Guest guest Posted September 19, 2005 Report Share Posted September 19, 2005 It's probably the IDEAL study. There are two kinds of Pegulated interferons on the market for hepatitis C and both are used in combination with Ribavirin/Copegus. Roche's is called Pegasys and is a larger molecule....stays in the system for 6 weeks, one dose for all. Schering's is called PegIntron....smaller molecule, stays in the system a week.....closer to 6 days actually...and the dose is weight based. The IDEAL study was supposed to be a comparison between the two products to see which one is better (though I feel the comparison is not trully fair since Schering can use higher dose of Riba). HOWEVER.....and this is the thing I wnat you to be aware of....the FDA also requested that another arm be added to the study to compare 2 doses of PegIntron.....that means that out of the people wqho get PegIntron, some will get what is considered the optimal dose of 1.5mg/Kg and another group will get 1.0mg/Kg which may not be enough to get people to clear. At 12 weeks, if you get at least a 2 log drop then you are allowed to continue......but if you don't then you will be terminated from the study. What's a 2 log drop? let's say that you start with a viral load of 1,000,000 then a 2 log drop....you remove the last two zeros and that leaves 10,000. You really need to know this things when you enroll in a study...then you can make an informed decision. Let me know if you have any questions. Silvia > > Hello everyone, > > I am relatively new to the group (signed up just a couple of weeks > ago > > or less.) I do not really remember and that is another issue I > will > > explain later. The postings have been so helpful and informative > to > > explain some of the issues I am dealing (trying to) with. The > reason > > for my delay is that I had a horse accident the end of May and have > > traumatic brain injury and three broken ribs. This group has been > most > > helpful in sorting out some of the issues related to HCV so that I > can > > know which are more TBI related. Apologizies in advance if I may > send > > info that does not make sense or I repeat info. Please keep up the > > good work of providing helpful information and places to research > so > > that we may come to our own conclusions in an informed manner. > Thank > > you all again! Sorry we are here, but glad to be in such good > > company! Kathy in SC > > > > > > > > > > It's a pleasure having you join in our conversations. We hope you > have found the support you need with us. > > > > If you are using email for your posts, for easy access to our > group, just click the link-- > http://groups.yahoo.com/group/Hepatitis_C_Central/ > > > > Happy Posting > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2005 Report Share Posted September 19, 2005 It's probably the IDEAL study. There are two kinds of Pegulated interferons on the market for hepatitis C and both are used in combination with Ribavirin/Copegus. Roche's is called Pegasys and is a larger molecule....stays in the system for 6 weeks, one dose for all. Schering's is called PegIntron....smaller molecule, stays in the system a week.....closer to 6 days actually...and the dose is weight based. The IDEAL study was supposed to be a comparison between the two products to see which one is better (though I feel the comparison is not trully fair since Schering can use higher dose of Riba). HOWEVER.....and this is the thing I wnat you to be aware of....the FDA also requested that another arm be added to the study to compare 2 doses of PegIntron.....that means that out of the people wqho get PegIntron, some will get what is considered the optimal dose of 1.5mg/Kg and another group will get 1.0mg/Kg which may not be enough to get people to clear. At 12 weeks, if you get at least a 2 log drop then you are allowed to continue......but if you don't then you will be terminated from the study. What's a 2 log drop? let's say that you start with a viral load of 1,000,000 then a 2 log drop....you remove the last two zeros and that leaves 10,000. You really need to know this things when you enroll in a study...then you can make an informed decision. Let me know if you have any questions. Silvia > > Hello everyone, > > I am relatively new to the group (signed up just a couple of weeks > ago > > or less.) I do not really remember and that is another issue I > will > > explain later. The postings have been so helpful and informative > to > > explain some of the issues I am dealing (trying to) with. The > reason > > for my delay is that I had a horse accident the end of May and have > > traumatic brain injury and three broken ribs. This group has been > most > > helpful in sorting out some of the issues related to HCV so that I > can > > know which are more TBI related. Apologizies in advance if I may > send > > info that does not make sense or I repeat info. Please keep up the > > good work of providing helpful information and places to research > so > > that we may come to our own conclusions in an informed manner. > Thank > > you all again! Sorry we are here, but glad to be in such good > > company! Kathy in SC > > > > > > > > > > It's a pleasure having you join in our conversations. We hope you > have found the support you need with us. > > > > If you are using email for your posts, for easy access to our > group, just click the link-- > http://groups.yahoo.com/group/Hepatitis_C_Central/ > > > > Happy Posting > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2005 Report Share Posted September 19, 2005 It's probably the IDEAL study. There are two kinds of Pegulated interferons on the market for hepatitis C and both are used in combination with Ribavirin/Copegus. Roche's is called Pegasys and is a larger molecule....stays in the system for 6 weeks, one dose for all. Schering's is called PegIntron....smaller molecule, stays in the system a week.....closer to 6 days actually...and the dose is weight based. The IDEAL study was supposed to be a comparison between the two products to see which one is better (though I feel the comparison is not trully fair since Schering can use higher dose of Riba). HOWEVER.....and this is the thing I wnat you to be aware of....the FDA also requested that another arm be added to the study to compare 2 doses of PegIntron.....that means that out of the people wqho get PegIntron, some will get what is considered the optimal dose of 1.5mg/Kg and another group will get 1.0mg/Kg which may not be enough to get people to clear. At 12 weeks, if you get at least a 2 log drop then you are allowed to continue......but if you don't then you will be terminated from the study. What's a 2 log drop? let's say that you start with a viral load of 1,000,000 then a 2 log drop....you remove the last two zeros and that leaves 10,000. You really need to know this things when you enroll in a study...then you can make an informed decision. Let me know if you have any questions. Silvia > > Hello everyone, > > I am relatively new to the group (signed up just a couple of weeks > ago > > or less.) I do not really remember and that is another issue I > will > > explain later. The postings have been so helpful and informative > to > > explain some of the issues I am dealing (trying to) with. The > reason > > for my delay is that I had a horse accident the end of May and have > > traumatic brain injury and three broken ribs. This group has been > most > > helpful in sorting out some of the issues related to HCV so that I > can > > know which are more TBI related. Apologizies in advance if I may > send > > info that does not make sense or I repeat info. Please keep up the > > good work of providing helpful information and places to research > so > > that we may come to our own conclusions in an informed manner. > Thank > > you all again! Sorry we are here, but glad to be in such good > > company! Kathy in SC > > > > > > > > > > It's a pleasure having you join in our conversations. We hope you > have found the support you need with us. > > > > If you are using email for your posts, for easy access to our > group, just click the link-- > http://groups.yahoo.com/group/Hepatitis_C_Central/ > > > > Happy Posting > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2005 Report Share Posted September 19, 2005 HOWEVER.....and this is the thing I wnat you to be aware of....the FDA also requested that another arm be added to the study to compare 2 doses of PegIntron.....that means that out of the people wqho get PegIntron, some will get what is considered the optimal dose of 1.5mg/Kg and another group will get 1.0mg/Kg which may not be enough to get people to clear. THAT should be illegal, to put someone through this tx without enough INF to help them clear.. What are they thinking? silvianursey wrote: It's probably the IDEAL study. There are two kinds of Pegulated interferons on the market for hepatitis C and both are used in combination with Ribavirin/Copegus. Roche's is called Pegasys and is a larger molecule....stays in the system for 6 weeks, one dose for all. Schering's is called PegIntron....smaller molecule, stays in the system a week.....closer to 6 days actually...and the dose is weight based. The IDEAL study was supposed to be a comparison between the two products to see which one is better (though I feel the comparison is not trully fair since Schering can use higher dose of Riba). HOWEVER.....and this is the thing I wnat you to be aware of....the FDA also requested that another arm be added to the study to compare 2 doses of PegIntron.....that means that out of the people wqho get PegIntron, some will get what is considered the optimal dose of 1.5mg/Kg and another group will get 1.0mg/Kg which may not be enough to get people to clear. At 12 weeks, if you get at least a 2 log drop then you are allowed to continue......but if you don't then you will be terminated from the study. What's a 2 log drop? let's say that you start with a viral load of 1,000,000 then a 2 log drop....you remove the last two zeros and that leaves 10,000. You really need to know this things when you enroll in a study...then you can make an informed decision. Let me know if you have any questions. Silvia > > Hello everyone, > > I am relatively new to the group (signed up just a couple of weeks > ago > > or less.) I do not really remember and that is another issue I > will > > explain later. The postings have been so helpful and informative > to > > explain some of the issues I am dealing (trying to) with. The > reason > > for my delay is that I had a horse accident the end of May and have > > traumatic brain injury and three broken ribs. This group has been > most > > helpful in sorting out some of the issues related to HCV so that I > can > > know which are more TBI related. Apologizies in advance if I may > send > > info that does not make sense or I repeat info. Please keep up the > > good work of providing helpful information and places to research > so > > that we may come to our own conclusions in an informed manner. > Thank > > you all again! Sorry we are here, but glad to be in such good > > company! Kathy in SC > > > > > > > > > > It's a pleasure having you join in our conversations. We hope you > have found the support you need with us. > > > > If you are using email for your posts, for easy access to our > group, just click the link-- > http://groups.yahoo.com/group/Hepatitis_C_Central/ > > > > Happy Posting > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2005 Report Share Posted September 19, 2005 HOWEVER.....and this is the thing I wnat you to be aware of....the FDA also requested that another arm be added to the study to compare 2 doses of PegIntron.....that means that out of the people wqho get PegIntron, some will get what is considered the optimal dose of 1.5mg/Kg and another group will get 1.0mg/Kg which may not be enough to get people to clear. THAT should be illegal, to put someone through this tx without enough INF to help them clear.. What are they thinking? silvianursey wrote: It's probably the IDEAL study. There are two kinds of Pegulated interferons on the market for hepatitis C and both are used in combination with Ribavirin/Copegus. Roche's is called Pegasys and is a larger molecule....stays in the system for 6 weeks, one dose for all. Schering's is called PegIntron....smaller molecule, stays in the system a week.....closer to 6 days actually...and the dose is weight based. The IDEAL study was supposed to be a comparison between the two products to see which one is better (though I feel the comparison is not trully fair since Schering can use higher dose of Riba). HOWEVER.....and this is the thing I wnat you to be aware of....the FDA also requested that another arm be added to the study to compare 2 doses of PegIntron.....that means that out of the people wqho get PegIntron, some will get what is considered the optimal dose of 1.5mg/Kg and another group will get 1.0mg/Kg which may not be enough to get people to clear. At 12 weeks, if you get at least a 2 log drop then you are allowed to continue......but if you don't then you will be terminated from the study. What's a 2 log drop? let's say that you start with a viral load of 1,000,000 then a 2 log drop....you remove the last two zeros and that leaves 10,000. You really need to know this things when you enroll in a study...then you can make an informed decision. Let me know if you have any questions. Silvia > > Hello everyone, > > I am relatively new to the group (signed up just a couple of weeks > ago > > or less.) I do not really remember and that is another issue I > will > > explain later. The postings have been so helpful and informative > to > > explain some of the issues I am dealing (trying to) with. The > reason > > for my delay is that I had a horse accident the end of May and have > > traumatic brain injury and three broken ribs. This group has been > most > > helpful in sorting out some of the issues related to HCV so that I > can > > know which are more TBI related. Apologizies in advance if I may > send > > info that does not make sense or I repeat info. Please keep up the > > good work of providing helpful information and places to research > so > > that we may come to our own conclusions in an informed manner. > Thank > > you all again! Sorry we are here, but glad to be in such good > > company! Kathy in SC > > > > > > > > > > It's a pleasure having you join in our conversations. We hope you > have found the support you need with us. > > > > If you are using email for your posts, for easy access to our > group, just click the link-- > http://groups.yahoo.com/group/Hepatitis_C_Central/ > > > > Happy Posting > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2005 Report Share Posted September 19, 2005 HOWEVER.....and this is the thing I wnat you to be aware of....the FDA also requested that another arm be added to the study to compare 2 doses of PegIntron.....that means that out of the people wqho get PegIntron, some will get what is considered the optimal dose of 1.5mg/Kg and another group will get 1.0mg/Kg which may not be enough to get people to clear. THAT should be illegal, to put someone through this tx without enough INF to help them clear.. What are they thinking? silvianursey wrote: It's probably the IDEAL study. There are two kinds of Pegulated interferons on the market for hepatitis C and both are used in combination with Ribavirin/Copegus. Roche's is called Pegasys and is a larger molecule....stays in the system for 6 weeks, one dose for all. Schering's is called PegIntron....smaller molecule, stays in the system a week.....closer to 6 days actually...and the dose is weight based. The IDEAL study was supposed to be a comparison between the two products to see which one is better (though I feel the comparison is not trully fair since Schering can use higher dose of Riba). HOWEVER.....and this is the thing I wnat you to be aware of....the FDA also requested that another arm be added to the study to compare 2 doses of PegIntron.....that means that out of the people wqho get PegIntron, some will get what is considered the optimal dose of 1.5mg/Kg and another group will get 1.0mg/Kg which may not be enough to get people to clear. At 12 weeks, if you get at least a 2 log drop then you are allowed to continue......but if you don't then you will be terminated from the study. What's a 2 log drop? let's say that you start with a viral load of 1,000,000 then a 2 log drop....you remove the last two zeros and that leaves 10,000. You really need to know this things when you enroll in a study...then you can make an informed decision. Let me know if you have any questions. Silvia > > Hello everyone, > > I am relatively new to the group (signed up just a couple of weeks > ago > > or less.) I do not really remember and that is another issue I > will > > explain later. The postings have been so helpful and informative > to > > explain some of the issues I am dealing (trying to) with. The > reason > > for my delay is that I had a horse accident the end of May and have > > traumatic brain injury and three broken ribs. This group has been > most > > helpful in sorting out some of the issues related to HCV so that I > can > > know which are more TBI related. Apologizies in advance if I may > send > > info that does not make sense or I repeat info. Please keep up the > > good work of providing helpful information and places to research > so > > that we may come to our own conclusions in an informed manner. > Thank > > you all again! Sorry we are here, but glad to be in such good > > company! Kathy in SC > > > > > > > > > > It's a pleasure having you join in our conversations. We hope you > have found the support you need with us. > > > > If you are using email for your posts, for easy access to our > group, just click the link-- > http://groups.yahoo.com/group/Hepatitis_C_Central/ > > > > Happy Posting > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2005 Report Share Posted September 19, 2005 Ok I got the idea,, lol,,, silvianursey wrote: Well...the first thing is .....I won't give her vermex...did you know it's used to kill fleas, worms and larvae? > > > Hello everyone, > > > I am relatively new to the group (signed up just a couple of > weeks > > ago > > > or less.) I do not really remember and that is another issue I > > will > > > explain later. The postings have been so helpful and informative > > to > > > explain some of the issues I am dealing (trying to) with. The > > reason > > > for my delay is that I had a horse accident the end of May and > have > > > traumatic brain injury and three broken ribs. This group has been > > most > > > helpful in sorting out some of the issues related to HCV so that > I > > can > > > know which are more TBI related. Apologizies in advance if I may > > send > > > info that does not make sense or I repeat info. Please keep up > the > > > good work of providing helpful information and places to research > > so > > > that we may come to our own conclusions in an informed manner. > > Thank > > > you all again! Sorry we are here, but glad to be in such good > > > company! Kathy in SC > > > > > > > > > > > > > > > It's a pleasure having you join in our conversations. We hope you > > have found the support you need with us. > > > > > > If you are using email for your posts, for easy access to our > > group, just click the link-- > > http://groups.yahoo.com/group/Hepatitis_C_Central/ > > > > > > Happy Posting > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2005 Report Share Posted September 19, 2005 Ok I got the idea,, lol,,, silvianursey wrote: Well...the first thing is .....I won't give her vermex...did you know it's used to kill fleas, worms and larvae? > > > Hello everyone, > > > I am relatively new to the group (signed up just a couple of > weeks > > ago > > > or less.) I do not really remember and that is another issue I > > will > > > explain later. The postings have been so helpful and informative > > to > > > explain some of the issues I am dealing (trying to) with. The > > reason > > > for my delay is that I had a horse accident the end of May and > have > > > traumatic brain injury and three broken ribs. This group has been > > most > > > helpful in sorting out some of the issues related to HCV so that > I > > can > > > know which are more TBI related. Apologizies in advance if I may > > send > > > info that does not make sense or I repeat info. Please keep up > the > > > good work of providing helpful information and places to research > > so > > > that we may come to our own conclusions in an informed manner. > > Thank > > > you all again! Sorry we are here, but glad to be in such good > > > company! Kathy in SC > > > > > > > > > > > > > > > It's a pleasure having you join in our conversations. We hope you > > have found the support you need with us. > > > > > > If you are using email for your posts, for easy access to our > > group, just click the link-- > > http://groups.yahoo.com/group/Hepatitis_C_Central/ > > > > > > Happy Posting > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 20, 2005 Report Share Posted September 20, 2005 Come on Jackie....it's done all the time. How about all the studies that have placebo. It's a comparison study. It is up to us to ask questions. Silvia > > > Hello everyone, > > > I am relatively new to the group (signed up just a couple of > weeks > > ago > > > or less.) I do not really remember and that is another issue I > > will > > > explain later. The postings have been so helpful and informative > > to > > > explain some of the issues I am dealing (trying to) with. The > > reason > > > for my delay is that I had a horse accident the end of May and > have > > > traumatic brain injury and three broken ribs. This group has been > > most > > > helpful in sorting out some of the issues related to HCV so that > I > > can > > > know which are more TBI related. Apologizies in advance if I may > > send > > > info that does not make sense or I repeat info. Please keep up > the > > > good work of providing helpful information and places to research > > so > > > that we may come to our own conclusions in an informed manner. > > Thank > > > you all again! Sorry we are here, but glad to be in such good > > > company! Kathy in SC > > > > > > > > > > > > > > > It's a pleasure having you join in our conversations. We hope you > > have found the support you need with us. > > > > > > If you are using email for your posts, for easy access to our > > group, just click the link-- > > http://groups.yahoo.com/group/Hepatitis_C_Central/ > > > > > > Happy Posting > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
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