Aa
Non-Responder Trial Protocol
Just spoke to the rep at Vertex. Below IS the protocol that will be used for non-responders 3 ARM trials, anticipated to start in the 3rd quarter, most likely September. Susan asked if you fail Telepravir, will they let you try again? I was told that that is still to be decided at this point. Here are the three ARMS:
- If you get into Arm A, you would be given VX-950 (along with Ribavirin & Interferon) for 12 weeks, then, 4 weeks of the placebo, then followed by standard treatment for 32 weeks with no VX-950.
- If you get into Arm B, you would be given the placebo (along with Ribavirin & Interferon) for the first 4 weeks, then the VX-950 (along with Ribavirin & Interferon) for 12 weeks, then followed by standard treatment for 32 weeks with no VX-950.
- If you get into Arm C, you would be given the placebo (along with Ribavirin & Interferon) for 16 weeks, followed by standard treatment for 32 weeks.
Standard treatment being Interferon & Ribavirin. He mentioned the length was 48 weeks for all three trials, which leads me to believe that the 32 weeks that was mentioned in ARM A & B will actually be 36 weeks....
Magnum
- If you get into Arm A, you would be given VX-950 (along with Ribavirin & Interferon) for 12 weeks, then, 4 weeks of the placebo, then followed by standard treatment for 32 weeks with no VX-950.
- If you get into Arm B, you would be given the placebo (along with Ribavirin & Interferon) for the first 4 weeks, then the VX-950 (along with Ribavirin & Interferon) for 12 weeks, then followed by standard treatment for 32 weeks with no VX-950.
- If you get into Arm C, you would be given the placebo (along with Ribavirin & Interferon) for 16 weeks, followed by standard treatment for 32 weeks.
Standard treatment being Interferon & Ribavirin. He mentioned the length was 48 weeks for all three trials, which leads me to believe that the 32 weeks that was mentioned in ARM A & B will actually be 36 weeks....
Magnum
Trish-
I think maybe the ‘greater than’ and ‘less than” symbols are involved somehow, and break html? I’ve had that happen to me before, and it’s frustrating.
Copyman-
My assigned riba dosage has been 2000 mg (2g) daily for the last three years. I’ve never required any intervention with epo, and right now 96 weeks in, my Hgb and hematocrit are within reference range. I know of others in nearly the same boat; one of them a woman Some patients tolerate riba well, although I doubt Vertex would include this in a trail arm, and risk tanking a full cohort population.
Bill
I think maybe the ‘greater than’ and ‘less than” symbols are involved somehow, and break html? I’ve had that happen to me before, and it’s frustrating.
Copyman-
My assigned riba dosage has been 2000 mg (2g) daily for the last three years. I’ve never required any intervention with epo, and right now 96 weeks in, my Hgb and hematocrit are within reference range. I know of others in nearly the same boat; one of them a woman Some patients tolerate riba well, although I doubt Vertex would include this in a trail arm, and risk tanking a full cohort population.
Bill
Okay, what gives? This time I checked my post and part of it is missing again. Does Medhelp have some kind of editing that goes with certain characters? My post is missing an entire sentence and the "greater than" symbol is not there in what DID get kept. Curious and frustrating.
I could swear I posted that differently but there it is...anyway, I can see them putting 75kg persons on the 1200mg/day of ribavirin. I think it's just the way you interpreted it.
That amount of Riba can not be true. Vertex would not chance giving that much riba as the dropout ratio would be greater then 50%. The human body can barely handle 1200 yet alone 2000+. There have been some on this forum that have upped their dose of Riba and mostly everyone of them ran into trouble with blood counts.
Magnum....that's the total daily dosage of ribavirin. There is no way they're giving 1000mg or 1200mg doses twice in one day. Those are the traditional weight-based dosing amounts. Usually 75kg will get 1200mg a day and usually, yes, broken out into two doses....3 x 200mg pills in the am and again in the pm for example.
can-do-man, that's even BETTER odds!!
Trish
can-do-man, that's even BETTER odds!!
Trish
Maybe what they MEANT to say was the 1000 dose was given in two doses...500 at a time? Cuz that's one hell of a lot of riba. I HATE riba.
Willow
Willow
"Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks".
This was the Vertex statement. Doesn't that sound like overkill? 2000-2400mg Ribavirin daily? Is that a race to see who will be killed first, the virus or the patient?
Magnum
This was the Vertex statement. Doesn't that sound like overkill? 2000-2400mg Ribavirin daily? Is that a race to see who will be killed first, the virus or the patient?
Magnum
With 650 in the trial and its 2-2-1 there would be 260 in group A 260 in group B and 130 in group C.
So that way 520 WILL get the vertex and 130 will not. Right???
can
So that way 520 WILL get the vertex and 130 will not. Right???
can
"I think it's sad that 130 people have no chance."
I guess one could look at it that way. However, without the trial it would be nobody has any chance at Telaprevir at all. I prefer to look at it that 260 people get a chance at a drug they wouldn't get otherwise and the other 130 people know going into it that they might not get it and can choose their options accordingly and their risk. Trials don't promise anyone a sure bet .. just calculated risk options.
I guess one could look at it that way. However, without the trial it would be nobody has any chance at Telaprevir at all. I prefer to look at it that 260 people get a chance at a drug they wouldn't get otherwise and the other 130 people know going into it that they might not get it and can choose their options accordingly and their risk. Trials don't promise anyone a sure bet .. just calculated risk options.
It all adds up to 48 weeks total, seems to me.
Arm A is 12 weeks of Telaprevir and SOC, followed by 4 weeks of placebo and SOC, then 32 weeks of SOC.
Arm B is 4 weeks of placebo/SOC, 12 weeks of Telaprevir and SOC, then 32 weeks of SOC.
16 weeks + 32 weeks = 48 weeks in both cases, yes?
Arm A is 12 weeks of Telaprevir and SOC, followed by 4 weeks of placebo and SOC, then 32 weeks of SOC.
Arm B is 4 weeks of placebo/SOC, 12 weeks of Telaprevir and SOC, then 32 weeks of SOC.
16 weeks + 32 weeks = 48 weeks in both cases, yes?
"Exclusion Criteria:
Patient is a previous non-responder that is classified as a viral breakthrough case"
Well I'm a bit shocked that they are excluding previous breakthrough'ers. I wonder if it is because those people might have a breakthrough before the start of the telaprevir dosing and that would spoil the party?
dointime
Patient is a previous non-responder that is classified as a viral breakthrough case"
Well I'm a bit shocked that they are excluding previous breakthrough'ers. I wonder if it is because those people might have a breakthrough before the start of the telaprevir dosing and that would spoil the party?
dointime
I did the VX-950 trial last year and drew the no Riba group C. I am told that I cannot retreat with the Telaprevir and so with that in mind, I entered into the Debio-025 on the 3rd of June. I'm currently through w/the Debio Part 1 where I got Debio + SOC and now I'm in Part 2, w/just the SOC. I'm awaiting my viral load results which were drawn on July 2nd.
Susan400
Susan400
Check this out...
Magnum
http://www.clinicaltrials.gov/ct2/results?state1=NA%3AUS%3AFL
Magnum
http://www.clinicaltrials.gov/ct2/results?state1=NA%3AUS%3AFL
Now I feel like a beginner! Are you contemplating the VX-950 trial? Where do you live?
Magnum
Magnum
What's more sad is that Susan and I have already been tortured at least 4 times each and may still get a placebo!
However, I have to re-emphasize my doctor's belief that even though I may not clear and get the placebo, we could slow down the progression until the FDA finally approves Telepravir.
Also, Dr. Gish, the Hepatologist said something else could come along before the end of the year.... So many variables...
Magnum
However, I have to re-emphasize my doctor's belief that even though I may not clear and get the placebo, we could slow down the progression until the FDA finally approves Telepravir.
Also, Dr. Gish, the Hepatologist said something else could come along before the end of the year.... So many variables...
Magnum
It's even sadder that close to a million of us have no choice either. News like this always makes me hopeful for the chance for all of us unable to participate in a study to get telaprevir. But while I'm hopeful....I'm also hoping they hurry up. I was a little disappointed that this study was centered around the "delayed start of telaprevir"....any of us non-responders still waiting...make up one huge trial of "delayed start of telaprevir".
Wishing you good luck, Mag and good luck to the rest of us very soon.
Willow
Wishing you good luck, Mag and good luck to the rest of us very soon.
Willow
Let me add this:
Eligibility
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL
Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria:
Patient is a previous non-responder that is classified as a viral breakthrough case
Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
Evidence of decompensated liver disease
Patient has condition that requires use of systemic corticosteroids
Magnum
Eligibility
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL
Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria:
Patient is a previous non-responder that is classified as a viral breakthrough case
Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
Evidence of decompensated liver disease
Patient has condition that requires use of systemic corticosteroids
Magnum
Here is a more detailed explanation from Vertex...
Primary Outcome Measures:
Primary objective is to demonstrate the efficacy of telaprevir in combination with Peg-INF and RBV compared to Peg-INF and RBV in patients with chronic HCV, genotype 1, infection who failed prior treatment 24 weeks after last intake of study medication.
Secondary Outcome Measures:
The secondary objective is to evaluate the effect of a delayed start of telaprevir on efficacy.
Estimated Enrollment: 650
Detailed Description:
This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment. Standard treatment is defined as treatment with Peg-INF and RBV. The trial is designed to compare the efficacy, safety, and tolerability of 2 regimens of telaprevir (with and without delayed start) combined with standard treatment versus standard treatment alone. The trial will consist of a screening period of approximately 4 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they (1) had an undetectable HCV Ribonucleic Acid (RNA) level at the end of a prior course of standard treatment but did not achieve a response (viral relapsers), or (2) never had an undetectable HCV RNA level during or at the end of a prior course of standard treatment (non-responders). Approximately 650 patients (350 prior relapsers and 300 prior non-responders) will be randomized in a 2:2:1 ratio to one of 3 treatment groups: Treatment group A will receive telaprevir with standard treatment for 12 weeks; followed by placebo with standard treatment for 4 weeks; followed by standard treatment for 32 weeks. Treatment group B will receive placebo with standard treatment for 4 weeks; followed by telaprevir with standard treatment for 12 weeks; followed by standard treatment for 32 weeks. Treatment group C will receive placebo with standard treatment for 16 weeks; followed by standard treatment for 32 weeks. In both telaprevir regimens (A and B), patients will receive 12 weeks of 750 mg of telaprevir every 8 hours along with 48 weeks of standard treatment.
Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks.
Magnum
Primary Outcome Measures:
Primary objective is to demonstrate the efficacy of telaprevir in combination with Peg-INF and RBV compared to Peg-INF and RBV in patients with chronic HCV, genotype 1, infection who failed prior treatment 24 weeks after last intake of study medication.
Secondary Outcome Measures:
The secondary objective is to evaluate the effect of a delayed start of telaprevir on efficacy.
Estimated Enrollment: 650
Detailed Description:
This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment. Standard treatment is defined as treatment with Peg-INF and RBV. The trial is designed to compare the efficacy, safety, and tolerability of 2 regimens of telaprevir (with and without delayed start) combined with standard treatment versus standard treatment alone. The trial will consist of a screening period of approximately 4 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they (1) had an undetectable HCV Ribonucleic Acid (RNA) level at the end of a prior course of standard treatment but did not achieve a response (viral relapsers), or (2) never had an undetectable HCV RNA level during or at the end of a prior course of standard treatment (non-responders). Approximately 650 patients (350 prior relapsers and 300 prior non-responders) will be randomized in a 2:2:1 ratio to one of 3 treatment groups: Treatment group A will receive telaprevir with standard treatment for 12 weeks; followed by placebo with standard treatment for 4 weeks; followed by standard treatment for 32 weeks. Treatment group B will receive placebo with standard treatment for 4 weeks; followed by telaprevir with standard treatment for 12 weeks; followed by standard treatment for 32 weeks. Treatment group C will receive placebo with standard treatment for 16 weeks; followed by standard treatment for 32 weeks. In both telaprevir regimens (A and B), patients will receive 12 weeks of 750 mg of telaprevir every 8 hours along with 48 weeks of standard treatment.
Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks.
Magnum
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