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Research Data on extended treatmet for 1's/ Use for other posts also
I need some hlp you great researchers out there on our great site. I need to vent a little also.

I am 1b I will finish treatment next Thursday night,18 months. I have been clear for about 10 months. I did have 2.5 log drop at 8 wks but did not clear till a little later but did have great drops and was very very low, like 180 IU/ml for a while and then by Jan 2004 I was at 30 IU/ml then I stopped testing till the end of 48 wks and then I tested <10 IU/mL in May 2004 so I decided to extend 24 more wks.

Frst I need the latest offical data on extended tx for 1's that give percentage of SVR for my type situation. If you guys could help with this it would be much appreciated. I am so dingy right now I just can hardly do anything or have any motivation other than get off treatment and then wait and see.

For you that know me I have been going thru a custody battle for my grandson Drake and it has put me, and my family thru Hell because of me not being at my best. I asked my Dr to right me a letter for the court simply that I am clear and nothing else. Well he puts in the letter I am clr at this time but ther is significant chance that the virus will come back over the next 6-12 months. Needless to say I thought he could have just left that statement out and was just covering his butt. I am pissed to say the least and my Hungarin temper has been getting the best of me lately. He does go on to say there is no reson at all that I can foster my grandson as even if virus comes back there is no scientific studies proving transmisson thru nrmal family contact.

Bob L


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What a bunch of ****! That was terrible for the doc to write that and you are right, there is no effect on raising a child if you have HCV. I am sure some people here will provide studies they already have. I know how tired you must be, I was just so tired after 18 months of tx. BUT the good news is I feel incredible energetic now. It took a month to start noticing anything but it will happen. I also was not clear on my first PCR at 3 months but had a 2 log drop and a low LV. I did 18 months and my 3 month post tx PCR was <2 and I expect another clear at 6 months. Only one more week! LL
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That is great I am so glad you are clr and feeling better. I just don't know whether to go after my Dr or what but I am really mad he put that statement in.

Thanks

Bob L
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Do you happen to recall where those numbers came from? I'm interested. Frank
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Thanks Scott

Bob L
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Drug Combination May Become New Treatment Paradigm for Hepatitis C Virus SourceURL:http://www.docguide.com
Mark L. Fuerst

BOSTON, MA -- November 3, 2004 -- The combination of a novel, oral polymerase inhibitor and pegylated interferon, may become the new treatment paradigm for hepatitis C virus (HCV) infections, according to results of an interim analysis presented here on November 1st at the 55th Annual Meeting of the American Association for the Study of Liver Diseases.

This new combination "may offer improved efficacy outcomes, especially for HCV patients who are nonresponders or have failed to clear the virus with standard therapy," said Nezam Afdhal, associate professor of medicine at Harvard University.

During his presentation, Dr. Afdhal said that the polymerase inhibitor, NM 283, is the first in a new class of designer drugs that specifically block a step in HCV viral replication. Unlike existing therapies, which are administered by injection, NM 283 is taken orally and appears to have fewer adverse effects than existing agents, Dr. Afdhal said.

He presented data from an ongoing, phase 2, clinical study that evaluated the combination of NM 283 and pegylated interferon. The trial includes 30 treatment-naïve patients with compensated chronic HCV infections. They received NM 283 in escalating daily doses of 400-, 600-, and 800-mg, alone or in combination with pegylated interferon 1.0 mcg/kg subcutaneously on days 8, 15, and 22. At day 8 they reached the 800-mg dose of NM 283.

Dr. Afdhal presented results from an interim analysis of 19 patients, 12 in the combination arm and 7 in the NM283 alone arm. He said that 75% of patients treated with the combination experienced early virologic response. An early virologic response was correlated with an improved chance of sustained viral clearance, he said.

Patients receiving the combination therapy achieved a mean 2.7 log viral load reduction through week 4, representing a 99.8% reduction in HCV RNA. Dr. Afdhal said that this result is consistent with preclinical data that suggested a synergistic antiviral effect for the combination of NM 283 plus interferon-alfa.

Dr. Afdhal said the safety of the combination therapy was "satisfactory, with typical side effects expected with interferon, and a high compliance rate [more than 90%]."

"This is the first agent in the class to be effective, it has a good safety profile, and is additive with interferon. It's the start of a new paradigm for treating HCV infection," Dr. Afdhal said.

[Presentation title: "Final Phase I/II Trial Results for NM283, a New Polymerase Inhibitor for Hepatitis C: Antiviral Efficacy and Tolerance in Patients with HCV-1 Infection, Including Previous Interferon Failures." Abstract LB03]
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Got it-Thanks.
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This is possibly a good thread to post the results of my first post tx appt.

One thing I asked the NP, was wether Dr. Bernstein is more receptive to extending Tx, after agreeing to do it for me....she was quick at stating "he wont do it again" that there is not enough data and studies to promote the theory of tx extension.
she went on to state that at the latest meeting in Boston, no studies were presented on tx beyond 48 wks. most research is now going towards upping the doses early in tx, more and more frequently (2 or 3x of peg, instead of once).  She said that most presenters with new approaches were from other countries, Japan, Spain, France, etc. The NP went on to say that more research funding is needed in the US, to test for effectiveness of new approaches( dosages, frequency, length) with the existing meds, instead of  mostly trying to find new meds.
Well, we know the US is not the top researcher on hcv, so no surprise most novel  studies come from abroad.
I wanted to know if my stats, could ever be used in a retrospect study and she said no.  that it involved more than me signing a waiver, it needed the agreement of all parties involved. I was sad to see that data like mine, is in limbo and unused. There are many patients out there like me, treated in private practice, whose stats will never be known to researchers. It could prove whether tx extension  for geno one is the most effective or not. the numbers could be greater than those in trials, but we will never know...
Theirs is a big research hospital and they do not do retrospect studies.

I am to go back for a quantitative pcr in January( about 4 wks post) and again 3 mo., 6mo, 12 mo post. If all negative, they do sonograms every 6 months or year(can't remember now) to check for cancer.
She wants me to continue Procrit 2 more wks, hgb was 10.3(4 days after Procrit) I think I forgot one weekly shot. I don't think I need more than one more, since the riba is done.
BTW, my short term memory has already improved, less than a week without the pills.
My neutrophils went back to the low normal range, on their own, after dropping for two months. last reading was 800 or so. It did not drop further, it came back up. What makes your body bounce back on its own? The human body is  amazing in  its ability to adjust and compensate.
So, the last 6 months or so, I only needed the Procrit and vicoprofen in addition to the antivirals to survive.
Ok, I can't remember anything else that I consider important from the meeting, so I will sign off now
be well, all
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