Re: Telaprevir - Likely To Be Fast-Tracked - Gloria

[Guest guest]

if it is like my trial if you are undetectable at week 4 it is 24 weeks, otherwise it is 48 weeks. Also(I think) if not undetectable at 12 weeks, but 2 log drop (and responding) I think the treatment is 72 week treatments. From: Gloria <gadamscan@...> Sent: Wed, August 11, 2010 6:44:12 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

DonThanks for the applaud; but, we actually did it for ourselves. I didn't actually begin to understand how much my success could possibly mean until I came to this site.However, please don't lean too hard on that 24 week thing. My sister-in-law was treatment naive going into the clinical that she was on and although I never learned what the actual reason was, they bumped her to the 48 weeks pretty quick. I think it was something to do with the platelets!!Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to Vertex because it helps differentiate telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

I really hope the treatment in general gets cut in half for everybody`-` 24 weeks is so much better than 48 weeks!The place I go is doign a trail (I think) with Telaprevir soon. From: Christ <ludichrist2000@...> Sent:

Wed, August 11, 2010 6:12:45 PMSubject: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to Vertex because it helps differentiate telaprevir from its main competition at this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

No I am not it is a study drug from Roche RO something, I can post some info about the study if you are interestedny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:30:35 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

I thought that you were on a trial with Teleprevir???

I really hope the treatment in general gets cut in half for everybody`-` 24 weeks is so much better than 48 weeks!The place I go is doign a trail (I think) with Telaprevir soon. From: Christ <ludichrist2000> Sent:

Wed, August 11, 2010 6:12:45 PMSubject: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to Vertex because it helps differentiate telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

Yeah if talking with the doctor, you would think that the viral load is the only thing that matters, I know it is important but the HGB going down WBC & RBS & platteles going down too are important too.I will find out next Thursday about this, I think I read something in the paper I have about 80 weeks too, so I think there are all kinds of dates depending on how well you respond. I will let you know after the next doc visit. I hope I don't have to do 72 weeks, but if that is what it takes I will!yeah the emotional part of tx is tough, I so know what you mean.the part of the weight loss does not bother me, as I needed to lose some. I think loosing so much so quickly is not good though From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:29:47 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Holy nyIf that is what they are doing, then no wonder you were so concerned about the "logs". I've never heard of it done that way - not even in the articles that I've read, that Don supplies us.Truthfully, I don't think that I could possibly have gone on for 72 weeks. This past tx definitely played hard ball with my emotions!! I loved the weight loss; but, the emotional part was bad.Gloria

if it is like my trial if you are undetectable at week 4 it is 24 weeks, otherwise it is 48 weeks. Also(I think) if not undetectable at 12 weeks, but 2 log drop (and responding) I think the treatment is 72 week treatments. From: Gloria <gadamscan (DOT) ca> Sent: Wed, August 11, 2010 6:44:12 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

DonThanks for the applaud; but, we actually did it for ourselves. I didn't actually begin to understand how much my success could possibly mean until I came to this site.However, please don't lean too hard on that 24 week thing. My sister-in-law was treatment naive going into the clinical that she was on and although I never learned what the actual reason was, they bumped her to the 48 weeks pretty quick. I think it was something to do with the platelets!!Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to Vertex because it helps differentiate

telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

I'd like that ny - can't imagine that they are just studying the accepted standard for tx, so it would be interesting to understand what clinical you are on.Gloria

No I am not it is a study drug from Roche RO something, I can post some info about the study if you are interestedny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:30:35 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" -

Gloria

I thought that you were on a trial with Teleprevir???

I really hope the treatment in general gets cut in half for everybody`-` 24 weeks is so much better than 48 weeks!The place I go is doign a trail (I think) with Telaprevir soon. From: Christ <ludichrist2000> Sent:

Wed, August 11, 2010 6:12:45 PMSubject: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to Vertex because it helps differentiate

telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

Yes, I think that the point to the clinical trials is to find out something new, improve the sides, time of tx, something, otherwise there is no point to it if they are just doing the standard tx.I will post some info I have. here is something for now the clinical trial page:http://clinicaltrials.gov/ct2/show/NCT01057667?term=RO5024048 & rank=2ny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 8:20:59 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

I'd like that ny - can't imagine that they are just studying the accepted standard for tx, so it would be interesting to understand what clinical you are on.Gloria

No I am not it is a study drug from Roche RO something, I can post some info about the study if you are interestedny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:30:35 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" -

Gloria

I thought that you were on a trial with Teleprevir???

I really hope the treatment in general gets cut in half for everybody`-` 24 weeks is so much better than 48 weeks!The place I go is doign a trail (I think) with Telaprevir soon. From: Christ <ludichrist2000> Sent:

Wed, August 11, 2010 6:12:45 PMSubject: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to Vertex because it helps differentiate

telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

nyNo matter what, my viral load was only taken every 3 months. I think the test for it, is a tad costly, so our system probably doesn't cover it more than that. Of course, I was never going to be told anything about the viral load or the log drops, because mine was a blinded study. However, just the very fact that I was still on tx, first past the 12th week, then the 24th and finally the 36th week - then I knew that I had responded and so they confirmed it. Honestly, on my 1st round of tx, my emotions were on a much slower roller coaster ride, than this last one. Just goes to show that tx can be different for the same person.I'm now at a spot that I have to watch putting back any weight. I could have easily dropped another 20 lbs and still

not be classified thin. So, I'm really going to start to fight with my sweet tooth and do a lot more juicing for it's benefits.Gloria

Yeah if talking with the doctor, you would think that the viral load is the only thing that matters, I know it is important but the HGB going down WBC & RBS & platteles going down too are important too.I will find out next Thursday about this, I think I read something in the paper I have about 80 weeks too, so I think there are all kinds of dates depending on how well you respond. I will let you know after the next doc visit. I hope I don't have to do 72 weeks, but if that is what it takes I will!yeah the emotional part of tx is tough, I so know what you mean.the part of the weight loss does not bother me, as I needed to lose some. I think loosing so much so quickly is not good though From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:29:47 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Holy nyIf that is what they are doing, then no wonder you were so concerned about the "logs". I've never heard of it done that way - not even in the articles that I've read, that Don supplies us.Truthfully, I don't think that I could possibly have gone on for 72 weeks. This past tx definitely played hard ball with my emotions!! I loved the weight loss; but, the emotional part was bad.Gloria

if it is like my trial if you are undetectable at week 4 it is 24 weeks, otherwise it is 48 weeks. Also(I think) if not undetectable at 12 weeks, but 2 log drop (and responding) I think the treatment is 72 week treatments. From: Gloria <gadamscan (DOT) ca> Sent: Wed, August 11, 2010 6:44:12 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

DonThanks for the applaud; but, we actually did it for ourselves. I didn't actually begin to understand how much my success could possibly mean until I came to this site.However, please don't lean too hard on that 24 week thing. My sister-in-law was treatment naive going into the clinical that she was on and although I never learned what the actual reason was, they bumped her to the 48 weeks pretty quick. I think it was something to do with the platelets!!Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to

Vertex because it helps differentiate

telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

Wow ny, this is a double blind test. Meaning neither you nor your doctor know if you are getting the third drug or not and they are only using patients who have not gone thru tx before... Wonder what drug this is? It will be cool to find out at the end which trial it was. That's some cool stuff there.Hugs,Teri From: Barrett <barrjohnm@...> Sent: Fri, August 13, 2010 1:26:47 AMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Yes, I think that the point to the clinical trials is to find out something new, improve the sides, time of tx, something, otherwise there is no point to it if they are just doing the standard tx.I will post some info I have. here is something for now the clinical trial page:http://clinicaltrials.gov/ct2/show/NCT01057667?term=RO5024048 & rank=2ny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 8:20:59 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

I'd like that ny - can't imagine that they are just studying the accepted standard for tx, so it would be interesting to understand what clinical you are on.Gloria

No I am not it is a study drug from Roche RO something, I can post some info about the study if you are interestedny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:30:35 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" -

Gloria

I thought that you were on a trial with Teleprevir???

I really hope the treatment in general gets cut in half for everybody`-` 24 weeks is so much better than 48 weeks!The place I go is doign a trail (I think) with Telaprevir soon. From: Christ <ludichrist2000> Sent:

Wed, August 11, 2010 6:12:45 PMSubject: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to Vertex because it helps differentiate

telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

OK, it still looks like a clinical trial by the other company (not Vertex). Perhaps that RO5.... is a Protease Inhibitor and then again, perhaps it's something else.Have you been taking those extra pills???Gloria

Yes, I think that the point to the clinical trials is to find out something new, improve the sides, time of tx, something, otherwise there is no point to it if they are just doing the standard tx.I will post some info I have. here is something for now the clinical trial page:http://clinicaltrials.gov/ct2/show/NCT01057667?term=RO5024048 & rank=2ny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 8:20:59 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

I'd like that ny - can't imagine that they are just studying the accepted standard for tx, so it would be interesting to understand what clinical you are on.Gloria

No I am not it is a study drug from Roche RO something, I can post some info about the study if you are interestedny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:30:35 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" -

Gloria

I thought that you were on a trial with Teleprevir???

I really hope the treatment in general gets cut in half for everybody`-` 24 weeks is so much better than 48 weeks!The place I go is doign a trail (I think) with Telaprevir soon. From: Christ <ludichrist2000> Sent:

Wed, August 11, 2010 6:12:45 PMSubject: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to

Vertex because it helps differentiate

telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

yes, the doctor said she does not know either and will not know until week 22. yes this trial you could not have gone through tx before, and for some reason they wanted hard cases & high viral loads(advance HCV fibruios & curious), not sure why. isn't treatment the same for all stages a tiny bit or advance chirious?I will let you know when I know, I am curious to know which one it is.ny From: Teri Gottlieb <theresagottlieb@...> Sent: Thu, August 12, 2010 8:44:40 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Wow ny, this is a double blind test. Meaning neither you nor your doctor know if you are getting the third drug or not and they are only using patients who have not gone thru tx before... Wonder what drug this is? It will be cool to find out at the end which trial it was. That's some cool stuff there.Hugs,Teri From: Barrett <barrjohnm@...> Sent: Fri, August 13, 2010 1:26:47 AMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Yes, I think that the point to the clinical trials is to find out something new, improve the sides, time of tx, something, otherwise there is no point to it if they are just doing the standard tx.I will post some info I have. here is something for now the clinical trial page:http://clinicaltrials.gov/ct2/show/NCT01057667?term=RO5024048 & rank=2ny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 8:20:59 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

I'd like that ny - can't imagine that they are just studying the accepted standard for tx, so it would be interesting to understand what clinical you are on.Gloria

No I am not it is a study drug from Roche RO something, I can post some info about the study if you are interestedny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:30:35 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" -

Gloria

I thought that you were on a trial with Teleprevir???

I really hope the treatment in general gets cut in half for everybody`-` 24 weeks is so much better than 48 weeks!The place I go is doign a trail (I think) with Telaprevir soon. From: Christ <ludichrist2000> Sent:

Wed, August 11, 2010 6:12:45 PMSubject: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to Vertex because it helps differentiate

telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

LOL of course he is - I wasn't thinking

Gloria, He would have extra pills either way.. Either real ones or placebo's... ny, are the pills that aren't the Riba's a tablet or a capsule or something else... coated?Hugs,Teri From: Gloria <gadamscan@...> Sent: Fri, August 13, 2010 1:55:04 AMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

OK, it still looks like a clinical trial by the other company (not Vertex). Perhaps that RO5.... is a Protease Inhibitor and then again, perhaps it's something else.Have you been taking those extra pills???Gloria

Yes, I think that the point to the clinical trials is to find out something new, improve the sides, time of tx, something, otherwise there is no point to it if they are just doing the standard tx.I will post some info I have. here is something for now the clinical trial page:http://clinicaltrials.gov/ct2/show/NCT01057667?term=RO5024048 & rank=2ny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 8:20:59 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

I'd like that ny - can't imagine that they are just studying the accepted standard for tx, so it would be interesting to understand what clinical you are on.Gloria

No I am not it is a study drug from Roche RO something, I can post some info about the study if you are interestedny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:30:35 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" -

Gloria

I thought that you were on a trial with Teleprevir???

I really hope the treatment in general gets cut in half for everybody`-` 24 weeks is so much better than 48 weeks!The place I go is doign a trail (I think) with Telaprevir soon. From: Christ <ludichrist2000> Sent:

Wed, August 11, 2010 6:12:45 PMSubject: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to

Vertex because it helps differentiate

telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

nyIt sounds to me like you are where I was when I did my 1st round of treatment. A fairly high viral load; but, more important was that I was at that Stage 3 hovering at Stage 4 and with the geno type 1B. In 2004 I don't believe that they knew yet, just how hard it was going to be to treat someone like us. However, turns out it was impossible in my case because I didn't beat the dragon that time. They figure that my virus mutated somewhere after the first 12 weeks because I was almost undetectable at that point. Yet, it was the only PCR test done on me until the end.They also know that they other genotypes are much easier to treat and will clear by high percentages, on the 24 weeks program. Now, I'm not sure about this genotype 4 because for a long

time there only appeared to be 3 in North America. Actually even genotype 2 was not well documented either.

yes, the doctor said she does not know either and will not know until week 22. yes this trial you could not have gone through tx before, and for some reason they wanted hard cases & high viral loads(advance HCV fibruios & curious), not sure why. isn't treatment the same for all stages a tiny bit or advance chirious?I will let you know when I know, I am curious to know which one it is.ny F'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html

[Guest guest]

Mine for the Telapravir was those 2 (not riba) but 3 times a day. Had to set an alarm clock for the 3rd timers. I'm thinking that you are likely on a trial with the one that is referred to as Bocepravir.

I heard the doctor say that "Protease Inhibitor" not sure what that means.yep I take them daily2 tiral twice a day3 ribas twice a day10 pills total daily From: Gloria <gadamscan@...> Sent: Thu, August 12,

2010 8:55:04 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

OK, it still looks like a clinical trial by the other company (not Vertex). Perhaps that RO5.... is a Protease Inhibitor and then again, perhaps it's something else.Have you been taking those extra pills???Gloria

Yes, I think that the point to the clinical trials is to find out something new, improve the sides, time of tx, something, otherwise there is no point to it if they are just doing the standard tx.I will post some info I have. here is something for now the clinical trial page:http://clinicaltrials.gov/ct2/show/NCT01057667?term=RO5024048 & rank=2ny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 8:20:59 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

I'd like that ny - can't imagine that they are just studying the accepted standard for tx, so it would be interesting to understand what clinical you are on.Gloria

No I am not it is a study drug from Roche RO something, I can post some info about the study if you are interestedny From: Gloria <gadamscan@...> Sent: Thu, August 12, 2010 6:30:35 PMSubject: Re: [ ] Telaprevir - Likely To Be "Fast-Tracked" -

Gloria

I thought that you were on a trial with Teleprevir???

I really hope the treatment in general gets cut in half for everybody`-` 24 weeks is so much better than 48 weeks!The place I go is doign a trail (I think) with Telaprevir soon. From: Christ <ludichrist2000> Sent:

Wed, August 11, 2010 6:12:45 PMSubject: [ ] Telaprevir - Likely To Be "Fast-Tracked" - Gloria

Hi Gloria

The news today had hundreds of articles about Vertex's - Telaprevir.

I only posted a couple because I didnt want to flood everyone.

Im real excited.

They are talking about cutting HCV TX time in half [24 weeks], and including geno's 2 and 3's too.

Not to mention those who failed with the combo.

It looks like a major step in HCV TX is about to happen.

Its about time too.

And its all your fault.

Just funnin. LOL :-)

Your a hero in my book Gloria.

You and all the other folks who did the trials and made this possible for the rest of us.

Thank you all soooooooo much.

love

don in ks

From: Gloria <gadamscan (DOT) ca>Subject: Re: [ ] Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked" Date: Wednesday, August 11, 2010, 10:55 PM

Well, here we go!! Getting closer and closer... Simply because of my experience alone, I sure hope that this additional protease inhibitor brings back hope for those that have treated before.

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

From Our Friend At Sherlingsplowed

h

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"'

More very encouraging Vertex

'

"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

.. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These

data are particularly important to

Vertex because it helps differentiate

telaprevir from its main competition at

this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .

'

Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/ New Merck's boceprevir.

http://Hepatitis Cne wdrugs.blogspot. com/2010/ 08/telaprevir- nearly-ready- for-fda-nda. html