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Date Posted: 18:36:53 04/18/02 Thu
Author: Susie
Author Host/IP: bgp425870bgs.union01.nj.comcast.net / 68.36.197.75
Subject: 
For Those Waiting for Pegasys
Jules Levin from NATAP is in Madrid and attended the teleconference today. Here is a small part of what we learned, written by Jules (why re-invent the wheel). Look for the slides from the presentation later this week on our website. If you have any questions just ask and Carol or I will answer them as best we can. Remember these figures are for treatment naive patients and Arm D of the study most closely relates to those of us in the USA (genotype 1 and viral load >2 million). Those with genotype 2 or 3 had a significantly better result in the 75% range.
RESULTS
Sustained Virologic response in Genotype 1
Arm A:Pegasys + 800 RBV 24 wks (n=101)- 29%
Arm B:Pegasys + 1000/1200 RBV 24 wks (n=118)- 41%
Arm C:Pegasys + 800 RBV 48 weeks (n=250)- 40%
Arm D:Pegasys + RBV 1000/1200 48 wks (n=271)- 51%
Genotype 1 and Low Viral Load
ARM A:Pegasys + 800 RBV 24 weeks (n=51) - 41%
ARM B:Pegasys + 1000/1200 RBV 24 weeks (n=71) - 51%
ARM C:Pegasys + 800 RBV 48 weeks (n=60)- 53%
ARM D:Pegasys + 1000/1200 RBV 48 weeks (n=85)- 61%
These results find 48 weeks treatment is preferable for genotype 1 and low
viral load. The genotype 1/low viral load patients who received 1000/1200 mg
had better results than patients who received 800 mg.
Genotype 1 and High Viral Load (the most prevalent & hardest group to treat)
ARM A:Pegasys + 800 RBV 24 weeks (n=50)- 16%
ARM B:Pegasys + 1000/1200 RBV 24 weeks (n=47)- 26%
ARM C:Pegasys + 800 RBV 48 weeks (n=190)- 35%
ARM D:Pegasys + 1000/1200 RBV 48 weeks (n=186)- 46%
These data find that genotype 1 and high viral load patients should be
treated for 48 weeks. Patients receiving 1000/1200 RBV did better than those
with 800 mg. This study found that all patients with genotype 1 whether they
had low or high viral load did better with 48 weeks treatment rather than 24
weeks.
Genotype non-1
ARM A: Pegasys + 800 RBV 24 weeks (n=106) - 78%
ARM B:Pegasys + 1000/1200 RBV 24 weeks (n=162)- 78%
ARM C:Pegasys + 800 RBV 48 weeks (n=111) - 73%
ARM D:Pegasys + 1000/1200 RBV 48 weeks (n=165) – 77%
Cirrhosis
Patients without cirrhosis had a 65% SVR (n=321) and patients with cirrhosis
had a 50% SVR (treatment was Pegasys + RBV 1000/1200 for 48 weeks).
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Replies:
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Thank you Susie. -- Anna, 19:23:47 04/18/02 Thu (ip68-1-115-246.pn.at.cox.net/68.1.115.246)
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Re: For Those Waiting for Pegasys -- sg, 19:25:24 04/18/02 Thu (Toronto-HSE-ppp3663134.sympatico.ca/65.95.154.237)
Hi Susie,
The info provided is great stuff and I'm glad you were able to get this information.
I do have a of question which you may or may not be able to answer. If not thats OK. You may want to respond via email. Its your call.
Q. Which if any of the arms in the genotype non-1, reflects a low viral count, and no cirrhosis?
With the exceptions that I am not naive to combo (old) treatment and I have a suppressed immune system I more closely fit an arm which is genotype non-1 and a low viral count. Of course I'm hoping that I could get the desired results on a 24 weeks treatment program. One can always hope.
sg
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SG -- Susie, 20:20:23 04/18/02 Thu (bgp425870bgs.union01.nj.comcast.net/68.36.197.75)
SG, I am not sure I can answer this question. What I took away from the conference is that non 1 genotypes only need 24 weeks of treatment as they did not fare better with Arm C or D which were the arms randomized to 48 weeks. All arms were stratified by geographic region, genotype and viral load. So your profile would fit you into Arm A or B, most definitely. I think once the slides are sent to us with the numbers and we can post them it will become clearer.
Does this help you at all?
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Re: SG. tnks, response makes me happy. I can get high and never leave the farm. -- sg, 20:27:49 04/18/02 Thu (Toronto-HSE-ppp3663134.sympatico.ca/65.95.154.237)
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HAHAHA. I Like That!! -- Susie, 20:29:27 04/18/02 Thu (bgp425870bgs.union01.nj.comcast.net/68.36.197.75)
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Encouraging...I wonder... -- terry, 20:09:34 04/18/02 Thu (NoHost/66.84.232.176)
Treatment naive? Meaning never having treated, I assume. Do you know if the numbers go down much for someone who's tried peg-intron first? Thanks!
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Re: Encouraging...I wonder... -- Susie, 20:25:30 04/18/02 Thu (bgp425870bgs.union01.nj.comcast.net/68.36.197.75)
Yup, that is exactly what treatment naive means. There have not been studies done yet for people who have already tried combo and failed but the docs believe the numbers will be very low. Dr. Shiffman told me he expects about a 13% clearnance rate in those who failed combo treatment. But hey, someone has to be in that 13%. I know I'm going to try.
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Re: Encouraging...I wonder...OUCH, that was short high. -- sg, 20:30:17 04/18/02 Thu (Toronto-HSE-ppp3663134.sympatico.ca/65.95.154.237)
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no sh*t, huh!! big drop. How's thangs sg? -- terry, 20:33:06 04/18/02 Thu (NoHost/66.84.232.176)
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Re: Blew my high. Things are gggreeaaat. So far. -- sg, 20:47:53 04/18/02 Thu (Toronto-HSE-ppp3663134.sympatico.ca/65.95.154.237)
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Re: Encouraging...I wonder...SUSIE do U know?? -- sg, 20:43:37 04/18/02 Thu (Toronto-HSE-ppp3663134.sympatico.ca/65.95.154.237)
Hi Susie,
When Dr Shiffman (I'm not familiar with the name), said he expected a 13% clearance rate for those who failed previous combo(3x week)was this in reference to PEGASYS?
Also, if you know (OK if you don't), am I correct to assume that failed equals - did not respond, and responded but then relapsed (cat came back)?
sg
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Re: Encouraging...I wonder... -- Susie, 20:46:08 04/18/02 Thu (bgp425870bgs.union01.nj.comcast.net/68.36.197.75)
Failed means never got to undetected. We were not talking about relapsers who have a much better chance than us flunkies, although not as good as naive patients. Dr. Schiffman works almost exclusively with Pegasys and he is the head of hepatology at Medical College of Virginia. He is very well respected in the States.
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Re: Encouraging...I wonder...OK, I'm back in the groove. -- sg, 20:50:20 04/18/02 Thu (Toronto-HSE-ppp3663134.sympatico.ca/65.95.154.237)
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I'm Glad :-) -- Susie, 21:25:46 04/18/02 Thu (bgp425870bgs.union01.nj.comcast.net/68.36.197.75)
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