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Vertex Telaprevir Responders Results
Just got off the phone with my contact Alan True at Vertex. We've been comunicating for over two years now and he has kept me updated with some valuable information. The email he just sent me has this information on results. I was particularly interested in the numbers with null responders. To me, although better numbers than with standard treatment, it seems a bit dismal for Null Responders, but here it is...
Of 50 enrolled patients in Telaprevir clinical trial without placebo:
UNDETECTABLE AT WEEK 4
Formerly Null Responders = 41%
Formerly Partial Responders = 86%
Formerly vBT = 88%
Formerly Prior Relapsers = 93%
Total = 68%
AT END OF TREATMENT:
Formerly Null Responders = 49%
Formerly Partial Responders = 79%
Formerly vBT = 75%
Formerly Prior Relapsers = 100%
Total = 71%
SVR RATES:
Formerly Null Responders = 37%
Formerly Partial Responders = 55%
Formerly vBT = 75%
Formerly Prior Relapsers = 97%
Total = 59%
SVR Rates In Patients who Archived Undetectability At Week 4:
Formerly Null Responders = 57%
Formerly Partial Responders = 64%
Formerly vBT = 86%
Formerly Prior Relapsers = 96%
Total = 75%
Relapse Rates Amongst Patients With Undetectable HVC RNA at Last Dose:
Formerly Null Responders = 24%
Formerly Partial Responders = 26%
Formerly vBT = 0%
Formerly Prior Relapsers = 3%
Total = 16%
SIDE EFFECTS TOTAL:
RASH (all types) = 48%
FATIGUE = 44%
PRURITUS = 38%
HEADACHE = 32%
NAUSEA = 27%
ANEMIA = 25%
INFLUENZA - LIKE ILLNESS = 24%
DIARREAH = 21%
All this was the results in the Berg EASL Slide Set 2010...
By the way, I mentioned the Telaprevir Sweepstakes, and unbelievably, he’s going to present the idea to Senior Staff for consideration, including a two-week vacation! He agreed it would be a terrific publicity ploy for the company, especially if CNN, CBS and NBC got wind of it. And guess who is going to contact the tree media networks if Vertex approves the idea?
Magnum
Of 50 enrolled patients in Telaprevir clinical trial without placebo:
UNDETECTABLE AT WEEK 4
Formerly Null Responders = 41%
Formerly Partial Responders = 86%
Formerly vBT = 88%
Formerly Prior Relapsers = 93%
Total = 68%
AT END OF TREATMENT:
Formerly Null Responders = 49%
Formerly Partial Responders = 79%
Formerly vBT = 75%
Formerly Prior Relapsers = 100%
Total = 71%
SVR RATES:
Formerly Null Responders = 37%
Formerly Partial Responders = 55%
Formerly vBT = 75%
Formerly Prior Relapsers = 97%
Total = 59%
SVR Rates In Patients who Archived Undetectability At Week 4:
Formerly Null Responders = 57%
Formerly Partial Responders = 64%
Formerly vBT = 86%
Formerly Prior Relapsers = 96%
Total = 75%
Relapse Rates Amongst Patients With Undetectable HVC RNA at Last Dose:
Formerly Null Responders = 24%
Formerly Partial Responders = 26%
Formerly vBT = 0%
Formerly Prior Relapsers = 3%
Total = 16%
SIDE EFFECTS TOTAL:
RASH (all types) = 48%
FATIGUE = 44%
PRURITUS = 38%
HEADACHE = 32%
NAUSEA = 27%
ANEMIA = 25%
INFLUENZA - LIKE ILLNESS = 24%
DIARREAH = 21%
All this was the results in the Berg EASL Slide Set 2010...
By the way, I mentioned the Telaprevir Sweepstakes, and unbelievably, he’s going to present the idea to Senior Staff for consideration, including a two-week vacation! He agreed it would be a terrific publicity ploy for the company, especially if CNN, CBS and NBC got wind of it. And guess who is going to contact the tree media networks if Vertex approves the idea?
Magnum
This is great info. thanks so much.
Any thoughts as to whether adding Vitamin D to the mix would help or hurt?
Any thoughts as to whether adding Vitamin D to the mix would help or hurt?
Boceprevir information on lead in:
SPRINT-1 included 595 treatment-naive patients with genotype 1 chronic hepatitis C in the U.S., Canada and Europe. Overall, 16% of participants were African-American, 7% had pre-existing liver cirrhosis, 56% had HCV genotype 1a, and 89% had high HCV viral load (> 600,000 IU/mL), all factors associated with poor response to interferon-based therapy.
Boceprevir (800 mg 3 times daily) was evaluated as part of 3 treatment regimens:
Lead-in therapy with 1.5 mcg/kg once-weekly pegylated interferon plus 800-1400 mg daily weight-adjusted ribavirin for 4 weeks, followed by the addition of boceprevir for 24 or 44 more weeks (for a total of 28 or 48 weeks of treatment);
Boceprevir in combination with the same doses of pegylated interferon plus ribavirin, with all 3 drugs taken together for 28 or 48 weeks.
Boceprevir plus pegylated interferon plus low-dose 400-1000 mg daily weight-adjusted ribavirin for 48 weeks (Part II).
In Part I of the study, the boceprevir regimens were compared against the approved standard of care control regimen of 1.5 mcg/kg once-weekly pegylated interferon plus 800-1400 mg daily weight-adjusted ribavirin, without boceprevir, for 48 weeks.
In Part II, boceprevir plus pegylated interferon plus low-dose ribavirin for 48 weeks was compared against boceprevir plus pegylated interferon plus full-dose ribavirin for 48 weeks.
The rationale for the lead-in period was based on the fact that both pegylated interferon alfa-2b and ribavirin reach steady-state concentrations by week 4, therefore patients had boceprevir added after levels of the other drugs were optimized and HCV viral load was reduced, according to a Schering-Plough press release describing the study findings. This approach may minimize the duration of "functional monotherapy" with the direct antiviral agent, thereby potentially reducing the likelihood of developing resistance.
The primary endpoint of the study was sustained virological response (SVR), or continued undetectable HCV RNA after 24 weeks of post-treatment follow-up.
Use of erythropoietin (EPO) to manage anemia (defined as hemoglobin < 10 g/dL) during treatment was allowed at the discretion of study investigators.
Results
In the 28-week and 48-week boceprevir/pegylated interferon/ribavirin triple-therapy arms with no lead-in period, SVR rates were 54% (58 of 107 patients) and 67% (69 of 103 patients), respectively.
In Part I of the study, response rates were improved in the arms with a 4-week pegylated interferon/ribavirin lead-in period before starting boceprevir.
The 4-week pegylated interferon/ribavirin lead-in followed by 44 weeks of triple combination therapy produced an SVR rate of 75% (77 of 103 patients), compared with 38% in the standard of care control arm (39 of 104 patients) (P < 0.0001).
The SVR rate was 56% (58 of 103 patients) using the 4-week pegylated interferon/ribavirin lead-in period followed by 24 weeks of triple combination therapy (P = 0.005 vs standard of care).
In the lead-in arms, 64% of all patients achieved rapid virologic response (RVR), defined as undetectable HCV RNA 4 weeks after adding boceprevir.
Among patients in the lead-in arms who achieved RVR, SVR rates were 94% using the 48-week regimen and 82% using the 28-week regimen.
In Part II of the study, the SVR rate for the triple-combination regimen with low-dose ribavirin was 36% (21 of 59 patients).
The low-dose ribavirin regimen was associated with an increased risk of viral breakthrough during treatment and a higher relapse rate after the end of treatment, resulting in a lower SVR rate.
Overall, triple-combination therapy was well tolerated.
In Part I of the study, 9%-19% of participants in the boceprevir arms discontinued therapy due to adverse events, compared with 8% in the standard of care control arm.
Fewer patients in the 28-week and 48-week lead-in arms discontinued treatment due to viral breakthrough (4% and 5%, respectively, vs 7% and 12% with no lead-in).
The most common adverse events reported in the boceprevir arms were fatigue, anemia, nausea, and headache.
The incidence of skin adverse events (rash or pruritus [itching]) was similar in the boceprevir and standard of care arms.
About one-half of patients in the boceprevir arms and about one-third in the standard therapy arm developed anemia during treatment.
39%-51% of patients in the boceprevir combination arms and 26% in the standard of care control arm used EPO.
Participants who developed anemia had a greater likelihood of achieving SVR than those without anemia.
"Both 28 and 48 week boceprevir regimens significantly increased SVR with very low relapse rates in 48 week regimens," the investigators concluded. "However, low dose ribavirin with PegIntron and boceprevir was associated with increased viral breakthrough, relapse and lower efficacy. In contrast, pegylated interferon/ribavirin lead-in prior to boceprevir substantially increased SVR and reduced viral breakthrough."
"These results are very exciting and provide important insights to help further define response guided therapy using a pegylated interferon/ribavirin lead-in boceprevir regimen with peginterferon and ribavirin backbone treatment," stated lead investigator Paul Kwo, MD, in the Schering-Plough press release. "Building on these results, the boceprevir Phase III clinical program individualizes treatment based on response, utilizing RVR criteria at week 4 of boceprevir treatment to determine overall duration of therapy. Based on the RVR rate seen in this Phase II study, we are hopeful that the majority of patients can be treated with 28 weeks of therapy."
Patient enrollment has been completed in 2 ongoing randomized, double-blind, placebo-controlled registration studies evaluating boceprevir in combination with PegIntron and ribavirin: HCV SPRINT-2 in treatment-naive patients and HCV RESPOND-2 in treatment-experienced relapsers and non-responders.
SPRINT-1 included 595 treatment-naive patients with genotype 1 chronic hepatitis C in the U.S., Canada and Europe. Overall, 16% of participants were African-American, 7% had pre-existing liver cirrhosis, 56% had HCV genotype 1a, and 89% had high HCV viral load (> 600,000 IU/mL), all factors associated with poor response to interferon-based therapy.
Boceprevir (800 mg 3 times daily) was evaluated as part of 3 treatment regimens:
Lead-in therapy with 1.5 mcg/kg once-weekly pegylated interferon plus 800-1400 mg daily weight-adjusted ribavirin for 4 weeks, followed by the addition of boceprevir for 24 or 44 more weeks (for a total of 28 or 48 weeks of treatment);
Boceprevir in combination with the same doses of pegylated interferon plus ribavirin, with all 3 drugs taken together for 28 or 48 weeks.
Boceprevir plus pegylated interferon plus low-dose 400-1000 mg daily weight-adjusted ribavirin for 48 weeks (Part II).
In Part I of the study, the boceprevir regimens were compared against the approved standard of care control regimen of 1.5 mcg/kg once-weekly pegylated interferon plus 800-1400 mg daily weight-adjusted ribavirin, without boceprevir, for 48 weeks.
In Part II, boceprevir plus pegylated interferon plus low-dose ribavirin for 48 weeks was compared against boceprevir plus pegylated interferon plus full-dose ribavirin for 48 weeks.
The rationale for the lead-in period was based on the fact that both pegylated interferon alfa-2b and ribavirin reach steady-state concentrations by week 4, therefore patients had boceprevir added after levels of the other drugs were optimized and HCV viral load was reduced, according to a Schering-Plough press release describing the study findings. This approach may minimize the duration of "functional monotherapy" with the direct antiviral agent, thereby potentially reducing the likelihood of developing resistance.
The primary endpoint of the study was sustained virological response (SVR), or continued undetectable HCV RNA after 24 weeks of post-treatment follow-up.
Use of erythropoietin (EPO) to manage anemia (defined as hemoglobin < 10 g/dL) during treatment was allowed at the discretion of study investigators.
Results
In the 28-week and 48-week boceprevir/pegylated interferon/ribavirin triple-therapy arms with no lead-in period, SVR rates were 54% (58 of 107 patients) and 67% (69 of 103 patients), respectively.
In Part I of the study, response rates were improved in the arms with a 4-week pegylated interferon/ribavirin lead-in period before starting boceprevir.
The 4-week pegylated interferon/ribavirin lead-in followed by 44 weeks of triple combination therapy produced an SVR rate of 75% (77 of 103 patients), compared with 38% in the standard of care control arm (39 of 104 patients) (P < 0.0001).
The SVR rate was 56% (58 of 103 patients) using the 4-week pegylated interferon/ribavirin lead-in period followed by 24 weeks of triple combination therapy (P = 0.005 vs standard of care).
In the lead-in arms, 64% of all patients achieved rapid virologic response (RVR), defined as undetectable HCV RNA 4 weeks after adding boceprevir.
Among patients in the lead-in arms who achieved RVR, SVR rates were 94% using the 48-week regimen and 82% using the 28-week regimen.
In Part II of the study, the SVR rate for the triple-combination regimen with low-dose ribavirin was 36% (21 of 59 patients).
The low-dose ribavirin regimen was associated with an increased risk of viral breakthrough during treatment and a higher relapse rate after the end of treatment, resulting in a lower SVR rate.
Overall, triple-combination therapy was well tolerated.
In Part I of the study, 9%-19% of participants in the boceprevir arms discontinued therapy due to adverse events, compared with 8% in the standard of care control arm.
Fewer patients in the 28-week and 48-week lead-in arms discontinued treatment due to viral breakthrough (4% and 5%, respectively, vs 7% and 12% with no lead-in).
The most common adverse events reported in the boceprevir arms were fatigue, anemia, nausea, and headache.
The incidence of skin adverse events (rash or pruritus [itching]) was similar in the boceprevir and standard of care arms.
About one-half of patients in the boceprevir arms and about one-third in the standard therapy arm developed anemia during treatment.
39%-51% of patients in the boceprevir combination arms and 26% in the standard of care control arm used EPO.
Participants who developed anemia had a greater likelihood of achieving SVR than those without anemia.
"Both 28 and 48 week boceprevir regimens significantly increased SVR with very low relapse rates in 48 week regimens," the investigators concluded. "However, low dose ribavirin with PegIntron and boceprevir was associated with increased viral breakthrough, relapse and lower efficacy. In contrast, pegylated interferon/ribavirin lead-in prior to boceprevir substantially increased SVR and reduced viral breakthrough."
"These results are very exciting and provide important insights to help further define response guided therapy using a pegylated interferon/ribavirin lead-in boceprevir regimen with peginterferon and ribavirin backbone treatment," stated lead investigator Paul Kwo, MD, in the Schering-Plough press release. "Building on these results, the boceprevir Phase III clinical program individualizes treatment based on response, utilizing RVR criteria at week 4 of boceprevir treatment to determine overall duration of therapy. Based on the RVR rate seen in this Phase II study, we are hopeful that the majority of patients can be treated with 28 weeks of therapy."
Patient enrollment has been completed in 2 ongoing randomized, double-blind, placebo-controlled registration studies evaluating boceprevir in combination with PegIntron and ribavirin: HCV SPRINT-2 in treatment-naive patients and HCV RESPOND-2 in treatment-experienced relapsers and non-responders.
"I say forget the 4 week lead-in and go right to PI's. Why fool around with potential success"
I agree let the PI's work and get to UND as fast as possible. PI's have shown to kill the virus within days!
I was UND in less then 3 weeks with Telaprevir.
I agree let the PI's work and get to UND as fast as possible. PI's have shown to kill the virus within days!
I was UND in less then 3 weeks with Telaprevir.
Actually thEIR aRE studies which prove people who do the "lead in" have faster results with RVR responses and greater SVR results,than with "no lead" with the Bocep Trials
I think both Telaprivar and the Schering product (Biociprever?) have found that results are imporved if they prime patients with the combo before introducing the new drugs. So SOC with the new stuff will likely include 4 weeks with the SOC anyway.
I say forget the 4 week lead-in and go right to PI's. Why fool around with potential success? If that doesn't work, then go to plan B. Seems to me things are being done backwards. Let the scientists and powerfully rich pharmaceutical companies experiment with animals more and leave us to relish the results. Lead-in, Schmead-in. Never mind all that, just lead me in to the PI's and let me get going on the treatment that promises more than lead-in . Otherwise, it's up to you...
Magnum
Magnum
"Obviously I don't really know, but I wouldn't be surprised if they realize it would be cheaper to treated people with 1a 1b and previous non-responders or relaspers with the new stuff and soc to begin with."
Yeah, but at four weeks on SOC the rate of sucess is highly predicatable now. So, I'm thinking the regime is going to be, do 4 weeks on SOC, and see how respond. If not RVR or significant decline, stop treatment, then in a months time, start with the new drugs in the mix.
Yeah, but at four weeks on SOC the rate of sucess is highly predicatable now. So, I'm thinking the regime is going to be, do 4 weeks on SOC, and see how respond. If not RVR or significant decline, stop treatment, then in a months time, start with the new drugs in the mix.
We weigh the risk against the risk of our progressing liver disease. If a person can afford to wait there will probably be new combos of drugs that won't do so much harm to our bodies and will have extremely high SVR rates. For some there is no more time and they have tried everything else. 500 people seems like a decent sized study to me, and the results though always somewhat skewed in any trial seem quite promising.
I have been following this drug for a VERY long time. What worries me about it is the miniscule size of the studies. When the different interferon regimens were studied, the numbers of persons who parcipated in the trials were in the tens of thousand and the trial centers were in virtually every state in the country. With this trial the numbers are like 1-6 per center and only a limited number of centers across the country. This seems too small to get valid results. I know that this drug has promise (that is why I have been following it) but what's going on with this limited trial? How can they get broad based data like this? Most importantly why are they doing it like this? Is it lack of funding or something else?
I know that side effects with this drug may be part of the reason. When this drug was first tested in the UK, the side effects were horrible! Many people ended up with the most terrible rash! I once heard it described as very painful dragon scales! It lasted in some, well beyond the finish of treatment and for all I know, some of them may still be suffering. The only way Vertex was able to stop this side effect was to withdrawl the drug after a very limited number of days. That is why the treatment is so short . . . anything any longer equals rash! So now I am wondering . . .are they trying to minimize the rash further by limiting trial size?
I am NOT sure that I want to be first in line to pay 100K for a drug that has the potential to cause side effects like that!
I know that side effects with this drug may be part of the reason. When this drug was first tested in the UK, the side effects were horrible! Many people ended up with the most terrible rash! I once heard it described as very painful dragon scales! It lasted in some, well beyond the finish of treatment and for all I know, some of them may still be suffering. The only way Vertex was able to stop this side effect was to withdrawl the drug after a very limited number of days. That is why the treatment is so short . . . anything any longer equals rash! So now I am wondering . . .are they trying to minimize the rash further by limiting trial size?
I am NOT sure that I want to be first in line to pay 100K for a drug that has the potential to cause side effects like that!
Good Advice Magnum, I'll suggest that too my little four year grandson. If he invests now he could be quite wealthy before long! Perhaps a little BP stock while it at a good price! LOL
Dave
Dave
I guess they may want the patient to try standard treatment first, or if they are convinced that it is likely they will treat twice they may not. Besides the cost of the treatment, there are always labs and doctors visits that get added to cost of TX. Obviously I don't really know, but I wouldn't be surprised if they realize it would be cheaper to treated people with 1a 1b and previous non-responders or relaspers with the new stuff and soc to begin with.
"by spectda , 14 hours ago
The insurance companies will probably not be paying those prices. That is part of the game. Thet charge them a fortune and the contacted price is much less. "
I'm willing to bet insurance companies might take a position that patients should try standard treatment first, if that doesn't work, then use one of these drugs. Makes sense, few sides on standard treatment (no rash).
The insurance companies will probably not be paying those prices. That is part of the game. Thet charge them a fortune and the contacted price is much less. "
I'm willing to bet insurance companies might take a position that patients should try standard treatment first, if that doesn't work, then use one of these drugs. Makes sense, few sides on standard treatment (no rash).
That's very true. Inflate the charges and hope Medicare or whatever insurance you have will return a percentage of the payment. This is a very common ploy in lawsuits as well. Sue for $12,000,000 and eventually receive a $500,000 settlement. Vertex, Johnson & Johnson, Merck, et al... know this, that's why the inflation. It's a money game to be sure.
Watch the CBS and NBC evening news and you will realize that 90% of all commercial in those prime slots are..... drugs....
So tell your grandchildren that in this country, if you want to become a billionaire, drill for oil or own a pharmaceutical company... I rest my case...
Magnum
Watch the CBS and NBC evening news and you will realize that 90% of all commercial in those prime slots are..... drugs....
So tell your grandchildren that in this country, if you want to become a billionaire, drill for oil or own a pharmaceutical company... I rest my case...
Magnum
The insurance companies will probably not be paying those prices. That is part of the game. Thet charge them a fortune and the contacted price is much less.
At those prices, you can bet the insurance companies won't be lining up to provide this drug.
Good info thanks. Then that means Boceprevir will cost around the same price. Having competition is always good and helps lower the price eventually.
Great thread, Magnum. Thanks for the info. Especially the contact numbers!!
Isobella
Isobella
Mag-
The $70,000 cost (Number I mentioned from the conference the other day) was Vertex's estimate of the cost for SOC meds.
I assume they will use this amount to calculate what they will be charging more due to less treatment time and higher chance of SRV.
Hectorsf
The $70,000 cost (Number I mentioned from the conference the other day) was Vertex's estimate of the cost for SOC meds.
I assume they will use this amount to calculate what they will be charging more due to less treatment time and higher chance of SRV.
Hectorsf
I forgot to mention Alan told me they are going to apply for license in December. Why the wait? Only Vertex and god knows... At least they are going to apply. I personally predict the release date to be mid 2011. He also mentioned their phones have been ringing off the wall from people trying to hurry the process along.
Although he empathizes with all of them (including me), their hands are tied by the FDA. I want to mention again that he said we publically have the right to email or call the FDA and ask for a speedier fast track to licensing.
Here are sobering facts:
Average treatment cost of Telaprevir = $70,000 (according to Vertex)
"According to the American Liver Foundation, the immediate transplant
costs (those associated with the surgery itself) average around
$250,000 for hospital and physician expenses. Pre-operative and
post-operative care pushes the average total cost to about $314,000.
(Other sources place this figure at closer to $500,000). The costs
associated with the surgery vary widely, depending upon a number of
factors, including the patient's age, overall health, and region of
the country, and transplant center:"
Maybe if the FDA and Medicare realize these facts, they could hopefully fast track the licensing, which by logic, the treatment could prevent transplants.
FDA = 301-796-1500
Magnum
Although he empathizes with all of them (including me), their hands are tied by the FDA. I want to mention again that he said we publically have the right to email or call the FDA and ask for a speedier fast track to licensing.
Here are sobering facts:
Average treatment cost of Telaprevir = $70,000 (according to Vertex)
"According to the American Liver Foundation, the immediate transplant
costs (those associated with the surgery itself) average around
$250,000 for hospital and physician expenses. Pre-operative and
post-operative care pushes the average total cost to about $314,000.
(Other sources place this figure at closer to $500,000). The costs
associated with the surgery vary widely, depending upon a number of
factors, including the patient's age, overall health, and region of
the country, and transplant center:"
Maybe if the FDA and Medicare realize these facts, they could hopefully fast track the licensing, which by logic, the treatment could prevent transplants.
FDA = 301-796-1500
Magnum
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