up.

[Rockerforlife]

heres the info on arm 2...BTW,,,,the 8 week maker is only for this arm


Arm 2: Experimental
Subjects in Arm 2 will be assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG + RBV (WBD) for 4 weeks followed by boceprevir + PEG + RBV (WBD) for 32 weeks, then:

36-week regimen: Subjects who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
48-week regimen: Subjects who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.

[Rockerforlife]

actually....now looking at this....by my blood being drawn eary is too my advantage...do you guys see what i mean?..if not ..ill explain

[Rockerforlife]

i under stand that...BUT...the big guys who know  what arm im in already want to know when i clear  before or after week 8 as so they can asign me to the 32 week or 48 week remaining time

[can-do-man]

I think your saying because your interferon level would be higher??? But the down side would be less boceprevir and riba in your system???

It looks like IF were in arm 2 and und at week 8 then we only do 36 weeks. Thing is we won't be told what arm were in till we reach that point

[Rockerforlife]

BUT...ill try to explain why its better for me to be detcable at week 8(really 71/2)....because i will get the chance to an etra 12 weeks,for a total of 48,as oppsoes to the 36....only thing is the last 12 weeks will be BOC/plcebo...id go for the 48 weeks here...wouldnt you?

[Rockerforlife]

Riddle me this?

Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion

DOES this mean i will the fake drugs only for the remaining 12 weeks,if i am UD by week 8....this is confusing this part...why give us fake drugs for 12 weeks if we are UN...DONT make sense to me

[can-do-man]

Sounds like if we are und but not in arm 2 then we will get the placebo for the remaining 12 weeks but stay on SOC for the remainder of tx. Sounds like no matter what 36 weeks of boceprevir will be the max.

BTW, i like your thinking on doing the whole 48 weeks even if the last 12 is SOC only. Had not thought of it that way but me being a geno 1 relapser and a stage 4 i'd gladly do the extra 12 weeks to boost my odds.... Good thinking guy

[Rockerforlife]

I may be crazy,but not stupid,easy but not sleazy...LOL....my nurse said the same thing when i mentionED this to her...its better to be detecable just a few days before the 'cut off"date...this way you get to go longer ...so you do see my point...?...EITHER WAY...we do 36 weeks of BOC and SOC....anyway....i want  arm 3....48 weeks with the pedal flat to the floor..both  SOC and BOC ....the  SVR odds are only 10% difference between going 32 weeks and 48 weeks...but thats in the navie trials...the non responder trial will be lower of course...we still have a chance to kill the monster

[Rockerforlife]

BTW...the trial study number i am asigned  has the same number as my birth date...0158...  and get this.....the name of the new BOC drugs that are 10 times more effective that the current BOC drugs...the code name is...you guessed it..."158"...i was born on the DEC1/58

[Rockerforlife]

IF THAT AINT A SIGN?...ill be a mokeys uncle

[can-do-man]

Yep i see your point...... Here were hoping to do tx longer, something about that does make us sound crazy. But after doing 86 weeks the first time, 48 weeks this time seems like i only have to do tx half the time........ Heck that makes me feel like a geno 2

[Rockerforlife]

Hell...id go 5 years of tx if they would let me...as long as i can still get redipen to my belly and the blue pills to my lips....aint this crazy?....wanting to do drugs just to save my a@ss

[foofighter]

So, if in Arm 2, you guys will be rolled into the 36 or 48 weeks soon? After TW8 labs come back?

Nothing happens for naives until TW28 (but what happens is still based on those week 8 VL results). In our Arm 2, if und at TW8, you are DONE. Kinda scary.

BTW, has anyone pinned their doc down on how the rollover works for Arm 1's?

Can-do, are your platelets hanging in? Do you have a problem with them on tx?

[Rockerforlife]

YOU SAID:
In our Arm 2, if und at TW8, you are DONE. Kinda scary.


it is,but at the same time its not...if you are clear at week 28...your odds are 82% to SVR.thats based on the lastest naive trial results...BUT...if are still detectable at week 28,you do another 12 weeks...now im not sure if those extra 12 weeks will be SOC,or with BOC/PLECBO..you know about that/?
....me thinks i want to clear at wk 28

AS FOR THE the arm 1 ,i think if your not clear by week 12...you get the real stuff

[Rockerforlife]

...if you are clear at week 28

i meant to say if yu stop tx at week 28 and clear by wek 8

[Rockerforlife]

sorry....im getting the two trail times (navie and nonresponder) mixed up here....but i think you know what im talkn about....

[Rockerforlife]

i just re read my papeers from my doc...it says if i am in arm 1 and i dont clear by wk 12....i have 2 options...i can decide to stop,which seems stupid too me...or i can continue with "open label' BOC will be given...it does not mention how long after the 12 weeks tho...but again...it looks good but it dont...its like a trade off...any way i look at these arms...its always better to RVR...seems like thats the most determing factor here...if you get chosen to be in arm 3 you have the best chance to SVR.....BUT...more drug toll on the body....it seems to me its all a trade off....i guess we cant have the cake and it it too again

[Rockerforlife]

BTW...i am calling the big guns on monday and find out once and for all what this study is all about....they didi call me back last week and they gave me an ext number...no offece to my dotors and stuff...but it seems like im in the dark still on details...I WILL FIND OUT

[StormRider]

Hi foo... Happy New Year!

Looks like you are getting some good results so far. Hang in there and keep the prize in your sights. I have not yet received my 4 week PCR, I do have all the other labs for week 4. You brought up some good questions about the different arms and duration, I scanned the trial docs in and did a copy/paste, thought we could use this for a quick reference if needed. If there are some grammer errors it's from the OCR. This is for the naive study only.
---------------------------------------------------------------------------------------------
How Long Will This Study Last?

The screening phase to determine whether you qualify for the study should take approximately 1 to 8 weeks. The study will include 28 or 48 weeks of therapy. The length of the study phase will be based on the study arm to which you will be assigned. The follow-up phase will, also depend on the study arm to which you are assigned, and will range from 24 weeks to 44 weeks. In total, you will be participating in the study for 72 weeks once you are randomly assigned to the study.

Study Procedures

All arms initially will start with “Lead-in”. The lead-in period will be therapy with only Peglntron and ribavirin for 4 weeks. Peglntron (1.5 mcg/kg) will be injected subcutaneously (under the skin) weekly and ribavirin (600 to 1400 mg/day, based on your weight) will be taken by mouth 2 times a day.
After the “lead in” period, the drugs you receive will depend on which arm of this study you are randomly assigned to and how the virus in your blood responds to the drugs.

How will the assignment be done?

Assignment to a study arm will be determined by chance like a toss of a coin. You will have a 2 out of 3 chance to receive the experimental drug boceprevir plus standard treatment with Peglntron and ribavirin, and a 1 out of 3 chance to receive standard treatment with Peglntron and ribavirin alone. The study subjects who receive Peglntron and ribavirin alone, will also receive a placebo, which by appearance looks like boceprevir, but doesn’t have any active medical ingredient. The study assignment will be done by a computerized system, called the Interactive Voice Response System (IVRS), in a “double blind” fashion. This means that neither you nor your study doctor will know which arm you are in and what drug regimen you will receive. The dose of your Peglntron and ribavirin will be based on your weight when you enter the study. The study procedures for each of the arms is described below:

Arm 1: Subjects in this arm will receive Peglntron 1.5 mcg/kg and ribavirin, along with placebo. The arm is called the “control” arm.

• Lead-in phase: Peglntron + ribavirin for 4 weeks (see above)
• After week 4 (TW4), you will be given a placebo pill. This will be taken by mouth 3 times a day, in addition to your Peglntron and ribavirin therapy.
• You may continue with placebo, Peglntron and ribavirin for up to 44 weeks.
• At TW 24, the amount of virus in your blood will be measured to determine whether or not you will be able to continue the study after week 28:
- If the hepatitis C virus is not detectable (no hepatitis C virus measured in your blood), you will continue with placebo + Peglntron and ribavirin therapy for a total of 48 weeks.
- If the hepatitis C virus is detectable after 24 weeks, you will be discontinued from the study at TW 28. If you are discontinued from this control arm, you will have two options. You can either proceed to follow-up, where you will no longer be receiving the study drug but will be monitored for side effects, or since you were in the control arm, you can choose to participate in another boceprevir study called “PROVIDE” (where you will be given boceprevir as well as your Peglntron and ribavirin treatment). While you are receiving the study drug, the study doctor and staff will not know you are in the control arm. If your virus is detected after week 24 and the study drug is stopped, the study doctor and staff will be informed by SPRI whether or not you are might qualify for the PROVIDE study. Your study doctor will discuss these options with you in detail during your discontinuation visit.

Arm 2: Subjects in this arm will receive a short period (24 weeks) of boceprevir plus Peglntron 1.5 mcg/kg and ribavirin and possibly an additional 20-week with Peglntron and ribavirin, along with boceprevir placebo, depending on how fast they respond to therapy.

• Lead-in phase: Peglntron + ribavirin for 4 weeks.
• After TW 4, boceprevir (800 mg by mouth, 3 times a day), will be added to the Peglntron + ribavirin.
• At TW 8, the amount of hepatitis C virus in your blood will be measured to determine whether or not, you will be continuing the study after week 28:
  -If the hepatitis C virus is not detectable in your blood at TW 8 and at all subsequent visits, then at TW 28 you will discontinue active study therapy, and proceed to 44 weeks of follow-up.
-If the hepatitis C virus is detectable in your blood at TW 8 or at any subsequent visit, t hen at TW 28 the boceprevir will be switched to a placebo pill (neither you nor your study doctor will know this has occurred), and you will continue, to take placebo + Peglntron + ribavirin for an additional 20 weeks (for a total duration of 48 weeks) followed by 24 week follow-up.
• At TW 24 the amount of virus, in your blood will be measured to determine whether or not you will be continuing the study therapy:
  -If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned therapy.
  -If the hepatitis C virus is detected in your blood after 24 weeks, you will be discontinued from the active study. For that reason you might be asked to come to the clinic for an unscheduled visit for a test of the amount of hepatitis C virus in your blood or to stop the study drug and enter follow-up. You will not be eligible for the “PROVIDE” study as you were not in the control arm. SPRI will notify the study doctor and staff of the subjects who are eligible for the “PROVIDE” study.

Arm 3: Subjects in this arm will receive 44 weeks of boceprevir, along with Peglntron 1.5 mcg/kg and ribavirin.
• Lead-in phase: Peglntron +ribavirin for 4 weeks
• After week 4, boceprevir (800 mg by mouth 3 times a day), will be added to the Peglntron + ribavirin.
• You will continue with boceprevir, Peglntron and ribavirin for up to 44 weeks (for a total duration of 48 weeks).
• At TW 24 the amount of virus in your blood will be measured to determine whether or not you will be continuing the study:
  -If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned study therapy.
  -If the hepatitis C virus is detected in your blood after 24 weeks, you will be discontinued from the active study at TW 28. For that reason you might be asked to come to clinic for an unscheduled visit for a test of the amount of hepatitis C in your blood or to stop the study drug and enter follow-up. You will not be eligible for the “PROVIDE” study as you were not in the control arm. SPRI will notify the study doctor and staff of the subjects who are eligible for the “PROVIDE” study.

Unblinding of the study

During the study neither you nor your study doctor or study staff will know whether you are receiving boceprevir, or placebo. After the study is completed at all centers worldwide, and the study report is issued, SPRI will provide the unblinded information to your study doctor. In case of emergency for which it is necessary to know whether you received boceprevir or placebo, your study doctor will call the IVRS (lab) which can provide this information 7days a week 24 hours per day.

[Rockerforlife]

It looks like no matter waht arm we are in....we have the option to get the real drugs at certain times in all 3 arms....not too bad

[Rockerforlife]

I do have all this info already...but for the life of me...i still dont fully understand it all..i need a "nut shell" version...LOL

[Rockerforlife]

I THINK THIS INFO is for the naive trial...because my papers say i have a 4 out of 5 chance of getting the real drugs...not 2/3...

[can-do-man]

Foo, yes my platelets tank on tx. Last time they got down into the 30 to 40,000 range. Also have problems with my hgb. Its already went down from over 15 to 11.

Rock, yes that is the navie trial study storm posted.... My Hepo told me my week 12 pcr should be back in a week, at which time if i'm on the placebo he will start me right then on the real thing. So your still looking at 35 weeks of boceprevir.

[Rockerforlife]

but if you clear by week 12 ,dont you just continue on with the SOC drugs if you are in arm 1?

[Rockerforlife]

thats the scary part of this trial i dont like...am i right ?....

[Rockerforlife]

Arm 1 is bogus....in order to have any chance in this arm...you need the virus in your blood at wK 12,in order to get the BOC...if you  clear at wk 12...you dont get the BOC...just 48 weeks of SOC....that really ***** for non responders...and the sad thing is....i dont think they will unblind you at wk 12....SCARY STUFF?

[Rockerforlife]

this means you can end up doing 48 weeks of tx with SOC...just like the last tx in 2006....what are the odds of SVR for that senario?....i am not liking this at all

[Rockerforlife]

am i right in saying we wont know what arm we are in until the trial is completely over....?

i wonder when unblind us ?


o well...just eat and shoot the freakn stuff

[can-do-man]

Yes from what i understand your right. My thinking is and i can't say for sure because my doctor never came right out and said this is because we are geno 1 relapsers/nonresponders that had to extend because we didn't clear by week 12 the first time the odds are we will be slow responders this tx.

One other thing is this is a double blinded trial but at week 12 does it become just blinded??? To where the doctor then is aware of what drug your getting and switch you over to the boceprevir in a blinded fashison.

Between brain fog and the time between my screening and long talk with the doctor i do remember him saying at some time i would get the real drug.

You have brought up alot of good questions and sense my hepo has been very involved in these trials my next visit i will have a list and i'll be checking it twice. And as i get the answers i will be writing them down.

[Rockerforlife]

Good luck...i try to get answers to these questions and it seems they are so busy..its like an assemly line....i cant really blame them because it seems they dont even know all the details..like i said...i shall call Schring and Plough on monday from work...i even have a ext ph number ...you gotta admit...it does seems a wee bit complicated...Arm 1 is the thorn in our sides...no pun intended

[can-do-man]

Good luck calling schering, when i first saw this trial posted i noticed the cut off limit on platelets was 100,000. I just had a CBC done and my level was at 80,000. I though oh s h i t that excludes me. I send an email right then to my hepo. He gave me a quick response...... Don't worry about it I'll get you in.

Still worried i called and talked with a rep at schering, he finally told me there was a 10% lead way which would allow one in at 90,000. He also told me that the final call would be my doctors so if my doctor said 80,000 was not a problem then it would not be a problem.

He also said while there is certain rules that must be followed even by the doctor there is also alot of things the doctor can do.

My Hepo is very comfortable in his skin and has no problem letting patients state their case, and yes there are times he's very busy and is in and out fast but for the most part he will set and gab and shoot the c r a p. Plus he has a hell of a sense of humor.