Boceprevir in May

[Magnum]

Just got back from my Gastro who said the Merck rep came in a few days ago and stated the Boceprevir will be released to the public in May. That's the good news...

The bad news: $60,000 for treatment (includes Ribavirin and Interferon)...

So, we who have Medicare have to keep our fingers crossed that they will approve payment for treatment. If not, we can always appeal. A doctor's appeal is best, but we can also appeal and send a double whammy to Medicare.

Good luck and keep your fingers crossed...

Magnum

[nygirl7]

It's not just your insurance my AetnaPPO wouldn't approve me extending a lousy six months (said it was experimental, idiots) and they too said they would pay for a transplant if I needed it.  All insurance makes no sense to me.

[Magnum]

I mentioned the difference in the cost of treatment to my Gastro: $60,000 for the new triple drug treatment, $250,000 for a liver transplant that Medicare would have to pay for. He said that it doesn't compute in the minds at Medicare in that way.

It's a mess in the political field on this matter. Logically, you would think that those with Cirrhosis would have no problem with Medicare approving the treatment at 60K to prevent paying 250K for a transplant, but Medicare only looks at the lower price when presented with this bill and does not delve into the possibility of the higher price for a transplant until it’s too late and they have to cough up the 250K. And so goes the business of big government with no plan to migrate to the logic of it all... Their backward thinking is the real problem...

Magnum

[tjrusert]

My husband looked a little shocked when I told him what the possible price of the tx would be.  But I told him that it would probably be cheaper than a possible liver transplant in the future.  I dont know if that is correct or not but it stops the nay sayers.  I just turned 50 so I might never have enough damage to my liver to end up needing a transplant but who knows.  One of my grandmothers lived to be 96 and the other will turn 100 this year.  I dont know how long Ive had this.  Its an answer for ppl who would be negative about the price.  Also they dont have to live with this.

[susan400]

That is GREAT NEWS, GREAT NEWS INDEED!  Should this come to pass as he quoted, in May, then, I will be planning to start the process for indigent drug coverage sometime later on, around the Sept. time frame..., knowing that it will take some time to get it all in place, i.e. getting the approvals done, the meds in, etc., etc., I hope to be able to begin treatment some time in Oct., if everything goes as planned.  AND I know that everything does not always fall into place exactly how I want, but it is what I'd like to have happen.  My doctor mentioned when I saw him in Jan., "it might be a good idea to get another biopsy right before you begin treatment, whenever that ends up being".  I just had one in June of 2010, but he said that it was something that we should consider.  Since my income, as a single is right at $15,000/yr, I do believe that I will qualify for some extra financial help.  My husband and I don't share the same residence and we filed our taxes as married filing separately..., have separate bills, electric, etc., etc., I don't think his income should have any bearing on my income level.  Since I know that my Medicare HMO Part D does not cover Peg-Intron, then, I will be able to prove that I've got no insurance coverage for this med.  I do think that it will mean that I meet their criteria.  I hope so at least.

Susan400

[spectda]

Both the vertex and merck strategy of no lead in vs lead in make sense. It's hard to say which is the better approach. They may be similar drugs but they are not identical. has vertex studied the lead vs no lead in approach?


http://www.natap.org/2009/AASLD/AASLD_09.htm

"Rationale for Lead-In Regimen

The use of the peginterferon and ribavirin lead-in prior to the addition of boceprevir was shown in the HCV SPRINT-1 study to reduce the incidence of viral breakthrough regardless of treatment duration. The rationale for the lead-in treatment regimen is based on the fact that both PEGINTRON and REBETOL reach steady-state concentrations by week 4, therefore patients have the protease inhibitor added at a time when the backbone drug levels have been optimized and the patient's immune system will have been activated and primed by PEGINTRON. With the lead-in strategy, initial peginterferon and ribavirin responsiveness is determined prior to the addition of a protease inhibitor, thus allowing the physician to take into account the potential for the development of resistance."

[nygirl7]

It might be the one good time to be a relapser Magnum I would think that would put you at a higher qualification than a naive for spending the extra money.

[spectda]

I believe that the lead in will be protocol with boceprevir specifically. Vertex takes a different approach with telaprevir and begins tx with 12 weeks of triple therapy and then continues with soc alone for the remainder of tx .

All the boceprevir trial data points to higher svr with a 4 week soc lead-in. Merck considers und at 8 week to be rvr because at that point boceprevir has only been in your system for 4 weeks (4 week lead in and and another 4 weeks of soc plus boceprevir). Of course the FDA may recommend a different protocol then Merck or Vertex have used during their trials.  

Good luck Magnum, hopefully 5th times a charm.

- Dave

[Magnum]

Doctor did not mention lead-in. He did say that studies show that just about everyone drops pretty quickly, but that the virus rebounds quickly after that, therefore the continuous bombardment. All of this news in new to me today, so I can't answer some questions that are presented now after I left his office.

Unfortunately, he did mention that I will be sick, but that's to be expected. However, I did not get so sick the last 4 tries (except the dreaded Infergen), that I had to stop or developed Anemia.

Naturally, since this is all we have to look forward to now, I am excited, as it may work once and for all. He did mention a lot of research is currently being done for treatment without Riba and Interferon...

Magnum

[Gee704]

"I believe we were talking about 24 weeks if I clear within 14 days. If not, then we go for 46 weeks."

Is that "clear" in 14 days after the four week lead in (as in week 6) or are they not going to lead in and you must be clear at week 2?

I am so happy for all you who have waited to treat with the PI's.

[Willy50]

Should point out Boceprevir will now be called Victrelis
================================================

I think that is what Vinnie Barbarino used on his ducktail when Lucky Tiger wasn't available.

Bad name; no cookie.

willy

[can-do-man]

Heres the link for the EASL news.

http://hepatitiscresearchandnewsupdates.blogspot.com/2011/03/merck-announces-new-data-analyses-for.html

[can-do-man]

Should point out Boceprevir will now be called Victrelis

[can-do-man]

To be presented at the EASL this spring......

The HCV RESPOND-2 study in treatment-failure patients and the HCV SPRINT-2 study in previously untreated patients each evaluated two treatment strategies with VICTRELIS administered in combination with PEGINTRON and ribavirin to assess the ability to improve sustained virologic response (SVR) 1 and potentially shorten overall treatment duration compared to treatment with PEGINTRON and ribavirin alone:

• Response-guided therapy, in which treatment-failure patients with undetectable virus at week 8 were able to stop all treatment at 36 weeks.

looks like your looking at lease 36 weeks..... Still not bad though... Good luck

[Magnum]

I believe we were talking about 24 weeks if I clear within 14 days. If not, then we go for 46 weeks. He may want to add a few more weeks to either number for fear of mutations. This all remains to be seen, but for now, the release in May will get me, Susan, Hector and others excited, if they choose to go with Boceprevir.

Dr. Robert Gish, the renowned Hepatologist will give a speech along the lines of PI’s to the doctors here in Las Vegas (where Dr. Gish will start a new clinic in May). I will report as to what the doctor will be told regarding all of this...

Magnum

[spectda]

Thanks for the information Magnum. Great news that boceprevir will be released in may and I assume telaprevir right around the same time or a few weeks later. Hopefully by next year many more of us will be svr.

[Willy50]

What is the cost without Boceprevir?

Is that for 24 or 48 weeks?

It may not be that bad if it increases the chances of clearing, shortens the treat time, gets it done in one TX.

I'd guess that mean Vertex will be higher or comparable.

willy