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29837 tn?1414538248

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
42 Responses
Avatar universal
Does anyone remember the defined difference between a null responder and a partial responder?  I have known this at one time but can't remember any more.  
Ev
9648 tn?1290094807
What is vBT?
29837 tn?1414538248
vBT is Viral Breaktrough

Magnum
Avatar universal
Null Responder: A null responder is someone who achieves little or no decrease in hepatitis C viral load during HCV treatment. Null responders are highly unlikely to respond to re-treatment with an interferon-based regimen.

Non-responder: Often referred to as a "treatment failure," a non-responder is someone who does not have an EVR or, if they stay on treatment for 24 weeks, does not ever have a 2-log (99%) drop in hepatitis C viral load or undetectable HCV RNA during hepatitis C treatment.

Partial Responder: A partial responder is someone who experiences at least a 2-log decrease in hepatitis C viral load during HCV treatment. Partial responders are more likely to respond to re-treatment than non-responders or null responders.

Relapser: The term relapser refers to someone who has had an EVR or ETR, but whose virus rebounded after they completed HCV treatment. People who had a relapse after completing HCV treatment are more likely to achieve SVR after re-treatment than partial responders, non-responders, or null responders.



9648 tn?1290094807
Fascinating. Those with vBT did particularly well.
446474 tn?1446351282
Magnum.

Yes that is consistent with all the data I've seem. About 40% chance of SVR for null responders like myself. With current SOC treatment the best chance I've seen is 10%. That is a 400% increase. That is good enough for me. Not that I have another choice. ;-)

Null Responder - less than 1 log drop by week 4. Less then 2 log drop by week 12.

Again, sign me up for the free meds and trip! Can we make it for the duration of treatment? 6 months or one year? CNN, CBS and NBC wants to see me inject peg into my stomach? Well at least I'll have a nice tan stomach! My bags are packed!
For LOST fans...no "Oceanic Flight 815" please.

Hectorsf
9648 tn?1290094807
I had less than a log drop by week 4 on the boceprevir trial (.6 as I recall)--which was the leadin period--and I am SVR. Wonder when the boceprevir results will be available?
Avatar universal
here's the Berg 2010 EASL presentation (with the definitions they used for null/partial). The percentages don't match however..

http://www.kenes.com/easl2010/Orals/108.htm

Also, as posted previously, note that the null responder SVR rate is calculated on the subset that was allowed to go on to T12/PR48.
446474 tn?1446351282
Good point. Definitions will change with new STAT-C meds.
Thanks willing!

I've been following Telaprevir...don't know when Boceprevir results are due.
I hope it is soon for both and FDA gives approval.
2011 could be a pivotal year for many of us.

Hectorsf
Avatar universal
I have a question....I was in the Vertex phase 3 trial. I went for  48 weeks and had horrible anemia that started at about week 4. I was transfused many times during this period.I became undetected (when I found out) for sure at week 24. Probably way before that as my enzymes were normal at about week 3.  I just found out I was in the placebo group. I was  SVR at the end of treatment, and then again  at the 6 month post ending. My question is: Do you know what if any chance there is that it could come back?
Thank you.
Avatar universal
It can come back after 6 months, but it is highly unlikely. How long has it been now? So you cleared with the normal drugs that many others have cleared with, congratulations and celebrate. If you are concerned it can't hurt to get tested again to put yourself at ease!
Avatar universal
Thanks. I had a 6 month post treatment end and was clear. I have a dr. appt this month which will be almost a year. a little nervous. When you said, 6 months it can come back, were you talking about the first 6 months after treatment ends? I think my chances of returning are probably slight,but ....... This will be the first PCR outside the study!  And yes, I do celebrate and still do and enjoy life ! All is good :)
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