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137025 tn?1217768341

Vertex trials in Washington State

My grand new doc from Seattle just called me, he is referring me to the recruiter for the Telapravir study they will be doing at U of Washington.  I should be ecstatic, right?  Well, I talked with her and OMG!

In the state of Washington, there will be eight, yes, eight non-responders on the Vertex trial.  Now, we may be a smaller state, stuck up north in the corner, but I gotta tell you, we have a lot of people here.  And when the recruiter told me eight folks would be chosen, I kind of choked.  She also said she had a list of about 200 folks already who were interested.  Jeeeeeeeee   sus!  

There will be trials all over, the total number of people will be very big, and the evil rash will be addressed and controlled, but to be fair and get a cross section of all of us, Washington state will have eight.  I am not sure I am that lucky of a person, but my doc is going to bat for me.

Wanted to let everyone know that Vertex isn't getting rash over the rash, the trial goes on, but here in Washington, it won't even start until June.  So we have a long wait.  At the bottom of a list of 200 people.  Man, oh, man.

Willow's wigged out
42 Responses
Avatar universal
Figure half the folks aren't serious or something so that leaves you, what, 8 out of 100 or an 8% chance of getting in. Maybe if you become the private patient of the lead investigator your chances could double that. No harm in giving it a shot. Ever think of moving out of a hick state to someplace with lots more people? LOL. But seriously, if the trials are successful, the next phase should be very large and hopefully those that don't get in now will get in then.

Be well,

-- Jim
Avatar universal
Hi Willows.  I was just looking through the list on the trials site and most states aren't open yet.  As you point out by the time they are open to recruit you may have a sizable list of people in front of you. Here's the link;
http://clinicaltrials.gov/ct/show/NCT00420784?order=1

Here's another way of looking at it.  Of the 200 people that are on the list there will be some of them that will not qualify for various reasons.  There may also be some wiggle room. Beyond the list of excluding factors listed on the trials site there could be some "grey areas" where the hospital, clinic, or whomever makes the call may decide that of the (this is just an example) of the 200 in line only 150 are actually qualified (not ruled out by the exclusions).  Of these there could be 50 "grey area" folks that qualify but other factors might make them less desirable.

I'd have to check the list but OTHER than the list @trials other sub-prime factors could be age, genotype (2's 3's and 4's may be better suited for a phase 3 trial), geographic proximity to the clinic, general health (for instance someone with dental problems, other unlisted excluding factors, and of course VIBE.  : )   They want people who can understand and that will follow the agreement.  They may have some sort of sense about who will complete the study and who, although they may fit the qualifications, may not seem like they will stick with it or that their life circumstances may make it harder for them to conform to the amount of contact required at the hospital/clinic.

Who knows; there may be a smaller group than 100 you have to beat out.  To increase your odds have your medical data up to date, make sure that any dental work is done in advance, think about "selling" yourself as an ideal trial applicant.  Even if people are in line ahead of you they could have a change of circumstances prior to the trial start date.  You need to be ready.

best of luck,
Willy
Avatar universal
I wonder why you say geno 2 and 3 would be "better suited" for a Prove3 trial? It's bad enough we aren't even included in anything so far! It's unreal to me that they would not even include any geno 2 and 3 all along in the trials here.

Why would you say we are any less "suited" than geno 1? It is completely unfair to leave us out of the trials.

Were geno 2 and 3 excluded in Europe too?

In the US geno 1 is the most prevelant, but that is not true in othere countries. I think geno 3 is most prevelant in Europe. I hope we are included there. Geno 3 is the most prevalent in Australia too.

Avatar universal
I agree with what Willy says.  Don't think about who else is in the running, just go for it yourself and give it everything you've got.

When I first put my name down for the trial I am currently in I found out that there were a whole lot of other people on the same waiting list as me.  However putting one's name down on a waiting list is not the same as making the huge commitment to take part in the trial.  I held out and at the end of the day because of this or that there were huge dropout numbers.  Add those to the people who did not meet the inclusion and exclusion criteria and we ended up with a group of only 9.  

If you carefully go over all the criteria for inclusion and exclusion and you reckon that you fit, and you are truthfully willing to make the commitment, then have no doubt that you are in with a chance.

Good luck
dointime.                
80575 tn?1207135964
Hey Willows; Indiana only has eight as well.  

I don't have a position locked in but I do have great rapport with my doc at IU Medical Center.  He knows that I'm motivated and educated which I believe has bearing on the selection.

If not this trial the next, which will be bigger.

Mike
80575 tn?1207135964
Hey Willows; Indiana only has eight as well.  

I don't have a position locked in but I do have great rapport with my doc at IU Medical Center.  He knows that I'm motivated and educated which I believe has bearing on the selection.

If not this trial the next, which will be bigger.

Mike
Avatar universal
Sorry.....I wrote a long post but it won't let me post it; dunno why.
Willy
Avatar universal
Study groups of 10 or so seem to be very common. Not sure why, but it may have something to do with the amount of work involved and having staff free to do it. My center has added at least one more trial coordinator since I started in the Prove 1 trial.

Are you sure that is the only site in Washington state??

All of the trials that Vertex have announced have been geno 1 only. The CEO mentioned in an investor presentation that other genotypes will be trialled later, but I got the impression this was to be after the geno 1 application achieved FDA approval.

Avatar universal
Study groups of 10 or so seem to be very common. Not sure why, but it may have something to do with the amount of work involved and having staff free to do it. My center has added at least one more trial coordinator since I started in the Prove 1 trial.

Are you sure that is the only site in Washington state??

All of the trials that Vertex have announced have been geno 1 only. The CEO mentioned in an investor presentation that other genotypes will be trialled later, but I got the impression this was to be after the geno 1 application achieved FDA approval.

Avatar universal
(by the way.....you made a typo.  I wrote Phase 3; you I think, wrote Prove 3 in your first sentance.  It's easy to get the two confused.

Sorry; visit the clinical trials site.  One of the inclusion requirement is;
"Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin "

I would guess that means any other genotype is an automatic exclusion.  I didn't really read it immediately before posting.  I'd heard them mention that they were going to have a trial for those easier to treat genotypes, so I just assumed it would be the case.

The reasoning is that in trials they are really mostly about procurring data.  There are more genotype 1's and we are harder to "cure".  That's why they are gathering data where it will do the most good.  That's where their customer base will be and that's where the "selling" of the product and vision will occur. And yes.......Prove 2 (Europe) was all geno 1 naive.

The good news about being of your genotype;

1)  I believe they may have a paper on treating "easier to treat" genotypes at the EASL conference.  They may be able to extrapolate a treatment time and dosage based on the PROVE 1 results.  (I'm speculating; the titles of papers and subjects are kept a secret)

2)  Since the basic premise will already have been tested on Geno 1's there may be more certainty involved in treating (for instance) genotype 2's.  For instance; IF you had gone first on trials you might have had to face 12 weeks of triple combination therapy.  WHAT IF based on successful results of the PROVE 1 trial (also keeping in mind this is hypothetical, we don't have the results yet) but if they ended up proving that they could successfully treat in 12 weeks?  What if they modeled a trial for Geno 2's and 3's for a 6 week treatment and even had a plan on shortening it based on RVR?  I'm just speculating on a hypothetical trial for Genotype 2's.  IF the news is good at the EASL they will start planning PHASE 3 plans with the FDA.  The could start Phase 3 later in this year in which the "easier to treat genotypes" will likely have a trial.  Vertex is also planning trials for BID dosing (twice a day), co-infected (HIV-HCV), and harder to treat groups (that could be Afro-Americans or advanced Liver disease groups).

Even if the news were not as successful at the EASL the planned trials for the easier to treat genotypes will be able to be constructed with much more precision based on the data gathered from the Prove 1 and 2 trials.  That could result in taking a lot of "trial and error" out of the trials.

Sorry....my wording about "suitable" threw you off; poor choice by me and also incorrect.  I do these things on the fly and they may not be quite ready to be "handed in".  : )

best,
Willy
Avatar universal
(by the way.....you made a typo.  I wrote Phase 3; you I think, wrote Prove 3 in your first sentance.  It's easy to get the two confused.

Sorry; visit the clinical trials site.  One of the inclusion requirement is;
"Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin "

I would guess that means any other genotype is an automatic exclusion.  I didn't really read it immediately before posting.  I'd heard them mention that they were going to have a trial for those easier to treat genotypes, so I just assumed it would be the case.

The reasoning is that in trials they are really mostly about procurring data.  There are more genotype 1's and we are harder to "cure".  That's why they are gathering data where it will do the most good.  That's where their customer base will be and that's where the "selling" of the product and vision will occur. And yes.......Prove 2 (Europe) was all geno 1 naive.

The good news about being of your genotype;

1)  I believe they may have a paper on treating "easier to treat" genotypes at the EASL conference.  They may be able to extrapolate a treatment time and dosage based on the PROVE 1 results.  (I'm speculating; the titles of papers and subjects are kept a secret)

2)  Since the basic premise will already have been tested on Geno 1's there may be more certainty involved in treating (for instance) genotype 2's.  For instance; IF you had gone first on trials you might have had to face 12 weeks of triple combination therapy.  WHAT IF based on successful results of the PROVE 1 trial (also keeping in mind this is hypothetical, we don't have the results yet) but if they ended up proving that they could successfully treat in 12 weeks?  What if they modeled a trial for Geno 2's and 3's for a 6 week treatment and even had a plan on shortening it based on RVR?  I'm just speculating on a hypothetical trial for Genotype 2's.  IF the news is good at the EASL they will start planning PHASE 3 plans with the FDA.  The could start Phase 3 later in this year in which the "easier to treat genotypes" will likely have a trial.  Vertex is also planning trials for BID dosing (twice a day), co-infected (HIV-HCV), and harder to treat groups (that could be Afro-Americans or advanced Liver disease groups).

Even if the news were not as successful at the EASL the planned trials for the easier to treat genotypes will be able to be constructed with much more precision based on the data gathered from the Prove 1 and 2 trials.  That could result in taking a lot of "trial and error" out of the trials.

Sorry....my wording about "suitable" threw you off; poor choice by me and also incorrect.  I do these things on the fly and they may not be quite ready to be "handed in".  : )

best,
Willy
Avatar universal
Study groups of 10 or so seem to be very common. Not sure why, but it may have something to do with the amount of work involved and having staff free to do it. My center has added at least one more trial coordinator since I started in the Prove 1 trial.

Are you sure that is the only site in Washington state??

All of the trials that Vertex have announced have been geno 1 only. The CEO mentioned in an investor presentation that other genotypes will be trialled later, but I got the impression this was to be after the geno 1 application achieved FDA approval.

149918 tn?1208132344
IS BOARD UP??
149918 tn?1208132344
hehehe..
149918 tn?1208132344
and I was one of 7 in my group.
Had no clue how lucky I was!!!!!
Avatar universal
(by the way.....you made a typo.  I wrote Phase 3; you I think, wrote Prove 3 in your first sentance.  It's easy to get the two confused.

Sorry; visit the clinical trials site.  One of the inclusion requirement is;
"Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin "

I would guess that means any other genotype is an automatic exclusion.  I didn't really read it immediately before posting.  I'd heard them mention that they were going to have a trial for those easier to treat genotypes, so I just assumed it would be the case.

The reasoning is that in trials they are really mostly about procurring data.  There are more genotype 1's and we are harder to "cure".  That's why they are gathering data where it will do the most good.  That's where their customer base will be and that's where the "selling" of the product and vision will occur. And yes.......Prove 2 (Europe) was all geno 1 naive.

The good news about being of your genotype;

1)  I believe they may have a paper on treating "easier to treat" genotypes at the EASL conference.  They may be able to extrapolate a treatment time and dosage based on the PROVE 1 results.  (I'm speculating; the titles of papers and subjects are kept a secret)

2)  Since the basic premise will already have been tested on Geno 1's there may be more certainty involved in treating (for instance) genotype 2's.  For instance; IF you had gone first on trials you might have had to face 12 weeks of triple combination therapy.  WHAT IF based on successful results of the PROVE 1 trial (also keeping in mind this is hypothetical, we don't have the results yet) but if they ended up proving that they could successfully treat in 12 weeks?  What if they modeled a trial for Geno 2's and 3's for a 6 week treatment and even had a plan on shortening it based on RVR?  I'm just speculating on a hypothetical trial for Genotype 2's.  IF the news is good at the EASL they will start planning PHASE 3 plans with the FDA.  The could start Phase 3 later in this year in which the "easier to treat genotypes" will likely have a trial.  Vertex is also planning trials for BID dosing (twice a day), co-infected (HIV-HCV), and harder to treat groups (that could be Afro-Americans or advanced Liver disease groups).

Even if the news were not as successful at the EASL the planned trials for the easier to treat genotypes will be able to be constructed with much more precision based on the data gathered from the Prove 1 and 2 trials.  That could result in taking a lot of "trial and error" out of the trials.

Sorry....my wording about "suitable" threw you off; poor choice by me and also incorrect.  I do these things on the fly and they may not be quite ready to be "handed in".  : )

best,
Willy
Avatar universal
(by the way.....you made a typo.  I wrote Phase 3; you I think, wrote Prove 3 in your first sentance.  It's easy to get the two confused.

Sorry; visit the clinical trials site.  One of the inclusion requirement is;
"Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin "

I would guess that means any other genotype is an automatic exclusion.  I didn't really read it immediately before posting.  I'd heard them mention that they were going to have a trial for those easier to treat genotypes, so I just assumed it would be the case.

The reasoning is that in trials they are really mostly about procurring data.  There are more genotype 1's and we are harder to "cure".  That's why they are gathering data where it will do the most good.  That's where their customer base will be and that's where the "selling" of the product and vision will occur. And yes.......Prove 2 (Europe) was all geno 1 naive.

The good news about being of your genotype;

1)  I believe they may have a paper on treating "easier to treat" genotypes at the EASL conference.  They may be able to extrapolate a treatment time and dosage based on the PROVE 1 results.  (I'm speculating; the titles of papers and subjects are kept a secret)

2)  Since the basic premise will already have been tested on Geno 1's there may be more certainty involved in treating (for instance) genotype 2's.  For instance; IF you had gone first on trials you might have had to face 12 weeks of triple combination therapy.  WHAT IF based on successful results of the PROVE 1 trial (also keeping in mind this is hypothetical, we don't have the results yet) but if they ended up proving that they could successfully treat in 12 weeks?  What if they modeled a trial for Geno 2's and 3's for a 6 week treatment and even had a plan on shortening it based on RVR?  I'm just speculating on a hypothetical trial for Genotype 2's.  IF the news is good at the EASL they will start planning PHASE 3 plans with the FDA.  The could start Phase 3 later in this year in which the "easier to treat genotypes" will likely have a trial.  Vertex is also planning trials for BID dosing (twice a day), co-infected (HIV-HCV), and harder to treat groups (that could be Afro-Americans or advanced Liver disease groups).

Even if the news were not as successful at the EASL the planned trials for the easier to treat genotypes will be able to be constructed with much more precision based on the data gathered from the Prove 1 and 2 trials.  That could result in taking a lot of "trial and error" out of the trials.

Sorry....my wording about "suitable" threw you off; poor choice by me and also incorrect.  I do these things on the fly and they may not be quite ready to be "handed in".  : )

best,
Willy
Avatar universal
(by the way.....you made a typo.  I wrote Phase 3; you I think, wrote Prove 3 in your first sentance.  It's easy to get the two confused.

Sorry; visit the clinical trials site.  One of the inclusion requirement is;
"Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin "

I would guess that means any other genotype is an automatic exclusion.  I didn't really read it immediately before posting.  I'd heard them mention that they were going to have a trial for those easier to treat genotypes, so I just assumed it would be the case.

The reasoning is that in trials they are really mostly about procurring data.  There are more genotype 1's and we are harder to "cure".  That's why they are gathering data where it will do the most good.  That's where their customer base will be and that's where the "selling" of the product and vision will occur. And yes.......Prove 2 (Europe) was all geno 1 naive.

The good news about being of your genotype;

1)  I believe they may have a paper on treating "easier to treat" genotypes at the EASL conference.  They may be able to extrapolate a treatment time and dosage based on the PROVE 1 results.  (I'm speculating; the titles of papers and subjects are kept a secret)

2)  Since the basic premise will already have been tested on Geno 1's there may be more certainty involved in treating (for instance) genotype 2's.  For instance; IF you had gone first on trials you might have had to face 12 weeks of triple combination therapy.  WHAT IF based on successful results of the PROVE 1 trial (also keeping in mind this is hypothetical, we don't have the results yet) but if they ended up proving that they could successfully treat in 12 weeks?  What if they modeled a trial for Geno 2's and 3's for a 6 week treatment and even had a plan on shortening it based on RVR?  I'm just speculating on a hypothetical trial for Genotype 2's.  IF the news is good at the EASL they will start planning PHASE 3 plans with the FDA.  The could start Phase 3 later in this year in which the "easier to treat genotypes" will likely have a trial.  Vertex is also planning trials for BID dosing (twice a day), co-infected (HIV-HCV), and harder to treat groups (that could be Afro-Americans or advanced Liver disease groups).

Even if the news were not as successful at the EASL the planned trials for the easier to treat genotypes will be able to be constructed with much more precision based on the data gathered from the Prove 1 and 2 trials.  That could result in taking a lot of "trial and error" out of the trials.

Sorry....my wording about "suitable" threw you off; poor choice by me and also incorrect.  I do these things on the fly and they may not be quite ready to be "handed in".  : )

best,
Willy
Avatar universal
(by the way.....you made a typo.  I wrote Phase 3; you I think, wrote Prove 3 in your first sentance.  It's easy to get the two confused.

Sorry; visit the clinical trials site.  One of the inclusion requirement is;
"Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin "

I would guess that means any other genotype is an automatic exclusion.  I didn't really read it immediately before posting.  I'd heard them mention that they were going to have a trial for those easier to treat genotypes, so I just assumed it would be the case.

The reasoning is that in trials they are really mostly about procurring data.  There are more genotype 1's and we are harder to "cure".  That's why they are gathering data where it will do the most good.  That's where their customer base will be and that's where the "selling" of the product and vision will occur. And yes.......Prove 2 (Europe) was all geno 1 naive.

The good news about being of your genotype;

1)  I believe they may have a paper on treating "easier to treat" genotypes at the EASL conference.  They may be able to extrapolate a treatment time and dosage based on the PROVE 1 results.  (I'm speculating; the titles of papers and subjects are kept a secret)

2)  Since the basic premise will already have been tested on Geno 1's there may be more certainty involved in treating (for instance) genotype 2's.  For instance; IF you had gone first on trials you might have had to face 12 weeks of triple combination therapy.  WHAT IF based on successful results of the PROVE 1 trial (also keeping in mind this is hypothetical, we don't have the results yet) but if they ended up proving that they could successfully treat in 12 weeks?  What if they modeled a trial for Geno 2's and 3's for a 6 week treatment and even had a plan on shortening it based on RVR?  I'm just speculating on a hypothetical trial for Genotype 2's.  IF the news is good at the EASL they will start planning PHASE 3 plans with the FDA.  The could start Phase 3 later in this year in which the "easier to treat genotypes" will likely have a trial.  Vertex is also planning trials for BID dosing (twice a day), co-infected (HIV-HCV), and harder to treat groups (that could be Afro-Americans or advanced Liver disease groups).

Even if the news were not as successful at the EASL the planned trials for the easier to treat genotypes will be able to be constructed with much more precision based on the data gathered from the Prove 1 and 2 trials.  That could result in taking a lot of "trial and error" out of the trials.

Sorry....my wording about "suitable" threw you off; poor choice by me and also incorrect.  I do these things on the fly and they may not be quite ready to be "handed in".  : )

best,
Willy
Avatar universal
(by the way.....you made a typo.  I wrote Phase 3; you I think, wrote Prove 3 in your first sentance.  It's easy to get the two confused.

Sorry; visit the clinical trials site.  One of the inclusion requirement is;
"Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin "

I would guess that means any other genotype is an automatic exclusion.  I didn't really read it immediately before posting.  I'd heard them mention that they were going to have a trial for those easier to treat genotypes, so I just assumed it would be the case.

The reasoning is that in trials they are really mostly about procurring data.  There are more genotype 1's and we are harder to "cure".  That's why they are gathering data where it will do the most good.  That's where their customer base will be and that's where the "selling" of the product and vision will occur. And yes.......Prove 2 (Europe) was all geno 1 naive.

The good news about being of your genotype;

1)  I believe they may have a paper on treating "easier to treat" genotypes at the EASL conference.  They may be able to extrapolate a treatment time and dosage based on the PROVE 1 results.  (I'm speculating; the titles of papers and subjects are kept a secret)

2)  Since the basic premise will already have been tested on Geno 1's there may be more certainty involved in treating (for instance) genotype 2's.  For instance; IF you had gone first on trials you might have had to face 12 weeks of triple combination therapy.  WHAT IF based on successful results of the PROVE 1 trial (also keeping in mind this is hypothetical, we don't have the results yet) but if they ended up proving that they could successfully treat in 12 weeks?  What if they modeled a trial for Geno 2's and 3's for a 6 week treatment and even had a plan on shortening it based on RVR?  I'm just speculating on a hypothetical trial for Genotype 2's.  IF the news is good at the EASL they will start planning PHASE 3 plans with the FDA.  The could start Phase 3 later in this year in which the "easier to treat genotypes" will likely have a trial.  Vertex is also planning trials for BID dosing (twice a day), co-infected (HIV-HCV), and harder to treat groups (that could be Afro-Americans or advanced Liver disease groups).

Even if the news were not as successful at the EASL the planned trials for the easier to treat genotypes will be able to be constructed with much more precision based on the data gathered from the Prove 1 and 2 trials.  That could result in taking a lot of "trial and error" out of the trials.

Sorry....my wording about "suitable" threw you off; poor choice by me and also incorrect.  I do these things on the fly and they may not be quite ready to be "handed in".  : )

best,
Willy
Avatar universal
(by the way.....you made a typo.  I wrote Phase 3; you I think, wrote Prove 3 in your first sentance.  It's easy to get the two confused.

Sorry; visit the clinical trials site.  One of the inclusion requirement is;
"Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin "

I would guess that means any other genotype is an automatic exclusion.  I didn't really read it immediately before posting.  I'd heard them mention that they were going to have a trial for those easier to treat genotypes, so I just assumed it would be the case.

The reasoning is that in trials they are really mostly about procurring data.  There are more genotype 1's and we are harder to "cure".  That's why they are gathering data where it will do the most good.  That's where their customer base will be and that's where the "selling" of the product and vision will occur. And yes.......Prove 2 (Europe) was all geno 1 naive.

The good news about being of your genotype;

1)  I believe they may have a paper on treating "easier to treat" genotypes at the EASL conference.  They may be able to extrapolate a treatment time and dosage based on the PROVE 1 results.  (I'm speculating; the titles of papers and subjects are kept a secret)

2)  Since the basic premise will already have been tested on Geno 1's there may be more certainty involved in treating (for instance) genotype 2's.  For instance; IF you had gone first on trials you might have had to face 12 weeks of triple combination therapy.  WHAT IF based on successful results of the PROVE 1 trial (also keeping in mind this is hypothetical, we don't have the results yet) but if they ended up proving that they could successfully treat in 12 weeks?  What if they modeled a trial for Geno 2's and 3's for a 6 week treatment and even had a plan on shortening it based on RVR?  I'm just speculating on a hypothetical trial for Genotype 2's.  IF the news is good at the EASL they will start planning PHASE 3 plans with the FDA.  The could start Phase 3 later in this year in which the "easier to treat genotypes" will likely have a trial.  Vertex is also planning trials for BID dosing (twice a day), co-infected (HIV-HCV), and harder to treat groups (that could be Afro-Americans or advanced Liver disease groups).

Even if the news were not as successful at the EASL the planned trials for the easier to treat genotypes will be able to be constructed with much more precision based on the data gathered from the Prove 1 and 2 trials.  That could result in taking a lot of "trial and error" out of the trials.

Sorry....my wording about "suitable" threw you off; poor choice by me and also incorrect.  I do these things on the fly and they may not be quite ready to be "handed in".  : )

best,
Willy
Avatar universal
(by the way.....you made a typo.  I wrote Phase 3; you I think, wrote Prove 3 in your first sentance.  It's easy to get the two confused.

Sorry; visit the clinical trials site.  One of the inclusion requirement is;
"Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin "

I would guess that means any other genotype is an automatic exclusion.  I didn't really read it immediately before posting.  I'd heard them mention that they were going to have a trial for those easier to treat genotypes, so I just assumed it would be the case.

The reasoning is that in trials they are really mostly about procurring data.  There are more genotype 1's and we are harder to "cure".  That's why they are gathering data where it will do the most good.  That's where their customer base will be and that's where the "selling" of the product and vision will occur. And yes.......Prove 2 (Europe) was all geno 1 naive.

The good news about being of your genotype;

1)  I believe they may have a paper on treating "easier to treat" genotypes at the EASL conference.  They may be able to extrapolate a treatment time and dosage based on the PROVE 1 results.  (I'm speculating; the titles of papers and subjects are kept a secret)

2)  Since the basic premise will already have been tested on Geno 1's there may be more certainty involved in treating (for instance) genotype 2's.  For instance; IF you had gone first on trials you might have had to face 12 weeks of triple combination therapy.  WHAT IF based on successful results of the PROVE 1 trial (also keeping in mind this is hypothetical, we don't have the results yet) but if they ended up proving that they could successfully treat in 12 weeks?  What if they modeled a trial for Geno 2's and 3's for a 6 week treatment and even had a plan on shortening it based on RVR?  I'm just speculating on a hypothetical trial for Genotype 2's.  IF the news is good at the EASL they will start planning PHASE 3 plans with the FDA.  The could start Phase 3 later in this year in which the "easier to treat genotypes" will likely have a trial.  Vertex is also planning trials for BID dosing (twice a day), co-infected (HIV-HCV), and harder to treat groups (that could be Afro-Americans or advanced Liver disease groups).

Even if the news were not as successful at the EASL the planned trials for the easier to treat genotypes will be able to be constructed with much more precision based on the data gathered from the Prove 1 and 2 trials.  That could result in taking a lot of "trial and error" out of the trials.

Sorry....my wording about "suitable" threw you off; poor choice by me and also incorrect.  I do these things on the fly and they may not be quite ready to be "handed in".  : )

best,
Willy
Avatar universal
Study groups of 10 or so seem to be very common. Not sure why, but it may have something to do with the amount of work involved and having staff free to do it. My center has added at least one more trial coordinator since I started in the Prove 1 trial.

Are you sure that is the only site in Washington state?? If you can find a list of Prove 1 sites, that should tell you how many were in WA. Its highly likely that Prove 1 sites will be participating in Prove 3 as well.

All of the trials that Vertex have announced have been geno 1 only. The CEO mentioned in an investor presentation that other genotypes will be trialled later, but I got the impression this was to be after the geno 1 application achieved FDA approval.

Dointime's approach worked for me. Being avaiable, communicative, and showing committment really makes a difference. They want subjects who are committed, and prepared to go the distance. Having a good clear medical history probably helps as well.
Avatar universal
Study groups of 10 or so seem to be very common. Not sure why, but it may have something to do with the amount of work involved and having staff free to do it. My center has added at least one more trial coordinator since I started in the Prove 1 trial.

Are you sure that is the only site in Washington state? If you can find a list of Prove 1 sites, that should tell you how many were in WA. Its highly likely that Prove 1 sites will be participating in Prove 3 as well.

All of the trials that Vertex have announced have been geno 1 only. The CEO mentioned in an investor presentation that other genotypes will be trialled later, but I got the impression this was to be after the geno 1 application achieved FDA approval.

Dointime's approach worked for me. Being avaiable, communicative, and showing committment really makes a difference. They want subjects who are committed, and prepared to go the distance. Having a good clear medical history probably helps as well.
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