Boceprevir Phase 3 initiated

[drofi]

http://tinyurl.com/63mqxv
Schering-Plough Corporation 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), an area of great unmet medical need. The two randomized, double-blind, placebo-controlled studies will evaluate the efficacy of boceprevir in combination with PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) compared to standard of care with PEGINTRON and REBETOL alone. The Company said the two pivotal studies will run concurrently and are projected to enroll a total of more than 1,400 patients at U.S. and international sites.

Comment drofi:
The study designs seem to be professional. Especially the pretreatment is clever. This will reduce the viral load and reduce the risks of resistancies against Boceprevir.

Good news for all of us!

[somuchmore2]

Great and thanks.

Perhaps there is hope to get into the next set of trials this fall. I certainly hope so as I still believe 1st order of business is get the HCV cured and then watch while doing all I can do maintain good liver function.

Transplant I hope would be far off or never I am 53 today...... but have low plalets, varcies, cirrhosis with genotype 1a. Treating in '97 then '03. Current function of liver is good.

[Bill1028]

Interesting, my doc put me on the top of the list for this trial.  He said that everyone will get the real drug, those that get the placebo at week 4 will get the real thing at week 8.  That was 4 months ago and the trial criteria was still going through the Institute Review Board.  I was surprised that I would be considered since I have cirrhosis and low platelets.  The other negative is that that there will not be any rescue drugs and would be drug dose reduction instead.  I needed Procrit 32 weeks of my first round of 48 weeks and needed it for 70 weeks of my second round of 76 weeks.  My doc isn’t pushing too hard for me to do this, he believes that I benefited from all the other interferon and can possibly wait.  I’m really torn about what to do, especially since I feel so good now.

[somuchmore2]

Within the report it states:

"will enroll treatment-failure patients who have documented previous interferon responsiveness by achieving at least a 2 log decrease in viral load by week 12 og peginterferon and rivavirin or who were viral negative at end of peg....ribra" etc........

Well I find that too difficult to fit because at 12 weeks I did not have 2 log decrease on peg/ribra. Oh well no way to get into this study as well.

Guess transplant looks again like only hope still.

Roche
Schering-Plough
Vertex
All seem to be too far away for approval and no way to get into study if stage 4 liver.

[viaduk]

drofi:  thanks for the info.  

Bill: I agree with you about the absurdity of  phase3 placebo-controlled studies for nonresponders.  It seems to me that a previous nonresponse to SOC, assuming tx compliance,  would be a built in  control.

I would get in line for this trial if not for the chance of going another 48 weeks of SOC

[somuchmore2]

I agree thank you for starting this dicussion up.

It is interesting in view of the tread about Roche trial study #NV 19865 ClinicalTrial#NCT00517439. As a non-responder genotype 1A I see these are the only path to avoid getting sicker.......  

[Bill200]

Yeah, I'll be glad when they get away from the double-blind stuff.  Makes no sense for me to do another peg+riba round.

[Trish77]

Thanks for posting this.  I did have my eye on boceprevir before the R1626 came my way.  It was looking good back then.  It will be interesting to see how this goes and exciting that they are going into Phase III trial.  The more the merrier, when it comes to protease and polymerase inhibitors.