Good news for Phase III trial of Danoprevir

[ninezero8]

Hey Folks....I began a Phase III trial on July 15th. It is with Danoprevir/r (r stands for Ratonevir which is a booster for the Danoprevir), also Ribovirin, and Pegasys. There are only four people in this trial in the U.S. so I am very fortunate. I went from a viral load of 2 million to 0 in six days. There is a woman on the same trial who began ahead of me and she achieved UND in five days. This trial is for patients with cirrhosis and null responders. So far the results have been amazing. I was on here a lot last Spring as I thought I was going to start the tx with Incivek. I was dreading the side effects and have put this off for several years because of work and side effects and so on. I had the opportunity to begin this trial and could not turn it down. I was still scared to death of the side effects, but guess what?! I am almost at the end of three weeks, today is day twenty, I have done three shots of the Pegasys and 200 pills without one single side effect. I am elated and the doctor and the gal who is administering my treatment are just plain stoked at the results and absence of side effects. She even mentioned one day that she will ask if there is a possibility that the new drugs somehow inhibit the side effects because the other lady on the same trial has had it pretty easy too. This may change after enough Ribovirin to that I become anemic, but without all the flu like symptoms and everything that I have anticipated I will not complain about being tired. The tx would have been 48 weeks....I was of course dreading the thought of that like you all who are treating with it now. This trial allows me to go for 24 weeks instead and obviously that is much more appealing than 48. I don't want to sound like I am boasting, but I do want people who have not treated and can wait a while to wait for this to be approved. My doctor is very confident that this is the next to be approved by the FDA. According to him they will not waste time once this Phase III trial is complete. There are only 20 people world wide in the trial. So I am very very fortunate to be one of them. So far I have not felt a bit different, I have been sleeping fine and dreaming, eating just fine, and exercising daily. I am amazed and can only hope that feeling good keeps up. The fact that this stuff wipes this virus out in five or six days if pretty dang cool! The doctors are loving it. After years of failed treatments and very sad stories they are finally excited and feel like it has all been worth to finally be at a point where people are being cured and it is tolerable. If you are new to the site, or not, this is probably a lot to absorb. Do a search on Danoprevir and you'll find the Phase I and II trials, which it looks like they had some issue and had to do a little fine tuning to get it right. So I take 1 Danoprevir, 1 Ratonevir, 3 Ribovirins in the morning and evening. So ten pills a day, not a big deal with vitamins on top of that. And of course one shot of Pegasys every Friday evening. I will gladly keep you all posted on how this goes for the next 21 weeks and feel free to write. If I can answer your questions I certainly will. Thanks for taking time to read this and the best to everyone from me and my family.  

[BoceprevirGal]

Wow, that is amazing. I wonder why they are using only 20 people in the study?
  Great news to know the sx are this slight, 3 weeks in. I am Triple Tx with Victrelis, and the Pegasys hasn't bothered me much either. I'm week 25 out of 28.
   Of course, the anemia DID bother me, from week 8~19, but I got riba-reduced then...4 pills instead of 6~
   It's amazing how ast the time lies, with these shorter Tx's..they are very "doable"

[MeWithC]

Yes...good news...a step in the right direction

[frijole]

Yes, please do keep us posted.  This does sound promising.  I think Pegasys is much easier on the system than PegIntron.  This tx I was on PegIntron.

My doctor seems to think they will not be able to take interferon out of treatment.  That is a shame but he thinks it will stay.

Congrats on your 6-day UND

bean

[Dee1956]

Hey guy!  This is great news, really happy to hear you are doing so well.
Thank you for coming back to let everyone know
My best
Dee

[pooh55811]

Thanks for posting. It is great to hear you are having such good results.