Check this Out

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

[Rockerforlife]

Schering-Plough Corporation (NYSE: SGP) provided an update on the clinical development program for boceprevir, its investigational oral hepatitis C protease inhibitor. Initial results from an ongoing Phase II study in treatment-naive (previously untreated) hepatitis C patients showed boceprevir (800 mg TID) in combination with PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) achieved a high rate of early virologic response, with up to 79 percent of patients having undetectable virus (HCV-RNA) at week 12 of boceprevir treatment compared to 34 percent of patients receiving PEGINTRON and REBETOL alone.

http://www.****.***

[Rockerforlife]

This is a good detail site of the trail i will began in Oct.

[Rockerforlife]

My nurse says 1in 5 patients will recieve the placebo drugs...so i have an 80% chance to get some of the good stuff.

[Trinity4]

Still sounds great to me Rock.  I think you'll have excellent results.  I will say a little prayer that you get the good stuff.  It's time to kick some a-s-s and turn the page on the hepc chapter of your life.  
Trin

[Rockerforlife]

The odds look good...up to 80% odds of staying clear at 12 weeks EOT...AND A 80% chance i will get the real drug....id go to las vegas with those odds and come bacd loaded

[Rockerforlife]

http://clinicaltrials.gov

[copyman]

hey Rock, Good luck on the trial. May I ask how you did not know what trial you were offered? Man you must be getting some good weed up your way :-)
All kidding aside Boceprevir is a very good PI and right up there with Telaprevir. There was some recent news about Shering-Plough misrepresenting trial data but regardless my doc said it is just as good. He has both trials going on at his office so I heard this from the "horses mouth". Best of luck

[Rockerforlife]

http://en.wikipedia.org/wiki/Protease_inhibitor_(pharmacology)

[Rockerforlife]

I thought there was only one protese drug...the Vertex....but when i called my nurse today i got the facts....i stopped smokn herb ...im afraid they will test me and find in in my system and i will be not allowe to do the trial...not taking any chances...i go for the screening next week...i start in Oct...im feelng happy about this news

[Rockerforlife]

In both Phase III clinical studies, patients will receive 4 weeks of treatment with PEGINTRON and REBETOL prior to the addition of boceprevir. The rationale for this novel treatment paradigm is based on the fact that both PEGINTRON and REBETOL reach steady-state concentrations by week 4, so patients have the protease inhibitor added at a time when the backbone drug levels have been optimized. In addition, the patient's immune system will have been activated and primed by PEGINTRON at the time that boceprevir is added to the regimen. This approach may minimize the period of time when there is a "functional monotherapy" with a direct antiviral, and may help reduce the likelihood for the development of resistance by identifying patients who are responders to interferon and ribavirin prior to their receiving a protease inhibitor.

http://findarticles.com/p/articles/mi_m4PRN/is_2008_May_21/ai_n25487875

[Rockerforlife]

In boceprevir clinical studies reported to date, the most common adverse events have been the same as those seen with PEGINTRON and REBETOL alone: fatigue, anemia, nausea and headache. Patients have been exposed to up to 56 weeks of boceprevir combination therapy. No increase in skin adverse events (rash or pruritus) beyond what was seen in the PEGINTRON and REBETOL control arm was observed.

[Rockerforlife]

74 Percent of Genotype 1 HCV Patients in Experimental HCV PI Boceprevir Phase II Study Achieve Sustained Virologic Response (SVR) at 48 Weeks

http://www.hivandhepatitis.com/hep_c/news/2008/080508_c.html

[copyman]

Not sure if they screen for pot but to be safe i would hold off  until you get accepted into the trial. Since you are a relapser why not try and get into the vertex relapser trial that is starting soon?

[Rockerforlife]

Importantly, for patients who received the PEGINTRON and REBETOL lead in and had rapid virologic response (RVR), defined as undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment, SVR (ITT) was 82 percent in the 28-week regimen and 92 percent in the 48 week regimen.

"These top-line results with boceprevir are very exciting, especially given that genotype 1 is the most common and hardest to treat form of hepatitis C," said Paul Kwo, M.D., associate professor of medicine and medical director, liver transplantation, Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, and lead investigator of the study. "Boceprevir was well tolerated by patients in this study, including those who received 48 weeks of boceprevir in the longer duration treatment arms."

[copyman]

great looking data but like I said before recent reports in the news suggest this data was skewed and not as good as first reported. Not saying it is not a very good prospect just that these companies want to make their drugs look like the best. In my opinion telaprevir has the edge, if not for anything else SVR with 24 weeks of tx.

[Rockerforlife]

Beggars cannot be choosers....did you notice vertex stock took a big hit when  the Boceprevir compant reported the good test results...they are both pretty close in the cure rates....i jus pray i dont get the plecebo

[can-do-man]

copy, , if not for anything else SVR with 24 weeks of tx.
----------------------------------------
The new vetex trial is ALSO 48 weeks of tx, not 24. And if vertex still don't allow "rescue" drugs then i'm sure their dropout rate will be higher, or they will have to lower the dosage. Either way not good. I would have never made it thru 48 weeks of tx without procrit. It seems like alot of people here need procrit to stay on tx, or to keep from having their meds reduced.... Boceprevir does allow procrit.

Also  the p/r lead-in results look better then the no lead-in arms. Both arms with Boceprevir trial is lead-in, and only one of the vertex is.

Rocker, best to you, good choice, and i hope to be following you.

cando

[Rockerforlife]

With my last tx i didnt need any rescue drugs...except for week 3, i needed one shot to raise my whites....even with a lttle dose reduction on the PI, still the odds will be up....and for free who can say no...ive decided im going for it....with 75% SVR rates...but some say those numbers are mis leading....but eh....we dont have to many choices.

[Rockerforlife]

http://www.pulsus.com/cddw2008/abs/252.htm

[Rockerforlife]

Failure to achieve SVR in overweight patients despite an RVR suggests weight may be a risk factor for lack of sustained viral loss.

[Marcia2202]

ROCK ON MY FRIEND!!!!!

Congrats! I'm so happy for you. You're gonna kill this bugger!!! I pray you get the real stuff, you deserve it sssoooo bad!

Marcia

[CoWriter]

I just saw a new webcast presentation that showed that even though NAIVE patients did well on Boceprevir......NON-RESPONDERS didn't.....SVR was only 7-14%


Phase II Boceprevir/Peg/Riba.....Non-Responder study, Genotype 1
SVR 7-14% (in the 3 different arms).

And 8-12% discontinued treatment for adverse events in the 3 Boceprevir arms vs 5% for Peg/Riba.



Here's the webcast presentation the info came from.  You may need to register to access it....

http://www.clinicianschannel.com/PIK/1813/1813Webcast.html

[can-do-man]

Not seen the webcast, but wasn't the last trial for Treatment-Naive only?

cando

[copyman]

yes the relapser / non-responder vertex trial is for 48 weeks. I meant telaprevir vs boceprevir in general looks better because of only 24 wks of tx. Its a no brainer, any tx that would keep peg & riba out of your body 6 months less is a winner! Just make sure to read the Boceprevir consent form and make sure they allow rescue drugs before signing.

[Rockerforlife]

I watched the presentation...good site...but from what i gather from this is the same SVR numbers from the studies ive been posting,up to 70% got SVR...Ididnt see SVR at 7-14% as you say....those number seen way too low...even treating with the the peg an riba,SVR was higher...could you clarify this a bit more...thanx

[Rockerforlife]

The last trial was phase II...it had naive and non responders in it....this new trial has only null-responders...this means NO NON-REPONDERS ALLOWED or naive patients...the difference between non and nul responders is:nul responders cleared between week 12-24...for me at week 12 i was at 70 copies i think..non responders dont clear until week 24...this is my understanding...BTW.the new phase III trial doesnt accept relapers either

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

[can-do-man]

Agree, 24 weeks for svr over 48 would be a no brainer. But sense both these trials are for 48 weeks we really don't have a choice. And yes Boceprevir will allow rescue drugs. Hopefully telaprevir will also.

[can-do-man]

During qualifying regimen, subjects must have either a documented undetectable HCV-RNA within 30 days of end of treatment (EOT) and a subsequent detectable HCV-RNA during follow-up or a documented decline in HCV-RNA by >=2 log10 by Treatment Week 12
------------------------------------------------------------
This would include relapsers.... Right???

cando getting confused

[can-do-man]

This is the results from the stage 2 trial, i can't find where they allowed non-responders only treatment navie patients.

http://biz.yahoo.com/prnews/080804/nym051b.html?.v=1

[Rockerforlife]

i guess a relaper means that the virus returnns after 30 days after EOT...thats what im gather here...i didnt know rescue druigs were allowed in the Boceprevir trial...i didn ask nurse yesterday...are you sure of this?

[can-do-man]

Yes Positive on the rescue drugs ( at least the procrit). Paul kwo who is the lead investigator thats in the stage 2 release is also my Doctor.

And yes a relapser is und at the end of tx but then the virus returns. So relapsers are good to go in this new trial...

[Rockerforlife]

ok...lets try to get to the bottom of this...here is a link to the Ph 3 trials...there are two arms in this one...."null" responders and naive patients...now back to that presentation co writer posted...i got the impression a phase 3 trial had taken place somewhere..beause it talked about null..or was non responders...now jm confused LOL


http://findarticles.com/p/articles/mi_m4PRN/is_2008_May_21/ai_n25487875

[Rockerforlife]

Bue he has to relapse with 30 days after tx..if he dont he wont be accepted..get it?

[Rockerforlife]

you said...I just saw a new webcast presentation that showed that even though NAIVE patients did well on Boceprevir......NON-RESPONDERS didn't.....SVR was only 7-14%


phase 3 was only for naive patients....are you sure you are reading this correct ms writer???????????

[can-do-man]

No, you had to be undetectable WITHIN 30 days of end of treatment, and THEN detectable after treatment.
----------------------------------------------------------------------

As for the phase 3 trials there will be two different ones....

One study will be in previously untreated (naive) patients and the other in patients who failed prior treatment (relapsers and nonresponders),

Hope this helps

cando

[Rockerforlife]

in the above post i meant to say there are only "nul responders" are accepted only for phase 3 Boceprevir trials..no naive patients allowed,and ther are 3 arms only...i hope i got this correct...someone else maybe wanna take a stab at this?

[Marcia2202]

You guys are really confusing

[can-do-man]

This is from your link on your post on lets get to the bottom of this.
-----------------------------------------------------------
KENILWORTH, N.J., May 21 /PRNewswire-FirstCall/ -- Schering-Plough Corporation , a leader in hepatitis research, today announced that it is initiating two large Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, in patients chronically infected with hepatitis C virus (HCV) genotype 1. One study will be in previously untreated (naive) patients and the other in patients who failed prior treatment (relapsers and nonresponders),
--------------------------------------------------------------------------------------
Phase 3 will have seperate studys, the one were interested in is for relapsers and nonresponders. The other study will be for treatment navie patients.

[can-do-man]

Got to go for now....... I do hope cowriter comes back and explains his post though. Take care guy;

cando

[Rockerforlife]

ok...i got it...seems like tho some trial sites only talk about one part of the study...thats why it can be confusing to me..

[Rockerforlife]

see what i mean about sites being confusing...this one does not even mention naive patients
http://clinicaltrials.gov/ct2/show/NCT00708500?recr=open&cond=%22Digestive+System+Diseases%22&rank=29

[can-do-man]

This is the study for treatment naive people

http://www.clinicaltrials.gov/ct2/show/NCT00705432?term=Boceprevir&rank=1

[Rockerforlife]

aww...i see now...there are 5 pages on that link...I NEED A COFFE OR SOMETHING...i stopped my saturday morning toke with my cartoons on tv....im having withdrawls....LOL

[scratchinghead]

I got my eye on you!

:)

[CoWriter]

Yeah, I'm sure.  

Look at the 5th topic called.....

"Can Stat-C Therapies Change the Course of HCV Infection in the Future?"

Go to Slide #34

At the top of the slide it says.....
"Boceprevir+PEG INT/RBV   Phase II Non-responder, Genotype 1"

It shows a graph with.....

A hot pink section for .....PEG INT 2b +RBV.....shows SVR 2%
Blue section for .....Boceprevir+ PEG INT 2b+ RBV(various arms)....shows 7-14% SVR


And the speaker said this was final data and added, "It's a sobering reminder that non-responders are going to have different patterns of response than naive patients."  

[copyman]

ok, this has become to confusing. good luck to whoever is going to treat. over and out

[Rockerforlife]

Non responders refer to patients who never did get a 2 log drop in the 12 weeks,this what the clip is talkng about...i fall into the null responders,,,i had large log drops i the 12 weeks i treated...here is my numbers...baseline vl-23 million

wk 4=318,000...2 log drop
wk 8=3000........2  log drop
wk 12=300........ 1 log drop

so iha a 5 log drop from baseline in 12 weeks but i cleared some where between wk 12 and 24...im a slow responder...not a non responder...i know my odds are not much bteer but its better than nothing....im thinking i would have a better chance if i did 72 weeks o SOC....any suggestions???.

[Rockerforlife]

im starting to think its all a waste of time now...maybe i should just go with living my llife and just eating ood foods and forget about tx....sometimes i feel like im fighting a losing battle with the odds i have...i figue by my calculatons i hav maybe a 25 -30% odds

[CoWriter]

"Not seen the webcast, but wasn't the last trial for Treatment-Naive only?"



"Boceprevir in Null Responders

The results from another study using boceprevir in combination with PegIntron plus ribavirin yielded less promising outcomes.  

In the study there were 357 genotype 1 patients enrolled who were deemed prior null responders – defined as either less than a 2 log10 drop in HCV RNA after 12 weeks of therapy with pegylated interferon/ribavirin therapy or who did not achieve undetectable HCV RNA if treated longer than 12 weeks.  There were 7 arms in this study – with or without different doses of boceprevir (100, 200, 400, 800 mg), and with and without ribavirin. This study had a lead-in phase using PegIntron alone.

The authors found that boceprevir is safe and well-tolerated.  The overall intent-to-treat sustained virological response rates were 2% in the group that only received PegIntron plus ribavirin and up to 14% in the groups that received triple combination of PegIntron, ribavirin and boceprevir.  It was found that the most effective dose of boceprevir was 800 mg TID and that the use of ribavirin would be required to optimize treatment outcome.  The treatment duration would include an additional 24 weeks after HCV RNA became undetectable."

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

[CoWriter]

"...i fall into the null responders,,,i had large log drops i the 12 weeks i treated."


You have it backwards.  A "null responder" is someone who did NOT get a 2 log drop by week 12.

[Rockerforlife]

Thank you cowriter ...you have opened my eyes to the reality of the this new trail....i may just go for SOC for 72 weeks....my odds will be better anyone know those numbers......i will have to pay 3000 dollars from my own pocket...but it it bumps up my odds over 50%...its worth every penny

[Marcia2202]

Would he than be a partial responder?

Marcia

[Rockerforlife]

so your saying im a non responder?....but i had a 2 log drop 4 weeks...i am so confused....Vinny Barbilino

[Rockerforlife]

my study said i was just a slow responder...the only way i can cheat the grim reaper is to do 72 weeks....i know this now

[Marcia2202]

Or to get the extra drug. Can't you do the trial and if you did get the placebo, switch over after the 48 weeks to a private doc and continue tx???

I don't know how it works, just wondering.

Marcia

[Marcia2202]

Or try to get into a telaprevir trial, if you are more comfortable with that. Ppl seem to have had good response with that.

Marcia

[Rockerforlife]

i will ask my nurse that... if can i continue on ...but i don think so...these trials follow very strict rules..its proberly even stated in the consent form...it does say a 24 week follow up is required at end of tx...i do belive in my heart tho i will get SVR if i do 72...i had it planned to to do larger doses oF SOC  drug and get ready for the rescue drugs...my doc says he will be as aggressive as he can without killin me in the process...LOL

[CoWriter]

"so your saying im a non responder?...."

I don't know because I don't know what the outcome of your treatment was.  All I know is that you got >2 log drop at week 12......and you cleared at week 24.

What happened after that?  Did you finish 48 weeks?  Did you remain clear until week 48?  When did the virus come back?

[CoWriter]

"Would he than be a partial responder?"

He cleared (at week 24) and then he didn't clear at the end.  I guess that makes him a tease.

LOL

[Rockerforlife]

i finished 48 weeks and  had  LFT test 1 month post tx...ang they were back up to high pre start levels...all tru tx LFT tests were nomal...so my nurse said i relapsed by that info...a viral load wasnt actually done intill the 24 week EOT period...i had very mild sx`s with no resuce drugs needed...thats my story..72 weeks here i come

[Marcia2202]

So you are not a non responder, partial responder, nor null responder....

You are a relapser...

I think you should follow your feeling... If you don't want to take the risk of ending up in the placebo arm and thus having done 48 for nothing... If your doc is agreeing to treat aggressively and you think he is a good doc... why not hook up with him instead?

Whatever you decide... I'm backing you with whatever support I can give, my friend.

Marcia

[CoWriter]

So you're a relapser....and that gives you a better chance of clearing than a non-responder.  If the virus responded before, it should respond again.  But you're right, you may need 72 weeks.  

[Rockerforlife]

it would be nice to do 72 weeks SOC with the PI....if i didn get SVR then...i would pack it in...untill then..."the fight must go on."...Freddie Mercury

[cindyh113]

My little my mind can't get around all that! Must be the riba.Thank God you can. I'm happy for you and will be praying you kick its butt. If I don't clear I will need your experience.
Cindy

[can-do-man]

Thanks, link wouldn't work but found this...
------------------------------------------------------------------
Boceprevir in Null Responders

The results from another study using boceprevir in combination with PegIntron plus ribavirin yielded less promising outcomes.  However, this trial was more about establishing the most effective dose of boceprevir, treatment duration, safety issues and if ribavirin was needed to maximize treatment response rates.  

In the study there were 357 genotype 1 patients enrolled who were deemed prior null responders – defined as either less than a 2 log10 drop in HCV RNA after 12 weeks of therapy with pegylated interferon/ribavirin therapy or who did not achieve undetectable HCV RNA if treated longer than 12 weeks.  There were 7 arms in this study – with or without different doses of boceprevir (100, 200, 400, 800 mg), and with and without ribavirin. This study had a lead-in phase using PegIntron alone.    

  

Bottom Line

It is hard to draw any concrete conclusions because of the small patient population and the many different treatment arms.  The group of patients in this study are some of the most difficult to treat and most did not receive the most effective dose of boceprevir.  The newly announced phase 3 studies will hopefully answer the question of the role of boceprevir in the retreatment of prior non-responders
-------------------------------------------------------------------------------------

Wondering if telaprevir has results also for non-responders to compare with? Also in the above study couldn't find how many weeks of tx,  Also no riba in some arms, different doses of boceprevir, lead-in with Pegintron only, and 7 ARMS, plus a big difference in non-responders and relapsers. I just don't think one can take much out of this.

cando

[can-do-man]

In this comment.....Wondering if telaprevir has results also for non-responders to compare with?

I should have added, close to the SAME conditions has the above bocprevir study for non-responders.

[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???

[Rockerforlife]

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

[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

[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

[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

[can-do-man]

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

can

[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

[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

[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]

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

[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

[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.

[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.

[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]

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.

[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.

[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

[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

[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....

[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.

[Bill200]

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

[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 (inflammation). 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.    

[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]

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