Bocep on shelves, plus patients Assistance Program

[can-do-man]

http://hepatitiscnewdrugs.blogspot.com/


Merck said that it will begin the shipping of Victrelis to pharmacies within a week so that patients will have access to this new medication as soon as possible.

Separately, Merck will also add Victrelis to its patient assistance program through which eligible patients may be able to receive product free of charge.
-----------------------------------------------------------
Great news,
Cando

[frijole]

Well, duh -- that was your thread!  Anyway, I hope there are not a lot of exclusions in europe.

[frijole]

So you had a break through.  I am afraid I am not knowledgeable in how PIs are to be used with break throughs. It sounds like (from another thread posted) that some of the european countries my not allow the PI's for treatment naive due to the costs.  I hope you will be able to get it.  You should since you failed prior treatment.  I don't know yet if I will be able to get it through my insurance company yet either.  I think I just need to get a prescription and see what happens.

frijole

[Diamando6]

Thank you very much , for your valuable informations. Sorry to hear that you too relapsed. There are so many  of us here with the same craving for a new medication. You , people will do very well, because you are in USA, i.e. your medication is almost there on the shelves. We, from Europe, we dont know yet, when a drug will be available. here. But, lets see first what happens , overthere. Everything best,

[frijole]

Well, I totally missed that you had been pulled.  I think you have done it though - killed those nasty little virons for good.  I hope you are on the way to recovery and your HGB is rising every day.  I know it took me a long time to rid the Ribavirin from my system.  

I had a blood test about 10 weeks post and noticed my ALT and AST were higher than end of treatment. My PCR was at 3 months and indeed, I had relapsed.  IF you had a PCR at 5 weeks and it was clear I think you can relax.

frijole

[davetx]

Watch video presentation about Boceprevir.

http://www.youtube.com/watch?v=QBpKLx-b1cc

[spectda]

Very exciting news that people now have these two Pis to choose from. When I heard the news I felt overwhelmed that a new day had come for many people suffering with hcv.

Best of luck with your coming treatment. Hopefully it will be reasonably tolerable this time and you will have thrown those little ba$tard virons to the mat for good and they won't get up again :)  

I had to stop treatment at 43 weeks because my hgb dropped below the limit allowed in the trial. I had a pcr at 5 weeks post and was und. I feeling pretty good about my chances, but as you know well time will tell.

I always like reading your intelligent and knowledgeable posts. I know how much having you and the others experience and advice helped me get through the whole mess, and we even laughed a little in the process.  

Take care,
Dave

[NinjaPinky]

Frijole thank you or reading and decifering this all for us im gonna go download the 31pages when i can get to an actual computer but for now thanks for the info! Im so excited calling my g.i. on monday!
Cas

[frijole]

wrong again -- reading these charts taxes my brain --

The only patients who will only do 24 weeks of BOC (after the lead in) are the treatment naive who clear at week 8.  Everyone else will do 32 weeks of BOC.

[frijole]

A correction --

Treatment naive --- If you do not have undetectable until week 24, you would do the 3 combo until week 36 and then only Peg and Inf through week 48

Relapser/Responders and Partial R/R  -- if you are not UND until week 24, you would do all 3 drugs until week 36 and then only Peg and Inf through week 48

So, in all cases it is 24 weeks of boceprevir.

Trish - I agree - Vertex will surely do the same for patient assistance.  I wonder how much of the market share they will lose by being second in this race.  I know I am reconsidering using BOC instead of TEL. -- The anemia difference according to the labeling is a hemoglobin drop of about 1.  That does not sound that significant, at least once you are used to the reduced levels.

Spectra - hope you are about at the end of your journey.


frijole

[James10500]

Wow this is awesome a great day for all those relapsers, non-responders, and newly diagnosed.

Our disease has changed BIG TIME  rejoice folks.

[spectda]

I am no expert on the subject but I would imagine that making the pills costs very little and giving them to someone is not an expense but rather one less person who is paying for years and years of research dollars and marketing expenses. I would suspect that these companies offer these programs either because they are required to by the approving boards, and/or because it is good PR and part of marketing.

Vertex has a relationship with Johnson and Johnson and tibotec since 2006 who will be distributing telaprevir in europe. Johnson and Johnson has provided huge financial support to vertex and has a vested interest in telaprevir's success. Besides the fact that the quality and efficacy of telaprevir speaks for itself, I don't think a lack of money will be constraining them.  
-Dave

[SusieS2010]

Vertex has definite plans to add Telaprevir to a patient assistance program.

[Trish77]

Frijole, I don't think Vertex can afford not to, even though they are a smaller company.  A total guess on my part and the fact that Boceprevir / Victrelis is launching this way is hopeful.  

So far, so good, eh?  

[frijole]

great news, can-do.  especially the part about the assistance program.  I wonder if Vertex can afford to do the same.

Here's the dosing labeling.

For treatment naive --

    4 weeks lead in with INF and RIBA, then 24 weeks with the 3 drugs  if you are UND at 8 wks, or 44 weeks if you are not UND until 24 weeks.

For relapsers and partial responders --

    4 weeks lead in with INF and RIBA, then 32 weeks with the 3 drugs if you are UND at 8 weeks or 44 weeks with the 3 if you are not UND until 24 weeks.

Dose reductions are not recommended!  

Treatment futility is determined if the VL is greater than 100 IU/mL at 24 weeks. Treatment is discontinued.

Anemia  -- Although RIBA dose reduction is suggested when the HGB goes below 10 and RIBA discontinuation is recommended when HGB goes below 8.5, the labeling goes on to add that erythropoiesis stimulating agents (i.e. Procrit) were used in trials at the discretion of the investigator with or without RIBA reduction.  This is good news, I think.

Neutropenia -- They make mention that 7% of trial participants had ANC less than 500, but they say to look to the labeling on the PEG and INF to determine if dose reductions are necessary -- so there are really no changes there.

VL testing -- to be done at 4, 8, 12, & 24 weeks.  The test should have a quantification of no less than 25 IU/mL  and detectible amounts under the limits of the testing are not to be treated as UND

I suggest anyone considering treatment with BOC download the 31 page labeling information.  It can be found at:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory

frijole

[spectda]

Great news, especially that it will be added to the patient assistance program

[Diamando6]

great news, tell me if this medication will be soon in Europe

[HectorSF]

Great news indeed.
Thanks!

Hectorsf