Boceprevir FDA application

Merck, known as MSD outside the United States and Canada, announced today that regulatory applications for boceprevir, Merck's investigational oral hepatitis C virus (HCV) protease inhibitor, were submitted in 2010 and have been accepted for expedited review in both the U.S. and the European Union.
that offer major advances in treatment, or provide a treatment where no adequate therapy exists. FDA's goal for completing a Priority Review is six months.

The U.S. Food and Drug Administration (FDA) granted the New Drug Application (NDA) for boceprevir Priority
Review status, a designation given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. FDA's goal for completing a Priority Review is six months.

Additionally, the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for boceprevir for accelerated assessment. Accelerated assessment is available for products that respond to unmet medical needs or represent a significant improvement over current treatment options within a major public health interest such as treatment of hepatitis C virus infection.

Data in the NDA and MAA have been provided in support of the proposed use of boceprevir for the treatment of chronic HCV genotype 1 infection, in combination with standard therapy, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

"We are pleased that the FDA and EMA have accepted boceprevir for expedited review. Our goal is to be able to bring forward a new treatment option for patients living with chronic hepatitis C, and we are now closer to that goal,” said Dr. Peter S. Kim, Ph.D., president, Merck Research Laboratories

[frijole]

So let the games begin.  It would seem that Vertex and Merck are running neck and neck.  I wonder who will be first?
frijole

[spectda]

Thanks for posting this, this is great news. For vertex and merck it may be a competition for the big dollars. For the infected it means more options since some will tolerate one PI better then the other.

Hope you are well- Dave

[larf]

what are the time scales ?

[nygirl7]

Wow if they keep it up they are going to beat Vertex outta the gate. They caught up pretty darn fast didn't they?  Good competition is a great motivator!!!!!!!!!!!!!  Excellent!!!!!!!!!!!!!

[mikesimon]

Merck Beats Vertex to FDA Hep C Filing

By Adam Feuerstein 01/06/11 - 10:07 AM EST

Or, as my kids would so delicately put it: "Vertex Pharmaceuticals(VRTX_), you just got burned!!!"

The U.S. Food and Drug Administration accepted Merck's approval filing for its hepatitis C drug boceprevir, the company said Thursday. The news from Merck is a bit of a surprise since the company hadn't previously announced or confirmed that boceprevir had been filed with U.S. regulators.

It's also a tad embarrassing for Vertex, which is still waiting to hear back from FDA about the acceptance of the approval filing for telaprevir, its competing hepatitis C drug. That news should come by Jan. 24, based on Vertex's previous announcement that it filed the drug's application on Nov. 23.

Still, it seems as if Merck beat Vertex to the FDA by at least two weeks.

Merck's boceprevir, therefore, has a chance to grab bragging rights as the first, next-generation hepatitis C drug approved by FDA.

If both drugs are approved, boceprevir could be on the market by the second week of May, or approximately two to three weeks before Vertex has a chance to do the same with telaprevir.

In the grand scheme of things, a two-week head start is trivial. But given Vertex's reputation for supreme confidence (some would say cockiness), the fact that slothy Big Pharma giant Merck has taken the early lead in the hepatitis C drug race is a surprising comeuppance.

Vertex shares were down 19 cents to $36.68 in early Thursday trading.

A Merck spokesman would not confirm the exact FDA filing date for boceprevir. A Vertex spokesman said, "We expect to hear from the FDA this month regarding our request for priority review."

Cheer up, Vertex. The race to approval for a new hepatitis C drug is really just the starting point. What really matters is how each drug fares in the commercial market. Merck's early lead now may not matter much once doctors and patients have a choice of which drug to use.

[mikesimon]

Link:

http://www.thestreet.com/story/10965215/1/merck-beats-vertex-to-fda-hep-c-filing.html?cm_ven=GOOGLEN

[frijole]

Hi everyone,
Long time no see.

larf - The article said 6 months for a priority review.  I am not sure what the time frame is after the review.

dave - It is great to see both of these on FDA review schedule.  It will make it a lot easier to make an informed decision.  So which will it be ---- skin issues or stomach/anemia issues????  How are you doing?  I haven't been checking posts much lately.

ny - hey, girl - how is it going.  Glad to see you are still keeping on top of all this.  Believe it or not, my hubby emailed this article to me from his email addy.  I guess he has alerts set up for Merck and got this today.  I would not have known it yet if not for him.  Maybe that means he is softening to my treating again (???).

frijole

[nygirl7]

FRIJOLE MY GIRL!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!  :D

Ah it means that maybe he doesn't want you to have to treat again but he sure sure does love you *sigh* ahhhhhhhhh.  ♥  He wants you to be happy and healthy that melts my heart.

Until all my friends have gotten to SVR I will stay on top of this.  it was such a battle to fight for me and the odds that I finally succeeded were so low that I sort of feel like I was a relapser too in a way.....but now everyone is going to have such great chances at success  and it's so exciting. I can't wait until you post your SVR thread.  It's coming!

[frijole]

Well, isn't that interesting.  Just why has Vertex not received approval for their application?  I didn't know there was another step in there.  I thought it was submit and  receive approval for the drug.  I didn't know the application itself had to be approved.

I went back to Vertex' website and their application requeting priority review was summitted November 23

"The submission includes a request for Priority Review, which would reduce the FDA's review time from 10 months to six months. The FDA grants Priority Review status for several reasons, including if the medicine is considered a major advance in treatment."

Now I am rooting for the underdog

frijole

[frijole]

Deb, there but for fortune --- no, there but for your informed decision -- you might have been down here with us r&r's (responder/relapers)

I might be up there with you SVR'ers had I stuck it out for the 72. You know, I just threw out stacks of downloaded literature on extended time for treating because I think that it is a thing of the past.  

kathy

[spectda]

It's always really good to hear from you. It won't be long before you and many of us will be free of this disease for good. As Deb said it sounds like your hubby really loves you a lot, how could he not!

I am pretty much in the thick of it. Now 34 weeks into the boceprevir trial. I didn't make the 8 week und required to stop treatment at 28 weeks, but I wanted to treat for 48 regardless.

I guess merck beat vertex to the application and made a savvy business decision by keeping it secret, it gave them an edge. I doubt it has anything to do with a preference for either drug on the fda's part.

I wonder if they told the trial investigators. I certainly heard not a word from my doc form their last conference except there would be good news before long.

Take Care,
Dave

[Willy50]

Interesting news, but the first to file is largely symbolic.

One never know how the FDA works, but I would expect the same expedited review of Telaprevir.  IF that happens the drugs may come to market within several weeks of each other.

Who would would be so anxious to treat that they would simply choose the first available drug?  What sensible doctor would recommend TX of the first approved basis?  I would think that the decision to treat will be based on other factors.

First of all...... whereas the FDA has the full phase 3 data from all the trials, both of Telaprevir and Boceprevir, we do not.  I believe that Vertex may have the final phase 3 TX failure results for us to peruse at the spring EASL.  I would think that one compares the 2 compounds one will be more interested in how they stack up against each other, and *not* which was approved first.

One will be concerned with the efficacy of the 2 treatments, the tolerability of the 2 compounds and the potential for one drug being able to provide a shorter or potentially longer treatment time.  These I believe will be the key factors in making the decision, as well as the yet to be understood issues involved with pricing and insurance coverage.

These two compounds cannot even be clearly compared for at least 2 reasons;
1)  Telaprevir had a more rigorous definition of defining past TX failures; if I recall correctly the null responders meaning that the since the definitions are not the same the numbers cannot be compared straight across.  Even so....Telaprevir in earlier trials beat out Boceprevir, so it may be the most potent drug.   The higher efficacy may mean shorter TX times and higher SVR rates.

2)  The boceprevir trials utlilized rescue drugs and for the most part the Vertex trials did not use them.  This is one more reason that one cannot make straight comparisons between the two compounds.  In spite of this, telaprevir still had a higher SVR rate.  We will see what the final results of the trials bring.

My main point is that a 2 or 3 week lead is bragging rights, but little else.  The real question will be how the two compounds stack up against each other.  In some cases Telaprevir has been able to produce similar SVR rates in 24 weeks that it took Boceprevir 48 weeks to produce.  (in phase 2 trials, I'm not up on phase 3 results yet; not sure they are released in full)

Would you want to treat with Boceprevir instead, just because it  became available 3 weeks earlier?  

Willy

[nygirl7]

I thought that most doctors prescribed by which hospital they were affiliated with and that they commonly stuck to whatever company they usually used.  Also, it seemed to me that a doctor already ought to be looking into these drugs and have decided on a preference a while ago. I remember seeing some poll 'which will you use' quite a while back. If that is the case it really won't matter at all unless the final data shows some huge differences.

I just think good for Boce they were pretty suave about the whole thing as where we've always heard so so much from Vertex, it sort of impressed me that they pulled it off.

[Trinity4]

From everything I've read so far, the treatment duration for relapsers will be 48 weeks.  Personally, after 72 weeks, a 48 week treatment course doesn't cause me a bit of concern.  Initially I didn't care what PI became available first, just as long as it was a PI.
Now I have my sights on Telaprevir.  I don't like the lead in time with Boce. I've always felt this virus needs to be hammered hard right out of the gate.  Anemia seems to be more prevalent with Boce and Tela has a slightly higher SVR rate.  
Waiting three weeks or three months isn't a big deal I would think, especially for a relapser.

Trinity  

[orleans]

competition is a wonderful thing

[willing]

well wasn't that sneaky! I was wondering how a mega-corp like Merck could quietly blow it's stated goal of completed filing by end of '10 without so much as a word of explanation. Turns out they must have actually filed by mid-Nov and not  said a word. Their press release is here:
http://www.merck.com/newsroom/news-release-archive/research-and-development/2011_0106.html

I think this is great news for pts and possibly  even good news for vrtx investors. Boce's anemia sides are likely to be seen as more serious (and more expensive to remediate) than tela's. So if boce got the 6-month green light it looks very likely tela will as well.

I personally don't care which of the two I add but since I've had to discontinue alinia am feeling more anxious about starting one or the other by July 1 . Will start exploring the specifics of the dates with my Dr. at next visit. I assume he can write the rx the day after fda approval and I can start an insco approval query at that time. Also found a good ERISA lawyer and will try to understand what the insco time frame for stalling/denying/appealing looks like.

thanks for the update.

[Andiamo1]

Vertex stock barely budged on the news.  I guess most analysts are more informed than Feuerstein who has never impressed me with his knowledge of HCV.

[Willy50]

The way that Vertex described the rescue drug situation was that the FDA wants the results of a THREE drug regimen.  A drug that necessitates the use of rescue drugs isn't really triple therapy.

Vertex ran a pretty clean trial; I think that i saw there were no rescue drugs in Phase 3 except in one trial which ran about 1%.

In this case the FDA and potential treaters may not only be deciding if they want to chose one drug over the other, but also if they want to run the risk of adding a 4th helper type drug for anemia.  You correctly point out that those are not cheap.

One must also add that the inclusion of anemia drugs add an increased risk as well as expense.

For me...... this almost guarantees that Vertex will get an expedited review.

I would also add that just promising to look at a drug on a faster track basis doesn't assure approval on a fast track basis.  The FDA can also ask for a Phase 4 trial or simply reject a drug in 6 months instead of 9.  If there is a large enough group that need the black box warning rescue drugs it may pose an approval issue.  Not only are they more dangerous and expensive but they take much more doctor skill to administer and oversee.

I think they will both get approved, a hope they both are since some genetic types my be more prone to rashes and so Boceprevir may be a good alternative to TVR.

Further...... I wonder if the price of TVR would be higher if Boceprevir were rejected or delayed?  I agree that competition is good for us.

willy

[IAmTheWalrus]

This is good news!

Willy says "Who would would be so anxious to treat that they would simply choose the first available drug?"

I think a lot of people would. I would treat with either one for the improved chances they both offer, and if I was in a hurry, I would certainly take the first available one.

In this case though, approval is simply approval of the request for priority review, not actual approval. The race for "first" will be who gets to the market. I am not sure what the reward for that will be other than the sales during the period before the "second" comes along. After that, it is real competition based on benefit. That may be why Vertex stock barely budged.

Frijole: Don't second guess yourself about not going for longer TX on SOC. I went that route and extended to 84 weeks, Smaug went 94, and we both are waiting for a new drug like you.
It seems that the most recent evidence indicates that longer TX is not of as much value as once thought.

I hope to be fainting or scratching by summer!

[Princess77746]

Hi I'm Princess77746  I'm new here I have Hep-c geo 1 stage 4 i HAVE cirrhosii of the liver I go to UNC every 6 months for Blood test .I will be going the 19 of this month in which they will do an MRI I have some spots on my liver they are watching.I did the treatment I was so sick and lost weight I got down to 103 pounds and thats not good I'm 5ft.6 inches and I looked sick before I went do the treatment the doctor told me geo 1 was the one it may not work for me he said it was like tossing a coin in the air 50/50 chance and it worked as long as I was on it then I went back for my check up and it was back I want you to know that in 1984 I recieved 2pints of blood the Hep-c did not show up until 2004 .20 years later and then it was found by mistake Luckly me .well I'm back up tp 135 lbs  I just wanted to share with everyone about me Princess77746 Oh by the way I'm 51 years old

[evangelin]

"I hope to be fainting or scratching by summer! "

This really made me laugh. :>)
Your attitude is admirable.  We are really struggling with the thought.  We are just really afraid of trashing out our lives again and have it all be for nothing...again.  Even our close relatives are very nervous to see Joe try it. How many times do you climb the mountain only to be kicked to the bottom.  Maybe we should just take our good supplements and set up a nice camp at the foot of the mountain.   If we could have the 3 drug cocktail I'd be more enthusiastic, If wishes were horses...
Maybe we will find the courage,
Ev

[Andiamo1]

You raise an important issue.  The fact the Boceprevir requires epo and does not have as strong a result as Telaprevir might mean that Vertex gets approval before Boceprevir even though they filed at about the same time.

I am very surprised that the stock price held up so well.  I think many analysts must be thinking the same thing.

[copyman]

My vote is for Vertex. After all they offer the shorter course of therapy that has proven to work. Add to that no rescue drugs and no serious anemia. It is a no brainer that Telaprevir will be the choice of most doctors.

[susan400]

Telaprevir is completely off of the table for me, but if I get to find a way to pay for Boceprevir, I will be on it....

Susan400

[willing]

I'm not sure there's any evidence for assuming boce requires epo - however anemia is definitely a more common sx with boce and rash with tela. Here's the projected sx incidence and cost for different tx regimes from AASLD abstract 1935
"Adverse Event-Related Treatment Costs Associated with Protease Inhibitor-Based Combination Therapy for Hepatitis C "
---
Treatment Anemia Depression Diarrhea Rash Avg AE Cost
BPR48     52%      28%   24%   22%   $2563-$3578
BPR28     56%      20%   26%   18%   $2400-$3422
T12PR48  29%     19%   34%   61%   $1738-$2517
T12PR24  32%     21%   33%   54%   $1732-$2404
SOC48     27%      21%   26%   29%   $1608-$2229

[copyman]

From your post it looks like it will cost more to treat with Bocep. This will be another reason for the doctors & insur companies to push for Telaprevir

[can-do-man]

Never seen so more stock pumpers in one place

[can-do-man]

Opps "more" should have been many...:)

[Andiamo1]

The issue is they used it in the trial.  My belief is that they have to specify its use in the NDA, since it was part of the trial.

[Trish77]

Telaprevir has a higher rate of side effects on diarrhea and then rash by a wide margin.  Anemia is a key factor in Boceprevir.  Depends on your outlook.  When adherence is key to success and management of side effects is part of the success of adherence, Telaprevir is potentially more of a challenge compared to Boceprevir, although cheaper perhaps to manage side effects like rash and diarrhea than anemia that could require rescue drugs.

If I were a patient going in......well, interesting.

[alphonsos]

it really doesnt matter what we think - we will have very little choice in which drug we receive and very little choice on how long we will be on it - if youre having severe problems with rash and or diarrhea you might be switched and if youre having severe problems with anemia you might be switched - the big problem is that most likely treatment will be stopped until a managed care team figures it all out

[Andiamo1]

I don't think diarrhea is a serious side effect of Telaprevir.  No one I knew in the trial including me experienced it.  A rash is the most common side effect and most people were able to tolerate it.  Many people, including me, experienced slightly worse anemia.  I did experience nausea, but treated it with large bowls of Dove unconditional chocolate :).

I was randomized into 24 weeks of Telaprevir and SOC + another 24 of SOC.  On the first day of treatment, I had a PCR done every hour. My viral load dropped from 8 million to 4 million in the first hour and down to 1 million after 4 hours, <30 at the end of the week and undetectable at week 2. I have been undetectable since then and I am now 3 years post treatment.

[susan400]

If I remember correctly, you didn't really get the rash from h*ll w/Telap., like some of us did.  It's not as easily tolerable to those of us who got it real bad, as one might think.  I was itching so bad I thought I was going to die and on top of that my skin had huge open sore-like welts/blisters.  It most certainly was not tolerable by any stretch of the imagination, in my opinion.  The cortizone cream didn't do anything to really help matters whatsoever.  Any type of normal itch creams like one would use for a Riba itch, did not work for the Telap type of rash.  Not even close to being comparable.  I've had a Riba itch and it was nothing compared to this.

Susan400

[Andiamo1]

You are correct, I didn't get the bad rash, but neither do most people.  I forget the numbers though.  Mremeet did get the rash and you did, but I don't remember anyone else.  Am I wrong about that?

[Willy50]

Safety & Tolerability Results from ILLUMINATE

The safety and tolerability profile of the telaprevir-based regimen in the ILLUMINATE study was similar to results reported from the Phase 3 ADVANCE study. The most common adverse events reported in the ILLUMINATE study, in order of frequency, were fatigue, pruritus, nausea, anemia, rash and headache. The majority of these adverse events were mild or moderate. Adverse events leading to discontinuation of all study drugs during the 12-week telaprevir dosing period occurred in 6.9% of people in the study. Treatment discontinuation of all drugs due to anemia and rash occurred in 1.1% and 0.6% of people in the study, respectively, during the telaprevir dosing period. Like in ADVANCE, the use of erythropoiesis-stimulating agents (ESAs) was not allowed in this study.
--------------------------------------------------------------------------------------

Notice the above only apples to the FIRST 12 weeks?

here are some results from an earlier trial
http://www.natap.org/2008/AASLD/AASLD_43.htm

Treatment Discontinuations

The overall proportion of discontinuations of all drugs for any reason was 15% (Table 2).
------------------------------------------------------------------------------------------------

It seems to me that I've heard a full course of SOC creates about a 11% drop out rate.

The 15% drop out rate pertains to a phase 2 trial and it may be that the drop out rate was improved upon.

IF so..... the drop out rate may come within a few points of the SOC drop out rate, and without the use of rescue drugs.
----------------------------------------------------------------
I would also point out that many so called drop outs or failures may go on to SVR.  Yes, they may have had to drop out due to the sides BUT success was still achieved.

willy

[Andiamo1]

Thanks for the data.  I think the lack of rescue drugs during the Telaprevir trials accounts for some of the dropouts.

[Magnum]

For those experiencing horrendous rashes, this is the drug my Gastro wants me on. However, the caveat with this drug is that it has the other side effect of Anemia. Decisions, decisions...

Magnum

[pcds]

I had anemia very early in tx so Boc is not likely my choice.  I had the riba rash, but it was managed.  Will discuss further with new doc in March.  But I think it will be Tela due to my prior anemia so early.

[Willy50]

I guess that it is a Boceprevir thread, i should stay on point.

I think we will see meaningful comparisons at the spring EASL.  I don't think that much can be unblinded at that point and the best arguments will be laid out with beautiful graphs and pie charts why each drug is the best.  : )  

I hope that they are both approved.  I believe that while they will be similar each one may have it's strong points for certain people.  I think that the spring presentations will help aid one in ones possible future choice of drug.  I rather assume that by the fall AASLD they will be treating patients with both drugs and so...... the forums could become busy places.  I also think it is a reason we will see a large information push here soon.

willy

[Willy50]

discontinuation rates SOC

http://www.hivandhepatitis.com/hep_c/news/2011/0107_2010_b.html

(end of 4th paragraph)

"Although the first DAAs still require concomitant use with current HCV medications, these new compounds will shorten the length of time on pegylated interferon and ribavirin therapy, which hepatitis specialists noted is often difficult to tolerate and has significant adverse event profiles that limit treatment in many patients. According to the latest data, between 15 and 30 percent of HCV patients started on current HCV therapy are unable to complete the year of treatment now required because they cannot tolerate the side effects."

--------------------------------------------------------
The upshot is that when things get out into the real HCV infected population things may change some when the infected aggregate gets treated with the aggregate of doctors that are out there....

It is still quite possible that a shorter triple therapy treatment, in spite of being more intense may have comparable discontinuation rates as SOC.  
There are a few compounds being tested for example, that reportedly have fewer sides than TVR or Boceprevir.  If they can also provide a shorter TX period presumably there will be a lower dropout rate.

Willy

[willing]

agreed that epo definitely will cost more than treating rash but until the relative cost of tela/boce is revealed it's hard to know if that's a big  factor.

The data above suggests most (61% and 54% of the two tela arms) will deal with rash - not the other way around, though hopefully for most it won't be as hellish as it was for susan, mremeet and dointime (and they were not alone given the posts in the archives)  Let's hope!

Personally I think for those hoping/planning to be early in line there's very little that will surface between now and July other than cost and manufacturing availability. In terms of making a choice, the phase III data is in (even if not in complete detail), and the brave pioneering fellow lab rats have shared their sx stories and results.    

[Trish77]

"I hope that they are both approved.  I believe that while they will be similar each one may have it's strong points for certain people. "

I think that's the key for me also.  Personally, I've favoured boceprevir more watching both of them for my own reasons, others would say telaprevir and isn't it great if patients had choice and more options.  So having both of them come to market is a good thing and hopefully insurance companies will not restrict to one or the other and treating docs for that matter and will take the one that suits their patient the best.  To me, key is to be able to be adherent and complete treatment and choosing the drug wisely from that perspective is important.  Adding a PI adds another layer of complexity to treatment - we haven't had to concern ourselves with resistance profiles until now and adherence will be more critical than ever with regards to resistance profiles as well.  Having a knowledgeable doctor becomes important who understands the extra variables that adding a PI brings.  Thankfully, one of those variables is significantly higher SVR rates.  Some things are worth the extra trouble.

[frijole]

I really hope that this is a comparison thread for Boceprevir and Telaprevir.  We all need to make informed decisions this summer.

I do think there are a lot of folks who will take the first one out of the starting box.  But my thinking is that the FDA will approve both at the same time, allowing competative pricing.  

I have not heard as many comments about stomach problems with Telaprevir as with Boc.  I think we all have to look to our natural status.  If we are prone to stomach disorders we should not take Boceprevir.  If we have sensitive skin we should not take Telaprevir.  As far as the anemia, I think many of us will take epogen whichever we take.  It seems to me that the drop outs in the Telaprevir trials would probably be those who needed epogen (except for the rash drop outs).   The anemia is one issue that I (personally) would like the advice of a hepatologist on.  I would like to be able to show a doctor my chart on my hemoglobin counts and Procrit shots and have him recommend whether Boceprevir would be too much.  

Willing - what is the deal with ERISA?

frijole

[miked]

This is a very interesting turn of events.  It's also interesting that Vertex stock is up today to $39.25.

I've been intentionally quiet about the topic but would appreciate more insights into what you guys think.

Take care,

miked

[nygirl7]

Hey Mike -- thats what I think :D

[miked]

Your comment cracked me up..."Hoping to be fainting or scratching by summer!".  I've been smiling about this all day.

I was in Vertex' Prove 3 trial and SVR'd after 24 weeks of tx.  Got the rash from he11 during tx.

Best of luck.

[miked]

Hi Deb, always good to hear from you.  

Agreed that docs made their minds up during the trials.  As a former 1b, my research pointed to VX950 as my best option.

You doing OK?

Take care.

[miked]

Sorry, I reread the thread and your comment cracked me up.  Thanks.

About your reply to Willy...I wouldn't make a decision to go with whoever is first to the market.  Willy's been a patient "wait and watch" person for a long time and making an informed decision.  It's a slow moving disease.

[willing]

so do you already know when/where you're going to put down your chips? I haven't seen much reason to make a clear call one way or the other. I don't trust my Drs (mostly because they can rarely be trusted to have had time to think about the  chart notes before making a  'decision') and I absolutely don't trust the drug cos or inscos, but I do trust my fellow lab rats and have been paying close attention to what Spectda is going through and the rash from h*** stories.

re ERISA I'm still hazy on the details and will  know more after I meet with the lawyer, but my understanding is that after the insco internal appeals of denials are complete it ends up in federal court under ERISA law as is the case for other employer-contributed benefits (401K, disability, COBRA). Different district courts have different precedent about whether judicial review is de-novo (all facts) or limited to procedural review, so the contents of the insco internal reviews submitted in  district court are critical. I'm in the 9th circuit which in principle allows a de-novo review.  

[frijole]

Since I did have anemia for most of treatment and I intend to work through treatment, and I don't have sensitive skin, it appearsTelaprevir would be the best for me. However, I like the successes I am seeing with hard cases on Boceprevir like Can do man and Ejoili to name a couple.

I would like to schedule a summer appointment with a hepatologist in Dallas and discuss it.  However the clinic where I consulted after relapse could never seem to get any of the R/R trials - only the treatment naive.  So whereas they have local data on that, I am not sure they are any more informed than me on responder/relapser results.  

So the jury is still out.  Are you still on line to add a PI to the mix as soon as they are out?

frijole

[can-do-man]

Hi ya kit kat, your a wise person so you will make the right decision...... Really great new about ejoli, she still might need the TP but it looks as if she will be HCV free.

can

[willing]

yup - since the clock is ticking I'll probably go with the first one available. If I hadn't had to drop the Alinia it might be more of an elective option.

[merryBe]

I know this will sound crazy, but since you are already treating, if one drug came out weeks or months before the other, I'd use it.

Look you could always switch PI's when they both arrived, assuming you preferred the stats on the latter release, but the sooner you get some sort of PI going the sooner you could be done with tx, so in your case it might be worth at least exploring the options.

I don't see what difference doing it this way would make in terms of your tx since you aren't in a trial. You can do whatever your doc will go along with.

As far as all the discussion about rescue drugs goes, perhaps one drug is more symbiotic with the riba, perhaps there are absorption differences there as well, as there are with riba as regards BBMV uptake. In any case, I'll have to keep an eye out for studies on PI absorption, ; )

mb

mb