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Me and Debio-025
Hi everybody. I've been 'away from my desk/computer', so to speak. I've actually been involved in a clinical trial. I just found out today that I'm allowed to talk about it on here on the message board. I wanted to make sure that it was okay before I started posting things.
I started out with a screening viral load of over 5 million copies, but their labs doesn't report over 5 million, so for the trials purposes, they just said that I was starting out as > 5 million copies. Well, I am on all 3 drugs this time. It's unblinded and I'm also being paid to participate in it. It's a Phase II trial. I am in Group E, which the way that it was set up is that on week 1, I was on the Peg - Riba and twice a day of Debio-025 400mg (which was 800mg total per day). On day 8, the Debio changed to once a day or 400mg daily. And I continued on with the 3 drugs. I will be on all 3 drugs until my last day of the Debio which will be day 29. By the time, I have to have had a 2 log drop in order to continue with SOC (standard of care drugs for newbies benefit). No rescue drugs allowed until after the Debio part is completed (Part 1). Then, if necessary, rescue drugs will be available under the SOC (Part 2). Debio will pay for my continuing on with the SOC drugs (if I get to).
How am I doing? I am feeling alot better than I have on my other treatments. No depression yet. A couple of "Riba" moments. In the beginning I had a slight problem with nausea, but that has disappeared and I never actually threw-up, just feel a bit like it.
Here's the GOOD news. By Day 3, I had dropped to 424,000 copies, which is already a 1 log drop according to my study nurse. It might actually be more than a 1 log drop considering that my viral load could have been 10 million copies! I mean, how would they even know how high it was? I'm cautiously optimistic! It's definitely a good start. My LFT's have already been cut in 1/2 and are now in normal range.
Here's the stats:
Screening: over 5 million copies
DAY 1:
4 hours after starting 3 drugs: 2,370,000
8 hours after " ": 2,070,000
12 hrs after " ": 937,000
DAY 2:
557,000
DAY 3:
424,000
My starting day was on June 4th. I've had another viral load since then, but the results on those were just drawn and not available yet. I also had one today. Hopefully, soon.
I had a small rise in my bilirubin, but it was not 'clinically significant', in that it was not to a worrisome level or anything of that nature.
It's storming hard and I don't want to lost this post!!! THANKS EVERYBODY FOR ALL OF YOUR WONDERFUL HELP!!!!
Susan400
I started out with a screening viral load of over 5 million copies, but their labs doesn't report over 5 million, so for the trials purposes, they just said that I was starting out as > 5 million copies. Well, I am on all 3 drugs this time. It's unblinded and I'm also being paid to participate in it. It's a Phase II trial. I am in Group E, which the way that it was set up is that on week 1, I was on the Peg - Riba and twice a day of Debio-025 400mg (which was 800mg total per day). On day 8, the Debio changed to once a day or 400mg daily. And I continued on with the 3 drugs. I will be on all 3 drugs until my last day of the Debio which will be day 29. By the time, I have to have had a 2 log drop in order to continue with SOC (standard of care drugs for newbies benefit). No rescue drugs allowed until after the Debio part is completed (Part 1). Then, if necessary, rescue drugs will be available under the SOC (Part 2). Debio will pay for my continuing on with the SOC drugs (if I get to).
How am I doing? I am feeling alot better than I have on my other treatments. No depression yet. A couple of "Riba" moments. In the beginning I had a slight problem with nausea, but that has disappeared and I never actually threw-up, just feel a bit like it.
Here's the GOOD news. By Day 3, I had dropped to 424,000 copies, which is already a 1 log drop according to my study nurse. It might actually be more than a 1 log drop considering that my viral load could have been 10 million copies! I mean, how would they even know how high it was? I'm cautiously optimistic! It's definitely a good start. My LFT's have already been cut in 1/2 and are now in normal range.
Here's the stats:
Screening: over 5 million copies
DAY 1:
4 hours after starting 3 drugs: 2,370,000
8 hours after " ": 2,070,000
12 hrs after " ": 937,000
DAY 2:
557,000
DAY 3:
424,000
My starting day was on June 4th. I've had another viral load since then, but the results on those were just drawn and not available yet. I also had one today. Hopefully, soon.
I had a small rise in my bilirubin, but it was not 'clinically significant', in that it was not to a worrisome level or anything of that nature.
It's storming hard and I don't want to lost this post!!! THANKS EVERYBODY FOR ALL OF YOUR WONDERFUL HELP!!!!
Susan400
It's just part of the trial...I can't tell you why, because I don't really know why. It's really not that big of a deal for me to do it. It causes me no pain whatsoever, so, I'll willingly do that one. If they had insisted on me getting another liver biopsy when I just had one last year, then I would have said flat out, NO WAY! I hate those. I've had 4 of them and as far as I'm concerned if anybody asks me to do another one they can pound sand, or they are going to have to give me some good drugs in order for me to agree to it. I don't care what anybody says to me, on 2 of the 4 occasions that I had one where they did not give me anything for pain, IT HURT ME alot and I will not consent to another one of them again without some good pain drugs in my I.V. ahead of time. Otherwise, I say, good-bye, I don't care, I'm not doing it. I'm rather sick of doctors and blood work and procedures and appts. and shots and all of it. After 10 years of treatments, this is it for me. I'm done, I quit. I will not pursue Vertex when it gets approved. The way I feel, I've given it all a good run and that's it for me. I'll know in a couple of weeks when my labwork comes in after the July 2nd blood draw on whether or not I'm allowed to continue onward w/SOC.
Susan
Susan
Keep your hopes high! They said some went down by day 29, that may be you.
Don't let this sink you to low (I know, I know....easily said), especially while the meds, sides, emotional upset of tx is setting in :(
We're pulling for you, you know we are :)
LL
Don't let this sink you to low (I know, I know....easily said), especially while the meds, sides, emotional upset of tx is setting in :(
We're pulling for you, you know we are :)
LL
Congratulations, thanks for the information too.
Why do they do a bone density?
How old are you and what genotype are you?
M
Just saw how old (young) you are. i"m 58
Why do they do a bone density?
How old are you and what genotype are you?
M
Just saw how old (young) you are. i"m 58
Yes, I do need those prayers! That would be nice to have some good news! Thanks so very much. Praying for you and Nick, too.
Susan400
Susan400
It all depends on what comes back after my July 2nd blood draw. If I don't get my 2 log drop by then, I'm out. If I have it, I continue on w/SOC and no Debio.
Susan400
Susan400
I am so happy that you got into the trial and are doing so well! Excellent news! Yeah God! Potentially how many wks in all does the trial last?
TV
TV
Things look very good! Congratulations. When I saw the post title, I thought, "Who is this Debio?" I'll know to watch for it now. Here's to you successful SVR!
Brent
Brent
It certainly seems like the trial is working for you and I wish you all the best. I am interested to keep hearing about it
I also wanted to say that another part of this trial is having 3 bone densitometry's done. I had one that was done as a baseline before doing treatment. It read that my hips and neck area were normal but that my lumbar spine showed mild osteopenia. Osteopenia is the precursor to osteoporosis for those of you who do not know this term. Anyhow, it was 'mild'. I will have bone D. #2 on July 2nd. I think, but I'm not absolutely positive, they are wanting to determine if TX affects the reading of the bone density. I will take the 3 reports and share them with my regular Internal Med doctor after I'm done with the trial. I can't really add in any new meds during the trial anyway, so.. After I get through Part 1, any new meds would have to be approved by the trial nurse. I think that part of my problem is that I will need to be adding in Vit. D to my regimen since I can't get out in the sun.
Susan400
Susan400
It's looking good. I read about some of their earlier results and it looks like this could be a winner for you this time. You've sure earned it. I love reading that the sides are manageable too.
Go go go.
Willy
Go go go.
Willy
Since I've talked to you just about every day since you started I don't have too much to add except YOWZA YOWZA YOWZA! It's AWESOME to be able to look at the actual viral load and how it's dying off isn't it? Susan - Lord God you know how much I'm rooting for you and will remain in your corner. you DESERVE SVR - except for Andiamo (who now HAS SVR) I can't remember ANYBODY EVER working so hard for it. I truly believe with all of my heart that as long as you never ever give up you do have hope and your time will come...........................................so it will.
you WILL be SVR.
And then my friend, you are coming to visit me in NY (ooops I forget I live in CT now but same difference) and we are going to PARTY! (Even if it is with 'virgin' drinks.....it will be one heck of a party none-the-less!)
Your friend forever, Deb
you WILL be SVR.
And then my friend, you are coming to visit me in NY (ooops I forget I live in CT now but same difference) and we are going to PARTY! (Even if it is with 'virgin' drinks.....it will be one heck of a party none-the-less!)
Your friend forever, Deb
Awww geeez! Forgot to call you back! Busy as ever this week, will call this afternoon and that's impressive :)
LL
LL
Same here wish you all the best, you deserve it.
So hope you beat it this time.
CS
So hope you beat it this time.
CS
I'm very excited for you to get into this trial. Thanks for posting and letting people know how you're doing. Not only are we all rooting for YOU .. you add that extra hope for other people keeping an eye on this drug along with others.
I sincerely hope this is the last time you have to tx, Susan....great results so far and hope to see them keep on coming!
Hope you manage well with sides as you go along.
Trish
I sincerely hope this is the last time you have to tx, Susan....great results so far and hope to see them keep on coming!
Hope you manage well with sides as you go along.
Trish
Glad to hear you've started tx and are doing well. That's great news, keep up the good work.. God Bless
Whooo hOOO.. It sounds like this one just may work for you .. I am excited for you , and hope you continue to drop at that rate or faster. Keep us posted.
Dana
Dana
Congratulations!!!!! I'm so glad you got into this trial. I became very interested in the Debio-025 when I first heard about it and wondered what happened with it. I started hearing more again after EASL.
It sounds like you're having great results!!
Wishing you all the best!
It sounds like you're having great results!!
Wishing you all the best!
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