Aa
Disappointed in VX-950
As one who will not do the SOC as it stands now, and hoping for better meds I was somewhat dissappointed in Vertex's latest web cast. They made it perfectly clear that they thought peg and riba were the lead drugs and vx-950 was just an add on.
Ron
Ron
i still see it as a silver bullet. i dont expect it to save everyone but i think it will clean up many hard to treat cases. i do have the highest of respect for
the lab rats who have to endure dead arms and no rescue drugs. from what i understand, there are scientists cracking the real code to make a vaccine.
when this day arrives i guess that 99% of us will be saved and the disease will disappear! the drug companies have determined they can make a ton on money on this deal. from what i can see they are all working pretty hard on it. i would bet that
in some lab somewhere is already a better silver bullet but needs more time to develope. unfortunately HCV is hard to crack but i predict progress to be exponential as this snowball keeps rolling. in my opinion, we are not being ignored and will soon (5 years or less) see spectacular progress.
hey, i forgot one more thing, your car just got stolen.
the lab rats who have to endure dead arms and no rescue drugs. from what i understand, there are scientists cracking the real code to make a vaccine.
when this day arrives i guess that 99% of us will be saved and the disease will disappear! the drug companies have determined they can make a ton on money on this deal. from what i can see they are all working pretty hard on it. i would bet that
in some lab somewhere is already a better silver bullet but needs more time to develope. unfortunately HCV is hard to crack but i predict progress to be exponential as this snowball keeps rolling. in my opinion, we are not being ignored and will soon (5 years or less) see spectacular progress.
hey, i forgot one more thing, your car just got stolen.
Back when I was first diagnosed there was talk of a PI called Biln 2061 that was expected to be the next great thing......or so it was hoped. In spite of some promising results the compound was pulled from trials. Fast forward about 3 plus years. We now have a compound in Phase 2 trials (Vertex TVR) with some very positive results so far. To be sure it isn't perfect but look at what we may soon see;
1) A treatment duration that is cut about in half. That means 24 weeks LESS of interferon and ribiviren treatment for most of us (unless we are some treatment failures who are facing 72 weeks of TX now).
2) A treatment which may come close to doubling the SVR rate. Even if it were only a 60% compared to todays 40ish percent for genotype 1"s....would that be so bad particularly when coupled with a shorter treatment?
3) New hope for people who have taken treatment over and over and who have failed over and over. These folks may be on the threshold of clearing or staying clear. Something a bit stronger or that helps them clear a bit faster may indeed be just enough to get them to SVR this time. It could save many, many lives. Just a few days ago another one of us died who could not be cured with conventional treatment as it now stands. An improved treatment a few years ago might have been a silver bullet for them and how many other heppers who have since died?
4) The webcast mentioned that TVR and interferon alone (no ribiviren arm Prove 2) did a better job of clearing the virus than existing SOC. That also suggests that some people who CAN'T do ribiviren may also have some new hope for being cured. They may not yet be done fiddling with the ribiviren; there could come a time where one ceased or tapered off without needing 24 straight weeks of it
5) We may at some point see the results of new viral kinetics which might allow doctors to sort people into groups that determine the type and duration of treatment they need. For instance if they can sort out the super responders they may be able to treat some people for less time than the 24 weeks. Already they proved in Prove 1 that nearly 40% of those that RVR'ed (cleared by week 4 and maintained that status) SVR'ed. They did this without ANY "rescue drugs". This was only in Phase II trials. Might they be able to improve that? (I think and hope so. : ) )
A silver bullet or miracle drug? Perhaps not, but whatever drug, compound, treatment or protocol that comes along and helps is surely to be appreciated. We've seen little snippets and great results from this drug trial. There's been a lot of speculation and there will be for a while yet but by fall I believe there's another liver conference around October we may get the Prove 1 and 2 trial results. We should also soon see the shape of the FDA approved Phase III trials if all goes well.
I know that this is a "Vertex" thread but any of the new drugs that may be added to the mix won't just be "another drug" added to SOC. It may be another additional 5 or 10% SVR rate added to what could become a tolerably successful and short(er) treatment.
I myself, have great hopes for this and other new drugs in the pipeline.
Willy
1) A treatment duration that is cut about in half. That means 24 weeks LESS of interferon and ribiviren treatment for most of us (unless we are some treatment failures who are facing 72 weeks of TX now).
2) A treatment which may come close to doubling the SVR rate. Even if it were only a 60% compared to todays 40ish percent for genotype 1"s....would that be so bad particularly when coupled with a shorter treatment?
3) New hope for people who have taken treatment over and over and who have failed over and over. These folks may be on the threshold of clearing or staying clear. Something a bit stronger or that helps them clear a bit faster may indeed be just enough to get them to SVR this time. It could save many, many lives. Just a few days ago another one of us died who could not be cured with conventional treatment as it now stands. An improved treatment a few years ago might have been a silver bullet for them and how many other heppers who have since died?
4) The webcast mentioned that TVR and interferon alone (no ribiviren arm Prove 2) did a better job of clearing the virus than existing SOC. That also suggests that some people who CAN'T do ribiviren may also have some new hope for being cured. They may not yet be done fiddling with the ribiviren; there could come a time where one ceased or tapered off without needing 24 straight weeks of it
5) We may at some point see the results of new viral kinetics which might allow doctors to sort people into groups that determine the type and duration of treatment they need. For instance if they can sort out the super responders they may be able to treat some people for less time than the 24 weeks. Already they proved in Prove 1 that nearly 40% of those that RVR'ed (cleared by week 4 and maintained that status) SVR'ed. They did this without ANY "rescue drugs". This was only in Phase II trials. Might they be able to improve that? (I think and hope so. : ) )
A silver bullet or miracle drug? Perhaps not, but whatever drug, compound, treatment or protocol that comes along and helps is surely to be appreciated. We've seen little snippets and great results from this drug trial. There's been a lot of speculation and there will be for a while yet but by fall I believe there's another liver conference around October we may get the Prove 1 and 2 trial results. We should also soon see the shape of the FDA approved Phase III trials if all goes well.
I know that this is a "Vertex" thread but any of the new drugs that may be added to the mix won't just be "another drug" added to SOC. It may be another additional 5 or 10% SVR rate added to what could become a tolerably successful and short(er) treatment.
I myself, have great hopes for this and other new drugs in the pipeline.
Willy
Elaine,
I didn't see your original text regarding the possible exclusion of ribavirin. In the PROVE 3 trial, there is an arm of the trial which is not blinded. This is Group C which does not include ribavirin. Perhaps this or one of the other PROVE trials is where you derived that information.
In PROVE 3, the Arms are as follows:
Group A. - Control Group - Placebo/Peg/Copeg for 24-weeks, then, Peg/Copeg for an additional 24-weeks
Group B - Telaprevir/Peg/Copeg for 24-weeks, then, Peg/Copeg for an additional 24-weeks.
Group C - Telaprevir/Peg for 24-weeks (not blinded)
Group D - Telaprevir/Peg/Copeg for 12-weeks, then, PlaceboPeg/Copeg for an additional 12-weeks.
Take care,
Steve
I didn't see your original text regarding the possible exclusion of ribavirin. In the PROVE 3 trial, there is an arm of the trial which is not blinded. This is Group C which does not include ribavirin. Perhaps this or one of the other PROVE trials is where you derived that information.
In PROVE 3, the Arms are as follows:
Group A. - Control Group - Placebo/Peg/Copeg for 24-weeks, then, Peg/Copeg for an additional 24-weeks
Group B - Telaprevir/Peg/Copeg for 24-weeks, then, Peg/Copeg for an additional 24-weeks.
Group C - Telaprevir/Peg for 24-weeks (not blinded)
Group D - Telaprevir/Peg/Copeg for 12-weeks, then, PlaceboPeg/Copeg for an additional 12-weeks.
Take care,
Steve
im in prove 1 (12 weeks vx/inf/riba followed by another 36 weeks soc). last shot will be july 6. needless to say, it's been a difficult year. but, if i have increased my odds of svr to 80%, which i'm convinced the vx will do, it will have been worth it to me. data from the 6 month group should be out some time in september. hopefully 12 months of tx won't be necessary anymore, which is my hunch. i also have a hunch that riba will need to be in the mix. to me vx has been about increasing my odds for a "cure", plain & simple.
I guess the way I look at it, it's an expectation thing...at first I was hoping it was a magic bullet (who wasn't?) but then I guess....oftentimes there's a glass of cold water that comes with high expectations...but even so, I'll take any improvement on a theme that I can get, even if all it indicates is a great promise of higher SVR rates, and shorter treatment times...though it comes with the old soc...
maybe the way it's panning out, they'll only give it to you at the beginning of treatment, to help clear it up fast...like someone said, better then a stick in the eye...
maybe the way it's panning out, they'll only give it to you at the beginning of treatment, to help clear it up fast...like someone said, better then a stick in the eye...
The following interesting information posted In a publication last week at www.hcvadvocate.org,
HEPATITIS JOURNAL REVIEW:
A Bi-Monthly Publication of the Hepatitis Support Project
June 15 , 2007
Volume 4, Issue 11
Resistance to Telaprevir
"One such directly targeted agent is the HCV NS34A protease inhibitor telaprevir (VX-950). Telaprevir demonstrates strong antiviral activity, but can lead to the emergence of drug-resistant virus, especially when used as monotherapy. As described in the May 2007 issue of Gastroenterology, C. Sarrazin and colleagues used a highly sensitive sequencing method to assess mutations in the NS3 protease catalytic domain in genotype 1 patients receiving various doses of telaprevir for 14 days. They identified several mutations that conferred low-level resistance (V36A/M, T54A, R155K/T, A156S) and high-level resistance (A156V/T, 36+155, 36+156) to the drug. After telaprevir was discontinued, most resistant variants were replaced by wild-type virus within 3-7 months.
HEPATITIS JOURNAL REVIEW:
A Bi-Monthly Publication of the Hepatitis Support Project
June 15 , 2007
Volume 4, Issue 11
Resistance to Telaprevir
"One such directly targeted agent is the HCV NS34A protease inhibitor telaprevir (VX-950). Telaprevir demonstrates strong antiviral activity, but can lead to the emergence of drug-resistant virus, especially when used as monotherapy. As described in the May 2007 issue of Gastroenterology, C. Sarrazin and colleagues used a highly sensitive sequencing method to assess mutations in the NS3 protease catalytic domain in genotype 1 patients receiving various doses of telaprevir for 14 days. They identified several mutations that conferred low-level resistance (V36A/M, T54A, R155K/T, A156S) and high-level resistance (A156V/T, 36+155, 36+156) to the drug. After telaprevir was discontinued, most resistant variants were replaced by wild-type virus within 3-7 months.
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