When is Boceprevir expected to be approved?

[susan400]

I've heard quite a bit on the boards about the Tele but not so much on when the Boce is supposed to be approved.  Has anybody heard anything on it?  I won't be treating w/the Tele again, but plan on treating w/Boce if I can find a way to pay for it. Let me know if you have heard anything.

Susan400

[scratchinghead]

Not sure about a miracle weight loss pill, but this book is really good:
The 4 Hour Body by Tim Ferris

[foofighter]

Article was published last summer before things got rolling with the FDA priority reviews.

Meta-analysis: re-treatment of genotype I hepatitis C nonresponders and relapsers after failing interferon and ribavirin combination therapy

A. G. Singal1, A. K. Waljee1, M. Shiffman2, B. R. Bacon3, P. S. Schoenfeld1,4

Article first published online: 15 AUG 2010

[nygirl7]

Michael

I am still waiting for a miracle weight loss pill and stockings that dont run as soon as you put them on.  I mean I'm sure they are out there but also sure they ain't ever going to give them to me.

It's getting that aggravating watching this crap, they better just release these drugs and make them 'widely available' soon. Yet another year goes by and still here we are talking about when it will get approved just like we did in what 2005? 2006? 2007? 2008? 2009? 2010? 2011?

[mikesimon]

I really know what you mean. I remember trying to get Viramidine (Taribavirin) back in 2003. I thought it was just around the corner and that maybe my transplant surgeon could get it. Well, now Taribavirin finally appears to be just around the corner but......................

Mike

[nygirl7]

how many years now have we been hearing the same damn thing - honestly they  have been so studied I dont know why they can't get approval easier on this stuff when so many people need it.

[mikesimon]

I just saw this today. I've assumed that the PIs would be available sometime in 2011.


Meta-analysis: Re-treatment of Genotype I Hepatitis C Nonresponders and Relapsers after Failing Interferon and Ribavirin Combination Therapy

'....Although treatment of HCV-infected individuals will probably advance to direct-acting antiviral (DAA) agents, also known as Specifically Targeted Anti-viral Therapy for hepatitis C (STAT-C), with protease inhibitors,[17,18]

              these agents may not be widely available in the US until 2012  

and may not be available in other countries until years later. Therefore, treatment failure patients who are at risk for developing decompensated cirrhosis, HCC and liver-related mortality may be appropriate candidates for re-treatment before DAA therapies become available, especially if they already have bridging fibrosis or compensated cirrhosis. Furthermore, the SVR data in our study will provide a comprehensive assessment of SVR rates that can be attained with high-dose or prolonged PEG-IFN combination therapy and these data can be used for comparison with SVR rates achieved with DAA based regimens...."

http://www.medscape.com/viewarticle/736014

Mike

[cakes8267]

I have Hep C, geno type 1, went through 66 wks of Pegasis and interferon,, level went down to zero at wk 15 but levels came back after 6 wks of stopping treatment.  I am thinking about getting involved with a research study with Boceprevir and Pegasis and interferon but am concerned that I may end up with the Palcebo.  Any thoughts if I should just wait for the FDA approval or go ahead and do the research drugs?  

[esub]

I've just found this site and I'm hoping that there is some type of accurate info out there.  I have HCV Genotype 1B and Stage 4 cirrhosis  It showed up in 2006 when I had an emergency appendectomy.  I guess I got it back in the early 1970's when I was stationed in the army.  They used the air guns for mass innoculations and didn't clean or sterilize the ends of them like they should have.  I haven't received any type of treatment for this since my doc says I'm borderline.  Both my red and white blood cell counts are low30 - 50K range.

Any usefull info would be appreciated.

[willing]

it's a proven lab-rat survival strategy - stay quiet and blend with the cage (but thanks - always good to read the encouragement and cheer you provide around here).

[nygirl7]

Willing you little rat where have you been hiding?  ;)  It is so good to see you (well to read your words anyway).  You cannot disappear for so long - the voice of reason and knowledge!!!!!

♥

[willing]

it's surprising  your hepa is focusing on boce since there is  wide overlap in the resistance mutations between boce and tela. You may avoid the rash with boce but whatever mutations survived tela will likely survive boce. Rather than retreat with a protease inhibitor using one of the drugs that targets another viral protein - eg the Roche or BMS drugs seems the safer strategy. Anyway, I can sympathize with frustration over the delay - I would also much prefer boce because of the rash issue but will likely have to add whatever is  available by next summer (if anything) and it seems that will be tela.

[spectda]

"I enjoyed your "Bocephus-vir" comment.  Im guessing that your right.  Hank probably wouldnt think it was funny.  But I did.  Apparently, I have the same kind of addled Hep C mind. :)"

Yes, thanks for the humor robert! It's important to keep our sense of humor!
- Dave

[scratchinghead]

me too

[tjrusert]

I enjoyed your "Bocephus-vir" comment.  Im guessing that your right.  Hank probably wouldnt think it was funny.  But I did.  Apparently, I have the same kind of addled Hep C mind. :)

[scratchinghead]

Found this webpage/website. It lists all the trails going on and what stage they are in.

http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

[susan400]

That's part of the problem, no one is really sure what the right drug or drugs is for me at this point.  I just can't do Telaprevir again and my hepatologist is leery of me even trying to because of the severe early onset rash that I had with it and because I've already been exposed to it so I have less of a likelihood of viral clearance on the Tele.  So, I will wait it out for the Boce, however long that takes and hope that I have a way to pay for it at that time.  Susan400

[StormRider]

You are correct, should have read end of 2011 or early 2012. : )

[spectda]

glad to hear your damage is not to severe. I think you should wait for the right drug or drugs so you don't have to keep doing this. No one should treat for 10 times, that just sounds awful. I could never do it.
Be well,
Dave

[pcds]

These new meds will be our time for success.  There will be a large number of us, me included starting as soon as Telaprevir is released which is before the boce.  Hoping by this time next year we will be in the middle of tx with new PI.
pcds

[susan400]

I am basically stage 2.  Two of my biopsies showed bridging, but the last biopsy didn't show any bridging.  So, I'm fortunate in that all of the treatments have kept everything under control pretty much.  I am just tired of having to deal with it, all of the monitoring of it, thinking about it, etc.  I just want to forget all about it and pretend that I don't even have it, you know?  

Susan400

[spectda]

Hi Susan-
It must be stressful waiting and having treated so many times. I know you've been on this forum for many years and most of the people know you're story well. What stage is your disease at?
Hang in there, Hopefully it won't be long before you get some help!
- Dave

[susan400]

Shoot...., at the slow rate that this is going, the world will end 2012..., before these dumb drugs become available!!!   LOL.   I gotta laugh about it, helps me with this long wait!  Susan400

[RobertBeWell]

Heh, every time I see the name "boceprivir" I think of Hank Williams Jr. - for some reason, my brain translates it as "Bocephus-vir".

Ahh, the addled Hep C mind of an ex hippy. I doubt Hank would find it amusing however :-O

[spectda]

Merck is expected to submit for approval at the end of the year for boceprevir. As Robert said I would guess that it is most likely to be approved by the end of 2011 or beginning of 2012. No one really knows when exactly it will be approved.

From what I have read telaprevir and boceprevir act on the same part of the hcv molecule. There are other drugs in development that work on different parts of the molecule, BMS-790052 is one of them. Vertex is also working on a combo tx of telaprevir and vx222. vx222>

"Vertex is currently conducting the first clinical trial to evaluate telaprevir dosed in combination with VX-222. This Phase 2 proof-of-concept trial is designed to evaluate SVR, or viral cure, rates using multiple 12-week response-guided regimens of telaprevir/VX-222-based combination therapy, including two-drug regimens that contain only telaprevir and VX-222. Vertex expects to obtain on-treatment clinical data from this trial in the second half of 2010."