Aa
Vertex Telaprevir EASL info: 68%
Yippee!
From an Australian paper:
RADICALLY improved treatments for one of the world's worst health scourges are looking more likely after scientists reported patients were cured more quickly and more often if an experimental new drug was added to the normal therapy.
http://tinyurl.com/6ctjkq
Excerpt from a financial article at the Motley Fool:
Yesterday, at the European Association for the Study of the Liver (EASL) conference, Vertex reported heartening new clinical trial data for its lead drug, telaprevir.
Vertex dispelled any ambiguity about the PROVE-2 results. Its new efficacy data showed that 68% of telaprevir-treated patients were ultimately cured of hepatitis C, compared to only 48% of patients in the control group. Obviously, that's a far more promising outcome, and it matches PROVE-1's 20-percentage-point improvement on current treatments' cure rates.
http://tinyurl.com/6xc2ry
And I bet the late breaker news on boceprevir and others will be good as well. The 2011 is a bummer to read...I am barreling down the road toward treatment, but if I fail at least there is hope for a Plan B now.
From an Australian paper:
RADICALLY improved treatments for one of the world's worst health scourges are looking more likely after scientists reported patients were cured more quickly and more often if an experimental new drug was added to the normal therapy.
http://tinyurl.com/6ctjkq
Excerpt from a financial article at the Motley Fool:
Yesterday, at the European Association for the Study of the Liver (EASL) conference, Vertex reported heartening new clinical trial data for its lead drug, telaprevir.
Vertex dispelled any ambiguity about the PROVE-2 results. Its new efficacy data showed that 68% of telaprevir-treated patients were ultimately cured of hepatitis C, compared to only 48% of patients in the control group. Obviously, that's a far more promising outcome, and it matches PROVE-1's 20-percentage-point improvement on current treatments' cure rates.
http://tinyurl.com/6xc2ry
And I bet the late breaker news on boceprevir and others will be good as well. The 2011 is a bummer to read...I am barreling down the road toward treatment, but if I fail at least there is hope for a Plan B now.
I've been waiting to read about the fallout from EASL. It appears that the news stories are beginning to trickle out about comparing Telaprevir to Boceprevir. The consensus seems to be that Vertex is still in the lead. In my opinion they are significantly so.
They seem to have the strongest proven efficacy.
To date with lots of data they have proven that they can effectively halve the treatment time WHILE increasing the SVR about half again over SOC.
They are on track to be first to market.
They may actually have a shot at using the Prove 3 treatment failures trial as a registration trial. That means that when the results of Prove 3 are all in (In only about a month) they can submit the data to the FDA and say; this is the only treatment that exists for prior treatment failures that improves response rates significantly better than SOC. The FDA could decide to rapidly approve the drug combo for treatment failures. It is conceivable that the drug could be approved (and only for past TX failures) fairly soon. The retreatment SVR rate for past SOC failures is generally thought to be in the single digits. Vertex could bring this much much higher and likely in a shorter period of time.
Yes, it's true that triple therapy may not be without it's dangers. SOC is dangerous enough as it is; read the black label warnings on the treatment that come with the drugs. Read the boards; there are threads about many TX related post treatment side effects; auto-immune disorders, IBS, CFS, dental issues, metabolic issues, depression, persistent pain which follows TX. I am not trying to be critical of SOC but I am saying that it is not without it's inherent problems. I am excited that a drug compound is soon to be available which could at the minimum halve our exposure to interferon and ribaviren. The new Phase 3 trial will have one arm in which the participants have only 8 weeks of triple therapy followed by 16 weeks of SOC.
IF there is little difference between response rates between the "8 & 16" compared to the "12 &12" then one could conclude that an even shorter course of triple therapy could be needed. One might not even need to treat for 24 weeks. The results of this trial won't be out for quite some time but I would venture a guess that some phase 3 trial participants will be posting here and you could get a preview WELL before the trial concludes. Obviously, a shorter triple therapy course of treatment should be safer, have fewer rash issues while still netting a shorter SOC couse of treatment.
I believe that triple therapy may prove to be safer and healthier than some of the enduro treatments we are now faced with. The new results are showing that ever so called "null responders" do indeed respond with tremendous rapid viral load reductions. A question that remains is if the viral load can be rapidly brought down whether standard SOC can take them the rest of the way home.
By the Fall liver conference (AASLD) I think there may be answers to a few of these questions.
Best,
Willy
They seem to have the strongest proven efficacy.
To date with lots of data they have proven that they can effectively halve the treatment time WHILE increasing the SVR about half again over SOC.
They are on track to be first to market.
They may actually have a shot at using the Prove 3 treatment failures trial as a registration trial. That means that when the results of Prove 3 are all in (In only about a month) they can submit the data to the FDA and say; this is the only treatment that exists for prior treatment failures that improves response rates significantly better than SOC. The FDA could decide to rapidly approve the drug combo for treatment failures. It is conceivable that the drug could be approved (and only for past TX failures) fairly soon. The retreatment SVR rate for past SOC failures is generally thought to be in the single digits. Vertex could bring this much much higher and likely in a shorter period of time.
Yes, it's true that triple therapy may not be without it's dangers. SOC is dangerous enough as it is; read the black label warnings on the treatment that come with the drugs. Read the boards; there are threads about many TX related post treatment side effects; auto-immune disorders, IBS, CFS, dental issues, metabolic issues, depression, persistent pain which follows TX. I am not trying to be critical of SOC but I am saying that it is not without it's inherent problems. I am excited that a drug compound is soon to be available which could at the minimum halve our exposure to interferon and ribaviren. The new Phase 3 trial will have one arm in which the participants have only 8 weeks of triple therapy followed by 16 weeks of SOC.
IF there is little difference between response rates between the "8 & 16" compared to the "12 &12" then one could conclude that an even shorter course of triple therapy could be needed. One might not even need to treat for 24 weeks. The results of this trial won't be out for quite some time but I would venture a guess that some phase 3 trial participants will be posting here and you could get a preview WELL before the trial concludes. Obviously, a shorter triple therapy course of treatment should be safer, have fewer rash issues while still netting a shorter SOC couse of treatment.
I believe that triple therapy may prove to be safer and healthier than some of the enduro treatments we are now faced with. The new results are showing that ever so called "null responders" do indeed respond with tremendous rapid viral load reductions. A question that remains is if the viral load can be rapidly brought down whether standard SOC can take them the rest of the way home.
By the Fall liver conference (AASLD) I think there may be answers to a few of these questions.
Best,
Willy
While these results appear hopefull on the surface, I also think people have to be a bit careful in assuming that this represents a better treatment just around the corner. For some people who have failed SOC, then yes, this could be the answer. But as to whether it is worthwhile to add another drug to the mix, that also has side effects (some of which we may not yet know), in the hope that will enable a shorter treatment period, I think the jury still remains out as to whether it is worth it. For some people, it may not be. The protocol may end up, try SOC first, see if you are RVR, and if not, restart a month later with this new treatment. The ideal protocol will probably take years to work out, just as it has with SOC.
Lets face it, people are struggling on our boards with SOC as it is. I'm not yet convinced that adding another drug, which results in a slightly higher response rate but more sides, is going to be as meaningful as some expect. Yes, it will help some. But, my fear, is that things like the "rash" may just scare more people away from treatment.
Lets face it, people are struggling on our boards with SOC as it is. I'm not yet convinced that adding another drug, which results in a slightly higher response rate but more sides, is going to be as meaningful as some expect. Yes, it will help some. But, my fear, is that things like the "rash" may just scare more people away from treatment.
The three doses have to be 8 hours apart. In my case that meant 8am 4pm and midnight. You are supposed to take it with 300 calories of food and eating that much at midnight was a pain for me.
I did discover Dove Unconditional Chocolate and that sure improved things -- LOL.
Eric
I did discover Dove Unconditional Chocolate and that sure improved things -- LOL.
Eric
It says 2010.
RADICALLY improved treatments for one of the world's worst health scourges are looking more likely after scientists reported patients were cured more quickly and more often if an experimental new drug was added to the normal therapy.
More than 180 million people worldwide, including 250,000 in Australia, are infected with the hepatitis C virus, which, if untreated, can lead to liver cirrhosis and cancer. Currently the only treatment is a 48-week course of two drugs, pegylated (or slow-release) interferon and ribavirin, which are notorious for causing a "brain fog" that makes it hard for people to stay at work.
Results from two studies presented to a European conference of liver specialists show that when a new drug called telaprevir was taken alongside the usual drugs for the first 12 weeks of treatment, the success rate increased from 41per cent of treated patients to 61per cent. More significantly, the treatment time for those given telaprevir was halved from 48weeks to 24 weeks.
In a separate but related study due to be presented last night, the success rate for patients given telaprevir rose to 68per cent.
Telaprevir is the most advanced of a new class of drugs for hepatitisC infection called protease inhibitors, which work by blocking a key stage of the virus's replication cycle.
Presenting the findings at the conference of the European Association for the Study of the Liver in Milan, John McHutchison, the Melbourne-trained lead investigator and professor of medicine at Duke University in the US, said that if these results were borne out in a larger trial about to start, the drug had the "potential to halve treatment duration in most subjects".
"This is a very big step forward," Professor McHutchison told The Weekend Australian. "If this goes well in phase III trials (about to start), we will be able to decrease the duration of therapy from a year to six months. This is a huge advance - but we have still got our hurdles."
Professor McHutchison said side effects from telaprevir were an issue and included an itchy rash and anaemia. As a result, more patients dropped out of telaprevir-based treatment (18 per cent) compared with normal therapy (4 per cent).
Australian experts at the conference welcomed the results as "absolutely exciting". Greg Dore, head of the viral hepatitis clinical research program at the Sydney-based National Centre in HIV Epidemiology and Clinical Research, said that although there was some additional toxicity from telaprevir, its ability to halve treatment time would be a huge benefit.
Neil Graham, the Adelaide-trained doctor who is leading the hepatitis C program for telaprevir's maker, Boston-based drug company Vertex, said that if subsequent trials went well, an application to register the drug could be lodged with US regulators in 2010.
RADICALLY improved treatments for one of the world's worst health scourges are looking more likely after scientists reported patients were cured more quickly and more often if an experimental new drug was added to the normal therapy.
More than 180 million people worldwide, including 250,000 in Australia, are infected with the hepatitis C virus, which, if untreated, can lead to liver cirrhosis and cancer. Currently the only treatment is a 48-week course of two drugs, pegylated (or slow-release) interferon and ribavirin, which are notorious for causing a "brain fog" that makes it hard for people to stay at work.
Results from two studies presented to a European conference of liver specialists show that when a new drug called telaprevir was taken alongside the usual drugs for the first 12 weeks of treatment, the success rate increased from 41per cent of treated patients to 61per cent. More significantly, the treatment time for those given telaprevir was halved from 48weeks to 24 weeks.
In a separate but related study due to be presented last night, the success rate for patients given telaprevir rose to 68per cent.
Telaprevir is the most advanced of a new class of drugs for hepatitisC infection called protease inhibitors, which work by blocking a key stage of the virus's replication cycle.
Presenting the findings at the conference of the European Association for the Study of the Liver in Milan, John McHutchison, the Melbourne-trained lead investigator and professor of medicine at Duke University in the US, said that if these results were borne out in a larger trial about to start, the drug had the "potential to halve treatment duration in most subjects".
"This is a very big step forward," Professor McHutchison told The Weekend Australian. "If this goes well in phase III trials (about to start), we will be able to decrease the duration of therapy from a year to six months. This is a huge advance - but we have still got our hurdles."
Professor McHutchison said side effects from telaprevir were an issue and included an itchy rash and anaemia. As a result, more patients dropped out of telaprevir-based treatment (18 per cent) compared with normal therapy (4 per cent).
Australian experts at the conference welcomed the results as "absolutely exciting". Greg Dore, head of the viral hepatitis clinical research program at the Sydney-based National Centre in HIV Epidemiology and Clinical Research, said that although there was some additional toxicity from telaprevir, its ability to halve treatment time would be a huge benefit.
Neil Graham, the Adelaide-trained doctor who is leading the hepatitis C program for telaprevir's maker, Boston-based drug company Vertex, said that if subsequent trials went well, an application to register the drug could be lodged with US regulators in 2010.
Why do you feel that dosing twice a day is better than 3x in a 24 hour period?
Thanks!
jasper
Thanks!
jasper
I think that Telaprevir is such a substantial improvement over SOC that it will be approved before 2011. Vertex is filing for approval for treatment failures bypassing phase 3 trials. |They are using data from Prove 3. If you listened to the latest presentation on the website, you will see some impressive numbers for relapsers, non - responders and null responders.
The phase three trial will have rescue drugs and a dermatologist to treat the rash, so the numbers will improve substantially again, since here will be fewer dropouts.
This is an emotional topic for me, so sorry if I appear antagonistic. Those of us that are stage 3 have no time to wait and this drug appears to have a good chance of treating many of the people that had no chance with SOC.
Right now, the latest data suggests 60 -68 percent SVR rates. That will improve when the move to twice daily dosing and provide rescue drugs and help with the rash.
The phase three trial will have rescue drugs and a dermatologist to treat the rash, so the numbers will improve substantially again, since here will be fewer dropouts.
This is an emotional topic for me, so sorry if I appear antagonistic. Those of us that are stage 3 have no time to wait and this drug appears to have a good chance of treating many of the people that had no chance with SOC.
Right now, the latest data suggests 60 -68 percent SVR rates. That will improve when the move to twice daily dosing and provide rescue drugs and help with the rash.
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