the equivalent press from release from Merck is
http://www.merck.com/newsroom/news-release-archive/research-and-development/2010_1001.html
note "As previously reported, Merck plans to submit a New Drug Application (NDA) for boceprevir to the U.S. Food and Drug Administration (FDA) on a rolling basis, and expects to complete regulatory submissions in the U.S. and E.U. in 2010."
so maybe those rumors are accurate and there's some hope for boce by 6/11.
At my last appt with the hep doc at kaiser a few week ago he said they have been getting memos from administration to be prepared for the new drugs to be out around mid 2011 he said they have literally hundreds of people waiting for this and administration wants to be ready.
I guess we are all coming out of the warehouse next year
why would you say that. It states that the application for telaprevir will be submitted at the end of 2010 which means it should be available mid to late 2011.
so this means that telaprevir will not be coming out in 2011?
It looks a long way away for anyone except geno1s - especially when you have want to take away the riba but I am certain that if the odds were so great that someone in his shoes could succeed he would try it. He tried so HARD it was so dreadful that he should not succeed. He is always the one I think of us 'brave' for what he endured just trying to remain on SOC.
Everyone with liver damage of course she stay as healthy as possible until such a day comes!
Vertex reported that there were no viral breakthroughs in ANY of the other arms, one of which would include Arm B which was a no-riba arm. I therefore believe it is too soon to write off the notion that one will need IFN and RBV to treat.
Vertex Trial design has people who meet certain response criteria end TX after 12 weeks; not bad for a G-1treatment.
The down side of small arms is that if you have a few extra resistant folks in Arm A or some more responsive in Arm B it can really skew the results. 25 people per arm may be a bare minimum to infer results.
Vertex reports that doing will end in the first half of 2011 and SVR rates in the 2nd half of 2011. Since there is very little relapsing in the PI trials they will probably know the results long before the official 24 week PCRs occur, although perhaps they will see a higher percentage of these where people only treat for 12 weeks, and perhaps more still where people treat without RBV.
I know people with thalessemia who have successfully treated with IFN and RBV, but for "only" 24 weeks due to their geno-2 status. These new forms of TX will cure a large number of us. The key then, may be staying healthy until such a day may come.
willy
A long time back now Susan got the no riba arm of a trial and it did not work. I am therefore not suprised to see such low numbers of the patients in the arms, it makes sense.
I too think interferon and riba will be with us much longer. wishing it were not true for someone like Mr. Beagle and his thalessemia so much though.
Strictly speaking..... it is just Arm A that was discontinued.
Arm B is also a no riba arm, but features 4 x the VX-222 dose. One might speculate that there will be a higher rate of success, but perhaps a less than stellar performance, but there are people who need to treat and whom cannot take extended or high doses of riba. This form of treatment, while perhaps being considered a failure buy some could STILL be a Godsend for many of people who cannot take extended periods of IFN or RBV. The cure rate won't be as good as others but it can still possibly cure some "niche" patients. Success or failure is all a matter of perspective. Vertex will know more when they compare it to the other no-riba Arm B.
Since both of the arms are backed us with 24 weeks of SOC we could still ultimately see SVR's and ultimate success, but it would appear that they know that this doing combination may not be the best route. One also has to wonder whether RBV in the first 4 or 6 weeks may also be all that is needed.
When I first saw the size of the trial, I was surprised at how small the arms were; only 25 people per arm. One can now better understand the rationale for that. Vertex was able to through trial design abler to discriminate the performance of the 4 arms but where there could be break through and resultant viral resistance issues, they were able to limit the number of people who may face the resultant issues. In this case 25 people in that arm, half of whom may respond and SVR via the 2 dose compound and perhaps 1/2 of those may ultimately succeed with the followup SOC treatment on the back end of the arm.
I'm sure we will know more later, but that's how I read this.
willy
Thank you for the update. I know many are waiting to treat with Telaprevir next year.
Hectorsf
bummer, looks like we will using ribaviron and interferon for a while longer.
Vertex announced today that it has modified its clinical trial evaluating telaprevir dosed in combination with Vertex's lead HCV polymerase inhibitor, VX-222. The company will discontinue Arm A of this study as a result of patients meeting a pre-defined stopping rule related to viral breakthrough during the first four weeks of dosing. Arm A was designed to evaluate a two-drug regimen of VX-222 (low dose; 100 mg) and telaprevir (1,125 mg) both dosed twice daily without pegylated-interferon and ribavirin.
In this case the actual trial consists of adding one more component (VX-222) to existing FDA approve drugs for treating HCV (assuming that TVR will be approved shortly), and it may also prove that drugs can be eliminated (IFN and RBV) and treatment time could be reduced to 12 weeks for responders.
Ultimately it may also prove an increased SVR rates for past TX failures, hope for people who cannot treat either with IFN or RBV, and due to a broader range of antiviral effectiveness it could also further improve the SVR rates for geno2's, g-3's and g-4's. TVR has shown to not be especially effective in G-3's and 4's.
One might also assume that the dual PI's, with no or reduced use of IFN and RBV could be used to treat some patients at or near decompensation with decreased risk and greater effectiveness, thus possibly sidestepping the need for transplantation.
willy