"Beautiful Boceprevir"(i love you)

The hepatitis virus is not in my body anymore,i am UNDECTABLE,...here are some numbers for those wh are interested

Day 1 VL=20,600,000--------RIBA /PEG
Wk 2  VL=      54,500--------RIBA/PEG
Wk 4  VL=        6,150--------RIBA/PEG
Wk 6  VL= UNDETECTED--RIBA/PEG/BOC
Wk 8  VL= UNDETECTED-  RIBA/PEG/BOC

[Rockerforlife]

The test used for the viral load was tagman 2.0 version<10...copies



Improved COBAS TaqMan Hepatitis C Virus Test (Version 2.0) for Use with the High Pure System: Enhanced Genotype Inclusivity and Performance Characteristics in a Multisite Study


http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2168538

[kitkat14]

Congratulations!!  Way to go!!

k

[Rockerforlife]

The high negative predictive value of a <2-logarithm decrease at week 12 of pegylated interferon/ribavirin combination therapy compared to the baseline has led to the introduction in treatment guidelines of a stopping rule which helps shorten therapy duration for nonresponsive patients

[GreatBird]

Woohoo!! I'm jumping up and down for you. At least in my head. That's SENSATIONAL news. Makes us a fan of those Very Blue pills.

[Rockerforlife]

Thank you kitty kat.....wishing you well.

[Rockerforlife]

It seems all the people in the study at my hospital are that are in this study are clearing at week 8....

[charm27]

Good luck! Wishing you SVR!  :}


Congrats!!

[charm27]

Good luck! Wishing you SVR!  :}


Congrats!!

[GreatBird]

Oh that is good news about the eight-week clearance. I'm hoping. (I've been worrying too much about it all lately.)

[Rockerforlife]

Great bird is flying around the room.

[GreatBird]

At least in her head. ;)

[Rockerforlife]

i cried on the train today goin to work....LOL

[GreatBird]

Tears of joy are glorious. Hang in there Rocker! You'll get your SVR!!!

[Rockerforlife]

MY other numbers are really great too...my reds are 12.5

whites are 1.2
AST=24
ALT=23

My reds are goin up...wahts up with that?....anyone ever see the red bloods rising?

[Tippyclubb]

Wow--Great news!  You must be feeling on top of the world?

[Rockerforlife]

Im just trying to find out exactly what my tagman test number they use....i think it is <10......it even may even be lower...its a newer tagman version on the go now

[Rockerforlife]

Im prerry sure im getting the real deal now...because in my last tx in 2006 i didnt clear until after 12 weeks...so clearing at week 6 is a sure bet im getting the "true blue"

[jt57]

so happy for you!!!!!   Way to go!

Jean

[Isobella]

This is AWESOME!!!!!  Congratulations on UND!!!!!  

Next stop....SVR!!!

Thanks for makin my day!!!!

Isobella

[sunqueen]

Congrats Rock. Here's to your SVR!

~clinks green tea glass

[Aim1]

Congrats Rocker.  I am jealous.  One question.  If my math is right, you had around a 3.3 log drop wtihout the Boceprevir in 4 weeks and you were a previous nonresponder on SOC?  Has anything else changed since your last attempt before the trial?  My results from pegasys in '03-'04 didn't even come close to numbers lke that.  In any case, thanks for bieing in the trial, and good luck in beating this thing.
T

[ejoli]

Hey, Congratulations!!!  I'm very Happy for you.........-Libby

[justme53]

Congratulations!! Tears of joy and relief I'm sure....

I'm thrilled for you!  Pam

[Rockerforlife]

YOU SAID.....

Has anything else changed since your last attempt before the trial?

could you be more specfic?....i havea list 10 feet long

[Rockerforlife]

this treatment regimen provided an indication of early predictability of response, with patients who had undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment achieving an SVR 12 rate of 86 percent. SVR rates are not yet available for patients in the 48-week boceprevir arms or the 48-week control arm, as treatment of these patients is ongoing

[Rockerforlife]

i cleared at week 6...so does this make my odds go up much higher i wonder?......

even my study nurse was excited...shes a real angel

[sunshine585]

I'm so excited for you, excellent news!

[Rockerforlife]

A positive result was considered to be any quantitative result, regardless of the value, or any result of “less than 10 IU/ml.”
Limit of detection. To determine the lowest level of HCV RNA in IU/ml that can be detected by the COBAS TaqMan HCV ASR assay, a six-level clinical specimen low-end dilution panel was obtained from Roche Molecular Systems, Inc., extracted, and amplified in replicate over five runs of 96 samples/run. The panel consisted of an HCV specimen of genotype 1a at concentrations of 0, 10, 25, 35, 50, and 100 IU/ml. Each run consisted of five different HCV panel members (n = 16/level/run), as well as a negative panel member (n = 15/run). Invalid results, defined as any result flagged by the COBAS TaqMan Analyzer as “invalid,” were excluded prior to performing calculations. A positive result was considered to be any quantitative result, regardless of the value, or any result of “less than 10 IU/ml.” Results which were “target not detected” were considered a negative result. For each of the five different concentration levels, the percent detection rate was calculated (number of detected samples/total number of valid results). PROBIT analysis was used with the preassigned titer values to calculate the concentration giving a 95% detection rate and its 95% confidence interval range


http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1153797

[epiphiny]

Woohoo, good on you, Rocker!!!  How great do you feel?! xxxxxxx

[can-do-man]

Way to go rocker. I think thats 2 of us hard to treat that cleared with 2 weeks of the blue pills.  I just hope the others treating here realize und that soon is not the normal. I just wish now they would tell us what arm were in sense its pretty clear were getting the real thing.

[Rockerforlife]

I am still trying to absorb the news.....well it sure looks like i am not in ARM 1....its gotta be arm 2 or 3....so by my calculations....i cleared bt wk 8...so that means i will be doing 36 weeks of the BOC with arm 2...OR,,,i will be doing 48 weeks with BOC...

heres an interesting thought

if i was a naive treater and i cleared by week 8...i woudnt know if it was the SOC or the BOC....BUT...being that im a slow responder and i didnt clear at week 12 in my last tx and i cleared by week 6,.....proves im getting the real stuff....anyone follow me here?.

if you clear at by week 12....and your are in arm 1....you continue for 48 weeks with SOC...that s a bummer...if you dont clear by week 12 and your in arm 1...you get the roll over BOC.....what im trying to say is....i know im not on arm 1 now....its hard to explain waht im tring to say

[Rockerforlife]

Are you sure its only 2 of us who cleared at wk 2 with the BOC?
I asked my nurse today about the waht arm ill be told im in....they wont tell us untill the fat lady sings...im not sure if its the 6 months EOT or the day after tx....i just cant ask her to many questions....there is acually no time...i have make my train to make it back to work...there is a lot of work involved in this trial

[Rockerforlife]

Does anyone know about the tagman test?....how low do they test down too....is <10 the lowest?

[epiphiny]

It's taQman!!  With a Q not a G!  

As far as I know that is as low as the TaQman goes and that it is a new version of the test from the Roche stable, only approved in the last quarter of 2008.  I actually though it only went down to 15 so you've got the latest and greatest there.

I do know that particular test is considered to be the most reliable available, even if it might not be the most sensitive.  That is why it is the preferred test for all clinical studies.

[can-do-man]

Doc said it tested down to 10. Hes very comfortable at that level.

BTW i meant 2 of us here on the board, virgocharm came in at 8

[Trinity4]

Alright you crazy Canadian.  I'll give you this one.  You were right.  You said you would clear at six and you did.  Congratulations.
Trinity

[Willy50]

I'm so pleased to hear it!!!!!

You've worked so hard to get there and you so deserve it.

best,
willy

[Marcia2202]

I'm so so happy for you my dear bro'!!!! I've got a big smile on my face and a little tear in my eyes. God bless you thousandfold!

Hugs, Marcia

[jmjm530]

Boceprevir, nah. It must be that pond seaweed stuff you're selling. LOL. But seriously, congratulations, you deserve it!

-- Jim

[all_is_well]

Congrats!!! Way to go!!!
Hope you get to that SVR!!!

I just need a little bit info if you don't mind.
I was thinking my VL is high (13.5 mil) but I see there is hope. I am on a regular Pegasys/Copegus treatment and in my 7th week. I don't have my test results from HCV RNA yet. I was told it takes 3-4 weeks to get them - according to Mount Sinai Hospital in TO.
Where are you going for your treatment? How did you get into these trials?

Anyway, wishing you ALL good LUCK!
A.

[Rockerforlife]

Same hospital...i get my results every 2 weeks.

[Rockerforlife]

How did you get into these trials?

i just asked

my study nurse to put my name down for any new PI trials that were upcoming she knew that was in the pipe line....simple...

actually if it were not for this fourm.i waould not have know about the PROTESE INHIBITORS....THANK YOU MED HELP AND ALL THE MEMBERS....you have helped me  BIG TIME

[comeagain]

Looking good Im so happy for you and can-do!!
Don´t you know how long your gonna treat ?

ca

[kitkat14]

I'm another patient at Mount Sinai treating with peg and ribiviron.  Week 35 of 48.

Welcome aboard.

k

[StormRider]

Congrats on the six and eight week UND! This is great news, here's to the blue pills kicking tail!!!

[Rockerforlife]

well...ive got it narrowed down now...looks like im not in arm 1...the plecebo  arm...by how fast i cleared...so that leaves arm 2 ...so ot looks like i will be **** either 36 weeks with BOC/SOC.......or i will be doing arm 3....48 weeks with BOC/SOC

[all_is_well]

Thanks buddy!
I will be on their tail if I don't get to my goal which is SVR.
Same here; I see this forum here is a REAL TREASURE!
THANKS TO YOU and ALL THE PEOPLE around here who make us being more positive than negative.
A.

[Rockerforlife]

Its not always positive around here...LOL....some heavy duty cage fighting go on on sunday nites....LOL...

[all_is_well]

Thanks K.,
I feel more confident now than ever that this HCV will be defeated.
I feel so lucky that I discovered this forum.
Thank you.
Good luck to you and of course I'll stay in touch. :)
A.

[all_is_well]

:) I'll look into that  ;)
But I don't believe this would turn me off...

[can-do-man]

Rocker is right, but it is usually them candadian gals you have to watch out for.:)

(OOPS)................ LOL, best of luck to you.

[Kristina538]

Congrats Rocker!!! Makes all that hard work over the last few years truly vindicated!!  I'm really thrilled for you;  this is HUGE :-).

[Keith_2008]

Congratulations! I know it has to be a relief to hear your undetectable. I just took a blood test for week 6. I don't have the results yet. It will be a few more days. I am on the Boceprevir trial as well. My last test still came out at 250,000 VL (coming down from 1 million). I'm not sure I will make it this time around unless that Boceprevir really kicks in. I'm hoping that by week 8 I will be undetectable.

[Andiamo1]

That is great news.  I am hoping for SVR for you.

Eric

[Xenigma]

EXCELLENT!!!
You're on your way!!
Great news  :-)))

[pilgrim1951]

Congrats, man.  Keep on, keepin' on.  Now on to SVR.  Yes!

Pilgrim  

[Rockerforlife]

If i am in arm 2,i have only 25 shots left...if im in arm 3 i have only 37 shots left.....and it look like i am not in arm 1...because i cleared by week 6..(thats with 2 weeks of boceprevir)..

I GUESS im officially a RVR

YA BABY

[Rockerforlife]

ive heard that just minutes after taking the PI`s...the virus dissappears from the the blood.

[Rockerforlife]

It all boils down to staying clear....most people clear the virus an matter what tx they do.....its keeping the monster locked in the cage

[portann]

Sweet stuff. You've got the whale by the tail and turned it inside out:

http://www.youtube.com/watch?v=VNhgzbjd4RA

Is there a 24 total week treatment arm in your study?

[Rockerforlife]

Is there a 24 total week treatment arm in your study?
just the 36 week and 48 week

[Rockerforlife]

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.

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

[lapis]

So happy for you!!  Congratulations!!

[GreatBird]

For tx naive, there's a shorter arm. It's part of arm 2. Some will finish at week 28. If I have that right.

[jacksonblue]

best of luck

[kickboxingmom]

You mut be on cloud nine.That's amazing news.Congratulations ! Hoping you reach SVR.
How many times have you tx ?
Tammy

[proud48]

I'm so happy for you! Congratulations.... :o)
proud48

[virgocharm]

congrats ROCK i knew you would do it. i wish you continued success. heres a toast for you.

[Rockerforlife]

This is my second round of tx...i did one with just riba /pegatron back in 2006.

[kickboxingmom]

Your words give me hope.I can see you listening to music and dancing around.That is so sweet news.
Tammy

[Rockerforlife]

http://www.youtube.com/watch?v=U98AXwUIe-g

[mikesimon]

Congratulations and Good luck!
Mike

[Trish77]

Congrats on your UND!!!  Keep it going!!

Trish

[Trish77]

"Rocker is right, but it is usually them candadian gals you have to watch out for.:)"

Hey!!!!  I resemble that remark!!!!!   :)

Trish

[Rockerforlife]

patients who had undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment achieving an SVR 12 rate of 86 percent.

[Rockerforlife]

for patients who received the boceprevir P/R lead-in regimen and had rapid virologic response (RVR), defined as undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment, SVR was 94 percent in the 48 week regimen and 82 percent in the 28-week regimen.

http://findarticles.com/p/articles/mi_m4PRN/is_2008_Nov_24/ai_n31030663

[can-do-man]

i pick door number 3, Monte

[BklynBoy81]

Yeah bro keep beatin the sh** out of it

[Rockerforlife]

LOL....im not in a bar fight....im slaying dragons...LOL

NICE number  81....LOL

[all_is_well]

--patients who had undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment achieving an SVR 12 rate of 86 percent. ---

What does SVR 12 rate means?

[Marcia2202]

Sustained Viral Response   and the 12 stand for 12 weeks after treatment

[Marcia2202]

sorry, meaning still undetected 12 weeks after completing treatment

[Rockerforlife]

Yes Marcia is correct..in other words... if 86 people out of a 100 who cleared the virus in the first 4 weeks of tx,went on to be virus free  12 weeks after the tx was completed...and i may add....12 weeks virus free after tx is 99% cured

[Rockerforlife]

• Percentages of patients achieving SVR according to early response status were as follows:


• No lead-in, 28 weeks: RVR 74%; EVR 69%;
• Lead-in, 28 weeks: RVR 82%; EVR 68%;
• No lead-in, 48 weeks: RVR 82%; EVR 83%;
• Lead-in, 48 weeks: RVR 92%; 89%;
• Standard therapy: RVR 100%; EVR 86%.




http://www.hivandhepatitis.com/2008icr/aasld/docs/110408_a.html

[Rockerforlife]

Just doing some thinking here...it looks like the BOC trial im in ,i will find out if its arm 2 or 3 i am in....its a simple process of elimiation....i know im not it arm 1 because of the RVR i had at week 6....and they saying if i RVR by week 8,(i did it in week 6.bonus...yaaa)..i will stop tx at week 36....if im in arm 3...i go on to tx for 48...


so....the blind fold will be removed at week 36.....

does this make anty sense?

[GreatBird]

Yes, it makes total sense. What I don't understand, though, is:

• Standard therapy: RVR 100%; EVR 86%.

Why are the numbers for standard therapy higher for RVR?

[Marcia2202]

Because ppl who RVR  (UND by week 4 of treatment) have a higher chance of reaching SVR

RVR (UND by week 4 of treatment)
EVR (UND by week 12 of treatment)

[Marcia2202]

Sorry..... Duhhhh

I wonder too, shouldn't they be lower?

[Rockerforlife]

you asked:
Why are the numbers for standard therapy higher for RVR?


because the studies for SOC  tx are loger and more data  to crunch those numbers...dont forget..the BOC trial is the very first one....with more trials and data on the PI`s ...you bet youer sweet a@ss ...the SRV for BOC will be 100% too...
thats my theory

[Rockerforlife]

and also those numbers posted are for that one specfic trial...i belive there was onlly a handful on SOC drugs in that trial....

am i making sense.....LOL

[dointime]

I am delighted to hear your good news.  

Also, I really appreciate your bringing us so much information about this new drug and how it behaves.

No reports of rash so far.  For anybody who got the Vertex rash (me) that is just the best.  

dointime  

[lalapple]

Great Job!

[Rockerforlife]

No problem...speaking of rashes...my injection sites on my tummy from the PEG itch at nite when i sleep....i just slather organic virgin coconut oil on thr red spots and it does help big time

[roscoe1]

congrats!!!!! Hey, I have an appt for boce naive trial, should I fast for possible blood work? I should have asked I was just to excited about getting the appt. Don't know what to expect. Congrats again! roscoe1

[Rockerforlife]

i was told to fast the nite before my screening...no food after 12 midnite ...and no breakfast...nothing...only water ..no coffe or tea....my appt was 8 am...important to not eat food...it may screw up the test

[Rockerforlife]

you are very lucky to be in this trial...only about 595 people worldwide were accepted

[can-do-man]

nothing here about fasting first, either for screening or any further cbc's

[Rockerforlife]

so did you eat a whole turkey before you screening?

[can-do-man]

big mac and large fries

[R Glass]

Great News, Congratulations

[Marcia2202]

with all the yes and no, I'd suggest you call them and find out...

Good luck with it!!!

Marcia

[Rockerforlife]

are you seeing a voodoo doctor.??..my GP even says to fast for my yearly check up

[Rockerforlife]

Thank you....im on my way to get my life back....

[can-do-man]

No i'm treating with the lead doctor with boceprevir,

[Rockerforlife]

and he said its ok to eat burgers and fries before your screen test?....your are yanking my chain

[can-do-man]

http://www.drugs.com/clinical_trials/interim-results-boceprevir-phase-ii-study-genotype-1-naive-hepatitis-c-patients-presented-easl-4095.html

http://janis7hepc.com/Hepatitis%20C%202008%20News.htm

Just go down at janis and you will see his video at the AASLD

[Rockerforlife]

i wouldnt eat burgers and fries on my death bed....let alone before a screening

[can-do-man]

I wouldn't either if it was a Glucose fasting, I don't tell him how to improve his golf came and he doesn't say much about my eating sense my cbc's are just fine and i'm not overweight

[Marcia2202]

you guys got me in tears again... I gotta go to sleep now. thanks for the laffs

[merryBe]

rock on oh hard one!!!

so how do they decide which Arm you are in...is it random or by genotype?

what genotype are you again?

and what SVR of 86% are they talking about...is this for 1a's or a general average for all types?

mb

[Rockerforlife]

good video...so i guess i have t play the wating game now,ive got my 2/4/6 and 8 week PCR tests over with..i do have one more at week 12...but im already UD...so it dont matter about week 12...the next milestone date for me now is the 36th week...this one determines what arm i am in and i will be unblinded...so i have 24 weeks of steady BOC/PEG/RIBA taking...with 4 weeks blood tests in between...i guess there is a chance of mutation or a viral breaktru   so you guys may not see me for 24 weeks...LOL


I guess your all saying....there is s aGod

[Rockerforlife]

Its randomiized before the trials are started..the big shots know what arm im in even before i start...im geno 1a..i think 1b is the hardest to cure...

The trials are all for geno 1 types..including 1b...

so can you imagine the SVR or the easy geno types....like 2 and 3....looks like we will all beat this monster soon...there is hope

[pjhep80]

ahhh congrats that is awesome news...

[Rockerforlife]

Thank you pjhhep

[moahunter]

I can't help thinking that  Boceprevir may be first to market now. Why would FDA approve Telepivar with its "rash", when there is an equivalent drug in the pipeline that seems to not make life much worse for those on treatment?

These stats are very good news.