Boceprevir Trial Started

Hi all,just did my first shot and and 3 Ribas in the Doctors office about 3 hours ago...juts waiting for the "shake rattle and roll" to hit me...BTW i like the palm pilot they give you to keep track of the the meds ...once a day you log on the machine and enter your data....make sit easier to NOT miss your meds...good thinking by someone out there in big pharma land...this thing is even wireless and has a camera and a key board...looks jus like a black berry...pretty wild...anywho...i do 3 more shots and then i go in for the BOC meds and pray i get the real deal...have a beautiful weekend to you all

r.s

[Isobella]

Yay for you!  Congrats on jumping back in.   Hope the weekend brings light and sunny sides =)

Here's to you getting the real deal.....all the best,

Izzy

[comeagain]

Welcome aboard, are you supposed to do 48 weeks or 24w ?
Yea we really hopes you get the real stuff'.

Good Gods bessings.

ca

[Rockerforlife]

Depends on the  trial arm i will be  randomly chosen to be in at wk 4...there are 3 different arms ...i will post the info in a sec

[nygirl7]

Good luck Rocker I hope this time is the charm, I really do.  Enough is enough.

[Rockerforlife]

Arm 1: Placebo Comparator
PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.


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.



Arm 3: Experimental
PEG + RBV (WBD) for 4 weeks followed by boceprevir + PEG + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.




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

[can-do-man]

Best of luck to you guy, i am suppose to start next friday.

cando

[Rockerforlife]

Thanks you guys....and gals...i will keep you all up todate on my progress....i can feel the shot already...its just like getting the flu....no big deal...the worse part of tx is the Riba i think...maybe my gogi berries and coconut oil will keep the ribs monster at bay.

[Rockerforlife]

ive been reading gogi berries are excellent for fatty liver....just wanted  to throm that in before i forget...I LOVE THOSE berries

[frijole]

rocker
Sounds great.  I too hope this is the one.  That palm pilot deal is pretty neat.  A camera?  What do they want -- to see you actually swallowing the pills and taking the shot?

cando -- you are on right now.  Hi guy.  You MUST email fishdoc and tell her! She was asking about you this week.  She said she would even get back on MH once you started!!!!!  Cando - I am just thrilled for you.
frijole

[meakea]

Welcome to the treatment amusement park ride.  :)  I wish you the best!!

[Bill1028]

Good luck Rocker!  I’m going in next Thursday for my start.  I don’t get why they want to give the first shot in the office.  I always did my shots on Friday nights and took a Tylenol PM and slept like a baby.

[copyman]

good luck rocker, you are right behind me. I started the telaprevir study 3 weeks ago. KILL the dragon!

[can-do-man]

Thanks gal, fishdoc back on at medhelp??? That makes doing tx worth it. That gal is more crazy then i am.:)

[Rockerforlife]

I did not have to do the first shot in the office...i just thought it would be wise...who knows if the shot gun delivery system had changed or not...im doing the redi-pen ..just wanted to make sure...also had a palm pilot instruction course...LOL..seems like a waste of money to me just to keep track of my neds...this thing cost at least 300 -500 bucks...guess im worth it

[Rockerforlife]

This palm pilot is freakin me out...it even has bluetooth and a phone   and the camera...i can even access the internet...AMAZING

[sugarplum49]

i am + for hep c the viral load is 177000 stage 2 grade 1  what does this mean ? Thanks so much ! God Bless

[Bill1028]

This will be my first time taking pegintron (hopefully my last).  If anyone has treated with pegintron and pegasys, how did you find pegintron compared to pegasys?

Thanks Rocker.  How was the redipen?  I’m a baby and had my wife give all the shots except for one.  Between all of the crying and shaking, I don’t even know if I got any of the injection.  Besides that, I’m not to be trusted with sharp objects.

[Rockerforlife]

What does this mean?....im  the same as you...stage 2...moderate damage to your liver..half way mark if you will...your VL looks  low in relative terms...my base load was 5 million starting this time ...whats your genetype ?...1..1A...2   OR 3?

[Rockerforlife]

I ACTUALLY love using the redi-pen...as opposed to the regular syringes...those things gives me the sahkes just lookn at them...never mine using them...the redi-pen is easy as pie...if you cant do the redi-pen...you have a problem...LOL...if you can stick the tail on the donkey...without the blind fold of course...your in


BTW....the shot is coming on now...it hurts my fingers to type...and you say your the baby?

[TeeVee36]

Congratulations on starting your tx!!

Is this a second time around for you?  I see that you have been a member since '05.

Anyway, take it easy and keep us posted.

So glad your journey has begun!

TV

[Rockerforlife]

I did the IDEAL STUDY back in 2006 and the monster reared its ugly head again after one month...im in another trial now...its the Boceprevir...i finally spelled that damn word right...

[can-do-man]

I will be getting that palm thingy next week, after tx do we get to keep them or do we have to steal them??? :)

[Fl_Gator]

Welcome to the club...I hope all goes well for you. Please keep us posted.

I did shot # 22 this morning. I should have waited another hour or two...I'm starting to feel it now and it's too early...the kids are coming over...I'm not cooking...they're getting pizza...dam'it....not cooking.  

[Marcia2202]

BADSS Bro', you kick a§§ big time!

I'm so happy you finally started! I'll be right here if you need me.

I think I'll get a bowl of goji berries and put them nest to my bed to nibble on them.


Hugs, Marcia

[susan400]

Do you HAVE to use the Redipen, or do you just prefer it?  Do they give you a choice?  Just curious.  Not that I'll even be able to get into a Boceprevir trial..., I am just asking for my own knowledge is all.

Susan400

[Rockerforlife]

The company Schering Plow only uses the redi-pen   its their trade mark...i call it the MAGIC MARKER....looks just like one....whats stopping you from the up coming BOC trials?....im sure there are coming protcols in you favour....ill ask my doc


Thank you Marcia....the lady from the Brady Bunch


i have problem with them berries...i cannot stop eating them,,,i went tru 4 pounds in one month

[Rockerforlife]

20 BUCKS A POUND...i am worth every penny

[Marcia2202]

That sure is a lot of crunchy delicious antioxidant superfood! Go for it!

[Xenigma]

I hope this time it's smooth sailing with
favorable results!

[Isobella]

About your new palm pilot thingy.................are you sure you didn't pick up the  nurse's i-phone by mistake and she is home trying to answer a pill alarm, LOL!!!  

Hope you have a good weekend =)

Izzy

[fretboard]

Glad to hear you started, hope you're doing well.  I go in on Thursday, I'm looking forward to the palm pilot thing.  Oh UND at 4wks would be nice too.  lol  Oh and the real pills too, and lets not forget SVR for all.  Anyways, hope you're feeling well and I hope y'all have a good week.

fret

[Rockerforlife]

IM supposed to make the gogi berries last one month...a small hand full...bout  1/4 cup is all ya need a day,make sure they are organic...they spray them a lot if there not...i tried the non-organic ones...gross tasting...there are supposed to help with fatty liver....i cant see these berries conflicting with treatmet drugs....its just a  berry..its food

[Rockerforlife]

BTW...the palm pilot is programed to just record the treatment...camera and phone are disabled

[virgocharm]

i bought the coconut oil. how do you take it.

[sunqueen]

Good luck Rocker!  Now go kick some buggggger butttttttt!

[susan400]

Nothing's stopping me!  I inquired at 2 of the trial sites that I've been involved with and neither one of them is doing Boceprevir and don't intend to do it.  They also told me that they have no upcoming trials for which I will qualify for..., for non-responders.  One of these 2 trial sites told me, "you will not be accepted into any of the trials for protease inhibitors".  Which I thought was rather negative in my opinion.  I mean how does she know if another trial would not consider me for Boceprevir, when A.) they are not even doing that trial and B.) I've never been exposed to Boceprevir so, how could I be resistant to it?  Anyhow, I sent my records off to yet, another trial site, which is doing the Boc. trial and I have yet to hear back from them.  Before I sent them, I was told that if I was even considered, that I would not be able to start until the next group after the first of the year - which is fine with me, if they will just accept me.  I asked about the Pen thing because I've never used them.  When I was the Peg-Intron in the past, I never used the pen, I always used the other method of Peg-Intron (a vial or Prefilled syringe - don't remember which it was).  It's been a few years since the Peg-Intron for me.  One time, I had this Pen-like device for another medication - not an interferon drug and I did not do well with it.  I was a device where you pushed it up against your skin and pushed a button and the drug was dispensed with a 'click' sound..., it made me jump, sort-of and when I got startled, I ended up moving my hand and squirting the medicine out away from my skin and basically wasted the med.  I had no problem with the prefilled syringes that Pegasys is used with.  I had no problem with a syringe and a vial.  For some reason that clicking mechanism makes me jump, jerk or whatever.  I'm sure that with practice and instruction on the first few shots that I could learn it and get past that.  I have the same knee-jerk reaction with closing my eyes on a flash picture.  

Susan400

[R Glass]

May the Force be with You

[HATCHJO]

Susan
They will not accept you in this trial. I was in the same Vertex trial as you Arm C.....I applied in Michigan as well as Toronto and was turned down because of the vertex experience. Sorry
Joanne

[Rockerforlife]

ITs a thing called a spoon...not sure of the year it was invented.its about 6 inches long with a small bowl shaped receptacle at the end of a handle..anyway..you just dip it into the jar of oil and lift to mouth and swallow..do not swallow spoon..may cause some dicomfort

[Rockerforlife]

If a click from a piece of plastic makes you jump like that...DO NOT   go hunting moose with a 12  gauge shot gun...you may end up on your a.ss with that kick

[Rockerforlife]

All joking aside...the besdt brand of coconut oil is DME    the rest is not good...its all processed even tho it says its organic virgin...DME is the ONLY one thats not processed..its taken directy from the tree and cold presed on bottled on the spot....i take a table spoon with my riba ...you can go with a teaspoon if you like...you dont need much

[susan400]

No worries, I'm not a gun owner!  I could never have the ability to shoot anything living.  I did go to the gun range once with my husband to shoot his Glock and every time I pulled the trigger, I CLOSED MY EYES!  My husband was laughing at me and told me that I might actually hit the target if I kept my eyes open!  I was wearing the safety goggles and still got started by the kick back of the shells.  Once I forced myself to open my eyes, I did finally hit the target but, it was a paper target in the diagram of a man and not a real human, or a live animal.  

Susan400

[portann]

You sure make those berries sound great. I've never had them or even seen them. If I went out today, where should I head to find them?

Any reason at all not to take them? Are they dried and therefore very high in sugar, for example? Could they in that case affect your  your insulin?

Thanks and good luck.

[SeiserL]

Thanks for the update. Sounds good for you.

And me. Liver biopsy scheduled 11/19, then into a phase 3 Boceprevir trial.

Been lurking and reading. Very helpful. Thanks for that.

Until again,
Lynn

[Trish77]

I just wanted to say "bon voyage" to all on the good ship Phase III Boceprevir.  

Here's rooting for all of you and for everyone hoping for good results from this trial.  It does look promising.  Good luck navigating the waters of the trial, hoping it's smooth sailing for everyone.

Trish