Check this Out

[Rockerforlife]

This protese inhibitor trial i am signed up for is not the Vertex one..its the Boceprevir Phase II Study ....anyone out there know anything on this.,,,here s a liink to some news on it...looks really good


http://findarticles.com/p/articles/mi_m4PRN/is_2008_August_4/ai_n27967944

[blonde333]

Thank you. Do you think that me being to skinny would make the side effects more intense? Also, If i were to mutate more and become resistant to the drug will it be just to the PI or to the Standard drugs as well? Thanks in advance

[copyman]

that is good you are trying to get into trial. i think this gives you the best chance at cure. if they do want another biopsy at least they pay for it :-) best of luck

[blonde333]

Thanks for all the links. I had been looking for some links to read about. It took me a while to learn this site but I think i got it now... lol....

I also may be participating in the trial in October, I go for screening in a week. I do have one thing against me and that is my biopsy hit its 3 year mark on 9/15. She said they can ask if I can slide since it is so close to the cut off. I am geno 1 naive. My last biopsy was 0 scarring and 1 inflamation. I found out about my hep c when I was preagnet 8 years ago. My doctor has told me in the past that I can wait but if I could do treatment I should he sayed my chances at clearing get a little better because I have no scarring and I am not overweight. But I am very skinny so i fear the sides are going to be really bad. I wish that I had a more recent biopsy cause I was drinking for awhile there. Not everyday but some weekends and i was drinking more than one or two, more like 5 or 6. I know i should not have! I am hoping this trial will be a good thing for me.    

[Bill200]

and here's the study link
http://www.clinicaltrials.gov/ct2/show/NCT00708500?term=boceprevir+Trials&rank=3

[Bill200]

I saw the doctor last week.  She told me the Boceprevir was working very well.  I was trying to get into the teleprevir trial.  My platelets are low and she said the Teleprevir trial didn't allow "rescue" drugs so I'd be better off trying to the the Boceprevir trial.  Still hadn't got my blood tests back for the platelet count so just wait and see for now.  She said Teleprevir wouldn't be available until 2010 or 2011 as a regular drug.  Before the appt I rode my bicycle and walked some stairs at the hospital to get my platelets up.  Just have to wait and see.

[Rockerforlife]

I am not in the naive arm of the trial...im a slow responder...my odds are a lttle lower than 74%,but i did have big log drops ...i almost cleared at week 12...i was 475...baseline was 25 million....ill give it my best shot....thats all i can do....

[virgocharm]

rocker, lookin at your numbers, i would say, you get a hold of the right s----. you will rock its world. i see you will be successful.  godspeed

[virgocharm]

i will be doing the bocepravil trial in october. its for naive genotype 1a. you have a  74% chance of clearing. i am 1a

[Wilko1956]

My doctors are waiting to get me better meds soon. They feel my situation and genotype 1a is not worth the treatments out now. My genotype and weight is the big issue. I must lose some pounds and wait for the new med trials. I don't want to get into the circle of using this and then that just to be looking for another treament later. That would just be more stress. I have the very best doctors. So I enjoy everyday and am getting my things in order. I expect the best. I do have good and not so good days but all are great days when surrounded by positive situations and a safe home environment. I thank you all.

[Wilko1956]

Hello!
I am not on any meds.
I have had a biopsy and I am stage 4/4 liver  per my GI Doctor.
The University study doctor says 2/4 liver.
I am genotype 1a.
The university doctors are starting a study with new meds in the new year. I have never been treated. I was diagnosed four months ago. The university doctor wants me to do an endoscopy, another blood test, and sonogram befor seeing him in Febuary
Okay-I'm reviewing paperwork here.
This is what it says;
LOBULAR ACTIVITY 2
SEVERE PORTAL FIBROSIS WITH CIRRHOSIS (FIBROSIS4)
(FATTY CHANGE 1)
(MALIGNANCY NOT IDENTIFIED)
------Maglignancy?-CANCER?------
Okay here's more---
HVC RNA (IU/ML)                2140000 H   <50 IU/ml
HVC RNA  (log IU/ML)              6.33 H      <1.70 Log IU/ml)

GENOTYPE 1a

Alpha Fetoprotein Tumor Marker         In Range      OUT OF RANGE   Reference Range
                                                         4.8                                          <6.1 ng/ml
I am also overweight and need to lose at least 50 pounds if not more before I recieve treatment.
I also suspect because of my history with depression is also a factor that the doctors don't want to give me old school medicine.

[Trish77]

Are you talking interferon only?  Nobody treats with interferon only anymore unless they're on a maintenance dose after treatment not working and that's not you.

If Roche offered you interferon AND ribavirin, that's another story.  As for side effects, try getting a treatment for Hep C without them that offers a cure.  There isn't one.  The amount and kinds of side effects you may get differ for everyone.  What is important is your mental ability to be able to commit to treatment and how much you educate yourself on what it involves.

And that 20% figure, what's up with that?  On combination therapy with interferon and ribavirin, the cure rate is 40 - 50% and there are quite alot of us here toughing it out to get those odds.  Add a good trial drug to that and your odds go up yet more for a treatment naive person who is lucky enough to get the right trial drug.

You may not be brain dead but you don't have your information right just yet.  I think you should be talking to other people with Hep C and asking questions other than just your doctors.  Either you're not understanding what they're telling you or they're telling you the wrong thing, one or the other, frankly.  Because this info you've posted doesn't add up.  So maybe that's why your girlfriend is freaking.

And yes, Genotype 1 and 1a are pretty much the same thing.  1a is a subtype of Genotype 1 but for all intents and purposes, basically the same thing.  

[Wilko1956]

Is Genotype 1 and 1a the same thing. If not what is the differences? I an 1a and have never been treated for Hep C. So this makes me a  " Naive " patient. My doctor told me Studies will really want me. Still I am waiting. I was told to come back in Febuary.
Roche offered Interferon free to me but my doctors at a university hospital told me it would work for 20 percent of 1a patients at best. I would get tons of side effects and that the new meds were going to be out soon and would be oral ones. I also need to lose at least 80 lbs for anything to work right. I'm hoping this will work. If not I'm not going to chase a pipe dream day in and out. Got to enjoy what you have when you have it.
Another thing...I should have never told my girlfriend. I cannot rest, sleep, or do anything without the chick getting involved and wanting me to take the Roche offer. You know I'm not brain dead, my doctors told me my options and would not be able to stop me from going the old route. I'd be stupid to do that because of the side effects. I'm not sure but would it make it less likely to get results from the new meds later? I know the University studies may not want me then. It would be time to pay for it.

[Wilko1956]

What can anyone tell me about  Treatment-Naive patients with geno type 1a?
Does this Boceprevir have results posted anywhere for 1a?
What will it be taken with?
Sorry for the questions. If anyone can help I would apreciate it greatly.
I'm just not ready for another pipe dream.
Still I'm sure it will help most people.

[Rockerforlife]

with these number i think i have good odds....not the best but worth taking.... dint have too many choices here...its do or die

[Rockerforlife]

475 is the correct number...i just rounded it off...to make it esay to see the 2  logdrops...baseline...30,000.000
                4 week  ............300,000                      
               8  wk..................    3000
              12 wk.........................300

actual numbers i have if you want

[CoWriter]

I hope you won't get offended by what I'm about to say, but I'm sort of concerned.  Your thinking doesn't seem to be clear.

Earlier today you said that your viral load at week 12 was 300 and now you're saying that "at week 12 my load was 475"

So you're saying two different things.

And both Marcia and I had told you that since you didn't clear at 12 weeks....cleared at 24 weeks and you were still clear at 48 weeks....and the virus came back after....that makes you a RELAPSER.

And now, you're asking the same things you were asking before....all over again.  

"Well...i know im not a RVR...So what the hell am i..im not a nul responder...im not a non responder"

And the 74% SVR you're looking at again.....is the one for NAIVE patients.

Anyway....take care.  

[Rockerforlife]

So this what you posted apllies to people like me and you?...well thats good news isnt it?....what co writer was posting seemed like a death sentence...LOL...i dont care any more...im just gonna gett my weight down to 185 lbs by OCT an go for the BOC trail...and if i dont make it then...i   WILL go for the 72 soc....odds are my liver may reverse a step too....THINK=POSITIVE BROTHER

[can-do-man]

Were both RESPONDERS so we need to forget the null responder bit as it doesn't apply to us... So as slow responders who relapsed this is what we should be interested in.
---------------------------------------------
In a 48-week treatment regimen, the SVR rate at 12 weeks after the end of treatment (SVR 12) was 74 percent (ITT) in patients who received 4 weeks of PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL® (ribavirin, USP) prior to the addition of boceprevir (800 mg TID) (P/R lead-in), compared to 38 percent for patients in the control group receiving 48-weeks of PEGINTRON and REBETOL alone.(1-3).
---------------------------------------------

What ever you decide i wish you the very best guy........

cando

[can-do-man]

Ok sue, your a slow responder who is also a relapser.

can

[Rockerforlife]

Well...i know im not a RVR...So what the hell am i..im not a nul responder...im not a non responder....i became UD some where between week 12 and 24...at week 12 my load was 475....call me a slow responder i guess...but what ever ya do...do not call me sue

[epiphiny]

Found these for you:

RAPID VIROLOGICAL RESPONSE (RVR): the probability of achieving a sustained virological response early in treatment based on a decline in HCV RNA (viral load). The generally accepted timeframe is 4 weeks after starting treatment.

RVR: Rapid Virological Response (4 Week PCR – UND)

UNDETECTABLE (UNQUANTIFIABLE): a viral load (amount of viral RNA) that is below the level of detection of the test being used.

A RVR, meaning HCV RNA levels <15 IU/ml

Division of Infectious Diseases, Department of Medicine, and Division of Virology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. 8/05/08

[CoWriter]

Yeah, I had posted the same thing to you....look at post #50.


Non-responders didn't do well no matter what dose of Boceprevir they used or whether they rolled them over to a different arm of the study that used a higher dose....or whether they extended the treatment.  The highest SVR was 14%.


This comes from Schering's site.....


Boceprevir in "Null" Nonresponder HCV Patients

Schering-Plough also reported top line results from a completed Phase II study evaluating boceprevir dose response and the need for ribavirin in patients chronically infected with HCV genotype 1 who were nonresponders to previous peginterferon and ribavirin combination therapy (i.e., patients who did not have undetectable HCV-RNA or who did not achieve a 2 log decline in viral load with a minimum of 12 weeks of peginterferon and ribavirin combination therapy). These "null" nonresponders to peginterferon and ribavirin combination therapy represent the most difficult-to-treat patient population. Patients who relapsed following previous HCV therapy (relapsers) were not included in this study.

This study was complex, involving seven different treatment arms. Patients were initially randomized to low doses of boceprevir (100, 200, 400 mg TID) before initiating an 800 mg TID boceprevir arm. Under the study protocol, patients received these boceprevir doses in combination with PEGINTRON (1.5 mcg/kg weekly) with or without REBETOL (800-1400 mg daily) for 24 or 48 weeks, or received PEGINTRON and REBETOL alone as a control. During the ongoing review of the study by the Data Safety Monitoring Board (DSMB), it was recommended that patients in the lower-dose boceprevir arms who demonstrated a substantial antiviral response during treatment cross over to boceprevir 800 mg TID in combination with PEGINTRON and REBETOL for an additional 24 weeks. Patients who did not demonstrate a substantial antiviral response during treatment were discontinued from the study. In addition, patients in the control arm who did not respond to PEGINTRON and REBETOL alone were allowed to cross over to boceprevir 800 mg TID in combination with PEGINTRON and REBETOL. Patients received a maximum of 24 weeks of the optimized regimen (boceprevir 800 mg TID in combination with PEGINTRON and REBETOL). In all, 357 patients were enrolled at centers in the United States and Europe, including 348 patients who received boceprevir at some point in the study.

In this study of well-documented null nonresponders, some patients achieved a sustained virologic response (SVR). Overall, 7-14 percent of patients in the boceprevir crossover arms achieved SVR compared to 2 percent in the control arm. SVR was associated with early virologic response and a longer course of therapy (more than 36 weeks). While potent antiviral activity with boceprevir was seen in the study, with viral loads in some patients decreasing below the limit of detection, viral loads for other patients decreased and then rebounded to baseline levels while on therapy and some patients relapsed following the end of treatment. Several resistant variants were observed in these patients. These HCV variants are similar to those reported after treatment with other HCV protease inhibitors and those previously observed in boceprevir in vitro studies. Whether the results of this study would have been different had all patients been started with the optimized regimen of boceprevir 800 mg TID in combination with PEGINTRON and REBETOL -- and with treatment extending to 48 weeks -- is not known.

"Although interferon nonresponders appear to respond to HCV protease inhibition, it seems that some significant element of interferon response is needed to achieve a sustained virologic response in the majority of these patients," said Eugene R. Schiff, M.D., chief, division of hepatology and director, Center for Liver Disease, University of Miami Miller School of Medicine, and the lead investigator of the study.

Schering-Plough said that in patients with little to no interferon response, alternative treatment strategies are required, and the company will continue to explore regimens containing boceprevir, PEGINTRON and REBETOL in the Phase II setting, using the insights gained in this initial study.

http://www.schering-plough.com/schering_plough/news/release.jsp?releaseID=1064540

[Rockerforlife]

BTW...i think my vl is only 2 million as of last month...thats a good sign

[Rockerforlife]

i did have a 2 log drop by week 4...i guess this is still noy considered a RVR?...MY BASELINE  was 20 million...what is the real definition of a RVR ..is it expressed in numbers or log results???